Summary of Clinical Outcome Measures for Sports

Transcription

Summary of Clinical Outcome Measures for Sports
Summary of Clinical Outcome Measures for
Sports-Related Knee Injuries
Final Report
June 5, 2012
AOSSM Outcomes Task Force
James Irrgang, PT, PhD, ATC, FAPTA
Table of Contents
AOSSM Outcomes Task Force……………………………………………………………………..…..1
Summary Table for All Clinical Outcome Measures……………………………………………….....2
International Knee Documentation Committee (IKDC) Subjective Knee Form………………………….…....6
Lysholm Knee Score ……………………………………………………....………………………………...........41
Tegner Activity Scale………………………………………………………………………………………….……74
Cincinnati Knee Scale …………………………………..…………………………………………………………87
Knee Injury and Osteoarthritis Outcome Score (KOOS) – Symptoms Subscale………………….…….…104
Knee Injury and Osteoarthritis Outcome Score (KOOS) – Pain Subscale…………………………….…...136
Knee Injury and Osteoarthritis Outcome Score (KOOS) – ADL Subscale………………………….…...….168
Knee Injury and Osteoarthritis Outcome Score (KOOS) – Sport/Rec Subscale…………………….…..…200
Knee Injury and Osteoarthritis Outcome Score (KOOS) – QOL Subscale…………………………….…...232
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Pain Subscale……….…264
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Function Subscale….….289
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Stiffness Subscale…..…314
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)–Overall Subscale……....336
Western Ontario Meniscus Evaluation Tool (WOMET)……………………………………………………....356
Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency………………………………….…361
Marx Activity Scale……………………………………………………………………………………………......369
Kujala Knee Score……………………………………………………………………………………………...…374
International Knee Documentation Committee (IKDC) Subjective Knee Form – Pediatric Version…..…381
AOSSM Task Force on Clinical Outcome Measures
AOSSM-Affiliated Members:
Members External to AOSSM:
• James Irrgang PT PhD
• Julie Agel MA ATC
• Allen Anderson MD
• Mark Clatworthy MD
• Warren Dunn MD MPH
• Jeffrey Katz MD MSc
• Min Kocher MD MPH
• RobRoy Martin PT PhD
• Robert Marx MD MSc
• Bart Mann PhD
• Lori McLeod PhD
• Marc Swiontkowski MD
• Bruce Miller MD
• Matt Provencher MD
• Bruce Reider MD
• John Richmond MD
1
Clinical Outcome Measures Table for All Instruments
IKDC
PEDS IKDC
Lysholm
Cincinnati
Designed to assess
Variety of knee conditions:
ACL, PCL, meniscus,
cartilage patellafemoral
problems
Knee condition: ACL,
PCL, meniscus,
cartilage patellafemoral
problems
Initially designed for
ACL. Subsequently
used for variety of
other knee conditions
ACL, PCL, MCL,
Lateral/postlateral knee
ligaments, meniscal
repairs and allografts,
high tibial osteomy
How to obtain instrument
http://www.sportsmed.org/M
edicalProfessionals/Research/Gr
ants/IKDC-Forms/
http://www.sportsmed.org/Me
dicalProfessionals/Research/Grant
s/IKDC-Forms/
Provided in reference:
Lysholm, Am J Sports
Med 10:150-154, 1982
Provided in reference:
Barber-Westin. Am J
Sports Med. 1999 JulAug;27(4):402-16
Permission
No
No
No
No
Cost and licensing fees
No
No
No
No
Generation and Selection of
Items
Clinical expert, Statistical
model
Clinical Experts, Patient
input
Clinical expert
Clinical expert
Normative data available
Yes
Not reported
Yes
Yes
Number of questions
18
13
8
Symptoms (4), Patient
Perception (1), Sports
Activity (4), ADL function
(3), Sports function (3),
Occupational (7),
Time to administer
~10 minutes
Not reported
~5 minutes
Not reported
Time to score by hand
Not reported
Not reported
Not reported
Not reported
Not available
Not Available
Not Available
English
English
English
(Verifying)
0 -100 (100 best)
0 – 100 (100 best)
*Various calculations
possible
Automated Scoring available
Languages available
Yes
(http://www.sportsmed.org/
MedicalProfessionals/Research/Gr
ants/IKDC-Forms/)
Brazilianⱡ, Simplified
Chineseⱡ, Traditional
Chineseⱡ, Englishⱡ, French,
German, Greek, Italianⱡ,
Japanese, Korean,
Swedish, Dutchⱡ
Scale (scoring)
0-100 (100 best)
Recall period
4 weeks
4 weeks
Present
Present
Validity
Demonstrates hypothesized
relationships to other similar
measures and to measures of
general physical and emotional
function
Demonstrates
hypothesized
relationships to
measures of general
physical and emotional
function
Demonstrates hypothesized
relationships to other similar
measures and to measures
of general physical and
emotional function
Demonstrates hypothesized
relationships to other similar
measures and to measures of
general physical and emotional
function
Internal consistency
α = .77-.97
α = 0.91
α = .65-.72
Not reported
Test-retest reliability
ICC = .87-.98
ICC = .91
ICC = .68-.97
ICC= .80 - .98
Responsiveness - Effect Size
ES = .76 - 2.11
ES = 1.39
ES = .76 - 1.2
ES = .60 - 3.49
SRM = 1.35
SRM = .73 – 1.14
SRM = .52 - 2.48
MCD = 18.3*
MCD = 8.9 – 15.8*
MCD = 27.5*
Not reported
MCID = 10.1
14.0 – 26.0
Responsiveness SRM = .57 - 1.5
Standardized Response Mean
Responsiveness - Minimal
MCD = 6.7 – 20.5*
Detectable Change
Responsiveness- Minimal
MCID = 3.19 - 16.7
Clinically Important Difference
*Includes calculated statistics
ⱡ Formal assessment of psychometric properties included in this report
Clinical Outcome Measures Table for All Instruments
KOOS (Symptoms)
KOOS (Pain)
KOOS (ADL)
KOOS (Sports/Rec)
KOOS (QOL)
Post traumatic osteoarthritis (OA); i.e. ACL, meniscus, chondral injuries
Designed to assess
How to obtain instrument
http://www.koos.nu/
Permission
No
No
Cost and licensing fees
Generation and Selection
of Items
Clinical expert, Patient input
Yes
Normative data available
Number of questions
7
9
17
4
~10 minutes for all 5 scales
Time to administer
Time to score by hand
Not reported
Automated Scoring
available
Yes (http://www.koos.nu/)
Languages available
5
Austrian-German, Czech, Chineseⱡ, Croatian, Danish, Dutchⱡ, Estonian, English, Frenchⱡ, German, Italian, Japanese,
Latvian, Lithuanian, Norwegian, Persianⱡ, Portuguese, Polish, Russian, Singapore English, Slovakian, Slovenian,
Spanish, Swedishⱡ, Thai, Turkish, Ukranian
Total: 0-100 (100 best)
Scale (scoring)
Last Week
Recall period
Validity
Demonstrates
hypothesized
relationships to other
similar measures and
to measures of general
physical and emotional
function
Demonstrates
hypothesized
relationships to other
similar measures and
to measures of
general physical and
emotional function
Demonstrates
hypothesized
relationships to other
similar measures
and to measures of
general physical and
emotional function
Demonstrates
hypothesized
relationships to
other similar
measures and to
measures of
general physical
and emotional
function
Demonstrates
hypothesized
relationships to
other similar
measures and to
measures of
general physical
and emotional
function
Internal consistency
α = .25 - .83
α = .65 - .94
α = .78 - .97
α = .84 - .98
α = .64 - .90
Test-retest reliability
ICC= .74 - .95
ICC= .80 - .92
ICC= .73 - .94
ICC= .45 - .89
ICC= .60 - .95
ES = .67 - 2.25
ES = .90 - 1.31
ES = 1.15 - 2.8
SRM = .75 - 1.8
SRM = .87 - .89
SRM = .76 - 1.93
11.9 – 31.5*
12.2 - 70.0*
14.2 – 34.0*
Not reported
Not reported
Not reported
Responsiveness - Effect
ES = .72 - 1.63
ES = .82 - 2.59
Size
Responsiveness SRM = .61 - 1.45
SRM = .71 - 1.85
Standardized Response
Mean
Responsiveness Minimal Detectable
9.9 – 24.3*
11.8 - 29.0*
Change
Responsiveness- Minimal
Clinically Important
Not reported
Not reported
Difference
*Includes calculated statistics
ⱡ Formal assessment of psychometric properties included in this report
3
Clinical Outcome Measures Table for All Instruments
Designed to assess
WOMAC (Pain)
WOMAC (Function)
WOMAC (Stiffness)
WOMAC (overall)
Rheumatoid arthritis,
hip/knee OA
Rheumatoid arthritis,
hip/knee OA
Rheumatoid arthritis,
hip/knee OA
Rheumatoid arthritis,
hip/knee OA
www.womac .org
How to obtain instrument
Permission
Yes
Cost and licensing fees
Yes
Generation and Selection of
Items
Clinical experts, Patient input
Normative data available
Yes
Number of questions
5
17
2
Time to administer
~12 minutes for all 3 scales
Time to score by hand
~5-10 minutes
Automated Scoring available
Not Available (Permission required)
Languages available
Scale (scoring)
24
Over 65 including: English, Arabic, Chinese, Dutch, French-Canadian, German, Hebrew, Italian, Thai, Turkishⱡ,
Spanishⱡ
5 Point Likert scale: Pain (0-20 pts), Stiffness (0-8 pts), Function (0-68 pts)
VAS scale: Pain (0-500 pts), Stiffness (0-200 pts), Function (0-1700 pts)
Composite scores can be converted to 0-100 scale (0 best)
Recall period
Current
Validity
Demonstrates
hypothesized
relationships to other
similar measures and to
measures of general
physical and emotional
function
Demonstrates
hypothesized
relationships to other
similar measures and to
measures of general
physical and emotional
function
Demonstrates
hypothesized
relationships to other
similar measures and to
measures of general
physical and emotional
function
Demonstrates
hypothesized relationships
to other similar measures
and to measures of
general physical and
emotional function
Internal consistency
α = .75 - .82
α = .84 - .96
α = .71-.84
α = .84 - .96
Test-retest reliability
ICC= .78 - .85
ICC= .81 - .93
ICC= .67 - .86
ICC= .86 - .93
Responsiveness - Effect Size
ES = .74 - 17.7
ES = .18 - 8.7
ES = .07 - 1.0
ES = .50 - 10.0
Responsiveness Standardized Response Mean
SRM = .35 - 1.5
SRM = .23 - 1.3
SRM = .08 - .64
SRM = .24 - 1.13
Responsiveness - Minimal
Detectable Change
MCD = 14.4 – 16.2*
MCD = 10.6 – 15.0*
MCD = 22.9-30.6*
MCD = 10.7 – 15.3*
Responsiveness- Minimal
Clinically Important Difference
MCID = 7.5 - 17.5
MCID = 5.89 - 8.1
MCID = 6.3 - 18.8
MCID = 11.5
* – Minimal detectable change ranges reported in article based on 5 point Likert version of the WOMAC
ⱡ Formal assessment of psychometric properties included in this report
4
`
Clinical Outcome Measures Table for All Instruments
WOMET
Mohtadi
Kujala
Tegner
Marx
ACL injury
Meniscus injury
Health related
quality of life due
to ACL injury
Patellofemeral
disorders
Activity level –
competitive sports,
recreational sports,
work and activities of
daily living
How to obtain
instrument
Sharon Griffin [email protected]
Provided in
reference:
Mohtadi. Am J
Sports Med.1998
MayJun;26(3):350-9
Contact author:
Kujala UM [email protected]
.fi
Provided in reference:
Tegner, Clin Orthop
198:43-49, 1985.
Provided in
reference: Marx,Am
J Sports Med. 2001
Mar-Apr;29(2):213-8
Permission
No
No
No
No
No
Cost and licensing fees
No
No
No
No
No
Generation and
Selection of Items
Patient input
Clinical expert,
Patient item
generation
Clinical Expert
Clinical expert
Clinical expert,
Patient input
Normative data
available
Not reported
Not reported
Not reported
Yes
Not reported
Number of questions
16
31
13
1 (10 levels)
4
Time to administer
~5 - 10 minutes
~10 - 15 minutes
~10 - 15 minutes
~1 - 2 minutes
~1 minute
Time to score by hand
Not reported
Not reported
Not reported
Not reported
Not reported
Automated Scoring
available
Not available
Not available
Not available
Not Available
Not available
Languages available
English
English
English, Turkishⱡ
English
English
Scale (scoring)
0-1600 (0 best)
0-100 (100 best)
0-100 (100 best)
0 -10 (10 best)
0 – 16 (16 best)
Recall period
1 week
Last 3 months
Present
Present
Past year
Validity
Demonstrates
hypothesized
relationships to other
similar measures and
to measures of
general physical
function
Not reported
Demonstrates
hypothesized
relationships to other
similar measures and
to measures of
general physical
function
Demonstrates
hypothesized relationships
to other similar measures
and to measures of
general physical and
emotional function
Demonstrates
hypothesized
relationships to
similar scales
Internal consistency
α = .91 - .92
Not reported
α = .82 - .84
Not reported
Not reported
Test-retest reliability
ICC = .92
Not reported
ICC= .86 - .94
ICC = 0.82 - 0.92
ICC = .97
Responsiveness Effect Size
ES = 1.17
Not reported
Not reported
ES = .61 - 1.1
Not reported
SRM = .65 - .90
Not reported
Not reported
SRM = .60 - 1.0
Not reported
Not reported
Not reported
Not reported
MCD = 1.0
9.9
Not reported
Not reported
Not reported
Not reported
Not reported
Designed to assess
Responsiveness Standardized
Response Mean
Responsiveness Minimal Detectable
Change
ResponsivenessMinimal Clinically
Important Difference
*Includes calculated statistics
ⱡ Formal assessment of psychometric properties included in this report
IKDC SUBJECTIVE KNEE FORM
Irrgang (1)
Padua (2)
Anderson (3)
Purpose
Reliability, validity
Reliability, validity of Italian
translation
Normative Data
Study
Population/Sample
(inclusion/exclusion)
Patients with a variety of knee
problems
Patients undergoing ACL
reconstruction
Random sample representative of
general population
Number
533
50
2670
Age range
(average ± SD, min-max)
37.5 years ±16.2 (6.2-86.6)
24 (18-42)
39 years ±14 (18-65)
Sex (% female)
47% (identified)
18%
51%
Internal consistency
α = 0.92
α = 0.91
NA
Test-retest reliability
ICC = 0.94
ICC = 0.90
NA
Time interval
50 days
5 days
NA
NA
NA
NA
Fair (25%), Moderate (75%)
correlation to general measures
of physical function
Little (75%), Fair (25%)
correlation to general measures
of mental function
Little (33%), Moderate (66%)
correlation to general
measures of physical function
Little (66%), Moderate (33%)
correlation to general
measures of mental function
ES
NA
NA
NA
SRM
NA
NA
NA
MDC
12.83(calc)
19.98 (calc)
NA
MCID
NA
NA
NA
Time Interval
NA
NA
NA
Floor/Ceiling Effect
No
No
No
Normal Distribution
NA
Yes
No
Normal Data
NA
NA
Yes
Study Characteristics
Reliability
Validity
Correlation to similar scale
Correlation to general measures
of Physical function
Correlation to general measures
of mental function
NA
NA
Responsiveness
Other
OA – Osteoarthritis
6
IKDC SUBJECTIVE KNEE FORM
Irrgang (4)
Haverkamp (5)
Crawford (6)
Purpose
Reliability, validity
Reliability, validity of Swedish
translation
Validity, Responsiveness
Study
Population/Sample
(inclusion/exclusion)
Patients with a variety of knee
problems
Patients with a variety of knee
problems
Patients with meniscus pathology
Number
207
145
Test re-test = 31, Construct/Content =
246, SF-12 group = 50,
Responsiveness = 100
Age range
(average ± SD, min-max)
40.5 years ± 16.7 (12.5-81.3)
54.6 (21-84)
Test re-test = 50.6 (19-73);
Construct/Content = 45.4 (18-81);
Responsiveness = 47.9 (18-81)
Sex (% female)
53%
58%
Test re-test = 32%, Construct/Content
= 29%, Responsiveness = 29%
Internal consistency
NA
α = 0.9
α = 0.773
Test-retest reliability
NA
ICC = 0.96
ICC = 0.95
Time interval
NA
1 week
4 weeks
Correlation to similar scale
NA
Little (66%), Excellent (33%)
correlation to similar scales
NA
Correlation to general measures
of Physical function
NA
Correlation to general measures
of mental function
NA
Study Characteristics
Reliability
Validity
Moderate (100%) correlation to
general measures of physical
function
Little(50%), Fair(50%)
correlation to general
measures of mental function
Moderate (100%) correlation to
general measures of physical function
NA
Responsiveness
ES
1.13
NA
2.11
SRM
0.94
NA
1.5
MDC
11.5 (sens =.82 spec = .64)
20.5 (sens =.84 spec = .64)
NA
8.8
MCID
11.5
NA
3.19
Time Interval
19 months
NA
12 months
Floor/Ceiling Effect
NA
No
No
Normal Distribution
NA
Yes
Yes
Normal Data
NA
NA
NA
Other
7
IKDC SUBJECTIVE KNEE FORM
Lertwanich (8)
Greco (10)
Metsavahl (11)
Fu (12)
Purpose
Validity,
Responsiveness of Thai
Translation
Reliability, validity
Reliability, validity of
Brazilian translation
Reliability, validity of
Chinese translation
Study
Population/Sample
(inclusion/exclusion)
Various knee related
complaints
Patients following articular
cartilage surgery
Patients with general knee
complaints
Patients with various knee
injuries
Number
55
Reliability = 17,
Responsiveness = 50
117
84
Age range
(average ± SD, minmax)
27.6 (18-50)
Reliability = 43.8 years ±
10.4 (21-60),
Responsiveness = 36.6
years±9.7 (15-56)
46.7 (15-84)
52.6 (16-85)
Sex (% female)
1.8%
Reliability = 39%,
Responsiveness = 39.2%
50.4%
36%
Internal consistency
α = 0.92
NA
α = .928 ; .935 (test ;
retest)
α = 0.97
Test-retest reliability
ICC = 0.92
ICC 6mo. = 0.91 ICC
12mo. = 0.93
ICC = 0.988
ICC = .87
Time interval
7 days
6 mo. 12 mo.
1 week
10 days
Correlation to similar
scale
NA
NA
Excellent (100%)
correlation to similar scale
NA
Correlation to general
measures of Physical
function
Fair (25%), Moderate
(75%) correlation to
general measures of
physical function
NA
Moderate (75%), Excellent
(25%) correlation to
general measures of
physical function
Moderate (100%)
correlation to general
measures of physical
function
Correlation to general
measures of mental
function
Fair (100%) correlation
to mental function
NA
Fair (100%) correlation to
mental function
Little (50%), Fair (50%)
correlation to mental
function
ES
NA
6mo = .76 12mo = 1.06
NA
NA
SRM
NA
6mo = 0.57 12mo = 1.0
NA
NA
MDC
8.8
11.4 (calc)
6.7
NA
MCID
NA
6mo = 6.3 12mo = 16.7
NA
NA
Time Interval
NA
6 and 12 months
Equation
NA
Floor/Ceiling Effect
No
Yes
No
NA
Normal Distribution
NA
NA
NA
NA
Normal Data
NA
NA
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
8
IKDC SUBJECTIVE KNEE FORM
Schmitt (13)
Study Characteristics
Validity, Reliability
Purpose
Study
Population/Sample
(inclusion/exclusion)
Variety of knee injuries
673
Number
Age range
(average ± SD, minmax)
6 - 18
54%
Sex (% female)
Reliability
α = 0.91
Internal consistency
Test-retest reliability
NA
Time interval
NA
Validity
Correlation to similar
scale
NA
Excellent (100%)
correlation to physical
function
Correlation to general
measures of Physical
function
Correlation to general
measures of mental
function
NA
Responsiveness
ES
NA
SRM
NA
MDC
NA
MCID
NA
Time Interval
NA
Other
Floor/Ceiling Effect
NA
Normal Distribution
NA
Normal Data
NA
9
IKDC STUDY CONSOLIDATION
REFERENCES
1) Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC, Shelborne KD. Development
and validation of the international knee documentation committee subjective knee form. Am J Sports Med. 2001 SepOct; 29(5): 600-13
2) Padua R, Bondi R, Ceccarelli E, Bondi L, Romanini E, Zanoli G, Campi S. Italian version of the International Knee
Documentation Committee Subjective Knee Form: cross- cultural adaptation and validation. Arthroscopy. 2004 Oct;
20(8): 819-23
3) Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast
JJ; International Knee Documentation Committee. The International Knee Documentation Committee Subjective Knee
Evaluation Form: normative data. Am J Sports Med. 2006 Jan; 34(1): 128-35
4) Irrgang JJ, Anderson AF, Boland AL, Harner CD, Neyret P, Richmond JC, Shelbourne KD; International Knee
Documation Committee. Responsiveness of the International Knee Documentation Committee Subjective Knee Form.
Am J Sports Med. 2006 Oct; 34(10): 1567-73
5) Haverkamp D, Sierevelt IN, Breugem SJ, Lohuis K, Blankevoort L, van Dijk CN. Translation and Validation of the
Dutch Version of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006
Oct; 34(10):1680-4
6) Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, Validity, and Responsiveness of the IKDC score for
meniscus injuries of the Knee. Arthroscopy. 2007 Aug: 23(8): 839-44
8) Lertwanich P, Praphruetkit T, Keyurapan E,Lamsam C, Kulthanan T. Validity and reliability of Thai version of the
International Knee Documentation Committee Subjective Knee Form. J.Med Assoc Thai.2008 Aug; 91(8):1218-25
10) Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee
Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities
Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular
cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. Epub 2009 Dec 31.
11) Metsavaht L, Leporace G, Riberto M, Sposito MM, Batista LA.Translation and Cross-Cultural Adaptation of the
Brazilian Version of the International Knee Documentation Committee Subjective Knee Form: Validity and
Reproducibility. Am J Sports Med. 2010 May 14.
12) Fu SN, Chan YH. Translation and validation of Chinese version of International Knee Documentation Committee
Subjective Knee Form. Disabil Rehab. 2011; 33(13-14):1186-9 - Epub 2010 Oct 22
13) Schmitt LC, Paterno MV, Huang S. Validity and internal consistency of the international knee documentation
committee subjective knee evaluation form in children and adolescents. Am J Sports Med. 2010 Dec;38(12):2443-7.
Epub 2010 Aug 30. PubMed PMID: 20805408.
10
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC SUBJECTIVE KNEE FORM
Irrgang
Development and Validation of the International Knee
Documentation Committee Subjective Knee Form
2001
11799013
Travis Hamilton
June 16, 2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
1
NA
1
1
1
2; positively skewed/platykurtic distribution
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36: Pearson coefficients PF=.63, RP=.47, BP=.64,
PCS=.66
NA
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36: RE=.26, MH=.25, MCS=.16
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
.92
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
1
11
Indicate value:
Testing interval (time between repeated measures)
.94
49.7 days ± 24.4 (4-92)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
37.5 years ±16.2 (6.2-86.6)
533
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
252/479 (patients sex not recorded in 54 cases)
Table 2
NA
1
1
4 weeks
1
1
Notes:
12
13
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC SUBJECTIVE KNEE FORM
Padua
Italian Version of the International Knee Documentation
Committee Subjective Knee Form: Cross-Cultural Adaptation
and Validation
2004
15483542
Travis Hamilton
6.25.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
1
1
Standard forward and backward translation (English to
Italian)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36: PF = .67, BP = .56, PCS = -.60
NA
1
SF-35: MH = -.65, MCS = -.40 RE = .44
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = 0.91
14
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
.90
5 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
24 (18-42)
50 (20 Pts. Randomly for reproducibility)
Male
Female
41
9
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
NA
NA
NA
4 WEEKS
Italian
2
Notes:
Correlation between the Italian IKDC and the SF-36 was calculated using the Spearman correlation (R).
15
16
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC SUBJECTIVE KNEE FORM
Anderson
The International Knee Documentation Committee Subjective
Knee Evaluation Form: Normative Data
2006
16219941
Travis Hamilton
June 16, 2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
3 (was not established for age group <18 years)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
1
1.
People experiencing knee problems would score
lower than those without knee problems.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
17
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
39 years ±14 (18-65)
2670 returned, used: 2625 right knee 2621 left knee (5246
Knees)
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1285
1385
NA
1
1
1
4 weeks
English
2
18
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC Subjective Knee Form
Irrgang
Responsiveness of International Knee Documentation
Committee Subjective Knee Form
2006
16870824
Travis H
June 16, 2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
1
NA
Group level analysis of between-groups differences used 7level global rating of change scale in comparison to IKDC.
ANOVA = 37.1% of change in IKDC was accounted for by global
scale.
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
19
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES = 1.13, SRM = 0.94
1
MCID 11.5
Previous data suggests minimal change ±12.8 (from
initial study)
1
NA
19 months ±2.9 (6-28.0)
Descriptive Features
Age range of sample
Number:
Sex
40.5 years ± 16.7 (12.5-81.3)
207
Male
Female
Diagnosis
47.1%
52.9%
Table 1
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
1
4 WEEKS
ENGLISH
2
Notes:
20
21
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC SUBJECTIVE KNEE FORM
Haverkamp
Translation and Validation of the Dutch Version of the
International Knee Documentation Committee Subjective
Knee Form
2006
16816150
Travis Hamilton
6.24.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
1 (Figure 1)
1
Standard forward and backward translation (English to
Dutch)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1 (Table 1)
SF-36: PF= .71, RP = .55, BP = .69
1 (Table 1)
VAS = -0.62, WOMAC = .77, Oxford 12 = -0.77
1
SF-36: RE = 0.30, MH = 0.21
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = .9
22
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC = 0.96; Pearson correlation (r = 0.92, P <.01)
1 Week
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
54.6 (21-84)
145
Male
Female
42%
58%
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
13 (9%)
42 (29%)
90 (62%)
17
NA
1
NA
4 weeks
1; Dutch
2
Notes:
•
Floor and ceiling effects were not investigated after treatment. It is possible that a ceiling effect occurs after treatment of the knee
injury; however, this did not occur in the original version of the IKDC.
23
24
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC SUBJECTIVE KNEE FORM
Crawford
Reliability, Validity, and Responsiveness of the IDKC Score for
Meniscus Injuries of the Knee
2007
17681205
Travis Hamilton
6.24.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
1
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1;
Physical Component of SF-12: P < 0.05; r = 0.60
1
Tegner; P < .001
NA
1
All hypotheses were significant (P < .05);
- Pts. with Workers’ Compensation claim had lower IKDC
than pts w/o claim – P < .001
- Pts. with more difficulty with ADL had lower IKDc scores
than pts with less difficulty – P < .001, r = 0.680
- Pts. w/ difficulty working bc of knee had lower IKDC scores
than pts that did not – P < .001, r = 0.645
- Pts. w/ difficulty w/ sports bc of knee had lower IKDC then
pts. who did not – P < .001, r = 0.638
- Pts. with abnormal knee assessment had lower IKDC
scores than pts. w/ normal assessments of overall function
– P < .001
- Pts. with degenerative/complex meniscus tears had lower
IKDC scores than pts. w/ simple tears – P = .004
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
25
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
Cronbach α = 0.773
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.95
Within 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES = 2.11; SRM = 1.5
1
MDC = 8.8; SE = 3.19
NA
NA
12 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Group A
Group B
50.6 (19-73)
31
45.4 (18-81)
264
21
10
All pts. had
meniscus
pathology
186
78
100%
100%
Group C
Group D
50
47.9 (18-81)
100
71
29
100%
100%
NA
NA
NA
4 weeks
ENGLISH
2
26
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC SUBJECTIVE KNEE FORM
Lertwanich
Validation and reliability of Thai Version of the International
Knee Documentation Committee Subjective Knee Form
2008
18788694
Travis Hamilton
6.25.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
NA
1
Standard forward-backward
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; PF = .75, RP = .37, BP = .76 PCS = .63
NA
1
SF-36; MH = .29, RE = .34, MCS = .34
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = 0.92
27
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.92
7 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
27.6 (18-50)
55
Male
Female
Diagnosis
54
1
Table 1.
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
4-WEEKS
Thai
2
28
29
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC SUBJECTIVE KNEE FORM
Greco
Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the
Western Ontario and McMaster Universities Osteoarthritis
Index, Modified Cincinnati Knee Rating System, and Short
Form 36 in Patients with Focal Articular Cartilage Defects.
2009
Year
PubMed ID:
Reviewer’s Name
Date of Review
Travis Hamilton
17-Jun-11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1 (for all instruments except IKDC)
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
30
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
IKCD (6 mo., 12mo.) = 0.91 ; 0.93
see above
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
IKDC ES (6 mo., 12mo.) = 0.76 ; 1.06
IKDC SRM (6 mo., 12mo.) =0.57 ; 1.00
(table 2)
1
6 month: IKDC MCID: 6.3 (Sens = 0.79 ; Spec = 0.74)
MCD: 15.6
12 month: IKDC MCID: 16.7 (Sens = 0.74 ; Spec = 0.8)
MCD: 13.7
(table 3)
1 (global scale)
6 months and 12 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Reliability (A)
43.8 years ± 10.4 (21-60)
17
61% male
Responsiveness (B)
36.6 years±9.7 (15-56)
50
60.8% male
17
50
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and
weighting of items:
Provided information about calculating
with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this
report
Is this the first or primary report about this
instrument?
1
1
4 weeks
NA
NA
2
31
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC SUBJECTIVE KNEE FORM
Metsavaht
Translation and Cross-Cultural Adaptation of the Brazilian
Version of the International Knee Documentation Committee
Subjective Knee Form
2010
20472755
Travis Hamilton
6.24.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
NA
1
Standard forward and backward translation (English to
Portuguese)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1 (table 2)
SF-36; PCS = .79, PF = .75, RF = .54, BP = .63
1 (table 2)
Lysholm = .89, WOMAC = .85
1 (table 2)
SF-36; MCS = .51, MH = .40, RE = .50
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = .928 ; .935 (test ; retest)
32
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC = 0.988 P< .001
1 week
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
1
MDC = 6.7
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Pretest Group (before
accepted translation)
48.9 ± 18.6 (20-82)
32
Final Testing Group (statistical
and correlational analysis)
46.7 (15-84)
117
31.3%
68.7%
49.6%
50.4%
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
18.8%
Hamstring insetional
tendinopathy (2.6%),
patellofemoral pain syndrome
(7.7%), patellar tendinopathy
(1.7%), tibial shaft fracture
(1.7%), knee effusion (1.7%),
posterior cruciate ligament
injury (.9%), adductor bursitis
(.9%), knee replacement (.9%)
20.5%
37.6%
2.6%
100%
NA
NA
NA
4 WEEKS
1; Portuguese
2
33
Notes:
•
For cultural adaptation, question relating to “skiing” was changed to “surfing”
34
IKDC Subjective Knee form
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC Subjective Knee Form
Fu
Translation and validation of Chinese version of International
Knee Documentation Committee Subjective Knee Form
2011
20969433
Travis Hamilton
7.6.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
NA
NA
NA
NA; (No effects were observed in the 20 pt. cohort
validation)
If yes. <30% of sample scored at endpoint
Data normally distributed
Was there a standard for translation?
If yes. How?
NA
1
Backward and Forward translation by professionals.
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36 (Chinese version): PF = .64; RP = .50; BP = .64
NA
1
SF-36 (Chinese version): RE - .24; MH = .41
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = 0.97
35
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.87
7 – 10 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
52.6 (16-85)
84
Male
Female
Diagnosis
54
30
Table 1.
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
4-WEEKS
1; chinese
2
36
37
IKDC SUBJECTIVE KNEE FORM
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC Subjective Knee Form – Pediatric Version
Schmitt
Validity and Internal Consistency of the International Knee
Documentation Committee Subjective Knee Evaluation Form
in Children and Adolescents
2010
Year
PubMed ID:
Reviewer’s Name
Date of Review
20805408
Travis Hamilton
8.10.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
PedsQL PCS: r = 0.83 (pediatric, r = .84; adolescnet, r = .84;
young adult, r = .79)
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: No deleted items = 0.911; 3 deleted items = 0.934
38
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
6-18
673
Male
Female
Diagnosis
312
361
Table 2.
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
4 WEEKS
English
2
Notes:
3 items deleted were questions 2 (pain frequency), 3 (pain severity), and 6 (locking/catching) did not appreciably influence internal consistency.
However the data indicate that the items may contribute to measurement error in the age group studied.
39
40
Lysholm Knee Score
Tegner (2)
Bengtsson (3)
Risberg (4)
Marx (5)
Paxton (6)
Purpose
Reliability, validity
Sensitivity, Reliability
Sensitivity
Reliability, validity,
responsiveness
Validity, Reliability
Study
Population/Sample
(inclusion/exclusion)
ACL injury
ACL, MT, PFPS, and
LAS injury***
ACL + combined
injury
Variety of knee injuries
Acute patellar dislocation
Number
76
31
120
Reliability = 41,
Validity = 133,
Responsiveness = 42
Validity = 110,
Test=retest = 81
Age range
(average ± SD, minmax)
27
ACL = 26.3 ± 7.8; MT
= 39.1 ± 13.8; PFPS =
24.1 ± 7.0; LAS 29.8 ±
5.6
27.8
Reliability = 32.6 (1660), Validity = 31.5 (1465), Responsiveness =
30.9 (15-61)
Validity =First dislocation:
16 (9-67), Prior dislocation:
18 (8-65) Test-retest=
First dislocation: 16 (9-48),
Prior dislocation: 22 (8-65)
Sex (% female)
28%
NA
47%
Reliability = 51%,
Validity = 48%,
Responsiveness = 54%
NA
Internal consistency
NA
NA
NA
NA
α = 0.71
Test-retest reliability
Intrapersonal CC = .97
Interpersonal CC = .90
Days 1-3: t = 0.75;
Days 1-14: t = 0.69;
Days 3 – 14: t = 0.68
(Kendall's correlation)
NA
ICC = 0.95
r = 0.88
Time interval
2 weeks
1-3 days, 1-14 days,
3-14 days
NA
5 days
21 days
Excellent (100%)
correlation to similar
scales
NA
Little (29%)
Fair (25%),
Moderate (29%),
Excellent (16%)
Moderate (50%),
Excellent (50%)
correlation to similar
scales
Little (50%), Excellent
(50%) correlation to similar
scales
NA
Fair (33.3%), Moderate
(66.6%) correlation to
general measures of
physical function
Fair (66.6%), Moderate
(33.3%) correlation to
general measures of
physical function
NA
Study Characteristics
Reliability
Validity
Correlation to similar
scale
Correlation to
general measures of
Physical function
NA
NA
NA
NA
NA
Little (50%), Fair (50%)
correlation to general
measures of mental
function
ES
NA
NA
NA
NA
NA
SRM
NA
NA
NA
0.9
NA
MDC
NA
NA
NA
11.6 (calc)
NA
MCID
NA
NA
NA
NA
NA
Guyatt
NA
NA
NA
NA
NA
Time Interval
NA
NA
3, 6, 12, 24
months (scores)
NA
NA
Floor/Ceiling Effect
NA
NA
NA
No
No
Normal Distribution
NA
NA
NA
NA
No
Normal Data
NA
NA
NA
NA
NA
Correlation to
general measures of
mental function
Responsiveness
Other
*** MT - Meniscus Tear, PFPS - Patello-femoral Pain Syndrome, LAS - Lateral Ankle Sprain
41
Lysholm Knee Score Continued
Kocher (7)
Briggs (8)
Heintjes (9)
Briggs (10)
Purpose
Reliability,
Responsiveness
Validity, Reliability,
Responsiveness
Reliability, validity,
responsiveness
Reliability, validity,
responsiveness
Study
Population/Sample
(inclusion/exclusion)
Patients with Choldral
lesions
Meniscal Injury
General knee complaints
ACL (plus concurrent)
injuries
Number
76
Age range
(average ± SD, min-max)
27
Sex (% female)
28%
Test-retest group = 36%,
Validity group 1 = 32%,
Validity group 2 = 23%
44%
Reliability = 51%,
Validity = 48%,
Responsiveness = 54%
Internal consistency
α = 0.65
α = 0.729
NA
α = .72
Test-retest reliability
ICC = 0.91
ICC = 0.92
NA
ICC = 0.94
Time interval
4 weeks
4 weeks
NA
4 weeks
Correlation to similar scale
Little (100%) correlation to
similar scales
NA
Little (29%)
Fair (25%),
Moderate (29%),
Excellent (16%)
Excellent (100%)
correlation to similar scales
Correlation to general
measures of Physical function
Fair (33.3%), Moderate
(66.6%) correlation to
general measures of
physical function
Moderate (100%) correlation
to measures of physical
function
NA
Fair (100%) correlation
general measures of
physical function
Correlation to general
measures of mental function
NA
NA
NA
Little (100%)correlation to
general measures of
mental function
ES
1.16
Validity Group 1 = 1.2,
Validity Group 2 = 1.2
Traumatic pts = 1.15
Nontraumatic pts = 0.76
6mo. = 1.0 , 9mo. = 1.0,
12mo. = 1.1, 24mo. = 1.1
SRM
1.1
Validity Group 1 =0.97,
Validity Group 2 = 1.13
Traumatic pts = 1.14
Nontraumatic pts = 0.73
6mo. = 0.925 , 9mo. = 1.1,
12mo. = 1.2, 24mo. = 0.93
MDC
15.8 (calc)
15.2 (calc)
NA
8.9
MCID
NA
10.1
NA
NA
Guyatt
NA
NA
Traumatic pts = 0.94
Nontraumatic pts = 1.11
NA
Time Interval
52 months
12 months
12 months
6, 9, 12, 24 months
Floor/Ceiling Effect
No
No
No
No
Normal Distribution
NA
NA
NA
Yes
Normal Data
NA
NA
NA
NA
Study Characteristics
Test-retest group = 122,
Validity group 1 = 191,
Validity group 2 = 477
Test-retest group = 48 (1476), Validity group 1 = 40
(13-81), Validity group 2 =
39 (18-62)
314
24.6 ± 7.5 (12-35)
Reliability = 41,
Validity = 133,
Responsiveness = 42
Reliability = 32.6 (16-60),
Validity = 31.5 (14-65),
Responsiveness = 30.9
(15-61)
Reliability
Validity
Responsiveness
Other
*** MT - Meniscus Tear, PFPS - Patello-femoral Pain Syndrome, LAS - Lateral Ankle Sprain
42
Demirdjian (11)
Study Characteristics
Purpose
Normative Data
Study
Population/Sample
(inclusion/exclusion)
High School and College
Students
Number
246
Age range
(average ± SD, min-max)
17.6 (13 – 25)
Sex (% female)
40%
Reliability
Internal consistency
NA
Test-retest reliability
NA
Time interval
NA
Validity
Correlation to similar scale
NA
Correlation to general
measures of Physical function
NA
Correlation to general
measures of mental function
NA
Responsiveness
ES
NA
SRM
NA
MDC
NA
MCID
NA
Guyatt
NA
Time Interval
NA
Other
Floor/Ceiling Effect
NA
Normal Distribution
NA
Normal Data
Yes
43
LYSHOLM STUDY CONSOLIDATION
REFERENCES
2) Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat
198:43-9
Res. 1985;
3) Bengtsson J, Mollborg J, Werner S. A study for testing the sensitivity and reliability of the Lysholm
scale. Knee Surg Sports Traumatol Arthrose 1996; 4: 27-31
knee scoring
4) Risberg MA, Holm I, Sten H, Beynnon BD. Sensitivity to changes over time for the IKDC form, the Lysholm score, and
the Cincinnati knee score a prospective study of 120 ACL reconstructed patients with a 2 year follow up Knee Surg
Sports Traumatol Arthroscopy 1999 7: 152-59
5) Marx RG, Jones EC, Allen AA, Altchek DW, O'Brien SJ, Rodeo SA, Williams RJ, Warren RF, Wickiewics TL.
Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am. 2001;
83: 1459-69
6) Paxton EW, Fithian DC, Stone ML, Silvia P. The reliability and validity of knee specific and general health instruments
in assessing acute patellar dislocation outcomes. Am J Sports Med 2003; 31 : 487-92
7) Kocher MS, Steadman JR, Briggs KK, Sterett WI, Hawkins RJ. Reliability, validity, and responsiveness of the Lysholm
knee scale for various chondral disorders of the knee. J Bone Joint Surg AM. 2004; 86: 1139-45
8)
Briggs KK, Kosher MS, Rodkey WG, Steadman JR. Reliability, Validity, and Responsiveness of the Lysholm Knee
Score and Tegner Activity Scale for Patients with Meniscal Injury of the Knee. J Bone Joint Surg Am. 2006; 88(4):
698-705
9)
Heintjes EM, Bierma-Zeinstra SM, Berger MY, Koes BW. Lysholm scale and WOMAC index were responsive in
prospective cohort of young general practice patients. J Clin Epidemol. 2008; 61 (5): 481-8
10) Briggs K, Lysholm J, Tegner Y, Rodkey WG, Kosher MS, Steadman R. Reliability, Validity, and Responsiveness of
the Lysholm Knee Score and Tegner Activity Scale for Anterior Cruciate Ligament Injuries of the Knee: 25 years later.
Am J Sports Med, 2009; 37: 890-897
11) Demirdjian AM, Petrie SG, Guanche CA, Thomas KA. The outcomes of two knee scoring questionnaires in a normal
population. Am J Sports Med. 1998 Jan-Feb;26(1):46-51
44
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Year
PubMed ID:
Lysholm Knee Score
Tegner
Rating System in the Evaluation of Knee Ligament Injuries
1985
Reviewer’s Name
Date of Review
4028566
Travis Hamilton
6.29.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
Marhall Scoring Scale; ( r = 0.78; p < .001) (r = Pearson
coefficient)
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
Intrapersonal correlation coefficient = .97 ( 2 weeks)
Interpersonal correlation coefficient. = .90 (same occasion by
physician and physiotherapist)
2 weeks
45
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
27
76
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
55
21
100%
NA
1
NA
Present
1
2
Notes:
This a comparative study investigating the differences between the Lysholm score and the Marshall score relative to knee injury. The results
suggests that patients who sore higher on the Lysholm scale, have “too-low” values when scored on the Marshall scale. Also, patients who score
low on the Lyholms scale are overestimated by the Marshall scale.
The intrapersonal coefficient of variation was estimated by letting the same orthopedic surgeon determine the score of 15 patients twice with an
interval of two weeks. To establish the interpersonal variation, an orthopedic surgeon and a physiotherapist determined the score for the same 15
patients on one and the same occasion.
The intrapersonal coefficient of variation = 3%
The interpersonal coefficient of variation = 4%
46
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Lysholm Knee Score
Bengtsson
A study for testing the sensitivity and reliability of the Lysholm
knee scoring scale
1996
8819060
Travis Hamilton
6.30.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
47
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
Days 1-3: τ = 0.75, P < .0001; Days 1-14: τ = 0.69, P < .0001;
Days 3 – 14: τ = 0.68, P < .0001
τ = Kendall’s correlation test
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Table 1
31
Male
Female
Diagnosis
Table 1
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
1
2
NOTES:
Patients that have not undergone surgery and have one of four knee/leg related injuries (ACL rupture, MT, PFPS, and LAS) were included in the
study. Patients were mailed a copy of the Lysholm scale and were assessed by phone interview their ratings for each category at 1, 3, and 14 day
increments. The sensitivity data show that patients in the ACL group scored significantly higher (P<0.01) on the Lysholm scale than for any of the
other groups. Therefore, the conclusion can be made that the Lysholm scale is less sensitive for patients with ACL injury as compared to any of
the other knee injuries studied. Group comparisons show there were significant differences between the ACL and MT group (P<0.01), as well as
the ACL and LAS group (P < 0.05) (table 3.)
48
49
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Lysholm Knee Score
Risberg
Sensitivity to changes over time for the IKDC form, the
Lysholm score, and the Cincinnati knee score
1999
10401651
Travis Hamilton
6.30.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
IKDC1-4 and IKDC-final form, Cincinnati – table 3.
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
NA
50
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
NA; table 2
NA
NA
NA
3 mo., 6.mo., 1 year, 2 years
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
27.8
120
Male
Female
64
56
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
58
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
62 (+ACL)
NA
NA
2
1
2
Notes:
120 subjects with either ACL or ACL combined injuries who underwent reconstruction using a bone-patellar-tendon –bone graft were included in
this study. Patients were assessed with 3 instruments (IKDC form, Lycholm, and Cincinnati score) at 4 different time periods (3mo., 6mo., 1 year,
2 years). A linear regression analysis comparing the Lysholm scale to the Cincinnati scale is as follows: y = 0.73x + 27.8 (y = Lysholm, x =
Cincinnati). The study indicates that the Lysholm scale gave significantly better results (high score) up to 1 year after surgery compared to the
Cincinnati. The Lysholm score was sensitive to clinical changes from 3 to 6 moth follow-up only and remained unchanged thereafter.
51
52
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Lysholm Knee Score
Marx
Reliability, validity, and responsiveness of four knee outcome
scales for athletic patients
2001
Year
PubMed ID:
Reviewer’s Name
Date of Review
11679594
Travis Hamilton
7.6.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36: PF = .66,;RP = .49; BP = .57
1
Cincinnati scale = .70; Activities of Daily Living Scale = .85
1
SF – 36: RE = .18; MH = .29
1
Confirmed Hypotheses:
•
The instruments would all correlate better with
each other than they would with the physical
component scale or the mental component scale
and the physical component scale would
correlate more strongly with the knee scales.
•
The knee-rating scales would correlate better
with each other than they would with any of the
eight SR-36 scales.
•
The knee scales would correlate better with
physical function and role-physical than they
would with vitality or social function and that
they would correlate better with GH, BP, VT, and
SF than they would with RE or MH.
•
Knee scales would be significantly correlated with
clinician-rated and patient-rated severity.
•
There would be a difference in the mean scores
on the knee specific instruments for patients who
had different patient rated severity scores as well
as for those who had different clinician-rated
severity score.
•
There would be no veiling or floor effects.
53
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.95
Mean = 5.2 (2-14)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
SRM = .9
NA
NA
NA
3 months minimum
Descriptive Features
Reliability
32.6 (16-60)
41
Validity
31.5 (14-65)
133
Responsiveness
30.9 (15-61)
42
Male
Female
20
21
69
64
19
23
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
28
1
4
12
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
2
57
2
5 (MCL) 4 (OCD), 3 (PT),
3 (PTO), 1 (OSD) ,
5(misc)
17
2
4
21
2
Age range of sample
Number:
Sex
Diagnosis
Provide normative data
3
6
15
6
NA
54
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
Present
1
2
Notes:
Spearman coefficient was used for all values testing for validity.
55
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Lysholm Knee Score
Paxton
The reliability and validity of knee-specific and general health
instruments in assessing acute patellar dislocation outcomes
2003
Year
PubMed ID:
Reviewer’s Name
Date of Review
12860533
Travis Hamilton
7.7.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; PF = 0.57, RP = 0.38, BP = 0.50
1
** Tegner = 0.24, Fulkerson = 0.93, Kujala = 0.86 , Modified
IKDC knee ligament form = -0.51
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = 0.71
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
** ρ = 0.88
Mean 21 (13-42)
56
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
TABLE 1.
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Acute patellar dislocation
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
NA
NA
NA
Present
1
2
Notes:
**Spearman’s rho coefficient was used to assess test-retest reliability and intercorrelations between instruments.
57
58
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Lysholm Knee Score
Kocher
Reliability, Validity, and Responsiveness of the Lsholm Knee
Scale for Various Chondral Disorders of the Knee
2004
Year
PubMed ID:
Reviewer’s Name
Date of Review
15173285
Travis Hamilton
7.8.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-12: PF = 0.537; RP = 0.476; BP = 0.559 (Pearson coeff.)
1
WOMAC: Pain ρ = -0.802; stiffness ρ = -0.657; function ρ = 0814 (Spearman ρ) : Tegner: = 0.346 (Pearson)
NA
1
1.
2.
3.
4.
5.
6.
7.
All were confirmed and significant (P<0.05)
Patients with lower activity levels would have lower
scores on the Lysholm knee scale.
Patients with a greater number of chondral surfaces
with Outerbridge grade-4 changes would have lower
scores on the Lysholm knee scale.
Patients with full0thickness chondral defects would
have lower scores on the Lysholm Knee scale than
would patients with partial-thickness chondral defects.
Patients with chondral defects and associated
meniscal tears would have lower scores on the lysholm
knee scale than would patients with isolated chondral
defects.
Patients who had more difficulty with activities of daily
living would have lower scores on the Lysholm scale
than would patients who had les difficulty with the
activities of daily living.
Patients who had more difficulty working because of
the knee would have lower scores on the Lysholm
scale than would patents who had les difficulty
working because of the knee.
Patients who had more difficulty with sports because
of the knee would have lower scores on the Lysholm
59
8.
9.
knee scale than would patients who had less difficulty
with sports because of the knee.
Patients with previous knee surgery would have lower
scores on the Lysholm knee scale than would patients
without previous knee surgery.
Patients with a poorer assessment of overall knee
function would have lower scores on the Lysholm knee
scales than would patients with a better assessment of
overall knee function.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = 0.65
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.91 *component scores Table 1.
Within 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES = 1.16; SRM = 1.10
NA
NA
NA
51.2 months (12.5-79.4)
Descriptive Features
Age range of sample
Number:
Sex
44 (14-88)
1657 (Group A)
Male
Female
1011
646
Diagnosis
Traumatic unicompartmental chondral lesions
Traumatic multicompartmental chondral lesions
679 (ligament injury = 230, meniscal injury = 285)
249 (ligament injury = 65, meniscal injury = 107)
60
Degenerative chondral lesions
Group B (subset of main group - A)
Group C (subset of main group - A)
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
729 (ligament injury = 80, meniscal injury = 277)
57
248
NA
NA
NA
Present
1
2
Internal consistency and content and construct validity was determined from patients in Group A. Test-retest reliability data was taken from
patients included in Group B. Criterion validity and Responsiveness was determined from group C. There were no overall floor and ceiling effects
observed. However, for the domains of squatting had a high (>30%) floor effect, and the domains of limp, instability, support, and locking had high
(>30%) ceiling effects
61
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Lysholm Knee Score
Briggs
Reliability, Validity, and Responsiveness of the Lysholm Knee
Score and Tegner Activity Scale for Patients with Meniscal
Injury of the Knee
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16595458
Travis Hamilton
7.8.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-12; r = 0.551 (p < 0.05)
NA
NA
1
1.
2.
3.
4.
5.
6.
All hypotheses significant (p< 0.05)
Patients with lower activity levels would have lower
Lysholm scores.
Bc of the pain, swelling, possible use of crutches and
overall disability associated with an acute nee injury,
patients with such an injury would have a lower mean
Lysholm score than would patients with a chronic knee
injury.
Patients with a Worker’s Compensation claim would
have a lower mean Lysholm score than would patients
without a Workers’ Compensation claim.
Patients with more difficulty with activities of daily
living would have lower Lysholm scores than would
patients with less difficulty with activities of daily
living.
Patients with more difficulty working because of
problems with knee would have lower Lysholm scores
than would patients with less difficulty because of
problems with the knee.
Patients with more difficulty participating in sports
activity because of problems with the knee would have
lower Lysholm scores than would patients with less
difficulty participating in sports activity because of
62
7.
8.
problems with the knee.
Patients who assessed their overall knee function as
abnormal or severely abnormal would have a lower
mean Lysholm score than would patients who
assessed it as normal or nearly normal.
Patients with a degenerative and/or complex mensical
tear would have a lower mean Lysholm score than
would patients with a simple tear of the meniscus.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = 0.729
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.927
4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
Group 1: ES = 1.2, SRM = 0.97; Group 2 = ES = 1.2, SRM
= 1.13
1
MDC = 10.1
NA
NA
12 months
Descriptive Features
Test-retest
group
Age range of sample
Number:
Sex
Male
Female
48 (14-76)
122
ICC/Content
Val./Construct val./
Group 1
40 (13-81)
191
ICC/Content
Val./Criterion Val.
Group 2
39 (18-62)
477
77
45
129
62
367
110
Diagnosis
63
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
Test-retest
group
ICC/Content
Val./Construct val./
Group 1
ICC/Content
Val./Criterion Val.
Group 2
1; MML = 59;
LML = 40;
MML+LML =
23; IML = 28
MML = 117; LML =
60; MML+LML = 14
Meniscal lesion +
associated intraarticular diseases
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing
values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
Present
1
2
Notes:
MML – Medial meniscal lesion, LML – lateral meniscal lesion, IML – Isolated meniscal lesion. In the Lysholm score, the domain of squatting and a
high floor effect and the domains of limp, instability, support, and locking had a high ceiling effect. Thus, these domains may lack the discriminative
ability to differentiate the functional status of patients with a meniscal injury of the knee.
64
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Lysholm Knee Score
Heintjes
Lysholm scale and WOMAC index were responsive in
prospective cohort of young general practice patients
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
18394542
Travis Hamilton
7.8.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
1
Overall hypotheses confirmed (combined groups)
1. Baseline pain and instrument scores should be
moderately correlated.
2. Changes in pain and instrument scores should be
moderately correlated.
3. The correlation between recovery scores and
change scores on the instruments adjusted for
baseline scores should be high.
4. Patients with good baseline COOP/WONCA
physical fitness scores should have better
instrument scores than patients with poor
physical fitness scores.
5. Patients refraining from daily duties because of
their knee complaints (employment, domestic
work, and school) should show lower scores than
patients who do not.
6. Patients bothered by their knee complaints
during daily duties (employment, domestic work,
and school) should show lower scores than
patients who are not.
7. Patients reporting moderate to severe pain with
at least four our of seven activities (walking stairs,
prolonged sitting with flexed knees, running,
jumping, squatting, kneeling, and cycling) should
show lower scores.
65
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
Traumatic patients: ES = 1.15, SRM = 1.14, Guyatt =
0.94; Nontraumatic patients: ES = 0.76, SRM = 0.73,
Guyatt = 1.11
NA
NA
NA
1 year
Descriptive Features
Age range of sample
Number:
24.6 ± 7.5 years (12-35)
314
Sex
Table 1.
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Traumatic – 184; Nontraumatic - 117
NA
66
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
1
Present
ENGLISH
2
Notes:
•
•
Analyses were performed for all patients combined and stratified per age group (aged 12-17 or 18 – 35) and per type of knee complain
(nontraumatic and traumatic). For responsiveness analysis, baseline scores and 1-year follow-up scores as well as perceived recovery
scores, which were available for 137 nontraumatic patients and 91 traumatic patients.
Construct validity was unsatisfactory in the analysis of the nontraumatic young adults. This is in part due to hypothesis 3. The correlation
between change scores and recovery (convergent construct validity) was unsatisfactory. However, because the Guyatt’s statistic is high,
the clinically important changes can still be detected in young adults.
67
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Lyscholm Knee Score
Briggs
The Reliability, Validity, and Responsiveness of the Lysholm
Score and Tegner Activity Scale for Anterior Cruciate Ligament
Injuries of the Knee: 25 Years Later
2009
Year
PubMed ID:
Reviewer’s Name
Date of Review
19261899
Travis Hamilton
6.28.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
1
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-12: r = .43
1
IKDC: r = .78, P > .001
1
SF-12 (mental component): r = .07, P < .05
1
All constructs were significant:
•
Patients with moderate to severe difficulty running
had lower Lysholm scores than patients with none to
mild difficulty. (P<.001)
•
Patients with more difficulty with activities of daily
living (ADL) had lower Lysholm score than patients
with less difficulty with ADL. (P<.001)
•
Patients with more difficulty working becaue3 of their
knee had lower Lysholm scores than patients with less
difficulty working because of their knee. (ρ = 0.43;
P<.001)
•
Patients with more difficulty with sports because of
their knee had lower Lysholm scores than patients
with less difficulty with sports because of their knee. (ρ
= 0.33; P<.001)
•
Patients with abnormal or severely abnormal
assessment of overall knee function had lower
Lysholm scores than patients with a normal or nearly
normal assessment of overall knee function. (P<.001)
•
Patients with ACL tears with associated complex
miniscal injuries requiring suture repair had a lower
Lysholm score than patients with isolated tears.
(P<.001)
68
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = .72
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.94
Within 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: 6 mo. = 1; 9 mo. = 1; 12 mo. = 1.1; 24 mo. = 1.1
SRM: : 6 mo. = .925; 9 mo. = 1.1; 12 mo. = 1.2; 24 mo.
= .93
1
MDC = 8.9
NA
NA
6 mo., 9 mo., 12 mo., 24 mo.
Descriptive Features
Age range of sample
Number:
Sex
37 (18-77)
1783 (table 1)
Male
Female
1034
749
Diagnosis
ACL injury/surgery
Provide normative data
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
100%; 593 ACL tears, 1190 concurrent injuries (meniscal
and/or cartilage damage)
NA
69
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
1
2
Notes:
70
Lysholm Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Lysholm Knee Score
Demirdjian
The Outcomes of Two Knee Scoring Questionnaires in a
Normal Population
1998
Year
PubMed ID:
Reviewer’s Name
Date of Review
9474400
Travis Hamilton
2.27.2012
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
71
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
17.6 (13 – 25)
246 (215 used for study)
Male
Female
Diagnosis
Normal Population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
131
84
100%
1
NA
NA
Present
English
2
72
Notes:
The average score for male subject is 99.10 ± 2.73 (77 – 100) and for female subjects is 97.16 ± 5.26 (75 – 100). For all categories of the Lysholm
questionnaire, the male subjects reported higher scores than the female subjects except for the Limp and Support categories. The total scores were
significantly greater for the male subjects than the female subjects (P = 0.00005)
73
Tegner Activity Scale
Paxton (2)
Briggs (3)
Briggs (4)
Briggs (5)
Validity, Reliability
Validity, Reliability,
Responsiveness
Reliability, validity,
responsiveness
Normative data, validity
Acute patellar dislocation
Meniscal injury
ACL (plus concurrent)
injuries
Normal Knees
Validity = 110, Test-retest =
81
Test-retest group =
122, Validity group 1 =
191, Validity group 2 =
477
1783
488
Validity =First dislocation: 16
(9-67), Prior dislocation: 18
(8-65) Test-retest= First
dislocation: 16 (9-48), Prior
dislocation: 22 (8-65)
Test-retest group = 48
(14-76), Validity group
1 = 40 (13-81), Validity
group 2 = 39 (18-62)
37 (18-77)
41 ( 18-85)
Test-retest group =
36%, Validity group 1 =
32%, Validity group 2 =
23%
42%
50.00%
Study Characteristics
Purpose
Study
Population/Sample
(inclusion/exclusion)
Number
Age range
(average ± SD, min-max)
Sex (% female)
NA
Reliability
Internal consistency
NA
NA
NA
NA
Test-retest reliability
r = 0.92
ICC = 0.82
ICC = .82
NA
Time interval
21 days
4 weeks
4 weeks
NA
Correlation to similar scale
Little (75%), Fair (25%)
correlation to similar scales
NA
Little (100%) correlation to
similar scales
Little (100%) correlation
to similar scales
Correlation to general
measures of Physical
function
Little (66.6%), Fair (33.3%)
correlation to general
measures of physical
function
Fair (100%) correlation
to general measures of
physical function
Little (100%) correlation to
general measures of
physical function
NA
Correlation to general
measures of mental
function
NA
NA
Little (100%) correlation to
general measures of
mental function
NA
ES
NA
Validity Group 1 = .61,
Validity Group 2 = .83
6mo = .74 , 9mo. = 1.1,
12mo. = 1.0, 24mo. = 1.1
NA
SRM
NA
Validity Group 1 = .60,
Validity Group 2 = .704
6mo. = 0.61 , 9mo. = .84,
12mo. = .96, 24mo. = 1.0
NA
MDC
NA
1
1
NA
MCID
NA
NA
NA
NA
Guyatt
NA
NA
NA
NA
Time Interval
NA
12 months
6 mo., 9 mo., 12 mo., 24
mo.
NA
Floor/Ceiling Effect
No
No
No
NA
Normal Distribution
No
NA
No
No
Normal Data
NA
NA
NA
Yes
Validity
Responsiveness
Other
74
TEGNER STUDY CONSOLIDATION
REFERENCES
2)
Paxton EW, Fithian DC, Stone ML, Silva P. The reliability and validity of knee specific and general health instruments
in assessing acute patellar dislocation outcomes. Am J Sports Med. 2003; 31: 487-92.
3)
Briggs KK, Kosher MS, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the Lysholm knee
score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am. 2006; 88(4): 698705
4)
Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kosher MS, Steadman R. Reliability, validity, and responsiveness of
the Lysholm knee score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am
J Sports Med, 2009; 37: 890-897
5)
Briggs KK, Steadman JR, Hay CJ and Hines SL: Lysholm score and Tegner activity with normal knees. Am J Sports
Med, 2009; 37: 898-901
75
Tegner Activity Level
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Tegner Activity Level
Paxton
The reliability and validity of knee-specific and general health
instruments in assessing acute patellar dislocation outcomes
2003
Year
PubMed ID:
Reviewer’s Name
Date of Review
12860533
Travis Hamilton
7.7.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; PF = 0.37, RP = 0.22, BP = 0.20
1
** Lysholm = 0.24, Fulkerson = 0.26, Kujala = 0.33 ,
Modified IKDC knee ligament form = -0.54
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
NA
76
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
** ρ = 0.92
Mean 21 (13-42)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
TABLE 1.
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Acute patellar dislocation
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
NA
NA
NA
Present
1
2
Notes:
**Spearman’s rho coefficient was used to assess test-retest reliability and intercorrelations between instruments.
77
78
Tegner Activity Level
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Tegner Activity Level
Briggs
Reliability, Validity, and Responsiveness of the Lysholm Knee
Score and Tegner Activity Scale for Patients with Meniscal
Injury of the Knee
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16595458
Travis Hamilton
7.8.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
;Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-12; r = .46 ; P < 0.05
NA
NA
1
9.
10.
11.
12.
13.
14.
15.
All hypotheses significant
Patients with moderate-to-severe pain with activity
would have a lower mean Tegner activity level than
would patients with no or mild pain with activity
Patients with moderate-to-severe difficulty running
would have a lower mean Tegner activity level than
would patients with no or mild difficulty running.
Patients with more difficulty with activities of daily
living would have lower Tegner activity levels than
would patients with less difficulty with activities of
daily living.
Patients with more difficulty working because of
problems with knee would have lower Tegner activity
levels than would patents with less difficulty working
because of problems with the knee.
Patients with more difficulty participating in sports
activity because of problems with the knee would have
lower Tegner activity levels than would patients with
less difficulty participating in sports activity because of
problems with the knee.
Patients who assessed their overall knee function as
abnormal or severely abnormal would have a lower
mean Tegner activity level than would patients who
assessed it as normal or nearly normal.
Because of the pain, swelling, possible use of crutches,
and overall disability associated with an acute knee
79
injury, patients with such an injury would have a lower
mean Tegner activity level than would patients with a
chronic knee injury.
16. Patients with a degenerative and/or complex meniscal
tear would have a lower mean Tegner activity level
than would patients with a simple meniscal tear.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.817
4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
Group 1: ES = .61, SRM = 0.60; Group 2 = ES = .836,
SRM = .704
1
MDC = 1
NA
NA
12 months
Descriptive Features
Test-retest
group
Age range of sample
Number:
Sex
Diagnosis
Male
Female
48 (14-76)
122
ICC/Content
Val./Construct val./
Group 1
42 (16-81)
80
ICC/Content
Val./Criterion Val.
Group 2
39 (18-62)
477
77
45
50
30
367
110
ACL injury/surgery
PCL injury/surgery
80
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing
values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Test-retest
group
ICC/Content
Val./Construct val./
Group 1
ICC/Content
Val./Criterion Val.
Group 2
1; MML = 59;
LML = 40;
MML+LML =
23; IML = 28
MML = 42; LML =
29; MML+LML = 9
Meniscal lesion +
associated intraarticular diseases
NA
NA
NA
Present
1
2
Notes:
MML – Medial meniscal lesion, LML – lateral meniscal lesion, IML – Isolated meniscal lesion.
81
Tegner Activity Level
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Tegner Activity Level
Briggs
The Reliability, Validity, and Responsiveness of the Lysholm
Score and Tegner Activity Scale for Anterior Cruciate Ligament
Injuries of the Knee: 25 Years Later
2009
Year
PubMed ID:
Reviewer’s Name
Date of Review
19261899
Travis Hamilton
6.28.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-12 (Physical component): ρ = .2, P<.05
1
IKDC: ρ = .22, P > .001
1
SF-12 (mental component): ρ = -0.01, P = .92
1
All constructs were significant:
•
Patients with moderate to severe pain with activity
had lower Tegner activity levels than patients with
none to mild pain with activity. (P < .05)
•
Patients with moderate to severe difficulty running
had lower Tegner activity levels than patients with
none to mild difficulty. (P < .01)
•
Patients with more difficulty with activities of daily
living had lower Tegner activity levels than patients
with less difficulty with activities of daily living. (ρ =
0.37, P < .01)
•
Patients with more difficulty working because of their
knee had lower Tegner activity levels than patients
with less difficulty working because of their knee. (ρ =
0.38, P < .01)
•
Patients with more difficulty with sports because of
their knee had lower Tegner activity levels than
patients with less difficulty with sports because of
their knee. (ρ = 0.35, P < .01)
•
Patients with abnormal or severely abnormal
assessment of overall knee function had lower Tegner
activity levels than patients with a normal or nearly
normal assessment of overall knee function. (P < .01)
82
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
.82
Within 4 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: 6 mo. = .74; 9 mo. = 1.1; 12 mo. = 1.0; 24 mo. = 1.0
SRM: : 6 mo. = .61; 9 mo. = .84; 12 mo. = .96; 24 mo. =
1.0
1
MDC = 1
NA
NA
6 mo., 9 mo., 12 mo., 24 mo.
Descriptive Features
Age range of sample
Number:
Sex
37 (18-77)
1783 (table 1)
Male
Female
Diagnosis
ACL injury/surgery
1034
749
100%; 593 ACL tears, 1190 concurrent injuries (meniscal
and/or cartilage damage)0.
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
83
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
1
2
84
Tegner Activity Scale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Tegner Activity Scale
Briggs
Lysholm Score and Tegner Activity Level in Individuals with
Normal Knees
2009
Year
PubMed ID:
Reviewer’s Name
Date of Review
19307332
Travis Hamilton
7.12.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
1
Lysholm: ρ = .07; P = .17 (not correlated)
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
NA
85
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
41 (18-85)
488
Male
Female
Normal Knees
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
244
244
100%
1
1
NA
Present
English
NA
Notes:
Tegner activity level was inversely correlated with age (ρ = -.40, P = .001). This was consistent for both men (ρ = -.48, P = .001) and women (ρ = -.34,
P = .001).
86
Cincinnati Knee Scale
Barber-Westin (1)
Risberg (2)
Marx (3)
Greco (5)
Reliability, Responsiveness,
Validity
Validity
Reliability, Responsiveness,
Validity
Reliability,
Responsiveness
Normal, Injured, ACL
reconstruction
ACL injury, combined
injury
Various injuries
Patients following articular
cartilage surgery
120
Reliability group = 41, Validity
group = 133, Responsiveness
group = 42
Reliability = 17,
Responsiveness = 50
27.8
Reliability group = 32.6 (16-60),
Validity group = 31.5 (14-65),
Responsiveness group = 30.9
(15-61)
Reliability = 43.8 years ±
10.4 (21-60),
Responsiveness = 36.6
years±9.7 (15-56)
Reliability group = 52%,
Validity group = 46%,
Responsiveness group = 54%
Reliability = 39%,
Responsiveness = 39.2%
Study Characteristics
Purpose
Study
Population/Sample
(inclusion/exclusion)
Number
Age range
(average ± SD, min-max)
Sex (% female)
Validity/Responsiveness
Groupn1 = 250, Test-retest
Group 2 = 50, Test-retest
Group 3 = 50
Validity/Responsiveness
Groupn1 = 29 (14-58),
Test-retest Group 2 = 36
(13-65), Test-retest Group
3 = 34 (20-59)
Validity/Responsiveness
Groupn1 = 29%, Test-retest
Group 2 = 44%, Test-retest
Group 3 = 56%
46%
Reliability
Internal consistency
NA
NA
NA
NA
Test-retest reliability
ICC: Sports activity = .98
(uninjured), .98 (patients)
Occupational rating = .87
(uninjured), .97 (patients)
NA
ICC = 0.88
6mo = 0.91, 12mo = 0.80
7 days
NA
5.2 days
6 mo, 12 mo
Correlation to similar scale
NA
Little(29%), Fair
(13%), Moderate
(33%), Excellent
(25%) correlation to
similar scales
Moderate (50%), Excellent
(50%) correlation to similar
scales
NA
Correlation to general
measures of Physical
function
NA
NA
Correlation to general
measures of mental
function
NA
NA
ES
3.49
NA
NA
6mo = 0.60, 12mo = 1.09
SRM
2.48
NA
0.8
6mo = 0.52, 12mo = 0.76
MDC
NA
NA
27.5 (calc)
(1.96)*(sqrt(2))*((28.7)*sqrt(1.88))
NA
MCID
NA
Na
NA
6mo = 14.0 (Sens = 0.64 ;
Spec = 0.70), 12mo = 26.0
(Sens = 0.55 ; Spec =
0.85)
Guyatt
NA
NA
NA
NA
Time Interval
27 months
NA
3 months
6, 12 months
Time interval
Validity
Moderate (100%) correlation to
general measures of physical
function
Little (100%) correlation
between general measures of
mental function
NA
NA
Responsiveness
Other
Floor/Ceiling Effect
No
NA
No
Yes
Normal Distribution
NA
NA
NA
NA
Normal Data
NA
All subscales
NA
Symptoms, function, and daily
activities
NA
Subscales used
NA
Symptoms and
Function
Sports activity, symptoms,
and overall rating scale
87
Demirdjian (6)
Study Characteristics
Purpose
Normative Data
Study
Population/Sample
(inclusion/exclusion)
High School and College Students
Number
246
Age range
(average ± SD, min-max)
17.6 (13 – 25)
Sex (% female)
40%
Reliability
Internal consistency
NA
Test-retest reliability
NA
Time interval
NA
Validity
Correlation to similar scale
NA
Correlation to general
measures of Physical function
NA
Correlation to general
measures of mental function
NA
Responsiveness
ES
NA
SRM
NA
MDC
NA
MCID
NA
Guyatt
NA
Time Interval
NA
Other
Floor/Ceiling Effect
NA
Normal Distribution
NA
Normal Data
Yes
Subscales used
Symptoms, Sports activity, Function, and
Overall
88
CINCINNATI KNEE SCALE CONSOLIDATION
REFERENCES
1)
Barber-Westin SD, Noyes FR, McCloskey JW. Rigorous statistical reliability, validity, and responsiveness testing of
the Cincinnati knee rating system in 350 subjects with uninjured, injured, or anterior cruciate ligament-reconstructed
knees. Am J Sports Med. 1999 Jul-Aug;27(4):402-16
2)
Risberg MA, Holm I, Sten H, Beynnon BD. Sensitivity to changes over time for the IKDC form, the Lysholm score,
and the Cincinnati knee score. A prospective study of 120 ACL reconstructed patients with a 2-year follow-up. Knee
Surg, Sports Traumatol, Arthroscophy (1999) 7:152-159
3)
Marx RG, Jones EC, Allen AA, Altchek DW, O'Brien SJ, Rodeo SA, Williams RJ, Warren RF, Wickiewicz TL.
Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am.
2001;83:1459-69
5)
Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International
Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster
Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal
articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
6)
Demirdjian AM, Petrie SG, Guanche CA, Thomas KA. The outcomes of two knee scoring questionnaires in a normal
population. Am J Sports Med. 1998 Jan-Feb;26(1):46-51
89
Cincinnati Knee Scale (all subscales)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Year
PubMed ID:
Cincinnati Knee Scale
Barber-Westin (all subscales)
Rigorous Statistical Reliability, Validity, and Responsiveness
Testing of the Cincinnati Knee Rating System in 350 Subjects
with Uninjured, Injured, or Anterior Cruciate LigamentReconstructed Knees
1999
10424208
Reviewer’s Name
Date of Review
Travis Hamilton
7.24.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
1
For those who had ACL injuries, there would be lower
results in the following:
1. Chronic injuries
2. Deteriorated articular cartilage
3. Prior failed ACL reconstructions
4. Poor or fair overall patient perception scores
5. (Not confirmed) Concurrent major operative
procedures such as a meniscus repairs or other
ligament reconstructions
6. Operative complications
7. Symptoms with sports or work at follow up
8. Inability to return to work or sports because of the
knee condition
9. Work related injuries
Criterion Validity
90
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
Table 1.
7 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
Overall ES = 3.49
Overall SRM = 2.48
NA
NA
NA
27 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Group 1 (Validity and
Responsiveness)
29 (14-58)
250
Group 2 (testretest)
36 (13-65)
50
Group 3 (test-retest)
34 (20-59)
50
177
73
28
22
22
28
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Other
No Knee related problems
1
1
1
1
1
1
91
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing
values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
1
Present
NA
NA
Notes:
92
Cincinnati Knee Scale – Symptoms and Function subscales
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Cincinnati Knee Scale (Symptoms and Function subscales)
Risberg
Sensitivity to changes over time for the IKDC form, the
Lysholm score, and the Cincinnati knee score
1999
10401651
Travis Hamilton
6.30.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
IKDC1-4 and IKDC-final form, Lysholm – table 3.
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
93
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
NA; table 2
NA
NA
NA
3 mo., 6.mo., 1 year, 2 years
Descriptive Features
Age range of sample
Number:
Sex
27.8
120
Male
Female
64
56
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
58
Diagnosis
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
62 (+ACL)
NA
NA
2
1
2
Notes:
The Symptoms and Function Subscales were used as described by Noyes in 1984
120 subjects with either ACL or ACL combined injuries who underwent reconstruction using a bone-patellar-tendon –bone graft were included in
this study. Patients were assessed with 3 instruments (IKDC form, Lysholm, and Cincinnati score) at 4 different time periods (3mo., 6mo., 1 year,
2 years). A linear regression analysis comparing the Lysholm scale to the Cincinnati scale is as follows: y = 0.73x + 27.8 (y = Lysholm, x =
Cincinnati). The study indicates that the Lysholm scale gave significantly better results (high score) up to 1 year after surgery compared to the
Cincinnati. The Cincinnati scale was the only outcome measurement sensitive enough to measure significant changes between all follow-up
94
intervals. This score has previously been found to be a sensitive outcome measurement both early and during long term follow up after ACL
reconstruction.
The papers cites the Cincinnati Scale used in the reference: “Abnormal lower limb symmetry determined by function hop tests after anterior
cruciate ligament rupture,” By Noyers et al. Which is indicative of the Sports Activity subscale.
95
Cincinnati Knee Scale – Sports Activity subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Cincinnati Knee Scale (Symptoms, Daily Activities, Sports
Function subscales)
Marx
Reliability, validity, and responsiveness of four knee outcome
scales for athletic patients
2001
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
11679594
Travis Hamilton
7.7.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36: PF = .68,;RP = .52; BP = .51
1
Lysholm scale = .70; Activities of Daily Living Scale = .80
1
SF – 36: RE = .18; MH = .24
1
Confirmed Hypotheses:
•
The instruments would all correlate better with
each other than they would with the physical
component scale or the mental component scale
and the physical component scale would
correlate more strongly with the knee scales.
•
The knee-rating scales would correlate better
with each other than they would with any of the
eight SR-36 scales.
•
The knee scales would correlate better with
physical function and role-physical than they
would with vitality or social function and that
they would correlate better with GH, BP, VT, and
SF than they would with RE or MH.
•
Knee scales would be significantly correlated with
clinician-rated and patient-rated severity.
•
There would be a difference in the mean scores
on the knee specific instruments for patients who
had different patient rated severity scores as well
as for those who had different clinician-rated
severity score.
•
There would be no veiling or floor effects.
96
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.88
Mean = 5.2 (2-14)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
SRM = 0.8
NA
NA
NA
3 month minimum
Descriptive Features
Reliability
32.6 (16-60)
41
Validity
31.5 (14-65)
133
Responsiveness
30.9 (15-61)
42
Male
Female
20
21
69
64
19
23
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
28
1
4
12
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
2
57
2
5 (MCL) 4 (OCD), 3
(PT), 3 (PTO), 1 (OSD)
, 5(misc)
17
2
4
21
2
Age range of sample
Number:
Sex
Diagnosis
3
6
15
97
Reliability
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Validity
Responsiveness
6
NA
NA
NA
Present
1
2
Notes:
The Symptoms, Daily Activities, and Sports function subscales were used as described by Barber-Westin (ref 1)
98
Cincinnati Knee Scale – (Sports activity, symptoms, and overall rating scale)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Cincinnati Knee Scale – (Sports activity, symptoms, and overall
Author’s Last Name
Title of the Article
Greco
Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the
Western Ontario and McMaster Universities Osteoarthritis
Index, Modified Cincinnati Knee Rating System, and Short
Form 36 in Patients with Focal Articular Cartilage Defects.
2010
20044494
Travis Hamilton
7.23.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
rating scale)
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
2
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
99
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
CKRS (6 mo., 12mo.) = 0.91 ; 0.80
6 mo, 12 mo
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
CKRS ES (6 mo., 12mo.) = 0.60 ; 1.09
CKRS SRM (6 mo., 12mo.) =0.52 ; 0.76
(table 2)
1
6 month: CKRS MCID: 14.0 (Sens = 0.64 ; Spec = 0.70)
12 month: CKRS MCID: 26.0 (Sens = 0.55 ; Spec = 0.85)
(table 3)
1 (global scale)
NA
6 months and 12 months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Reliability (A)
43.8 years ± 10.4 (21-60)
17
61% male
Responsiveness (B)
36.6 years±9.7 (15-56)
50
60.8% male
17
NA
50
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and
weighting of items:
Provided information about calculating
with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this
report
Is this the first or primary report about this
instrument?
1
NA
Present
NA
2
100
Cincinnati Knee Score – (Cincinnati Knee Score (Symptoms, Sports activity, Function, and Overall subscales)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Cincinnati Knee Score (Symptoms, Sports activity, Function,
and Overall subscales)
Demirdjian
The Outcomes of Two Knee Scoring Questionnaires in a
Normal Population
1998
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
9474400
Travis Hamilton
2.27.2012
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
101
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
17.6 (13 – 25)
246
Male
Female
Normal Population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
131
84
100%
1
NA
NA
Present
English
2
102
Notes:
The scores for the Cincinnati are based on the Symptoms, Sports activity, Function, and Overall subscales as described by Noyes in 1990.
The average score for male subject is 99.10 ± 3.77 (68 – 100) and for female subjects is 97.82 ± 4.97 (72 – 100). For all categories of the Cincinnati
questionnaire, the male subjects reported higher scores than the female subjects except for the walking category. The total scores were
significantly greater for the male subjects than the female subjects (P = 0.0051)
103
KOOS- SYMPTOMS SUBSCALE
Roos (1)
Roos (2)
Xie (4)
Ornetti (6)
Purpose
Reliability,
Responsiveness, Validity
Validity, Reliability of
Swedish Version
Validity, Reliability of
Singapore English and
Chinese Version
Validity, Reliability of French
version
Study
Population/Sample
(inclusion/exclusion)
ACL Injury/Surgery
Variety of knee
disorders/injury
Osteoarthritis
Osteoarthritis
Number
21
142
Singapore English = 127
Chinese = 131
Medicine Group = 37, Surgery
Group = 30
Age range
(average ± SD, minmax)
32 (18-36)
14-89
Singapore English = 65.3
Chinese = 67.8
Medicine Group = 70  10 (45-91),
Surgery Group = 71  10 (42-85)
Sex (% female)
57%
37%
Singapore English = 76%
Chinese = 88%
Medicine Group = 68% Surgery
Group = 73%
Internal consistency
NA
α = .74
α:Singapore English = .70
Chinese = .64
α = .76
Test-retest reliability
ICC = .93
ICC = .84
ICC: Singapore English = .87
Chinese = .85
ICC = .91
Time interval
9 days
8 days
6 days
2 weeks
Correlation to similar
scale
NA
Fair (100%) correlation to
similar scale
English: No(100%) Chinese:
No (100%) correlation to
similar scales
Little (20%), Fair (80%) correlation
to similar scales
Correlation to general
measures of Physical
function
Little (33%), Fair (66%)
correlation to general
measures of physical
function
Little (33.3%), Fair (66%)
correlation to general
measures of physical
function
English: Little (33.3%),Fair
(66.6%) Chinese: Little
(33.3%), Fair (66.6%)
correlation to general measure
of physical function
NA
Correlation to general
measures of mental
function
Litle (100%) correlation
to general measures of
mental function
Little (100%) correlation to
general measures of
mental function
English: Little (100%) Chinese:
Little (50%), Fair (50%)
correlation to general
measures of mental function
NA
ES
0.87
0.93
NA
1.63
SRM
NA
NA
NA
1.45
16.6 (calc)
Study Characteristics
Reliability
Validity
Responsiveness
MDC
9.9 (calc)
21.5 (calc)
Singapore English = 19.0
(calc)
Chinese = 19.1 (calc)
MCID
NA
NA
NA
NA
Guyatt
NA
NA
NA
NA
Time Interval
6 month
3 months
NA
3 month
Floor/Ceiling Effect
NA
No
No
No
Normal Distribution
NA
NA
NA
NA
Normal Data
NA
NA
NA
NA
Other
104
KOOS- SYMPTOMS SUBSCALE CONTINUED
De Groot (7)
Salavati (10)
Bekkers (11)
Purpose
Validity, Reliability of Dutch version
Validity, Reliability of Persian
version
Validity, reliability
Study
Population/Sample
(inclusion/exclusion)
Osteoarthritis
Meniscus, ACL, Combined Knee
injury
Cartilage Degeneration/Surgery
Number
Mild OA = 36 , Moderate OA = 62 ,
Severe OA = 47 , TKA = 63 ,
Revision TKA = 54
147
40
Age range
(average ± SD, min-max)
Mild OA = 36 (27-50) , Moderate OA
= 56 (27-72) , Severe OA = 65 (4281) , TKA = 61(42-78) , Revision TKA
= 77(36-89)
31.4 (16 – 59)
35±12 (18-55)
Sex (% female)
Mild OA = 22% , Moderate OA = 32%
, Severe OA = 52% , TKA = 51% ,
Revision TKA = 78%
11%
30%
Internal consistency
α: Mild OA = .71 , Moderate OA = .83
, Severe OA = .56 , TKA = .74 ,
Revision TKA = .78
α = .25
α = 0.74
Test-retest reliability
ICC: Mild OA = .74 , Moderate OA =
.87 , Revision TKA = .89
ICC = .83
ICC = 0.95
Time interval
3 weeks
8 days
2 days
Correlation to similar scale
NA
NA
NA
Correlation to general measures of
Physical function
Little (20%), Fair(33.3%), Moderate
(46.7%) correlation with general
measures of physical function
Little (66.6%), Fair (33.3%)
correlation with general measures
of physical function
NA
Correlation to general measures of
mental function
Little (50%), Fair (50%) correlation
with general measures of mental
function
Little (100%) correlation to general
measures of mental function
NA
ES
NA
NA
0.72
SRM
NA
NA
0.61
MDC
ICC: Mild OA = 10.0 , Moderate OA =
24.3 , Revision TKA = 19.7
14.74 (calc)
10.5 (calc)
MCID
NA
NA
NA
Guyatt
NA
NA
NA
Time Interval
NA
NA
36 months
Floor/Ceiling Effect
Yes
No
No
Normal Distribution
NA
NA
NA
Normal Data
NA
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
105
Paradowski (12)
Study Characteristics
Purpose
Study
Population/Sample
(inclusion/exclusion)
Number
Age range
(average ± SD, min-max)
Sex (% female)
Normative Data
General Population
568
568
52.0%
Reliability
Internal consistency
Test-retest reliability
Time interval
NA
NA
NA
Validity
Correlation to similar scale
NA
Correlation to general measures of
Physical function
NA
Correlation to general measures of
mental function
NA
Responsiveness
ES
NA
SRM
NA
MDC
NA
MCID
NA
Guyatt
NA
Time Interval
NA
Other
Floor/Ceiling Effect
NA
Normal Distribution
No
Normal Data
Yes
106
KOOS SYMPTOMS SUBSCALE CONSOLIDATION SUBSCALE
REFERENCES
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2): 88-96
2)
Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation of
a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4)
Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis Cartilage.
Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury and
Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov; 14(11):1098-103.
Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural
adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in knee
osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and Osteoarthritis
Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10) Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation
of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries.
Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis
Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9
12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and
gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score
(KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
107
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Symptoms
subscale
Roos
Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure
1998
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
9699158
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
1
1
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; TABLE 3. - PF = .29 , RP = .27 , BP = .08
NA
1
SF-36; TABLE 3. - RE =-.17 , MH = .13
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
108
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: symptoms = .93
Within 9 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
TABLE 5.
NA
NA
Table 4
3 and 6 month
Descriptive Features
Age range of sample
Number:
Sex
32 (18-46)
21
Male
Female
9
12
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
2
1
1
1 week
1; English and Swedish
1
109
110
111
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – symptoms
subscale
Roos
Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version
1998
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
9863983
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1 Table 2.
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. Table 4 - PF = .32 , RP = .14 , BP = .29
1
Lysholm. Table 4
1
SF-36. Table 4 - RE =.0 , MH = .04
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: Symptoms = .74
112
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: Symptoms = .84
Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: Symptoms = .93
na
na
3 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Diagnosis
142
Table 1.
Figure 1 and 2
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
1
1
Past week
Swedish
2
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
113
114
115
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Symptoms
Subscale
Xie
Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis
outcome score koos in Asians with knee osteoarthritis in
Singapore
2006
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
16814575
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA; cultural adaptation
NA
1
1
NA
1
Forward and reverse translations by separate
translators.
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
English SF-36: PF = .40 RB = .21 BP = .44/Chinese SF-36 PF =
.31 RB = .18 BP = .43
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
EQ-5D; Table 4.
NA
English SF-36: RE = .14 MH = .23/Chinese SF-36 RE = .17 MH
= .29
NA
NA
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
116
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α :Singapore English:, Symptoms = .70
Chinese: Symptoms = .64
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: Singapore English; Symptoms = .87
Chinese; Symptoms = .85
6 days
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Singapore English
65.3
127 (test-retest = 47)
Chinese
67.8
131 (test-retest = 55)
30
97
15
116
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
1; no missing items
Present
1; Chinese and Singapore English
2
117
118
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms Subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Symptoms
Subscale
Ornetti
Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in
knee osteoarthritis patients
2008
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
17905602
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
NA
1
Translation – back translation
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
OAKHQOL, Table 2
NA
1
1.
2.
3.
The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with
the OAKHQOL pain and physical activities domain, and
would correlate weakly with the other OOAKHQOL
domains.
The KOOS sports and recreation domain would
correlate weakly with all OAKHQOL domains, since this
domain has previously been reported as weakly
correlated with all 36-item short form health survey
SF-36 domains.
The KOOS QOL domain would correlate strongly or
moderately with all OAKHQOL domains.
119
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: Symptoms = .76
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: Symptoms = .91
2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: Symptoms = 1.63
SRM: Symptoms = 1.45
NA
NA
NA
3 Months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Medicine Group
70 ± 10 (45-91)
37
Surgery Group
71 ± 10 (42-85)
30
32%
68%
27%
73%
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
1
NA
120
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
1
Present
French
2
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The
surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
121
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Symptoms
subscale
de Groot
The Dutch version of the knee injury and osteoarthritis
outcome score a validation study
2008
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
18302729
Travis Hamilton
7.15.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
1
1
NA
1
notes
NA
1
Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; VAS. Table 4, 5, 6, 7, 8
NA
1
SF-36; VAS. Table 4, 5, 6, 7, 8
1
Convergent hypotheses:
1. The correlation between KOOS Pain and Sf-36 BP,
between KOOS Pain and SF-36 PF, KOOS (all subscales)
and VAS for Pain and KOOS ADL and SF-36 PF should
be ≥ 0.60.
2. KOOS Pain has a stronger correlation with SF-36 BP
compared to the correlation with SF-36 PF. This
difference should be at least 0.05 higher.
3. KOOS Pain has a stronger correlation with VAS for pain
compared to the correlation of the other subscales of
the KOOS with the VAS for Pain. This difference should
be at least 0.05 higher.
4. KOOS ADL was expected to have a 0.05 higher
correlation with SF-36 PF compared to the correlation
of the other subscales of the SF-36.
Divergent hypotheses:
122
1.
All other correlations between the KOOS subscales and
the SF-36 should be higher than 0.30 and lower than
0.60
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: MILD OA Symptoms = .74
MODERATE OA Symptoms = .87
REVISION of TKA: Symptoms = .89
3 WEEKS
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Mild OA
Age range of sample
36 (2750)
36
Number:
Sex
Diagnosis
Male
Female
78
22
Moderate
OA
56 (27-72)
Severe OA
TKA
65 (42-81)
61 (42-78)
Revision
of TKA
77 (36-89)
62
47
63
54
68
32
48
52
49
51
22
78
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
123
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing
values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
NA
Last week
Dutch
2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were
present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor
effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate
construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
124
125
126
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score- Symptoms
subscale
Salavati
Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee
injuries
2008
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
18411065
Travis Hamilton
7.17.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
notes
NA
1
Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. TABLE 4 - PF = .16 , RP = .15 , BP = .34
NA
1
SF-36. TABLE 4 - RE =.13 , MH = .15
1
All hypotheses supported:
1. The correlations between the KOOS Pain and SF=36 BP
subscales should be high.
2. The correlations between the KOOS ADL and Sport/Rec
and Sf-36 PF subscales should be high.
3. The correlations between the KOOS subscales and the
SF-36 subscales of Physical Health (PF, RP, BP) should
be higher than between the KOOS subscales and the
SF-36 subscales of Mental Health (GH, VT, RE, MH)
127
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
A
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α : Symptoms = .25
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC Symptoms = .83
6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
31.4 (16 – 59)
147
Male
Female
131
16
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
60
31
56
NA
NA
1
128
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Last week
Persian
2
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec
and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
129
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Symptoms subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Symptoms
subscale
Bekkers
Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions
2009
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
19454278
Travis Hamilton
7.17.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
1
A priori moderate – strong hypotheses:
1. KOOS symptoms with SF-36 physical functioning
2. KOOS pain with SF-36 bodily pain and WE-VAS
3. KOOS ADL with the complete SF-36 questionnaire.
4. KOOS sport and recreation with the Lysholm knee
scoring scale
5. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
130
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
Symptoms = 0.74
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC = 0.95. table 1
2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: Symptoms = .72
SRM: Symptoms = .61
NA
NA
NA
36 MONTH
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
35±12 (18-55)
40
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
70%
30%
1
NA
NA
2
Last week
ENGLISH
2
131
132
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score
Paradowski
Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee
injury and Osteoarthritis Outcome Score (KOOS)
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16670005
Travis Hamilton
11.8.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA (Notes)
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
133
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
568 (figure 1)
Male
Female
274 (48%)
294 (52%)
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
General Population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
1 (table 1./ notes)
NA
NA
Swedish
2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women
aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function compared to the subscale ADL
function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
134
daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower
extremity functions.
135
KOOS - PAIN SUBSCALE
Roos (1)
Roos (2)
Xie (4)
Purpose
Reliability, Responsiveness, Validity
Validity, Reliability of Swedish
version
Validity, Reliability of Singapore
English and Chinese version
Study
Population/Sample
ACL injury/ Surgery
Variety of Knee disorders/injury
Osteoarthritis
Number
21
142
Singapore English = 127 Chinese =
131
Age range
32 (18-46)
14-89
Singapore English = 65.3 Chinese
= 67.8
Sex (% female)
57%
37%
Singapore English = 76% Chinese
= 88%
Internal consistency
NA
α = .84
α:Singapore English = .79 Chinese
= .65
Test-retest reliability
ICC = .85
ICC = .91
ICC: Singapore English = .88
Chinese = .87
Time interval
9 days
8 days
6 days
Correlation to similar
scale
NA
Moderate (100%) correlation to
similar scale
English: No(100%) Chinese: No
(100%) correlation to similar scales
Correlation to general
measures of Physical
function
Little (66%), Fair (33%) correlation
to general measures of physical
function
Little (33%), Fair (33%), Moderate
(33%) correlation to general
measures of physical function
Correlation to general
measures of mental
function
Little (100%) correlation to general
measures of mental function
Little (100%) correlation to general
measures of mental function
ES
0.84
1.11
NA
SRM
NA
NA
NA
MDC
13.8 (calc)
13.9 (calc)
Singapore English = 15.3 (calc)
Chinese = 12.8 (calc)
MCID
NA
NA
NA
Guyatt
NA
NA
NA
Time Interval
6 month
3 months
NA
Floor/Ceiling Effect
NA
No
No
Normal Distribution
NA
NA
NA
Normal Data
NA
NA
NA
Study Characteristics
Reliability
Validity
English: Little (33%) Fair (66%)
Chinese: Little (33%), Fair (66%)
correlation to general measure of
physical function
English: Little (100%) Chinese: Little
(50%), Fair (50%) correlation to
general measures of mental
function
Responsiveness
Other
136
KOOS - PAIN SUBSCALE CONTINUED
Ornetti (6)
DeGroot (7)
Purpose
Validity, Reliability of French version
Validity, Reliability of Dutch version
Study
Population/Sample
Osteoarthritis
Osteoarthritis
Number
Medicine Group = 37,
Surgery Group = 30
Mild OA = 36 , Moderate OA = 62 , Severe OA = 47 ,
TKA = 63 , Revision TKA = 54
Age range
Medicine Group = 70 ± 10 (45-91), Surgery Group
= 71 ± 10 (42-85)
Mild OA = 36 (27-50) , Moderate OA = 56 (27-72) ,
Severe OA = 65 (42-81) , TKA = 61(42-78) , Revision
TKA = 77(36-89)
Sex (% female)
Medicine Group = 68% Surgery Group = 73%
Mild OA = 22% , Moderate OA = 32% , Severe OA =
52% , TKA = 51% , Revision TKA = 78%
Internal consistency
α = .84
α: Mild OA = .94 , Moderate OA = .93 , Severe OA =
.80 , TKA = .92 , Revision TKA = .87
Test-retest reliability
ICC = .88
ICC: Mild OA = .80 , Moderate OA = .87 , Revision
TKA = .80
Time interval
2 weeks
3 weeks
Correlation to similar
scale
Little (20%), Fair (80%) correlation to similar
scales
NA
Correlation to general
measures of Physical
function
NA
Little (13.3%), Fair (33.3%), Moderate (53.3%)
correlation with general measures of physical function
Correlation to general
measures of mental
function
NA
Little (60%), Fair (40%), correlation with general
measures of mental function
ES
2.59
NA
SRM
1.85
NA
MDC
15.3 (calc) (1.96)*(sqrt(2))*((16)*sqrt(1-.88))
ICC: Mild OA = 22.9 (calc) , Moderate OA = 25.6
(calc) , Revision TKA = 29.0 (calc) **used baseline
group**
MCID
NA
NA
Guyatt
NA
NA
Time Interval
3 month
NA
Floor/Ceiling Effect
No
Yes
Normal Distribution
NA
NA
Normal Data
NA
NA
Study Characteristics
Reliability
Validity
Responsivenss
Other
137
KOOS - PAIN SUBSCALE
Paradowski (12)
Salavati (10)
Bekkers (11)
Purpose
Validity, Reliability of Persian version
Validity, Reliability
Study
Population/Sample
Meniscus, ACL, Combined Knee injury
Cartilage Degeneration/Surgery
Number
147
40
Age range
31.4 (16 – 59)
35±12 (18-55)
Sex (% female)
11%
30%
Internal consistency
α = .88
α = .88
NA
Test-retest reliability
ICC = .91
ICC = .92
NA
Time interval
8 days
2 days
Correlation to similar
scale
NA
NA
NA
Correlation to general
measures of Physical
function
Fair (66.6%), Moderate (33.3%) correlation
with general measures of physical function
NA
NA
Correlation to general
measures of mental
function
Little (50%), Fair (50%) correlation to
general measures of mental function
NA
ES
NA
0.82
NA
SRM
NA
0.71
NA
MDC
16.54 (calc)
11.8 (calc)
MCID
NA
NA
NA
Guyatt
NA
NA
NA
Time Interval
NA
36 months
NA
Floor/Ceiling Effect
No
No
Normal Distribution
NA
NA
Normal Data
NA
NA
Study Characteristics
Normative Data
General Population
568
568
52.0%
Reliability
NA
Validity
NA
Responsivenss
NA
Other
NA
No
Yes
138
KOOS PAIN SUBSCALE CONSOLIDATION
REFRENCES
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score
(KOOS) - development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2):
88-96
2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation
of a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis
Cartilage. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury
and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov;
14(11):1098-103. Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural
adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in
knee osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and
Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10)Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M.
Validation of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee
injuries. Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis
Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 14349
12)
Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and
gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome
Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
139
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – Pain subscale
Roos
Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure
1998
Year
PubMed ID:
Reviewer’s Name
Date of Review
9699158
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
1
1
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; TABLE 3. PF = .29 , RP = .07 , BP = .46
1
SF-36; TABLE 3. RE =-.02 , MH = .09
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
140
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: Pain = .85
Within 9 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
TABLE 5.
NA
NA
Table 4
3 and 6 month
Descriptive Features
Age range of sample
Number:
Sex
32 (18-46)
21
Male
Female
9
12
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
2
1
1
1 week
1; English and Swedish
1
141
142
143
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – Pain subscale
Roos
Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version
1998
Year
PubMed ID:
Reviewer’s Name
Date of Review
9863983
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
Table 2.
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. Table 4 - PF = .49 , RP = .24 , BP = .65
1
Lysholm. Table 4
1
SF-36. Table 4, RE =.15 , MH = .23,
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: Pain = .84
144
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: Pain = .86
Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: Pain = 1.11
NA
NA
NA
3 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Diagnosis
142
Table 1.
Figure 1 and 2
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
1
1
Past week
Swedish
2
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
145
146
147
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – Pain Subscale
Xie
Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis
outcome score koos in Asians with knee osteoarthritis in
Singapore
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16814575
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA; cultural adaptation
NA
1
1
NA
1
Forward and reverse translations by separate
translators.
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
English SF-36: PF = .50 RB = .23 BP = .37/Chinese SF-36 PF =
.48 RB = .23 BP = .31
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
EQ-5D; Table 4.
NA
English SF-36: RE = -.01 MH = -.05/Chinese SF-36 RE = .13
MH = .30
NA
NA
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
148
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α :Singapore English: Pain = .79
Chinese: Pain = .65
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: Singapore English; Pain = .88
Chinese; Pain = .87
6 days
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Singapore English
65.3
127 (test-retest = 47)
Chinese
67.8
131 (test-retest = 55)
30
97
15
116
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
1; no missing items
Present
1; Chinese and Singapore English
2
149
150
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain Subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – Pain Subscale
Ornetti
Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in
knee osteoarthritis patients
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
17905602
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
NA
1
Translation – back translation
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
OAKHQOL, Table 2
NA
1
4.
5.
6.
The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with
the OAKHQOL pain and physical activities domain, and
would correlate weakly with the other OOAKHQOL
domains.
The KOOS sports and recreation domain would
correlate weakly with all OAKHQOL domains, since this
domain has previously been reported as weakly
correlated with all 36-item short form health survey
SF-36 domains.
The KOOS QOL domain would correlate strongly or
moderately with all OAKHQOL domains.
Criterion Validity
Correlated with “gold standard”
NA
151
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: Pain = .84
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: Pain = .88
2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: Pain = 2.59
SRM: Pain = 1.85
NA
NA
NA
3 Months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Medicine Group
70 ± 10 (45-91)
37
Surgery Group
71 ± 10 (42-85)
30
32%
68%
27%
73%
1
NA
NA
1
Present
152
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
French
2
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The
surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
153
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – Pain subscale
de Groot
The Dutch version of the knee injury and osteoarthritis
outcome score a validation study
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
18302729
Travis Hamilton
7.15.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
1
1
NA
1
notes
NA
1
Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; VAS. Table 4, 5, 6, 7, 8
NA
1
SF-36; VAS. Table 4, 5, 6, 7, 8
1
Convergent hypotheses:
5. The correlation between KOOS Pain and Sf-36 BP,
between KOOS Pain and SF-36 PF, KOOS (all subscales)
and VAS for Pain and KOOS ADL and SF-36 PF should
be ≥ 0.60.
6. KOOS Pain has a stronger correlation with SF-36 BP
compared to the correlation with SF-36 PF. This
difference should be at least 0.05 higher.
7. KOOS Pain has a stronger correlation with VAS for pain
compared to the correlation of the other subscales of
the KOOS with the VAS for Pain. This difference should
be at least 0.05 higher.
8. KOOS ADL was expected to have a 0.05 higher
correlation with SF-36 PF compared to the correlation
of the other subscales of the SF-36.
2.
Divergent hypotheses:
All other correlations between the KOOS subscales and
154
the SF-36 should be higher than 0.30 and lower than
0.60
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: MILD OA: Pain = .80
MODERATE OA: Pain = .87
REVISION of TKA: Pain = .80
3 WEEKS
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Mild OA
Age range of sample
Number:
Sex
36 (2750)
36
Male
Female
78
22
Moderate
OA
56 (27-72)
Severe OA
TKA
65 (42-81)
61 (42-78)
Revision
of TKA
77 (36-89)
62
47
63
54
68
32
48
52
49
51
22
78
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
1
155
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing
values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
Last week
Dutch
2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were
present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor
effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate
construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
156
157
158
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score
Salavati
Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee
injuries
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
18411065
Travis Hamilton
7.17.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
notes
NA
1
Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. TABLE 4 - PF = .48 , RP = .38 , BP = .65
NA
1
SF-36. TABLE 4 - RE =.26 , MH = .17
1
All hypotheses supported:
4. The correlations between the KOOS Pain and SF=36 BP
subscales should be high.
5. The correlations between the KOOS ADL and Sport/Rec
and Sf-36 PF subscales should be high.
6. The correlations between the KOOS subscales and the
SF-36 subscales of Physical Health (PF, RP, BP) should
be higher than between the KOOS subscales and the
SF-36 subscales of Mental Health (GH, VT, RE, MH)
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
A
159
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α : Pain = .88
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: Pain = .91
6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
31.4 (16 – 59)
147
Male
Female
131
16
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
60
31
56
NA
NA
1
Last week
Persian
2
160
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec
and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
161
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – Pain subscale
Bekkers
Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions
2009
Year
PubMed ID:
Reviewer’s Name
Date of Review
19454278
Travis Hamilton
7.17.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
1
A priori moderate – strong hypotheses:
6. KOOS symptoms with SF-36 physical functioning
7. KOOS pain with SF-36 bodily pain and WE-VAS
8. KOOS ADL with the complete SF-36 questionnaire.
9. KOOS sport and recreation with the Lysholm knee
scoring scale
10. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
162
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
Pain = 0.88
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC = 0.92. table 1
2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: Pain = .82
SRM: Pain = .71
NA
NA
NA
36 MONTH
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
35±12 (18-55)
40
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
70%
30%
1
NA
NA
2
Last week
ENGLISH
2
163
164
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score
Paradowski
Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee
injury and Osteoarthritis Outcome Score (KOOS)
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16670005
Travis Hamilton
11.8.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA (Notes)
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
165
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
568 (figure 1)
Male
Female
274 (48%)
294 (52%)
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
General Population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
1 (table 1./ notes)
NA
NA
Swedish
2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women
aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function compared to the subscale ADL
function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
166
daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower
extremity functions.
167
KOOS - ADL SUBSCALE
Roos (1)
Roos (2)
Xie (4)
Purpose
Reliability, Responsiveness, Validity
Validity, Reliability of Swedish Version
Validity, Reliability of Singapore
English and Chinese Version
Study
Population/Sample
ACL Injury/Surgery
Variety of knee disorders/injury
Osteoarthritis
Number
21
142
Singapore English = 127
Chinese = 131
Age range
32 (18-46)
14-89
Singapore English = 65.3 Chinese =
67.8
Sex (% female)
57%
37%
Singapore English = 76% Chinese =
88%
Internal consistency
NA
α = 0.95
α:Singapore English = .92
Chinese = .82
Test-retest reliability
ICC = 0.75
ICC = 0.91
ICC: Singapore English = .91
Chinese = .84
Time interval
9 days
8 days
6 days
Correlation to similar
scale
NA
Moderate (100%) correlation to similar
scale
English: No (100%) Chinese:
No (100%) correlation to similar scales
Correlation to general
measures of Physical
function
Fair (66%) , Moderate (33%)
correlation to general measures of
physical function
Fair (33%), Moderate(66%)
correlation to general measures of
physical function
English: Fair (66%), Moderate (33%)
Chinese Little (33%), Fair (33%),
Moderate (33%) correlation to general
measure of physical function
Correlation to general
measures of mental
function
Little (100%) correlation to general
measures of mental function
Little (100%) correlation to general
measures of mental function
English: Little (100%) Chinese: Fair
(100%) correlation to general
measures of mental function
ES
0.94
0.67
NA
SRM
NA
NA
NA
MDC
11.9 (calc)
15.3 (calc)
Singapore English = 14.0 (calc)
Chinese = 14.4 (calc)
MCID
NA
NA
NA
Guyatt
NA
NA
NA
Time Interval
6 month
3 months
NA
Floor/Ceiling Effect
NA
No
No
Normal Distribution
NA
NA
NA
Normal Data
NA
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
**Used preop SD to calculate MCD
168
KOOS - ADL SUBSCALE
Ornetti (6)
DeGroot (7)
Purpose
Validity, Reliability of French Version
Validity, Reliability of Dutch Version
Study
Population/Sample
Osteoarthritis
Osteoarthritis
Number
Medicine Group = 37, Surgery Group = 30
Mild OA = 36 , Moderate OA = 62 , Severe OA =
47 , TKA = 63 , Revision TKA = 54
Age range
Medicine Group = 70  10 (45-91), Surgery
Group = 71 +/- 10 (42-85)
Mild OA = 36 (27-50) , Moderate OA = 56 (27-72)
, Severe OA = 65 (42-81) , TKA = 61(42-78) ,
Revision TKA = 77(36-89)
Sex (% female)
Medicine Group = 68%
Surgery Group = 73%
Mild OA = 22% , Moderate OA = 32% , Severe
OA = 52% , TKA = 51% , Revision TKA = 78%
Internal consistency
α = .93
α: Mild OA = .78 , Moderate OA = .97 , Severe
OA = .94 , TKA = .94 , Revision TKA = .93
Test-retest reliability
ICC = .85
ICC: Mild OA = .85 , Moderate OA = .94 ,
Revision TKA = .73
Time interval
2 weeks
3 weeks
Correlation to similar scale
Little (20%), Fair (60%), Moderate (20%)
correlation to similar scales
NA
Correlation to general measures of
Physical function
NA
Little (6.6%), Fair (33.3%), Moderate (53.3%),
Excellent (6.6%) correlation to general measures
of physical function
Correlation to general measures of
mental function
NA
Little (30%), Fair (60%), Moderate (10%)
correlation to general measures of mental
function
ES
2.25
NA
SRM
1.8
NA
MDC
17.1 (calc)
ICC: Mild OA = 16.2 , Moderate OA = 15.0 ,
Revision TKA = 31.5 (calc) **used baseline
group**
MCID
NA
NA
Guyatt
NA
NA
Time Interval
3 month
NA
Floor/Ceiling Effect
No
Yes
Normal Distribution
NA
NA
Normal Data
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
**Used preop SD to calculate MCD
169
KOOS - ADL SUBSCALE
Salavati (10)
Bekkers (11)
Purpose
Validity, Reliability of Persian version
Validity, reliability
Study
Population/Sample
Meniscus, ACL, Combined Knee
Injury
Cartilage Degeneration/Surgery
Number
147
40
Age range
31.4 (16 – 59)
35±12 (18-55)
Sex (% female)
11%
30.00%
Internal consistency
α = .94
α = 0.95
NA
Test-retest reliability
ICC = .90
ICC = 0.87
NA
Time interval
8 days
2 days
NA
Correlation to similar scale
NA
NA
NA
Correlation to general
measures of Physical
function
Fair (33%), Moderate(66%)
correlation to general measures of
physical function
NA
NA
Correlation to general
measures of mental function
Little (50%), Fair (50%) correlation to
general measures of mental function
NA
NA
ES
NA
0.7
NA
SRM
NA
0.75
NA
MDC
17.3 (calc)
13.9 (calc)
NA
MCID
NA
NA
NA
Guyatt
NA
NA
NA
Time Interval
NA
36 months
NA
Floor/Ceiling Effect
No
No
NA
Normal Distribution
NA
NA
No
Normal Data
NA
NA
Yes
Paradowski (12)
Study Characteristics
Normative Data
General Population
568
568
52.0%
Reliability
Validity
Responsiveness
Other
**Used preop SD to calculate MCD
170
KOOS ADL SUBSCALE CONSOLIDATION
REFERENCES
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2): 88-96
2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation of
a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis Cartilage.
Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury and
Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov; 14(11):1098-103.
Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural
adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in knee
osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and Osteoarthritis
Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10) Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation
of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries.
Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis
Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9
12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and
gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score
(KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
171
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – ADL subscale
Roos
Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure
1998
Year
PubMed ID:
Reviewer’s Name
Date of Review
9699158
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
1
1
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; TABLE 3. – PF = .57 , RP = .34 , BP = .35
NA
1
SF-36; TABLE 3. RE = -.05, MH =.22
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
172
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: adl = .75
Within 9 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
TABLE 5.
NA
NA
Table 4
3 and 6 month
Descriptive Features
Age range of sample
Number:
Sex
32 (18-46)
21
Male
Female
9
12
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
2
1
1
1 week
1; English and Swedish
1
173
174
175
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – ADL subscale
Roos
Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version
1998
Year
PubMed ID:
Reviewer’s Name
Date of Review
9863983
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1 Table 2.
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. Table 4 - PF = .68 , RP = .36 , BP = .65 ,
1
Lysholm. Table 4
1
SF-36. Table 4 RE =.18 , MH = .16,
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: ADL = .95
176
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: ADL = .91
Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: ADL = .67
3 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Diagnosis
142
Table 1.
Figure 1 and 2
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
1
1
Past week
Swedish
2
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
177
178
179
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – ADL Subscale
Xie
Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis
outcome score koos in Asians with knee osteoarthritis in
Singapore
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16814575
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA; cultural adaptation
NA
1
1
1
Forward and reverse translations by separate
translators.
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
English SF-36: PF = .65 RB = .33 BP = .38/Chinese SF-36 PF =
.64 RB = .36 BP = .14; Table 4.
1
EQ-5D: Table 4
1
English SF-36: RE = .10 MH = .14/Chinese SF-36 RE = .33 MH
= .32
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
180
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α :Singapore English: ADL = .92
Chinese: ADL = .82
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: Singapore English; ADL = .91
Testing interval (time between repeated measures)
Chinese; ADL = .84
6 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Singapore English
65.3
127 (test-retest = 47)
Chinese
67.8
131 (test-retest = 55)
30
97
15
116
1
NA
NA
1; no missing items
Present
1; Chinese and Singapore English
2
181
182
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – ADL subscale
Ornetti
Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in
knee osteoarthritis patients
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
17905602
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
NA
1
Translation – back translation
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
OAKHQOL, Table 2
NA
1
7.
8.
9.
The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with
the OAKHQOL pain and physical activities domain, and
would correlate weakly with the other OOAKHQOL
domains.
The KOOS sports and recreation domain would
correlate weakly with all OAKHQOL domains, since this
domain has previously been reported as weakly
correlated with all 36-item short form health survey
SF-36 domains.
The KOOS QOL domain would correlate strongly or
moderately with all OAKHQOL domains.
183
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: ADL = .93
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC ADL = .85
2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ESADL = 2.25
SRMADL = 1.8
NA
NA
NA
3 Months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Medicine Group
70 ± 10 (45-91)
37
Surgery Group
71 ± 10 (42-85)
30
32%
68%
27%
73%
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
1
NA
184
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Medicine Group
NA
1
Present
French
2
Surgery Group
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The
surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
185
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – ADL subscale
de Groot
The Dutch version of the knee injury and osteoarthritis
outcome score a validation study
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
18302729
Travis Hamilton
7.15.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
notes
NA
1
Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; VAS. Table 4, 5, 6, 7, 8
NA
1
SF-36; VAS. Table 4, 5, 6, 7, 8
1
Convergent hypotheses:
9. The correlation between KOOS Pain and Sf-36 BP,
between KOOS Pain and SF-36 PF, KOOS (all subscales)
and VAS for Pain and KOOS ADL and SF-36 PF should
be ≥ 0.60.
10. KOOS Pain has a stronger correlation with SF-36 BP
compared to the correlation with SF-36 PF. This
difference should be at least 0.05 higher.
11. KOOS Pain has a stronger correlation with VAS for pain
compared to the correlation of the other subscales of
the KOOS with the VAS for Pain. This difference should
be at least 0.05 higher.
12. KOOS ADL was expected to have a 0.05 higher
correlation with SF-36 PF compared to the correlation
of the other subscales of the SF-36.
3.
Divergent hypotheses:
All other correlations between the KOOS subscales and
the SF-36 should be higher than 0.30 and lower than
0.60
186
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: MILD OA: ADL = .85
MODERATE OA ADL = .94
REVISION of TKA: ADL = .73
3 WEEKS
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Mild OA
Age range of sample
Number:
Sex
Diagnosis
36 (2750)
36
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
78
22
Moderate
OA
56 (27-72)
Severe OA
TKA
65 (42-81)
61 (42-78)
Revision
of TKA
77 (36-89)
62
47
63
54
68
32
48
52
49
51
22
78
1
187
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing
values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
Last week
Dutch
2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were
present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor
effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate
construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
188
189
190
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL Subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – ADL subscale
Salavati
Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee
injuries
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
18411065
Travis Hamilton
7.17.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1 notes
NA
1
Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. TABLE 4 - PF = .63 , RP = .38 , BP = .62
NA
1
SF-36. TABLE 4 RE =.34 , MH = .23
1
All hypotheses supported:
7. The correlations between the KOOS Pain and SF=36 BP
subscales should be high.
8. The correlations between the KOOS ADL and Sport/Rec
and Sf-36 PF subscales should be high.
9. The correlations between the KOOS subscales and the
SF-36 subscales of Physical Health (PF, RP, BP) should
be higher than between the KOOS subscales and the
SF-36 subscales of Mental Health (GH, VT, RE, MH)
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
A
191
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α : ADL = .94
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: ADL = .90
6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
31.4 (16 – 59)
147
Male
Female
131
16
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
60
31
56
NA
NA
1
Last week
Persian
2
192
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec
and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
193
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – ADL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – ADL subscale
Bekkers
Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions
2009
Year
PubMed ID:
Reviewer’s Name
Date of Review
19454278
Travis Hamilton
7.17.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
1
A priori moderate – strong hypotheses:
11. KOOS symptoms with SF-36 physical functioning
12. KOOS pain with SF-36 bodily pain and WE-VAS
13. KOOS ADL with the complete SF-36 questionnaire.
14. KOOS sport and recreation with the Lysholm knee
scoring scale
15. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
194
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
ADL = 0.95
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC = 0.87. table 1
2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: ADL = .70
SRM: ADL = .75
NA
NA
NA
36 MONTH
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
35±12 (18-55)
40
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
70%
30%
1
NA
NA
2
Last week
ENGLISH
2
195
196
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score
Paradowski
Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee
injury and Osteoarthritis Outcome Score (KOOS)
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16670005
Travis Hamilton
11.8.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA (Notes)
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
197
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
568 (figure 1)
Male
Female
274 (48%)
294 (52%)
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
General Population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
1 (table 1./ notes)
NA
NA
Swedish
2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women
aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function comared to the subscale ADL
function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
198
daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower
extremity functions.
199
KOOS- SPORT/REC SUBSCALE
Roos (1)
Roos (2)
Xie (4)
Purpose
Reliability, Responsiveness,
Validity
Validity, Reliability of Swedish
version
Validity, Reliability of Singapore English
and Chinese version
Study
Population/Sample
(inclusion/exclusion)
ACL injury/ Surgery
Variety of Knee disorders/injury
Osteoarthtis
Number
21
142
Singapore English = 127 Chinese = 131
Age range
(average ± SD, min-max)
32 (18-46)
14-89
Singapore English = 65.3
Chinese = 67.8
Sex (% female)
57%
37%
Singapore English = 76%
Chinese = 88%
Internal consistency
NA
α = .85
α:Singapore English = .89
Chinese = .88
Test-retest reliability
ICC = .81
ICC = .78
ICC: Singapore English = .65
Chinese = .78
Time interval
9 days
8 days
6 days
Correlation to similar scale
NA
Moderate (100%) correlation to
similar scale
English: No(100%) Chinese: No (100%)
correlation to similar scales
Correlation to general measures of
Physical function
Little (33%), Fair (66.6%)
correlation to general measures
of physical function
Fair (66.6%), Moderate (33.3%)
correlation to general measures
of physical function
English: Fair (100%) Chinese: Little
(100%) correlation to general measure of
physical function
Correlation to general measures of
mental function
Little (100%) correlation to
general measures of mental
function
Little (50%) to fair (50%)
correlation to general measures
of mental function
English: Little (100%) Chinese: Little
(100%) correlation to general measures
of mental function
ES
1.16
0.9
NA
SRM
NA
NA
NA
MDC
22.9 (calc)
30.68 (calc)
Singapore English = 20.0 (calc)
Chinese = 12.2 (calc)
MCID
NA
NA
NA
Guyatt
NA
NA
NA
Time Interval
6 months
3 months
NA
Floor/Ceiling Effect
NA
No
Yes*
Normal Distribution
NA
NA
NA
Normal Data
NA
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
200
KOOS- SPORT/REC SUBSCALE
Ornetti (6)
DeGroot (7)
Salavati (10)
Bekkers (11)
Reliability,
Responsiveness, Validity
Validity, Reliability of Dutch
version
Validity, Reliability of Persian
version
Validity, reliability
Osteoarthtis
Osteoarthtis
Meniscus, ACL, Combined
Knee injury
Cartilage
Degeneration/Surgery
Number
Medicine Group = 37,
Surgery Group = 30
Mild OA = 36 , Moderate OA
= 62 , Severe OA = 47 , TKA
= 63 , Revision TKA = 54
147
40
Age range
(average ± SD, minmax)
Medicine Group = 70  10
(45-91), Surgery Group =
71  10 (42-85)
Mild OA = 36 (27-50) ,
Moderate OA = 56 (27-72) ,
Severe OA = 65 (42-81) ,
TKA = 61(42-78) , Revision
TKA = 77(36-89)
31.4 (16 – 59)
35±12 (18-55)
Sex (% female)
Medicine Group = 68%
Surgery Group = 73%
Mild OA = 22% , Moderate
OA = 32% , Severe OA =
52% , TKA = 51% , Revision
TKA = 78%
11%
30%
Internal consistency
α = .84
α: Mild OA = .87 ,
Moderate OA = .95 ,
Severe OA = .98 , TKA = .88 ,
Revision TKA = .95
α = .89
α = 0.89
Test-retest reliability
ICC = .82
ICC: Mild OA = .85 ,
Moderate OA = .87 ,
Revision TKA = .45
ICC = .61
ICC = 0.89
Time interval
2 weeks
3 weeks
8 days
2 days
Correlation to similar
scale
Little (80%), Fair (20%)
correlation to similar scales
NA
NA
NA
Correlation to general
measures of Physical
function
NA
Little (26.6%), Fair (53.3%),
Moderate (20%) correlation
with general measures of
physical function
Fair (100%)correlation with
general measures of physical
function
NA
Correlation to general
measures of mental
function
NA
Little (70%), Fair (30%)
correlation with general
measures of mental function
Little (100%) correlation to
general measures of mental
function
NA
ES
1.31
NA
NA
0.98
SRM
0.89
NA
NA
0.87
MDC
23.5 (calc)
ICC: Mild OA = 25.1 ,
Moderate OA = 31.9 ,
Revision TKA = 70.0 (calc)
**used baseline group**
39.8 (calc)
23.9 (calc)
MCID
NA
NA
NA
NA
Guyatt
NA
NA
NA
NA
Time Interval
3 month
NA
NA
36 months
Floor/Ceiling Effect
No
Yes
No
No
Normal Distribution
NA
NA
NA
NA
Normal Data
NA
NA
NA
NA
Study Characteristics
Purpose
Study
Population/Sample
Reliability
Validity
Responsiveness
Other
201
KOOS- SPORT/REC SUBSCALE
Paradowski (12)
Study Characteristics
Purpose
Normative Data
Study
Population/Sample
General Population
Number
568
Age range
(average ± SD, min-max)
568
Sex (% female)
52.0%
Reliability
Internal consistency
NA
Test-retest reliability
NA
Time interval
NA
Validity
Correlation to similar scale
NA
Correlation to general
measures of Physical
function
NA
Correlation to general
measures of mental
function
NA
Responsiveness
ES
NA
SRM
NA
MDC
NA
MCID
NA
Guyatt
NA
Time Interval
NA
Other
Floor/Ceiling Effect
NA
Normal Distribution
No
Normal Data
Yes
202
KOOS SPORT AND REC SUBSCALE CONSOLIDATION
REFERENCES
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2): 88-96
2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation of
a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis Cartilage.
Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury and
Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov; 14(11):1098-103.
Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural
adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in knee
osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and Osteoarthritis
Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10) Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M. Validation
of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee injuries.
Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis
Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 1434-9
12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and
gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score
(KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
203
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec Subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score- Sport/Rec
subscale
Roos
Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure
1998
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
9699158
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
1
1
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; TABLE 3. - PF = .47 , RP = .24 , BP = .27
NA
1
SF-36; TABLE 3. - RE =.03 , MH = .23
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
204
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: sport and rec function = .81
Within 9 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
TABLE 5.
NA
NA
Table 4
3 and 6 month
Descriptive Features
Age range of sample
Number:
Sex
32 (18-46)
21
Male
Female
9
12
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
2
1
1
1 week
1; English and Swedish
1
205
206
207
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Sport/Rec
subscale
Roos
Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version
1998
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
9863983
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1 Table 2.
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. Table 4 - PF = .57 , RP = .43 , BP = .43
1
Lysholm. Table 4
1
SF-36. Table 4 - RE =.26 , MH = .12
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α Sport/Rec = .85
208
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: Sport and Rec. function = .78
Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: Sport/Rec = .90
3 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Diagnosis
142
Table 1.
Figure 1 and 2
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
1
1
Past week
Swedish
2
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
209
210
211
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Sport/Rec
Subscale
Xie
Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis
outcome score koos in Asians with knee osteoarthritis in
Singapore
2006
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
16814575
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
NA
NA; cultural adaptation
NA
1
2. 66.9% - Singapore English; 73.3% - Singapore
Chinese
NA
1
Forward and reverse translations by separate
translators.
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
English SF-36: PF = .47 RB = .25 BP = .31/Chinese SF-36 PF =
.24 RB = .10 BP = -.04
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
EQ-5D; Table 4.
NA
English SF-36: RE = -.06 MH = -.02/Chinese SF-36 RE = -.01
MH = -.03
NA
NA
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
212
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α :Singapore English: Sprt/Rec = .89
Chinese: Sprt/Rec = .88
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: Singapore English: Sprt/Rec = .65
Chinese; Sprt/Rec = .78
6 days
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Singapore English
65.3
127 (test-retest = 47)
Chinese
67.8
131 (test-retest = 55)
30
97
15
116
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
1
NA
NA
1; no missing items
Present
1; Chinese and Singapore English
213
Is this the first or primary report about this instrument?
2
214
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Sport/Rec
subscale
Ornetti
Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in
knee osteoarthritis patients
2008
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
17905602
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
NA
1
Translation – back translation
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
OAKHQOL, Table 2
NA
1
10. The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with
the OAKHQOL pain and physical activities domain, and
would correlate weakly with the other OOAKHQOL
domains.
11. The KOOS sports and recreation domain would
correlate weakly with all OAKHQOL domains, since this
domain has previously been reported as weakly
correlated with all 36-item short form health survey
SF-36 domains.
12. The KOOS QOL domain would correlate strongly or
moderately with all OAKHQOL domains.
Criterion Validity
215
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: Sport/Rec = .84
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: Sport/Rec = .82
2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ESSport/Rec = 1.31
SRM: Sport/Rec = .89
NA
NA
NA
3 Months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Medicine Group
70 ± 10 (45-91)
37
Surgery Group
71 ± 10 (42-85)
30
32%
68%
27%
73%
1
NA
NA
1
216
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Present
French
2
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The
surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
217
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec Subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Sport/Rec
subscale
de Groot
The Dutch version of the knee injury and osteoarthritis
outcome score a validation study
2008
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
18302729
Travis Hamilton
7.15.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
1
1
NA
1
notes
NA
1
Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; VAS. Table 4, 5, 6, 7, 8
NA
1
SF-36; VAS. Table 4, 5, 6, 7, 8
1
Convergent hypotheses:
13. The correlation between KOOS Pain and Sf-36 BP,
between KOOS Pain and SF-36 PF, KOOS (all subscales)
and VAS for Pain and KOOS ADL and SF-36 PF should
be ≥ 0.60.
14. KOOS Pain has a stronger correlation with SF-36 BP
compared to the correlation with SF-36 PF. This
difference should be at least 0.05 higher.
15. KOOS Pain has a stronger correlation with VAS for pain
compared to the correlation of the other subscales of
the KOOS with the VAS for Pain. This difference should
be at least 0.05 higher.
16. KOOS ADL was expected to have a 0.05 higher
correlation with SF-36 PF compared to the correlation
of the other subscales of the SF-36.
4.
Divergent hypotheses:
All other correlations between the KOOS subscales and
the SF-36 should be higher than 0.30 and lower than
0.60
218
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: MILD OA: Spt/Rec = .85
MODERATE OA Spt/Rec = .87
REVISION of TKA: Spt/Rec = .45
3 WEEKS
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Mild OA
Age range of sample
36 (2750)
36
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
78
22
Moderate
OA
56 (27-72)
Severe OA
TKA
65 (42-81)
61 (42-78)
Revision
of TKA
77 (36-89)
62
47
63
54
68
32
48
52
49
51
22
78
1
219
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing
values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
Last week
Dutch
2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were
present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor
effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate
construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
220
221
222
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec Subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Knee Injury and Osteoarthritis Outcome Score – Sport/Rec
subscale
Salavati
Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee
injuries
2008
Author’s Last Name
Title of the Article
Year
PubMed ID:
Reviewer’s Name
Date of Review
18411065
Travis Hamilton
7.17.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
notes
NA
1
Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. TABLE 4 - PF = .48 , RP = .32 , BP = .48
NA
1
SF-36. TABLE 4 - RE =.20 , MH = .07
1
All hypotheses supported:
10. The correlations between the KOOS Pain and SF=36 BP
subscales should be high.
11. The correlations between the KOOS ADL and Sport/Rec
and Sf-36 PF subscales should be high.
12. The correlations between the KOOS subscales and the
SF-36 subscales of Physical Health (PF, RP, BP) should
be higher than between the KOOS subscales and the
SF-36 subscales of Mental Health (GH, VT, RE, MH)
223
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α : Sport/Rec = .89
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC:, Sport/Rec = .61
6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
31.4 (16 – 59)
147
Male
Female
131
16
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
60
31
56
NA
NA
1
224
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Last week
Persian
2
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec
and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
225
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – Sport/Rec
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – Sport/Rec
Bekkers
Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions
2009
Year
PubMed ID:
Reviewer’s Name
Date of Review
19454278
Travis Hamilton
7.17.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
1
A priori moderate – strong hypotheses:
16. KOOS symptoms with SF-36 physical functioning
17. KOOS pain with SF-36 bodily pain and WE-VAS
18. KOOS ADL with the complete SF-36 questionnaire.
19. KOOS sport and recreation with the Lysholm knee
scoring scale
20. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
226
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
Sport/Rec. = 0.89
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC = 0.89. table 1
2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: Sport/Rec = .98
SRM: Sport/Rec = .87
NA
NA
NA
36 MONTH
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
35±12 (18-55)
40
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
70%
30%
1
NA
NA
2
Last week
ENGLISH
2
227
228
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score
Paradowski
Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee
injury and Osteoarthritis Outcome Score (KOOS)
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16670005
Travis Hamilton
11.8.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA (Notes)
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
229
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
568 (figure 1)
Male
Female
274 (48%)
294 (52%)
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
General Population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
1 (table 1./ notes)
NA
NA
Swedish
2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women
aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function compared to the subscale ADL
function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
230
daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower
extremity functions.
231
KOOS- QOL Subscale
Roos (1)
Roos (2)
Xie (4)
Validity, Reliability of Swedish
version
Validity, Reliability of Singapore English
and Chinese version
Study Characteristics
Purpose
Reliability, responsiveness,
validity
Study
Population/Sample
(inclusion/exclusion)
ACL Injury/Surgery
Variety of knee disorders/injury
Osteoarthritis
Number
21
142
Singapore Englsih = 127
Chinese = 131
Age range
(average ± SD, min-max)
32 (18-46)
14-89
Singapore English = 65.3
Chinese = 131
Sex (% female)
57%
37%
Singapore English = 76%
Chinese = 88%
Internal consistency
NA
α = .71
Α:Singapore English = .74
Chinese = .71
Test-retest reliability
ICC = .86
ICC = .83
ICC: Singapore English = .86
Chinese = .60
Time interval
9 days
8 days
6 days
Correlation to similar scale
NA
Moderate (100%) correlation to
similar scale
English: No (100%) Chinese:
No (1005) correlation to similar scales
Correlation to general measures of
Physical function
Little (100%) correlation to
general measures of physical
function
Fair (66.6%), Moderate (33.3%)
correlation to general measures
of physical function
English: Fair (66.6%) Moderate (33.3)
Chinese: Fair (100%) correlation to
general measure of physical function
Correlation to general measures of
mental function
Little (50%), Moderate (50%)
correlation to general measures
of mental function
Little (100%) correlation to
general measures of mental
function
English: Little (100%) Chinese: Little
(50%), Fair (50%) correlation to general
measures of mental function
ES
1.65
1.15
NA
SRM
NA
NA
NA
MDC
15.4 (calc)
(1.96)*(sqrt(2))*((14.9)*sqrt(1.86))
17.8 (calc)
(1.96)*(sqrt(2))*((15.6)*sqrt(1.83))
Singapore English = 19.5 (calc)
(1.96)*(sqrt(2))*((18.8)*sqrt(1-.86))
Chinese = 34.0 (calc)
(1.96)*(sqrt(2))*((19.4)*sqrt(1-.60))
MCID
NA
NA
NA
Guyatt
NA
NA
NA
Time Interval
6 month
3 months
NA
Floor/Ceiling Effect
NA
No
No
Normal Distribution
NA
NA
NA
Normal Data
NA
NA
NA
Reliability
Validity
Responsiveness
Other
232
KOOS- QOL Subscale
Ornetti (6)
DeGroot (7)
Salavati (10)
Bekkers (11)
Purpose
Validity, Reliability of
French version
Validity, Reliability of Dutch
version
Validity, Reliability of
Persian version
Validity, reliability
Study
Population/Sample
(inclusion/exclusion)
Osteoarthritis
Osteoarthritis
Meniscus, ACL,
Combined Knee Injury
Cartilage
Degeneration/Surgery
Number
Medicine Group = 37
Surgery Group = 30
Mild OA = 36 , Moderate OA
= 62 , Severe OA = 47 , TKA
= 63 , Revision TKA = 54
147
40
Age range
(average ± SD, minmax)
Medicine Group = 70  10
(45-91), Surgery Group =
71  10 (42-85)
Mild OA = 36 (27-50) ,
Moderate OA = 56 (27-72) ,
Severe OA = 65 (42-81) ,
TKA = 61(42-78) , Revision
TKA = 77(36-89)
31.4 (16 – 59)
35±12 (18-55)
Sex (% female)
Medicine Group = 68%
Surgery Group = 73%
Mild OA = 22% , Moderate
OA = 32% , Severe OA =
52% , TKA = 51% , Revision
TKA = 78%
11%
30%
Internal consistency
α = .83
α: Mild OA = .81 , Moderate
OA = .85 , Severe OA = .73 ,
TKA = .81 , Revision TKA =
.90
α = .64
α = 0.90
Test-retest reliability
ICC = .75
ICC: Mild OA = .88 ,
Moderate OA = .91 , Revision
TKA = .84
ICC = .88
ICC = 0.95
Time interval
2 weeks
3 weeks
8 days
2 days
Little (20%) Fair (60%)
Moderate (20%)
correlation to similar
scales
NA
NA
NA
NA
Little (6.6%), Fair (53.3%),
Moderate (40%) correlation
with general measures of
physical function
Fair (100%) correlation
with general measures of
physical function
NA
NA
Little (60%), Fair (40%)
correlation with general
measures of mental function
Little(50%), Fair (50%)
correlation to general
measures of mental
function
NA
ES
2.8
NA
NA
1.32
SRM
1.93
NA
NA
0.76
MDC
23.5 (calc)
(1.96)*(sqrt(2))*((17)*sqrt(
1-.75))
ICC: Mild OA = 20.7 ,
Moderate OA = 21.8 ,
Revision TKA = 29.5 (calc)
**used baseline group**
16.9 (calc)
(1.96)*(sqrt(2))*((17.7)*sq
rt(1-.88))
14.2 (calc)
MCID
NA
NA
NA
NA
Guyatt
NA
NA
NA
NA
Time Interval
3 month
NA
NA
36 months
Floor/Ceiling Effect
No
Yes
No
No
Normal Distribution
NA
NA
NA
NA
Normal Data
NA
NA
NA
NA
Study Characteristics
Reliability
Validity
Correlation to similar
scale
Correlation to general
measures of Physical
function
Correlation to general
measures of mental
function
Responsiveness
Other
233
KOOS- QOL Subscale
Paradowski (12)
Study Characteristics
Purpose
Study
Population/Sample
(inclusion/exclusion)
Number
Age range
(average ± SD, min-max)
Sex (% female)
Normative Data
General Population
568
568
52.0%
Reliability
Internal consistency
Test-retest reliability
Time interval
NA
NA
NA
Validity
Correlation to similar scale
NA
Correlation to general measures of
Physical function
NA
Correlation to general measures of
mental function
NA
Responsiveness
ES
NA
SRM
NA
MDC
NA
MCID
NA
Guyatt
NA
Time Interval
NA
Other
Floor/Ceiling Effect
NA
Normal Distribution
No
Normal Data
Yes
234
KOOS QOL SUBSCALE CONSOLIDATION
REFERENCE
1) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score
(KOOS) - development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug; 28(2):
88-96
2) Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee Injury and Osteoarthritis Outcome Score (KOOS) - validation
of a Swedish version Scand J Med Sci Sports. 1998 Dec; 8(6):439-49
4) Xie F, Li SC, Roos EM, Fong KY, Lo NN, Yeo SJ, Tang KY, Teo W, Chong HC, Thumboo J. Osteoarthritis
Cartilage. Cross-cultural adaptation and validation of Singapore English and Chinese versions of the Knee Injury
and Osteoarthritis Outcome Score (KOOS) in Asians with knee osteoarthritis in Singapore. 2006 Nov;
14(11):1098-103. Epub 2006 Jun 30
6) Ornetti P, Parratte S, Gossec L, Tavernier C, Argenson JW, Roos EM, Guillemin F, Maillefert JF. Cross-cultural
adaptation and validation of the French version of the Knee Injury and Osterarthritis Outcome Score (KOOS) in
knee osteoarthritis patients. Osteoarthritis Cartilage. 2008 Apr; 16(4): 423-8. Epub 2007 Oct 1
7) de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of Knee Injury and
Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008 Feb 26;6:16
10) Salavati M, Mazaheri M, Negahban H, Sohani SM, Ebrahimian MR, Ebrahimi I, Kazemnejad A, Salavati M.
Validation of a Persian-version of Knee Injury and Osteoarthritis Outcome Score (KOOS) in Iranians with knee
injuries. Osteoarthritis Cartilage. 2008 Oct; 16(10):1178-82. Epub 2008 Apr 14
11) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis
Outcome Score (KOOS) for the treatment of focal cartilage lesions Osteoarthritis Cartilage. 2009; 17 (11): 14349
12) Paradowski PT, Bergman S, Sundén-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and
gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome
Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38.
235
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – QOL subscale
Roos
Knee Injury and Osteoarthritis Outcome Score KOOS
Development of a Self Administered Outcome Measure
1998
Year
PubMed ID:
Reviewer’s Name
Date of Review
9699158
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
1
1
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; TABLE 3. - PF = .19 , RP = .20 , BP = .02 ,
NA
1
SF-36; TABLE 3. RE =-.02 , MH = .33
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: QOL = .86
Within 9 days
236
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
TABLE 5.
NA
NA
Table 4
3 and 6 month
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
32 (18-46)
21
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
9
12
1
2
1
1
1 week
1; English and Swedish
1
237
238
239
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – QOL subscale
Roos
Knee injury and osteoarthritis outcome score KOOS validation
of a Swedish version
1998
Year
PubMed ID:
Reviewer’s Name
Date of Review
9863983
Travis Hamilton
7.13.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1 Table 2.
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. Table 4 - PF = .45 , RP = .36 , BP = .54
1
Lysholm. Table 4
1
SF-36. Table 4 - RE =.11 , MH = .06
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: QOL = .71
240
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: QOL = .83
Within 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: QOL = 1.15
NA
NA
NA
3 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Diagnosis
142
Table 1.
Figure 1 and 2
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
1
1
Past week
Swedish
2
For validity statistics Rate of perfect agreement: 67% (54-84%); Rate of one step variation on the five point scale: 94% (86-100%).
241
242
243
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – QOL Subscale
Xie
Cross cultural adaptation and validation of Singapore English
and Chinese versions of the knee injury and osteoarthritis
outcome score koos in Asians with knee osteoarthritis in
Singapore
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16814575
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA; cultural adaptation
NA
1
1
NA
1
Forward and reverse translations by separate
translators.
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
English SF-36: PF = .56 RB = .32 BP = .37/Chinese SF-36 PF =
.41 RB = .34 BP = .38
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
EQ-5D; Table 4.
NA
English SF-36: RE = .12 MH = .13/Chinese SF-36 RE = .18 MH
= .35
NA
NA
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
244
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α :Singapore English: QOL = .74
Chinese:QOL = .71
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: Singapore English; QOL = .86
Chinese; QOL = .60
Testing interval (time between repeated measures)
6 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Singapore English
65.3
127 (test-retest = 47)
Chinese
67.8
131 (test-retest = 55)
30
97
15
116
1
NA
NA
1; no missing items
245
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Present
1; Chinese and Singapore English
2
246
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – QOL subscale
Ornetti
Cross cultural adaptation and validation of the French version
of the Knee injury and Osteoarthritis Outcome Score KOOS in
knee osteoarthritis patients
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
17905602
Travis Hamilton
7.14.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
NA
1
Translation – back translation
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
OAKHQOL, Table 2
NA
1
13. The KOOS symptom, pain, and activity of daily life
domains would correlate strongly or moderately with
the OAKHQOL pain and physical activities domain, and
would correlate weakly with the other OOAKHQOL
domains.
14. The KOOS sports and recreation domain would
correlate weakly with all OAKHQOL domains, since this
domain has previously been reported as weakly
correlated with all 36-item short form health survey
SF-36 domains.
15. The KOOS QOL domain would correlate strongly or
moderately with all OAKHQOL domains.
247
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: QOL = .83
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: QOL = .75
2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: QOL = 2.8
SRM: QOL = 1.93
NA
NA
NA
3 Months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Medicine Group
70 ± 10 (45-91)
37
Surgery Group
71 ± 10 (42-85)
30
32%
68%
27%
73%
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
1
NA
248
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
1
Present
French
2
NOTES:
The medicine group was formed y all consecutive outpatients consulting for knee OA in the Rheumatology Dpt of the Dijon University Hospital. The
surgery group was recruited in the Orthopedic Surgery Dpt of Marseille University Hospital.
249
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score- QOL subscale
de Groot
The Dutch version of the knee injury and osteoarthritis
outcome score a validation study
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
18302729
Travis Hamilton
7.15.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
notes
NA
1
Standard forward-backward translation from Swedish
to Dutch
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36; VAS. Table 4, 5, 6, 7, 8
NA
1
SF-36; VAS. Table 4, 5, 6, 7, 8
1
Convergent hypotheses:
17. The correlation between KOOS Pain and Sf-36 BP,
between KOOS Pain and SF-36 PF, KOOS (all subscales)
and VAS for Pain and KOOS ADL and SF-36 PF should
be ≥ 0.60.
18. KOOS Pain has a stronger correlation with SF-36 BP
compared to the correlation with SF-36 PF. This
difference should be at least 0.05 higher.
19. KOOS Pain has a stronger correlation with VAS for pain
compared to the correlation of the other subscales of
the KOOS with the VAS for Pain. This difference should
be at least 0.05 higher.
20. KOOS ADL was expected to have a 0.05 higher
correlation with SF-36 PF compared to the correlation
of the other subscales of the SF-36.
5.
Divergent hypotheses:
All other correlations between the KOOS subscales and
250
the SF-36 should be higher than 0.30 and lower than
0.60
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
Table 2.
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC: MILD OA: QOL = .88
MODERATE OA: QOL = .91
REVISION of TKA:, QOL = .84
3 WEEKS
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Mild OA
Age range of sample
Number:
Sex
36 (2750)
36
Male
Female
78
22
Moderate
OA
56 (27-72)
Severe OA
TKA
65 (42-81)
61 (42-78)
Revision
of TKA
77 (36-89)
62
47
63
54
68
32
48
52
49
51
22
78
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
1
251
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing
values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
NA
Last week
Dutch
2
Notes:
Neither floor effects nor ceiling effects were found for the patients with moderate OA patients and the TKA patients. Only ceiling effects were
present in the mild OA group for the subscales Pain, Symptoms and ADL and for subscale Sport/Recreation in the severe OA TKA group. Floor
effects were found for the subscales Sport/Recreation and QOL in the severe OA and revision TKA
From the pre-defined hypotheses 60% or more could be confirmed in both the mild and moderate OA group and inpatients after TKA (moderate
construct validity). Less than 45% of the hypotheses could be confirmed for patients with severe OA and after revision TKA.
252
253
254
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – QOL subscale
Salavati
Validation of a Persian version of Knee injury and
Osteoarthritis Outcome Score KOOS in Iranians with knee
injuries
2008
Year
PubMed ID:
Reviewer’s Name
Date of Review
18411065
Travis Hamilton
7.17.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
notes
NA
1
Standard forward and backward translation (English to
Persian)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36. TABLE 4- PF = .41 , RP = .37 , BP = .45 ,
NA
1
SF-36. TABLE 4 - RE =.28 , MH = .13
1
All hypotheses supported:
13. The correlations between the KOOS Pain and SF=36 BP
subscales should be high.
14. The correlations between the KOOS ADL and Sport/Rec
and Sf-36 PF subscales should be high.
15. The correlations between the KOOS subscales and the
SF-36 subscales of Physical Health (PF, RP, BP) should
be higher than between the KOOS subscales and the
SF-36 subscales of Mental Health (GH, VT, RE, MH)
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
A
255
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α : QOL = .64
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC: QOL = .88
6 – 8 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
31.4 (16 – 59)
147
Male
Female
131
16
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
60
31
56
NA
NA
1
Last week
Persian
2
256
Notes:
The number of patients receiving floor or ceiling effects was negligible for KOOS Pain, Symptom, and ADL subscales. For the subscales Sport/Rec
and QOL the worst possible score was detected in 21 and 17 subjects, respectively.
257
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) – QOL subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score – QOL subscale
Bekkers
Validation of the Knee Injury and Osteoarthritis Outcome
Score KOOS for the treatment of focal cartilage lesions
2009
Year
PubMed ID:
Reviewer’s Name
Date of Review
19454278
Travis Hamilton
7.17.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
1
A priori moderate – strong hypotheses:
21. KOOS symptoms with SF-36 physical functioning
22. KOOS pain with SF-36 bodily pain and WE-VAS
23. KOOS ADL with the complete SF-36 questionnaire.
24. KOOS sport and recreation with the Lysholm knee
scoring scale
25. KOOS QOL with EQ-5D
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
258
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
QOL = 0.90
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC = 0.95. table 1
2 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES: QOL = 1.32
SRM: Sport/Rec = .76
NA
NA
NA
36 MONTH
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
35±12 (18-55)
40
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
70%
30%
1
NA
NA
2
Last week
ENGLISH
2
259
260
KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Knee Injury and Osteoarthritis Outcome Score
Paradowski
Knee complaints vary with age and gender in the adult
population. Population-based reference data for the Knee
injury and Osteoarthritis Outcome Score (KOOS)
2006
Year
PubMed ID:
Reviewer’s Name
Date of Review
16670005
Travis Hamilton
11.8.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA (Notes)
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
261
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
568 (figure 1)
Male
Female
274 (48%)
294 (52%)
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
General Population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
1 (table 1./ notes)
NA
NA
Swedish
2
Notes:
For the comparable KOOS subscales ADL the 95 % confidence interval of the mean for women aged 18-24 (n = 36) was 4.7 points and for women
aged 75 – 84 (n = 34) 13.7 points.
The decline in function with older age groups was more apparent for the subscales Sport and recreation function compared to the subscale ADL
function. The subscale Sport and Recreation Function hold items representing more difficult lower extremity function not required for activities of
262
daily living as defined by the items of the KOOS subscale ADL. The Sport and Recreation subscale is thus more sensitive to reduction of lower
extremity functions.
263
WOMAC PAIN SUBSCALE
Davies (1)
Angst (2)
Escobar (3)
Purpose
Responsiveness
Responsiveness
Validity, Reliability of Spanish
translation
Study
Population/Sample
(inclusion/exclusion)
Hip/Knee OA
Hip/Knee OA
Hip/Knee OA
Number
Placebo group = 50, Ibuprofen
group = 54
223
Hip Group = 100,
Knee Group = 103
Age range
(average ± SD, min-max)
Placebo group = 62.1 ± 7.2 (4579), Ibuprofen group = 61 ± 9.3
(45 – 77)
65.1 ± 10.0 (37-86)
Hip Group = 68.6 ± 10.3,
Knee Group = 70.9 ±6
Sex (% female)
Placebo group = 64% Ibuprofen
group = 63%
71%
Hip Group = 56%
Knee Group = 70%
NA
NA
Study Characteristics
Reliability
Internal consistency
Test-retest reliability
NA
NA
α = 0.82
ICC = 0.78
NA
NA
Correlation to similar scale
NA
NA
NA
Correlation to general measures
of Physical function
Moderate (100%) correlation to
general measures of physical
function
NA
Little (100%) correlation to general
measures of physical function
Correlation to general measures
of mental function
NA
NA
Little (100%) correlation to general
measures of mental function
ES
7 day = 9.4, 14 day = 6.6, 28
day = 17.7
.33
1.8
SRM
NA
0.37
1.5
MDC
NA
NA
NA
MCID
NA
NA
NA
Guyatt
NA
0.52
NA
Time Interval
7, 14, 28 days
3 months
6 months
Floor/Ceiling Effect
NA
No
NA
Normal Distribution
NA
NA
NA
Normal Data
NA
NA
NA
Time interval
15 days
Validity
Responsiveness
Other
OA – Osteoarthritis
264
WOMAC PAIN SUBSCALE
Salaffi (4)
Tuzun (5)
Kersten (7)
Purpose
Reliability, Validity
Reliability, Validity,
Responsiveness of Turkish
translation
Validity, Responsiveness
Study
Population/Sample
(inclusion/exclusion)
Patients following articular
cartilage surgery
OA
Hip/Knee OA
Number
Reliability = 17,
Responsiveness = 50
72
221
Age range
(average ± SD, min-max)
Reliability = 43.8 years ± 10.4
(21-60), Responsiveness =
36.6 years±9.7 (15-56)
61 ± 9 (41-80)
66.8 ± 8.3
Sex (% female)
Reliability = 39%,
Responsiveness = 39.2%
86%
58%
Internal consistency
NA
α: Baseline = 0.75, Treatment
= 0.81
α = 0.82
Test-retest reliability
ICC: 6mo = 0.81, 12mo = 0.85
NA
NA
NA
NA
Study
Reliability
Time interval
10 days
Validity
Correlation to similar scale
Moderate (100%) correlation to
similar scales
Moderate (100%) correlation to
similar scales
NA
Correlation to general measures
of Physical function
Little (100%) correlation to
general measures of physical
function
Little (100%) correlation to
general measures of physical
function
NA
Correlation to general measures
of mental function
Little (100%) correlation to
general measures of physical
function
Little (100%) correlation to
general measures of physical
function
NA
ES
NA
Group 1 = 0.88,
Group 2 = 0.74
NA
SRM
NA
Group 1 = 1.0
Group 2 = 0.78
Raw score – 0.55
Rasch score = 0.35
NA
NA
Responsiveness
MDC
144 (calc)
MCID
NA
NA
NA
Guyatt
NA
0.52
NA
Time Interval
7, 14, 28 days
3 months
6 weeks
Floor/Ceiling Effect
No
No
NA
Normal Distribution
No
NA
NA
Normal Data
NA
NA
NA
Other
OS - Osteoarthritis
265
WOMAC PAIN SUBSCALE CONTINUED
Greco (8)
Bellamy (9)
Purpose
Reliability , Responsiveness
Normative Data
Study
Population/Sample
(inclusion/exclusion)
Patients following articular cartilage surgery
General Population
Number
Reliability = 17, Responsiveness = 50
7420
Age range
(average ± SD, min-max)
Reliability = 43.8 years ± 10.4 (21-60),
Responsiveness = 36.6 years±9.7 (15-56)
27-104
Sex (% female)
Reliability = 39%,
Responsiveness = 39.2%
50%
Internal consistency
NA
NA
Test-retest reliability
ICC: 6mo = 0.81,
12mo = 0.85
NA
Study Characteristics
Reliability
Time interval
6 month, 12 months
NA
Validity
Correlation to similar scale
NA
NA
Correlation to general measures
of Physical function
NA
NA
Correlation to general measures
of mental function
NA
NA
ES
6mo = 0.98, 12mo = 1.14
NA
SRM
6mo = 0.91, 12mo = 1.13
NA
MDC
6mo = 16.2, 12mo = 14.4
NA
MCID
6mo = 17.5 (sens = .68, spec = .70), 12mo = 7.5
(sens = .87,
spec = .5)
NA
Guyatt
NA
NA
Time Interval
6, 12 months
NA
Floor/Ceiling Effect
No
NA
Normal Distribution
NA
NA
Normal Data
NA
Yes
Responsiveness
Other
OA - Osteoarthritis
266
WOMAC PAIN SUBSCALE CONSOLIDATION
REFERENCES
1) Davies GM, Watson DJ, Bellamy N. Comparison of the responsiveness and relative effect size of the Western
Ontario and McMaster Universities Osteoarthritis Index and the Short-Form Medical Outcomes Study Survey in a
randomized, clinical trial of the osteoarthritis patients. Arthritis Care & Research 1999 12: 172-9
2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation
intervention. Ann Rheum Dis 2001;60:834-840
3) Escobar A, Quintana JM, Bilbao A, Azkarate J, Guenaga Ji. Validation of the Spanish version of the WOMAC
questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities
Osteoarthritis Index. Clin Rheumatol. 2001 Nov;21(6):466-71
4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and
quality of life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities
(WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003
Aug; 11(8): 551-60.
5) Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of
the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33
7) Kersten P, White PJ, Tennant A. The Visual Analogue WOMAC 3.0 scale - internal validity and responsiveness of
the VAS. BMC Musculoskelet Disord. 2010 Apr 30; 11(1):80
8) Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International
Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster
Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with
focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster
WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5
267
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Pain subscale
Davies
Comparison of the Responsiveness and Relative Effect Size of
the WOMAC and Short-Form Medical Outcomes Study Survey
in a Randomized, Clinical Trial of Osteoarthritis Patients
1999
10513507
Travis Hamilton
7.26.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36(14 DAYS); BP = 0.64, PF = 0.72, PCS = 075
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
268
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES Pain; 7day = 9.4, 14 day = 6.6, 28 day = 17.7
NA
NA
TABLE 3
7, 14, 28 DAYS
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
Placebo
62.1 ± 7.2 (45-79)
50
Ibuprofen
61 ± 9.3 (45 – 77)
54
36%
64%
37%
63%
Hip = 12%, Knee = 70%,
Both = 18%
Hip = 5.6%, Knee = 66.7%, Both
= 27.8%
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
NA
NA
NA
NA
2
Patients with OA of the knee or hip were randomized to receive either placebo or 2400 mg/day of ibuprofen for 28 days. Patients completed the
WOMAC and SF-36 at baseline and days 7, 14, and 28 of the trail.
269
270
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC - Pain
Angst
Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the
leg undergoing a comprehensive rehabilitation intervention
2001
11502609
Travis Hamilton
7.27.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
271
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
3 month: ES: Pain = .33, SRM : Pain = .37 Guyatt: Pain
= .52
NA
NA
End of rehabilitation(3-4 weeks): ES: Pain = .56 SRM :
Pain = .72 Guyatt: Pain = .87
1 month, 3 month
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
65.1 ± 10.0 (37-86)
223
Male
Female
64
159
Hip
Knee
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
93
130
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
NA
Present
NA
2
Notes:
272
273
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Pain subscale
Escobar
Validation of the Spanish Version of the WOMAC
Questionnaire for Patients with Hip or Knee Osteoarthritis
2002
12447629
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36 Table 3.
PAIN:BP = -0.6, PF = -0.4, RP = -0.35,
NA
1
SF-36
PAIN RE = -0.31, MH = -0.41
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α:
Pain = 0.82
274
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC
Pain = 0.78
Testing interval (time between repeated measures)
15 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
ES
Pain = 1.8
SRM
Pain = 1.5
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
6 months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Hip Replacement
68.6 ± 10.3
Knee Replacement
70.9 ±6
44
56
30
73
1
1
NA
NA
NA
Present
Spanish
2
Notes:
275
The validity coefficients are negative because the WOMAC compared to the SF-36 showed scores with decreased improvements in Health Related
Quality of Life
276
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC
Salaffi
Reliability and validity of the Western Ontario and McMaster
Universities Osteoarthritis Index in Italian patients with
osteoarthritis of the knee
2003
12880577
Travis Hamilton
7.28.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
2
1
Standard forward-backward translation (English)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36:
Pain: BP = -0.6, PS = -0.61, SF-36 overall = -.608
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
1
Lequesne algofunctional index
Pain = 0.70
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36: MCS
Pain = -0.58
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
277
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α:
Pain = 0.91
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC
Pain = 0.86
Testing interval (time between repeated measures)
10 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
65.7 ± 9.3 (50 – 82)
304
Male
Female
30%
70%
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
NA
Italian
2
278
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Pain subscale
Tuzun
Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index
2005
15639634
Travis Hamilton
7.28.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
Pain: PS = -0.55, RP = -0.36, BP = -0.51,
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
1
Lequesne algofunctional index
Pain = 0.64
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36:
Pain: RE = -.28, MH = -0.40
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
1.
2.
3.
4.
5.
Skewness statistics range from -1 to +1.
Floor and ceiling effects are less than 20%
WOMAC pain and physical function (and lesser extent
stiffness) scores are highly correlated with similar
subscale (physical function and bodily pain) scores
derived from SF-36.
WOMAC index subscales are inadequately or weakly
correlated with theoretically unrelated subscale
(mental component subscales) scores derived from SF36.
WOMAC total is highly correlated with Lequesne
index.
Criterion Validity
Correlated with “gold standard”
279
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: Time 1
Pain = 0.75
α: Time 2
Pain = 0.81
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
Group 1
ES: Pain = 0.88
SRM: : Pain = 1.0
Group 2
ES: Pain = 0.74
SRM: : Pain = 0.78
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
2 weeks
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
61 ± 9 (41-80)
72
(table 1)
10
62
1
280
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
1
Turkish
2
Notes:
Patients were split into two groups, each receiving different exercise methods depicted in table 1(Group 1 = isotonic exercise, Group 2 = isokinetic
exercise).
Time 1: Baseline
rd
Time 2: 3 day after treatment period (2 WEEKS)
281
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Pain subscale
Kersten
The Visual Anologue WOMAC 3.0 scale – internal validity and
responsiveness of the VAS version
2010
20433732
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α
Pain = 0.82
282
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
Ordinal data (raw scores)
SRM: Pain = 0.55
Interval data (Rasch transformed scores)
SRM: Pain = 0.35
NA
NA
NA
6 weeks
Descriptive Features
Age range of sample
Number:
Sex
66.8 ± 8.3
221
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
42%
58%
40% hip, 60% knee
NA
NA
NA
NA
2
283
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Pain subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Pain subscale
Greco
Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the
Western Ontario and McMaster Universities Osteoarthritis
Index, Modified Cincinnati Knee Rating System, and Short
Form 36 in Patients with Focal Articular Cartilage Defects.
2010
20044494
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
284
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
Testing interval (time between repeated measures)
6 mo. ICC
Pain = 0.81
6 mo., 12 mo.
12 mo. ICC
Pain = 0.85
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
ES
6 mo.
SRM
Pain = 0.98,
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
12 mo.
SRM
Pain =
1.14,
Pain = 0.94,
= 1.13
1
MCD
Pain = 16.2,
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
Pain = 0.91,
ES
6 mo.
MCID
Pain = 17.5
(sens = .68,
spec = .70),
MCD
12 mo.
MCID
Pain = 14.4,
Pain = 7.5
(sens = .87,
spec = .5),
NA
6 months and 12 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Reliability (A)
43.8 years ± 10.4 (21-60)
17
61% male
Responsiveness (B)
36.6 years±9.7 (15-56)
50
60.8% male
17
50
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and
weighting of items:
Provided information about calculating
with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this
report
Is this the first or primary report about this
instrument?
1
1
NA
NA
2
285
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC
Bellamy
Population-Based Normative Values for the Western Ontario
and McMaster (WOMAC) Osteoarthritis Index: Part 1
2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
21546065
Travis Hamilton
1.2.2012
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
286
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
27-104
7420 (respondents)
Male
Female
3707 (~50%)
3713 (~50%)
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
General population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
1
NA
NA
English
1
Notes:
287
288
WOMAC FUNCTION SUBSCALE
Davies (1)
Angst (2)
Escobar (3)
Purpose
Responsiveness
Responsiveness
Validity, Reliability of Spanish
translation
Study
Population/Sample
(inclusion/exclusion)
Hip/Knee OA
Hip/Knee OA
Hip/Knee OA
Number
Placebo group = 50, Ibuprofen
group = 54
223
Hip Group = 100, Knee Group = 103
Age range
(average ± SD, min-max)
Placebo group = 62.1 ± 7.2 (4579), Ibuprofen group = 61 ± 9.3
(45 – 77)
65.1 ± 10.0 (37-86)
Hip Group = 68.6 ± 10.3, Knee Group
= 70.9 ±6
Sex (% female)
Placebo group = 64% Ibuprofen
group = 63%
71%
Hip Group = 56% Knee Group = 70%
Internal consistency
NA
NA
α = 0.93
Test-retest reliability
NA
NA
ICC = 0.81
Time interval
NA
NA
15 days
Correlation to similar scale
NA
NA
NA
Correlation to general measures
of Physical function
Moderate (100%) correlation to
general measures of physical
function
NA
Little (100%) correlation to general
measures of physical function
Correlation to general measures
of mental function
NA
NA
Little (100%) correlation to general
measures of mental function
ES
7 day = 8.7, 14 day = 8.4, 28
day = 7.9
0.18
1.5
SRM
NA
0.23
1.3
MDC
NA
NA
NA
MCID
NA
NA
NA
Guyatt
NA
0.31
NA
Time Interval
7, 14, 28 days
3 months
6 months
Floor/Ceiling Effect
NA
No
NA
Normal Distribution
NA
NA
NA
Normal Data
NA
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
OA – Osteoarthritis
289
WOMAC FUNCTION SUBSCALE CONTINUED
Salaffi (4)
Tuzun (5)
Kersten (7)
Purpose
Reliability, Validity
Reliability, Validity,
Responsiveness of Turkish
translation
Validity, Responsiveness
Study
Population/Sample
(inclusion/exclusion)
OA
OA
Hip/Knee OA
Number
304
72
221
Age range
(average ± SD, min-max)
65.7 ± 9.3 (50 – 82)
61 ± 9 (41-80)
66.8 ± 8.3
Sex (% female)
70%
86%
58%
Internal consistency
α = 0.84
α: Baseline = 0.94, Treatment
= 0.96
α = 0.95
Test-retest reliability
ICC = 0.89
NA
NA
Time interval
10 days
NA
NA
Correlation to similar scale
Moderate (100%) correlation to
similar scales
Moderate (100%) correlation to
similar scales
NA
Correlation to general measures
of Physical function
Little (100%) correlation to
general measures of physical
function
Little (100%) correlation to
general measures of physical
function
NA
Correlation to general measures
of mental function
Little (100%) correlation to
general measures of mental
function
Little (100%) correlation to
general measures of mental
function
NA
ES
NA
Group 1 = 0.79, Group 2 =
0.50
NA
SRM
NA
Group 1 = 0.94, Group 2 =
0.69
Raw score = 0.49, Rasch score = 0.37
MDC
350.8 (calc) (1.96)*(sqrt(2))
*((381.6)*sqrt(1-.89))
NA
NA
MCID
NA
NA
NA
Guyatt
NA
NA
NA
Time Interval
NA
2 weeks
6 weeks
Floor/Ceiling Effect
No
No
NA
Normal Distribution
No
NA
NA
Normal Data
NA
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
OA - Osteoarthritis
290
WOMAC FUNCTION SUBSCALE CONTINUED
Greco (8)
Bellamy (9)
Purpose
Reliability, Responsiveness
Normative Data
Study
Population/Sample
(inclusion/exclusion)
Patient’s following articular cartilage surgery
General Population
Number
Reliability = 17, Responsiveness = 50
7420
Age range
(average ± SD, min-max)
Reliability = 43.8 years ± 10.4 (21-60),
Responsiveness = 36.6 years±9.7 (15-56)
27-104
Sex (% female)
Reliability = 39%, Responsiveness = 39.2%
50%
Internal consistency
NA
NA
Test-retest reliability
ICC: 6mo = 0.93, 12mo = 0.86
NA
Time interval
6 months, 12 months
NA
Correlation to similar scale
NA
NA
Correlation to general measures of
Physical function
NA
NA
Correlation to general measures of
mental function
NA
NA
ES
6mo = 0.88, 12mo = 1.20
NA
SRM
6mo = 0.86, 12mo = 1.13
NA
MDC
6mo = 10.6, 12mo = 15
NA
MCID
6mo = 8.1(sens = .79, spec = .52), 12mo =
5.89(sens = .94, spec = .50)
NA
Guyatt
NA
NA
Time Interval
6, 12 months
NA
Floor/Ceiling Effect
No
NA
Normal Distribution
NA
NA
Normal Data
NA
Yes
Study Characteristics
Reliability
Validity
Responsiveness
Other
OA - Osteoarthritis
291
WOMAC FUNCTION SUBSCALE CONSOLIDATION
REFERENCES
1) Davies GM, Watson DJ, Bellamy N. Comparison of the responsiveness and relative effect size of the Western
Ontario and McMaster Universities Osteoarthritis Index and the Short-Form Medical Outcomes Study Survey in a
randomized, clinical trial of the osteoarthritis patients. Arthritis Care & Research 1999 12: 172-9
2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation
intervention. Ann Rheum Dis 2001;60:834-840
3) Escobar A, Quintana JM, Bilbao A, Azkarate J, Guenaga Ji. Validation of the Spanish version of the WOMAC
questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities
Osteoarthritis Index. Clin Rheumatol. 2001 Nov;21(6):466-71
4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and
quality of life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities
(WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003
Aug; 11(8): 551-60.
5) Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of
the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33
7. Kersten P, White PJ, Tennant A. The Visual Analogue WOMAC 3.0 scale - internal validity and responsiveness of
the VAS. BMC Musculoskelet Disord. 2010 Apr 30; 11(1):80
8. Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International
Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster
Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with
focal articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster
WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5
292
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Function subscale
Davies
Comparison of the Responsiveness and Relative Effect Size of
the WOMAC and Short-Form Medical Outcomes Study Survey
in a Randomized, Clinical Trial of Osteoarthritis Patients
1999
10513507
Travis Hamilton
7.26.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36(14 DAYS); BP = 0.64, PF = 0.72, PCS = 0.75
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
293
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES Function; 7day = 8.7, 14 day = 8.4, 28 day = 7.9
NA
NA
TABLE 3
7, 14, 28 DAYS
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
Placebo
62.1 ± 7.2 (45-79)
50
Ibuprofen
61 ± 9.3 (45 – 77)
54
36%
64%
37%
63%
Hip = 12%, Knee = 70%,
Both = 18%
Hip = 5.6%, Knee = 66.7%, Both
= 27.8%
NA
NA
NA
NA
2
Patients with OA of the knee or hip were randomized to receive either placebo or 2400 mg/day of ibuprofen for 28 days. Patients completed the
WOMAC and SF-36 at baseline and days 7, 14, and 28 of the trail.
294
295
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – function subscale
Angst
Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the
leg undergoing a comprehensive rehabilitation intervention
2001
11502609
Travis Hamilton
7.27.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
NA
296
Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
3 month: ES: Function = .18 SRM Function = .23
Guyatt: Function = .31
NA
End of rehabilitation(3-4 weeks): ES Function = .42
SRM Function = .62 Guyatt Function = .73
1 month, 3 month
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
65.1 ± 10.0 (37-86)
223
Male
Female
64
159
Hip
Knee
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
93
130
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
NA
Present
NA
2
Notes:
297
298
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Function subscale
Escobar
Validation of the Spanish Version of the WOMAC
Questionnaire for Patients with Hip or Knee Osteoarthritis
2002
12447629
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36 Table 3.
FUNCTION: BP = -0.63, PF = -0.52, RP = -0.43
NA
1
SF-36
FUNCTION RE = -0.31, MH = -0.43
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α:
Function = 0.93
299
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC
Function = 0.81
Testing interval (time between repeated measures)
15 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
ES
Function = 1.5
SRM
Function = 1.3
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
6 months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Hip Replacement
68.6 ± 10.3
Knee Replacement
70.9 ±6
44
56
30
73
1
1
NA
NA
NA
Present
Spanish
2
Notes:
300
The validity coefficients are negative because the WOMAC compared to the SF-36 showed scores with decreased improvements in Health Related
Quality of Life
301
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Function subscale
Salaffi
Reliability and validity of the Western Ontario and McMaster
Universities Osteoarthritis Index in Italian patients with
osteoarthritis of the knee
2003
12880577
Travis Hamilton
7.28.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
2
1
Standard forward-backward translation (English)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36:
Function: BP = -0.59, PS = -0.70, SF-36 overall = -.65
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
1
Lequesne algofunctional index
Function = 0.75
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36: MCS
Function = -0.56
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
302
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α:
Function = 0.84
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC
Function = 0.89
Testing interval (time between repeated measures)
10 days
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
65.7 ± 9.3 (50 – 82)
304
Male
Female
30%
70%
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
NA
Italian
2
303
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Function subscale
Tuzun
Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index
2005
15639634
Travis Hamilton
7.28.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
1
Function: PS = -0.72, RP = -0.48, BP = -0.54
1
Lequesne algofunctional index
Function = 0.68
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36:
Function: RE = -.40, MH = -0.37
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
6.
7.
8.
Skewness statistics range from -1 to +1.
Floor and ceiling effects are less than 20%
WOMAC pain and physical function (and lesser extent
stiffness) scores are highly correlated with similar
subscale (physical function and bodily pain) scores
derived from SF-36.
9. WOMAC index subscales are inadequately or weakly
correlated with theoretically unrelated subscale
(mental component subscales) scores derived from SF36.
10. WOMAC total is highly correlated with Lequesne
index.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
304
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: Time 1
α: Time 2
Function = 0.94
Function = 0.96
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
Group 1
ES: Function = 0.79
SRM: : Function = 0.94
Group 2
ES: Function = 0.50
SRM: : Function = 0.69
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
2 weeks
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
61 ± 9 (41-80)
72
(table 1)
10
62
1
NA
NA
305
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
Turkish
2
Notes:
Patients were split into two groups, each receiving different exercise methods depicted in table 1(Group 1 = isotonic exercise, Group 2 = isokinetic
exercise).
Time 1: Baseline
rd
Time 2: 3 day after treatment period (2 WEEKS)
306
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Function subscale
Kersten
The Visual Analogue WOMAC 3.0 scale – internal validity and
responsiveness of the VAS version
2010
20433732
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α Function = 0.95
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
307
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
Ordinal data (raw scores)
SRMFunction = 0.49
Interval data (Rasch transformed scores)
SRM: Function = 0.37
NA
NA
NA
6 weeks
Descriptive Features
Age range of sample
Number:
Sex
66.8 ± 8.3
221
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
42%
58%
40% hip, 60% knee
NA
NA
NA
NA
2
308
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Function subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Function subscale
Greco
Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the
Western Ontario and McMaster Universities Osteoarthritis
Index, Modified Cincinnati Knee Rating System, and Short
Form 36 in Patients with Focal Articular Cartilage Defects.
2010
20044494
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
6 mo. ICC
Function = 0.93
6 mo., 12 mo.
12 mo. ICC
Function = 0.86
309
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
6 mo.
SRM
ES
Function =
0.88
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
12 mo.
SRM
Function =
1.20
Function =
1.13
1
MCD
Function =
10.6
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
Function =
0.86
ES
6 mo.
MCID
Function =
8.1(sens = .79,
spec = .52)
MCD
12 mo.
MCID
Function =
15.0
Function =
5.89(sens =
.94, spec =
.50)
NA
6 months and 12 months
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Reliability (A)
43.8 years ± 10.4 (21-60)
17
61% male
Responsiveness (B)
36.6 years±9.7 (15-56)
50
60.8% male
17
50
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and
weighting of items:
Provided information about calculating
with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this
report
Is this the first or primary report about this
instrument?
1
1
NA
NA
2
310
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC
Bellamy
Population-Based Normative Values for the Western Ontario
and McMaster (WOMAC) Osteoarthritis Index: Part 1
2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
21546065
Travis Hamilton
1.2.2012
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
311
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
27-104
7420 (respondents)
Male
Female
3707 (~50%)
3713 (~50%)
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
General population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
1
NA
NA
English
1
Notes:
312
313
WOMAC STIFFNESS SUBSCALE
Angst (2)
Escobar (3)
Salaffi (4)
Purpose
Responsiveness
Validity, Reliability of Spanish
translation
Reliability, Validity
Study
Population/Sample
(inclusion/exclusion)
Hip/Knee OA
Hip/Knee OA
OA
Number
223
Hip Group = 100, Knee Group
= 103
304
Age range
(average ± SD, min-max)
65.1 ± 10.0 (37-86)
Hip Group = 68.6 ± 10.3, Knee
Group = 70.9 ±6
65.7 ± 9.3 (50 – 82)
Sex (% female)
71%
Hip Group = 56% Knee Group
= 70%
70%
Internal consistency
NA
α = 0.81
α = 0.84
Test-retest reliability
NA
ICC = 0.67
ICC = 0.68
Time interval
NA
15 days
10 days
Correlation to similar scale
NA
NA
Moderate (100%) correlation to similar
scales
Correlation to general measures
of Physical function
NA
Little (100%) correlation to
general measures of physical
function
Little (100%) correlation to general
measures of physical function
Correlation to general measures
of mental function
NA
Little (100%) correlation to
general measures of mental
function
Little (100%) correlation to general
measures of mental function
ES
0.07
1
NA
SRM
0.08
0.8
NA
MDC
NA
NA
80.2 (calc)
MCID
NA
NA
NA
Guyatt
0.1
NA
NA
Time Interval
3 months
6 months
NA
Floor/Ceiling Effect
No
NA
No
Normal Distribution
NA
NA
No
Normal Data
NA
NA
NA
Study
Reliability
Validity
Responsiveness
Other
OA – Osteoarthritis
314
WOMAC STIFFNESS SUBSCALE CONTINUED
Tuzun (5)
Kersten (7)
Greco (8)
Purpose
Reliability, Validity,
Responsiveness of Turkish
translation
Validity, Responsiveness
Reliability, Responsiveness
Study
Population/Sample
(inclusion/exclusion)
OA
Hip/knee OA
Patients following articular cartilage
surgery
Number
72
221
Reliability = 17,
Responsiveness = 50
Age range
(average ± SD, min-max)
61 ± 9 (41-80)
66.8 ± 8.3
Reliability = 43.8 years ± 10.4 (21-60),
Responsiveness = 36.6 years±9.7
(15-56)
Sex (% female)
86%
58%
Reliability = 39%, Responsiveness =
39.2%
Internal consistency
α: Baseline = 0.71, Treatment =
0.76
α = 0.80
NA
Test-retest reliability
NA
NA
ICC: 6mo = 0.86, 12mo = 0.75
Time interval
NA
NA
6 mo, 12 mo
Correlation to similar scale
Moderate (100%) correlation to
similar scales
NA
NA
Correlation to general measures
of Physical function
Little (100%) correlation to
general measures of physical
function
NA
NA
Correlation to general measures
of mental function
Little (100%) correlation to
general measures of mental
function
NA
NA
ES
Group 1 = 0.44, Group 2 = 0.32
NA
6mo = 0.51, 12mo = 0.72
SRM
Group 1 = 0.52, Group 2 = 0.29
MDC
NA
NA
6mo = 22.9, 12mo = 30.6
MCID
NA
NA
6mo = 6.3(sens = .68, spec = .48) ,
12mo =18.8(sens = .55, spec = .65)
Guyatt
NA
NA
NA
Time Interval
2 weeks
6 weeks
6, 12 months
Floor/Ceiling Effect
No
NA
No
Normal Distribution
NA
NA
NA
Normal Data
NA
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
6mo = 0.40, 12mo = 0.64
Other
OA – Osteoarthritis
315
WOMAC STIFFNESS
SUBSCALE CONTINUED
Bellamy (9)
Study Characteristics
Purpose
Normative Data
Study
Population/Sample
(inclusion/exclusion)
General Population
Number
7420
Age range
(average ± SD, min-max)
27-104
Sex (% female)
50%
Reliability
Internal consistency
NA
Test-retest reliability
NA
Time interval
NA
Validity
Correlation to similar scale
NA
Correlation to general measures
of Physical function
NA
Correlation to general measures
of mental function
NA
Responsiveness
ES
NA
SRM
NA
MDC
NA
MCID
NA
Guyatt
NA
Time Interval
NA
Other
Floor/Ceiling Effect
NA
Normal Distribution
NA
Normal Data
Yes
316
WOMAC STIFFNESS SUBSCALE CONSOLIDATION
REFERENCES
2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared
with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann
Rheum Dis 2001;60:834-840
3)
Escobar A, Quintana JM, Bilbao A, Azkarate J, Guenaga Ji. Validation of the Spanish version of the WOMAC
questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities Osteoarthritis
Index. Clin Rheumatol. 2001 Nov;21(6):466-71
4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and quality of
life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC)
Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug; 11(8): 551-60.
5)
Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33
7)
Kersten P, White PJ, Tennant A. The Visual Analogue WOMAC 3.0 scale - internal validity and responsiveness of the
VAS. BMC Musculoskelet Disord. 2010 Apr 30; 11(1):80
8)
Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International
Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster
Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal
articular cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster
WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5
317
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Stiffness subscale
Angst
Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the
leg undergoing a comprehensive rehabilitation intervention
2001
11502609
Travis Hamilton
7.27.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
318
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
3 month: ES:Stiffness = .07 SRM Stiffness = .08,
Guyatt: Stiffness = .10
NA
NA
End of rehabilitation(3-4 weeks): ES: Stiffness = .34,
SRM Stiffness = .38 Guyatt: Stiffness = .45
1 month, 3 month
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
65.1 ± 10.0 (37-86)
223
Male
Female
64
159
Hip
Knee
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
93
130
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
NA
Present
NA
2
Notes:
319
320
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – stiffness subscale
Escobar
Validation of the Spanish Version of the WOMAC
Questionnaire for Patients with Hip or Knee Osteoarthritis
2002
12447629
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36 Table 3.
STIFFNESS: BP = -0.5, PF = -0.38, RP = -0.33
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
NA
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36
STIFFNESS RE = -0.27, MH = -0.33
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α:
Stiffness = 0.81
321
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC
Stiffness = 0.67
15 days
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES
Stiffness = 1
SRM
Stiffness = 0.8
NA
NA
NA
6 months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Hip Replacement
68.6 ± 10.3
Knee Replacement
70.9 ±6
44
56
30
73
1
1
NA
NA
NA
Present
Spanish
2
Notes:
The validity coefficients are negative because the WOMAC compared to the SF-36 showed scores with decreased improvements in Health Related
Quality of Life
322
323
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Stiffness subscale
Salaffi
Reliability and validity of the Western Ontario and McMaster
Universities Osteoarthritis Index in Italian patients with
osteoarthritis of the knee
2003
12880577
Travis Hamilton
7.28.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
2
1
Standard forward-backward translation (English)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36:
Stiffness: BP = -0.46, PS = -0.54, SF-36 overall = -.51
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
1
Lequesne algofunctional index
Stiffness = 0.58
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36: MCS
Stiffness = -0.40
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
324
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α:
Stiffness = 0.84
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
ICC
Stiffness = 0.68
10 days
Testing interval (time between repeated measures)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
65.7 ± 9.3 (50 – 82)
304
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
30%
70%
1
NA
NA
NA
Italian
2
325
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Stiffness subscale
Tuzun
Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index
2005
15639634
Travis Hamilton
7.28.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
Stiffness: PS = -0.38, RP = -0.47, BP = -0.40
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
1
Lequesne algofunctional index
Stiffness = 0.50
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF-36:
Stiffness: RE = -.34, MH = -0.31
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
11. Skewness statistics range from -1 to +1.
12. Floor and ceiling effects are less than 20%
13. WOMAC pain and physical function (and lesser extent
stiffness) scores are highly correlated with similar
subscale (physical function and bodily pain) scores
derived from SF-36.
14. WOMAC index subscales are inadequately or weakly
correlated with theoretically unrelated subscale
(mental component subscales) scores derived from SF36.
15. WOMAC total is highly correlated with Lequesne
index.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
326
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α: Time 1
Stiffness = 0.71
α: Time 2
Stiffness = 0.76
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
Group 1
ES: Stiffness = 0.44
SRM: : Stiffness = 0.52
Group 2
ES: Stiffness = 0.32
SRM: : Stiffness = 0.29
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
2 weeks
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
61 ± 9 (41-80)
72
(table 1)
10
62
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
1
327
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
NA
NA
1
Turkish
2
Notes:
Patients were split into two groups, each receiving different exercise methods depicted in table 1(Group 1 = isotonic exercise, Group 2 = isokinetic
exercise).
Time 1: Baseline
rd
Time 2: 3 day after treatment period (2 WEEKS)
328
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Stiffness subscale
Kersten
The Visual Analogue WOMAC 3.0 scale – internal validity and
responsiveness of the VAS version
2010
20433732
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α
Stiffness = 0.80
329
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
Ordinal data (raw scores)
SRM: Stiffness = 0.34
Interval data (Rasch transformed scores)
SRM: Stiffness = 0.43
NA
NA
NA
6 weeks
Descriptive Features
Age range of sample
Number:
Sex
66.8 ± 8.3
221
Male
Female
42%
58%
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
40% hip, 60% knee
NA
NA
NA
NA
2
330
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Stiffness subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Stiffness subscale
Greco
Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the
Western Ontario and McMaster Universities Osteoarthritis
Index, Modified Cincinnati Knee Rating System, and Short
Form 36 in Patients with Focal Articular Cartilage Defects.
2010
20044494
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
331
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
Testing interval (time between repeated measures)
6 mo. ICC
Stiffness = 0.86
6 mo., 12 mo.
12 mo. ICC
Stiffness = 0.75
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
6 mo.
SRM
ES
Stiffness =
0.51,
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
1
MCD
Stiffness =
22.9
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
Stiffness =
0.40,
6 mo.
MCID
Stiffness =
6.3(sens = .68,
spec = .48)
ES
12 mo.
SRM
Stiffness =
0.72
MCD
Stiffness =
30.6
Stiffness =
0.64
12 mo.
MCID
Stiffness =
18.8(sens =
.55, spec =
.65)
NA
6 months and 12 months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Reliability (A)
43.8 years ± 10.4 (21-60)
17
61% male
Responsiveness (B)
36.6 years±9.7 (15-56)
50
60.8% male
17
50
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and
weighting of items:
Provided information about calculating
with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this
report
Is this the first or primary report about this
instrument?
1
1
NA
NA
2
332
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC
Bellamy
Population-Based Normative Values for the Western Ontario
and McMaster (WOMAC) Osteoarthritis Index: Part 1
2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
21546065
Travis Hamilton
1.2.2012
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
333
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
27-104
7420 (respondents)
Male
Female
3707 (~50%)
3713 (~50%)
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
General population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
1
NA
NA
English
1
Notes:
334
335
WOMAC OVERALL SUBSCALE
Davies (1)
Angst (2)
Salaffi (4)
Purpose
Reliability, Validity,
Responsiveness
Reliability, Responsiveness
Reliability, Validity
Study
Population/Sample
(inclusion/exclusion)
OA
Patients following articular
cartilage surgery
OA
Number
72
Reliability = 17,
Responsiveness = 50
304
Age range
(average ± SD, min-max)
61 ± 9 (41-80)
Reliability = 43.8 years ± 10.4
(21-60), Responsiveness =
36.6 years±9.7 (15-56)
65.7 ± 9.3 (50 – 82)
Sex (% female)
Placebo group = 64%
Ibuprofen group = 63%
Reliability = 39%,
Responsiveness = 39.2%
70%
Internal consistency
NA
NA
α = 0.84
Test-retest reliability
NA
NA
ICC = 0.89
Time interval
NA
NA
10 days
Correlation to similar scale
NA
NA
Moderate (100%) correlation to similar
scales
Correlation to general measures
of Physical function
Moderate (100%) correlation to
general measures of physical
function
NA
Little (100%) correlation to general
measures of physical function
Correlation to general measures
of mental function
NA
NA
Little (100%) correlation to general
measures of mental function
ES
7 day = 10.0, 14 day = 9.6, 28
day = 9.5
0.18
NA
SRM
NA
MDC
NA
NA
477.8 (calc) (
MCID
NA
NA
NA
Guyatt
NA
Time Interval
7, 14, 28 days
3 months
NA
Floor/Ceiling Effect
NA
No
No
Normal Distribution
NA
NA
No
Normal Data
NA
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
0.24
0.34
NA
NA
Other
OA – Osteoarthritis
336
WOMAC – Overall Subscale
Tuzun (5)
Greco (8)
Bellamy (9)
Purpose
Reliability, Validity, Responsiveness
of Turkish translation
Reliability, Responsiveness
Normative Data
Study
Population/Sample
(inclusion/exclusion)
OA
Patients following articular cartilage
surgery
General Population
Number
72
Reliability = 17, Responsiveness = 50
7420
Age range
(average ± SD, min-max)
61 ± 9 (41-80)
Reliability = 43.8 years ± 10.4 (21-60),
Responsiveness = 36.6 years±9.7 (1556)
27-104
Sex (% female)
86%
Reliability = 39%, Responsiveness =
39.2%
50%
Internal consistency
α: Baseline = 0.94, Treatment = 0.96
NA
NA
Test-retest reliability
NA
ICC: 6mo = 0.93, 12mo = 0.86
NA
Time interval
NA
6 mo, 12 mo
NA
Correlation to similar scale
Moderate (100%) correlation to
similar scales
NA
NA
Correlation to general
measures of Physical
function
Little (100%) correlation to general
measures of physical function
NA
NA
Correlation to general
measures of mental
function
Little (100%) correlation to general
measures of mental function
NA
NA
ES
Group 1 = 0.79, Group 2 = 0.50
6mo = 0.96, 12mo = 1.19
NA
SRM
Group 1 = 0.94, Group 2 = 0.69
6mo = 0.91, 12mo = 1.13
NA
MDC
NA
6mo = 10.9, 12mo = 15.3
NA
MCID
NA
6mo =11.5 (sens = .79, spec = .57),
12mo = 11.5 (sens = .84, spec = .55)
NA
Guyatt
NA
NA
NA
Time Interval
2 weeks
6, 12 months
NA
Floor/Ceiling Effect
No
No
NA
Normal Distribution
NA
NA
NA
Normal Data
NA
NA
Yes
Study Characteristics
Reliability
Validity
Responsiveness
Other
OA - Osteoarthritis
337
WOMAC OVERALL SUBSCALE CONSOLIDATION
REFERENCES
1) Davies GM, Watson DJ, Bellamy N. Comparison of the responsiveness and relative effect size of the Western Ontario
and McMaster Universities Osteoarthritis Index and the Short-Form Medical Outcomes Study Survey in a randomized,
clinical trial of the osteoarthritis patients. Arthritis Care & Research 1999 12: 172-9
2) Angst F. Aeschlismann Am Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared
with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann
Rheum Dis 2001;60:834-840
4) Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L. Gonorthrosis and quality of
life assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC)
Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug; 11(8): 551-60.
5) Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramogly M. Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan; 13(1):28-33
8) Greco JJ, Anderson AF, Mann BJ, Cole BJ, Farr, J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee
Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities
Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular
cartilage defects. Am J Sports Med. 2010 May; 38(5):891-902. Epub 2009 Dec 31
9) Bellamy N, Wilson C, Hendrikz J. Population-based normative values for the Western Ontario and McMaster
WOMAC)Osteoarthritis Index: part I. Semin Arthritis Rheum. 2011 Oct;41(2):139-48. Epub 2011 May 5
338
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Overall subscale
Davies
Comparison of the Responsiveness and Relative Effect Size of
the WOMAC and Short-Form Medical Outcomes Study Survey
in a Randomized, Clinical Trial of Osteoarthritis Patients
1999
10513507
Travis Hamilton
7.26.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36(14 DAYS); BP = 0.64, PF = 0.72, PCS = 075
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
339
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES overall; 7day = 10.0, 14 day = 9.6, 28 day = 9.5
NA
NA
TABLE 3
7, 14, 28 DAYS
Descriptive Features
Age range of sample
Number:
Sex
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
Placebo
62.1 ± 7.2 (45-79)
50
Ibuprofen
61 ± 9.3 (45 – 77)
54
36%
64%
37%
63%
Hip = 12%, Knee = 70%,
Both = 18%
Hip = 5.6%, Knee = 66.7%, Both
= 27.8%
NA
NA
NA
NA
2
Patients with OA of the knee or hip were randomized to receive either placebo or 2400 mg/day of ibuprofen for 28 days. Patients completed the
WOMAC and SF-36 at baseline and days 7, 14, and 28 of the trail.
340
341
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall Subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC
Angst
Responsiveness of the WOMAC osteoarthritis index as
compared with the SF-36 in patients with osteoarthritis of the
leg undergoing a comprehensive rehabilitation intervention
2001
11502609
Travis Hamilton
7.27.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
342
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
NA
Time interval between baseline and follow-up assessments
1 month, 3 month
3 month: ES: global = .18; SRM : global = .24; Guyatt:,
global = .34
NA
End of rehabilitation(3-4 weeks): ES: global = .47; SRM
: global = .67; Guyatt: global = .82
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
65.1 ± 10.0 (37-86)
223
Male
Female
64
159
Hip
Knee
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
93
130
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
NA
Present
NA
2
Notes:
343
344
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Overall Subscale
Salaffi
Reliability and validity of the Western Ontario and McMaster
Universities Osteoarthritis Index in Italian patients with
osteoarthritis of the knee
2003
12880577
Travis Hamilton
7.28.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Was the document translated using standard procedure?
If yes. How?
NA
NA
NA
1
1
2
1
Standard forward-backward translation (English)
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
SF-36:
Overall: BP = -0.60, PS = -0.70, SF-36 overall = -.66
1
Lequesne algofunctional index
Overall = 0.77
1
Overall = -0.57
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
345
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
65.7 ± 9.3 (50 – 82)
304
Male
Female
30%
70%
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
NA
Italian
2
346
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC – Overall subscale
Tuzun
Acceptability, reliability, validity and responsiveness of the
Turkish version of WOMAC osteoarthritis index
2005
15639634
Travis Hamilton
7.28.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
Overall: PS = -0.63, RP = -0.52, BP = -0.55,
1
Lequesne algofunctional index
Overall = 0.70
1
SF-36:
Overall: RE = -.40, MH = -0.42
1
16. Skewness statistics range from -1 to +1.
17. Floor and ceiling effects are less than 20%
18. WOMAC pain and physical function (and lesser extent
stiffness) scores are highly correlated with similar
subscale (physical function and bodily pain) scores
derived from SF-36.
19. WOMAC index subscales are inadequately or weakly
correlated with theoretically unrelated subscale
(mental component subscales) scores derived from SF36.
20. WOMAC total is highly correlated with Lequesne
index.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
347
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
Group 1
ES: Overall = 0.78
SRM: : Overall = 1.02
Group 2
ES: Overall = 0.60
SRM: Overall = 0.70
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
2 weeks
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
61 ± 9 (41-80)
72
(table 1)
10
62
1
NA
NA
1
348
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Turkish
2
Notes:
Patients were split into two groups, each receiving different exercise methods depicted in table 1(Group 1 = isotonic exercise, Group 2 = isokinetic
exercise).
Time 1: Baseline
rd
Time 2: 3 day after treatment period (2 WEEKS)
349
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – Overall subscale
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
WOMAC – Overall subscale
Author’s Last Name
Title of the Article
Greco
Responsiveness of the International Knee Documentation
Committee Subjective Knee Form in comparison of the
Western Ontario and McMaster Universities Osteoarthritis
Index, Modified Cincinnati Knee Rating System, and Short
Form 36 in Patients with Focal Articular Cartilage Defects.
2010
20044494
Travis Hamilton
7.28.11
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
350
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
1
Testing interval (time between repeated measures)
6 mo. ICC
Overall = 0.93
6 mo., 12 mo.
12 mo. ICC
Overall = 0.86
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
1
ES
Overall =
0.96
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Overall =
0.91
ES
12 mo.
SRM
Overall =
1.19
Overall =
1.13
1
MCD
Overall =
10.9
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
6 mo.
SRM
6 mo.
MCID
Overall = 11.5
(sens = .79,
spec = .57)
MCD
Overall =
15.3
12 mo.
MCID
Overall =
11.5 (sens =
.84, spec =
.55)
NA
6 months and 12 months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Reliability (A)
43.8 years ± 10.4 (21-60)
17
61% male
Responsiveness (B)
36.6 years±9.7 (15-56)
50
60.8% male
17
50
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and
weighting of items:
Provided information about calculating
with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this
report
Is this the first or primary report about this
instrument?
1
1
NA
NA
2
351
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
WOMAC
Bellamy
Population-Based Normative Values for the Western Ontario
and McMaster (WOMAC) Osteoarthritis Index: Part 1
2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
21546065
Travis Hamilton
1.2.2012
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
352
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
27-104
7420 (respondents)
Male
Female
3707 (~50%)
3713 (~50%)
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
General population
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
100%
1
NA
NA
English
1
Notes:
353
354
355
WOMET
Kirkley (1)
Sihvonen (2)
Purpose
Validity, Reliability
Validity, Reliability, Responsiveness
Study Population/Sample
(inclusion/exclusion)
Meniscus injury
Meniscus injury
Number
Reliability group = 78, Validity group = 61
485 (100 – validity; 385 – psychometric
testing[40 test retest])
Age range (average ± SD, min-max)
NA
53 (18 – 81)
Sex (% female)
NA
44.7%
Internal consistency
α = 0.923
α = .917
Test-retest reliability
ICC = .92
95% LOA = 20.10 and -20.11
Time interval
2 weeks
2 weeks
Correlation to similar scale
Fair (50%), Moderate (50%) correlation to
similar scales
Moderate (100%)
Correlation to general measures of physical
function
NA
Fair (100%)
Correlation to general measures of mental
function
NA
NA
ES
NA
1.17
SRM
0.65
.90
MDC
NA
NA
MCID
NA
NA
Guyatt
NA
NA
Time Interval
6 months
6 months
Floor/Ceiling Effect
No
No
Normal DIstribution
NA
Yes
Normal Data
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
WOMET SCALE CONSOLIDATION
REFERENCES
1) Kirkley A, Griffin S, Whelan D. The development and validation of a quality of life-measurement tool for patients
with meniscal pathology: the Western Ontario Meniscal Evaluation Tool (WOMET). Clin J Sport Med. 2007 Sep;
17(5): 349-56
2) Sihvonen R, Järvelä T, Aho H, Järvinen TL. Validation of the Western Ontario Meniscal Evaluation Tool
(WOMET) for Patients with a Degenerative Meniscal Tear: A Meniscal Pathology-Specific Quality-of-Life Index. J
Bone Joint Surg Am. 2012 May 16;94(10):e651-8.
Western Ontario Meniscal Evaluation Tool (WOMET)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Western Ontario Meniscal Evaluation Tool (WOMET)
Kirkley
The Development and Validation of a Quality of Life
Measurement Tool for Patients with Meniscal Pathology: The
Western Ontario Meniscal Evaluation Tool WOMET
2007
17873546
Travis Hamilton
7.26.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
1
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
ACL-QOL, Lysholm TABLE 3
NA
1
1.
2.
WOMET would have positive correlations with both
the Lysholm and ACL-QOL.
Because the ACL-QOL was specifically designed assess
HRQOL, the correlation between it and the WOMET
was anticipated to be slightly stronger than the
correlation between the Lysholm and the WOMET.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = 0.923
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.78
2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
SRM = 0.65
NA
NA
6 months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Reliability
Validity
78
61
3
9
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
Subtotal Menisectomy
General knee pain
Subtotal menisectomy
No surgery
Isolated Meniscal Debridement/Partial menisectomy
Repaired (meniscus pathology)
Meniscus pathology
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
2
9
22
36
NA
1
NA
NA
1
8
23
34
Western Ontario Meniscal Evaluation Tool (WOMET)
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Western Ontario Meniscal Evaluation Tool (WOMET)
Sihvonen
Validation of the Western Ontario Meniscal Evaluation Tool
(WOMET) for Patients with a Degenerative Meniscal Tear
2012
Year
PubMed ID:
Reviewer’s Name
Date of Review
Travis
6.14.2012
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
Used standard forward and reverse translation process?
NA
NA
NA
1
1
1
1
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
15-D = .311
1
Lysholm = .558
1
Table 2 (all were significant and the one discriminate
hypothesis showed no significant difference between the
two groups of patients)
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
W/o OA = .913; w/ OA = .931
Overall = .917
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
95% limits of agreement = 20.10 and -20.11 (fig 1)
2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES = 1.17; SRM = .90
WOMET score was greater for patients who reported
knee was better after surgery (31 ± 21) vs same/worse
(-3 ± 16) (p < 0.001)
6 months
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
53 (18 – 81)
485 (100 – validity; 385 – psychometric testing[40 test retset])
Male
Female
Arthroscopically verified meniscal tear
268
217
100%
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Notes:
NA
1
NA
Finnish/Swedish?
2
MOHTADI QOL
Mohtadi(1)
Tanner(2)
Purpose
Development and validation
Development and validation
Study Population/Sample
(inclusion/exclusion)
ACL injury
ACL injury, Meniscal tears, Osteoarthritis
Number
Responsiveness = 25, Construct Validity =
50, Test re-test = 25
153
Age range (average ± SD, min-max)
Responsiveness = 27.6 years (16-43),
Construct Validity = 27.14 years± (16-43),
Test Re-test = NA
44.6 (14-82)
Sex (% female)
Responsiveness= 48%, Construct Validity =
40%, Test Re-test = NA
51%
Internal consistency
NA
NA
Test-retest reliability
Average Error = 6%
NA
Time interval
2 weeks
NA
Correlation to similar scale
NA
NA
Correlation to general measures of
Physical function
NA
NA
Correlation to general measures of
mental function
NA
NA
ES
NA
NA
SRM
NA
NA
MDC
NA
NA
MCID
NA
NA
Guyatt
NA
NA
Time interval
NA
NA
Floor/Ceiling effect
No
NA
Normal Distribution
NA
NA
Normal Data
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
361
MOHTADI QOL CONSOLIDATION QUESTIONNAIRE
REFERENCES
1) Mohtadi N. Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior
cruciate ligament deficiency. Am J Sports Med. 1998 May-Jun;26(3):350-9.
2) Tanner SM, Dainty KN, Marx RG, Kirkley A. Knee-specific quality-of-life instruments: which ones measure symptoms
and disabilities most important to patients? Am J Sports Med. 2007 5(9):1450-8. Epub 2007 May 14
362
Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Mohtadi QOL measure for ACL deficiency
Mohtadi
Development and Validation of the Quality of Life Outcome
Measure (Questionnaire) for Chronic Anterior Cruciate
Ligament Deficiency
1998
9617395
Travis Hamilton
7.26.2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
1
1
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
1
1.
2.
The ACL-QOL outcome measure should reflect all
severity of chronic ACL deficiency and therefore cover
the spectrum of score from 0 – 100.
Those patients who were booked for surgery based on
clinical evaluation only, independently of the results of
the ACL-QOL measure, should have scores lower than
50 and should score lower, on average, than patients
not requiring surgery.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
NA
363
(eg.. Cronbach’s α > .60)
Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
Average error = 6%
2 weeks
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA (NOTES)
NA
NA
Over a 6 month period
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
Responsiveness
27.6 (16 – 43)
25
Construct Validity
27.14 (16-43)
50
13
12
30
20
1
1
Test Retest
25
1
NA
NA
NA
PRESNENT
NA
1
364
Notes:
Responsiveness: 21 out of 25 (84%) had appropriate overall scores on the repeat administration of the ACL-QOL questionnaire based on the clinical
changes that had occurred. Of these 21 patients, 9 had clinically improved, 10 remained unchanged, and 2 had deteriorated. Three of the four
patients who did not correctly match their overall clinical impression on the second ACL-QOL questionnaire were in the postoperative period after
their knee surgery.
365
Mohtadi Quality of Life Outcome Measure for Chronic ACL Deficiency
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Mohtadi QOL measure for ACL deficiency
Tanner
Knee-specific Quality-of-Life Instruments Which Ones
Measure Symptoms and Disabilities Most Important to
Patients
2007
Year
PubMed ID:
Reviewer’s Name
Date of Review
17502427
Travis Hamilton
7.28.2011
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
NA
366
(eg.. Cronbach’s α > .60)
Indicate value:
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
NA
NA
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
44.6 (14-82)
153
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
75
78
Table 3
1
1
1
NA
NA
NA
Present
ENGLISH
2
Notes:
153 patients with ACL, Isolated meniscal tears, or OA were polled to complete a questionnaire of 111 items by combining 222 patient directed
questions from 11 knee specific quality of life instruments. The groups were broken down by the type of injury, then group statistics including
the mean importance ranking and the frequency importance product (FIP = frequency x mean importance) were calculated. For the population
367
with ACL deficiency, patients endorsed 87 % (27/31) questions on the Mohtadi QOL. The endorsement statistic for the Mohtadi QOL was not
reported for patients with Osteoarthritis and Meniscal tears.
368
Marx Activity
Marx (1)
Study Characteristics
Purpose
Validity, Reliability
Study
Population/Sample
(inclusion/exclusion)
Normal/Sports active
Number
40
Age range
(average ± SD, min-max)
33.7 (18-50)
Sex (% female)
32%
Reliability
Internal consistency
NA
Test-retest reliability
ICC = .97
Time interval
1 year
Validity
Correlation to similar scale
Moderate (100%) correlation to similar scales
Correlation to general measures
of Physical function
NA
Correlation to general measures
of mental function
NA
Responsiveness
ES
NA
SRM
NA
MDC
9.9 (calc) (1.96)*(sqrt(2))*((20.8)*sqrt(1-.97))
MCID
NA
Guyatt
NA
Time Interval
NA
Other
Floor/Ceiling Effect
NA
Normal Distribution
NA
Normal Data
NA
369
MARX ACTIVITY SCALE CONSOLIDATON
REFERENCES
1)
Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale
for disorders of the knee. Am. J Sports Med 2001; 29: 21.3-218
370
MARX ACTIVITY LEVEL
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Marx Activity Level
Marx
Development and Evaluation of an Activity Rating Scale for
Disorders of the Knee
2001
Year
PubMed ID:
Reviewer’s Name
Date of Review
11292048
Travis Hamilton
7.25.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
1
1
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
1
Tegner = 0.66, Cincinnati = 0.67,Daniel scale = 0.52 (
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
NA
371
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
0.97
1 week
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
33.7 (18-50)
40
Male
Female
27
13
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Participates in sports on a regular basis
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
28
NA
NA
NA
Present
English
1
Notes:
Items of importance were generated by interviewing 10 orthopaedic surgeons who specialize in sports medicine, 5 physical therapists and athletic
trainers who specialize in sports medicine and 10 athletic patients with disorders of the knee. Nine relevant items were generated: getting out of a
low chair, going up stairs, going down stairs, running, cutting, pivoting, jumping, decelerating, and doing a deep knee bend/squat. The top 4 items
were selected for the scale (Running, cutting, decelerating, and pivoting) depicted in table 1.
372
373
Kujala Activity Level
Paxton (1)
Kuru (2)
Purpose
Validity, Reliability
Validity, Reliability of Turkish
translation
Study
Population/Sample
(inclusion/exclusion)
Acute patellar dislocation
Patellar femoral disorder
Number
Validity = 110, Test-retest = 81
40
Age range
(average ± SD, min-max)
Validity =First dislocation: 16 (967), Prior dislocation: 18 (8-65)
Test-retest= First dislocation: 16
(9-48), Prior dislocation: 22 (8-65)
33 ±12 (17 – 54)
Sex (% female)
NA
NA
Internal consistency
α = .82
α = 0.84
Test-retest reliability
ICC = .86
MCC** = .94
Time interval
21 days
NA
Correlation to similar scale
Demonstrate Little (20%),
moderate (20%), excellent (60%)
correlation to similar scales
NA
Correlation to general measures
of Physical function
Demonstrates excellent (100%)
correlations to similar scales
NA
Correlation to general measures
of mental function
NA
NA
ES
NA
NA
SRM
NA
NA
MDC
NA
NA
MCID
NA
NA
Guyatt
NA
NA
Time Interval
NA
NA
Floor/Ceiling Effect
No
NA
Normal Distribution
No
NA
Normal Data
NA
NA
Study Characteristics
Reliability
Validity
Responsiveness
Other
** MCC = Mean Correlation Coefficient
374
KUJALA CONSOLIDATION
REFERENCES
1)
Paxton EW, Fithian DC, Stone ML, Silva P. The reliability and validity of knee-specific and general health instruments
in assessing acute patellar dislocation outcomes. Am J Sports Med. 2003 Jul-Aug;31(4):487-92.
2) Kuru T, Dereli EE, Yaliman A. Validity of the Turkish version of the Kujala patellofemoral score in patellofemoral pain
syndrome. Acta Orthop Traumatol Turc. 2010;44(2):152-6
375
Kujala Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Kujala Knee Score
Paxton
The reliability and validity of knee-specific and general health
instruments in assessing acute patellar dislocation outcomes
2003
Year
PubMed ID:
Reviewer’s Name
Date of Review
12860533
Travis Hamilton
9.12.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
2
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
1
SF – 36: PF = .64, RP = .44, BP = .45
MFA: Total = -.52, Mobility = -.1, Leisure = -.51
1
Tegner = .33, Fulkerson = .85, Lysholm = .86, IKDC
(modified) = -.54
NA
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
1
376
(eg.. Cronbach’s α > .60)
Indicate value:
α = .82
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
.86
21 days (13-42)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
Table 1.
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
Acute Patellar Dislocation
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
1
NA
NA
NA
English
2
Notes:
377
378
Kujala Knee Score
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
Kujala Knee Score
Kuru
Validity of the Turkish version of the Kujala patellofemoral
score in patellofemoral pain syndrome
2010
Year
PubMed ID:
Reviewer’s Name
Date of Review
Travis Hamilton
9.12.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA (Standard forward and reverse translation)
NA
NA
NA
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
NA
NA
NA
NA
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = 0.84
379
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
Mean correlation coefficient = 0.94
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
NA
NA
NA
NA
Descriptive Features
Age range of sample
Number:
Sex
33 ±12 (17 – 54)
40
Male
Female
Diagnosis
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
8
32
1
NA
NA
NA
Turkish
2
380
INTERNATIONAL KNEE DOCUMENTATION COMMITTEE (IKDC) SUBJECTIVE KNEE FORM – PEDIATRIC VERSION
Kocher (1)
Study Characteristics
Purpose
Validity, Reliability, Responsiveness
Study
Population/Sample
Inclusion/exclusion)
Variety of knee injuries
Number
589
Age range
(average ± SD,
min-max)
Sex (% female)
14.6 ± 2.5 (10.0 - 18.9)
51%
Reliability
Internal consistency
α = 0.91
Test-re-test reliability
ICC = .91
Time interval
17 days
Validity
Correlation to similar scale
NA
Correlation to general
measures of physical
function
Fair (33%) to Moderate (66%) correlation to
physical function
Correlation to general
measures of mental function
Fair (100%), correlation to mental function
Responsiveness
ES
1.39
SRM
1.35
MDC
18.3 (calc) (1.96)*(sqrt(2))*((22)*sqrt(1-.91))
MCID
NA
Time interval
7.5 weeks
Other
Floor/Ceiling effect
No
Normal Distribution
NA
Normal Data
NA
381
International Knee Documentation Committee (IKDC) Subjective Knee Form – Pediatric Version
REFERENCES
1) Kocher MS, Smith JT, Iversen MD, Brustowicz K, Ogunwole O, Andersen J, Yoo WJ, McFeely ED, Anderson AF,
Zurakowski D. Reliability, validity, and responsiveness of a modified International Knee Documentation
Committee Subjective Knee Form (Pedi-IKDC) in children with knee disorders. Am J Sports Med. 2011
May;39(5):933-9. Epub 2010 Nov 10. PubMed PMID: 21068443
382
IKDC SUBJECTIVE KNEE FORM – PEDIATRIC VERSION
Ratings
1
2
3
NA
Yes
No
Not evaluated or not reported
Not applicable
Outcome Measure
Author’s Last Name
Title of the Article
IKDC pediatric version
Kocher
Reliability, Validity, and Responsiveness of a Modified
International Knee Documentation Committee Subjective
Knee Form (Pedi-IKDC) in Children With Knee Disorders
2011
Year
PubMed ID:
Reviewer’s Name
Date of Review
Travis Hamilton
9.12.11
Content Validity
Reported that items were generated by team of experts
Reported that items were developed from patient input
Reported that content was developed from statistical modeling
Evaluated floor and ceiling effect
If yes. <30% of sample scored at endpoint
Data normally distributed
NA
NA
NA
1
1
NA
Construct Validity
Correlated with a generic instrument/scale
If yes. Indicate instrument/scale and correlation coefficient
Correlated with theoretically similar scale
If yes. Indicate instrument/scale and correlation coefficient
Uncorrelated with theoretically distinct scale
If yes. Indicate instrument/scale and correlation coefficient
Tested specific hypothesis to demonstrate construct validity?
If yes. What is found?
1
**CHQ; PF = .65, RL = .35, BL = .20, PL = .45, BP = .61, GH =
.20, FA = .37, overall = .15, family cohesion = .05 (Bold =
used for validity comparisons)
NA
1
CHQ: EL = .35, MH = .30, SE = .32
1
All hypotheses were confirmed:
1. Patients with greater difficulty walking several
blocks or climbing several flights of stairs would
have lower pedi-IKDC scores.
2. Patients with greater difficulty getting around
their school, neighborhood, or playground would
have lower pedi-IKDC scores.
3. Patients with greater difficulty walking 1 block or
climbing 1 flight of stairs would have lower pediIKDC scores.
4. Patients with greater difficulty doing their tasks
around the ouse would have lower pedi-IKDC
scores.
5. Patients with greater difficulty bending, lifting, or
stooping would have lower pedi-IKDC scores.
6. Patients with greater difficulty doing certain kinds
of schoolwork or activities with friends would
have lower pedi-IKDC scores.
7. Patients with more severe bodily pain or
383
discomfort during the past 4 weeks would have
lower pedi-IKDC scores.
8. Patients with more frequent bodily pain or
discomfort would have lower pedi-IKDC scores.
9. Patients who felt worse about their ability to play
sports would have lower pedi-IKDC scores.
10. Patients who felt worse about the things they can
do would have lower pedi-IKDC scores.
11. Patients whose health or behavior has more
regularly limited types of activities that they could
do as a family during the past 4 weeks would
have lower pedi-IKDC scores.
Criterion Validity
Correlated with “gold standard”
Predictive of a future outcome
If yes to either of above, report how this was demonstrated
NA
Internal Consistency
Evidence for acceptable internal consistency
(eg.. Cronbach’s α > .60)
Indicate value:
1
α = 0.91
Test-Retest Reliability
Evidence for test-retest reliability (eg.. ICC>.70)
Indicate value:
Testing interval (time between repeated measures)
1
ICC = 0.91
17 days (3-67)
Interrater Reliability
Evidence for interrater reliability (eg..Kappa > .60)
Indicate Value:
NA
Responsiveness
Group level statistics reported (eg. Effect size. Standardized response
mean. Guyatt’s responsiveness index. Regression model)
Report statistics: ES. SRM. Guyatt’s
Individual level statistics reported (eg. Minimal detectable change.
Minimum clinically important change)
Report statistics:
Change in measure related to change in external standard
Measure demonstrated change for patients who received known
efficacious treatment (indicate statistic)
Time interval between baseline and follow-up assessments
1
ES = 1.39, SRM = 1.35
NA
NA
NA
7.5 weeks (.4 – 29.1)
384
Descriptive Features
Age range of sample
Number:
Sex
Diagnosis
14.6 ± 2.5 (10.0 – 18.9)
589
Male
Female
ACL injury/surgery
PCL injury/surgery
Other ligament injury/surgery + ACL
Meniscus. Articuler artroscopy +ACL
OA
PF
General knee pain
Combined injury
Sport related
Cartilage degeneration or surgery
Provide normative data
Provide information about scoring and weighting of items:
Provided information about calculating with missing values:
Recall period (eg. “in the last month”)
Language(s) of instrument used in this report
Is this the first or primary report about this instrument?
288 (48.9%)
301 (51.1%)
Table 1.
NA
NA
NA
NA
ENGLISH
2
Notes:
Physical functioning (PF), emotional limitations (EM), behavioral limitations (BL), physical limitations (PL), bodily pain (BP), mental health (MH), self
esteem (SE), general health perceptions (GHP), and family activities (FA),
385