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