Optimal Use of the Axya Shoulder Fixation System

AAOS Clinical Practice
Guidelines:
Do They Matter & Which
Ones Should I Follow?
ETO Las Vegas, Nv Dec. 2014
Louis F. McIntyre, MD
Chair Health Policy And Practice Committee
Arthroscopy Association North America
Presenter Disclosure
Information
Louis F. McIntyre, MD
Disclosure Information
The following relationships exist:
Stock Options: Tornier Medical
Speaker Fees: Depuy-Mitek, Quintiles Medical
Research Grant: Depuy-Mitek
Board Member: AANA, AIM, FairHealth PAB
Editorial Board: Orthopedics Today
Ownership: OPMI
Member Coding, Coverage and Reimbursement
Committee of AAOS
A new challenge to access to care:
Evidence Based Treatment Guidelines
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Clinical Practice Guidelines
Comparative Effectiveness Research
Appropriate Use Criteria
Health Technology Assessment
ALL can and are being used to limit
access to treatments NOW and in the
future
Evidence Based Medicine
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Use of the best available evidence
Expert opinion
 Patient preference
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Most now stress Level I RCT
 Gold standard in pharma literature
 Used by Cochrane and other EBM
leaders
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Methodology for Comparative
Effectiveness Research
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Perform studies comparing outcomes with alternative interventions
Perform systematic literature review to identify all the available data
Rank available data by the methodological rigor of the studies that
generated them:
Assess highest quality available data using qualitative or quantitative
(e.g., meta-analysis) methods
Once all the available evidence is assessed, categorize treatment as "likely
to be beneficial,” "likely to be harmful,” or "evidence did not
support either benefit or harm."
EBM: Clinical Practice
Guideline
Goal and Rationale
The purpose of this clinical practice guideline is to
evaluate the current best evidence associated with
treatment. Evidence-based medicine (EBM)
standards advocate for use of empirical evidence by
physicians their clinical decision making.
EBM: Clinical Practice
Guideline
Intended User
 This guideline is intended to be used by
appropriately trained physicians and clinicians who
manage the treatment of osteoarthritis of the
knee. It also serves as an information resource for
developers and applied users of clinical practice
guidelines.
 This guideline is not intended for use as a
benefits determination document. It does not
cover allocation of resources, business and ethical
considerations, and other factors needed to
determine the material value of care.
AAOS
Clinical Practice Guideline
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Management of Hip Fractures in the Elderly
Management of Anterior Cruciate Ligament
Injuries
Treatment of Osteoarthritis of the Knee
Prevention of Orthopaedic Implant Infection in
Patients Undergoing Dental Procedures
AAOS
Clinical Practice Guideline
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Preventing Venous Thromboembolic Disease in
Patients Undergoing Elective Hip and Knee
Arthroplasty
The Treatment of Pediatric Supracondylar
Humerus Fractures
Diagnosis and Treatment of Osteochondritis
Dissecans
Optimizing the Management of Rotator Cuff
Problems
AAOS
Clinical Practice Guideline
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Treatment of Symptomatic Osteoporotic Spinal
Compression Fractures
Diagnosis of Periprosthetic Joint Infections of the
Hip and Knee
Diagnosis And Treatment of Acute Achilles Tendon
Rupture
Treatment of Distal Radius Fractures
AAOS
Clinical Practice Guideline
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Treatment of Glenohumeral Joint Osteoarthritis
Treatment of Pediatric Diaphyseal Femur Fractures
Treatment of Carpal Tunnel Syndrome
Detection and Nonoperative Management of
Pediatric Developmental Dysplasia of the Hip in
Infants up to Six Months of Age
AAOS CGP:
Achilles Tendon 2009
16 Recommendations
Strong
0
Moderate
2
Limited
4
Inconclusive 8
Consensus
2
12% High level Recommendation
AAOS CGP:
Osteochondritis Dessicans 2010
15 Recommendations
Strong
0
Moderate
2
Limited
2
Inconclusive 9
Consensus
4
12% High level Recommendation
AAOS CGP:
Rotator Cuff 2010
14 Recommendations
Strong
0
Moderate
4
Limited
6
Inconclusive 15
Consensus
2
14% High level Recommendation
AAOS CGP:
ACL 2014
14 Recommendations
Strong
5
Moderate
2
Limited
5
Inconclusive 0
Consensus
2
50% High level Recommendation
AAOS CGP:
OAK 2013 (2nd Edition)
15 Recommendations
Strong
6
Moderate
3
Limited
1
Inconclusive 7
Consensus
1
50% High level Recommendation
AAOS OAK CPG 2013
RECOMMENDATION 9
 We cannot recommend using hyaluronic acid for
patients with symptomatic osteoarthritis of the knee.
Strength of Recommendation: Strong
 Description: Evidence is based on two or more “High”
strength studies with consistent findings for recommending
for or against the intervention. A Strong recommendation
means that the quality of the supporting evidence is high. A
harms analysis on this recommendation was not performed.
 Implications: Practitioners should follow a Strong
recommendation unless a clear and compelling rationale for
an alternative approach is present.
Despite statistically significant improvement and good safety profile!
AAOS OAK CPG 2013
Is statistically significant improvement
enough?
MCII: Meaningful Clinical Important
Improvement
 MCID: Meaningful Clinical Important
Difference
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Point out the controversial use of
MCII in measuring between-group
differences
 An illustration that it is all about THE
PROCESS!!
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Health Plan
Situation
BCBS of Kansas City
Implemented on 11/1/2013
BCBS of Arizona
Implemented on 1/1/14: Rescinded
7/14/14
BCBS of North Dakota
Rescinded
Lifewise
Regional and local coverage restrictions.
No official plan to eliminate coverage
nationally.
implementation delayed until December
1, 2014
Policy implementation delayed until
December 1, 2014
Capital BCBS (PA)
Rescinded
PacificSource
Implemented
HMSA (BCBS HI)
Rescinded
BCBS of MA
Implemented
BCBS of Kansas
Implemented
BCBS Western NY
Implemented
New York Medicaid
Implemented
Oklahoma Medicaid
Implemented
BCBS of Arkansas
Implemented from October
BCBS South Carolina
Rescinded
Kaiser Health Plan US
Premera BCBS
Notes
The plan was forced due to language in their
provider contract.
Flaws in AAOS analysis and provider pushback
caused reversal
The data from AAOS was controversial – plan
chose to reverse
Health tech group reviewed thru the AAOS
lens. Many patients are upset-this is likely to
change in the future
Premera has pushed back implementation 3 times
Same as Premera- (Sister plans)
Based on an understanding of the problems with
the AAOS analysis
Upon learning about the flaws in the AAOS
analysis, the plan reversed
Flaws in AAOS analysis and provider pushback
caused reversal
Is there an alternative?
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Appropriate Use Criteria (AUC)
Evidence synthesis EBM with expert opinion
AUC can’t include treatments NOT recommended
by CPG!
How do we get better??
DATA!!!!!
Widespread data collection with
patient centered, validated outcomes
 Standardize the validated metrics
that we use
 Keep Level of Evidence, project name
in mind when designing research
projects
 Draw concise conclusions from such
research!
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Level 1, No trauma, Kellgren-Lawrence 0, 1
Both arms had surgery
Improvement in each arm was similar
Conclusion: “the results argue against the current
practice of performing arthroscopic partial
menisectomy in patients with degenerative
meniscal tear.”
How do we get better??
Standardized validated outcomes
metrics
 Widespread collection/storage with
EMR technology
 Develop AUCs
 Historical controls to determine
comparative effectiveness
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Thank You!