AAOS ANNUAL MEETING 2013 SCIENTIFIC EXHIBIT

Transcription

1 AAOS ANNUAL MEETING 2013 SCIENTIFIC EXHIBIT EVIDENCE-BASED ORTHOPAEDICS AAOS COMMITTEE ON EVIDENCE-BASED QUALITY AND VALUE

2 INTRODUCTION Evidence Based Medicine is an essential component of contemporary patient care. Empirical evidence has always been part of clinical decision making; it now has even greater importance with the advent of quality evaluation, payer financial decisions and regulatory oversight. This exhibit will: a. Summarize the principles of Evidence-Based Medicine b. Present recently approved AAOS Evidence-Based Guidelines and Appropriate Use Criteria c. Explain Guideline and Appropriate Use Criteria development methodology d. Highlight the initiative of the Research inosteochondritis of the Knee (R.O.C.K.) group aaos.org/ebm

3 WHAT IS EVIDENCE-BASED MEDICINE? The practice of EBM is the integration of the best research evidence with clinical expertise and patient s values. (Sackett DL, 2000) AAOS Department of Research and Scientific Affairs works with volunteers to develop Evidence-Based Medicine Tools such as Clinical Practice Guidelines and Appropriate Use Criteria. Sackett DL, Straus SE, Richardson WS, et al. Evidence-based medicine: how to practice and teach EBM. 2d ed. Edinburgh: Churchill Livingstone, aaos.org/ebm

4 Clinical Practice Guidelines Clinical Practice Guidelines are statements that include recommendations intended to optimize patient care. They are informed by a systematic review of evidence and an assessment of benefits and harms of alternative care options (IOM, 2011). American Academy of Orthopaedic Surgeons (AAOS) physician volunteer Work Groups develop Evidence-Based Clinical Practice Guidelines to serve as an educational tool based on assessment of current scientific and clinical information, and accepted approaches to treatment. AAOS has developed 14 Clinical Practice Guidelines. IOM (Institute of Medicine) Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. aaos.org/guidelines

5 AAOS EVIDENCE-BASED CLINICAL PRACTICE GUIDELINES TIMELINE (DATE APPROVED) Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures (December 7, 2012) Treatment of Pediatric Supracondylar Humerus Fractures (September 24, 2011) Diagnosis and Treatment of Osteochondritis Dissecans (December 4, 2010) Guideline Update: Treatment of Carpal Tunnel Syndrome (September 24, 2010) Diagnosis of Periprosthetic Joint Infections of the Hip and Knee(June 18, 2010) Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty (September 24, 2011) Optimizing the Management of Rotator Cuff Problems (December 4, 2010) Treatment of Symptomatic Osteoporotic Spinal Compression Fractures (September 24, 2010) Diagnosis and Treatment of Acute Achilles Tendon Rupture (December 4, 2009) Treatment of Glenohumeral Joint Osteoarthritis (December 5, 2009) Treatment of Distal Radius Fractures (December 5, 2009) Treatment of Osteoarthritis (OA) of the Knee (December 5, 2008) Diagnosis of Carpal Tunnel Syndrome (May 18, 2007) Treatment of Pediatric Diaphyseal Femur Fractures (June 19, 2009) Treatment of Carpal Tunnel Syndrome (September 12, 2008)

6 AAOS CPGs in Development March Nominate CPG topic (open to all) 2. Select Topic; Solicit for Work Group (WG) members CPG on Surgical Management of Osteoarthritis of the Knee (SMOAK) CPG on Management of Hip Fractures in Elderly Patients (Hip Fx) CPG on Anterior Cruciate Ligament Injuries (ACL) CPG on Pediatric Developmental Dysplasia of the Hip (DDH) AAOS/ADA CPG on Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures 3. Apply/Nominate WG Members AAOS/BOS/BOC/Others organizations as appropriate 4. Appointment of WG Members (no relevant conflicts allowed) 5. Formulate Questions, Set inclusion criteria ~completed by WG at Introductory Meeting 6. Review Literature (staff); Appraise Quality (staff) 7. Approve included articles ~ completed by WG during teleconferences 8. Review Evidence; Develop recommendations and assign ratings ~Completed by WG at final meeting 9. Peer Review Process ~ Officially 1 month 10. Review and respond to peer reviews; revise as needed; any revisions require Work Group approval 11. Public Comment ~ Officially 30 days 12. Review Comments and revise if needed; any revisions require Work Group approval 13. Approval Process 14. Communication, Dissemination, Implementation Seek input on the selection of questions/topics from patients, payors, stakeholders, AAOS members and others. CPG on Treatment of Osteoarthritis of the Knee (OAK) The final CPG is reviewed and approved by: Work Group Guideline Oversight Section Committee on Evidence Based Quality and Value (EBQV) Council on Research and Quality (CORQ) AAOS Board of Directors

7 AAOS Evidence-Based Clinical Practice Guidelines Appraising Evidence Quality and Applicability The Guideline Work Group formulates questions and sets inclusion criteria for the literature review. AAOS staff research analyst appraises research studies that meet the inclusion criteria using the APPRAISE system adopted from the GRADE Working Group¹. The studies are classified into four categories for evidence appraisal: 1) Intervention 2) Incidence and Prevalence 3) Prognosis 4) Screening and Diagnosis. We have provided an example of how the appraisal process is completed for Intervention Studies. Studies of Interventions Quality Domains Prospective Statistical Power Group Assignment Blinding Group Comparability Treatment Integrity Measurement Bias Domain Questions The study was prospective Study statistically significant Number of patients in the analysis Stochastic Quasi-random assignment Matched Groups Consecutive Enrollment Blinded Patients Blinded Assessors Blinded Verified Allocation Concealment > 80% follow up < 20% Completion difference Similar Baseline Outcome Values Comparable Patient Characteristics Same Control Group Results Same Experiential Group Results Same Centers Same Treatment Duration in and across all groups Same Concomitant Treatment to All groups (controlled studies only) No confounding treatments (case-series only) Same Instruments Valid Instruments Article & Abstract Agree All outcomes reported A Priori Analysis Literature is appraised using the series of questions in each domain. To arrive at the quality and applicability of the evidence for a given outcome, all domains except Statistical Power are termed flawed if one or more of the questions are answered No, or if there are two or more Unclear answers. The Statistical Power domain is considered flawed if a given study did not enroll enough patients to detect a standardized difference between means of at least 0.2. The Quality and Applicability categories below determine the strength of evidence of each article. Relationship between Quality and Domain Scores for Studies of Interventions Number of Flawed Quality Domains Strength of Evidence 0-1 High 2-3 Moderate 4-5 Low >5 Very Low Relationship between Applicability and Domain Scores for Studies of Interventions Number of Flawed Applicability Domains Strength of Evidence 0 High 1,2,3 Moderate 4 Low Appraisal Domains Participants Interventions and Expertise Compliance and Adherence Analysis Note: More information on the Quality and Applicability appraisals for studies of Incidence and Prevalence, Prognosis, and Screening and Diagnosis, is available in the Methods section of our CPGs. Visit Domain Questions All type of participants enrolled Flexible Instructions to Practitioners Full Range of Experimental Practitioners Usual Practice Control Full Range of Control Practitioners No Formal Follow-up Usual and Meaningful Outcome Compliance Not Measured No Measure of Practitioners Adherence All Patients in Analysis Quality + Applicability = Strength of Evidence The preliminary strength of evidence should be modified based on its applicability. If the quality of the study is High, the strength cannot be further upgraded so the final study strength is also High, if applicability is High or Moderate. If the quality of the study is Very Low, the evidence is considered too weak to allow for increased confidence in it, so the final study strength will be Low regardless of how applicable it is. The preliminary study strength can be upgraded by one step if the applicability is High or downgraded by one level if applicability is Low. Study strength is not modified if the applicability is Moderate. Moderate Quality + High Applicability = High Strength of Evidence Moderate Quality + Moderate Applicability = Moderate Strength of Evidence Moderate Quality + Low Applicability = Low Strength of Evidence ¹GRADE handbook for grading quality of evidence and strength of recommendation. The GRADE Working Group; 2009.

8 Statement Rating Description of Evidence Strength Implication for Practice Strong Evidence is based on two or more High strength studies with consistent findings for recommending for or against the intervention. Moderate AAOS EVIDENCE-BASED CLINICAL PRACTICE GUIDELINES STRENGTH OF RECOMMENDATION DESCRIPTIONS A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and/or that the strength of the supporting evidence is high. Evidence from two or more Moderate strength studies with consistent findings, or evidence from a single High quality study for recommending for or against the intervention. Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. Limited² New wording! Previously titled as Weak Inconclusive Consensus¹ A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Evidence from two or more Low strength studies with consistent findings, or evidence from a single Moderate quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria. Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. ¹The AAOS will issue a consensus-based recommendation only when the service in question has virtually no associated harm and is of low cost (e.g. a history and physical) or when not establishing a recommendation could have catastrophic consequences. ²In December 2012, the AAOS Board of Directors approved to change the word, Weak to Limited in all AAOS CPG ratings. The criteria and definition/description remains the same.

9 THE CLINICAL PRACTICE GUIDELINE ON THE PREVENTION OF ORTHOPAEDIC IMPLANT INFECTION IN PATIENTS UNDERGOING DENTAL PROCEDURES SUMMARY OF RECOMMENDATIONS NOTE: This summary does not contain rationales that explain how and why these recommendations were developed, nor does it provide the evidence supporting these recommendations. This summary of recommendations is not intended to stand alone. Treatment decisions should be based on circumstances presented by the patient. Treatments and procedures applicable to the individual patient rely on mutual communication between patient, physician, dentist and other healthcare practitioners. 1. The practitioner might consider discontinuing the practice of routinely prescribing prophylactic antibiotics for patients with hip and knee prosthetic joint implants undergoing dental procedures. Grade of Recommendation: Limited Description: Evidence from two or more Low strength studies with consistent findings, or evidence from a single Moderate quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Evidence from two or more Low strength studies with consistent findings, or evidence from a single Moderate quality study recommending for or against the intervention or diagnostic. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. 2. We are unable to recommend for or against the use of topical oral antimicrobials in patients with prosthetic joint implants or other orthopaedic implants undergoing dental procedures. Grade of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. 3. In the absence of reliable evidence linking poor oral health to prosthetic joint infection, it is the opinion of the work group that patients with prosthetic joint implants or other orthopaedic implants maintain appropriate oral hygiene. Grade of Recommendation: Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria. The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. The full guideline document, the guideline shared decision making tool and editorial can be found on our website: aaos.org/guidelines

10 Appropriate Use Criteria Appropriate Use Criteria are used to identify for whom a treatment is appropriate. An appropriate procedure is one for which the expected health benefits exceed the expected health risks by a wide margin. Evidence-based information in conjunction with the clinical expertise of physicians from multiple medical specialties is used to develop AAOS AUC in order to improve patient care and obtain the best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. AAOS has developed its first AUC on the Treatment of Distal Radius Fractures. AAOS has three additional AUCs in development: Optimizing the Treatment of Rotator Cuff Problems Non surgical treatment of Osteoarthritis of the Knee Imaging for Knee Pain aaos.org/auc

11 AAOS AUCs in Development March AUC Committee selects topic Imaging for Knee Pain Non-surgical Treatment of Osteoarthritis of the Knee (OAK) 2. Solicit AAOS Members and medical/specialty society for nominees to serve on: - Writing Panel - Review Panel - Voting Panel (multidisciplinary group) 3. Writing Panel develops criteria (indications, scenarios, definitions, and assumptions) 4. AAOS staff produces literature review based on updating and supplementing an existing AAOS clinical practice guideline 5. Review Panel reviews criteria developed by the Writing Panel and provides feedback Treatment of Distal Radius Fractures (DRF) 6. Writing Panel makes edits based on Review Panel feedback and finalizes criteria 7a. Voting Panel rates criteria independently (Round One Voting occurs online) 7b. Voting Panel members meet in person, discuss any discrepancies in results of first round voting and rate criteria again (Round Two Voting) 8. Approval 9. Publication Optimizing the Treatment of Rotator Cuff Problems (RC) The final AUC is reviewed and approved by: AUC Section Council on Research and Quality (CORQ) AAOS Board of Directors

12 Treatment of Distal Radius Fracture (DRF) Appropriate Use Criteria (AUC) DRF AUC Indications and Classifications Criteria Indications Classifications Indications Classifications AO Fracture Type A ASA Status ASA 1-3 B (co-morbidities) ASA 4 C Associated Injuries No associated injuries Mechanism of Injury High Energy Grade I or II Open Low Energy Fracture Grade III Open Fracture Functional Demands Homebound Median Nerve Injury Independent Other Ipsilateral Injury Normal High aaos.org/auc

13 Treatment of Distal Radius Fracture Appropriate Use Criteria The AUC Treatment Ratings Appropriate May be Appropriate Rarely Appropriate Out of 2160 total voting items (216 patient scenarios x 10 treatments) 767 (36%) voting items were rated as Appropriate 953 (44%) voting items were rated as May be Appropriate 440 (20%) voting items were rated as Rarely Appropriate See Demo of DRF AUC Mobile App at the Evidence-Based Quality and Value Initiatives Booth at Academy Row! aaos.org/auc

14 RESEARCH IN OSTEOCHONDRITIS DISSECANS OF THE KNEE (ROCK) GROUP In 2010, AAOS published a clinical practice guideline (CPG) on the diagnosis and treatment of osteochondritis dissecans (OCD) of the knee 1. This CPG included sixteen recommendations. Because of significant gaps in the literature, the evidence strengths of fourteen recommendations were either inconclusive or consensus-based. The two recommendations that could be rated on the basis of evidence were graded as limited, the category that reflects few well designed studies. The CPG identified the following areas necessary for future research: reliability studies for classifications systems for arthroscopy, MRI, and radiographs, prospective cohort studies to identify predictors of healing, RCTs to establish optimal nonsurgical treatment, RCTs to establish optimal surgical treatment for those that fail conservative treatment, and establish optimal post-operative physical therapy protocols. The AAOS Practice Guideline provides an excellent template for future research. The Research in OsteoChondritis dissecans of the Knee (ROCK) Group 2 was formed in 2009 using the future research recommendations of the AAOS CPG as a roadmap for the group s research agenda. The ROCK Group is comprised of 22 members at 14 centers across the U.S. and Canada. Current Areas of Research 1. Development of classification systems for arthroscopy, MRI, and radiographs a. Inter- and intra-rater reliability studies are currently in progress 2. Prospective patient registry a. Currently enrolling patients 3. Randomized clinical trial for trans- and retro-articular drilling for stable juvenile OCD lesions of the knee OCD is a focal, idiopathic alteration of subchondral bone with risk for instability and disruption of adjacent articular cartilage that may result in premature osteoarthritis. a. Currently enrolling patients 4. Largest epidemiology study of OCD in children and adolescents a. Publications in progress 5. Basic science and translational research a. Genomic characterization of OCD b. Development of an animal model for OCD i. Porcine model ii. Rabbit model ROCK Group planning meeting. Chicago, November Chambers HG, Shea KG, Anderson AF, et al. Diagnosis and treatment of osteochondritis dissecans. J Am Acad Orthop Surg. 2011;19(5): For more information on the ROCK Group, visit or

15 Members of the Committee on Evidence-Based Quality and Value (EBQV) David S. Jevsevar, MD EBQV Chair Michael J. Goldberg, MD Guidelines Oversight Section Leader David Jevsevar, MD, MBA, Committee Chair William Timothy Brox, MD, Committee Member James L. Carey, MD, MPH, Committee Member Robert H. Haralson, III, MD, MBA, Committee Member William Obremskey, MD, Committee Member Robert H. Quinn, MD, Committee Member Bruce Laron Smith, Jr., MD, Committee Member* Nelson Fong SooHoo, MD, Committee Member* Kevin Shea, MD, Committee Member** James O. Sanders, MD Appropriate Use Criteria Section Leader William C. Watters, III, MD** Past Appropriate Use Criteria Section Leader The EBQV Committee is sponsoring this Scientific Exhibit. The authors have no relevant or perceived conflicts of interest related to this exhibit. No conflict of interest *Indicates committee member whose term begins on 3/22/2013 **Indicates committee member whose term ends on 3/22/2013 Michael J. Goldberg, MD, Section Leader, Guidelines Oversight Section Gregory A. Brown, MD, PhD, Committee Member, Guidelines Oversight Section William B. Ericson, Jr., MD, Committee Member, Guidelines Oversight Section Charles A. Reitman, MD, Committee Member, Guidelines Oversight Section Bruce Rougraff, MD, Committee Member, Guidelines Oversight Section William Orlon Shaffer, MD, Committee Member, Guidelines Oversight Section Walter Stanwood, MD, Committee Member, Guidelines Oversight Section Stephen J. Pinney, MD, Committee Member, Guidelines Oversight Section** James O. Sanders, MD, Section Leader, Appropriate Use Criteria Section Brent Graham, MD, Committee Member, Appropriate Use Criteria Section Michael H. Heggeness, MD, Committee Member, Appropriate Use Criteria Section Michael Warren Keith, MD, Committee Member, Appropriate Use Criteria Section Charles T. Mehlman, DO, MPH, Committee Member, Appropriate Use Criteria Section William C. Watters, III, MD, Past Section Leader, Appropriate Use Criteria Section** Joseph A. Bosco, III, MD, Committee Member, Appropriate Use Criteria Section**

16 Visit the Evidence-Based Quality and Value Initiatives Booth at Academy Row to learn more about the AAOS s CPGs and AUCs