APPROPRIATE USE CRITERIA FOR ACL INJURY PREVENTION PROGRAMS Adopted by the American Academy of Orthopaedic Surgeons Board of Directors October 2, 2015 www.OrthoGuidelines.org/auc Disclaimer Volunteer physicians from multiple medical specialties created and categorized these Appropriate Use Criteria. These Appropriate Use Criteria are not intended to be comprehensive or a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. These Appropriate Use Criteria represent patients and situations that clinicians treating or diagnosing musculoskeletal conditions are most likely to encounter. The clinician’s independent medical judgment, given the individual patient’s clinical circumstances, should always determine patient care and treatment. Disclosure Requirement In accordance with American Academy of Orthopaedic Surgeons policy, all individuals whose names appear as authors or contributors to this document filed a disclosure statement as part of the submission process. All authors provided full disclosure of potential conflicts of interest prior to participation in the development of these Appropriate Use Criteria. Disclosure information for all panel members can be found in Appendix B. Funding Source The American Academy of Orthopaedic Surgeons exclusively funded development of these Appropriate Use Criteria. The American Academy of Orthopaedic Surgeons received no funding from outside commercial sources to support the development of these Appropriate Use Criteria. FDA Clearance Some drugs or medical devices referenced or described in this document may not have been cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific use only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice. Copyright All rights reserved. Reproduction, storage in a retrieval system, or transmission, in any form, or by any means, electronic, mechanical, photocopying, recording, or otherwise, of any part of this document, requires prior written permission from the American Academy of Orthopaedic Surgeons. Published 2015 by the American Academy of Orthopaedic Surgeons 9400 West Higgins Road Rosemont, IL 60018 First Edition Copyright 2015 by the American Academy of Orthopaedic Surgeons For a more user-friendly version of this AUC, or to view additional AUCs, please visit the AAOS AUC web-based app at: www.OrthoGuidelines.org/auc Table of Contents Writing Panel ............................................................................................................................... i Voting Panel................................................................................................................................. i Voting Panel Round Two Discussion Moderators....................................................................... i AUC Section Leader, AAOS Committee on Evidence-Based Quality and Value ..................... ii Chair, AAOS Committee on Evidence-Based Quality and Value .............................................. ii Chair, AAOS Council on Research and Quality ......................................................................... ii AAOS Staff ................................................................................................................................. ii I. INTRODUCTION ...................................................................................................................1 Overview ..................................................................................................................................... 1 Conditions Not Covered by this AUC ........................................................................................ 2 II. METHODS ..............................................................................................................................3 Developing Criteria ..................................................................................................................... 3 Formulating Indications and Scenarios ................................................................................... 4 Creating Definitions and Assumptions ................................................................................... 5 Literature Review........................................................................................................................ 6 Determining Appropriateness ..................................................................................................... 6 Voting Panel............................................................................................................................ 6 Rating Appropriateness/Helpfulness ...................................................................................... 6 Round One Voting .................................................................................................................. 7 Round Two Voting ................................................................................................................. 8 Final Ratings ........................................................................................................................... 8 Revision Plans ............................................................................................................................. 9 Disseminating Appropriate Use Criteria ..................................................................................... 9 III. PATIENT INDICATIONS AND TREATMENTS ...............................................................10 Indications ................................................................................................................................. 10 Treatments................................................................................................................................. 11 IV. RESULTS OF APPROPRIATENESS RATINGS ................................................................12 Appropriate Use Criteria for Anterior Cruciate Ligament Injury Prevention Programs........... 16 Appendices ................................................................................................................................ 20 Appendix A. Documentation of Approval ............................................................................ 21 Appendix B. Disclosure Information .................................................................................... 22 Appendix C. References ....................................................................................................... 26 WRITING PANEL Robert Marx, MD, MSc, FRCSC American Orthopaedic Society for Sports Robert A. Magnussen MD, MPH Medicine International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine Rick Wright, MD American Orthopaedic Society for Sports David Anthony Parker MBBS, BMedSci, Medicine FRACS International Society of Arthroscopy, Knee Jeffrey P. Feden, MD, FACEP Surgery and Orthopaedic Sports Medicine American College of Emergency Physicians Elvire Servien MD, PhD, Prof Brian Pietrosimone PhD, ATC International Society of Arthroscopy, Knee National Academy of Sports Medicine Surgery and Orthopaedic Sports Medicine Anthony Beutler, MD Peter H. Seidenberg, MD, FAAFP, FACSM American Medical Society for Sports Medicine American College of Sports Medicine Daniel C. Herman, MD, PhD, CAQSM Michael Khazzam, MD American Academy of Physical Medicine and American Academy of Orthopaedic Suregons Rehabilitation William G. DeLong Jr., MD Christopher C. Kaeding MD American College of Surgeons International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine VOTING PANEL Sandra J. Shultz, PhD Anna L. Waterbrook, MD, FACEP National Athletic Trainers’ Association American College of Emergency Physicians Bradley J. Nelson, MD Kevin R. Vincent, MD, PhD American Orthopaedic Society for Sports Medicine American Academy of Physical Medicine and Rehabilitation Steven B. Singleton, MD Arthroscopy Association of North America T David Hayes, MD The Knee Society Neeru Jayanthi, MD American Medical Society for Sports Medicine Douglas W. Lundy, MD American College of Surgeons Cynthia R. LaBella, MD American Medical Society for Sports Medicine Moira Davenport, MD American College of Emergency Physicians VOTING PANEL ROUND TWO DISCUSSION MODERATORS i James O. Sanders, MD Gregory A. Brown, MD, PhD AUC SECTION LEADER, AAOS COMMITTEE ON EVIDENCE-BASED QUALITY AND VALUE Robert H. Quinn, MD CHAIR, AAOS COMMITTEE ON EVIDENCE-BASED QUALITY AND VALUE David S. Jevsevar, MD, MBA CHAIR, AAOS COUNCIL ON RESEARCH AND QUALITY Kevin J. Bozic, MD, MBA AAOS STAFF William O. Shaffer, MD Medical Director Deborah S. Cummins, PhD Director, Department of Research and Scientific Affairs Jayson Murray, MA Manager, Evidence-Based Medicine Unit Ryan Pezold, MA Research Analyst, Evidence-Based Medicine Unit Peter Shores, MPH Statistician, Evidence-Based Medicine Kaitlyn Sevarino Evidence-Based Quality and Value (EBQV) Coordinator Erica Linskey Administrative Assistant, Evidence-Based Medicine Unit ii I. INTRODUCTION OVERVIEW The American Academy of Orthopaedic Surgeons (AAOS) has developed this Appropriate Use Criteria (AUC) to determine the appropriateness/helpfulness of using a supervised Anterior Cruciate Ligament (ACL) injury prevention program to prevent ACL injuries in individuals who are involved in competitive and/or recreational athletics, have no prior history of ACL reconstruction, and no current history of ACL deficiency. An “appropriate/helpful” healthcare service is one for which the expected health benefits exceed the expected negative consequences by a sufficiently wide margin.2 Evidence-based information, in conjunction with the clinical expertise of physicians from multiple medical specialties, was used to develop the criteria in order to improve preventative care and obtain the best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. The foundation for this AUC is the 2014 Management of Anterior Cruciate Ligament Injuries Clinical Practice Guideline, which can be accessed via the following link: http://www.aaos.org/research/guidelines/ACLGuidelineFINAL.pdf The purpose of this AUC is to help determine the appropriateness/helpfulness of using a supervised ACL injury prevention program to prevent ACL injuries in individuals who are involved in competitive and/or recreational athletics, have no prior history of ACL reconstruction, and no current history of ACL deficiency. The best available scientific evidence is synthesized with collective expert opinion on topics where gold standard randomized clinical trials are not available or are inadequately detailed for identifying distinct patient types. When there is evidence corroborated by consensus that expected benefits substantially outweigh potential risks, exclusive of cost, a procedure is determined to be appropriate. The AAOS uses the RAND/UCLA Appropriateness Method (RAM).2 Our process includes these steps: reviewing the results of the evidence analysis, compiling a list of clinical vignettes, and having an expert panel comprised of representatives from multiple medical specialties determine the appropriateness/helpfulness of each of the clinical indications for treatment. To access an intuitive and more user-friendly version of the appropriate use criteria for this topic online, please visit the AAOS OrthoGuidelines website at www.orthoguidelines.org/auc. These criteria should not be construed as including all indications or excluding indications reasonably directed to obtaining the same results. The criteria intend to address the most common clinical scenarios facing all appropriately trained clinicians managing patients under consideration for preventing anterior cruciate ligament injuries. The ultimate judgment regarding any specific criteria should address all circumstances presented by the patient and the needs and resources particular to the locality or institution. It is also important to state that these criteria were developed as guidelines and are not meant to supersede clinician expertise and experience or patient preference. INTERPRETING THE APPROPRIATENESS RATINGS To prevent misuse of these criteria, it is extremely important that the user of this document understands how to interpret the appropriateness ratings. The appropriateness rating scale ranges from one to nine and there are three main range categories that determine how the median rating is defined (i.e. 1-3 = “Rarely Helpful for Preventing an ACL Injury”, 4-6 = “May Be Helpful for 1 AAOS Evidence-Based Medicine Unit AAOS AUC Web-Based Application: www.orthoguidelines.org/auc Preventing an ACL Injury”, and 7-9 = “Likely Helpful for Preventing an ACL Injury”). Before these appropriate use criteria are consulted, the user should read through and understand all contents of this document. ASSUMPTIONS OF THE WRITING PANEL Before these criteria are consulted, it is assumed that: 1. Individual is involved in competitive and/or recreational athletics 2. No prior history of ACL reconstruction 3. No current history of ACL deficiency CONDITIONS NOT COVERED BY THIS AUC  Tibial eminence fracture  Collateral ligament injuries  Re-tears of prior reconstructions  Partial ACL injuries PATIENT POPULATION & SCOPE OF GUIDELINE This document is intended for use for both skeletally immature and skeletally mature patients who have been diagnosed with an ACL injury of the knee. BURDEN OF DISEASE Persons who suffer ACL injuries are at increased risk for developing arthritis later in life.3 Females are two to eight times more likely to suffer an ACL injury compared to males.3 ETIOLOGY ACL rupture is typically the result of a traumatic, sports-related injury. This injury may be contact or non-contact. INCIDENCE AND PREVALENCE The annual rate of patients who present with anterior cruciate ligament injuries has been estimated at 252,000.3 POTENTIAL BENEFITS, HARMS, AND CONTRAINDICATIONS Most treatments are associated with some known risks, especially invasive and operative treatments. Contraindications vary widely based on the treatment administered. A particular concern when treating ACL injuries is routine surgical complications such as infection, DVT, anesthesia complications, etc. Other complications associated with ACL surgery include: postoperative loss of motion or arthrofibrosis, ongoing instability episodes, neurovascular injury, etc. Additional factors may affect the physician’s choice of treatment including but not limited to associated injuries the patient may present with as well as the individual’s co-morbidities, skeletal maturity, and/or specific patient characteristics including obesity, activities, work demands, etc.. Clinician input based on experience increases the probability of identifying 2 AAOS Evidence-Based Medicine Unit AAOS AUC Web-Based Application: www.orthoguidelines.org/auc patients who will benefit from specific treatment options. The individual patient and the patient’s family dynamic will also influence treatment decisions therefore, discussion of available treatments and procedures applicable to the individual patient rely on mutual communication between the patient and the patient’s guardian (when appropriate for minor patients) and physician, weighing the potential risks and benefits for that patient. Once the patient and patient’s guardian has been informed of available therapies and has discussed these options with the patient and guardian (if appropriate), an informed decision can be made. II. METHODS This AUC for Anterior Cruciate Ligament Injury Prevention Programs is based on a review of the available literature and a list of clinical scenarios (i.e. criteria) constructed and voted on by experts in orthopaedic surgery and other relevant medical fields. This section describes the methods adapted from the RAND/UCLA Appropriateness Method (RAM)2. This section also includes the activities and compositions of the various panels that developed, defined, reviewed, and voted on the criteria. Two panels participated in the development of the AAOS AUC for Anterior Cruciate Ligament Injury Prevention Programs (see list on page i). Members of the writing panel developed a list of 48 patient scenarios, for which the appropriateness/helpfulness of a supervised rehabilitation program was evaluated. The voting panel participated in two rounds of voting. During the first round of voting, the voting panel was given approximately one month to independently rate the appropriateness/helpfulness of a supervised rehabilitation program for each of the relevant patient scenarios via an electronic ballot. After the first round of appropriateness ratings were submitted, AAOS staff calculated the median ratings for each patient scenario. An in-person voting panel meeting was held in Rosemont, IL on April 25th of 2015. During this meeting, voting panel members addressed the scenarios which resulted in disagreement (definition of disagreement can be found in Table 3). The voting panel members were asked to rerate their first round ratings during the voting panel meeting, only if they were persuaded to do so by the discussion and available evidence. The voting panel determined appropriateness by rating supervised rehabilitation program as ‘Likely Helpful for Preventing an ACL Injury for Patient Profile of Interest’, ‘May Be Helpful for Preventing an ACL Injury for Patient Profile of Interest’, or ‘Rarely Helpful for Preventing an ACL Injury for Patient Profile of Interest’. There was no attempt to obtain consensus about appropriateness. AAOS Appropriate Use Criteria Section, the AAOS Council on Research and Quality, and the AAOS Board of Directors sequentially approved the Appropriate Use Criteria for Management of Anterior cruciate ligament injuries. AAOS submits this AUC to the National Guidelines Clearinghouse and, in accordance with the National Guidelines Clearinghouse criteria, will update or retire this AUC within five years of the publication date. DEVELOPING CRITERIA Members of the AUC for Anterior Cruciate Ligament Injury Prevention Programs writing panel, who are orthopaedic specialists in treating knee-related injuries/diseases, developed clinical scenarios using the following guiding principles: 3 AAOS Evidence-Based Medicine Unit AAOS AUC Web-Based Application: www.orthoguidelines.org/auc  Patient scenarios must include a broad spectrum of patients that may be eligible for treatment of anterior cruciate ligament injuries [comprehensive]  Patient indications must classify patients into a unique scenario [mutually exclusive]  Patient indications must consistently classify similar patients into the same scenario [reliable, valid indicators] The writing panel developed the scenarios by categorizing patients in terms of indications evident during the clinical decision making process (Figure 1). These scenarios relied upon definitions and general assumptions, mutually agreed upon by the writing panel during the development of the scenarios. These definitions and assumptions were necessary to provide consistency in the interpretation of the clinical scenarios among experts voting on the scenarios and readers using the final criteria. FORMULATING INDICATIONS AND SCENARIOS The AUC writing panel began the development of the scenarios by identifying clinical indications typical of patients commonly presenting with anterior cruciate ligament injuries in clinical practice. Indications are most often parameters observable by the clinician, including symptoms or results of diagnostic tests. Additionally, “human factor” (e.g. activity level) or demographic variables can be considered. Figure 1. Developing Criteria Indication: Classification: Observable/appreciable patient Class/category of an indication; parameter standardized by definitions* Major clinical indication Clinical Scenario: Chapter: Combination of a single Group of scenarios based on classification from each indication; the major clinical indication assumptions assist interpretation* Criteria: A unique clinical scenario with a final appropriateness rating 4 AAOS Evidence-Based Medicine Unit AAOS AUC Web-Based Application: www.orthoguidelines.org/auc