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Making Clinical Practice Guidelines ROCK

CPG on osteochondritis dissecans of the knee serves as a roadmap for research

Kevin G. Shea, MD; James L. Carey, MD, MPH; Nathan L. Grimm, BS; and John C. Jacobs, BS

The Institute of Medicine (IOM) and other healthcare agencies have called for the increased use of evidence-based clinical practice guidelines (CPG) to reduce practice variation, improve quality of care, and decrease inefficiencies. The IOM has even outlined the qualities of a trust-worthy guideline.

Guideline development is based on an unbiased and transparent process, a systematic appraisal of the quality of the published literature, and use of the highest quality research to provide optimal care to patients. The Academy’s CPG development process is consistent with this approach and with the IOM recommendations.

With the growing emphasis on evidence-based medicine practices, higher quality research evidence will increasingly be used in coverage and reimbursement decisions. Thus, the Academy’s commitment to the guideline process will become even more important.

The CPG development process can help clinicians in several areas. The enormity of the orthopaedic and medical literature means that sorting through the appropriate articles and ranking the levels of evidence requires considerable effort, time, and expertise. The CPGs that materialize from these efforts, however, provide an efficient, cost-effective source of information for the best treatment and continuing medical education.

CPGs also provide a summary of important clinical questions and suggestions about needed research. The AAOS CPG process can support research groups, which can use the guidelines to set their priorities. The multicenter Research group for Osteochondritis Dissecans of the Knee (ROCK), for example, developed as a result of the AAOS CPG on the diagnosis and treatment of osteochondritis dissecans (OCD).

From CPG to ROCK
OCD of the knee predominantly impacts affects adolescent and young adult patients, many of whom are involved in athletics (Fig. 1). Because OCD can lead to pain, swelling, mechanical symptoms, and the inability to continue to play sports, this condition can have a dramatic impact on these individuals.

Degenerative arthritis may develop in these patients at a young age. Although the etiology of OCD remains unknown, several possibilities have been proposed, including possible familial inheritance, repetitive micro-trauma, growth disorders, and ischemia. The incidence of OCD may be increasing.

Among the research areas for OCD of the knee outlined in the AAOS CPG are the following:

  1. Inter- and intra-rater reliability studies on lesion classification for radiographs, MRI, and arthroscopy.
  2. Prospective cohort studies of knee OCD lesions treated nonsurgically to identify independent predictors of successful nonsurgical management of an OCD lesion.
  3. Randomized controlled trials (RCT) to establish the optimal nonsurgical and surgical treatments, as well as the optimal postoperative management strategies.

Because OCD is a rare condition, many of these trials will need to be designed and conducted as multicenter studies. Multicenter studies allow for faster enrollment of an adequate sample size, enabling researchers to attain statistical power for rare diseases. They also provide greater external validity so the outcome data can be generalized to a more diverse population.

The ROCK study group used the AAOS CPG to outline its research agenda. ROCK has 14 sites, with 16 orthopaedic surgeons, two physical therapists, two musculoskeletal radiologists, and one PhD. A grant from the Orthopaedic Research and Education Foundation enabled the ROCK group to sponsor a 3-day research meeting in November 2011. Over the past 3 years, the ROCK group has worked on the following projects:

  1. An updated epidemiology study of OCD of the knee, using a large electronic medical record system (more than 10 million patients). This work, led by Kevin F. Shea; MD, Jeffrey I. Kessler, MD; and Jennifer M. Weiss, MD, has generated new information about the locations, prevalence, and incidence of OCD, which will be presented in 2013.
  2. Development of OCD classification systems for MRI, radiographs, and arthroscopy using an expert, consensus-based method.
  3. Validation of classification systems. This work has been led by several ROCK members, including three of the authors of this article, as well as Eric Wall, MD, and Theodore J. Ganley, MD. The ROCK group completed the validations for arthroscopy, which demonstrate excellent reliability scores, and will present their findings in 2013. Validation for the MRI and radiographic classification will continue during the coming year.
  4. Development of a multicenter OCD prospective registry that currently involves 12 centers in North America, to better understand the epidemiology, natural history, and treatment outcomes.
  5. An RCT comparing trans-articular to retro-articular drilling for OCD, initiated in September 2012. This study has been funded by the American Orthopaedic Society for Sports Medicine and is being led by Benton E. Heyworth, MD.
  6. With respect to translational research, Dr. Carey, as the principal investigator, has received funding for a porcine animal model for OCD study at Penn through the Pilot and Feasibility Grant Program of the National Institutes of Health/National Institute for Arthritis and Musculoskeletal and Skin Diseases-supported Penn Center for Musculoskeletal Disorders (AR050950).

Conclusion
In summary, the AAOS CPG process is consistent with the highest standards established by the IOM. Although the guidelines have limitations, they can have a positive impact on physician education and patient care.

These guidelines may serve as a road map for future clinical research, because the review process identifies the important recommendations for clinical care and provides an assessment of the quality of the supporting evidence. The CPG process emphasizes the “evidence-based culture” within orthopaedics, and the Academy’s commitment to better patient care through outcomes research.

The evidence for evaluation and treatment efficacy will continue to affect future coverage and funding decisions, and the authors applaud the AAOS for its ongoing efforts in these areas.

Kevin F. Shea, MD; James L. Carey, MD, MPH; Nathan L. Grimm, BS; and John C. Jacobs, BS, are participants in the ROCK.

Disclosure information: The authors report no conflicts.

ROCK members and institutions
Henry G. Chambers, MD, and Eric W. Edmonds, MD

San Diego Children’s Hospital, San Diego

Kevin G. Shea, MD, and JoJo Brunelle, PT, DPT
St. Luke’s Health System, Boise, Idaho

Nate Grimm, BS
University of Utah School of Medicine, Salt Lake City

John D. Polousky, MD
Rocky Mountain Children’s Hospital, Denver

Roger M. Lyon, MD
University of Wisconsin, Madison, Wisc.

Eric Wall, MD; Greg Myers ATC, PhD; Mark Paterno, DPT; Tal Laor, MD; Andrew Zboniewicz, MD
Cincinnati Children’s Hospital, Cincinnati

James L. Carey, MD
University of Pennsylvania, Philadelphia

Theodore L. Ganley, MD, and Sabah Servaes, MD
Children’s Hospital of Philadelphia, Philadelphia

Allen F. Anderson, MD
Nashville, Tenn.

Lucas Murnaghan, MD
Hospital for Sick Children, Toronto

Benton E. Heyworth, MD, and Mininder S. Kocher, MD, MPH
Boston Children’s Hospital, Boston

Carl W. Nissen, MD
Connecticut Children’s Hospital, Hartford, Conn.

Rick W. Wright, MD
Washington University, St Louis

Jennifer M. Weiss, MD
Children’s Hospital Los Angeles, Los Angeles

References:

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  2. Smith TJ, Hillner BE: Ensuring quality cancer care by the use of clinical practice guidelines and critical pathways. J Clin Oncol 2001;19:2886–2897.
  3. Institute of Medicine (US). Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC, National Academy Press, 2001.
  4. Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs). Institute of Medicine, 2011. http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx Accessed August 27, 2011.
  5. Guideline development process and procedures. American Academy of Orthopaedic Surgeons, 2011. http://www.aaos.org/research/guidelines/Guideline_Development.asp. Accessed August 27, 2011.

AAOS Now
December 2012 Issue
http://www.aaos.org/news/aaosnow/dec12/research2.asp