Frequently asked questions about clinical practice guidelines

The AAOS Vision Statement maintains that the AAOS will be “the authoritative source of knowledge and leadership in musculoskeletal health.” The reality of healthcare reform makes it more important than ever for the Academy to fulfill this claim.

If we, as orthopaedic surgeons, cannot effectively demonstrate the reasons for treatment decisions in an evidence-based fashion, groups less familiar with our specialty will make decisions for us. In a recent speech to the American Medical Association, President Obama stated that “the government and the medical industry should explore a range of ideas about how to put patient safety first, how to let doctors focus on practicing medicine, and how to encourage broader use of evidence-based guidelines.”

The AAOS leadership made a critical commitment in 2006 to fund and develop evidence-based clinical practice guidelines (CPGs) on the diagnosis and/or treatment of a wide spectrum of orthopaedic conditions. According to Charles Turkelson, PhD, director of the AAOS department of research and scientific affairs, the AAOS CPGs are “comprehensive, evidence-based efforts designed to reflect the best available data and obtain the best possible input across a broad spectrum of practitioners.”

Dr. Turkelson has assembled and trained an outstanding group of AAOS staff with advanced training and degrees in public health and outcomes. After several years of getting new workgroups started, enough topics are now in the pipeline to produce guidelines at the planned rate of 4 per year (Table 1).

Many fellows, however, still have questions about the guideline process and the AAOS commitment to producing CPGs. Following are the questions I am most frequently asked and my responses.

How does the process work?
Individuals or specialty societies can submit potential topics using the online CPG topic nomination form. The Guidelines and Technology Oversight Committee (GTOC), under the leadership of William C. Watters III, MD, and Michael J. Goldberg, MD, works with the Evidence-Based Practice Committee (EBPC), chaired by Michael W. Keith, MD, to choose the topics based on specific criteria.

A workgroup of six to eight individuals is selected for each guideline with an effort to include diverse viewpoints. Most workgroups include nonorthopaedists such as physical therapists, rheumatologists, or plastic surgeons, depending on the topic.

The EBPC sets the standards for guideline development, and the GTOC implements these standards. The AAOS staff evidence and analysis group finds and analyzes the data based on specific questions devised by the workgroup. The workgroup works with the staff to write a set of recommendations with a rationale for each recommendation. Each rationale is based on information in the comprehensive systematic review of all available, relevant, clinical literature, and the final document is often 300 to 400 pages. The entire process is designed to combat bias (both intellectual and financial).

After the draft guideline is developed, during a peer review period, relevant individuals, committees, and specialty societies are asked to carefully critique the report. During the public commentary period, members of the Board of Councilors, Board of Specialty Societies, and outside organizations are asked to comment on the document. Suggested changes that are supported by evidence are made to the guideline based on the review process. The final guideline must be formally approved by the following groups: the EBPC; the GTOC; the Council on Research, Quality Assessment, and Technology; and the AAOS Board of Directors.

The entire guideline is posted on the AAOS Web site at www.aaos.org/guidelines

How long does this take?
It takes 9 to 18 months to complete an AAOS guideline, depending on the breadth of the topic and timing of the approval process. Although this seems like a long time, it is actually quick when benchmarked to other groups. For example, the American College of Cardiology (ACC) takes 18 to 36 months to develop a guideline; the National Kidney Foundation takes about 30 months; and the American Urological Association (AUA) takes 18 to 36 months.

Five guidelines have been approved by the AAOS; nine others are in the pipeline. Workgroups are currently working on topics related to distal radius fractures, glenohumeral osteoarthritis, ankle arthritis, Achilles tendon rupture, periprosthetic joint infections, spinal insufficiency fractures, osteochondritis dissecans (knee), rotator cuff tears, and pediatric supracondylar elbow fractures.

How much does a guideline cost?
Development costs are primarily indirect (staff salaries). Direct costs include library fees for articles and two meetings of each guideline workgroup. The 2009 cost per guideline is approximately $128,000, considerably less than per guideline costs incurred by other organizations such as the American College of Chest Physicians ($600,000), the ACC ($550,000), or the AUA ($250,000).

Are the AAOS guidelines considered high quality?
Whether a guideline is considered ‘good’ or ‘bad’ depends on the methodology, the resulting transparency, and the freedom of bias. With the exception of the guideline “Prevention of Symptomatic Pulmonary Embolism in Patients Undergoing Total Hip or Knee Arthroplasty,” all AAOS guidelines have been developed ‘in-house,’ using a consistent methodology.

Peer review of AAOS guidelines has resulted in their unsolicited endorsement by other major medical societies. The Joint Guidelines Committee of the American Association of Neurological Surgeons and the College of Neurological Surgeons formally endorsed the guideline on Treatment of Carpal Tunnel Syndrome and “was very impressed with the AAOS response to its comments and views it as a model for how all external reviews should be conducted.” A recent article in the Journal of the American Medical Association saw the AAOS Guideline on Treatment of Osteoarthritis (OA) of the Knee (Nonarthroplasty) as “a common sense approach to a common disease,” and the “recommendations as balanced, fair, and accurate.” In addition, the author believed that it was “refreshing that it didn’t call for more invasive treatment.”

By these standards, AAOS guidelines are of extremely high quality.

What happens to the guidelines after they are approved?
Approved guidelines are actively disseminated to AAOS fellows via subspecialty meetings, the AAOS Annual Meeting, Orthopaedics Knowledge Online, Journal of the AAOS, Journal of Bone and Joint Surgery, AAOS Now, Webinars, and the AAOS Web site. After the OA knee guideline was approved in December 2008, more than 4,500 Web site hits were recorded in that month alone!

The guidelines are also distributed to the National Guidelines Clearinghouse and the recommendations are used as the basis for the Orthopaedic In-Training Examination and self-assessment examination questions. In the future, these guidelines will likely provide material for American Board of Orthopaedic Surgery Part I examination questions and as a way to complete Maintenance of Certification requirements (Practice Improvement Modules).

Press releases on each guideline prepared by the AAOS public relations department generate media interest. For example, the OA knee guideline generated 66 print and online placements—more than 17.5 million media impressions.

Why should AAOS continue to produce CPGs?
The value of AAOS guidelines is far-reaching. They touch the areas of education, research, and advocacy. The new information gained from each guideline is used to update existing AAOS educational materials for members and patients. The conclusions will be published and used as the basis of test questions for residents and established surgeons.

The guidelines not only identify the available evidence on a particular topic, they also identify gaps in knowledge that can guide future research studies. For institutions and individuals with a strong interest in clinical trials, these projects have the potential to lead to extramural funding. There is currently great interest in comparative effectiveness research (CER), and evidence-based CPGs developed after systematic review of the literature are an important form of CER.

CPGs benefit our patients by providing orthopaedic surgeons with a set of defensible best practices that can result in better delivery of health care.

President Obama has suggested that doctors who act in accordance with their specialty’s professional guidelines may be presumed to have acted reasonably, which might be helpful in terms of medical liability reform. In addition, the guidelines provide true credibility for the AAOS. Orthopaedic surgeons become part of the solution by demonstrating to policy makers that we are focused on determining what works and what does not work in our field. In this way, the AAOS fulfills its vision of being the authoritative source of knowledge and leadership in musculoskeletal health.

Kristy L. Weber, MD, is chair of the AAOS Council on Research, Quality Assessment, and Technology. She can be reached at kweber6@jhmi.edu

References:

1. Voelker R: Guideline provides evidence-based advice for treating osteoarthritis of the knee. JAMA 2009; 301:475-476
2. Guideline Topic Nomination Form