The American Academy of Orthopaedic Surgeons (AAOS) and the Orthopaedic Research and Education Foundation (OREF) have forged a strategic partnership to help ensure that the most clinically impactful research questions in the field of orthopedics are being adequately addressed. The fact is…there are important gaps in current musculoskeletal clinical research.
This is something that Kristy Weber, M.D., past president of the American Academy of Orthopaedic Surgeons has known for years. “I used to chair the AAOS research and quality committee,” commented Dr. Weber to OTW, “where we developed clinical practice guidelines and a systematic review of important clinical areas in orthopedics. In performing complex reviews in order to determine where gaps were in musculoskeletal research, we found a long list of unanswered research questions. I always wondered, ‘Why are we not jumping on these gaps?’”
Money, Scope, Relevance
The reality, says Dr. Weber, is that the funding required to address a given issue may be significant, or the research itself may be extraordinarily complex, or the research itself raises questions of clinical relevance. “Traditionally, we sat down with the OREF team once a year in order to align our areas of research but this did not lead to meaningful change in the status quo. It became increasingly clear that there were common goals and objectives, so in September 2019 the volunteer and staff leadership had a meeting. Because this unfolded within the context of a burgeoning interest in biologics and regenerative medicine in musculoskeletal health, we could see that this area of research was going to be on the forefront of our efforts..”
They could also see that these were areas that were crying out for leadership. Dr. Weber: “Stem cell injections were surging and there was not a lot of data or regulation in this area. AAOS wanted to take a leadership role and identify gaps in our knowledge about the safety and efficacy of biologics. OREF and AAOS developed a memorandum of understanding and then signed an agreement to partner on clinical research questions and raising the necessary funds to answer key questions.”
But what questions?
A bit of order was in order, so the AAOS/OREF committees devised a systematic approach to sort through the research prospects.
Robert H. Quinn, M.D. is the John J. Hinchey M.D. and Kathryn Hinchey Chair in Orthopaedics at the University of Texas Health Science Center San Antonio. Dr. Quinn, chair of the Council Research and Quality, told OTW, “As chair of the council, I lead several committees that address varying research areas. The most robust committee is the one on evidence-based questions and value—this is the committee that formulates clinical practice guidelines. We select topics for clinical practice guidelines based on overall orthopedic prioritization. Essentially, we ask, ‘What evidence is available in a given area to answer XYZ question(s)?’ So even if spine fusion is a hot topic, if there is insufficient evidence to answer questions in that area, then spine fusion will be registered as lower on the priority list.”
So much orthopedic research has been conducted for so many years, says Dr. Quinn, but we still lack a robust way to answer questions in a critical way. “Both organizations were aware that much of the research in the field does not rise to the level of a randomized controlled trial (RCT). We set out to elevate the level of evidence to better answer questions in an informed evidence-based manner.”
To derive their short list of worthy projects, the committee examines the existing evidence for a given research question and if they find a gap, they then funnel research funds to that question—but they do so at the randomized control study level. However, says Dr. Quinn, clinical problems are not always generalizable. “In order to be a candidate for an RCT, a patient has to be the kind of person who is going to follow through. A simple RCT involves taking pills—only two options…sugar pills and real pills. But patients still must reliably take the pills on time, document any side effects, etc. Thus, we are essentially cherry picking the best potential patients. However, in reality it turns out that 50% of patients don’t follow the pill taking regimen and/or don’t recognize or document the side effects. Sometimes a well-designed cohort study is better because you are looking at real patients.”
