AAOS, OREF Announce Strategic Partnership

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.”

The fundamental question?

Dr. Quinn: “Ultimately, we want to know, ‘What project is the highest priority given our limited resources…and which would be most appealing to researchers? We need to look at what kinds of things that entities such as the National Institutes of Health (NIH) and the Department of Defense (DOD) are likely to fund. After much work, we provide a short list of options to OREF.”

“At this point, we have three potential projects. The first is a study examining the efficacy of biologics for the treatment of orthopedic diseases, with a particular focus on platelet rich plasma and growth factor injections for full-thickness rotator cuff tears and osteoarthritis of the knee. The second study will be a review of the existing clinical research on the effects of tobacco, vaping, and/or marijuana use on postoperative outcomes for total joint arthroplasty. The third proposed project is an examination of the effectiveness of antibiotic bone cement for the prevention of periprosthetic joint infections.”

Conflicts of Interest

“We take biases and any conflict of interest very seriously, from the manuscript submission to everyone who participates in the CPG [Clinical Practice Guidelines] process. As for industry, we may work with them if they approach us in the following manner: ‘We want to fund research on bone cement. We’ll give you $1 million and you decide how to funnel it. We are out of the process.’”

Looking Forward

Dr. Quinn and his team have submitted their suggestions to OREF and are now awaiting finalization of the list.

“Over the next 6-12 months I think we will have enough funding for one pilot project that will then hopefully attract other, matching funding. And we are fortunate that a lot of orthopedic surgeons donate to OREF and can earmark specific areas that they want to support.”

And sometimes Dr. Quinn has to make his colleagues take their medicine.

“I call the whole quality initiative or evidence-based medicine push the ‘eat your spinach’ directive. Most practitioners take offense a la, ‘How dare you use big data and other avenues to tell me how to practice medicine?’ I tell them, ‘Eat your spinach. It’s good for medicine and good for you if we can do it in a way that we end up following the best evidence.’ Many people forget that one of the biggest complaints orthopedic surgeons have is that our products don’t contain the highest levels of evidence.”

Kristy Weber: “This collaboration draws strength from OREF’s grant expertise and AAOS’ ability to identify clinical gaps and to market to the entire field. We were fortunate to have the input of Michael Parks, M.D., past president of OREF, who was critical to this process.”

Dr. Parks: “There are fundamental challenges facing orthopedic researchers, one of which is the extreme variations in treatments. Specifically, there are so many biologic treatments involving injections in the knee, stem cells and other formulations and they are being done by different types of healthcare providers. Another challenge is that patients frequently come in asking about the value of XYZ treatment and sometimes there is just not enough data to provide them with solid answers.”

The COVID-19 Wrench

“With the COVID-19 pandemic, the funding ‘pie’ has shrunk significantly,” states Dr. Parks. “Just as everything else in this country has been slowed down since March, our program will be slower to ramp up. However, there is a significant interest particularly among patients and caregivers to know more about biologics. Because of this high level of interest, people will donate and earmark those funds for this research.”

“OREF is grounded in the belief that it is well-researched knowledge that will advance orthopaedic practice,” said Richard F. Kyle, M.D., OREF president. “This collaboration with the AAOS will go a long way toward funding investigational grants that will catalyze research and help drive effective patient care.”