Study Finds Most Surgeons Don’t Use Disclosures
Question to sports medicine specialists: Are conflict of interest disclosures important in interpreting data? Answer: Yes! Do you use them? No. Fotios Tjoumakaris, M.D., a sports medicine specialist at the Rothman Institute in Philadelphia, is the first researcher to delve into this topic. He tells OTW:
“We sent 750 orthopedic surgeons a survey asking whether they used disclosure information to interpret study results; we received 522 responses. We presented participants with a hypothetical study on an OA [osteoarthritis] drug, along with the disclosure conflicts, namely, that the authors of the study received compensation to perform the study in question. We then changed the scenario of the study and the results (academic v. community setting, randomized study v. case series, and positive outcomes v. negative outcome of the drug) and asked how the respondents felt about the introduction of bias into the results.
We found that only about 50% of participants used the disclosure information to interpret results at meetings. One surprise in our results was that people didn’t care whether the study was occurring in an academic center or in a community center; I think people generally believe that orthopedic surgeons are ethical and trust the results that are reported. And the influence of the institution didn’t matter. We initially thought that if the authors were from, say, Harvard then that might hold more cache, but in fact respondents seemed to feel that quality research could come from any corner.
Interestingly, 20% of respondents felt that using disclosure information to interpret study results was not important. I was surprised it was this high, but I think with more surgeons being trained under the new rules of governance of reporting by the academy and other associations, that we will begin seeing disclosure as routine practice and will incorporate this information into how we interpret data.
Going forward we want to formulate better questions and tease out each of the questions, such as the lack of reporting of negative results in journals. Our study clearly showed that when negative results were reported, it had the highest confidence factor among readers, even in the presence of obvious conflict among the researchers. We would like to know how many negative studies are reported, compare that to the positive results reporting, and see what people think of that conflict. I would also like to get more data driven analysis, i.e., look at studies where the author indicates having a conflict and have readers interpret them and see if that changes their perception of the study. Ultimately, it’s important for all of us to know how we view data in the literature and how this data is used to drive clinical treatment decisions.”
180 Hospitals and 35, 000 Arthroplasties now In Joint Replacement Registry
Benchmarks, report cards, quality improvement…all are a part of the now very active American Joint Replacement Registry (AJRR). David Lewallen, M.D. is an orthopedic surgeon with Mayo Clinic in Rochester, Minnesota, and is the medical director of this grand undertaking. Dr. Lewallen, past president of both The Hip Society and the American Association of Hip and Knee Surgeons, commented to OTW:
“We are excited that things are really accelerating now; we’re adding hospitals rapidly and have 180 hospitals participating, 89 of which are submitting data. A total of over 2, 200 procedures were downloaded into our system by hospitals in just the last week, which now contains information on over 35, 000 arthroplasties. It’s quite a prolonged process to get through the necessary legal work and IT security discussions…and then get the hospitals to begin submitting data. But we have exceeded our annual goal for 2013, and are just now bringing on a large group in New York with 17 hospitals.
A year from now we want to be collecting higher levels of data. Initially we are gathering level one data such as on the hospital, patient, surgeon, and implant. We will eventually come up with implant survivorship curves and can then look at data by category of hospital, size of hospital, and implant type. Then we will be able to provide data back to the surgeon, hospital, and manufacturers including information on how they ‘score’ relative to both an overall national benchmark and compared to hospitals or surgeons performing an equivalent volume.
We think that most surgeons will be pleased to get what is in essence a report card. Everyone involved in this work, whether it’s a company, a hospital, or a surgeon, understands that there will be an increasing transparency of data with regard to these procedures over the years ahead. How nice it would be to get this information early on and have a chance to do something with it before it’s more widely available. It would also be good if we could work together as a community to interpret the raw data. For example, let’s say we get raw data on infection rates. We have no idea of whether a given hospital has especially tough cases and their revision rates or infection rates are better or worse than would be expected unless there is some sort of risk stratification. Otherwise it is possible for a facility seeing mainly younger, healthy patients to have an infection rate twice that expected and still appear at or below the overall national average, and vice versa for those seeing more complex, older patients with multiple comorbidities.
We also have an active public advisory board that includes patients who have had the surgery and representatives from patient advocacy groups like the Arthritis Foundation, AARP, and the Joint Commission. They provide great input to our governing board, which includes representation from the AAOS [American Academy of Orthopaedic Surgeons], the Hip Society, the Knee Society AAHKS, the insurance industry, orthopedic manufacturers and hospitals. Orthopedic manufacturers have been especially supportive via their organization—AdvaMED [Advanced Medical Technology Association]—because of the benefits provided by early detection of the occasional problem implants and equally important benefits of confirming the efficacy of those many implants which work well. Orthopedic surgeons can help support this effort by being local ‘surgeon champions’ at their hospital or institution. This person meets with the hospital CEO and others in administration to help explain the importance of this initiative and can provide an ongoing local contact for our AJRR staff. This effort will only gain in strength. In fact, in the future participation by surgeons may help fulfill quality improvement requirements such as the practice improvement portion of Maintenance of Certification through the ABOS [American Board of Orthopaedic Surgery]. There is another important discussion underway at present in Washington regarding the potential for financial incentives from government payors for surgeons and even hospitals for participation in ‘qualified’ registries which could quickly drive interest and participation rates even higher over the coming years.”
Stronger Implants Needed for Arthroscopic Biceps Tendonesis
Arthroscopic biceps tendonesis is becoming increasingly popular for severe biceps tendonopathy, superior labral anterior posterior (SLAP) tears and other shoulder conditions. Mark D. Miller, M.D., the S. Ward Casscells Professor of Orthopaedic Surgery at the University of Virginia, tells OTW, “Biceps tendonesis, which can be done several ways, is exploding in popularity. We are beginning to realize that the bicep tendon is more of a problem that previously thought. The concern is that we may be doing too many tenodesises. Additionally, it is important to realize that the learning curve is steep, especially for the arthroscopic version; it is difficult to identify the biceps tendon in the subacromial space and it bleeds easily, thus making it difficult. You can do labs, go to a bioskills lab, and observe other surgeons, but there is nothing like doing it yourself with a live patient. We need stronger implants as well. I am hoping that companies recognize the importance and popularity of this technique and that they begin developing more tools for us. The implants we have at present pose some concerns about their pullout strength and ease of insertion, so there is definitely room for improvement.”
Leaving Ilizarov Method Raises New Issues
Sanjeev Sabharwal, M.D., MPH is a pediatric orthopedic surgeon specializing in limb deformities. Dr. Sabharwal, president of the Limb Lengthening and Reconstruction Society, tells OTW:
“The Ilizarov method of slowly pulling apart the bone ends and allowing new bone to form in the created gap remains a time tested and biologically sound method of treating a variety of congenital and acquired limb deformities and shortening among all age groups. About 15 years ago we transitioned to a more sophisticated computer assisted planning and execution method for treating such patients. While external fixators are still very useful and versatile, these devices can be associated with pin site drainage and be cumbersome for the patient. In the world of limb lengthening and deformity correction, there has been a push to transition from traditional surgical treatment relying solely on external fixation to using hybrid techniques with internal fixation, including intramedullary nails using a variety of ingenious methods for accomplishing controlled lengthening. However, there may be a new set of complications related to such emerging technologies and implants. Thus, while there is cautious optimism, these emerging techniques cannot be applied to all patients at this time. Furthermore, longer follow-up with greater number of patients treated at different centers would be necessary before these devices can be adopted universally.
As the surgical techniques become easier, it is plausible that more surgeons may start implanting lengthening nails without fully comprehending the biology and potential complications associated with distraction osteogenesis. For example, patients with congenital shortening often have ligamentous laxity and potential instability at the knee and hip joints. If appropriate steps are not taken before and during limb lengthening in such individuals, the hip and knee joints can become unstable and dislocate over time. We, as surgeons and caregivers, have the responsibility to not only stay current with emerging technologies, but also remember the basic biologic principles of bone healing. We also need to look out for new and possibly different complications that may be associated with these emerging technologies. In the end, our goal is to deliver safe and efficient care and optimize functional outcome with the least amount of strain on the patient and the society.”
