Friday, June 1, 2018

Are practice guidelines for sale?

An Evaluation of Industry Relationships Among Contributors to AAOS Clinical Practice Guidelines and Appropriate Use Criteria

These authors point out that the long-standing relationship between orthopaedic surgeons and industry has made financial conflicts of interest a concerning issue. Research supports that financial conflicts of interest can influence both medical research and clinical practice. Financial conflicts of interest may also influence clinical practice guideline recommendations and their corresponding appropriate use criteria. Because of the influential nature of these guidelines, it is imperative that care be taken to minimize bias during guideline development.

To investigate these relationships, they retrieved clinical practice guidelines and their corresponding appropriate use criteria from the American Academy of Orthopaedic Surgery that were published or revised between 2013 and 2016. They extracted industry payments received by physicians using the Centers for Medicare & Medicaid Services Open Payments database and evaluated the value and types of these payments. They also used these data to determine whether disclosure statements were accurate and whether guideline development was in adherence with the Institute of Medicine’s (IOM’s) standards.

They found that of the 106 physicians that were evaluated, 85 (80%) received at least 1 industry payment, 56 (53%) accepted >$1,000, and 35 (33%) accepted >$10,000. Financial payments amounted to a mean of $93,512 per physician. Total reimbursement for the 85 clinical practice guideline and appropriate use criteria contributors was $9,912,309. They found that disclosure statements disagreed with the Open Payments data and that the IOM standards were not completely enforced.

They concluded that clinical practice guideline and appropriate use criteria contributors received substantial payments from industry, many disclosure statements were inaccurate, and the IOM standards were not completely met. Clinical practice guidelines and appropriate use criteria are critical for practicing evidence-based medicine. If financial conflicts of interest are present during their development, it is possible that patient care may be compromised.

The authors recommend that:
(1) The chair and cochair of guideline committees not have any financial conflicts of interest (FCOI)
(2) Workgroup members with FCOIs be limited to one third of the group
(3) Disclosure statements should include a broader range of years and a higher degree of detail (e.g., the date of the FCOI, the amount of the FCOI, and whether the relationship is ongoing) and
(4)The AAOS should use Open Payments and Dollars for Docs to verify disclosure statement accuracy and to ensure that workgroups are in compliance with IOM and AAOS standards.

Comment: Financial payments can influence the decisions that people make. Buying influence is one of the reasons that industry makes "general payments" to physicians. When such payments are made to individual practitioners, they may influence the implants they use. When such payments are made to surgeons who review articles for publication, they may influence which articles get published. When such payments are made to speakers at symposia or instructional courses, they may alter how information is presented. And when such payments are made to the authors of practice guidelines, they may influence the recommendations forwarded. While the effect of these payments is a substantial concern, an even greater concern is when the receipt of such payments is not openly and completely acknowledged in a way that the conflict of interest is readily apparent to the persons consuming the information. 
We can do better. Consider this example of an informative disclosure, "the authors of these recommendations have received a total of X dollars in payment from these companies (A, B, C) over the years during which the recommendations were being formulated. It is possible that these payments have biased the recommendations."
Finally, we need to recall that the money that goes to these financial payments adds to the cost of the implants, driving up the cost of care. This effect is compounded if the purchased influence drives us to use more expensive treatments than are necessary for the welfare of the patient.

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