July 1, 2020 - Many studies published by major spinal surgery journals do not include full disclosure of researchers' financial conflicts of interest (COIs), reports a study in Spine. The journal is published in the Lippincott portfolio by Wolters Kluwer.
"[A] large number of physician-industry interactions...are underreported by authors publishing within the surgical spine literature," according to the study by Jeremy D. Shaw, MD, and colleagues of University of Pittsburgh Medical Center. They propose steps to encourage more accurate disclosure of potential COIs - especially in spinal surgery, where relationships between surgeons and the biomedical device industry play a crucial role in research and innovation.
High Rate of Incomplete Financial Disclosures in Spinal Surgery Studies
The researchers reviewed financial COIs by authors who published studies in Spine and two other major spinal surgery journals between 2014 and 2017. The analysis included nearly 40,000 authors contributing to about 6,800 research articles.
The COI disclosures for each author were compared to those in the Center for Medicare and Medicaid Services' publicly available Open Payments Database (OPD). Established under the Affordable Care Act, the OPD requires pharmaceutical, medical device, and biological products manufacturers to report all payments to physicians of more than $10. Overall, 15.8 percent of spinal surgery authors had payments reported in the OPD.
Dr. Shaw and colleagues then compared payments reported to the OPD with the authors' financial disclosures in the published studies. Most payments reported to the OPD were reflected in the COI statements. Of the total $1.90 billion received by authors, approximately $1.48 billion - 78 percent of the total - was accurately disclosed.
"Undisclosed payments included $180 million in researcher funding and $188 million in royalties," Dr. Shaw and colleagues write. Charitable contributions and payments from royalties/licenses were most likely to be accurately reported, while funds for research and entertainment were least likely to be disclosed.
About 77 percent of authors of studies published in Spine had accurate disclosures, compared to a little over 40 percent for the other two journals. This might reflect differences in reporting criteria between journals - for example, Spine presents disclosure statements for all authors combined, rather than individually.
Although physician-industry relations are essential for medical progress, they have the potential to introduce bias that may influence research findings. "The connection between industry and spine surgery is essential for the further development of surgical techniques and hardware," Dr. Shaw and coauthors write. They add: "There is a need for transparency in academic publishing with the increasing public scrutiny of medical publishing."
The authors emphasize that their study is not aimed at making accusations of misconduct, and that under-disclosure likely does not involve conscious effort to hide financial interactions. For example, the study found that less-experienced authors were more likely to have inaccurate disclosures than more-experienced authors - suggesting that junior researchers may need mentoring on the importance of accurately reporting COIs.
Dr. Shaw and colleagues suggest a system to improve financial transparency: searching public databases such as the OPD to actively verify relationships between authors and industry, before studies are published. The researchers conclude: "There is a need to standardize COI reporting and actively query the publicly available databases of payments to increase rates of correct financial COI disclosure in the spine literature."
Recognized internationally as the leading journal in its field, Spine (http://www.spinejournal.com) is an international, peer-reviewed, bi-weekly periodical that considers for publication original articles in the field of spine. It is the leading subspecialty journal for the treatment of spinal disorders. Only original papers are considered for publication with the understanding that they are contributed solely to Spine. According to the latest ISI Science Citation Impact Factor, Spine is the most frequently cited spinal deformity journal among general orthopaedic journals and subspecialty titles.
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