Abstract
In the words of former Editor-in-Chief David Thordarson in his 2017 editorial for Foot & Ankle International, “The presence of conflict of interest within medical literature continues to be a troubling issue.” 3 Now, almost seven years on, our Editorial Board has reassessed our approach to disclosures and have decided that the process for authors can and should be streamlined for simplicity and clarity of purpose.
This conflict of interest (COI) concern was first promoted by the Physician Payments Sunshine Act related to the Affordable Care Act passed by the United States Congress in 2010. 2 This required a report to the federal government when drug and device (and later biologics) companies or manufacturers made payments to physicians exceeding $10. These payments were then available to the public through the Centers for Medicare & Medicaid Services (CMS) Open Payments public database. This resulted in the recognition of significant relationships between industry and physicians who developed their instrumentation or product, naturally receiving royalties or licenses for their work. Other financial categories included consulting services, paid lectures, and hospitality (travel/lodging/meals). These categories have expanded over the years, and the current CMS Enterprise Portal for Program Year 2021 has three new Nature of Payment categories listing “acquisitions, debt forgiveness, and long-term medical supply or device loan.” 1 This system has resulted in more comprehensive reporting but has inadvertently resulted in confusion over the relative effect of certain disclosures on true conflict of interest that could bias a manuscript. Due to the CMS Open Payments public database, United States authors are held to a higher level of scrutiny than physicians outside the United States. We embrace the intent and results of this reporting effort, but realize the significant limitations involved with interpreting these data for the use of identifying potential conflict of interests in medical publications.
Fundamentally, an international journal’s disclosure system must depend on a self-reporting mechanism that assumes the integrity and honesty of all participants to ensure the dissemination of accurate, credible, and scientifically valuable information related to the subject of a submitted manuscript. The increasing complexity of financial and non-financial interests and the current reporting system widely used in medical publishing has made it challenging to determine if the interests significantly bias the content of a manuscript. The involvement of skilled physicians in the development of new medical products is crucial; without their innovative contributions, many advancements might not be realized. Financial reward clearly motivates entrepreneurship. However, monetary renumeration by investigators may consciously or subconsciously impact related scientific research at any level from framing of a study question to methods and study design, analysis approach and/or interpretation of findings. This underscores the challenging and nuanced nature of identifying potential bias in scientific reports. Consequently, disclosure of potential conflicts is a crucial, first step to assess the content of the work submitted to journals.
To make this process unambiguous for all involved – readers, authors, reviewers and editors, the Editorial Board of FAI/FAO is simplifying the COI disclosure process. We have developed a straightforward form, largely modeled on the existing ICMJE form. The most important aspect of the new form is for the author(s) to indicate whether they (or a family member) have received external support from a company related to the subject of their submitted manuscript.
Additionally, all editors will continue to submit annual comprehensive COI disclosures, with an obligation to report any significant changes as they arise during any calendar year. In the manuscript review process, all reviewers and editors are expected to step aside should they recognize any potential bias in their assessment of a submission. Upholding an impartial perspective during the review of submitted manuscripts is paramount in safeguarding patient care through the integrity and caliber of our publications.
Footnotes
This editorial has been copublished in Foot & Ankle International.