Medical Governance Research Institute, Tokyo, Japan
Tohoku University School of Medicine, Miyagi, Japan.
Clin J Am Soc Nephrol. 2022 Jun;17(6):819-826. doi: 10.2215/CJN.14661121.
Rigorous and transparent management strategies for conflicts of interest and clinical practice guidelines with the best available evidence are necessary for the development of nephrology guidelines. However, there was no study assessing financial and nonfinancial conflicts of interest, quality of evidence underlying the Japanese guidelines for CKD, and conflict of interest policies for guideline development.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This cross-sectional study examined financial and nonfinancial conflicts of interest among all 142 authors of CKD guidelines issued by the Japanese Society of Nephrology using a personal payment database from all 92 major Japanese pharmaceutical companies between 2016 and 2019 and self-citations by guideline authors. Also, the quality of evidence and strength of recommendations underlying the guidelines and conflicts of interest policies of Japanese, US, and European nephrology societies were evaluated.
Among 142 authors, 125 authors (88%) received $6,742,889 in personal payments from 56 pharmaceutical companies between 2016 and 2019. Four-year combined median payment per author was $8258 (interquartile range, $2230‒$51,617). The amounts of payments and proportion of guideline authors with payments remained stable during and after guideline development. The chairperson, vice chairperson, and group leaders received higher personal payments than other guideline authors. Of 861 references in the guidelines, 69 (8%) references were self-cited by the guideline authors, and 76% of the recommendations were on the basis of low or very low quality of evidence. There were no fully rigorous and transparent conflicts of interest policies for nephrology guideline authors in the United States, Europe, and Japan.
Most of the Japanese CKD guideline recommendations were on the basis of low quality of evidence by the guideline authors tied with pharmaceutical companies, suggesting the need for better financial conflicts of interest management.
为制定肾脏病学指南,需要对利益冲突进行严格透明的管理,并采用最佳现有证据制定临床实践指南。然而,目前尚无研究评估日本慢性肾脏病指南背后的财务和非财务利益冲突、证据质量以及指南制定的利益冲突政策。
设计、设置、参与者和测量:本横断面研究使用日本 92 家主要制药公司在 2016 年至 2019 年期间的所有个人支付数据库,以及指南作者的自我引用,对日本肾脏病学会发布的所有 142 名慢性肾脏病指南作者的财务和非财务利益冲突进行了研究。此外,还评估了指南背后的证据质量和推荐强度以及日本、美国和欧洲肾脏病学会的利益冲突政策。
在 142 名作者中,有 125 名(88%)作者在 2016 年至 2019 年期间从 56 家制药公司获得了 6742889 美元的个人报酬。每位作者的四年合并中位数报酬为 8258 美元(四分位距,2230-51617 美元)。支付金额和有报酬的指南作者比例在指南制定期间和之后保持稳定。主席、副主席和组长收到的个人报酬高于其他指南作者。在指南中的 861 篇参考文献中,有 69 篇(8%)参考文献被指南作者自我引用,76%的推荐意见是基于低质量或极低质量的证据。美国、欧洲和日本都没有针对肾脏病学指南作者的完全严格透明的利益冲突政策。
大多数日本慢性肾脏病指南推荐意见是基于与制药公司有关联的指南作者的低质量证据,这表明需要更好地管理财务利益冲突。