Shigeta Haruki, Murayama Anju, Kamamoto Sae, Saito Hiroaki, Ozaki Akihiko
School of Medicine, Tohoku University, Sendai, JPN.
School of Medicine, Hamamatsu University School of Medicine, Hamamatsu, JPN.
Cureus. 2023 Mar 23;15(3):e36567. doi: 10.7759/cureus.36567. eCollection 2023 Mar.
Clinical practice guidelines make recommendations based on the best available evidence. Proper management and disclosure of financial conflicts of interest (FCOIs) are necessary for trustworthy clinical practice guidelines. This study evaluated the prevalence of FCOIs and quality of evidence underlying the American Diabetes Association (ADA) guidelines.
Using the Open Payments Database (OPD) between 2018 and 2020, we examined the research and general payments to all authors of the Standards of Medical Care in Diabetes, 2021. The quality of evidence and tone of recommendations were assessed and the associations between the two were evaluated by logistic regression analysis.
Of the 25 guideline authors, 15 (60.0%) were United States (US)-based physicians eligible for the OPD search. Eight (32.0%) and 12 (48.0%) received one or more industry payments one year and three years prior to the guideline publication, respectively. The median total payments (interquartile range) per author were $33,262 ($4,638‒$101,271) in 2020 and $18,053 ($2,529‒$220,659) in 2018-2020. One author received a research payment of over $10,000 undeclared. Of 471 recommendations, 61 (13.0%) and 97 (20.6%) were supported by low-quality evidence and expert opinions, respectively. Also, 439 (93.2%) recommendations had a positive tone. The lower quality of evidence tended to recommend positively with an odds ratio of 1.56 (95% confidence interval: 0.96-2.56, p=0.075) without reaching statistical significance.
A minority of the guideline authors received industry payments from the healthcare industry, and declared FCOIs were mostly accurate. However, the ADA FCOI policy required the guideline authors to declare their FCOIs for one year before publication. A more transparent and rigorous FCOI policy is needed in the ADA guidelines.
临床实践指南基于现有最佳证据提出建议。对财务利益冲突(FCOI)进行妥善管理和披露是可信临床实践指南的必要条件。本研究评估了美国糖尿病协会(ADA)指南中FCOI的流行情况及证据质量。
利用2018年至2020年的开放支付数据库(OPD),我们研究了2021年《糖尿病医疗护理标准》所有作者的研究和一般支付情况。评估了证据质量和建议的语气,并通过逻辑回归分析评估了两者之间的关联。
在25位指南作者中,有15位(60.0%)是符合OPD搜索条件的美国医生。分别有8位(32.0%)和12位(48.0%)在指南发布前一年和三年收到过一次或多次行业支付。每位作者在2020年的支付总额中位数(四分位间距)为33,262美元(4,638 - 101,271美元),在2018 - 2020年为18,053美元(2,529 - 220,659美元)。有一位作者未申报超过10,000美元的研究支付。在471条建议中,分别有61条(13.0%)和97条(20.6%)得到低质量证据和专家意见的支持。此外,439条(93.2%)建议的语气是积极的。证据质量较低的建议往往更倾向于给出积极的推荐,优势比为1.56(95%置信区间:0.96 - 2.56,p = 0.075),未达到统计学显著性。
少数指南作者接受了医疗行业的支付,且申报的FCOI大多准确。然而,ADA的FCOI政策要求指南作者在发布前一年申报其FCOI。ADA指南需要更透明、更严格的FCOI政策。