Division of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre and University of Toronto, Toronto, Ontario, Canada.
Oncology Department, Hospital de la Santa Creu i Sant Pau and Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain.
Cancer. 2019 Nov 15;125(22):4069-4075. doi: 10.1002/cncr.32408. Epub 2019 Jul 29.
Clinical practice guidelines (CPGs) are crucial to the practice of evidence-based medicine. Declared author financial conflicts of interest (FCOIs) are common in CPGs and have been associated with endorsement of treatment. Less is known about undeclared FCOIs.
The American Society of Clinical Oncology (ASCO) website was searched to identify all CPGs for systemic therapy published between August 2013 and June 2018. Data on self-reported author FCOIs and funding sources were extracted. The Open Payments database was then searched to identify compensation to CPG authors. Concordance between declared and undeclared but verified FCOIs was assessed with Cohen's κ.
For 26 CPGs, 314 nonduplicate authors were identified; 184 of these authors (59%) disclosed FCOIs. Among the remaining 130 authors, data in Open Payments were unavailable for 71 authors (non-US residents or authors affiliated with a nonprofit organization). Among the 59 authors who declared no FCOIs and for whom Open Payments data were available, 55 (93%) had received payment from industry. The κ value for agreement between disclosed and verified FCOIs was 0.092. Among the 243 authors with FCOIs verifiable via Open Payments, 239 (98%) received payment from industry. Thirty-four authors (62%) received more than $1000 in nonresearch funding, and 19 (35%) received more than $5000. Among the 52 first and last authors, 44 (85%) received payment from industry; 14 of these payments (32%) were not declared.
FCOIs among authors of ASCO CPGs are common and are not disclosed by a substantial proportion of authors with Open Payments data. Improved transparency of FCOIs should become standard practice among CPG authors. Professional societies and journal editors need to create a mechanism to verify self-reported FCOIs.
临床实践指南(CPGs)对循证医学实践至关重要。CPGs 中常见声明的作者财务利益冲突(FCOI),并与治疗的认可有关。但对于未申报的 FCOI 知之甚少。
搜索美国临床肿瘤学会(ASCO)网站,以确定 2013 年 8 月至 2018 年 6 月期间发表的所有系统治疗 CPG。提取作者自我报告的 FCOI 和资金来源数据。然后,搜索 Open Payments 数据库以确定 CPG 作者的薪酬。使用 Cohen's κ 评估申报和未申报但经核实的 FCOI 的一致性。
对于 26 项 CPG,确定了 314 位非重复作者;其中 184 位作者(59%)披露了 FCOI。在其余 130 位作者中,71 位作者(非美国居民或隶属于非营利组织的作者)的 Open Payments 数据不可用。在 59 位声明没有 FCOI 且 Open Payments 数据可用的作者中,55 位(93%)收到了来自行业的薪酬。披露的和经核实的 FCOI 之间的 κ 值为 0.092。在可通过 Open Payments 验证的 243 位有 FCOI 的作者中,239 位(98%)收到了来自行业的薪酬。34 位作者(62%)收到了超过 1000 美元的非研究资金,19 位(35%)收到了超过 5000 美元。在 52 位第一和最后作者中,44 位(85%)收到了来自行业的薪酬;其中 14 笔薪酬(32%)未申报。
ASCO CPG 作者的 FCOI 很常见,并且有相当一部分有 Open Payments 数据的作者并未披露。提高 FCOI 的透明度应成为 CPG 作者的标准做法。专业协会和期刊编辑需要创建一个机制来验证自我报告的 FCOI。