Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, Oregon, United States of America.
PLoS One. 2012;7(11):e47343. doi: 10.1371/journal.pone.0047343. Epub 2012 Nov 7.
Conflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs) and high rates of COI among guideline authors have been reported in the past. Our objective was to report current rates of disclosure and specific author COI across a broad range of CPGs and to examine whether CPG characteristics were associated with the presence of disclosures and of conflicts.
We selected a random sample of 250 CPGs listed in the National Guideline Clearinghouse on November 22, 2010, representing approximately a 10% sample of guidelines listed in the NGC on that date. We abstracted information on author COI from each CPG and examined predictors of the disclosures and COI using a logistic generalized estimating equation regression model. 87% of organizations developing guidelines had a CPG-specific policy, however, 40% of CPGs did not indicate that they had collected disclosures from guideline authors. In addition, 42% of organizations that did collect author disclosures did not have those disclosures available in the public domain. Of CPGs where we had disclosures for all authors, 60% had one or more authors with a conflict. On average, 28% of the authors of CPGs with available disclosures had a COI. Guidelines that were published in journals with an impact factor greater than 5.0 were more likely to have one or more authors with a COI than guidelines not published in journals.
Rates of disclosure of author COI and the public availability of that information are unacceptably low, however rates of COI among guideline authors may have decreased in recent years. Continued efforts are needed to establish and enforce optimal COI policies in clinical practice guideline development in order to minimize the risk of bias associated with those conflicts.
利益冲突(COI)是临床实践指南(CPG)制定中潜在的重要偏倚来源,过去曾有报道称指南作者中 COI 发生率较高。我们的目的是报告广泛的 CPG 中当前的披露率和特定作者的 COI,并研究 CPG 特征是否与披露和冲突的存在相关。
我们从 2010 年 11 月 22 日列入国家指南清除中心的 250 个 CPG 中随机选择了一个样本,代表了该日期列入 NGC 的指南的大约 10%。我们从每个 CPG 中提取作者 COI 的信息,并使用逻辑广义估计方程回归模型检查了披露和 COI 的预测因素。87%的制定指南的组织都有特定于 CPG 的政策,但是 40%的 CPG 并未表明他们已经从指南作者那里收集了披露信息。此外,42%的收集作者披露信息的组织并未将这些披露信息公开。对于我们有所有作者披露信息的 CPG,60%的作者有一个或多个存在冲突的作者。平均而言,有 28%的可披露信息的 CPG 作者存在 COI。在具有大于 5.0 的影响因子的期刊上发表的指南比未在期刊上发表的指南更有可能有一个或多个作者存在 COI。
作者 COI 披露率和该信息的公众可用性低得令人无法接受,但是近年来指南作者的 COI 发生率可能已经降低。为了最大限度地降低与这些冲突相关的偏倚风险,需要继续努力在临床实践指南制定中建立和执行最佳的 COI 政策。