The Edmond J. Safra Center for Ethics, Harvard University, Cambridge, MA, USA.
J Eval Clin Pract. 2013 Aug;19(4):674-81. doi: 10.1111/jep.12016. Epub 2012 Dec 21.
There is increasing concern that conflicts of interest affect the development process of clinical practice guidelines. We evaluated The American Psychiatric Association's Practice Guideline for the Treatment of Patients with Major Depressive Disorder to determine the existence of financial and intellectual conflicts of interest and examine their possible effects. We selected this guideline because of its influence on clinical practice and because this guideline recommends pharmacotherapy for all levels of depression, despite controversies over the evidence base.
We determined the number and type of financial conflicts of interest for members of the guideline development group as well as for the independent panel charged with mitigating any effect of these conflicts. We also quantified the potential for intellectual conflicts of interest. We examined the quality of references used to support recommendations, as well as the degree of congruence between the research results and the recommendations. Fewer than half (44.4%) of the studies supporting the recommendations met criteria for high quality. Over one-third (34.2%) of the cited research did not study outpatients with major depressive disorder, and 17.2% did not measure clinically relevant results. One-fifth (19.7%) of the references were not congruent with the recommendations. Financial ties to industry were disclosed by all members (100%) of the guideline development committee with members reporting a mean 20.5 relationships (range 9-33). The majority of the committee participated on pharmaceutical companies' speakers' bureaus. Members of the independent panel that reviewed the guidelines for bias had undeclared financial relationships. As a marker of intellectual conflict of interest, 9.1% of all cited research and 13% of references supporting the recommendations were co-authored by the six guideline developers.
The prevalence of conflicts of interest among panel members was high. The quality of the evidence cited raises questions about the validity of the recommendations. Attention to the quality of cited studies and to the risk of bias resulting from conflicts of interest should be a priority for guideline development groups.
越来越多的人担心利益冲突会影响临床实践指南的制定过程。我们评估了《美国精神病学协会治疗重性抑郁障碍患者实践指南》，以确定是否存在财务和智力利益冲突，并研究其可能的影响。我们选择该指南是因为它对临床实践有影响，而且该指南建议对所有程度的抑郁症进行药物治疗，尽管对证据基础存在争议。
我们确定了指南制定小组成员以及负责减轻这些冲突影响的独立小组的财务利益冲突的数量和类型。我们还量化了智力利益冲突的可能性。我们检查了支持建议的参考文献的质量，以及研究结果与建议之间的一致性程度。支持建议的研究中，不到一半（44.4%）符合高质量标准。三分之一以上（34.2%）引用的研究没有研究门诊重性抑郁障碍患者，17.2%没有测量临床相关结果。五分之一（19.7%）的参考文献与建议不一致。指南制定委员会的所有成员（100%）都披露了与行业的财务关系，成员报告的平均关系数为 20.5 个（范围 9-33）。大多数委员会成员都在制药公司的演讲者局工作。审查指南以评估偏见的独立小组的成员存在未申报的财务关系。作为智力利益冲突的标志，所有引用的研究中有 9.1%，支持建议的参考文献中有 13%是由六名指南制定者共同撰写的。
小组成员之间的利益冲突发生率很高。引用的证据质量引起了对建议有效性的质疑。关注引用研究的质量以及利益冲突导致的偏倚风险应成为指南制定小组的优先事项。
