Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States
Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States
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DOI：
10.1371/journal.pmed.1001500
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发表时间：
2013-08-01
期刊：
影响因子：
15.8
通讯作者：
Glasziou, Paul P.
中科院分区：
文献类型：
--
作者：
Moynihan, Raymond N.;Cooke, Georga P. E.;Glasziou, Paul P.
背景资料：卫生专业人员和行业之间的经济联系可能会过度影响专业判断，一些研究人员认为，扩大疾病定义可能是过度诊断的一个驱动因素，可能会带来不必要的标签和伤害。我们的目的是确定疾病定义改变的指南，评估任何拟议的改变是否会增加被认为患有疾病的个人数量，是否调查了扩大疾病定义的潜在危害，以及成员的行业联系程度。方法和发现：我们进行了一次交叉-对2000年至2013年期间国家和国际指南小组关于美国常见疾病定义或诊断标准的最新出版物进行的部分研究States.我们评估了拟议的变更是否扩大或缩小了疾病定义，提供的理由，提及这些变更的潜在危害，以及成员与制药或器械公司之间披露的联系的性质和程度。在关于14种常见疾病的16份出版物中，有10份提出了扩大定义范围的修改，1份提出了缩小定义范围的修改。五是影响不明显。扩大分为三类：创造“疾病前”;降低诊断阈值;提出更早或不同的诊断方法。该报告包括标准化的诊断标准和关于以前被认为没有这种疾病的人的风险的新证据。没有出版物包括对拟议变更的潜在危害的严格评估。在14个披露信息的小组中，与行业有联系的成员的平均比例为75%。其中12人是由有联系的人担任主席的。对于有联系的成员，他们与之有联系的公司的中位数为7家。与最高比例的会员有联系的公司在相关的治疗领域很活跃。局限性来自于仅依赖于已披露的关系，以及排除了过于宽泛的条件，无法对单一面板出版物进行分析。对于所研究的常见疾病，大多数专家组建议改变疾病定义，增加被认为患有这种疾病的人数，没有人报告对这种扩大的潜在危害进行严格评估，大多数成员都披露了与制药公司的财务关系。
Background: Financial ties between health professionals and industry may unduly influence professional judgments and some researchers have suggested that widening disease definitions may be one driver of over-diagnosis, bringing potentially unnecessary labeling and harm. We aimed to identify guidelines in which disease definitions were changed, to assess whether any proposed changes would increase the numbers of individuals considered to have the disease, whether potential harms of expanding disease definitions were investigated, and the extent of members' industry ties.Methods and Findings: We undertook a cross-sectional study of the most recent publication between 2000 and 2013 from national and international guideline panels making decisions about definitions or diagnostic criteria for common conditions in the United States. We assessed whether proposed changes widened or narrowed disease definitions, rationales offered, mention of potential harms of those changes, and the nature and extent of disclosed ties between members and pharmaceutical or device companies. Of 16 publications on 14 common conditions, ten proposed changes widening and one narrowing definitions. For five, impact was unclear. Widening fell into three categories: creating "pre-disease''; lowering diagnostic thresholds; and proposing earlier or different diagnostic methods. Rationales included standardising diagnostic criteria and new evidence about risks for people previously considered to not have the disease. No publication included rigorous assessment of potential harms of proposed changes. Among 14 panels with disclosures, the average proportion of members with industry ties was 75%. Twelve were chaired by people with ties. For members with ties, the median number of companies to which they had ties was seven. Companies with ties to the highest proportions of members were active in the relevant therapeutic area. Limitations arise from reliance on only disclosed ties, and exclusion of conditions too broad to enable analysis of single panel publications.Conclusions: For the common conditions studied, a majority of panels proposed changes to disease definitions that increased the number of individuals considered to have the disease, none reported rigorous assessment of potential harms of that widening, and most had a majority of members disclosing financial ties to pharmaceutical companies.