Bond University, Robina, Australia.
PLoS Med. 2013 Aug;10(8):e1001500. doi: 10.1371/journal.pmed.1001500. Epub 2013 Aug 13.
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.
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.
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. Please see later in the article for the Editors' Summary.
健康专业人员与行业之间的财务关系可能会不当影响专业判断，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，从而带来潜在的不必要的标签和伤害。我们旨在确定疾病定义发生变化的指南，评估任何拟议的变化是否会增加被认为患有该疾病的人数，是否调查了扩大疾病定义的潜在危害，以及成员与制药或医疗器械公司之间关系的程度。
我们对 2000 年至 2013 年间美国国家和国际指南小组就常见疾病的定义或诊断标准做出决定的最新出版物进行了一项横断面研究。我们评估了拟议的变化是否扩大或缩小了疾病定义，提出的理由，对这些变化潜在危害的提及，以及成员与制药或医疗器械公司之间关系的性质和程度。在 16 篇关于 14 种常见疾病的出版物中，有 10 篇提出了扩大定义，1 篇提出了缩小定义。对于其中 5 篇，影响尚不清楚。扩大定义分为三类：创建“疾病前期”；降低诊断阈值；提出更早或不同的诊断方法。提出这些理由包括使诊断标准标准化，以及关于以前被认为没有该疾病的人群的风险的新证据。没有一份出版物包括对拟议变化的潜在危害进行严格评估。在有披露的 14 个小组中，平均有 75%的成员与行业有联系。12 个小组由有联系的人担任主席。对于有联系的成员，他们与公司的联系中位数为 7 家。与有最多成员联系的公司在相关治疗领域活跃。限制因素是仅依赖于已披露的关系，以及排除了过于广泛而无法对单个小组出版物进行分析的条件。
在所研究的常见疾病中，大多数小组都提议修改疾病定义，增加了被认为患有该疾病的人数，没有一份报告严格评估了这种扩大的潜在危害，而且大多数小组都有多数成员披露与制药公司的财务关系。请在文章稍后部分查看编辑总结。
