Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States

摘要: Background Financial ties between health professionals and industry may unduly influence professional judgments some researchers have suggested that widening disease definitions be one driver of over-diagnosis, bringing potentially unnecessary labeling harm. We aimed to identify guidelines in which were changed, assess whether any proposed changes would increase the numbers individuals considered disease, potential harms expanding investigated, extent members' ties. Methods Findings We undertook a cross-sectional study most recent publication 2000 2013 from national international guideline panels making decisions about or diagnostic criteria for common conditions United States. assessed widened narrowed definitions, rationales offered, mention those changes, nature disclosed members pharmaceutical device companies. Of 16 publications on 14 conditions, ten narrowing definitions. For five, impact was unclear. Widening fell into three categories: creating “pre-disease”; lowering thresholds; proposing earlier different methods. Rationales included standardising new evidence risks people previously not disease. No rigorous assessment changes. Among with disclosures, average proportion 75%. Twelve chaired by ties. ties, median number companies they had seven. Companies highest proportions active relevant therapeutic area. Limitations arise reliance only exclusion too broad enable analysis single panel publications. Conclusions For studied, majority increased none reported widening, disclosing financial companies. Please see later article Editors' Summary