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

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. Please see later in the article for the Editors' Summar

Effect of two behavioural 'nudging' interventions on management decisions for low back pain: A randomised vignette-based study in general practitioners

Objective €Nudges' are subtle cognitive cues thought to influence behaviour. We investigated whether embedding nudges in a general practitioner (GP) clinical decision support display can reduce low-value management decisions. Methods Australian GPs completed four clinical vignettes of patients with low back pain. Participants chose from three guideline-concordant and three guideline-discordant (low-value) management options for each vignette, on a computer screen. A 2×2 factorial design randomised participants to two possible nudge interventions: €partition display' nudge (low-value options presented horizontally, high-value options listed vertically) or €default option' nudge (high-value options presented as the default, low-value options presented only after clicking for more). The primary outcome was the proportion of scenarios where practitioners chose at least one of the low-value care options. Results 120 GPs (72% male, 28% female) completed the trial (n=480 vignettes). Participants using a conventional menu display without nudges chose at least one low-value care option in 42% of scenarios. Participants exposed to the default option nudge were 44% less likely to choose at least one low-value care option (OR 0.56, 95%CI 0.37 to 0.85; p=0.006) compared with those not exposed. The partition display nudge had no effect on choice of low-value care (OR 1.08, 95%CI 0.72 to 1.64; p=0.7). There was no interaction between the nudges (OR 0.94, 95% CI 0.41 to 2.15; p=0.89). Interpretation A default option nudge reduced the odds of choosing low-value options for low back pain in clinical vignettes. Embedding high value options as defaults in clinical decision support tools could improve quality of care. More research is needed into how nudges impact clinical decision-making in different contexts

Expanding disease definitions in guidelines and expert panel ties to industry: A cross-sectional study of common conditions in the United States

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

Current dilemmas in defining the boundaries of disease

Boorse's biostatistical theory states that diseases should be defined in ways that reflect disturbances of biological function and that are objective and value free. We use three examples from contemporary medicine that demonstrate the complex issues that arise when defining the boundaries of disease: polycystic ovary syndrome, chronic kidney disease, and myocardial infarction. We argue that the biostatistical theory fails to provide sufficient guidance on where the boundaries of disease should be drawn, contains ambiguities relating to choice of reference class, and is out of step with medical processes for identifying disease boundaries. Although proponents of the biostatistical theory might regard these practical issues as irrelevant to the aim of providing a theoretical account of disease, we take them to indicate the need for a theoretical account that is adequate for current needs-including limiting new forms of medicalization that are driven by the identification of disease based on dysfunction. Our processes for determining the boundaries for disease need to recognize that there is no value-free method for making these decisions