38 Is honesty the best policy? the adequacy of disclosure as a strategy for addressing competing interests in patient decision aid development

Abstract

Objectives Competing interests among patient decision aid developers have the potential to undermine the capacity of these tools to support patients and others to make informed health decisions. Prominent decision aid quality frameworks (e.g., the International Patient Decision Aids Standards (IPDAS), the (United States) National Standards for the Certification of Patient Decision Aids) attempt to address this issue by advocating disclosure of decision aid funding sources and developers’ competing interests. Although the adequacy of this approach has been questioned on more than one occasion, we are aware of no empirical evidence pertaining to patients’ understanding of and reactions to competing interest disclosure statements. Here we present a secondary analysis of data collected in the process of developing a patient decision aid on postpartum contraception to shed light on this issue. Method We administered an online survey of people who were currently pregnant and/or ≤24 months postpartum, could read and write English, and resided in the United States. Participants were recruited using a commercial panel service. As part of the survey, we presented participants with a list of six information elements and solicited their views on whether each ought to be included in the decision aid itself or in a supporting document. One of the information elements was, ‘information about whether those who wrote the guide will make money based on what decisions people make after using the guide’. Other elements pertained to decision aid development and user testing, evidence sources, update policy, readability, and authors and their qualifications. Immediately after this, an open text question invited participants to elaborate on their responses or make additional suggestions. Results Of the 286 eligible participants, 46% responded that information on competing interests should be included in the decision aid itself, while 54% felt that it should be included in a supporting document. Notably, competing interest information was endorsed for inclusion in the decision aid less frequently than most other information elements. Some participants’ open text responses reiterated the perceived importance of competing interest information (‘Full disclosure of who is to profit from choices presented by the guide.’) However, other participants’ comments suggested a limited understanding of its relevance and/or little interest in it (‘I don’t think people need information about what is going to happen with money when using the guide, it has nothing to do with birth control,’ ‘The information is more important than who is making money off it because someone is always making money off something’). Conclusions Relying on mere disclosure of competing interests among patient decision aid developers may not adequately mitigate the negative effects of those interests for all decision aid users. Further research dedicated to exploring diverse patients’ understanding of and attitudes toward competing interest disclosure statements, as well as if and how such statements modify patients’ interpretation of the content and perceived trustworthiness of the decision aid, is warranted.