Trustworthy patient decision aids: a qualitative analysis addressing the risk of competing interests.

OBJECTIVE: Our aim in this study was to examine the competing interest policies and procedures of organisations who develop and maintain patient decision aids. DESIGN: Descriptive and thematic analysis of data collected from a cross-sectional survey of patient decision aid developer's competing interest policies and disclosure forms. RESULTS: We contacted 25 organisations likely to meet the inclusion criteria. 12 eligible organisations provided data. 11 organisations did not reply and 2 declined to participate. Most patient decision aid developers recognise the need to consider the issue of competing interests. Assessment processes vary widely and, for the most part, are insufficiently robust to minimise the risk of competing interests. Only half of the 12 organisations had competing interest policies. Some considered disclosure to be sufficient, while others imposed differing levels of exclusion. CONCLUSIONS: Patient decision aid developers do not have a consistent approach to managing competing interests. Some have developed policies and procedures, while others pay no attention to the issue. As is the case for clinical practice guidelines, increasing attention will need to be given to how the competing interests of contributors of evidence-based publications may influence materials, especially if they are designed for patient use.

Patient Decision Aids: A Case for Certification at the National Level in the United States.

Patient decision aids enable patients to be better informed about the potential benefits and harms of their healthcare options. Certification of patient decision aids at the national level in the United States is a critical step towards responsible governance-primarily as a quality measure that increases patients' safety, as mandated in the U.S. Patient Protection and Affordable Care Act (PPACA). Certification would provide a verification process to identify conflicts of interest that may otherwise bias the scientific evidence presented in decision aids. Certification also benefits clinicians who may otherwise face malpractice claims based on harm to patients caused by possible reliance on patient decision aids that are inaccurate, incomplete, or presented in a manner that biases the patient's decision. Existing work by the International Patient Decision Aid Standards Collaboration could guide the establishment of a certification process within the U.S. This article argues for national certification of patient decision aids and discusses how that may be achieved.