Purpose: Current informed consent processes tend to emphasize information provision rather than careful deliberation and decision-making. The International Patient Decision Aids Standards (IPDAS) provide recommendations for working systematically through difficult decisions, such that decision makers will understand outcome probabilities, explicitly weigh benefits and harms, and consider which outcomes they value most. We assessed informed consent documents (ICDs) according to these recommendations.
Methods: 139 ICDs for trials registered with ClinicalTrials.gov were obtained from study investigators. Using a 4-point scale (strongly agree, agree, disagree, strongly disagree), two raters assessed each ICD on 32 items. If the mean rating was within the “agree” range, the ICD was said to conform to that item.
Results: Overall agreement between raters was 95.1%. For the 12 items focused on providing information about options, conformity (i.e. the percentage of the sample rated ‘strongly agree’ or ‘agree’ to that item) was above 50% for only 3 items, while conformity was 0% for another 4 items. For 8 items focused on clear presentation of probabilities of outcomes, conformity was below 20% for all 8. For the 2 items focused on clarifying and expressing values, conformity was below 10%. For the 2 items focused on improving structured guidance in deliberation, conformity was below 5%. For the 4 items focused on using evidence to facilitate decision making, 1 item showed conformity in more than 50% of the sample, while the others showed conformity below 5%. For 4 items focused on disclosure and transparency, conformity was high (above 60% for 2, above 80% for the others).
Conclusions: This study shows that existing ICDs do not conform to many standards known to encourage good-quality decision making. These standards make clear and testable predictions about how one might go about improving the extent to which trial participation decisions are fully informed.