BackgroundResearchers worry that patients in early-phase research experience unrealistic optimism about benefits and risks of participation. The standard measure of unrealistic optimism is the Comparative Risk/Benefit Assessment questionnaire, which asks people to estimate their chances of an outcome relative to others in similar situations. Such a comparative framework may not be a natural way for research participants to think about their chances.ObjectiveTo examine how people interpret questions measuring unrealistic optimism and how their interpretations are associated with their responses.MethodsUsing an early-phase (...) cancer trial vignette, we administered the CRBA to 297 adults from the general public. They estimated their comparative chances of risk and benefit, then provided rationales for their estimates.ResultsFor both CRBA benefit and risk questions, about 50% of respondents chose 0, and 50% chose a non-0 response. Respondents’ rationales for their estimates showed that overall only about 40%–44% gave comparative rationales, indicating that they interpreted the CRBA as intended. 68.7% of respondents who gave the ‘correct’ 0 rating gave comparative rationales, whereas only 11.6% of respondents who gave non-0 ratings did so. A similar trend was seen for chances of risk.ConclusionResearch participants may not understand comparative benefit and risk questions as intended; attributions of unrealistic optimism may require additional evidence that the respondents’ estimates are intended to be comparative. (shrink)

Almost 35 years ago, my colleagues and I first reported a new phenomenon: the decisions of many freshly enrolled research subjects appeared to be based on confusion between the nature of research and of ordinary treatment.1 We called the phenomenon ‘therapeutic misconception’ (TM), and noted that it was characterised by inaccurate beliefs about the degree of individualisation of treatment and likelihood of benefit associated with enrolment in a clinical trial. Since that original paper, dozens of studies from around the world (...) have confirmed the existence of TM and its substantial prevalence, with rates of some degree of TM approaching or exceeding 50% in many studies.2 The concept of TM has become a given in the world of research ethics. Commonly accepted concepts, of course, are prime targets for academic revisionism, so it is not a surprise to see an article like that by Kim et al in this issue of JME.3 Indeed, Kim et al have embarked on a series of studies aimed at challenging the idea that TM is a major concern in consent to research. This is not the place to comment on the project as a whole, but the study reported here exemplifies its problems. It is based on the notion that “the apparent prevalence of TM indicates [sic] a form of measurement error”, that …. (shrink)