Understanding people's 'unrealistic optimism' about clinical research participation.

BACKGROUND: Researchers 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 (CRBA) 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. OBJECTIVE: To examine how people interpret questions measuring unrealistic optimism and how their interpretations are associated with their responses. METHODS: Using 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 (7-point scale: -3 less likely to +3 more likely), then provided rationales for their estimates. RESULTS: For both CRBA benefit and risk questions, about 50% of respondents chose 0 (the 'correct' response of 'average likelihood'), 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 (p<0.001 for both). CONCLUSION: Research 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.

Advance euthanasia directives: a controversial case and its ethical implications.

Authorising euthanasia and assisted suicide with advance euthanasia directives (AEDs) is permitted, yet debated, in the Netherlands. We focus on a recent controversial case in which a Dutch woman with Alzheimer's disease was euthanised based on her AED. A Dutch euthanasia review committee found that the physician performing the euthanasia failed to follow due care requirements for euthanasia and assisted suicide. This case is notable because it is the first case to trigger a criminal investigation since the 2002 Dutch euthanasia law was enacted. Thus far, only brief descriptions of the case have been reported in English language journals and media. We provide a detailed description of the case, review the main challenges of preparing and applying AEDs for persons with dementia and briefly assess the adequacy of the current oversight system governing AEDs.

Ethical Acceptability of Postrandomization Consent in Pragmatic Clinical Trials.

Importance: Pragmatic clinical trials that seek informed consent after randomization (ie, postrandomization consent) are increasingly used, but debate on ethics persists because control arm patients are not specifically informed about the trials and randomization occurs before consent for the trials. The public's attitude toward postrandomization consent trials is unknown, but the way the trials are described could bias people's views. Objectives: To assess the attitudes of the US general public toward postrandomization informed consent for pragmatic trials and to measure potential framing and other factors associated with those attitudes. Design, Setting, and Participants: An online, 2 × 2 experimental survey (fielded between February 23 and April 3, 2018) portraying 4 scenarios of postrandomization informed consent (with prior broad consent for medical record use) was conducted. These scenarios included traditional randomized clinical trial language framing vs alternative framing in a high-stakes trial (ie, survival in leukemia) or low-stakes trial (ie, blood glucose level in diabetes). A total of 3793 individuals invited to participate were part of an existing panel representative of the US general public (GfK KnowledgePanel). Main Outcomes and Measures: The proportion of participants who would recommend that an ethics review board approve a postrandomization consent pragmatic trial. Results: A total of 2042 of 3739 invitees (54.6%) responded; after exclusion of 38 incomplete surveys, 2004 participants were included in the analysis. Of these, 997 (49.8%) were women, 1440 (71.9%) were white non-Hispanic, 199 (9.9%) were black non-Hispanic, and 233 (11.6%) were Hispanic. Mean (SD) age was 47.5 (17.4) years. Across scenarios, weighted data showed that 75.4% of the participants would recommend approval of the postrandomization consent pragmatic trial, 20.4% would probably not recommend approval, and 4.2% would definitely not recommend approval. Approval was not sensitive to framing language (traditional vs new framing in high-stakes scenario, 74.3% vs 76.8%, P = .40; in low-stakes scenario, 77.7% vs 72.9%, P = .10) or to the stakes (low vs high stakes in traditional framing, 77.7% vs 74.3%, P = .25; in new framing, 72.9% vs 76.8%, P = .18). Better understanding of the postrandomization consent design was associated with higher rate of approval (78.1% vs 65.0%, P = .002 for high-stakes scenario; 77.2% vs 64.9%, P = .004 for low-stakes scenario), especially among those with less education. However, opinions about personal involvement in the control arm were more cautious (range depending on scenario, 45.6%-59.7%) and sensitive to stakes but not to framing. Conclusions and Relevance: The public's generally high rate of approval of the ethics of postrandomization informed consent for pragmatic trial designs does not appear to be affected by whether postrandomization consent design is framed using traditional randomized clinical trial terminology, regardless of the stakes of the trial. Promoting better understanding of the design may increase its acceptance by the public.

Euthanasia and physician-assisted suicide not meeting due care criteria in the Netherlands: a qualitative review of review committee judgements.

ObjectivesTo assess how Dutch regional euthanasia review committees (RTE) apply the euthanasia and physician-assisted suicide (EAS) due care criteria in cases where the criteria are judged not to have been met ('due care not met' (DCNM)) and to evaluate how the criteria function to set limits in Dutch EAS practice. DESIGN: A qualitative review using directed content analysis of DCNM cases in the Netherlands from 2012 to 2016 published on the RTE website (https://www.euthanasiecommissie.nl/) as of 31 January 2017. RESULTS: Of 33 DCNM cases identified (occurring 2012-2016), 32 cases (97%) were published online and included in the analysis. 22 cases (69%) violated only procedural criteria, relating to improper medication administration or inadequate physician consultation. 10 cases (31%) failed to meet substantive criteria, with the most common violation involving the no reasonable alternative (to EAS) criterion (seven cases). Most substantive cases involved controversial elements, such as EAS for psychiatric disorders or 'tired of life', in incapacitated patients or by physicians from advocacy organisations. Even in substantive criteria cases, the RTE's focus was procedural. The cases were more about unorthodox, unprofessional or overconfident physician behaviours and not whether patients should have received EAS. However, in some cases, physicians knowingly pushed the limits of EAS law. Physicians from euthanasia advocacy organisations were over-represented in substantive criteria cases. Trained EAS consultants tended to agree with or facilitate EAS in DCNM cases. Physicians and families had difficulty applying ambiguous advance directives of incapacitated patients. CONCLUSION: As a retrospective review of physician self-reported data, the Dutch RTEs do not focus on whether patients should have received EAS, but instead primarily gauge whether doctors conducted EAS in a thorough, professional manner. To what extent this constitutes enforcement of strict safeguards, especially when cases contain controversial features, is not clear.