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Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.
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Consentimento Livre e Esclarecido , Projetos de Pesquisa , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Diálise Renal , Ética em PesquisaRESUMO
BACKGROUND: Psychiatrists depend on their patients for clinical information and are obligated to regard them as trustworthy, except in special circumstances. Nevertheless, some critics of psychiatry have argued that psychiatrists frequently perpetrate epistemic injustice against patients. Epistemic injustice is a moral wrong that involves unfairly discriminating against a person with respect to their ability to know things because of personal characteristics like gender or psychiatric diagnosis. METHODS: We review the concept of epistemic injustice and several claims that psychiatric practice is epistemically unjust. RESULTS: While acknowledging the risk of epistemic injustice in psychiatry and other medical fields, we argue that most concerns that psychiatric practice is epistemically unjust are unfounded. CONCLUSIONS: The concept of epistemic injustice does not add significantly to existing standards of good clinical practice, and that it could produce changes in practice that would be deleterious. Psychiatrists should resist calls for changes to clinical practice based on this type of criticism.
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Transtornos Mentais , Psiquiatria , Humanos , Transtornos Mentais/terapia , Filosofia Médica , Princípios MoraisRESUMO
BACKGROUND: Irremediability is a key requirement for euthanasia and assisted suicide for psychiatric disorders (psychiatric EAS). Countries like the Netherlands and Belgium ask clinicians to assess irremediability in light of the patient's diagnosis and prognosis and 'according to current medical understanding'. Clarifying the relevance of a default objective standard for irremediability when applied to psychiatric EAS is crucial for solid policymaking. Yet so far, a thorough examination of this standard is lacking. METHODS: Using treatment-resistant depression (TRD) as a test case, through a scoping review in PubMed, we analyzed the state-of-the-art evidence for whether clinicians can accurately predict individual long-term outcome and single out irremediable cases, by examining the following questions: (1) What is the definition of TRD; (2) What are group-level long-term outcomes of TRD; and (3) Can clinicians make accurate individual outcome predictions in TRD? RESULTS: A uniform definition of TRD is lacking, with over 150 existing definitions, mostly focused on psychopharmacological research. Available yet limited studies about long-term outcomes indicate that a majority of patients with long-term TRD show significant improvement over time. Finally, evidence about individual predictions in TRD using precision medicine is growing, but methodological shortcomings and varying predictive accuracies pose important challenges for its implementation in clinical practice. CONCLUSION: Our findings support the claim that, as per available evidence, clinicians cannot accurately predict long-term chances of recovery in a particular patient with TRD. This means that the objective standard for irremediability cannot be met, with implications for policy and practice of psychiatric EAS.
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Transtorno Depressivo Resistente a Tratamento , Eutanásia , Suicídio Assistido , Humanos , Países Baixos , BélgicaRESUMO
All contemporary frameworks of mental capacity stipulate that we must begin from the presumption that an adult has capacity. This presumption is crucial, as it manifests respect for autonomy and guards against prejudice and paternalism on the part of the evaluator.Given its ubiquity, we might presume that we all understand the presumption's meaning and application in the same way. Evidence demonstrates that this is not the case and that this has led to harm in vulnerable persons. There is thus strong reason to question our presumptions about the presumption of capacity.We distinguish between two main ways of understanding and applying the presumption of capacity, and advocate for the one that we argue mitigates risk of harm. Our proposed interpretation offers many advantages in that it is consonant with actual practice of capacity evaluations, precludes confused and abusive avoidance of needed evaluations, and preserves the respect for autonomy motivating the presumption in the first place.
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Challenges to the legitimacy of mental capacity over the past 10 years have been spearheaded by the Committee on the Rights of Persons with Disabilities, the treaty body for the UN Convention on the Rights of Persons with Disabilities (CRPD). This challenge has been asserted to have produced a 'paradigm shift'. In this article, we examine why that interpretation has had such limited traction in the legal policy arena, and whether it should have traction. We also analyse whether the Committee has subtly but importantly shifted its position. We then develop an argument that the true goal, compatible with the CRPD, is the satisfactory determination of whether a person has or lacks mental capacity to make or take a relevant decision. Our article contextualises multi-disciplinary, research-informed guidelines designed as a contribution to satisfactory determination. While our article is based upon the position in England and Wales, we suggest that our conclusions are of wider application.
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Pessoas com Deficiência , Transtornos Mentais , Humanos , Direitos Humanos , Nações Unidas , Cooperação Internacional , InglaterraRESUMO
The preponderance of women among persons who request and receive euthanasia and assisted suicide based on a psychiatric condition, as shown by data from The Netherlands and Belgium, is virtually unexplored. We provide a critical discussion of this gender gap, and propose that it can inform a key debate point in the controversy over the practice, namely its conflict with suicide prevention.
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Eutanásia , Transtornos Mentais , Suicídio Assistido , Feminino , Humanos , Países Baixos/epidemiologiaRESUMO
Most jurisdictions require that a mental capacity assessment be conducted using a functional model whose definition includes several abilities. In England and Wales and in increasing number of countries, the law requires a person be able to understand, to retain, to use or weigh relevant information and to communicate one's decision. But interpreting and applying broad and vague criteria, such as the ability 'to use or weigh' to a diverse range of presentations is challenging. By examining actual court judgements of capacity, we previously developed a descriptive typology of justifications (rationales) used in the application of the Mental Capacity Act (MCA) criteria. We here critically optimise this typology by showing how clear definitions-and thus boundaries-between the criteria can be achieved if the 'understanding' criterion is used narrowly and the multiple rationales that fall under the ability to 'use or weigh' are specifically enumerated in practice. Such a typology-aided practice, in theory, could make functional capacity assessments more transparent, accountable, reliable and valid. It may also help to create targeted supports for decision making by the vulnerable. We also discuss how the typology could evolve legally and scientifically, and how it lays the groundwork for clinical research on the abilities enumerated by the MCA.
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Tomada de Decisões , Competência Mental , Humanos , Inglaterra , País de GalesRESUMO
INTRODUCTION: Stereotactic neurosurgical techniques are increasingly used to deliver biologics, such as cells and viruses, although standardized procedures are necessary to ensure consistency and reproducibility. OBJECTIVE: We provide an instructional guide to help plan for complex image-guided trajectories; this may be of particular benefit to surgeons new to biologic trials and companies planning such trials. METHODS: We show how nuclei can be segmented and multiple trajectories with multiple injection points can be created through a single or multiple burr hole(s) based on preoperative images. Screenshots similar to those shown in this article can be used for planning purposes and for quality control in clinical trials. RESULTS: This method enables the precise definition of 3-D target structures, such as the putamen, and efficient planning trajectories for biologic injections. The technique is generalizable and largely independent of procedural format, and thus can be integrated with frame-based or frameless platforms to streamline reproducible therapeutic delivery. CONCLUSIONS: We describe an easy-to-use and generalizable protocol for intracerebral trajectory planning for stereotactic delivery of biologics. Although we highlight intracerebral stem cell delivery to the putamen using a frame-based stereotactic delivery system, similar strategies may be employed for different brain nuclei using different platforms. We anticipate this will inform future advanced and fully automated neurosurgical procedures to help unify the field and decrease inherent variability seen with manual trajectory planning.
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Produtos Biológicos , Técnicas Estereotáxicas , Humanos , Imageamento Tridimensional , Imageamento por Ressonância Magnética/métodos , Procedimentos Neurocirúrgicos/métodos , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: To describe the parental experience of recruitment and assess differences between parents who participated and those who declined to enroll in a neonatal clinical trial. STUDY DESIGN: This was a survey conducted at 12 US neonatal intensive care units of parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial or who were eligible but declined enrollment. Questions assessed 6 factors of the parental experience of recruitment: (1) interactions with research staff; (2) the consent experience; (3) perceptions of the study; (4) decisional conflict; (5) reasons for/against participation; and (6) timing of making the enrollment decision. RESULTS: In total, 269 of 387 eligible parents, including 183 of 242 (75.6%) of those who enrolled their children in HEAL and 86 of 145 (59.3%) parents who declined to enroll their children in HEAL, were included in analysis. Parents who declined to enroll more preferred to be approached by clinical team members rather than by research team members (72.9% vs 49.2%, P = .005). Enrolled parents more frequently reported positive initial impressions (54.9% vs 10.5%, P < .001). Many parents in both groups made their decision early in the recruitment process. Considerations of reasons for/against participation differed by enrollment status. CONCLUSIONS: Understanding how parents experience recruitment, and how this differs by enrollment status, may help researchers improve recruitment processes for families and increase enrollment. The parental experience of recruitment varied by enrollment status. These findings can guide future work aiming to inform optimal recruitment strategies for neonatal clinical trials.
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Tomada de Decisões , Pais/psicologia , Seleção de Pacientes , Estudos Transversais , Humanos , Lactente , Recém-Nascido , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e QuestionáriosRESUMO
BACKGROUND: We previously introduced the concept of "two-stage" (or "just-in-time") informed consent for randomized trials with usual care control. We argued that conducting consent in two stages-splitting information about research procedures from information about the experimental intervention-would reduce the decisional anxiety, confusion, and information overload commonly associated with informed consent. We implemented two-stage consent in a low-stakes randomized trial of a mindfulness meditation intervention for procedural distress in patients undergoing prostate biopsy. Here, we report accrual rates and patient understanding of the consent process. METHODS: Patients approached for consent for the biopsy trial were asked to complete the standard "Quality of Informed Consent" questionnaire to assess their knowledge and understanding of the trial. RESULTS: Accrual was excellent with 108 of 110 (98%) patients approached for consent signing first-stage consent. All 51 patients randomized to the experimental arm and who later presented for biopsy signed second-stage consent and received the mindfulness intervention. Quality of Informed Consent data were available for 48 patients assigned to the mindfulness treatment arm and 44 controls. The mean Quality of Informed Consent score was similar in the meditation and control arms with and overall mean of 75 (95% confidence interval = 74-76) for the knowledge section and 86 (95% confidence interval = 81-90) for understanding, comparable to the normative scores of 80 and 88. On further analysis and patient interview, two of the Quality of Informed Consent questions were found to be misleading in the context of a two-stage consent study for a mindfulness intervention. Excluding these questions increased knowledge scores to 88 (95% confidence interval = 87-90). CONCLUSION: We found promising data that two-stage consent facilitated accrual without compromising patient understanding of randomized trials or compliance with allocated treatment. Further research is needed incorporating randomized comparison of two-stage consent to standard consent approaches, measuring patient anxiety and distress as an outcome, using suitable modifications to the Quality of Informed Consent questionnaire and trials with higher stakes.
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Consentimento Livre e Esclarecido , Projetos de Pesquisa , Protocolos Clínicos , Humanos , Masculino , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e QuestionáriosRESUMO
The COVID-19 pandemic put a large burden on many healthcare systems, causing fears about resource scarcity and triage. Several COVID-19 guidelines included age as an explicit factor and practices of both triage and 'anticipatory triage' likely limited access to hospital care for elderly patients, especially those in care homes. To ensure the legitimacy of triage guidelines, which affect the public, it is important to engage the public's moral intuitions. Our study aimed to explore general public views in the UK on the role of age, and related factors like frailty and quality of life, in triage during the COVID-19 pandemic. We held online deliberative workshops with members of the general public (n=22). Participants were guided through a deliberative process to maximise eliciting informed and considered preferences. Participants generally accepted the need for triage but strongly rejected 'fair innings' and 'life projects' principles as justifications for age-based allocation. They were also wary of the 'maximise life-years' principle, preferring to maximise the number of lives rather than life years saved. Although they did not arrive at a unified recommendation of one principle, a concern for three core principles and values eventually emerged: equality, efficiency and vulnerability. While these remain difficult to fully respect at once, they captured a considered, multifaceted consensus: utilitarian considerations of efficiency should be tempered with a concern for equality and vulnerability. This 'triad' of ethical principles may be a useful structure to guide ethical deliberation as societies negotiate the conflicting ethical demands of triage.
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Euthanasia or assisted suicide (EAS) is permitted in a handful of jurisdictions. But its scope (ranging from being restricted to the end of life to no restrictions save those of autonomy) and its legal basis (ranging from a necessary prerogative of physicians to a human right) vary greatly. The debate over psychiatric EAS (pEAS) needs to be understood within this complex context. This essay addresses one specific aspect: can pEAS be grounded on a basic human right? The author argues against pEAS as grounded on a basic human right by showing that such a view has several implications we ought not accept.
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Eutanásia , Médicos , Psiquiatria , Suicídio Assistido , Humanos , Países BaixosRESUMO
Online health misinformation is a growing problem, and health information professionals and consumers would benefit from an evaluation of health websites for reliability and trustworthiness. Terms from the Google COVID-19 Search Trends dataset were searched on Google to determine the most frequently appearing consumer health information websites. The quality of the resulting top five websites was evaluated. The top five websites that appeared most frequently were WebMD, Mayo Clinic, Healthline, MedlinePlus, and Medical News Today, respectively. All websites, except Medline Plus, received HONcode certification. Based on DISCERN and CRAAP scores, MedlinePlus was found to be the most reliable health website.
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COVID-19 , Informação de Saúde ao Consumidor , Humanos , Internet , Reprodutibilidade dos Testes , SARS-CoV-2 , Ferramenta de BuscaRESUMO
Potentially curative but high-risk trials of gene therapy or stem cell transplantation (PBSCT) for sickle cell disease (SCD) pose new opportunities for adults with SCD, many of whom experience significant disease burden and complications with few treatment options, as well as stigma and disparities in care. We explored motivations and decision-making processes of enrollees and decliners of such trials. Semistructured interviews were conducted with a purposive sample of 20 enrollees and 6 decliners. Interviews explored participants' SCD experiences, motivations, and decision-making about trial participation, understanding of research-related information, and retrospective reflections. Interviews were analyzed with content analysis. Most identified the purpose of research, risks, and uncertainties of participation. Both enrollees and decliners described deliberative weighing of study risks and potential benefits (especially the prospect of a cure), with heavy factoring of their SCD status, experiences, and desire for a better life. Despite the influence of spirituality/religion and support of family and friends, all described the decision about participation as their own. In some patients, the primary outcome status defined by the trial did not match the patients' perceived outcomes. Patients with negative experiences expressed a desire for greater emphasis on risks and possible outcomes during informed consent. This cohort of adults with SCD were thoughtfully deliberative in their decisions about gene therapy or PBSCT trials. Future participants' decision-making may be enhanced by emphasizing that "successful" scientific outcomes can still involve complications or symptoms and be facilitated by referrals to former research participants and anticipatory discussions.
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Anemia Falciforme , Motivação , Adulto , Anemia Falciforme/terapia , Tomada de Decisões , Humanos , Pesquisa Qualitativa , Estudos RetrospectivosRESUMO
BACKGROUND: Euthanasia and assisted suicide (EAS) based on a psychiatric disorder (psychiatric EAS) continue to pose ethical and policy challenges, even in countries where the practice has been allowed for years. We conducted a systematic review of reasons, a specific type of review for bioethical questions designed to inform rational policy-making. Our aims were twofold: (1) to systematically identify all published reasons for and against the practice (2) to identify current gaps in the debate and areas for future research. METHODS: Following the PRISMA guidelines, we performed a search across seven electronic databases to include publications focusing on psychiatric EAS and providing ethical reasons. Reasons were grouped into domains by qualitative content analysis. RESULTS: We included 42 articles, most of which were written after 2013. Articles in favor and against were evenly distributed. Articles in favor were mostly full-length pieces written by non-clinicians, with articles against mostly reactive, commentary-type pieces written by clinicians. Reasons were categorized into eight domains: (1) mental and physical illness and suffering (2) decisional capacity (3) irremediability (4) goals of medicine and psychiatry (5) consequences for mental health care (6) psychiatric EAS and suicide (7) self-determination and authenticity (8) psychiatric EAS and refusal of life-sustaining treatment. Parity- (or discrimination-) based reasons were dominant across domains, mostly argued for by non-clinicians, while policy reasons were mostly pointed to by clinicians. CONCLUSIONS: The ethical debate about psychiatric EAS is relatively young, with prominent reasons of parity. More direct engagement is needed to address ethical and policy considerations.
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Eutanásia/ética , Política de Saúde , Transtornos Mentais/terapia , Psiquiatria/ética , Suicídio Assistido/ética , Tomada de Decisões , Eutanásia/legislação & jurisprudência , Humanos , Competência Mental , Autonomia Pessoal , Psiquiatria/legislação & jurisprudência , Suicídio Assistido/legislação & jurisprudênciaRESUMO
BACKGROUND: Euthanasia or assisted suicide (EAS) for psychiatric disorders, legal in some countries, remains controversial. Personality disorders are common in psychiatric EAS. They often cause a sense of irremediable suffering and engender complex patient-clinician interactions, both of which could complicate EAS evaluations. METHODS: We conducted a directed-content analysis of all psychiatric EAS cases involving personality and related disorders published by the Dutch regional euthanasia review committees (N = 74, from 2011 to October 2017). RESULTS: Most patients were women (76%, n = 52), often with long, complex clinical histories: 62% had physical comorbidities, 97% had at least one, and 70% had two or more psychiatric comorbidities. They often had a history of suicide attempts (47%), self-harming behavior (27%), and trauma (36%). In 46%, a previous EAS request had been refused. Past psychiatric treatments varied: e.g. hospitalization and psychotherapy were not tried in 27% and 28%, respectively. In 50%, the physician managing their EAS were new to them, a third (36%) did not have a treating psychiatrist at the time of EAS request, and most physicians performing EAS were non-psychiatrists (70%) relying on cross-sectional psychiatric evaluations focusing on EAS eligibility, not treatment. Physicians evaluating such patients appear to be especially emotionally affected compared with when personality disorders are not present. CONCLUSIONS: The EAS evaluation of persons with personality disorders may be challenging and emotionally complex for their evaluators who are often non-psychiatrists. These factors could influence the interpretation of EAS requirements of irremediability, raising issues that merit further discussion and research.
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Eutanásia/estatística & dados numéricos , Transtornos da Personalidade/epidemiologia , Médicos/estatística & dados numéricos , Trauma Psicológico/epidemiologia , Comportamento Autodestrutivo/epidemiologia , Suicídio Assistido/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Eutanásia/legislação & jurisprudência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Suicídio Assistido/legislação & jurisprudência , Adulto JovemRESUMO
OBJECTIVE: To describe the characteristics of persons with dementia receiving euthanasia/assisted suicide (EAS) and how the practice is regulated in the Netherlands. DESIGNS: Qualitative directed content analysis of dementia EAS reports published by the Dutch euthanasia review committees between 2011 and October 5, 2018. RESULTS: Seventy-five cases were reviewed: 59 concurrent requests and 16 advance requests. Fifty-three percent (40/75) were women, and 48% (36/75) had Alzheimer disease. Advance request EAS patients were younger, had dementia longer, and more frequently had personal experience with dementia. Some concurrent request EAS patients were quite impaired: 15% (9/59) were deemed incompetent by at least one physician; in 24% (14/59), patients' previous statements or current body language were used to assess competence. In 39% (29/75), patients' own physicians declined to perform EAS; in 43% (32/75), the physician performing EAS was new to them. Physicians disagreed about patients' eligibility in 21% (16/75). All advance request and 14 (25%) concurrent request patients had an advance euthanasia directive but the conditions of applicability often lacked specificity. In 5 of 16 advance request EAS and 2 of 56 concurrent request EAS cases, EAS procedure was modified (e.g., premedication). Twenty-five percent (4/16) of advance request cases did not meet legal due care criteria, in particular the "unbearable suffering" criterion. CONCLUSIONS: Advance and concurrent request EAS cases differ in age, duration of illness, and past experience. Advance request EAS cases were complicated by ambiguous directives, patients being unaware of the EAS procedure, and physicians' difficulty assessing "unbearable suffering." Notably, some concurrent request patients were quite impaired yet deemed competent by appeals to previous statements.
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Demência/terapia , Eutanásia/estatística & dados numéricos , Competência Mental , Médicos/psicologia , Suicídio Assistido/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Tomada de Decisões , Eutanásia/legislação & jurisprudência , Feminino , Regulamentação Governamental , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Médicos/legislação & jurisprudência , Padrão de Cuidado , Suicídio Assistido/legislação & jurisprudência , Recusa do Paciente ao Tratamento/estatística & dados numéricosRESUMO
OBJECTIVES: Euthanasia and assisted suicide (EAS) of individuals with mental disorders is a growing practice in several countries, including the Netherlands. Here, we aimed to identify the most frequent dimensions of and associated factors to psychological pain, which has been associated with suicidality, in individuals undergoing psychiatric EAS. METHODS: An exploratory retrospective content analysis of the English translation of 66 digital case records of individuals who died by EAS in the Netherlands between 2011 and 2014 was performed. Nine standard psychological pain dimensions (irreversibility, loss of control, emptiness, emotional flooding, freezing, social distancing, narcissistic wounds, confusion, and self-estrangement), illness, and sociodemographic variables were evaluated by 2 independent raters using a premade data abstraction form (Kohen κ > 0.8 in all cases). RESULTS: The mean number of dimensions was 4.64 ± 1.20 (median = 5), out of 9. The most frequent dimensions were irreversibility, loss of control, emptiness, and emotional flooding, in decreasing order. Past treatment refusal and the mention of social connections in case descriptions were related to the higher number of psychological pain dimensions (4.89 ± 1.24 vs. 4.31 ± 1.07, P = 0.03 and 5.05 ± 1.17 vs. 4.43 ± 1.17, P = 0.03, respectively). Emotional flooding was the only dimension specifically associated with specific psychiatric conditions, namely posttraumatic phenomena and personality disorders. CONCLUSIONS: Numerous psychological pain dimensions were detected in case descriptions of individuals who underwent EAS before the procedure. Subjective nature of the study precludes definite conclusions but suggest that future studies should explore psychological pain and the role of interventions targeting it in patients requesting EAS.
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Eutanásia , Suicídio Assistido , Humanos , Países Baixos , Dor , Estudos RetrospectivosRESUMO
The modern legal and ethical movement against traditional welfare paternalism in medical decision-making extends to how decisions are made for patients lacking decisional capacity, prioritising surrogates' judgment about what patients would have decided over even their best interests. In England and Wales, the Mental Capacity Act 2005 follows this trend of prioritising the patient's prior wishes, values and beliefs but the dominant interpretation in life-sustaining treatment cases does so by in effect calling those values the 'best interests' of the patient and focusing nearly exclusively on the 'subjective' viewpoint of the patient. In this article, we examine the recent Court of Protection judgment in Barnsley Hospitals NHS Foundation Trust v MSP [2020] EWCOP 26, which adhered closely to this approach, to suggest that it could have unexpected negative consequences. These include insufficient information gathering about and attention to patients' objective medical interests, inadequacy of the evidentiary standard used for the substituted decision-making and, in some cases, even prioritising a surrogate's current substituted judgment over the potential for an actual judgment by the patient.
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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.