Understanding preferences regarding consent for pragmatic trials in acute care

Abstract

Background There has been debate about the role of consent in pragmatic trials comparing qualitatively similar interventions. Consent preferences may differ in acute care contexts given severe illness, time constraints, and other barriers to consent. In addition, studies have not assessed the impact of disclosing financial considerations as a justification for trials. This study was designed to assess preferences of the general public regarding consent for a pragmatic trial in ST-elevation myocardial infarction. Methods This survey was completed using an online, probability-based panel representative of the U.S. population. It incorporated a randomized, experimental (2 × 2) design assessing: 1) preference for written consent versus an alternative (notification after enrollment or brief verbal consent); and 2) impact of including cost as a motivating factor for the trial. The survey used a scenario based on a recent pragmatic trial in ST-elevation myocardial infarction. Primary independent variables were personal preference and recommendation as a member of a review board regarding written consent versus the assigned alternative strategy and personal attitude toward trial enrollment. Descriptive analyses were conducted using post-stratification weights. Regression models were created to examine relationships between demographic variables and consent preference and willingness to enroll. Provision of cost information was incorporated into a regression model to examine its impact on consent preference. Results The study included 2027 participants. 51.1% vs 45.8% stated a personal preference for written consent versus notification after enrollment; however, 60.0% vs. 35.5% preferred brief verbal consent to written consent. Even among respondents stating they would be unlikely to enroll in the trial if asked, more respondents (50.6%) preferred brief verbal consent. The preference for verbal consent was generally shared across demographic categories, although lower educational attainment was associated with reduced acceptance (p=0.001 for trend). Respondents were more likely to support an alternative to written consent when asked their personal preference than when asked their recommendation as a member of a review board. The provision of cost information did not have a meaningful effect on consent preferences, attitudes toward enrollment, or views about the study. Conclusions Respondents generally supported prospective involvement in enrollment decisions in the setting of acute myocardial infarction and were particularly supportive of brief verbal consent. This support persisted across demographic categories. The finding that individuals were more likely to support alternatives to written consent when asked for a personal preference rather than as a “committee member” suggests that conservative institutional approaches to consent could hinder implementation of more patient-centered approaches. The role of cost transparency in consent discussions warrants further study.

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

“…(48,57) As such, verbal consent has previously been proposed as a function-based approach to informed consent. (58–60) Shortening the consent form is another consideration to reduce complexity, however, a longer consent form may be appropriate for proxy decision making. (35,61,62) Overall, a more targeted consent model may be preferable on an ethical basis due to the time sensitive nature of benefit to the patient and the potential to enhance patient understanding.…”

Public Attitudes toward Consent When Research Is Integrated into Care—Any “Ought” from All the “Is”?

“…Both Nayak et al and Cho et al found that respondents preferred traditional written consent to streamlined consent 21 . Dickert and colleagues, however, found that more individuals preferred streamlined consent with verbal permission to traditional written consent for studies of acute events like myocardial infarction (60 percent versus 35.5 percent) 22 . Again, situational constraints on decision‐making specific to the acute‐care context may be at play.…”

“…Neal Dickert and colleagues conducted an experimental survey of preferences for consent in the context of a pragmatic trial for myocardial infarction. Only a bare majority of respondents (51.5 percent) preferred written consent to post‐enrollment notification 20 . This may reflect situational constraints on decision‐making specific to the acute‐care context.…”

“…To date, however, only Dickert et al and Jagsi et al have systematically examined the association between demographics and perspectives on consent in the context of pragmatic research. Dickert and colleagues found that respondents of all races examined (White, Black, Hispanic, and “other”) favored verbal consent in the acute‐care context and noted that the transparency afforded by such an approach “may be especially important for communities who are less trustful of research.” 64 Race was a significant predictor of lower odds of being willing to enroll. Jagsi and colleagues found significant differences by race or ethnicity 65 .…”