Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design

Dickert, Neal W.; Hendershot, Kristopher A; Speight, Candace; Fehr, Alexandra

doi:10.1136/medethics-2016-103866

Cited by 9 publications

(10 citation statements)

References 23 publications

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“…However, the level of acceptability varied associated with the nature and purpose of the study (see Additional file 3: Table S8 reporting the studies' key findings, and suppl. 9additional reporting [130][131][132][133]). Most studies (59.1%) were conducted with public members (including researchers, healthy populations, IRBs) and used observational designs (e.g.…”

Section: Public Attitudes On Enrolling Adults Lacking Capacity In Resmentioning

confidence: 99%

Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)

Evans

Yorganci

Lewis

et al. 2020

BMC Med

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Background: Involving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum. Methods: Methods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert 'think-tank' to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.

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Section: Public Attitudes On Enrolling Adults Lacking Capacity In Resmentioning

confidence: 99%

Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)

Evans

Yorganci

Lewis

et al. 2020

BMC Med

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“…Other studies [14,22] have demonstrated that patients' confidence in healthcare professionals is generally strong, and this might be an explanation for the patients' satisfaction and trust in verbal information in the acute phase of an AMI. Fig.…”

Section: Informationmentioning

confidence: 97%

“…The current common practice in AMI trials is to obtain prospective, most often written IC [12], but this has recently been debated [3,[12][13][14][15]. In the HEAT-PPCI trial, comparing bivalirudin and heparin, the ethics committee in the UK approved a delayed IC process [16].…”

Section: Introductionmentioning

confidence: 99%

Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial

Olsson

Ring²,

Josefsson

et al. 2020

Trials

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Objective: We aimed to assess the patient experience of informed consent (IC) during acute myocardial infarction (AMI) in a sub-study of the VALIDATE-SWEDEHEART trial. The original trial compared two anticoagulant agents in patients undergoing coronary intervention. A witnessed oral IC was required prior to randomization in patients with ST-segment elevation myocardial infarction, which was subsequently complemented with a written IC after percutaneous coronary intervention. Written consent was obtained before angiography in patients with non-STsegment elevation myocardial infarction.Background: The IC process in patients with AMI is under debate. Earlier trials in this population have required prospective consent before randomization. A trial published some years ago used deferred consent, but the patient experience of this process is poorly studied.Methods: A total of 414 patients who participated in the main trial were enrolled and asked the following questions: (1) Do you remember being asked to participate in a study? (2) How was your experience of being asked to participate; do you remember it being positive or negative? (3) Would you have liked more information about the study? (4) Do you think it would have been better if you were included in the study without being informed until a later time?Results: Of these patients, 94% remembered being included; 85% of them experienced this positively, 12% were neutral and 3% negative. Regarding more information, 88% did not want further information, and 68% expressed that they wanted to be consulted before inclusion. Of the patients, 5% thought it would have been better to have study inclusion without consent, and 27% considered it of no importance. Conclusion: It is reasonable to ask patients for verbal IC in the acute phase of AMI. Most patients felt positively about being asked to participate and had knowledge of being enrolled in a scientific study. In addition they objected to providing IC after randomization and treatment. Trial registration: VALIDATE-SWEDEHEART European Union Clinical Trials Register: 2012-005260-10. ClinicalTrials.gov: NCT02311231. Registered on 8 Dec 2014.

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“…While prior data suggest a general preference for consent across various types of trials in MI, future work examining the impact of study features on specific consent preferences would be useful. 15 Third, the response rate limits generalizability to some extent, but respondents were similar demographically to the general population. The experimental design also adds internal validity.…”

Section: Limitationsmentioning

confidence: 99%

“…6,14 Second, available data suggest patients generally prefer to be asked permission prior to research enrollment, even for acute conditions. 12–15 Third, surveys of the public have suggested a preference for prospective consent in pragmatic trials in less acute settings, even when treatment-related risks are low and treatments are similar. 16,17 Fourth, failure to obtain research consent could potentially undermine public trust.…”

Section: Introductionmentioning

confidence: 99%

Understanding preferences regarding consent for pragmatic trials in acute care

et al. 2018

Self Cite

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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.

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Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design

Cited by 9 publications

References 23 publications

Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)

Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement)

Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial

Understanding preferences regarding consent for pragmatic trials in acute care

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