Patients acceptance and comprehension to written and verbal consent (PAC–VC)

BMC Medical Ethics

Research Article

Shane Kimber¹  Justin Ezekowitz¹  Robert C. Welsh¹  Rabia Kashur¹ 

[1] Division of Cardiology, University of Alberta and Mazankowski Alberta Heart Institute, 2C2 WMC, 8440 – 112 Street NW, T6G 2B7, Edmonton, AB, Canada;

关键词: Informed consent;    Acute myocardial infarction;    Verbal assent;    Written consent;    Clinical trials;   

DOI  :  10.1186/s12910-023-00893-1

 received in 2021-02-17, accepted in 2023-02-16,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAcute myocardial infarction (AMI) research is challenging as it requires enrollment of acutely ill patients. Patients are generally in a suboptimal state for providing informed consent. Patients’ understanding to verbal assents have not been previously examined in AMI research. Patients Acceptance and Comprehension to Written and Verbal Consent (PAC–VC) compared patients’ understanding and attitudes to verbal and written consents in AMI RCTs.MethodsPAC–VC recruited patients from 3 AMI trials using both verbal N = 12 and written N = 6 consents. We compared patients’ understanding using two survey questionnaires. The first questionnaire used open-ended questions with multiple choice answers. The second questionnaire used a 5-point Likert scale to measure patients understanding and attitudes to the consent process. Overall answers average scores were categorized into three groups: Adequate understanding (71–100) %, Partial understanding (41–70)% and Inadequate understanding (0–40)%.ResultsResponses showed patients with verbal assent had adequate understanding to most components of informed consent, close to those of written consent. Most patients did not read written information entirely and believed that it is not important to make a final decision. Patients favoured to have written information be part of the consent but not necessarily presented during the initial consent process. Patients felt less pressured in the verbal assent arm than those of written consent.ConclusionPatients had adequate understanding to most components of verbal assent and comparable to those of written consent. Utilizing verbal assents in the acute care setting should be further assessed in larger trials.

【 授权许可】

CC BY   
© The Author(s) 2023

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