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Determinants of Patient and Surrogate Experiences With Acute Care Research Consent: A Key Informant Interview Study.

Abstract：

:Background Informed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data are crucial to making consent processes more context appropriate. Methods and Results We conducted a qualitative interview study with 27 patients and surrogates enrolled in acute myocardial infarction and stroke trials in the past 5 years. Purposive sampling from the P-CARE (Patient-Centered Approaches to Research Enrollment) study was based on participant characteristics and responses to initial patient-centered interviews. In-depth interviews used open-ended questions to explore factors influencing consent experiences. Qualitative descriptive analysis was performed utilizing a multilevel coding strategy. Participants identified specific researcher behaviors as important, including expressions of respect, professionalism, and nonpressuring communication. Participants preferred consent conversations focused on risks/benefits and the trial protocol. They had varying views of consent forms and communicated several reasons the form was valuable unrelated to informational content. Participants also valued postenrollment interactions as opportunities to ask questions and learn about the study. Conclusions Barriers to consent in acute myocardial infarction and stroke trials are unavoidable, but participants identified productive ways to demonstrate respect for patients during enrollment conversations. These include key researcher behaviors, concentrating consent discussions on what participants find most important, and structured postenrollment follow-up.

journal_name

J Am Heart Assoc

journal_title

Journal of the American Heart Association

authors

Scicluna VM,Goldkind SF,Mitchell AR,Pentz RD,Speight CD,Silbergleit R,Dickert NW

doi

10.1161/JAHA.119.012599

subject

Has Abstract

pub_date

2019-11-19 00:00:00

pages

e012599

issue

issn

2047-9980

journal_volume

pub_type

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Determinants of Patient and Surrogate Experiences With Acute Care Research Consent: A Key Informant Interview Study.