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

Abstract

BackgroundInformed 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 ResultsWe 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.ConclusionsBarriers 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.

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

“…Informed consent is a mechanism for patients to exercise autonomy in trial enrollment, but patients and their surrogates also derive value from informed consent discussions. (35,36) As such, the manner of patient participation is intrinsically an ethical factor in trials without straightforward informed consent processes, such as trials of acute stroke or other emergency treatments. Investigators surveyed from the AbESTT II trial indicated that obtaining informed consent produces unnecessary delays, but simultaneously felt an exemption for informed consent was inappropriate.…”

“…(47) To address this issue, patient assent can be required in addition to proxy consent, which was performed in some of the trials in this study. (35) Although surrogate decision makers must make difficult choices, the research team should still involve the patient to their fullest extent by attempting to gain assent when patient capacity is determined to be lacking.…”

“…(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. (17)…”

“…(47) To address this issue, patient assent can be required in addition to proxy consent, which was performed in some of the trials in this study. (35) Although surrogate All rights reserved. No reuse allowed without permission.…”

Exploring the Delay in the Informed Consent Procedures of Patients with ST-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention: Is It Worth the Wait?

“…5,16 Although there are researches that investigated the process of informed consent, the majority of them qualitatively explored the approaches to improving it, [17][18][19][20] and other qualitative research examined informed consent obtaining during a clinical trial instead of surgery. 21,22 Furthermore, to our knowledge, in countries like China where it is strictly required to obtain consent prior to emergent surgery, there are scant studies conducted to probe causes of delay in the informed consent obtaining and associated in-hospital mortality.…”