Abstract 224: Why Do Patients Decline to Participate in Heart Failure Trials?

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Abstract

Background: Randomized controlled trials (RCTs) remain the gold standard in establishing clinical efficacy. However, low patient enrollment escalates costs of conducting trials and selective enrollment leads to under-representation of the real-world population. Limited data exists on why patients decline participation in RCTs and what factors may lead to increased participation rates.

Methods: In-person and telephone interviews were conducted with 20 patients with congestive heart failure who declined participation in a RCT using a semi-structured interview guide. Questions assessed comprehension of the trial they were approached for, perceived risks and benefits, perception about the recruiter, rationale behind declining participation, and suggestions to improve participation. Qualitative descriptive analysis was conducted of transcribed responses.

Results: Participants’ median age was 63 years (IQR 51.5-69), 50% were female, and 60% were African-American. Only 6 participants could accurately describe the intervention and understood design of the trial in which they were asked to participate. Majority of the participants (n=15) had a positive view of the recruiter who approached them. Most participants made the decision to not participate quickly while only 2 participants took extended time to deliberate. The most common reasons for not participating was due to concern for adverse events from the intervention being studied (n=15) and because participation was thought to be too burdensome (n=10). Other reasons for not participating included mistrust of research staff (n=3), concern for receiving inadequate treatment (n=3) and lack of involvement or consultation with the patient’s physician (n=3). The most common suggestion provided to increase participant recruitment was involving primary care physicians or cardiologists known to the patients. Overall, 5 decliners reported previously participating in research studies stating prior participation was less burdensome (n=2), they were previously approached by physicians known to them (n=2) or their health was better and participation seemed less risky (n=1).

Conclusion: Slow participant enrollment in clinical trials threatens our ability to produce timely data necessary to guide clinical practice, while increasing cost of conducting them. The most common suggestion to improve participation made by patients who declined enrollment in a clinical trial was engaging physicians known to the patient in the process of recruitment while making participation less burdensome. Accordingly, educating potential participants regarding clinical trials, clarifying study risks and benefits with incorporation of design features that reduce burden such as frequency of invasive testing and follow-up visits can help increase participation rates.

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