Challenges in Recruiting Patients for Mental Health Trials
Author Information
Author(s): Howard Louise, de Salis Isabel, Tomlin Zelda, Thornicroft Graham, Donovan Jenny
Primary Institution: King's College London
Hypothesis
What are the reasons for under-recruitment in an RCT of patients with severe mental illness?
Conclusion
Recruitment difficulties in trials involving patients with severe mental illness stem from general trial issues and specific misconceptions related to this patient group.
Supporting Evidence
- Care coordinators had misconceptions about randomised controlled trials.
- Clinicians expressed a lack of equipoise regarding the trial arms.
- Patients often confused the trial with routine care, leading to therapeutic misconception.
- Eligibility criteria were interpreted differently by various care coordinators.
- Clinicians exhibited paternalism, prioritizing their perceptions of patient needs over informed consent.
Takeaway
It's hard to get people with severe mental illness to join research studies because they and their doctors often misunderstand how the studies work.
Methodology
Qualitative study involving interviews with trial staff and clinicians to identify recruitment barriers.
Potential Biases
Potential recall bias and the influence of clinicians' personal beliefs on patient eligibility.
Limitations
The study is based on a small sample of interviewees and may not represent all recruitment challenges.
Participant Demographics
Patients with severe mental illness, aged 18-65, with psychotic or chronic affective disorders for over 2 years.
Digital Object Identifier (DOI)
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