Challenges to and Facilitators of Recruitment to an Alzheimer's Disease Clinical Trial: A Qualitative Interview Study

阿尔茨海默病临床试验招募的挑战与促进因素:一项定性访谈研究

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Abstract

BACKGROUND: Low participation in clinical trials is a major challenge to advancing clinical Alzheimer's disease (AD) research and care. Factors influencing recruitment to AD trials are not fully understood. OBJECTIVE: To identify barriers to, and facilitators of, recruitment in a UK multi-center, secondary care AD trial (Reducing pathology in Alzheimer's Disease through Angiotensin TaRgeting (RADAR) trial) and implications for improving recruitment to AD trials. METHODS: Semi-structured qualitative telephone interviews with a purposive sample of 17 trial site staff explored the RADAR trial recruitment pathway and views and experiences of recruitment. Interviews were analyzed thematically. RESULTS: Diagnostic and care pathways hindered identifying patients with mild-moderate AD, with a lack of up-to-date patient records and data access problems affecting screening. Research is not routinely embedded in AD care but facilitated recruitment when it was. Clinicians' and patients' favorable view of the trial purpose facilitated recruitment, although the complexity of participant information sheets and requirement for study companion created challenges. CONCLUSION: These findings have important implications for the design of future AD trials and for planning how to best interface with clinical commitments to ensure sufficient and timely recruitment. Challenges to AD trial recruitment can occur at care pathway, clinician, and patient and companion levels. Recruitment can be facilitated by: improving diagnostic processes and systems for recording and sharing patient information, embedding research into routine patient care, collaborating with a range of services to identify and approach eligible patients, training and engaging trial staff, and providing patients with clear and concise study information.

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