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Improving patient engagement in clinical trials: Launching the BOAT trial with key stakeholders
Henil Upadhyay1, Anna Robinson-Barella2, Andrew Husband3
1School of Pharmacy, Newcastle University, United Kingdom; Adult Bronchiectasis Service, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom.
Abstract:
Non-cystic fibrosis bronchiectasis is a chronic inflammatory disease associated with recurrent exacerbations and reduced quality of life. The Bronchiectasis: Optimising Azithromycin prevention Treatment (BOAT) trial is a double-blind, randomised, non-inferiority trial to compare the clinical effectiveness of complete discontinuation of azithromycin prophylaxis vs continuous azithromycin prophylaxis as a standard of care. A Study Within A Trial (SWAT) was developed for the BOAT trial to assess the use of video animations as a recruitment tool, guided by active Patient and Public Involvement and Engagement (PPIE). Focus groups and interviews were held with bronchiectasis patients, which informed the development, design, and translation of the trial animation. Early involvement of PPIE groups led to marked improvement in our patient-facing materials. When developing a trial video, researchers should consider factors such as the format, ease of download, compatibility across different devices, and the inclusion of links to clinical trial host websites, ensuring that sites with varying firewalls and security protocols can use the videos in ways best suited to their existing infrastructure. PPIE contributions ensured the appropriateness and acceptability of our trial design and patient-facing documents.
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