Exploring patients’ and public perspectives on an oral capsule for gastric submucosal delivery in Denmark and the USA: a mixed-methods study protocol
Caroline Buhl, Lourdes Cantarero-Arévalo, Jesús Sánchez, Silvia E Rabionet, Lene Havsteen, Karsten Lindhardt, Anna Birna AlmarsdóttirIntroduction
Oral capsules for gastric submucosal delivery represent a fundamentally new route of administration for biologics, which are currently limited to injection. Involving patients and members of the public to understand their perspectives on this novel pharmaceutical form, distinct from both injections and traditional oral tablets, is essential for the clinical development, regulatory approval, adoption and acceptability. This study aims to identify perceived benefits, concerns and communication preferences regarding oral capsules for gastric submucosal delivery, using BIONDD as a case study, to initially document the elements of the perceived value proposition and potential reservations about the oral delivery system from the patient and public perspectives.
Methods and analysis
This two-country exploratory sequential mixed-methods study will be conducted in Denmark and the USA. First, focus group interviews with purposively sampled patients and members of the public will explore attitudes towards oral capsules for gastric submucosal delivery. Qualitative data will be analysed using thematic analysis, combining manual and artificial intelligence-assisted coding. Insights from the focus groups will inform the development of a structured questionnaire, which will subsequently be distributed to a broader sample in both countries. Survey data will be analysed descriptively, and where possible, exploratory comparisons between country samples will be made. Main outcomes will include perceived benefits, concerns, acceptability and preferred terminology for discussing this novel pharmaceutical form.
Ethics and dissemination
The study has been approved by the relevant ethics committees at the University of Copenhagen and Nova Southeastern University. All data will be managed confidentially in line with General Data Protection Regulation and local regulations. Informed consent will be obtained in accordance with site-specific ethical procedures, and withdrawal will be possible up to a defined stage of data processing, after which data cannot be linked to individual participants. Results will be disseminated in peer-reviewed journals, at conferences and on institutional websites, in accordance with established ethical research and authorship guidelines.