Clinical Translation and Implementation of a Bioartificial Pancreas Therapy: A Qualitative Study Exploring the Perspectives of People With Type 1 Diabetes

Autor: Dide de Jongh, MSc, Silke Lapré, BSc, Behiye Özcan, MD, PhD, Robert Zietse, MD, PhD, Eline M. Bunnik, PhD, Emma K. Massey, PhD, the VANGUARD consortium, Ekaterine Berishvili, Laura Mar Fonseca, Fanny Lebreton, Kevin Bellofatto, Juliette Bignard, Jochen Seissler, Leila Wolf-van Buerck, Mohsen Honarpisheh, Yichen Zhang, Yutian Lei, Monika Pehl, Antonia Follenzi, Christina Olgasi, Alessia Cucci, Chiara Borsotti, Simone Assanelli, Lorenzo Piemonti, Antonio Citro, Silvia Pellegrini, Cataldo Pignatelli, Francesco Campo, Olivier Thaunat, Morgane Fouché, Devi Mey, Chiara Parisotto, Giovanna Rossi, Patrick Kugelmeier, Markus Mühlemann, Karolina Pal-Kutas, Marco Cavallaro, Julia Götz, Jeanette Müller
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Transplantation Direct, Vol 10, Iss 10, p e1711 (2024)
Druh dokumentu: article
ISSN: 2373-8731
00000000
DOI: 10.1097/TXD.0000000000001711
Popis: Background. The development of a hybrid beta-cell replacement approach, referred to as a personalized, transplantable bioartificial pancreas (BAP), holds promise to treat type 1 diabetes (T1D). This interview study aimed to explore patients’ expectations, needs, concerns, and considerations when considering to undergo a BAP transplantation. Research Design and Methods. Semistructured interviews were conducted with 24 participants diagnosed with T1D. Data collection stopped once data saturation was reached. Audio recordings of the interviews were transcribed verbatim. The interviews were independently analyzed by 2 researchers. A qualitative content analysis using an inductive approach was used. Results. Three main themes emerged as follow: (1) hoped-for benefits, (2) concerns and decision-making considerations, and (3) procedural aspects. First, the participants expected benefits across medical, psychological, and social domains. Over these 3 domains, 9 subthemes were identified, including improved clinical outcomes, a cure for diabetes, more headspace, emotional relief, a shift in responsibility, protection of privacy, improved flexibility in daily life, less visible diseases, and improved relationships with others. Second, concerns and considerations about undergoing a BAP transplant comprised adverse events, the functionality of the BAP, the surgery procedure, the biological materials used, the transplant location, and the intrusiveness associated with follow-up care. Finally, procedural considerations included equitable access, patient prioritization, and trust and control. Conclusions. Incorporating insights from this study into the clinical development and implementation of the BAP is crucial to ensure alignment of the product and procedures with the needs and expectations of people with T1D.
Databáze: Directory of Open Access Journals