Exploring factors for meaningful patient involvement in infectious disease clinical studies: A qualitative pilot study among key stakeholders

Abstract

AbstractIntroductionThe attitude towards patient involvement in clinical research has changed dramatically over the years, from research about patient to research with patients. This qualitative study aimed to explore perceptions, ideas, and opinions of stakeholders about integrating the patient perspective into clinical research in infectious diseases in the Netherlands.MethodsStakeholders involved with clinical research in infectious diseases were purposefully sampled between March and June 2023. Interviews were conducted using a semi-structured guide based on the Consolidated Framework for Intervention Research and feasibility framework.ResultsOf the thirteen stakeholders, six were (clinical) researchers, two represented pharmaceutical companies, two were involved with policy making, and three were patient representatives. Patient involvement in the design and conduct of clinical research in infectious diseases was seen as crucial, although the mode of involvement could differ between research in acute and chronic infections. Stakeholders observed a gap among patients and clinical researchers, which was believed to lead to a phenomenon described as an ivory tower. Key opinion leaders may potentially bridge these barriers and serve as protagonists for meaningful patient involvement. Stakeholders acknowledged the need of communication and expertise to integrate the patient perspective in clinical research in infectious diseases.ConclusionOur qualitative analysis underlines that despite barriers, such as communication and expertise, stakeholders recognize the importance of integrating the patient perspective in clinical research in infectious diseases to improve the quality, relevance, recruitment, and dissemination. Further research is needed to address distinctions between acute and chronic infectious diseases in terms of patient involvement.