Clinical research for life-threatening illnesses requiring emergency hospitalisation: a critical interpretive synthesis of qualitative data related to the experience of participants and their caregivers

Trials

Review

David S. Lawrence¹  Joseph N. Jarvis¹  Agnes Ssali²  Janet Seeley² 

[1]Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK

[2]Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana

[3]Social Aspects of Health Across the Life-Course Programme, MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda

[4]Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK

关键词: Informed consent;    Emergency;    Clinical trial;    Clinical research;    Decision-making;    Review;    Qualitative research;   

DOI  :  10.1186/s13063-023-07183-6

 received in 2022-09-15, accepted in 2023-02-17,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundResearch into life-threatening illnesses which require emergency hospitalisation is essential. This group of patients is unique in that they are experiencing an unfolding emergency when they are approached, enrolled, and followed up in a research study. We aimed to synthesise qualitative data from trial participants and surrogate decision-makers to deepen our understanding and inform the design and conduct of future clinical trials for life-threatening illnesses.MethodsWe conducted a critical interpretive synthesis of qualitative data from trial participants and surrogate decision-makers related to the experience of participating in a clinical research study when suffering from a life-threatening illness. A scoping review informed a systematic review of published data. We searched research databases and reviewed papers for inclusion. Primary data and interpretations of data were extracted from each paper. Data were analysed using reciprocal translational analysis, refutational synthesis, and lines of argument synthesis to develop a synthetic construct.ResultsTwenty-two papers were included. Most individuals had no previous knowledge or experience with clinical research. Individuals making decisions were directly experiencing or witness to an unfolding emergency which came with a myriad of physical and psychological symptoms. It was difficult to differentiate clinical research and routine care, and understanding of core concepts around research, particularly randomisation and equipoise, was limited. We found that this led to an underestimation of risk, an overestimation of benefit, and an expectation of being allocated to the intervention arm. The decision-making process was heavily influenced by trust in the research team. Individuals suggested that abbreviated information, presented in different ways and continuously throughout the research process, would have increased knowledge and satisfaction with the research process.ConclusionIndividuals suffering from a life-threatening illness who are being invited to participate in clinical research need to be managed in a way that adapts to the severity of their illness and there is a need to tailor research processes, including informed consent, accordingly. We provide suggestions for further research and implementation work around research participation for individuals suffering from a life-threatening illness.Trial registrationPROSPERO CRD42020207296

【 授权许可】

CC BY   
© The Author(s) 2023

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