Louise Locock1, Lorraine Smith. 1. Department of Primary Health Care, University of Oxford, UK. Louise.locock@phc.ox.ac.uk
Abstract
OBJECTIVE: To investigate people's experiences of and attitudes to participation in clinical trials. METHODS: 42 in-depth qualitative interviews, covering different types of trial and intervention, analysed thematically using a modified grounded theory approach. RESULTS: Many participants argued for a right to participate in research. This may be partly because personal benefit was a common primary motivation for taking part - but the benefits cited were not only personal health outcomes. Whilst most were satisfied with information received, some felt it was too complex. Gaps in understanding were evident, especially around randomisation, but trust in trial staff was high. Desire for feedback of trial results was common. CONCLUSION: Unintended consequences may arise from efforts to give full information and challenge therapeutic misconceptions. People wanted 'enough' information to help them decide, but their definition of 'enough', and the relative importance of written information versus discussion/advice from trusted professionals, varied by individual. In seeking to minimise misunderstanding we stress uncertainty and risk but have perhaps lost sight of the value people derive from trial participation. PRACTICE IMPLICATIONS: Better information on trial availability, shorter trial leaflets and greater emphasis on face-to-face discussion are suggested. Recruitment literature could appeal to a wider range of benefits.
OBJECTIVE: To investigate people's experiences of and attitudes to participation in clinical trials. METHODS: 42 in-depth qualitative interviews, covering different types of trial and intervention, analysed thematically using a modified grounded theory approach. RESULTS: Many participants argued for a right to participate in research. This may be partly because personal benefit was a common primary motivation for taking part - but the benefits cited were not only personal health outcomes. Whilst most were satisfied with information received, some felt it was too complex. Gaps in understanding were evident, especially around randomisation, but trust in trial staff was high. Desire for feedback of trial results was common. CONCLUSION: Unintended consequences may arise from efforts to give full information and challenge therapeutic misconceptions. People wanted 'enough' information to help them decide, but their definition of 'enough', and the relative importance of written information versus discussion/advice from trusted professionals, varied by individual. In seeking to minimise misunderstanding we stress uncertainty and risk but have perhaps lost sight of the value people derive from trial participation. PRACTICE IMPLICATIONS: Better information on trial availability, shorter trial leaflets and greater emphasis on face-to-face discussion are suggested. Recruitment literature could appeal to a wider range of benefits.
Authors: Adam Gilbertson; Elizabeth Poole Kelly; Stuart Rennie; Gail Henderson; JoAnn Kuruc; Joseph D Tucker Journal: AIDS Res Hum Retroviruses Date: 2018-08-22 Impact factor: 2.205