R Dobra1, J S Elborn2, S Madge3, L Allen4, M Boeri5, F Kee2, S Goundry6, T Purcell3, C Saunders7, J C Davies8. 1. National Heart Lung Institute, Imperial College London, London, United Kingdom; Department of Paediatric Respiratory Medicine, Royal Brompton and Harefield Trust, London, United Kingdom. Electronic address: r.dobra@rbht.nhs.uk. 2. School of Medicine, Dentistry and Biomedical Sciences, Queen's University, Belfast, United Kingdom. 3. Department of Adult Cystic Fibrosis, Royal Brompton and Harefield Trust, London, United Kingdom. 4. Clinical Trials Accelerator Platform, Cystic Fibrosis Trust, United Kingdom. 5. RTI Health Solutions, Health Preference Assessment, Belfast, United Kingdom. 6. Queen Elizabeth Hospital, Birmingham, United Kingdom. 7. National Heart Lung Institute, Imperial College London, London, United Kingdom. 8. National Heart Lung Institute, Imperial College London, London, United Kingdom; Department of Paediatric Respiratory Medicine, Royal Brompton and Harefield Trust, London, United Kingdom.
Abstract
BACKGROUND: Making trials more patient-centred improves recruitment and retention, patient satisfaction and makes research accessible to a more representative population. We aimed to understand the factors that influence participation and engagement in clinical trials in cystic fibrosis (CF) trials to guide the rational design and delivery of patient-centred trials. METHODS: We used a Delphi process, supported by extensive literature review and 3 workshops, to determine which factors stakeholders think exert significant influence in participation and engagement in CF trials. Panellists were recruited from across the UK and the study was administered online. RESULTS: We had representation from 19 CF centres; 28 people with CF (pwCF), 26 parents and 30 healthcare professionals (HCPs). Panels were presented with a shortlist of 104 factors and asked which they thought influence participation and engagement in CF trials. After 3 iterations, 43 statements met consensus for pwCF, 48 for the parents and 69 for the HCPs. CONCLUSIONS: We identified many targets to make trials more patient-centred. Whilst some require an overhaul of trial delivery, many are relatively easy to implement. We outline a list of 'dos and don'ts' for sponsors and research teams including: focus on good communication; recognise that lack of time is the greatest barrier to trial participation so minimise the frequency and length of visits; help participants fit trials around busy lives; remember trial participation can be a major life-event and support participants accordingly; and don't underestimate the impact of simple strategies e.g. on-site access to Wifi and cups of tea.
BACKGROUND: Making trials more patient-centred improves recruitment and retention, patient satisfaction and makes research accessible to a more representative population. We aimed to understand the factors that influence participation and engagement in clinical trials in cystic fibrosis (CF) trials to guide the rational design and delivery of patient-centred trials. METHODS: We used a Delphi process, supported by extensive literature review and 3 workshops, to determine which factors stakeholders think exert significant influence in participation and engagement in CF trials. Panellists were recruited from across the UK and the study was administered online. RESULTS: We had representation from 19 CF centres; 28 people with CF (pwCF), 26 parents and 30 healthcare professionals (HCPs). Panels were presented with a shortlist of 104 factors and asked which they thought influence participation and engagement in CF trials. After 3 iterations, 43 statements met consensus for pwCF, 48 for the parents and 69 for the HCPs. CONCLUSIONS: We identified many targets to make trials more patient-centred. Whilst some require an overhaul of trial delivery, many are relatively easy to implement. We outline a list of 'dos and don'ts' for sponsors and research teams including: focus on good communication; recognise that lack of time is the greatest barrier to trial participation so minimise the frequency and length of visits; help participants fit trials around busy lives; remember trial participation can be a major life-event and support participants accordingly; and don't underestimate the impact of simple strategies e.g. on-site access to Wifi and cups of tea.
Authors: Rebecca Dobra; Siân Bentley; Claire Edmondson; Maxine Ovens; Clare Saunders; Christopher Short; Gemma Wilson; Jane C Davies; Andrew Bush Journal: Children (Basel) Date: 2022-07-20