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• W4242106227 abstract "Abstract Background Recruitment and retention in clinical trials remains an important challenge, particularly in the context of advanced illness. It is important to understand what affects retention to improve trial quality, minimise attrition and reduce missing data. Person centred care (PCC) has been shown to improve patient outcomes in advanced disease or complex needs. Therefore, we considered whether the same principles could be applied to clinical trials. This study aimed to explore what influenced participants to take part and remain in a feasibility trial of mirtazapine for chronic breathlessness. Methods Qualitative study embedded within a double blind randomised trial. Participants with cancer, Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), or Chronic Heart Failure (CHF), with a Modified Medical Research Council Dyspnoea Scale grade 3/4 were recruited from three UK sites. A purposive subsample completed qualitative interviews after the trial. Interviews were analysed using thematic analysis. Results were interpreted in relation to the core elements of PCC. Results 22 participants were interviewed. 11 had a diagnosis of COPD, 8 ILD, 2 CHF, and 1 lung cancer. Median age was 71 years (56-84). 16 were male. 20 had completed the trial, 2 withdrew due to adverse effects. Three main themes were identified as important for recruitment and retention; the relationship between patient and professional, the context, and potential benefit to self and others. Within ‘relationships’ the personal attributes of the researcher, and continuity of research team were identified as particularly important when considering why people remained in the trial. We interpreted results in relation to PCC and developed a model of the person centred trial. Conclusions We propose that a PCC approach can improve recruitment and retention in clinical trials. The importance of the relationship between the patient and professional, and continuity within the research team has implications for future funding of clinical trials, the focus of which is often based on monthly recruitment targets and not on retention. Future work should aim to evaluate this model across other settings and in countries outside of the United Kingdom. Trial registration Registry name: ISRCTN Registration number: ISRCTN32236160 Date of registration: 13/06/2016" @default.
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• W4242106227 date "2019-06-27" @default.
• W4242106227 modified "2023-09-27" @default.
• W4242106227 title "Applying person-centred care to support trial recruitment and retention in a randomised trial for patients with refractory breathlessness and advanced disease: a qualitative study." @default.
• W4242106227 doi "https://doi.org/10.21203/rs.2.10706/v1" @default.
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