Pollock, KG;
Dickerson, C;
Kainth, M;
Lawton, S;
Hurst, M;
Sugrue, DM;
Arden, C;
Davies, DW;
Martin, A-C;
Sandler, B;
et al.
Pollock, KG; Dickerson, C; Kainth, M; Lawton, S; Hurst, M; Sugrue, DM; Arden, C; Davies, DW; Martin, A-C; Sandler, B; Gordon, J; Farooqui, U; Clifton, D; Mallen, C; Rogers, J; Hill, NR; Camm, AJ; Cohen, AT
(2024)
Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers.
BMC Prim Care, 25 (1).
p. 7.
ISSN 2731-4553
https://doi.org/10.1186/s12875-023-02246-8
SGUL Authors: Camm, Alan John
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Abstract
BACKGROUND: Conducting effective and translational research can be challenging and few trials undertake formal reflection exercises and disseminate learnings from them. Following completion of our multicentre randomised controlled trial, which was impacted by the COVID-19 pandemic, we sought to reflect on our experiences and share our thoughts on challenges, lessons learned, and recommendations for researchers undertaking or considering research in primary care. METHODS: Researchers involved in the Prediction of Undiagnosed atriaL fibrillation using a machinE learning AlgorIthm (PULsE-AI) trial, conducted in England from June 2019 to February 2021 were invited to participate in a qualitative reflection exercise. Members of the Trial Steering Committee (TSC) were invited to attend a semi-structured focus group session, Principal Investigators and their research teams at practices involved in the trial were invited to participate in a semi-structured interview. Following transcription, reflexive thematic analysis was undertaken based on pre-specified themes of recruitment, challenges, lessons learned, and recommendations that formed the structure of the focus group/interview sessions, whilst also allowing the exploration of new themes that emerged from the data. RESULTS: Eight of 14 members of the TSC, and one of six practices involved in the trial participated in the reflection exercise. Recruitment was highlighted as a major challenge encountered by trial researchers, even prior to disruption due to the COVID-19 pandemic. Researchers also commented on themes such as the need to consider incentivisation, and challenges associated with using technology in trials, especially in older age groups. CONCLUSIONS: Undertaking a formal reflection exercise following the completion of the PULsE-AI trial enabled us to review experiences encountered whilst undertaking a prospective randomised trial in primary care. In sharing our learnings, we hope to support other clinicians undertaking research in primary care to ensure that future trials are of optimal value for furthering knowledge, streamlining pathways, and benefitting patients.
Item Type: | Article | ||||||
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Additional Information: | © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | ||||||
Keywords: | Primary care, Qualitative research, Randomised controlled trial, Recruitment, Reflection exercise, Humans, Aged, Pandemics, Prospective Studies, COVID-19, Primary Health Care, Artificial Intelligence, Randomized Controlled Trials as Topic, Humans, Prospective Studies, Artificial Intelligence, Aged, Primary Health Care, Randomized Controlled Trials as Topic, Pandemics, COVID-19, Qualitative research, Reflection exercise, Randomised controlled trial, Primary care, Recruitment | ||||||
SGUL Research Institute / Research Centre: | Academic Structure > Molecular and Clinical Sciences Research Institute (MCS) | ||||||
Journal or Publication Title: | BMC Prim Care | ||||||
ISSN: | 2731-4553 | ||||||
Language: | eng | ||||||
Dates: |
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Publisher License: | Creative Commons: Attribution 4.0 | ||||||
PubMed ID: | 38166641 | ||||||
Web of Science ID: | WOS:001135218200008 | ||||||
Go to PubMed abstract | |||||||
URI: | https://openaccess.sgul.ac.uk/id/eprint/116061 | ||||||
Publisher's version: | https://doi.org/10.1186/s12875-023-02246-8 |
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