Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers
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...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | BMC Primary Care |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12875-023-02246-8 |
| _version_ | 1797362985743679488 |
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| author | Kevin G. Pollock Carissa Dickerson Manjit Kainth Sarah Lawton Michael Hurst Daniel M. Sugrue Chris Arden D. Wyn Davies Anne-Céline Martin Belinda Sandler Jason Gordon Usman Farooqui David Clifton Christian Mallen Jennifer Rogers Nathan R. Hill A. John Camm Alexander T. Cohen |
| author_facet | Kevin G. Pollock Carissa Dickerson Manjit Kainth Sarah Lawton Michael Hurst Daniel M. Sugrue Chris Arden D. Wyn Davies Anne-Céline Martin Belinda Sandler Jason Gordon Usman Farooqui David Clifton Christian Mallen Jennifer Rogers Nathan R. Hill A. John Camm Alexander T. Cohen |
| author_sort | Kevin G. Pollock |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T16:15:03Z |
| format | Article |
| id | doaj.art-27c52a2dc0a040fbb3abfb3cdcb472c8 |
| institution | Directory Open Access Journal |
| issn | 2731-4553 |
| language | English |
| last_indexed | 2024-03-08T16:15:03Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Primary Care |
| spelling | doaj.art-27c52a2dc0a040fbb3abfb3cdcb472c82024-01-07T12:37:41ZengBMCBMC Primary Care2731-45532024-01-0125111110.1186/s12875-023-02246-8Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchersKevin G. Pollock0Carissa Dickerson1Manjit Kainth2Sarah Lawton3Michael Hurst4Daniel M. Sugrue5Chris Arden6D. Wyn Davies7Anne-Céline Martin8Belinda Sandler9Jason Gordon10Usman Farooqui11David Clifton12Christian Mallen13Jennifer Rogers14Nathan R. Hill15A. John Camm16Alexander T. Cohen17Bristol Myers Squibb Pharmaceutical LtdHealth Economics and Outcomes Research LtdPrimrose Lane Health CentreSchool of Medicine, Keele UniversityBristol Myers Squibb Pharmaceutical LtdHealth Economics and Outcomes Research LtdUniversity Hospital SouthamptonLondon Heart PracticeService de Cardiologie, Université de Paris, Innovative Therapies in Haemostasis, INSERM, Hôpital Européen Georges PompidouBristol Myers Squibb Pharmaceutical LtdHealth Economics and Outcomes Research LtdBristol Myers Squibb Pharmaceutical LtdInstitute of Biomedical Engineering, Department of Engineering Science, University of OxfordSchool of Medicine, Keele UniversityPHASTARBristol Myers Squibb Pharmaceutical LtdCardiology Clinical Academic Group, Molecular & Clinical Sciences Research Institute, St. George’s University of LondonDepartment of Haematological Medicine, Guys and St Thomas’ NHS Foundation Trust, King’s College LondonAbstract 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.https://doi.org/10.1186/s12875-023-02246-8Qualitative researchReflection exerciseRandomised controlled trialPrimary careRecruitment |
| spellingShingle | Kevin G. Pollock Carissa Dickerson Manjit Kainth Sarah Lawton Michael Hurst Daniel M. Sugrue Chris Arden D. Wyn Davies Anne-Céline Martin Belinda Sandler Jason Gordon Usman Farooqui David Clifton Christian Mallen Jennifer Rogers Nathan R. Hill A. John Camm Alexander T. Cohen Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers BMC Primary Care Qualitative research Reflection exercise Randomised controlled trial Primary care Recruitment |
| title | Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers |
| title_full | Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers |
| title_fullStr | Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers |
| title_full_unstemmed | Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers |
| title_short | Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers |
| title_sort | undertaking multi centre randomised controlled trials in primary care learnings and recommendations from the pulse ai trial researchers |
| topic | Qualitative research Reflection exercise Randomised controlled trial Primary care Recruitment |
| url | https://doi.org/10.1186/s12875-023-02246-8 |
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