Evidence map›Paper›PMID 38166641›Full record

ArticleBMC primary care2024

Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers.

Kevin G Pollock, Carissa Dickerson, Manjit Kainth, Sarah Lawton, Michael Hurst, Daniel M Sugrue, Chris Arden, D Wyn Davies, Anne-Céline Martin, Belinda Sandler and 8 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in BMC primary care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 53% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 2 countries.

Kevin G PollockBristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK.
Carissa DickersonHealth Economics and Outcomes Research Ltd, Cardiff, UK.
Manjit KainthPrimrose Lane Health Centre, Wolverhampton, UK.
Sarah LawtonSchool of Medicine, Keele University, Staffordshire, UK.
Michael HurstBristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK.
Daniel M SugrueHealth Economics and Outcomes Research Ltd, Cardiff, UK.
Chris ArdenUniversity Hospital Southampton, Southampton, UK.
D Wyn DaviesLondon Heart Practice, London, UK.
Anne-Céline MartinService de Cardiologie, Université de Paris, Innovative Therapies in Haemostasis, INSERM, Hôpital Européen Georges Pompidou, 20 rue Leblanc, Paris, France.
Belinda SandlerBristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK.
Jason GordonHealth Economics and Outcomes Research Ltd, Cardiff, UK. jason.gordon@heor.co.uk.
Usman FarooquiBristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK.
David CliftonInstitute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK.
Christian MallenSchool of Medicine, Keele University, Staffordshire, UK.
Jennifer RogersPHASTAR, London, UK.
Nathan R HillBristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK.
A John CammCardiology Clinical Academic Group, Molecular & Clinical Sciences Research Institute, St. George's University of London, London, UK.
Alexander T CohenDepartment of Haematological Medicine, Guys and St Thomas' NHS Foundation Trust, King's College London, London, UK.
Bristol-Myers Squibb (United Kingdom) · GBHealth Economics and Outcomes Research (United Kingdom) · GBKeele University · GBKing's College London · GBSt George's, University of London · GBUniversité Paris Cité · FRUniversity Hospital Southampton NHS Foundation Trust · GBUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConducting 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.

methodsResearchers 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.

resultsEight 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.

conclusionsUndertaking 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.

Indexed as

COVID-19PandemicsAgedArtificial IntelligenceHumansPrimary Health CareProspective StudiesRandomized Controlled Trials as TopicPrimary careQualitative researchRandomised controlled trialRecruitmentReflection exercise

Identifiers

PMID38166641
PMCPMC10759575
OpenAlexW4390493043

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.