Evidence map›Paper›PMID 36931669›Full record

ReviewBMJ open2023

Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar.

Chris Farmer, Ellie Santer, Alan West, John Darby, Melanie Rees-Roberts, Timothy Doulton, Douglas MacInnes, Jamie O'Driscoll, Rachel Borthwick, Tracy Pellatt-Higgins and 4 more

Open access · goldFull text readReview
In one paragraph

Review in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
6.4field-weighted citation impact, top 4% 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

4 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
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

14 authors at 6 institutions in 3 countries.

Chris FarmerCentre for Health Services Studies, University of Kent, Canterbury, UK.
Ellie SanterCentre for Health Services Studies, University of Kent, Canterbury, UK.
Alan WestPublic Co-applicant, Canterbury, UK.
John DarbyPublic Co-applicant, Canterbury, UK.
Melanie Rees-RobertsCentre for Health Services Studies, University of Kent, Canterbury, UK.
Timothy DoultonRenal Department, East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.
Douglas MacInnesFaculty of Health and Wellbeing, Canterbury Christ Church University, Canterbury, UK.ORCID 0000-0002-3723-7859
Jamie O'DriscollSport, Exercise and Rehabilitation Sciences, Canterbury Christ Church University, Canterbury, UK.
Rachel BorthwickCentre for Health Services Studies, University of Kent, Canterbury, UK.
Tracy Pellatt-HigginsCentre for Health Services Studies, University of Kent, Canterbury, UK.
Katerina GousiaCentre for Health Services Studies, University of Kent, Canterbury, UK.
Vanessa ShortNewton Place Surgery, Faversham, UK.
Pauline A SwiftResearch and Development, Epsom and St Helier University Hospitals NHS Trust, London, UK.
Jonathan WilesSport, Exercise and Rehabilitation Sciences, Canterbury Christ Church University, Canterbury, UK jim.wiles@canterbury.ac.uk.ORCID 0000-0002-7790-8063
University of Kent · GBCanterbury Christ Church University · GBCanterbury Archaeological Trust · GBCentro Universitário Newton Paiva · BREast Kent Hospitals University NHS Foundation Trust · GBEpsom and St Helier University Hospitals NHS Trust · GB

Funding

Department of Health NIHR200485
6 · The paper itself

Abstract

The COVID-19 pandemic has significantly impacted on the delivery of clinical trials in the UK, posing complicated organisational challenges and requiring adaptations, especially to exercise intervention studies based in the community. We aim to identify the challenges of public involvement, recruitment, consent, follow-up, intervention and the healthcare professional delivery aspects of a feasibility study of exercise in hypertensive primary care patients during the COVID-19 pandemic. While these challenges elicited many reactive changes which were specific to, and only relevant in the context of 'lockdown' requirements, some of the protocol developments that came about during this unprecedented period have great potential to inform more permanent practices for carrying out this type of research. To this end, we detail the necessary adaptations to many elements of the feasibility study and critically reflect on our approach to redesigning and amending this ongoing project in order to maintain its viability to date. Some of the more major protocol adaptations, such as moving the study to remote means wherever possible, had further unforeseen and undesirable outcomes (eg, additional appointments) with regards to extra resources required to deliver the study. However, other changes improved the efficiency of the study, such as the remote informed consent and the direct advertising with prescreening survey. The adaptations to the study have clear links to the UK Plan for the future of research delivery. It is intended that this specific documentation and critical evaluation will help those planning or delivering similar studies to do so in a more resource efficient and effective way. In conclusion, it is essential to reflect and respond with protocol changes in the current climate in order to deliver clinical research successfully, as in the case of this particular study.

Indexed as

COVID-19HypertensionExerciseFeasibility StudiesHumansPandemicsSARS-CoV-2Clinical trialsHypertensionSPORTS MEDICINE

Identifiers

PMID36931669
PMCPMC10030278
OpenAlexW4327811884

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read6
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.