Evidence map›Paper›PMID 34895305›Full record

ArticleTrials2021

A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond.

Jane A H Masoli, Kim Down, Gary Nestor, Sharon Hudson, John T O'Brien, James D Williamson, Carolyn A Young, Camille Carroll, NIHR Remote Trial Delivery Working Group

Open access · goldAbstract readLetter
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.7field-weighted citation impact, top 10% 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

17 citing papers in PubMed, 20 citations in OpenAlex.

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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

9 authors at 7 institutions in 1 country.

Jane A H MasoliRoyal Devon and Exeter NHS Foundation Trust, Exeter, UK. j.masoli@exeter.ac.uk.ORCID http://orcid.org/0000-0003-3794-7065
Kim DownNIHR Clinical Research Network Cluster E, Campus for Ageing and Vitality, Newcastle University, Newcastle, UK.
Gary NestorNIHR Clinical Research Network Cluster E, Campus for Ageing and Vitality, Newcastle University, Newcastle, UK.
Sharon HudsonCornwall Partnership NHS Foundation Trust, Bodmin, UK.
John T O'BrienDepartment of Psychiatry, University of Cambridge School of Clinical Medicine, Cambridge, UK.
James D WilliamsonNational Institute for Health Research, Leeds, UK.
Carolyn A YoungWalton Centre NHS Foundation Trust, Liverpool, UK.
Camille CarrollUniversity of Plymouth, Plymouth, UK.
NIHR Remote Trial Delivery Working Group
NIHR Research Delivery Network · GBCornwall Partnership NHS Foundation Trust · GBNational Institute for Health Research · GBUniversity of Cambridge · GBUniversity of Exeter · GBUniversity of Liverpool · GBUniversity of Plymouth · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrior to the COVID-19 pandemic, the majority of clinical trial activity took place face to face within clinical or research units. The COVID-19 pandemic resulted in a significant shift towards trial delivery without in-person face-to-face contact or "Remote Trial Delivery". The National Institute of Health Research (NIHR) assembled a Remote Trial Delivery Working Group to consider challenges and enablers to this major change in clinical trial delivery and to provide a toolkit for researchers to support the transition to remote delivery.

methodsThe NIHR Remote Trial Delivery Working Group evaluated five key domains of the trial delivery pathway: participant factors, recruitment, intervention delivery, outcome measurement and quality assurance. Independent surveys were disseminated to research professionals, and patients and carers, to ascertain benefits, challenges, pitfalls, enablers and examples of good practice in Remote Trial Delivery. A toolkit was constructed to support researchers, funders and governance structures in moving towards Remote Trial Delivery. The toolkit comprises a website encompassing the key principles of Remote Trial Delivery, and a repository of best practice examples and questions to guide research teams.

resultsThe patient and carer survey received 47 respondents, 34 of whom were patients and 13 of whom were carers. The professional survey had 115 examples of remote trial delivery practice entered from across England. Key potential benefits included broader reach and inclusivity, the ability for standardisation and centralisation, and increased efficiency and patient/carer convenience. Challenges included the potential exclusion of participants lacking connectivity or digital skills, the lack of digitally skilled workforce and appropriate infrastructure, and validation requirements. Five key principles of Remote Trial Delivery were proposed: national research standards, inclusivity, validity, cost-effectiveness and evaluation of new methodologies.

conclusionsThe rapid changes towards Remote Trial Delivery catalysed by the COVID-19 pandemic could lead to sustained change in clinical trial delivery. The NIHR Remote Trial Delivery Working Group provide a toolkit for researchers recommending five key principles of Remote Trial Delivery and providing examples of enablers.

Indexed as

COVID-19PandemicsHumansSARS-CoV-2United KingdomWorkforceRemote researchRemote trial deliveryTrial methodologyVirtual research

Identifiers

PMID34895305
PMCPMC8665850
OpenAlexW4226119416

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.