Evidence map›Paper›PMID 37817277›Full record

ArticleTrials2023

e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence.

E J Mitchell, D Appelbe, A Bravery, L Culliford, H Evans, A J Farrin, K Gillies, K Hood, S B Love, M R Sydes and 3 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 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
–field-weighted citation impact
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.

  1. Article
  2. Article
  3. Review
  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

13 authors.

E J Mitchell *Nottingham Clinical Trials Unit, School of Medicine, Applied Health Research Building, University Park, Nottingham, NG7 2RD, UK. eleanor.mitchell@nottingham.ac.uk.ORCID http://orcid.org/0000-0002-6998-4533
D Appelbe *Oxford Trauma and Emergency Care, Kadoorie Research Centre, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. duncan.appelbe@ndorms.ox.ac.uk.ORCID http://orcid.org/0000-0003-1493-0391
A BraveryImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.ORCID http://orcid.org/0000-0001-5415-0037
L CullifordBristol Trials Centre, University of Bristol, Bristol Medical School, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK.ORCID http://orcid.org/0000-0002-9255-6617
H EvansClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.
A J FarrinClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9NL, UK.ORCID http://orcid.org/0000-0002-2876-0584
K GilliesHealth Services Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.ORCID http://orcid.org/0000-0001-7890-2854
K HoodCentre for Trial Research, College of Biomedical & Life Sciences, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.ORCID http://orcid.org/0000-0002-5268-8631
S B LoveMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, 90 High Holborn, London, WC1V 6LJ, UK.ORCID http://orcid.org/0000-0002-6695-5390
M R SydesMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, 90 High Holborn, London, WC1V 6LJ, UK.ORCID http://orcid.org/0000-0002-9323-1371
P R WilliamsonMRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK.ORCID http://orcid.org/0000-0001-9802-6636
N WakefieldNottingham Clinical Trials Unit, School of Medicine, Applied Health Research Building, University Park, Nottingham, NG7 2RD, UK.ORCID http://orcid.org/0000-0001-5474-3115
as part of the e-Consent collaborative group

Funding

Chief Scientist Office HSRU1Medical Research Council MC_UU_00004/08Medical Research Council MR/S014357/1
6 · The paper itself

Abstract

backgroundDuring the COVID-19 pandemic, in-person healthcare visits were reduced. Consequently, trial teams needed to consider implementing remote methods for conducting clinical trials, including e-Consent. Although some clinical trials may have implemented e-Consent prior to the pandemic, anecdotes of uptake for this method increased within academic-led trials. When the increased use of this process emerged, representatives from several large academic clinical trial groups within the UK collaborated to discuss ways in which trialists can learn from one another when implementing e-Consent.

methodsA survey of UKCRC-registered Clinical Trials Units (CTUs) was undertaken in April-June 2021 to understand the implementation of and their views on the use of e-Consent and experiences from the perspectives of systems programmers and quality assurance staff on the use of e-Consent. CTUs not using e-Consent were asked to provide any reasons/barriers (including no suitable trials) and any plans for implementing it in the future. Two events for trialists and patient and public involvement (PPI) representatives were then held to disseminate findings, foster discussion, share experiences and aid in the identification of areas that the academic CTU community felt required more research.

resultsThirty-four (64%) of 53 CTUs responded to the survey, with good geographical representation across the UK. Twenty-one (62%) of the responding CTUs had implemented e-Consent in at least one of their trials, across different types of trials, including CTIMPs (Clinical Trial of Investigational Medicinal Product), ATIMPs (Advanced Therapy Medicinal Products) and non-CTIMPs. One hundred ninety-seven participants attended the two workshops for wide-ranging discussions.

conclusione-Consent is increasingly used in academic-led trials, yet uncertainties remain amongst trialists, patients and members of the public. Uncertainties include a lack of formal, practical guidance and a lack of evidence to demonstrate optimal or appropriate methods to use. We strongly encourage trialists to continue to share their own experiences of the implementation of e-Consent.

Indexed as

PandemicsResearch DesignHumansInformed ConsentSample SizeUnited KingdomClinical trialConsente-Consent

Identifiers

PMID37817277
PMCPMC10565982

What OpenQuestion holds

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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.