Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments.
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Authors
Ogburn, Emma
Pinches, Heather
Coleman, Garry
Seymour, David
Woodard, Fran
Manohar, Sinduja
Monsur, Marjia
Landray, Martin
Dalton, Gaynor
Morris, Andrew D
Chinnery, Patrick F
UK COVID-19 National Core Studies Consortium
Hobbs, FD Richard
Butler, Christopher
Publication Date
2022-01-20Journal Title
Trials
ISSN
1745-6215
Publisher
Springer Science and Business Media LLC
Volume
23
Issue
1
Language
eng
Type
Article
This Version
VoR
Metadata
Show full item recordCitation
Cake, C., Ogburn, E., Pinches, H., Coleman, G., Seymour, D., Woodard, F., Manohar, S., et al. (2022). Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments.. Trials, 23 (1) https://doi.org/10.1186/s13063-021-05965-4
Abstract
BACKGROUND: The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses) is the UK national platform investigating repurposed therapies for COVID-19 treatment of older people in the community at high risk of complications. Standard methods of patient recruitment were failing to meet the required pace and scale of enrolment. This paper describes the development and appraisal of a near real-time, data-driven, ethical approach for enhancing recruitment in community care by contacting people with a recent COVID-19 positive test result from the central NHS Test and Trace service within approximately 24-48 h of their test result. METHODS: A multi-disciplinary team was formed to solve the technical, ethical, public perception, logistical and information governance issues required to provide a near-real time (approximately within 24-48 h of receiving a positive test) feed of potential trial participants from test result data to the research team. PRINCIPLE was also given unique access to the Summary Care Record (SCR) to ensure safe prescribing, and to enable the trial team to quickly and safely bring consented patients into the trial. A survey of the public was used to understand public perceptions of the use of test data for this proposed methodology. RESULTS: Prior to establishing the data service, PRINCIPLE registered on average 87 participants per week. This increased by up to 87 additional people registered per week from the test data, contributing to an increase from 1013 recruits to PRINCIPLE at the start of October 2020 to 2802 recruits by 20 December 2020. Whilst procedural caveats were identified by the public consultation, out of 2639 people contacted by PRINCIPLE following a positive test result, no one raised a concern about being approached. CONCLUSIONS: This paper describes a novel approach to using near-real time NHS operational data to recruit community-based patients within a few days of presentation with acute illness. This approach increased recruitment and reduced time between positive test and randomisation, allowing more rapid evaluation of treatments and increased safety for participants. End-to-end public and patient involvement in the design of the approach provided evidence to inform information governance decisions. TRIAL REGISTRATION: PRINCIPLE is funded by UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research. EudraCT number: 2020-001209-22 . 26/03/2020 ISRCTN registry: ISRCTN86534580 . 20/03/2020 REC number: 20/SC/058 IRAS number: 281958.
Keywords
Recruitment, Data, Clinical Trials, Primary Care, Healthcare, Covid-19, Public And Patient Involvement And Engagement, Humans, Patient Selection, Aged, Pandemics, COVID-19, SARS-CoV-2
Sponsorship
Wellcome Trust (212219/Z/18/Z)
MRC (MR/S035699/1)
Identifiers
PMC8771189, 35057841
External DOI: https://doi.org/10.1186/s13063-021-05965-4
This record's URL: https://www.repository.cam.ac.uk/handle/1810/334291
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