Getting our ducks in a row: The need for data utility comparisons of healthcare systems data for clinical trials.

DUCkS Data utility Data utility comparison studies Electronic health records Health policy Healthcare systems data RCTs Real world data Routinely-collected data Routinely-collected healthcare data

Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
25 Mar 2024
Historique:
received: 13 10 2023
revised: 23 02 2024
accepted: 24 03 2024
medline: 28 3 2024
pubmed: 28 3 2024
entrez: 27 3 2024
Statut: aheadofprint

Résumé

Better use of healthcare systems data, collected as part of interactions between patients and the healthcare system, could transform planning and conduct of randomised controlled trials. Multiple challenges to widespread use include whether healthcare systems data captures sufficiently well the data traditionally captured on case report forms. "Data Utility Comparison Studies" (DUCkS) assess the utility of healthcare systems data for RCTs by comparison to data collected by the trial. Despite their importance, there are few published UK examples of DUCkS. Building from ongoing and selected recent examples of UK-led DUCkS in the literature, we set out experience-based considerations for the conduct of future DUCkS. Developed through informal iterative discussions in many forums, considerations are offered for planning, protocol development, data, analysis and reporting, with comparisons at "patient-level" or "trial-level", depending on the item of interest and trial status. DUCkS could be a valuable tool in assessing where healthcare systems data can be used for trials and in which trial teams can play a leading role. There is a pressing need for trials to be more efficient in their delivery and research waste must be reduced. Trials have been making inconsistent use of healthcare systems data, not least because of an absence of evidence of utility. DUCkS can also help to identify challenges in using healthcare systems data, such as linkage (access and timing) and data quality. We encourage trial teams to incorporate and report DUCkS in trials and funders and data providers to support them.

Sections du résumé

BACKGROUND BACKGROUND
Better use of healthcare systems data, collected as part of interactions between patients and the healthcare system, could transform planning and conduct of randomised controlled trials. Multiple challenges to widespread use include whether healthcare systems data captures sufficiently well the data traditionally captured on case report forms. "Data Utility Comparison Studies" (DUCkS) assess the utility of healthcare systems data for RCTs by comparison to data collected by the trial. Despite their importance, there are few published UK examples of DUCkS.
METHODS-AND-RESULTS UNASSIGNED
Building from ongoing and selected recent examples of UK-led DUCkS in the literature, we set out experience-based considerations for the conduct of future DUCkS. Developed through informal iterative discussions in many forums, considerations are offered for planning, protocol development, data, analysis and reporting, with comparisons at "patient-level" or "trial-level", depending on the item of interest and trial status.
DISCUSSION CONCLUSIONS
DUCkS could be a valuable tool in assessing where healthcare systems data can be used for trials and in which trial teams can play a leading role. There is a pressing need for trials to be more efficient in their delivery and research waste must be reduced. Trials have been making inconsistent use of healthcare systems data, not least because of an absence of evidence of utility. DUCkS can also help to identify challenges in using healthcare systems data, such as linkage (access and timing) and data quality. We encourage trial teams to incorporate and report DUCkS in trials and funders and data providers to support them.

Identifiants

DOI: 10.1016/j.cct.2024.107514 PMID: 38537901
pubmed: 38537901
pii: S1551-7144(24)00097-1
doi: 10.1016/j.cct.2024.107514
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

107514

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Auteurs

Matthew R Sydes (MR)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK; BHF Data Science Centre, Health Data Research UK, London, UK. Electronic address: m.sydes@ucl.ac.uk.

Macey L Murray (ML)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: macey.murray@ucl.ac.uk.

Saiam Ahmed (S)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: saiam.ahmed@ucl.ac.uk.

Sophia Apostolidou (S)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: s.apostolidou@ucl.ac.uk.

Judith M Bliss (JM)

Clinical Trials and Statistics Unit, Division of Clinical Studies, The Institute of Cancer Research, London, UK. Electronic address: judith.bliss@icr.ac.uk.

Claire Bloomfield (C)

Insitro Inc, San Francisco, CA, USA. Electronic address: cbloomfield@insitro.com.

Rebecca Cannings-John (R)

Centre for Trials Research, Cardiff University, Cardiff, UK. Electronic address: canningsrl@cardiff.ac.uk.

James Carpenter (J)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK; London School of Hygiene and Tropical Medicine, London, UK. Electronic address: j.carpenter@ucl.ac.uk.

Tim Clayton (T)

Department of Medical Statistics and Clinical Trials Unit, London School of Hygiene and Tropical Medicine (LSHTM), London, UK. Electronic address: Tim.Clayton@Lshtm.ac.uk.

Madeleine Clout (M)

Bristol Trials Centre, University of Bristol, Bristol, UK. Electronic address: madeleine.clout@bristol.ac.uk.

Rebecca Cosgriff (R)

NHS Transformation Directorate, NHS England & NHS Improvement, London, UK. Electronic address: r.cosgriff@nhs.net.

Amanda Farrin (A)

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK. Electronic address: A.J.Farrin@leeds.ac.uk.

Aleksandra Gentry-Maharaj (A)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: a.gentry-maharaj@ucl.ac.uk.

Duncan Gilbert (D)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: duncan.gilbert@ucl.ac.uk.

Charlie Harper (C)

Nuffield Department of Population Health, University of Oxford, Oxford, UK. Electronic address: charlie.harper@ndph.ox.ac.uk.

Nicholas D James (ND)

The Institute of Cancer Research, London, UK. Electronic address: nick.james@icr.ac.uk.

Ruth E Langley (RE)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: ruth.langley@ucl.ac.uk.

Sarah Lessels (S)

BHF Data Science Centre, Health Data Research UK, London, UK. Electronic address: Sarah.Lessels@hdruk.ac.uk.

Fiona Lugg-Widger (F)

Centre for Trials Research, Cardiff University, Cardiff, UK. Electronic address: LuggFV@cardiff.ac.uk.

Isla S Mackenzie (IS)

MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK. Electronic address: i.s.mackenzie@dundee.ac.uk.

Marion Mafham (M)

Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), NDPH, University of Oxford, Oxford, UK. Electronic address: marion.mafham@ndph.ox.ac.uk.

Usha Menon (U)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: u.menon@ucl.ac.uk.

Harriet Mintz (H)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: HXM074@student.bham.ac.uk.

Heather Pinches (H)

DigiTrials, NHS, England, Leeds, UK; Centre for Advanced Research Computing, University College London, London, UK. Electronic address: h.pinches@nhs.net.

Michael Robling (M)

Centre for Trials Research, Cardiff University, Cardiff, UK. Electronic address: Roblingmr@cardiff.ac.uk.

Alexandra Wright-Hughes (A)

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK. Electronic address: A.Wright-Hughes@leeds.ac.uk.

Victoria Yorke-Edwards (V)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: v.yorke-edwards@ucl.ac.uk.

Sharon B Love (SB)

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. Electronic address: s.love@ucl.ac.uk.

Classifications MeSH