Evidence map›Paper›PMID 38287428›Full record

ArticleTrials2024

Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.

Alice-Maria Toader, Marion K Campbell, Jennifer K Quint, Michael Robling, Matthew R Sydes, Joanna Thorn, Alexandra Wright-Hughes, Ly-Mee Yu, Tom E F Abbott, Simon Bond and 25 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
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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

35 authors.

Alice-Maria Toader *MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK. Sgatoade@liverpool.ac.uk.ORCID http://orcid.org/0000-0002-3801-3486
Marion K CampbellHealth Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK.
Jennifer K QuintSchool of Public Health &, National Heart and Lung Institute, Imperial College London, London, UK.
Michael RoblingCentre for Trials Research, Cardiff University, Cardiff, CF14 4YS, UK.
Matthew R SydesMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.
Joanna ThornHealth Economics Bristol, Population Health Sciences, University of Bristol, Bristol, UK.
Alexandra Wright-HughesClinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.
Ly-Mee YuOxford Primary Care CTU, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Tom E F AbbottWilliam Harvey Research Institute, Queen Mary University of London, London, EC1M 6BQ, UK.
Simon BondCambridge Clinical Trials Unit, Cambridge, UK.
Fergus J CaskeyBHF Data Science Centre, Health Data Research UK, London, UK.
Madeleine CloutBristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK.
Michelle CollinsonClinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.
Bethan CopseyClinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.
Gwyneth DaviesUCL Great Ormond Street Institute of Child Health, London, WC1N 1EH, UK.
Timothy DriscollSwansea Trials Unit, Swansea University, Swansea, SA2 8PP, UK.
Carrol GambleLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
Xavier L GriffinBarts Bone and Joint Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Thomas HamborgPragmatic Clinical Trials Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, E1 2AB, UK.
Jessica HarrisBristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS, UK.
David A HarrisonIntensive Care National Audit & Research Centre, London, UK.
Deena HarjiClinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.
Emily J HendersonAgeing and Movement Research Group, Bristol Medical School, University of Bristol, Bristol, UK.
Pip LoganSchool of Medicine, University of Nottingham and Nottingham City Care Partnership, Nottingham, UK.
Sharon B LoveMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.
Laura A MageeDepartment of Women and Children's Health, King's College London, London, UK.
Alastair O'BrienDivision of Medicine, UCL Institute for Liver and Digestive Health, Royal Free Campus, Upper 3Rd FloorRowland Hill Street, London, NW3 2PF, UK.
Maria PufuleteBristol Medical School, University of Bristol, Bristol, BS8 2PS, UK.
Padmanabhan RamnarayanDepartment of Surgery and Cancer, Imperial College London, London, W21PB, UK.
Athanasios SaratzisDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK.
Jo SmithKeele Clinical Trials Unit, Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK.
Ivonne Solis-TrapalaKeele Clinical Trials Unit, Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK.
Clive StubbsBirmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research College of Medical and Dental Sciences, The University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Amanda Farrin *Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research,, University of Leeds, Leeds, LS2 9JT, UK.
Paula Williamson *MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK.

Funding

Cancer Research UK 24432Cancer Research UK 25350Medical Research Council MC_UU_00004/08Medical Research Council MR/S014357/1Medical Research Council MR/T041285/1
6 · The paper itself

Abstract

backgroundHealthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community.

methodsThe PRIMORANT study had three phases. First, an initial workshop was held to scope the issues faced by trialists when considering whether to use HSDs for trial outcomes. Second, a consultation exercise was undertaken with clinical trials unit (CTU) staff, trialists, methodologists, clinicians, funding panels and data providers. Third, a final discussion workshop was held, at which the results of the consultation were fed back, case studies presented, and issues considered in small breakout groups.

resultsKey topics included in the consultation process were the validity of outcome data, timeliness of data capture, internal pilots, data-sharing, practical issues, and decision-making. A majority of consultation respondents (n = 78, 95%) considered the development of guidance for trialists to be feasible. Guidance was developed following the discussion workshop, for the five broad areas of terminology, feasibility, internal pilots, onward data sharing, and data archiving.

conclusionsWe provide guidance to inform decisions about whether or not to use HSDs for outcomes, and if so, to assist trialists in working with registries and other HSD providers to improve the design and delivery of trials.

Indexed as

Delivery of Health CareInformation DisseminationHumansRegistriesClinical trialsData validityHealthcare systems dataOutcomesRegistriesRoutinely collected data

Identifiers

PMID38287428
PMCPMC10823676

What OpenQuestion holds

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LicenceCC BY
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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.