Evidence map›Paper›PMID 36997954›Full record

ArticleTrials2023

A DELPHI study priority setting the remaining challenges for the use of routinely collected data in trials: COMORANT-UK.

Adam D N Williams, Gwyneth Davies, Amanda J Farrin, Marion Mafham, Michael Robling, Matthew R Sydes, Fiona V Lugg-Widger

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 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. 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

7 authors.

Adam D N WilliamsCentre for Trials Research, Cardiff University, Cardiff, UK.ORCID http://orcid.org/0000-0002-4825-8997
Gwyneth DaviesUCL Great Ormond Street Institute of Child Health, London, UK.
Amanda J FarrinClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Marion MafhamClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Michael RoblingCentre for Trials Research, Cardiff University, Cardiff, UK.
Matthew R SydesMRC Clinical Trials Unit at UCL, Institute of Clinical Trial and Methodology, University College London, London, UK.
Fiona V Lugg-WidgerCentre for Trials Research, Cardiff University, Cardiff, UK. LuggFV@cardiff.ac.uk.

Funding

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

Abstract

backgroundResearchers are increasingly seeking to use routinely collected data to support clinical trials. This approach has the potential to transform the way clinical trials are conducted in the future. The availability of routinely collected data for research, whether healthcare or administrative, has increased, and infrastructure funding has enabled much of this. However, challenges remain at all stages of a trial life cycle. This study, COMORANT-UK, aimed to systematically identify, with key stakeholders across the UK, the ongoing challenges related to trials that seek to use routinely collected data.

methodsThis three-step Delphi method consisted of two rounds of anonymous web-based surveys and a virtual consensus meeting. Stakeholders included trialists, data infrastructures, funders of trials, regulators, data providers and the public. Stakeholders identified research questions or challenges that they considered were of particular importance and then selected their top 10 in the second survey. The ranked questions were taken forward to the consensus meeting for discussion with representatives invited from the stakeholder groups.

resultsIn the first survey, 66 respondents yielded over 260 questions or challenges. These were thematically grouped and merged into a list of 40 unique questions. Eighty-eight stakeholders then ranked their top ten from the 40 questions in the second survey. The most common 14 questions were brought to the virtual consensus meeting in which stakeholders agreed a top list of seven questions. We report these seven questions which are within the following domains: trial design, Patient and Public Involvement, trial set-up, trial open and trial data. These questions address both evidence gaps (requiring further methodological research) and implementation gaps (requiring training and/or service re-organisation).

conclusionThis prioritised list of seven questions should inform the direction of future research in this area and should direct efforts to ensure that the benefits in major infrastructure for routinely collected data are achieved and translated. Without this and future work to address these questions, the potential societal benefits of using routinely collected data to help answer important clinical questions will not be realised.

Indexed as

Research DesignRoutinely Collected Health DataClinical Trials as TopicDelphi TechniqueHealth PrioritiesHumansUnited KingdomConsensusPriority settingRoutinely collected dataTrials methodology

Identifiers

PMID36997954
PMCPMC10064573

What OpenQuestion holds

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Registered trials

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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.