Evidence map›Paper›PMID 28835254›Full record

ReviewTrials2017

Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access.

G A Powell, L J Bonnett, C Tudur-Smith, D A Hughes, P R Williamson, A G Marson

Abstract readReview
In one paragraph

Review in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

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

  1. Equitable inclusion of patients with cancer on the palliative care register: a systematic review in primary care.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025
    Pooled it
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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

6 authors.

G A PowellDepartment of Molecular and Clinical Pharmacology, Clinical Sciences Centre, Lower Lane, Fazakerley, Liverpool, L9 7LJ, UK. gpowell@liverpool.ac.uk.
L J BonnettDepartment of Biostatistics, University of Liverpool, Waterhouse Building, Block F, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
C Tudur-SmithDepartment of Biostatistics, University of Liverpool, Waterhouse Building, Block F, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
D A HughesCentre for Health Economics and Medicines Evaluation, Institute of Medical and Social Care Research, College of Health and Behavioural Sciences, Bangor University, Ardudwy, Normal Site, Gwynedd, North Wales, LL57 2PZ, UK.
P R WilliamsonDepartment of Biostatistics, University of Liverpool, Waterhouse Building, Block F, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
A G MarsonDepartment of Molecular and Clinical Pharmacology, Clinical Sciences Centre, Lower Lane, Fazakerley, Liverpool, L9 7LJ, UK.

Funding

Department of Health PDF-2015-08-044Medical Research Council MR/K025635/1Medical Research Council MR/L004933/1Medical Research Council MR/L004933/2
6 · The paper itself

Abstract

backgroundIn the UK, routinely recorded data may benefit prospective studies including randomised controlled trials (RCTs). In an on-going study, we aim to assess the feasibility of access and agreement of routinely recorded clinical and non-clinical data compared to data collected during a RCT using standard prospective methods. This paper will summarise available UK routinely recorded data sources and discuss our experience with the feasibility of accessing routinely recorded data for participants of a RCT before finally proposing recommendations for improving the access and implementation of routinely recorded data in RCTs.

methodsSetting: the case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK, multicentre, phase IV RCT assessing the clinical and cost-effectiveness of antiepileptic drug treatments for newly diagnosed epilepsy.

participants98 participants have provided written consent to permit the request of routinely recorded data. Study procedures: routinely recorded clinical and non-clinical data were identified and data requested through formal applications from available data holders for the duration that participants have been recruited into SANAD II. The feasibility of accessing routinely recorded data during a RCT is assessed and recommendations for improving access proposed.

resultsSecondary-care clinical and socioeconomic data is recorded on a national basis and can be accessed, although there are limitations in the application process. Primary-care data are recorded by a number of organisations on a de-identified basis but access for specific individuals has not been feasible. Access to data recorded by non-clinical sources, including The Department for Work and Pensions and The Driving and Vehicle Licensing Agency, was not successful.

conclusionsRecommendations discussed include further research to assess the attributes of routinely recorded data, an assessment of public perceptions and the development of strategies to collaboratively improve access to routinely recorded data for research.

trial registrationInternational Standard Randomised Controlled Trials, ISRCTN30294119 . Registered on 3 July 2012. EudraCT No: 2012-001884-64. Registered on 9 May 2012.

Indexed as

Access to InformationResearch DesignAnticonvulsantsClinical Trials, Phase IV as TopicCost-Benefit AnalysisDatabases, FactualData MiningDrug CostsElectronic Health RecordsEndpoint DeterminationEpilepsyFeasibility StudiesHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicAnticonvulsantsAdministrative dataData collectionFeasibilityRoutine data

Identifiers

PMID28835254
PMCPMC5569524

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.