Evidence map›Paper›PMID 28381307›Full record

Observational studyTrials2017

Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study.

Amy E Maxwell, Mary Joan MacLeod, Anu Joyson, Sharon Johnson, Hawraman Ramadan, Ruth Bellfield, Anthony Byrne, Caroline McGhee, Anthony Rudd, Fiona Price and 27 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Trials, 2017. 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
1.2field-weighted citation impact, top 21% of its field
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, 14 citations in OpenAlex.

  1. Trial
  2. 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

37 authors at 20 institutions in 1 country.

Amy E MaxwellCentre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
Mary Joan MacLeodAberdeen Royal Infirmary, Aberdeen, UK.
Anu JoysonAberdeen Royal Infirmary, Aberdeen, UK.
Sharon JohnsonBarnsley Hospital NHS Foundation Trust, Barnsley, UK.
Hawraman RamadanBradford Royal Infirmary, Bradford, UK.
Ruth BellfieldBradford Royal Infirmary, Bradford, UK.
Anthony ByrneForth Valley Royal Hospital, Larbert, UK.
Caroline McGheeForth Valley Royal Hospital, Larbert, UK.
Anthony RuddGuys & St Thomas, London, UK.
Fiona PriceHereford County Hospital, Hereford, UK.
Evangelos VasileiadisHillingdon Hospital, Uxbridge, UK.
Melinda HoldenHillingdon Hospital, Uxbridge, UK.
Jonathan HewittYstrad Mynach Hospital, Newport, UK.
Michael CarpenterPinderfields Hospital, Wakefield, UK.
Ann NeedlePinderfields Hospital, Wakefield, UK.
Stacey ValentineQueen Alexandra Hospital, Portsmouth, UK.
Farzana PatelRoyal Blackburn Hospital, Blackburn, UK.
Frances HarringtonRoyal Cornwall Hospital, Cornwall, UK.
Paul MuddRoyal Devon & Exeter Hospital, Exeter, UK.
Hedley EmsleyRoyal Preston Hospital, Preston, UK.
Bindu GregaryRoyal Preston Hospital, Preston, UK.
Ingrid KaneRoyal Sussex County Hospital, Brighton, UK.
Keith MuirSouth Glasgow University Hospital, Glasgow, UK.
Divya TiwariThe Royal Bournemouth Hospital, Bournemouth, UK.
Peter Owusu-AgyeiPeterborough City Hospital, Peterborough, UK.
Natalie TemplePeterborough City Hospital, Peterborough, UK.
Lakshmanan SekaranLuton & Dunstable NHSFT University Hospital, Luton, UK.
Suzanne RagabPoole Hospital, Poole, UK.
Timothy EnglandDerby Royal Hospital, Derby, UK.
Amanda HedstromDerby Royal Hospital, Derby, UK.
Phil JonesBronglais Hospital, Aberystwyth, UK.
Sarah JonesBronglais Hospital, Aberystwyth, UK.
Mandy DohertySouth West Acute Hospital, Enniskillen, UK.
Mark O McCarronAltnagelvin Hospital, Londonderry, UK.
David L CohenNorthwick Park Hospital, Harrow, UK.
Sharon TysoeSouthend University Hospital NHS Foundation Trust, Southend-on-Sea, UK.
Rustam Al-Shahi SalmanCentre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK. Rustam.Al-Shahi@ed.ac.uk.
Aberdeen Royal Infirmary · GBBradford Royal Infirmary · GBBronglais General Hospital · GBForth Valley Royal Hospital · GBHillingdon Hospital · GBPeterborough City Hospital · GBPinderfields Hospital · GBRoyal Derby Hospital · GBRoyal Preston Hospital · GBUniversity of Edinburgh · GBAltnagelvin Area Hospital · GBBarnsley Hospital NHS Foundation Trust · GBCounty Hospital · GBLuton and Dunstable University Hospital NHS Foundation Trust · GBNorthwick Park Hospital · GBPoole Hospital · GBQueen Alexandra Hospital · GBRoyal Blackburn Teaching Hospital · GBRoyal Bournemouth Hospital · GBRoyal Cornwall Hospital · GB

Funding

British Heart Foundation PG/14/50/30891British Heart Foundation SP/12/2/29422Medical Research Council G1002605Medical Research Council MR/N003403/1
6 · The paper itself

Abstract

backgroundRecruitment to randomised prevention trials is challenging, not least for intracerebral haemorrhage (ICH) associated with antithrombotic drug use. We investigated reasons for not recruiting apparently eligible patients at hospital sites that keep screening logs in the ongoing REstart or STop Antithrombotics Randomised Trial (RESTART), which seeks to determine whether to start antiplatelet drugs after ICH.

methodBy the end of May 2015, 158 participants had been recruited at 108 active sites in RESTART. The trial coordinating centre invited all sites that kept screening logs to submit screening log data, followed by one reminder. We checked the integrity of data, focused on the completeness of data about potentially eligible patients and categorised the reasons they were not randomised.

resultsOf 108 active sites, 39 (36%) provided usable screening log data over a median of ten (interquartile range = 5-13) months of recruitment per site. During this time, sites screened 633 potentially eligible patients and randomised 53 (8%) of them. The main reasons why 580 patients were not randomised were: 43 (7%) patients started anticoagulation, 51 (9%) patients declined, 148 (26%) patients' stroke physicians were not uncertain about using antiplatelet drugs, 162 (28%) patients were too unwell and 176 (30%) patients were not randomised due to other reasons.

conclusionRESTART recruited ~8% of eligible patients. If more physicians were uncertain about the therapeutic dilemma that RESTART is addressing, RESTART could have recruited up to four times as many participants. The trial coordinating centre continues to engage with physicians about their uncertainty.

trial registrationEU Clinical Trials, EudraCT 2012-003190-26 . Registered on 3 July 2012.

Indexed as

Eligibility DeterminationPatient SelectionRandomized Controlled Trials as TopicResearch PersonnelAttitude of Health PersonnelCerebral HemorrhageFibrinolytic AgentsHealth Knowledge, Attitudes, PracticeHumansPhysician's RolePlatelet Aggregation InhibitorsSample SizeSecondary PreventionUnited KingdomFibrinolytic AgentsPlatelet Aggregation InhibitorsIntracerebral haemorrhageRecruitmentScreening logStroke

Identifiers

PMID28381307
PMCPMC5382439
OpenAlexW2605008535

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.