title: Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study.
abstract: Recruitment 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.
  
  
  
  By 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.
  
  
  
  Of 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.
  
  
  
  RESTART 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.
  
  
  
  EU Clinical Trials, EudraCT 2012-003190-26 . Registered on 3 July 2012.
authors.affiliation: Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
authors.forename: Amy E
authors.initials: AE
authors.lastname: Maxwell
authors.affiliation: Aberdeen Royal Infirmary, Aberdeen, UK.
authors.forename: Mary Joan
authors.initials: MJ
authors.lastname: MacLeod
authors.affiliation: Aberdeen Royal Infirmary, Aberdeen, UK.
authors.forename: Anu
authors.initials: A
authors.lastname: Joyson
authors.affiliation: Barnsley Hospital NHS Foundation Trust, Barnsley, UK.
authors.forename: Sharon
authors.initials: S
authors.lastname: Johnson
authors.affiliation: Bradford Royal Infirmary, Bradford, UK.
authors.forename: Hawraman
authors.initials: H
authors.lastname: Ramadan
authors.affiliation: Bradford Royal Infirmary, Bradford, UK.
authors.forename: Ruth
authors.initials: R
authors.lastname: Bellfield
authors.affiliation: Forth Valley Royal Hospital, Larbert, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Byrne
authors.affiliation: Forth Valley Royal Hospital, Larbert, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: McGhee
authors.affiliation: Guys & St Thomas, London, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Rudd
authors.affiliation: Hereford County Hospital, Hereford, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Price
authors.affiliation: Hillingdon Hospital, Uxbridge, UK.
authors.forename: Evangelos
authors.initials: E
authors.lastname: Vasileiadis
authors.affiliation: Hillingdon Hospital, Uxbridge, UK.
authors.forename: Melinda
authors.initials: M
authors.lastname: Holden
authors.affiliation: Ystrad Mynach Hospital, Newport, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Hewitt
authors.affiliation: Pinderfields Hospital, Wakefield, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Carpenter
authors.affiliation: Pinderfields Hospital, Wakefield, UK.
authors.forename: Ann
authors.initials: A
authors.lastname: Needle
authors.affiliation: Queen Alexandra Hospital, Portsmouth, UK.
authors.forename: Stacey
authors.initials: S
authors.lastname: Valentine
authors.affiliation: Royal Blackburn Hospital, Blackburn, UK.
authors.forename: Farzana
authors.initials: F
authors.lastname: Patel
authors.affiliation: Royal Cornwall Hospital, Cornwall, UK.
authors.forename: Frances
authors.initials: F
authors.lastname: Harrington
authors.affiliation: Royal Devon & Exeter Hospital, Exeter, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Mudd
authors.affiliation: Royal Preston Hospital, Preston, UK.
authors.forename: Hedley
authors.initials: H
authors.lastname: Emsley
authors.affiliation: Royal Preston Hospital, Preston, UK.
authors.forename: Bindu
authors.initials: B
authors.lastname: Gregary
authors.affiliation: Royal Sussex County Hospital, Brighton, UK.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Kane
authors.affiliation: South Glasgow University Hospital, Glasgow, UK.
authors.forename: Keith
authors.initials: K
authors.lastname: Muir
authors.affiliation: The Royal Bournemouth Hospital, Bournemouth, UK.
authors.forename: Divya
authors.initials: D
authors.lastname: Tiwari
authors.affiliation: Peterborough City Hospital, Peterborough, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Owusu-Agyei
authors.affiliation: Peterborough City Hospital, Peterborough, UK.
authors.forename: Natalie
authors.initials: N
authors.lastname: Temple
authors.affiliation: Luton & Dunstable NHSFT University Hospital, Luton, UK.
authors.forename: Lakshmanan
authors.initials: L
authors.lastname: Sekaran
authors.affiliation: Poole Hospital, Poole, UK.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Ragab
authors.affiliation: Derby Royal Hospital, Derby, UK.
authors.forename: Timothy
authors.initials: T
authors.lastname: England
authors.affiliation: Derby Royal Hospital, Derby, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Hedstrom
authors.affiliation: Bronglais Hospital, Aberystwyth, UK.
authors.forename: Phil
authors.initials: P
authors.lastname: Jones
authors.affiliation: Bronglais Hospital, Aberystwyth, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Jones
authors.affiliation: South West Acute Hospital, Enniskillen, UK.|Altnagelvin Hospital, Londonderry, UK.
authors.forename: Mandy
authors.initials: M
authors.lastname: Doherty
authors.affiliation: Altnagelvin Hospital, Londonderry, UK.
authors.forename: Mark O
authors.initials: MO
authors.lastname: McCarron
authors.affiliation: Northwick Park Hospital, Harrow, UK.
authors.forename: David L
authors.initials: DL
authors.lastname: Cohen
authors.affiliation: Southend University Hospital NHS Foundation Trust, Southend-on-Sea, UK.
authors.forename: Sharon
authors.initials: S
authors.lastname: Tysoe
authors.affiliation: Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK. Rustam.Al-Shahi@ed.ac.uk.
authors.forename: Rustam
authors.initials: R
authors.lastname: Al-Shahi Salman
mesh_terms: D006801:Humans; D001291:Attitude of Health Personnel; D002543:Cerebral Hemorrhage / Q000139:chemically induced / Q000175:diagnosis / Q000517:prevention & control; D004608:Eligibility Determination; D005343:Fibrinolytic Agents / Q000009:adverse effects; D007722:Health Knowledge, Attitudes, Practice; D018579:Patient Selection; D010819:Physician's Role; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects; D012108:Research Personnel / Q000523:psychology; D018401:Sample Size; D055502:Secondary Prevention / Q000379:methods; D006113:United Kingdom; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000523:psychology
chemical_list: D005343:Fibrinolytic Agents; D010975:Platelet Aggregation Inhibitors
keywords: Intracerebral haemorrhage; Recruitment; Screening log; Stroke