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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage
T2 - observational study
AU - Maxwell, Amy E.
AU - MacLeod, Mary Joan
AU - Joyson, Anu
AU - Johnson, Sharon
AU - Ramadan, Hawraman
AU - Bellfield, Ruth
AU - Byrne, Anthony
AU - McGhee, Caroline
AU - Rudd, Anthony
AU - Price, Fiona
AU - Vasileiadis, Evangelos
AU - Holden, Melinda
AU - Hewitt, Jonathan
AU - Carpenter, Michael
AU - Needle, Ann
AU - Valentine, Stacey
AU - Patel, Farzana
AU - Harrington, Frances
AU - Mudd, Paul
AU - Emsley, Hedley
AU - Gregary, Bindu
AU - Kane, Ingrid
AU - Muir, Keith
AU - Tiwari, Divya
AU - Owusu-Agyei, Peter
AU - Temple, Natalie
AU - Sekaran, Lakshmanan
AU - Ragab, Suzanne
AU - England, Timothy
AU - Hedstrom, Amanda
AU - Jones, Phil
AU - Jones, Sarah
AU - Doherty, Mandy
AU - McCarron, Mark O.
AU - Cohen, David L.
AU - Tysoe, Sharon
AU - Al-Shahi Salman, Rustam
PY - 2017/4/5
Y1 - 2017/4/5
N2 - 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.
AB - 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.
KW - Stroke
KW - Intracerebral haemorrhage
KW - Recruitment
KW - Screening log
U2 - 10.1186/s13063-017-1909-4
DO - 10.1186/s13063-017-1909-4
M3 - Journal article
VL - 18
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 162
ER -