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

Amy E  Maxwell; Mary Macleod; Anu Joyson; Sharon  Johnson; Hawraman  Ramadan; Ruth  Bellfield; Anthony  Byrne; Caroline  McGhee; Anthony  Rudd; Fiona  Price; Evangelos  Vasileiadis; Jonathan Hewitt; Michael  Carpenter; Ann  Needle; Stacey  Valentine; Farzana  Patel; Frances  Harrington; Paul  Mudd; Hedley  Emsley; Bindu  Gregary; Ingrid Kane; Keith Muir; Divya  Tiwar; Peter Owusu-Agyei; Natalie  Temple; Lakshmanan  Sekaran; Suzanne  Ragab; Timothy  England; Amanda  Hedstrom; Phil  Jones; Sarah  Jones; Mandy  Doherty; Mark  O McCarron; David L  Cohen; Sharon  Tysoe; Rustam Al-Shahi Salman

doi:10.1186/s13063-017-1909-4

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

Amy E Maxwell, Mary Macleod, Anu Joyson, Sharon Johnson, Hawraman Ramadan, Ruth Bellfield , Anthony Byrne, Caroline McGhee, Anthony Rudd, Fiona Price, Evangelos Vasileiadis, Jonathan Hewitt, Michael Carpenter, Ann Needle, Stacey Valentine, Farzana Patel, Frances Harrington, Paul Mudd, Hedley Emsley, Bindu GregaryIngrid Kane, Keith Muir, Divya Tiwar, Peter Owusu-Agyei, Natalie Temple, Lakshmanan Sekaran, Suzanne Ragab, Timothy England, Amanda Hedstrom, Phil Jones , Sarah Jones, Mandy Doherty, Mark O McCarron, David L Cohen, Sharon Tysoe, Rustam Al-Shahi Salman (Corresponding Author)

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Abstract

Background
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.

Method
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.

Results
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.

Conclusion
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.

Original language	English
Article number	162
Journal	Trials
Volume	18
DOIs	https://doi.org/10.1186/s13063-017-1909-4
Publication status	Published - 5 Apr 2017

Bibliographical note

RESTART is supported by British Heart Foundation Special Project (SP/12/2/29422) and Project (PG/14/50/30891) grants.

Keywords

Stroke
Intracerebral Haemorrhage
Recruitment
Screening Log

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Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage observational study
© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated
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Maxwell, A. E., Macleod, M., Joyson, A., Johnson, S., Ramadan, H., Bellfield , R., Byrne, A., McGhee, C., Rudd, A., Price, F., Vasileiadis, E., Hewitt, J., Carpenter, M., Needle, A., Valentine, S., Patel, F., Harrington, F., Mudd, P., Emsley, H., ... Al-Shahi Salman, R. (2017). Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study. Trials, 18, Article 162. https://doi.org/10.1186/s13063-017-1909-4

Maxwell, AE, Macleod, M, Joyson, A, Johnson, S, Ramadan, H, Bellfield , R, Byrne, A, McGhee, C, Rudd, A, Price, F, Vasileiadis, E, Hewitt, J, Carpenter, M, Needle, A, Valentine, S, Patel, F, Harrington, F, Mudd, P, Emsley, H, Gregary, B, Kane, I, Muir, K, Tiwar, D, Owusu-Agyei, P, Temple, N, Sekaran, L, Ragab, S, England, T, Hedstrom, A, Jones , P, Jones, S, Doherty, M, O McCarron, M, Cohen, DL, Tysoe, S & Al-Shahi Salman, R 2017, 'Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study', Trials, vol. 18, 162. https://doi.org/10.1186/s13063-017-1909-4

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

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{\textquoteright} 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.",

keywords = "Stroke, Intracerebral Haemorrhage, Recruitment, Screening Log",

author = "Maxwell, {Amy E} and Mary Macleod and Anu Joyson and Sharon Johnson and Hawraman Ramadan and Ruth Bellfield and Anthony Byrne and Caroline McGhee and Anthony Rudd and Fiona Price and Evangelos Vasileiadis and Jonathan Hewitt and Michael Carpenter and Ann Needle and Stacey Valentine and Farzana Patel and Frances Harrington and Paul Mudd and Hedley Emsley and Bindu Gregary and Ingrid Kane and Keith Muir and Divya Tiwar and Peter Owusu-Agyei and Natalie Temple and Lakshmanan Sekaran and Suzanne Ragab and Timothy England and Amanda Hedstrom and Phil Jones and Sarah Jones and Mandy Doherty and {O McCarron}, Mark and Cohen, {David L} and Sharon Tysoe and {Al-Shahi Salman}, Rustam",

note = "RESTART is supported by British Heart Foundation Special Project (SP/12/2/29422) and Project (PG/14/50/30891) grants.",

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doi = "10.1186/s13063-017-1909-4",

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volume = "18",

journal = "Trials",

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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

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 - 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 - Tiwar, 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 - O McCarron, Mark

AU - Cohen, David L

AU - Tysoe, Sharon

AU - Al-Shahi Salman, Rustam

N1 - RESTART is supported by British Heart Foundation Special Project (SP/12/2/29422) and Project (PG/14/50/30891) grants.

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 - Article

SN - 1745-6215

VL - 18

JO - Trials

JF - Trials

M1 - 162

ER -

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

Abstract

Bibliographical note

Keywords

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