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

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

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2017

Schlagwörter:	Stroke Intracerebral haemorrhage Recruitment Screening log

Anmerkung:	© The Author(s). 2017

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 18(2017), 1 vom: 05. Apr.
Übergeordnetes Werk:	volume:18 ; year:2017 ; number:1 ; day:05 ; month:04

Links:	Volltext

DOI / URN:	10.1186/s13063-017-1909-4

Katalog-ID:	SPR030094615

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520			\|a 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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012.
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700	1		\|a MacLeod, Mary Joan \|4 aut
700	1		\|a Joyson, Anu \|4 aut
700	1		\|a Johnson, Sharon \|4 aut
700	1		\|a Ramadan, Hawraman \|4 aut
700	1		\|a Bellfield, Ruth \|4 aut
700	1		\|a Byrne, Anthony \|4 aut
700	1		\|a McGhee, Caroline \|4 aut
700	1		\|a Rudd, Anthony \|4 aut
700	1		\|a Price, Fiona \|4 aut
700	1		\|a Vasileiadis, Evangelos \|4 aut
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700	1		\|a Needle, Ann \|4 aut
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700	1		\|a Patel, Farzana \|4 aut
700	1		\|a Harrington, Frances \|4 aut
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allfields	10.1186/s13063-017-1909-4 doi (DE-627)SPR030094615 (SPR)s13063-017-1909-4-e DE-627 ger DE-627 rakwb eng Maxwell, Amy E. verfasserin aut Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012. Stroke (dpeaa)DE-He213 Intracerebral haemorrhage (dpeaa)DE-He213 Recruitment (dpeaa)DE-He213 Screening log (dpeaa)DE-He213 MacLeod, Mary Joan aut Joyson, Anu aut Johnson, Sharon aut Ramadan, Hawraman aut Bellfield, Ruth aut Byrne, Anthony aut McGhee, Caroline aut Rudd, Anthony aut Price, Fiona aut Vasileiadis, Evangelos aut Holden, Melinda aut Hewitt, Jonathan aut Carpenter, Michael aut Needle, Ann aut Valentine, Stacey aut Patel, Farzana aut Harrington, Frances aut Mudd, Paul aut Emsley, Hedley aut Gregary, Bindu aut Kane, Ingrid aut Muir, Keith aut Tiwari, Divya aut Owusu-Agyei, Peter aut Temple, Natalie aut Sekaran, Lakshmanan aut Ragab, Suzanne aut England, Timothy aut Hedstrom, Amanda aut Jones, Phil aut Jones, Sarah aut Doherty, Mandy aut McCarron, Mark O. aut Cohen, David L. aut Tysoe, Sharon aut Al-Shahi Salman, Rustam aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 05. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:05 month:04 https://dx.doi.org/10.1186/s13063-017-1909-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 05 04
spelling	10.1186/s13063-017-1909-4 doi (DE-627)SPR030094615 (SPR)s13063-017-1909-4-e DE-627 ger DE-627 rakwb eng Maxwell, Amy E. verfasserin aut Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012. Stroke (dpeaa)DE-He213 Intracerebral haemorrhage (dpeaa)DE-He213 Recruitment (dpeaa)DE-He213 Screening log (dpeaa)DE-He213 MacLeod, Mary Joan aut Joyson, Anu aut Johnson, Sharon aut Ramadan, Hawraman aut Bellfield, Ruth aut Byrne, Anthony aut McGhee, Caroline aut Rudd, Anthony aut Price, Fiona aut Vasileiadis, Evangelos aut Holden, Melinda aut Hewitt, Jonathan aut Carpenter, Michael aut Needle, Ann aut Valentine, Stacey aut Patel, Farzana aut Harrington, Frances aut Mudd, Paul aut Emsley, Hedley aut Gregary, Bindu aut Kane, Ingrid aut Muir, Keith aut Tiwari, Divya aut Owusu-Agyei, Peter aut Temple, Natalie aut Sekaran, Lakshmanan aut Ragab, Suzanne aut England, Timothy aut Hedstrom, Amanda aut Jones, Phil aut Jones, Sarah aut Doherty, Mandy aut McCarron, Mark O. aut Cohen, David L. aut Tysoe, Sharon aut Al-Shahi Salman, Rustam aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 05. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:05 month:04 https://dx.doi.org/10.1186/s13063-017-1909-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 05 04
allfields_unstemmed	10.1186/s13063-017-1909-4 doi (DE-627)SPR030094615 (SPR)s13063-017-1909-4-e DE-627 ger DE-627 rakwb eng Maxwell, Amy E. verfasserin aut Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012. Stroke (dpeaa)DE-He213 Intracerebral haemorrhage (dpeaa)DE-He213 Recruitment (dpeaa)DE-He213 Screening log (dpeaa)DE-He213 MacLeod, Mary Joan aut Joyson, Anu aut Johnson, Sharon aut Ramadan, Hawraman aut Bellfield, Ruth aut Byrne, Anthony aut McGhee, Caroline aut Rudd, Anthony aut Price, Fiona aut Vasileiadis, Evangelos aut Holden, Melinda aut Hewitt, Jonathan aut Carpenter, Michael aut Needle, Ann aut Valentine, Stacey aut Patel, Farzana aut Harrington, Frances aut Mudd, Paul aut Emsley, Hedley aut Gregary, Bindu aut Kane, Ingrid aut Muir, Keith aut Tiwari, Divya aut Owusu-Agyei, Peter aut Temple, Natalie aut Sekaran, Lakshmanan aut Ragab, Suzanne aut England, Timothy aut Hedstrom, Amanda aut Jones, Phil aut Jones, Sarah aut Doherty, Mandy aut McCarron, Mark O. aut Cohen, David L. aut Tysoe, Sharon aut Al-Shahi Salman, Rustam aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 05. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:05 month:04 https://dx.doi.org/10.1186/s13063-017-1909-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 05 04
allfieldsGer	10.1186/s13063-017-1909-4 doi (DE-627)SPR030094615 (SPR)s13063-017-1909-4-e DE-627 ger DE-627 rakwb eng Maxwell, Amy E. verfasserin aut Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012. Stroke (dpeaa)DE-He213 Intracerebral haemorrhage (dpeaa)DE-He213 Recruitment (dpeaa)DE-He213 Screening log (dpeaa)DE-He213 MacLeod, Mary Joan aut Joyson, Anu aut Johnson, Sharon aut Ramadan, Hawraman aut Bellfield, Ruth aut Byrne, Anthony aut McGhee, Caroline aut Rudd, Anthony aut Price, Fiona aut Vasileiadis, Evangelos aut Holden, Melinda aut Hewitt, Jonathan aut Carpenter, Michael aut Needle, Ann aut Valentine, Stacey aut Patel, Farzana aut Harrington, Frances aut Mudd, Paul aut Emsley, Hedley aut Gregary, Bindu aut Kane, Ingrid aut Muir, Keith aut Tiwari, Divya aut Owusu-Agyei, Peter aut Temple, Natalie aut Sekaran, Lakshmanan aut Ragab, Suzanne aut England, Timothy aut Hedstrom, Amanda aut Jones, Phil aut Jones, Sarah aut Doherty, Mandy aut McCarron, Mark O. aut Cohen, David L. aut Tysoe, Sharon aut Al-Shahi Salman, Rustam aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 05. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:05 month:04 https://dx.doi.org/10.1186/s13063-017-1909-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 05 04
allfieldsSound	10.1186/s13063-017-1909-4 doi (DE-627)SPR030094615 (SPR)s13063-017-1909-4-e DE-627 ger DE-627 rakwb eng Maxwell, Amy E. verfasserin aut Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2017 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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012. Stroke (dpeaa)DE-He213 Intracerebral haemorrhage (dpeaa)DE-He213 Recruitment (dpeaa)DE-He213 Screening log (dpeaa)DE-He213 MacLeod, Mary Joan aut Joyson, Anu aut Johnson, Sharon aut Ramadan, Hawraman aut Bellfield, Ruth aut Byrne, Anthony aut McGhee, Caroline aut Rudd, Anthony aut Price, Fiona aut Vasileiadis, Evangelos aut Holden, Melinda aut Hewitt, Jonathan aut Carpenter, Michael aut Needle, Ann aut Valentine, Stacey aut Patel, Farzana aut Harrington, Frances aut Mudd, Paul aut Emsley, Hedley aut Gregary, Bindu aut Kane, Ingrid aut Muir, Keith aut Tiwari, Divya aut Owusu-Agyei, Peter aut Temple, Natalie aut Sekaran, Lakshmanan aut Ragab, Suzanne aut England, Timothy aut Hedstrom, Amanda aut Jones, Phil aut Jones, Sarah aut Doherty, Mandy aut McCarron, Mark O. aut Cohen, David L. aut Tysoe, Sharon aut Al-Shahi Salman, Rustam aut Enthalten in Trials London : BioMed Central, 2000 18(2017), 1 vom: 05. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:18 year:2017 number:1 day:05 month:04 https://dx.doi.org/10.1186/s13063-017-1909-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2017 1 05 04
language	English
source	Enthalten in Trials 18(2017), 1 vom: 05. Apr. volume:18 year:2017 number:1 day:05 month:04
sourceStr	Enthalten in Trials 18(2017), 1 vom: 05. Apr. volume:18 year:2017 number:1 day:05 month:04
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Stroke Intracerebral haemorrhage Recruitment Screening log
isfreeaccess_bool	true
container_title	Trials
authorswithroles_txt_mv	Maxwell, Amy E. @@aut@@ MacLeod, Mary Joan @@aut@@ Joyson, Anu @@aut@@ Johnson, Sharon @@aut@@ Ramadan, Hawraman @@aut@@ Bellfield, Ruth @@aut@@ Byrne, Anthony @@aut@@ McGhee, Caroline @@aut@@ Rudd, Anthony @@aut@@ Price, Fiona @@aut@@ Vasileiadis, Evangelos @@aut@@ Holden, Melinda @@aut@@ Hewitt, Jonathan @@aut@@ Carpenter, Michael @@aut@@ Needle, Ann @@aut@@ Valentine, Stacey @@aut@@ Patel, Farzana @@aut@@ Harrington, Frances @@aut@@ Mudd, Paul @@aut@@ Emsley, Hedley @@aut@@ Gregary, Bindu @@aut@@ Kane, Ingrid @@aut@@ Muir, Keith @@aut@@ Tiwari, Divya @@aut@@ Owusu-Agyei, Peter @@aut@@ Temple, Natalie @@aut@@ Sekaran, Lakshmanan @@aut@@ Ragab, Suzanne @@aut@@ England, Timothy @@aut@@ Hedstrom, Amanda @@aut@@ Jones, Phil @@aut@@ Jones, Sarah @@aut@@ Doherty, Mandy @@aut@@ McCarron, Mark O. @@aut@@ Cohen, David L. @@aut@@ Tysoe, Sharon @@aut@@ Al-Shahi Salman, Rustam @@aut@@
publishDateDaySort_date	2017-04-05T00:00:00Z
hierarchy_top_id	326173552
id	SPR030094615
language_de	englisch
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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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. 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author	Maxwell, Amy E.
spellingShingle	Maxwell, Amy E. misc Stroke misc Intracerebral haemorrhage misc Recruitment misc Screening log Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study
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topic_title	Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study Stroke (dpeaa)DE-He213 Intracerebral haemorrhage (dpeaa)DE-He213 Recruitment (dpeaa)DE-He213 Screening log (dpeaa)DE-He213
topic	misc Stroke misc Intracerebral haemorrhage misc Recruitment misc Screening log
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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
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title_full	Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study
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author_browse	Maxwell, Amy E. MacLeod, Mary Joan Joyson, Anu Johnson, Sharon Ramadan, Hawraman Bellfield, Ruth Byrne, Anthony McGhee, Caroline Rudd, Anthony Price, Fiona Vasileiadis, Evangelos Holden, Melinda Hewitt, Jonathan Carpenter, Michael Needle, Ann Valentine, Stacey Patel, Farzana Harrington, Frances Mudd, Paul Emsley, Hedley Gregary, Bindu Kane, Ingrid Muir, Keith Tiwari, Divya Owusu-Agyei, Peter Temple, Natalie Sekaran, Lakshmanan Ragab, Suzanne England, Timothy Hedstrom, Amanda Jones, Phil Jones, Sarah Doherty, Mandy McCarron, Mark O. Cohen, David L. Tysoe, Sharon Al-Shahi Salman, Rustam
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title_sort	reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study
title_auth	Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study
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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012. © The Author(s). 2017
abstractGer	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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012. © The Author(s). 2017
abstract_unstemmed	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. Trial registration EU Clinical Trials, EudraCT 2012-003190-26. Registered on 3 July 2012. © The Author(s). 2017
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title_short	Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study
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author2	MacLeod, Mary Joan Joyson, Anu Johnson, Sharon Ramadan, Hawraman Bellfield, Ruth Byrne, Anthony McGhee, Caroline Rudd, Anthony Price, Fiona Vasileiadis, Evangelos Holden, Melinda Hewitt, Jonathan Carpenter, Michael Needle, Ann Valentine, Stacey Patel, Farzana Harrington, Frances Mudd, Paul Emsley, Hedley Gregary, Bindu Kane, Ingrid Muir, Keith Tiwari, Divya Owusu-Agyei, Peter Temple, Natalie Sekaran, Lakshmanan Ragab, Suzanne England, Timothy Hedstrom, Amanda Jones, Phil Jones, Sarah Doherty, Mandy McCarron, Mark O. Cohen, David L. Tysoe, Sharon Al-Shahi Salman, Rustam
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Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study

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