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




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Trials

, 18:162

First Online: 05 April 2017Received: 04 October 2016Accepted: 18 March 2017DOI: 10.1186-s13063-017-1909-4

Cite this article as: Maxwell, A.E., MacLeod, M.J., Joyson, A. et al. Trials 2017 18: 162. doi:10.1186-s13063-017-1909-4

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.

KeywordsStroke Intracerebral haemorrhage Recruitment Screening log AbbreviationsCIChief Investigator

ICHIntracerebral haemorrhage

RCTRandomised controlled trial

RESTARTREstart or STop Antithrombotics Randomised Trial





Author: Amy E. Maxwell - Mary Joan MacLeod - Anu Joyson - Sharon Johnson - Hawraman Ramadan - Ruth Bellfield - Anthony Byrne - Ca

Source: https://link.springer.com/







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