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

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

Trials, April 2017

28381307

Amy E. Maxwell, Mary Joan MacLeod, Anu Joyson, Sharon Johnson, Hawraman Ramadan, Ruth Bellfield, Anthony Byrne, Caroline McGhee, Anthony Rudd, Fiona Price, Evangelos Vasileiadis, Melinda Holden, Jonathan Hewitt, Michael Carpenter, Ann Needle, Stacey Valentine, Farzana Patel, Frances Harrington, Paul Mudd, Hedley Emsley, Bindu Gregary, Ingrid Kane, Keith Muir, Divya Tiwari, 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

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.