• Julie Bernhardt, Richard I Lindley, Erin Lalor, Fiona Ellery, Jan Chamberlain, John Van Holsteyn, Janice M Collier, Helen M Dewey, Brooke Parsons, Marjory Moodie, Sheila Lennon, Geoffrey A Donnan, Amanda G Thrift, Leonid Churilov, Peter Langhorne, and AVERT Collaboration Group.
• NHMRC (National Health and Medical Research Council) Centre of Research Excellence in Stroke Rehabilitation and Brain Recovery and Head, Stroke Division, Florey Institute of Neuroscience and Mental Health, Heidelberg, VIC 3084, Australia Julie.Bernhardt@florey.edu.au.
• BMJ. 2015 Jan 1;351:h6432.

ObjectiveTo report the number of participants needed to recruit per baby born to trial staff during AVERT, a large international trial on acute stroke, and to describe trial management consequences.DesignRetrospective observational analysis.Setting56 acute stroke hospitals in eight countries.Participants1074 trial physiotherapists, nurses, and other clinicians.Outcome MeasuresNumber of babies born during trial recruitment per trial participant recruited.ResultsWith 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average.ConclusionThe staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group.Trial RegistrationAustralian New Zealand Clinical Trials Registry no 12606000185561.DisclaimerParticipation in a rehabilitation trial does not guarantee successful reproductive activity.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

33 keywords...

hide…