AVERT2 (a very early rehabilitation trial, a very effective reproductive trigger): retrospective observational analysis of the number of babies born to trial staff [AVERT2（具有很好生育触发效果的早期复原试验）：试验人员与出生婴儿数量的回顾性观察分析]

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BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h6432 (Published 11 December 2015)
Cite this as: BMJ 2015;351:h6432

Authors
Julie Bernhardt, director, Richard I Lindley, professor of geriatric medicine, Erin Lalor, chief executive officer, Fiona Ellery, AVERT trial manager, Jan Chamberlain, CRE program manager, John Van Holsteyn, honorary associate, Janice M Collier, AVERT data manager, Helen M Dewey, director of neurosciences, Brooke Parsons, AVERT consumer representative, Marjory Moodie, deputy head (research), Sheila Lennon, head of physiotherapy, Geoffrey A Donnan, director, Amanda G Thrift, head of epidemiology and prevention division, Leonid Churilov, head of statistics and informatics platform, Peter Langhorne, professor of stroke care on behalf of the AVERT Collaboration Group

Abstract
Objective: To 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.

Design: Retrospective observational analysis.

Setting: 56 acute stroke hospitals in eight countries.

Participants: 1074 trial physiotherapists, nurses, and other clinicians.

Outcome measures: Number of babies born during trial recruitment per trial participant recruited.

Results: With 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.

Conclusion: The 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 registration: Australian New Zealand Clinical Trials Registry no 12606000185561.

Disclaimer: Participation in a rehabilitation trial does not guarantee successful reproductive activity.