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.
This retrospective observational analysis involved 1074 trial physiotherapists, nurses, and other clinicians working in 56 acute stroke hospitals in eight countries.
The study concluded that 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.
Authors: 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