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AVERT2 (a very early rehabilitation trial, a very effective reproductive trigger): retrospective observational analysis of the number of babies born to trial staff

Bernhardt J 1 , Lindley RI 2 , Lalor E 3 , Ellery F 4 , Chamberlain J 4 , Van Holsteyn J 5 Show all authors , Collier JM 4 , Dewey HM 6 , Parsons B 4 , Moodie M 7 , Lennon S 8 , Donnan GA 9 , Thrift AG 10 , Churilov L 9 , Langhorne P 11 , AVERT Collaboration Group

Affiliations 

  • 1 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
  • 2 George Institute for Global Health and Westmead Hospital Clinical School, University of Sydney, NSW, Australia
  • 3 National Stroke Foundation, Melbourne, VIC, Australia
  • 4 Florey Institute of Neuroscience and Mental Health, Heidelberg
  • 5 School of Nursing and Midwifery, La Trobe University, Melbourne
  • 6 Eastern Health Clinical School, Monash University, Box Hill, VIC, Australia
  • 7 Deakin Health Economics, Faculty of Health, Deakin University, Burwood, VIC, Australia
  • 8 Flinders University, Health Sciences Building, Repatriation General Hospital, Adelaide, SA, Australia
  • 9 Florey Institute of Neuroscience and Mental Health, Parkville, VIC, Australia
  • 10 Stroke and Ageing Research Centre, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia
  • 11 University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK
BMJ, 2015 Dec 11;351:h6432.
PMID: 26658193 DOI: 10.1136/bmj.h6432

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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