title: AVERT2 (a very early rehabilitation trial, a very effective reproductive trigger): retrospective observational analysis of the number of babies born to trial staff.
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.
  
  
  METHODS
  Retrospective observational analysis.
  
  
  METHODS
  56 acute stroke hospitals in eight countries.
  
  
  METHODS
  1074 trial physiotherapists, nurses, and other clinicians.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry no 12606000185561.
  
  
  CONCLUSIONS
  Participation in a rehabilitation trial does not guarantee successful reproductive activity.
authors.affiliation: 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.
authors.forename: Julie
authors.initials: J
authors.lastname: Bernhardt
authors.affiliation: George Institute for Global Health and Westmead Hospital Clinical School, University of Sydney, NSW, Australia.
authors.forename: Richard I
authors.initials: RI
authors.lastname: Lindley
authors.affiliation: National Stroke Foundation, Melbourne, VIC, Australia.
authors.forename: Erin
authors.initials: E
authors.lastname: Lalor
authors.affiliation: Florey Institute of Neuroscience and Mental Health, Heidelberg.
authors.forename: Fiona
authors.initials: F
authors.lastname: Ellery
authors.affiliation: Florey Institute of Neuroscience and Mental Health, Heidelberg.
authors.forename: Jan
authors.initials: J
authors.lastname: Chamberlain
authors.affiliation: School of Nursing and Midwifery, La Trobe University, Melbourne.
authors.forename: John
authors.initials: J
authors.lastname: Van Holsteyn
authors.affiliation: Florey Institute of Neuroscience and Mental Health, Heidelberg.
authors.forename: Janice M
authors.initials: JM
authors.lastname: Collier
authors.affiliation: Eastern Health Clinical School, Monash University, Box Hill, VIC, Australia.
authors.forename: Helen M
authors.initials: HM
authors.lastname: Dewey
authors.affiliation: Florey Institute of Neuroscience and Mental Health, Heidelberg.
authors.forename: Brooke
authors.initials: B
authors.lastname: Parsons
authors.affiliation: Deakin Health Economics, Faculty of Health, Deakin University, Burwood, VIC, Australia.
authors.forename: Marjory
authors.initials: M
authors.lastname: Moodie
authors.affiliation: Flinders University, Health Sciences Building, Repatriation General Hospital, Adelaide, SA, Australia.
authors.forename: Sheila
authors.initials: S
authors.lastname: Lennon
authors.affiliation: Florey Institute of Neuroscience and Mental Health, Parkville, VIC, Australia.
authors.forename: Geoffrey A
authors.initials: GA
authors.lastname: Donnan
authors.affiliation: Stroke and Ageing Research Centre, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
authors.forename: Amanda G
authors.initials: AG
authors.lastname: Thrift
authors.affiliation: Florey Institute of Neuroscience and Mental Health, Parkville, VIC, Australia.
authors.forename: Leonid
authors.initials: L
authors.lastname: Churilov
authors.affiliation: University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Langhorne
mesh_terms: D000328:Adult; D001315:Australia / Q000453:epidemiology; D001723:Birth Rate / Q000639:trends*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008296:Malaysia / Q000453:epidemiology; D008297:Male; D009520:New Zealand / Q000453:epidemiology; D018579:Patient Selection; D011247:Pregnancy; D016032:Randomized Controlled Trials as Topic; D012108:Research Personnel / Q000706:statistics & numerical data*; D012189:Retrospective Studies; D012846:Singapore / Q000453:epidemiology; D000071939:Stroke Rehabilitation; D006113:United Kingdom / Q000453:epidemiology