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Observational Study
. 2015 Dec 11:351:h6432.
doi: 10.1136/bmj.h6432.

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

Julie Bernhardt  1 , Richard I Lindley  2 , Erin Lalor  3 , Fiona Ellery  4 , Jan Chamberlain  4 , John Van Holsteyn  5 , Janice M Collier  4 , Helen M Dewey  6 , Brooke Parsons  4 , Marjory Moodie  7 , Sheila Lennon  8 , Geoffrey A Donnan  9 , Amanda G Thrift  10 , Leonid Churilov  9 , Peter Langhorne  11 ; AVERT Collaboration Group
Collaborators, Affiliations
Observational Study

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

Julie Bernhardt et al. BMJ. .

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.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the NHMRC, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, UK Stroke Association, and UK National Institute of Health Research for the submitted work; AT received funding from the NHMRC (grant no 1042600), during the study; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Fig 1  Accumulated recruitment of patients and babies born during AVERT
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Fig 2  Case study from one selected trial site showing recruitment of patients, babies born to site investigators, and onsite training delivered
See this image and copyright information in PMC

References

    1. Bernhardt J, Dewey H, Collier Jet al. A Very Early Rehabilitation Trial (AVERT). Int J Stroke 2006;1: 169-71. 10.1111/j.1747-4949.2006.00044.x 18706042 - DOI - PubMed
    1. Bernhardt J, Churilov L, Dewey Het al.AVERT Collaborators. Statistical analysis plan (SAP) for A Very Early Rehabilitation Trial (AVERT): an international trial to determine the efficacy and safety of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset vs. usual stroke unit care. Int J Stroke 2015;10: 23-4. 10.1111/ijs.12423 25491547 - DOI - PubMed
    1. AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet 2015;386: 46-55. 10.1016/S0140-6736(15)60690-0 25892679 - DOI - PubMed
    1. Australian Institute of Health and Welfare. Nursing and Midwifery Workforce 2012. Canberra, Australia: 2013 Contract No: HWL 52.
    1. Australian Institute of Health and Welfare. Allied Health Workforce 2012. Canberra: 2013 Contract No: HWL 51.

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