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Neurology
Research
Exploring threats to generalisability in a large international rehabilitation trial (AVERT)
  1. Julie Bernhardt1,
  2. Audrey Raffelt1,
  3. Leonid Churilov1,
  4. Richard I Lindley2,
  5. Sally Speare1,
  6. Jacqueline Ancliffe3,
  7. Md Ali Katijjahbe4,
  8. Shahul Hameed5,
  9. Sheila Lennon6,
  10. Anna McRae7,
  11. Dawn Tan8,
  12. Jan Quiney9,
  13. Hannah C Williamson10,
  14. Janice Collier1,
  15. Helen M Dewey11,
  16. Geoffrey A Donnan12,
  17. Peter Langhorne13,
  18. Amanda G Thrift14
  19. on behalf of the AVERT Trialists’ Collaboration
  1. 1Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia
  2. 2Westmead Clinical School and The George Institute for Global Health, Westmead Hospital C24, Sydney, New South Wales, Australia
  3. 3Royal Perth Hospital, Perth, Western Australia, Australia
  4. 4Physiotherapy Unit, Medical Rehabilitation Services Department, UKM Medical Centre, Kuala Lumpur, Malaysia
  5. 5Singapore General Hospital, Singapore, Singapore
  6. 6School of Health Sciences, Flinders University, Repatriation General Hospital, Daw Park, South Australia, Australia
  7. 7Community and Long Term Conditions Directorate, Auckland District Health Board, Auckland City Hospital, Auckland, New Zealand
  8. 8Department of Physiotherapy, Singapore General Hospital, Singapore, Singapore
  9. 9Royal Melbourne Hospital, Parkville, Victoria, Australia
  10. 10Department of Physiotherapy, Austin Health, Austin Hospital, Heidelberg, Victoria, Australia
  11. 11Florey Institute of Neuroscience and Mental Health, and Faculty of Medicine, Nursing and Health Sciences, Monash University, Box Hill Hospital, Box Hill, Victoria, Australia
  12. 12Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia
  13. 13Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK
  14. 14School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia
  1. Correspondence to Dr Julie Bernhardt; julie.bernhardt{at}florey.edu.au

Abstract

Objective The purpose of this paper is to examine potential threats to generalisability of the results of a multicentre randomised controlled trial using data from A Very Early Rehabilitation Trial (AVERT).

Design AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.

Setting Acute stroke units at 44 hospitals in 8 countries.

Participants The first 20 000 patients screened for AVERT, of whom 1158 were recruited and randomised.

Model We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.

Results The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).

Conclusions A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.

Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).

  • Generalisability
  • Rehabilitation
  • Randomised Control Trial
  • Proximal Similarity Model

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2015-008378

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