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Title: Exploring threats to generalisability in a large international rehabilitation trial (AVERT).
Austin Authors: Bernhardt, Julie;Raffelt, Audrey;Churilov, Leonid ;Lindley, Richard I;Speare, Sally;Ancliffe, Jacqueline;Katijjahbe, Md Ali;Hameed, Shahul;Lennon, Sheila;McRae, Anna;Tan, Dawn;Quiney, Jan;Williamson, Hannah C;Collier, Janice;Dewey, Helen M;Donnan, Geoffrey A ;Langhorne, Peter;Thrift, Amanda G
Affiliation: The Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia
Westmead Clinical School and The George Institute for Global Health, Westmead Hospital C24, Sydney, New South Wales, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Physiotherapy Unit, Medical Rehabilitation Services Department, UKM Medical Centre, Kuala Lumpur, Malaysia
Singapore General Hospital, Singapore, Singapore
School of Health Sciences, Flinders University, Repatriation General Hospital, Daw Park, South Australia, Australia
Community and Long Term Conditions Directorate, Auckland District Health Board, Auckland City Hospital, Auckland, New Zealand
Department of Physiotherapy, Singapore General Hospital, Singapore, Singapore
Royal Melbourne Hospital, Parkville, Victoria, Australia
Department of Physiotherapy, Austin Health, Heidelberg, Victoria, Australia
Florey Institute of Neuroscience and Mental Health, and Faculty of Medicine, Nursing and Health Sciences, Monash University, Box Hill Hospital, Box Hill, Victoria, Australia
Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK
School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia
Issue Date: 17-Aug-2015
Date: 2015-08-17
Publication information: BMJ Open 2015; 5(8): e008378
Abstract: 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). AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT. Acute stroke units at 44 hospitals in 8 countries. The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised. 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. 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). 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. Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and (NCT01846247).
DOI: 10.1136/bmjopen-2015-008378
ORCID: 0000-0002-9807-6606
Journal: BMJ Open
PubMed URL: 26283667
Type: Journal Article
Subjects: Generalisability
Proximal Similarity Model
Randomised Control Trial
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