Exploring threats to generalisability in a large international rehabilitation trial (AVERT)

Bernhardt, J. et al. (2015) Exploring threats to generalisability in a large international rehabilitation trial (AVERT). BMJ Open, 5(8), e008378. (doi: 10.1136/bmjopen-2015-008378) (PMID:26283667) (PMCID:PMC4550737)

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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Langhorne, Professor Peter
• Authors: Bernhardt, J., Raffelt, A., Churilov, L., Lindley, R. I., Speare, S., Ancliffe, J., Katijjahbe, M. A., Hameed, S., Lennon, S., McRae, A., Tan, D., Quiney, J., Williamson, H. C., Collier, J., Dewey, H. M., Donnan, G. A., Langhorne, P., and Thrift, A. G.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: BMJ Open
• Publisher: BMJ Publishing Group
• ISSN: 2044-6055
• ISSN (Online): 2044-6055
• Copyright Holders: Copyright © 2015 Bernhardt J, et al.
• First Published: First published in BMJ Open 5(8):e008378
• Publisher Policy: Reproduced under a Creative Commons License