Evidence map›Paper›PMID 26283667›Full record

Trial reportBMJ open2015

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

Julie Bernhardt, Audrey Raffelt, Leonid Churilov, Richard I Lindley, Sally Speare, Jacqueline Ancliffe, Md Ali Katijjahbe, Shahul Hameed, Sheila Lennon, Anna McRae and 9 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01846247 (A Phase 3, Multicentre, Randomised Controlled Trial of Very Early Rehabilitation After Stroke.), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01846247 nacompletednot on this map

A Phase 3, Multicentre, Randomised Controlled Trial of Very Early Rehabilitation After Stroke.

TypeinterventionalSponsorNeuroscience Trials AustraliaRan2006 to 2015Enrolled2,014ConditionsStrokeArmsStandard Care + VEM, Standard care
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Very early versus delayed mobilisation after stroke.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Julie BernhardtFlorey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia.
Audrey RaffeltFlorey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia.
Leonid ChurilovFlorey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia.
Richard I LindleyWestmead Clinical School and The George Institute for Global Health, Westmead Hospital C24, Sydney, New South Wales, Australia.
Sally SpeareFlorey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia.
Jacqueline AncliffeRoyal Perth Hospital, Perth, Western Australia, Australia.
Md Ali KatijjahbePhysiotherapy Unit, Medical Rehabilitation Services Department, UKM Medical Centre, Kuala Lumpur, Malaysia.
Shahul HameedSingapore General Hospital, Singapore, Singapore.
Sheila LennonSchool of Health Sciences, Flinders University, Repatriation General Hospital, Daw Park, South Australia, Australia.
Anna McRaeCommunity and Long Term Conditions Directorate, Auckland District Health Board, Auckland City Hospital, Auckland, New Zealand.
Dawn TanDepartment of Physiotherapy, Singapore General Hospital, Singapore, Singapore.
Jan QuineyRoyal Melbourne Hospital, Parkville, Victoria, Australia.
Hannah C WilliamsonDepartment of Physiotherapy, Austin Health, Austin Hospital, Heidelberg, Victoria, Australia.
Janice CollierFlorey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia.
Helen M DeweyFlorey Institute of Neuroscience and Mental Health, and Faculty of Medicine, Nursing and Health Sciences, Monash University, Box Hill Hospital, Box Hill, Victoria, Australia.
Geoffrey A DonnanFlorey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia.
Peter LanghorneInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Amanda G ThriftSchool of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia.
AVERT Trialists’ Collaboration

Funding

Department of Health 12/01/16
6 · The paper itself

Abstract

objectiveThe 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).

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

settingAcute stroke units at 44 hospitals in 8 countries.

participantsThe 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.

resultsThe 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).

conclusionsA 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).

Indexed as

Patient SelectionStroke RehabilitationAgedAged, 80 and overAustraliaFemaleHospitalsHumansMalaysiaMaleMiddle AgedNew ZealandProspective StudiesResearch DesignSeverity of Illness IndexSingaporeGeneralisabilityProximal Similarity ModelRandomised Control TrialRehabilitation

Identifiers

PMID26283667
PMCPMC4550737

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.