Evidence map›Paper›PMID 36273182›Full record

ArticleTrials2022

Statistical analysis plan for the stepped wedge clinical trial Healing Right Way-enhancing rehabilitation services for Aboriginal Australians after brain injury.

Elizabeth Armstrong, Tapan Rai, Deborah Hersh, Sandra Thompson, Juli Coffin, Natalie Ciccone, Leon Flicker, Dominique Cadilhac, Erin Godecke, Deborah Woods and 4 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 47% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Trial
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

14 authors at 7 institutions in 1 country.

Elizabeth ArmstrongSchool of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027, Australia. b.armstrong@ecu.edu.au.ORCID http://orcid.org/0000-0003-4469-1117
Tapan RaiSchool of Mathematical and Physical Sciences, University of Technology Sydney, Broadway, Australia.
Deborah HershCurtin School of Allied Health, Curtin University, Perth, Australia.
Sandra ThompsonWestern Australian Centre for Rural Health, University of Western Australia, Geraldton, Australia.
Juli CoffinTelethon Kids Institute, Broome, Australia.
Natalie CicconeSchool of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA, 6027, Australia.
Leon FlickerMedical School, University of Western Australia, Perth, Australia.
Dominique CadilhacSchool of Clinical Sciences, Monash University, Melbourne, Australia.
Erin GodeckeSchool of Medical and Health Sciences, Edith Cowan University and Sir Charles Gairdner and Osborne Park Healthcare Group, Perth, Australia.
Deborah WoodsGeraldton Regional Aboriginal Medical Service, Geraldton, Australia.
Colleen HaywardCentre for Indigenous Australian Education and Research, Kurongkurl Katitjin, Australia Edith Cowan University, Perth, Australia.
Graeme J HankeyMedical School, Faculty of Medical and Health Sciences, University of Western Australia, Perth, Australia.
Meaghan McAllisterSchool of Medical and Health Sciences, Edith Cowan University, Perth, Australia.
Judith KatzenellenbogenSchool of Population and Global Health, University of Western Australia, Perth, Australia.
Edith Cowan University · AUThe University of Western Australia · AUCurtin University · AUMonash University · AUTharawal Aboriginal · AUThe Kids Research Institute Australia · AUUniversity of Technology Sydney · AU

Funding

National Health and Medical Research Council Australia 1132468Royal Perth Hospital Medical Research Foundation 1132468Western Australian Department of Health 1132468
6 · The paper itself

Abstract

backgroundAboriginal Australians are known to suffer high levels of acquired brain injury (stroke and traumatic brain injury) yet experience significant barriers in accessing rehabilitation services. The aim of the Healing Right Way trial is to evaluate a culturally secure intervention for Aboriginal people with newly acquired brain injury to improve their rehabilitation experience and quality of life. Following publication of the trial protocol, this paper outlines the statistical analysis plan prior to locking the database. 

methodsThe trial involves a stepped wedge design with four steps over 3 years. Participants were 108 adult Aboriginal Australians admitted to one of eight hospitals (four rural, four urban) in Western Australia within 6 weeks of onset of a new stroke or traumatic brain injury who consented to follow-up for 26 weeks. All hospital sites started in a control phase, with the intervention assigned to pairs of sites (one metropolitan, one rural) every 26 weeks until all sites received the intervention. The two-component intervention involves training in culturally safe care for hospital sites and enhanced support provided to participants by Aboriginal Brain Injury Coordinators during their hospital stay and after discharge. The primary outcome is quality of life as measured by the Euro QOL-5D-3L VAS. A mixed effects linear regression model will be used to assess the between-group difference at 26 weeks post-injury. The model will control for injury type and severity, age at recruitment and time since commencement of the trial, as fixed effects. Recruitment site and participant will be included as random effects. Secondary outcomes include measurements of function, independence, anxiety and depression, carer strain, allied health occasions of service received and hospital compliance with minimum processes of care based on clinical guidelines and best practice models of care. DISCUSSION: The trial will provide the first data surrounding the effectiveness of an intervention package for Aboriginal people with brain injury and inform future planning of rehabilitation services for this population. The statistical analysis plan outlines the analyses to be undertaken.

trial registrationAustralia New Zealand Clinical Trials Registry ACTRN12618000139279. Registered 30 January, 2018.

Indexed as

Brain Injuries, TraumaticStrokeAdultAustraliaClinical Trials as TopicHumansQuality of LifeAboriginalBrain injuryRehabilitationStatistical analysis planStepped wedge randomised control trialStroke

Identifiers

PMID36273182
PMCPMC9587581
OpenAlexW4307135329

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.