Evidence map›Paper›PMID 35710437›Full record

Trial reportTrials2022

Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial.

Erin Godecke, Emily Brogan, Natalie Ciccone, Miranda L Rose, Elizabeth Armstrong, Anne Whitworth, Fiona Ellery, Audrey Holland, Sandy Middleton, Tapan Rai and 3 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 42% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

13 authors at 9 institutions in 2 countries.

Erin GodeckeSchool of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Dve, Joondalup, Western Australia, 6027, Australia. e.godecke@ecu.edu.au.ORCID http://orcid.org/0000-0002-7210-1295
Emily BroganSchool of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Dve, Joondalup, Western Australia, 6027, Australia.
Natalie CicconeSchool of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Dve, Joondalup, Western Australia, 6027, Australia.
Miranda L RoseCentre of Research Excellence in Aphasia Rehabilitation Recovery, Melbourne, Victoria, Australia.
Elizabeth ArmstrongSchool of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Dve, Joondalup, Western Australia, 6027, Australia.
Anne WhitworthCurtin University, Perth, Western Australia, Australia.
Fiona ElleryStroke Division, The Florey Institute of Neuroscience and Mental Health, Melbourne, Victoria, Australia.
Audrey HollandUniversity of Arizona, Tucson, Arizona, USA.
Sandy MiddletonCentre of Research Excellence in Aphasia Rehabilitation Recovery, Melbourne, Victoria, Australia.
Tapan RaiUniversity of Technology Sydney, Sydney, New South Wales, Australia.
Graeme J HankeySchool of Medicine and Pharmacology, The University of Western Australia, Perth, Australia.
Dominique CadilhacCentre of Research Excellence in Aphasia Rehabilitation Recovery, Melbourne, Victoria, Australia.
Julie BernhardtCentre of Research Excellence in Aphasia Rehabilitation Recovery, Melbourne, Victoria, Australia.
Edith Cowan University · AUFlorey Institute of Neuroscience and Mental Health · AUCurtin University · AULa Trobe University · AUMonash University · AUSt Vincent's Health · AUThe University of Western Australia · AUUniversity of Arizona · USUniversity of Technology Sydney · AU

Funding

National Health and Medical Research Council 1044973
6 · The paper itself

Abstract

backgroundTreatment fidelity is inconsistently reported in aphasia research, contributing to uncertainty about the effectiveness of types of aphasia therapy following stroke. We outline the processes and outcomes of treatment fidelity monitoring in a pre-specified secondary analysis of the VERSE trial.

methodsVERSE was a 3-arm, single-blinded RCT with a 12-week primary endpoint comparing Usual Care (UC) to two higher intensity treatments: Usual Care-Plus (UC-Plus) and VERSE, a prescribed intervention. Primary outcome results were previously reported. This secondary analysis focused on treatment fidelity. Video-recorded treatment sessions in the higher intensity study arms were evaluated for treatment adherence and treatment differentiation. Treatment components were evaluated using a pre-determined fidelity checklist. PRIMARY OUTCOME: prescribed amount of therapy time (minutes); secondary outcomes: (i) adherence to therapy protocol (%) and (ii) treatment differentiation between control and high intensity groups.

resultsTwo hundred forty-six participants were randomised to Usual Care (n=81), Usual Care-Plus (n=82), and VERSE (n=83). One hundred thirty-five (82%) participants in higher intensity intervention arms received the minimum prescribed therapy minutes. From 10,805 (UC 7787; UC-Plus 1450; VERSE 1568) service events, 431 treatment protocol deviations were noted in 114 participants. Four hundred thirty-seven videos were evaluated. The VERSE therapists achieved over 84% adherence to key protocol elements. Higher stroke and aphasia severity, older age, and being in the UC-Plus group predicted more treatment deviations.

conclusionsWe found high levels of treatment adherence and differentiation between the intervention arms, providing greater confidence interpreting our results. The comprehensive systems for intervention fidelity monitoring and reporting in this trial make an important contribution to aphasia research and, we argue, should set a new standard for future aphasia studies.

trial registrationACTRN 12613000776707.

Indexed as

AphasiaStrokeStroke RehabilitationHumansSpeechSpeech TherapyAphasiaBehavioural therapyRandomised control trialRehabilitationStrokeTreatment fidelity

Identifiers

PMID35710437
PMCPMC9204960
OpenAlexW4283022495

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.