Treatment fidelity in the Very Early Rehabilitation in SpEech (VERSE) randomised controlled trial: An exploration of treatment for aphasia
Date of Award
Doctor of Philosophy
School of Medical and Health Sciences
Associate Professor Natalie Ciccone
Associate Professor Erin Godecke
Field of Research Code
Aphasia is a neurological condition that affects the expression and/or comprehension of language and can have considerable impact on a person’s quality of life. Treatment for aphasia from speech language pathologists is effective. However, more information is needed on the nature of effective intervention including consideration for what therapy is provided, when it is commenced and how it is delivered. Treatment fidelity is concerned with ensuring research treatment protocols are implemented as they were intended, which assists in uncovering the specifics of how and why treatments work. When treatment fidelity is investigated thoroughly, researchers and research consumers can be confident of the research findings. Increased confidence in the highest level of evidence may improve research translation and ultimately improve the delivery of services to people with aphasia. Treatment fidelity within aphasia research is receiving increasing attention as greater rigour is applied to clinical trials. Each publication in this thesis addresses a different aspect of treatment fidelity within an aphasia randomised controlled trial including treatment integrity, differentiation, dosage and reporting of usual care therapy provision.
A published literature review of the reporting of treatment fidelity in aphasia randomised controlled trials is presented in Chapter Three. For the remaining studies, data was collected using an observational study design involving the analysis of therapy videos collected within the Very Early Rehabilitation in SpEech (VERSE) trial. VERSE was a multicentre randomised controlled trial that investigated whether intensive aphasia therapy was more effective and cost saving than usual care in very early aphasia recovery after stroke. Within the trial, therapists video recorded therapy sessions in the prescribed therapy conditions. Fifty three of these therapy videos were randomly selected comprising 12% of the total received in the trial. Therapy videos were transcribed and coded according to the aims of this thesis. Using this data, treatment differentiation and integrity is investigated statistically in Chapter Five. Dosage, is quantified by the number of active ingredients present within each session and is described using a model of cumulative intervention intensity in Chapter Six. In Chapter Seven, descriptive data is presented for the Usual Care-Plus therapy arm according to the Template for Intervention Description and Replication (TIDieR) statement
The literature review reports nine (21%) of forty-two aphasia randomised controlled trial articles explicitly reporting treatment fidelity. From the video analysis, therapists in the VERSE arm of the study were found to be highly adherent to the treatment protocol however, treatment differentiation between trial arms was not established in this sample. Total verbal utterances and cues used with success were independent positive predictors of outcome at six months post stroke and hypothesized as key therapeutic ingredients of the trial treatments. According to a model of cumulative intervention intensity, collectively, these key ingredients occurred over 10,000 times per participant during the treatment period. Usual care therapy provision according to the TIDieR statement was documented and showed considerable variability in task selection and therapists producing the majority of verbal utterances during sessions.
This thesis provides a detailed insight into the aphasia interventions delivered within the VERSE trial to assist in the interpretation of the trial outcomes. It documents the current status of treatment fidelity reporting in aphasia randomised controlled trials and provides recommendations for measuring treatment fidelity in future research. These include the suggestion that significant attention should be given to operationalising treatment fidelity procedures, using piloting to establish active ingredients, prior to the commencement of the main trial. This work also heightens the general understanding of therapy provision for aphasia. The challenge for further developing the methodology for measuring dosage in aphasia rehabilitation is set.
Access to this thesis is embargoed until June 1st, 2021.
Brogan, E. L. (2019). Treatment fidelity in the Very Early Rehabilitation in SpEech (VERSE) randomised controlled trial: An exploration of treatment for aphasia. https://ro.ecu.edu.au/theses/2264