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Developing, monitoring, and reporting of fidelity in aphasia trials: Core recommendations from the collaboration of aphasia trialists (CATs) trials for aphasia panel
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Behn, Nicholas; Harrison, Madeleine; Brady, Marian C.; Breitenstein, Caterina; Carragher, Marcella; Fridriksson, Julius; Godecke, Erin; Hillis, Argye; Kelly, Helen; Palmer, Rebecca; Rose, Miranda L.; Thomas, Shirley; Tippett, Donna; Worrall, Linda; Becker, Frank; Hilari, Katerina
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In: Research outputs 2022 to 2026 (2022)
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Abstract:
Background: Developing, monitoring, and reporting of fidelity are essential and integral components to the design of randomised controlled trials (RCTs) in stroke and aphasia. Treatment fidelity refers to the degree to which an intervention is delivered as intended and is directly related to the quality of the evidence generated by RCTs. Clear documentation of treatment fidelity in trials assists in the evaluation of the clinical implications of potential benefits attributed to the intervention. Consideration of the implementation requirements of a research-based intervention as intended in a clinical context is necessary to achieve similar outcomes for a clinical population. Despite this, treatment fidelity is rarely reported in RCTs of aphasia intervention. Aim: To describe fidelity strategies and develop core recommendations for developing, monitoring, and reporting of fidelity in aphasia intervention RCTs. Scope: Relevant conceptual frameworks were considered. The Behaviour Change Consortium comprehensive framework of fidelity was adopted. It includes five areas: study design, training providers, delivery of treatment, treatment receipt, and treatment enactment. We explored fidelity in RCTs with a range of complex aphasia interventions (e.g., ASK, Big CACTUS, COMPARE, FCET2EC, POLAR, SUPERB, and VERSE) and described how different trial design factors (e.g., phase of trial, explanatory vs. pragmatic, number and location of sites, and number and type of treatment providers) influenced the fidelity strategies chosen. Strategies were mapped onto the five areas of the fidelity framework with a detailed exploration of how fidelity criteria were developed, measured, and monitored throughout each trial. This information was synthesised into a set of core recommendations to guide aphasia researchers towards the adequate measurement, capture, and reporting of fidelity within future aphasia intervention studies. Conclusions/Recommendations: Treatment fidelity should be a core consideration in planning an intervention trial, a concept that goes beyond treatment adherence alone. A range of strategies should be selected depending on the phase and design of the trial being undertaken and appropriate investment of time and costs should be considered.
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Keyword:
adherence; Aphasia; fidelity; Medicine and Health Sciences; recommendations; trials
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URL: https://ro.ecu.edu.au/cgi/viewcontent.cgi?article=1407&context=ecuworks2022-2026 https://ro.ecu.edu.au/ecuworks2022-2026/407
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ICT usage in aphasia rehabilitation – beliefs, biases, and influencing factors from the perspectives of speech and language therapists
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Self-reported feedback in ICT-delivered aphasia rehabilitation: a literature review
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Rating experience of ICT-delivered aphasia rehabilitation: co-design of a feedback questionnaire
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A core outcome set for aphasia treatment research: The ROMA consensus statement
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In: Research outputs 2014 to 2021 (2019)
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Self-reported feedback in ICT-delivered aphasia rehabilitation: a literature review ...
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Self-reported feedback in ICT-delivered aphasia rehabilitation: a literature review ...
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Internet delivery of intensive speech and language therapy for children with cerebral palsy: a pilot randomised controlled trial
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The methodological quality of short-term/working memory treatments in post-stroke aphasia: A systematic review
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Rating experience of ICT-delivered aphasia rehabilitation: co-design of a feedback questionnaire
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Perspectives on ICT-delivered aphasia rehabilitation: exploring feasibility, usability and acceptance of this mode of rehabilitation
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Self-reported feedback in ICT-delivered aphasia rehabilitation: a literature review
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Attention control comparisons with SLT for people with aphasia following stroke: methodological concerns raised following a systematic review ...
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supplementary_Material – Supplemental material for Attention control comparisons with SLT for people with aphasia following stroke: methodological concerns raised following a systematic review ...
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Attention control comparisons with SLT for people with aphasia following stroke: methodological concerns raised following a systematic review ...
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supplementary_Material – Supplemental material for Attention control comparisons with SLT for people with aphasia following stroke: methodological concerns raised following a systematic review ...
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Development of an ICT-delivered control programme for use in aphasia crossover intervention study
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Attention control comparisons with SLT for people with aphasia following stroke: methodological concerns raised following a systematic review
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Co-design of a feedback questionnaire for ICT-delivered aphasia rehabilitation
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A core outcome set for aphasia treatment research: the ROMA consensus statement
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