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失语症干预可行性试验中的治疗保真度:虚拟精细语义特征分析

Treatment Fidelity in a Feasibility Trial of the Aphasia Intervention, Virtual Elaborated Semantic Feature Analysis.

作者信息

Devane Niamh, Mazzoleni Sofia, Behn Nicholas, Marshall Jane, Wilson Stephanie, Hilari Katerina

机构信息

Department of Language and Communication Science, City St George's, University of London, London, UK.

East London NHS Foundation Trust, London, UK.

出版信息

Int J Lang Commun Disord. 2025 May-Jun;60(3):e70054. doi: 10.1111/1460-6984.70054.

Abstract

BACKGROUND AND AIMS

The reliability and validity of an intervention can be improved by checking treatment fidelity (TF). TF methods identify core components of an intervention, check their presence (or absence) and identify threats to fidelity. The Virtual Elaborated Semantic Feature Analysis (VESFA) intervention comprised individual sessions of word-finding treatment and group sessions of conversation practice. All sessions were delivered in the virtual world of EVA Park. This paper describes the TF in the VESFA trial that explored (1) if the treatment was delivered as planned, (2) which components influenced treatment adherence scores and (3) the reliability of the fidelity checklists.

METHODS AND PROCEDURES

Strategies to improve fidelity were employed in the study design, the delivery of treatment, treatment receipt and treatment enactment. Two fidelity checklists were developed with input from advisors with aphasia to establish the core components of the intervention (individual and group). During the trial, treatment sessions were video-recorded. A sample of 20% of sessions was randomly selected for adherence rating. Seven research students were trained to rate the videos using the fidelity checklists. Inter- and intra-rater reliability was established.

OUTCOMES AND RESULTS

Study design strategies ensured 94% of sessions ran as planned and 75% of participants (12/16) received over 90% (>36/40h) of the intended dose. The average TF across all sessions rated was 81%, demonstrating a high degree of fidelity in the delivery of the VESFA intervention. The fidelity of the individual sessions was lower (78%) than the group elements (84%). The components that most threatened treatment adherence were (1) providing a rationale for the activities and (2) specific feedback for performance. Nevertheless, participants consistently practised target words both in individual sessions and in conversations in the group sessions, demonstrating treatment receipt. Ninety-four percent of participants (14/15) reported the words and phrases practiced in EVA Park were used in real-world conversations, indicating treatment enactment. The fidelity checklists were reliable: Inter-rater reliability was moderate (average Kappa of 0.76) and intra-rater reliability was strong (average Kappa of 0.89).

CONCLUSIONS AND IMPLICATIONS

A range of TF strategies were embedded within the trial protocol leading to high adherence to the core components of the VESFA intervention. Findings add to the evidence that aphasia therapies can be administered faithfully within the virtual environment of EVA Park.

TRIAL REGISTRATION

The feasibility trial was not registered.

WHAT THIS PAPER ADDS

What is already known on this subject Monitoring treatment fidelity improves both internal and external validity. Reports of treatment fidelity from aphasia trials are increasing, but the guidance is not yet applied uniformly. What this study add to the existing knowledge This study demonstrates how treatment fidelity guidance has been applied across a range of fidelity areas to monitor and support a feasibility trial of a novel aphasia intervention. It is a rare reporting of strategies to monitor treatment enactment. What are the potential or actual clinical implications of this study? This study adds to the evidence base for the VESFA intervention, demonstrating that the intervention can be delivered faithfully to the manual. It builds on the evidence base for treatment fidelity monitoring in aphasia, broadening the strategies to improve the validity of interventions.

摘要

背景与目的

通过检查治疗保真度(TF)可提高干预措施的可靠性和有效性。TF方法可识别干预措施的核心组成部分,检查其是否存在,并识别对保真度的威胁。虚拟精细语义特征分析(VESFA)干预包括单词查找治疗的个体疗程和对话练习的小组疗程。所有疗程均在EVA Park的虚拟世界中进行。本文描述了VESFA试验中的TF情况,该试验探讨了(1)治疗是否按计划实施,(2)哪些组成部分影响治疗依从性评分,以及(3)保真度检查表的可靠性。

方法与程序

在研究设计、治疗实施、治疗接受和治疗执行过程中采用了提高保真度的策略。在失语症顾问的参与下制定了两份保真度检查表,以确定干预措施(个体和小组)的核心组成部分。在试验期间,对治疗疗程进行录像。随机抽取20%的疗程样本进行依从性评分。7名研究学生接受培训,使用保真度检查表对视频进行评分。建立了评分者间和评分者内的可靠性。

结果

研究设计策略确保94%的疗程按计划进行,75%的参与者(12/16)接受了超过90%(>36/40小时)的预期剂量。所有评分疗程的平均TF为81%,表明VESFA干预的实施具有高度保真度。个体疗程的保真度(78%)低于小组部分(84%)。最威胁治疗依从性的组成部分是(1)为活动提供理论依据和(2)对表现的具体反馈。然而,参与者在个体疗程和小组疗程的对话中都持续练习目标单词,表明接受了治疗。94%的参与者(14/15)报告在EVA Park练习的单词和短语在现实世界对话中被使用,表明治疗得到执行。保真度检查表是可靠的:评分者间可靠性为中等(平均Kappa值为0.76),评分者内可靠性较强(平均Kappa值为0.89)。

结论与启示

一系列TF策略被纳入试验方案,导致对VESFA干预核心组成部分的高度依从。研究结果进一步证明失语症治疗可以在EVA Park的虚拟环境中如实地实施。

试验注册

可行性试验未注册。

本文补充内容

关于该主题的已知信息 监测治疗保真度可提高内部和外部效度。失语症试验中关于治疗保真度的报告在增加,但指导尚未统一应用。本研究对现有知识的补充 本研究展示了如何在一系列保真度领域应用治疗保真度指导,以监测和支持一项新型失语症干预的可行性试验。这是罕见的关于监测治疗执行策略的报告。本研究的潜在或实际临床意义是什么?本研究为VESFA干预增加了证据基础,表明该干预可以如实地按照手册实施。它建立在失语症治疗保真度监测的证据基础上,拓宽了提高干预效度所需的策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a243/12099486/2873d8880691/JLCD-60-0-g002.jpg

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