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测量失语症试验中的沟通情况作为核心结局指标:ROMAA-2 国际核心结局集开发会议的结果。

Measuring communication as a core outcome in aphasia trials: Results of the ROMA-2 international core outcome set development meeting.

机构信息

School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, QLD, Australia.

Queensland Aphasia Research Centre, Brisbane, QLD, Australia.

出版信息

Int J Lang Commun Disord. 2023 Jul-Aug;58(4):1017-1028. doi: 10.1111/1460-6984.12840. Epub 2022 Dec 30.


DOI:10.1111/1460-6984.12840
PMID:36583427
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10946976/
Abstract

BACKGROUND: Evidence-based recommendations for a core outcome set (COS; minimum set of outcomes) for aphasia treatment research have been developed (the Research Outcome Measurement in Aphasia-ROMA, COS). Five recommended core outcome constructs: communication, language, quality of life, emotional well-being and patient-reported satisfaction/impact of treatment, were identified through three international consensus studies. Constructs were paired with outcome measurement instruments (OMIs) during an international consensus meeting (ROMA-1). Before the current study (ROMA-2), agreement had not been reached on OMIs for the constructs of communication or patient-reported satisfaction/impact of treatment. AIM: To establish consensus on a communication OMI for inclusion in the ROMA COS. METHODS & PROCEDURES: Research methods were based on recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Participants with expertise in design and conduct of aphasia trials, measurement instrument development/testing and/or communication outcome measurement were recruited through an open call. Before the consensus meeting, participants agreed on a definition of communication, identified appropriate OMIs, extracted their measurement properties and established criteria for their quality assessment. During the consensus meeting they short-listed OMIs and participants without conflicts of interest voted on the two most highly ranked instruments. Consensus was defined a priori as agreement by ≥ 70% of participants. OUTCOMES & RESULTS: In total, 40 researchers from nine countries participated in ROMA-2 (including four facilitators and three-panel members who participated in pre-meeting activities only). A total of 20 OMIs were identified and evaluated. Eight short-listed communication measures were further evaluated for their measurement properties and ranked. Participants in the consensus meeting (n = 33) who did not have conflicts of interest (n = 29) voted on the top two ranked OMIs: The Scenario Test (TST) and the Communication Activities of Daily Living-3 (CADL-3). TST received 72% (n = 21) of 'yes' votes and the CADL-3 received 28% (n = 8) of 'yes' votes. CONCLUSIONS & IMPLICATIONS: Consensus was achieved that TST was the preferred communication OMI for inclusion in the ROMA COS. It is currently available in the original Dutch version and has been adapted into English, German and Greek. Further consideration must be given to the best way to measure communication in people with mild aphasia. Development of a patient-reported measure for satisfaction with/impact of treatment and multilingual versions of all OMIs of the COS is still required. Implementation of the ROMA COS would improve research outcome measurement and the quality, relevance, transparency, replicability and efficiency of aphasia treatment research. WHAT THIS PAPER ADDS: What is already known on this subject International consensus has been reached on five core constructs to be routinely measured in aphasia treatment studies. International consensus has also been established for OMIs for the three constructs of language, quality of life and emotional well-being. Before this study, OMIs for the constructs of communication and patient-reported satisfaction/impact of treatment were not established. What this paper adds to existing knowledge We gained international consensus on an OMI for the construct of communication. TST is recommended for inclusion in the ROMA COS for routine use in aphasia treatment research. What are the potential or actual clinical implications of this work? The ROMA COS recommends OMIs for a minimum set of outcomes for adults with post-stroke aphasia within phases I-IV aphasia treatment research. Although not intended for clinical use, clinicians may employ the instruments of the ROMA COS, considering the quality of their measurement properties. The systematic inclusion of a measure of communication, such as TST, in clinical practice could ultimately support the implementation of research evidence and best practices.

摘要

背景:已经制定了(研究结果测量在失语症中的应用-核心结局测量集,COS)针对失语症治疗研究的核心结局集(最小结局集)的循证建议。通过三项国际共识研究,确定了五个推荐的核心结局结构:沟通、语言、生活质量、情绪健康和患者报告的治疗满意度/影响。在国际共识会议(ROMA-1)期间,通过国际共识研究确定了与沟通或患者报告的治疗满意度/影响的结构相匹配的结局测量工具(OMI)。在目前的研究(ROMA-2)之前,尚未就沟通或患者报告的治疗满意度/影响的结构达成 OMIs 的一致意见。

目的:为包括在 ROMA COS 中的沟通 OMI 建立共识。

方法和程序:研究方法基于核心结局测量在有效性试验(COMET)倡议中的建议。通过公开征集,招募了在失语症试验设计和实施、测量工具开发/测试和/或沟通结局测量方面具有专业知识的参与者。在共识会议之前,参与者就沟通的定义达成一致,确定了适当的 OMIs,提取了他们的测量特性,并为其质量评估建立了标准。在共识会议期间,他们对 OMIs 进行了筛选,没有利益冲突的参与者投票选出了排名前两位的仪器。共识的定义是:≥70%的参与者表示同意。

结果:共有来自九个国家的 40 名研究人员参加了 ROMA-2(包括四名促进者和三名仅参加会前活动的小组成员)。共确定了 20 个 OMI 并进行了评估。进一步评估了 8 个短名单沟通措施的测量特性并进行了排名。在共识会议上(n=33)没有利益冲突的参与者(n=29)对排名前两位的 OMIs 进行了投票:情景测试(TST)和日常生活沟通活动-3(CADL-3)。TST 获得了 72%(n=21)的“是”票,CADL-3 获得了 28%(n=8)的“是”票。

结论和影响:已经达成共识,TST 是首选的沟通 OMI,包括在 ROMA COS 中。它目前有荷兰语的原始版本,并已被翻译成英语、德语和希腊语。在轻度失语症患者中,还需要进一步考虑如何最好地测量沟通。还需要制定一个关于治疗满意度/影响的患者报告测量工具,并开发所有 COS 的 OMIs 的多语言版本。实施 ROMA COS 将改善失语症治疗研究的研究结果测量以及质量、相关性、透明度、可重复性和效率。

本文的新增内容:关于这个主题已经知道了什么国际共识已经达成,即要在失语症治疗研究中常规测量五个核心结构。国际共识也已经确定了语言、生活质量和情绪健康这三个结构的 OMIs。在此研究之前,沟通和患者报告的治疗满意度/影响的结构的 OMIs 尚未建立。本文对现有知识有何新增内容我们就沟通结构达成了 OMIs 的国际共识。TST 被推荐用于包括在 ROMA COS 中,用于常规使用失语症治疗研究。这项工作有哪些潜在或实际的临床意义?ROMA COS 为成人中风后失语症的 I-IV 期失语症治疗研究推荐了最小结局集的 OMIs。尽管不是用于临床使用,但临床医生可能会考虑其测量特性,使用 ROMA COS 的仪器。在临床实践中系统地纳入沟通测量,例如 TST,最终可以支持研究证据和最佳实践的实施。

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本文引用的文献

[1]
Adaptation of The Scenario Test for Greek-speaking people with aphasia: A reliability and validity study.

Int J Lang Commun Disord. 2022-7

[2]
A core outcome set for aphasia treatment research: The ROMA consensus statement.

Int J Stroke. 2018-10-10

[3]
Psychometric properties of discourse measures in aphasia: acceptability, reliability, and validity.

Int J Lang Commun Disord. 2018-11

[4]
Cultural adaptation and psychometric testing of The Scenario Test UK for people with aphasia.

Int J Lang Commun Disord. 2018-7

[5]
Reviewing the quality of discourse information measures in aphasia.

Int J Lang Commun Disord. 2017-11

[6]
Determining the Association between Language and Cognitive Tests in Poststroke Aphasia.

Front Neurol. 2017-5-5

[7]
A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis.

BMJ. 2017-5-17

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Am J Speech Lang Pathol. 2016-12-1

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Core Outcomes in Aphasia Treatment Research: An e-Delphi Consensus Study of International Aphasia Researchers.

Am J Speech Lang Pathol. 2016-12-1

[10]
Core Outcome Set-STAndards for Reporting: The COS-STAR Statement.

PLoS Med. 2016-10-18

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