背景:结果测量仪器(OMI)用于衡量治疗效果。在中风后失语症康复中,需要有意义变化的基准来支持对患者结果的解释。这项研究是一项研究计划的一部分,旨在为核心OMI建立最小重要变化(MIC)值(患者认为自己发生了重要变化的最小变化)。作为这个过程的第一步,探讨了失语症患者和临床医生的观点,并就临床意义改变的阈值达成共识.
方法:采用顺序混合方法设计。参与者包括中风后失语症患者和言语病理学家。失语症患者根据中风后的时间进行有目的地采样,年龄和性别,而言语病理学家根据他们的工作环境(医院或社区)进行采样。每个参与者都参加了一个焦点小组,然后是一个带有调查内容的共识讲习班。在焦点小组中,探索了测量失语症恢复过程中有意义变化的经验和方法。定性数据采用反身性主题分析进行转录和分析。在共识研讨会上,参与者对语言核心结果结构有意义变化的阈值进行了投票,通信,情绪健康和生活质量,使用6点评分量表(更糟糕的是,稍差一点,没有变化,略有改善,大大改善并完全恢复)。共识被先验地定义为70%的协议。使用描述性统计报告投票结果。
结果:5名失语症患者(n=4,卒中后>6个月;n=5,<65岁;n=3,男性)和8名言语病理学家(n=4,医院设置;n=4,社区设置)参加了四个焦点小组之一(持续时间:92-112分钟)。确定了四个主题,描述了有意义的变化如下:(1)每个人的不同;(2)小的持续改进;(3)通过个人相关目标的进展来衡量;(4)受个人因素的影响。“轻微改善”被认为是中风后6个月内锚定评定量表(75%-92%)的MIC阈值,而在6个月后,有一种趋势是支持“大大改善”(36%-66%)。
结论:我们对失语症患者和言语病理学家的混合方法研究提供了新的证据来告知MIC在失语症康复中的定义。未来的研究将旨在为核心OMI建立MIC值。
■这项工作是有中风后失语症生活经验的人之间参与的结果,包括失语症患者,家庭成员,临床医生和研究人员。在整个研究周期中进行参与,以确保研究任务是参与者可以接受和容易理解的,并且研究结果与失语症社区相关。这种参与包括共同开发结果的简单英文摘要。根据昆士兰州健康消费者指南,顾问获得了报酬。临床医生的采访指南由从事失语症康复工作的言语病理学家试行。
BACKGROUND: Outcome measurement instruments (OMIs) are used to gauge the effects of treatment. In post-stroke aphasia rehabilitation, benchmarks for meaningful change are needed to support the interpretation of patient outcomes. This study is part of a research programme to establish minimal important change (MIC) values (the smallest change above which patients perceive themselves as importantly changed) for core OMIs. As a first step in this process, the views of people with aphasia and clinicians were explored, and consensus was sought on a threshold for clinically meaningful change.
METHODS: Sequential mixed-methods design was employed. Participants included people with post-stroke aphasia and speech pathologists. People with aphasia were purposively sampled based on time post-stroke, age and gender, whereas speech pathologists were sampled according to their work setting (hospital or community). Each participant attended a focus group followed by a consensus workshop with a survey component. Within the focus groups, experiences and methods for measuring meaningful change during aphasia recovery were explored. Qualitative data were transcribed and analysed using reflexive thematic analysis. In the consensus workshop, participants voted on thresholds for meaningful change in core outcome constructs of language, communication, emotional well-being and quality of life, using a six-point rating scale (much worse, slightly worse, no change, slightly improved, much improved and completely recovered). Consensus was defined a priori as 70% agreement. Voting results were reported using descriptive statistics.
RESULTS: Five people with aphasia (n = 4, > 6 months after stroke; n = 5, < 65 years; n = 3, males) and eight speech pathologists (n = 4, hospital setting; n = 4, community setting) participated in one of four focus groups (duration: 92-112 min). Four themes were identified describing meaningful change as follows: (1) different for every single person; (2) small continuous improvements; (3) measured by progress towards personally relevant goals; and (4) influenced by personal factors. \'Slightly improved\' was agreed as the threshold of MIC on the anchor-rating scale (75%-92%) within 6 months of stroke, whereas after 6 months there was a trend towards supporting \'much improved\' (36%-66%).
CONCLUSIONS: Our mixed-methods research with people with aphasia and speech pathologists provides novel evidence to inform the definition of MIC in aphasia rehabilitation. Future research will aim to establish MIC values for core OMIs.
UNASSIGNED: This work is the result of engagement between people with lived experience of post-stroke aphasia, including people with aphasia, family members, clinicians and researchers. Engagement across the research cycle was sought to ensure that the research tasks were acceptable and easily understood by participants and that the outcomes of the study were relevant to the aphasia community. This engagement included the co-development of a plain English summary of the results. Advisors were remunerated in accordance with Health Consumers Queensland guidelines. Interview guides for clinicians were piloted by speech pathologists working in aphasia rehabilitation.