School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, England.
Geoffrey Jefferson Brain Research Centre, The Manchester Academic Health Science Centre, Northern Care Alliance and the University of Manchester, Manchester, UK.
Trials. 2023 Jan 25;24(1):57. doi: 10.1186/s13063-022-06958-7.
Dysarthria after stroke is when speech intelligibility is impaired, and this occurs in half of all stroke survivors. Dysarthria often leads to social isolation, poor psychological well-being and can prevent return to work and social lives. Currently, a variety of outcome measures are used in clinical research and practice when monitoring recovery for people who have dysarthria. When research studies use different measures, it is impossible to compare results from trials and delays our understanding of effective clinical treatments. The aim of this study is to develop a core outcome set (COS) to agree what aspects of speech recovery should be measured for dysarthria after stroke (COS-Speech) in research and clinical practice.
The COS-Speech study will include five steps: (1) development of a long list of possible outcome domains of speech that should be measured to guide the survey; (2) recruitment to the COS-Speech study of three key stakeholder groups in the UK and Australia: stroke survivors, communication researchers and speech and language therapists/pathologists; (3) two rounds of the Delphi survey process; (4) a consensus meeting to agree the speech outcomes to be measured and a follow-up consensus meeting to match existing instruments/measures (from parallel systematic review) to the agreed COS-Speech; (5) dissemination of COS-Speech.
There is currently no COS for dysarthria after stroke for research trials or clinical practice. The findings from this research study will be a minimum COS, for use in all dysarthria research studies and clinical practice looking at post-stroke recovery of speech. These findings will be widely disseminated using professional and patient networks, research and clinical forums as well as using a variety of academic papers, videos, accessible writing such as blogs and links on social media.
COS-Speech is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, October 2021 https://www.comet-initiative.org/Studies/Details/1959 . In addition, "A systematic review of the psychometric properties and clinical utility of instruments measuring dysarthria after stroke" will inform the consensus meeting to match measures to COS-Speech. The protocol for the systematic reviews registered with the International Prospective Register of Systematic Reviews. PROSPERO registration number: CRD42022302998 .
脑卒中后发生的构音障碍会导致言语清晰度受损，这种情况在所有脑卒中幸存者中占一半。构音障碍常常导致社交孤立、心理健康状况不佳，并可能妨碍重返工作和社交生活。目前，在监测患有构音障碍的人群的康复情况时，临床研究和实践中使用了各种结局测量指标。当研究使用不同的指标时，就不可能对试验结果进行比较，从而阻碍了我们对有效临床治疗方法的理解。本研究旨在制定一个核心结局集（COS），以确定脑卒中后构音障碍（COS-Speech）研究和临床实践中应测量的言语恢复的哪些方面。
COS-Speech 研究将包括五个步骤：（1）制定一个可能的言语恢复结果的长列表，以指导调查；（2）在英国和澳大利亚的三个关键利益相关者群体中招募到 COS-Speech 研究：脑卒中幸存者、沟通研究人员和言语语言治疗师/病理学家；（3）进行两轮德尔菲调查流程；（4）召开共识会议，以确定要测量的言语结果，并召开后续共识会议，将现有仪器/措施（来自平行系统评价）与商定的 COS-Speech 相匹配；（5）传播 COS-Speech。
目前，针对研究试验或临床实践，尚无脑卒中后构音障碍的 COS。本研究的结果将是一个最小的 COS，用于所有脑卒中后言语恢复的构音障碍研究和临床实践。这些结果将通过专业和患者网络、研究和临床论坛以及各种学术论文、视频、易于理解的写作（如博客）和社交媒体上的链接广泛传播。
COS-Speech 于 2021 年 10 月在核心结局测量在有效性试验（COMET）数据库中注册，网址为 https://www.comet-initiative.org/Studies/Details/1959 。此外，“评估测量脑卒中后构音障碍的工具的心理测量特性和临床实用性的系统评价”将为匹配措施与 COS-Speech 的共识会议提供信息。该系统评价的方案已在国际前瞻性系统评价注册库中注册。PROSPERO 注册号：CRD42022302998 。
