ABSTRACT

Background

We require high-quality information on the current burden, the types of therapy and resources available, methods of delivery, care pathways and long-term outcomes for people with aphasia.

Aim

To document and inform international delivery of post-stroke aphasia treatment, to optimise recovery and reintegration of people with aphasia.

Methods & Procedures

Multi-centre, prospective, non-randomised, open study, employing blinded outcome assessment, where appropriate, including people with post-stroke aphasia, able to attend for 30 minutes during the initial language assessment, at first contact with a speech and language therapist for assessment of aphasia at participating sites. There is no study-mandated intervention. Assessments will occur at baseline (first contact with a speech and language therapist for aphasia assessment), discharge from Speech and Language Therapy (SLT), 6 and 12-months post-stroke. Our primary outcome is changed from baseline in the Amsterdam Nijmegen Everyday Language Test (ANELT/Scenario Test for participants with severe verbal impairments) at 12-months post-stroke. Secondary outcomes at 6 and 12 months include the Therapy Outcome Measure (TOMS), Subjective Index of Physical and Social Outcome (SIPSO), Aphasia Severity Rating Scale (ASRS), Western Aphasia Battery Aphasia Quotient (WAB-AQ), stroke and aphasia quality of life scale (SAQoL-39), European Quality of Life Scale (EQ-5D), lesion description, General Health Questionnaire (GHQ-12), resource use, and satisfaction with therapy provision and success. We will collect demography, clinical data, and therapy content. Routine neuroimaging and medication administration records will be accessed where possible; imaging will be pseudonymised and transferred to a central reading centre. Data will be collected in a central registry. We will describe demography, stroke and aphasia profiles and therapies available. International individual participant data (IPD) meta-analyses will examine treatment responder rates based on minimal detectable change & clinically important changes from baseline for primary and secondary outcomes at 6 and 12 months. Multivariable meta-analyses will examine associations between demography, therapy, medication use and outcomes, considering service characteristics. Where feasible, costs associated with treatment will be reported. Where available, we will detail brain lesion size and site, and examine correlations with SLT and language outcome at 12 months.

Conclusion

International differences in care, resource utilisation and outcomes will highlight avenues for further aphasia research, promote knowledge sharing and optimise aphasia rehabilitation delivery. IPD meta-analyses will enhance and expand understanding, identifying cost-effective and promising approaches to optimise rehabilitation to benefit people with aphasia.

中文翻译：

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卒中后失语症国际人口登记发展方案 (I-PRAISE)

摘要

背景

我们需要有关失语症患者当前负担、治疗类型和可用资源、交付方法、护理途径和长期结果的高质量信息。

目的

记录和通知国际提供中风后失语症治疗，以优化失语症患者的康复和重新融入社会。

方法和程序

多中心、前瞻性、非随机、开放式研究，在适当情况下采用盲法结果评估，包括中风后失语症患者，能够在初始语言评估期间参加 30 分钟，首次接触语言和语言治疗师用于评估参与地点的失语症。没有研究强制干预。评估将在基线（第一次与言语和语言治疗师联系以进行失语评估）、言语和语言治疗 (SLT) 出院、中风后 6 个月和 12 个月时进行。我们的主要结果与中风后 12 个月的阿姆斯特丹奈梅亨日常语言测试（针对严重语言障碍的参与者的 ANELT/情景测试）的基线相比发生了变化。6 个月和 12 个月的次要结果包括治疗结果测量 (TOMS)、身体和社会结果主观指数 (SIPSO)、失语严重程度评定量表 (ASRS)、西方失语电池失语商 (WAB-AQ)、中风和失语生活质量量表 (SAQoL-39)、欧洲生活质量量表 (EQ -5D)、病变描述、一般健康问卷 (GHQ-12)、资源使用以及对治疗提供和成功的满意度。我们将收集人口统计学、临床数据和治疗内容。在可能的情况下，将访问常规神经影像和药物管理记录；成像将被化名并转移到中央阅读中心。数据将收集在中央登记处。我们将描述人口统计学、中风和失语症的概况和可用的治疗方法。国际个体参与者数据 (IPD) 荟萃分析将根据 6 个月和 12 个月的主要和次要结果从基线的最小可检测变化和临床上重要变化来检查治疗反应率。多变量荟萃分析将检查人口统计学、治疗、药物使用和结果之间的关联，并考虑服务特征。在可行的情况下，将报告与治疗相关的费用。在可用的情况下，我们将详细说明脑损伤的大小和部位，并在 12 个月时检查与 SLT 和语言结果的相关性。将报告与治疗相关的费用。在可用的情况下，我们将详细说明脑损伤的大小和部位，并在 12 个月时检查与 SLT 和语言结果的相关性。将报告与治疗相关的费用。在可用的情况下，我们将详细说明脑损伤的大小和部位，并在 12 个月时检查与 SLT 和语言结果的相关性。

结论

在护理、资源利用和结果方面的国际差异将突出进一步研究失语症、促进知识共享和优化失语症康复服务的途径。IPD 荟萃分析将增强和扩大理解，确定具有成本效益和有前景的方法来优化康复，以造福失语症患者。