Protocol for the development of the international population registry for aphasia after stroke (I-PRAISE)
Protocol for the development of the international population registry for aphasia after stroke (I-PRAISE)
复制标题
DOI：
10.1080/02687038.2021.1914813
复制
发表时间：
2021-06-28
期刊：
影响因子：
2
通讯作者：
Brady, M. C.
中科院分区：
文献类型：
--
作者：
Ali, M.;Ben Basat, A. Lifshitz;Brady, M. C.
背景：我们需要关于失语症患者当前负担、治疗类型和可用资源、分娩方法、护理路径和长期结果的高质量信息。目的：记录和通报卒中后失语症治疗的国际传播，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、开放研究，在适当的情况下，采用盲法结果评估，包括中风后失语症患者，在最初的语言评估期间，能够参加30分钟的初始语言评估，在参与地点首次接触语言和语言治疗师以评估失语症。没有研究强制的干预措施。评估将在基线(首次接触语言和语言治疗师以评估失语症)、从语言和语言治疗(SLT)出院、中风后6个月和12个月进行。我们的主要结果是在中风后12个月改变了阿姆斯特丹奈梅亨日常语言测试(ANELT/严重言语障碍参与者的情景测试)的基线。6个月和12个月的次要结果包括治疗结果量表(TOMS)、身体和社会结果主观指数(SIPSO)、失语症严重程度评定量表(ASRS)、西方失语症成套失语商(WAB-AQ)、中风和失语症生活质量量表(SAQL-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。我们将收集人口学、临床数据和治疗内容。在可能的情况下，将查阅常规的神经成像和用药记录；成像将被化名并转移到中央阅读中心。数据将在中央登记处收集。我们将描述人口学、中风和失语症概况以及可用的治疗方法。国际个体参与者数据(IPD)荟萃分析将基于最小的可检测变化-6个月和12个月主要和次要结果基线的临床重要变化-检查治疗应答率。考虑到服务特点，多变量荟萃分析将考察人口统计学、治疗、用药和结果之间的关系。在可行的情况下，将报告与治疗相关的费用。如果可能，我们将详细说明大脑病变的大小和位置，并在12个月时检查与SLT和语言预后的相关性。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失语症研究的途径，促进知识共享和优化失语症康复交付。IPD元分析将增强和扩大理解，确定成本效益高和有希望的方法来优化康复，使失语症患者受益。
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.