Department of Speech and Language Therapy, University Hospital Limerick, Limerick, Ireland.
School of Allied Health, University of Limerick, Co. Limerick, Ireland.
Clin Rehabil. 2023 Oct;37(10):1375-1385. doi: 10.1177/02692155231172009. Epub 2023 May 15.
To examine the proportion of people with aphasia (PwA) included and retained in randomised controlled trials (RCTs) of stroke interventions published in the previous 6 years, as well as aphasia-relevant eligibility criteria and inclusion/retention strategies.
Comprehensive searching of Embase, PubMed and Medline (Ovid) for the period January 2016 - November 2022.
RCTs examining stroke interventions targeting cognition, psychological wellbeing/health-related quality of life (HRQL), multidisciplinary rehabilitation, and self-management were included. Methodological quality was assessed using the Critical Appraisal Skills Programme (CASP) Randomised Controlled Trial checklist. Descriptive statistics were applied to extracted data, and results were reported narratively.
Fifty-seven RCTs were included. These examined self-management (32%), physical (26%) psychological wellbeing/HRQL (18%), cognitive (14%), and multidisciplinary (11%) interventions. Of 7313 participants, 107 (1.5%) had aphasia and were included in three trials. About one-third did not report on aphasia (32%); over one quarter required functional communication (28%); one quarter excluded all aphasia (25%); and 14% excluded severe aphasia. No aphasia-specific inclusion/retention strategies were available.
The findings highlight ongoing under-representation. However, due to shortcomings in aphasia reporting, the findings may underestimate actual inclusion rate. Excluding PwA has implications for the external validity, effectiveness, and implementation of stroke research findings. Triallists may require support in aphasia research strategies and methodological reporting.
检查过去 6 年发表的中风干预措施随机对照试验（RCT）中纳入和保留的失语症患者（PwA）的比例，以及与失语症相关的入选标准和纳入/保留策略。
全面检索 Embase、PubMed 和 Medline（Ovid），检索时间为 2016 年 1 月至 2022 年 11 月。
纳入了针对认知、心理幸福感/健康相关生活质量（HRQL）、多学科康复和自我管理的中风干预措施的 RCT。使用批判性评估技能计划（CASP）随机对照试验检查表评估方法学质量。对提取的数据进行描述性统计，并进行叙述性报告。
纳入了 57 项 RCT。这些试验研究了自我管理（32%）、身体（26%）、心理幸福感/HRQL（18%）、认知（14%）和多学科（11%）干预措施。在 7313 名参与者中，有 107 名（1.5%）患有失语症，其中 3 项试验纳入了这 107 名患者。大约三分之一的研究没有报告失语症情况（32%）；超过四分之一的研究需要功能性交流（28%）；四分之一的研究排除了所有失语症患者（25%）；14%的研究排除了严重失语症患者。没有发现专门的失语症纳入/保留策略。
研究结果强调了持续存在的代表性不足问题。然而，由于在失语症报告方面存在缺陷，这些发现可能低估了实际的纳入率。排除 PwA 会影响中风研究结果的外部有效性、有效性和实施。试验研究者可能需要在失语症研究策略和方法学报告方面得到支持。
