ABSTRACT

Background

Collation of aphasia research data across settings, countries and study designs using big data principles will support analyses across different language modalities, levels of impairment, and therapy interventions in this heterogeneous population. Big data approaches in aphasia research may support vital analyses, which are unachievable within individual trial datasets. However, we lack insight into the requirements for a systematically created database, the feasibility and challenges and potential utility of the type of data collated.

Aim

To report the development, preparation and establishment of an internationally agreed aphasia after stroke research database of individual participant data (IPD) to facilitate planned aphasia research analyses.

Methods

Data were collated by systematically identifying existing, eligible studies in any language (≥10 IPD, data on time since stroke, and language performance) and included sourcing from relevant aphasia research networks. We invited electronic contributions and also extracted IPD from the public domain. Data were assessed for completeness, validity of value-ranges within variables, and described according to pre-defined categories of demographic data, therapy descriptions, and language domain measurements. We cleaned, clarified, imputed and standardised relevant data in collaboration with the original study investigators. We presented participant, language, stroke, and therapy data characteristics of the final database using summary statistics.

Results

From 5256 screened records, 698 datasets were potentially eligible for inclusion; 174 datasets (5928 IPD) from 28 countries were included, 47/174 RCT datasets (1778 IPD) and 91/174 (2834 IPD) included a speech and language therapy (SLT) intervention. Participants’ median age was 63 years (interquartile range [53, 72]), 3407 (61.4%) were male and median recruitment time was 321 days (IQR 30, 1156) after stroke. IPD were available for aphasia severity or ability overall (n = 2699; 80 datasets), naming (n = 2886; 75 datasets), auditory comprehension (n = 2750; 71 datasets), functional communication (n = 1591; 29 datasets), reading (n = 770; 12 datasets) and writing (n = 724; 13 datasets). Information on SLT interventions were described by theoretical approach, therapy target, mode of delivery, setting and provider. Therapy regimen was described according to intensity (1882 IPD; 60 datasets), frequency (2057 IPD; 66 datasets), duration (1960 IPD; 64 datasets) and dosage (1978 IPD; 62 datasets).

Discussion

Our international IPD archive demonstrates the application of big data principles in the context of aphasia research; our rigorous methodology for data acquisition and cleaning can serve as a template for the establishment of similar databases in other research areas.

中文翻译：

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利用基于系统评价的方法创建用于荟萃和网络荟萃分析的个体参与者数据数据库：卒中后失语症的 RELEASE 数据库

摘要

背景

使用大数据原则对不同环境、国家和研究设计的失语症研究数据进行整理，将支持对这一异质人群的不同语言模式、障碍程度和治疗干预进行分析。失语症研究中的大数据方法可能支持生命分析，这在单个试验数据集中是无法实现的。然而，我们缺乏对系统创建数据库的要求、所整理数据类型的可行性和挑战以及潜在效用的洞察力。

目的

报告国际公认的卒中后失语症个体参与者数据 (IPD) 研究数据库的开发、准备和建立，以促进计划中的失语症研究分析。

方法

通过系统地识别任何语言的现有合格研究（≥10 IPD、中风后的时间数据和语言表现）来整理数据，并包括来自相关失语症研究网络的来源。我们邀请了电子投稿，还从公共领域提取了 IPD。评估数据的完整性、变量内值范围的有效性，并根据预定义的人口统计数据类别、治疗描述和语言域测量进行描述。我们与最初的研究调查人员合作，清理、澄清、估算和标准化相关数据。我们使用汇总统计数据展示了最终数据库的参与者、语言、中风和治疗数据特征。

结果

从 5256 条筛选记录中，有 698 个数据集可能符合纳入条件；包括来自 28 个国家的 174 个数据集（5928 个 IPD），47/174 个 RCT 数据集（1778 个 IPD）和 91/174 个（2834 个 IPD）包括言语和语言治疗（SLT）干预。参与者的中位年龄为 63 岁（四分位距 [53, 72]），3407 人（61.4%）为男性，中位招募时间为中风后 321 天（IQR 30, 1156）。IPD 可用于失语症严重程度或总体能力（n = 2699；80 个数据集）、命名（n = 2886；75 个数据集）、听觉理解（n = 2750；71 个数据集）、功能交流（n = 1591；29 个数据集）、读取（n = 770；12 个数据集）和写入（n = 724；13 个数据集）。通过理论方法、治疗目标、交付方式、设置和提供者描述了有关 SLT 干预的信息。

讨论

我们的国际 IPD 档案展示了大数据原则在失语症研究中的应用；我们严格的数据采集和清理方法可以作为在其他研究领域建立类似数据库的模板。