Background/Aims:The demand for simplified data collection within trials to increase efficiency and reduce costs has led to broader interest in repurposing routinely collected administrative data for use in clinical trials research. The aim of this scoping review is to describe how and why administrative data have been used in Australian randomised controlled trial conduct and analyses, specifically the advantages and limitations of their use as well as barriers and enablers to accessing administrative data for use alongside randomised controlled trials.Methods:Databases were searched to November 2022. Randomised controlled trials were included if they accessed one or more Australian administrative data sets, where some or all trial participants were enrolled in Australia, and where the article was published between January 2000 and November 2022. Titles and abstracts were independently screened by two reviewers, and the full texts of selected studies were assessed against the eligibility criteria by two independent reviewers. Data were extracted from included articles by two reviewers using a data extraction tool.Results:Forty-one articles from 36 randomised controlled trials were included. Trial characteristics, including the sample size, disease area, population, and intervention, were varied; however, randomised controlled trials most commonly linked to government reimbursed claims data sets, hospital admissions data sets and birth/death registries, and the most common reason for linkage was to ascertain disease outcomes or survival status, and to track health service use. The majority of randomised controlled trials were able to achieve linkage in over 90% of trial participants; however, consent and participant withdrawals were common limitations to participant linkage. Reported advantages were the reliability and accuracy of the data, the ease of long term follow-up, and the use of established data linkage units. Common reported limitations were locating participants who had moved outside the jurisdictional area, missing data where consent was not provided, and unavailability of certain healthcare data.Conclusions:As linked administrative data are not intended for research purposes, detailed knowledge of the data sets is required by researchers, and the time delay in receiving the data is viewed as a barrier to its use. The lack of access to primary care data sets is viewed as a barrier to administrative data use; however, work to expand the number of healthcare data sets that can be linked has made it easier for researchers to access and use these data, which may have implications on how randomised controlled trials will be run in future.

中文翻译：

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澳大利亚随机对照试验中关联管理数据的使用：范围界定审查

背景/目标：为了提高效率和降低成本，对试验中简化数据收集的需求引起了人们对重新利用常规收集的管理数据用于临床试验研究的更广泛兴趣。本次范围界定审查的目的是描述在澳大利亚随机对照试验的实施和分析中如何以及为何使用行政数据，特别是其使用的优点和局限性，以及获取行政数据以与随机对照试验一起使用的障碍和推动因素方法：检索数据库至 2022 年 11 月。如果随机对照试验访问了一个或多个澳大利亚行政数据集，其中部分或全部试验参与者在澳大利亚入组，并且文章发表于 2000 年 1 月至 2022 年 11 月期间，则纳入随机对照试验。标题和摘要由两名评审员独立筛选，所选研究的全文由两名独立评审员根据资格标准进行评估。两名评审员使用数据提取工具从纳入的文章中提取数据。结果：纳入了来自 36 项随机对照试验的 41 篇文章。试验特征，包括样本量、疾病区域、人群和干预措施各不相同；然而，随机对照试验最常与政府报销的索赔数据集、入院数据集和出生/死亡登记联系起来，而联系的最常见原因是为了确定疾病结果或生存状态，并跟踪卫生服务的使用情况。大多数随机对照试验能够在超过 90% 的试验参与者中实现关联；然而，同意和参与者退出是参与者联系的常见限制。报告的优点是数据的可靠性和准确性、易于长期跟踪以及使用已建立的数据链接单元。报告的常见局限性是定位已移出管辖区域的参与者、未提供同意的情况下丢失数据以及无法获得某些医疗保健数据。结论：由于链接的管理数据不用于研究目的，因此需要对数据集有详细的了解研究人员认为，接收数据的时间延迟被视为其使用的障碍。无法获取初级保健数据集被视为行政数据使用的障碍；然而，扩大可链接的医疗保健数据集数量的工作使研究人员更容易访问和使用这些数据，这可能会对未来如何进行随机对照试验产生影响。