Center for Medical Statistics, Informatics and Intelligent Systems, Department of Medical Information Management, Medical University of Vienna, Austria.
Department of Neurology, Medical University of Vienna, Austria.
Stud Health Technol Inform. 2021 May 7;279:62-69. doi: 10.3233/SHTI210090.
In healthcare studies, the analysis of claims data is gaining an increasingly important role. Observational studies should be reported in a manner that promotes internal and external validity assessment, with the exact and standardized description of items. Several international guidelines and checklists for reporting on secondary data are available. The aim of this work was to analyse the applicability of reporting guidelines especially for claims data. The STROSA-2 guidelines recommendations were evaluated by means of a report on a study on triptan medications in Austria. Six items were identified which could be expanded to support complete and transparent report on Austrian claims data. Therefore, we would suggest to add some details in the STROSA-2 guidelines concerning study design, legal foundations, data protection, data flow, descriptive results and risk of bias. The guidelines for reporting on Austrian claims data were successfully compiled with additional items. New guidelines should be further processed and tested with strong recommendations to focus on data limitations and legal aspects.
在医疗保健研究中，索赔数据分析的作用日益重要。观察性研究应该以促进内部和外部有效性评估的方式进行报告，对项目进行准确和标准化的描述。有几个关于二次数据报告的国际指南和清单可用。这项工作的目的是分析报告指南，特别是针对索赔数据的适用性。通过报告奥地利曲普坦药物的研究，评估了 STROSA-2 指南的建议。确定了六个可以扩展的项目，以支持对奥地利索赔数据的完整和透明报告。因此，我们建议在 STROSA-2 指南中添加一些关于研究设计、法律依据、数据保护、数据流程、描述性结果和偏差风险的详细信息。成功编制了针对奥地利索赔数据的报告指南，并添加了新项目。新的指南应进一步处理和测试，并提出强有力的建议，重点关注数据限制和法律方面。
