Development and validation of reporting guidelines for studies involving data linkage

Objective: Data or record linkage is commonly used to combine existing data sets for the purpose of creating more comprehensive information to conduct research. Linked data may create additional concerns about error if cases are not linked accurately. It is important that factors compromising the quality of studies using linked data be reported in a clear and consistent way that allows readers and researchers to accurately appraise the results. The aim of this study was to develop and test reporting guidelines for evaluating the methodological quality of studies using linked data. Method: The development process included a literature review, a Delphi process and a validation process. Participants in the process were all Australian and included biostatisticians, epidemiologists, registry administrators, academic clinicians and a peer-reviewed journal editor. Results: The final guidelines included four domains and 14 reporting items. These included: data sources (six items), research selected variables (four items), linkage technology and data analysis (three items), and ethics, privacy and data security (one item). Conclusion: This study is the first to develop guidelines for appraising the quality of reported data linkage studies. Implications: These guidelines will assist authors to report their results in a consistent, high-quality manner. They will also assist readers to interpret the quality of results derived from data linkage studies.