The HMO Research Network (HMORN) Virtual Data Warehouse (VDW) is a public, non-proprietary, research-focused data model implemented at 17 health care systems across the United States. The HMORN has created a governance structure and specified policies concerning the VDW’s content, development, implementation, and quality assurance. Data extracted from the VDW have been used by thousands of studies published in peer-reviewed journal articles. Advances in software supporting care delivery and claims processing and the availability of new data sources have greatly expanded the data available for research, but substantially increased the complexity of data management. The VDW data model incorporates software and data advances to ensure that comprehensive, up-to-date data of known quality are available for research. VDW governance works to accommodate new data and system complexities. This article highlights the HMORN VDW data model, its governance principles, data content, and quality assurance procedures. Our goal is to share the VDW data model and its operations to those wishing to implement a distributed interoperable health care data system.
PurposeDefining a study population and creating an analytic dataset from longitudinal healthcare databases involves many decisions. Our objective was to catalogue scientific decisions underpinning study execution that should be reported to facilitate replication and enable assessment of validity of studies conducted in large healthcare databases.MethodsWe reviewed key investigator decisions required to operate a sample of macros and software tools designed to create and analyze analytic cohorts from longitudinal streams of healthcare data. A panel of academic, regulatory, and industry experts in healthcare database analytics discussed and added to this list.ConclusionEvidence generated from large healthcare encounter and reimbursement databases is increasingly being sought by decision‐makers. Varied terminology is used around the world for the same concepts. Agreeing on terminology and which parameters from a large catalogue are the most essential to report for replicable research would improve transparency and facilitate assessment of validity. At a minimum, reporting for a database study should provide clarity regarding operational definitions for key temporal anchors and their relation to each other when creating the analytic dataset, accompanied by an attrition table and a design diagram.A substantial improvement in reproducibility, rigor and confidence in real world evidence generated from healthcare databases could be achieved with greater transparency about operational study parameters used to create analytic datasets from longitudinal healthcare databases.
Real-time surveillance combining dynamic data files, aggregation of data, and sequential analysis methods offers a useful and highly adaptable approach to early detection of adverse events after the introduction of new vaccines.
Pharmacoepidemiologic and pharmacoeconomic analysis of health care databases has become a vital source of evidence to support health care decision making and efficient management of health care organizations. However, decision makers often consider studies done in nonrandomized health care databases more difficult to review than randomized trials because many design choices need to be considered. This is perceived as an important barrier to decision making about the effectiveness and safety of medical products. Design flaws in longitudinal database studies are avoidable but can be unintentionally obscured in the convoluted prose of methods sections, which often lack specificity. We propose a simple framework of graphical representation that visualizes study design implementations in a comprehensive, unambiguous, and intuitive way; contains a level of detail that enables reproduction of key study design variables; and uses standardized structure and terminology to simplify review and communication to a broad audience of decision makers. Visualization of design details will make database studies more reproducible, quicker to review, and easier to communicate to a broad audience of decision makers.
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