Sentinel Initiative

Sentinel Modular Program Report: Estimating Optimal Quantities for Initial Opioid Analgesic Prescriptions for Acute Pain Conditions Presenting to Surgical Settings.

View more information here.

Epidemiological study reporting is improving but is not transparent enough for easy evaluation or replication. One barrier is insufficient details about design elements in published studies. Using a previously conducted drug safety evaluation in claims as a test case, we investigated the impact of small changes in five key design elements on risk estimation. These elements are index day of incident exposure's determination of look-back or follow-up periods, exposure duration algorithms, heparin exposure exclusion, propensity score model variables, and Cox proportional hazard model stratification. We covaried these elements using a fractional factorial design, resulting in 24 risk estimates for one outcome. We repeated eight of these combinations for two additional outcomes. We measured design effects on cohort sizes, follow-up time, and risk estimates.

Healthcare databases are very useful sources of post-marketing real-world information, generating evidence on drug use, safety and effectiveness, particularly in populations where such information may be lacking in pre-clinical studies, such as paediatric and geriatric populations. However, healthcare databases can also provide pre-marketing information by measuring the burden of disease, identifying unmet clinical needs and estimating the number of patients potentially eligible for innovative and costly treatment. Whether in a pre- or post-marketing setting, these data sources can provide regulatory agencies with evidence that can inform the development/implementation of regulatory interventions and answer questions of high, and often urgent, public health interest. In April 2019, the Italian Drug Agency (Agenzia Italiana del Farmaco) organised a workshop on the role of healthcare databases in supporting drug regulatory agencies in their pre- and post-marketing regulatory activities. The experiences of the USA, Canada, Spain and Italy in this context were presented.

The Sentinel Data Quality Review and Characterization Programs are used by the Sentinel Operations Center (SOC) for data quality review and characterization of the Sentinel Distributed Database (SDD). To create the SDD, each Data Partner transformed local source data into the Sentinel Common Data Model (SCDM) format. The SOC created a set of data quality review and characterization programs to ensure that the SDD meets reasonable standards for data transformation consistency and quality and that the SDD data meets expectations needed for a distributed health data network.

The documentation, appendices, and SAS programs associated with version 6.0.0 of the Sentinel Data Quality Review and Characterization Programs can be found externally in Sentinel's Git Repository. 

Sentinel has created the Sentinel CMS DataMart, containing 100% Medicare FFS administrative claims data housed in the Center for Medicare and Medicaid Services' CMS Virtual Research Data Center (VRDC). Duke University Department of Population Health Sciences (DPHS) serves as the Sentinel Data Partner in accessing the source data in the VRDC, transforming it into a Sentinel Common Data Model (SCDM) compliant database, executing queries, and returning results to the Sentinel Operations Center (SOC). There are three components made available to the public: (1) Program Specifications; (2) Code pack; and (3) User Guide.

The Sentinel Query Builder is a web application which allows users to visualize, draft, and create medical product utilization queries with a user-friendly interface from a set of pre-defined parameters and convert them into Sentinel query request packages. The Sentinel Query Builder application can now be downloaded onto users' computers.