This webpage provides access to Sentinel Health Outcome of Interest (HOI) activities that have been conducted by the FDA. The search options below can be used to find more information about each study type or health outcome. Code lists (such as ICD-9-CM codes, ICD-10 codes, procedure codes, etc.), algorithm criteria, and literature reviews for these activities appear in the form of reports or Microsoft Excel workbooks. These materials can be found by clicking on either the hyperlinked Deliverables listed or the hyperlinked Title to navigate to the activity’s webpage which also lists the Deliverables.
- Novel Approaches to More Efficient Outcome Validation aim to identify solutions to the governance, process, and technology barriers to support more efficient outcome validation as a starting point for greater sufficiency of Active Risk Identification and Analysis (ARIA), a stronger Sentinel System, and a more rigorous evidence generation enterprise.
- Validations Supported by Traditional Medical Chart Review involve checking codes derived from electronic medical records and administrative claims-based data against medical chart information to verify that the electronic codes validly and reliably identify individuals with particular medical conditions.
- Outcomes Assessed in Inferential Analyses identify medical conditions defined as outcomes of interest in inferential analyses and their respective code lists and algorithm criteria.
- Coding Trend Analyses display the trends for outcome definitions across the ICD-9-CM and ICD-10-CM/PCS eras.
- Literature Reviews primarily concern identification of health outcomes and focus on determining which codes in electronic medical record and administrative claims-based data are the most valid and reliable indicators of the presence of particular medical conditions.