Health Outcomes Among Individuals Exposed to Medical Products
These assessments examine the occurrence of pre-specified health outcomes, or health events, among individuals exposed to particular medical products. Health outcomes can include the subsequent occurrence of new diagnoses, additional medical procedures, or use of other additional medical products (or combinations of these). The specifications of an assessment can vary widely based on the definition of exposures, comparators, outcomes, cohort inclusion and exclusion criteria, time periods, and analytic approaches. There are three subcategories of assessments:
- Modular program based one-time assessments. These assessments provide rapid response by making use of adaptable standardized programs ("modular programs"). These assessments can provide stratified results by age group, sex, and calendar year.
- Prospective Routine Observational Monitoring Program Tools (PROMPT) assessments. These assessments involve repeated evaluation of electronic, administrative and claims-based healthcare data as they accrue within the Mini-Sentinel Distributed Database. PROMPT assessments perform active surveillance of newly approved medical products in a prospective and semi-automated manner as experience with these products accumulates in near real time. A small number of study designs and analytical methods ("PROMPT tools") have been implemented that can be modified quickly to accommodate specific products, outcomes, populations, and time periods for evaluation. The emphasis is on detecting potential excess risk of adverse events associated medical products rather than formal assessment of causal relationships. This approach requires that signals be carefully followed up to understand the explanation for the finding.
- Protocol based assessments.These assessments use customized study designs and protocols that allow 1) detailed specification of exposure groups and health events, 2) adjustment for a range of potential confounding factors, and 3) comparison of event rates between different medical products. These may be one-time assessments or may involve repeated evaluation of information as it accrues within the Mini-Sentinel Distributed Dataset. They may use a variety of study designs and statistical methods, including sequential methods.
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