Picture the boring table or bar chart you inserted in your presentation. Yawn. Allow me to nibble at the edges a little bit and liven it up. Its a long trip--we might as well make the best of it. Let me share a few highlights of different types of data that can increase your data granularity--at the patient level.
FDA Adverse Events Reporting System (FAERS)
The FDA monitors safety concerns in all marketed products. If a concern is detected by FAERS further evaluation may include additional studies and maybe even regulatory action. The Sentinel System is an additional database that includes data from ~ 18 data partners (since I last checked). There are important trends aggregrated from data provided by Aetna, HealthCore, the HMO Research Network (6 sites), Humana, Kaiser Permanente (6 sites), Lovelace Clinic Foundation, OptumInsight, and Vanderbilt. Funded by the FDA, you can do your own statistical analysis or request information through the Freedom of Information Act.
Mini-Sentinel is a pilot project of a fully operational active surveillance system for monitoring the safety of FDA-regulated medical products. Collaborators provide access to health care data and ongoing scientific, technical, methodological, and organizational expertise from EHR systems and other databases.
Patient-centered is the new blockbuster innovation and the ability to observe and analyze data describing enrollment in health plans, demographics, pharmacy dispensing, unique healthcare visits, deaths, cause of death and laboratory results potentially linked with PCORI data should be celebrated.
These data describe the outcome of the patient as defined in U.S. reporting regulations (21 CFR 310.305, 314.80, 314.98, 600.80) and Forms FDA 3500 and 3500A (the MedWatch forms). Serious means that one or more of the following outcomes were documented in the report: death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome. Documenting one or more of these outcomes in a report does not necessarily mean that the suspect product(s) named in the report was the cause of these outcomes.
My goal here is to continue to introduce a variety of databases available to you as you create content, presentations, or research. The book will be more granular but feel free to follow along for ongoing discussions...Blueprint: a scalable healthcare data strategy is being offered at pre-order discount pricing.
We are challenged to bring the patient into the healthcare conversation. The first step is locating data that can provide a voice at the patient level. Its all about data--because data talks, people mumble.