1 Cohort Identification within FDA's Mini-Sentinel Program
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1 1 Cohort Identification within FDA's Mini-Sentinel Program October 31, 2013
2 Mini-Sentinel partner organizations Lead HPHC Institute Data and scientific partners Scientific partners Institute for Health 2
3 3 Cohort identification within Mini-Sentinel Summary table queries Modular programs De novo programming
4 4 Query fulfillment process What do you really want?
5 5 Query fulfillment process Issue the query and get results
6 6 Query fulfillment process Review results, create report
7 7 Query fulfillment process All queries are also a data check
8 8 Questions How many people use lindane? How many people are overweight? How many patients had an acute myocardial infarction? How many patients underwent revascularization procedures? How many patients use antidepressants and proton pump inhibitors concomitantly? For how long? What is the background rate of Guillain-Barre syndrome by age, sex, and year? How many patients receive a statin within 60 days of a stroke? How many warfarin patients had a new bleeding event within 30 days of treatment initiation?
9 9 Summary tables Counts of medical utilization, dispensings, and enrollment Stratified by age group, sex, and year Created via distributed programs run against Mini-Sentinel Common Data Model Aggregate data held by the Data Partners Use PopMedNet to securely send queries and responses Point-and-click interface to generate and send query Data partners execute query and respond using the software Query tracking and auditing No technical expertise needed
10 10 Summary tables Standard output for dispensing queries Total users (incident/prevalent), dispsenings and days supplied Days per user Dispensings per user Days per dispensing Prevalence and incidence rates Standard output for medical utilization queries Patients and count of encounters Count by care setting (ambulatory, ER, inpatient, any) Visits per person
11 Mini-Sentinel distributed query tool 11
12 Number of Users Total Days Supplied Lindane users and days supplied by year 14, ,000 12, ,000 10, ,000 8, ,000 6, ,000 4,000 2,000 50, Sum of Users Sum of DaysSupply info@mini-sentinel.org 12
13 Prevalence Rate (Users per 1,000 Enrollees) Lindane prevalence rate by year
14 Prevalent acute myocardial infarction patients by year, sex, and age group: Inpatient diagnoses Table 1. Number of Acute Myocardial Infarction Patients in the Inpatient Setting by Year, Sex, and Age Group Sum of Patients Period Sex Age Group Total Year 2000 Sex Age Patients 14, , , , , , , , , , F 26,948 M , , , ,499 About 65k to 80k hospitalized AMIs in most recent years Report stratified by year, sex, and age group info@mini-sentinel.org 14
15 15 Modular programs Parameterized SAS programs Based on the Mini-Sentinel Common Data Model Input forms for each program Each program focused on a common question Flexible parameters to determine treatment exposure, inclusion/exclusion criteria, outcomes, etc Output (incident/prevalent) Users, dispsenings/visits, days supplied, dispensings per user, days per user, days per dispensing
16 Lindane use: Prevalent and incident counts 16
17 17 Reports posted online
18 18 Cohort Identification within FDA's Mini-Sentinel Program October 31, 2013
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