Level 2 analyses:
- Identify cohorts of interest
- Perform more complex adjustment for confounding
- Generate effect estimates and confidence intervals
Below you will find descriptions of the different types of cohort identification strategies and tools for level 2 analysis.
Type 2+: Exposures and Follow-up Time with Propensity Score Analysis
What this program does:
- Identifies exposures, follow-up time, outcomes, and covariates
- Estimates a propensity score (based on predefined covariates and/or via a high-dimensional propensity score approach)
- Uses matching, stratification, inverse probability of treatment weighting (IPTW), or stratum weighting for confounder adjustment and follows the analytic cohort for outcome assessment in a survival analysis framework
Output metrics include:
- Tables of patient characteristics (unadjusted and adjusted cohorts)
- Measures of covariate balance
- Distribution of propensity score by exposure group
- Hazard ratios (with 95% confidence intervals)
- Kaplan-Meier curves
- IPTW/PS stratum weights
- Attrition table
Continue reading about propensity score analysis on Sentinel's Git Repository.
Type 2+: Exposures and Follow-up Time with Covariate Stratification
What this program does:
- Conducts covariate stratification within each Sentinel Data Partner site via distributed programming code; returns data to the Sentinel Operations Center (SOC), aggregated, and used to calculate effect estimates
- Groups patients in exposed and comparator cohorts into strata defined by unique values for any requester-defined combination of sex, age group, and/or year of index date
Continue reading about covariate stratification on Sentinel's Git Repository.
Type 3: Self-Controlled Risk Interval Design
What this program does:
- Identifies exposure of a medical product of interest
- Defines risk and control windows relative to the exposure date
- Examines the occurrence of health outcomes of interest during the risk and control windows
Output metrics include:
- Number of exposure episodes
- Exposed individuals
- Individuals with a health outcome of interest in the risk and/or control windows
- Censored individuals overall
- Attrition table
Stratified by requester-defined:
- Age group
- Sex
- Year
- Year-month
- Time-to-event (in days)
- Race (available upon request)
- Ethnicity (available upon request)
- Geographic region (available upon request)
This program provides estimates of relative risk (RR) and 95% confidence intervals.
Continue reading about self-controlled risk interval design on Sentinel's Git Repository.
Type 4+: Medical Product Use During Pregnancy with Propensity Score Analysis
What this program does:
- Identifies exposures, follow-up time, outcomes, and covariates in a population of pregnant women
- Estimates a propensity score (based on predefined covariates and/or via a high-dimensional propensity score approach)
- Uses matching, stratification, inverse probability of treatment weighting (IPTW), or stratum weighting for confounder adjustment and a binary outcome assignment framework for maternal outcome assessment among the pregnant mothers or birth outcome assessment among the infants or a survival analysis framework for maternal outcomes assessment among pregnant mothers
Output metrics include:
- Tables of patient characteristics (unadjusted and adjusted cohorts)
- Hazard ratios (with 95% confidence intervals)
- IPTW/PS stratum weights
- Measures of covariate balance
- Distribution of propensity score by exposure group
- Risk ratios (with 95% confidence intervals)
- Attrition table
Continue reading about propensity score analysis on Sentinel's Git Repository.
Type 4+: Medical Product Use During Pregnancy with Covariate Stratification
What this program does:
- Conducts covariate stratification within each Sentinel Data Partner site via distributed programming code; returns data to the Sentinel Operations Center (SOC), aggregated, and used to calculate effect estimates
- Groups patients in exposed and comparator cohorts into strata defined by unique values for any requester-defined combination of sex, age group, and/or year of index date
Continue reading about covariate stratification on Sentinel's Git Repository.
Want more details on the functional and technical documentation of each level 2 analysis? Visit Sentinel's Git Repository.