The objective of this project is to write a detailed functional specification to perform disease risk score (DRS) estimation in the Sentinel Distributed Database (SDD).
This enhancement will enable options for DRS estimation in three cohorts: (1) the full concurrent cohort (i.e., all patients who contribute to the analysis); (2) comparator patients in the concurrent cohort (i.e., patients in the concurrent cohort exposed to the comparator product); and (3) a historical cohort of patients exposed to the comparator product.
This specification will include options for DRS development using both Cox proportional hazards regression and logistic regression; various options for the approach to follow-up for patients contributing to the DRS model; and options for inclusion of interaction terms among pre-specified variables. The specification will also include multiple options for using the estimated DRS, including matching, stratification, and inclusion as a covariate in an outcome regression model.
Joshua J. Gagne, PharmD, ScD; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA