Obesity Demonstration Projects Initial Query Goals and Timeline

Obesity Demonstration Projects – Initial Query Goals and Timeline Study-Specific Data Characterization Wave 1 – July 2016 § § Who: All participating Data. Marts (DMs) with approved IRB, signed DSA, approved DRN OC prep-to-research status Goal: Characterize tables not included in DRN OC Data Characterization (includes: Dispensing, Labs, Condition, PRO, Prescribing, Death, and Death Cause) Study-Specific Data Characterization Wave 2 – August/September 2016 § § Who: all participating DMs with approved IRB, signed DSA, approved DRN OC prep-to-research status, successful completion of obesity wave 1 Goal: create cohorts for studies and produce “Table 1” for each study Aim 1 Individual-Level Queries – September 2016 § § Who: All participating DMs with approved IRB, signed DSA, approved DRN OC prep-to-research status, successful completion of obesity wave 1 data characterization, agree to share individual-level data Goal: Aim 1 analyses. Individual-level data included to address missing data, confounding, and covariates • Not all DMs participating in individual-level data queries – some will only participate with aggregate data Aim 1 Aggregate-Level Queries – Fall 2016/Winter 2017 § § Who: All participating DMs with approved IRB, signed DSA, approved DRN OC prep-to-research status, successful completion of obesity wave 1 data characterization Goal: Repeat Aim 1 analyses with aggregate data PBS: Queries for Aims 2 and 3 will come in 2017 ABX: Aggregate query data for Aims 2 and 3 will be collected with Aim 1 data with the exception of maternal-child linkage 1

Participation Deadlines Deadline #1: August 31, 2016 § Deadline to participate in Aim 1 Individual-Level Queries § Must complete: IRB approval, DSA signature, successful completion of study-specific data characterization § Participating sites should still work to complete contracting, IRB determinations, and signing of DSAs as soon as possible Deadline #2: November 30, 2016 (estimated - date still to be finalized) § Deadline to contribute data to either study § Must complete: IRB approval, DSA signature, process wave 1 study-specific data characterization 2

Query Cover Sheet High-level query metadata includes: standardized name, priority, due date, level of PHI disclosure Description details: § Requester § Confidentiality § Purpose of query § Data required § Output produced § Planned use of output § Program package contents, details 3