Research and Reporting Jim Oates, MD Informatics Medical Director of Research and Reporting September 15, 2016 Epic Research Team Les Lenert, CRIO Melissa Habrat – Program Manager Bob Warren, CMIO Signe Denmark, Research Opportunities & Collaborations

Objectives – be familiar with What types of data are available from Epic versus the Clinical Data Warehouse Self-service tools for feasibility queries How to request research data or recruiting tools

Outline Sources of data at MUSC and HSSC How to request data Feasibility Chart review/data extract recruitment Examples of research uses of data

Feasibility Tools & Consultation Self-service tools for de-identified patient counts Honest Broker services for identified data & de-identified queries Need help navigating the self-service tools? SCTR provides free Self-Service Research Data & Feasibility consultations Epic and MUSC CDW report builds for research Queries related to regional and national data networks

Epic/CDW data use examples Patient Counts for Feasibility Chart Review/Data extract for analysis Recruitment Data Preparatory to Research

Epic/CDW data use examples Patient Counts for Feasibility Chart Review/Data extract for analysis Recruitment Data Preparatory to Research

Self-Service Research Data & Feasibility Consultation Service Epic RDW Slicer Dicer Research Query Tool Aggregate Data Encounters since May 2012 Aggregate Data Encounters since 1993 HSSC StatewideData i2b2

Self-Service Research Data and Feasibility

SlicerDicer This tool allows de-identified query access to all patients available in Epic (Ambulatory 5/2012, Emergency 11/2012, Inpatient 7/2014)

SlicerDicer Access Complete training in MyQuest (search SlicerDicer) Epic SlicerDicer for Research 2017 (interactive training online) Once you complete the training in MyQuest, email Paul Powers powersp@musc.edu to enable your access Additional available training in MyQuest: Epic Research Creating a Population in SlicerDicer (tipsheet) Epic Research Opening SlicerDicer (tipsheet) Epic Research Requestihng PHI fro the Honest Broker in SlicerDicer (tipsheet)

Clinical Data Warehouse (CDW) The MUSC CDW is a single, secure, integrated database extracted from the MUSC Clinical Data Repository, which includes (since 1993): Patient demographics Visit information ICD-coded diagnoses and procedures Medications Laboratory test results Etc. Other fields are continually being added Epic results since July 1, 2014 Self service access via the Research Query Tool http://academicdepartments.musc.edu/bmic

Clinical Data Warehouse MUSC faculty and faculty-sponsored staff may access the CDW. Faculty can sponsor full-time MUSC staff members by completing the sponsorship form and returning it to datarequest@musc.edu. De-identified aggregate data Restricted query interface Data use assurance (DUA) to comply with HIPAA guidelines Some aggregate, de-identified queries that are more complex/require multiple variables may need to be performed by an honest broker and requested through the Research Data Request process.

Clinical Data Warehouse View a basic tutorial of the CDW self-query tool at http://academicdepartments.musc.edu/bmic/CDW/cdwbasictutorial.html

Example: Patient count for feasibility study

Example: Patients in medication class - feasibility

Health Sciences South Carolina (HSSC) Clinical Data Warehouse (CDW) Health Sciences Health Improvement (HSHI), LLC, a South Carolina limited liability company, which is a wholly-owned subsidiary of Health Sciences South Carolina (HSSC), and Participants have been working to establish a statewide Clinical Data Warehouse (CDW) system as part of its mission to improve the health of all South Carolinians. The creation of the CDW and the data management platform support the goal of significant growth in clinical trials and medical research by facilitating collaboration across HSSC member organizations.

Health Sciences South Carolina (HSSC) Clinical Data Warehouse (CDW) Those who have eIRB access have access to HSSC. http://www.healthsciencessc.org/cdw.asp    

MUSC i2b2 Project

How to gain access to i2b2 User management policy follows the same policy as the Research Query Tool Who can access MUSC i2b2? MUSC faculty and sponsored staff members have access All non-faculty users must be sponsored by a MUSC faculty member; Email completed Sponsorship Form to datarequest@musc.edu Access is granted within 1-2 business days. http://academicdepartments.musc.edu/bmic/DataRequest.html

MUSC i2b2 query tool

Example query

PCORI MUSC query tool

TriNetX: Data-Driven Clinical Trial Design & Recruitment Real world data network of providers and pharma August 2016 Go live at MUSC 2 years of Epic encounter data currently populated in TriNetX

MUSC Self-Service Feasibility Tools Which self-service tool do I choose?   MUSC Self-Service Feasibility Tools MUSC i2b2 TriNetX (consult service) Epic SlicerDicer CDW Research Query tool User friendly interface X Requires MUSC Faculty sponsorship Training Required Provide aggregate counts Query by demographics Query by medication orders Query by labs Query by Diagnosis Use Sequential Criteria Data available only after 7/2014 Query on Cancer registry data Query based on encounter location Create a query to share with an honest broker for recruitment patient list Export a de-identified limited data set

Which self-service tool do I choose? Do you need to receive more than aggregate counts of patients? Do you need information counts for MUSC patients only HSSC i2b2 (Includes MUSC, Greenville Health System, Palmetto Health, Spartanburg Regional Healthcare System) Do you need data prior to 2014 Do you need cancer registry data or to filter by procedures? SlicerDicer MUSC i2b2 Research Query Tool Will you need to receive identifiable data? Will you need data prior to 2014 MUSC I2B2 Research Data Request Will you need data only on your own clinical patients? Will you need data prior to 2014? Will you need cancer registry data or need to filter by procedures? Yes No No Yes No Yes No Yes No Yes Yes No No Yes Create a key for requires training, No Yes

How do I ask for data for research BEYOND self service Obtain IRB approval Request through SCTR SPARC Approval by Data Request Committee (usually in 24 hours) Fulfilled by Epic or BMIC honest brokers

IRB Approved CDW Data Services IRB approved process for Self-Service via i2b2 and Honest Broker for identified data access. Details at: http://academicdepartments.musc.edu/bmic/cdw.html CDW IRB approval Researchers Results Honest Broker Data Use Agreement aggregate data only De-identified aggregate data DRC Self-Service Access Brokered Access MUSC and planned for HSSC.

Epic/CDW data use examples Patient Counts for Feasibility Chart Review Recruitment Data Preparatory to Research

Research Data Request

Tips for completing Research Data Request Form Be as specific as possible with selection criteria Include ICD9/ICD10 codes, CPT codes, etc. Make sure the data points you are requesting, have been listed and approved in your IRB application/amendment Including “Chart review” vs “Data Request” in your application Exempt protocols can receive only clinical data OR identifiers but not both Your Pre-Data Request consult will allow you to work with a data analyst to identify the most feasible and appropriate query for the purposes of obtaining the data you desire

Data Preparatory to Research Requests Can be requested without IRB approval HIPAA Privacy rule preparatory to Research Provision 45 CFR 164.512(i)(1)(ii)  The following attestation much be agreed upon and adhered to with regards to the received data Because you selected "Preparatory to Research requiring identifiers", you must agree that: (A) Use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research; (B) No protected health information is to be removed from the covered entity by the researcher in the course of the review; and (C) The protected health information requested is the MINIMUM level necessary for assessment of the feasibility of this research project

Epic/CDW data use examples Patient Counts for Feasibility Chart Review Recruitment Data Preparatory to Research

Research Data Request

Recruiting tools Reports in EDW created by honest broker, run as needed Epic Reporting Workbench Best Practice Alerts Pop ups for providers InBasket messages for coordinators Soft Alerts

Honest broker report Patients seen by Rheumatologists with lupus

Epic Reporting Workbench

Summary A great deal of data are out there Aggregate data simpler to query (CDW, i2b2, SlicerDicer) Patient level data available with IRB approval and Data Request Committee approval All roads lead from SCTR SPARC Quality improvement study data requests go to the Analytics Group www.musc.edu/eir

843-792-8300 success@musc.edu sctr.musc.edu