Center for Drug Safety and Effectiveness So you want to use MarketScan … 1. Attestation of agreement with the Data Use Agreement Please read the Data Use Agreement that Johns Hopkins has signed with Truven Analytics. If you are agreeable to all statements, please sign here. ______________________________ Signature _____________ date Version 1.0 This License is due to the generous support of the following Johns Hopkins entities: JHSPH Department of Biostatistics JHSPH Department of Health, Policy and Management Center for Drug Safety and Effectiveness (CDSE) Center for Health Services and Outcomes Research (CHSOR) Center for Population Health Information Technology (CPHIT) Center for Surgical Trials and Outcomes Research (CSTOR) Department of Otolaryngology-Head and Neck Surgery Institute for Clinical and Translational Research (ICTR) 615 North Wolfe Street, W6035 Baltimore, Maryland 21205 www.jhsph.edu/dept/epi/ galexand@jhsph.edu Center for Drug Safety and Effectiveness 2. Information about MarketScan data We encourage you to read Health Research Data for the Real world: The MarketScan Data Databases. This describes the sources of Truven’s data and how they are packaged into datasets accessible to researchers. We have access to the A. MarketScan Commercial Claims and Encounters Database 2010-2012 (see page 7 of the white paper) and B. the Market Scan Lab Database (see page 11 of the white paper). Note: we do not have inpatient drug use data, nor do we have the health risk assessment data. A. MarketScan Commercial Claims and Encounters Database 615 North Wolfe Street, W6035 Baltimore, Maryland 21205 www.jhsph.edu/dept/epi/ galexand@jhsph.edu Center for Drug Safety and Effectiveness B. Market Scan Lab Database 3. Data Request In order to track usage and to provide assistance, we request a brief application so that we can get you the data you need. The process is as follows: a. Submit attestation of data use agreement to cdse@jhsph.edu b. Submit IRB application – this will be considered exempt as there are no unique identifiers in this data and the individuals cannot be identified. c. Forward IRB notification to cdse@jhsph.edu d. An analytic data set will be prepared according to your specifications and will be placed on the high-capacity computer in biostatistics. You will be given a password with which you can enter to retrieve your data file, which will then need to be transferred for storage and use on your local server. We are not storing analytic files on the high-capacity computer and analytic extracts that are left there may be deleted. We can also transfer the file to a CD or to an external hard drive if you prefer. The files will be delivered in SAS. e. Any publications that come from using this data must acknowledge the source of data in the text and beneath any tables or figures. The acknowledgement can be: This study used MarketScan Commercial Claims and Encounters data as provided by Truven Health Analytics Inc. f. Unless our license is renewed, at the end of our license period – April 10th 2016 – you will destroy all copies of your data. Therefore, plan ahead for manuscript submissions as you will not be able to reanalyze data after this date. g. Please look at the MarketScan Users Guide and at the MarketScan Data Dictionary before proceeding with your data request. 615 North Wolfe Street, W6035 Baltimore, Maryland 21205 www.jhsph.edu/dept/epi/ galexand@jhsph.edu Center for Drug Safety and Effectiveness NOTE: This data is free-for-use for unfunded or internally funded work only. If you are submitting a grant for external funding, you will be asked to request funding from the granting agency as specified in our Data Use Agreement (varies based on the funding source and the size of the funding request). 615 North Wolfe Street, W6035 Baltimore, Maryland 21205 www.jhsph.edu/dept/epi/ galexand@jhsph.edu Center for Drug Safety and Effectiveness Please complete the following for your data request online: Part A. Investigator Requesting School/Department/Division: PI: Study Title: Funding source (if any): Funding period (if relevant): Part B. Study Background (one paragraph): The background should succinctly highlight gaps in the current knowledge or practice in the field of study. The researcher must show that he or she understands the important studies that form the foundation for the protocol and indicate how the project will go beyond them. Study Objectives/Research Questions (few sentences): The objectives should pinpoint what the researcher plans to do and expects to achieve. Study Design (few sentences): Describe how the MarketScan data will be used to address the hypotheses. We will deliver data in the MarketScan files to you for the members of your cohort. You need to tell us how to define your cohort. For most studies, the cohort will be defined based on a set of ICD-9 or CPT codes, or possible an age range, or exposure to a drug of interest. Our plan is to deliver to you ALL data on patients in your cohort (inpatient, outpatient, etc) regardless of whether you think you will use this data in your analyses. Cohorts should be carefully specified and we urge investigators to review published literature using claims data for examples of cohort specifications. Part C. Cohort Definition 615 North Wolfe Street, W6035 Baltimore, Maryland 21205 www.jhsph.edu/dept/epi/ galexand@jhsph.edu Center for Drug Safety and Effectiveness Part C. Cohort Definition (Example) Our cohort is defined as individuals over the age of 18 with diabetes mellitus on metformin. For this study, this will be operationalized as: A. One or more dispensings of metformin AND B. Hba1c greater than 6.5% twice OR Fasting glucose greater than 126mg/dl twice on different days OR Random glucose greater than 200 mg/dl twice on different days OR Any inpatient discharge diagnosis of ICD-9 250x, 357.2, 366.41, 362.01-362.07 OR Outpatient visit diagnoses of ICD-9 250x, 357.2, 366.41, 362.01-362.07 twice on separate days Part D. Instructions for Analyst You will need to tell the analyst in which table he should look for these variables. In the Data Dictionary you will see a list of variables and the tables in which they found. I: Inpatient Admissions F: Facility Header S: Inpatient Services O: Outpatient Services D: Outpatient Drug Claims P: Populations A: Annual Summary Enrollment T: Detail Enrollment Supplementary Table (drugs) RED BOOK ® 615 North Wolfe Street, W6035 Baltimore, Maryland 21205 www.jhsph.edu/dept/epi/ galexand@jhsph.edu Center for Drug Safety and Effectiveness Relevant Tables Variable Table Using the example above: Relevant Tables (Example) Variable Table Metformin D: Outpatient Drug Claims RedBook Tables ICD-9 codes I, F, S,O Age On all tables 615 North Wolfe Street, W6035 Baltimore, Maryland 21205 www.jhsph.edu/dept/epi/ galexand@jhsph.edu