Sentinel pilot has created a distributed data system with over 125 million lives and nearly 350 million person. Mini sentinel federal partners collaboration no exchange of individual data no exchange of individual data data maintained behind data owners firewall data maintained behind data owners firewall common database model mscdm individual database models at each site one protocol and one sas program used at all sites distributed by msoc. Minisentinel goals to develop a distributed database and supporting infrastructure to enable an active surveillance system for monitoring the safety of drugs, biologics and devices in the united states the secretary shalldevelop validated methods for the establishment of a postmarket risk identification and analysis. Minisentinel distributed database populations with welldefined persontime for which most medicallyattended events are known million individuals 382 million personyears of observation time 3. Dec 05, 2014 the role of health data in the learning health system richard platt harvard pilgrim health care institute harvard medical school december 5, 2014. Mini sentinel is a pilot project sponsored by the u. Minisentinel relies on a distributed database model that is currently able to access electronic health data from more than 150 million healthcare records administered by 18.
Minisentinel is an effort to develop a smaller working model of the distributed. Pharmasug 2015 paper ha07 distributed data networks. As of september 20, the msdd contained data on 153 million individuals, 358 million personyears of observation time, 4 billion outpatient dispensings and 4 billion. The system is designed with multiple manual steps to allow partners to. Statistical methods sentinel explores the application of a wide range of. Populations with welldefined person time for which most medicallyattended events are known. Nih collaboratory distributed research network users guide. Although the agency foresees using a distributed data model for the initial implementation of the sentinel initiative, other approaches should be explored and. Prospective postmarketing surveillance of acute myocardial. Observational medical outcomes partnership and mini.
Metabolic effects of second generation antipsychotics in youth. Summary of scholarly activitiesdepartment of pathology202014. Popovic, harvard pilgrim health care instituteharvard medical. This pilot project, which has now transitioned to the fullfledged sentinel system, built a distributed database of insurance claims and administrative data using a com. Populations with welldefined persontime for which most medicallyattended events are known. We conducted a cohort assessment to evaluate the ability of the sentinel. If the address matches an existing account you will receive an email with instructions to reset your password. Methods design of the mini sentinel cdm principles and priorities. The pilot allows the fda to use modular analytic programs to assess suspected safety signals quickly. Validity of administrative and claims data for the identification of cases of anaphylaxis in the mini sentinel distributed. Distributed dbms distributed databases tutorialspoint. The database includes 316,009,067 personyears of observation time, with members contributing, on average, 27.
The minisentinel distributed query tool was used to obtain a description of counts and prevalence of one diagnosis code for progressive multifocal leukoencephalapathy in the mini. Distributed systems for sharing clinical research information richard platt. Overcoming statistical challenges to the reuse of data. Minisentinel major deliverables 1st year a coordinating center with secure communications capability for sharing confidential information between fda and minisentinel collaborators. Minisentinel major deliverables 1st year a coordinating center with secure communications capability for sharing confidential information between fda and minisentinel collaborators communications capability for public sharing of nonconfidential work products the first version of the minisentinel distributed database. The mini sentinel distributed database msdd currently consists of qualitychecked data held by 18 partner organizations health insurers or managed care consortiums. Data characterization tools in distributed networks. System aers, a database that captures reports of suspected adverse drug. Data inventory, plus a prioritized list of data needs develop and implement common data model first version of minisentinel distributed database. Data the sentinel distributed database sdd is comprised of qualitychecked data held by 18 partner institutions. Large electronic healthcare databases for medical product. For example, fictitious patient bob shown below is a male who is enrolled in a health plan and experiences several medical encounters between 2011 and 2014.
The minisentinel distributed query tool was used to obtain a description of counts and prevalence of one diagnosis code for progressive multifocal leukoencephalapathy in the mini sentinel distributed database. Cdm supports implementation of standardized analytics across organizations with different. Sentinel is a program sponsored by the us food and drug administration to monitor the safety of medical products. We conducted a retrospective study using administrative and claims data from eight health plans. Fdas sentinel initiative a national strategy for monitoring. An earlier version of this work was presented as a poster evaluation of medication use during pregnancy in the minisentinel distributed database at the 30th international conference on pharmacoepidemiology and therapeutic risk management held in taipei, taiwan october 2427, 2014. Overview of fdas minisentinel pilot brookings institution. The minisentinel provides an essential public health service. A distributed database management system distributed dbms is the software system that permits the management of the distributed database and makes the distribution transparent to the users 1. This paper introduces the concept of a distributed data network, its purposes and benefits and, using the mini sentinel pilot project as a case study, discusses using sas to design and build infrastructure for a successful multisite, collaborative distributed data network.
Jan 01, 2012 read design considerations, architecture, and use of the mini. For subproject 1, the minisentinel distributed database msdd will be employed to define a minisentinel msn patient cohort of new initiators of sgas to replicate the max. Oct 31, 2014 mini sentinel relies on a distributed database model that is currently able to access electronic health data from more than 150 million healthcare records administered by 18 distinct data partners. Governance14 and privacy issues15 are addressed elsewhere. Sentinel distributed data system, pharmacoepidemiology and drug safety on deepdyve, the largest online rental. Meeting summary overcoming statistical challenges to the reuse of data within the mini sentinel distributed database september 5, 2012. Fdas minisentinel program to evaluate the safety of. Overcoming statistical challenges to the reuse of data within. Utilizing this standardized data format, the mscc is able to write a single analytical software program for a given safety question and provide it to each of. Disclaimer i am a minisentinel investigator and an ohdsi. Avoids many concerns about inappropriate use of confidential personal data data partners maintain physical control of. The queries were run against the icd 9cm 3digit diagnosis code summary. Minisentinel anonymous linking of distributed databases description this report summarizes an effort to link individuals with records in two different electronic health systems. For subproject 1, the minisentinel distributed database msdd will be employed to define a minisentinel msn patient cohort of new initiators of sgas to replicate the max analyses.
Building a national platform for evidence generation. This study characterized new drug uptake in the mini. Read design considerations, architecture, and use of the mini. Us initiatives omop and sentinel tobias gerhard, bspharm, phd ernest mario school of pharmacy rutgers university. We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the mini sentinel pilot program of the us food and drug administration fda. Validity of administrative and claims data for the identification of cases of anaphylaxis in the minisentinel distributed database.
Minisentinel distributed database 178 million individuals 358 million person years of observation time 36 million individuals have over 3 years of data 4 billion dispensings. Several factors limit the statistical power of drug safety surveillance during the early post. A database management system that manages a database that is distributed across the nodes of a computer network and makes this distribution transparent to. Supports data source provisioning based on rbac and additional data source specific metadata queries distributed using a pull model instead of push model minisentinel distributed analysis. Approaches to continuous improvement using largescale. Sentinel distributed data system, pharmacoepidemiology and drug safety on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. Minisentinel distributed database 178 million individuals 358 million person years of observation time 36 million individuals have over 3 years of data 4 billion dispensings populations with welldefined longitudinal persontime for which most medically attended events are known. Need to create single assignment statements variable1 some function of var2, var3, varn multiple statements not permitted. A distributed database management system ddbms is a centralized software system that manages a distributed database in a manner as if it were all stored in a single location. As of july 2014, the sentinel distributed database comprised data from 18 data partner sites covering approximately 178 million individuals cumulatively from january 2000 through january 2014. Summary of scholarly activitiesdepartment of pathology. Lessons learned from distributed data networks sas support.
The role of health data in the learning health system. First version of minisentinel distributed database, encompassing quality checked adminclaims data. Minisentinel distributed database 16 approved october 19, 2010 indication of nonvalvular atrial fibrillation unexpected level of reports to faers on severe bleeding, primarily gi. Approaches to continuous improvement using largescale data. Distributed data networks represent a paradigm shift in healthcare data sharing. Using diagnosis and procedure codes, we developed an algorithm to identify. The minisentinel distributed database msdd currently consists of qualitychecked data held by 18 partner organizations health insurers or managed care consortiums. Surveillance of medication use during pregnancy in the. Validity of administrative and claims data for the identification of. Minisentinel 5year pilot developed in response to the fda amendments act of 2007 develop scientific operations for active medical product safety surveillance create a coordinating center with continuous access to automated healthcare data systems, and the following capabilities. Minisentinel anonymous linking of distributed databases. Surveillance of medication use during pregnancy in the mini.
A paradigm shift in data sharing and healthcare analytics jennifer r. Food and drug administration fda minisentinel pilot project was a collaboration to build an active surveillance system for medical product safety 12. Paper 17722014 programming in a distributed data network. Defining and evaluating possible database models to. Food and drug administration fda mini sentinel pilot project was a collaboration to build an active surveillance system for medical product safety 12. Sentinel modular program for propensityscore matched cohort. Minisentinel distributed database populations with welldefined persontime for which most medicallyattended events are known million individuals 382 million personyears of. Sentinel modular program for propensityscore matched. Innovative use of existing public and private data sources. Sentinel distributed database and determined statistical power to detect levels of risk in post. Minisentinel uses pmn to facilitate medical product safety and related public health surveillance activities. The fda minisentinel initiative is 1 such pioneering approach to aggregate large patientlevel data sets from various sources intending to monitor the safety of pharmaceutical products in. Distributed systems for sharing clinical research information.
Workshop to advance the use of electronic data for. A distributed database ddb is a collection of multiple, logically interrelated databases distributed over a computer network. Read a comparative assessment of observational medical outcomes partnership and minisentinel common data models and analytics. We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the minisentinel pilot program of the us food and drug. Use of antidiabetic drugs during pregnancy among u. Design considerations, architecture, and use of the mini. Statistical methods sentinel explores the application of a wide range of methods to enhance medical product safety assessment.
Populations with welldefined persontime for which medicallyattended events are known. The sentinel distributed database is comprised of qualitychecked electronic data held by 17 partner organizations. Journal of comparative effectiveness research vol 6, no 1. Populations with well defined periods for which medicallyattended. Created minisentinel distributed database v1, encompassing quality checked administrative and claims for 69 million individuals. Design for identification, retrieval and adjudication of acute myocardial infarction cases in the minisentinel distributed database. Sep 24, 20 mini sentinel anonymous linking of distributed databases description this report summarizes an effort to link individuals with records in two different electronic health systems via anonymous linking methods that avoid requiring either party to disclose protected health information phi to the other. At the final analysis of this surveillance, the distributed database included 178 million individuals and 358 million personyears of longitudinal observation time from 2000 to. The minisentinel common data model standardizes administrative and clinical. Minisentinel uses a distributed data approach in which data partners maintain physical and operational control over electronic data in their existing environments. Qualitychecked data held by 17 partner organizations. Created mini sentinel distributed database v1, encompassing quality checked administrative and claims for 69 million individuals.
Results of subproject 1 will inform whether or not the model developed using the maxderived cohort performs similarly in the msnderived cohort. It is used to create, retrieve, update and delete distributed databases. Workshop to advance the use of electronic data for conducting. Data minisentinel distributed dataset and tools used to access the data.
676 208 1016 997 1120 802 933 1419 251 683 1494 21 1117 1012 868 299 215 657 1003 434 216 960 355 119 526 108 492 329 671 374 1550 362 261 1090 885 952 1387 1435 1322 339 1492 517 19 820 1251 913 724 574 379