KP Center for Effectiveness & Safety Research
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1 KP Center for Effectiveness & Safety Research Robert L. Davis, MD, MPH Director of Research, Center for Health Research SE Kaiser Permanente Georgia September 13, 2010
2 Kaiser Permanente Research Transforming the Future of Health Care Research mission is critical to KP - has been and will continue to be so in the future CESR is a response to a changing world of research and the needs for translation to clinical care
3 Research Today: A Major Activity $140 Million budget 3,500 Studies underway 1,200 Clinical trials underway
4 Kaiser Permanente established the Center for Effectiveness and Safety Research (CESR) to build upon research capabilities Leadership Resource Uniqueness Laboratory CESR enables KP a leadership role in a national agenda to evaluate the effectiveness and safety of drugs, devices and biologics. CESR is a program-wide resource supported by Kaiser Permanente investment and external funding Builds on the scientific achievements of KP researchers; on a health plan with over 8.7 million diverse members; on a integrated care delivery system that provides comprehensive health care; and on the sophisticated electronic medical record and data infrastructure that captures essentially all health care provided to members across the program. This system serves, in turn, as a laboratory that can feed back and translate research findings into practice, both within Kaiser Permanente and more broadly through publication and dissemination.
5 Center for Effectiveness & Safety Research Investigator Network Investigator Development and Leadership DCC/Data Management Network Data Standardization and Management Leadership Administrative Network Administrative and Operations Leadership
6 Center for Effectiveness & Safety Research Stable and diverse (racially/ethnically, socio-economically) membership of over 8 million individuals, across the United States Rich, longitudinal clinical electronic database that includes health care delivery, payment, decision-making and behavioral data -- in primary, secondary and tertiary care across inpatient and outpatient settings Sufficient number of individuals with diverse disease conditions, e.g., asthma, HIV, diabetes, rare conditions, etc. Close connection with delivery system to pose questions and translate findings Expanding database to include genetic and environmental exposure data
7 Center for Effectiveness & Safety Research: Capacity for Multi-Site Pediatric Safety Studies CardioVascular Research Network (CVRN; 14 HMOs): Use & safety of statins in children Cancer Research Network (CRN; 14 HMOs): Preventing errors in the home health care of children with cancer Mental Health Research Network (MHRN; 8 HMOs): Comparative effectiveness of commonly used therapies for children with Autism Spectrum Disorder
8 Center for Effectiveness & Safety Research: Year 1 Demonstration Projects H1N1 Infection During Pregnancy: Impact on pregnancy (eclampsia), developing infant (prematurity), & woman s health (pneumonia) Glycemic Control & Joint Replacement Surgery Impact of pre/peri/post operative glucose control on surgical outcomes
9 Center for Effectiveness & Safety Research (CESR): Outward Facing Food and Drug Administration (FDA) Mini-Sentinel Initiative The Mini-Sentinel Initiative supports the FDA Sentinel Initiative, a Congressional mandate to create an active surveillance system using electronic health data for 100 million people by 2012 National Institutes of Health (NIH) Research Collaboratory NIH has proposed a unique research collaboratory that would include Kaiser Permanente and other members of the HMO Research Network for CER & other research
10 Center for Effectiveness & Safety Research (CESR): Outward Facing Food and Drug Administration (FDA) (MEPREP) Medication Exposure in Pregnancy Risk Evaluation Program Collaborative research program between the FDA, HMO Research Network, Vanderbilt University, and Kaiser Permanente Northern and Southern California Linked data on mothers & infants born Administrative and birth certificate data on over 1,045,373 children linked to mothers
11 Center for Effectiveness & Safety Research (CESR): Outward Facing International Serious Adverse Events Consortium (SAEC) Objective: To study patients with drug-related serious AEs and identify genetic underpinnings that place certain patients at risk DILI; SJS; Extreme weight gain on atyp antipsychotics Eventually integrate findings within data systems so as to screen & prevent SAEs in the future
12 HMO Research Network (HMORN)
13
14 Regional Roadmap Tasks: Regional Data Standardization In collaboration with the Data Coordinating Center, the regions identified over 30 Data Standardization Tasks that could be addressed by regional data management teams (distinct from the VDW specialists) Virtually all regions addressed/exceeded their expected outcomes for the data standardization tasks
15 Prior Experience Has Shown Little or no exchange of person-level data is needed to answer many safety, effectiveness, and quality questions. A relatively small subset of items in electronic health data systems can answer most safety, effectiveness, and quality questions. Essential to have data partner input in interpretation of findings; keep data close to the experts. Data partners do not like having their data outside their control. Concentrate analytics in a single team. Minimize impact on health plan operations.
16 KP Center for Effectiveness & Safety Research (CESR) CESR Guiding Principles: Create capacity for KP to participate as a single entity for comparative effectiveness and safety research Develop interregional databases as a resource for use Have KP National Leadership & Regional commitment to a national research agenda in safety and comparative effectiveness Commit to sharing the outcomes of this research to the benefit of our members and patients, and for the public welfare
17
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