Marsha A. Raebel, PharmD, BCPS, FCCP, is an investigator in Pharmacotherapy at the Institute for Health Research. Dr. Raebel's research is in patient safety and pharmacoepidemiology, specifically focusing on reducing medication and laboratory monitoring errors in the outpatient setting and on adverse drug event surveillance. She is the coordinating investigator across Kaiser Permanente for the FDA Mini-Sentinel initiative, is a collaborating investigator in the Health Care Research Network (HCSRN), Center for Education and Research in Therapeutics (CERTs), and an investigator in the FDA-sponsored Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP).
Efforts to Develop the Sentinel Initiative
The Sentinel System will be a national electronic active surveillance system that greatly enhances the ability of the FDA to track the safety of FDA-regulated drugs, biologics, and medical devices. The pilot program, known as Mini-Sentinel, is the Agency’s first step towards building this nationwide rapid-response electronic safety surveillance system.
Funder: United States Food and Drug Administration
Multi-Institutional Consortium for CER in Diabetes Treatment and Prevention (PROSPECT; SUPREME-DM)
In this “next-generation” multi-system registry we are proposing, it is intended to serve as a resource for a wide range of CER on both individual therapies and system-level interventions, and specifically to support examination of heterogeneity in effectiveness across patient subgroups defined by race/ethnicity, age, co-morbidities, or psychosocial variables, and across systems.
Funder: Agency for Healthcare Research and Quality
Mini-Sentinel: Analytic Methods for Using Laboratory Test Results in Active Database Surveillance
The objective of this project is to select and test statistical methods appropriate for use when analyzing cross-sectional and longitudinal observational healthcare administrative, claims, and clinical data, with specific attention to clinical laboratory test results data when missing data are expected.
Mini-Sentinel: SUPREME DM & M-S Data Linkage
The purpose of this project to validate diagnostic algorithms for Type1 and Type 1 diabetes mellitus in the Mini-Sentinel Distributed Database using the SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) DataLink as the alternative reference standard.
Funder: United States Food and Drug Administration
RFTOP Opioids and Neural Tube Defects Using Data from the Medication Exposure in Pregnancy Risk Evaluation Program
The overall objective of this project is to evaluate the feasibility of conducting a retrospective cohort study of the association between opioid use during pregnancy and neural tube defects using the MEPREP database.
Funder: United States Food and Drug Administration
Privacy-Preserving Analytic and Stat-Sharing Methods for Clinical and Patient-Powered data Networks
The project will 1) increase the understanding and utility of privacy-preserving methods in multi-center patient-centered outcomes research (PCOR) studies, 2) Develop a suite of flexible analytic and data-sharing methods to handle a wide range of stakeholder needs, preferences, and priorities in multi-center PCOR studies, and 3) Improve the efficiency of multi-site PCOR studies by reducing barriers to data sharing.
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Long-term Use of Antihypertensive Agents and Breast Cancer Risk
There are important clinical and public health implications if the hypothesis that long-term calcium channel blocker (CCB) use increases the risk of breast cancer is confirmed. Nationally, CCBs were the ninth most commonly prescribed class of drugs in 2009, and breast cancer is the most commonly occurring cancer location and second leading cause of cancer death among women. This study will employ an observational design to address the question of long-term use of five different classes of antihypertensive medications and incident breast cancer.
Funder: KP Program Office
Associations between Hyperuricemia and Cardiovascular and Renal Outcomes among Patients with Diagnosed Gout
In this project we will determine t distribution of serum uric acid result values in a population of patients with diagnosed gout, assess independent associations of hyperuricemia and risk of selected cardiovascular outcomes, incident chronic kidney disease, and all-cause mortality, and assess the association between sUA and total medical care costs.
Funder: Pharmaceutical Industry
The Safety and Effectiveness of Diabetes Quality Metrics in Elderly Patients
In a cohort of older patients with diabetes, we will examine the impact of advanced age and specific comorbidities on adherence to cardiovascular disease (CVD) risk factor medications, compare the effectiveness of meeting specified targets for CVD risk factor medication adherence of differing intensities of medication usage on achieving CVD risk factor control and the occurrence of adverse events, hospitalizations, and emergency department visits, and disseminate the findings of these analyses among a wide range of clinical, operational, and policy stakeholders in an effort to improve quality metrics and clinical care for these patients.
Funder: National Institute on Aging (NIA)
Raebel MA, Schmittdiel J, Karter AJ, Konieczny JL, Steiner JF. Standardizing terminology and definitions of medication adherence and persistence in electronic health records-based research. Medical Care 2013;51:S11-S21.
Raebel MA, Xu S, Goodrich GK, Schroeder EB, Schmittdiel JA, Segal JB, O’Connor PJ, Nichols GA, Lawrence JM, Kirchner HL, Elston Lafata J, Butler M, Newton KM, Steiner JF. Initial antihyperglycemic drug therapy among 241,327 adults with newly identified diabetes from 2005 through 2010: a SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) study. Ann Pharmacother. 2013;47(10):1280–1291.
Raebel MA, Newcomer SR, Reifler LM, Boudreau D, Elliott TE, DeBar L, Ahmed A, Pawloski PA, Fisher D, Donahoo WT, Bayliss EA. Chronic use of opioid medications before and after bariatric surgery. JAMA. 2013:310(13):1369-1376.
McClure DL, Raebel MA, Yih WK, Shoaibi A, Mullersman JE, Anderson-Smits C, Glanz JM. Mini-Sentinel methods: Framework for assessment of positive results from signal refinement. Pharmacoepidemiol Drug Saf. 2014;23:3-8. DOI: 10.1002/pds.3547.
Vaz LE, Kleinman KP, Raebel MA, Nordin JD, Lakoma MD, Dutta-Linn MM, Finkelstein JA. Recent trends in outpatient antibiotic use in children. Pediatrics. 2014 Feb 2 [Epub ahead of print]. PMID: 24488744
Raebel MA, Haynes K, Woodworth TS, Saylor G, Cavagnaro E, Coughlin KO, Curtis LH, Weiner MG, Archdeacon P, Brown JS. Electronic clinical laboratory test results data tables: lessons from Mini-Sentinel. Pharmacoepidemiol Drug Saf. 2014;23(6):609-18. PMID: 24677577.
Xu S, Shetterly S, Raebel MA, Ho PM, Tsai TT, Magid D. Estimating the effects of time-varying exposures in observational studies using Cox models with stabilized weights adjustment. Pharmacoepidemiol Drug Saf. 2014;23(8):812-8. DOI: 10.1002/pds.3601.
Raebel MA, Ellis JL, Schroeder EB, Xu S, O’Connor PJ, Segal JB, Butler MG, Schmittdiel JA, Kirchner HL, Goodrich GK, Lawrence JM, Nichols GA, Newton KM, Pathak RD, Steiner JF. Intensification of antihyperglycemic therapy among patients with incident diabetes: a SUrveillance PREvention and ManagEment of Diabetes Mellitus (SUPREME-DM) study. Pharmacoepidemiol Drug Saf. 2014; 23:699–710. PM:24639086.
Raebel MA, Newcomer SR, Ahmed A, Bayliss EA, Boudreau D, DeBar L, Elliott TE, Fisher D, Pawloski PA, Donahoo WT. Chronic opioid use emerging after bariatric surgery. Pharmacoepidemiol Drug Saf. 2014;23(12):1247-57. PM:24733580.
Xu S, Shetterly S, Goodrich GK, O’Connor PJ, Schroeder EB, Steiner JF, Schmittdiel JA, Desai J, Pathak R, Neugebauer R, Butler MG, Kirchner, L, Raebel MA. Accuracy of hemoglobin A1c imputation using fasting plasma glucose in diabetes research using electronic medical record data. Stat Optim Inf Comput 2014;2:93-104.
Holmes JH, Elliott TE, Brown JS, Raebel MA, Davidson A, Nelson AF, Chung A, La Chance P, Steiner JF. Clinical data warehouse governance for distributed research networks in the United States: a systematic review of the literature. J Am Med Inform Assoc 2014;Jul;21(4):730-736. PM:24682495.
Schroeder EB, Goodrich GK, Newton KM, Schmittdiel JA, Raebel MA. Implications of different laboratory-based incident diabetic kidney disease definitions on comparative effectiveness studies. J Comp Eff Res 2014;3(4):359-369. PM:25275233.
Schmittdiel JA, Raebel MA, Dyer W, Steiner JF, Goodrich GK, Karter AJ, Nichols GA. Medicare STAR excludes patients with poor CVD risk factor control. Am J Manag Care. 2014;20(12):e581-e589.
Lu C, Zang F, Lakoma M, Madden J, Penfold R, Simon G, Ahmedani, B, Clarke G, Hunkeler E, Waitzfelder B, Owen-Smith A, Raebel M, Rossom R, Coleman K, Copeland L, Soumerai S. Changes in youth antidepressant use and suicidal behavior following FDA warnings and media coverage. BMJ. 2014;348:g3596 doi: 10.1136/bmj.g3596. [Epub ahead of print]
Schmittdiel JA, Raebel MA, Dyer W, Xu S, Goodrich GK, Schroeder EB, Segal JB, O’Connor PJ, Nichols GA, Lawrence JM, Kirchner HL, Karter AJ, Elston Lafata J, Butler MG, Steiner JF. Prescription medication use in patients with newly-diagnosed diabetes: a SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) study. J Amer Pharm Assoc (2003). 2014 May 23:e251-e259. doi: 10.1331/JAPhA.2014.13195.
Li DK, Raebel MA, Cheetham TC, Hansen C, Avalos L, Chen H, Davis R. Genital herpes and its treatment in relation to preterm delivery. Am J Epidemiol. 2014;180(11):1109-1117. PM:25392064.
Raebel MA, Penfold R, McMahon AW, Reichman M, Shetterly S, Goodrich G, Andrade S, Correll CU, Gerhard T. Adherence to guidelines for glucose assessment in starting second-generation antipsychotics. Pediatrics. Nov;134(5):e1308-e1314. PM:25287454.
Nichols GA, Schroeder EB, Karter AJ, Gregg EW, Desai J, Lawrence JM, O’Connor PJ, Xu S, Newton K, Schmittdiel J, Raebel MA, Pathak RD, Waitzfelder B, Segal J, Elston Lafata J, Butler, MG, Kirchner LH, Thomas A, Steiner JF, On behalf of the SUPREME-DM Study Group. Trends in diabetes incidence, 2006-2011, in seven million insured US adults: the SUPREME-DM project. Am J Epidemiol. 2015;181(1);32-39. PM:25515167.
Schmittdiel JA, Nichols GA, Dyer W, Steiner JF, Karter AJ, Raebel MA. Health care system-level factors associated with performance on Medicare STAR adherence metrics in a large, integrated delivery system. Medical Care. 2015;53:332-337. PMID: 25719517Davis RL, Gallagher MA, Asgari MM, Eide MJ, Margolis DJ, Macy E, Burmester JK, Selvam N, Boscarino JA, Cromwell LF, Feigelson HS, Kuntz JL, Pawloski PA, Penfold RB, Raebel MA, Sridhar G, Schild LA, Wu A, La Grenade LA, Pacanowski MA, Pinheiro SP. Identification of Stevens-Johnson Syndrome and toxic epidermal necrolysis in electronic health record databases. 2015 Apr 29 [Epub ahead of print] Pharmacoepidemiol Drug Saf. DOI: 10.1002/pds.3778.