In the absence of randomized trials, analyses of observational (non-experimental) data can provide timely results to fill the pressing need for information on comparative effectiveness. But unlike well-conducted randomized trials, observational studies may be biased due to differences between those that receive one treatment rather than another. Doubly robust (DR) estimation is a novel statistical method which combines two regression models to provide some additional protection against bias due to confounding. The proposed research will systematically evaluate six key aspects of DR estimators: 1) quantify the degree to which DR estimation leads to bias reduction relative to standard methods, 2) evaluate estimated standard errors under a broad range of conditions, 3) determine the optimal covariate types for inclusion in the component models, 4) validate a new approach to variable and model-form selection, 5) develop and test strategies specific to DR estimation for the identification of non-uniform treatment effects, and 6) identify conditions under which DR methods perform worse than standard methods. Dr Jonsson Funk will use more realistic and complex data as the basis for the Monte Carlo simulations by creating a hybrid of covariate data from de-identified records of actual patients combined with simulated exposures and outcomes. Dr Jonsson Funk will employ the DR method in three comparative effectiveness analyses of large healthcare databases to evaluate its use in real-world applications, and ultimately disseminate 'best practices'for using DR estimation in comparative effectiveness research. In addition to the comprehensive evaluation of DR methods, this award would provide protected time for the candidate to undertake formal and informal training in the use of large healthcare databases to complete the skill set needed for a productive career in comparative effectiveness research. Drawing on rich local resources including Decide and EPC sites, experts in advanced methods, clinical colleagues, and key healthcare databases, the proposed portfolio of research will make important advances in comparative effectiveness research and firmly establish the candidate as an independent investigator. Making an informed choice among treatment options depends on the availability of reliable data about the comparative effectiveness and safety of the alternatives. Dr Jonsson Funk will develop and disseminate 'best practices'for using a new statistical method in an effort to deliver more robust and relevant information in a timely manner to support patients, providers, payers and policy-makers making critical decisions about healthcare.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Scientist Development Award - Research (K02)
Project #
5K02HS017950-04
Application #
8213789
Study Section
HSR Health Care Research Training SS (HCRT)
Program Officer
Anderson, Kay
Project Start
2009-02-01
Project End
2014-01-31
Budget Start
2012-02-01
Budget End
2013-01-31
Support Year
4
Fiscal Year
2012
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Camelo Castillo, Wendy; Boggess, Kim; Stürmer, Til et al. (2014) Trends in glyburide compared with insulin use for gestational diabetes treatment in the United States, 2000-2011. Obstet Gynecol 123:1177-84
Wyss, Richard; Ellis, Alan R; Brookhart, M Alan et al. (2014) The role of prediction modeling in propensity score estimation: an evaluation of logistic regression, bCART, and the covariate-balancing propensity score. Am J Epidemiol 180:645-55
Wu, Jennifer M; Matthews, Catherine A; Conover, Mitchell M et al. (2014) Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol 123:1201-6
Panozzo, Catherine A; Becker-Dreps, Sylvia; Pate, Virginia et al. (2014) Direct, indirect, total, and overall effectiveness of the rotavirus vaccines for the prevention of gastroenteritis hospitalizations in privately insured US children, 2007-2010. Am J Epidemiol 179:895-909
Jonsson Funk, Michele; Siddiqui, Nazema Y; Pate, Virginia et al. (2013) Sling revision/removal for mesh erosion and urinary retention: long-term risk and predictors. Am J Obstet Gynecol 208:73.e1-7
Watkins, Stephanie; Jonsson-Funk, Michele; Brookhart, M Alan et al. (2013) An empirical comparison of tree-based methods for propensity score estimation. Health Serv Res 48:1798-817
Panozzo, Catherine A; Becker-Dreps, Sylvia; Pate, Virginia et al. (2013) Patterns of rotavirus vaccine uptake and use in privately-insured US infants, 2006-2010. PLoS One 8:e73825
Jonsson Funk, Michele; Edenfield, Autumn L; Pate, Virginia et al. (2013) Trends in use of surgical mesh for pelvic organ prolapse. Am J Obstet Gynecol 208:79.e1-7
Berggren, Erica K; Boggess, Kim A; Funk, Michele Jonsson et al. (2012) Racial disparities in perinatal outcomes among women with gestational diabetes. J Womens Health (Larchmt) 21:521-7
Jonsson Funk, Michele; Levin, Pamela J; Wu, Jennifer M (2012) Trends in the surgical management of stress urinary incontinence. Obstet Gynecol 119:845-51

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