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Rough, Kathryn

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Rough

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Kathryn

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Rough, Kathryn

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2013 - 20172

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Author's Publications: search.filters.isAuthorOfPublication.2ce9473b-d7e4-407a-98b4-71c2b7de1ff8

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    Comparative Safety of Antiretroviral Drugs to Treat HIV During Pregnancy
    (2017-01-23) Rough, Kathryn; Seage, George R.; Hernandez-Diaz, Sonia; Williams, Paige L.
    Each year, nearly 1.5 million women with HIV become pregnant, and require antiretroviral treatment to reduce risk of perinatal transmission of the virus and improve their own health. The safety of currently approved antiretroviral medications for the fetus is largely unknown; recommendations about preferred regimens during pregnancy are often based on a small body of clinical safety data, expert opinion, and programmatic considerations, including regimen harmonization across sub-populations. Therefore, there is a public health need to identify the specific antiretroviral drugs and combinations of drugs that are safest for use during pregnancy. Across the papers that comprise this Dissertation, we apply different epidemiological methods to observational data sources in order to provide information on clinically-motivated questions. In Chapter II, we used descriptive statistics to explore how substance use, one important risk factor for adverse infant birth outcomes, changed over time among pregnant women with HIV in the US. We found that substance use in this population dramatically decreased from 1990 to 2012, and that substance use had correlations with treatment, which means it may act as an important confounder in subsequent antiretroviral safety studies. In Chapter III, we further investigated the relationship between specific antiretroviral regimens and adverse birth outcomes, providing information on safety questions raised by a recent clinical trial. Pooling data from two prospective cohorts, we compared three antiretroviral regimens and concluded that the use of tenofovir with protease inhibitors not including lopinavir/ritonavir do not increase adverse birth outcomes. In Chapter IV, we examined the relationship between first trimester use of the antiretroviral zidovudine and congenital malformations. We summarized results of published studies using a systematic review and meta-analysis, and used Bayesian methods to incorporate this information with new data from Medicaid. We concluded that there appears to be a link between first trimester zidovudine use and increased risk of male genital malformations. We hope that the research undertaken in this Dissertation will substantially contribute to the growing body of antiretroviral safety information available to women with HIV and their clinicians, ultimately allowing them to make more well-informed treatment decisions.
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    Individual-Based Simulation Models of HIV Transmission: Reporting Quality and Recommendations
    (Public Library of Science, 2013) Abuelezam, Nadia; Rough, Kathryn; Seage III, George R.
    Background: Individual-based modeling is a growing technique in the HIV transmission and prevention literature, but insufficient attention has been paid to formally evaluate the quality of reporting in this field. We present reporting recommendations for individual-based models for HIV treatment and prevention, assess the quality of reporting in the existing literature, and comment on the contribution of this model type to HIV policy and prediction. Methods: We developed reporting recommendations for individual-based HIV transmission mathematical models, and through a systematic search, used them to evaluate the reporting in the existing literature. We identified papers that employed individual-based simulation models and were published in English prior to December 31, 2012. Articles were included if the models they employed simulated and tracked individuals, simulated HIV transmission between individuals in a particular population, and considered a particular treatment or prevention intervention. The papers were assessed with the reporting recommendations. Findings: Of 214 full text articles examined, 32 were included in the evaluation, representing 20 independent individual-based HIV treatment and prevention mathematical models. Manuscripts universally reported the objectives, context, and modeling conclusions in the context of the modeling assumptions and the model’s predictive capabilities, but the reporting of individual-based modeling methods, parameterization and calibration was variable. Six papers discussed the time step used and one discussed efforts to maintain internal validity in coding. Conclusion: Individual-based models represent detailed HIV transmission processes with the potential to contribute to inference and policy making for many different regions and populations. The rigor in reporting of assumptions, methods, and calibration of individual-based models focused on HIV transmission and prevention varies greatly. Higher standards for reporting of statistically rigorous calibration and model assumption testing need to be implemented to increase confidence in existing and future modeling results.