Sign In

Biostatistics Core Publications


A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial

Excess gestational weight gain (GWG) among women with overweight or obesity synergistically increases their already elevated risk of having gestational diabetes, a caesarean delivery, a large for gestational age infant, and post-partum weight retention, a...
Author(s): Ferrara A; Hedderson MM; Brown SD; Ehrlich SF; Tsai AL; Feng J; Galarce M; Marcovina S; Catalano P; Quesenberry CP

Lancet Diabetes Endocrinol. 2020 Jun;8(6):490-500.

PubMed abstract

Comparative Effectiveness of 2 Diabetes Prevention Lifestyle Programs in the Workplace: The City and County of San Francisco Diabetes Prevention Trial

Data on the comparative effectiveness of Diabetes Prevention Programs (DPPs) in the workplace are limited. Between September 2015 and July 2016, employees of the City and County of San Francisco who were at risk for type 2 diabetes (N = 158) were randomly...
Author(s): Ferrara A; McDonald JC; Brown SD; Alexander JG; Christian-Herman JL; Fisher S; Quesenberry CP

Prev Chronic Dis. 2020 May 28;17:E38. Epub 2020-05-28.

PubMed abstract

Exploiting nonsystematic covariate monitoring to broaden the scope of evidence about the causal effects of adaptive treatment strategies

In studies based on electronic health records (EHR), the frequency of covariate monitoring can vary by covariate type, across patients, and over time, which can limit the generalizability of inferences about the effects of adaptive treatment strategies. I...
Author(s): Kreif N; Sofrygin O; Schmittdiel JA; Adams AS; Grant RW; Zhu Z; van der Laan MJ; Neugebauer R

Biometrics. 2020 Apr 15.

PubMed abstract

Learning to learn from data: Using deep adversarial learning to construct optimal statistical procedures

Traditionally, statistical procedures have been derived via analytic calculations whose validity often relies on sample size growing to infinity. We use tools from deep learning to develop a new approach, adversarial Monte Carlo meta-learning, for constru...
Author(s): Luedtke A; Carone M; Simon N; Sofrygin O

Sci Adv. 2020 Feb;6(9):eaaw2140. Epub 2020-02-26.

PubMed abstract

Adjuvant endocrine therapy for breast cancer patients: impact of a health system outreach program to improve adherence

Reports suggest that up to 50% of women with hormone receptor-positive (HR+) breast cancer (BC) do not complete the recommended 5 years of adjuvant endocrine therapy (AET). We examined the impact of an outreach program at Kaiser Permanente Northern C...
Author(s): Lee C; Check DK; Manace Brenman L; Kushi LH; Epstein MM; Neslund-Dudas C; Pawloski PA; Achacoso N; Laurent C; Fehrenbacher L; Habel LA

Breast Cancer Res Treat. 2020 Jan 23.

PubMed abstract

Comparison of Mortality and Major Cardiovascular Events Among Adults With Type 2 Diabetes Using Human vs Analogue Insulins

The comparative cardiovascular safety of analogue and human insulins in adults with type 2 diabetes who initiate insulin therapy in usual care settings has not been carefully evaluated using machine learning and other rigorous analytic methods. To examine...
Author(s): Neugebauer R; Schmittdiel JA; Dyer W; Pimentel N; O'Connor PJ; et al.

JAMA Netw Open. 2020 Jan 03;3(1):e1918554. Epub 2020-01-03.

PubMed abstract

Depletion-of-susceptibles bias in influenza vaccine waning studies: how to ensure robust results

Vaccine effectiveness studies are subject to biases due to depletion-of-persons at risk of infection, or at especially high risk of infection, at different rates from different groups (depletion-of-susceptibles bias), a problem that can also lead to biase...
Author(s): Lipsitch M; Goldstein E; Ray GT; Fireman B

Epidemiol Infect. 2019 Nov 27;147:e306. Epub 2019-11-27.

PubMed abstract

Validity of Self-reported Cannabis Use Among Pregnant Females in Northern California

Most clinical and epidemiologic estimates of prenatal cannabis use are based on self-report, and the validity of self-reported cannabis use has not been examined in a large, representative population of pregnant women. We determined the validity of self-r...
Author(s): Young-Wolff KC; Sarovar V; Tucker LY; Goler N; Conway A; Weisner C; Armstrong MA; Alexeeff S

J Addict Med. 2019 Nov 04.

PubMed abstract

Use of Time-Dependent Propensity Scores to Adjust Hazard Ratio Estimates in Cohort Studies with Differential Depletion of Susceptibles

Estimating hazard ratios (HR) presents challenges for time-to-event analyses of cohorts with differential depletion of susceptibles. When the treatment effect is not null, cohorts that were balanced at baseline tend to become unbalanced on baseline charac...
Author(s): Wyss R; Fireman B; et al.

Epidemiology. 2019 Sep 26.

PubMed abstract

Time-to-event analysis when the event is defined on a finite time interval

Acute graft-versus-host disease (GVHD) is a frequent complication following hematopoietic cell transplantation (HCT). Research on risk factors for acute GVHD has tended to ignore two important clinical issues. First, post-transplant mortality is high. In ...
Author(s): Lee C; Lee SJ; Haneuse S

Stat Methods Med Res. 2019 Aug 22:962280219869364.

PubMed abstract

Depletion of Susceptibles Bias in Analyses of Intra-season Waning of Influenza Vaccine Effectiveness

Bias arises in studies of waning vaccine effectiveness when higher-risk individuals are depleted from the population at-risk, at different rates between study groups. We examine how this bias arises and how it can be avoided. Reanalysis of data from Calif...
Author(s): Ray GT; Lewis N; Klein NP; Daley MF; Lipsitch M; Fireman B

Clin Infect Dis. 2019 Jul 28.

PubMed abstract

If Influenza Vaccines Wane Can We Delay Vaccination Without Compromising Coverage?

Author(s): Klein NP; Fireman B

Clin Infect Dis. 2019 Jun 29.

PubMed abstract

Targeted learning with daily EHR data

Electronic health records (EHR) data provide a cost- and time-effective opportunity to conduct cohort studies of the effects of multiple time-point interventions in the diverse patient population found in real-world clinical settings. Because the computat...
Author(s): Sofrygin O; Zhu Z; Schmittdiel JA; Adams AS; Grant RW; van der Laan MJ; Neugebauer R

Stat Med. 2019 Apr 25.

PubMed abstract

Reproductive Factors and Mammographic Density: Associations Among 24,840 Women and Comparison of Studies Using Digitized Film-Screen Mammography and Full-Field Digital Mammography

Breast density is a modifiable factor that is strongly associated with breast cancer risk. We sought to understand the influence of newer technologies of full-field digital mammography (FFDM) on breast density research and to determine whether results are...
Author(s): Alexeeff SE; Achacoso N; Habel LA; et al.

Am J Epidemiol. 2019 Mar 13.

PubMed abstract

Comparative effectiveness of treatment of actinic keratosis with topical fluorouracil and imiquimod in the prevention of keratinocyte carcinoma: a cohort study

The effectiveness of 5-fluorouracil compared to imiquimod for preventing keratinocyte carcinoma is unknown. To compare the effectiveness of 5-fluorouracil and imiquimod in preventing keratinocyte carcinoma in a real-world practice setting. We identified 5...
Author(s): Neugebauer R; Su KA; Zhu Z; Sokil M; Chren MM; Friedman GD; Asgari MM

J Am Acad Dermatol. 2018 Nov 17.

PubMed abstract

simcausal R Package: Conducting Transparent and Reproducible Simulation Studies of Causal Effect Estimation with Complex Longitudinal Data

The simcausal R package is a tool for specification and simulation of complex longitudinal data structures that are based on non-parametric structural equation models. The package aims to provide a flexible tool for simplifying the conduct of transparent ...
Author(s): Sofrygin O; van der Laan MJ; Neugebauer R

J Stat Softw. 2017;81. Epub 2017-10-16.

PubMed abstract

Intra-season Waning of Influenza Vaccine Effectiveness

In the United States it is recommended that health care providers offer influenza vaccination by October, if possible. However, if the vaccine's effectiveness soon begins to wane, the optimal time for vaccination may be somewhat later. We examined whether...
Author(s): Ray GT; Lewis N; Klein NP; Daley MF; Wang SV; Kulldorff M; Fireman B

Clin Infect Dis. 2018 Sep 10.

PubMed abstract

Use of non-steroidal anti-inflammatory drugs during pregnancy and the risk of miscarriage

Non-steroidal anti-inflammatory drugs (NSAIDs) remain one of the medications most widely used by pregnant women, and previous studies reported an increased risk of miscarriage associated with NSAID use during pregnancy. Although the findings have not alwa...
Author(s): Li DK; Ferber JR; Odouli R; Quesenberry C

Am J Obstet Gynecol. 2018 Jun 08.

PubMed abstract

High-resolution mapping of traffic related air pollution with Google street view cars and incidence of cardiovascular events within neighborhoods in Oakland, CA

Some studies have linked long-term exposure to traffic related air pollutants (TRAP) with adverse cardiovascular health outcomes; however, previous studies have not linked highly variable concentrations of TRAP measured at street-level within neighborhood...
Author(s): Alexeeff SE; Roy A; Shan J; Liu X; Messier K; Apte JS; Portier C; Sidney S; Van Den Eeden SK

Environ Health. 2018 May 15;17(1):38. Epub 2018-05-15.

PubMed abstract

A real-world, community-based cohort study comparing the effectiveness of topical fluoruracil vs. topical imiquimod for the treatment of actinic keratosis

The most widely used topical agents for the field-based treatment of multiple actinic keratoses (AKs) are 5-fluorouracil and imiquimod, but their comparative effectiveness has not been assessed in a real-world setting. We compared the effectiveness of 5-f...
Author(s): Neugebauer R; Levandoski KA; Zhu Z; Sokil M; Chren MM; Friedman GD; Asgari MM

J Am Acad Dermatol. 2017 Dec 22.

PubMed abstract

Exposure to Magnetic Field Non-Ionizing Radiation and the Risk of Miscarriage: A Prospective Cohort Study

Magnetic field (MF) non-ionizing radiation is widespread and everyone is exposed to some degree. This prospective cohort study of 913 pregnant women examined the association between high MF exposure and miscarriage risk. Cox (proportional hazards) regress...
Author(s): Li DK; Chen H; Ferber JR; Odouli R; Quesenberry C

Sci Rep. 2017 Dec 13;7(1):17541. Epub 2017-12-13.

PubMed abstract

Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study

The cardiovascular safety of saxagliptin, a dipeptidyl-peptidase 4 inhibitor, compared with other antihyperglycemic treatments is not well understood. We prospectively examined the association between saxagliptin use and acute myocardial infarction (AMI)....
Author(s): Toh S; Reichman ME; Graham DJ; Hampp C; Zhang R; Butler MG; Iyer A; Rucker M; Pimentel M; Hamilton J; Lendle S; Fireman BH; Mini-Sentinel Saxagliptin-AMI Surveillance Writing Group

Diabetes Care. 2017 Nov 09.

PubMed abstract

simcausal R Package: Conducting Transparent and Reproducible Simulation Studies of Causal Effect Estimation with Complex Longitudinal Data

The simcausal R package is a tool for specification and simulation of complex longitudinal data structures that are based on non-parametric structural equation models. The package aims to provide a flexible tool for simplifying the conduct of transparent ...
Author(s): Oleg Sofrygin; Mark J. van der Laan; Romain Neugebauer

​Sofrygin O, van der Laan MJ and Neugebauer R (2017). simcausal R Package: Conducting Transparent and Reproducible Simulation Studies of Causal Effect Estimation with Complex Longitudinal Data. Journal of Statistical Software, 81(2), pp. 1–47. doi: 10.18637/jss.v081.i02

PubMed abstract

Age at menarche and late adolescent adiposity associated with mammographic density on processed digital mammograms in 24,840 women

High mammographic density is strongly associated with increased breast cancer risk. Some, but not all, risk factors for breast cancer are also associated with higher mammographic density. The study cohort (N=24,840) was drawn from the Research Program in ...
Author(s): Alexeeff SE; Odo N; Lipson JA; Achacoso N; Rothstein JH; Yaffe MJ; Liang RY; Acton L; McGuire V; Whitmore AS; Rubin DL; Sieh W; Habel LA

Cancer Epidemiol Biomarkers Prev. 2017 Jul 11.

PubMed abstract

Identification of the joint effect of a dynamic treatment intervention and a stochastic monitoring intervention under the no direct effect assumption

The management of chronic conditions is characterized by frequent re-assessment of therapy decisions in response to the patient's changing condition over the course of the illness. Evidence most suitable to inform care thus often concerns the contrast of ...
Author(s): Neugebauer R; Schmittdiel JA; Adams AS; Grant RW; van der Laan MJ

J Causal Inference. 2017 03;5(1). Epub 2017-01-18.

PubMed abstract