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Biostatistics Core Publications


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

Semi-Parametric Estimation and Inference for the Mean Outcome of the Single Time-Point Intervention in a Causally Connected Population.

We study the framework for semi-parametric estimation and statistical inference for the sample average treatment-specific mean effects in observational settings where data are collected on a single network of connected units (e.g.,...
Author(s): Sofrygin O; van der Laan MJ;

​J Causal Inference. 2017 Mar;5(1). pii: 20160003. doi: 10.1515/jci-2016-0003. Epub 2016 Nov 29.

PubMed abstract

Risks and Predictors of Gastric Adenocarcinoma in Patients with Gastric Intestinal Metaplasia and Dysplasia: A Population-Based Study

Gastric intestinal metaplasia and dysplasia are precursor lesions for adenocarcinoma. The risks of progression to malignancy from these lesions are not well characterized, particularly in the US populations. We identified 4,331 Kaiser Permanente Northern ...
Author(s): Li D; Bautista MC; Jiang SF; Daryani P; Brackett M; Armstrong MA; Hung YY; Postlethwaite D; Ladabaum U

Am J Gastroenterol. 2016 May 17.

PubMed abstract

A Case Study of the Impact of Data-Adaptive Versus Model-Based Estimation of the Propensity Scores on Causal Inferences from Three Inverse Probability Weighting Estimators

Consistent estimation of causal effects with inverse probability weighting estimators is known to rely on consistent estimation of propensity scores. To alleviate the bias expected from incorrect model specification for these nuisance parameters in observ...
Author(s): Neugebauer R; Schmittdiel JA; van der Laan MJ

Int J Biostat. 2016 May 1;12(1):131-55.

PubMed abstract

Evaluation of propensity scores, disease risk scores, and regression in confounder adjustment for the safety of emerging treatment with group sequential monitoring

The objective of this study was to evaluate regression, matching, and stratification on propensity score (PS) or disease risk score (DRS) in a setting of sequential analyses where statistical hypotheses are tested multiple times. In a setting of sequentia...
Author(s): Xu S; Shetterly S; Cook AJ; Raebel MA; Goonesekera S; Shoaibi A; Roy J; Fireman B

Pharmacoepidemiol Drug Saf. 2016 Feb 15.

PubMed abstract

Does adopting a prenatal substance use protocol reduce racial disparities in CPS reporting related to maternal drug use? A California case study

This study examined whether adopting a standardized prenatal substance use protocol (protocol) in a hospital labor and delivery unit reduced racial disparities in reporting to child protective services (CPS) related to maternal drug use during pregnancy. ...
Author(s): Roberts SC; Zahnd E; Sufrin C; Armstrong MA

J Perinatol. 2015 Feb;35(2):146-50. Epub 2014-09-18.

PubMed abstract

High-dimensional propensity score algorithm in comparative effectiveness research with time-varying interventions

The high-dimensional propensity score (hdPS) algorithm was proposed for automation of confounding adjustment in problems involving large healthcare databases. It has been evaluated in comparative effectiveness research (CER) with point treatments to handl...
Author(s): Neugebauer R; Schmittdiel JA; Zhu Z; Rassen JA; Seeger JD; Schneeweiss S

Stat Med. 2014 Dec 8.

PubMed abstract

Targeted learning in real-world comparative effectiveness research with time-varying interventions

In comparative effectiveness research (CER), often the aim is to contrast survival outcomes between exposure groups defined by time-varying interventions. With observational data, standard regression analyses (e.g., Cox modeling) cannot account for time-d...
Author(s): Neugebauer R; Schmittdiel JA; van der Laan MJ

Stat Med. 2014 Jun 30;33(14):2480-520. Epub 2014-02-17.

PubMed abstract

Impact of Specific Glucose-Control Strategies on Microvascular and Macrovascular Outcomes in 58,000 Adults With Type 2 Diabetes

Comparative effectiveness research methods are used to compare the effect of four distinct glucose-control strategies on subsequent myocardial infarction and nephropathy in type 2 diabetes. A total of 58,000 adults with type 2 diabetes and A1C <7% (53 ...
Author(s): Neugebauer R; Fireman B; Roy JA; O'Connor PJ

Diabetes Care. 2013 Nov;36(11):3510-6. Epub 2013-07-22.

PubMed abstract

Super learning to hedge against incorrect inference from arbitrary parametric assumptions in marginal structural modeling

OBJECTIVE: Clinical trials are unlikely to ever be launched for many comparative effectiveness research (CER) questions. Inferences from hypothetical randomized trials may however be emulated with marginal structural modeling (MSM) using observational...
Author(s): Neugebauer R; Fireman B; Roy JA; Raebel MA; Nichols GA; O'Connor PJ

J Clin Epidemiol. 2013 Aug;66(8 Suppl):S99-109.

PubMed abstract

The value of additional pathology comments indicating suspicion of adenocarcinoma among women diagnosed preoperatively with complex atypical endometrial hyperplasia

Over 40% of women with a preoperative diagnosis of complex atypical hyperplasia (CAH) will have endometrial cancer at hysterectomy. CAH diagnoses are often qualified by comments indicating suspicion of cancer. We examine whether these comments correlate w...
Author(s): Suh-Burgmann E; Hung YY; Armstrong MA

Int J Gynecol Pathol. 2012 May;31(3):222-6.

PubMed abstract

Dynamic marginal structural modeling to evaluate the comparative effectiveness of more or less aggressive treatment intensification strategies in adults with type 2 diabetes

PURPOSE: Chronic disease care typically involves treatment decisions that are frequently adjusted to the patient's evolving clinical course (e.g., hemoglobin A1c monitoring and treatment intensification in diabetes patients). Thus, in comparative effe...
Author(s): Neugebauer R; Fireman B; Roy JA; O'Connor PJ; Selby JV

Pharmacoepidemiol Drug Saf. 2012 May;21 Suppl 2:99-113.

PubMed abstract

Complex atypical endometrial hyperplasia: the risk of unrecognized adenocarcinoma and value of preoperative dilation and curettage

OBJECTIVE: To evaluate whether preoperative dilation and curettage (D&C) lowers the risk of unexpected cancer at hysterectomy. METHODS: Women with complex atypical endometrial hyperplasia on sampling from January 2000 to May 2008 who underwent...
Author(s): Suh-Burgmann E; Hung YY; Armstrong MA

Obstet Gynecol. 2009 Sep;114(3):523-9.

PubMed abstract

Using drink size to talk about drinking during pregnancy: a randomized clinical trial of Early Start Plus

This clinical trial compared two brief alcohol use interventions in prenatal clinics: Early Start (ES), a substance-abuse screening and treatment program integrated with prenatal care focused on abstention (n=298), and Early Start Plus (ESP), adding a...
Author(s): Armstrong MA; Kaskutas LA; Witbrodt J; Taillac CJ; Hung YY; Osejo VM; Escobar GJ

Soc Work Health Care. 2009 Jan;48(1):90-103.

PubMed abstract

Documentation of contraception and pregnancy when prescribing potentially teratogenic medications for reproductive-age women

BACKGROUND: Certain medications are identified by the U.S. Food and Drug Administration (FDA) as class D or X because they increase the risk for birth defects if used during pregnancy. OBJECTIVE: To assess pregnancy rates and the frequency of cont...
Author(s): Schwarz EB; Postlethwaite DA; Hung YY; Armstrong MA

Ann Intern Med. 2007 Sep 18;147(6):370-6.

PubMed abstract