Studies comparing the effect of aromatase inhibitor (AI) and tamoxifen use on cardiovascular disease (CVD) risk factors in hormone receptor-positive breast cancer (BC) survivors report conflicting results. We examined associations of endocrine therapy use with incident diabetes, dyslipidemia, and hypertension.…
The results of current prospective trials comparing the effectiveness of carotid endarterectomy (CEA) vs standard medical therapy for long-term stroke prevention in patients with asymptomatic carotid stenosis (ACS) will not be available for several years. In this study, we compared…
Studies comparing the effect of aromatase inhibitor (AI) and tamoxifen use on cardiovascular disease (CVD) risk factors in hormone-receptor positive breast cancer (BC) survivors report conflicting results. We examined associations of endocrine therapy use with incident diabetes, dyslipidemia, and hypertension.…
Practice patterns and outcomes associated with the use of oral anticoagulation for arterial thromboembolism prevention following a hospitalization with new-onset atrial fibrillation (AF) during sepsis are unclear. Retrospective, observational cohort study of patients ≥40 years of age discharged alive following…
In the United States, there has been controversy over whether treatment of mild-to-moderate hypertension during pregnancy conveys more benefit than risk. The objective of the study was to compare risks and benefits of treatment of mild-to-moderate hypertension during pregnancy. This…
Real-world evidence used for regulatory, payer, and clinical decision-making requires principled epidemiology in design and analysis, applying methods to minimize confounding given the lack of randomization. One technique to deal with potential confounding is propensity score (PS) analysis, which allows…
The incidence of cardiometabolic risk factors in breast cancer (BC) survivors has not been well described. Thus, we compared risk of hypertension, diabetes, and dyslipidemia in women with and without BC. Women with invasive BC diagnosed from 2005 to 2013…
To examine cardiovascular disease (CVD) and mortality risk in women with breast cancer (BC) by cancer therapy received relative to women without BC. The study population comprised Kaiser Permanente Northern California members. Cases with invasive BC diagnosed from 2005 to…
Nearly 30% of individuals with gestational diabetes (GDM) do not achieve glycemic control with lifestyle modification alone and require medication treatment. Oral agents, such as glyburide, have several advantages over insulin for the treatment of GDM, including greater patient acceptance;…
Studies of hypertension in pregnancy that use electronic health care data generally identify hypertension using hospital diagnosis codes alone. We sought to compare results from this approach to an approach that included diagnosis codes, antihypertensive medications and blood pressure (BP)…
To compare maternal and infant outcomes with different antihypertensive medications in pregnancy. Retrospective cohort study. Kaiser Permanente, a large healthcare system in the United States. Women aged 15-49 years with a singleton birth from 2005-2014 treated for hypertension. We identified…
Cardiovascular events and mortality are the principal causes of excess mortality and health care costs for people with type 2 diabetes. No large studies have specifically compared long-acting insulin alone with long-acting plus short-acting insulin with regard to cardiovascular outcomes.…
This study is designed to help patients with type 2 diabetes and their clinicians identify which glucose-lowering medications among SGLT2 inhibitors, GLP-1 receptor agonists, DPP4 inhibitors, or Sulfonylureas have the most favorable effects on heart health and other patient-important outcomes;…
Observational studies reporting on adjusted associations between childhood body mass index (BMI; weight (kg)/height (m)2) rebound and subsequent cardiometabolic outcomes have often not paid explicit attention to causal inference, including definition of a target causal effect and assumptions for unbiased…
Embedded researchers could play a central role in developing tools to personalize care using electronic medical records (EMRs). However, few studies have described the steps involved in developing such tools, or evaluated the key factors in success and failure. This…
Persons living with human immunodeficiency virus (HIV; PLWH) experience a high burden of cancer. It remains unknown which cancer types are reduced in PLWH with earlier initiation of antiretroviral therapy (ART). We evaluated AIDS-free, ART-naive PLWH during 1996-2014 from 22…
It is important to understand relationships of gestational weight gain with adverse pregnancy outcomes in women with chronic hypertension, given their high baseline risk of adverse outcomes. We assessed associations of gestational weight gain with adverse pregnancy outcomes in women…
To estimate the effects of exercise during the first trimester on the risks of abnormal screening and gestational diabetes mellitus (GDM). Data come from PETALS, a prospectively followed pregnancy cohort (n = 2,246, 79% minorities) receiving care at Kaiser Permanente…
Mail order pharmacy (MOP) use has been linked to improved medication adherence and health outcomes among patients with diabetes. However, no large-scale intervention studies have assessed the effect of encouraging MOP use on medication adherence. To assess an intervention to…
Bisphosphonate (BP) therapy has been associated with atypical femur fracture (AFF). However, the threshold of treatment duration leading to increased AFF risk is unclear. In a retrospective cohort of older women initiating BP, we compared the AFF risk associated with…
Clinical trials have demonstrated the antifracture efficacy of bisphosphonate drugs for the first 3 to 5 years of therapy. However, the efficacy of continuing bisphosphonate for as long as 10 years is uncertain. To examine the association of discontinuing bisphosphonate…
Continuity of patient information across settings can improve transitions after hospital discharge, but outpatient clinicians often have limited access to complete information from recent hospitalizations. We examined whether providers' timely access to clinical information through shared inpatient-outpatient electronic health records…
Chemotherapy-associated peripheral neuropathy (CPN) affects nearly 70% of cancer patients. An estimated 30% of cancer survivors have persistent CPN, which can have a devastating impact on their quality of life and functioning. Our objective is to develop and validate a…
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. In addition, monitoring…
People living with human immunodeficiency virus (HIV; PLWH) have a markedly elevated anal cancer risk, largely due to loss of immunoregulatory control of oncogenic human papillomavirus infection. To better understand anal cancer development and prevention, we determined whether recent, past,…
This cohort study sought to estimate the differences in risk of delivering infants who were small or large for gestational age (SGA or LGA, respectively) according to exercise during the first trimester of pregnancy (vs. no exercise) among 2,286 women…
Few studies have examined factors that determine bisphosphonate (BP) continuation beyond 5 years in clinical practice. To investigate factors associated with BP continuation among women who completed 5 years of BP therapy. Women who received 5 consecutive years of oral…
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 the association…
To incorporate blood pressure (BP), diagnoses codes, and medication fills from electronic medical records (EMR) to identify pregnant women with hypertension. A retrospective cohort study of singleton pregnancies at three US integrated health delivery systems during 2005-2014. Women were considered…
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 computational cost of analyzing EHR data…
This study develops generalized per-protocol analyses based on Inverse Probability Weighting and Targeted Learning to control for or evaluate the effect of medication nonadherence in observational studies that use electronic health databases to inform the management of chronic conditions. Unlike…
Assigning drug exposure is a necessary first step in examining bisphosphonate (BP) treatment in observational studies using pharmacy data. To determine whether the choice of adherence level using the proportion of days covered (PDC) affected BP exposure assignment. 10,381 female…
The effectiveness of 5-fluorouracil compared with that of imiquimod for preventing keratinocyte carcinoma is unknown. To compare the effectiveness of 5-fluorouracil and that of imiquimod in preventing keratinocyte carcinoma in a real-world practice setting. We identified 5700 subjects who filled…
Research is needed to better understand relations between immunosuppression and HIV viraemia and risk for non-Hodgkin lymphoma, a common cancer in people living with HIV. We aimed to identify key CD4 count and HIV RNA (viral load) predictors of risk…
Electronic medical records hold promise to transform clinical practice. However, technological and other barriers may preclude using them to guide care in real time. We used the Virtual Data Warehouse (VDW) to develop a tool that enables physicians to generate…
For patients with diabetes, many with multiple complex chronic conditions, using a patient portal can support self-management and coordination of health care services, and may impact the frequency of in-person health care visits. To examine the impact of portal access…
To evaluate the effectiveness of automated symptom and side effect monitoring on quality of life among individuals with symptomatic diabetic peripheral neuropathy. We conducted a pragmatic, cluster randomized controlled trial (July 2014 to July 2016) within a large healthcare system.…
Cutaneous melanoma incidence may be modestly elevated in people with HIV (PWH) vs. people without HIV. However, little is known about the relationship of immunosuppression, HIV replication, and antiretroviral therapy (ART) with melanoma risk. PWH of white race in the…
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-fluorouracil and imiquimod in…
To assess recent trends of administering adjuvant gemcitabine-docetaxel (GD) chemotherapy for Stage I uterine leiomyosarcoma, and to compare disease-free and overall survival between women who received and did not receive adjuvant GD chemotherapy. All patients diagnosed with Stage I uterine…
Kaposi sarcoma (KS) remains common among HIV-infected persons. To better understand KS etiology and to help target prevention efforts, we comprehensively examined a variety of CD4 T-cell count and HIV-1 RNA viral load (VL) measures, as well as antiretroviral therapy…
To examine trends in minimally invasive hysterectomy and power morcellation use over time and associated clinical characteristics. We conducted a trend analysis and retrospective cohort study of all women 18 years of age and older undergoing hysterectomy for benign conditions…
This study aims to evaluate the practicability and practical advantages of: 1) Targeted Minimum Loss based Estimation (TMLE), and 2) a high-dimensional propensity score (hdPS) algorithm to fit dynamic Marginal Structural Models (MSM) in a longitudinal comparative effectiveness research (CER)…
This project aims to develop SAS macros to automate the data structuring required for implementation of Causal Inference methods with electronic health records data in studies with time-varying exposures, confounding and selection bias (e.g., marginal structural modeling with inverse probability…
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 adaptive treatment…
Many Americans continue to smoke, increasing their risk of disease and premature death. Both telephone-based counseling and in-person tobacco cessation classes may improve access for smokers seeking convenient support to quit. Little research has assessed whether such programs are effective…
To evaluate the impact of a population-based telephonic wellness coaching program on weight loss. Individual-level segmented regression analysis of interrupted time series data comparing the BMI trajectories in the 12 months before versus the 12 months after initiating coaching among…
This study aims to strengthen causal inferences based on Marginal Structural Modeling (MSM) and large healthcare databases for Comparative Effectiveness Research in Type 2 Diabetes Mellitus (T2DM), specifically, it aims to: 1) Develop a consensus for the types and quantity…
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 and reproducible…
Physicians and investigators have sought to determine the relationship between body mass index (BMI [calculated as weight in kilograms divided by height in meters squared]) and colorectal cancer (CRC) outcomes, but methodologic limitations including sampling selection bias, reverse causality, and…
Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation…
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 observational studies, data-adaptive estimation and in…
Evidence is conflicting about the association of abacavir use and cardiovascular disease (CVD) among HIV-infected individuals. Previous studies may have been biased by the preferential initiation or continuation of abacavir in patients with renal dysfunction. We conducted a cohort study…
Several epidemiologic studies suggest that compared to white women, Asians have a greater propensity to suffer an atypical femur fracture (AFF) while taking bisphosphonate therapy. This study examines the relative risk of AFF following bisphosphonate initiation for Asian compared to…
To estimate the incidence of occult uterine sarcoma and leiomyosarcoma in hysterectomies for leiomyomas and the risk associated with their morcellation. We conducted a population-based cohort study. All uterine sarcomas from 2006-2013 in an integrated health care system were identified.…
Reducing patient cost-sharing and engaging patients in disease management activities have been shown to increase uptake of evidence-based care. To evaluate the effect of employer purchase of a disease-specific plan with reduced cost-sharing and disease management (the Diabetes Health Plan/DHP)…
This study evaluates an employer-based diabetes/prediabetes screening intervention that invited at-risk employees via letters, secure e-mails, and automated voice messages to complete blood glucose testing at a health plan facility. Quasi-experimental cohort study among health plan members insured by two…
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 handle baseline confounding through matching or covariance adjustment…
Health coaching can improve lifestyle behaviors known to prevent or manage chronic conditions. Little is known about effective ways to encourage health and wellness coaching among people who might benefit. The purpose of this randomized encouragement trial was to assess…
Contemporary femur fracture rates were examined in northern California women and compared by race/ethnicity. During 2006-2012, hip fracture rates declined, but diaphyseal fracture rates increased, especially in Asians. Women with diaphyseal fracture were younger and more likely to be bisphosphonate-treated.…
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-dependent confounders on causal pathways between exposures and…
Lack of regular physical activity is highly prevalent in U.S. adults and significantly increases mortality risk. To examine the clinical impact of a newly implemented program ("Exercise as a Vital Sign" [EVS]) designed to systematically ascertain patient-reported exercise levels at…
In studies that use electronic health record data, imputation of important data elements such as Glycated hemoglobin (A1c) has become common. However, few studies have systematically examined the validity of various imputation strategies for missing A1c values. We derived a…
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
IMPORTANCE: The US federal government is spending billions of dollars in physician incentives to encourage the meaningful use of electronic health records (EHRs). Although the use of EHRs has potential to improve patient health outcomes, the existing evidence has been…
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 data, but success in adjusting for time-dependent confounding…
Health coaching can improve lifestyle behaviors known to prevent or manage chronic conditions such as diabetes. However, little is known about the patient experience with telephonic coaching programs in real-world care settings. We examined patient satisfaction, patient's perceived success in…
Primary prevention of diabetes is increasingly recognized by both health plans and employers as an important strategy to improve the health of insured populations. As a part of the Natural Experiments in Translation for Diabetes (NEXT-D) network, the Kaiser Permanente…
One of the identifiability assumptions of causal effects defined by marginal structural model (MSM) parameters is the experimental treatment assignment (ETA) assumption. Practical violations of this assumption frequently occur in data analysis when certain exposures are rarely observed within some…
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 effectiveness and safety research (CER), it often is less…
OBJECTIVE: To identify preoperative, intraoperative, and postoperative variables that predict higher short- and long-term patient satisfaction with Mohs surgery. DESIGN: Prospective cohort study. SETTING: A university-based dermatology practice and the affiliated Veterans Affairs medical center dermatology clinic. Patients A total…
BACKGROUND: Few studies have compared cancer risk between HIV-infected individuals and a demographically similar HIV-uninfected internal comparison group, adjusting for cancer risk factors.METHODS: We followed 20,775 HIV-infected and 215,158 HIV-uninfected individuals enrolled in Kaiser Permanente (KP) California for incident cancer…
In randomized trials, investigators typically rely upon an unadjusted estimate of the mean outcome within each treatment arm to draw causal inferences. Statisticians have underscored the gain in efficiency that can be achieved from covariate adjustment in randomized trials with…
The authors evaluated the association between ambient ozone levels and cardiac mortality in California's South Coast Air Basin during the period 1983-2000 and compared inferences from several types of marginal structural model (MSM) estimators. The authors undertook an ecologic study…
A new class of Marginal Structural Models (MSMs), History-Restricted MSMs (HRMSMs), was recently introduced for longitudinal data for the purpose of defining causal parameters which may often be better suited for public health research or at least more practicable than…
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