Pamela A. Shaw
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View article: Data validation in multinational observational studies with error-prone data: applying an optimal validation sampling strategy in a study of Kaposi sarcoma and HIV
Data validation in multinational observational studies with error-prone data: applying an optimal validation sampling strategy in a study of Kaposi sarcoma and HIV Open
A large multi-center study was conducted to investigate factors associated with Kaposi sarcoma (KS) among people with HIV (PWH). The study used routinely collected (eg, electronic health record) data from 257 429 PWH in Latin America and E…
View article: Recruitment of mid‐life adults to a randomized clinical trial: The multicultural healthy diet study to reduce cognitive decline and Alzheimer's disease risk
Recruitment of mid‐life adults to a randomized clinical trial: The multicultural healthy diet study to reduce cognitive decline and Alzheimer's disease risk Open
INTRODUCTION Poor representation of racial/ethnic minority groups limits the validity and generalizability of clinical trials and contributes to inequities in medicine and science. OBJECTIVES To recruit a multicultural sample of mid‐life i…
View article: Behavioral Interventions Improve Mailed Colorectal Cancer Screening Among Overdue Patients in a Randomized Trial
Behavioral Interventions Improve Mailed Colorectal Cancer Screening Among Overdue Patients in a Randomized Trial Open
gov, Number: NCT05341622.
View article: Optimal two-phase sampling designs for generalized raking estimators with multiple parameters of interest
Optimal two-phase sampling designs for generalized raking estimators with multiple parameters of interest Open
Large observational datasets compiled from electronic health records are a valuable resource for medical research but are often affected by measurement error and misclassification. Valid statistical inference requires proper adjustment for…
View article: Ascertainment Conditional Maximum Likelihood for Continuous Outcome Under Two‐Phase Response‐Selective Design
Ascertainment Conditional Maximum Likelihood for Continuous Outcome Under Two‐Phase Response‐Selective Design Open
Data collection procedures are often time‐consuming and expensive. An alternative to collecting full information from all subjects enrolled in a study is a two‐phase design: Variables that are inexpensive or easy to measure are obtained fo…
View article: Proceedings of the University of Pennsylvania 16th annual conference on statistical issues in clinical trials: Optimizing dose selection across the clinical trials spectrum
Proceedings of the University of Pennsylvania 16th annual conference on statistical issues in clinical trials: Optimizing dose selection across the clinical trials spectrum Open
View article: The Multicultural Healthy Diet Study to Reduce Cognitive Decline & Alzheimer’s Disease: A Randomized Controlled Trial in a Diverse Cohort of Middle-Aged Adults
The Multicultural Healthy Diet Study to Reduce Cognitive Decline & Alzheimer’s Disease: A Randomized Controlled Trial in a Diverse Cohort of Middle-Aged Adults Open
View article: Associations Between 10-Year Physical Performance and Activities of Daily Living Trajectories and Physical Behaviors in Older Adults
Associations Between 10-Year Physical Performance and Activities of Daily Living Trajectories and Physical Behaviors in Older Adults Open
Physical function is likely bidirectionally associated with physical activity (PA), sedentary behavior (SB), and sleep. We examined trajectories of physical function as predictors of these behaviors in community-dwelling adults aged ≥65 y …
View article: A peek into the pipeline: Expert views on emerging therapies
A peek into the pipeline: Expert views on emerging therapies Open
Alzheimer's disease (AD) trials: A field in (r)evolution AD remains a major societal challenge, but more than a century of research is gradually leading to an exciting (r)evolution in AD and other tauopathy trials. Initially, amyloid-beta-…
View article: Optimum Allocation for Adaptive Multi-Wave Sampling in <i>R</i>: The <i>R</i> Package <b>optimall</b>
Optimum Allocation for Adaptive Multi-Wave Sampling in <i>R</i>: The <i>R</i> Package <b>optimall</b> Open
View article: Assessing treatment effects in observational data with missing confounders: A comparative study of practical doubly-robust and traditional missing data methods
Assessing treatment effects in observational data with missing confounders: A comparative study of practical doubly-robust and traditional missing data methods Open
In pharmacoepidemiology, safety and effectiveness are frequently evaluated using readily available administrative and electronic health records data. In these settings, detailed confounder data are often not available in all data sources a…
View article: ASSOCIATIONS BETWEEN 10-YEAR PHYSICAL FUNCTION TRAJECTORIES AND 24-HOUR ACTIVITY CYCLE BEHAVIORS IN OLDER ADULTS
ASSOCIATIONS BETWEEN 10-YEAR PHYSICAL FUNCTION TRAJECTORIES AND 24-HOUR ACTIVITY CYCLE BEHAVIORS IN OLDER ADULTS Open
Physical activity (PA), sedentary behavior (SB), and sleep comprise an individual’s 24-hour activity cycle, which is likely bidirectionally associated with physical function over the life course. To explore how function predicts activity, …
View article: Efforts to increase the racial and ethnic and socioeconomic diversity of the Adult Changes in Thought study cohort
Efforts to increase the racial and ethnic and socioeconomic diversity of the Adult Changes in Thought study cohort Open
Background The Adult Changes in Thought (ACT) study is an ongoing population‐based prospective cohort study that began in 1994 and aims to identify risk and preventive factors for dementia. ACT randomly selects and enrolls Kaiser Permanent…
View article: Analyzing missingness patterns in real-world data using the SMDI toolkit: application to a linked EHR-claims pharmacoepidemiology study
Analyzing missingness patterns in real-world data using the SMDI toolkit: application to a linked EHR-claims pharmacoepidemiology study Open
We were able to demonstrate the practical application of the SMDI toolkit in a real-world setting. Application of the SMDI toolkit and the resulting insights of potential missingness patterns can inform the choice of appropriate analytic m…
View article: Understanding resilience: Lifestyle-based behavioral predictors of mental health and well-being in community-dwelling older adults during the COVID-19 pandemic
Understanding resilience: Lifestyle-based behavioral predictors of mental health and well-being in community-dwelling older adults during the COVID-19 pandemic Open
Background Changes in sleep, physical activity and mental health were observed in older adults during early stages of the COVID-19 pandemic. Here we describe effects of the COVID-19 pandemic on older adult mental health, wellbeing, and lif…
View article: High-dimensional multiple imputation (HDMI) for partially observed confounders including natural language processing-derived auxiliary covariates
High-dimensional multiple imputation (HDMI) for partially observed confounders including natural language processing-derived auxiliary covariates Open
Multiple imputation (MI) models can be improved by including auxiliary covariates (AC), but their performance in high-dimensional data is not well understood. We aimed to develop and compare high-dimensional MI (HDMI) approaches using stru…
View article: A Principled Approach to Characterize and Analyze Partially Observed Confounder Data from Electronic Health Records
A Principled Approach to Characterize and Analyze Partially Observed Confounder Data from Electronic Health Records Open
Principled diagnostics provided reliable insights into missingness mechanisms. When assumptions allow, multiple imputation with nonparametric models could help reduce bias.
View article: CCR5-edited CD4+ T cells augment HIV-specific immunity to enable post-rebound control of HIV replication
CCR5-edited CD4+ T cells augment HIV-specific immunity to enable post-rebound control of HIV replication Open
View article: smdi: an R package to perform structural missing data investigations on partially observed confounders in real-world evidence studies
smdi: an R package to perform structural missing data investigations on partially observed confounders in real-world evidence studies Open
Objectives Partially observed confounder data pose a major challenge in statistical analyses aimed to inform causal inference using electronic health records (EHRs). While analytic approaches such as imputation are available, assumptions o…
View article: Publisher Correction: Quantifying and correcting bias due to outcome dependent self-reported weights in longitudinal study of weight loss interventions
Publisher Correction: Quantifying and correcting bias due to outcome dependent self-reported weights in longitudinal study of weight loss interventions Open
View article: Practical Considerations for Sandwich Variance Estimation in 2-Stage Regression Settings
Practical Considerations for Sandwich Variance Estimation in 2-Stage Regression Settings Open
In this paper, we present a practical approach for computing the sandwich variance estimator in 2-stage regression model settings. As a motivating example for 2-stage regression, we consider regression calibration, a popular approach for a…
View article: Three‐phase generalized raking and multiple imputation estimators to address error‐prone data
Three‐phase generalized raking and multiple imputation estimators to address error‐prone data Open
Validation studies are often used to obtain more reliable information in settings with error‐prone data. Validated data on a subsample of subjects can be used together with error‐prone data on all subjects to improve estimation. In practic…
View article: Associations Between Gestational Weight Gain, Gestational Diabetes, and Childhood Obesity Incidence
Associations Between Gestational Weight Gain, Gestational Diabetes, and Childhood Obesity Incidence Open
View article: Effects of Aircraft Noise on Sleep: Federal Aviation Administration National Sleep Study Protocol
Effects of Aircraft Noise on Sleep: Federal Aviation Administration National Sleep Study Protocol Open
Aircraft noise can disrupt sleep and impair recuperation. The last U.S. investigation into the effects of aircraft noise on sleep dates back more than 20 years. Since then, traffic patterns and the noise levels produced by single aircraft …
View article: Quantifying and correcting bias due to outcome dependent self-reported weights in longitudinal study of weight loss interventions
Quantifying and correcting bias due to outcome dependent self-reported weights in longitudinal study of weight loss interventions Open
View article: Testing the missing at random assumption in generalized linear models in the presence of instrumental variables
Testing the missing at random assumption in generalized linear models in the presence of instrumental variables Open
Practical problems with missing data are common, and many methods have been developed concerning the validity and/or efficiency of statistical procedures. On a central focus, there have been longstanding interests on the mechanism governin…
View article: Issues in Implementing Regression Calibration Analyses.
Issues in Implementing Regression Calibration Analyses. Open
Regression calibration is a popular approach for correcting biases in estimated regression parameters when exposure variables are measured with error. This approach involves building a calibration equation to estimate the value of the unkn…
View article: An augmented likelihood approach for the Cox proportional hazards model with interval-censored auxiliary and validated outcome data—with application to the Hispanic Community Health Study/Study of Latinos
An augmented likelihood approach for the Cox proportional hazards model with interval-censored auxiliary and validated outcome data—with application to the Hispanic Community Health Study/Study of Latinos Open
In large epidemiologic studies, it is typical for an inexpensive, non-invasive procedure to be used to record disease status during regular follow-up visits, with less frequent assessment by a gold standard test. Inexpensive outcome measur…
View article: Nutritional Blood Concentration Biomarkers in the Hispanic Community Health Study/Study of Latinos: Measurement Characteristics and Power
Nutritional Blood Concentration Biomarkers in the Hispanic Community Health Study/Study of Latinos: Measurement Characteristics and Power Open
Measurement error is a major issue in self-reported diet that can distort diet-disease relationships. Use of blood concentration biomarkers has the potential to mitigate the subjective bias inherent in self-reporting. As part of the Hispan…
View article: Supplementary Methods, Tables 1 - 19, Figures 1 - 5 from Identification of Predictive Biomarkers for Cytokine Release Syndrome after Chimeric Antigen Receptor T-cell Therapy for Acute Lymphoblastic Leukemia
Supplementary Methods, Tables 1 - 19, Figures 1 - 5 from Identification of Predictive Biomarkers for Cytokine Release Syndrome after Chimeric Antigen Receptor T-cell Therapy for Acute Lymphoblastic Leukemia Open
Supplementary methods, statistical methods, results, tables, and figures. Supplementary Table 1. CRS grading system. Supplementary Table 2. Samples collected and time points on the trials. Supplementary Table 3. HLH diagnostic criteria. Su…