@article{long_reich_staicu_meitzen_2023, title={A nonparametric test of group distributional differences for hierarchically clustered functional data}, volume={3}, ISSN={["1541-0420"]}, DOI={10.1111/biom.13846}, abstractNote={Biological sex and gender are critical variables in biomedical research, but are complicated by the presence of sex‐specific natural hormone cycles, such as the estrous cycle in female rodents, typically divided into phases. A common feature of these cycles are fluctuating hormone levels that induce sex differences in many behaviors controlled by the electrophysiology of neurons, such as neuronal membrane potential in response to electrical stimulus, typically summarized using a priori defined metrics. In this paper, we propose a method to test for differences in the electrophysiological properties across estrous cycle phase without first defining a metric of interest. We do this by modeling membrane potential data in the frequency domain as realizations of a bivariate process, also depending on the electrical stimulus, by adopting existing methods for longitudinal functional data. We are then able to extract the main features of the bivariate signals through a set of basis function coefficients. We use these coefficients for testing, adapting methods for multivariate data to account for an induced hierarchical structure that is a product of the experimental design. We illustrate the performance of the proposed approach in simulations and then apply the method to experimental data.}, journal={BIOMETRICS}, author={Long, Alexander S. and Reich, Brian J. and Staicu, Ana-Maria and Meitzen, John}, year={2023}, month={Mar} }
 @article{swaminathan_snyder_hong_stevens_long_yanchenko_qiu_liu_zhang_fischer_et al._2023, title={External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources}, volume={208}, ISSN={["1535-4970"]}, DOI={10.1164/rccm.202210-1947OC}, abstractNote={RATIONALE
Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease for which novel therapies are needed. External controls (ECs) could enhance IPF trial efficiency, though the direct comparability of ECs to concurrent controls is unknown.


OBJECTIVES
To develop IPF ECs by fit for purpose data standards to historical randomized clinical trial (RCT), multicenter registry (Pulmonary Fibrosis Foundation Patient Registry [PFF-PR]), and electronic health record (EHR) data and to evaluate endpoint comparability among ECs and the BMS-986020 phase 2 RCT.


METHODS
After data curation, the rate of change in forced vital capacity (FVC) from baseline to 26 weeks among participants receiving BMS-986020 600 mg twice daily was compared with the BMS-placebo arm and ECs using mixed effects models with inverse probability weights.


MEASUREMENTS AND MAIN RESULTS
At 26 weeks, the rate of change in FVC was -32.71 mL (BMS-986020) versus -130.09 mL (BMS-placebo; difference, 97.4 mL, 95% CI, 24.6, 170.2), replicating the original BMS-986020 RCT. RCT-ECs showed treatment effect point estimates within the 95% CI of the original BMS-986020 RCT. Both PFF-PR-ECs and EHR-ECs experienced a slower rate of FVC decline compared with the BMS-placebo arm, resulting in treatment effect point estimates outside of the 95% CI of the original BMS-986020 RCT.


CONCLUSIONS
IPF ECs generated from historical RCT placebo arms result in comparable primary treatment effects to that of the original clinical trial, while ECs from real-world data sources, including registry or EHR data, do not. RCT-ECs may serve as a potentially useful supplement to future IPF RCTs.}, number={5}, journal={AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE}, author={Swaminathan, Aparna C. and Snyder, Laurie D. and Hong, Hwanhee and Stevens, Susanna R. and Long, Alexander S. and Yanchenko, Eric and Qiu, Ying and Liu, Rong and Zhang, Hongtao and Fischer, Aryeh and et al.}, year={2023}, month={Sep}, pages={579–588} }
 @article{rosenbloom_senthil_long_robinson_peeples_fiadjoe_litman_2017, title={A limited evaluation of the association of race and anesthetic medication administration: A single-center experience with appendectomies}, volume={27}, ISSN={["1460-9592"]}, DOI={10.1111/pan.13217}, abstractNote={Although it is known that a patient's race may influence their medical care, racial patterns of medication administration in pediatric anesthesia have not been well‐studied. The aim of this study was to determine if differences exist between Black and White children with regard to administration of anesthetic and analgesic medications for a single procedure at our institution.}, number={11}, journal={PEDIATRIC ANESTHESIA}, author={Rosenbloom, Julia M. and Senthil, Kumaran and Long, Alexander S. and Robinson, Whitney R. and Peeples, Kenneth N. and Fiadjoe, John E. and Litman, Ronald S.}, year={2017}, month={Nov}, pages={1142–1147} }