A5035488631- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Advanced Causal Inference Techniques
- Acute Ischemic Stroke Management
- Meta-analysis and systematic reviews
- Statistical Methods and Bayesian Inference
- Optimal Experimental Design Methods
- Stroke Rehabilitation and Recovery
- Statistical Methods and Inference
- Intracerebral and Subarachnoid Hemorrhage Research
- Cardiac, Anesthesia and Surgical Outcomes
- Emergency and Acute Care Studies
- Drug-Induced Hepatotoxicity and Protection
- Neurosurgical Procedures and Complications
- Pharmaceutical Economics and Policy
- Ethics in Clinical Research
- Liver Disease and Transplantation
- Healthcare Systems and Technology
- Primary Care and Health Outcomes
- Biomedical Text Mining and Ontologies
- Cardiac Ischemia and Reperfusion
- Anesthesia and Neurotoxicity Research
- Cerebrovascular and Carotid Artery Diseases
- Treatment of Major Depression
- Gene expression and cancer classification
Medical University of South Carolina
2016-2025
University of California, Los Angeles
2015-2021
University of California, Irvine
2021
Chapman University
2021
Stanford University
2015
Neurological Surgery
2015
University of Southern California
2015
Article Abstract Background: Remission of illness in patients with major depressive disorder (MDD) is achieved less than half initially treated medication. Electroconvulsive therapy (ECT) another treatment option. We report the speed response and remission rates a cohort depressed who received course acute-phase ECT initial phase an ongoing multicenter randomized trial continuation versus pharmacotherapy. Method: Patients MDD according to DSM-IV criteria bilateral 3 times weekly. Prior each...
<h3>Importance</h3> Many patients receive suboptimal rehabilitation therapy doses after stroke owing to limited access therapists and difficulty with transportation, their knowledge about is often limited. Telehealth can potentially address these issues. <h3>Objectives</h3> To determine whether treatment targeting arm movement delivered via a home-based telerehabilitation (TR) system has comparable efficacy dose-matched, intensity-matched in traditional in-clinic (IC) setting, examine this...
Isoniazid (INH)-induced hepatotoxicity remains one of the most common causes drug-induced idiosyncratic liver injury and failure. This form is not believed to be immune-mediated because it usually associated with fever or rash, does recur more rapidly on rechallenge, previous studies have failed identify anti-INH antibodies (Abs). In this study, we found Abs present in sera 15 19 cases INH-induced Anti-INH were 8 sera; 11 had anti–cytochrome P450 (CYP)2E1 Abs, 14 against CYP2E1 modified by...
In January 2011, the US Food and Drug Administration (FDA) announced a mandate to limit acetaminophen (paracetamol) 325 mg/tablet in combination opioid medications, with manufacturer compliance required by March 2014.To assess odds of hospitalization proportion acute liver failure (ALF) cases toxicity prior after mandate.This interrupted time-series analysis used data from 2007-2019 involving ICD-9/ICD-10 codes consistent both National Inpatient Sample (NIS), large database, ALF 1998-2019...
In many clinical trials, baseline covariates could affect the primary outcome. Commonly used strategies to balance include stratified constrained randomization and minimization. Stratification is limited few categorical covariates. Minimization lacks randomness of treatment allocation. Both apply only As a result, serious imbalances occur in important not included algorithm. Furthermore, allocation be significantly compromised because high proportion deterministic assignments associated with...
Abstract Background The design of a multi-center randomized controlled trial (RCT) involves multiple considerations, such as the choice sample size, number centers and their geographic location, strategy for recruitment study participants, amongst others. There are plenty methods to sequentially randomize patients in RCT, with or without considering stratification factors. goal this paper is perform systematic assessment randomization 1:1 RCT assuming competitive policy patient process....
ABSTRACT This manuscript derives the allocation predictability measured by correct guess probability and of being deterministic for individual treatment assignments, as well averages a randomization sequence, based on imbalance transition matrix conditional probability. The methods described are applicable to restricted designs that satisfy following criteria: (1) two‐arm equal allocation, (2) restriction maximum tolerated imbalance, (3) fully determined observed current imbalance....
Abstract To evaluate the performance of randomization designs under various parameter settings and trial sample sizes, identify optimal with respect to both treatment imbalance allocation randomness, we 260 design scenarios from 14 15 sizes range 10 300, using three measures for randomness. The maximum absolute correct guess (CG) probability are selected assess trade‐off each design. As measured by CG probability, found that performances located in a closed region upper boundary (worst case)...
Stratified permuted block randomization has been the dominant covariate‐adaptive procedure in clinical trials for several decades. Its high probability of deterministic assignment and low capacity covariate balancing have well recognized. The popularity this sub‐optimal method is largely due to its simplicity implementation lack better alternatives. Proposed paper a two‐stage that uses urn design or big stick stage one restrict treatment imbalance within each stratum, biased‐coin...
Background Clinical trial investigators and sponsors invest vast amounts of resources energy into conducting trials often face daily challenges with data management, project quality control. Rather than waiting months for study progress reports, need the ability to use real-time coordination management activities across all team members including site investigators, oversight committees, safety monitoring boards, medical monitors. Web-based systems are beginning meet this but what...
This paper presents and compares several methods of measuring continuous baseline covariate imbalance in clinical trial data. Simulations illustrate that though the t-test is an inappropriate method assessing imbalance, test statistic itself a robust measure capturing distributions. Guidelines to assess effects on bias, type I error rate power for hypothesis treatment effect outcomes are presented, benefit covariate-adjusted analysis (ANCOVA) also illustrated.
To evaluate the effect of intensive rehabilitation on modified Rankin Scale (mRS), a measure activities limitation commonly used in acute stroke studies, and to define specific changes body structure/function (motor impairment) most related mRS gains.Patients were enrolled >90 days poststroke. Each was evaluated before 30 after 6-week course daily targeting arm. Activity gains, measured using mRS, examined compared Fugl-Meyer (FM) motor scale. Additional analyses whether activity gains more...
In recent decades, several randomization designs have been proposed in the literature as better alternatives to traditional permuted block design (PBD), providing higher allocation randomness under same restriction of maximum tolerated imbalance (MTI). However, PBD remains most frequently used method for randomizing subjects clinical trials. This status quo may reflect an inadequate awareness and appreciation statistical properties these designs, a lack simple methods their implementation....
Background: Despite the proven effectiveness of many medications for chronic diseases, patients do not refill their prescriptions in required timeframe. Objective: Compare 3 pharmacist strategies to decrease time common diseases. Research Design/Subjects: A randomized, controlled clinical trial with as unit randomization. Nine pharmacies within a medium-sized grocery store chain South Carolina were included, representing urban, suburban, and rural areas from variety socioeconomic...
In logistic regression analysis for binary clinical trial data, adjusted treatment effect estimates are often not equivalent to unadjusted in the presence of influential covariates. This article uses simulation quantify benefit covariate adjustment regression. However, International Conference on Harmonization guidelines suggest that be prespecified. Unplanned analyses should considered secondary. Results if is possible or unplanned a setting, balance continuous covariates can alleviate some...
The maximal procedure is a restricted randomization method that maximizes the number of feasible allocation sequences under constraints maximum tolerated imbalance and sequence length. It assigns an equal probability to all sequences. However, its implementation not easy due lack Markovian property conditional probabilities. In this paper, we propose asymptotic procedure, which replaces sequence-length-dependent probabilities with their values. new compared original few other procedures via...