Ordered categorical data are frequently encountered in clinical studies. A popular method for comparing the efficacy of treatments is to use logistic regression with the proportional odds assumption. The test statistic is based on the Wilcoxon-Mann-Whitney test. However, the proportional odds assumption may not be appropriate. In such cases, the probability of rejecting the null hypothesis is much inflated even though the treatments have the same mean efficacy. An alternative approach that does not rely on the proportional odds assumption is to conceptualize the responses as manifestations of some underlying continuous variables. However, statistical procedures were developed only for the comparison of two treatments. In this article, we derive testing procedures that compare several treatments to a control, utilizing a latent normal distribution with the latent variable model. The proposed procedure is useful because multiple comparisons with a control is very frequently an objective of a clinical study. Data from clinical trials are used to illustrate the proposed procedures.
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http://dx.doi.org/10.1177/0962280211434425 | DOI Listing |
Paediatr Drugs
January 2025
Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China.
Background: This study aimed to provide a comprehensive review of adverse events (AEs) associated with factor Xa (FXa) inhibitors in pediatric patients.
Methods: We searched PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the European Union Clinical Trials Register for English-language records from the establishment of the database up to October 17, 2023.
Int J Gynaecol Obstet
January 2025
Department of Obstetrics and Gynecology, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Background: Prematurity complications are a leading cause of mortality and morbidity in offspring, including adverse neurodevelopmental outcomes. The association between preterm birth (PTB) and autism spectrum disorder (ASD) remains debated.
Objective: To investigate the association between PTB and ASD diagnosis during childhood.
Sci Rep
January 2025
Department of Dermatology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.
Brodalumab, a humanized monoclonal antibody that targets the interleukin-17 receptor A, is primarily used to manage moderate-to-severe plaque psoriasis. Although it has demonstrated favorable efficacy and safety in clinical trials, the strict inclusion and exclusion criteria may not fully reflect its safety profile in real-world settings. As its use becomes more widespread in clinical practice, understanding its safety in real-world applications is crucial.
View Article and Find Full Text PDFInt J Clin Pharm
January 2025
Department of Pharmacology, The First People's Hospital of Yancheng, Yancheng, 224000, Jiangsu, China.
Background: Maribavir is a novel antiviral agent targeting cytomegalovirus through inhibition of the UL97 protein kinase, exhibiting a distinct mechanism of action. However, limited data are available on its safety profile post-marketing.
Aim: This study aimed to evaluate the adverse events (AEs) associated with maribavir using the Food and Drug Administration's Adverse Event Reporting System (FAERS), providing insights to inform clinical practice.
BMJ Open
January 2025
Department of Critical Care Medicine, Foresea Life Insurance Guangzhou General Hospital, Guangzhou, China
Objective: This study planned to analyse the association between ondansetron use within 24 hours before intensive care unit (ICU) admission to within 48 hours after ICU admission and the risk of sepsis in ICU patients.
Design: A cohort study.
Setting And Participants: Data of 65 366 participants in Medical Information Mart for Intensive Care IV from ICU in the Beth Israel Deaconess Medical Center.
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