Simulating time-to-event data subject to competing risks and clustering: A review and synthesis.

Simulation studies play an important role in evaluating the performance of statistical models developed for analyzing complex survival data such as those with competing risks and clustering. This article aims to provide researchers with a basic understanding of competing risks data generation, techniques for inducing cluster-level correlation, and ways to combine them together in simulation studies, in the context of randomized clinical trials with a binary exposure or treatment. We review data generation with competing and semi-competing risks and three approaches of inducing cluster-level correlation for time-to-event data: the frailty model framework, the probability transform, and Moran's algorithm.

A comparison of analytical strategies for cluster randomized trials with survival outcomes in the presence of competing risks.

While statistical methods for analyzing cluster randomized trials with continuous and binary outcomes have been extensively studied and compared, little comparative evidence has been provided for analyzing cluster randomized trials with survival outcomes in the presence of competing risks. Motivated by the Strategies to Reduce Injuries and Develop Confidence in Elders trial, we carried out a simulation study to compare the operating characteristics of several existing population-averaged survival models, including the marginal Cox, marginal Fine and Gray, and marginal multi-state models. For each model, we found that adjusting for the intraclass correlations through the sandwich variance estimator effectively maintained the type I error rate when the number of clusters is large.

Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study.

This study aims to investigate the knowledge and attitudes of participants and potential participants in clinical trials toward electronic informed consent. We conducted a survey-based cross-sectional study in Hunan Province, China in March 2021. A total of 547 respondents were included in this study.

A Bayesian approach for estimating the partial potential impact fraction with exposure measurement error under a main study/internal validation design.

The partial potential impact fraction describes the proportion of disease cases that can be prevented if the distribution of modifiable continuous exposures is shifted in a population, while other risk factors are not modified. It is a useful quantity for evaluating the burden of disease in epidemiologic and public health studies. When exposures are measured with error, the partial potential impact fraction estimates may be biased, which necessitates methods to correct for the exposure measurement error.

Costs of Implementing an Integrated Package of Maternal and Pediatric Interventions Including SQ-LNS in Rural Niger.

Background: In January 2015, the Alliance for International Medical Action and Bien Être de la Femme et de l'Enfant au Niger launched the 1000 Days Program in Mirriah District, Niger, to provide an integrated package of maternal and pediatric preventive and curative interventions. A new component of the package was the provision of small-quantity lipid-based nutritional supplements (SQ-LNS) for children 6 to 23 months.

Objective: The objective of this study was to estimate the costs associated with providing the 1000 days package.

HIV and associated factors among female sex workers in Tajikistan: Analysis from a national bio-behavioral survey.

Tajikistan, a country of approximately nine million people, has a relatively small but quickly growing HIV epidemic. No peer-reviewed study has assessed factors associated with HIV, or associated risk factors, among female sex workers (FSWs) in Tajikistan. The purpose of the current study is to elucidate the factors associated with HIV status and risk factors in the Tajikistani context and add to the scant literature on risk factors among FSWs in Tajikistan and Central Asia.

Developing Quality and Efficiency of Institutional Review Board Review Under a Human Research Protection Program at a Leading Hospital in Central Southern China: A Descriptive Analysis of the First Three Years.

This study analyzes the Institutional Review Board (IRB) quality and efficiency at a leading hospital in Central Southern China, under the first three years of a Human Research Protection Program (HRPP). We conducted a descriptive, retrospective analysis from 2015 through 2017. We extracted characteristics from the protocol archive in duplicate.