Explanipedia

Who benefits? Uncovering hidden heterogeneity of treatment effects in adaptive trials using Bayesian methods: a systematic review Open

Chaochao Gao, Yongdong Ouyang, Jessie Cunningham, Allen L. Pimienta, Anna Heath · 2025

Background Adaptive clinical trials increasingly aim to detect heterogeneity of treatment effect (HTE) to guide personalized care. However, most adaptive designs rely on predefined subgroups and are limited in their ability to uncover unkn…

Evaluation of injury prevention interventions using the stepped wedge cluster randomised trial design: key considerations Open

Yongdong Ouyang, Christian Sandrock, Anna Heath, Monica Taljaard, Colin Macarthur · 2025

Background Injury prevention interventions are often implemented at the group level via communities, hospitals, schools, etc, making cluster randomisation a suitable approach to evaluation. The stepped-wedge cluster randomised trial (SW-CR…

Who Benefits? Uncovering Hidden Heterogeneity of Treatment Effects in Adaptive Trials Using Bayesian Methods: A Systematic Review Open

Rachel Giblon, Chaochao Gao, Kuan Liu, Yongdong Ouyang, Jessie Cunningham , et al. · 2025

Background. Adaptive clinical trials increasingly aim to detect heterogeneity of treatment effect (HTE) to guide personalized care. Yet most adaptive designs rely on predefined subgroups and are limited in their ability to uncover unknown …

Bayesian Analysis of Time-To-Event Data in a Cluster-Randomized Trial: Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP) Trial Open

Yongdong Ouyang, Bin Luo, Stephanie N. Dixon, Ahmed A. Al‐Jaishi, P.J. Devereaux , et al. · 2025

Background: MyTEMP was a cluster-randomized trial to assess the effect of using a personalized cooler dialysate compared to standard temperature dialysate for potential cardiovascular benefits in patients receiving maintenance hemodialysis…

A systematic review of sample size determination in Bayesian randomized clinical trials: full Bayesian methods are rarely used Open

Yanara Marks, Jessie Cunningham, Arlene Jiang, Linke Li, Yi-Shu Lin , et al. · 2025

Utilizing Bayesian methods in clinical trials has become increasingly popular, as they can incorporate historical data and expert opinions into the design and allow for smaller sample sizes to reduce costs while providing reliable and robu…

Bayesian adaptive enrichment design in multi-arm clinical trials: The BayesAET package for R users Open

Denghuang Zhan, Yongdong Ouyang, Fidel Vila‐Rodriguez, Mohammad Ehsanul Karim, Hubert Wong · 2025

BayesAET provides a comprehensive tool for designing and analyzing Bayesian adaptive enrichment trials to identify the optimal treatments with pre-specified subpopulations.

Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial Open

Karen J. Bosma, Myriam Lafrenière‐Roula, Arlene Jiang, Anna Heath, Yongdong Ouyang , et al. · 2024

ClinicalTrials.gov Identifier: NCT02447692 prospectively registered May 19, 2015.

Estimates of intra-cluster correlation coefficients from 2018 USA Medicare data to inform the design of cluster randomized trials in Alzheimer’s and related dementias Open

Yongdong Ouyang, Fan Li, Xiaojuan Li, Julie Bynum, Vincent Mor , et al. · 2024

We presented both adjusted and unadjusted ICCs for outcomes as well as unadjusted ICCs for covariates of potential interest from population-level data in the USA and demonstrated how the estimates may be used in sample size calculations fo…

A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials Open

Guangyu Tong, Pascale Nevins, Mary Ryan, Kendra Davis‐Plourde, Yongdong Ouyang , et al. · 2024

Background/Aims Stepped-wedge cluster randomized trials tend to require fewer clusters than standard parallel-arm designs due to the switches between control and intervention conditions, but there are no recommendations for the minimum num…

Priors from Envisioned Posterior Judgments: A Novel Elicitation Approach With Application to Bayesian Clinical Trials Open

Yongdong Ouyang, Janice J. Eng, Denghuang Zhan, Hubert Wong · 2024

Background: The uptake of formalized prior elicitation from experts in Bayesian clinical trials has been limited due to challenges such as complex statistical modeling, lack of practical tools, and the cognitive burden placed on experts ar…

Maintaining the validity of inference from linear mixed models in stepped-wedge cluster randomized trials under misspecified random-effects structures Open

Yongdong Ouyang, Monica Taljaard, Andrew Forbes, Fan Li · 2024

Linear mixed models are commonly used in analyzing stepped-wedge cluster randomized trials. A key consideration for analyzing a stepped-wedge cluster randomized trial is accounting for the potentially complex correlation structure, which c…

Bayesian Adaptive Enrichment Design in Multi-Arm Clinical Trials: The Bayesaet Package for R Users Open

Denghuang Zhan, Yongdong Ouyang, Fidel Vila‐Rodriguez, Mohammad Ehsanul Karim, Hubert Wong · 2024

Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial Open

Saunya Dover, Alexandra Ahmet, Karen Bluth, Brian M. Feldman, Ellen B. Goldbloom , et al. · 2023

Background Adolescents living with type 1 diabetes (T1D) often experience diabetes distress (DD), a construct distinct from depression or anxiety that refers to the negative emotions that arise from living with and managing diabetes. Self-…

Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022 Open

Pascale Nevins, Mary Ryan, Kendra Davis‐Plourde, Yongdong Ouyang, Jules Antoine Pereira Macedo , et al. · 2023

Background/Aims The stepped-wedge cluster randomized trial (SW-CRT), in which clusters are randomized to a time at which they will transition to the intervention condition – rather than a trial arm – is a relatively new design. SW-CRTs hav…

Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial (Preprint) Open

Saunya Dover, Alexandra Ahmet, Karen Bluth, Brian M. Feldman, Ellen B. Goldbloom , et al. · 2023

BACKGROUND Adolescents living with type 1 diabetes (T1D) often experience diabetes distress (DD), a construct distinct from depression or anxiety that refers to the negative emotions that arise from living with and managing diabetes. Self…

A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal Saline to Ringer’s Lactate: Protocol and Statistical Analysis Plan of The FLUID Trial Open

Julia F Shaw, Yongdong Ouyang, Dean Fergusson, Tracy McArdle, Claudio M. Martin , et al. · 2023

Background Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids given to hospitalized patients. Despite concern about possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney functio…

Does it decay? Obtaining decaying correlation parameter values from previously analysed cluster randomised trials Open

Jessica Kasza, Rhys Bowden, Yongdong Ouyang, Monica Taljaard, Andrew Forbes · 2023

A frequently applied assumption in the analysis of data from cluster randomised trials is that the outcomes from all participants within a cluster are equally correlated. That is, the intracluster correlation, which describes the degree of…

Maintaining the validity of inference from linear mixed models in stepped-wedge cluster randomized trials under misspecified random-effects structures Open

Yongdong Ouyang, Monica Taljaard, Andrew Forbes, Fan Li · 2023

Linear mixed models are commonly used in analyzing stepped-wedge cluster randomized trials (SW-CRTs). A key consideration for analyzing a SW-CRT is accounting for the potentially complex correlation structure, which can be achieved by spec…

A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal Saline to Ringer’s Lactate: Protocol and Statistical Analysis Plan of The FLUID Trial (Preprint) Open

Julia F Shaw, Yongdong Ouyang, Dean Fergusson, Tracy McArdle, Claudio M. Martin , et al. · 2023

BACKGROUND Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids given to hospitalized patients. Despite concern about possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney functi…

Evaluating the effectiveness of a multifaceted intervention to reduce low-value care in adults hospitalized following trauma: a protocol for a pragmatic cluster randomized controlled trial Open

Lynne Moore, Mélanie Bérubé, Amina Belcaïd, Alexis F. Turgeon, Monica Taljaard , et al. · 2023

Background While simple Audit & Feedback (A&F) has shown modest effectiveness in reducing low-value care, there is a knowledge gap on the effectiveness of multifaceted interventions to support de-implementation efforts. Given the need to m…

Estimating intra-cluster correlation coefficients for planning longitudinal cluster randomized trials: a tutorial Open

Yongdong Ouyang, Karla Hemming, Fan Li, Monica Taljaard · 2023

It is well-known that designing a cluster randomized trial (CRT) requires an advance estimate of the intra-cluster correlation coefficient (ICC). In the case of longitudinal CRTs, where outcomes are assessed repeatedly in each cluster over…

Accounting for complex intracluster correlations in longitudinal cluster randomized trials: a case study in malaria vector control Open

Yongdong Ouyang, Manisha A. Kulkarni, Natacha Protopopoff, Fan Li, Monica Taljaard · 2023

A scoping review described diversity in methods of randomization and reporting of baseline balance in stepped-wedge cluster randomized trials Open

Pascale Nevins, Kendra Davis‐Plourde, Jules Antoine Pereira Macedo, Yongdong Ouyang, Mary P. Ryan , et al. · 2023

A Methodological Review Found that Randomization is Often Fragile in Stepped-Wedge Cluster Randomized Trials Open

Monica Taljaard, Pascale Nevins, Kendra Davis‐Plourde, Jules Pereira Macedo, Yongdong Ouyang , et al. · 2023

Antibiotics for Acute Exacerbations of Chronic Obstructive Pulmonary Disease Managed in the Outpatient Setting: A Systematic Review and Meta-Analysis Open

Bo Zheng, Anastasia Turner, Monica Taljaard, Shawn D. Aaron, Krishan Yadav , et al. · 2023

Reporting of and explanations for under-recruitment and over-recruitment in pragmatic trials: a secondary analysis of a database of primary trial reports published from 2014 to 2019 Open

Pascale Nevins, Stuart G. Nicholls, Yongdong Ouyang, Kelly Carroll, Karla Hemming , et al. · 2022

Objectives To describe the extent to which pragmatic trials underachieved or overachieved their target sample sizes, examine explanations and identify characteristics associated with under-recruitment and over-recruitment. Study design and…

Control of Line Complications with KiteLock (CLiCK) in the critical care unit: study protocol for a multi-center, cluster-randomized, double-blinded, crossover trial investigating the effect of a novel locking fluid on central line complications in the critical care population Open

Marlena Ornowska, Hubert Wong, Yongdong Ouyang, Anish Mitra, Aaron P. White , et al. · 2022

Background Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADs are prone to complications such as b…

Accounting for complex intracluster correlations in longitudinal cluster randomized trials: a case study in malaria vector control Open

Yongdong Ouyang, Manisha A. Kulkarni, Natacha Protopopoff, Fan Li, Monica Taljaard · 2022

Background: The effectiveness of malaria vector control interventions is commonly evaluated using parallel-arm cluster randomized trials with outcomes assessed using repeated cross-sectional surveys. A key requirement in designing and anal…

Sample size calculators for planning stepped-wedge cluster randomized trials: a review and comparison Open

Yongdong Ouyang, Fan Li, John S. Preisser, Monica Taljaard · 2022

Summary Recent years have seen a surge of interest in stepped-wedge cluster randomized trials (SW-CRTs). SW-CRTs include several design variations and methodology is rapidly developing. Accordingly, a variety of power and sample size calcu…

Control of Line Complications With KiteLock (CLiCK) in the Critical Care Unit: Study Protocol for a Multi-center, Cluster-randomized, Double-blinded, Crossover Trial Investigating the Effect of a Novel Locking Fluid on Central Line Complications in the Critical Care Population. Open

Marlena Ornowska, Hubert Wong, Yongdong Ouyang, Anish R. Mitra, Aaron P. White , et al. · 2022

• Background: Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADs are prone to complications such a…

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