Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Group sequential methods for cluster randomization trials with binary outcomes.

Guang Yong Zou1, Allan Donner, Neil Klar

  • 1Department of Epidemiology & Biostatistics, Schulich School of Medicine & Dentistry, University of Western Ontario, London, Ontario, Canada. gzou@robarts.ca

Clinical Trials (London, England)
|January 21, 2006
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Severe (level 3) hypoglycaemia occurrence in a real-world cohort of adults with type 1 or 2 diabetes mellitus (iNPHORM, United States).

Diabetes, obesity & metabolism·2023
Same author

Development and validation of a real-world model to predict 1-year Level 3 (severe) hypoglycaemia risk in adults with diabetes (the iNPHORM study, United States).

Diabetes, obesity & metabolism·2023
Same author

Does Shiftwork Impact Cognitive Performance? Findings from the Canadian Longitudinal Study on Aging (CLSA).

International journal of environmental research and public health·2022
Same author

Printed educational materials directed at Ontario family physicians do not improve adherence to guideline recommendations for diabetes management: a pragmatic, factorial, cluster randomized controlled trial [ISRCTN72772651].

BMC family practice·2021
Same author

Relationships between sleep and internalizing problems in early adolescence: Results from Canadian National Longitudinal Survey of Children and Youth.

Journal of psychosomatic research·2020
Same author

Correction to: To develop a regional ICU mortality prediction model during the first 24 h of ICU admission utilizing MODS and NEMS with six other independent variables from the critical care information system (CCIS) Ontario, Canada.

Journal of intensive care·2020
Same journal

A statistical evaluation of decision-making methods and the efficiency of Bayesian multi-arm multi-stage trials.

Clinical trials (London, England)·2026
Same journal

Accounting for non-adherence: A re-analysis of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results trial.

Clinical trials (London, England)·2026
Same journal

Phase I design for partially ordered groups with late-onset toxicity.

Clinical trials (London, England)·2026
Same journal

Trial informed consent forms, the Declaration of Helsinki and the SPIRIT 2025 statement.

Clinical trials (London, England)·2026
Same journal

17th Annual University of Pennsylvania Conference on statistical issues in clinical trials - Covariate adjustment in randomized clinical trials: New methods and applications (Morning panel discussion).

Clinical trials (London, England)·2026
Same journal

17th Annual University of Pennsylvania Conference on statistical issues in clinical trials - Covariate adjustment in randomized clinical trials: New methods and applications (Afternoon panel discussion).

Clinical trials (London, England)·2026
See all related articles

Standard group sequential methods are valid for cluster randomization trials with binary outcomes. These methods simplify interim analyses, even with limited clusters, enhancing healthcare innovation evaluation.

Area of Science:

  • Biostatistics
  • Clinical Trials Methodology
  • Public Health Research

Background:

  • Cluster randomization trials (CRTs) are increasingly used for healthcare delivery innovations.
  • Methodological challenges in CRTs, particularly for monitoring, require robust statistical solutions.
  • Existing methods for sequential monitoring in CRTs are limited, especially for irreversible outcomes.

Purpose of the Study:

  • To assess the validity of standard group sequential methods for CRTs with binary outcomes.
  • To provide reliable statistical tools for monitoring cluster randomization trials during interim analyses.

Main Methods:

  • Derivation of large sample distributions for five sequential test statistics.
  • Simulation study to evaluate finite sample properties of these statistics.

Related Experiment Videos

  • Illustration using data from the World Health Organization antenatal care trial.

    • Main Results:

    • Asymptotic covariance structures simplify group sequential methods.
    • Four of five tested statistics show satisfactory performance with as few as 10 clusters per arm.
    • The methods are applicable for interim analyses in cluster randomization trials.

    Conclusions:

    • Standard group sequential methods are applicable to cluster randomization trials.
    • These methods provide a foundation for effect estimation in group sequential CRTs.
    • The findings support the use of interim analyses in CRTs with binary outcomes.