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Comparison of Bayesian and classical methods in the analysis of cluster randomized controlled trials with a binary
Jinhui Ma1, Lehana Thabane, Janusz Kaczorowski
1Department of Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada. maj26@mcmaster.ca
Insights
Comparing statistical methods for cluster randomized trials (CRTs) in older adults showed robust results across approaches. Bayesian regression offered the most conservative estimates for blood pressure management interventions.
Area of Science:
- Biostatistics
- Clinical Trials
- Public Health
Background:
- Cluster randomized trials (CRTs) are vital for evaluating health interventions.
- Little attention has been given to the efficiency and consistency of analytical methods for binary outcomes in CRTs.
- The Community Hypertension Assessment Trial (CHAT) evaluated a pharmacy-led intervention for blood pressure management in older adults.
Purpose of the Study:
- To compare various statistical approaches for analyzing binary outcomes in CRTs.
- To assess the efficiency and consistency of different analytical methods using CHAT data.
- To determine the most appropriate statistical methods for CRT analysis.
Main Methods:
- Compared three cluster-level (un-weighted/weighted linear regression, random-effects meta-regression) and six individual-level (standard logistic regression, robust standard errors, GEE, random-effects meta-analytic, random-effects logistic, Bayesian random-effects regression) methods.
- Analyzed binary outcomes from the CHAT study.
- Investigated robustness of estimates after adjusting for covariates.
Main Results:
- Bayesian random-effects logistic regression provided the most conservative odds ratio estimates.
- All methods demonstrated robust results, indicating no significant effect of the CHAT intervention compared to usual care for blood pressure management in seniors.
- Standard logistic regression was deemed least appropriate due to ignoring intra-cluster correlation.
Conclusions:
- Comparing diverse analytical methods for CRTs enhances result interpretation and sensitivity analysis.
- The CHAT trial data provided a valuable case study for evaluating statistical approaches in CRTs.
- Robustness of findings across methods supports reliable conclusions regarding intervention effectiveness.
Background:
Cluster randomized trials (CRTs) are increasingly used to assess the effectiveness of interventions to improve health outcomes or prevent diseases. However, the efficiency and consistency of using different analytical methods in the analysis of binary outcome have received little attention. We described and compared various statistical approaches in the analysis of CRTs using the Community Hypertension Assessment Trial (CHAT) as an example. The CHAT study was a cluster randomized controlled trial aimed at investigating the effectiveness of pharmacy-based blood pressure clinics led by peer health educators, with feedback to family physicians (CHAT intervention) against Usual Practice model (Control), on the monitoring and management of BP among older adults.
Methods:
We compared three cluster-level and six individual-level statistical analysis methods in the analysis of binary outcomes from the CHAT study. The three cluster-level analysis methods were: i) un-weighted linear regression, ii) weighted linear regression, and iii) random-effects meta-regression. The six individual level analysis methods were: i) standard logistic regression, ii) robust standard errors approach, iii) generalized estimating equations, iv) random-effects meta-analytic approach, v) random-effects logistic regression, and vi) Bayesian random-effects regression. We also investigated the robustness of the estimates after the adjustment for the cluster and individual level covariates.
Results:
Among all the statistical methods assessed, the Bayesian random-effects logistic regression method yielded the widest 95% interval estimate for the odds ratio and consequently led to the most conservative conclusion. However, the results remained robust under all methods - showing sufficient evidence in support of the hypothesis of no effect for the CHAT intervention against Usual Practice control model for management of blood pressure among seniors in primary care. The individual-level standard logistic regression is the least appropriate method in the analysis of CRTs because it ignores the correlation of the outcomes for the individuals within the same cluster.
Conclusion:
We used data from the CHAT trial to compare different methods for analysing data from CRTs. Using different methods to analyse CRTs provides a good approach to assess the sensitivity of the results to enhance interpretation.
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