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Published on: August 16, 2021
Contamination effects in cluster randomised trials of TB interventions
K E LeGrand1, K Allel2, P Khan3
1Department of Infectious Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine (LSHTM), London, UK.
Cluster randomised trials (CRTs) for tuberculosis (TB) interventions show mixed results, potentially due to contamination. Improved reporting and design are needed to accurately assess intervention impact.
Area of Science:
- Epidemiology
- Public Health
- Clinical Trials
Background:
- Cluster randomised trials (CRTs) for tuberculosis (TB) interventions yield inconsistent results.
- Contamination, due to population mobility, may dilute intervention effects in CRTs.
- Assessing population-level impact of TB interventions requires careful trial design.
Purpose of the Study:
- To systematically review literature on CRTs for TB interventions.
- To identify factors influencing the effectiveness and reporting of CRTs.
- To provide recommendations for improving CRT design and reporting.
Main Methods:
- Systematic literature review of CRTs for TB interventions.
- Extraction of trial design, intervention, outcome, population, and geographic data.
- Descriptive statistics and spatial analyses of included trials.
Main Results:
- 20 reports from seven CRTs were included after screening 1,039 abstracts.
- Median cluster number was 32; population per cluster ranged from 400-50,000.
- Potential for contamination was inconsistently reported; design limitations were acknowledged.
Conclusions:
- Gaps exist in the reporting of methods and results for CRTs.
- Standardised reporting tools are needed for CRTs.
- Improved CRT design and reporting practices are recommended to accurately measure TB intervention impact.
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