Question
The following questions relate to the paper:
Mausezahl D et al. Solar drinking water disinfection (SODIS) to reduce childhood diarrhoea in rural Bolivia: A cluster-randomized, controlled trial. PLoS Med 6(8) 2009.
a. Describe the randomization process used in this study. Specifically, discuss the unit of randomization and method of randomization.
b. What is the main benefit of randomization? What is the main worry regarding randomization when conducting cluster-randomized trials.
c. The authors explain how they assessed compliance (page 3 column 2). Explain why it is important to evaluate compliance (adherence) in trials. How should non-compliance be handled in the analysis if you use a per protocol analysis? What about intent to treat analysis?
d. Discuss how compliance affected efficacy vs. effectiveness in the laboratory setting, previous RCTs and in the Mausezahl study.
e. Would it have been possible to blind participants and/or assessors in this trial? Please explain your response.
Source: PB HLTH 250B Question Bank 9.1
