Inconsistency in Diarrhea Measurements when Assessing Intervention Impact in a Non-Blinded Cluster-Randomized Controlled Trial.

To explore the consistency in impact evaluation based on reported diarrhea, we compared diarrhea data collected through two different surveys and with observed diarrhea-associated hospitalization for children aged <= 5 years from a non-blinded cluster-randomized trial conducted over 2 years in urban Dhaka. We have previously reported that the interventions did not reduce diarrhea-associated hospitalization for children aged <= 5 years in this trial. We randomly allocated 90 geographic clusters comprising > 60,000 low-income households into three groups: cholera vaccine only, vaccine plus behavior change (cholera vaccine and handwashing plus drinking water chlorination promotion), and control. We calculated reported diarrhea prevalence within the last 2 days using data collected from two different survey methods. The "census" data were collected from each household every 6 months for updating household demographic information. The "monthly survey" data were collected every month from a subset of randomly selected study households for monitoring the uptake of behavior change interventions. We used binomial regression with a logarithmic link accounting for clustering to compare diarrhea prevalence across intervention and control groups separately for both census and monthly survey data. No intervention impact was detected in the census (vaccine only versus control: 2.32% versus 2.53%; P = 0.49; vaccine plus behavior change versus control: 2.44% versus 2.53%; P = 0.78) or in the vaccine only versus control in the monthly survey (3.39% versus 3.80%; P = 0.69). However, diarrhea prevalence was lower in the vaccine-plus-behavior-change group than control in the monthly survey (2.08% versus 3.80%; P = 0.02). Although the reasons for different observed treatment effects in the census and monthly survey data in this study are unclear, these findings emphasize the importance of assessing objective outcomes along with reported outcomes from non-blinded trials.