Evaluations of water, sanitation and hygiene interventions should not use diarrhoea as (primary) outcome

Abstract

Water, sanitation and hygiene interventions have been the subject of cluster trials of unprecedented size, scale and cost in recent years. However, the question ‘what works in water, sanitation, hygiene (WASH)?’ remains poorly understood. Evaluations of community interventions to prevent infectious disease typically use lab-confirmed infection as a primary outcome; however, WASH trials mostly use reported diarrhoea. While diarrhoea is a significant source of morbidity, it is subjected to significant misclassification error with respect to enteric infection due to the existence of non-infectious diarrhoea and asymptomatic infection. We show how this may lead to bias of estimated effects of interventions from WASH trials towards no effect. The problem is further compounded by other biases in the measurement process. Alongside testing for infection of the gut, an examination of the causal assumptions underlying WASH interventions present several other reliable alternative and complementary measurements and outcomes. Contemporary guidance on the evaluation of complex interventions requires researchers to take a broad view of the causal effects of an intervention across a system. Reported diarrhoea can fail to even be a reliable measure of changes to gastrointestinal health and so should not be used as a primary outcome if we are to progress our knowledge of what works in WASH.