%0 Journal Article %T The effect of improved rural sanitation on diarrhoea and helminth infection: design of a cluster-randomized trial in Orissa, India %A Thomas Clasen %A Sophie Boisson %A Parimita Routray %A Oliver Cumming %A Marion Jenkins %A Jeroen H J Ensink %A Melissa Bell %A Matthew C Freeman %A Soosai Peppin %A Wolf-Peter Schmidt %J Emerging Themes in Epidemiology %D 2012 %I BioMed Central %R 10.1186/1742-7622-9-7 %X Randomisation resulted in an acceptable balance between trial arms. The sample size requirements appear to be met for the main study outcomes. Delays in intervention roll-out caused logistical problems especially for the planning of health outcome follow-up surveys. Latrine coverage at the end of the construction period (55%) remained below the target of 70%, a result that may, however, be in line with many other TSC intervention areas in India.We discuss a number of methodological problems encountered thus far in this study that may be typical for sanitation trials. Nevertheless, it is expected that the trial procedures will allow measuring the effectiveness of a typical rural sanitation campaign, with sufficient accuracy and validity.Diseases associated with poor sanitation cause a large burden of disease worldwide. Diarrhoea alone causes an estimated 4 billion cases and 1.9 million deaths each year among children under 5 years, or 19% of all under-5 deaths in low income settings [1]. Other major diseases associated with poor sanitation are soil-transmitted worm infections, trachoma, lymphatic filariasis and schistosomiasis [2]. In contrast to other Millennium Development Goals, sanitation coverage remains low with 2.5 billion people still lacking access to sanitation. Only 6% of rural residents in India have access to improved sanitation, and about 69% practice open defecation [3].Systematic reviews have suggested that improved sanitation may reduce diarrhoeal diseases by 22% to 36% [2,4-8]. The studies included in these reviews were observational or small-scale before/after intervention studies that combined sanitation with water supplies or hygiene. The methodological quality of the studies was generally poor [2,5-8]. To date, there is no randomized controlled trial of sanitation interventions to prevent diarrhoeal diseases [2,4-8]. Large RCTs may have been deemed difficult due to logistical constraints, including the long time frame of sanitation campaigns bot %U http://www.ete-online.com/content/9/1/7