Clasen Thomas, Boisson Sophie, Routray Parimita, Cumming Oliver, Jenkins Marion, Ensink Jeroen H J, Bell Melissa, Freeman Matthew C, Peppin Soosai, Schmidt Wolf-Peter
Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
Emerg Themes Epidemiol. 2012 Nov 13;9(1):7. doi: 10.1186/1742-7622-9-7.
Infectious diseases associated with poor sanitation such as diarrhoea, intestinal worms, trachoma and lymphatic filariasis continue to cause a large disease burden in low income settings and contribute substantially to child mortality and morbidity. Obtaining health impact data for rural sanitation campaigns poses a number of methodological challenges. Here we describe the design of a village-level cluster-randomised trial in the state of Orissa, India to evaluate the impact of an ongoing rural sanitation campaign conducted under the umbrella of India's Total Sanitation Campaign (TSC).We randomised 50 villages to the intervention and 50 villages to control. In the intervention villages the implementing non-governmental organisations conducted community mobilisation and latrine construction with subsidies given to poor families. Control villages receive no intervention. Outcome measures include (1) diarrhoea in children under 5 and in all ages, (2) soil-transmitted helminth infections, (3) anthropometric measures, (4) water quality, (5) number of insect vectors (flies, mosquitoes), (6) exposure to faecal pathogens in the environment. In addition we are conducting process documentation (latrine construction and use, intervention reach), cost and cost-effectiveness analyses, spatial analyses and qualitative research on gender and water use for sanitation.
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.
与卫生条件差相关的传染病，如腹泻、肠道寄生虫病、沙眼和淋巴丝虫病，在低收入地区仍然造成巨大的疾病负担，并在很大程度上导致儿童死亡率和发病率上升。获取农村卫生运动的健康影响数据面临一些方法学挑战。在此，我们描述了印度奥里萨邦一项村级整群随机试验的设计，以评估在印度全面卫生运动（TSC）框架下正在进行的农村卫生运动的影响。我们将50个村庄随机分为干预组和50个村庄为对照组。在干预村庄，实施的非政府组织进行社区动员并建造厕所，同时向贫困家庭提供补贴。对照村庄不接受干预。结果指标包括：（1）5岁以下儿童和所有年龄段人群的腹泻情况；（2）土壤传播的蠕虫感染情况；（3）人体测量指标；（4）水质；（5）昆虫媒介（苍蝇、蚊子）数量；（6）环境中粪便病原体的暴露情况。此外，我们正在进行过程记录（厕所建造和使用情况、干预覆盖范围）、成本和成本效益分析、空间分析以及关于性别与卫生用水的定性研究。
随机分组使得试验组之间达到了可接受的平衡。主要研究结果的样本量要求似乎得到了满足。干预措施推出的延迟导致了后勤问题，尤其是对健康结果后续调查的规划产生了影响。建造期结束时的厕所覆盖率（55%）仍低于70%的目标，不过这一结果可能与印度许多其他TSC干预地区的情况相符。
我们讨论了本研究中迄今为止遇到的一些方法学问题，这些问题可能是卫生试验中的典型问题。尽管如此，预计试验程序将能够以足够的准确性和有效性来衡量典型农村卫生运动的效果。
