The Screening India's Twin Epidemic: Study design and methodology (SITE-1)

OBJECTIVES: The recent years have seen a surge in the prevalence of both diabetes and hypertension. Significant demographic variations reported on the prevalence patterns of diabetes and hypertension in India establish a clear need for a nation-wide surveillance study. The Screening India's Twin Epidemic (SITE) study aimed at collecting information on the prevalence of diagnosed and undiagnosed diabetes and hypertension cases in outpatient settings in major Indian states to better understand disease management, as well as to estimate the extent of underlying risk factors. MATERIALS AND METHODS: During 2009–2010, SITE was conducted in eight states, in waves – one state at a time. It was planned to recruit about 2000 patients from 100 centers per wave. Each center enrolled the first 10 eligible patients (≥18 years of age, not pregnant, signed data release consent form, and ready to undergo screening tests) per day on two consecutive days. Patient demographics, medical history, and laboratory investigation results were collected and statistically interpreted. The protocol defined diabetes and hypertension as per the American Diabetes Association (ADA) and Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommendations, respectively. RESULTS: After the first two pilot phases in Maharashtra and Delhi, the protocol was refined and the laboratory investigations were simplified to be further employed for all other states, namely, Tamil Nadu, West Bengal, Karnataka, Andhra Pradesh, Madhya Pradesh, and Gujarat. CONCLUSION: SITE's nation-wide approach will provide a real-world perspective on diabetes and hypertension and its contributing risk factors. Results from the study will raise awareness on the need for early diagnosis and management of these diseases to reduce complications.