Children whose parents were unable to give consent were also excluded. After receiving written informed consent, the following information was gathered from the parent/guardian using questionnaire: subject’s demographics including medical history, socio-economic details (e.g. annual family income, area of residence), and family details (e.g. number of members in family, number of siblings); information about
direct costs (e.g. OPD, medicines, extra drinking fluids, expenses on conveyance for visit), and impact caused selleck kinase inhibitor by RVGE (e.g. monetary impact of lost days of work for parent/guardian and parental stress). The monetary impact of lost days of work was calculated based on daily wages of the parent/guardian. The stress suffered by the parent/guardian due to child’s disease was scored on a scale of 0–10, where learn more ‘0’ was no stress and ‘10’ was extreme stress. At enrollment, following detailed clinical data were recorded using questionnaire: date of onset of symptoms (diarrhea, vomiting, and fever), number of days for which each symptom continued, maximum frequency of stools and vomiting episodes per day, maximum temperature recorded, dehydration status, behavioral signs and symptoms, and treatment given to the subject. The severity of dehydration of the subject was assessed as mild, moderate, or severe by the investigator based
on patient examination for restlessness, lethargy,
aminophylline sunken eyes, skin pinch, normal or poor feeding. The number of IV rehydration bottles administered to the subject was also recorded. Occurrences of behavioral signs and symptoms such as irritable/less playful, lethargic/listless, and convulsions were also recorded. The parent/guardian was given a diary card and questionnaires to record follow-up information on daily symptoms of the subject, and costs and impact caused due to the disease. The questionnaire used on the day of enrollment and follow-up questionnaires used to collect information after OPD visit or Day 1 were designed specifically for this study, and contained simple and easily understandable questions in local vernacular language. The parent/guardian was trained to fill the diary card and questionnaires. Study personnel made two telephonic contacts with the parent/guardian, first after Day 7 and second after Day 14, for collecting follow-up information for Day 1–Day 7 and Day 8–Day 14, respectively. Additional information such as healthcare utilization (e.g. repeat OPD visit/s, hospitalization, intravenous [IV] hydration) and impact of disease and its progress during Day 1–Day 7 and Day 8–Day 14 was also collected telephonically. The severity of AGE was scored by the physician based on physical examination of child and the information collected for the duration and severity of disease symptoms.