Rotavirus Mortality in India: Estimates Based on a Nationally Representative Survey of Diarrhoeal deaths/La Mortalite Du Rotavirus En Inde: Estimations Fondees Sur Une Enquete Nationale Representative Des Deces Par diarrhee/La Mortalidad Por Rotavirus En India: Estimaciones Basadas En Una Encuesta Representativa a Nivel Nacional De Muertes Por Diarrea

Introduction Diarrhoeal diseases are a major cause of hospitalizations and child deaths globally. Together they account for approximately one in six deaths among children younger than five years. (1) Of India's more than 2.3 million annual deaths among children, about 334 000 are attributable to diarrhoeal diseases. (1-3) Rotavirus is the leading cause of severe diarrhoea in children in developed and developing countries. (3,4) Two rotavirus vaccines have been shown to be effective against rotavirus and have been licensed in more than 100 countries, including India. (5-7) Introduction of these vaccines is expected to reduce child mortality by decreasing the incidence of severe diarrhoea and the frequency of death from diarrhoeal disease. There is considerable controversy in India regarding the introduction of rotavirus vaccines, especially because of uncertainty surrounding the estimates of deaths and hospitalizations caused by rotavirus and because of the current cost of the vaccines. (8) Studies estimate that 90 000-153 000 children die from rotavirus infection in India each year but these numbers are not based on nationally representative samples. (3,9,10) Here, we present new estimates of the frequency and number of diarrhoeal deaths attributable to rotavirus among Indian children younger than 5 years by combining direct estimates of diarrhoea-related mortality from a nationally representative study of deaths (2) with the fraction of diarrhoeal hospitalizations in selected Indian urban centres that were caused by rotavirus. (11) We also calculate the number of deaths preventable in India by a national rotavirus vaccination programme by using the estimated annual number of rotavirus-associated deaths in India and rotavirus vaccine efficacy data from clinical trials in two developing countries. Methods We ascertained the number of deaths from diarrhoea among children during 2001-2003 on the basis of findings from the Million Death Study. (2,12,13) The Million Death Study is an ongoing project conducted with the Registrar General of India and collaborators to determine causes of death in India. The study derives its data from a nationally representative sample of 6.3 million people in 1.1 million households within the Sample Registration System, a large, routine demographic survey performed by the Registrar General of India in all 28 Indian states and seven union territories that has been the primary system for the collection of Indian fertility and mortality data since 1971. Sample units are randomly selected to ensure that they are representative of the population at the state level. Enrolment in the system is voluntary and its confidentiality and consent procedures are defined as part of the Registration of Births and Deaths Act of 1969. Additional details about the Sample Registration System are available elsewhere. (12) A dual-recording system was used in which births and deaths were continuously enumerated by a resident part-time enumerator and a retrospective survey was conducted independently every six months by a full-time supervisor. When a death occurred, the cause was assessed using the Routine, Reliable, Representative and Re-sampled Household Investigation of Mortality with Medical Evaluation, a standard verbal autopsy questionnaire. (13.14) Two independent physicians reviewed the field reports and assigned a single cause of death by use of International classification of diseases, 10th revision codes. (15) Deaths were defined as due to diarrhoea if they received a final code of A00-A09. Differences in coding were resolved by anonymous reconciliation of initial codes and, if needed, a third, senior physician adjudicated the final cause of death. We characterized diarrhoeal deaths by sex, age (