Perspectives The Million Death Study in : Can It Help in Monitoring the Millennium Development Goals? Zulfi qar A. Bhutta he Registrar General of Box 1. Sample Frames of India’s only half a million of an estimated India’s Sample Registration SRS annual 9.5 million deaths in India. System (SRS), a large routine Public health surveillance and T “There are two SRS sample frames. The demographic survey, is the country’s monitoring systems have a key role in primary system for the collection of fi rst SRS sample frame covers 6.3 million local health policymaking, so it would fertility and mortality data (Box 1). It people (including 2.9 million adults have been valuable for the SRS to have is widely regarded as an innovative way aged 25 years or older) in all 28 states given information with district-level of capturing essential information on and seven union territories of India. An specifi city. It is also unclear if the SRS mortality patterns that may infl uence average of 150 households are drawn sample covers pockets of deprivation public health policy. However, from each of 6,671 sample units (4,436 in urban and periurban slums, where although this monitoring system has rural and 2,235 urban), which in turn are health care and health indicators are been in place since 1971, there are selected using 1991 census data. The even worse than in rural populations relatively few evaluations to indicate new SRS sample frame covers about [2]. Given the increasingly devolved if the SRS is truly representative or 7.6 million people (including 3.5 million health-care system, any surveillance functional as a robust monitoring adults aged 25 years or older) in all 28 and monitoring system must have local system. states and seven union territories of India. specifi city, and given the scope and The Million Death Study in India is Households are drawn from 7,597 sample timescale of the study, these issues an ambitious project being undertaken units (4,433 rural and 3,164 urban) are best addressed at the outset. This by the SRS in close collaboration with selected from the 2001 census” [1]. study could have been the stimulus to the Centre for Global Health Research expand the SRS sample size to refl ect at the University of Toronto, leading district level trends, as well as maternal Indian and other overseas academic the Million Death Study will provide mortality (a reduction in maternal institutions, and the Indian Council valuable information for India that may mortality is an important Millennium of Medical Research. The study will also be relevant to other developing Development Goal [MDG]). use the SRS framework to obtain countries. The major limitation in terms of information, from a reasonably large The researchers involved in the expanding the SRS is cost. The current cohort of deaths (1 million deaths study have shown great foresight in study is being undertaken with an over 16 years), on the underlying making their protocols available for incremental budget of a mere US$2 causes of child and adult deaths, as public scrutiny. It may, therefore, million. While the resources are clearly well as key risk factors for these deaths be worthwhile to ask a few pertinent a limitation for this study, the low (behavioral, physical, environmental, questions at this early stage in the level of public health spending in the and, possibly, genetic). In a new study project. region nevertheless largely refl ects PLoS Medicine in , Prabhat Jha and Is the “Large Sample” Truly colleagues report on the rationale, Representative? design, and implementation of the Citation: Bhutta ZA (2006) The million death study Is the SRS framework adequate for in India: Can it help in monitoring the Millenium Million Death Study in India [1]. Development Goals? PLoS Med 3(2): e103. The study will use a combination India’s current and future surveillance of methods, looking at both a needs? While the scale of the study Copyright: © 2006 Zulfi qar A. Bhutta. This is an and the sample of 1 million deaths open-access article distributed under the terms retrospective and a prospective cohort of the Creative Commons Attribution License, of deaths. These methods include case spanning the period 1998–2014 is which permits unrestricted use, distribution, and daunting, one can see some limitations reproduction in any medium, provided the original control studies, risk assessments, and author and source are credited. genetic association studies. Given the of this unique exercise given the unique characteristics of the health- population size and diversity in India. Abbreviations: MDG, Millennium Development Goal; SRS, Sample Registration System care system in India, and the country’s The study is largely embedded within enormous double burden of infectious the revised SRS framework, and Zulfi qar A. Bhutta is husein Laji Dewraj Professor and noncommunicable diseases, capitalizes on the existing system. and Chairman, Department of Paediatrics & Child Although the new SRS sample frame is Health, Aga Khan University, Karachi, Pakistan. E-mail: zulfi [email protected] larger than before, the 7,597 sampling The Perspectives section is for experts to discuss the units cover only 7.6 million people Competing Interests: The author has declared that no competing interests exist. clinical practice or public health implications of a out of India’s population of just over 1 published article that is freely available online. billion people. The new sample covers DOI: 10.1371/journal.pmed.0030103

PLoS Medicine | www.plosmedicine.org 0163 February 2006 | Volume 3 | Issue 2 | e103 misplaced priorities [3]. I would argue survey coordinated by India’s widespread nutritional defi ciencies and that perhaps the study itself might have International Institute for Population genetic polymorphisms. The planned been the impetus to expand the SRS Sciences) [10], suggesting that the SRS study offers a unique opportunity to sample to a more representative sample data are indeed robust. Nevertheless, capture the true burden of premature with the power to track important MDG such cross-checking of the primary mortality and potentially decrease indicators in all strata. SRS data would be necessary through handicaps relating to perinatal events additional periodic surveys. and congenital malformations, on Is the Focus Appropriate? The Million Death Study proposes which almost no data exist from large The Million Death Study largely to use verbal autopsy instruments, for population settings. focuses on adult mortality and, as example, recording details of deaths indicated by the authors, it may not as reported by family or friends to a Ethical Considerations have suffi cient power to address trained but nonmedical fi eldworker. The planned inclusion of genetic maternal mortality. This is unfortunate Verbal autopsy instruments are already studies and the setting up of bio- because the persistently high burden in use for recording SRS deaths, and banks (collections of samples of of maternal morbidity and mortality is they have been validated for adult bodily substances that are, or can be, a unique challenge for South Asia [4]. mortality, except for those at the associated with personal data) are a While the constraints of an adequate welcome initiative, as these studies population sample for maternal The challenge have important implications for public mortality are understandable, it would health preventive strategies [18]. have been useful to see a few more is to ensure that However, the use of such tools and reproductive health indicators in the the study is relevant research must be strictly regulated current repertoire of risk factors that by ethical guidelines and criteria, the investigators intend to track. With to the MDG targets such as those developed by the the global health community now that India has set itself. Indian Council for Medical Research focusing on achieving the MDGs [5], [19]. The ethical issues involved in it is important to critically review and extremes of age. The infant and child the use of biological materials in expand the repertoire of studies on verbal autopsy tool [11] referred to population surveys are a subject of maternal and childhood mortality. in the proposed study has not been intense debate, and while there are India has a high burden of fetal validated for use within the neonatal few universally applicable guidelines malnutrition [6], so it is also important period, and several modifi cations [20], the Million Death Study offers to strengthen the emerging evidence have been made to adapt it to such an opportunity for progress in this of the link between maternal and fetal use [12–14]. Given that almost 50% of dynamic fi eld. Although these ethical malnutrition, childhood growth, and all infant deaths in India occur in the aspects are not fully elaborated in long-term adverse outcomes such as neonatal period [15], the validation the current proposal, one hopes that diabetes and premature cardiovascular of the verbal autopsy tool employed in the investigators will use the available disease [7–8]. It may be possible to the SRS is critically important. Such opportunity to address them. While include variables on size at birth and studies for validation of modifi ed these ethical issues may be important in early growth parameters within the neonatal verbal autopsy instruments mortality studies, they are particularly planned substudies of the Million are currently underway (S. Qazi, germane to the planned nested case- Death Study, as these variables may World Health Organization, personal control studies. be important correlates of adult-onset communication). diseases and premature mortality. While the current study plans Conclusion to focus on the “usual suspects” in In summary, despite the questions I Are the Tools Robust? causing neonatal deaths, such as deaths have raised above, the Million Death Although the validity of routinely due to birth asphyxia, prematurity, Study is one of the most important monitoring health data by health- and serious infections, it is equally projects in population health, with the system employees can be questioned, important to be aware of emerging real potential of addressing priority the proposed study will have additional issues in neonatal health. The high issues in public health. The challenge components that will involve secondary global burden of stillbirths, especially is to ensure that the study is relevant analyses of the data by external those that occur in the intrapartum to the MDG targets that India has staff. It would also be important to period, has been recently recognized set itself, and that it also informs have protocols in place for regular [16]. Given that these deaths may public health policy as it evolves. external validation of the primary represent the hidden burden of Addressing this challenge may mean data. Previous evaluations have shown birth asphyxia and perinatal care, potentially increasing the sampling close concordance between the data it would be appropriate to evaluate frame to make the data more relevant on smoking and alcohol consumption the importance of fresh stillbirths in at the district level, and including generated by the Special Fertility and the current framework (the Million additional maternal and newborn Mortality Survey (the baseline survey of Death Study framework appears to health indicators within the current the Million Death Study) [9] and the exclude stillbirths). The same may repertoire. Pushing the envelope in an data from the National Family Health apply to infant deaths relating to already large project at this stage may Survey 2 (the National Family Health malformations such as neural tube yield much greater dividends in due Survey is a large-scale, multiround defects [17], which may represent both course.

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