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1.  Nutritional status of young children in Mumbai slums: a follow-up anthropometric study 
Nutrition Journal  2012;11:100.
Background
Chronic childhood malnutrition remains common in India. As part of an initiative to improve maternal and child health in urban slums, we collected anthropometric data from a sample of children followed up from birth. We described the proportions of underweight, stunting, and wasting in young children, and examined their relationships with age.
Methods
We used two linked datasets: one based on institutional birth weight records for 17 318 infants, collected prospectively, and one based on follow-up of a subsample of 1941 children under five, collected in early 2010.
Results
Mean birth weight was 2736 g (SD 530 g), with a low birth weight (<2500 g) proportion of 22%. 21% of infants had low weight for age standard deviation (z) scores at birth (<−2 SD). At follow-up, 35% of young children had low weight for age, 17% low weight for height, and 47% low height for age. Downward change in weight for age was greater in children who had been born with higher z scores.
Discussion
Our data support the idea that much of growth faltering was explained by faltering in height for age, rather than by wasting. Stunting appeared to be established early and the subsequent decline in height for age was limited. Our findings suggest a focus on a younger age-group than the children over the age of three who are prioritized by existing support systems.
Funding
The trial during which the birth weight data were collected was funded by the ICICI Foundation for Inclusive Growth (Centre for Child Health and Nutrition), and The Wellcome Trust (081052/Z/06/Z). Subsequent collection, analysis and development of the manuscript was funded by a Wellcome Trust Strategic Award: Population Science of Maternal and Child Survival (085417ma/Z/08/Z). D Osrin is funded by The Wellcome Trust (091561/Z/10/Z).
doi:10.1186/1475-2891-11-100
PMCID: PMC3546020  PMID: 23173787
2.  MaiMwana women’s groups: a community mobilisation intervention to improve mother and child health and reduce mortality in rural Malawi 
This article presents a detailed description of a community mobilization intervention involving women’s groups in Mchinji District, Malawi. The intervention was implemented between 2005 and 2010.
The intervention aims to build the capacities of communities to take control of the mother and child health issues that affect them. To achieve this it comprises trained local female facilitators establishing groups and using a manual, participatory rural appraisal tools and picture cards to guide them through a community action cycle to identify and implement solutions to mother and child health problems. Significant resource inputs include salaries for facilitators and supervisors, and training, equipment and materials to support their work with groups.
It is hypothesized that the groups will catalyse community collective action to address mother and child health issues and improve the health and reduce the mortality of mothers and children. Their impact, implementation and cost-effectiveness have been rigorously evaluated through a randomized controlled trial design. The results of these evaluations will be reported in 2011.
PMCID: PMC3345770  PMID: 21977831
3.  Linking families and facilities for care at birth: What works to avert intrapartum-related deaths? 
Background
Delays in receiving effective care during labor and at birth may be fatal for the mother and fetus, contributing to 2 million annual intrapartum stillbirths and intrapartum-related neonatal deaths each year.
Objective
We present a systematic review of strategies to link families and facilities, including community mobilization, financial incentives, emergency referral and transport systems, prenatal risk screening, and maternity waiting homes.
Results
There is moderate quality evidence that community mobilization with high levels of community engagement can increase institutional births and significantly reduce perinatal and early neonatal mortality. Meta-analysis showed a doubling of skilled birth attendance and a 35% reduction in early neonatal mortality. However, no data are available on intrapartum-specific outcomes. Evidence is limited, but promising, that financial incentive schemes and community referral/transport systems may increase rates of skilled birth attendance and emergency obstetric care utilization; however, impact on mortality is unknown. Current evidence for maternity waiting homes and risk screening is low quality.
Conclusions
Empowering communities is an important strategy to reduce the large burden of intrapartum complications. Innovations are needed to bring the poor closer to obstetric care, such as financial incentives and cell phone technology. New questions need to be asked of “old” strategies such as risk screening and maternity waiting homes. The effect of all of these strategies on maternal and perinatal mortality, particularly intrapartum-related outcomes, requires further evaluation.
doi:10.1016/j.ijgo.2009.07.012
PMCID: PMC3428847  PMID: 19815201
Asphyxia neonatorum; Birth asphyxia; Cash transfers; Community-based health insurance; Community mobilization; Community transport system; Demand for obstetric care; Hypoxia; Maternity waiting homes stillbirth; Neonatal mortality; Risk screening; Vouchers
5.  Perinatal interventions and survival in resource-poor settings: which work, which don’t, which have the jury out? 
Archives of disease in childhood  2010;95(12):1039-1046.
Perinatal conditions make the largest contribution to the burden of disease in low-income countries. Although postneonatal mortality rates have declined, stillbirth and early neonatal mortality rates remain high in many countries in Africa and Asia, and there is a concentration of mortality around the time of birth. Our article begins by considering differences in the interpretation of ‘intervention’ to improve perinatal survival. We identify three types of intervention: a single action, a collection of actions delivered in a package and a broader social or system approach. We use this classification to summarise the findings of recent systematic reviews and meta-analyses. After describing the growing evidence base for the effectiveness of community-based perinatal care, we discuss current concerns about integration: of women’s and children’s health programmes, of community-based and institutional care, and of formal and informal sector human resources. We end with some thoughts on the complexity of choices confronting women and their families in low-income countries, particularly in view of the growth in non-government and private sector healthcare.
doi:10.1136/adc.2009.179366
PMCID: PMC3428881  PMID: 20980274
6.  Vitamin A supplementation and maternal mortality 
Lancet  2010;375(9727):1675-1677.
doi:10.1016/S0140-6736(10)60443-6
PMCID: PMC3428885  PMID: 20435344
7.  Spoilt for choice? Cross-sectional study of care-seeking for health problems during pregnancy in Mumbai slums 
Global public health  2011;6(7):746-759.
This study considers care-seeking patterns for maternal morbidity in Mumbai’s slums. Our objectives were to document women’s self-reported symptoms and care-seeking, and to quantify their choice of health provider, care-seeking delays and referrals between providers. The hypothesis that care-seeking sites for maternal morbidity mirror those used for antenatal care was also tested. We analysed data for 10,754 births in 48 slum areas and interviewed mothers about their illnesses and care-seeking during pregnancy. Institutional care-seeking was high across the board (>80%), and higher for ‘trigger’ symptoms suggestive of complications (>88%). Private-sector care was preferred, and increased with socio-economic status, although public providers also played an important role. Most women sought treatment at the same site they received their antenatal care, most were treated within 2 days, and less than 2% were referred to other providers. Our findings suggest that poor women in Mumbai recognise symptoms of obstetric complications and the need for health care. However, that more than 80% also sought care for minor conditions implies that the tendency to seek institutional care for serious conditions reflects a broader picture of care-seeking for all illnesses. The role of private health-care providers needs greater recognition, and further research is required on provider motivations and behaviour.
doi:10.1080/17441692.2010.520725
PMCID: PMC3428887  PMID: 20981600
urban health; maternal morbidity; care-seeking; slums; India
8.  Four million neonatal deaths: counting and attribution of cause of death 
Summary
Each year there are an estimated four million neonatal deaths and at least 3.2 million stillbirths. Three-quarters of the world’s neonatal deaths are counted only through five-yearly retrospective household surveys. Without these surveys we would have no data, but limitations remain particularly in detecting deaths on the first day of life. Comparable reliable neonatal cause of death data through vital registration are available for less than 5% of the world’s neonatal deaths, necessitating modelled estimates for the majority of the world. Improving the quantity, quality and frequency of data for numbers and causes of neonatal deaths is essential to effectively guide the increasing investments to reduce these deaths. Advancing the data requires general investment in information systems and specific improvements of tools and methods for both household surveys and verbal autopsy, particularly the use of consistent case definitions and hierarchical attribution of cause of death. An important paradigm shift is from historical categories for cause of death (‘perinatal causes’) to programmatic categories which are consistent with the International Classification of Diseases. If neonatal deaths remain uncounted, they cannot count in policy and in programmes.
doi:10.1111/j.1365-3016.2008.00960.x
PMCID: PMC3428888  PMID: 18782248
neonatal death; stillbirth; verbal autopsy; cause of death data
9.  The lives of Malawian Nurses: The stories behind the statistics 
Malawi faces a critical shortage of nurses. Challenging working conditions and poor remuneration have led many nurses to seek employment overseas. The study uses qualitative biographical methods to describe the experiences of migrant Malawian nurses and compares them with the experiences of nurses who remain in Malawi. Choices made about pursuing a nursing career in Malawi, and decisions to migrate, are complex and heavily entwined with nurses’ personal circumstances. In addition, although nurses in Malawi perceive that conditions in the UK are difficult, many still aspire to migrate themselves.
doi:10.1016/j.trstmh.2009.03.005
PMCID: PMC3428889  PMID: 19349055
International Migration; Human resources; Malawi; Nurses
10.  Chlorhexidine cord cleansing to reduce neonatal mortality 
Lancet  2012;379(9820):984-986.
doi:10.1016/S0140-6736(12)60114-7
PMCID: PMC3428896  PMID: 22322125
11.  Community Mobilization in Mumbai Slums to Improve Perinatal Care and Outcomes: A Cluster Randomized Controlled Trial 
PLoS Medicine  2012;9(7):e1001257.
David Osrin and colleagues report findings from a cluster-randomized trial conducted in Mumbai slums; the trial aimed to evaluate whether facilitator-supported women's groups could improve perinatal outcomes.
Introduction
Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women's groups worked to improve local perinatal health.
Methods and Findings
A cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women's groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60–1.22), and the neonatal mortality rate higher (1.48, 1.06–2.08). The extended perinatal mortality rate did not differ between arms (1.19, 0.90–1.57). We have no evidence that these differences could be explained by the intervention.
Conclusions
Facilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors.
Trial registration
Current Controlled Trials ISRCTN96256793
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Substantial progress is being made to reduce global child mortality (deaths of children before the age of 5 years) and maternal mortality (deaths among women because of complications of pregnancy and childbirth)—two of the Millennium Development Goals agreed by world leaders in 2000 to end extreme poverty. Even so, worldwide, in 2010, 7.6 million children died before their fifth birthday and there were nearly 360,000 maternal deaths. Almost all child and maternal deaths occur in developing countries—a fifth of under-five deaths and more than a quarter of neonatal deaths (deaths during the first month of life, which account for two-fifths of all child deaths) occur in India alone. Moreover, most child and maternal deaths are caused by avoidable conditions. Specifically, the major causes of neonatal death—complications of preterm delivery, breathing problems during or after delivery, and infections of the blood (sepsis) and lungs (pneumonia)—and of maternal deaths—hemorrhage (abnormal bleeding), sepsis, unsafe abortion, obstructed labor, and hypertensive diseases of pregnancy—could all be largely prevented by improved access to reproductive health services and skilled health care workers.
Why Was This Study Done?
Experts believe that improvements to maternal and newborn health in low-income settings require both health service strengthening and community action. That is, the demand for better services, driven by improved knowledge about maternal and newborn health (perinatal issues), has to be increased in parallel with the supply of those services. To date, community mobilization around perinatal issues has largely been undertaken in rural settings but populations in developing countries are becoming increasingly urban. In India, for example, 30% of the population now lives in cities. In this cluster randomized controlled trial (a study in which groups of people are randomly assigned to receive alternative interventions and the outcomes in the differently treated “clusters” are compared), City Initiative for Newborn Health (CINH) researchers investigate the effect of an intervention designed to help women's groups in the slums of Mumbai work towards improving local perinatal health. The CINH aims to improve maternal and newborn health in slum communities by improving public health care provision and by working with community members to improve maternal and newborn care practices and care-seeking behaviors.
What Did the Researchers Do and Find?
The researchers enrolled 48 Mumbai slum communities of at least 1,000 households into their trial. In each of the 24 intervention clusters, a facilitator supported local women's groups through a 36-meeting learning cycle during which group members discussed their perinatal experiences, improved their knowledge, and took action. To measure the effect of the intervention, the researchers monitored births, stillbirths, and neonatal deaths in all the clusters and interviewed mothers 6 weeks after delivery. During the 3-year trial, there were 18,197 births in the participating settlements. The women in the intervention clusters were enthusiastic about acquiring new knowledge and made substantial efforts to reach out to other women but were less successful in undertaking collective action such as negotiations with civic authorities for more amenities. There were no differences between the intervention and control communities in the uptake of antenatal care, reported work, rest, and diet in late pregnancy, institutional delivery, or in breast feeding and care-seeking behavior. Finally, the combined rate of stillbirths and neonatal deaths (the extended perinatal mortality rate) was the same in both arms of the trial, as was maternal mortality.
What Do These Findings Mean?
These findings indicate that it is possible to facilitate the discussion of perinatal health care by urban women's groups in the challenging conditions that exist in the slums of Mumbai. However, they fail to show any measureable effect of community mobilization through the facilitation of women's groups on perinatal health at the population level. The researchers acknowledge that more intensive community activities that target the poorest, most vulnerable slum dwellers might produce measurable effects on perinatal mortality, and they conclude that, in cities with multiple sources of health care and inequitable access to services, it remains important to integrate community mobilization with attempts to deliver services to the poorest and most vulnerable, and with initiatives to improve the quality of health care in both the public and private sector.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001257.
The United Nations Childrens Fund (UNICEF) works for children's rights, survival, development, and protection around the world; it provides information on the reduction of child mortality (Millennium Development Goal 4); its Childinfo website provides information about all the Millennium Development Goals and detailed statistics about on child survival and health, newborn care, and maternal health (some information in several languages)
The World Health Organization also has information about Millennium Development Goal 4 and Millennium Development Goal 5, the reduction of maternal mortality, provides information on newborn infants, and provides estimates of child mortality rates (some information in several languages)
Further information about the Millennium Development Goals is available
Information on the City Initiative for Newborn Health and its partners and a detailed description of its trial of community mobilization in Mumbai slums to improve care during pregnancy, delivery, postnatally and for the newborn are available
Further information about the Society for Nutrition, Education and Health Action (SNEHA) is available
doi:10.1371/journal.pmed.1001257
PMCID: PMC3389036  PMID: 22802737
12.  Reproductive health, and child health and nutrition in India: meeting the challenge 
Lancet  2011;377(9762):332-349.
India, with a population of more than 1 billion people, has many challenges in improving the health and nutrition of its citizens. Steady declines have been noted in fertility, maternal, infant and child mortalities, and the prevalence of severe manifestations of nutritional deficiencies, but the pace has been slow and falls short of national and Millennium Development Goal targets. The likely explanations include social inequities, disparities in health systems between and within states, and consequences of urbanisation and demographic transition. In 2005, India embarked on the National Rural Health Mission, an extraordinary effort to strengthen the health systems. However, coverage of priority interventions remains insufficient, and the content and quality of existing interventions are suboptimum. Substantial unmet need for contraception remains, adolescent pregnancies are common, and access to safe abortion is inadequate. Increases in the numbers of deliveries in institutions have not been matched by improvements in the quality of intrapartum and neonatal care. Infants and young children do not get the health care they need; access to effective treatment for neonatal illness, diarrhoea, and pneumonia shows little improvement; and the coverage of nutrition programmes is inadequate. Absence of well functioning health systems is indicated by the inadequacies related to planning, financing, human resources, infrastructure, supply systems, governance, information, and monitoring. We provide a case for transformation of health systems through effective stewardship, decentralised planning in districts, a reasoned approach to financing that affects demand for health care, a campaign to create awareness and change health and nutrition behaviour, and revision of programmes for child nutrition on the basis of evidence. This agenda needs political commitment of the highest order and the development of a people’s movement.
doi:10.1016/S0140-6736(10)61492-4
PMCID: PMC3341742  PMID: 21227494
13.  Association between Clean Delivery Kit Use, Clean Delivery Practices, and Neonatal Survival: Pooled Analysis of Data from Three Sites in South Asia 
PLoS Medicine  2012;9(2):e1001180.
A pooled analysis of data from three studies in South Asia demonstrates an association between use of clean delivery kits during home births and reduced risk of neonatal mortality.
Background
Sepsis accounts for up to 15% of an estimated 3.3 million annual neonatal deaths globally. We used data collected from the control arms of three previously conducted cluster-randomised controlled trials in rural Bangladesh, India, and Nepal to examine the association between clean delivery kit use or clean delivery practices and neonatal mortality among home births.
Methods and Findings
Hierarchical, logistic regression models were used to explore the association between neonatal mortality and clean delivery kit use or clean delivery practices in 19,754 home births, controlling for confounders common to all study sites. We tested the association between kit use and neonatal mortality using a pooled dataset from all three sites and separately for each site. We then examined the association between individual clean delivery practices addressed in the contents of the kit (boiled blade and thread, plastic sheet, gloves, hand washing, and appropriate cord care) and neonatal mortality. Finally, we examined the combined association between mortality and four specific clean delivery practices (boiled blade and thread, hand washing, and plastic sheet). Using the pooled dataset, we found that kit use was associated with a relative reduction in neonatal mortality (adjusted odds ratio 0.52, 95% CI 0.39–0.68). While use of a clean delivery kit was not always accompanied by clean delivery practices, using a plastic sheet during delivery, a boiled blade to cut the cord, a boiled thread to tie the cord, and antiseptic to clean the umbilicus were each significantly associated with relative reductions in mortality, independently of kit use. Each additional clean delivery practice used was associated with a 16% relative reduction in neonatal mortality (odds ratio 0.84, 95% CI 0.77–0.92).
Conclusions
The appropriate use of a clean delivery kit or clean delivery practices is associated with relative reductions in neonatal mortality among home births in underserved, rural populations.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Worldwide, around 3.3 million babies die in the first month of life, according to data for 2009 from the World Health Organization. Although the global neonatal mortality rate declined by 28% (from 33.2 deaths per 1,000 live births to 23.9) between 1990 and 2009, the proportion of child deaths that are now in the neonatal period has increased in all regions of the world, and currently stands at 41%. This figure is concerning and neonatal mortality remains a big obstacle to the international community in meeting the target of Millennium Development Goal 4—to reduce deaths in children under 5 years by two-thirds from 1990 levels by 2015. At least 15% of all neonatal deaths are due to sepsis (systematic bacterial infection) and an estimated 30%–40% of infections are transmitted at the time of birth. Therefore preventing infections through clean delivery practices is an important strategy to reduce sepsis-related deaths in newborns and can contribute to reducing the overall burden of neonatal deaths.
Why Was This Study Done?
In South Asia, around 65% of deliveries occur at home, without skilled birth attendants, making practices around clean delivery particularly challenging. To date, evidence on the impact of clean delivery kits and clean delivery practices on neonatal mortality or sepsis-related neonatal deaths from community-based studies is scarce. In this study the researchers explored the associations between neonatal mortality, the use of clean delivery kits, and individual clean delivery practices by using data from the control arms of three cluster-randomized controlled trials conducted among rural populations in South Asia.
What Did the Researchers Do and Find?
The researchers used data from almost 20,000 (19,754) home births available from the control arms of three community-based cluster-randomized trials conducted between 2000 and 2008 in India (n = 6,841, 18 clusters), Bangladesh (n = 7,041, five clusters), and Nepal (n = 5,872, five clusters). The researchers did not include data from other previously conducted trials on clean delivery practices because of the mix of designs used in these studies and limited their analysis to live-born singleton infants delivered at home in control areas, for whom data on birth kit use were available. The researchers conducted a separate analysis for each country on kit use and clean delivery practices and also analyzed the pooled dataset for all countries while controlling for factors about the mother, the pregnancy, the delivery, and the postnatal period.
Using these methods, the researchers found that kits were used for 18.4% of home births in India, 18.4% in Bangladesh, and 5.7% in Nepal. Importantly, according to the pooled analysis, kit use was associated with a 48% relative reduction in neonatal mortality (odds ratio/chance 0.52), which was similar across all countries: 57% relative reduction in neonatal mortality in India, 32% in Bangladesh, and 49% in Nepal. Delivery practices were also important: in the pooled country analysis, the use of a boiled blade to cut the cord, antiseptic to clean the cord, a boiled thread to tie the cord, and a plastic sheet for a clean delivery surface were all associated with significant relative reductions in mortality after controlling for kit use and confounders common to all sites. The researchers found a 16% relative reduction in mortality with each additional clean delivery practice used.
What Do These Findings Mean?
These findings show that the appropriate use of a clean delivery kit and clean delivery practices could lead to substantial reductions in neonatal mortality among home births in poor rural communities with limited access to health care. The results also reinforce the importance of each clean delivery practice; hand washing and use of a sterilised blade, boiled thread, and plastic sheet were linearly associated with a reduction in neonatal deaths with each additional clean delivery practice used. Costs of such kits are low (US$0.44 in India, US$0.40 in Nepal, and US$0.27 in Bangladesh, although these costs may still be prohibitive for the poorest women), and given the impact of clean delivery kits and clean delivery practices in reducing neonatal practices, such strategies should be widely promoted by the international community.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001180.
A recent PLoS Medicine study by Oestergaard et al. has the latest figures on neonatal mortality worldwide
UNICEF has information about progress toward Millennium Development Goal 4
The United Nations Population Fund has more information about safe birth practices
The EquiNam web site describes ongoing work on socioeconomic inequalities in newborn and maternal health in Asia and Africa by some of the study authors
doi:10.1371/journal.pmed.1001180
PMCID: PMC3289606  PMID: 22389634
14.  Adaptation of a probabilistic method (InterVA) of verbal autopsy to improve the interpretation of cause of stillbirth and neonatal death in Malawi, Nepal, and Zimbabwe 
Background
Verbal autopsy (VA) is a widely used method for analyzing cause of death in absence of vital registration systems. We adapted the InterVA method to extrapolate causes of death for stillbirths and neonatal deaths from verbal autopsy questionnaires, using data from Malawi, Zimbabwe, and Nepal.
Methods
We obtained 734 stillbirth and neonatal VAs from recent community studies in rural areas: 169 from Malawi, 385 from Nepal, and 180 from Zimbabwe. Initial refinement of the InterVA model was based on 100 physician-reviewed VAs from Malawi. InterVA indicators and matrix probabilities for cause of death were reviewed for clinical and epidemiological coherence by a pediatrician-researcher and an epidemiologist involved in the development of InterVA. The modified InterVA model was evaluated by comparing population-level cause-specific mortality fractions and individual agreement from two methods of interpretation (physician review and InterVA) for a further 69 VAs from Malawi, 385 from Nepal, and 180 from Zimbabwe.
Results
Case-by-case agreement between InterVA and reviewing physician diagnoses for 69 cases from Malawi, 180 cases from Zimbabwe, and 385 cases from Nepal were 83% (kappa 0.76 (0.75 - 0.80)), 71% (kappa 0.41(0.32-0.51)), and 74% (kappa 0.63 (0.60-0.63)), respectively. The proportion of stillbirths identified as fresh or macerated by the different methods of VA interpretation was similar in all three settings. Comparing across countries, the modified InterVA method found that proportions of preterm births and deaths due to infection were higher in Zimbabwe (44%) than in Malawi (28%) or Nepal (20%).
Conclusion
The modified InterVA method provides plausible results for stillbirths and newborn deaths, broadly comparable to physician review but with the advantage of internal consistency. The method allows standardized cross-country comparisons and eliminates the inconsistencies of physician review in such comparisons.
doi:10.1186/1478-7954-9-48
PMCID: PMC3160941  PMID: 21819599
15.  Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications 
Trials  2011;12:151.
Background
Public health interventions are increasingly evaluated using cluster-randomised trials in which groups rather than individuals are allocated randomly to treatment and control arms. Outcomes for individuals within the same cluster are often more correlated than outcomes for individuals in different clusters. This needs to be taken into account in sample size estimations for planned trials, but most estimates of intracluster correlation for perinatal health outcomes come from hospital-based studies and may therefore not reflect outcomes in the community. In this study we report estimates for perinatal health outcomes from community-based trials to help researchers plan future evaluations.
Methods
We estimated the intracluster correlation and the coefficient of variation for a range of outcomes using data from five community-based cluster randomised controlled trials in three low-income countries: India, Bangladesh and Malawi. We also performed a simulation exercise to investigate the impact of cluster size and number of clusters on the reliability of estimates of the coefficient of variation for rare outcomes.
Results
Estimates of intracluster correlation for mortality outcomes were lower than those for process outcomes, with narrower confidence intervals throughout for trials with larger numbers of clusters. Estimates of intracluster correlation for maternal mortality were particularly variable with large confidence intervals. Stratified randomisation had the effect of reducing estimates of intracluster correlation. The simulation exercise showed that estimates of intracluster correlation are much less reliable for rare outcomes such as maternal mortality. The size of the cluster had a greater impact than the number of clusters on the reliability of estimates for rare outcomes.
Conclusions
The breadth of intracluster correlation estimates reported here in terms of outcomes and contexts will help researchers plan future community-based public health interventions around maternal and newborn health. Our study confirms previous work finding that estimates of intracluster correlation are associated with the prevalence of the outcome of interest, the nature of the outcome of interest (mortality or behavioural) and the size and number of clusters. Estimates of intracluster correlation for maternal mortality need to be treated with caution and a range of estimates should be used in planning future trials.
doi:10.1186/1745-6215-12-151
PMCID: PMC3136407  PMID: 21672223
16.  Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial 
Trials  2011;12:136.
Background
Neonatal mortality remains high in rural Nepal. Previous work suggests that local women's groups can effect significant improvement through community mobilisation. The possibility of identification and management of newborn infections by community-based workers has also arisen.
Methods/Design
The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers.
MIRA Dhanusha community groups: a participatory intervention with women's groups. MIRA Dhanusha sepsis management: training of community volunteers in the recognition and management of neonatal sepsis.
The study design is a cluster randomized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design.
MIRA Dhanusha community groups: Female Community Health Volunteers (FCHVs) are supported in convening monthly women's groups. Nine groups per cluster (270 in total) work through two action research cycles in which they (i) identify local issues around maternity, newborn health and nutrition, (ii) prioritise key problems, (iii) develop strategies to address them, (iv) implement the strategies, and (v) evaluate their success. Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practices.
MIRA Dhanusha sepsis management: FCHVs are trained to care for vulnerable newborn infants. They (i) identify local births, (ii) identify low birth weight infants, (iii) identify possible newborn infection, (iv) manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin, and (v) follow up infants and support families.
Primary outcome: neonatal mortality rates. Secondary outcomes: MIRA Dhanusha community group: stillbirth, infant and under-two mortality rates, care practices and health care seeking behaviour, maternal diet, breastfeeding and complementary feeding practices, maternal and under-2 anthropometric status. MIRA Dhanusha sepsis management: identification and treatment of neonatal sepsis by community health volunteers, infection-specific neonatal mortality.
Trial Registration no
ISRCTN: ISRCTN87820538
doi:10.1186/1745-6215-12-136
PMCID: PMC3130670  PMID: 21635791
17.  Community mobilisation and health management committee strengthening to increase birth attendance by trained health workers in rural Makwanpur, Nepal: study protocol for a cluster randomised controlled trial 
Trials  2011;12:128.
Background
Birth attendance by trained health workers is low in rural Nepal. Local participation in improving health services and increased interaction between health systems and communities may stimulate demand for health services. Significant increases in birth attendance by trained health workers may be affected through community mobilisation by local women's groups and health management committee strengthening. We will test the effect of community mobilisation through women's groups, and health management committee strengthening, on institutional deliveries and home deliveries attended by trained health workers in Makwanpur District.
Design
Cluster randomised controlled trial involving 43 village development committee clusters. 21 clusters will receive the intervention and 22 clusters will serve as control areas. In intervention areas, Female Community Health Volunteers are supported in convening monthly women's groups. The groups work through an action research cycle in which they consider barriers to institutional delivery, plan and implement strategies to address these barriers with their communities, and evaluate their progress. Health management committees participate in three-day workshops that use appreciative inquiry methods to explore and plan ways to improve maternal and newborn health services. Follow-up meetings are conducted every three months to review progress. Primary outcomes are institutional deliveries and home deliveries conducted by trained health workers. Secondary outcome measures include uptake of antenatal and postnatal care, neonatal mortality and stillbirth rates, and maternal morbidity.
Trial registration number
ISRCTN99834806
doi:10.1186/1745-6215-12-128
PMCID: PMC3121607  PMID: 21595902
18.  A Rapid Assessment Scorecard to Identify Informal Settlements at Higher Maternal and Child Health Risk in Mumbai 
The communities who live in urban informal settlements are diverse, as are their environmental conditions. Characteristics include inadequate access to safe water and sanitation, poor quality of housing, overcrowding, and insecure residential status. Interventions to improve health should be equity-driven and target those at higher risk, but it is not clear how to prioritise informal settlements for health action. In implementing a maternal and child health programme in Mumbai, India, we had conducted a detailed vulnerability assessment which, though important, was time-consuming and may have included collection of redundant information. Subsequent data collection allowed us to examine three issues: whether community environmental characteristics were associated with maternal and newborn healthcare and outcomes; whether it was possible to develop a triage scorecard to rank the health vulnerability of informal settlements based on a few rapidly observable characteristics; and whether the scorecard might be useful for future prioritisation. The City Initiative for Newborn Health documented births in 48 urban slum areas over 2 years. Information was collected on maternal and newborn care and mortality, and also on household and community environment. We selected three outcomes—less than three antenatal care visits, home delivery, and neonatal mortality—and used logistic regression and classification and regression tree analysis to test their association with rapidly observable environmental characteristics. We developed a simple triage scorecard and tested its utility as a means of assessing maternal and newborn health risk. In analyses on a sample of 10,754 births, we found associations of health vulnerability with inadequate access to water, toilets, and electricity; non-durable housing; hazardous location; and rental tenancy. A simple scorecard based on these had limited sensitivity and positive predictive value, but relatively high specificity and negative predictive value. The scorecard needs further testing in a range of urban contexts, but we intend to use it to identify informal settlements in particular need of family health interventions in a subsequent program.
doi:10.1007/s11524-011-9556-7
PMCID: PMC3191203  PMID: 21487826
Urban health; Mumbai; Maternal health; Newborn health; Slum; India
19.  Scaling Up Diarrhea Prevention and Treatment Interventions: A Lives Saved Tool Analysis 
PLoS Medicine  2011;8(3):e1000428.
Using the Lives Saved Tool (LiST) Christa Fischer-Walker and colleagues estimate that scale-up of diarrhea prevention and treatment interventions over 5 years in 68 high child mortality countries could avert nearly 5 million deaths.
Background
Diarrhea remains a leading cause of mortality among young children in low- and middle-income countries. Although the evidence for individual diarrhea prevention and treatment interventions is solid, the effect a comprehensive scale-up effort would have on diarrhea mortality has not been estimated.
Methods and Findings
We use the Lives Saved Tool (LiST) to estimate the potential lives saved if two scale-up scenarios for key diarrhea interventions (oral rehydration salts [ORS], zinc, antibiotics for dysentery, rotavirus vaccine, vitamin A supplementation, basic water, sanitation, hygiene, and breastfeeding) were implemented in the 68 high child mortality countries. We also conduct a simple costing exercise to estimate cost per capita and total costs for each scale-up scenario. Under the ambitious (feasible improvement in coverage of all interventions) and universal (assumes near 100% coverage of all interventions) scale-up scenarios, we demonstrate that diarrhea mortality can be reduced by 78% and 92%, respectively. With universal coverage nearly 5 million diarrheal deaths could be averted during the 5-year scale-up period for an additional cost of US$12.5 billion invested across 68 priority countries for individual-level prevention and treatment interventions, and an additional US$84.8 billion would be required for the addition of all water and sanitation interventions.
Conclusion
Using currently available interventions, we demonstrate that with improved coverage, diarrheal deaths can be drastically reduced. If delivery strategy bottlenecks can be overcome and the international community can collectively deliver on the key strategies outlined in these scenarios, we will be one step closer to achieving success for the United Nations' Millennium Development Goal 4 (MDG4) by 2015.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Diarrhea—passing three or more loose or liquid stools per day—kills about 1.5 million young children every year, mainly in low- and middle-income countries. It is the second leading cause of death in under-5-year olds and causes nearly one in five child deaths. Diarrhea, which can lead to life-threatening dehydration, is a common symptom of gastrointestinal infections. The viruses, bacteria and parasites that cause diarrhea spread through contaminated food or drinking water, and from person-to-person through poor hygiene and inadequate sanitation (unsafe disposal of human excreta). Interventions that prevent diarrhea include improvements in water supplies, sanitation and hygiene, the promotion of breastfeeding, vitamin A supplementation, and vaccination against rotavirus (a major cause of diarrhea). Treatments for diarrhea include oral rehydration salts (ORS), which prevent and treat dehydration, and zinc supplementation, which decreases the severity and duration of diarrhea, and antibiotics for dysentery.
Why Was This Study Done?
Deaths from diarrhea in young children have declined markedly over the past 30 years. However, if diarrhea deaths are not reduced further, it is unlikely that Millennium Development Goal 4 (MDG4; one of the goals agreed by world leaders in 2000 to reduce poverty)—the reduction of child mortality by two-thirds of the 1990 level by 2015—will be reached. In 2009, UNICEF and the World Health Organization (WHO) proposed a new diarrhea reduction plan. Although the effect of individual interventions in this plan is established, the likely effect of the whole package on diarrhea mortality has not been estimated. Such information would be useful for health policy planning. In this study, the researchers use the Lives Saved Tool (LiST) to estimate the potential lives saved by scale-up of diarrhea prevention and treatment interventions in 68 high child mortality countries that together account for 95% of child deaths. LiST is a child survival modeling tool that uses country-level under-5 death rates and cause of death profiles to model the effects of changes in health intervention package coverage on deaths among children.
What Did the Researchers Do and Find?
The researchers calculated 2010 (baseline) coverage values for seven prevention interventions (breastfeeding, vitamin A supplementation, hand washing with soap, improved sanitation, improved water source, better household water treatment, and rotavirus vaccination) and for three treatment interventions (ORS, zinc supplementation, and antibiotics for dysentery) from published data. They then used LiST to estimate the effect on diarrhea deaths of scaling up intervention coverage according to two scenarios. The “ambitious” scenario assumed a feasible increase in the coverage of all interventions from the baseline year to 2015 in 68 countries with high child mortality. The “universal” scenario assumed an increase to near 100% coverage for all the interventions. Diarrhea mortality was reduced by 78% and 92% by 2015 under the ambitious and universal scenarios, respectively. Over the 5 years of the scale-up, the universal scenario averted nearly 5 million deaths. The researchers also estimated that the additional costs in 2015 of personal prevention and treatment interventions would be US$0.80 per capita with universal coverage; the additional costs for these interventions and all sanitation and water interventions would be US$3.24 per capita.
What Do These Findings Mean?
These findings suggest that, with currently available interventions, it should be possible to reduce diarrhea deaths substantially at a reasonable cost. As with all computer models, the accuracy of these findings depends on the data and assumptions fed into the model, which does not, for example, account for the difficulties that may be encountered in scaling up intervention coverage in hard to reach populations. Similarly, the estimated costs associated with the two scenarios do not include the resources required to strengthen health systems in developing countries so that they are able to sustain high coverage levels of diarrhea prevention and treatment interventions. Nevertheless, these findings suggest that child mortality due to diarrhea could be significantly reduced by 2015 provided the international community acts collectively to deliver these interventions. Most importantly, the potential 1.4 million lives saved in that year would bring MDG4 a step closer simply by implementing existing low cost and effective interventions.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000428.
The World Health Organization provides information on diarrhea (in several languages); its 2009 report with UNICEF Diarrhea: why children are still dying and what can be done, which includes the WHO/UNICEF treatment and prevention plan, can be downloaded from the Internet
The children's charity UNICEF, which protects the rights of children and young people around the world, provides information on water, sanitation, and hygiene, and on diarrhea (in several languages)
The United Nations Millennium Development Goals provides information on ongoing world efforts to reduce child mortality
More details on LiST are available
doi:10.1371/journal.pmed.1000428
PMCID: PMC3062532  PMID: 21445330
20.  Maternal and neonatal health expenditure in mumbai slums (India): A cross sectional study 
BMC Public Health  2011;11:150.
Background
The cost of maternity care can be a barrier to access that may increase maternal and neonatal mortality risk. We analyzed spending on maternity care in urban slum communities in Mumbai to better understand the equity of spending and the impact of spending on household poverty.
Methods
We used expenditure data for maternal and neonatal care, collected during post-partum interviews. Interviews were conducted in 2005-2006, with a sample of 1200 slum residents in Mumbai (India). We analysed expenditure by socio-economic status (SES), calculating a Kakwani Index for a range of spending categories. We also calculated catastrophic health spending both with and without adjustment for coping strategies. This identified the level of catastrophic payments incurred by a household and the prevalence of catastrophic payments in this population. The analysis also gave an understanding of the protection from medical poverty afforded by coping strategies (for example saving and borrowing).
Results
A high proportion of respondents spent catastrophically on care. Lower SES was associated with a higher proportion of informal payments. Indirect health expenditure was found to be (weakly) regressive as the poorest were more likely to use wage income to meet health expenses, while the less poor were more likely to use savings. Overall, the incidence of catastrophic maternity expenditure was 41%, or 15% when controlling for coping strategies. We found no significant difference in the incidence of catastrophic spending across wealth quintiles, nor could we conclude that total expenditure is regressive.
Conclusions
High expenditure as a proportion of household resources should alert policymakers to the burden of maternal spending in this context. Differences in informal payments, significantly regressive indirect spending and the use of savings versus wages to finance spending, all highlight the heavier burden borne by the most poor. If a policy objective is to increase institutional deliveries without forcing households deeper into poverty, these inequities will need to be addressed. Reducing out-of-pocket payments and better regulating informal payments should have direct benefits for the most poor. Alternatively, targeted schemes aimed at assisting the most poor in coping with maternal spending (including indirect spending) could reduce the household impact of high costs.
doi:10.1186/1471-2458-11-150
PMCID: PMC3061914  PMID: 21385404
21.  Setting Research Priorities to Reduce Almost One Million Deaths from Birth Asphyxia by 2015 
PLoS Medicine  2011;8(1):e1000389.
Joy Lawn and colleagues used a systematic process developed by the Child Health Nutrition Research Initiative (CHNRI) to define and rank research options to reduce mortality from intrapartum-related neonatal deaths (birth asphyxia) by the year 2015.
doi:10.1371/journal.pmed.1000389
PMCID: PMC3019109  PMID: 21305038
22.  A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality 
Trials  2010;11:88.
Background
The UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and early childhood. The MaiMwana Project aims to test community-based interventions that tackle maternal and child health problems through increasing awareness and local action.
Methods/Design
This study uses a two-by-two factorial cluster-randomised controlled trial design to test the impact of two interventions. The impact of a community mobilisation intervention run through women's groups, on home care, health care-seeking behaviours and maternal and infant mortality, will be tested. The impact of a volunteer-led infant feeding and care support intervention, on rates of exclusive breastfeeding, uptake of HIV-prevention services and infant mortality, will also be tested. The women's group intervention will employ local female facilitators to guide women's groups through a four-phase cycle of problem identification and prioritisation, strategy identification, implementation and evaluation. Meetings will be held monthly at village level. The infant feeding intervention will select local volunteers to provide advice and support for breastfeeding, birth preparedness, newborn care and immunisation. They will visit pregnant and new mothers in their homes five times during and after pregnancy.
The unit of intervention allocation will be clusters of rural villages of 2500-4000 population. 48 clusters have been defined and randomly allocated to either women's groups only, infant feeding support only, both interventions, or no intervention. Study villages are surrounded by 'buffer areas' of non-study villages to reduce contamination between intervention and control areas. Outcome indicators will be measured through a demographic surveillance system. Primary outcomes will be maternal, infant, neonatal and perinatal mortality for the women's group intervention, and exclusive breastfeeding rates and infant mortality for the infant feeding intervention.
Structured interviews will be conducted with mothers one-month and six-months after birth to collect detailed quantitative data on care practices and health-care-seeking. Further qualitative, quantitative and economic data will be collected for process and economic evaluations.
Trial registration
ISRCTN06477126
doi:10.1186/1745-6215-11-88
PMCID: PMC2949851  PMID: 20849613
23.  Examining the “Urban Advantage” in Maternal Health Care in Developing Countries 
PLoS Medicine  2010;7(9):e1000327.
Andrew Channon and colleagues outline the complexities of urban advantage in maternal health where the urban poor often have worse access to health care than women in rural areas.
doi:10.1371/journal.pmed.1000327
PMCID: PMC2939019  PMID: 20856899
24.  Prospective study of determinants and costs of home births in Mumbai slums 
Background
Around 86% of births in Mumbai, India, occur in healthcare institutions, but this aggregate figure hides substantial variation and little is known about urban home births. We aimed to explore factors influencing the choice of home delivery, care practices and costs, and to identify characteristics of women, households and the environment which might increase the likelihood of home birth.
Methods
As part of the City Initiative for Newborn Health, we used a key informant surveillance system to identify births prospectively in 48 slum communities in six wards of Mumbai, covering a population of 280 000. Births and outcomes were documented prospectively by local women and mothers were interviewed in detail at six weeks after delivery. We examined the prevalence of home births and their associations with potential determinants using regression models.
Results
We described 1708 (16%) home deliveries among 10 754 births over two years, 2005-2007. The proportion varied from 6% to 24%, depending on area. The most commonly cited reasons for home birth were custom and lack of time to reach a healthcare facility during labour. Seventy percent of home deliveries were assisted by a traditional birth attendant (dai), and 6% by skilled health personnel. The median cost of a home delivery was US$ 21, of institutional delivery in the public sector US$ 32, and in the private sector US$ 118. In an adjusted multivariable regression model, the odds of home delivery increased with illiteracy, parity, socioeconomic poverty, poorer housing, lack of water supply, population transience, and hazardous location.
Conclusions
We estimate 32 000 annual home births to residents of Mumbai's slums. These are unevenly distributed and cluster with other markers of vulnerability. Since cost does not appear to be a dominant disincentive to institutional delivery, efforts are needed to improve the client experience at public sector institutions. It might also be productive to concentrate on intensive outreach in vulnerable areas by community-based health workers, who could play a greater part in helping women plan their deliveries and making sure that they get help in time.
doi:10.1186/1471-2393-10-38
PMCID: PMC2928174  PMID: 20670456
25.  Countdown to 2015: will the Millennium Development Goal for child survival be met? 
Archives of Disease in Childhood  2007;92(6):551-556.
The Millennium Development Goals (MDGs), ratified by most nations in 2000, set specific targets for poverty reduction, eradication of hunger, education, gender equality, health and environmental sustainability. MDG 4 aims to reduce child mortality with a target of reducing under‐five mortality rates by two thirds over the period 1990–2015. Over the last year, Live Aid, Make Poverty History, the G8 summits and prominent entertainers have directed unprecedented attention towards development and health. Africa particularly has been in the spotlight. Reports are published and commitments are made, but is there real progress? Are poor people being reached with essential health care? Who will hold leaders to account: celebrities, activists or health professionals?
doi:10.1136/adc.2006.099291
PMCID: PMC2066179  PMID: 17515627

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