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1.  Are village health sanitation and nutrition committees fulfilling their roles for decentralised health planning and action? A mixed methods study from rural eastern India 
BMC Public Health  2016;16:59.
Background
In India, Village Health Sanitation and Nutrition Committees (VHSNCs) are participatory community health forums, but there is little information about their composition, functioning and effectiveness. Our study examined VHSNCs as enablers of participatory action for community health in two rural districts in two states of eastern India – West Singhbhum in Jharkhand and Kendujhar, in Odisha.
Methods
We conducted a cross-sectional survey of 169 VHSNCs and ten qualitative focus group discussions with purposively selected better and poorer performing committees, across the two states. We analysed the quantitative data using descriptive statistics and the qualitative data using a Framework approach.
Results
We found that VHSNCs comprised equitable representation from vulnerable groups when they were formed. More than 75 % members were women. Almost all members belonged to socially disadvantaged classes. Less than 1 % members had received any training. Supervision of committees by district or block officials was rare. Their work focused largely on strengthening village sanitation, conducting health awareness activities, and supporting medical treatment for ill or malnourished children and pregnant mothers. In reality, 62 % committees monitored community health workers, 6.5 % checked sub-centres and 2.4 % monitored drug availability with community health workers. Virtually none monitored data on malnutrition. Community health and nutrition workers acted as conveners and record keepers. Links with the community involved awareness generation and community monitoring of VHSNC activities. Key challenges included irregular meetings, members’ limited understanding of their roles and responsibilities, restrictions on planning and fund utilisation, and weak linkages with the broader health system.
Conclusions
Our study suggests that VHSNCs perform few of their specified functions for decentralized planning and action. If VHSNCs are to be instrumental in improving community health, sanitation and nutrition, they need education, mobilisation and monitoring for formal links with the wider health system.
doi:10.1186/s12889-016-2699-4
PMCID: PMC4722712  PMID: 26795942
Village health sanitation and nutrition committee; Community participation; Decentralized governance; Planning; India
2.  Cause-specific neonatal mortality: analysis of 3772 neonatal deaths in Nepal, Bangladesh, Malawi and India 
Objective
Understanding the causes of death is key to tackling the burden of three million annual neonatal deaths. Resource-poor settings lack effective vital registration systems for births, deaths and causes of death. We set out to describe cause-specific neonatal mortality in rural areas of Malawi, Bangladesh, Nepal and rural and urban India using verbal autopsy (VA) data.
Design
We prospectively recorded births, neonatal deaths and stillbirths in seven population surveillance sites. VAs were carried out to ascertain cause of death. We applied descriptive epidemiological techniques and the InterVA method to characterise the burden, timing and causes of neonatal mortality at each site.
Results
Analysis included 3772 neonatal deaths and 3256 stillbirths. Between 63% and 82% of neonatal deaths occurred in the first week of life, and males were more likely to die than females. Prematurity, birth asphyxia and infections accounted for most neonatal deaths, but important subnational and regional differences were observed. More than one-third of deaths in urban India were attributed to asphyxia, making it the leading cause of death in this setting.
Conclusions
Population-based VA methods can fill information gaps on the burden and causes of neonatal mortality in resource-poor and data-poor settings. Local data should be used to inform and monitor the implementation of interventions to improve newborn health. High rates of home births demand a particular focus on community interventions to improve hygienic delivery and essential newborn care.
doi:10.1136/archdischild-2014-307636
PMCID: PMC4552925  PMID: 25972443
Neonatology; Mortality; Epidemiology; Measurement; Data Collection
3.  Using Observational Data to Estimate the Effect of Hand Washing and Clean Delivery Kit Use by Birth Attendants on Maternal Deaths after Home Deliveries in Rural Bangladesh, India and Nepal 
PLoS ONE  2015;10(8):e0136152.
Background
Globally, puerperal sepsis accounts for an estimated 8–12% of maternal deaths, but evidence is lacking on the extent to which clean delivery practices could improve maternal survival. We used data from the control arms of four cluster-randomised controlled trials conducted in rural India, Bangladesh and Nepal, to examine associations between clean delivery kit use and hand washing by the birth attendant with maternal mortality among home deliveries.
Methods
We tested associations between clean delivery practices and maternal deaths, using a pooled dataset for 40,602 home births across sites in the three countries. Cross-sectional data were analysed by fitting logistic regression models with and without multiple imputation, and confounders were selected a priori using causal directed acyclic graphs. The robustness of estimates was investigated through sensitivity analyses.
Results
Hand washing was associated with a 49% reduction in the odds of maternal mortality after adjusting for confounding factors (adjusted odds ratio (AOR) 0.51, 95% CI 0.28–0.93). The sensitivity analysis testing the missing at random assumption for the multiple imputation, as well as the sensitivity analysis accounting for possible misclassification bias in the use of clean delivery practices, indicated that the association between hand washing and maternal death had been over estimated. Clean delivery kit use was not associated with a maternal death (AOR 1.26, 95% CI 0.62–2.56).
Conclusions
Our evidence suggests that hand washing in delivery is critical for maternal survival among home deliveries in rural South Asia, although the exact magnitude of this effect is uncertain due to inherent biases associated with observational data from low resource settings. Our findings indicating kit use does not improve maternal survival, suggests that the soap is not being used in all instances that kit use is being reported.
doi:10.1371/journal.pone.0136152
PMCID: PMC4546655  PMID: 26295838
4.  Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies 
Trials  2015;16:351.
Background
Three arguments are usually invoked in favour of stepped wedge cluster randomised controlled trials: the logistic convenience of implementing an intervention in phases, the ethical benefit of providing the intervention to all clusters, and the potential to enhance the social acceptability of cluster randomised controlled trials. Are these alleged benefits real? We explored the logistic, ethical, and political dimensions of stepped wedge trials using case studies of six recent evaluations.
Methods
We identified completed or ongoing stepped wedge evaluations using two systematic reviews. We then purposively selected six with a focus on public health in high, middle, and low-income settings. We interviewed their authors about the logistic, ethical, and social issues faced by their teams. Two authors reviewed interview transcripts, identified emerging issues through qualitative thematic analysis, reflected upon them in the context of the literature, and invited all participants to co-author the manuscript.
Results
Our analysis raises three main points. First, the phased implementation of interventions can alleviate problems linked to simultaneous roll-out, but also brings new challenges. Issues to consider include the feasibility of organising intervention activities according to a randomised sequence, estimating time lags in implementation and effects, and accommodating policy changes during the trial period. Second, stepped wedge trials, like parallel cluster trials, require equipoise: without it, randomising participants to a control condition, even for a short time, remains problematic. In stepped wedge trials, equipoise is likely to lie in the degree of effect, effectiveness in a specific operational milieu, and the balance of benefit and harm, including the social value of better evaluation. Third, the strongest arguments for a stepped wedge design are logistic and political rather than ethical. The design is advantageous when simultaneous roll-out is impractical and when it increases the acceptability of using counterfactuals.
Conclusions
The logistic convenience of phased implementation is context-dependent, and may be vitiated by the additional requirements of phasing. The potential for stepped wedge trials to enhance the social acceptability of cluster randomised trials is real, but their ethical legitimacy still rests on demonstrating equipoise and its configuration for each research question and setting.
doi:10.1186/s13063-015-0837-4
PMCID: PMC4538739  PMID: 26278521
Stepped wedge trials; Ethics; Methodology; Public health
5.  Five questions to consider before conducting a stepped wedge trial 
Trials  2015;16:350.
Researchers should consider five questions before starting a stepped wedge trial.
Why are you planning one? Researchers sometimes think that stepped wedge trials are useful when there is little doubt about the benefit of the intervention being tested. However, if the primary reason for an intervention is to measure its effect, without equipoise there is no ethical justification for delaying implementation in some clusters. By contrast, if you are undertaking pragmatic research, where the primary reason for rolling out the intervention is for it to exert its benefits, and if phased implementation is inevitable, a stepped wedge trial is a valid option and provides better evidence than most non-randomized evaluations.
What design will you use? Two common stepped wedge designs are based on the recruitment of a closed or open cohort. In both, individuals may experience both control and intervention conditions and you should be concerned about carry-over effects. In a third, continuous-recruitment, short-exposure design, individuals are recruited as they become eligible and experience either control or intervention condition, but not both.
How will you conduct the primary analysis? In stepped wedge trials, control of confounding factors through secular variation is essential. ‘Vertical’ approaches preserve randomization and compare outcomes between randomized groups within periods. ‘Horizontal’ approaches compare outcomes before and after crossover to the intervention condition. Most analysis models used in practice combine both types of comparison. The appropriate analytic strategy should be considered on a case-by-case basis.
How large will your trial be? Standard sample size calculations for cluster randomized trials do not accommodate the specific features of stepped wedge trials. Methods exist for many stepped wedge designs, but simulation-based calculations provide the greatest flexibility. In some scenarios, such as when the intracluster correlation coefficient is moderate or high, or the cluster size is large, a stepped wedge trial may require fewer clusters than a parallel cluster trial.
How will you report your trial? Stepped wedge trials are currently challenging to report using CONSORT principles. Researchers should consider how to demonstrate balance achieved by randomization and how to describe trends for outcomes in both intervention and control clusters.
doi:10.1186/s13063-015-0841-8
PMCID: PMC4538743  PMID: 26279013
Methodology; Public health; Stepped wedge trials
6.  Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014 
Trials  2015;16:353.
Background
In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design’s perceived logistical and analytical advantages. However, the interventions included in these systematic reviews were often poorly reported and did not adequately describe the analysis and/or methodology used. Since 2010, a number of additional stepped wedge trials have been published. This article aims to update previous systematic reviews, and consider what interventions were tested and the rationale given for using a stepped wedge design.
Methods
We searched PubMed, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Web of Science, the Cochrane Library and the Current Controlled Trials Register for articles published between January 2010 and May 2014. We considered stepped wedge randomised controlled trials in all fields of research. We independently extracted data from retrieved articles and reviewed them. Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy.
Results
Our review identified 37 stepped wedge trials, reported in 10 articles presenting trial results, one conference abstract, 21 protocol or study design articles and five trial registrations. These were mostly conducted in developed countries (n = 30), and within healthcare organisations (n = 28). A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being ‘instruction on how to perform a behaviour’ (n = 32) and ‘persuasive source’ (n = 25). Authors gave a wide range of reasons for the use of the stepped wedge trial design, including ethical considerations, logistical, financial and methodological. The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size.
Conclusions
The popularity of stepped wedge trials has increased since 2010, predominantly in high-income countries. However, there is a need for further guidance on their reporting and analysis.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0839-2) contains supplementary material, which is available to authorized users.
doi:10.1186/s13063-015-0839-2
PMCID: PMC4538902  PMID: 26278881
Stepped wedge trials; Systematic review; Methodology; Public health
7.  How important is randomisation in a stepped wedge trial? 
Trials  2015;16:359.
In cluster randomised trials, randomisation increases internal study validity. If enough clusters are randomised, an unadjusted analysis should be unbiased. If a smaller number of clusters are included, stratified or matched randomisation can increase comparability between trial arms. In addition, an adjusted analysis may be required; nevertheless, randomisation removes the possibility for systematically biased allocation and increases transparency. In stepped wedge trials, clusters are randomised to receive an intervention at different start times (‘steps’), and all clusters eventually receive it. In a recent study protocol for a ‘modified stepped wedge trial’, the investigators considered randomisation of the clusters (hospital wards), but decided against it for ethical and logistical reasons, and under the assumption that it would not add much to the rigour of the evaluation. We show that the benefits of randomisation for cluster randomised trials also apply to stepped wedge trials. The biggest additional issue for stepped wedge trials in relation to parallel cluster randomised trials is the need to control for secular trends in the outcome. Analysis of stepped wedge trials can in theory be based on ‘horizontal’ or ‘vertical’ comparisons. Horizontal comparisons are based on measurements taken before and after the intervention is introduced in each cluster, and are unbiased if there are no secular trends. Vertical comparisons are based on outcome measurements from clusters that have switched to the intervention condition and those from clusters that have yet to switch, and are unbiased under randomisation since at any time point, which clusters are in intervention and control conditions will have been determined at random. Secular outcome trends are a possibility in many settings. Many stepped wedge trials are analysed with a mixed model, including a random effect for cluster and fixed effects for time period to account for secular trends, thereby combining both vertical and horizontal comparisons of intervention and control clusters. The importance of randomisation in a stepped wedge trial is that the effects of time can be estimated from the data, and bias from secular trends that would otherwise arise can be controlled for, provided the trends are correctly specified in the model.
doi:10.1186/s13063-015-0872-1
PMCID: PMC4537545  PMID: 26275907
8.  Generating Insights from Trends in Newborn Care Practices from Prospective Population-Based Studies: Examples from India, Bangladesh and Nepal 
PLoS ONE  2015;10(7):e0127893.
Background
Delivery of essential newborn care is key to reducing neonatal mortality rates, yet coverage of protective birth practices remains incomplete and variable, with or without skilled attendance. Evidence of changes over time in newborn care provision, disaggregated by care practice and delivery type, can be used by policymakers to review efforts to reduce mortality. We examine such trends in four areas using control arm trial data.
Methods and Findings
We analysed data from the control arms of cluster randomised controlled trials in Bangladesh (27 553 births), eastern India (8 939), Dhanusha, Nepal (15 344) and Makwanpur, Nepal (6 765) over the period 2001–2011. For each trial, we calculated the observed proportion of attended births and the coverage of WHO essential newborn care practices by year, adjusted for clustering and stratification. To explore factors contributing to the observed trends, we then analysed expected trends due only to observed shifts in birth attendance, accounted for stratification, delivery type and statistically significant interaction terms, and examined disaggregated trends in care practice coverage by delivery type. Attended births increased over the study periods in all areas from very low rates, reaching a maximum of only 30% of deliveries. Newborn care practice trends showed marked heterogeneity within and between areas. Adjustment for stratification, birth attendance and interaction revealed that care practices could change in opposite directions over time and/or between delivery types – e.g. in Bangladesh hygienic cord-cutting and skin-to-skin contact fell in attended deliveries but not home deliveries, whereas in India birth attendant hand-washing rose for institutional deliveries but fell for home deliveries.
Conclusions
Coverage of many essential newborn care practices is improving, albeit slowly and unevenly across sites and delivery type. Time trend analyses of birth patterns and essential newborn care practices can inform policy-makers about effective intervention strategies.
doi:10.1371/journal.pone.0127893
PMCID: PMC4503724  PMID: 26176535
9.  Participatory women’s groups and counselling through home visits to improve child growth in rural eastern India: protocol for a cluster randomised controlled trial 
BMC Public Health  2015;15:384.
Background
Child stunting (low height-for-age) is a marker of chronic undernutrition and predicts children’s subsequent physical and cognitive development. Around one third of the world’s stunted children live in India. Our study aims to assess the impact, cost-effectiveness, and scalability of a community intervention with a government-proposed community-based worker to improve growth in children under two in rural India.
Methods
The study is a cluster randomised controlled trial in two rural districts of Jharkhand and Odisha (eastern India). The intervention tested involves a community-based worker carrying out two activities: (a) one home visit to all pregnant women in the third trimester, followed by subsequent monthly home visits to all infants aged 0–24 months to support appropriate feeding, infection control, and care-giving; (b) a monthly women’s group meeting using participatory learning and action to catalyse individual and community action for maternal and child health and nutrition. Both intervention and control clusters also receive an intervention to strengthen Village Health Sanitation and Nutrition Committees.
The unit of randomisation is a purposively selected cluster of approximately 1000 population. A total of 120 geographical clusters covering an estimated population of 121,531 were randomised to two trial arms: 60 clusters in the intervention arm receive home visits, group meetings, and support to Village Health Sanitation and Nutrition Committees; 60 clusters in the control arm receive support to Committees only. The study participants are pregnant women identified in the third trimester of pregnancy and their children (n = 2520). Mothers and their children are followed up at seven time points: during pregnancy, within 72 hours of delivery, and at 3, 6, 9, 12 and 18 months after birth. The trial’s primary outcome is children’s mean length-for-age Z scores at 18 months. Secondary outcomes include wasting and underweight at all time points, birth weight, growth velocity, feeding, infection control, and care-giving practices. Additional qualitative and quantitative data are collected for process and economic evaluations.
Discussion
This trial will contribute to evidence on effective strategies to improve children's growth in India.
Trial registration
ISRCTN register 51505201; Clinical Trials Registry of India number 2014/06/004664.
Electronic supplementary material
The online version of this article (doi:10.1186/s12889-015-1655-z) contains supplementary material, which is available to authorized users.
doi:10.1186/s12889-015-1655-z
PMCID: PMC4410595  PMID: 25886587
Stunting; India; Child; Nutrition; Public health
10.  The effect of participatory women's groups on infant feeding and child health knowledge, behaviour and outcomes in rural Bangladesh: a controlled before-and-after study 
Background
Despite efforts to reduce under-5 mortality rates worldwide, an estimated 6.6 million under-5 children die every year. Community mobilisation through participatory women's groups has been shown to improve maternal and newborn health in rural settings, but little is known about the potential of this approach to improve care and health in children after the newborn period.
Methods
Following on from a cluster-randomised controlled trial to assess the effect of participatory women's groups on maternal and neonatal health outcomes in rural Bangladesh, 162 women's groups continued to meet between April 2010 and December 2011 to identify, prioritise and address issues that affect the health of children under 5 years. A controlled before-and-after study design and difference-in-difference analysis was used to assess morbidity outcomes and changes in knowledge and practices related to child feeding, hygiene and care-seeking behaviour.
Findings
Significant improvements were measured in mothers’ knowledge of disease prevention and management, danger signs and hand washing at critical times. Significant increases were seen in exclusive breast feeding for at least 6 months (15.3% (4.2% to 26.5%)), and mean duration of breast feeding (37.9 days (17.4 to 58.3)). Maternal reports of under-5 morbidities fell in intervention compared with control areas, including reports of fever (−10.5% (−15.1% to −6.0%)) and acute respiratory infections (−12.2% (−15.6% to −8.8%)). No differences were observed in dietary diversity scores or immunisation uptake.
Conclusions
Community mobilisation through participatory women's groups can be successfully adapted to address health knowledge and practice in relation to child's health, leading to improvements in a number of child health indicators and behaviours.
doi:10.1136/jech-2014-204271
PMCID: PMC4392217  PMID: 25472635
Community Mobilisation; Participatory Women's Groups; Rural Areas; Bangladesh
11.  Community perceptions of health and chronic disease in South Indian rural transitional communities: a qualitative study 
Global Health Action  2015;8:10.3402/gha.v8.25946.
Background
Chronic diseases are now the leading cause of death and disability worldwide; this epidemic has been linked to rapid economic growth and urbanisation in developing countries. Understanding how characteristics of the physical, social, and economic environment affect behaviour in the light of these changes is key to identifying successful interventions to mitigate chronic disease risk.
Design
We undertook a qualitative study consisting of nine focus group discussions (FGDs) (n=57) in five villages in rural Andhra Pradesh, South India, to understand people's perceptions of community development and urbanisation in relation to chronic disease in rural transitional communities. Specifically, we sought to understand perceptions of change linked to diet, physical activity, and pollution (because these exposures are most relevant to chronic diseases), with the aim of defining future interventions. The transcripts were analysed thematically.
Results
Participants believed their communities were currently less healthy, more polluted, less physically active, and had poorer access to nutritious food and shorter life expectancies than previously. There were contradictory perceptions of the effects of urbanisation on health within and between individuals; several of the participants felt their quality of life had been reduced.
Conclusions
In the present study, residents viewed change and development within their villages as an inevitable and largely positive process but with some negative health consequences. Understanding how these changes are affecting populations in transitional rural areas and how people relate to their environment may be useful to guide community planning for health. Measures to educate and empower people to make healthy choices within their community may help reduce the spread of chronic disease risk factors in future years.
doi:10.3402/gha.v8.25946
PMCID: PMC4323408  PMID: 25669238
chronic disease; urbanisation; community environment; qualitative; India
12.  Prevalence and determinants of caesarean section in private and public health facilities in underserved South Asian communities: cross-sectional analysis of data from Bangladesh, India and Nepal 
BMJ Open  2014;4(12):e005982.
Objectives
To describe the prevalence and determinants of births by caesarean section in private and public health facilities in underserved communities in South Asia.
Design
Cross-sectional study.
Setting
81 community-based geographical clusters in four locations in Bangladesh, India and Nepal (three rural, one urban).
Participants
45 327 births occurring in the study areas between 2005 and 2012.
Outcome measures
Proportion of caesarean section deliveries by location and type of facility; determinants of caesarean section delivery by location.
Results
Institutional delivery rates varied widely between settings, from 21% in rural India to 90% in urban India. The proportion of private and charitable facility births delivered by caesarean section was 73% in Bangladesh, 30% in rural Nepal, 18% in urban India and 5% in rural India. The odds of caesarean section were greater in private and charitable health facilities than in public facilities in three of four study locations, even when adjusted for pregnancy and delivery characteristics, maternal characteristics and year of delivery (Bangladesh: adjusted OR (AOR) 5.91, 95% CI 5.15 to 6.78; Nepal: AOR 2.37, 95% CI 1.62 to 3.44; urban India: AOR 1.22, 95% CI 1.09 to 1.38). We found that highly educated women were particularly likely to deliver by caesarean in private facilities in urban India (AOR 2.10; 95% CI 1.61 to 2.75) and also in rural Bangladesh (AOR 11.09, 95% CI 6.28 to 19.57).
Conclusions
Our results lend support to the hypothesis that increased caesarean section rates in these South Asian countries may be driven in part by the private sector. They also suggest that preferences for caesarean delivery may be higher among highly educated women, and that individual-level and provider-level factors interact in driving caesarean rates higher. Rates of caesarean section in the private sector, and their maternal and neonatal health outcomes, require close monitoring.
doi:10.1136/bmjopen-2014-005982
PMCID: PMC4283435  PMID: 25550293
OBSTETRICS; PUBLIC HEALTH
13.  Impact of a Participatory Intervention with Women’s Groups on Psychological Distress among Mothers in Rural Bangladesh: Secondary Analysis of a Cluster-Randomised Controlled Trial 
PLoS ONE  2014;9(10):e110697.
Background
Perinatal common mental disorders (PCMDs) are a major cause of disability among women and disproportionately affect lower income countries. Interventions to address PCMDs are urgently needed in these settings, and group-based and peer-led approaches are potential strategies to increase access to mental health interventions. Participatory women’s health groups led by local women previously reduced postpartum psychological distress in eastern India. We assessed the effect of a similar intervention on postpartum psychological distress in rural Bangladesh.
Method
We conducted a secondary analysis of data from a cluster-randomised controlled trial with 18 clusters and an estimated population of 532,996. Nine clusters received an intervention comprising monthly meetings during which women’s groups worked through a participatory learning and action cycle to develop strategies for improving women’s and children’s health. There was one group for every 309 individuals in the population, 810 groups in total. Mothers in nine control clusters had access to usual perinatal care. Postpartum psychological distress was measured with the 20-item Self Reporting Questionnaire (SRQ-20) between six and 52 weeks after delivery, during the months of January to April, in 2010 and 2011.
Results
We analysed outcomes for 6275 mothers. Although the cluster mean SRQ-20 score was lower in the intervention arm (mean 5.2, standard deviation 1.8) compared to control (5.3, 1.2), the difference was not significant (β 1.44, 95% CI 0.28, 3.08).
Conclusions
Despite promising results in India, participatory women’s groups focused on women’s and children’s health had no significant effect on postpartum psychological distress in rural Bangladesh.
doi:10.1371/journal.pone.0110697
PMCID: PMC4199763  PMID: 25329470
14.  Is essential newborn care provided by institutions and after home births? Analysis of prospective data from community trials in rural South Asia 
Background
Provision of essential newborn care (ENC) can save many newborn lives in poor resource settings but coverage is far from universal and varies by country and place of delivery. Understanding gaps in current coverage and where coverage is good, in different contexts and places of delivery, could make a valuable contribution to the future design of interventions to reduce neonatal mortality. We sought to describe the coverage of essential newborn care practices for births in institutions, at home with a skilled birth attendant, and at home without a skilled birth attendant (SBA) in rural areas of Bangladesh, Nepal, and India.
Methods
We used data from the control arms of four cluster randomised controlled trials in Bangladesh, Eastern India and from Makwanpur and Dhanusha districts in Nepal, covering periods from 2001 to 2011. We used these data to identify essential newborn care practices as defined by the World Health Organization. Each birth was allocated to one of three delivery types: home birth without an SBA, home birth with an SBA, or institutional delivery. For each study, we calculated the observed proportion of births that received each care practice by delivery type with 95% confidence intervals, adjusted for clustering and, where appropriate, stratification.
Results
After exclusions, we analysed data for 8939 births from Eastern India, 27 553 births from Bangladesh, 6765 births from Makwanpur and 15 344 births from Dhanusha. Across all study areas, coverage of essential newborn care practices was highest in institutional deliveries, and lowest in home non-SBA deliveries. However, institutional deliveries did not provide universal coverage of the recommended practices, with relatively low coverage (20%-70%) across all study areas for immediate breastfeeding and thermal care. Institutions in Bangladesh had the highest coverage for almost all care practices except thermal care. Across all areas, fewer than 20% of home non-SBA deliveries used a clean delivery kit, the use of plastic gloves was very low and coverage of recommended thermal care was relatively poor. There were large differences between study areas in handwashing, immediate breastfeeding and delayed bathing.
Conclusions
There remains substantial scope for health facilities to improve thermal care for the newborn and to encourage immediate and exclusive breastfeeding. For unattended home deliveries, increased handwashing, use of clean delivery kits and basic thermal care offer great scope for improvement.
doi:10.1186/1471-2393-14-99
PMCID: PMC4016384  PMID: 24606612
15.  Understanding psychological distress among mothers in rural Nepal: a qualitative grounded theory exploration 
BMC Psychiatry  2014;14:60.
Background
There is a large burden of psychological distress in low and middle-income countries, and culturally relevant interventions must be developed to address it. This requires an understanding of how distress is experienced. We conducted a qualitative grounded theory study to understand how mothers experience and manage distress in Dhanusha, a low-resource setting in rural Nepal. We also explored how distressed mothers interact with their families and the wider community.
Methods
Participants were identified during a cluster-randomised controlled trial in which mothers were screened for psychological distress using the 12-item General Health Questionnaire (GHQ-12). We conducted 22 semi-structured interviews with distressed mothers (GHQ-12 score ≥5) and one with a traditional healer (dhami), as well as 12 focus group discussions with community members. Data were analysed using grounded theory methods and a model was developed to explain psychological distress in this setting.
Results
We found that distress was termed tension by participants and mainly described in terms of physical symptoms. Key perceived causes of distress were poor health, lack of sons, and fertility problems. Tension developed in a context of limited autonomy for women and perceived duty towards the family. Distressed mothers discussed several strategies to alleviate tension, including seeking treatment for perceived physical health problems and tension from doctors or dhamis, having repeated pregnancies until a son was delivered, manipulating social circumstances in the household, and deciding to accept their fate. Their ability to implement these strategies depended on whether they were able to negotiate with their in-laws or husbands for resources.
Conclusions
Vulnerability, as a consequence of gender and social disadvantage, manifests as psychological distress among mothers in Dhanusha. Screening tools incorporating physical symptoms of tension should be envisaged, along with interventions to address gender inequity, support marital relationships, and improve access to perinatal healthcare.
doi:10.1186/1471-244X-14-60
PMCID: PMC3943437  PMID: 24581309
Nepal; South Asia; Psychological distress; Postnatal depression; Perinatal common mental disorders; Maternal mental health; Rural health
16.  Predictors of psychological distress among postnatal mothers in rural Nepal: A cross-sectional community-based study☆ 
Journal of Affective Disorders  2014;156(100):76-86.
Background
Perinatal common mental disorders are a major cause of disability among women and have consequences for children's growth and development. We aimed to identify factors associated with psychological distress, a proxy for common mental disorders, among mothers in rural Dhanusha, Nepal.
Methods
We used data from 9078 mothers who were screened for distress using the 12-item General Health Questionnaire (GHQ-12) around six weeks after delivery. We assessed the association between GHQ-12 score and socioeconomic, gender-based, cultural and reproductive health factors using a hierarchical analytical framework and multilevel linear regression models.
Results
Using a threshold GHQ-12 score of ≥6 to indicate caseness, the prevalence of distress was 9.8% (886/9078). Factors that predicted distress were severe food insecurity (β 2.21 (95% confidence interval 1.43, 3.40)), having a multiple birth (2.28 (1.27, 4.10)), caesarean section (1.70 (0.29, 2.24)), perinatal health problems (1.58 (1.23, 2.02)), no schooling (1.37 (1.08, 1.73)), fewer assets (1.33 (1.10, 1.60)), five or more children (1.33 (1.09, 1.61)), poor or no antenatal care (1.31 (1.15, 1.48) p<0.001), having never had a son (1.31 (1.14, 1.49)), not staying in the parental home in the postnatal period (1.15 (1.02, 1.30)), having a husband with no schooling (1.17 (0.96, 1.43)) and lower maternal age (0.99 (0.97, 1.00)).
Limitations
The study was cross-sectional and we were therefore unable to infer causality. Because data were not collected for some established predictors, including infant death, domestic violence and history of mental illness, we could not assess their associations with distress.
Conclusions
Socioeconomic disadvantage, gender inequality and poor reproductive health predict distress among mothers in Dhanusha. Maternal and child health programmes, as well as poverty-alleviation and educational interventions, may be beneficial for maternal mental health.
doi:10.1016/j.jad.2013.11.018
PMCID: PMC3969296  PMID: 24370265
Postnatal psychological distress; Postnatal depression; Common mental disorder; Nepal; Maternal mental health; Rural health
17.  Maternal infection and risk of intrapartum death: a population based observational study in South Asia 
Background
Approximately 1.2 million stillbirths occur in the intrapartum period, and a further 717,000 annual neonatal deaths are caused by intrapartum events, most of which occur in resource poor settings. We aim to test the ‘double-hit’ hypothesis that maternal infection in the perinatal period predisposes to neurodevelopmental sequelae from an intrapartum asphyxia insult, increasing the likelihood of an early neonatal death compared with asphyxia alone. This is an observational study of singleton newborn infants with signs of intrapartum asphyxia that uses data from three previously conducted cluster randomized controlled trials taking place in rural Bangladesh and India.
Methods
From a population of 81,778 births in 54 community clusters in rural Bangladesh and India, we applied mixed effects logistic regression to data on 3890 singleton infants who had signs of intrapartum asphyxia, of whom 769 (20%) died in the early neonatal period. Poor infant condition at five minutes post-delivery was our proxy measure of intrapartum asphyxia. We had data for two markers of maternal infection: fever up to three days prior to labour, and prolonged rupture of membranes (PROM). Cause-specific verbal autopsy data were used to validate our findings using previously mentioned mixed effect logistic regression methods and the outcome of a neonatal death due to intrapartum asphyxia.
Results
Signs of maternal infection as indicated by PROM, combined with intrapartum asphyxia, increased the risk of an early neonatal death relative to intrapartum asphyxia alone (adjusted odds ratio (AOR) 1.28, 95% CI 1.03 – 1.59). Results from cause-specific verbal autopsy data verified our findings where there was a significantly increased odds of a early neonatal death due to intrapartum asphyxia in newborns exposed to both PROM and intrapartum asphyxia (AOR: 1.52, 95% CI 1.15 – 2.02).
Conclusions
Our data support the double-hit hypothesis for signs of maternal infection as indicated by PROM. Interventions for pregnant women with signs of infection, to prevent early neonatal deaths and disability due to asphyxia, should be investigated further in resource-poor populations where the chances of maternal infection are high.
doi:10.1186/1471-2393-13-245
PMCID: PMC3897987  PMID: 24373126
Maternal infection; Double hit hypothesis; Intrapartum-related neonatal death; Prolonged rupture of membranes; Neonatal mortality; Low-income countries; Resource-poor
18.  Psychosocial Interventions for Perinatal Common Mental Disorders Delivered by Providers Who Are Not Mental Health Specialists in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis 
PLoS Medicine  2013;10(10):e1001541.
In a systematic review and meta-analysis, Kelly Clarke and colleagues examine the effect of psychosocial interventions delivered by non–mental health specialists for perinatal common mental disorders in low- and middle-income countries.
Please see later in the article for the Editors' Summary
Background
Perinatal common mental disorders (PCMDs) are a major cause of disability among women. Psychosocial interventions are one approach to reduce the burden of PCMDs. Working with care providers who are not mental health specialists, in the community or in antenatal health care facilities, can expand access to these interventions in low-resource settings. We assessed effects of such interventions compared to usual perinatal care, as well as effects of interventions based on intervention type, delivery method, and timing.
Methods and Findings
We conducted a systematic review, meta-analysis, and meta-regression. We searched databases including Embase and the Global Health Library (up to 7 July 2013) for randomized and non-randomized trials of psychosocial interventions delivered by non-specialist mental health care providers in community settings and antenatal health care facilities in low- and middle-income countries. We pooled outcomes from ten trials for 18,738 participants. Interventions led to an overall reduction in PCMDs compared to usual care when using continuous data for PCMD symptomatology (effect size [ES] −0.34; 95% CI −0.53, −0.16) and binary categorizations for presence or absence of PCMDs (odds ratio 0.59; 95% CI 0.26, 0.92). We found a significantly larger ES for psychological interventions (three studies; ES −0.46; 95% CI −0.58, −0.33) than for health promotion interventions (seven studies; ES −0.15; 95% CI −0.27, −0.02). Both individual (five studies; ES −0.18; 95% CI −0.34, −0.01) and group (three studies; ES −0.48; 95% CI −0.85, −0.11) interventions were effective compared to usual care, though delivery method was not associated with ES (meta-regression β coefficient −0.11; 95% CI −0.36, 0.14). Combined group and individual interventions (based on two studies) had no benefit compared to usual care, nor did interventions restricted to pregnancy (three studies). Intervention timing was not associated with ES (β 0.16; 95% CI −0.16, 0.49). The small number of trials and heterogeneity of interventions limit our findings.
Conclusions
Psychosocial interventions delivered by non-specialists are beneficial for PCMDs, especially psychological interventions. Research is needed on interventions in low-income countries, treatment versus preventive approaches, and cost-effectiveness.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Perinatal common mental health disorders are among the most common health problems in pregnancy and the postpartum period. In low- and middle-income countries, about 16% of women during pregnancy and about 20% of women in the postpartum period will suffer from a perinatal common mental health disorder. These disorders, including depression and anxiety, are a major cause of disability in women and have been linked to young children under their care being underweight and stunted.
Why Was This Study Done?
While research shows that both pharmacological (e.g., antidepressants or anti-anxiety medications) and non-pharmacological (e.g., psychotherapy, education, or health promotion) interventions are effective for preventing and treating perinatal common mental disorders, most of this research took place in high-income countries. These findings may not be applicable in low-resource settings, where there is limited access to mental health care providers such as psychiatrists and psychologists, and to medications. Thus, non-pharmacological interventions delivered by providers who are not mental health specialists may be important as ways to treat perinatal common mental health disorders in these types of settings. In this study the researchers systematically reviewed research estimating the effectiveness of non-pharmacological interventions for perinatal common mental disorders that were delivered by providers who were not mental health specialists (including health workers, lay persons, and doctors or midwives) in low- and middle-income countries. The researchers also used meta-analysis and meta-regression—statistical methods that are used to combine the results from multiple studies—to estimate the relative effects of these interventions on mental health symptoms.
What Did the Researchers Do and Find?
The researchers searched multiple databases using key search terms to identify randomized and non-randomized clinical trials. Using specific criteria, the researchers retrieved and assessed 37 full papers, of which 11 met the criteria for their systematic review. Seven of these studies were from upper middle-income countries (China, South Africa, Columbia, Mexico, Argentina, Cuba, and Brazil), and four trials were from the lower middle-income countries of Pakistan and India, but there were no trials from low-income countries. The researchers assessed the quality of the selected studies, and one study was excluded from meta-analysis because of poor quality.
Combining results from the ten remaining studies, the researchers found that compared to usual perinatal care (which in most cases included no mental health care), interventions delivered by a providers who were not mental health specialists were associated with an overall reduction in mental health symptoms and the likelihood of being diagnosed with a mental health disorder. The researchers then performed additional analyses to assess relative effects by intervention type, timing, and delivery mode. They observed that both psychological interventions, such as psychotherapy and cognitive behavioral therapy, and health promotion interventions that were less focused on mental health led to significant improvement in mental health symptoms, but psychological interventions were associated with greater effects than health promotion interventions. Interventions delivered both during pregnancy and postnatally were associated with significant benefits when compared to usual care; however, when interventions were delivered during pregnancy only, the benefits were not significantly greater than usual care. When investigating mode of delivery, the researchers observed that both group and individual interventions were associated with improvements in symptoms.
What Do These Findings Mean?
These findings indicate that non-pharmacological interventions delivered by providers who are not mental health specialists could be useful for reducing symptoms of perinatal mental health disorders in middle-income countries. However, these findings should be interpreted with caution given that they are based on a small number of studies with a large amount of variation in the study designs, settings, timing, personnel, duration, and whether the intervention was delivered to a group, individually, or both. Furthermore, when the researchers excluded studies of the lowest quality, the observed benefits of these interventions were smaller, indicating that this analysis may overestimate the true effect of interventions. Nevertheless, the findings do provide support for the use of non-pharmacological interventions, delivered by non-specialists, for perinatal mental health disorders. Further studies should be undertaken in low-income countries.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001541
The World Health Organization provides information about perinatal mental health disorders
The UK Royal College of Psychiatrists has information for professionals and patients about perinatal mental health disorders
doi:10.1371/journal.pmed.1001541
PMCID: PMC3812075  PMID: 24204215
19.  Women’s groups practising participatory learning and action to improve maternal and newborn health in low-resource settings: a systematic review and meta-analysis 
Lancet  2013;381(9879):1736-1746.
Summary
Background
Maternal and neonatal mortality rates remain high in many low-income and middle-income countries. Different approaches for the improvement of birth outcomes have been used in community-based interventions, with heterogeneous effects on survival. We assessed the effects of women’s groups practising participatory learning and action, compared with usual care, on birth outcomes in low-resource settings.
Methods
We did a systematic review and meta-analysis of randomised controlled trials undertaken in Bangladesh, India, Malawi, and Nepal in which the effects of women’s groups practising participatory learning and action were assessed to identify population-level predictors of effect on maternal mortality, neonatal mortality, and stillbirths. We also reviewed the cost-effectiveness of the women’s group intervention and estimated its potential effect at scale in Countdown countries.
Findings
Seven trials (119 428 births) met the inclusion criteria. Meta-analyses of all trials showed that exposure to women’s groups was associated with a 37% reduction in maternal mortality (odds ratio 0·63, 95% CI 0·32–0·94), a 23% reduction in neonatal mortality (0·77, 0·65–0·90), and a 9% non-significant reduction in stillbirths (0·91, 0·79–1·03), with high heterogeneity for maternal (I2=58·8%, p=0·024) and neonatal results (I2=64·7%, p=0·009). In the meta-regression analyses, the proportion of pregnant women in groups was linearly associated with reduction in both maternal and neonatal mortality (p=0·026 and p=0·011, respectively). A subgroup analysis of the four studies in which at least 30% of pregnant women participated in groups showed a 55% reduction in maternal mortality (0·45, 0·17–0·73) and a 33% reduction in neonatal mortality (0·67, 0·59–0·74). The intervention was cost effective by WHO standards and could save an estimated 283 000 newborn infants and 41 100 mothers per year if implemented in rural areas of 74 Countdown countries.
Interpretation
With the participation of at least a third of pregnant women and adequate population coverage, women’s groups practising participatory learning and action are a cost-effective strategy to improve maternal and neonatal survival in low-resource settings.
Funding
Wellcome Trust, Ammalife, and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care for Birmingham and the Black Country programme.
doi:10.1016/S0140-6736(13)60685-6
PMCID: PMC3797417  PMID: 23683640
20.  Identifying priorities to improve maternal and child nutrition among the Khmu ethnic group, Laos: a formative study 
Maternal & child nutrition  2012;9(4):452-466.
Chronic malnutrition in children remains highly prevalent in Laos, particularly among ethnic minority groups. There is limited knowledge of specific nutrition practices among these groups. We explored nutritional status, cultural beliefs and practices of Laos’ Khmu ethnic group to inform interventions for undernutrition as part of a Primary Health Care (PHC) project. Mixed methods were used. For background, we disaggregated anthropometric and behavioural indicators from Laos’ Multiple Indicator Cluster Survey. We then conducted eight focus group discussions and 33 semi-structured interviews with Khmu villagers and health care workers, exploring beliefs and practices related to nutrition.The setting was two rural districts in Luang Prabang province, in one of which the PHC project had been established for 3 years. There was a higher prevalence of stunting in the Khmu than in other groups. Disaggregation showed nutrition behaviours were associated with ethnicity, including exclusive breastfeeding. Villagers described strong adherence to post-partum food restrictions for women, while little change was described in intake during pregnancy. Most children were breastfed, although early introduction of pre-lacteal foods was noted in the non-PHC district. There was widespread variation in introduction and diversity of complementary foods. Guidance came predominantly from the community, with some input from health care workers. Interventions to address undernutrition in Khmu communities should deliver clear, consistent messages on optimum nutrition behaviours. Emphasis should be placed on dietary diversity for pregnant and post-partum mothers, encouraging exclusive breastfeeding and timely, appropriate complementary feeding. The impact of wider governmental policies on food security needs to be further assessed.
doi:10.1111/j.1740-8709.2012.00406.x
PMCID: PMC3496764  PMID: 22515273
beliefs; child feeding; community based; education; Laos; Khmu; maternal nutrition
21.  Taking ethical photos of children for medical and research purposes in low-resource settings: an exploratory qualitative study 
BMC Medical Ethics  2013;14:27.
Background
Photographs are commonly taken of children in medical and research contexts. With the increased availability of photographs through the internet, it is increasingly important to consider their potential for negative consequences and the nature of any consent obtained. In this research we explore the issues around photography in low-resource settings, in particular concentrating on the challenges in gaining informed consent.
Methods
Exploratory qualitative study using focus group discussions involving medical doctors and researchers who are currently working or have recently worked in low-resource settings with children.
Results
Photographs are a valuable resource but photographers need to be mindful of how they are taken and used. Informed consent is needed when taking photographs but there were a number of problems in doing this, such as different concepts of consent, language and literacy barriers and the ability to understand the information. There was no consensus as to the form that the consent should take. Participants thought that while written consent was preferable, the mode of consent should depend on the situation.
Conclusions
Photographs are a valuable but potentially harmful resource, thus informed consent is required but its form may vary by context. We suggest applying a hierarchy of dissemination to gauge how detailed the informed consent should be. Care should be taken not to cause harm, with the rights of the child being the paramount consideration.
doi:10.1186/1472-6939-14-27
PMCID: PMC3750443  PMID: 23835013
Photography; Ethics; Informed consent; Teleconference
22.  The equity impact of participatory women’s groups to reduce neonatal mortality in India: secondary analysis of a cluster-randomised trial 
Progress towards the Millennium Development Goals (MDGs) has been uneven. Inequalities in child health are large and effective interventions rarely reach the most in need. Little is known about how to reduce these inequalities. We describe and explain the equity impact of a women’s group intervention in India that strongly reduced the neonatal mortality rate (NMR) in a cluster-randomised trial. We conducted secondary analyses of the trial data, obtained through prospective surveillance of a population of 228 186. The intervention effects were estimated separately, through random effects logistic regression, for the most and less socio-economically marginalised groups. Among the most marginalised, the NMR was 59% lower in intervention than in control clusters in years 2 and 3 (70%, year 3); among the less marginalised, the NMR was 36% lower (35%, year 3). The intervention effect was stronger among the most than among the less marginalised (P-value for difference = 0.028, years 2-3; P-value for difference = 0.009, year 3). The stronger effect was concentrated in winter, particularly for early NMR. There was no effect on the use of health-care services in either group, and improvements in home care were comparable. Participatory community interventions can substantially reduce socio-economic inequalities in neonatal mortality and contribute to an equitable achievement of the unfinished MDG agenda.
doi:10.1093/ije/dyt012
PMCID: PMC3619953  PMID: 23509239
23.  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
24.  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
25.  Predictors of maternal psychological distress in rural India: A cross-sectional community-based study 
Journal of Affective Disorders  2012;138(3):277-286.
Background
Maternal common mental disorders are prevalent in low-resource settings and have far-reaching consequences for maternal and child health. We assessed the prevalence and predictors of psychological distress as a proxy for common mental disorders among mothers in rural Jharkhand and Orissa, eastern India, where over 40% of the population live below the poverty line and access to reproductive and mental health services is low.
Method
We screened 5801 mothers around 6 weeks after delivery using the Kessler-10 item scale, and identified predictors of distress using multiple hierarchical logistic regression.
Results
11.5% (95% CI: 10.7–12.3) of mothers had symptoms of distress (K10 score > 15). High maternal age, low asset ownership, health problems in the antepartum, delivery or postpartum periods, caesarean section, an unwanted pregnancy for the mother, small perceived infant size and a stillbirth or neonatal death were all independently associated with an increased risk of distress. The loss of an infant or an unwanted pregnancy increased the risk of distress considerably (AORs: 7.06 95% CI: 5.51–9.04 and 1.49, 95% CI: 1.12–1.97, respectively).
Limitations
We did not collect data on antepartum depression, domestic violence or a mother's past birth history, and were therefore unable to examine the importance of these factors as predictors of psychological distress.
Conclusions
Mothers living in underserved areas of India who experience infant loss, an unwanted pregnancy, health problems in the perinatal and postpartum periods and socio-economic disadvantage are at increased risk of distress and require access to reproductive healthcare with integrated mental health interventions.
doi:10.1016/j.jad.2012.01.029
PMCID: PMC3343258  PMID: 22342117
Common mental disorder; Maternal depression; India; Rural health

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