Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2).

BACKGROUND: Neonatal mortality in India has fallen steadily and was estimated to be 24 per 1000 live births in the year 2017. However, neonatal mortality remains high in rural parts of the country. The Community Health Promotion and Medical Provision and Impact On Neonates (CHAMPION2) trial investigates the effect of a complex health intervention on neonatal mortality in the Satna District of Madhya Pradesh. METHODS/DESIGN: The CHAMPION2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is neonatal mortality. The effect of the active intervention on the primary outcome (compared to usual care) will be expressed as a risk ratio, estimated using a generalised estimating equation approach with robust standard errors that take account of clustering at village level. Secondary outcomes include maternal mortality, stillbirths, perinatal deaths, causes of death, health care and knowledge, hospital admissions of enrolled women during pregnancy or in the immediate post-natal care period or of their babies (during the neonatal period), maternal blood transfusions, and the cost effectiveness of the intervention. A total of 196 villages have been randomised and over 34,000 women have been recruited in CHAMPION2. DISCUSSION: This update to the published trial protocol gives a detailed plan for the statistical analysis of the CHAMPION2 trial. TRIAL REGISTRATION: Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2

Temporal trends (1977-2007) and ethnic inequity in child mortality in rural villages of southern Guinea Bissau

Background Guinea Bissau is one of the poorest countries in the world, with one of the highest under-5 mortality rate. Despite its importance for policy planning, data on child mortality are often not available or of poor quality in low-income countries like Guinea Bissau. Our aim in this study was to use the baseline survey to estimate child mortality in rural villages in southern Guinea Bissau for a 30 years period prior to a planned cluster randomised intervention. We aimed to investigate temporal trends with emphasis on historical events and the effect of ethnicity, polygyny and distance to the health centre on child mortality. Methods A baseline survey was conducted prior to a planned cluster randomised intervention to estimate child mortality in 241 rural villages in southern Guinea Bissau between 1977 and 2007. Crude child mortality rates were estimated by Kaplan-Meier method from birth history of 7854 women. Cox regression models were used to investigate the effects of birth periods with emphasis on historical events, ethnicity, polygyny and distance to the health centre on child mortality. Results High levels of child mortality were found at all ages under five with a significant reduction in child mortality over the time periods of birth except for 1997-2001. That period comprises the 1998/99 civil war interval, when child mortality was 1.5% higher than in the previous period. Children of Balanta ethnic group had higher hazard of dying under five years of age than children from other groups until 2001. Between 2002 and 2007, Fula children showed the highest mortality. Increasing walking distance to the nearest health centre increased the hazard, though not substantially, and polygyny had a negligible and statistically not significant effect on the hazard. Conclusion Child mortality is strongly associated with ethnicity and it should be considered in health policy planning. Child mortality, though considerably decreased during the past 30 years, remains high in rural Guinea Bissau. Temporal trends also suggest that civil wars have detrimental effects on child mortality. Trial Registration Current Controlled Trials ISRCTN5243333

Intergenerational Wealth Transmission and the Dynamics of Inequality in Small-Scale Societies

Small-scale human societies range from foraging bands with a strong egalitarian ethos to more economically stratified agrarian and pastoral societies. We explain this variation in inequality using a dynamic model in which a population’s long-run steady-state level of inequality depends on the extent to which its most important forms of wealth are transmitted within families across generations. We estimate the degree of intergenerational transmission of three different types of wealth (material, embodied, and relational), as well as the extent of wealth inequality in 21 historical and contemporary populations. We show that intergenerational transmission of wealth and wealth inequality are substantial among pastoral and small-scale agricultural societies (on a par with or even exceeding the most unequal modern industrial economies) but are limited among horticultural and foraging peoples (equivalent to the most egalitarian of modern industrial populations). Differences in the technology by which a people derive their livelihood and in the institutions and norms making up the economic system jointly contribute to this pattern

The surprisingly dire situation of children's education in rural west Africa: results from the CREO study in Guinea-Bissau

We conducted a survey covering 20% of villages with 200-1000 population in rural Guinea-Bissau. We interviewed household heads, care-givers of children, and their teachers and schools. We analysed results from 9,947 children, aged 7-17, tested for literacy and numeracy competency. Only 27% of children were able to add two single digits, and just 19% were able to read and comprehend a simple word. Our unannounced school checks found 72% of enrolled children in grades 1-4 attending their schools, but the schools were poorly equipped. Teachers were present at 86% of schools visited. Despite surveying 351 schools, we found no examples of successful schools where children reached reasonable levels of literacy and numeracy for age. Our evidence suggests that interventions that raise school quality in these villages, rather than those which target enrolment, may be most important to generate very sharp improvements in children’s educational outcomes

Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2)

Abstract Background India has made steady progress in improving rates of primary school enrolment but levels of learning achievement remain low. The Support To Rural India’s Public Education System (STRIPES) trial provided evidence that an after-school para-teacher intervention improved numeracy and literacy levels in Telangana, India. The STRIPES2 trial investigates whether such an intervention will have a similar effect on the literacy and numeracy of primary school age children in the Satna District of Madhya Pradesh, India. Methods/design The STRIPES2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is a combined literacy and numeracy score. Secondary outcomes include separate scores for literacy and numeracy; caregivers’ engagement with child’s learning; expenditure on education; enrolment in school; caregiver’s report of school attendance and the cost effectiveness of the intervention. Over 7000 primary school age children have been recruited and randomised in STRIPES2. Discussion This update to the published trial protocol gives a detailed plan for the statistical analysis of the STRIPES 2 trial. Trial registration Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%2

Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).

BACKGROUND: India has made steady progress in improving rates of primary school enrolment but levels of learning achievement remain low. The Support To Rural India's Public Education System (STRIPES) trial provided evidence that an after-school para-teacher intervention improved numeracy and literacy levels in Telangana, India. The STRIPES2 trial investigates whether such an intervention will have a similar effect on the literacy and numeracy of primary school age children in the Satna District of Madhya Pradesh, India. METHODS/DESIGN: The STRIPES2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is a combined literacy and numeracy score. Secondary outcomes include separate scores for literacy and numeracy; caregivers' engagement with child's learning; expenditure on education; enrolment in school; caregiver's report of school attendance and the cost effectiveness of the intervention. Over 7000 primary school age children have been recruited and randomised in STRIPES2. DISCUSSION: This update to the published trial protocol gives a detailed plan for the statistical analysis of the STRIPES 2 trial. TRIAL REGISTRATION: Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27

Effects of community health interventions on under-5 mortality in rural Guinea-Bissau (EPICS): a cluster-randomised controlled trial

Background: Evidence suggests that community-based interventions that promote improved home-based practices and care-seeking behaviour can have a large impact on maternal and child mortality in regions where rates are high. We aimed to assess whether an intervention package based on the WHO Integrated Management of Childhood Illness handbook and community mobilisation could reduce under-5 mortality in rural Guinea-Bissau, where the health service infrastructure is weak. Methods: We did a non-masked cluster-randomised controlled trial (EPICS) in the districts of Tombali and Quinara in Guinea-Bissau. Clusters of rural villages were stratified by ethnicity and distance from a regional health centre, and randomly assigned (1:1) to intervention or control using a computerised random number generator. Women were eligible if they lived in one of the clusters at baseline survey prior to randomisation and if they were aged 15–49 years or were primary caregivers of children younger than 5 years. Their children were eligible if they were younger than 5 years or were liveborn after intervention services could be implemented on July 1, 2008. In villages receiving the intervention, community health clubs were established, community health workers were trained in case management, and traditional birth attendants were trained to care for pregnant women and newborn babies, and promote facility-based delivery. Registered nurses supervised community health workers and offered mobile clinic services. Health centres were not improved. The control group received usual services. The primary outcome was the proportion of children dying under age 5 years, and was analysed in all eligible children up to final visits to villages between Jan 1 and March 31, 2011. This trial is registered with ISRCTN, number ISRCTN52433336. Findings: On Aug 30, 2007, we randomly assigned 146 clusters to intervention (73 clusters, 5669 women, and 4573 children) or control (73 clusters, 5840 women, and 4675 children). From randomisation until the end of the trial (last visit by June 30, 2011), the intervention clusters had 3093 livebirths and the control clusters had 3194. 6729 children in the intervention group and 6894 in the control group aged 0–5 years on July 1, 2008, or liveborn subsequently were analysed for mortality outcomes. 311 (4·6%) of 6729 children younger than 5 years died in the intervention group compared with 273 (4·0%) of 6894 in the control group (relative risk 1·16 [95% CI 0·99–1·37]). Interpretation: Our package of community-based interventions did not reduce under-5 mortality in rural Guinea-Bissau. The short timeframe and other trial limitations might have affected our results. Community-based health promotion and basic first-line services in fragile contexts with weak secondary health service infrastructure might be insufficient to reduce child deaths. Funding: Effective Intervention

The EPICS trial: enabling parents to increase child survival through the introduction of community-based health interventions in rural Guinea Bissau

Background Guinea-Bissau is a small country in West Africa with a population of 1.7 million. The WHO and UNICEF reported an under-five child mortality of 203 per 1000, the 10th highest amongst 192 countries. The aim of the trial is to assess whether an intervention package that includes community health promotion campaign and education through health clubs, intensive training and mentoring of village health workers to diagnose and provide first-line treatment for children's diseases within the community, and improved outreach services can generate a rapid and cost-effective reduction in under-five child mortality in rural regions of Guinea-Bissau. Effective Intervention plans to expand the project to a much larger region if there is good evidence after two and a half years that the project is generating a cost-effective, sustainable reduction in child mortality. Methods/design This trial is a cluster-randomised controlled trial involving 146 clusters. The trial will run for 2.5 years. The interventions will be introduced in two stages: seventy-three clusters will receive the interventions at the start of the project, and seventy-three control clusters will receive the interventions 2.5 years after the first clusters have received all interventions if the research shows that the interventions are effective. The impact of the interventions and cost-effectiveness will be measured during the first stage. The package of interventions includes a community health promotion campaign and education through health clubs, and intensive training and mentoring of village health workers to diagnose and provide first-line treatment for common children's diseases within the community. It also includes improved outreach services to encourage provision of antenatal and post natal care and provide ongoing monitoring for village health workers. The primary outcome of the trial will be the proportion of children that die under 5 years of age during the trial. Secondary outcomes will include age at and cause of child deaths, neonatal mortality, infant mortality, maternal mortality, health knowledge, health seeking behaviour, morbidity and costs. Discussion The trial will be run by research and service delivery teams that act independently, overseen by a trial steering committee. A data monitoring committee will be appointed to monitor the outcome and any adverse effects