Publications by authors named "Simon Cousens"

214 Publications

Investigating the effect of relationship satisfaction on postpartum women's health-related quality of life in Burkina Faso: a cross-sectional analysis.

BMJ Open 2021 09 2;11(9):e048230. Epub 2021 Sep 2.

Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.

Introduction: The period following childbirth poses physiological, physical, social and psychological challenges to women that may affect their quality of life. Few studies in Africa have explored women's health-related quality of life (HrQoL) and its determinants in postpartum populations, including the quality of women's relationships with their male partners. We investigated whether relationship satisfaction was associated with better HrQoL among postpartum women in Burkina Faso, 8 months after childbirth.

Methods: We analysed data from 547 women from the control arm of a randomised controlled trial in Burkina Faso. The study outcome was a woman's HrQoL, assessed using the cross-culturally validated WHOQOL-BREF tool, with response categories adapted for Burkina Faso. The exposure was relationship satisfaction measured using questions adapted from the Dyadic Adjustment Scale and Marital Assessment Test tools. We calculated the median HrQOL scores for the study sample, overall and for each domain of HrQOL (physical, psychological, social and environmental). The association between relationship satisfaction and HrQoL was examined using multiple linear regression models with robust SEs.

Results: Postpartum women had high median HrQoL scores in the physical (88.1), psychological (93.1), social (86.1) and environmental (74.0) domains and overall HrQoL (84.0). We found that higher relationship satisfaction is associated with increased HrQoL. After adjusting for potential confounders, we found that for each point increase in relationship satisfaction score, the increase in HrQoL was 0.39 (p<0.001) for the overall HrQoL; 0.32 (p=0.013) for the physical domain; 0.25 (p=0.037) for the psychological domain; 0.46 (p<0.001) for the social domain and 0.49 (p<0.001) for the environmental domain.

Conclusion: Higher relationship satisfaction is associated with higher HrQoL scores. Policies should aim to support women to cope with the challenges of childbirth and childcare in the postpartum period to improve postpartum women's HrQoL.
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http://dx.doi.org/10.1136/bmjopen-2020-048230DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8413953PMC
September 2021

Dietary diversity and social determinants of nutrition among late adolescent girls in rural Pakistan.

Matern Child Nutr 2021 Aug 31:e13265. Epub 2021 Aug 31.

Centre for Global Child Health, Hospital for Sick Children, Toronto, Ontario, Canada.

The conditions in which adolescent girls mature shape their health, development and nutrition. Nutrient requirements increase to support growth during adolescence, but gaps between consumption and requirements exist in low- and middle-income countries. We aimed to identify and quantify the relationship between dietary intake and diverse social determinants of nutrition (SDN) among a subset of adolescent girls 15-18.9 years (n = 390) enrolled within the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial. The primary outcome, dietary diversity score (DDS), was derived by applying the Minimum Dietary Diversity for Women 10-item scale to 24-h dietary recall data collected three times per participant. To examine the associations between the SDN-related explanatory variables and DDS, we generated a hierarchical, causal model using mixed effects linear regression to account for the cluster-randomized trial design. Using all data, diets lacked diversity (DDS mean ± SD: 3.35 ± 1.03 [range: 1-7; n = 1170]), and the minimum cut-off for dietary diversity was infrequently achieved (13.5%; 95% CI: 11.6-15.6%). Consumption of starches was reported in all recalls, but micronutrient-rich food consumption was less common. Of the SDN considered, wealth quintile had the strongest association with DDS (P < 0.0001). The diets of the sampled Pakistani adolescent girls were insufficient to meet micronutrient requirements. Poverty was the most important predictor of a diet lacking in diversity, indicating limited purchasing power or access to nutritious foods. Dietary diversification and nutrition education strategies alone are unlikely to lead to improved diets without steps to tackle this barrier, for example, through fortification of staple foods and provision of supplements.
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http://dx.doi.org/10.1111/mcn.13265DOI Listing
August 2021

Global, regional, and national estimates and trends in stillbirths from 2000 to 2019: a systematic assessment.

Lancet 2021 08;398(10302):772-785

Department of Biostatistics and Epidemiology, University of Massachusetts Amherst, Amherst, MA, USA.

Background: Stillbirths are a major public health issue and a sensitive marker of the quality of care around pregnancy and birth. The UN Global Strategy for Women's, Children's and Adolescents' Health (2016-30) and the Every Newborn Action Plan (led by UNICEF and WHO) call for an end to preventable stillbirths. A first step to prevent stillbirths is obtaining standardised measurement of stillbirth rates across countries. We estimated stillbirth rates and their trends for 195 countries from 2000 to 2019 and assessed progress over time.

Methods: For a systematic assessment, we created a dataset of 2833 country-year datapoints from 171 countries relevant to stillbirth rates, including data from registration and health information systems, household-based surveys, and population-based studies. After data quality assessment and exclusions, we used 1531 datapoints to estimate country-specific stillbirth rates for 195 countries from 2000 to 2019 using a Bayesian hierarchical temporal sparse regression model, according to a definition of stillbirth of at least 28 weeks' gestational age. Our model combined covariates with a temporal smoothing process such that estimates were informed by data for country-periods with high quality data, while being based on covariates for country-periods with little or no data on stillbirth rates. Bias and additional uncertainty associated with observations based on alternative stillbirth definitions and source types, and observations that were subject to non-sampling errors, were included in the model. We compared the estimated stillbirth rates and trends to previously reported mortality estimates in children younger than 5 years.

Findings: Globally in 2019, an estimated 2·0 million babies (90% uncertainty interval [UI] 1·9-2·2) were stillborn at 28 weeks or more of gestation, with a global stillbirth rate of 13·9 stillbirths (90% UI 13·5-15·4) per 1000 total births. Stillbirth rates in 2019 varied widely across regions, from 22·8 stillbirths (19·8-27·7) per 1000 total births in west and central Africa to 2·9 (2·7-3·0) in western Europe. After west and central Africa, eastern and southern Africa and south Asia had the second and third highest stillbirth rates in 2019. The global annual rate of reduction in stillbirth rate was estimated at 2·3% (90% UI 1·7-2·7) from 2000 to 2019, which was lower than the 2·9% (2·5-3·2) annual rate of reduction in neonatal mortality rate (for neonates aged <28 days) and the 4·3% (3·8-4·7) annual rate of reduction in mortality rate among children aged 1-59 months during the same period. Based on the lower bound of the 90% UIs, 114 countries had an estimated decrease in stillbirth rate since 2000, with four countries having a decrease of at least 50·0%, 28 having a decrease of 25·0-49·9%, 50 having a decrease of 10·0-24·9%, and 32 having a decrease of less than 10·0%. For the remaining 81 countries, we found no decrease in stillbirth rate since 2000. Of these countries, 34 were in sub-Saharan Africa, 16 were in east Asia and the Pacific, and 15 were in Latin America and the Caribbean.

Interpretation: Progress in reducing the rate of stillbirths has been slow compared with decreases in the mortality rate of children younger than 5 years. Accelerated improvements are most needed in the regions and countries with high stillbirth rates, particularly in sub-Saharan Africa. Future prevention of stillbirths needs increased efforts to raise public awareness, improve data collection, assess progress, and understand public health priorities locally, all of which require investment.

Funding: Bill & Melinda Gates Foundation and the UK Foreign, Commonwealth and Development Office.
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http://dx.doi.org/10.1016/S0140-6736(21)01112-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8417352PMC
August 2021

Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial.

EClinicalMedicine 2021 Sep 6;39:101050. Epub 2021 Aug 6.

Department of Infectious Disease Epidemiology and MARCH Centre, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London, UK.

Background: Understanding the effect of early kangaroo mother care on survival of mild-moderately unstable neonates <2000 g is a high-priority evidence gap for small and sick newborn care.

Methods: This non-blinded pragmatic randomised clinical trial was conducted at the only teaching hospital in The Gambia. Eligibility criteria included weight <2000g and age 1-24 h with exclusion if stable or severely unstable. Neonates were randomly assigned to receive either standard care, including KMC once stable at >24 h after admission (control) versus KMC initiated <24 h after admission (intervention). Randomisation was stratified by weight with twins in the same arm. The primary outcome was all-cause mortality at 28 postnatal days, assessed by intention to treat analysis. Secondary outcomes included: time to death; hypothermia and stability at 24 h; breastfeeding at discharge; infections; weight gain at 28d and admission duration. The trial was prospectively registered at www.clinicaltrials.gov (NCT03555981).

Findings: Recruitment occurred from 23rd May 2018 to 19th March 2020. Among 1,107 neonates screened for participation 279 were randomly assigned, 139 (42% male [ = 59]) to standard care and 138 (43% male [ = 59]) to the intervention with two participants lost to follow up and no withdrawals. The proportion dying within 28d was 24% (34/139, control) vs. 21% (29/138, intervention) (risk ratio 0·84, 95% CI 0·55 - 1·29,  = 0·423). There were no between-arm differences for secondary outcomes or serious adverse events (28/139 (20%) for control and 30/139 (22%) for intervention, none related). One-third of intervention neonates reverted to standard care for clinical reasons.

Interpretation: The trial had low power due to halving of baseline neonatal mortality, highlighting the importance of implementing existing small and sick newborn care interventions. Further mortality effect and safety data are needed from varying low and middle-income neonatal unit contexts before changing global guidelines.
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http://dx.doi.org/10.1016/j.eclinm.2021.101050DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8358420PMC
September 2021

Direct maternal morbidity and the risk of pregnancy-related deaths, stillbirths, and neonatal deaths in South Asia and sub-Saharan Africa: A population-based prospective cohort study in 8 countries.

PLoS Med 2021 06 28;18(6):e1003644. Epub 2021 Jun 28.

London School of Hygiene & Tropical Medicine, London, United Kingdom.

Background: Maternal morbidity occurs several times more frequently than mortality, yet data on morbidity burden and its effect on maternal, foetal, and newborn outcomes are limited in low- and middle-income countries. We aimed to generate prospective, reliable population-based data on the burden of major direct maternal morbidities in the antenatal, intrapartum, and postnatal periods and its association with maternal, foetal, and neonatal death in South Asia and sub-Saharan Africa.

Methods And Findings: This is a prospective cohort study, conducted in 9 research sites in 8 countries of South Asia and sub-Saharan Africa. We conducted population-based surveillance of women of reproductive age (15 to 49 years) to identify pregnancies. Pregnant women who gave consent were include in the study and followed up to birth and 42 days postpartum from 2012 to 2015. We used standard operating procedures, data collection tools, and training to harmonise study implementation across sites. Three home visits during pregnancy and 2 home visits after birth were conducted to collect maternal morbidity information and maternal, foetal, and newborn outcomes. We measured blood pressure and proteinuria to define hypertensive disorders of pregnancy and woman's self-report to identify obstetric haemorrhage, pregnancy-related infection, and prolonged or obstructed labour. Enrolled women whose pregnancy lasted at least 28 weeks or those who died during pregnancy were included in the analysis. We used meta-analysis to combine site-specific estimates of burden, and regression analysis combining all data from all sites to examine associations between the maternal morbidities and adverse outcomes. Among approximately 735,000 women of reproductive age in the study population, and 133,238 pregnancies during the study period, only 1.6% refused consent. Of these, 114,927 pregnancies had morbidity data collected at least once in both antenatal and in postnatal period, and 114,050 of them were included in the analysis. Overall, 32.7% of included pregnancies had at least one major direct maternal morbidity; South Asia had almost double the burden compared to sub-Saharan Africa (43.9%, 95% CI 27.8% to 60.0% in South Asia; 23.7%, 95% CI 19.8% to 27.6% in sub-Saharan Africa). Antepartum haemorrhage was reported in 2.2% (95% CI 1.5% to 2.9%) pregnancies and severe postpartum in 1.7% (95% CI 1.2% to 2.2%) pregnancies. Preeclampsia or eclampsia was reported in 1.4% (95% CI 0.9% to 2.0%) pregnancies, and gestational hypertension alone was reported in 7.4% (95% CI 4.6% to 10.1%) pregnancies. Prolonged or obstructed labour was reported in about 11.1% (95% CI 5.4% to 16.8%) pregnancies. Clinical features of late third trimester antepartum infection were present in 9.1% (95% CI 5.6% to 12.6%) pregnancies and those of postpartum infection in 8.6% (95% CI 4.4% to 12.8%) pregnancies. There were 187 pregnancy-related deaths per 100,000 births, 27 stillbirths per 1,000 births, and 28 neonatal deaths per 1,000 live births with variation by country and region. Direct maternal morbidities were associated with each of these outcomes.

Conclusions: Our findings imply that health programmes in sub-Saharan Africa and South Asia must intensify their efforts to identify and treat maternal morbidities, which affected about one-third of all pregnancies and to prevent associated maternal and neonatal deaths and stillbirths.

Trial Registration: The study is not a clinical trial.
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http://dx.doi.org/10.1371/journal.pmed.1003644DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8277068PMC
June 2021

The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation.

Trials 2021 Jun 21;22(1):408. Epub 2021 Jun 21.

Department of Disease Control, London School of Hygiene and Tropical Medicine, London, UK.

Introduction: Diarrhoeal disease remains a leading cause of mortality and morbidity worldwide. Cholera alone is estimated to cause 95,000 deaths per year, most of which occur in endemic settings with inadequate water access. Whilst a global strategy to eliminate cholera by 2030 calls for investment in improved drinking water services, there is limited rigorous evidence for the impact of improved water supply on endemic cholera transmission in low-income urban settings. Our protocol is designed to deliver a pragmatic health impact evaluation of a large-scale water supply intervention in Uvira (Democratic Republic of the Congo), a cholera transmission hotspot.

Methods/design: A stepped-wedge cluster randomised trial (SW-CRT) was designed to evaluate the impact of a large-scale drinking water supply intervention on cholera incidence among the 280,000 inhabitants of Uvira. The city was divided into 16 clusters, where new community and household taps will be installed following a randomised sequence over a transition period of up to 8 weeks in each cluster. The primary trial outcomes are the monthly incidence of "confirmed" cholera cases (patients testing positive by rapid detection kit) and of "suspected" cholera cases (patients admitted to the cholera treatment centre). Concurrent process and economic evaluations will provide further information on the context, costs, and efficiency of the intervention.

Discussion: In this protocol, we describe a pragmatic approach to conducting rigorous research to assess the impacts of a complex water supply intervention on severe diarrhoeal disease and cholera in an unstable, low-resource setting representative of cholera-affected areas. In particular, we discuss a series of pre-identified risks and linked mitigation strategies as well as the value of combining different data collection methods and preparation of multiple analysis scenarios to account for possible deviations from the protocol. The study described here has the potential to provide robust evidence to support more effective cholera control in challenging, high-burden settings.

Trial Registration: This trial is registered on clinicaltrials.gov ( NCT02928341 , 10th October 2016) and has received ethics approval from the London School of Hygiene and Tropical Medicine (8913, 10603) and from the Ethics Committee from the School of Public Health, University of Kinshasa, Democratic Republic of the Congo (ESP/CE/088/2015).
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http://dx.doi.org/10.1186/s13063-021-05249-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8215491PMC
June 2021

PRIME-IPD SERIES Part 1. The PRIME-IPD tool promoted verification and standardization of study datasets retrieved for IPD meta-analysis.

J Clin Epidemiol 2021 08 24;136:227-234. Epub 2021 May 24.

School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada; WHO Collaborating Centre for Knowledge Translation and Health Technology Assessment in Health Equity, Bruyère Research Institute, 85 Primrose Ave, Ottawa, Ontario, K1R 6M1, Canada; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario, K1Y 4W7, Canada.

Objectives: We describe a systematic approach to preparing data in the conduct of Individual Participant Data (IPD) analysis.

Study Design And Setting: A guidance paper proposing methods for preparing individual participant data for meta-analysis from multiple study sources, developed by consultation of relevant guidance and experts in IPD. We present an example of how these steps were applied in checking data for our own IPD meta analysis (IPD-MA).

Results: We propose five steps of Processing, Replication, Imputation, Merging, and Evaluation to prepare individual participant data for meta-analysis (PRIME-IPD). Using our own IPD-MA as an exemplar, we found that this approach identified missing variables and potential inconsistencies in the data, facilitated the standardization of indicators across studies, confirmed that the correct data were received from investigators, and resulted in a single, verified dataset for IPD-MA.

Conclusion: The PRIME-IPD approach can assist researchers to systematically prepare, manage and conduct important quality checks on IPD from multiple studies for meta-analyses. Further testing of this framework in IPD-MA would be useful to refine these steps.
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http://dx.doi.org/10.1016/j.jclinepi.2021.05.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8442853PMC
August 2021

PRIME-IPD SERIES Part 3. The PRIME-IPD tool fills a gap in guidance for preparing IPD for analysis.

J Clin Epidemiol 2021 08 15;136:224-226. Epub 2021 May 15.

School of Epidemiology and Public Health, University of Ottawa, 600 Peter Morand Crescent, Ottawa, Ontario, K1G 5Z3, Canada; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario, K1Y 4W7, Canada.

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http://dx.doi.org/10.1016/j.jclinepi.2021.05.001DOI Listing
August 2021

An Integrated eDiagnosis Approach (IeDA) versus standard IMCI for assessing and managing childhood illness in Burkina Faso: a stepped-wedge cluster randomised trial.

BMC Health Serv Res 2021 Apr 16;21(1):354. Epub 2021 Apr 16.

Centre for Maternal Adolescent Reproductive and Child Health (MARCH), London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.

Background: The Integrated eDiagnosis Approach (IeDA), centred on an electronic Clinical Decision Support System (eCDSS) developed in line with national Integrated Management of Childhood Illness (IMCI) guidelines, was implemented in primary health facilities of two regions of Burkina Faso. An evaluation was performed using a stepped-wedge cluster randomised design with the aim of determining whether the IeDA intervention increased Health Care Workers' (HCW) adherence to the IMCI guidelines.

Methods: Ten randomly selected facilities per district were visited at each step by two trained nurses: One observed under-five consultations and the second conducted a repeat consultation. The primary outcomes were: overall adherence to clinical assessment tasks; overall correct classification ignoring the severity of the classifications; and overall correct prescription according to HCWs' classifications. Statistical comparisons between trial arms were performed on cluster/step-level summaries.

Results: On average, 54 and 79% of clinical assessment tasks were observed to be completed by HCWs in the control and intervention districts respectively (cluster-level mean difference = 29.9%; P-value = 0.002). The proportion of children for whom the validation nurses and the HCWs recorded the same classifications (ignoring the severity) was 73 and 79% in the control and intervention districts respectively (cluster-level mean difference = 10.1%; P-value = 0.004). The proportion of children who received correct prescriptions in accordance with HCWs' classifications were similar across arms, 78% in the control arm and 77% in the intervention arm (cluster-level mean difference = - 1.1%; P-value = 0.788).

Conclusion: The IeDA intervention improved substantially HCWs' adherence to IMCI's clinical assessment tasks, leading to some overall increase in correct classifications but to no overall improvement in correct prescriptions. The largest improvements tended to be observed for less common conditions. For more common conditions, HCWs in the control districts performed relatively well, thus limiting the scope to detect an overall impact.

Trial Registration: ClinicalTrials.gov NCT02341469 ; First submitted August 272,014, posted January 19, 2015.
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http://dx.doi.org/10.1186/s12913-021-06317-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8052659PMC
April 2021

Multiple-micronutrient supplementation in pregnant adolescents in low- and middle-income countries: a systematic review and a meta-analysis of individual participant data.

Nutr Rev 2021 Apr 13. Epub 2021 Apr 13.

E.C. Keats, N. Akseer, P. Thurairajah, and Z.A. Bhutta are with the Centre for Global Child Health, The Hospital for Sick Children, Toronto, Ontario, Canada. S. Cousens is with the London School of Hygiene & Tropical Medicine, London, United Kingdom. Z.A. Bhutta is with the Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. Z.A. Bhutta is with the Aga Khan University, Karachi, Pakistan. H. Ali is with the JiVitA Maternal and Child Nutrition and Health Research Project, Gaibandha, Bangladesh. S. El Arifeen is with the International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh. U. Ashorn is with the Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland. J. Belizan is with the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. R.E. Black, P. Christian, A.B. Labrique, K. West, and L.S-F. Wu are with the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. L.M. De-Regil is with Nutrition International, Ottawa, Ontario, Canada. K. Dewey is with the University of California, Davis, Davis, California, USA. M.J. Dibley is with The University of Sydney, Sydney, New South Wales, Australia. W. Fawzi and C.R. Sudfeld are with the Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA. H. Friis and P. Kaestel are with the University of Copenhagen, Copenhagen, Denmark. E. Gomo is with the University of Zimbabwe, Harare, Zimbabwe. L. Huybregts is with the International Food Policy Research Institute, Washington, DC, USA. R. Jayatissa is with the Medical Research Institute, Colombo, Sri Lanka. S.K. Khatry is with the Nepal Nutrition Intervention Project-Sarlahi, Kathmandu, Nepal. P.W. Kolsteren is with Ghent University, Ghent, Belgium. M. McCauley is with the Centre for Maternal and Newborn Health, Liverpool School of Tropical Medicine, Liverpool, United Kingdom. B.M. Oaks is with the University of Rhode Island, Kingston, Rhode Island, USA. E. Piwoz is with the Bill & Melinda Gates Foundation, Seattle, Washington, USA. S. Shaikh is with the Society for Applied Studies, New Delhi, India. D.D. Soekarjo is with the Savica Consultancy, Jakarta, Indonesia. W. Urassa is with the Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania. N. Zagre is with the UNICEF Regional Office for West and Central Africa, Dakar, Senegal. L. Zeng and Z. Zhu are with the School of Public Health, Xi'an Jiaotong University Health Science Centre, Xi'an, Shaanxi, China.

Context: Approximately 7.3 million births occur annually among adolescents in low- and middle-income countries. Pregnant adolescents constitute a nutritionally vulnerable group that could benefit from intervention to mitigate the mortality and adverse birth outcomes associated with adolescent pregnancy.

Objective: The aim of this systematic review and meta-analysis was to assess the following: (1) the effect of multiple-micronutrient (MMN) supplementation vs iron and folic acid (IFA) supplementation among adolescents on maternal morbidity, birth outcomes, and mortality outcomes, (2) the effects of MMN supplementation in adolescents compared with the effects in adult women, and (3) the effect modification, if any, of MMN supplementation by baseline and geographic characteristics of adolescents.

Data Sources: MEDLINE and Cochrane databases were searched, along with the reference lists of relevant reviews.

Study Selection: Multiple-micronutrient supplementation trials in pregnancy that were conducted in a low- or middle-income country and had included at least 100 adolescents (10-19 years of age) were eligible for inclusion. Two independent reviewers assessed study eligibility.

Data Extraction: Thirteen randomized controlled trials conducted in Africa and Asia were identified from 1792 reviews and 1578 original trials. Individual-level data was shared by study collaborators and was checked for completeness and extreme values. One- and two-stage individual participant data meta-analyses were conducted using data from randomized controlled trials of MMN supplementation.

Results: A total of 15 283 adolescents and 44 499 adult women with singleton births were included in the individual participant data meta-analyses of MMN supplementation vs IFA supplementation. In adolescents, MMN supplementation reduced low birth weight (1-stage OR = 0.87, 95%CI 0.77-0.97; 2-stage OR = 0.81; 95%CI 0.74-0.88), preterm birth (1-stage OR = 0.88, 95%CI 0.80-0.98; 2-stage OR = 0.86, 95%CI 0.79-0.95), and small-for-gestational-age births (1-stage OR = 0.90, 95%CI 0.81-1.00; 2-stage OR = 0.86, 95%CI 0.79-0.95) when compared with IFA supplementation. The effects of MMN supplementation did not differ between adolescents and older women, although a potentially greater reduction in small-for-gestational-age births was observed among adolescents. Effect modification by baseline characteristics and geographic region was inconclusive.

Conclusions: Multiple-micronutrient supplementation can improve birth outcomes among pregnant adolescents in low- and middle-income countries. Policy related to antenatal care in these settings should prioritize MMN supplementation over the currently recommended IFA supplementation for all pregnant women, especially adolescents.
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http://dx.doi.org/10.1093/nutrit/nuab004DOI Listing
April 2021

Improving estimates of the burden of severe wasting: analysis of secondary prevalence and incidence data from 352 sites.

BMJ Glob Health 2021 03;6(3)

UNICEF, New York City, New York, USA.

Introduction: Estimates of incident cases of severe wasting among young children are not available for most settings but are needed for optimal planning of treatment programmes and burden estimation. To improve programme planning, global guidance recommends a single 'incidence correction factor' of 1.6 be applied to available prevalence estimates to account for incident cases. This study aimed to update estimates of the incidence correction factor to improve programme planning and inform the approach to burden estimation for severe wasting.

Methods: A global call was issued for secondary data from severe wasting treatment programmes including prevalence, population size, programme admission and programme coverage through a UNICEF-led effort. Site-specific incidence correction factors were calculated as the number of incident cases (annual programme admissions/programme coverage) divided by the number of prevalent cases (prevalence*population size). Estimates were aggregated by country, region and overall using inverse-variance weighted random-effects meta-analysis.

Results: We estimated incidence correction factors from 352 sites in 20 countries. Estimates aggregated by country ranged from 1.3 (Nigeria) to 30.1 (Burundi). Excluding implausible values, the overall incidence correction factor was 3.6 (95% CI 3.4 to 3.9).

Conclusion: Our results suggest that incidence correction factors vary between sites and that the burden of severe wasting will often be underestimated using the currently recommended incidence correction factor of 1.6. Application of updated incidence correction factors represents a simple way to improve programme planning when incidence data are not available and could inform the approach to burden estimation.
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http://dx.doi.org/10.1136/bmjgh-2020-004342DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929878PMC
March 2021

The polychoric dual-component wealth index as an alternative to the DHS index: Addressing the urban bias.

J Glob Health 2021 Jan 30;11:04003. Epub 2021 Jan 30.

London School of Hygiene and Tropical Medicine, London, UK.

Background: The DHS wealth index - based on a statistical technique known as principal component analysis - is used extensively in mainstream surveys and epidemiological studies to assign individuals to wealth categories from information collected on common assets and household characteristics. Since its development in the late nineties, the index has established itself as a standard and, due to its ease of use, has led to a large and welcome increase in the analysis of inequalities. The index is, however, known to present some serious limitations, one being a bias towards patterns of urban wealth: the so-called "urban bias".

Methods: We use 10 data sets - 5 MICS (Multiple Indicator Cluster Survey), 4 DHS (Demographic and Health Survey) and one HBS (Household Budget Survey) - to demonstrate that urban bias continues to be a prominent and worrying feature of the wealth index, even after several methodological changes implemented in recent years to try to reduce it. We then propose and investigate an approach to improve the performance of the index and reduce the urban bias. This approach involves the use of ordinal rather than dummy variables, of a polychoric instead of a product-moment correlation matrix, and the use of two principal components rather than one. These approaches are used jointly to produce the polychoric dual-component wealth index (P2C).

Results: The P2C index enables a larger proportion of the variance of the asset variables to be accounted for, results in all assets contributing positively to the wealth score, exploits added analytical power from ordinal variables, and incorporates the extra dimension of wealth expressed by the second principal component. It results in a better representation of typically rural characteristics of wealth and leads to the identification of more plausible distributions of both the urban and rural populations across wealth quintiles, which are closer to expenditure quintiles than the standard DHS index.

Conclusions: The P2C wealth index can be easily applied to mainstream surveys, such as the MICS and DHS, and to epidemiological studies; it yields more credible distributions of rural and urban subpopulations across wealth quintiles. It is proposed as an alternative to the DHS wealth index.
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http://dx.doi.org/10.7189/jogh.11.04003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897450PMC
January 2021

Stillbirth maternity care measurement and associated factors in population-based surveys: EN-INDEPTH study.

Popul Health Metr 2021 02 8;19(Suppl 1):11. Epub 2021 Feb 8.

Department of Health Policy, Planning and Management, Makerere University School of Public Health, Kampala, Uganda.

Background: Household surveys remain important sources of maternal and child health data, but until now, standard surveys such as Demographic and Health Surveys (DHS) have not collected information on maternity care for women who have experienced a stillbirth. Thus, nationally representative data are lacking to inform programmes to address the millions of stillbirths which occur annually.

Methods: The EN-INDEPTH population-based survey of women of reproductive age was undertaken in five Health and Demographic Surveillance System sites in Bangladesh, Ethiopia, Ghana, Guinea-Bissau and Uganda (2017-2018). All women answered a full birth history with additional questions on pregnancy losses (FBH+) or full pregnancy history (FPH). A sub-sample, including all women reporting a recent stillbirth or neonatal death, was asked additional maternity care questions. These were evaluated using descriptive measures. Associations between stillbirth and maternal socio-demographic characteristics, babies' characteristics and maternity care use were assessed using a weighted logistic regression model for women in the FBH+ group.

Results: A total of 15,591 women reporting a birth since 1 January 2012 answered maternity care questions. Completeness was very high (> 99%), with similar proportions of responses for both live and stillbirths. Amongst the 14,991 births in the FBH+ group, poorer wealth status, higher parity, large perceived baby size-at-birth, preterm or post-term birth, birth in a government hospital compared to other locations and vaginal birth were associated with increased risk of stillbirth after adjusting for potential confounding factors. Regarding association with reported postnatal care, women with a stillbirth were more likely to report hospital stays of > 1 day. However, women with a stillbirth were less likely to report having received a postnatal check compared to those with a live birth.

Conclusions: Women who had experienced stillbirth were able to respond to questions about pregnancy and birth, and we found no reason to omit questions to these women in household surveys. Our analysis identified several potentially modifiable factors associated with stillbirth, adding to the evidence-base for policy and action in low- and middle-income contexts. Including these questions in DHS-8 would lead to increased availability of population-level data to inform action to end preventable stillbirths.
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http://dx.doi.org/10.1186/s12963-020-00240-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7869205PMC
February 2021

Gestational age data completeness, quality and validity in population-based surveys: EN-INDEPTH study.

Popul Health Metr 2021 02 8;19(Suppl 1):16. Epub 2021 Feb 8.

Maternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UK.

Background: Preterm birth (gestational age (GA) <37 weeks) is the leading cause of child mortality worldwide. However, GA is rarely assessed in population-based surveys, the major data source in low/middle-income countries. We examined the performance of new questions to measure GA in household surveys, a subset of which had linked early pregnancy ultrasound GA data.

Methods: The EN-INDEPTH population-based survey of 69,176 women was undertaken (2017-2018) in five Health and Demographic Surveillance System sites in Bangladesh, Ethiopia, Ghana, Guinea-Bissau and Uganda. We included questions regarding GA in months (GAm) for all women and GA in weeks (GAw) for a subset; we also asked if the baby was 'born before expected' to estimate preterm birth rates. Survey data were linked to surveillance data in two sites, and to ultrasound pregnancy dating at <24 weeks in one site. We assessed completeness and quality of reported GA. We examined the validity of estimated preterm birth rates by sensitivity and specificity, over/under-reporting of GAw in survey compared to ultrasound by multinomial logistic regression, and explored perceptions about GA and barriers and enablers to its reporting using focus group discussions (n = 29).

Results: GAm questions were almost universally answered, but heaping on 9 months resulted in underestimation of preterm birth rates. Preference for reporting GAw in even numbers was evident, resulting in heaping at 36 weeks; hence, over-estimating preterm birth rates, except in Matlab where the peak was at 38 weeks. Questions regarding 'born before expected' were answered but gave implausibly low preterm birth rates in most sites. Applying ultrasound as the gold standard in Matlab site, sensitivity of survey-GAw for detecting preterm birth (GAw <37) was 60% and specificity was 93%. Focus group findings suggest that women perceive GA to be important, but usually counted in months. Antenatal care attendance, women's education and health cards may improve reporting.

Conclusions: This is the first published study assessing GA reporting in surveys, compared with the gold standard of ultrasound. Reporting GAw within 5 years' recall is feasible with high completeness, but accuracy is affected by heaping. Compared to ultrasound-GAw, results are reasonably specific, but sensitivity needs to be improved. We propose revised questions based on the study findings for further testing and validation in settings where pregnancy ultrasound data and/or last menstrual period dates/GA recorded in pregnancy are available. Specific training of interviewers is recommended.
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http://dx.doi.org/10.1186/s12963-020-00230-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7869446PMC
February 2021

Four decades of measuring stillbirths and neonatal deaths in Demographic and Health Surveys: historical review.

Popul Health Metr 2021 02 8;19(Suppl 1). Epub 2021 Feb 8.

Maternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UK.

Background: Worldwide, an estimated 5.1 million stillbirths and neonatal deaths occur annually, 98% in low- and middle-income countries. Limited coverage of civil and vital registration systems necessitates reliance on women's retrospective reporting in household surveys for data on these deaths. The predominant platform, Demographic and Health Surveys (DHS), has evolved over the last 35 years and differs by country, yet no previous study has described these differences and the effects of these changes on stillbirth and neonatal death measurement.

Methods: We undertook a review of DHS model questionnaires, protocols and methodological reports from DHS-I to DHS-VII, focusing on the collection of information on stillbirth and neonatal deaths describing differences in approaches, questionnaires and geographic reach up to December 9, 2019. We analysed the resultant data, applied previously used data quality criteria including ratios of stillbirth rate (SBR) to neonatal mortality rate (NMR) and early NMR (ENMR) to NMR, comparing by country, over time and by DHS module.

Results: DHS has conducted >320 surveys in 90 countries since 1984. Two types of maternity history have been used: full birth history (FBH) and full pregnancy history (FPH). A FBH collecting information only on live births has been included in all model questionnaires to date, with data on stillbirths collected through a reproductive calendar (DHS II-VI) or using additional questions on non-live births (DHS-VII). FPH collecting information on all pregnancies including live births, miscarriages, abortions and stillbirths has been used in 17 countries. We found no evidence of variation in stillbirth data quality assessed by SBR:NMR over time for FBH surveys with reproductive calendar, some variation for surveys with FBH in DHS-VII and most variation among the surveys conducted with a FPH. ENMR:NMR ratio increased over time, which may reflect changes in data quality or real epidemiological change.

Conclusion: DHS remains the major data source for pregnancy outcomes worldwide. Although the DHS model questionnaire has evolved over the last three and half decades, more robust evidence is required concerning optimal methods to obtain accurate data on stillbirths and neonatal deaths through household surveys and also to develop and test standardised data quality criteria.
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http://dx.doi.org/10.1186/s12963-020-00225-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7869207PMC
February 2021

Stillbirth outcome capture and classification in population-based surveys: EN-INDEPTH study.

Popul Health Metr 2021 02 8;19(Suppl 1):13. Epub 2021 Feb 8.

Maternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UK.

Background: Household surveys remain important sources of stillbirth data, but omission and misclassification are common. Classifying adverse pregnancy outcomes as stillbirths requires accurate reporting of vital status at birth and gestational age or birthweight for every pregnancy. Further categorisation, e.g. by sex, or timing (intrapartum/antepartum) improves data to understand and prevent stillbirth.

Methods: We undertook a cross-sectional population-based survey of women of reproductive age in five health and demographic surveillance system sites in Bangladesh, Ethiopia, Ghana, Guinea-Bissau and Uganda (2017-2018). All women answered a full birth history with pregnancy loss questions (FBH+) or a full pregnancy history (FPH). A sub-sample across both groups were asked additional stillbirth questions. Questions were evaluated using descriptive measures. Using an interpretative paradigm and phenomenology methodology, focus group discussions with women exploring barriers to reporting birthweight for stillbirths were conducted. Thematic analysis was guided by an a priori codebook.

Results: Overall 69,176 women reported 98,483 livebirths (FBH+) and 102,873 pregnancies (FPH). Additional questions were asked for 1453 stillbirths, 1528 neonatal deaths and 12,620 surviving children born in the 5 years prior to the survey. Completeness was high (> 99%) for existing FBH+/FPH questions on signs of life at birth and gestational age (months). Discordant responses in signs of life at birth between different questions were common; nearly one-quarter classified as stillbirths on FBH+/FPH were reported born alive on additional questions. Availability of information on gestational age (weeks) (58.1%) and birthweight (13.2%) was low amongst stillbirths, and heaping was common. Most women (93.9%) were able to report the sex of their stillborn baby. Response completeness for stillbirth timing (18.3-95.1%) and estimated proportion intrapartum (15.6-90.0%) varied by question and site. Congenital malformations were reported in 3.1% stillbirths. Perceived value in weighing a stillborn baby varied and barriers to weighing at birth a nd knowing birthweight were common.

Conclusions: Improving stillbirth data in surveys will require investment in improving the measurement of vital status, gestational age and birthweight by healthcare providers, communication of these with women, and overcoming reporting barriers. Given the large burden and effect on families, improved data must be made available to end preventable stillbirths.
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http://dx.doi.org/10.1186/s12963-020-00239-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7869203PMC
February 2021

The Clean pilot study: evaluation of an environmental hygiene intervention bundle in three Tanzanian hospitals.

Antimicrob Resist Infect Control 2021 01 7;10(1). Epub 2021 Jan 7.

Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.

Background: Healthcare associated infections (HAI) are estimated to affect up to 15% of hospital inpatients in low-income countries (LICs). A critical but often neglected aspect of HAI prevention is basic environmental hygiene, particularly surface cleaning and linen management. TEACH CLEAN is an educational intervention aimed at improving environmental hygiene. We evaluated the effectiveness of this intervention in a pilot study in three high-volume maternity and newborn units in Dar es Salaam, Tanzania.

Methods: This study design prospectively evaluated the intervention as a whole, and offered a before-and-after comparison of the impact of the main training. We measured changes in microbiological cleanliness [Aerobic Colony Counts (ACC) and presence of Staphylococcus aureus] using dipslides, and physical cleaning action using gel dots. These were analysed with descriptive statistics and logistic regression models. We used qualitative (focus group discussions, in-depth interviews, and semi-structured observation) and quantitative (observation checklist) tools to measure why and how the intervention worked. We describe these findings across the themes of adaptation, fidelity, dose, reach and context.

Results: Microbiological cleanliness improved during the study period (ACC pre-training: 19%; post-training: 41%). The odds of cleanliness increased on average by 1.33 weekly during the pre-training period (CI = 1.11-1.60), and by 1.08 (CI = 1.03-1.13) during the post-training period. Cleaning action improved only in the pre-training period. Detection of S. aureus on hospital surfaces did not change substantially. The intervention was well received and considered feasible in this context. The major pitfalls in the implementation were the limited number of training sessions at the hospital level and the lack of supportive supervision. A systems barrier to implementation was lack of regular cleaning supplies.

Conclusions: The evaluation suggests that improvements in microbiological cleanliness are possible using this intervention and can be sustained. Improved microbiological cleanliness is a key step on the pathway to infection prevention in hospitals. Future research should assess whether this bundle is cost-effective in reducing bacterial and viral transmission and infection using a rigorous study design.
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http://dx.doi.org/10.1186/s13756-020-00866-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789081PMC
January 2021

Assessment of the validity of the measurement of newborn and maternal health-care coverage in hospitals (EN-BIRTH): an observational study.

Lancet Glob Health 2021 03 14;9(3):e267-e279. Epub 2020 Dec 14.

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.

Background: Progress in reducing maternal and neonatal deaths and stillbirths is impeded by data gaps, especially regarding coverage and quality of care in hospitals. We aimed to assess the validity of indicators of maternal and newborn health-care coverage around the time of birth in survey data and routine facility register data.

Methods: Every Newborn-BIRTH Indicators Research Tracking in Hospitals was an observational study in five hospitals in Bangladesh, Nepal, and Tanzania. We included women and their newborn babies who consented on admission to hospital. Exclusion critiera at admission were no fetal heartbeat heard or imminent birth. For coverage of uterotonics to prevent post-partum haemorrhage, early initiation of breastfeeding (within 1 h), neonatal bag-mask ventilation, kangaroo mother care (KMC), and antibiotics for clinically defined neonatal infection (sepsis, pneumonia, or meningitis), we collected time-stamped, direct observation or case note verification data as gold standard. We compared data reported via hospital exit surveys and via hospital registers to the gold standard, pooled using random effects meta-analysis. We calculated population-level validity ratios (measured coverage to observed coverage) plus individual-level validity metrics.

Findings: We observed 23 471 births and 840 mother-baby KMC pairs, and verified the case notes of 1015 admitted newborn babies regarding antibiotic treatment. Exit-survey-reported coverage for KMC was 99·9% (95% CI 98·3-100) compared with observed coverage of 100% (99·9-100), but exit surveys underestimated coverage for uterotonics (84·7% [79·1-89·5]) vs 99·4% [98·7-99·8] observed), bag-mask ventilation (0·8% [0·4-1·4]) vs 4·4% [1·9-8·1]), and antibiotics for neonatal infection (74·7% [55·3-90·1] vs 96·4% [94·0-98·6] observed). Early breastfeeding coverage was overestimated in exit surveys (53·2% [39·4-66·8) vs 10·9% [3·8-21·0] observed). "Don't know" responses concerning clinical interventions were more common in the exit survey after caesarean birth. Register data underestimated coverage of uterotonics (77·9% [37·8-99·5] vs 99·2% [98·6-99·7] observed), bag-mask ventilation (4·3% [2·1-7·3] vs 5·1% [2·0-9·6] observed), KMC (92·9% [84·2-98·5] vs 100% [99·9-100] observed), and overestimated early breastfeeding (85·9% (58·1-99·6) vs 12·5% [4·6-23·6] observed). Inter-hospital heterogeneity was higher for register-recorded coverage than for exit survey report. Even with the same register design, accuracy varied between hospitals.

Interpretation: Coverage indicators for newborn and maternal health care in exit surveys had low accuracy for specific clinical interventions, except for self-report of KMC, which had high sensitivity after admission to a KMC ward or corner and could be considered for further assessment. Hospital register design and completion are less standardised than surveys, resulting in variable data quality, with good validity for the best performing sites. Because approximately 80% of births worldwide take place in facilities, standardising register design and information systems has the potential to sustainably improve the quality of data on care at birth.

Funding: Children's Investment Fund Foundation and Swedish Research Council.
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http://dx.doi.org/10.1016/S2214-109X(20)30504-0DOI Listing
March 2021

Deworming children for soil-transmitted helminths in low and middle-income countries: systematic review and individual participant data network meta-analysis.

J Dev Effect 2019 6;11(3):288-306. Epub 2019 Dec 6.

Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.

Intestinal parasites affect millions of children globally. We aimed to assess effects of deworming children on nutritional and cognitive outcomes across potential effect modifiers using individual participant data (IPD). We searched multiple databases to 27 March 2018, grey literature, and other sources. We included randomised and quasi randomised trials of deworming compared to placebo or other nutritional interventions with data on baseline infection. We used a random-effects network meta-analysis with IPD and assessed overall quality, following a pre-specified protocol. We received IPD from 19 trials of STH deworming. Overall risk of bias was low. There were no statistically significant subgroup effects across age, sex, nutritional status or infection intensity for each type of STH. These analyses showed that children with moderate or heavy intensity infections, deworming for STH may increase weight gain (very low certainty). The added value of this review is an exploration of effects on growth and cognition in children with moderate to heavy infections as well as replicating prior systematic review results of small effects at the population level. Policy implications are that complementary public health strategies need to be assessed and considered to achieve growth and cognition benefits for children in helminth endemic areas.
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http://dx.doi.org/10.1080/19439342.2019.1691627DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7077355PMC
December 2019

Randomised comparison of two household survey modules for measuring stillbirths and neonatal deaths in five countries: the Every Newborn-INDEPTH study.

Lancet Glob Health 2020 04;8(4):e555-e566

Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh.

Background: An estimated 5·1 million stillbirths and neonatal deaths occur annually. Household surveys, most notably the Demographic and Health Survey (DHS), run in more than 90 countries and are the main data source from the highest burden regions, but data-quality concerns remain. We aimed to compare two questionnaires: a full birth history module with additional questions on pregnancy losses (FBH+; the current DHS standard) and a full pregnancy history module (FPH), which collects information on all livebirths, stillbirths, miscarriages, and neonatal deaths.

Methods: Women residing in five Health and Demographic Surveillance System sites within the INDEPTH Network (Bandim in Guinea-Bissau, Dabat in Ethiopia, IgangaMayuge in Uganda, Matlab in Bangladesh, and Kintampo in Ghana) were randomly assigned (individually) to be interviewed using either FBH+ or FPH between July 28, 2017, and Aug 13, 2018. The primary outcomes were stillbirths and neonatal deaths in the 5 years before the survey interview (measured by stillbirth rate [SBR] and neonatal mortality rate [NMR]) and mean time taken to complete the maternity history section of the questionnaire. We also assessed between-site heterogeneity. This study is registered with the Research Registry, 4720.

Findings: 69 176 women were allocated to be interviewed by either FBH+ (n=34 805) or FPH (n=34 371). The mean time taken to complete FPH (10·5 min) was longer than for FBH+ (9·1 min; p<0·0001). Using FPH, the estimated SBR was 17·4 per 1000 total births, 21% (95% CI -10 to 62) higher than with FBH+ (15·2 per 1000 total births; p=0·20) in the 5 years preceding the survey interview. There was strong evidence of between-site heterogeneity (I=80·9%; p<0·0001), with SBR higher for FPH than for FBH+ in four of five sites. The estimated NMR did not differ between modules (FPH 25·1 per 1000 livebirths vs FBH+ 25·4 per 1000 livebirths), with no evidence of between-site heterogeneity (I=0·7%; p=0·40).

Interpretation: FPH takes an average of 1·4 min longer to complete than does FBH+, but has the potential to increase reporting of stillbirths in high burden contexts. The between-site heterogeneity we found might reflect variations in interviewer training and survey implementation, emphasising the importance of interviewer skills, training, and consistent implementation in data quality.

Funding: Children's Investment Fund Foundation.
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http://dx.doi.org/10.1016/S2214-109X(20)30044-9DOI Listing
April 2020

Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC).

Trials 2020 Mar 6;21(1):247. Epub 2020 Mar 6.

Faculty of Epidemiology and Population Health, and MARCH Centre, London School of Hygiene & Tropical Medicine (LSHTM), Keppel Street, London, UK.

Background: Complications of preterm birth cause more than 1 million deaths each year, mostly within the first day after birth (47%) and before full post-natal stabilisation. Kangaroo mother care (KMC), provided as continuous skin-to-skin contact for 18 h per day to fully stabilised neonates ≤ 2000 g, reduces mortality by 36-51% at discharge or term-corrected age compared with incubator care. The mortality effect of starting continuous KMC before stabilisation is a priority evidence gap, which we aim to investigate in the eKMC trial, with a secondary aim of understanding mechanisms, particularly for infection prevention.

Methods: We will conduct a single-site, non-blinded, individually randomised, controlled trial comparing two parallel groups to either early (within 24 h of admission) continuous KMC or standard care on incubator or radiant heater with KMC when clinically stable at > 24 h of admission. Eligible neonates (n = 392) are hospitalised singletons or twins < 2000 g and 1-24 h old at screening who are mild to moderately unstable as per a trial definition using cardio-respiratory parameters. Randomisation is stratified by weight category (< 1200 g; ≥ 1200 g) and in random permuted blocks of varying sizes with allocation of twins to the same arm. Participants are followed up to 28 ± 5 days of age with regular inpatient assessments plus criteria-led review in the event of clinical deterioration. The primary outcome is all-cause neonatal mortality by age 28 days. Secondary outcomes include the time to death, cardio-respiratory stability, hypothermia, exclusive breastfeeding at discharge, weight gain at age 28 days, clinically suspected infection (age 3 to 28 days), intestinal carriage of extended-spectrum beta-lactamase producing (ESBL) Klebsiella pneumoniae (age 28 days), and duration of the hospital stay. Intention-to-treat analysis will be applied for all outcomes, adjusting for twin gestation.

Discussion: This is one of the first clinical trials to examine the KMC mortality effect in a pre-stabilised preterm population. Our findings will contribute to the global evidence base in addition to providing insights into the infection prevention mechanisms and safety of using this established intervention for the most vulnerable neonatal population.

Trial Registration: ClinicalTrials.gov NCT03555981. Submitted 8 May 2018 and registered 14 June 2018. Prospectively registered.
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http://dx.doi.org/10.1186/s13063-020-4149-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059319PMC
March 2020

Suboptimal infant and young child feeding practices in rural Boucle du Mouhoun, Burkina Faso: Findings from a cross-sectional population-based survey.

PLoS One 2019 12;14(11):e0224769. Epub 2019 Nov 12.

Centre for Maternal Adolescent Reproductive and Child Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.

Introduction: In Burkina Faso in 2016, 27% and 8% of children under-5 were estimated to suffer from stunting and wasting respectively. Here, we report on infant and young child feeding (IYCF) practices in rural areas of the Boucle du Mouhoun region.

Materials And Methods: A cross-sectional population-based survey was performed in 2017 in a representative sample of mothers of children aged 6 to 23 months. IYCF practices were assessed using 24-hour dietary recall. Logistic regression was used to identify predictors of IYCF practices. All analyses accounted for sampling stratification by child's age group and for data clustering.

Results: According to mothers' reports, 60% (95%CI 55, 65%) of children received the minimum meal frequency, but only 18% (95%CI 15, 22%) and 13% (95%CI 10, 16%) benefited from the minimum dietary diversity and the minimum acceptable diet respectively. Only 16% (95%CI 13, 20%) of mothers reported increasing breastfeeding or liquids and continued feeding during an episode of child illness. Knowledge of timely introduction of complementary foods and recommended feeding practices during an illness were low. Despite positive attitudes towards the introduction of key food groups, mother's perceived self-efficacy to provide children with these food groups every day was relatively low.

Discussion: Our findings highlight the need for interventions to improve mothers' knowledge and practices in relation to IYCF in the Boucle du Mouhoun region. Behaviour change communication strategies have the potential to improve IYCF indicators but should be tailored to the local context. The high attendance of health facilities for preventive well-baby consultations represents an opportunity for contact with caretakers that should be exploited for promotion and child growth monitoring.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224769PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850548PMC
March 2020

Coverage and equity of maternal and newborn health care in rural Nigeria, Ethiopia and India.

CMAJ 2019 Oct;191(43):E1179-E1188

Faculties of Infectious and Tropical Diseases (Marchant, Berhanu, Gautham, Umar, Armstrong Schellenberg) and of Epidemiology and Population Health (Beaumont, Makowiecka, Tomlin, Cousens, Allen), London School of Hygiene & Tropical Medicine, London, UK; Ethiopian Public Health Institute (Berhanu) and JaRco Consulting (Tessema), Addis Ababa, Ethiopia; Sambodhi Research and Communications Pvt. Ltd. (Singh), New Delhi, India; Data Research and Mapping Consult (Usman), Abuja, Nigeria.

Background: Despite progress toward meeting the Sustainable Development Goals, a large burden of maternal and neonatal mortality persists for the most vulnerable people in rural areas. We assessed coverage, coverage change and inequity for 8 maternal and newborn health care indicators in parts of rural Nigeria, Ethiopia and India.

Methods: We examined coverage changes and inequity in 2012 and 2015 in 3 high-burden populations where multiple actors were attempting to improve outcomes. We conducted cluster-based household surveys using a structured questionnaire to collect 8 priority indicators, disaggregated by relative household socioeconomic status. Where there was evidence of a change in coverage between 2012 and 2015, we used binomial regression models to assess whether the change reduced inequity.

Results: In 2015, we interviewed women with a birth in the previous 12 months in Gombe, Nigeria ( = 1100 women), Ethiopia ( = 404) and Uttar Pradesh, India ( = 584). Among the 8 indicators, 2 positive coverage changes were observed in each of Gombe and Uttar Pradesh, and 5 in Ethiopia. Coverage improvements occurred equally for all socioeconomic groups, with little improvement in inequity. For example, in Ethiopia, coverage of facility delivery almost tripled, increasing from 15% (95% confidence interval [CI] 9%-25%) to 43% (95% CI 33%-54%). This change was similar across socioeconomic groups ( = 0.2). By 2015, the poorest women had about the same facility delivery coverage as the least poor women had had in 2012 (32% and 36%, respectively), but coverage for the least poor had increased to 60%.

Interpretation: Although coverage increased equitably because of various community-based interventions, underlying inequities persisted. Action is needed to address the needs of the most vulnerable women, particularly those living in the most rural areas.
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http://dx.doi.org/10.1503/cmaj.190219DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6821501PMC
October 2019

Aetiology of invasive bacterial infection and antimicrobial resistance in neonates in sub-Saharan Africa: a systematic review and meta-analysis in line with the STROBE-NI reporting guidelines.

Lancet Infect Dis 2019 11 12;19(11):1219-1234. Epub 2019 Sep 12.

MARCH Centre, London School of Hygiene & Tropical Medicine, London, UK.

Background: Aetiological data for neonatal infections are essential to inform policies and programme strategies, but such data are scarce from sub-Saharan Africa. We therefore completed a systematic review and meta-analysis of available data from the African continent since 1980, with a focus on regional differences in aetiology and antimicrobial resistance (AMR) in the past decade (2008-18).

Methods: We included data for microbiologically confirmed invasive bacterial infection including meningitis and AMR among neonates in sub-Saharan Africa and assessed the quality of scientific reporting according to Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI) checklist. We calculated pooled proportions for reported bacterial isolates and AMR.

Findings: We included 151 studies comprising data from 84 534 neonates from 26 countries, almost all of which were hospital-based. Of the 82 studies published between 2008 and 2018, insufficient details were reported regarding most STROBE-NI items. Regarding culture positive bacteraemia or sepsis, Staphylococcus aureus, Klebsiella spp, and Escherichia coli accounted for 25% (95% CI 21-29), 21% (16-27), and 10% (8-10) respectively. For meningitis, the predominant identified causes were group B streptococcus 25% (16-33), Streptococcus pneumoniae 17% (9-6), and S aureus 12% (3-25). Resistance to WHO recommended β-lactams was reported in 614 (68%) of 904 cases and resistance to aminoglycosides in 317 (27%) of 1176 cases.

Interpretation: Hospital-acquired neonatal infections and AMR are a major burden in Africa. More population-based neonatal infection studies and improved routine surveillance are needed to improve clinical care, plan health systems approaches, and address AMR. Future studies should be reported according to standardised reporting guidelines, such as STROBE-NI, to aid comparability and reduce research waste.

Funding: Uduak Okomo was supported by a Medical Research Council PhD Studentship.
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http://dx.doi.org/10.1016/S1473-3099(19)30414-1DOI Listing
November 2019

Children and Young People's Health Partnership (CYPHP) Evelina London model of care: protocol for an opportunistic cluster randomised controlled trial (cRCT) to assess child health outcomes, healthcare quality and health service use.

BMJ Open 2019 09 3;9(8):e027301. Epub 2019 Sep 3.

Department of Women & Children's Health, King's College London, London, UK.

Introduction: Children and young people (CYP) in many high-income settings have poor healthcare outcomes, especially those with long-term conditions (LTCs). Emergency and outpatient hospital service use is increasing unsustainably. To address these problems, the Children and Young People's Health Partnership (CYPHP) has developed and is evaluating an integrated model of care as part of a health systems strengthening programme across two boroughs of London, UK that are characterised by mixed ethnic populations and varying levels of deprivation. The CYPHP Evelina London model of care comprises proactive case-finding and triage, specialist clinics and transformative education and training for professionals working with CYP. Services are delivered by multidisciplinary health teams with an emphasis on increased coordination across primary, community and hospital settings and integration of physical and mental healthcare that accounts for the CYP's social context.

Methods And Analysis: The phased roll out of the CYPHP Evelina London model allows an opportunistic population-based evaluation using a cluster randomised controlled trial design. Seventy general practices across two London boroughs, grouped into 23 clusters, were randomised to provide either the CYPHP model of care (n=11) or enhanced usual care (n=12).The evaluation will measure the impact of the CYPHP Evelina London model of care on child and parent health and well-being, healthcare quality and health service use up to 2 years postimplementation. A population-level evaluation will use routinely collected pseudonymised healthcare data to conduct a service-use analysis for all CYP registered with a participating general practice (n=~90 000) with the rate of non-elective admissions as the primary outcome. We will seek consent from a subset of this population, with specific conditions (target n=2138) to assess the impact on patient-reported outcomes using the Paediatric Quality of Life Inventory (PedsQL) and Warwick-Edinburgh Mental Well-Being Scale (WEBWMS) as, respectively, the child- and parent-related primary outcomes.

Ethics And Dissemination: Ethics approval obtained from South West-Cornwall & Plymouth Research Ethics Committee. Results will be submitted for publication in peer-reviewed journals. Findings will be generalisable to community-based models of care, especially in urban settings. Our process evaluation will identify barriers and enablers of implementation and delivery of care salient to the context and condition.

Trial Registration Number: NCT03461848; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-027301DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6731859PMC
September 2019

Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries.

Ann N Y Acad Sci 2019 05 27;1444(1):6-21. Epub 2019 May 27.

Department of Nutrition, University of California, Davis, Davis, California.

Inadequate micronutrient intakes are relatively common in low- and middle-income countries (LMICs), especially among pregnant women, who have increased micronutrient requirements. This can lead to an increase in adverse pregnancy and birth outcomes. This review presents the conclusions of a task force that set out to assess the prevalence of inadequate micronutrient intakes and adverse birth outcomes in LMICs; the data from trials comparing multiple micronutrient supplements (MMS) that contain iron and folic acid (IFA) with IFA supplements alone; the risks of reaching the upper intake levels with MMS; and the cost-effectiveness of MMS compared with IFA. Recent meta-analyses demonstrate that MMS can reduce the risks of preterm birth, low birth weight, and small for gestational age in comparison with IFA alone. An individual-participant data meta-analysis also revealed even greater benefits for anemic and underweight women and female infants. Importantly, there was no increased risk of harm for the pregnant women or their infants with MMS. These data suggest that countries with inadequate micronutrient intakes should consider supplementing pregnant women with MMS as a cost-effective method to reduce the risk of adverse birth outcomes.
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http://dx.doi.org/10.1111/nyas.14121DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6852202PMC
May 2019

National, regional, and worldwide estimates of low birthweight in 2015, with trends from 2000: a systematic analysis.

Lancet Glob Health 2019 07 15;7(7):e849-e860. Epub 2019 May 15.

Maternal Adolescent Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UK.

Background: Low birthweight (LBW) of less than 2500 g is an important marker of maternal and fetal health, predicting mortality, stunting, and adult-onset chronic conditions. Global nutrition targets set at the World Health Assembly in 2012 include an ambitious 30% reduction in LBW prevalence between 2012 and 2025. Estimates to track progress towards this target are lacking; with this analysis, we aim to assist in setting a baseline against which to assess progress towards the achievement of the World Health Assembly targets.

Methods: We sought to identify all available LBW input data for livebirths for the years 2000-16. We considered population-based national or nationally representative datasets for inclusion if they contained information on birthweight or LBW prevalence for livebirths. A new method for survey adjustment was developed and used. For 57 countries with higher quality time-series data, we smoothed country-reported trends in birthweight data by use of B-spline regression. For all other countries, we estimated LBW prevalence and trends by use of a restricted maximum likelihood approach with country-level random effects. Uncertainty ranges were obtained through bootstrapping. Results were summed at the regional and worldwide level.

Findings: We collated 1447 country-years of birthweight data (281 million births) for 148 countries of 195 UN member states (47 countries had no data meeting inclusion criteria). The estimated worldwide LBW prevalence in 2015 was 14·6% (uncertainty range [UR] 12·4-17·1) compared with 17·5% (14·1-21·3) in 2000 (average annual reduction rate [AARR] 1·23%). In 2015, an estimated 20·5 million (UR 17·4-24·0 million) livebirths were LBW, 91% from low-and-middle income countries, mainly southern Asia (48%) and sub-Saharan Africa (24%).

Interpretation: Although these estimates suggest some progress in reducing LBW between 2000 and 2015, achieving the 2·74% AARR required between 2012 and 2025 to meet the global nutrition target will require more than doubling progress, involving both improved measurement and programme investments to address the causes of LBW throughout the lifecycle.

Funding: Bill & Melinda Gates Foundation, The Children's Investment Fund Foundation, United Nations Children's Fund (UNICEF), and WHO.
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http://dx.doi.org/10.1016/S2214-109X(18)30565-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6560046PMC
July 2019

National, regional, and state-level all-cause and cause-specific under-5 mortality in India in 2000-15: a systematic analysis with implications for the Sustainable Development Goals.

Lancet Glob Health 2019 06;7(6):e721-e734

Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.

Background: India had the largest number of under-5 deaths of all countries in 2015, with substantial subnational disparities. We estimated national and subnational all-cause and cause-specific mortality among children younger than 5 years annually in 2000-15 in India to understand progress made and to consider implications for achieving the Sustainable Development Goal (SDG) child survival targets.

Methods: We used a multicause model to estimate cause-specific mortality proportions in neonates and children aged 1-59 months at the state level, with causes of death grouped into pneumonia, diarrhoea, meningitis, injury, measles, congenital abnormalities, preterm birth complications, intrapartum-related events, and other causes. AIDS and malaria were estimated separately. The model was based on verbal autopsy studies representing more than 100 000 neonatal deaths globally and 16 962 deaths among children aged 1-59 months at the subnational level in India. By applying these proportions to all-cause deaths by state, we estimated cause-specific numbers of deaths and mortality rates at the state, regional, and national levels.

Findings: In 2015, there were 25·121 million livebirths in India and 1·201 million under-5 deaths (under-5 mortality rate 47·81 per 1000 livebirths). 0·696 million (57·9%) of these deaths occurred in neonates. There were disparities in child mortality across states (from 9·7 deaths [Goa] to 73·1 deaths [Assam] per 1000 livebirths) and regions (from 29·7 deaths [the south] to 63·8 deaths [the northeast] per 1000 livebirths). Overall, the leading causes of under-5 deaths were preterm birth complications (0·330 million [95% uncertainty range 0·279-0·367]; 27·5% of under-5 deaths), pneumonia (0·191 million [0·168-0·219]; 15·9%), and intrapartum-related events (0·139 million [0·116-0·165]; 11·6%), with cause-of-death distributions varying across states and regions. In states with very high under-5 mortality, infectious-disease-related causes (pneumonia and diarrhoea) were among the three leading causes, whereas the three leading causes were all non-communicable in states with very low mortality. Most states had a slower decline in neonatal mortality than in mortality among children aged 1-59 months. Ten major states must accelerate progress to achieve the SDG under-5 mortality target, while 17 are not on track to meet the neonatal mortality target.

Interpretation: Efforts to reduce vaccine-preventable deaths and to reduce geographical disparities should continue to maintain progress achieved in 2000-15. Enhanced policies and programmes are needed to accelerate mortality reduction in high-burden states and among neonates to achieve the SDG child survival targets in India by 2030.

Funding: Bill & Melinda Gates Foundation.
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http://dx.doi.org/10.1016/S2214-109X(19)30080-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6527517PMC
June 2019

"-BIRTH" protocol: observational study validating indicators for coverage and quality of maternal and newborn health care in Bangladesh, Nepal and Tanzania.

J Glob Health 2019 Jun;9(1):010902

Nepal Health Research Council, Kathmandu, Nepal.

Background: To achieve Sustainable Development Goals and Universal Health Coverage, programmatic data are essential. The Every Newborn Action Plan, agreed by all United Nations member states and >80 development partners, includes an ambitious Measurement Improvement Roadmap. Quality of care at birth is prioritised by both Every Newborn and Ending Preventable Maternal Mortality strategies, hence metrics need to advance from health service contact alone, to content of care. As facility births increase, monitoring using routine facility data in DHIS2 has potential, yet validation research has mainly focussed on maternal recall surveys. The - Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study aims to validate selected newborn and maternal indicators for routine tracking of coverage and quality of facility-based care for use at district, national and global levels.

Methods: EN-BIRTH is an observational study including >20 000 facility births in three countries (Tanzania, Bangladesh and Nepal) to validate selected indicators. Direct clinical observation will be compared with facility register data and a pre-discharge maternal recall survey for indicators including: uterotonic administration, immediate newborn care, neonatal resuscitation and Kangaroo mother care. Indicators including neonatal infection management and antenatal corticosteroid administration, which cannot be easily observed, will be validated using inpatient records. Trained clinical observers in Labour/Delivery ward, Operation theatre, and Kangaroo mother care ward/areas will collect data using a tablet-based customised data capturing application. Sensitivity will be calculated for numerators of all indicators and specificity for those numerators with adequate information. Other objectives include comparison of denominator options (ie, true target population or surrogates) and quality of care analyses, especially regarding intervention timing. Barriers and enablers to routine recording and data usage will be assessed by data flow assessments, quantitative and qualitative analyses.

Conclusions: To our knowledge, this is the first large, multi-country study validating facility-based routine data compared to direct observation for maternal and newborn care, designed to provide evidence to inform selection of a core list of indicators recommended for inclusion in national DHIS2. Availability and use of such data are fundamental to drive progress towards ending the annual 5.5 million preventable stillbirths, maternal and newborn deaths.
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http://dx.doi.org/10.7189/jogh.09.01902DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6406050PMC
June 2019
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