Publications by authors named "Sachiyo Yoshida"

32 Publications

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 Jun 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

Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight.

N Engl J Med 2021 05;384(21):2028-2038

The affiliations of the members of the writing committee are as follows: the Department of Maternal, Newborn, Child, and Adolescent Health, and Ageing, World Health Organization, Geneva (S.P.N.R., S.Y., N.M., H.V.J., H.T., R.B.); Vardhman Mahavir Medical College and Safdarjung Hospital (S.A., P.M., N.C., J.S., P.A., K.N., I.S., K.C.A., H.C.) and the All India Institute of Medical Sciences (M.J.S.), New Delhi, and Translational Health Science and Technology Institute, Faridabad (N.W.) - all in India; Muhimbili University of Health and Allied Sciences (H.N., E.A., A.M.) and Muhimbili National Hospital (M.N., R.M.) - both in Dar es Salaam, Tanzania; the University of Malawi, College of Medicine, Blantyre, Malawi (K.K., L.G., A.T.M., V.S., Q.D.); Obafemi Awolowo University, Ile-Ife, Nigeria (C.H.A., O.K., B.P.K., E.A.A.); Kwame Nkrumah University of Science and Technology (S.N., R.L.-R., D.A., G.P.-R.) and Komfo Anokye Teaching Hospital (A.B.-Y., N.W.-B., I.N.), Kumasi, and the School of Public Health, University of Ghana, Accra (A.A.M.) - all in Ghana; Karolinska University Hospital (A.L.) and Karolinska Institute (N.B., A.L., B.W.), Stockholm; the Institute for Safety Governance and Criminology, University of Cape Town, Cape Town, South Africa (B.M.); and Stavanger University Hospital, Stavanger, Norway (S.R.).

Background: "Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain.

Methods: We conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life.

Results: A total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care.

Conclusions: Among infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.).
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http://dx.doi.org/10.1056/NEJMoa2026486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108485PMC
May 2021

Preterm care during the COVID-19 pandemic: A comparative risk analysis of neonatal deaths averted by kangaroo mother care versus mortality due to SARS-CoV-2 infection.

EClinicalMedicine 2021 Mar 15;33:100733. Epub 2021 Feb 15.

Maternal, Adolescent, Reproductive and Child Health Centre, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London WC1E 7HT, United Kingdom.

Background: COVID-19 is disrupting health services for mothers and newborns, particularly in low- and middle-income countries (LMIC). Preterm newborns are particularly vulnerable. We undertook analyses of the benefits of kangaroo mother care (KMC) on survival among neonates weighing ≤2000 g compared with the risk of SARS-CoV-2 acquired from infected mothers/caregivers.

Methods: We modelled two scenarios over 12 months. Scenario 1 compared the survival benefits of KMC with universal coverage (99%) and mortality risk due to COVID-19. Scenario 2 estimated incremental deaths from reduced coverage and complete disruption of KMC. Projections were based on the most recent data for 127 LMICs (~90% of global births), with results aggregated into five regions.

Findings: Our worst-case scenario (100% transmission) could result in 1,950 neonatal deaths from COVID-19. Conversely, 125,680 neonatal lives could be saved with universal KMC coverage. Hence, the benefit of KMC is 65-fold higher than the mortality risk of COVID-19. If recent evidence of 10% transmission was applied, the ratio would be 630-fold. We estimated a 50% reduction in KMC coverage could result in 12,570 incremental deaths and full disruption could result in 25,140 incremental deaths, representing a 2·3-4·6% increase in neonatal mortality across the 127 countries.

Interpretation: The survival benefit of KMC far outweighs the small risk of death due to COVID-19. Preterm newborns are at risk, especially in LMICs where the consequences of disruptions are substantial. Policymakers and healthcare professionals need to protect services and ensure clearer messaging to keep mothers and newborns together, even if the mother is SARS-CoV-2-positive.

Funding: Eunice Kennedy Shriver National Institute of Child Health & Human Development; Bill & Melinda Gates Foundation; Elma Philanthropies; Wellcome Trust; and Joint Global Health Trials scheme of Department of Health and Social Care, Department for International Development, Medical Research Council, and Wellcome Trust.
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http://dx.doi.org/10.1016/j.eclinm.2021.100733DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955179PMC
March 2021

Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results from randomized trials in Africa.

PLoS One 2021 15;16(3):e0247977. Epub 2021 Mar 15.

Department of Maternal, Newborn, Child and Adolescent Health and Ageing, World Health Organization, Geneva, Switzerland.

Introduction: Serious bacterial neonatal infections are a major cause of global neonatal mortality. While hospitalized treatment is recommended, families cannot access inpatient treatment in low resource settings. Two parallel randomized control trials were conducted at five sites in three countries (Democratic Republic of Congo, Kenya, and Nigeria) to compare the effectiveness of treatment with experimental regimens requiring fewer injections with a reference regimen A (injection gentamicin plus injection procaine penicillin both once daily for 7 days) on the outpatient basis provided to young infants (0-59 days) with signs of possible serious bacterial infection (PSBI) when the referral was not feasible. Costs were estimated to quantify the financial implications of scaleup, and cost-effectiveness of these regimens.

Methods: Direct economic costs (including personnel, drugs and consumable costs) were estimated for identification, prenatal and postnatal visits, assessment, classification, treatment and follow-up. Data on time spent by providers on each activity was collected from 83% of providers. Indirect marginal financial costs were estimated for non-consumables/capital, training, transport, communication, administration and supervision by considering only a share of the total research and health system costs considered important for the program. Total economic costs (direct plus indirect) per young infant treated were estimated based on 39% of young infants enrolled in the trial during 2012 and the number of days each treated during one year. The incremental cost-effectiveness ratio was calculated using treatment failure after one week as the outcome indicator. Experimental regimens were compared to the reference regimen and pairwise comparisons were also made.

Results: The average costs of treating a young infant with clinical severe infection (a sub-category of PSBI) in 2012 was lowest with regimen D (injection gentamicin once daily for 2 days plus oral amoxicillin twice daily for 7 days) at US$ 20.9 (95% CI US$ 16.4-25.3) or US$ 32.5 (2018 prices). While all experimental regimens B (injection gentamicin once daily plus oral amoxicillin twice daily, both for 7 days), regimen C (once daily of injection gentamicin injection plus injection procaine penicillin for 2 days, thereafter oral amoxicillin twice daily for 5 days) and regimen D were found to be more cost-effective as compared with the reference regimen A; pairwise comparison showed regimen D was more cost-effective than B or C. For fast breathing, the average cost of treatment with regimen E (oral amoxicillin twice daily for 7 days) at US$ 18.3 (95% CI US$ 13.4-23.3) or US$ 29.0 (2018 prices) was more cost-effective than regimen A. Indirect costs were 32% of the total treatment costs.

Conclusion: Scaling up of outpatient treatment for PSBI when the referral is not feasible with fewer injections and oral antibiotics is cost-effective for young infants and can lead to increased access to treatment resulting in potential reductions in neonatal mortality.

Clinical Trial Registration: The trial was registered with Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247977PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7959374PMC
March 2021

Multiomics Characterization of Preterm Birth in Low- and Middle-Income Countries.

JAMA Netw Open 2020 12 1;3(12):e2029655. Epub 2020 Dec 1.

Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.

Importance: Worldwide, preterm birth (PTB) is the single largest cause of deaths in the perinatal and neonatal period and is associated with increased morbidity in young children. The cause of PTB is multifactorial, and the development of generalizable biological models may enable early detection and guide therapeutic studies.

Objective: To investigate the ability of transcriptomics and proteomics profiling of plasma and metabolomics analysis of urine to identify early biological measurements associated with PTB.

Design, Setting, And Participants: This diagnostic/prognostic study analyzed plasma and urine samples collected from May 2014 to June 2017 from pregnant women in 5 biorepository cohorts in low- and middle-income countries (LMICs; ie, Matlab, Bangladesh; Lusaka, Zambia; Sylhet, Bangladesh; Karachi, Pakistan; and Pemba, Tanzania). These cohorts were established to study maternal and fetal outcomes and were supported by the Alliance for Maternal and Newborn Health Improvement and the Global Alliance to Prevent Prematurity and Stillbirth biorepositories. Data were analyzed from December 2018 to July 2019.

Exposures: Blood and urine specimens that were collected early during pregnancy (median sampling time of 13.6 weeks of gestation, according to ultrasonography) were processed, stored, and shipped to the laboratories under uniform protocols. Plasma samples were assayed for targeted measurement of proteins and untargeted cell-free ribonucleic acid profiling; urine samples were assayed for metabolites.

Main Outcomes And Measures: The PTB phenotype was defined as the delivery of a live infant before completing 37 weeks of gestation.

Results: Of the 81 pregnant women included in this study, 39 had PTBs (48.1%) and 42 had term pregnancies (51.9%) (mean [SD] age of 24.8 [5.3] years). Univariate analysis demonstrated functional biological differences across the 5 cohorts. A cohort-adjusted machine learning algorithm was applied to each biological data set, and then a higher-level machine learning modeling combined the results into a final integrative model. The integrated model was more accurate, with an area under the receiver operating characteristic curve (AUROC) of 0.83 (95% CI, 0.72-0.91) compared with the models derived for each independent biological modality (transcriptomics AUROC, 0.73 [95% CI, 0.61-0.83]; metabolomics AUROC, 0.59 [95% CI, 0.47-0.72]; and proteomics AUROC, 0.75 [95% CI, 0.64-0.85]). Primary features associated with PTB included an inflammatory module as well as a metabolomic module measured in urine associated with the glutamine and glutamate metabolism and valine, leucine, and isoleucine biosynthesis pathways.

Conclusions And Relevance: This study found that, in LMICs and high PTB settings, major biological adaptations during term pregnancy follow a generalizable model and the predictive accuracy for PTB was augmented by combining various omics data sets, suggesting that PTB is a condition that manifests within multiple biological systems. These data sets, with machine learning partnerships, may be a key step in developing valuable predictive tests and intervention candidates for preventing PTB.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.29655DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749442PMC
December 2020

Global research priorities for social, behavioural and community engagement interventions for maternal, newborn and child health.

Health Res Policy Syst 2020 Aug 27;18(1):97. Epub 2020 Aug 27.

Department of Maternal, Newborn, Child and Adolescent Health and Ageing, World Health Organization, Avenue Appia 20, 1202, Geneva, Switzerland.

Background: Social, behavioural and community engagement (SBCE) interventions are essential for global maternal, newborn and child health (MNCH) strategies. Past efforts to synthesise research on SBCE interventions identified a need for clear priorities to guide future research. WHO led an exercise to identify global research priorities for SBCE interventions to improve MNCH.

Methods: We adapted the Child Health and Nutrition Research Initiative method and combined quantitative and qualitative methods to determine MNCH SBCE intervention research priorities applicable across different contexts. Using online surveys and meetings, researchers and programme experts proposed up to three research priorities and scored the compiled priorities against four criteria - health and social impact, equity, feasibility, and overall importance. Priorities were then ranked by score. A group of 29 experts finalised the top 10 research priorities for each of maternal, newborn or child health and a cross-cutting area.

Results: A total of 310 experts proposed 867 research priorities, which were consolidated into 444 priorities and scored by 280 experts. Top maternal and newborn health priorities focused on research to improve the delivery of SBCE interventions that strengthen self-care/family care practices and care-seeking behaviour. Child health priorities focused on the delivery of SBCE interventions, emphasising determinants of service utilisation and breastfeeding and nutrition practices. Cross-cutting MNCH priorities highlighted the need for better integration of SBCE into facility-based and community-based health services.

Conclusions: Achieving global targets for MNCH requires increased investment in SBCE interventions that build capacities of individuals, families and communities as agents of their own health. Findings from this exercise provide guidance to prioritise investments and ensure that they are best directed to achieve global objectives. Stakeholders are encouraged to use these priorities to guide future research investments and to adapt them for country programmes by engaging with national level stakeholders.
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http://dx.doi.org/10.1186/s12961-020-00597-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7450986PMC
August 2020

Pelvic lymph node metastasis in extramammary Paget disease of the scrotum without inguinal lymph node metastasis.

Australas J Dermatol 2019 May 18;60(2):151-153. Epub 2018 Nov 18.

Department of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.

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http://dx.doi.org/10.1111/ajd.12959DOI Listing
May 2019

Differential regulation of the sphere formation and maintenance of cancer-initiating cells of malignant mesothelioma via CD44 and ALK4 signaling pathways.

Oncogene 2018 12 30;37(49):6357-6367. Epub 2018 Jul 30.

Laboratory of Immunobiology, School of Pharmacy, Hyogo University of Health Sciences, Kobe, Hyogo, Japan.

Malignant mesothelioma (MM) has a poor prognosis and is largely resistant to standard treatments, so it is important to seek novel therapeutic strategies for this disease. Cancer-initiating cells (CICs) were previously identified in MM using stem cell-associated markers in combination with spheroid cultures. However, the mechanisms underlying the induction and maintenance of CICs in MM remain to be fully explored. Here we showed that the CICs, which had high aldehyde dehydrogenase levels (ALDH) and stem cell-associated genes, were expanded in MM cells cultured under sphere-forming conditions. The MM spheroids also initiated tumors in immunodeficient mice more efficiently than did conventional adherent MM cells. In the MM spheroids, the expression of hyaluronan (HA) synthases was upregulated. Inhibiting the HA synthesis or CD44 functions by gene knockdown or neutralizing antibody abolished the formation of large-sized spheroids and the expansion of ALDH CICs. The expression of activin-A was also increased in the spheroids, and type I activin-A receptor subunit (ALK4) was upregulated in the ALDH CICs. The neutralization of activin-A or functional inactivation of ALK4 diminished the ALDH CICs without affecting spheroid formation. The knockdown of CD44 or ALK4 strongly suppressed the tumor growth in immunodeficient mice. These results together suggest that the HA-CD44 and activin-A-ALK4 pathways differentially regulate the spheroid formation and maintenance of ALDH CICs in MM cells, and that both pathways play critical roles in tumor growth in immunodeficient hosts. Our findings provide a novel therapeutic option for MM that targets signaling pathways that promote the CIC compartment through CD44 and ALK4.
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http://dx.doi.org/10.1038/s41388-018-0405-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6283855PMC
December 2018

Research priorities for adolescent health in low- and middle-income countries: A mixed-methods synthesis of two separate exercises.

J Glob Health 2018 Jun;8(1):010501

The Population Council, New York, New York, USA.

Background: In order to clarify priorities and stimulate research in adolescent health in low- and middle-income countries (LMICs), the World Health Organization (WHO) conducted two priority-setting exercises based on the Child Health and Nutrition Research Initiative (CHNRI) methodology related to 1) adolescent sexual and reproductive health and 2) eight areas of adolescent health including communicable diseases prevention and management, injuries and violence, mental health, non-communicable diseases management, nutrition, physical activity, substance use, and health policy. Although the CHNRI methodology has been utilized in over 50 separate research priority setting exercises, none have qualitatively synthesized the ultimate findings across studies. The purpose of this study was to conduct a mixed-method synthesis of two research priority-setting exercises for adolescent health in LMICs based on the CHNRI methodology and to situate the priority questions within the current global health agenda.

Methods: All of the 116 top-ranked questions presented in each exercise were analyzed by two independent reviewers. Word clouds were generated based on keywords from the top-ranked questions. Questions were coded and content analysis was conducted based on type of delivery platform, vulnerable populations, and the Survive, Thrive, and Transform framework from the United Nations Global Strategy for Women's, Children's, and Adolescents' Health, 2016-2030.

Findings: Within the 53 top-ranked intervention-related questions that specified a delivery platform, the platforms specified were schools (n = 17), primary care (n = 12), community (n = 11), parenting (n = 6), virtual media (n = 5), and peers (n = 2). Twenty questions specifically focused on vulnerable adolescents, including those living with HIV, tuberculosis, mental illness, or neurodevelopmental disorders; victims of gender-based violence; refugees; young persons who inject drugs; sex workers; slum dwellers; out-of-school youth; and youth in armed conflict. A majority of the top-ranked questions (108/116) aligned with one or a combination of the Survive (n = 39), Thrive (n = 67), and Transform (n = 28) agendas.

Conclusions: This study advances the CHNRI methodology by conducting the first mixed-methods synthesis of multiple research priority-setting exercises by analyzing keywords (using word clouds) and themes (using content analysis).
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http://dx.doi.org/10.7189/jogh.08.010501DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5825976PMC
June 2018

Understanding biological mechanisms underlying adverse birth outcomes in developing countries: protocol for a prospective cohort (AMANHI bio-banking) study.

J Glob Health 2017 Dec;7(2):021202

World Health Organization (MCA/MRD), Geneva, Switzerland.

Objectives: The AMANHI study aims to seek for biomarkers as predictors of important pregnancy-related outcomes, and establish a biobank in developing countries for future research as new methods and technologies become available.

Methods: AMANHI is using harmonised protocols to enrol 3000 women in early pregnancies (8-19 weeks of gestation) for population-based follow-up in pregnancy up to 42 days postpartum in Bangladesh, Pakistan and Tanzania, with collection taking place between August 2014 and June 2016. Urine pregnancy tests will be used to confirm reported or suspected pregnancies for screening ultrasound by trained sonographers to accurately date the pregnancy. Trained study field workers will collect very detailed phenotypic and epidemiological data from the pregnant woman and her family at scheduled home visits during pregnancy (enrolment, 24-28 weeks, 32-36 weeks & 38+ weeks) and postpartum (days 0-6 or 42-60). Trained phlebotomists will collect maternal and umbilical blood samples, centrifuge and obtain aliquots of serum, plasma and the buffy coat for storage. They will also measure HbA1C and collect a dried spot sample of whole blood. Maternal urine samples will also be collected and stored, alongside placenta, umbilical cord tissue and membrane samples, which will both be frozen and prepared for histology examination. Maternal and newborn stool (for microbiota) as well as paternal and newborn saliva samples (for DNA extraction) will also be collected. All samples will be stored at -80°C in the biobank in each of the three sites. These samples will be linked to numerous epidemiological and phenotypic data with unique study identification numbers.

Importance Of The Study: AMANHI biobank proves that biobanking is feasible to implement in LMICs, but recognises that biobank creation is only the first step in addressing current global challenges.
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http://dx.doi.org/10.7189/jogh.07.021202DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5665675PMC
December 2017

Development and validation of a simplified algorithm for neonatal gestational age assessment - protocol for the Alliance for Maternal Newborn Health Improvement (AMANHI) prospective cohort study.

J Glob Health 2017 Dec;7(2):021201

Brigham & Women's Hospital, Massachusetts General Hospital, Boston, Massachusetts, USA.

Objective: The objective of the Alliance for Maternal and Newborn Health Improvement (AMANHI) gestational age study is to develop and validate a programmatically feasible and simple approach to accurately assess gestational age of babies after they are born. The study will provide accurate, population-based rates of preterm birth in different settings and quantify the risks of neonatal mortality and morbidity by gestational age and birth weight in five South Asian and sub-Saharan African sites.

Methods: This study used on-going population-based cohort studies to recruit pregnant women early in pregnancy (<20 weeks) for a dating ultrasound scan. Implementation is harmonised across sites in Ghana, Tanzania, Zambia, Bangladesh and Pakistan with uniform protocols and standard operating procedures. Women whose pregnancies are confirmed to be between 8 to 19 completed weeks of gestation are enrolled into the study. These women are followed up to collect socio-demographic and morbidity data during the pregnancy. When they deliver, trained research assistants visit women within 72 hours to assess the baby for gestational maturity. They assess for neuromuscular and physical characteristics selected from the Ballard and Dubowitz maturation assessment scales. They also measure newborn anthropometry and assess feeding maturity of the babies. Computer machine learning techniques will be used to identify the most parsimonious group of signs that correctly predict gestational age compared to the early ultrasound date (the gold standard). This gestational age will be used to categorize babies into term, late preterm and early preterm groups. Further, the ultrasound-based gestational age will be used to calculate population-based rates of preterm birth.

Importance Of The Study: The AMANHI gestational age study will make substantial contribution to improve identification of preterm babies by frontline health workers in low- and middle- income countries using simple evaluations. The study will provide accurate preterm birth estimates. This new information will be crucial to planning and delivery of interventions for improving preterm birth outcomes, particularly in South Asia and sub-Saharan Africa.
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http://dx.doi.org/10.7189/jogh.07.021201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5665676PMC
December 2017

Setting health research priorities using the CHNRI method: VII. A review of the first 50 applications of the CHNRI method.

J Glob Health 2017 Jun;7(1):011004

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

Background: Several recent reviews of the methods used to set research priorities have identified the CHNRI method (acronym derived from the "Child Health and Nutrition Research Initiative") as an approach that clearly became popular and widely used over the past decade. In this paper we review the first 50 examples of application of the CHNRI method, published between 2007 and 2016, and summarize the most important messages that emerged from those experiences.

Methods: We conducted a literature review to identify the first 50 examples of application of the CHNRI method in chronological order. We searched Google Scholar, PubMed and so-called grey literature.

Results: Initially, between 2007 and 2011, the CHNRI method was mainly used for setting research priorities to address global child health issues, although the first cases of application outside this field (eg, mental health, disabilities and zoonoses) were also recorded. Since 2012 the CHNRI method was used more widely, expanding into the topics such as adolescent health, dementia, national health policy and education. The majority of the exercises were focused on issues that were only relevant to low- and middle-income countries, and national-level applications are on the rise. The first CHNRI-based articles adhered to the five recommended priority-setting criteria, but by 2016 more than two-thirds of all conducted exercises departed from recommendations, modifying the CHNRI method to suit each particular exercise. This was done not only by changing the number of criteria used, but also by introducing some entirely new criteria (eg, "low cost", "sustainability", "acceptability", "feasibility", "relevance" and others).

Conclusions: The popularity of the CHNRI method in setting health research priorities can be attributed to several key conceptual advances that have addressed common concerns. The method is systematic in nature, offering an acceptable framework for handling many research questions. It is also transparent and replicable, because it clearly defines the context and priority-setting criteria. It is democratic, as it relies on "crowd-sourcing". It is inclusive, fostering "ownership" of the results by ensuring that various groups invest in the process. It is very flexible and adjustable to many different contexts and needs. Finally, it is simple and relatively inexpensive to conduct, which we believe is one of the main reasons for its uptake by many groups globally, particularly those in low- and middle-income countries.
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http://dx.doi.org/10.7189/jogh.07.011004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481891PMC
June 2017

Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial.

Trials 2017 06 7;18(1):262. Epub 2017 Jun 7.

Centre for Intervention Science in Maternal and Child Health, Department of Global Public Health and Primary Care, University of Bergen, N-5020, Bergen, Norway.

Background: Around 70% neonatal deaths occur in low birth weight (LBW) babies. Globally, 15% of babies are born with LBW. Kangaroo Mother Care (KMC) appears to be an effective way to reduce mortality and morbidity among LBW babies. KMC comprises of early and continuous skin-to-skin contact between mother and baby as well as exclusive breastfeeding. Evidence derived from hospital-based studies shows that KMC results in a 40% relative reduction in mortality, a 58% relative reduction in the risk of nosocomial infections or sepsis, shorter hospital stay, and a lower risk of lower respiratory tract infections in babies with birth weight <2000 g. There has been considerable interest in KMC initiated outside health facilities for LBW babies born at home or discharged early. Currently, there is insufficient evidence to support initiation of KMC in the community (cKMC). Formative research in our study setting, where 24% of babies are born with LBW, demonstrated that KMC is feasible and acceptable when initiated at home for LBW babies. The aim of this trial is to determine the impact of cKMC on the survival of these babies.

Methods/design: This randomized controlled trial is being undertaken in the Palwal and Faridabad districts in the State of Haryana, India. Neonates weighing 1500-2250 g identified within 3 days of birth and their mothers are being enrolled. Other inclusion criteria are that the family is likely to be available in the study area over the next 6 months, that KMC was not initiated in the delivery facility, and that the infant does not have an illness requiring hospitalization. Eligible neonates are randomized into intervention and control groups. The intervention is delivered through home visits during the first month of life by study workers with a background and education similar to that of workers in the government health system. An independent study team collects mortality and morbidity data as well as anthropometric measurements during periodic home visits. The primary outcomes of the study are postenrollment neonatal mortality and mortality between enrollment and 6 months of age. The secondary outcomes are breastfeeding practices; prevalence of illnesses and care-seeking practices for the same; hospitalizations; weight and length gain; and, in a subsample, neurodevelopment.

Discussion: This efficacy trial will answer the question whether the benefits of KMC observed in hospital settings can also be observed when KMC is started in the community. The formative research used for intervention development suggests that the necessary high level of KMC adoption can be reached in the community, addressing a problem that seriously constrained conclusions in the only other trial in which researchers examined the benefits of cKMC.

Trial Registration: ClinicalTrials.gov identifier: NCT02653534 . Registered on 26 December 2015 (retrospectively registered).
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http://dx.doi.org/10.1186/s13063-017-1991-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5463407PMC
June 2017

Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition: a randomised trial in India.

BMJ Glob Health 2016 30;1(4):e000144. Epub 2016 Dec 30.

Department of Maternal, Newborn, Child and Adolescent Health, World Health Organisation, Geneva, Switzerland.

Objective: To assess the efficacy of ready-to-use therapeutic food (RUTF), centrally produced RUTF (RUTF-C) or locally prepared RUTF (RUTF-L) for home-based management of uncomplicated severe acute malnutrition (SAM) compared with micronutrient-enriched (augmented) energy-dense home-prepared foods (A-HPF, the comparison group).

Methods: In an individually randomised multicentre trial, we enrolled 906 children aged 6-59 months with uncomplicated SAM. The children enrolled were randomised to receive RUTF-C, RUTF-L or A-HPF. We provided foods, counselling and feeding support until recovery or 16 weeks, whichever was earlier and measured outcomes weekly (treatment phase). We subsequently facilitated access to government nutrition services and measured outcomes once 16 weeks later (sustenance phase). The primary outcome was recovery during treatment phase (weight-for-height ≥-2 SD and absence of oedema of feet).

Results: Recovery rates with RUTF-L, RUTF-C and A-HPF were 56.9%, 47.5% and 42.8%, respectively. The adjusted OR was 1.71 (95% CI 1.20 to 2.43; p=0.003) for RUTF-L and 1.28 (95% CI 0.90 to 1.82; p=0.164) for RUTF-C compared with A-HPF. Weight gain in the RUTF-L group was higher than in the A-HPF group (adjusted difference 0.90 g/kg/day, 95% CI 0.30 to 1.50; p=0.003). Time to recovery was shorter in both RUTF groups. Morbidity was high and similar across groups. At the end of the study, the proportion of children with weight-for-height Z-score (WHZ) >-2 was similar (adjusted OR 1.12, 95% CI 0.74 to 1.95; p=0.464), higher for moderate malnutrition (WHZ<-2 and ≥-3; adjusted OR 1.46, 95% CI 1.02 to 2.08; p=0.039), and lower for those with SAM (adjusted OR 0.58, 95% CI 0.40 to 0.85; p=0.005) in the RUTF-L when compared with the A-HPF group.

Conclusions: This first randomised trial comparing options for home management of uncomplicated SAM confirms that RUTF-L is more efficacious than A-HPF at home. Recovery rates were lower than in African studies, despite longer treatment and greater support for feeding.

Trial Registration Number: NCT01705769; Pre-results.
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http://dx.doi.org/10.1136/bmjgh-2016-000144DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5321385PMC
December 2016

Neonatal mortality within 24 hours of birth in six low- and lower-middle-income countries.

Bull World Health Organ 2016 Oct 30;94(10):752-758B. Epub 2016 Aug 30.

Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, avenue Appia 20, 1211 Geneva 27, Switzerland .

Objective: To estimate neonatal mortality, particularly within 24 hours of birth, in six low- and lower-middle-income countries.

Methods: We analysed epidemiological data on a total of 149 570 live births collected between 2007 and 2013 in six prospective randomized trials and a cohort study from predominantly rural areas of Bangladesh, Ghana, India, Pakistan, the United Republic of Tanzania and Zambia. The neonatal mortality rate and mortality within 24 hours of birth were estimated for all countries and mortality within 6 hours was estimated for four countries with available data. The findings were compared with published model-based estimates of neonatal mortality.

Findings: Overall, the neonatal mortality rate observed at study sites in the six countries was 30.5 per 1000 live births (range: 13.6 in Zambia to 47.4 in Pakistan). Mortality within 24 hours was 14.1 per 1000 live births overall (range: 5.1 in Zambia to 20.1 in India) and 46.3% of all neonatal deaths occurred within 24 hours (range: 36.2% in Pakistan to 65.5% in the United Republic of Tanzania). Mortality in the first 6 hours was 8.3 per 1000 live births, i.e. 31.9% of neonatal mortality.

Conclusion: Neonatal mortality within 24 hours of birth in predominantly rural areas of six low- and lower-middle-income countries was higher than model-based estimates for these countries. A little under half of all neonatal deaths occurred within 24 hours of birth and around one third occurred within 6 hours. Implementation of high-quality, effective obstetric and early newborn care should be a priority in these settings.
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http://dx.doi.org/10.2471/BLT.15.160945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5043199PMC
October 2016

Setting health research priorities using the CHNRI method: VI. Quantitative properties of human collective opinion.

J Glob Health 2016 Jun;6(1):010503

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

Introduction: Crowdsourcing has become an increasingly important tool to address many problems - from government elections in democracies, stock market prices, to modern online tools such as TripAdvisor or Internet Movie Database (IMDB). The CHNRI method (the acronym for the Child Health and Nutrition Research Initiative) for setting health research priorities has crowdsourcing as the major component, which it uses to generate, assess and prioritize between many competing health research ideas.

Methods: We conducted a series of analyses using data from a group of 91 scorers to explore the quantitative properties of their collective opinion. We were interested in the stability of their collective opinion as the sample size increases from 15 to 90. From a pool of 91 scorers who took part in a previous CHNRI exercise, we used sampling with replacement to generate multiple random samples of different size. First, for each sample generated, we identified the top 20 ranked research ideas, among 205 that were proposed and scored, and calculated the concordance with the ranking generated by the 91 original scorers. Second, we used rank correlation coefficients to compare the ranks assigned to all 205 proposed research ideas when samples of different size are used. We also analysed the original pool of 91 scorers to to look for evidence of scoring variations based on scorers' characteristics.

Results: The sample sizes investigated ranged from 15 to 90. The concordance for the top 20 scored research ideas increased with sample sizes up to about 55 experts. At this point, the median level of concordance stabilized at 15/20 top ranked questions (75%), with the interquartile range also generally stable (14-16). There was little further increase in overlap when the sample size increased from 55 to 90. When analysing the ranking of all 205 ideas, the rank correlation coefficient increased as the sample size increased, with a median correlation of 0.95 reached at the sample size of 45 experts (median of the rank correlation coefficient = 0.95; IQR 0.94-0.96).

Conclusions: Our analyses suggest that the collective opinion of an expert group on a large number of research ideas, expressed through categorical variables (Yes/No/Not Sure/Don't know), stabilises relatively quickly in terms of identifying the ideas that have most support. In the exercise we found a high degree of reproducibility of the identified research priorities was achieved with as few as 45-55 experts.
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http://dx.doi.org/10.7189/jogh.06.010503DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4920008PMC
June 2016

Setting health research priorities using the CHNRI method: V. Quantitative properties of human collective knowledge.

J Glob Health 2016 Jun;6(1):010502

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

Introduction: The CHNRI method for setting health research priorities has crowdsourcing as the major component. It uses the collective opinion of a group of experts to generate, assess and prioritize between many competing health research ideas. It is difficult to compare the accuracy of human individual and collective opinions in predicting uncertain future outcomes before the outcomes are known. However, this limitation does not apply to existing knowledge, which is an important component underlying opinion. In this paper, we report several experiments to explore the quantitative properties of human collective knowledge and discuss their relevance to the CHNRI method.

Methods: We conducted a series of experiments in groups of about 160 (range: 122-175) undergraduate Year 2 medical students to compare their collective knowledge to their individual knowledge. We asked them to answer 10 questions on each of the following: (i) an area in which they have a degree of expertise (undergraduate Year 1 medical curriculum); (ii) an area in which they likely have some knowledge (general knowledge); and (iii) an area in which they are not expected to have any knowledge (astronomy). We also presented them with 20 pairs of well-known celebrities and asked them to identify the older person of the pair. In all these experiments our goal was to examine how the collective answer compares to the distribution of students' individual answers.

Results: When answering the questions in their own area of expertise, the collective answer (the median) was in the top 20.83% of the most accurate individual responses; in general knowledge, it was in the top 11.93%; and in an area with no expertise, the group answer was in the top 7.02%. However, the collective answer based on mean values fared much worse, ranging from top 75.60% to top 95.91%. Also, when confronted with guessing the older of the two celebrities, the collective response was correct in 18/20 cases (90%), while the 8 most successful individuals among the students had 19/20 correct answers (95%). However, when the system in which the students who were not sure of the correct answer were allowed to either choose an award of half of the point in all such instances, or withdraw from responding, in order to improve the score of the collective, the collective was correct in 19/20 cases (95%), while the 3 most successful individuals were correct in 17/20 cases (85%).

Conclusions: Our experiments showed that the collective knowledge of a group with expertise in the subject should always be very close to the true value. In most cases and under most assumption, the collective knowledge will be more accurate than the knowledge of an "average" individual, but there always seems to be a small group of individuals who manage to out-perform the collective. The accuracy of collective prediction may be enhanced by allowing the individuals with low confidence in their answer to withdraw from answering.
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http://dx.doi.org/10.7189/jogh.06.010502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4920010PMC
June 2016

Setting health research priorities using the CHNRI method: II. Involving researchers.

J Glob Health 2016 Jun;6(1):010302

Centre for Global Health Research, the Usher Institute for Population Health Sciences and Informatics, the University of Edinburgh, Edinburgh, Scotland, UK; Nossal Institute for Global Health, University of Melbourne, Melbourne, Australia.

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http://dx.doi.org/10.7189/jogh.06.010302DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4920006PMC
June 2016

Setting health research priorities using the CHNRI method: III. Involving stakeholders.

J Glob Health 2016 Jun;6(1):010303

Centre for Global Health Research, The Usher Institute for Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, Scotland, UK; Nossal Institute for Global Health, University of Melbourne, Melbourne, Australia.

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http://dx.doi.org/10.7189/jogh.06.010303DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4894379PMC
June 2016

Strengthening accountability to end preventable maternal deaths.

Int J Gynaecol Obstet 2015 Oct 26;131 Suppl 1:S3-5. Epub 2015 Feb 26.

World Health Organization, Geneva, Switzerland.

The present paper describes the ongoing efforts to revitalize the accountability of national governments toward preventable maternal deaths. Maternal death reviews are included in the national health policies of the majority of countries contributing 95% of global maternal deaths. However in actual practice, the extent of implementation and follow-up of recommended actions on lessons learnt from maternal death reviews is inadequate. This paper describes and discusses the role of the Maternal Death Surveillance and Response (MDSR) system in strengthening accountability and ending preventable maternal deaths. MDSR provides a surveillance tool for timely information on where, when, and why maternal deaths occur, builds on maternal death reviews, and includes the missing "response" component for improving quality of care and preventing maternal deaths.
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http://dx.doi.org/10.1016/j.ijgo.2015.02.012DOI Listing
October 2015

Setting research priorities to improve global newborn health and prevent stillbirths by 2025.

J Glob Health 2016 Jun;6(1):010508

Departments of Pediatrics, Pharmacology & Surgery, University of Alberta, Canada.

Background: In 2013, an estimated 2.8 million newborns died and 2.7 million were stillborn. A much greater number suffer from long term impairment associated with preterm birth, intrauterine growth restriction, congenital anomalies, and perinatal or infectious causes. With the approaching deadline for the achievement of the Millennium Development Goals (MDGs) in 2015, there was a need to set the new research priorities on newborns and stillbirth with a focus not only on survival but also on health, growth and development. We therefore carried out a systematic exercise to set newborn health research priorities for 2013-2025.

Methods: We used adapted Child Health and Nutrition Research Initiative (CHNRI) methods for this prioritization exercise. We identified and approached the 200 most productive researchers and 400 program experts, and 132 of them submitted research questions online. These were collated into a set of 205 research questions, sent for scoring to the 600 identified experts, and were assessed and scored by 91 experts.

Results: Nine out of top ten identified priorities were in the domain of research on improving delivery of known interventions, with simplified neonatal resuscitation program and clinical algorithms and improved skills of community health workers leading the list. The top 10 priorities in the domain of development were led by ideas on improved Kangaroo Mother Care at community level, how to improve the accuracy of diagnosis by community health workers, and perinatal audits. The 10 leading priorities for discovery research focused on stable surfactant with novel modes of administration for preterm babies, ability to diagnose fetal distress and novel tocolytic agents to delay or stop preterm labour.

Conclusion: These findings will assist both donors and researchers in supporting and conducting research to close the knowledge gaps for reducing neonatal mortality, morbidity and long term impairment. WHO, SNL and other partners will work to generate interest among key national stakeholders, governments, NGOs, and research institutes in these priorities, while encouraging research funders to support them. We will track research funding, relevant requests for proposals and trial registers to monitor if the priorities identified by this exercise are being addressed.
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http://dx.doi.org/10.7189/jogh.06.010508DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576458PMC
June 2016

Approaches, tools and methods used for setting priorities in health research in the 21(st) century.

Authors:
Sachiyo Yoshida

J Glob Health 2016 Jun;6(1):010507

Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.

Background: Health research is difficult to prioritize, because the number of possible competing ideas for research is large, the outcome of research is inherently uncertain, and the impact of research is difficult to predict and measure. A systematic and transparent process to assist policy makers and research funding agencies in making investment decisions is a permanent need.

Methods: To obtain a better understanding of the landscape of approaches, tools and methods used to prioritize health research, I conducted a methodical review using the PubMed database for the period 2001-2014.

Results: A total of 165 relevant studies were identified, in which health research prioritization was conducted. They most frequently used the CHNRI method (26%), followed by the Delphi method (24%), James Lind Alliance method (8%), the Combined Approach Matrix (CAM) method (2%) and the Essential National Health Research method (<1%). About 3% of studies reported no clear process and provided very little information on how priorities were set. A further 19% used a combination of expert panel interview and focus group discussion ("consultation process") but provided few details, while a further 2% used approaches that were clearly described, but not established as a replicable method. Online surveys that were not accompanied by face-to-face meetings were used in 8% of studies, while 9% used a combination of literature review and questionnaire to scrutinise the research options for prioritization among the participating experts.

Conclusion: The number of priority setting exercises in health research published in PubMed-indexed journals is increasing, especially since 2010. These exercises are being conducted at a variety of levels, ranging from the global level to the level of an individual hospital. With the development of new tools and methods which have a well-defined structure - such as the CHNRI method, James Lind Alliance Method and Combined Approach Matrix - it is likely that the Delphi method and non-replicable consultation processes will gradually be replaced by these emerging tools, which offer more transparency and replicability. It is too early to say whether any single method can address the needs of most exercises conducted at different levels, or if better results may perhaps be achieved through combination of components of several methods.
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http://dx.doi.org/10.7189/jogh.06.010507DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576459PMC
June 2016

Setting health research priorities using the CHNRI method: I. Involving funders.

J Glob Health 2016 Jun;6(1):010301

Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.

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http://dx.doi.org/10.7189/jogh.06.010301DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576461PMC
June 2016

Health-related quality of life in parents of pediatric solid organ transplant recipients in Japan.

Pediatr Transplant 2015 May 5;19(3):332-41. Epub 2015 Feb 5.

Department of Family Nursing, The University of Tokyo, Hongo, Bunkyo-ku, Tokyo, Japan; Department of Transplant Surgery, Jichi Medical University, Shimotsuke City, Tochigi, Japan.

Few studies have examined HRQOL in pediatric Tx recipients' parents. This study investigated HRQOL in these parents and relationships between HRQOL and perceived burden of nurturing, family functioning, and social support. Self-report anonymous questionnaires and a survey of medical records were completed between September and December 2013. The SF-36v2, which evaluates physical, psychological, and social health, was used to measure HRQOL. While values for physical and psychological health were higher than standard values (Cohen's d = 0.34 and 0.17, respectively), social health scores were lower (d = 0.21). "Parental consultation unrelated to donation" (standardized partial regression coefficient: β = -0.52) was associated with physical health. "Family functioning" and "Commuting time between home and primary follow-up hospital" (β = 0.57 and -0.31) were related to psychological health. "Total score for perceived burden of nurturing" (β = -0.31) was related to social health. Regarding parental HRQOL, while physical and psychological health was favorable, social health was impaired. In clinical practice, interventions targeting parents' physical conditions and facilitation of community and family understanding and support to share recipients' nurturing are important in improving parental HRQOL.
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http://dx.doi.org/10.1111/petr.12435DOI Listing
May 2015

Efficacy of early neonatal supplementation with vitamin A to reduce mortality in infancy in Haryana, India (Neovita): a randomised, double-blind, placebo-controlled trial.

Lancet 2015 Apr 11;385(9975):1333-42. Epub 2014 Dec 11.

Centre for Health Research and Development, Society for Applied Studies, New Delhi, India. Electronic address:

Background: Vitamin A supplementation in children aged 6 months to 5 years has been shown to reduce mortality. The efficacy of neonatal supplementation with vitamin A to reduce mortality in the first 6 months of life is plausible but not established. We aimed to assess the efficacy of neonatal oral supplementation with vitamin A to reduce mortality between supplementation and 6 months of age.

Methods: We undertook an individually randomised, double-blind, placebo-controlled trial in Haryana, India. We identified pregnant women through a surveillance programme undertaken every 3 months of all female residents in two districts of Haryana, India, aged 15-49 years, and screened every identified livebirth. Eligible participants were neonates whose parents consented to participate, were likely to stay in the study area until at least 6 months of age, and were able to feed orally at the time of enrolment. Participants were randomly assigned to receive oral capsules containing vitamin A (retinol palmitate 50,000 IU plus vitamin E 9·5-12·6 IU) or placebo (vitamin E 9·5-12·6 IU) within 72 h of birth. Randomisation was in blocks of 20 according to a randomisation list prepared by a statistician not otherwise involved with the trial. Investigators, participants' families, and the data analysis team were masked to treatment allocation. The primary outcome was mortality between supplementation and 6 months of age. Analysis included all participants assigned to study groups. This trial is registered with ClinicalTrials.gov, number NCT01138449, and the Indian Council of Medical Research Clinical Trial Registry, number CTRI/2010/091/000220.

Findings: Between June 24, 2010, and July 1, 2012 we screened 47,777 neonates and randomly assigned 44,984 to receive vitamin A (22,493) or placebo (22,491). Between supplementation and 6 months of age, 656 infants died in the vitamin A group compared with 726 in the placebo group (29·2 per 1000 vs 32·3 per 1000; difference -3·1 per 1000, 95% CI -6·3 to 0·1; risk ratio 0·90, 95% CI 0·81 to 1·00). We noted no significant interactions between the intervention effect and sex on mortality at 6 months (p=0·409). Supplementation with 50,000 IU vitamin A within the first 72 h of life was generally safe and well tolerated, with the exception of a small excess risk of transient bulging fontanelle (205 cases in the vitamin A group confirmed by physician vs 80 cases in the placebo group, risk ratio 2·56 [95% CI 1·98-3·32]).

Interpretation: The findings of this study, done in a population in which vitamin A deficiency is a moderate public health problem, are consistent with a modest reduction in mortality between supplementation and 6 months of age. These findings must be viewed together with similar trials in other populations to enable determination of appropriate public health policy.

Funding: Bill & Melinda Gates Foundation to WHO.
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http://dx.doi.org/10.1016/S0140-6736(14)60891-6DOI Listing
April 2015

Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial.

Lancet 2015 Apr 11;385(9975):1324-32. Epub 2014 Dec 11.

Harvard School of Public Health, Department of Global Health and Population, Boston, MA, USA.

Background: Supplementation of vitamin A in children aged 6-59 months improves child survival and is implemented as global policy. Studies of the efficacy of supplementation of infants in the neonatal period have inconsistent results. We aimed to assess the efficacy of oral supplementation with vitamin A given to infants in the first 3 days of life to reduce mortality between supplementation and 180 days (6 months).

Methods: We did an individually randomised, double-blind, placebo-controlled trial of infants born in the Morogoro and Dar es Salaam regions of Tanzania. Women were identified during antenatal clinic visits or in the labour wards of public health facilities in Dar es Salaam. In Kilombero, Ulanga, and Kilosa districts, women were seen at home as part of the health and demographic surveillance system. Newborn infants were eligible for randomisation if they were able to feed orally and if the family intended to stay in the study area for at least 6 months. We randomly assigned infants to receive one dose of 50,000 IU of vitamin A or placebo in the first 3 days after birth. Infants were randomly assigned in blocks of 20, and investigators, participants' families, and data analysis teams were masked to treatment assignment. We assessed infants on day 1 and day 3 after dosing, as well as at 1, 3, 6, and 12 months after birth. The primary endpoint was mortality at 6 months, assessed by field interviews. The primary analysis included only children who were not lost to follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12610000636055.

Findings: Between Aug 26, 2010, and March 3, 2013, 31,999 newborn babies were randomly assigned to receive vitamin A (n=15,995) or placebo (n=16,004; 15,428 and 15,464 included in analysis of mortality at 6 months, respectively). We did not find any evidence for a beneficial effect of vitamin A supplementation on mortality in infants at 6 months (26 deaths per 1000 livebirths in vitamin A vs 24 deaths per 1000 livebirths in placebo group; risk ratio 1·10, 95% CI 0·95-1·26; p=0·193). There was no evidence of a differential effect for vitamin A supplementation on mortality by sex; risk ratio for mortality at 6 months for boys was 1·08 (0·90-1·29) and for girls was 1·12 (0·91-1·39). There was also no evidence of adverse effects of supplementation within 3 days of dosing.

Interpretation: Neonatal vitamin A supplementation did not result in any immediate adverse events, but had no beneficial effect on survival in infants in Tanzania. These results strengthen the evidence against a global policy recommendation for neonatal vitamin A supplementation.

Funding: Bill & Melinda Gates Foundation to WHO.
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http://dx.doi.org/10.1016/S0140-6736(14)61731-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4419827PMC
April 2015

Newborn health research priorities beyond 2015.

Lancet 2014 Jul 19;384(9938):e27-9. Epub 2014 May 19.

Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva 1211, Switzerland. Electronic address:

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http://dx.doi.org/10.1016/S0140-6736(14)60263-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048618PMC
July 2014

Facilitators and barriers to quality of care in maternal, newborn and child health: a global situational analysis through metareview.

BMJ Open 2014 May 22;4(5):e004749. Epub 2014 May 22.

Department of Maternal, Newborn, Child & Adolescent Health, World Health Organization, Geneva, Switzerland.

Objective: Conduct a global situational analysis to identify the current facilitators and barriers to improving quality of care (QoC) for pregnant women, newborns and children.

Study Design: Metareview of published and unpublished systematic reviews and meta-analyses conducted between January 2000 and March 2013 in any language. Assessment of Multiple Systematic Reviews (AMSTAR) is used to assess the methodological quality of systematic reviews.

Settings: Health systems of all countries. Study outcome: QoC measured using surrogate indicators--effective, efficient, accessible, acceptable/patient centred, equitable and safe.

Analysis: Conducted in two phases (1) qualitative synthesis of extracted data to identify and group the facilitators and barriers to improving QoC, for each of the three population groups, into the six domains of WHO's framework and explore new domains and (2) an analysis grid to map the common facilitators and barriers.

Results: We included 98 systematic reviews with 110 interventions to improve QoC from countries globally. The facilitators and barriers identified fitted the six domains of WHO's framework--information, patient-population engagement, leadership, regulations and standards, organisational capacity and models of care. Two new domains, 'communication' and 'satisfaction', were generated. Facilitators included active and regular interpersonal communication between users and providers; respect, confidentiality, comfort and support during care provision; engaging users in decision-making; continuity of care and effective audit and feedback mechanisms. Key barriers identified were language barriers in information and communication; power difference between users and providers; health systems not accounting for user satisfaction; variable standards of implementation of standard guidelines; shortage of resources in health facilities and lack of studies assessing the role of leadership in improving QoC. These were common across the three population groups.

Conclusions: The barriers to good-quality healthcare are common for pregnant women, newborns and children; thus, interventions targeted to address them will have uniform beneficial effects. Adopting the identified facilitators would help countries strengthen their health systems and ensure high-quality care for all.
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http://dx.doi.org/10.1136/bmjopen-2013-004749DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4039842PMC
May 2014

Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial.

Trials 2012 Feb 23;13:22. Epub 2012 Feb 23.

Department of Maternal Newborn Child and Adolescent Health, World Health Organization, Avenue Appia 20, 1211 Geneva 27, Switzerland.

Background: Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplementation. Three trials were therefore initiated in Ghana, India and Tanzania to determine if vitamin A supplementation (50,000 IU) given to neonates once orally on the day of birth or within the next two days will reduce mortality in the period from supplementation to 6 months of age compared to placebo.

Methods/design: The trials are individually randomized, double masked, and placebo controlled. The required sample size is 40,200 in India and 32,000 each in Ghana and Tanzania. The study participants are neonates who fulfil age eligibility, whose families are likely to stay in the study area for the next 6 months, who are able to feed orally, and whose parent(s) provide informed written consent to participate in the study. Neonates randomized to the intervention group receive 50,000 IU vitamin A and the ones randomized to the control group receive placebo at the time of enrollment. Mortality and morbidity information are collected through periodic home visits by a study worker during infancy. The primary outcome of the study is mortality from supplementation to 6 months of age. The secondary outcome of the study is mortality from supplementation to 12 months of age. The three studies will be analysed independent of each other. Subgroup analysis will be carried out to determine the effect by birth weight, sex, and timing of DTP vaccine, socioeconomic groups and maternal large-dose vitamin A supplementation.

Discussion: The three ongoing studies are the largest studies evaluating the efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies.
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http://dx.doi.org/10.1186/1745-6215-13-22DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3337818PMC
February 2012

Neonatal mortality levels for 193 countries in 2009 with trends since 1990: a systematic analysis of progress, projections, and priorities.

PLoS Med 2011 Aug 30;8(8):e1001080. Epub 2011 Aug 30.

World Health Organization, Department of Health Statistics and Informatics, Geneva, Switzerland.

Background: Historically, the main focus of studies of childhood mortality has been the infant and under-five mortality rates. Neonatal mortality (deaths <28 days of age) has received limited attention, although such deaths account for about 41% of all child deaths. To better assess progress, we developed annual estimates for neonatal mortality rates (NMRs) and neonatal deaths for 193 countries for the period 1990-2009 with forecasts into the future.

Methods And Findings: We compiled a database of mortality in neonates and children (<5 years) comprising 3,551 country-years of information. Reliable civil registration data from 1990 to 2009 were available for 38 countries. A statistical model was developed to estimate NMRs for the remaining 155 countries, 17 of which had no national data. Country consultation was undertaken to identify data inputs and review estimates. In 2009, an estimated 3.3 million babies died in the first month of life-compared with 4.6 million neonatal deaths in 1990-and more than half of all neonatal deaths occurred in five countries of the world (44% of global livebirths): India 27.8% (19.6% of global livebirths), Nigeria 7.2% (4.5%), Pakistan 6.9% (4.0%), China 6.4% (13.4%), and Democratic Republic of the Congo 4.6% (2.1%). Between 1990 and 2009, the global NMR declined by 28% from 33.2 deaths per 1,000 livebirths to 23.9. The proportion of child deaths that are in the neonatal period increased in all regions of the world, and globally is now 41%. While NMRs were halved in some regions of the world, Africa's NMR only dropped 17.6% (43.6 to 35.9).

Conclusions: Neonatal mortality has declined in all world regions. Progress has been slowest in the regions with high NMRs. Global health programs need to address neonatal deaths more effectively if Millennium Development Goal 4 (two-thirds reduction in child mortality) is to be achieved.
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http://dx.doi.org/10.1371/journal.pmed.1001080DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3168874PMC
August 2011
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