Publications

2017
Verani, JR, et al. 2017. “Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls”. Vaccine. Published in VaccineAbstract
Case-control studies are commonly used to evaluate effectiveness of licensed vaccines after deployment in public health programs. Such studies can provide policy-relevant data on vaccine performance under ‘real world’ conditions, contributing to the evidence base to support and sustain introduction of new vaccines. However, case-control studies do not measure the impact of vaccine introduction on disease at a population level, and are subject to bias and confounding, which may lead to inaccurate results that can misinform policy decisions. In 2012, a group of experts met to review recent experience with case-control studies evaluating the effectiveness of several vaccines; here we summarize the recommendations of that group regarding best practices for planning, design and enrollment of cases and controls. Rigorous planning and preparation should focus on understanding the study context including healthcare-seeking and vaccination practices. Case-control vaccine effectiveness studies are best carried out soon after vaccine introduction because high coverage creates strong potential for confounding. Endpoints specific to the vaccine target are preferable to non-specific clinical syndromes since the proportion of non-specific outcomes preventable through vaccination may vary over time and place, leading to potentially confusing results. Controls should be representative of the source population from which cases arise, and are generally recruited from the community or health facilities where cases are enrolled. Matching of controls to cases for potential confounding factors is commonly used, although should be reserved for a limited number of key variables believed to be linked to both vaccination and disease. Case-control vaccine effectiveness studies can provide information useful to guide policy decisions and vaccine development, however rigorous preparation and design is essential. Keywords
  • Vaccines; 
  • Case-control studies; 
  • Evaluation studies
Verani, JR, et al. 2017. “Case-control vaccine effectiveness studies: Data collection, analysis and reporting results”. Vaccine. Published in VaccineAbstract
The case-control methodology is frequently used to evaluate vaccine effectiveness post-licensure. The results of such studies provide important insight into the level of protection afforded by vaccines in a ‘real world’ context, and are commonly used to guide vaccine policy decisions. However, the potential for bias and confounding are important limitations to this method, and the results of a poorly conducted or incorrectly interpreted case-control study can mislead policies. In 2012, a group of experts met to review recent experience with case-control studies evaluating vaccine effectiveness; we summarize the recommendations of that group regarding best practices for data collection, analysis, and presentation of the results of case-control vaccine effectiveness studies. Vaccination status is the primary exposure of interest, but can be challenging to assess accurately and with minimal bias. Investigators should understand factors associated with vaccination as well as the availability of documented vaccination status in the study context; case-control studies may not be a valid method for evaluating vaccine effectiveness in settings where many children lack a documented immunization history. To avoid bias, it is essential to use the same methods and effort gathering vaccination data from cases and controls. Variables that may confound the association between illness and vaccination are also important to capture as completely as possible, and where relevant, adjust for in the analysis according to the analytic plan. In presenting results from case-control vaccine effectiveness studies, investigators should describe enrollment among eligible cases and controls as well as the proportion with no documented vaccine history. Emphasis should be placed on confidence intervals, rather than point estimates, of vaccine effectiveness. Case-control studies are a useful approach for evaluating vaccine effectiveness; however careful attention must be paid to the collection, analysis and presentation of the data in order to best inform evidence-based vaccine policies. Keywords
  • Vaccines; 
  • Case-control studies; 
  • Evaluation studies
Welch, VA, et al. 2017. “CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials”. BMJ. Publisher's VersionAbstract
We outline CONSORT-Equity 2017 reporting standards, an extension to the CONSORT (Consolidated Standards of Reporting Trials) statement that aims to improve the reporting of intervention effects in randomised trials where health equity is relevant. Health inequities are unfair differences in health that can be avoided by reasonable action. We defined a randomised trial where health equity is relevant as one that assesses effects on health equity by evaluating an intervention focused on people experiencing social disadvantage or by exploring the difference in the effect of the intervention between two groups (or as a gradient across more than two groups) experiencing different levels of social disadvantage, or both. We held a consensus meeting with diverse potential users from high, middle, and low income countries, including knowledge users such as patients and methodologists. We discussed evidence for each proposed extension item from empirical studies, reviews, key informant interviews, and an online survey, aiming to improve clarity of reporting without imposing undue burden on authors. The new guidance contains equity extensions to 16 items from CONSORT 2010 plus one new item on research ethics reporting, with examples of good practice and a brief explanation and elaboration for each. Widespread uptake of this guidance for the reporting of trials where health equity is relevant will make it easier for decision makers to find and use evidence from randomised trials to reduce unfair inequalities in health.
Onarheim, KH, et al. 2017. “What if the baby doesn't survive? Health-care decision making for ill newborns in Ethiopia”. Social Science & Medicine. Publisher's VersionAbstract
Despite efforts to improve access to and quality of care for newborns, the first month after birth remains the most dangerous period of life. Given high neonatal mortality in low-income countries, saving newborn lives is a key priority for global and national health policy agendas. However, little is known about how these policies resonate with local understandings, experiences and household priorities. In this qualitative study we examined families' decision making and health-care-seeking in Butajira, Ethiopia. Data were collected through observation in hospital, in-depth interviews (41), and focus group discussions (7) with family members, health-care workers, and community members (October–November 2015). Transcripts and field notes were analyzed inductively using qualitative content analysis. Findings indicate that newborn health was not always the family's priority. Local perceptions of newborns as not yet useful members of the household alongside costly health-care services delayed decision making and care-seeking. While sickness was recognized as dangerous for the ill newborn, seeking health-care could be harmful for the economic survival of the family. In a resource-constrained setting, families' focused on productive assets in order to minimize long-term risks, and waited before seeking newborn health-care services. Until the baby had survived the first vulnerable weeks and months of life, the unknown newborn was not yet seen as a social person by the community. Personhood evolved progressively as the baby became a part of the family. A newborn death was surrounded by silence, and families received minimal support from traditional financial associations, iddirs. Decisions regarding health-care were contingent upon families' understandings of newborns and their resource-constrained circumstances. Improving newborn health involves recognizing why families choose to (not) seek health-care, and their actual opportunities and constraints in making such decisions. The everyday realities of vulnerable newborns must be at the center of global and national policy discussions and local implementation. Keywords: EthiopiaNewborn healthHealth-care-seekingDecision makingPersonhoodPovertyQualitative research
Katirayi, L, et al. 2017. “Echoes of old HIV paradigms: reassessing the problem of engaging men in HIV testing and treatment through women's perspectives”. Reproductive Health. Article in PumedAbstract
BACKGROUND: With the introduction of 2016 World Health Organization guidelines recommending universal antiretroviral therapy (ART), there has been increased recognition of the lack of men engaging in HIV testing and treatment. Studies in sub-Saharan Africa indicate there have been challenges engaging men in HIV testing and HIV-positive men into treatment. METHODS:This qualitative study explored women's perspective of their male partner's attitudes towards HIV and ART and how it shapes woman's experience with ART. Data were collected through in-depth interviews and focus group discussions with HIV-positive pregnant and postpartum women on Option B+ and health care workers in Malawi and Zimbabwe. In Malawi, 19 in-depth interviews and 12 focus group discussions were conducted from September-December 2013. In Zimbabwe, 15 in-depth interviews and 21 focus-group discussions were conducted from July 2014-March 2014. RESULTS:The findings highlighted that many men discourage their partners from initiating or adhering to ART. One of the main findings indicated that despite the many advancements in HIV care and ART regimens, there are still many lingering negative beliefs about HIV and ART from the earlier days of the epidemic. In addition to existing theories explaining men's resistance to/absence in HIV testing and treatment as a threat to their masculinity or because of female-focused health facilities, this paper argues that men's aversion to HIV may be a result of old beliefs about HIV and ART which have not been addressed. CONCLUSIONS: Due to lack of accurate and up to date information about HIV and ART, many men discourage their female partners from initiating and adhering to ART. The effect of lingering and outdated beliefs about HIV and ART needs to be addressed through strengthened communication about developments in HIV care and treatment. Universal ART offers a unique opportunity to curb the epidemic, but successful implementation of these new guidelines is dependent on ART initiation and adherence by both women and men. Strengthening men's understanding about HIV and ART will greatly enhance women's ability to initiate and adhere to ART and improve men's health. KEYWORDS: ART initiation; Africa; HIV; Lifelong treatment; Male engagement; PMTCT; Qualitative; Universal treatment
Hailu, A, et al. 2017. “Economic burden of malaria and predictors of cost variability to rural households in south-central Ethiopia”. Plos One. Article in PumedAbstract
BACKGROUND: While recognizing the recent remarkable achievement in the global malaria reduction, the disease remains a challenge to the malaria endemic countries in Africa. Beyond the huge health consequence of malaria, policymakers need to be informed about the economic burden of the disease to the households. However, evidence on the economic burden of malaria in Ethiopia is scanty. The aims of this study were to estimate the economic burden of malaria episode and to identify predictors of cost variability to the rural households. METHODS:A prospective costing approach from a household perspective was employed. A total of 190 malaria patients were enrolled to the study from three health centers and nine health posts in Adami Tullu district in south-central Ethiopia, in 2015. Primary data were collected on expenditures due to malaria, forgone working days because of illness, socioeconomic and demographic situation, and households' assets. Quantile regression was applied to predict factors associated with the cost variation. Socioeconomic related inequality was measured using concentration index and concentration curve. RESULTS: The median cost of malaria per episode to the household was USD 5.06 (IQR: 2.98-8.10). The direct cost accounted for 39%, while the indirect counterpart accounted for 61%. The history of malaria in the last six months and the level of the facility visited in the health system predominantly influenced the direct cost. The indirect cost was mainly influenced by the availability of antimalarial drugs in the health facility. The concentration curve and the concentration index for direct cost indicate significant pro-rich inequality. Plasmodium falciparum is significantly more costly for households compared to Plasmodium vivax. CONCLUSION:The economic burden of malaria to the rural households in Ethiopia was substantial-mainly to the poor-indicating that reducing malaria burden could contribute to the poverty reduction as well.
Jull, J, et al. 2017. “When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework”. BMJ Open. Publisher's VersionAbstract
Background Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. Methods An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. Results A randomised trial can usefully be classified as ‘health equity relevant’ if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as ‘health equity relevant’ may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. Conclusion The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.
  • health
  • equity
  • randomized controlled trials
  • framework
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Chowdhury, R, et al. 2017. “Gender differences in infant survival: A secondary data analysis in rural North India”. BMJ Open 7. Publisher's VersionAbstract
Objective To examine gender differences in infant survival on the first day of life, in the first week of life, and in the neonatal and post-neonatal periods by socio-demographic and economic variables. Design Secondary data analysis was performed on data from a cluster randomised trial on the effect of implementation of the Integrated Management of Neonatal and Childhood Illness programme, India. Settings The study setting was Palwal and Faridabad, districts of Haryana, a state in North India. Measures Multiple logistic regression models taking the cluster design into account were used to estimate gender differences in mortality in different periods of infancy. Results A total of 60 480 infants were included in these analyses. Of 4060 infant deaths, 2054 were female (7.2% of all females born) and 2006 were male (6.3% of all males born). The death rate was significantly higher in females in the post-neonatal period but not during the neonatal period. The odds of death at 29–180 days and at 181–365 days were 1.4 (95% CI 1.3 to 1.6) and 1.7 (95% CI: 1.4 to 2.0) higher in females compared with males, respectively. This increase was seen across all socio-demographic and economic strata. Conclusion Gender differences during the post-neonatal period are a major threat to the survival and health of female infants in India. Programmes need to identify measures that can specifically reduce female mortality.
Nankabirwa, V, et al. 2017. “Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial.”. Trials. Article in Pubmed Abstract
BACKGROUND: Yearly, nearly all the estimated worldwide 2.7 million neonatal deaths occur in low- and middle-income countries. Infections, including those affecting the umbilical cord (omphalitis), are a significant factor in approximately a third of these deaths. In fact, the odds of all-cause mortality are 46% higher among neonates with omphalitis than in those without. Five large randomized controlled trials in Asia and Sub-Saharan Africa (SSA) have examined the effect of multiple cord stump applications with 4% chlorhexidine (CHX) for at least 7 days on the risk of omphalitis and neonatal death. These studies, all community-based, show that multiple CHX applications reduced the risk of omphalitis. Of these trials, only one study from South Asia (the Bangladeshi study) and none from Africa examined the effect of a single application of CHX as soon as possible after birth. In this Bangladeshi trial, CHX led to a reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an African setting, to explore the effect of a single application among health-facility births. A single application is programmatically much simpler to implement than daily applications for 7 days. Therefore, our study compares umbilical cord cleansing with a single application of 4% CHX at birth with dry cord care among Ugandan babies born in health facilities, on the risk of omphalitis and severe neonatal illness. METHODS: The CHX study is a facility-based, individually randomized controlled trial that will be conducted among 4760 newborns in Uganda. The primary outcomes are severe illness and omphalitis during the neonatal period. Analysis will be by intention-to-treat. DISCUSSION: This study will provide novel evidence, from a Sub-Saharan African setting, of the effect of umbilical cord cleansing with a single application of 4% CHX at birth and identify modifiable risk factors for omphalitis. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02606565. Registered on 12 November 2015. KEYWORDS: Chlorhexidine; Neonatal; Newborn; Omphalitis; Severe illness; Trial
Mazumder, S, et al. 2017. “Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial.”. Trials. Article in Pubmed Abstract
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). KEYWORDS: Community-initiated Kangaroo Mother Care; Low birth weight babies; Mortality
Sanou, AS, et al. 2017. “Maternal alcohol consumption during pregnancy and child's cognitive performance at 6-8 years of age in rural Burkina Faso: an observational study”. Peer J. Article in Pubmed Abstract
BACKGROUND: In Burkina Faso, it is not uncommon for mothers to drink alcohol, even during pregnancy. We aimed to study the association between maternal alcohol consumption during pregnancy and the child's cognitive performance using the Kaufman Assessment Battery for Children, 2nd edition (KABC-II) and the Children's Category Test Level 1 (CCT-1) in rural Burkina Faso. METHODS:We conducted a follow-up study of a community cluster-randomised Exclusive breastfeeding trial, and re-enrolled the children in rural Burkina Faso. A total of 518 children (268 boys and 250 girls) aged 6-8 years were assessed using the KABC-II and the CCT-1. We examined the effect size difference using Cohen's d and conducted a linear regression analysis to examine the association. RESULTS: Self-reported alcohol consumption during pregnancy was 18.5% (96/518). Children whose mothers reported alcohol consumption during pregnancy performed significantly poorly for memory and spatial abilities tests from small effect size difference for 'Atlantis' (0.27) and 'Triangle' (0.29) to moderate effect size difference for 'Number recall' (0.72) compared to children whose mothers did not consume alcohol during pregnancy; the exposed children scored significantly higher errors with a small effect size (0.37) at problem solving (CCT-1) test compared to unexposed children. At unstandardized and standardized multivariable analysis, children whose mothers reported alcohol consumption during pregnancy performed significantly poorer for memory-'Atlantis' (p = 0.03) and 'Number recall' (p = 0.0001), and spatial ability tests-'Triangle' (p = 0.03); they scored significantly higher errors at problem solving CCT-1 test (p = 0.002); all the results were adjusted for age, sex, schooling, stunting, father's education, mother's employment and the promotion of exclusive breastfeeding. No statistical association was found for visual abilities-'Conceptual Thinking', 'Face recognition', 'Story completion', and reasoning tests-'Rover', 'Block counting', and 'Pattern Reasoning'. CONCLUSION: Maternal alcohol consumption during pregnancy is associated with poorer cognitive performance for memory, spatial ability, and problem solving tests in the offspring in rural Burkina Faso. Futures studies needs to assess in more detail the maternal alcohol consumption patterns in Burkina Faso and possible preventive strategies. KEYWORDS: Africa; Burkina Faso; CCT-1; Child development; Children; Cognitive test; KABC-II; Maternal alcohol consumption; Pregnancy
Haugen, J, et al. 2017. “Vitamin D status is associated with treatment failure and duration of illness in Nepalese children with severe pneumonia.”. Pediatric Research. Article in Pubmed Abstract
BACKGROUND: There is no consensus on optimal Vitamin D status. The objective of this study was to estimate the extent to which vitamin D status predicts illness duration and treatment failure in children with severe pneumonia by using different cut-offs for vitamin D concentration. METHODS: We measured the plasma-concentration of 25(OH)D in 568 children hospitalized with WHO-defined severe pneumonia. The associations between vitamin D status, using the most frequently used cut-offs of vitamin D insufficiency (25(OH)D <50 and <75 nmol/l) and risk of treatment failure and time until recovery were analysed in multiple logistic regression and Cox proportional hazards models, respectively. RESULTS: Of the 568 children, 322 (56.7%) had plasma-25(OH)D ≥75 nmol/l, 179 (31.5%) 50-74.9 nmol/l and 67 (%) <50 nmol/l. Plasma-25(OH)D <50 nmol/l was associated with increased risk of treatment failure and longer time until recovery. CONCLUSION: Our findings indicate that low vitamin D status (25(OH)D <50 nmol/l) is an independent risk factor for treatment failure and delayed recovery of severe lower respiratory infections in children. TRIAL REGISTRATION: NCT00252304.Pediatric Research accepted article preview online, 05 July 2017. doi:10.1038/pr.2017.71.
Wadhwa, N, et al. 2017. “Zinc as an adjunct treatment for reducing case fatality due to clinical severe infection in young infants: study protocol for a randomized controlled trial”. BMC Pharmacology and Toxicology. Article in Pubmed Abstract
BACKGROUND: An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality.METHODS/DESIGN:This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment. DISCUSSION: A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants. TRIAL REGISTRATION: Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017. KEYWORDS: India; Infants; Neonate; Nepal; Sepsis; Severe infection; Zinc
Birungi, N, et al. 2017. “Assessing causal effects of early life-course factors on early childhood caries in 5-year-old Ugandan children using directed acyclic graphs (DAGs): A prospective cohort study.”. Community Dental and Oral Epidemiology. Article in PubMedAbstract
OBJECTIVE:To estimate the effect of distal and proximal early life-course factors on early childhood caries (ECC) in 5-year-old Ugandan children, particularly focusing on the causal effect of exclusive breast feeding (EBF) on ECC using directed acyclic graphs (DAGs) for confounder selection. METHODS:This study had a nested prospective cohort design, focusing on 5 years of follow-ups of caregiver-children pairs from the PROMISE-EBF trial (ClinicalTrials.gov no: NCT00397150) conducted in 2011 in Eastern Uganda. Data were from recruitment interviews, 24-week, 2-year and 5-year follow-ups of a cohort of 417 mother-children pairs. Trained research assistants performed interviews with caregivers in the local language and ECC was recorded under field conditions using the World Health Organization's (WHO) decayed missing or filled teeth (dmft) index. Early life-course factors in terms of socio-demographic characteristics, EBF and other feeding habits were assessed at the various follow-ups. The outcome (ECC; dmft>0) was assessed at the 5-year follow-up. Causal diagrams as DAGs were constructed to guide the selection of confounding and collider variables to be included in or excluded from the final multivariable analysis. Negative binomial regression analyses were performed based on two comparative DAGs representing different causal models. RESULTS:Model 1 based on DAG 1, showed EBF to be a protective factor against ECC, with an IRR and 95% CI of 0.62 (0.43-0.91). According to Model 2 based on DAG 2, EBF and having both parents living together had protective effects: the corresponding IRRs and 95% CI were 0.60 (0.41-0.88) and 0.48 (0.25-0.90), respectively. CONCLUSIONS:Both plausible models indicated that being exclusively breastfed for 24 weeks had a protective causal effect against ECC. Further research, examining the unmeasured variables included in the DAGs is necessary to strengthen the present finding and allow stronger causal claims. OBJECTIVE: To estimate the effect of distal and proximal early life-course factors on early childhood caries (ECC) in 5-year-old Ugandan children, particularly focusing on the causal effect of exclusive breast feeding (EBF) on ECC using directed acyclic graphs (DAGs) for confounder selection. METHODS: This study had a nested prospective cohort design, focusing on 5 years of follow-ups of caregiver-children pairs from the PROMISE-EBF trial (ClinicalTrials.gov no: NCT00397150) conducted in 2011 in Eastern Uganda. Data were from recruitment interviews, 24-week, 2-year and 5-year follow-ups of a cohort of 417 mother-children pairs. Trained research assistants performed interviews with caregivers in the local language and ECC was recorded under field conditions using the World Health Organization's (WHO) decayed missing or filled teeth (dmft) index. Early life-course factors in terms of socio-demographic characteristics, EBF and other feeding habits were assessed at the various follow-ups. The outcome (ECC; dmft>0) was assessed at the 5-year follow-up. Causal diagrams as DAGs were constructed to guide the selection of confounding and collider variables to be included in or excluded from the final multivariable analysis. Negative binomial regression analyses were performed based on two comparative DAGs representing different causal models. RESULTS: Model 1 based on DAG 1, showed EBF to be a protective factor against ECC, with an IRR and 95% CI of 0.62 (0.43-0.91). According to Model 2 based on DAG 2, EBF and having both parents living together had protective effects: the corresponding IRRs and 95% CI were 0.60 (0.41-0.88) and 0.48 (0.25-0.90), respectively. CONCLUSIONS: Both plausible models indicated that being exclusively breastfed for 24 weeks had a protective causal effect against ECC. Further research, examining the unmeasured variables included in the DAGs is necessary to strengthen the present finding and allow stronger causal claims.
Ogutto, DW, et al. 2017. “Rapid reduction of malaria following introduction of vector control interventions in Tororo District, Uganda: a descriptive study.”. Malaria Journal. Article in PubmedAbstract
BACKGROUND: In 2012, Tororo District had the highest malaria burden in Uganda with community Plasmodium prevalence of 48%. To control malaria in the district, the Ministry of Health introduced universal distribution of long lasting insecticide-treated nets (LLINs) in 2013 and added indoor residual spraying (IRS) in 2014. This study assessed malaria incidence, test positivity rates and outpatient (OPD) attendance due to malaria before and after vector control interventions. METHODS: This study was based on analysis of Health Management Information System (HMIS) secondary malaria surveillance data of 2,727,850 patient records in OPD registers of 61 health facilities from 2012 to 2015. The analysis estimated monthly malaria incidence for the entire population and also separately for <5- and ≥5-year-olds before and after introduction of vector control interventions; determined laboratory test positivity rates and annual percentage of malaria cases in OPD. Chi square for trends was used to analyse annual change in malaria incidence and logistic regression for monthly reduction. RESULTS: Following universal LLINs coverage, the annual mean monthly malaria incidence fell from 95 cases in 2013 to 76 cases per 1000 in 2014 with no significant monthly reduction (OR = 0.99, 95% CI 0.96-1.01, P = 0.37). Among children <5 years, the malaria incidence reduced from 130 to 100 cases per 1000 (OR = 0.98, 95% CI 0.97-1.00, P = 0.08) when LLINs were used alone in 2014, but declined to 45 per 1000 in 2015 when IRS was combined with LLINs (OR = 0.94, 95% CI 0.91-0.996, P < 0.0001). Among individuals aged ≥5 years, mean monthly malaria incidence reduced from 59 to 52 cases per 1000 (OR = 0.99, 95% CI 0.97-1.02, P = 0.8) when LLINs were used alone in 2014, but reduced significantly to 25 per 1000 in 2015 (OR = 0.91, 95% CI 0.88-0.94, P < 0.0001). Malaria test positivity rate reduced from 57% in 2013 to 30% (Chi = 15, P < 0.0001) in 2015. Slide positivity rate reduced from 45% in 2013 to 21% in 2015 (P = 0.004) while RDT positivity declined from 69 to 40%. CONCLUSIONS: A rapid reduction in malaria incidence was observed in Tororo District following the introduction of IRS in addition to LLINs. There was no significant reduction in malaria incidence following universal distribution of LLINs to communities before introduction of IRS. KEYWORDS: Control; Incidence; Malaria; Reduction; Vector
Pay, ASD, et al. 2017. “Symphysis-fundus measurement - the predictive value of a new reference curve.”. Tidsskrift for den norske legeforening. Article in Pubmed
The International Stillbirth Alliance Collaborative for Improving Classification of Perinatal Deaths,, et al. 2017. “Classification of causes and associated conditions for stillbirths and neonatal deaths”. Semin Fetal Neonatal Med. Article in PubMedAbstract
Accurate and consistent classification of causes and associated conditions for perinatal deaths is essential to inform strategies to reduce the five million which occur globally each year. With the majority of deaths occurring in low- and middle-income countries (LMICs), their needs must be prioritised. The aim of this paper is to review the classification of perinatal death, the contemporary classification systems including the World Health Organization's International Classification of Diseases - Perinatal Mortality (ICD-PM), and next steps. During the period from 2009 to 2014, a total of 81 new or modified classification systems were identified with the majority developed in high-income countries (HICs). Structure, definitions and rules and therefore data on causes vary widely and implementation is suboptimal. Whereas system testing is limited, none appears ideal. Several systems result in a high proportion of unexplained stillbirths, prompting HICs to use more detailed systems that require data unavailable in low-income countries. Some systems appear to perform well across these different settings. ICD-PM addresses some shortcomings of ICD-10 for perinatal deaths, but important limitations remain, especially for stillbirths. A global approach to classification is needed and seems feasible. The new ICD-PM system is an important step forward and improvements will be enhanced by wide-scale use and evaluation. Implementation requires national-level support and dedicated resources. Future research should focus on implementation strategies and evaluation methods, defining placental pathologies, and ways to engage parents in the process.
Nankabirwa, V, et al. 2017. “Early versus late BCG vaccination in HIV-1-exposed infants in Uganda: study protocol for a randomized controlled trial”. Trials 18(152). Published ini TrialsAbstract
Background Bacillus Calmette-Guérin (BCG) vaccination may have nonspecific effects, i.e., effects on childhood morbidity and mortality that go beyond its effect on the risk of childhood tuberculosis (TB). Though the available scientific literature is mostly from observational studies, and is fraught with controversy, BCG vaccination at birth may protect infants in high-mortality populations against serious infections other than TB. Yet, other studies indicate that giving BCG later in infancy may modify immune responses to non-TB antigens and potentially enhance immunity, potentially also against tuberculosis (TB). It is unclear whether BCG vaccination very early in life offers adequate protection against TB and other infections among HIV-1-exposed children because even those who remain uninfected with HIV-1 show signs of impaired immunocompetence early in infancy. This study will compare BCG vaccination at birth with BCG vaccination at 14 weeks of age in HIV-1-exposed infants. Methods This is an individually randomized controlled trial in 2200 HIV-1-exposed infants. The intervention is BCG vaccination within 24 h of birth while the comparator is BCG given at 14 weeks of age. The study co-primary outcomes are severe illness in the first 14 weeks of life, and production of tumor necrosis factor, interleukin (IL)-1β, IL-6 and interferon-γ in response to mycobacterial and nonmycobacterial antigens. The study is being conducted in three health centers in Uganda. Discussion A well-timed BCG vaccination could have important nonspecific effects in HIV-1-exposed infants. This trial could inform the development of appropriate timing of BCG vaccination for HIV-1-exposed infants. Trial registration ClinicalTrials.gov, identifier: NCT02606526. Registered on 12 November 2015. Keywords BCG Vaccination Infants HIV-1-exposed Nonspecific effects Trial
Shrestha, M, et al. 2017. “How much do Nepalese mothers know about child development?”. Early Child Development and Care. Article in Early Child Development and CareAbstract
Parental knowledge on child development is important for maximal developmental potential. This study was conducted to assess mothers’ knowledge on child development in Nepal. The Caregivers Knowledge of Child Development Inventory (CKCDI) was used to interview mothers. Total of 1272 mothers were interviewed. Out of the total CKCDI score of 40, mean score (SD) obtained by mothers was 20 (4.8). Mothers’ knowledge on the developmental milestone composite was better than stimulation composite with scores of 11.14 (3.09) and 8.9 (3.17), respectively (p < .005). Few mothers (38%) identified the correct ages of developmental milestones. Although most of the mothers knew about teaching their children to count or name colors, few knew when to start to read with children. With low level of knowledge on child development among Nepalese mothers, early childhood development programmes should be considered integrated with other health care programmes targeting young children and families.
Byaro, M, and P Musonda. 2017. “Per capita income and public health expenditure: what makes good child health outcome in Tanzania? a comparison of Frequentist and Bayesian approach (1995-2013)”. International Journal of Health 5(1): 74-81. Published in International Journal of HealthAbstract
Using data for World Bank Development Indicators (2015) database from 1995 to 2013, this paper explores the impact of public health expenditure on national health outcomes in Tanzania while GDP per capita and improved sanitation facilities as explanatory variables were controlled for. Two national health outcomes indicators namely, infant and under-five mortality were used as dependent variables. With separate modeling approach, Frequentist and Bayesian based on time series and Markov Chain Monte Carlo (MCMC) respectively, empirical evidence shows that income, represented by real GDP per capita lower infant and under-five mortality in Tanzania. Under both methodological approach regardless of the sample size, we failed to support evidence that, public health expenditure and improved sanitation facilities had an impact on child health outcomes. Our results imply that, public health spending in Tanzania is poorly targeted to bring good child health outcomes. The paper draws attention to policy makers in Tanzania to focus either within public health spending composition or beyond to other close determinants of infant and under-five mortality.

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