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.
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.
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.
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.
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.
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.
ClinicalTrials.gov, identifier: NCT02606526. Registered on 12 November 2015.
BCG Vaccination Infants HIV-1-exposed Nonspecific effects Trial
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.
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.
Background: Poor vitamin B-12 (cobalamin) status is widespread in South Asia. Insufficient vitamin B-12 status has been linked to poor neurodevelopment in young children.
Objective: We measured the associations between vitamin B-12 status in infancy (2–12 mo) and the development and cognitive functioning in Nepalese children 5 y later.
Design: Vitamin B-12 status was assessed in infancy with the use of plasma cobalamin, total homocysteine (tHcy), and methylmalonic acid (MMA). At 5 y of age, we measured development with the use of the Ages and Stages Questionnaire, 3rd edition (ASQ-3), and cognitive functioning by using the Developmental Neuropsychological Assessment, 2nd edition (NEPSY II), in 320 children. In regression models, we estimated the associations between vitamin B-12 status, including a combined indicator of vitamin B-12 status (3cB12) and scores on the ASQ-3 and NEPSY II subtests.
Results: All markers of vitamin B-12 status with the exception of plasma cobalamin were significantly associated with the total ASQ-3 scores in the multiple regression models. A 1-unit increase in the 3cB12 score was associated with an increase in the total ASQ-3 score of 4.88 (95% CI: 2.09, 7.68; P = 0.001). Increases in both plasma tHcy and MMA (indicating poorer status) were associated with a decrease in scores on the NEPSY II affect recognition and geometric puzzle subtests. Each unit increment in 3cB12 scores was associated with increases of 0.82 (95% CI: 0.49, 1.14; P < 0.0005), 0.59 (95% CI: 0.10, 1.09; P = 0.020), and 0.24 (95% CI: 0.02, 0.47; P = 0.035) in the affect recognition, geometric puzzle, and block construction scores, respectively.
Conclusions: Vitamin B-12 status in infancy is associated with development and performance on social perception tasks and visuospatial abilities at 5 y of age. The long-term effects of poor vitamin B-12 status in infancy need further investigation in randomized controlled trials.
Recent studies have demonstrated a relationship between poor vitamin D status and respiratory infections and diarrhea among young children. Acute lower respiratory infections (ALRI) and diarrhea are among the two most important causes of death in under-5 children. In this paper, we examined the extent to which vitamin-D deficiency (<10 ng/ml) predicts ALRI, clinical pneumonia and diarrhea among 6 to 30 months old children.
We used data from a randomized controlled trial (RCT) of daily folic acid and/or vitamin B12 supplementation for six months in 6 to 30 months old children conducted in Delhi, India. Generalized estimating equations (GEE) were used to examine the associations between vitamin-D deficiency and episodes of ALRI, clinical pneumonia and diarrhea.
Of the 960 subjects who had vitamin-D concentrations measured, 331(34.5%) were vitamin-D deficient. We found, after controlling for relevant potential confounders (age, sex, breastfeeding status, wasting, stunting, underweight, anemia status and season), that the risk of ALRI was significantly higher among vitamin-D deficient (OR 1.26; 95% CI: 1.03 to 1.55) compared to vitamin-D-replete children in the six months follow-up period. Vitamin-D status was not associated with episodes of diarrhea or clinical pneumonia.
Vitamin-D deficiency is common in young children in New Delhi and is associated with a higher risk of ALRI. The role of vitamin D in Indian children needs to be elucidated in further studies.
BACKGROUND:Child health interventions were drastically scaled up in the period leading up to 2015 as countries aimed at meeting the 2015 target of the Millennium Development Goals (MDGs). MDGs were defined in terms of achieving improvements in average health. Significant improvements in average child health are documented, but evidence also points to rising inequality. It is important to investigate factors that drive the increasing disparities in order to inform the post-2015 development agenda of reducing inequality, as captured in the Sustainable Development Goals (SDGs). We investigated changes in socioeconomic inequality in stunting and fever in Zambia in 2007 and 2014. Unlike the huge literature that seeks to quantify the contribution of different determinants on the observed inequality at any given time, we quantify determinants of changes in inequality.METHODS:Data from the 2007 and 2014 waves of the Zambia Demographic and Health Survey (DHS) were utilized. Our sample consisted of children aged 0-5 years (n = 5,616 in 2007 and n = 12,714 in 2014). We employed multilevel models to assess the determinants of stunting and fever, which are two important child health indicators. The concentration index (CI) was used to measure the magnitude of inequality. Changes in inequality of stunting and fever were investigated using Oaxaca-type decomposition of the CI. In this approach, the change in the CI for stunting/fever is decomposed into changes in CI for each determinant and changes in the effect-measured as an elasticity-of each determinant on stunting/fever.
RESULTS:While average rates of stunting reduced in 2014 socioeconomic inequality in stunting increased significantly. Inequality in fever incidence also increased significantly, but average rates of fever did not reduce. The increase in the inequality (CI) of determinants accounted for the largest part (42.5%) of the increase in inequality of stunting, while the increase in the effect of determinants explained 35% of the increase. The determinants with the greatest total contribution (change in CI plus change in effect) to the increase in inequality of stunting were mother's height and weight, wealth, birth order, facility delivery, duration of breastfeeding, and maternal education. For fever, almost all (86%) the increase in inequality was accounted for by the increase in the effect of determinants of fever, while the distribution of determinants mattered less. The determinants with the greatest total contribution to the increase in inequality of fever were wealth, maternal education, birth order and breastfeeding duration. In the multilevel model, we found that the likelihood of a child being stunted or experiencing fever depends on the community in which they live.
CONCLUSIONS: To curb the increase in inequality of stunting and fever, policy may focus on improving levels of, and reducing inequality in, access to facility deliveries, maternal nutrition (which may be related to maternal weight and height), complementary feeding (for breastfed children), wealth, maternal education, and child care (related to birth order effects). Improving overall levels of these determinants contribute to the persistence of inequality if these determinants are unequally concentrated on the well off to begin with.
Poor vitamin D status has been associated with increased risk and severity of respiratory tract infections. Whether or not inflammation and infection affects 25-hydroxy vitamin D (25(OH)D) concentration is controversial and is important in the interpretation of observational studies using plasma-25(OH)D as a biomarker for status. Our objectives were to measure whether 25(OH)D concentration was altered by an episode of acute lower respiratory tract infection and whether markers of inflammation predicted the 25(OH)D concentration. Children aged 2-35 months with severe (n = 43) and non-severe (n = 387) community-acquired, WHO-defined pneumonia were included. 25(OH)D concentration and inflammatory markers (cytokines, chemokines, and growth factors) were measured in plasma during the acute phase and 14, 45, and 90 days later. Predictors for 25(OH)D concentrations were identified in multiple linear regression models. Mean 25(OH)D concentration during the acute phase and after recovery (14, 45, and 90 days) was 84.4 nmol/L ± 33.6, and 80.6 ± 35.4, respectively. None of the inflammatory markers predicted 25(OH)D concentration in the multiple regression models. Age was the most important predictor for 25(OH)D concentration, and there were no differences in 25(OH)D concentrations during illness and after 14, 45, and 90 days when adjusting for age. Infection and inflammation did not alter the 25(OH)D concentration in young children with acute lower respiratory tract infections.
KEYWORDS: Nepal; acute lower respiratory tract infection; children; inflammation; vitamin D
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
BACKGROUND: During the last decade there has been a growing concern about the lack of results in the health sectors of many low income countries. Progress has been particularly slow in maternal- and child health. Prompted by the need to accelerate progress towards these health outcomes, pay-for- performance (P4P) schemes have been initiated in a number of countries. This paper explores the perceptions and experiences of health workers with P4P bonus distribution in the health system context of rural Tanzania.
METHODS:This qualitative study was based on the P4P pilot in Pwani Region of Tanzania. The study took place in 11 health care facilities in Rufiji District. The study informants and participants were different cadres of health workers assigned to different outpatient and inpatient departments at the health facilities, and local administrators of the P4P bonus distribution. Thirty two in-depth interviews (IDIs) with administrators and health care workers, and six focus group discussions (FGDs with Reproductive and Child Health (RCH) staff, non-RCH staff and non-medical staff were conducted. Collected data was analyzed through qualitative content analysis.
RESULTS:The study found that the bonus distribution modality employed in the P4P programme was experienced as fundamentally unjust. The bonuses were calculated according to the centrality of the health worker position in meeting targeted indicators, drawn from the reproductive and child health (RCH) section. Both RCH staff and non-RCH perceived the P4P bonus as unfair. Non-RCH objected to getting less bonus than RCH staff, and RCH staff running the targeted RCH services, objected to not getting more P4P bonus. Non-RCH staff and health administrators suggested a flat-rate across board as the fairest way of distributing P4P bonuses. The perceived unfairness affected work motivation, undermined teamwork across departments and created tensions in the social relations at health facilities.
CONCLUSION: Our results suggest that the experience of unfairness in the way bonuses are distributed and administered at the health facility level undermines the legitimacy of the P4P scheme. More importantly, long term tensions and conflicts at the workplace may impact negatively on the quality of care which P4P was intended to improve. We argue that fairness is a critical factor to the success of a P4P scheme and that particular attention should be paid to aspects of workplace justice in the design of P4P bonus structures.
KEYWORDS: Distributive and procedural justice; Fairness; Health sector; Health worker motivation; Incentives; Pay for Performance (P4P); Results-based financing (RBF); Social relations; Tanzania
Adolescent pregnancies pose a risk to the young mothers and their babies. In Zambia, 35% of young girls in rural areas have given birth by the age of 18 years. Pregnancy rates are particularly high among out-of-school girls. Poverty, low enrolment in secondary school, myths and community norms all contribute to early childbearing. This protocol describes a trial aiming to measure the effect on early childbearing rates in a rural Zambian context of (1) economic support to girls and their families, and (2) combining economic support with a community intervention to enhance knowledge about sexual and reproductive health and supportive community norms.
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.
BACKGROUND: Electronic health registries - eRegistries - can systematically collect relevant information at the point of care for reproductive, maternal, newborn and child health (RMNCH). However, a suite of process and outcome indicators is needed for RMNCH to monitor care and to ensure comparability between settings. Here we report on the assessment of current global indicators and the development of a suite of indicators for the WHO Essential Interventions for use at various levels of health care systems nationally and globally.
METHODS: Currently available indicators from both household and facility surveys were collated through publicly available global databases and respective survey instruments. We then developed a suite of potential indicators and associated data points for the 45 WHO Essential Interventions spanning preconception to newborn care. Four types of performance indicators were identified (where applicable): process (i.e. coverage) and outcome (i.e. impact) indicators for both screening and treatment/prevention. Indicators were evaluated by an international expert panel against the eRegistries indicator evaluation criteria and further refined based on feedback by the eRegistries technical team.
RESULTS: Of the 45 WHO Essential Interventions, only 16 were addressed in any of the household survey data available. A set of 216 potential indicators was developed. These indicators were generally evaluated favourably by the panel, but difficulties in data ascertainment, including for outcome measures of cause-specific morbidity and mortality, were frequently reported as barriers to the feasibility of indicators. Indicators were refined based on feedback, culminating in the final list of 193 total unique indicators: 93 for preconception and antenatal care; 53 for childbirth and postpartum care; and 47 for newborn and small and ill baby care.
CONCLUSIONS: Large gaps exist in the availability of information currently collected to support the implementation of the WHO Essential Interventions. The development of this suite of indicators can be used to support the implementation of eRegistries and other data platforms, to ensure that data are utilised to support evidence-based practice, facilitate measurement and accountability, and improve maternal and child health outcomes.
KEYWORDS: Intervention coverage; Maternal health; Newborn health; Outcome indicators; Performance indicators; Perinatal health; Process indicators; Registries; ehealth
Electronic health registries - eRegistries - can systematically collect relevant information at the point of care for reproductive, maternal, newborn and child health (RMNCH). However, a suite of process and outcome indicators is needed for RMNCH to monitor care and to ensure comparability between settings. Here we report on the assessment of current global indicators and the development of a suite of indicators for the WHO Essential Interventions for use at various levels of health care systems nationally and globally.
Currently available indicators from both household and facility surveys were collated through publicly available global databases and respective survey instruments. We then developed a suite of potential indicators and associated data points for the 45 WHO Essential Interventions spanning preconception to newborn care. Four types of performance indicators were identified (where applicable): process (i.e. coverage) and outcome (i.e. impact) indicators for both screening and treatment/prevention. Indicators were evaluated by an international expert panel against the eRegistries indicator evaluation criteria and further refined based on feedback by the eRegistries technical team.
Of the 45 WHO Essential Interventions, only 16 were addressed in any of the household survey data available. A set of 216 potential indicators was developed. These indicators were generally evaluated favourably by the panel, but difficulties in data ascertainment, including for outcome measures of cause-specific morbidity and mortality, were frequently reported as barriers to the feasibility of indicators. Indicators were refined based on feedback, culminating in the final list of 193 total unique indicators: 93 for preconception and antenatal care; 53 for childbirth and postpartum care; and 47 for newborn and small and ill baby care.
Large gaps exist in the availability of information currently collected to support the implementation of the WHO Essential Interventions. The development of this suite of indicators can be used to support the implementation of eRegistries and other data platforms, to ensure that data are utilised to support evidence-based practice, facilitate measurement and accountability, and improve maternal and child health outcomes.
Intervention coverage; Maternal health; Newborn health; Outcome indicators; Performance indicators; Perinatal health; Process indicators; Registries; ehealth
BACKGROUND: Each year, about 5.3 million babies die in the perinatal period. Understanding of causes of death is critical for prevention, yet there is no globally acceptable classification system. Instead, many disparate systems have been developed and used. We aimed to identify all systems used or created between 2009 and 2014, with their key features, including extent of alignment with the International Classification of Diseases (ICD) and variation in features by region, to inform the World Health Organization's development of a new global approach to classifying perinatal deaths.
METHODS: A systematic literature review (CINAHL, EMBASE, Medline, Global Health, and PubMed) identified published and unpublished studies and national reports describing new classification systems or modifications of existing systems for causes of perinatal death, or that used or tested such systems, between 2009 and 2014. Studies reporting ICD use only were excluded. Data were independently double-extracted (except from non-English publications). Subgroup analyses explored variation by extent and region.
RESULTS: Eighty-one systems were identified as new, modifications of existing systems, or having been used between 2009 and 2014, with an average of ten systems created/modified each year. Systems had widely varying characteristics: (i) comprehensiveness (40 systems classified both stillbirths and neonatal deaths); (ii) extent of use (systems were created in 28 countries and used in 40; 17 were created for national use; 27 were widely used); (iii) accessibility (three systems available in e-format); (iv) underlying cause of death (64 systems required a single cause of death); (v) reliability (10 systems tested for reliability, with overall Kappa scores ranging from .35-.93); and (vi) ICD alignment (17 systems used ICD codes). Regional databases were not searched, so system numbers may be underestimated. Some non-differential misclassification of systems was possible.
CONCLUSIONS: The plethora of systems in use, and continuing system development, hamper international efforts to improve understanding of causes of death. Recognition of the features of currently used systems, combined with a better understanding of the drivers of continued system creation, may help the development of a truly effective global system.
KEYWORDS: Cause of death; Classification; Classification system; Neonatal death; Perinatal death; Stillbirth
BACKGROUND: Facility-based births have been promoted as the main strategy to reduce maternal and neonatal death risks at global scale. To improve birth outcomes, it is critical that health facilities provide quality care. Using a framework to assess quality of care, this paper examines health workers' perceptions about access to facility birth; the effectiveness of the care provided and obstacles to quality birth care in a rural area of Burkina Faso.
METHODS: A qualitative study was conducted in 2011 in the Banfora Region, Burkina Faso. Participant observations were carried out in four different health centres for a period of three months; more than 30 deliveries were observed. In-depth interviews were conducted with 12 frontline health workers providing birth care and with two staff of the local health district management team. Interview transcripts and field notes were analysed thematically.
RESULTS:Health workers in this rural area of Burkina Faso provided birth care in a context of limited financial resources, insufficient personnel and poorly equipped facilities; the quality of the birth care provided was severely compromised. Health workers tended to place the responsibility for poor quality of care on infrastructural limitations and patient behaviour, while our observational data also identified missed opportunities that would not demand additional resources throughout the process of care like early initiation of breastfeeding and skin-to-skin contact after birth. Health workers felt disempowered, having limited abilities to prevent and treat birth complications, and resorted to alternative and potentially harmful strategies.
CONCLUSIONS: We found poor quality of care at birth, missed opportunities, and health worker disempowerment in rural health facilities of Banfora, Burkina Faso. There is an urgent need to provide health workers with the necessary tools to prevent and handle birth complications, and to ensure that existing low cost life-saving interventions in maternal and new-born health are appropriately used and integrated into the daily routines in maternity wards at all levels.
KEYWORDS: (Sub-Saharan) Africa; Childbirth; Primary healthcare; Quality of healthcare
BACKGROUND: To reduce the burden of 5.3 million stillbirths and neonatal deaths annually, an understanding of causes of deaths is critical. A systematic review identified 81 systems for classification of causes of stillbirth (SB) and neonatal death (NND) between 2009 and 2014. The large number of systems hampers efforts to understand and prevent these deaths. This study aimed to assess the alignment of current classification systems with expert-identified characteristics for a globally effective classification system.
METHODS:Eighty-one classification systems were assessed for alignment with 17 characteristics previously identified through expert consensus as necessary for an effective global system. Data were extracted independently by two authors. Systems were assessed against each characteristic and weighted and unweighted scores assigned to each. Subgroup analyses were undertaken by system use, setting, type of death included and type of characteristic.
RESULTS: None of the 81 systems were aligned with more than 9 of the 17 characteristics; most (82 %) were aligned with four or fewer. On average, systems were aligned with 19 % of characteristics. The most aligned system (Frøen 2009-Codac) still had an unweighted score of only 9/17. Alignment with individual characteristics ranged from 0 to 49 %. Alignment was somewhat higher for widely used as compared to less used systems (22 % v 17 %), systems used only in high income countries as compared to only in low and middle income countries (20 % vs 16 %), and systems including both SB and NND (23 %) as compared to NND-only (15 %) and SB-only systems (13 %). Alignment was higher with characteristics assessing structure (23 %) than function (15 %).
CONCLUSIONS: There is an unmet need for a system exhibiting all the characteristics of a globally effective system as defined by experts in the use of systems, as none of the 81 contemporary classification systems assessed was highly aligned with these characteristics. A particular concern in terms of global effectiveness is the lack of alignment with "ease of use" among all systems, including even the most-aligned. A system which meets the needs of users would have the potential to become the first truly globally effective classification system.
KEYWORDS: Cause; Classification; Classification system; Neonatal death; Perinatal death; Stillbirth
BACKGROUND: The limited availability of maternal and child health data has limited progress in reducing mortality and morbidity among pregnant women and children. Global health agencies, leaders, and funders are prioritizing strategies that focus on acquiring high quality health data. Electronic maternal and child health registries (eRegistries) offer a systematic data collection and management approach that can serve as an entry point for preventive, curative and promotive health services. Due to the highly sensitive nature of reproductive health information, careful consideration must be accorded to privacy, access, and data security. In the third paper of the eRegistries Series, we report on the current landscape of ethical and legal governance for maternal and child health registries in developing countries.
METHODS:This research utilizes findings from two web-based surveys, completed in 2015 that targeted public health officials and health care providers in 76 countries with high global maternal and child mortality burden. A sample of 298 public health officials from 64 countries and 490 health care providers from 59 countries completed the online survey. Based on formative research in the development of the eRegistries Governance Guidance Toolkit, the surveys were designed to investigate topics related to maternal and child health registries including ethical and legal issues.
RESULTS: According to survey respondents, the prevailing legal landscape is characterized by inadequate data security safeguards and weak support for core privacy principles. Respondents from the majority of countries indicated that health information from medical records is typically protected by legislation although legislation dealing specifically or comprehensively with data privacy may not be in place. Health care provider trust in the privacy of health data at their own facilities is associated with the presence of security safeguards.
CONCLUSION: Addressing legal requirements and ensuring that privacy and data security of women's and children's health information is protected is an ethical responsibility that must not be ignored or postponed, particularly where the need is greatest. Not only are the potential harm and unintended consequences of inaction serious for individuals, but they could impact public trust in health registries leading to decreased participation and compromised data integrity.
KEYWORDS: Data privacy; Ethics; Governance; Law; Maternal and child health; Registry; Security