Looking beyond the numbers: quality assurance procedures in the Global Network for Women's and Children's Health Research Maternal Newborn Health Registry.

BACKGROUND: Quality assurance (QA) is a process that should be an integral part of research to protect the rights and safety of study participants and to reduce the likelihood that the results are affected by bias in data collection. Most QA plans include processes related to study preparation and regulatory compliance, data collection, data analysis and publication of study results. However, little detailed information is available on the specific procedures associated with QA processes to ensure high-quality data in multi-site studies. METHODS: The Global Network for Women's and Children's Health Maternal Newborn Health Registy (MNHR) is a prospective population-based registry of pregnancies and deliveries that is carried out in 8 international sites. Since its inception, QA procedures have been utilized to ensure the quality of the data. More recently, a training and certification process was developed to ensure that standardized, scientifically accurate clinical definitions are used consistently across sites. Staff complete a web-based training module that reviews the MNHR study protocol, study forms and clinical definitions developed by MNHR investigators and are certified through a multiple choice examination prior to initiating study activities and every six months thereafter. A standardized procedure for supervision and evaluation of field staff is carried out to ensure that research activites are conducted according to the protocol across all the MNHR sites. CONCLUSIONS: We developed standardized QA processes for training, certification and supervision of the MNHR, a multisite research registry. It is expected that these activities, together with ongoing QA processes, will help to further optimize data quality for this protocol.

The Novelty of Inhalable Medications: Interest, Use, and Impact of Inhalant Medications in Low-Resource Settings.

INTRODUCTION: Postpartum haemorrhage (PPH) claims more than 100,000 maternal lives annually worldwide, most of them in low-resource settings. To address morbidity and mortality from PPH, the global health community is exploring novel drug formulations, such as inhalable medicine, to improve treatment availability and use, especially in community settings with limited access to skilled birth attendants. A major limitation in the ability to prevent or treat PPH in resource-limited settings is that the most effective medications for prevention and treatment are injectables, which require administration by skilled birth attendants. METHODOLOGY: We conducted formative research, including online surveys and in-person interviews, with a range of providers across a variety of health-care settings in Guatemala, Indonesia, Kenya, and Nigeria, to better understand the standard of care for mothers and newborns in low-resource settings, including care practices related to PPH. RESULTS: It is estimated that up to 40% of PPH deaths could be averted if an inhalable prevention and treatment were available. However, survey and interview respondents noted a desire for more intravenous and oral medicinal formulations over inhalable formulations. DISCUSSION/CONCLUSION: Lack of knowledge and use of inhalable medicines among these health workers illuminates key challenges to introducing novel formulations in low-resource settings.

Maternal and Neonatal Directed Assessment of Technologies (MANDATE): Methods and Assumptions for a Predictive Model for Maternal, Fetal, and Neonatal Mortality Interventions.

Maternal, fetal, and neonatal mortality disproportionately impact low- and middle-income countries, and many current interventions that can save lives are often not available nor appropriate for these settings. Maternal and Neonatal Directed Assessment of Technologies (MANDATE) is a mathematical model designed to evaluate which interventions have the greatest potential to save maternal, fetal, and neonatal lives saved in sub-Saharan Africa and India. The MANDATE decision-support model includes interventions such as preventive interventions, diagnostics, treatments, and transfers to different care settings to compare the relative impact of different interventions on mortality outcomes. The model is calibrated and validated based on historical and current rates of disease in sub-Saharan Africa and India. In addition, each maternal, fetal, or newborn condition included in MANDATE considers disease rates specific to sub-Saharan Africa and India projected to intervention rates similar to those seen in high-income countries. Limitations include variance in quality of data to inform the estimates and generalizability of findings of the effectiveness of the interventions. The model serves as a valuable resource to compare the potential impact of multiple interventions, which could help reduce maternal, fetal, and neonatal mortality in low-resource settings. The user should be aware of assumptions in evaluating the model and interpret results accordingly.

The MANDATE model for evaluating interventions to reduce postpartum hemorrhage.

OBJECTIVE: To create a comprehensive model of the comparative impact of various interventions on maternal, fetal, and neonatal (MFN) mortality. METHODS: The major conditions and sub-conditions contributing to MFN mortality in low-resource areas were identified, and the prevalence and case fatality rates documented. Available interventions were mapped to these conditions, and intervention coverage and efficacy were identified. Finally, a computer model developed by the Maternal and Neonatal Directed Assessment of Technology (MANDATE) initiative estimated the potential of current and new interventions to reduce mortality. RESULTS: For PPH, the sub-causes, prevalence, and MFN case fatality rates were calculated. Available interventions were mapped to these sub-causes. Most available interventions did not prevent or treat the overall condition of PPH, but rather sub-conditions associated with hemorrhage and thus prevented only a fraction of the associated deaths. CONCLUSION: The majority of current interventions address sub-conditions that cause death, rather than the overall condition; thus, the potential number of lives saved is likely to be overestimated. Additionally, the location at which mother and infant receive care affects intervention effectiveness and, therefore, the potential to save lives. A comprehensive view of MFN conditions is needed to understand the impact of any potential intervention.

Clinical algorithms for the identification of sick newborns in community-based settings.

UNLABELLED: Clinical algorithms can be powerful tools for the identification of sick newborns at risk of neonatal mortality. Several studies have evaluated clinical signs for newborns aged 0-60 days to identify severe illness; however, few studies have focused specifically on the most vulnerable time period for neonatal death, the first week of life. Therefore, we reviewed the studies that evaluated clinical signs in newborns 0-60 days, focusing on infants 0 to <7 days. Based on a comparison of relevant studies, we then identified the common, important clinical signs shown to be useful for the identification of at-risk newborns by health workers in community-based and low-resource settings. CONCLUSION: We concluded that further work is urgently needed to develop a clinical algorithm for widespread validation in various community-based settings, which focuses specifically on newborns <7 days at risk of early neonatal mortality.

Neonatal mortality from respiratory distress syndrome: lessons for low-resource countries.

Respiratory distress syndrome (RDS) is a major contributor to neonatal mortality worldwide. However, little information is available regarding rates of RDS-specific mortality in low-income countries, and technologies for RDS treatment are used inconsistently in different health care settings. Our objective was to better understand the interventions that have decreased the rates of RDS-specific mortality in high-income countries over the past 60 years. We then estimated the effects on RDS-specific mortality in low-resource settings. Of the sequential introduction of technologies and therapies for RDS, widespread use of oxygen and continuous positive airway pressure were associated with the time periods that demonstrated the greatest decline in RDS-specific mortality. We argue that these 2 interventions applied widely in low-resource settings, with appropriate supportive infrastructure and general newborn care, will have the greatest impact on decreasing neonatal mortality. This historical perspective can inform policy-makers for the prioritization of scarce resources to improve survival rates for newborns worldwide.

Lessons for low-income regions following the reduction in hypertension-related maternal mortality in high-income countries.

OBJECTIVES: To evaluate pre-eclampsia/eclampsia-associated maternal mortality in high-income countries to understand better the potential improvements in pre-eclampsia/eclampsia-related mortality in low-income countries. METHODS: We searched Medline, PubMed, and the Cochrane Database (1900-2010) using relevant search terms. Studies of the incidence of pre-eclampsia/eclampsia and case fatality rates in various geographic regions were included. The incidence of pre-eclampsia/eclampsia and the pre-eclampsia/eclampsia-associated case fatality rates are presented by location and year. RESULTS: Most declines in maternal mortality associated with pre-eclampsia/eclampsia in high-income countries occurred between 1940 and 1970 and were associated with a 90% reduction in the incidence of eclampsia and a 90% reduction in the case fatality rate in women with eclampsia. The most important interventions were widespread use of prenatal care with blood pressure and urine protein measurement, and increased access to hospital care for timely induction of labor or cesarean delivery for women with severe pre-eclampsia or seizures. CONCLUSIONS: A substantial reduction in pre-eclampsia/eclampsia-related mortality could be made in low-income countries by widespread hypertension and proteinuria screening and early delivery of women with severe disease. Magnesium sulfate may reduce mortality, but should not be the cornerstone of maternal mortality reduction programs.