Data quality monitoring and performance metrics of a prospective, population-based observational study of maternal and newborn health in low resource settings

Goudar, Shivaprasad S.; Stolka, Kristen; Koso‐Thomas, Marion; Honnungar, Narayan V; Mastiholi, Shivanand C.; Ramadurg, Umesh Y; Dhaded, Sangappa; Pasha, Omrana; Patel, Archana; Esamai, Fabian; Chomba, Elwyn; Garcés, Ana; Althabe, Fernando; Carlo, Waldemar A.; Goldenberg, Robert L.; Hibberd, Patricia L.; Liechty, Edward A.; Krebs, Nancy F.; Hambidge, Michael; Moore, Janet; Wallace, Dennis; Derman, Richard J.; S, Bhalachandra, Kodkany; Bose, Carl

doi:10.1186/1742-4755-12-s2-s2

Cited by 21 publications

(22 citation statements)

References 23 publications

(24 reference statements)

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“…6 Moi University School of Medicine, Eldoret, Kenya. 7 Lata Medical Research Foundation, Nagpur, India. 8 University Teaching Hospital, Lusaka, Zambia.…”

Section: Fundingmentioning

confidence: 99%

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The Global Network Maternal Newborn Health Registry: a multi-country, community-based registry of pregnancy outcomes

et al. 2020

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Background The Global Network for Women's and Children’s Health Research (Global Network) conducts clinical trials in resource-limited countries through partnerships among U.S. investigators, international investigators based in in low and middle-income countries (LMICs) and a central data coordinating center. The Global Network’s objectives include evaluating low-cost, sustainable interventions to improve women’s and children’s health in LMICs. Accurate reporting of births, stillbirths, neonatal deaths, maternal mortality, and measures of obstetric and neonatal care is critical to determine strategies for improving pregnancy outcomes. In response to this need, the Global Network developed the Maternal Newborn Health Registry (MNHR), a prospective, population-based registry of pregnant women, fetuses and neonates receiving care in defined catchment areas at the Global Network sites. This publication describes the MNHR, including participating sites, data management and quality and changes over time. Methods Pregnant women who reside in or receive healthcare in select communities are enrolled in the MNHR of the Global Network. For each woman and her offspring, sociodemographic, health care, and the major outcomes through 42-days post-delivery are recorded. Study visits occur at enrollment during pregnancy, at delivery and at 42 days postpartum. Results From 2010 through 2018, the Global Network MNHR sites were located in Guatemala, Belagavi and Nagpur, India, Pakistan, Democratic Republic of Congo, Kenya, and Zambia. During this period at these sites, 579,140 pregnant women were consented and enrolled in the MNHR, nearly 99% of all eligible women. Delivery data were collected for 99% of enrolled women and 42-day follow-up data for 99% of those delivered. In this supplement, the trends over time and assessment of differences across geographic regions are analyzed in a series of 18 manuscripts utilizing the MNHR data. Conclusions Improving maternal, fetal and newborn health in countries with poor outcomes requires an understanding of the characteristics of the population, quality of health care and outcomes. Because the worst pregnancy outcomes typically occur in countries with limited health registration systems and vital records, alternative registration systems may prove to be highly valuable in providing data. The MNHR, an international, multicenter, population-based registry, assesses pregnancy outcomes over time in support of efforts to develop improved perinatal healthcare in resource-limited areas. Trial Registration The Maternal Newborn Health Registry is registered at Clinicaltrials.gov (ID# NCT01073475). Registered February 23, 2019. https://clinicaltrials.gov/ct2/show/NCT01073475

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“…6 Moi University School of Medicine, Eldoret, Kenya. 7 Lata Medical Research Foundation, Nagpur, India. 8 University Teaching Hospital, Lusaka, Zambia.…”

Section: Fundingmentioning

confidence: 99%

“…The Global Network's Maternal Newborn Health Registry (MNHR) is a prospective, population-based registry implemented in the catchment areas of low-resource countries [4][5][6][7][8][9][10][11]. The MNHR began in 2008 in research sites in Argentina, Guatemala, India (2 sites), Pakistan, Kenya and Zambia.…”

Section: Introductionmentioning

confidence: 99%

The Global Network Maternal Newborn Health Registry: a multi-country, community-based registry of pregnancy outcomes

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“…To date, more than 450,000 pregnant women have been enrolled, of which delivery outcome data have been reported for 98.9% of women enrolled and 98% of 42 day follow-up visits, overall. No site has had >5% loss to follow-up at 42 days postpartum [36]. Each site develops a monitoring plan to ensure the quality of the data through assessment of various indicators of completeness of data collection, data quality, data accuracy and data entry.…”

Section: Landmark Trialsmentioning

confidence: 99%

The Global Network for Women's and Children's Health Research: A model of capacity-building research

Koso‐Thomas

McClure

2015

Seminars in Fetal and Neonatal Medicine

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SUMMARY In response to the global effort to accelerate progress towards the Millennium Development Goals 4 and 5, a partnership was created between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Bill and Melinda Gates Foundation to establish the Global Network for Women's and Children's Health Research (Global Network) in 2000. The Global Network was developed with a goal of building local maternal and child health research capacity in resource-poor settings. The objective of the network was to conduct research focused on several high-need areas, such as preventing life-threatening obstetric complications, improving birth weight and infant growth, and improving childbirth practices in order to reduce mortality. Scientists from developing countries, together with peers in the USA, lead research teams that identify and address population needs through randomized clinical trials and other research studies. Global Network projects develop and test cost-effective, sustainable interventions for pregnant women and newborns and provide guidance for national policy and for the practice of evidence-based medicine. This article reviews the results of the Global Network's research, the impact on policy and practice, and highlights the capacity-building efforts and collaborations developed since its inception.

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“…At the start of the MNHR, the investigators determined the critical data to collect, developed common definitions based on the WHO criteria, and also defined common methods to collect the data. In addition, the MNHR introduced a process of ongoing data quality monitoring, including metrics to assess missingness and accuracy, which was conducted both with local research teams and centrally, with a process for rapid feedback and resolution of data issues (Table 1) [12].…”

Section: Introductionmentioning

confidence: 99%

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

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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.

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Data quality monitoring and performance metrics of a prospective, population-based observational study of maternal and newborn health in low resource settings

Cited by 21 publications

References 23 publications

The Global Network Maternal Newborn Health Registry: a multi-country, community-based registry of pregnancy outcomes

The Global Network Maternal Newborn Health Registry: a multi-country, community-based registry of pregnancy outcomes

The Global Network for Women's and Children's Health Research: A model of capacity-building research

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

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