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

Abstract

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.

Why are the Pakistani maternal, fetal and newborn outcomes so poor compared to other low and middle-income countries?

“…11 Indiana School of Medicine, University of Indiana, Indianapolis, IN, USA. 12 University of Colorado School of Medicine, Denver, CO, USA. 13 Thomas Jefferson University, Philadelphia, PA, USA.…”

“…Interval maternal and newborn health and vital status are assessed at a third visit on day 42 after birth. The same study protocol and similar operational mechanisms are utilized at all the sites across the GN [12].…”

Birth weight and gestational age distributions in a rural Kenyan population

“…A major strength of our cohort is the data originated from a prospectively designed study. Subjects were enrolled early in pregnancy as part of the ASPIRIN trial, and tracked prospectively through delivery to 42 days postpartum, as part of our established, population-based maternal newborn health registry, which employs rigorous quality assurance procedures [42]. This design ensured that, as much as possible, all pregnancies were tracked, not just those enrolling late in gestation or even after delivery.…”

Reports from the NICHD Global Network’s Maternal and Newborn Health Registry: supplement introduction

“…To provide an overall picture of pregnancy and its outcomes and trends over time in LMIC, the Global Network developed this collection of papers. This supplement features 19 publications describing the Global Network and the Registry data from 2010 to 2018 [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19]. This supplement covers a wide variety of topics related to pregnancy outcome and neonatal health, focusing on ways to improve outcomes for the pregnant women and their fetuses and newborns.…”

“…Finally, the Global Network has put a great deal of effort into improving not only the quality of care for its subjects, but also into improving the quality of the data being collected. While metrics to assess quality have been a cornerstone of the Registry since its beginning, over time, improvements in data quality have occurred as reported by Garces et al [ 17 ]. Patel et al evaluated the quality of care around delivery related to early neonatal mortality [ 18 ].…”