Using a monitoring and evaluation framework to improve study efficiency and quality during a prospective cohort study in infants receiving rotavirus vaccination in El Alto, Bolivia: the Infant Nutrition, Inflammation, and Diarrheal Illness (NIDI) study

• Type of Material: Article
• Authors: Anna M. Aceituno, RTI International; Kaitlyn K. Stanhope, Emory University; Paulina Rebolledo, Emory University; Rachel M. Burke, Emory University; Rita Revollo, Servicio Departamental de Salud; VOlga Iniguez, Universidad Mayor de San Andrés; Parminder Suchdev, Emory University; Juan Leon, Emory University
• Language: English
• Date: 2017-11-28
• Publisher: BioMed Central
• Publication Version: Final Published Version
• Copyright Statement: © 2017 The Author(s).
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s12889-017-4904-5
• Title of Journal or Parent Work: BMC Public Health
• ISSN: 1471-2458
• Volume: 17
• Issue: 1
• Start Page: 911
• End Page: 911
• Grant/Funding Information: Study design, data collection, and data analysis were supported by NIH-NIAID grants 1K01AI087724–01 and U19-AI057266 (received by JL), the Emory + Children’s Pediatric Center Seed Grant Program (received by PS), the Public Health Service Grant UL1 TR000454 from the NIH Clinical and Translational Science Award Program (received by JL), and the International Collaborative Award for Research from the International Pediatric Research Foundation (received by PS).; KS’s time for analysis and interpretation of data and writing the manuscript was supported by the Laney Graduate School of Emory University.; RB’s time and travel for data collection and analysis were supported by the Laney Graduate School of Emory University, a NIH T32 Institutional National Research Service Award training grant in Reproductive, Pediatric and Perinatal Epidemiology (HD052460–01), and the Burroughs Wellcome Fund’s Molecules to Mankind Program (M2 M).; We are grateful to the Emory University Global Health Institute and Emory University Rollins School of Global Public Health Global Field Experience Fund for travel support of several Emory graduate students who participated in this research.; PR’s time and travel for data collection and analysis were supported by the Thrasher Research Fund 2015 Early Career Award and the NIH Vaccinology Training Program award T32AI074492.; AA’s time for analysis and interpretation of data and writing the manuscript was supported by RTI International.
• Keywords: EARLY CHILD-DEVELOPMENT; DETERMINANTS; YOUNG-CHILDREN; DISEASE; Life Sciences & Biomedicine; ANEMIA BRINDA PROJECT; DEVELOPING-COUNTRIES; ZINC-DEFICIENCY; BIOMARKERS REFLECTING INFLAMMATION; Science & Technology; VACCINES; Public, Environmental & Occupational Health; RETINOL-BINDING-PROTEIN
• Research Categories: Health Sciences, Public Health; Health Sciences, Epidemiology

Abstract

Background: Implementing rigorous epidemiologic studies in low-resource settings involves challenges in participant recruitment and follow-up (e.g., mobile populations, distrust), biological sample collection (e.g., cold-chain, laboratory equipment scarcity) and data collection (e.g., literacy, staff training, and infrastructure). This article describes the use of a monitoring and evaluation (M & E) framework to improve study efficiency and quality during participant engagement, and biological sample and data collection in a longitudinal cohort study of Bolivian infants. Methods: The study occurred between 2013 and 2015 in El Alto, Bolivia, a high-altitude, urban, low-resource community. The study's M & E framework included indicators for participant engagement (e.g., recruitment, retention, safety), biological sample (e.g., stool and blood), and data (e.g., anthropometry, questionnaires) collection and quality. Monitoring indicators were measured regularly throughout the study and used for course correction, communication, and staff retraining. Results: Participant engagement indicators suggested that enrollment objectives were met (461 infants), but 15% loss-to-follow-up resulted in only 364 infants completing the study. Over the course of the study, there were four study-related adverse events (minor swelling and bruising related to a blood draw) and five severe adverse events (infant deaths) not related to study participation. Biological sample indicators demonstrated two blood samples collected from 95% (333 of 350 required) infants and stool collected for 61% of reported infant diarrhea episodes. Anthropometry data quality indicators were extremely high (median SDs for weight-for-length, length-for-age and weight-for-age z-scores 1.01, 0.98, and 1.03, respectively), likely due to extensive training, standardization, and monitoring efforts. Conclusions: Conducting human subjects research studies in low-resource settings often presents unique logistical difficulties, and collecting high-quality data is often a challenge. Investing in comprehensive M & E is important to improve participant recruitment, retention and safety, and sample and data quality. The M & E framework from this study can be applied to other longitudinal studies.