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.

Autor: Aceituno AM; RTI International, 3040 E. Cornwallis Road, PO Box 12194, Research Triangle Park, NC, 27709, USA. aaceituno@rti.org.; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA. aaceituno@rti.org., Stanhope KK; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA., Rebolledo PA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.; Emory School of Medicine, Atlanta, GA, USA., Burke RM; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA., Revollo R; Servicio Departamental de Salud, La Paz, Bolivia., Iñiguez V; Instituto de Biotecnología y Microbiología, Universidad Mayor de San Andrés, La Paz, Bolivia., Suchdev PS; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.; Emory School of Medicine, Atlanta, GA, USA.; Nutrition Branch, Centers for Disease Control and Prevention, Atlanta, GA, USA., Leon JS; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Jazyk: angličtina
Zdroj: BMC public health [BMC Public Health] 2017 Nov 28; Vol. 17 (1), pp. 911. Date of Electronic Publication: 2017 Nov 28.
DOI: 10.1186/s12889-017-4904-5
Abstrakt: 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.
Databáze: MEDLINE
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