Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Nov 28;17(1):911.
doi: 10.1186/s12889-017-4904-5.

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

Anna M Aceituno  1   2 , Kaitlyn K Stanhope  3 , Paulina A Rebolledo  4   5 , Rachel M Burke  3 , Rita Revollo  6 , Volga Iñiguez  7 , Parminder S Suchdev  4   5   8 , Juan S Leon  4
Affiliations

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

Anna M Aceituno et al. BMC Public Health. .

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.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

The study protocol, consent forms, documents, annual reports, and amendments were reviewed and approved by the Bolivian National Bioethics Committee, Research Ethics Commission (Comisión de Ética de la Investigación - Comité Nacional de Bioética) and by Emory University’s Institutional Review Board (IRB00056127). The study convened a Bolivian scientific advisory board, composed of three Bolivian pediatricians, to provide independent oversight and advocate for study participants. The scientific advisory board met annually 2012–2015 and reviewed all study data, protocol changes, and adverse event and severe adverse event reports. Mothers provided written consent in Spanish or Aymara after explaining the purpose of the study in their own words. The 42 mothers who were minors also needed their parent’s consent.

Consent for publication

Not applicable.

Competing interests

The authors declare they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The NIDI Study Enrollment and Loss to Follow-up, 2013–2015. * Five twin pairs were enrolled. ¥ The third infant blood draw was at 12–18 months of age due to new funding and new research questions, after many pairs had already completed the final study visit, resulting in a smaller sample size
Fig. 2
Fig. 2
NIDI Study Documents. a An example of the growth charts included in the handout mothers were given at the end of the study. See Appendix A for SAS program code used to create the growth chart, NIDIGrowthCurveMacro.sas. b The NIDI study logo (pending copyright), featuring an indigenous Aymara mother and infant. The logo was used on study documents, staff clothing and identification cards so that study participants could quickly find and identify staff. c An example of a figure from the monthly monitoring and evaluation reports. Identifying any digit preferences in anthropometric measurements was one method used to monitor measurement quality
See this image and copyright information in PMC

References

    1. Tindana PO, Singh JA, Tracy CS, Upshur REG, Daar AS, Singer PA, Frohlich J, Lavery JV. Grand Challenges in Global Health: Community Engagement in Research in Developing Countries. PLoS Med. 2007;4(9):e273. doi: 10.1371/journal.pmed.0040273. - DOI - PMC - PubMed
    1. Sitthi-Amorn C, Somrongthong R. Strengthening health research capacity in developing countries: a critical element for achieving health equity. BMJ. 2000;321(7264):813–817. doi: 10.1136/bmj.321.7264.813. - DOI - PMC - PubMed
    1. Matthias DM, Robertson J, Garrison MM, Newland S, Nelson C. Freezing temperatures in the vaccine cold chain: a systematic literature review. Vaccine. 2007;25(20):3980–3986. doi: 10.1016/j.vaccine.2007.02.052. - DOI - PubMed
    1. White F. Capacity-building for health research in developing countries: a manager's approach. Rev Panam Salud Publica. 2002;12:165–172. doi: 10.1590/S1020-49892002000900004. - DOI - PubMed
    1. Murray-Kolb LE, Rasmussen ZA, Scharf RJ, Rasheed MA, Svensen E, Seidman JC, Tofail F, Koshy B, Shrestha R, Maphula A, et al. The MAL-ED cohort study: methods and lessons learned when assessing early child development and caregiving mediators in infants and young children in 8 low- and middle-income countries. Clin Infect Dis. 2014;59(Suppl 4):S261–S272. doi: 10.1093/cid/ciu437. - DOI - PMC - PubMed

Substances