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Table 2 Example Evaluation Indicators for Participant Enrollment, Follow-Up, Safety and Biological Samples, NIDI Study, 2013–2015

From: 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

Study Area Indicator Data Source for Indicator Results
Enrollment All eligible M-I pairs at each hospital are screened Clinical records review 2331 charts screened; 2203 age-eligible infants identified
Enrollment of 422 M-I pairs in 3 months (3–4 pairs/day/hospital) Enrollment data (weekly monitoring throughout study) Enrollment of 456 M-I pairs in 9 months
100% of M-I pairs have properly documented consent forms Paper copies of consent forms Successful consent collection from 100% of pairs
Follow-up 10% LTFU (8–9 pairs lost/visit, 380 pairs complete study) Enrollment data (weekly monitoring throughout study) 15% LTFU (364 infants completed study)
Safety 0 adverse events and 0 study-related severe adverse events Documentation and follow up of all adverse events (with standard form) 4 adverse eventsa; 5 severe adverse events, 0 study-related severe adverse events
Infant and maternal death rates below DHS rates for Bolivia Documentation and follow up of all deaths Among infants enrolled in the NIDI study, there were 0 maternal deaths and 5 infant deaths, equivalent to 10.8 per 1000, less than half of Bolivia’s infant mortality rateb.
Monthly reporting of AE/SAE, details of any deaths, reasons for all withdrawals Documentation of AE/SAE, deaths and reasons for withdrawal using standard forms 100% of withdrawals, deaths, AE/SAE documented
Biological Samples Successful collection of both infant blood samples from 82% of M-I pairs Documentation of blood sample collection through survey and laboratory data Successful collection of first two infant blood samples from 327 infants (75%)
Successful collection of shedding stool samples from 50% of infants Documentation of stool collection through survey and laboratory data Successful collection of shedding stool samples from 75% of infants
Successful collection of 25% of diarrhea samples (50% loss to non-reporting, collect 50% reported samples) Documentation of stool collection through survey and laboratory data
Comparison to Bolivia DHS data
Successful collection of 61% samples of reported diarrhea cases.
  1. aAdverse events included minor bruising and swelling from blood draws
  2. b In Bolivia, there were 23 infant deaths per 1000 post-neonatal infants; 34.7 maternal deaths per 100,000 live births (DHS, 2008)