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