Table 6.
Summary of recommendations for future efforts in standardization of AEFI definitions.
| Recommendation 1. Case definitions should be of sufficient detail and consistency of language to avoid ambiguity with respect to: | - Cut-offs/thresholds defining related AEs - Severity strata - Physiological or other evaluative criteria - Diagnostic methodology - Definition of key terms (e.g., gestational age as weeks of amenorrhea or as weeks post-conception) |
| Recommendation 2. Effort should be made to encourage the following qualities: | - Consistent reporting in Section 2 of AE definitions used or specific classification schemes/codes (e.g., ICD-9 codes) in all studies - Consistent reporting in results of all AEs defined |
| Recommendation 3. Explore the use of frequency analysis to inform standardization efforts where multiple case definitions for a given AE are available | |
| Recommendation 4. Prioritize appropriate standardization for future studies over “back-compatibility” with definitions in previous studies, given the substantial variability in existing definitions | |