Quality question Number (proportion) ‘yes’
01 Was study design clear? 15 (100%)
02 Were methods used to identify ADRs described in detail? 7 (47%)
03 Were data collection methods clearly described? 12 (80%)
04 Were the individuals who identified ADRs clearly described? 10 (67%)
05 Was the process of establishing the causal relationship described in detail? 8 (53%)
06 Were standard methods used in causality assessment? 13 (87%)
07 Was the process of establishing avoidability described in detail? 7 (47%)
08 Were standard methods used in avoidability assessment? 7 (47%)
09 Was the process of establishing seriousness or severity described in detail? 5 (33%)
10 Were standard methods used in seriousness or severity assessment? 8 (53%)