McMaster tool for assessing quality of harms assessment and reporting in study reports (McHarm)
| Question | |
| 1 | Were the harms predefined using standardised or precise definitions? |
| 2 | Were serious events precisely defined? |
| 3 | Were severe events precisely defined? |
| 4 | Were the number of deaths in each study group specified or were the reason(s) for not specifying them given? |
| 5 | Was the mode of harm collection specified as active? |
| 6 | Was the mode of harm collection specified as passive? |
| 7 | Did the study specify who collected the harms? |
| 8 | Did the study specify the training or background of who ascertained the harms? |
| 9 | Did the study specify the timing and frequency of collection of the harms? |
| 10 | Did the author(s) use standard scale(s) or checklist(s) for harms collection? |
| 11 | Did the authors specify if the harms reported encompass all the events collected or a selected sample? |
| 12 | Was the number of participants that withdrew or were lost to follow-up specified for each study group? |
| 13 | Was the total number of participants affected by harms specified for each study arm? |
| 14 | Did the author(s) specify the number for each type of harmful event for each study group? |
| 15 | Did the author(s) specify the type of analyses undertaken for harms data? |