Table 2

McMaster tool for assessing quality of harms assessment and reporting in study reports (McHarm)

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