Table 2.

Adapted McMaster Harms Evaluation with Best Practice Evaluation

BokemeyerBretthauerCausada-CaloRabeneckZwinkZafar
Were there harms PRE-DEFINED using standardized or precise definitions?YesNoYesYesYesYes
Were SERIOUS events precisely defined?YesNoNoNoYesNo
Were SEVERE events precisely defined?YesNoNoNoNoNo
Were the number of DEATHS in each study group specified OR were the reason(s) for not specifying them given?YesYesYesYesYesYes
Was the mode of harms collection specified as ACTIVE?NoNoNoNoYesNo
Was the mode of harms collection specified as PASSIVE?YesYesYesYesNoYes
Did the study specify WHO collected the harms?NoNoYesNoYesNo
Did the study specify the TRAINING or BACKGROUND of who ascertained the harms?NoNoNoNoNoNo
Did the study specify the TIMING and FREQUENCY of collection of the harms?YesYesYesYesYesYes
Did the author(s) use STANDARD scale(s) or checklist(s) for harms collection?YesNoYesYesNoNo
Did the authors specify if the harms reported encompass ALL the events collected or a selected SAMPLE?AllAllAllAllAllAll
Was the NUMBER of participants that withdrew or were lost to follow-up specified for each study group?N/AYesN/AN/AYesN/A
Was the TOTAL NUMBER of participants affected by harms specified for each study arm?YesYesYesYesYesYes
Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?YesYesYesYesYesYes
Did the author(s) specify the type of analyses undertaken for harms data?NoNoYesYesYesYes