McMaster Tool for Assessing Quality of Harms Assessment and Reporting in Study Reports (McHarm)
| 1. | Were the harms PRE-DEFINED using standardized 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 harms collection specified as ACTIVE? |
| 6. | Was the mode of harms 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? |
Source: Santaguida PL, Raina P. The development of the McHarm quality assessment scale for adverse events: Delphi consensus on important criteria for evaluating harms. Available at: http://hiru.mcmaster.ca/epc/mcharm.pdf. Accessed May 14, 2008.