Table 1

Summary of methodological quality assessments

McHarm* criteriaRatingNo of studies
(%)
(1) Were the harms PRE-DEFINED using standardised or precise definitions?Yes6 (7)
No79 (93)
Unsure0
(2) Were SERIOUS events precisely defined?Yes2 (2)
No83 (98)
Unsure0
(3) Were SEVERE events precisely defined?Yes0
No85 (100)
Unsure0
(4) Were the number of DEATHS in each study group specified OR were the reason(s) for not specifying them given?Yes10 (12)
No75 (88)
Unsure0
(5) Was the mode of harms collection specified as ACTIVE?Yes46 (54)
No37 (44)
Unsure2 (2)
(6) Was the mode of harms collection specified as PASSIVE?Yes11 (13)
No73 (86)
Unsure1 (1)
(7) Did the study specify WHO collected the harms?Yes22 (26)
No63 (74)
Unsure0
(8) Did the study specify the TRAINING or BACKGROUND of who ascertained the harms?Yes20 (24)
No65 (76)
Unsure0
(9) Did the study specify the TIMING and FREQUENCY of collection of the harms?Yes39 (46)
No45 (53)
Unsure1 (1)
(10) Did the author(s) use STANDARD scale(s) or checklist(s) for harms collection?Yes6 (7)
No76 (89)
Unsure3 (4)
(11) Did the authors specify if the harms reported encompass ALL the events collected or a selected SAMPLE?Yes80 (94)
No2 (2)
Unsure3 (4)
(12) Was the NUMBER of participants that withdrew or were lost to follow-up specified for each study group?Yes24 (28)
No61 (72)
Unsure0
(13) Was the TOTAL NUMBER of participants affected by harms specified for each study arm?Yes16 (19)
No69 (81)
Unsure0
(14) Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?Yes43 (51)
No39 (46)
Unsure3 (4)
(15) Did the author(s) specify the type of analyses undertaken for harms data?Yes10 (12)
No75 (88)
Unsure0
  • *Methodological quality of publications/studies as assessed by the McHarm scale.17

  • †Sum of percentages may not total 100 due to rounding.