Table 3 Compliance with criteria for reporting and methodology for non-inferiority and equivalence trials presented as number (%)
| Â | All trials (n = 209) | Non-inferiority (n = 167) | Equivalence (n = 42) |
|---|---|---|---|
Criteria related to reporting quality generally important for randomised trials | |||
Method of randomisation reported | 115 (55) | 94 (56) | 21 (50) |
Restriction method reported | Â | Â | Â |
Blocking | 59 (28) | 45 (27) | 14 (33) |
Stratification | 88 (42) | 73 (44) | 15 (36) |
Minimisation | 11 (5) | 10 (6) | 1 (2) |
Method of blinding reported | 190 (91) | 152 (91) | 38 (91) |
Single blind | 23 (11) | 18 (11) | 5 (12) |
Double blind | 90 (43) | 73 (44) | 17 (41) |
Not blinded | 77 (37) | 61 (37) | 16 (38) |
Double dummy design | 39 (19) | 35 (21) | 4 (10) |
Blinding of administrators reported | 30 (14) | 26 (16) | 4 (10) |
Blinding of outcome assessor reported | 57 (27) | 46 (28) | 11 (26) |
Dates defining period of patient recruitment | 130 (62) | 104 (62) | 26 (62) |
Dates defining period of follow-up reported | 20 (10) | 16 (10) | 4 (10) |
Flow of participants presented as diagram | 146 (70) | 122 (73) | 24 (57) |
Baseline information presented for each group | 201 (96) | 162 (97) | 39 (93) |
Adverse events reported | 159 (76) | 133 (80) | 26 (62) |
Criteria related to reporting quality particularly important for non-inferiority and equivalence trials | |||
Clearly identified as non-inferiority or equivalence trial in title or abstract | 175 (84) | 139 (83) | 36 (86) |
Justification for using non-inferiority or equivalence design reported | 101 (48) | 80 (48) | 21 (50) |
Hypothesis stated clearly (text or formula) | 104 (50) | 85 (51) | 19 (45) |
Primary outcome identified clearly | 196 (94) | 159 (95) | 37 (88) |
Sample size calculation reported | 187 (90) | 151 (90) | 36 (86) |
All elements for recalculation of sample size reported | 124 (59) | 104 (62) | 20 (48) |
Justification of margin reported | 51 (24) | 38 (23) | 13 (31) |
Justification of margin reported by | Â | Â | Â |
statistical considerations only | 5 (2) | 4 (2) | 1 (2) |
Justification of margin reported by clinical considerations only | 31 (15) | 23 (14) | 8 (19) |
Justification of margin reported by statistical as well as clinical considerations or results of a previous study | 15 (7) | 11 (7) | 4 (10) |
Statistical methods used for comparison reported | 184 (88) | 149 (89) | 35 (83) |
Analysis sets reported | 188 (90) | 156 (93) | 32 (76) |
Criteria related to methodological quality of non-inferiority and equivalence trials | |||
Non-inferiority or equivalence margin defined | 197 (94) | 161 (96) | 36 (86) |
Sample size taking into account the margin | 163 (78) | 136 (81) | 27 (64) |
Results reported using confidence interval | 177 (85) | 142 (85) | 35 (83) |
Figure showing confidence intervals and margins | 34 (16) | 24 (14) | 10 (24) |
Both per-protocol and ITT/modified ITT reported | 87 (42) | 74 (44) | 13 (31) |
Interpretation of results given in the reports | Â | Â | Â |
Interpretation referring to results presented | Â | Â | Â |
Comprehensible and accurate | 165 (79) | 135 (81) | 30 (71) |
Wrong | 14 (7) | 11 (7) | 3 (7) |
Incomprehensible | 30 (14) | 21 (13) | 9 (21) |
Statement on expected advantage | 70 (34) | 59 (35) | 11 (26) |
Expected advantage confirmed by results | 52 (25) | 46 (28) | 6 (14) |