Characteristics | Number of studies with characteristics | % of studies with characteristics | 95% Confidence Interval |
---|---|---|---|
Crossover studies | 17 | 36 | 24, 51 |
Parallel treatment studies | 30 | 64 | 49, 76 |
Title and Abstract specifying that trial is a noninferiority or equivalence trial | 6 | 13 | 6, 25 |
Articles whose background or introduction section contains a rationale for using a noninferiority or equivalence trial design | 5 | 11 | 5, 23 |
Articles with a clear objective or hypothesis pertaining to noninferiority or equivalence | 13 | 28 | 17, 42 |
Sample size determination: Studies that appropriately described how the sample size was determined* | 34 | 72 | 58, 83 |
Randomization: Studies stating the methods used in the generation of the random allocation sequence | 22 | 47 | 33, 61 |
Masking: | Â | Â | Â |
   Two or more groups | 35 | 75 | 60, 85 |
   Patients only | 4 | 9 | 3, 20 |
   Open label studies (i.e. studies that were not masked) | 8 | 17 | 9, 30 |
Allocation concealment: Studies reporting this characteristic | 10 | 21 | 12, 35 |
Statistical methods and numbers analyzed: | Â | Â | Â |
   Studies that employed the combined test of noninferiority and superiority | 8 | 17 | 9, 30 |
   Studies presenting results of only ITT population with no mention of PP population | 17 | 36 | 24, 51 |
   Studies presenting results of only PP population with no mention of ITT population | 13 | 28 | 17, 42 |
   Studies presenting only results of ITT population but mentioned that PP produced similar results | 12 | 26 | 15, 39 |
   Studies presenting only results of PP population but mentioned that ITT produced similar results | 2 | 4 | 1, 14 |
   Studies reporting and presenting results of both ITT and PP populations | 3 | 6 | 2, 17 |
Results: | Â | Â | Â |
   Studies presenting a figure showing the range of the confidence interval relative to the pre-specified noninferiority/equivalence margin | 1 | 2 | 0.5, 11 |