|
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:
| | | |
|
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:
| | | |
|
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:
| | | |
|
Studies presenting a figure showing the range of the confidence interval relative to the pre-specified noninferiority/equivalence margin
|
1
|
2
|
0.5, 11
|
