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Table 2 Methodological quality and reporting

From: Reporting of noninferiority and equivalence randomized trials for major prostaglandins: A systematic survey of the ophthalmology literature

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:

   

   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

  1. * = appropriate sample size determination stating all of the following; a predetermined noninferiority or equivalence margin, standard deviation used, significance level [α], and the power used