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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