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Table 1 Study characteristics

From: Intention-to-treat analysis may be more conservative than per protocol analysis in antibiotic non-inferiority trials: a systematic review

 

All comparisons within studies

(N = 164)

Primary analysis population as per author

 ITT only

42 (25.6%)

 PP only

45 (27.4%)

 ITT and PP

55 (33.5%)

 Not specified

22 (13.4%)

Sample size per group in the ITT population, Median (IQR)

221.5 (129.5, 326.0)

Proportion of treatment arm in the ITT population that was included in the PP population, Median (IQR)

0.86 (0.79, 0.93)

Proportion of control arm in the ITT population that was included in the PP population, Median (IQR)

0.87 (0.77, 0.92)

Definition of ITT

 Based on assignment alone

54 (32.9%)

 Use of drug at least once

95 (57.9%)

 Other exclusion criteria used

34 (20.7%)

PP population clearly defined

138 (84.2%)

Definition of PP population

 Exclusion based on concomitant therapy

96 (58.5%)

 Exclusion based on incompliance

123 (75.0%)

 Exclusion based on lost to follow-up

118 (72.0%)

 Exclusion based on withdrawn from study due to other reasons

29 (17.7%)

 Exclusion for other reasons

28 (17.1%)

Description of methods for handling missing data

64 (39.0%)

Missing data methods used

 Missing data as failure

58 (35.4%)

 Tipping point analysisa

3 (1.8%)

 Multiple imputation

4 (2.4%)

 Last outcome carried forward

2 (1.2%)

CI reported

 2-sided 95% or 1-sided 97.5% CIb

142 (86.6%)

  1. CI Confidence interval, IQR Interquartile range, ITT Intention-to-treat, PP Per-protocol
  2. aTipping point analysis assumes that all missing patients in the treatment group were failures and all missing patients in the control group were successes
  3. bOther CIs include 1-sided 95% CI (N = 4), 2-sided 90% (N = 9), 2-sided 97.5% (N = 4). Five studies did not report any CI