Table 4 Changes of trial characteristics ^a and adherence ^b to criteria related to reporting and methological quality of non-inferiority and equivalence trials reported before and after publication of the CONSORT extension

Number of trials reported per year

2.6 (2.1, 3.2)

2.9 (2.3, 3.7)

1.8 (1.2, 2.8)

Inclusion of a placebo arm

4.6 (2.2, 10.2)

5.5 (2.4, 14.3)

2.0 (0.3, 14.9)

Comparison of different treatments

2.0 (1.6, 2.6)

2.4 (1.8, 3.1)

1.1 (0.6, 2.0)

Comparison of same treatments

7.0 (4.3, 11.6)

8.4 (4.7, 16.4)

4.7 (2.1, 11.6)

Two strategies

6.1 (3.4, 11.5)

7.1 (3.3, 16.9)

4.9 1.9, 13.9)

Two doses

18.0 (5.5, 92.7)

24.0 (6.0, 209.5)

6.0 (0.5, 315.0)

Two durations

2.5 (0.5, 12.6)

1.3 (0.1, 11.6)

4.0 (0.2, 236.0)

Absolute change in % (95% CI) of adherence (2009 to 2003/4)

Criteria related to reporting quality

All trials

Non-inferiority

Equivalence

Clearly identified as non-inferiority or equivalence trial in title or abstract

−15.6 (−20.8, -10.5)

na

na

Trial described as double blind

−15.0 (20.8, 10.5)

−12.3 (−24.1, -0.6)

−13.0 (−33.6, 7.5)

Justification of margin reported

4.0 (−4.5, 12.5)

2.1 (−7.7, 11.8)

11.4 (−6.7, 29.5)

Sample size calculation reported

11.1 (3.5, 18.7)

11.1 (2.5, 19.7)

9.6 (−6.6, 25.9)

All elements for recalculation of sample size reported

5.6 (−4.5, 15.8)

8.0 (−3.7, 19.6)

−4.6 (−25.5, 16.3)

Criteria related to methodological quality

Non-inferiority or equivalence margin defined

−2.0 (−6.3, 2.3)

−0.1 (−4.5, 4.2)

−9.9 (−22.1, 2.2)

Sample size calculation taking into account the margin

6.4 (−2.6, 15.3)

11.6 (1.4, 21.8)

−11.8 (−30.8, 7.2)

Results reported using confidence interval

0.7 (−6.7, 6.2)

3.1 (−5.7, 12.0)

−5.8 (−20.2, 8.6)

Both per-protocol and ITT/modified ITT-analysis reported

−1.0 (−11.1, 9.2)

0.4 (−11.4, 12.1)

−8.2 (−28.1, 11.7)

All 4 methodological quality criteria fulfilled

14.1 (5.1, 23.0)

17.0 (6.6, 27.5)

1.9 (−15.0, 18.8)