Skip to main content

Table 1 Characteristics of Included Randomised Controlled Trials.

From: Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study

Characteristics

All trials

Type of Intention-to-treat reporting N (%)

 

N = 367

ITT

197 (54)

mITT

56 (15)

'no ITT'

114 (31)

Journal

    

Medical journals

200 (55)

123 (62)

33 (59)

44 (38)

Specialty journals

167 (45)

74 (38)

23 (41)

70 (61)

Study design features

    

Phase II

13 (4)

7 (4)

1 (2)

5 (4)

Equivalence/Noninferiority

31 (8)

14 (7)

9 (13)

10 (9)

Sample size [median, (IQR)]

368

(140-991)

476

(200-1160)

426

(198-1093)

201

(81-620)

Trials with post-randomization exclusions

177 (48)

84 (43)

37 (66)

56 (49)

Proportion of post-randomization exclusions [median, (IQR)]

4

(1-11)

3

(1-11)

4

(1-10)

5

(3-12)

Placebo use

123 (34)

51 (26)

27 (48)

45 (40)

Reporting and Quality assessment

    

Flow chart

222 (60)

137 (70)

37 (66)

48 (42)

Reporting of sample size calculation

285 (78)

172 (87)

42 (79)

69 (61)

Reporting of lost to follow-up/withdrawal

211 (57)

127 (64)

35 (63)

49 (43)

Adequate sequence generation

167 (46)

108 (55)

21 (39)

38 (33)

Adequate allocation concealment

125 (34)

78 (40)

22 (39)

25 (22)

Adequate blinding

110 (30)

57 (29)

25 (45)

28 (25)

Funding

    

Not-for-profit organization

137 (37)

88 (45)

9 (16)

40 (35)

For-profit agency

121 (33)

52 (26)

40 (71)

32 (28)

Co-financed

66 (18)

42 (21)

5 (9)

19 (17)

Not reported

43 (12)

18 (9)

2 (4)

23 (20)

Author's conflict of interest

    

Author declaring no competing interests

113 (31)

74 (38)

8 (14)

31 (27)

Author on behalf of a for-profit agency

143 (39)

70 (36)

40 (71)

33 (29)

Author disclosing other financial ties

61 (17)

42 (21)

3 (5)

16 (15)

No report of competing interests

50 (14)

11 (6)

5 (9)

34 (30)

Primary Outcome

    

Favorable to test drug

216 (60)

110 (56)

38 (70)

68 (60)

  1. IQR = Inter-quartile range;