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Table 2 Characteristics of randomized controlled trials

From: Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board

Characteristics of RCTs

n = 50

2003–2008 (6 y) n = 27

2009–2014 (6 y) n = 23

 

Total n (%)

Drug 20 (74)

Non drug 7 (26)

Drug 20 (87)

Non drug 3 (13)

Experimental design

 Parallel

43 (86)

19

5

17

2

0.697

 Cross-over

7 (14)

1

2

3

1

 

Level of blind

 Double blind

29 (58)

13

1

14

1

0.052

 Single blind

2 (4)

1

0

0

1

 

 Open labeled

19 (38)

6

6

6

1

 

Allocation concealment

 Inadequate

4 (8)

2

0

2

0

0.055

 Unclear

20 (40)

7

6

5

2

 

 Adequate

26 (52)

11

1

13

1

 

Jadad class

 Median [interquartile range]

 

4 [3–5]

1 [1–2]

5 [2.5–5]

3 [1–5]

0.758

 Low quality <3

15 (30)

3

6

5

1

 

 High quality ≥3

35 (70)

17

1

15

2

 

Jadad class in sensitivity analysis

 Median [interquartile range]

 

5 [3–5]

3 [1–5]

5 [4–5]

5 [5–5]

0.650

 Low quality <3

5 (15)

2

1

2

0

 

 High quality ≥3

28 (25)

13

1

12

2

 
  1. Data are n (%) of RCTs and median [1st quartile – 3rd quartile] of Jadad score
  2. The p value corresponds to the comparison of the two periods for each listed variable including both “drug” and “non drug” RCTs