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Table 2 Characteristics of included trials by blinding status of the statistician

From: Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study

Characteristic

Statistician blinded prior to the final analysis

 

No (N = 83)

Yes (N = 69)

Unknown (N = 27)

Total (N = 179)

Publication year, n (%)

 2016

20 (56%)

12 (33%)

4 (11%)

36

 2017

12 (43%)

11 (39%)

5 (18%)

28

 2018

22 (58%)

13 (34%)

3 (8%)

38

 2019

17 (44%)

15 (38%)

7 (18%)

39

 2020

12 (32%)

18 (47%)

8 (21%)

38

Journal, n (%)

 HTA

64 (44%)

59 (41%)

22 (15%)

145

 EME

19 (56%)

10 (29%)

5 (15%)

34

Trial design, n (%)

 Individually randomised

72 (46%)

60 (38%)

24 (15%)

156

 Cluster

8 (50%)

7 (44%)

1 (6%)

16

 Factorial

1 (25%)

2 (50%)

1 (25%)

4

 Other

2 (67%)

0 (0%)

1 (33%)

3

Interventions, n (%)

 Drug

36 (49%)

25 (34%)

12 (16%)

73

 Device

4 (44%)

2 (22%)

3 (33%)

9

 Surgery

11 (69%)

1 (6%)

4 (25%)

16

 Complex

34 (38%)

45 (51%)

10 (11%)

89

CTIMP, n (%)

 No

48 (44%)

46 (42%)

15 (14%)

109

 Yes

35 (50%)

23 (33%)

12 (17%)

70

Hypothesis testing framework, n (%)

 Superiority

75 (46%)

66 (40%)

22 (13%)

163

 Non-inferiority

8 (57%)

2 (14%)

4 (29%)

14

 Equivalence

0 (0%)

1 (50%)

1 (50%)

2

Treatment groups, n (%)

 2

69 (48%)

54 (37%)

22 (15%)

145

 >2

14 (41%)

15 (44%)

5 (15%)

34

Placebo controlled, n (%)

 No

60 (45%)

52 (39%)

20 (15%)

132

 Yes

23 (49%)

17 (36%)

7 (15%)

47

Multiple primary outcomes, n (%)

 No

64 (44%)

60 (41%)

21 (14%)

145

 Yes

19 (56%)

9 (26%)

6 (18%)

34

Clinical area, n (%)

 Blood

2 (67%)

0 (0%)

1 (33%)

3

 Cancer

7 (64%)

2 (18%)

2 (18%)

11

 Cardiovascular

5 (42%)

5 (42%)

2 (17%)

12

 Generic health relevance

5 (36%)

6 (43%)

3 (21%)

14

 Infection

12 (71%)

2 (12%)

3 (18%)

17

 Inflammatory and immune system

2 (50%)

2 (50%)

0 (0%)

4

 Injuries and accidents

5 (63%)

2 (25%)

1 (13%)

8

 Mental health

6 (25%)

13 (54%)

5 (21%)

24

 Metabolic and endocrine

5 (71%)

1 (14%)

1 (14%)

7

 Musculoskeletal

2 (67%)

1 (33%)

0 (0%)

3

 Neurological

6 (40%)

5 (33%)

4 (27%)

15

 Oral and gastrointestinal

3 (43%)

2 (29%)

2 (29%)

7

 Renal and urogenital

3 (50%)

2 (33%)

1 (17%)

6

 Reproductive health and childbirth

8 (50%)

7 (44%)

1 (6%)

16

 Respiratory

5 (50%)

5 (50%)

0 (0%)

10

 Skin

2 (29%)

5 (71%)

0 (0%)

7

 Stroke

4 (33%)

7 (58%)

1 (8%)

12

 Other

1 (33%)

2 (67%)

0 (0%)

3

  1. Table displays frequencies and row percentages
  2. CTIMP Clinical Trials of Investigational Medicinal Products