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Table 3 Selected SPIRIT item components with highest absolute improvement in adequate reporting (2016 vs 2012)

From: A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study

SPIRIT component

Belonging to SPIRIT Item Number

2012

2016

Absolute increase

Industry sponsorship (n=49)

Non-industry sponsorship (n=54)

Total 2012 (n=103)

Industry sponsorship (n=62)

Non-industry sponsorship (n=46)

Total 2016 (n=108)

Basic study design in title

1

31 (63.3%)

9 (16.7%)

40 (38.8%)

53 (85.5%)

24 (52.2%)

77 (71.3%)

32.5%

Name and contact details of sponsor

5b

12 (24.5%)

16 (29.6%)

28 (27.2%)

31 (50.0%)

31 (67.4%)

62 (57.4%)

30.2%

Steering Committee General Membership and Role

5d

35 (71.4%)

45 (83.3%)

81 (77.7%)

56 (90.3%)

39 (84.8%)

73 (98.0%)

20.3%

 Of which not applicable

 

30 (61.2%)

29 (53.7%)

59 (57.3%)

46 (74.2%)

24 (52.2%)

70 (64.8%)

 

Research question described and justified

6a

11 (22.5%)

9 (16.7%) 2NA

20 (19.4%)

35 (56.5%)

13 (28.3%)

48 (44.4%)

25.0%

Strategies to improve or monitoring of adherence

11c

33 (67.4%)

34 (63.0%)

67 (65.1%)

57 (91.9%)

40 (87.0%)

97 (89.8%)

24.7%

 Of which not applicable

 

9 (18.4%)

25 (46.3%)

34 (33.0%)

23 (37.1%)

28 (60.9%)

51 (41.2%)

 

Expected recruitment rate

15

7 (14.3%)

15 (14.3%)

22 (21.4%)

20 (32.3%)

25 (45.4%)

45 (41.7%)

20.3%

Method for generation of random sequence

16a

21 (42.8%)

29 (53.7%)

50 (48.5%)

51 (82.3%)

30 (65.2%)

81 (75.0%)

26.5%

Strategies to promote participant retention and complete follow-up

18b

9 (18.4%)

20 (38.0%)

29 (28.4%)

38 (61.3%)

16 (34.8%)

54 (50.0%)

21.6%

 Of which not applicable

 

2 (4.1%)

2 (3.7%)

4 (3.9%)

-

-

-

 

Data entry and coding

19

11 (22.5%)

9 (15.5%)

20 (18.7%)

49 (79.0%)

20 (43.5%)

69 (63.9%)

45.2%

Process for making amendments described

25

27 (55.1%)

8 (14.8%)

35 (34.0%)

50 (80.7%)

21 (45.7%)

71 (65.7%)

31.7%

Declaration of Interests

28

8 (16.3%)

4 (7.4%)

12 (11.7%)

60 (96.8%)

10 (21.7%)

70 (64.8%)

53.1%

Ancillary and post-trial care

30

4 (8.2%)

8 (14.8%)

12 (11.7%)

29 (46.8%)

31 (67.4%)

60 (55.6%)

43.9%