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. 2022 Jul 27;23:601. doi: 10.1186/s13063-022-06516-1

Table 3.

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

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%