Table 4 Selected SPIRIT item components which were least often adequately reported (<60%) in study protocols of randomised controlled trial protocols that were approved in 2016
SPIRIT component | Belonging to SPIRIT Item Number | Industry sponsorship (n=62) | Non-industry sponsorship (n=46) | Total 2016 (n=108) |
|---|---|---|---|---|
Names of protocol contributors/authors | 5a | 5 (8.1%) | 7 (15.2%) | 12 (11.1%) |
Name and contact details of sponsor | 5b | 31 (50.0%) | 31 (67.4%) | 62 (57.4%) |
Research question described and justified | 6a | 35 (56.5%) | 13 (28.3%) | 48 (44.4%) |
Countries where data will be collected listed | 9 | 9 (14.5%) | 36 (78.3%) | 45 (41.7%) |
Eligibility criteria for study centres and who will perform the intervention | 10 | 8 (12.9%) | 24 (52.2%) | 32 (29.6%) |
Sample size: assumed values for outcome | 14 | 41 (36.9%) | 20 (43.5%) | 61 (56.5%) |
Location of participant recruitment | 15 | 7 (11.3%) | 36 (78.3%) | 43 (39.8%) |
Person(s) who will recruit participants | 15 | 5 (8.1%) | 31 (61.4%) | 36 (33.3%) |
Expected recruitment rate | 15 | 20 (32.3%) | 25 (45.4%) | 45 (41.7%) |
Person who will enrol/assign participants | 16c | 12 (19.4%) | 17 (37.0%) | 29 (26.7%) |
Personnel who will collect data | 18a | 19 (30.7%) | 24 (52.2%) | 43 (39.8%) |
Strategies to promote participant retention and complete follow-up | 18b | 38 (61.3%) | 16 (34.8%) | 54 (50.0%) |
DMC is planned or why it is not planned | 21a | 41 (66.1%) | 22 (47.8%) | 63 (58.3%) |
Audits/external monitoring described | 23 | 26 (41.9%) | 3 (5.5%) | 29 (26.9%) |
Who will have access to full dataset | 29 | 18 (29.0%) | 7 (15.2%) | 25 (23.2%) |
Plans to disseminate trial results to key stakeholders/publication provided | 31a | 29 (46.8%) | 31 (67.4%) | 60 (55.6%) |
Authorship eligibility criteria | 31b | 23 (37.1%) | 15 (32.6%) | 38 (35.2%) |
Plans for granting access to full trial protocol | 31c | 6 (9.7%) | 2 (4.4%) | 8 (7.4%) |