From: The SPIRIT Checklist—lessons from the experience of SPIRIT protocol editors
SPIRIT item | Number of submissions in which item was left unspecified | |
---|---|---|
n | % | |
Administrative information | ||
2b – WHO registration data set | 42 | 47% |
3 – Protocol version and date | 13 | 14% |
5c – Role of sponsors | 17 | 18% |
5d – Trial oversight groups | 32 | 36% |
Methods: participants, intervention, and outcomes | ||
11b – Criteria for modification | 25 | 28% |
11c – Adherence monitoring | 17 | 19% |
11d – Concomitant care | 25 | 28% |
Methods: assignment of interventions | ||
17b – Unblinding procedures | 50 | 56% |
Methods: data collection, management, and analysis | ||
18b – Participant retention | 16 | 18% |
20b – Additional analyses | 17 | 19% |
20c – Analysis population and missing data | 12 | 13% |
Methods: monitoring | ||
21a – Data monitoring committee | 22 | 24% |
21b – Interim analyses | 48 | 53% |
22 – Harms assessment | 13 | 14% |
23 – Trial auditing procedures | 42 | 47% |
Ethics and dissemination | ||
25 – Protocol amendments | 17 | 19% |
26b – Consent for use in ancillary studies | 73 | 81% |
29 – Access to data | 16 | 18% |
30 – Ancillary and post-trial care | 54 | 60% |
31a – Dissemination of results | 23 | 26% |
31b – Authorship eligibility | 45 | 50% |
31c – Data sharing and access | 48 | 53% |
32 – Model consent form | 46 | 51% |
33 – Biological specimen procedures | 77 | 86% |