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Table 3 SPIRIT Checklist items left unspecified in at least 10% of original protocol submissions (n = 90)

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%