Skip to main content

Table 2 Adherence to SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) reporting guidelines in randomised clinical trials that received ethical Approval in 2012 and 2016, respectively

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

 

2012

2016

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)

SPIRIT items (n=33) adequately reported (median; IQR)a

22.5 (20.8–22.9)

19.8 (15.3–22.3)

21.4 (19.0–22.8)

25.0 (23.5–26.1)

21.5 (17.0–25.2)

23.9 (21.6–25.8)

Proportion of SPIRIT items adequately reported (median; IQR)

67.4% (64.1–69.4%)

59.8% (46.5–67.7%)

64.9% (57.6–69.2%)

75.6% (71.2–79.0%)

65.3% (51.6–76.3%)

72.5% (65.3–78.3%)

  1. aUsing the “major item approach” in which adequately reported components of items receive partial credit. See design paper for more details about individual approach [17] and appendix Table S1 for sensitivity analyses using other pre-defined approaches