Table 1.
Before the SPIRIT statement | After the SPIRIT statement | |
Author characteristics | ||
Authors per protocol (median, range) | 8, 1 to 90 | 8, 2 to 80 |
One or more authors with expertise or experience in epidemiology or statistics (n, %) | 50, 33.3% | 48, 32% |
Trial characteristics | ||
Total planned sample size (median) | 214.5 | 200 |
Multicentre status (n, %) | 70, 46.7% | 64, 42.7% |
Protocol word length >3500 (n, %) | 105, 70% | 106, 70.7% |
Industry funding (n, %) | 8, 6% | 10, 7% |
SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.