Summary of document length and complexity for clinical trial patient information sheets and informed consent forms for clinical trials conducted during acute COVID-19 infection
Trial | Total words | Reading time (minutes) | Flesch-Kincaid Grade Level* | Gunning-Fog score† | Flesch Reading Ease Score‡ | Average sentence length (words) | ||
175 wpm (lower bound) | 240 wpm (mean) | 300 wpm (upper bound) | ||||||
Phase III platform trials | ||||||||
RECOVERY | 1559 | 8.9 | 6.5 | 5.2 | 9.9 | 12.2 | 55.2 | 20.5 |
REMAP-CAP | 3688 | 21.1 | 15.4 | 12.3 | 10.5 | 12.1 | 48.2 | 18 |
TACTIC-E | 5685 | 32.5 | 23.7 | 19.0 | 10.6 | 12.4 | 49.1 | 20.5 |
TACTIC-R | 4994 | 28.5 | 20.8 | 16.6 | 10.8 | 12.7 | 48.9 | 20.1 |
Phase III single agent commercial | ||||||||
GS-US-540-5773 | 5139 | 29.4 | 21.4 | 17.1 | 9.1 | 10.6 | 57.8 | 19.4 |
RUXCOVID | 6855 | 39.2 | 28.6 | 22.9 | 9.2 | 10.4 | 55.0 | 18.5 |
SPRINTER | 5467 | 31.2 | 22.8 | 19.1 | 9.8 | 11.8 | 54.4 | 20.4 |
Phase II | ||||||||
ACCORD-2 | 7026 | 40.1 | 29.3 | 23.4 | 10.0 | 11.9 | 54.6 | 19.1 |
COVASE | 3544 | 20.3 | 14.8 | 11.8 | 9.7 | 11.3 | 54.8 | 18.9 |
ILEAD-7 | 4626 | 26.4 | 19.3 | 15.4 | 11.2 | 13.0 | 47.0 | 20.6 |
OSCAR GSK | 6046 | 34.5 | 25.2 | 20.2 | 9.3 | 11.6 | 56.5 | 16.3 |
SYNAIRGEN SG016 | 6455 | 36.9 | 26.9 | 21.7 | 9.0 | 11.2 | 58.3 | 18.9 |
Theravance 0188 | 4468 | 25.5 | 18.6 | 14.9 | 9.7 | 11.6 | 54.2 | 18 |
Overall | ||||||||
Median | 5139 | 29.4 | 21.4 | 17.1 | 9.8 | 11.8 | 54.6 | 19.1 |
*Range 0–18, higher score is more complex, recommended ≤6.
†Range 0–20, higher score is less readable, recommended ≤6.
‡Range 0–100, 100 is best readability, recommended ≥60.