Table 4

Mean, median, range and SD per readability criteria for full PIL/ICF and Regulatory section

Full PIL/ICF				Regulatory section of PIL/ICF					P value (t-test)
n=133	Mean	Median	Range	SD	Mean	Median	Range	SD	P value (t-test)
Flesch Reading Ease	49.24	50	27–66	7.4	43.67	45	22–57	7.33	<0.001
Flesch-Kincaid Grade Level	11.31	11.4	8.2–15.4	1.43	12.18	12.18	8.6–16.6	1.54	<0.001
Gunning Fog	12.05	12.1	9.3–15	1.15	12.69	12.69	9–16.4	1.46	<0.001
SMOG	13.03	13	8–16.2	1.18	13.60	13.60	10.7–17.1	1.30	<0.001
Raygor	10.53	11.0	7–17	1.78	11.56	11.56	8–17	1.84	<0.001
Fry	12.3	12.0	8–17	2.10	13.54	13.0	10–17	2.00	<0.001
NDC	10.68	10.0	6–15	1.67	11.69	12.0	8–15	1.63	<0.001

ICF, Informed Consent Form; NDC, New Dale Chall; PIL, Patient Information Leaflet; SMOG, Simplified Measure of Gobbledegook.