[How to consent without understanding?].
BACKGROUND
The Consent Form (CF) is an important document that informs patients about benefits and risks of a study, it assures patients the right to accept or reject participation in a procedure related to their health. Some authors believe that Consent Forms are complex and difficult to read for most people.


OBJECTIVE
Correlate the difficulty of understanding CF, through the Flesch Index (FI) and Flesch-Kincaid Index (FKI), used in our oncology outpatient clinic, with the profile of our patient's education. We also wanted to verify readability and presence of the information which must be part of these CF according to item IV.1 from Resolution 196/96 of the Brazilian Health Council.


RESULTS
We obtained 10 CFs, according to FI and FKI the mean was 38.5 and 18.16 respectively, indicating that, at least, 18 years of study are needed for the comprehension. This result is incompatible with the Brazilian population where more than 50% have less than 8 years of study. According to the quality of the CF, they were well elaborated, and had most of the necessary contents. When the authors correlated FKI and quality of CF, they concluded that the quality of CF does not correlate with readability (p= 0.884, Pearson correlation coefficients 0.053).


CONCLUSIONS
Despite the good content quality of most of the analyzed CF, their level of reading difficulty is not compatible with the literacy skills of a major part of the Brazilian population.
Miranda
Vanessa da Costa
Vda C
Faculdade de Medicina do ABC, São Paulo, SP.
Fêde
Angelo Bezerra de Souza
AB
Lera
Andréa Thaumaturgo
AT
Ueda
Aline
A
Antonangelo
Daniela Veiga
DV
Brunetti
Karina
K
Riechelmann
Rachel
R
Del Giglio
Auro
A
D001938:Brazil; D032882:Comprehension; D032962:Consent Forms / Q000592:standards; D003430:Cross-Sectional Studies; D004522:Educational Status; D006801:Humans; D007258:Informed Consent / Q000523:psychology; D011932:Reading