Purpose: The aims of the present study were to determine the readability of informed consent documents on the one hand, and to analyze the quantity of the information contained on them on the other. Method: To do this, the information sheets received by patients when scheduled to undergo cardiac catheterization in five public hospitals in Barcelona were analyzed. We evaluated whether the information contained on the sheets was appropriate according to the minimum requirements established by Spanish legislation. The technical complexity of vocabulary was evaluated through collaboration with two external volunteers, both university graduates working outside the health professions, who identified words whose meaning they were unable to explain. Readability was quantified throgh the Flesch-Kinkaid index, the sentence complexity index and the integrated readability index (LEGIN). Results: The results obtained show that the mean readability was inadequate (Flesch -Kinkaid Index = 5.7), although most were written with simple sentences (a mean sentence complexity of 32.5), achieving an acceptable integrated readability (LEGIN = 73). Of the information items analyzed, those with the lowest scores related to description of alternative treatments and balance between risk and benefits, while a high percentage (75%) described the aims and the treatment that could be used. All the documents indicated the name of the attending physician. Regarding technical complexity of 1058 words, there were 6 whose meaning the two external readers did not know, representing 0.56%. Conclusions: Poor readability of informed consent documents does not bode well for achieving the aim of written informed consent. If written information substitutes dialogue and if priority is given to exhaustiveness over understanding, the real aim of informed consent is obscured and becomes a purely legal requirement. 1302Gains in physical capacity after cardiac rehabilitation
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