• Gerardo Rubiera, Ricardo Arbizu, Angel Alzueta, Juan José Agúndez, and José Ramón Riera.
• Medicina Preventiva y Salud Pública, Hospital Universitario Marqués de Valdecilla, Asturias, Spain. grubiera@telecable.es
• Gac Sanit. 2004 Mar 1;18(2):153-8.

ObjectiveTo evaluate the readability of the informed consent documents (ICD) used in the health centers of Asturias (Spain) with the aim of verifying whether the ICD are understandable and sufficient as a vehicle of information to empower patients to participate in decisions related to their diagnosis and treatment.MethodA total of 1114 ICD were gathered from the health centers in Asturias. A representative random sample from each hospital was selected and the following readability indexes were obtained: the Flesch index, the sentence complexity index, and the integrated legibility index.ResultsOf the ICD in the sample studied, legibility was acceptable in 77.3% (221 out of 286) according to the integrated legibility index, in 75.2% (215 out of 286) according to the sentence complexity index and in 3.5% (10 out of 286) according to the Flesch index. The mean values of the indexes differed among hospitals (p < 0.001, ANOVA test).ConclusionsICD written in Spanish achieved low readability scores in the Flesch index and require corrective measures. Three quarters of the ICD were acceptable due to the use of simple sentences in the text. We believe that readability indexes should be used when drafting or improving informed consent documents.

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