[Formal quality assessment of informed consent documents in 9 hospitals]

Informed consent forms are very important in the process of medical information. The aim of this study is to design reliable formal quality criteria of these documents and their application in the evaluation of those used in the hospitals of a regional health service.

Criteria have been designed from the analysis of existing regulations, previous studies and consultation with key experts. The interobserver concordance was assessed using the kappa index. Criteria evaluation was performed on 1425 documents of 9 hospitals.

A total of 19 criteria used in the evaluation of the quality of informed consent forms have been obtained. Kappa values were higher than 0,60 in 17 of them and higher than 0,52 in the other 2. The average number of defects per document was 7.6, with a high-low ratio among hospitals of 1.84. More than 90% of the documents had defects in the information on consequences and contraindications, and in about 90% it did not mention the copy to the patient. More than 60% did not comply with stating the purpose of the procedure, a statement of having understood and clarified doubts, and the treatment options.

A tool has been obtained to reliably assess the formal quality of the informed consent forms. The documents assessed have a wide margin for improvement related to giving a copy to the patient, and some aspects of the specific information that patients should receive.