Formal Quality and Compliance of Informed Consent Forms in Critical Care and Surgical Areas in Spain: An Observational Study

Abstract

(1) Background: The informed consent form must contain all the relevant information about the procedure to be performed to guarantee the patient’s freedom to choose. (2) Objective: To analyze the formal quality of, and compliance with informed consent forms in critical care and surgical areas in a county hospital in Spain. (3) Methods: The formal quality of informed consent forms in critical care and surgical areas from the hospital were analyzed, following the established formal quality criteria for informed consent forms. The compliance with specific criteria for each of the operated patients during the period of study was also evaluated. (4) Results: The formal quality of 224 informed consent forms was analyzed from 8 disciplines observing a median of non-compliances of 4 with a minimum of 1 and a maximum of 5, with the most breaches being in verifying the delivery of a copy to the patient and showing contraindications. The compliance of 376 documents from 188 operated patients were assessed, highlighting that the non-complied items were: the personalized risks and complete identification of the patient and the physician. A significant association was found between disciplines analyzed and the identification of the physician and personalized risks, with anesthesia and critical care showing the best compliance. (4) Conclusions: The informed consent forms in critical care and surgical areas were shown to have a deficient formal quality and an inadequate compliance. These deficiencies should be corrected to improve the information received by the patients and to guarantee their freedom to choose. As nurses have a responsibility to ensure that patients are adequately informed about both nursing interventions and care, as well as the surgical treatments they receive, consideration should be given to the possibility of nursing professionals taking the lead in obtaining informed consent.

Keywords

• informed consent
• patient’s freedom to choose
• compliance
• critical care
• surgical areas
• consent forms