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.

Nursing Roles in the Quality of Information in Informed Consent Forms of a Spanish County Hospital

“…The complexity of the procedures specific to each specialty may make the drafting of these forms difficult and be a possible cause of this result [ 28 , 29 , 30 , 31 , 32 , 33 , 36 ]. In comparison with other research carried out in similar hospital settings in our country, which used the same formal quality criteria for the analysis of the informed consent forms [ 11 , 17 , 27 ], the existence of a lower number of non-compliances with the formal quality criteria in the forms evaluated has been observed in this study. This result could be a consequence of the hospital’s interest in standardizing the informed consent forms with the participation of all the healthcare professionals involved, including nursing professionals.…”

“…As in other studies [ 11 , 17 , 27 ], the non-compliance with the formal quality criterion in all the informed consent forms for non-surgical procedures analyzed was the verification of the delivery of a copy to the patient. Non-compliance with this criterion prevents a thorough reading of the form and consultation of the details with professionals, family, friends, or even the Internet.…”

“…As in previous studies, other important formal quality criteria that have also been non-compliance in these informed consent forms for non-surgical procedures have been failure to include contraindications (94.59%), alternatives (93.78%), or personalized risks (5.40%) for each procedure [ 11 , 17 , 18 , 20 , 27 , 40 , 41 ]. Non-compliance with these formal quality criteria negatively influences the patient’s decision making and legally and ethically invalidates the informed consent process by restricting the patient’s freedom of choice [ 38 ].…”

“…The statistically significant differences observed between the different informed consent forms of the different disciplines analyzed with respect to compliance with the different formal quality criteria (the name of the procedure appears, the description of the procedure appears, the purpose of the procedure appears, and the alternatives of the procedure appear) and the formal quality score may be due to the characteristics of each of the disciplines or to the specific guidelines established by their respective scientific societies for the preparation of these forms. The unification of the formal quality criteria for all the informed consent forms for the different procedures, regardless of the discipline to which they belong, would allow all these deficiencies to be corrected by increasing the information that these forms provide in order to adapt it to the needs of the patient [ 11 , 17 , 27 ].…”

“…This result could be due to the fact that most of the forms evaluated (72.97%) presented a formal quality score of 16 points for non-compliance with the same three formal quality criteria: item 13 (the contraindications of the procedure appear), item 14 (the alternatives to the procedure appear), and item 19 (verification of the delivery of a copy to the patient). If all the forms could be standardized to include these three criteria, the information they can provide would be substantially improved, and patient decision making would be greatly facilitated [ 11 , 17 , 20 , 27 , 41 ].…”