The performance and perception of informed consent in a health-care section of Catalonia

BACKGROUND: Informed consent entails a process which involves more than signing a form to give one's consent. This process involves the mutual exchange of information, understanding, trust and consent between physician and patient. The purpose of this study is that of ascertaining the degree to which those consumers who have gone through the informed consent process in a health care district in Catalonia have filled out and fully understood this form. METHODS: Telephone survey conducted among 314 former surgery patients at hospitals in a given district, ages 18-75, who had undergone surgery within the three months immediately prior to the date on which the survey was conducted for the purpose of ascertaining the opinion of these consumers regarding the consent process. A review of the clinical records of 30% of these individuals was conducted for the purpose of ascertaining the degree of compliance with the consent form process. RESULTS: Sixty-one percent (61%) of the patients surveyed remembered having signed the consent form, 59.2% recalling explanations regarding risks or complications of the surgery they were to undergo. Nine percent (9%) did not understand well enough what was going to be done to them during the surgery, and 36% were of the understanding that the consent form released the health care professionals from liability. A statistically significant relationship was found to exist among the age group, educational level and admissions channel. Seventy-eight percent (78%) of the clinical records reviewed included informed consent forms. The diagnosis was stated on 14.9% of these forms, and 48.9% had been signed by the attending physician. A statistically significant relationship was found between the channels through which patients were admitted to the hospital. CONCLUSIONS: The informed consent process is not being implemented correctly at the two hospitals analyzed. Physicians are not totally involved in the process.