Complete information before an invasive procedure is an ethical requirement, and it is very important to involve the patient in decision-making regarding the treatment. Well-informed patients are generally more satisfied and file fewer legal claims [17,18,19,20,21]. Conversely, patients who were not informed about the risks of surgery regretted the decision after the surgery [11, 22,23,24].
We analyzed the four elements contributing to correct utilization of written IC forms: delivery, signature, reading and comprehensibility. Delivery and signature are formal and compulsory actions that comply with Italian laws. Reading and comprehensibility are key actions that allow the patient to become aware of the risk benefit of the practical intervention. Therefore, in our study the main shortcoming of the written IC process has been that almost all patients received and signed it, but only half of them read it adequately.
Possible reasons for the findings are: first, many patients showed scarce interest in the IC document, probably preferring to rely on the surgeon’s expertise or they would not be able to understand. In our study, the patients with a higher educational level and who were not older than 60 years old were more likely to read the IC form [25]. Secondly, surgeons might have shown a lack of interest in the document, sought signatures without giving adequate support and motivation to the patients and hence did not explain to them the importance of reading the document [22, 26,27,28]. Thirdly, almost half the patients received the form immediately or just a few hours before the surgical procedure—when they were more stressed and vulnerable, with little time to read and reflect on it [13]. A probable reason for this is that in the Italian culture, physicians regard the delivery and the signing of written IC form as a fulfillment of the law [3], while more importance is given to oral information. Indeed, two-thirds of patients reported that at the handover, the consent was also explained, and almost all received information beyond what was in the IC form at various times before the surgical intervention.
In agreement with findings of other authors [29, 30], when delivering oral information, patients stated that the surgeons focus principally on the diagnosis and on the type of surgical procedure; a lower percentage of patients reported being informed about other aspects of the treatment, such as prognosis, consequences of a missed treatment or the possible surgical complications. No information was provided about possible deficiencies in the facilities’ biomedical equipment or specific diagnostic tools that can reduce safety aspects of the procedures [3]. Therefore to improve the quality of communication with the written IC, we agree with Ghulam, who suggests that a structured conversation helps physicians establish relationships with the patients, facilitates the documentation and offers a valid legal proof for patients and physicians regarding the adequacy of the information provided [13].
Though there is an ethical imperative to inform the patient, it is not always reassuring to the patient: indeed, about one fourth of patients experienced nocebo effects, such as increased anxiety because of the acquired knowledge [11,12,13,14]. Moreover, the majority of patients were hardly influenced or not at all influenced by the written and oral information, having previously decided to undergo the surgery. These findings recall a well-known dilemma of IC. If IC is too detailed, it might violate the principle of nonmaleficence by causing nocebo effect. If it is less detailed, it might violate the principle of autonomy not allowing a conscious choice by the patient. Wells and Kaptchuk [14] try to overcome this dilemma by proposing a contextualized informed consent. They consider it an ethical procedure whereby a provider takes into account the possible side effects, the typology of patient, and the diagnosis involved, to provide information tailored in view to reduce expectancy-induced side effects, and, at the same time, to respect patient autonomy and conscious choice. Therefore, the previous relative definition of “complete” IC, as reported at the beginning of the discussion, should be concluded with the statement “considering the possibility of inducing nocebo effect”.
The main limitation of the present survey is the potential recall bias because the information was obtained through face-to-face interview many days after the delivery of the written IC and after discharge that caused many answers “I don’t know/ I don’t remember” reported in the tables. The patients satisfaction has not been collected as direct question, but has been evaluated as surrogate variable, interpreting the answer to a different question.
Furthermore, patients who had required intensive care or had been brought back into surgery were excluded. Therefore, the results would not be generalized to patients in more severe settings.