Does written informed consent adequately inform surgical patients? A cross sectional study

Informed consent (IC) is a process by which a physician interacts with a patient, enabling the latter to make a knowledgeable decision regarding the treatment of his or her disease. IC consists not only of the form that patients must read and sign, it also involves oral communication that helps physicians establish a stronger relationship with the patients, which is considered by some to be a prerequisite for well-reasoned decision-making [1]. Moreover, two distinct but interrelated components characterize IC: the information about risks, benefits and alternatives and consent to undergo the proposed surgical procedure.

Italian jurisprudence has further broadened the meaning of IC to include information on supplies and equipment—as well as their service records—so that patients can opt to transfer to better-equipped facilities [2]. Despite these guidelines, implementing comprehensive IC is elusive.

Seeking informed consent is often a formal act in which a patient’s signature is obtained, with physicians believing that an important obligation has been fulfilled regardless of whether the patient has been provided with adequate information about the medical intervention that is about to take place [3].

Challenges and limitations of IC are widely discussed in different health care settings for different patients typologies [4–9]. The four principles of biomedical ethics (autonomy, beneficence, nonmaleficence and justice) are generally taken into account in these discussions [10]. Among them, the more pertinent to the ethics of IC is the principle of autonomy for which the person has the right, at all ages and stages of life, to have for himself, to the extent permitted by ethical evidence and by law, choosing whether to accept or refuse the ad, also offered from outside, on its health. And that it Is possible only as consequences of an adequate information.

We must remain mindful that there are patients who will not to be informed, who will not participate in treatment decisions and who will experience anxiety or other negative effects (this is known as “nocebo effect”), especially if they become aware of serious side effects due to surgery [11–14].

Surgical IC is particularly critical for the following reasons: the acute and the particularly vulnerable condition of patients; the urgency of the processes that must take place; the high technological level; the multiplicity of critical points of the process that can cause serious harm to the patient. Consequently, a greater difficulty arises for the patient to understand all these aspects and to decide accordingly, which includes consideration of any alternatives to the surgery [15, 16].

We explored whether the written IC form was delivered to patients, whether they signed the consent form and whether they read and understood the information about the surgical intervention. We also investigated verbal communication between patients and physicians and whether it affected patient decision making.

Not all patients had the written consent for explained to them; it was explained orally only to 65.6%; however, 93.9% of patients received further oral information; among these 68.6% judged this information to be incomplete, and only 31.4% considered it complete.

Among those who claim to have been influenced, 66.7% declared that they were mainly persuaded by the oral information, and 2.2% opined that they were more influenced by the written IC form. Among patients who received information, 88.2% were satisfied and did not believe they were in need of further details and, in fact, 64.4% of them reported that they had the opportunity to seek further information to answer their questions. Almost one in two patients (49.8%) were relieved to get the information, while 23.2% experienced an increase in anxiety because of the knowledge acquired.

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 [17–21]. Conversely, patients who were not informed about the risks of surgery regretted the decision after the surgery [11, 22–24].

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, 26–28]. 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 [11–14]. 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.

Written IC is essential in medicine in order to ensure that patients have the needed information to make an aware choice and consenting to treatment. Furthermore, various authors have demonstrated that written information is best understood by patients who can read the information many times and can discuss it with relatives and friends [3, 13], who are reassuring points of reference for post-operative progress. Oral information is not always easily absorbed because of the escalated stress level just prior to surgery [13].

In our experience, written information has not provided patients with adequate decision-making tools for imminent health matters, while pre-operative oral information was better suited to meet patients’ needs.

Finally, we agree with authors who think it is necessary that physicians also enhance their communication skills to enable them to build alliances with patients in order to become effective partners and ensure that patients can make informed choices in accordance with their own feelings and values [3, 22, 31, 32]. Because of this, we must implement communication training for doctors as an integral part of clinical skills to reach a complete patient compliance. This must be incorporated into training at all levels, including postgraduate medical programs, in order to improve physicians’ listening skills and develop interactive communication skills. Such a trained physician can help patients in defining what is the best choice to make in order to improve their own health status, in accordance to their experiences and values and within a relationship of trust and collaboration (shared decision making) [33]. This seems to be the main way to ensure patients’ “self-determination” in health care.