is a process by which a physician interacts with a patient, allowing him to make an informed decision about the treatment of his illness . In this process, communication plays a central role  and helps the physicians to establish a stronger relationship with the patient, which is considered by some to be a prerequisite for well-founded decision making . Furthermore, two distinct but interrelated components characterize SIC: information about the risk, benefits and alternatives and the written consent .
Few studies have been carried out in Portugal about the obtainment of the SIC. Their results suggested that the application of informed consent in different health units was very heterogeneous, independently of their size. They also found that even in health units submitted to an international accreditation process, the interpretation of informed consent was very diverse and many practices were frankly deficient in regard to their application .
The aim of this project was to assess our conducts regarding informed consenting and then use the results to optimize the entire process. We analyzed the compliance to the process of obtaining the SIC (physical presence, information and signature) and identified considerable deficiencies in that process. Most of the SIC only included basic information (identification of the procedure, doctor/institution and patient’s signature). Only a small percentage of the SIC mentioned important information regarding the treatment, such as prognosis, consequences of a missed treatment, possible complications and treatment alternatives. Those results didn’t conform to the standard regulations of Portugal’s health authorities regarding SIC.
A probable cause for this is that in our hospital culture, physicians consider SIC to be a mere legal formality, while more importance is given to oral information. Other possible reason is the short period of time available for consultation and discussion of the clinical situation.
Difficulties and limitations when obtaining the SIC are described, for instance the noise that can be established in communication. This obstacle can be originated from the lack of time to discuss the disease with the patient, which can easily be seen in the face of productivity pressure made in health structures. The relationship of authority and fear that can be established between doctor and patient, in view of social contexts, that overestimate the role of doctors in society, and that can be transposed to the clinical relationship, is other obstacle in this process. The insufficient development of communication skills throughout the process of training doctors; the existence of language barriers between doctors and patients and the occurrence of stressful situations can create difficulties in communication .
The results of this study imply that there is a significant risk of litigation due to our current practice. Studies show that most legal cases are not due to treatment failures but due to poor communication and discrepancies between expected and achieved results (55%) and incorrect information (30%) are the main reasons for patient complaints. Contrary to what would be expect, most complaints are generated after smallr elective operations (70%) .
According to Portuguese law, the duty to inform is provided in several documents, such as the Basic Health Law: “Base XIV, nº 1 - Users have the right to be informed about their situation, possible treatment alternatives and the probable evolution of his/her condition” and in article nº 157 of the Penal Code: “For the purposes of the previous article, consent is only effective when the patient has been properly informed about the diagnosis and the nature, scope and possible consequences of the intervention or treatment ( ...) ” . In addition, the general health entity rule nº 015/2013 serves as a guideline . In this document, written informed consent is not mandatory for most of the surgical procedures. Although there is no legal requirement in a specific way for the effectiveness of consent, its formalization appears, however, as the only mean of realizing the right to clarification, particularly when medical interventions are involved, such as diagnostic or surgical procedures that pose a serious risk to the patient's life or health. The existence of a form seems to be the simplest, clearest and easiest way to provide and obtain consent .
In legal terms, the existence of excellent quality forms does not ensure that procedures associated with the filling process will occur properly. Several foreign court decisions are known to have denied legal validity to these documents, because they were convinced that the signature had been reduced to a simple formality, lacking real information. The best way of demonstrate that the doctrine of informed consent is implanted in the Hospital, is the institution adopt strategies that demonstrates a structured organization with established protocols for obtaining consent.
It is important to share the results of this audit with the surgical team to raise awareness of current failures in clinical practices and thereby to create strategies to modify and improve the obtaining of SIC.
Different strategies must be carried out as team training and development of program that training and improved non-technical skills [1, 9]. Effective communication is recognized as a core non-technical skill. It is crucial for delivering high-quality healthcare. The awareness of the ethical aspects of surgical practice that involve non-technical skills stimulated the increase of the focus on education of this skills, such as communication and interpersonal relationships while continuing to strive for technical excellence of procedures and patient care .
Other strategy maybe it’s the use an integrated interactive computer program to fill the recommended items of the informed consent form, but there is some resistance because of equipment issues and time consuming in consult . Currently, for simplicity, it is available an online model type, by the Portuguese Health Authority, with editable fields for including general and personalized information.
Another strategy will be for the surgical services to organize and create a database of pre-elaborated surgical consents for the different surgeries, in order to make it faster to fill in the different items on the form. However, this strategy may jeopardize the individualization of SIC, so it is important don’t forget to individualize the consent for each patient when filling out the form.
The creation of information leaflets that explain the surgical acts with the availability of support numbers, may allow patients to reflect on the clinical situation without the pressure of the doctor's presence and the short consultation time and make a more thoughtful decision, always having a contact to clarify any doubts that may arise.
Despite the fact that the majority of the population undergoing surgery is of a high age, it will be important to develop strategies that also reach a younger population, with greater ease in obtaining information. It is imperative to adapt our clinical practice to the new information technologies, making information available through new communication channels (ex: apps, podcast, among others).
One last suggestion would be to reinforce the existence of a checklist, that prevent the arrival of patients to the operation room without the informed consent filled in and signed.
The limitations of the study were the patient’s sample, that was collected randomly rather than the whole population being studied over an extended period of time. In addition, this has been collected data of different surgical specialty which represented a mixed cohort of patient of different ages, diagnosis and pathologies.