Introduction

Informed consent (IC) has undergone changes over time and has gone from being a simple formality based on a form to become a human right(¹).

Obtaining informed consent is considered a key component in the area of health sciences since it guarantees ethics during the processes and protects the principle of patient or user autonomy(²), in addition to improving their quality (³).

One of the difficulties encountered is that although the ethical and legal requirement is met, it has been evident that in most cases, the documents are unclear to patients and that there is little understanding of what they are signing (²)(⁴); it has been found that most professionals are aware that it is essential to dedicate time and space to clarify doubts and reduce the fear of users during the realization of the IC(¹).

Most IC have clear language (⁵) and meet the basic requirements such as defining the name of the procedure to be performed and the possible risks, but it has been found that only 8% recognize the patient's freedom to reconsider their decision (⁶), on the other hand; it is important to mention in the document that the professional may also decide to suspend treatments if he considers that the patient does not follow his indications and recommendations(⁷), this applies both to procedures and to studies or research(⁸-¹⁰).

Materials and methods

The research has a qualitative approach, it is descriptive and transversal. It was carried out within the facilities of the Faculty of Dentistry of the UCR. The participants were one hundred people over 18 years of age, who were starting treatment at the Clinic of Oral and Maxillofacial Surgery, who answered the questionnaire after having signed the informed consent.

To collect the data, a questionnaire was developed, consisting of two parts: the first collects sociodemographic data such as age, sex, place of residence, level of schooling and occupation; the second consists of 26 closed questions in order to know the level of understanding of informed consent. The questionnaire was applied physically (printed), after the informed consent had been signed.

Prior to the application of the questionnaire to patients, it required a validation process, which consisted first of a review and approval by a specialist in statistics and analysis of the information, after that the questionnaire was applied to five patients, to verify the understanding of the questions. Then, the questions that were unclear were analyzed, made the necessary corrections, and applied the corrected questions. Once the understanding of the questions was confirmed, the questionnaire was applied to all patients.

The questionnaire was administered by five members of the research group. Each one applied twenty questionnaires, which were answered by patients who were attended by 5th year students in the oral surgery clinic, after the patient had read and signed the informed consent provided prior to performing a clinical procedure. Before patients completed the questionnaire, they were given informed consent through which they agreed to participate in the research.

All this was done to patients who began their treatment at the Faculty between the months of August and September of the year 2022. The sample is composed of one hundred people on the basis that, in this case, p = 0.5 ie 50%, and the precision is 0.1, ie 10%. The exact calculation gives N=96, rounded to 100

Discussion

Table 1 shows the sociodemographic characteristics of the study participants. With regard to sex, thepercentage of men and women was almost the same: 49% and 51% respectively. In terms of age, the highest percentage was between 20-30 years (35%), participants between 70-80 years represent the lowest percentage (3%) and under 20 years 4% (which could be due to the fact that only patients over 18 years of age participated). In relation to the place of residence, 64% live in San José, 2% live in Guanacaste and Limón, no participant resides in Puntarenas. The remoteness between San Jose and provinces like Guanacaste, Limon and Puntarenas could be a reason why patients don't attend dental school to be seen. On the other hand, Alajuela and Heredia, both with 8% of patients residing in these provinces, being a small percentage of attendance at the Faculty, could be due to the long transfer time.

Regarding the level of schooling, the highest percentage of participants were those who have an incomplete university degree with 36%, while 19% have completed or incomplete primary school, 28% have completed or incomplete secondary school and 51% have completed or incomplete university. There was a high percentage of participants who had university studies, later we will analyze how this variable influenced the understanding of informed consent. Finally, 91% of patients presented themselves to receive surgical treatment, 7% restorative and only 2% periodontics, it should be noted that in endodontics there were 0% of patients, this for the type of treatment provided in the clinic, which would be to restore, heal and preserve the teeth.

According to the results obtained regarding the application or suggestions of the patients of the Clinic of Oral Surgery of the UCR, we can observe (see table 2) that 69% of the patients read the IC by themselves, and 31% reported that the document had been read by the student. This document contains clinical vocabulary that, when explained by an advanced student (in this case fifth-year students of the Dentistry career, UCR), could have a more significant scope of understanding than doing the reading by themselves, and thus avoid being classified as a simple protocol act (¹¹).

It is important that 44% selected in the questionnaire that they would like to be able to read the informed consent days in advance. This is contradictory, since the majority of participants, 93%, consider that they had enough time to analyze informed consent. According to the data obtained, it is important to mention that 100% of patients agreed that there was no persuasion to sign the IC.

Regarding the tools for improving the understanding of the document, the patients consulted reported: 20% that it would be clearer to explain it with drawings, another 20% with photos, 6% considered, according to the data obtained, that it would improve the understanding of informed consent with the use of videos, while the highest percentage of participants 57% thought that it was not necessary to use any of these ideas (drawings, photos or videos) to understand the consent, and that with the written information as it was exposed, it would be enough.

Regarding factors that influenced the understanding of informed consent (Table 3), almost all patients with university studies (98%) previously knew what this document was, while the percentage of those without university studies was 88%, so it can be said that almost all participants knew the concept of IC. However, despite knowing the concept, only 36% of participants with university degrees and 29% without university studies, had been explained at some point what consent was. Given these results, the question arises as to whether the participants understood with total clarity what informed consent is and all that it implies, despite not having received a prior explanation.

A 22% of patients with university studies and 37% without university studies, reported that a teacher clarified doubts after reading the informed consent. While it is true, there were 47% with university studies and 27% without university studies who had no doubts, there are still 31% with university studies and 37% without university studies that indicated that no teacher clarified their doubts.

An important part before signing the informed consent is that the patient knows what his diagnosis is, in this case 92% of patients with university studies and 94% without university studies received an explanation before signing the informed consent. However, there were patients who were explained their diagnosis after having signed the document, 6% with university studies and 5% without university studies, and there was a patient with university studies, who indicated that his diagnosis was not explained either before or after signing the consent.

It is essential that informed consent contains veracity and clarity of the clinical procedures to be performed, what are the risks, benefits, and alternatives available, as well as the possible consequences of not performing the recommended treatment. It is important that this information is written in the informed consent and is not just a verbal explanation. In this regard, a high percentage, 88% of university patients and 90% of non-university patients, mentioned that they were explained what could happen if the recommended treatment was not performed, those who indicated that they had not received the explanation were 12% of university patients and 10% non-university patients.

It is essential that the patient is clear about the possible side effects, because when performing the required procedures there is no surprise, the data obtained in this aspect were not of great difference between university patients who were 73% and non-university 67%, who mentioned that they had knowledge about side effects, On the other hand, 27% and 33% of university and non-university patients respectively had no notion of the effects. In both cases the difference between university and non-university was 5%, so the lack of knowledge about the effects is not associated with the level of schooling, but possibly they were not mentioned or there was no understanding of these and did not express the concern. This is where the data obtained from patients who made consultations during the reading arise, with non-university patients requesting more consultations with 51%, while those who did not ask questions were university patients with 63%. On the other hand, patients who had doubts or who thought about not signing were quite low, 6% university and 4% non-university, these percentages should be at 0% since no one is obliged to sign the consent if they have any doubts.

Regarding the clarity of IC, the results focus on whether it is very clear or clear. Where the percentages of patients who indicated that it was very clear were 61% for university patients and 57% for non-university patients, while those who indicated that consent was clear were 37% (university students) and 41% (non-university students), these data are compatible with other studies where it is evident that there is no total understanding of the information (⁴) and makes it clear that it needs to be improved(¹²-¹⁷).

Finally, with regard to the principle of revocation of informed consent, 82% and 84% of university and non-university patients indicated that it cannot be revoked, which shows that the principle of revocation is not clear, both in university and non-university students.

Conclusions From the results obtained in the questionnaires carried out, it can be concluded that the highest percentage of patients participating in this study have a level of university education, and that the majority (93%) reported knowing the concept of informed consent, however; only 33% obtained the correct answers to the clinical questions asked, whichled to an unclear understanding of important concepts, such as possible complications or immediate or late adverse reactions produced by the effect of dental treatment or surgical procedure included in informed consent. This may be because the majority, 69% of the participants read the document themselves, and 35% were not previously explained the document they were going to sign. It is contradictory that most participants (93%) consider that they had enough time to be able to analyze the document, but 44% of the same participants reported that they wish they could read the informed consent days before. It is possible that they consider this document as a legal and important tool, which deserves to be analyzed in detail, perhaps they interpreted that there was time to read it, but not to understand it in depth, this reflects in some way why 40% of patients who filled out the questionnaires consider that consent was "clear", and not sufficiently "clear". Finally, most patients indicated that consent as it currently stands is clear and does not require additional tools to improve, but it is concluded that it is essential for the student to read, explain and fully clarify informed consent, so that they have an excellent understanding of it and assimilate that the purpose of the consent is not to exempt the treating person from responsibility as has been concluded in other studies(¹⁰).