Do the patients read the informed consent?

OpenAlex İngilizce

Informed consent (IC) is one of the keystones of medical applications and takes its source from the autonomy principle.It is a process which consists of informing the patient about the medical interventions planned to be applied to their body and making the patient active in the decision making process (1).The doctor who undertakes the medical care is responsible for providing the requirements throughout this process.For this reason, obtaining the patient's approval after the informed consent procedure is made compulsory via legal regulations throughout the world (2, 3).During the IC process, the information that the patient receives, with the help of the communication between the doctor and the patient, is given to the patient as a written informed consent document (ICD) and the process ends with the patient signing the form (4).It has been found that the anxiety of the patients increases and they are less satisfied when they do not receive sufficient information about the medical interventions and have difficulties making decisions (5).However, there are a few studies that have investigated the reading behaviours of patients when the information is provided to them as the IC.This study was conducted in the Gülhane Military Medical School to evaluate whether the patients read the ICD or not and if not, to determine the reasons; also, we aimed to find out the opinions of the patients about the ICD.Background: Informed consent is a process which consists of informing the patient about the medical interventions planned to be applied to the patient's body and making the patient active in the decision making process.Aims: The aim of this study was to evaluate whether the patients read the informed consent document or not and if not, to determine why they did not read it.This was achieved via a questionnaire administered at the pre-anaesthetic visit to assess the perception of patients to the informed consent process. Study Design: Survey study.Methods: The patients were given a questionnaire after signing the informed consent document at the pre-anaesthetic visit.We studied whether the patients read the informed consent document or not and asked for their reasons if they did not.Results: A total of 522 patients were included during the two month study (mean age: 38.1 years; 63.8% male, 36.2% female).Overall, 54.8% of patients reported that they did not read the informed consent.Among them, 50.3% did not care about it because they thought they would have the operation anyway, 13.4% did not have enough time to read it, 11.9% found it difficult to understand, 5.9% could not read because they had no glasses with them, and 5.2% found it frightening and gave up reading.Inpatients, older patients and patients with co-morbidities were less likely to read the informed consent document than outpatients, and younger and healthy patients (p<0.05).Also, 57.9% of parents whose children would be operated on had read the document. Conclusion:This study shows that the majority of our patients did not understand the importance of the informed consent.It is therefore concluded that informed consent documents should be rearranged to be easily read and should be supported with visual elements such as illustrations or video presentations, as informed consent is a process rather than just simply signing a form.