KNOWLEDGE AND AWARENESS OF INFORMED CONSENT AMONG DENTAL PATIENTS

Obtaining informed consent from the patient is fundamental. The consent document should be in local language and should be simple and easy to understand. The awareness and knowledge on informed consent among both patients and the physician is essential in order to practice an efficient process as it is a continuous, two- way communication where transparency and partnership plays an important role.This study was undertaken to examine patients knowledge and awareness about informed consent process. 100 patients attending the Out Patient department were interviewed through questionnaire to assess the awareness and knowledge of the informed consent process. The present study revealed the percentage of patients who were aware of the informed consent process and the information provided in it.

Obtaining informed consent from the patient is fundamental. The consent document should be in local language and should be simple and easy to understand. The awareness and knowledge on informed consent among both patients and the physician is essential in order to practice an efficient process as it is a continuous, two-way communication where transparency and partnership plays an important role.This study was undertaken to examine patient's knowledge and awareness about informed consent process. 100 patients attending the Out Patient department were interviewed through questionnaire to assess the awareness and knowledge of the informed consent process. The present study revealed the percentage of patients who were aware of the informed consent process and the information provided in it.

…………………………………………………………………………………………………….... Introduction:-
In both dental and medical setting, obtaining informed consent from the patient is fundamental. Consent is more than just signing the document. Informed consent is a process of communication between the health care professionals and the patient where the doctor explains and educates the patients about the condition of the patient and also the solutions to it. Despite the legal aspects of the informed consent, attention should be given in providing patients with appropriate information about the treatment procedure, benefits, risks associated, treatment alternatives and cost 1,2 . A patient should understand completely about a treatment procedure and it's the duty of the healthcare professional to help the patient to make an informed choice.
Although, obtaining informed consent has been routinely done in medicine and dentistry, the process of educating the patient about the treatment so that they are truly informed has not been done. So, a majority of the patients who sign the consent form are not fully aware of the problems they have and the treatment given to them and are not been informed properly. A formal and documented consent is legally ineffective if the patient lacks the understanding of the material information about the treatment being carried out. So, the consent document should be in local language and should be simple and easy to understand. Patients often feel powerless and vulnerable and it's a fact that patient's awareness regarding informed consent is often limited. Hence, this study was undertaken to examine patient's knowledge and awareness about informed consent process.

Materials And Methods:-
The present cross-sectional study was conducted in the Out Patient Department of Rajah Muthiah Dental College and Hospital, Annamalai University, Chidambaram during February 2021 to April 2021. 100 patients attending the Out Patient department were interviewed to assess the awareness and knowledge of the informed consent process.
The survey was conducted using a pre-designed questionnaire. The patients were selected on a daily first-come basis using convenience sampling. The questionnaire was designed in local language (Tamil). The purpose and nature of the study were explained to the patient and the patients were requested to participate in the study. A written consent was obtained from the patients who were willing to participate in the study.
The questionnaire consisted of 10 dichotomous (Yes/No) questions along with the 'Reason for hospital visit'. The questions were simple to determine the familiarity of the patients with the process and also some detailed questions to know the awareness and knowledge of the patients about informed consent. The obtained responses were coded and analysed by using the Statistical Package SPSS Version 21. The cross Tabulation Statistical tool was used to analyse the categorical data. Out of the 100 patients interviewed, 79% of the patients were aware of their disease and the treatment options available and 21% were unaware. 86% were interested to know about their disease whereas 14% of the patients were not interested. A majority of 93% of the patients were willing to know about the treatment procedure and 7% were not interested. 90% were also interested to know if proper treatment is given to them and 10% were not interested.

Results:-
When asked about the information given to the patients regarding the treatment procedure, 85% of the patients were explained about the treatment procedure whereas 15 % were not explained. 45% of the patients were explained about the various treatment options available for their condition, however, majority of the patients around 55% were not given the information about the treatment options.
62% of the patients were explained about the risks and benefits associated with the treatment procedure and 38% were not explained. 66% of the patients said that their doctor explained the consequences of not taking the treatment and 34 % were not been explained about it. 98% of the patients were satisfied with the attitude of the doctor towards them and only 2% were not satisfied.

Discussion:-
Informed consent is a 'shared decision making process' between a doctor and a patient. The awareness of patient's ethical and legal issues in a hospital is often limited, though patients are willing to know about it. Proper and adequate information about the patient's condition, treatment procedure, the risks and benefits of the treatment, cost of the procedure and the various treatment options available is fundamental in obtaining an informed consent.
The present study revealed that 79% of the patients were aware about their disease and the treatment options available. It was also found that majority of the patients were interested to know about their disease condition, the treatment procedure and also if proper treatment was given to them.

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A consent becomes fully informed only when the doctor explains these five areas to the patient: 1) The nature of the disease, 2) The purpose to carry out treatment, 3)The risks of the treatment procedure, 4) The benefits of treatment and 5) The treatment options available and also the risks involved in not taking the treatment. The exceptions to these areas are in case of emergency, waiver, therapeutic privilege and incompetence. Ethical issues are related each of these areas if not addressed properly by the doctor 3 .
In our study, it was also found that though there was a lack of patient's awareness and knowledge on informed consent, it was clear from the results that the major content of the informed consent was explained properly to the patients by the doctor before undergoing a particular treatment procedure and a majority of 98% of the patients were completely satisfied with the doctor's attitude towards them in explaining their concerns. Our results are in accordance with the study done by Bhurghi et al 4 .
The awareness and knowledge on informed consent among both patients and the physician is essential in order to practice an efficient process as it is a continuous, two-way communication where transparency and partnership plays an important role 5,6 . A study by Ghafurian on dental patients understanding of informed consent concluded that the reading level of informed consent form exceeds that of the average patient and that as education level increased so did the understanding and the number of confusing statements decreased 7 . The comprehensibility improved when patient could ask questions regarding the form to the concerned doctor/dental surgeon. Hence, it's the responsibility of the dental surgeon to ensure that the informed consent is truly informed and the results of our study corroborates the same.
The legal aspects of the informed consent and the awareness of patients regarding their ethical and legal rights in a hospital were not included in this study andhence future studies should be carried out to assess these parameters to follow an efficient informed consent process in our daily practice.

Conclusion:-
The study concludes that there is a lack of awareness and knowledge about the informed consent process among the patients but the content of the informed content has been explained properly by the doctor in helping the patient make an informed choice. Nevertheless, the patients are keen and interested to learn about their disease and the treatment procedure. It's evident from the study that, the patient's understanding of the material information in the informed consent form lies in the hands of the doctor/dental surgeon. Patient awareness programs and public health programs for the dental surgeons should be carried out to educate both the patient and the doctor to legalise the informed consent process.