|Year : 2022 | Volume
| Issue : 4 | Page : 407-414
Knowledge, attitudes, and perceptions toward informed consent and its implications among dental professionals in South India: A cross-sectional study
Kuna Vandana1, Ghanta Shruti2, J Narendra Babu3
1 Department of Public Health Dentistry, Pinnamaneni Siddhartha Institute of Medical Sciences, Gannavaram, Andhra Pradesh, India
2 Dr. Sudha and Nageswara Rao Siddhartha Institute of Dental Sciences, Gannavaram, Andhra Pradesh, India
3 Department of Orthopaedics, Pinnamaneni Siddhartha Institute of Medical Sciences, Gannavaram, Andhra Pradesh, India
|Date of Submission||28-Jan-2021|
|Date of Decision||04-Sep-2022|
|Date of Acceptance||22-Sep-2022|
|Date of Web Publication||19-Dec-2022|
Department of Public Health Dentistry, Dr. Sudha and Nageswara Rao Siddhartha Institute of Dental Sciences, Gannavaram, Andhra Pradesh
Source of Support: None, Conflict of Interest: None
Objectives: To assess the current knowledge, attitudes, and perceptions toward informed consent and legal conflicts among Dental professionals in the Dental colleges of South India. Methods: This descriptive cross-sectional study was carried out at eight dental teaching institutions of Andhra Pradesh and Telangana. A structured close-ended questionnaire was used to obtain data from the dentists, including the postgraduates and teaching staff. The aim was to assess the knowledge on informed consent in the routine practice of dentistry. Results: A total of 450 professionals were approached; among them, 368 were included in the survey. Independent variables such as age, gender, clinical practice experience, and levels of designation were assessed for association with perceptions of informed consent. Majority of the study population felt the necessity of informed consent in daily dental practices. In addition, 75.2% of the professional population were aware of legal conflicts as they reported that if a doctor working in an institution does fault in providing treatment services without consent, then they will be liable before the law. There was a statistically significant association between the age of the study population and their attitude toward the necessity of consent in treating patients (P = 0.03). Similarly, there were variations in the opinions of gender toward the nature of informed consent, which was proved to be statistically significant (P = 0.027). Moreover, clinical practice experience was significantly associated with knowledge of informed consent evolution and types of consent required for a child between 7 and 17 years of age (P = 0.002 and 0.028), respectively. Conclusion: About 86% of the surveyed dentists are aware of the importance of informed consent in practical dentistry and consider it as an ethical and legal obligation. Moreover, expressed consent is the preferred means of obtaining consent from patients for the most dental procedure. Majority (89%) of them responded that the questionnaire gave them additional information about lawsuits and preferred streamlining the process of informed consent through Institutional review boards to avoid legal conflicts.
Conflicts, dentistry, ethics, informed consent, legal
|How to cite this article:|
Vandana K, Shruti G, Babu J N. Knowledge, attitudes, and perceptions toward informed consent and its implications among dental professionals in South India: A cross-sectional study. J Indian Assoc Public Health Dent 2022;20:407-14
| Introduction|| |
Advances in dentistry in terms of procedures, invasiveness, cost, and the recognition of human rights have realized the importance of informed consent in the dental profession.
Informed consent is an important aid of ethical dental practice. It is the process of exchange of information with patients that is necessary to their ability to make primary choices among multiple options according to their felt need. It is universally recognized as an essential safeguard to ensure the preservation of individual's rights and freedom.
Informed consent contains information related to treatment steps as well as risks involved in the procedure. Moreover, it should be structured avoiding technical riding and allowing the patient to understand the treatment. It represents a symbol of autonomy given to the patient in relation to the dental treatment and contributes to a better relationship between doctor and patient. In current dental practice, dentists come across common ethical issues.
The core ethical issues in dental ethics are patient–doctor relationship, patient confidentiality and the need to obtain informed consent. Informed consent is universally recognized as an essential safeguard to ensure the preservation of individual right, so they are routinely provided in all health-care institutions, including dental colleges, as an important source of information to help patients make informed decisions about their proposed treatment. The concept of informed consent is often perceived as necessary for legal protection against malpractice claims. To practice in professionally responsible manner, dentists must assist patients to make well-informed decisions about treatment procedures. Informed consent is a willing agreement between patient and doctor about treatments and procedures.
To our knowledge, there is no work done either at the micro level or macro level with respect to dental professionals perspective toward informed consent. Hence, the present study was conducted to assess knowledge, perceptions, and attitudes toward informed consent in the dental profession.
| Methods|| |
Study design and setting
A cross-sectional study was conducted in Dental Educational Institutes in Andhra Pradesh and Telangana, from August to September 2018.
A total of 450 professionals were surveyed. They were further sorted according to their gender, designated level, and years of teaching experience.
Those who were present on the day of investigation, those who have MDS degree qualifications, and those pursuing MDS and were present on the day of the investigation were included in the study.
Those not willing to participate and not satisfying the inclusion criteria were excluded from the study.
Ethical clearance and informed consent
Ethical clearance was obtained from Institutional Review Boards (ECR/804/Inst/AP/2016). Prior to the start of the survey, permission to conduct the survey was obtained from principals of the selected Postgraduate Dental Institutions in Andhra Pradesh. The purpose of the survey was explained to the study participants, and informed consent was obtained from them during the survey.
A pilot survey was conducted among sixty faculty members and postgraduates of one of the Dental institutions of Andhra Pradesh to assess the reliability of the questionnaire using test–retest design. It was given to the same faculty members and postgraduates twice with 7 days apart. Reliability was assessed for knowledge, perception, and practice questions in the questionnaire. Croanbach's alpha statistics was 0.8734*, 0.7-0.9 high positive correlation. Validity was checked using face validity by giving a questionnaire to 5 faculty members and postgraduates well versed in both English and Telugu languages to check whether translation for each question from English to Telugu is correctly done or not; their remarks were noted and subsequently modified in the final questionnaire.
The sample size was calculated using the formula SS = z2 pq/d2. Considering the prevalence of knowledge at 72%, 95% confidence level, and 80% power, and allowable error d = 4.75, sample size of 358 was obtained, which was rounded off to 400 to avoid attrition ratio.
List of the total of 17 dental colleges was obtained from the website of Dr. NTR University of Health Sciences (www.ntruhs.ac.in). From this list, eight dental colleges were selected by simple random sampling, and 450 faculty members and postgraduates were included from these colleges.
Collection of data
Data were collected using a pretested, self-administered structured questionnaire in their respective institutions. The questionnaire was divided into three parts, pertaining to knowledge of informed consent, types of informed consent, malpractice lawsuits, and ethical review boards. Questionnaire was distributed to all the study participants who were present on the day of the investigation of selected postgraduate institutions and collected back on the same day.
The collected data were analyzed using SPSS 22 version statistical package. International business machines corporation (Newyork, U.S.A). Descriptive statistics were performed to analyze the influence of age, gender, and professional title on knowledge scores' relationship with informed consent using analysis of variance and t-test. Chi-square test was used to find the difference between the groups. A P ≤ 0.05 was considered statistically significant, and P ≤ 0.001 was considered highly statistically significant.
| Results|| |
Among 400 study participants, a total of 368 Dental professionals were included in the study, as others were unable to return the questionnaire in complete format due to lack of time or interest. Among them, males constituted 37.8%, females 62.2%, respectively. Study participants were also segregated based on years of clinical practice experience as <3 years, 3–6 years and >6 years, most of them (69%) were with <3 years of clinical practice experience. When levels of designation were assessed, 67.6% of study participants had completed masters in dental sciences, followed by assistant professors (16.6%). Moreover, most of them (65.2%) were below 25 years of age [Table 1].
When a question was asked regarding the necessity of informed consent in dental practice, most of them (96%) reported that there is the necessity of informed consent in routine dental practices. When a question was asked about the nature of informed consent, majority (86%) of them reported it as respect for autonomy. Moreover, 74% of the study population stated that purpose, adverse effects, and financial aspects of the study are major elements of informed consent [Table 2].
Almost half of the participants (53%) were not sure about the evolution of informed consent. In addition, assent is the variant of consent which is applicable for children below 18 years of age. Surprisingly, 70.6% of participants were aware of the purpose of assent. Similarly, 76% of the dental professionals reported that proxy consent from the parents/guardians is necessary for treating vulnerable/disabled population [Table 2].
Half of the study participants (53%) recommended both assent and proxy consent for treating a child between 7 and 17 years of age. However, majority (85%) of participants felt that there is a need for expressed consent in private practice setup or multicorporate institutions before treating patients [Table 2].
About 75.2% of the professional population reported that if a doctor working at Inan Institution does a fault in providing treatment services without consent, then they will be liable before the law. However, less than half of the study population (48%) reported that indemnity insurance or policies would protect those professionals from malpractice lawsuits. Majority of participants (72.5%) preferred the necessity of streamlining the process of informed consent through Institutional Review Boards. Moreover, 89% of participants had gained some additional information about informed consent through this questionnaire [Table 2].
Independent variables such as age, gender, clinical practice experience, and levels of designation were assessed for association with knowledge and attitudes on informed consent. It was found that there is a statistically significant association between the age of the study population and the necessity for consent in treating patients (P = 0.03) [Table 3].
|Table 3: Association between age and perceptions of study participants towards questionnaire|
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Similarly, the gender difference was significantly associated with the nature of informed consent, prioritizing it as respect for the autonomy of the patient (P = 0.027) [Table 4].
|Table 4: Association between years of experience and perceptions of study participants towards questionnaire|
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Moreover, clinical practice experience was significantly correlated with knowledge on informed consent evolution and types of consent required for a child between 7 and 17 years of age (P = 0.002 and 0.028), respectively [Table 5].
|Table 5: Association between designation and perceptions of study participants towards questionnaire|
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However, there was no statistically significant association between levels of designation and knowledge about informed consent [Table 6].
|Table 6: Association between gender and perceptions of study participants towards questionnaire|
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| Discussion|| |
The current study was conducted among 368 dental Practitioners of Andhra Pradesh, India to assess their knowledge and attitudes toward informed consent with a 100% response rate. Moreover, the self-administered questionnaire which was used in this study was validated for the present study population. Moreover, participants are assured that their responses would be used solely for the research.
In the present study, 94.8% of dental professionals acknowledged that there is a necessity for informed consent in dental practice. The Brazilian code of dental ethics mandates that any treatment procedure without patient consent will breach the ethical principles. Moreover, the dentists are encouraged to provide a copy of the consent document to the patient so that this copy can be revisited by the patient and read out of the dental office. Our results are in accordance with a study conducted by Farhat et al. 2013, where he found that 99% of participants regarded consent as an integral part of dentistry. Moreover, a study reported by Graziele Rodrigues et al. 2017 found that 38% of dentists were not using informed consent forms in routine clinical practice.
Dental professionals who had >6 years of work experience had more knowledge about the application, elements, and evolution of informed consent than those who had 3–6 or <3 years of work experience. This might be due to the fact that experienced dental professionals are becoming more knowledgeable and aware about informed consent importance and the risks they have to face against the law if the procedure happens to fail without taking consent. Moreover, dentists are updating themselves to provide efficient dental care. The findings of the present study were similar to a study reported by Gupta et al. 2015.
The process of obtaining informed consent before treating children can be difficult; however, 70.6% and 76% of respondents in the current study perceived that obtaining assent and proxy consent for treating children and vulnerable/disabled groups is mandatory. However, minority (24%) of the population felt that they did not need to obtain assent for children and proxy consent for vulnerable groups. Moreover, the American Academy of Pediatrics believes that patients who are mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients in the form of assent. In addition, assent from children of age 7 years for medical interventions may help them become more involved and can foster moral growth and development of autonomy. Similarly, a study reported that the issue of obtaining informed consent prior to treating children would be difficult.
Eighty-six percentage of dental professionals agreed that they take signatures as necessary for expressed consent in private practice setup before treating patients. This finding was similar to a study reported by Avaramova and Krassimira. Written consent provides some evidence that patients have been informed of the details and cost of their proposed treatment. Providing exclusive verbal explanation does not exempt the dentist from the obligation of provided a written informed consent form reported by Petruzzi et al. 2013. Moreover, a study reported by Graziele Rodrigues et al. 2017 found that 33.5% of dentists provided verbal explanations but did not use informed consent form. Reasons might be the dentist having complete dental records signed by patients or having a good relationship with patients or they were insured for civil liability. However, insurance for civil liability is not useful to defend the dentist against legal action but exclusively to cover financial penalties in case of conviction. However, all the reasons do not replace ethically the role of signed informed consent form.
Gupta et al. 2015 study concluded that majority of the dentists take consent for surgical procedures. It was not surprising that among those who reported that they did not obtain informed consent in all cases, surgical intervention was the most likely procedure to cause them to seek consent. The risks of complications following third molar extraction are well documented, and the use of consent forms for patients to sign prior to such surgery is widespread.,, However, one study has reported that the majority of patients undergoing oral surgery did not remember the information that they had received prior to signing their consent forms.
Similarly, 75% of the respondents had awareness regarding laws for professional safety if he or she does the fault in providing treatment services without consent and 48% are aware of the insurance and policies which protects the professionals from Malpractice lawsuits. Similarly, the consumer movement in the 1980s led the government of India to enact the Consumer Protection Act (CPA) in 1986, paving the way for the establishment of consumer courts. The CPA is meant to protect the rights and interests of consumers, those who hire or avail of services from others. Compensation is judged and decided upon the doctrine of deficient service, and unfair trade practice. The Supreme Court of India, in a landmark judgment on November 13, 1995, included the healthcare profession under Section 2 (1) (0) of the CPA, 1986. A study conducted by Singh et al. among dental and medical health professionals found that the medical professionals had greater awareness of CPA when compared to dental professionals. The lack of awareness of CPA among dentists, in particular, implies that they are ill-equipped to deal with litigations that may arise in their dental practice.
Majority (72.5%) of the participants felt that there is a necessity for the Institutional review Board to streamline a protocol about the information to be provided in consent forms. A study reported by Ochieng et al. 2014 described a more comprehensive approach by the development of informed consent template that has adequate information and room for modification to facilitate the informed consent process. Moreover, 89% of the patients interviewed through questionnaire are benefited with the information received through this questionnaire, and this finding was higher than the study reported by AlMahmoud.
Limitations of the current study are about perceptions of responses toward the questionnaire. The current study concluded that the dental practitioners had unbalanced knowledge on evolution and types of consent necessary for children between 7 and 17 years of age. To overcome this, emphasis should be given in undergraduate and postgraduate training on legal jurisprudence, and legal medicine, as this is essential for dentists to protect themselves from civil litigation and even criminal proceedings for common assault. However, contrary to this finding, a study reported by Ochieng et al. 2013 stated that there was no significant difference in obtaining informed consent among doctors with different levels of education and experience. On further analysis, there was a statistically significant association between males and females which is similar to a study reported by AlMahmoud. A study by Bickel and Ruffin reported that women were more likely to claim numerous subjects as inadequately covered by the curriculum than men. This study opens a new vista for more detailed results among other dental practitioners in other parts of the country.
| Conclusion|| |
Eighty-six percentages of the surveyed dentists, are aware of the importance of informed consent in practical dentistry and consider it as an ethical and legal obligation. Moreover, expressed consent is the preferred means of obtaining consent from patients for the most dental procedure. Majority (89%) of them responded that the questionnaire gave them additional information about lawsuits and preferred streamlining the process of informed consent through Institutional review boards to avoid legal conflicts.
As the study was conducted among different colleges of two states we could predict the situtation in part of South India, but further studies are encouraged with wider sample to enhance validity.
To increase the quality of informed consent practice in private practice setups we should plan to arrange small group work shop and awareness seminars for health care personals. Additionally refresher training and continuing education with focus on dental ethics can be made mandatory for all dental professionals.
Declarations (single blind)
Ethics approval and consent to participate: Ethical Clearance was obtained from Institutional Review Boards (ECR/804/Inst/AP/2016). Prior to the start of the survey permission to conduct the survey was obtained from principals of the selected postgraduate dental institutions in Andhra Pradesh. The purpose of the survey was explained to the study participants, and written informed consent was obtained from them during the survey.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]