|Year : 2015 | Volume
| Issue : 6 | Page : 242-247
Knowledge and awareness of informed consent among orthodontists and patients: A pilot study
Anitha Alagesan1, Vina Vaswani2, Ravi Vaswani3, Uma Kulkarni4
1 Department of Orthodontics and Dentofacial Orthopaedics, A.J. Institute of Dental Sciences, Mangalore, Karnataka, India
2 Department of Forensic Medicine, Yenepoya University, Mangalore, Karnataka, India
3 Department of Internal Medicine, Faculty in Centre for Ethics, Yenepoya University, Mangalore, Karnataka, India
4 Department of Opthalmology, Faculty in Centre for Ethics, Yenepoya University, Mangalore, Karnataka, India
|Date of Web Publication||8-Oct-2015|
Department of Orthodontics and Dentofacial Orthopaedics, A.J. Institute of Dental Sciences, Mangalore . 575004, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Aim: Despite fixed professional opinion of what might constitute optimal treatment, patients must be informed of the various treatment options available in orthodontics to manage their clinical problem. The purpose of this study was to compare and evaluate the knowledge and awareness among practicing orthodontists and patients with regard to informed consent in clinical practice and research.
Materials and Methods: Twenty-five orthodontists and 25 patients were enrolled in a questionnaire study which was descriptive and cross-sectional in the nature. The questionnaire focused on the following aspects; contents of informed consent, at what age and who can give consent.
Results: The study showed a majority of orthodontists (79.14%) were aware of knowledge regarding informed consent when compared to patients(35.14%).
Conclusion: The overall result showed the huge gap that exists between orthodontists and patients and thus making it categorical for patients to be more involved in the decision-making process.
Keywords: Informed consent, orthodontics, questionnaire
|How to cite this article:|
Alagesan A, Vaswani V, Vaswani R, Kulkarni U. Knowledge and awareness of informed consent among orthodontists and patients: A pilot study. Contemp Clin Dent 2015;6, Suppl S2:242-7
|How to cite this URL:|
Alagesan A, Vaswani V, Vaswani R, Kulkarni U. Knowledge and awareness of informed consent among orthodontists and patients: A pilot study. Contemp Clin Dent [serial online] 2015 [cited 2019 Jul 19];6, Suppl S2:242-7. Available from: http://www.contempclindent.org/text.asp?2015/6/6/242/166822
| Introduction|| |
Orthodontic treatment is a composite of various objective and subjective factors. While objective factors are derived from diagnosis and are definitive, subjective factors depend primarily on esthetics, and psychological considerations. Orthodontist's view of the subjective factors may vary considerably from patient to parent. So to come to an agreement regarding various procedures, there should be an open dialogue between the orthodontist and the parent-patient party. Seeking and obtaining this perspective in a clinical setting is possible through informed consent.
The autonomy of individuals lies in the rational concept of informed consent., It is imperative that orthodontists treat patients with respect and act in their best interests. The three main goals of informed consent process are: To inform individuals of necessary details regarding treatment, to document that the individuals were informed, and to establish individual's voluntary and autonomous decision to participate. Currently in orthodontics, informed consent forms an integral part of any treatment and research. Adequately informing a patient confirms that the patient-doctor relationship is based on trust. Another important objective of informed consent is the fulfillment of legal obligation by the orthodontist to inform the patient to best of his/her knowledge regarding the clinical situation. If a patient has not consented to any proposed investigations or treatment, any clinical activity can leave the practitioner open to allegations of negligence for which damages are liable.
As a clinician, his/her goal should be to bridge the gap between the professional's and patient's point of view and thereby achieve consensus. The objectives of this pilot study were to compare and evaluate the knowledge and awareness of informed consent between orthodontists and patients, to identify the areas where lacuna exists in planning the protocol for obtaining informed consent and thereby suggest changes in clinical situations to better comprehend the role of informed consent for both orthodontists and patients.
| Materials and Methods|| |
The study was conducted after approval from the Ethical Committee of A. J. Institute of Medical Science, Mangalore. Fifty participants from Dakshina Kannada consisting of 25 orthodontists and 25 patients were included in the study. This questionnaire-based study was descriptive and cross-sectional in nature [Table1]., Subjects who met the inclusion/exclusion criteria were selected by using purposive sampling technique.
- Patients aged between 18 and 35 years
- Patients undergoing orthodontic treatment for duration of 6 months and above
- Orthodontists having private practice
- Orthodontists practicing in Dakshina Kannada district.
- Patients undergoing removable orthodontic therapy
- Patients with any mental illness
- Patients who cannot read or write.
The questionnaire was validated by four subject experts. It was structured and consisted of 14 multiple choice questions (Q1–Q14) and three Likert format statements (Q15–Q17). The Likert format statements consisted of five response choices (strongly agree, agree, not sure, disagree, and strongly disagree). Positive statements were scored from five to one; score five for the most accurate response and score one for the least accurate response. The time taken to complete the questionnaire was 10–15 min. It was found to be clear, feasible, and there was no ambiguity in the language (the patient's questionnaire was replaced with few layman terms). A participant information sheet was provided to all, and an informed consent was taken from each participant before starting the study. The data collected were tabulated and analyzed statistically using Chi-square test and P value.
| Results|| |
The first part of the study was to compare the results between the two groups with respect to multiple choice questions. Comparison of results (no. of correct answers) between orthodontists and patients is shown in [Table 2]. Significant differences were seen with respect to Q1, Q4, Q6, and Q9.
|Table 2: Comparison of results between orthodontists and patients for multiple choice questions|
Click here to view
Comparison of total results between orthodontists and patients is shown in [Table 3]. While orthodontists accounted for 79.14% of correct answers and patients only 35.14%, vast differences were seen between the two groups. From [Graph 1] it is clearly seen that except for Q2, significant differences were seen in the answers between the two groups.
|Table 3: Comparison of overall results between orthodontists and patients for multiple choice questions|
Click here to view
The second part of the study was to compare the results between the two groups with respect to Likert scale. Comparison of results between orthodontists and patients is shown in [Table 4]. Both groups scored above average in Likert scale. Q15 was scored higher by patients than the orthodontists.
| Discussion|| |
Adequate information should be provided to the parent-patient party concerning any treatment or intervention that is to be undertaken. This can be achieved through the process of informed consent which will enable them to make a well-informed decision. Not many studies are presently available in the literature to acknowledge the lack of awareness that exists about informed consent in orthodontics.
The present study focuses on this concept by designing a questionnaire to reinforce its significance. The investigations revealed that majority of orthodontists (79.14%) were well-informed about the consent process than patients (35.14%) as seen in [Table 4]. A study conducted by Wardah et al. showed that 99% of the dental practitioners considered informed consent to be an integral part of dentistry and verbal consent (84%) was a favored method of acquiring consent compared to the written form. While verbal consent is generally acceptable for less complex dental procedures; the documentation must be thorough. Since orthodontic treatment is an elective procedure with inherent risks and limitations, written consent is a prerequisite. However, various deterrents like excessive patient overload, fear of refusal of treatment by the patient, or negligence by the orthodontist may make the process of gaining written consent cumbersome.
Our study was also helpful in identifying key areas were lack of knowledge about informed consent exists among the patients undergoing orthodontic treatment especially with regard to; contents of informed consent, at what age and who can give consent. According to the American Association of Orthodontists, an informed consent for orthodontic treatment should consist of the following details: Results of treatment, length of treatment, presence of discomfort, chances of relapse, and extractions; if needed, orthognathic surgery; if needed, occurrence of decalcification and dental caries, possibilities of root resorption; nerve damage, periodontal diseases; injury from orthodontic appliances, prospect of temperomandibular joint dysfunction, presence of impacted; ankylosed; unerupted teeth, occlusal adjustments; if any, nonideal results, status of third molars, allergies, general health problems, consequences of use of tobacco products, and use of temporary anchorage devices for treatment. It should also contain attached copies of acknowledgement, consent to undergo orthodontic treatment, authorization for release of patient information and consent to the use of records. The legal age for giving a competent consent in India is 18 years of age or older as per the Indian Majority Act. For a person below this age, or of unsound mind, his/her guardians/person in whose lawful custody he/she is can give consent. In our present study, the significant differences seen between the two groups may be attributed to lack of education in school/college curriculum about informed consent as well as inadequate knowledge provided by the orthodontists to patients before starting treatment.
Patient photographs are used for many purposes in orthodontic practice. They are placed in medical records as an adjunct to clinical care, displayed to colleagues, student and audiences in educational setting, and published in medical/dental journals or other media as part of the research. Hood et al. emphasized in his study that “the inherent and electronic publishing are powerful tools for the dissemination of medical information and have created a demand for medical images and that medical images of patient stated, in most circumstances not to be used without consent.” In the digital age, however, the links between images and individuals are complex and nonintuitive. In our study, patients scored higher for Q2 (60%) compared to orthodontists (52%). The reason for this difference could be patient's awareness toward protecting their privacy and confidentiality especially in this day and age when social media plays a major role in individual's life. In our study, just half the orthodontists were able to understand the necessity of obtaining consent for records. This could be attributed to the fear of refusal of permission from the patient or oversight by the orthodontist.
Ernst et al. conducted a study to determine the level of patient and/or parent recall of previous consent to orthodontic treatment. Patients and parents demonstrated a high level of recall for the consent process concerning appliance type (89.8%), the reasons for treatment (96%), risks (75.5%), length of treatment (83.3%), the opportunity to ask questions (96%), and whether other information was provided (94%). However, further questioning on risks demonstrated poor recall for important factors such as decay (36.8%), root resorption (<21%), retention (56.3%), and length of retention (35%). They concluded that overall the consent process works well but specific areas of concern center around the risks of orthodontic treatment. However, our study showed significant differences regarding the same.
In this study, enlightening the area with more effort is required by the educators and service providers to equip patients with right for information concerning the various protocols needed to be fulfilled, so that the patient is fully aware of all that is to be done before enrolling for orthodontic treatment.
| Conclusion|| |
Other than providing a safeguard to the practitioner from medico-legal issues, the process of informed consent will also help to build a good rapport toward the patients and parents. This will further enhance trust and cooperation and thus improve the overall outcome., The present study was an attempt to evaluate the knowledge and awareness among practicing orthodontists and patients in Dakshina Kannada with regard to informed consent in clinical practice. While the results showed that orthodontists were perceptive, it was not the same with patients. The lack of knowledge displayed by the patients as revealed by this investigation will help the orthodontists to develop an effective approach to involving the patient's interest and respecting their decisions along the line of treatment.
| Acknowledgement|| |
The authors are thankful to all the orthodontists and patients who participated in the study. Special thanks to Dr. Rohan Mascarenhas, MDS, Senior Professor, Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya University.
Source of Support:
Conflict of Interest:
| References|| |
Ackerman JL, Proffit WR. Communication in orthodontic treatment planning: Bioethical and informed consent issues. Angle Orthod 1995;65:253-61.
Wardah F, Fahad Q, Syed MA, Muslim K, Hadia K. Informed consent in dentistry: Percieved importance and limitations in Khyber Pukhtunkhwa. JKCD 2013;3:14-9.
American Association of Orthodontists. Fact Sheet: Informed Consent for the Orthodontic Patient: Risks and Limitations of Orthodontic Treatment. USA: American Association of Orthodontists; 2005.
Chate RA. An audit of the level of knowledge and understanding of informed consent amongst consultant orthodontists in England, Wales and Northern Ireland. Br Dent J 2008;205:665-73.
Wendler D, Grady C. What should research participants understand to understand they are participants in research? Bioethics 2008;22:203-8.
Brons S, Becking AG, Tuinzing DB. Value of informed consent in surgical orthodontics. J Oral Maxillofac Surg 2009;67:1021-5.
Harrison JE. Orthodontic Clinical Trials III: Reporting of ethical issues associated with clinical trials published in three orthodontic journals between 1989 and 1998. J Orthod 2005;32:115-21.
Sanchez S, Salazar G, Tijero M, Diaz S. Informed consent procedures: Responsibilities of researchers in developing countries. Bioethics 2001;15:398-412.
Ratanlal L, Dhirajlal K. The Law of Torts. 9th ed. Nagpur: Vadhwa & Co.; 2006. p. 248-53.
Hood CA, Hope T, Dove P. Videos, photographs, and patient consent. BMJ 1998;316:1009-11.
Mortensen MG, Kiyak HA, Omnell L. Patient and parent understanding of informed consent in orthodontics. Am J Orthod Dentofacial Orthop 2003;124:541-50.
Ernst S, Elliot T, Patel A, Sigalas D, Llandro H, Sandy JR, et al
. Consent to orthodontic treatment – Is it working? Br Dent J 2007;202:E25.
Oliver J, Daljit S, Farhad B. Informed Consent and orthodontic treatment. Orthop Update 2008;1:70-6.
Ferrús-Torres E, Valmaseda-Castellón E, Berini-Aytés L, Gay-Escoda C. Informed consent in oral surgery: The value of written information. J Oral Maxillofac Surg 2011;69:54-8.
[Table 1], [Table 2], [Table 3], [Table 4]