Perception of consent among dental professionals.

BACKGROUND: Informed Consent concept has been recognized in all patient care fields. The contents and wordings of the informed consent are still being debated and experimented. Dental care services have considered the role of informed consent since 1980's, after some legal claims of malpractices.
METHODOLOGY: A cross-sectional analytic study was undertaken involving 375 senior dental students and fresh graduates in their house job. A self-administered questionnaire explored their knowledge, attitude and practices regarding the need and importance of informed consent in dental services. The study instrument was designed keeping in view the content of courses in dental education and international standards. The questionnaire was pre-tested on a small group for assessing the suitability and validity of the responses.
RESULTS: The data was entered in SPSS version 16 and cross-tabulated through it. Most of the respondents (87%) were aware of the concept of informed consent, 6.9% considered it unnecessary and 21.9% were not practicing it. Invasiveness of dental procedure was found to be directly related to the need of including informed consent. Major justification for presence of informed consent was to protect the dentist from any legal proceedings.
CONCLUSION: Dental professionals were aware about the informed consent as a step, but were unaware about its precise significance, content application and practice.

Introduction

Advances in medical procedures, invasiveness, cost and recognition of human rights (both patient’s and medical practitioners’) have realized the application of informed consent in almost all health care disciplines.

Safeguarding legal and ethical rights of the patients as well as of attending physicians became a part of preliminary steps during the last two decades. It was also aimed at strengthening the level of trust between the patient and the dental surgeon (1).

Historically some facts link informed consent to Hippocrates who eluded to patients rights. In the recent history (18th century) surgical steps were required to be undertaken after patient’s consent. However World War II triggered the need for informed consent which was formalized in the 1964 Helsinki Declaration, in which the main argument was ethics. In the succeeding years of the 20th century, lots of additional elements and steps have been added to formalize and standardize informed consent, in public health research, as well as in practice of medicine (2). In the field of Dentistry, informed consent gained recognition in the mid-1980s, and over the years this element has been covered in the academic teaching (1).

Informed consent comprises of implied and expressed consent. Implied consent is assumed by patient’s attitude and applied mostly to the noninvasive procedures such as consultation, examination and diagnosis, whereas expressed consent is a formal type of permission related to more invasive procedures, including nature of decision for the procedures to be undertaken, reasonable alternatives to proposed interventions, the relevant risks, benefits related to each procedure, understanding of patient about the procedures and his/her acceptance for intervention.

In dental practice, verbal consent is one form of expressed consent and used adequately for routine dental treatment such as dental filling, extraction etc., whereas in written consent another form of consent is taken for more extensive treatments such as procedures requiring sedation and analgesia, etc.

In case of children under the age of 16 or 18 years, in most part of the world they are presumed incompetent to take part in decision-making process. Some children, even less than 10 years of age, are considered better than their parents to grasp the concept of treatment and its consequences. In Pakistan the age limit for children giving consent is 18 years and over.

It is still the ethical duty of medical or dental doctor to give importance to the children under the age of 18 years and respect the ideas of child for the treatment. This also helps the dentist to develop good patient-doctor relationship by discussing the treatment modalities with them and their concerns towards treatment.

The use of informed consent prevents malpractices or quackery in dental practice; the purpose and benefits of treatment are well understood by patients themselves and parents, in case of minor children, to protect patient’s rights from malpractices.

This study was designed to assess the gaps in the knowledge and perceived importance of informed consent among dental students/house surgeons who are interacting with patients for their dental treatment.

Materials and Methods

This was a cross sectional descriptive study. After the clearance of institutional review board, objectives of the study were explained to dental students of 3rd and 4th year and dental house surgeons of government and private dental colleges/hospitals, (de’Montmorency College of Dentistry/Dental hospital Lahore, Fatima Memorial college of Dentistry/Dental Hospital Lahore and Margalla College/Dental Hospital Rawalpindi. Pakistan). The subjects of the study had given their willingness to respond to the questionnaire. A group of 125 students each from 3rd year, 4th year and dental house surgeons were included in the study on the basis of non-probability convenient sample (Appendix-1).

Statistical analysis

A self administered questionnaire was given to each respondent. The data was analyzed by SPSS version 16. The analysed data was qualitative and between-groups comparison was made by applying Chi Square test for assessing significance.

Results

The present study was conducted on 375 dental field professionals, 250 students of senior dental classes and 125 dentists in house jobs. Table 1 show that 84.8% of the respondents were females and 15.2% males. This proportion was almost similar in the three sub groups.

Table 1:

Distribution of subjects by gender and knowledge about main types of informed consent

Gender	Third year N= 125		Final year N= 125		House surgeons N= 125		Total N= 375
	N	%	N	%	N	%	N	%
Male	19.0	15.2	15	12.0	23	18.4	57	15.2
Female	106	84.8	110	88.0	102	81.6	318	84.8
Knowledge
Verbal consent	24	19.2	19	15.2	16	12.8	59	15.7
Written consent	75	60.0	62	49.6	74	59.2	191	50.9
Both verbal & written consent	23	18.4	28	22.4	25	20.0	76	20.3
Neither	3	2.4	16	12.8	10	8.0	49	13.1
Total	125	100.0	125	100.0	125	100.0	375	100.0

P < 0.05 was considered significant

On the question of basic knowledge about the type of Informed Consent, 15.7% knew about the verbal type, 50.9% for written, 20.3% for verbal and written types both, and 13.1% did not know about any of the types of informed consent.

The difference between the groups was not found statistically significant. In the third year students, only 2.4% had no knowledge about any type of informed consent, while it was in 12.8% of the fourth year and 8.0% among dental surgeons in house job (Table-1).

In response to the question, “who should provide the informed consent”, the majority (69.9%) mentioned the patients, 22.1% the parents and 7.2% other relatives accompanying the patient. The dental surgeons in house job were the highest, 80%, in mentioning the patient as informed consent provider, and they were the lowest, 12%, in mentioning parents as informed consent providers. These differences were statistically significant (P < 0.05) (Table-2).

Table 2:

Sources of obtaining informed consent & attitude towards informed consent

Source	Third year		Final year		House surgeons		Total
	N	%	N	%	n	%	n	%
Patients	75	60.0	87	69.6	100	80.0	262	69.9
Parents	37	29.6	31	24.8	15	12.0	83	22.1
Other relatives	10	83.0	7	5.6	10	8.0	27	7.2
Friends or relatives accompanying patients	3	2.4	-	-	-	-	3	0.8
Importance
Quite important	65	52.0	71	56.8	93	74.4	229	61.1
May be taken	31	24.8	24	19.2	21	16.8	76	20.3
Only situational	15	12.0	18	14.4	11	8.8	44	11.7
Not very important	14	11.2	12	9.6	-	-	26	6.9

On inquiring about the importance of obtaining informed consent, the majority, 61.1%, considered it as quite important. However this gradually increased from 52% in the third year students to 74.4% in dental surgeons in house job. Almost 7.0% of students did not consider informed consent to be of any importance. None of the dental surgeons in house job considered informed consent to be unimportant (table-2).

Since most of the respondents were in the clinical practice of dealing with the dental problems, it was asked as to how often they were actually taking the informed consent. Only 5.3% were taking it mostly, 16% usually, 56.8% sometimes and 21.9% were not obtaining informed consent. The group not obtaining the informed consent was highest in students (36% and 20.8%) and lowest (8.8%) among dental surgeons in house job. These differences were also statistically significant (Table 3).

Table 3:

Current practice and procedure requiring informed consent

Practice	Third year		Final year		House surgeons		Total
	N	%	N	%	n	%	n	%
Almost always taken	5	4.0	7	5.6	8	6.4	20	5.3
Usually taken	15	12.0	20	16.0	25	20.0	60	16.0
Sometimes taken	60	48.0	72	57.6	81	64.8	213	56.8
Mostly not taken	45	36.0	26	20.8	11	8.8	82	21.9
Procedure
Scaling & preventive steps	5	2.5	10	3.8	14	4.3	29	3.7
Caries & fillings	3	1.5	7	2.7	16	4.9	26	3.4
Periodontal diseases	3	1.5	8	3.1	12	3.7	23	2.9
Endo dental care	8	4.0	22	8.6	31	9.6	61	7.8
Root canal/crown bridge	70	35.0	92	35.9	112	34.7	274	35.2
Dentures	5	2.5	8	3.1	13	4.0	26	3.4
Maxillo facial surgeries	105	53.0	110	42.8	125	38.7	340	43.6

The respondents were given a list of dental procedures and were asked to identify situations where they considered informed consent to be important. Surgery (43.6%) and root canal/crown bridge procedures (35.2%) were mainly identified as necessary for informed consent. All other dental procedures were considered as less important for informed consent (Table 3).

In an answer to mention the person requiring the informed consent, the doctor was considered as protected (68%) through it. Some (13.8%) considered informed consent to be just as a routine step and only 9.1% thought that informed consent was a patient’s right. Similar proportion (9.1%) considered informed consent to be a research linked step (Table 4).

Table 4:

Reference need and contents of informed consent (perception)

Need	Third year		Final year		House surgeons		Total
	N	%	N	%	n	%	n	%
Patient’s right	6	4.8	12	9.6	16	12.8	34	9.1
Doctor’s protection	70	56.0	94	75.2	91	72.8	255	68.0
Research	5	4	14	11.2	15	12.0	34	9.1
As a routine	44	35.2	5	4.0	3	2.4	52	13.8
Content
About procedures	60	48.0	65	52.0	60	48.0	185	49.3
About risks/complications	3	2.4	5	4.0	8	6.4	16	4.3
Economic involvement	20	16.0	9	7.2	6	4.8	35	9.3
Psychological relaxation	33	26.4	40	32.0	45	36.0	118	31.5
Long term effects	9	7.2	6	4.8	6	4.8	21	5.6

The respondents were asked to identify the information to be included in the informed consent form. ‘Describing’, the procedure was the main information considered by the majority (49.3%). This was followed by statements relaxing the patient psychologically (31.5%). Other areas like informing about risks, short-and long-term effects were mentioned by less than 10% respondents (table 4).

Finally they were asked about the source of their information for informed consent. Four sources were mentioned in almost equal numbers; for 86 (22.9%) the source was teacher, whereas for 92 (24.5%) it was printed material in form of books/journals, 83 (22.2%) got the information from colleagues and friends and for 114 (30.4%) source was the media.

Discussion

Informed consent is the educational process which focuses on patient’s absolute right to understand their status and practioner’s proposed treatment plan. Laws regarding informed consent vary from country to country; American Dental Association’s Principles of Ethics in this regard states “the dentist should inform the patient of the proposed treatment and any reasonable alternatives, in a manner that allows the patient to become involved in treatment decision (3).

In this cross-sectional descriptive study carried among 3rd year, final year students of dentistry and dental surgeons doing their house job, a self-administered questionnaire comprising of 17 questions to investigate the perception and practices of dental professionals in matters relating to informed consent were explored.

The information obtained suggested that 87% of the respondents were aware of the informed consent; whether verbal or written, and 13% had no knowledge. Similarly 92% also knew that either the patient or the parents have to provide informed consent. These suggested that at least the significance of informed consent has been included in the academic curriculum.

In a survey conducted elsewhere more that 90% of the students had heard about the informed consent, and the consent was understood by 70%–73% of them (4). In current study, by attitude only, 6.9% did not consider informed consent to be an essential step in the dental care services. However to examine, treat, manage or operate upon patient without consent is assault in law, even if it is beneficial and done in good faith (5).

In this study, there was a wider gap of 21.9% who still did not obtain informed consent as a routine protocol. This could probably be due to hurry, lack of time or negligence on the part of the dental professionals. However the seniors (house surgeons) were more involved in obtaining informed consent than the juniors, perhaps due to improved realization of its importance. It is also very important that patient or parents in case of minors should completely understand what they are consenting for. In an observational study among 70 parents, it was found that 74% were able to participate fully in survey and 40% of the written consent obtained from parents was not valid (6).

In a survey among 232 dental students for identifying the topics in ethics course, which can influence their professional practice, 21% of the students identified confidentiality, 21% identified informed consent and 19% identified obtaining assent from children and adolescent as the most important (7).

Interestingly in this study, importance of informed consent was not uniformly realized for all procedures and only more invasive and surgical procedures were considered eligible for obtaining informed consent. Maxillofacial surgery and root canal procedures thus were mentioned by 79% of the respondents.

In the current study, two thirds of the respondents considered informed consent to be a safeguard for the doctors mainly and as a right for the patient. There was also diversity about what should be the contents of the informed consent.

In another informal survey among 252 dentists, it was found out that they only obtain written informed consent for the administration of local anesthesia (8).

The results of a study conducted in India showed that written informed consent is usually obtained for anesthesia involving sedation or general anesthesia and not for local anesthesia considering it to be extremely safe. However it is important to remember that having a patient sign a written consent form does not excuse the dentist from the responsibility of having adequate discussion with patient about the proposed treatment and explaining the risks-benefits and possible alternatives (9).

Conclusion

There is high sensitization about the concept of informed consent but there are many gaps in the realization of its contents, need, application and practice. This calls for better attention of the teachers to stress on the role of informed consent in a systematic way.

Date: __________________	Serial No.___________
Class of student: ________________

a)	Verbal Consent	yes/no/not sure
b)	Written Consent	yes/no/not sure

Patient	Written/Verbal
Parents	Written/Verbal
Guardian	Written/Verbal
Spouse	Written/Verbal
Others	Written/Verbal

Extractions	Crown/Bridges	Endodontic therapy
Dentures	Filling	Peridontal disease
Fixed/Removable orthodontic appliances		Dental implants
Maxillofacial surgeries		Laser whitening

a)	In protecting the rights of the patient
b)	In protecting the rights of the doctor
c)	For research purpose

a)	Verbal Consent
b)	Written Consent

a)	As a routine
b)	As an ‘when necessary’
c)	Only if one remembers