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Introduction
The doctrine of informed consent has appeared relatively recently in the philosophy of
healthcare. The driving force behind the concept of involving patients in the management
of their illness through informed and shared decision-making was the Nuremberg trials at
the end of the Second World War. By the middle of the 20th century, therefore, consent
had become a recognized doctrine in medical intervention underpinned by ethical and
legal principles.
The importance of this is highlighted in a number of publications, largely based on case
law, providing explicit direction to healthcare professionals on how to obtain consent.
1,2,3,4,5,6,7
Even so, it is apparent, a proportion of professionals within the healthcare
system have not read them or cannot dependably recollect them. 8 Furthermore, within
orthodontics, it is clear that issues relating to the importance of informed consent seem
not to be apparent to all as yet. 9
This study, aimed at training grades group in orthodontics, was conducted to assess their
level of knowledge and understanding with respect to key principles underpinning the
process of informed consent.
1
Subjects and Method
In July 2007 a questionnaire (Appendix 1) was posted to 207 members of the training
grades group (TGG) in England, Wales and Northern Ireland, using an address list held
by the British Orthodontic Society’s TGG database together with an invitation to
participate. Scottish law differs significantly with respect to child consent and in relation
to an adult deemed incapable, 10, 11, 12 therefore TGG members in Scotland were excluded
from the study. Assurances were given that the data would be kept confidential and the
results would be rendered anonymous in the invitation to participate.
Participants were requested to complete all parts of the questionnaire and provide their
name and GDC number to help identify non-responders in order to facilitate repeat
mailings to them. A numerical code enabling identification of participants was also
included on the return envelopes in the event of any responders returning an
unidentifiable completed questionnaire.
A repeat mailing to non responders was conducted in September 2007 and where
appropriate, differing addresses to those initially supplied by the BOS, as obtained from
the GDC register were used. The deadline for final returns following the second
circulation was set for the end of January 2008 when data collection ceased. No
completed questionnaires were received after the data collection deadline had passed.
A similar study targeting the consultant orthodontic group (COG) was being conducted
concurrently. A separate publication detailing the results for the COG can be found
elsewhere.13
2
Questionnaire Design
The questionnaire was designed by R. Chate and consisted of 11 closed and open ended
questions with a possible 21 answers (Appendix 1). Part of the questionnaire was
compiled using extracts from a questionnaire used in a previous study used to test the
knowledge and understanding amongst doctors and health care professionals in Bristol.8
In addition, questions based on Department of Health and General Dental Council (GDC)
guidelines were conceived, validated by an independent medico-legal expert and
incorporated into the questionnaire. Questions covered areas of fundamental importance
in relation to consent, difficult clinical situations and common consent dilemmas.
Pilot Study
In June 2005, a similar questionnaire was circulated to 14 orthodontic consultants and 16
members of the TGG who worked in the East of England prior to a subsequent regional
audit (figure 1). After reviewing responses and agreeing standards the questionnaire was
reissued the following year and the audit ‘loop’ closed in September 2006.
The data above was used to refine the questionnaire for possible national circulation and
submitted to the British Orthodontic Society (BOS) Clinical Standards committee in
November 2006 for its endorsement which was received in March 2007. The committee
had recommended some minor alterations which led to final draft of the questionnaire
(Appendix 1).
Data Analysis
Data was entered into Microsoft Excel (Microsoft Corporation, Redmond WA, USA) and
analysis was carried out with the use of descriptive statistics.
3
Results
Figure 1 illustrates that of the 207 TGG orthodontists who were approached to complete
the survey, 126 complied (61%) and 83 did not (39%).
Overall, out of the 21 potential answers the mean, median and mode correct response
rates were 13 (62%), 13 (62%), and 14 (67%) respectively.
The performance of the TGG specific to each question was as follows:
Question 1.
For a patient to be able to consent to a course of treatment, what must the clinician
explain to them?
Table 1 illustrates that 98% of TGG members knew that this would involve explaining
the risks and benefits of the proposed treatment. However, 29% did not realize that this
should also include the risks and benefits of any alternative treatment and 76% did not
know that the potential consequences of remaining untreated should be explained.
Question 2.
For a clinician to judge whether a patient has the capacity to give informed consent,
what must the patient be able to demonstrate after all explanations have been given?
Table 2 illustrates that nearly all of the participants (97%) knew this would involve the
patient understanding and recalling the information they had been given, but 77% had not
realised they also had to judge whether the patient could use and weigh this information
when they came to decide what they wanted to do.
4
Question 3.
In the case of a conscious adult deemed incapable of giving consent for a course of
treatment that cannot be delayed, explain how best to proceed.
Approximately 75% of TGG members knew to seek a second professional opinion;
involve the carers and relatives in the discussion process and to only carry out treatment
deemed to be in the patient’s best interest (Table 3). However, only 7% knew to check if
any advance directives were made by the patient if and when they were previously
competent.
Question 4.
(a) In the case of a patient aged between 16 and 18 who is deemed incapable of giving
consent, can the patient’s mother legally give consent? and,
(b) Once the same patient reaches the age of 18, can his next of kin sign a consent form
on his behalf?
Table 4 shows that 72% of TGG members answered the first stem of this question
correctly and 86% answered the second stem correctly.
When taken in combination, however, only 60% of participants answered both parts of
this question correctly and 3 TGG members (2%) answered both parts incorrectly (Table
4).
Question 5.
If a competent child under 16 years of age consents to undergo a course of treatment, can
the child’s mother legally override that consent?
Table 5 shows that One hundred TGG members (79%) answered this question correctly
correctly.
5
Question 6.
If a competent child under 16 years of age refuses to undergo a course of treatment, can
the child’s father legally consent instead? (Two conditions need to qualify the first part of
this question, Appendix 1).
Overall 76% of participants answered the first part correctly by circling ‘yes’ in response
to this question (Table 6). Thirty TGG orthodontists (24%) gave the incorrect response
(Table 6 – combination 5).
The correct answer to the first part of the question needs to be qualified by two conditions
(Chapter 3. ‘Children and young people’, paragraphs 8, 8.1 and 10)3 and only 21% of
TGG members correctly cited these two conditions (Table 6 – combination 3) and 7%
could not qualify the correct answer they gave to first part of the question with either of
the qualify conditions (Table 6 – combination 1).
A total of 60 TGG members (48%) were able to cite one of the two correct qualifying
conditions in conjunction with a correct response to the first stem of the question (Table
6 – combination 2 and 4).
Question 7.
Is a signed consent form essential before non-urgent treatment?
Correct answer – No.3
Eighty seven TGG orthodontists (67%) answered this question correctly.
6
Question 8.
According to current Department of Health guidelines, can all major treatment
complications with an incidence of less than 1% be omitted from being discussed during
the process of obtaining consent?
Correct answer – No.3
Fifty nine (74%) of participants answered this question correctly whilst 26% answered
this question incorrectly.
Question 9.
According to current Department of Health guidelines, if a patient has signed a consent
form more than six months prior to the treatment starting, must the patient re-sign the
form for validity?
Correct answer – No).3
Only 31 (25%) correctly answered no they need not whilst 75% of responses to this
question were incorrect.
Question 10.
In those cases where some aspect of the patient’s dental treatment cannot be performed
without a general anaesthetic, who has responsibility for obtaining the anaesthetic
consent?
Correct answers – the referring dentist and the treating dentist.
Although 87% of TGG members responded correctly by stating that a dentist who was to
provide treatment under a general anaesthetic (GA) would need to obtain consent for the
7
anaesthetic, only 26% knew that if a clinician was to refer a patient for treatment under a
GA they would have the same obligation.
Question 11.
According to the General Dental Council’s May 2005 Standards Guidance, whenever a
patient returns to start a course of treatment following an examination or assessment,
must they be given a written treatment plan?
Correct answer – Yes.14
Eighty-eight (70%) of the TGG orthodontists who returned the questionnaire responded
correctly in answer to this question.
8
Discussion
Members of the Training Grades Group of the British Orthodontic Society represent an
important arm of the current and more importantly, the future orthodontic workforce with
many assuming key responsible positions as either hospital based consultants or
specialists practitioners of the future. As such, a fundamental and thorough understanding
of principles relating to obtaining informed consent lawfully should be viewed as a
mandatory requirement. The authors are not aware of any other publication that has
surveyed the understanding of the law as it relates to obtaining informed consent aimed at
this important sub-group of the orthodontic workforce.
After two mailings there were a total of 126 responses, giving a response rate of 61%.
This figure may seem favorable in relation to other questionnaire based studies published
within the dental literature.15 However, when compared to other similar questionnaire
based studies conducted within the specialty of orthodontics it is disappointing that the
response rate achieved was much lower in this survey. 13, 16
A possible explanation for the relatively poor response rate, particularly in comparison to
the consultant group of orthodontist13 may be the timing of the survey. The current study
started in the month of July and extended through to the month of September. These
months of the year, for most members of the TGG, represents an important time in their
training pathway as it coincides with the period during which preparation for and/or
sitting of examinations take place. This discriminating factor may well account for the
relatively large difference observed between the response rates seen in this study
9
compared to a similar survey conducted amongst the consultant group of orthodontists
carried out at a similar time of the year. 13
Overall, of the twenty one possible answers in response to the eleven questions posed, on
average, participants only provided correct answers for thirteen (61%) . This figure
should be viewed with some degree of pessimism as in light of ethical/ legal requirements
and obligations all healthcare professionals responsible for obtaining consent should
ideally be expected to achieve response rates of 100% . In relation to this exemplary
standard, not one of the eleven questions asked elicited a 100% correct response rate.
However, when compared to the consultant orthodontic group who participated in a
similar study, the TGG of orthodontist fared better as the overall correct response rate for
the former was a worrying 12 ( out of 21) questions (57%).13 Furthermore, a similar study
conducted with a group of medical doctors revealed an average correct score for
questions asked to be only 54% suggesting a lack of understanding of the law in relation
to obtaining consent to be more widespread amongst healthcare professionals in general. 8
The present study is not without weakness. As with most questionnaire based studies the
influence of responder bias cannot be ignored. Where response rates are low the influence
of responder bias may be more pronounced. In the current study, 39% failed to return a
completed questionnaire and one could make the assumption that a higher response rate
may have lead to even less favorable response outcomes. This would be based on the
premise that only those participants who felt confident and/or comfortable in answering
the questions returned the questionnaires whereas those who weren’t as familiar with
10
issues relating to informed consent did not, particularly, as the questionnaire was not
anonymous in design. Having said this, one of the strengths of such a study is to highlight
areas where changes to an individuals practice may be necessary and /or beneficial as
well as focus an individual to keep abreast of the changes in legislation with reference to
obtaining consent lawfully. This could not be more pertinent in an area such as consent
where case law continues to evolve, in turn, influencing legal developments almost
imposing a duty on health professionals to keep up to date with developments that may
influence their clinical practice.17, 18
As orthodontist’s most of us are primarily involved in treating children, therefore,
management of the child patient and an understanding of the consent process in relation
to the child patient is essential. Furthermore, many members of the TTG group will go
onto work in the community sector and as hospital based consultants where they will be
managing patients with special needs thus a complete comprehension of the law as it
relates to this group of patients is also necessary.
Questions 4, 5 and 6 (Appendix 1) explored the important areas outlined above. Although
72% of TGG orthodontists answered the first part of question four correctly and 86%
answered the second part correctly, when taken in combination only 60% answered both
parts correctly suggesting a lack of full understanding of the law as it relates to the
incapable patient’s age and consent (Table 4). This figure, although low, was noticeably
better in comparison to a similar study directed at the consultant orthodontist, where
somewhat worryingly, it was observed that only 45% of respondents answered both parts
correctly. 13
11
In relation to question five (Appendix 1), 79% of TGG members gave the correct
response. This figure may seem high and favorably better in comparison to the results of
similar surveys conducted amongst the consultant group of orthodontists where 71%
replied correctly and a group of medical doctors where only 68% replied correctly in
response to the same question. 8, 13 However, disappointingly, it is clear that almost one in
five members of the TGG group in orthodontics, by answering this question incorrectly,
were not aware of the issues relating to a Gillick competent child, a fundamental area of
the law as it relates to consent for a child that is universally taught as part of the national
undergraduate dental curriculum.
In response to question six (Appendix 1), 76% of TGG orthodontists answered correctly
that a father could indeed legally consent for treatment that his competent child was
refusing to undergo (Table 6). However, only 21% of TGG members cited the two
qualifying conditions correctly in relation to the correct response (Table 6). Therefore,
only one in five members of the TGG groups who responded were fully aware of the
circumstances where a father can consent for a child under 16 years of age who refuses to
undergo a course of treatment. This low correct response rate, worryingly, compares
favorably with that achieved by the consultant orthodontic group where only 14% cited
both qualifying conditions in response to the correct answer thus demonstrating a
complete understanding of the law in this area.
13
On a positive note, in comparison to
group of doctors asked the same question as part of another study only 50% gave the
correct answer to the first part of this question8, a much lower correct response rate
compared to either the TGG of orthodontists (76%) or the consultant orthodontic group
(75%).13
12
In day to day orthodontic practice, it is wholly feasible that situations will arise where
patients will be accompanied by their father’s and for the purposes of obtaining lawful
consent clinicians must be familiar with the legal conditions that are placed upon fathers.
Furthermore, where the situation exists that a child is in conflict with his/ her parents in
relation to undertaking / not undertaking treatment clinicians should be acutely aware of
the law as it pertains to consent for children given we are branch of dentistry that treats a
significant number of children as a proportion of our overall workload. As such, it is
vital that all clinicians are aware of the correct answers to questions five and six and
importantly have some understanding of the law that underpins those principles. The
importance of this is echoed by the General Dental Council, in their guidance to dentists
as the regulatory body of our profession, in stating that dental professionals must make
themselves aware of the laws and regulations that affect their work. 19
A comprehensive knowledge and understanding of the issues relating to informed
consent has a number of other implications relevant to the clinical practice of
orthodontics over and above our ethical and legal requirements as healthcare
professionals. Well informed patients have been shown to be less anxious20, require
reduced pain medication21, exhibit better compliance22 and gain increased satisfaction
from treatment23. Furthermore, well-informed patients are believed to have more
reasonable expectations from treatment and are less likely to file lawsuits for malpractice,
24
which in an increasingly litigious society is of extreme relevance to practicing
clinicians. The value of obtaining informed consent in a manner that promotes the above
is of particular importance in orthodontics. This is because, treatment is usually of long
13
duration, involving a number of appointments and is extremely reliant on the patients cooperation, in particular with appliance care, wear and maintenance of good oral hygiene.
The Development and Standards Committee of the British Orthodontic Society, in
recognition of the above, believe the practice of obtaining informed consent should be
aimed at achieving the highest standards of ethical practice rather than just the legal
minimum. In an attempt to achieve this, the committee has published guidelines for
consent in orthodontics based on the Department of Health document “12 key points on
consent: the Law in England”. 5
The results of this survey have highlighted certain key areas of deficiency in the
knowledge and understanding of the law as it pertains to informed consent amongst the
Training Grades Group of the British Orthodontic Society. As healthcare professionals
we need to make ourselves aware of the current regulations surrounding issues relating to
informed consent and commit to a cycle of learning to ensure we remain up to date with
developments that take place within this area of healthcare in the future.
Conclusion

Certain key areas of deficiency in the knowledge and understanding of the law as
it pertains to informed consent exists amongst the Training Grades Group in
orthodontics.

All clinicians are encouraged to improve their knowledge and understanding
through education thus ensuring they comply with ethical and legal requirements
in relation to obtaining informed consent.
14
15
16
Table 1.
The number (n) and percentage of the 126 TGG orthodontists who answered the
first question correctly.
Response
n (%)
123 (98)
The risks and benefits of the proposed treatment
90 (71)
The risks and benefits of any alternative treatments
30 (24)
The consequences of remaining untreated
Reference Source: Chapter 1. ‘Seeking consent’, paragraphs 4 and 5.3 (3)
17
Table 2.
The number (n) and percentage of the 126 TGG orthodontists who answered the
second question correctly.
Response
n (%)
The information about the proposed treatment is
122 (97)
both understood and retained
The patient can use and weigh this information in the
29 (23)
decision making process
Reference Source: Chapter 1. ‘Seeking consent’, paragraph 2. (3)
18
Table 3.
The number (n) and percentage of the 126 TGG orthodontists who answered the
third question correctly.
Response
n (%)
Ascertain whether any advance directives were made
by the patient if and when they were previously
9 (7)
competent *
Involve the carers and relatives in the discussion
92 (73)
process **
Seek a second professional opinion ***
95 (75)
Only carry out treatment deemed to be in the
91 (72)
patient’s best interest ****
Reference Sources:
*
Chapter 1. ‘Seeking consent’, paragraph 19 (3)
**
Chapter 2. ‘Adults without capacity’, paragraph 6.1 (3)
*** Consent Form 4. For adults who are unable to consent (4)
**** Chapter 2. ‘Adults without capacity’, paragraphs 3 and 6 (3)
19
Table 4.
The number (n) and percentage of the 126 TGG orthodontists who answered both parts of question 4 correctly or incorrectly.
Combination
Question
Combination 2
Combination 3
Combination 4
n
n
n
16
75
-
-
91 (72)
no
-
-
32
3
35 (28)
yes
16
-
-
3
18 (14)
-
75
32
-
108 (86)
16 (13)
75 (60)
32 (25)
3 (2)
Response
1
n (%)
n
Yes *
4a
(Correct answer)
4b
No**
(Correct answer)
n (%)
Reference Sources:
* Chapter 3. ‘Children and young people’, paragraph 9. (3)
** Chapter 2. ‘Adults without capacity’, paragraph 1. (3)
20
Table 5.
The number (n) and percentage of the 126 TGG orthodontists who answered question 5 correctly.
Response
n (%)
26 (21)
Yes
100 (79)
No (correct answer)
Reference Sources:
Chapter 3. ‘Children and young people’, paragraphs 5 and 6.3
21
Table 6.
The number (n) and percentage of the 126 TGG orthodontists who answered the three parts of question 6 correctly, incorrectly or partly correct.
Question
Yes
6
Combination
Combination
Combination
Combination
Combination
1
2
3
4
5
10
20
26
40
Answer
(Correct answer)
n (%)
No
First
96 (76)
30
Correctly Given *
20
26
30 (24)
46 (37)
Qualifying
Not Given
Condition
Second
10
40
Correctly Given †
26
30
40
80 (63)
66 (52)
Qualifying
Not Given
Condition
n (%)
10
20
10 (7)
20 (16)
30
26 (21)
Reference Sources:
* Chapter 3. ‘Children and young people’, paragraphs 8 and 8.1 (3)
† Chapter 3. ‘Children and young people’, paragraph 10 (3)
22
40 (32)
30 (24)
60 (48)
Appendix 1.
NAME.
GDC Number.
Informed Consent Questionnaire
(a)
(b)
(c)
(d)
For a patient to be able to consent to a course of treatment, what must the clinician explain to
them?
[3 answers]



For a clinician to judge whether a patient has the capacity to give informed consent, what must
the patient be able to demonstrate after all explanations have been given?
[2 answers]


In the case of a conscious adult deemed incapable of giving consent for a course of treatment
that cannot be delayed, explain how best to proceed.
[4 answers]




In the case of a patient aged between 16 and 18 who is deemed incapable of giving consent,
can the patient’s mother legally give consent?

YES / NO
Once the same patient reaches the age of 18, can his next of kin sign a consent form on his behalf?

YES / NO
(e)
If a competent child under 16 years of age consents to undergo a course of treatment, can the
child’s mother legally override that consent?

(f)
(g)
YES / NO
If a competent child under 16 years of age refuses to undergo a course of treatment, can the
child’s father legally consent instead?
[3 answers]

YES / NO Your answer needs to be qualified by TWO conditions which are:


Is a signed consent form essential before non urgent treatment?

YES / NO
(h)
According to current Department of Health guidelines, can all major treatment complications with an
incidence of less than 1% be omitted from being discussed during the process of obtaining consent?

YES / NO
(i)
According to current Department of Health guidelines, if a patient has signed a consent form
more than 6 months prior to the treatment starting, must the patient re-sign the form for validity?

YES / NO
(j)
In those cases where some aspect of the patient’s dental treatment cannot be performed
without a general anaesthetic, who has responsibility for obtaining the anaesthetic consent?
[2 answers]


According to the GDC’s May 2005 Standards Guidance, whenever a patient returns to start a
course of treatment following an examination or assessment, must they be given a written
treatment plan?
(k)

YES / NO
23
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3
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4
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5
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7
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