PhiliPPine Journal of otolaryngology-head and neck Surgery Vol. 25 no. 2 July – december 2010
ORIGINAL ARTICLES
18 PhiliPPine Journal of otolaryngology-head and neck Surgery
Philipp J Otolaryngol Head Neck Surg 2010; 25 (2): 18-22 c Philippine Society of Otolaryngology – Head and Neck Surgery, Inc.
ABSTRACT
Objective: To determine patient satisfaction with the informed consent process in ear, nose
and throat (ENT) diseases requiring surgery. Specifically, to determine relationships between
educational levels of patients and their satisfaction with information given by doctors versus
self-gathered information; whether complications of the operation were explained to, and could
be listed by patients; the types of complications patients expected to be informed about and
the importance of this information to them; their familiarity with the term “informed consent”
and their preference for written or spoken information; and whether they were convinced about
what they consented to.
Methods:
Design: Cross-sectional Descriptive study
Setting: Tertiary Public Hospital
Population: One Hundred
Results: There were 55 males and 45 females (average age 26.7 years, range 4 - 74 years). Ten
percent (all children) had no formal education, 56% had primary to high school education, 23%
had certificate level education and 11% had a baccalaureate or masters degree. Ninety-five
percent claimed they knew what informed consent was. Ninety percent were satisfied with the
information given to them by doctors. Eighty percent, mainly with educational levels of high
school and above preferred to receive written information from doctors. Twenty three percent
accessed other sources of information. Those with certificate level education talked with previously
operated patients (10%) or read magazines (2%) while the internet was favored by almost all of
those with baccalaureate degrees (8%) and all those with masters degrees (2%). Of those who
accessed self-gathered information, 21% were not satisfied while only 2% were satisfied. Seventy
percent considered the information given by doctors very important. Similarly, seventy percent
(mostly from the higher educational levels) considered the impact of information provided by
the doctor completely convincing for decision making while 30% (mostly from lower educational
levels) only found the information partly convincing. Forty nine percent (again from the lower
educational levels) could not list even a single complication. Nineteen percent with educational
levels of certificate and above wanted to know all complications of surgery including those that
were very rare while 56% wanted to know most of the complications.
Informed Consent In Patients Undergoing ENT
Surgery: What Do Patients Want To Know?
Bikash lal Shrestha, MBBS, MS (ENT-HNS)1
1Department of Otorhinolaryngology
Kathmandu University Hospital
Dhulikhel, Kathmandu, Nepal
Correspondence: Bikash lal Shrestha, MBBS, MS (ENT-HNS)
Department of Otorhinolaryngology
Kathmandu University Hospital, Dhulikhel GPO.11008
Kathmandu, Nepal
Phone: (977)-11-490497
Fax: (977)-11-490707
Email: bikash001@hotmail.com
Reprints will not be available from the author.
The author declared that this represents original material
that is not being considered for publication or has not been
published or accepted for publication elsewhere, in full or
in part, in print or electronic media; that the manuscript
has been read and approved by the author, that the
requirements for authorship have been met by the author,
and that the author believes that the manuscript represents
honest work.
Disclosures: The author signed a disclosure that there are
no financial or other (including personal) relationships,
intellectual passion, political or religious beliefs, and
institutional affiliations that might lead to a conflict of
interest.
PhiliPPine Journal of otolaryngology-head and neck Surgery Vol. 25 no. 2 July – december 2010
ORIGINAL ARTICLES
PhiliPPine Journal of otolaryngology-head and neck Surgery 19
Conclusion: We should not underestimate the importance of the
outpatient consultation, the importance of written material and non
medical information sources as patients’ expectations are quite high and
the majority of them want to be informed about most complications. We
should also find ways to improve the provision of patient information
where possible and appropriate as per specific patient groups.
Keywords: Informed consent, otorhinolaryngology, surgical
procedures.
Informed consent is the permission given by the patient/relatives
after being given appropriate information about a proposed medical/
surgical intervention. The process is called the informed consent
process.1 It may be obtained in one sitting or over a period of time, either
orally or in writing or as a combination of the two.2 Studies suggest that
in practice only minimal formal efforts are made to obtain informed
consent for routine interventions.3,4 Some have suggested using the
“prudent patient standard,” in which the physician must disclose all
risks so that a reasonably prudent patient would make a decision
whether to undergo or refuse a particular procedure.5,6,7 Others have
hypothesized that better informed consent could improve the patient-
physician relationship, establish trust, increase patient compliance, and
provide information that could reduce medical error.2,8 Still others state
support that a reasonably prudent physician would disclose to his or
her patient.6,7 The informed consent process may be influenced by the
educational level of the patient. Studies have suggested that patients
with higher education levels tended to have better understanding of
informed consent, grasped more information and also had better recall
than those with no formal education.9,10
The aim of this present study was to determine patient
satisfaction with the informed consent process in ear, nose and
throat (ENT) diseases requiring surgery. Specifically, the study sought
to determine relationships between educational levels of patients
and their satisfaction with information given by doctors about their
recommended operation versus self-gathered information (if any);
whether complications of the operation were explained to, and could
be listed by patients; the types of complications patients expected to
be informed about and the importance of this information to them;
their familiarity with the term “informed consent” and their preference
for written or spoken information; and whether they were convinced
about what they consented to.
METhODS
This study was carried out among 100 patients in the Department
of ENT, Kathmandu University Hospital, Dhulikhel from January to May
2010. All the patients posted for elective surgery were included. The
study was performed in the following phases:
Questionnaires were constructed inspired and based on the study
performed by Adhikari et al.11 and Albera et al.12 A statistician and
the Department of Community Medicine were consulted regarding
the validity and reliability of the questionnaire but no pre-tests were
conducted. The survey questionnaires were framed in English and
translated into native Nepali but were not back-translated. Questions
covered demographic data and satisfaction with information obtained
from doctors; whether complications of the operation were explained
by doctors and could be listed by patients; the types of complications
patients expected to be informed about and the importance of this
information to them; knowledge of the term “informed consent,”
whether they were convinced about what they consented to; whether
they looked for further information regarding the surgical procedure;
the sources of and satisfaction with self-gathered information; and
modes of information patients prefer from doctors (Appendix). Patients
who opted for modalities of management other than surgery were
excluded from the study.
During the outpatient examination, the patients were given
explanations about their disease, the risks and benefits of the
recommended surgery, alternative methods of management and costs
of surgery to reach the ultimate decision. Questionnaires were handed
over to nursing staff with clear instructions on how to complete them
for patients to complete prior to discharge. Patients with no formal
education and children whose parents had no formal education were
assisted in accomplishing the questionnaires. These records were
collected and analyzed by simple manual analysis using frequencies
and percentages.
RESUlTS
Results were obtained from the sample of 100 subjects. There
were 55 males and 45 females with an average age of 26.7 years
and a range of 4 to 74 years. Seventeen percent were children. Ten
percent (all children) had no formal education, 56% had primary to
high school education, 23% had certificate level education, and 11%
had a baccalaureate or masters degree. (Table 1) Ninety-five percent
of the patients claimed they knew what informed consent was. (Table
2) Ninety percent of our patients were satisfied with the information
given to them by doctors. (Table 3) Eighty percent of patients,
mainly with educational levels of high school and above, preferred
to receive written information from doctors. (Table 4) Twenty three
percent of patients accessed other sources of information. Those with
certificate level education talked with previously operated patients
for information (10%) or read magazines (2%), while the internet was
PhiliPPine Journal of otolaryngology-head and neck Surgery Vol. 25 no. 2 July – december 2010
ORIGINAL ARTICLES
20 PhiliPPine Journal of otolaryngology-head and neck Surgery
favored by almost all of those with baccalaureate degrees (8%) and all
those with masters degrees (2%). (Table 5) Of the patients who accessed
self-gathered information, 21% were not satisfied while only 2%, (both
with certificate educational level) were satisfied. (Table 6) Seventy
percent considered the information given by doctors very important,
29% considered such information important and only one considered
it somewhat important. More importance seemed to be accorded by
those with higher educational levels. (Table 7) Similarly, 70% of the
patients (mostly from the higher educational levels) considered the
impact of information provided by the doctor completely convincing for
decision making, while 30% (mostly from lower educational levels) only
found the information partly convincing. (Table 8) Forty nine percent of
patients (again from the lower educational levels) could not list even a
single complication while an increasing number of complications could
be listed by those with increasing levels of education (Table 9). Nineteen
percent of our patients with educational levels of certificate and above
wanted to know all complications of surgery including those that were
very rare while 56% wanted to know most of the complications. (Table
10)
DISCUSSION
The components of informed consent include a description of
the patient’s condition and the proposed treatment, the benefits
of proposed treatment and the discussion of alternative treatment
including the implications of no treatment. Almost all our patients
replied that they knew what informed consent was, echoing findings of
other studies.6, 11 The majority of our patients (90%) were satisfied with
the information given by doctors before surgery, similar to findings
in previous studies by Adhikari et al.11 and Albera et al.12 On the other
hand, 80% of our patients preferred to receive written information from
physicians, in complete contrast to another study12 which showed that
only 20% preferred the written form. It may be because our patients
think that the written form of information instilled trust and hope.
Less than one fourth (23%), mainly the well-educated patients,
looked for further information regarding the surgical procedure. These
are less than the figures of Burns et al.6 where two thirds of patients
sought information elsewhere prior to signing their consent form,
but more than those of Adhikari et al.11 and comparable to those of
Lavelle –Jones et al.13 This may suggest a need to increase awareness
and interest among our patients and exert more effort to help non-
formally educated patients understand their disease. Obtaining proper
informed consent and good communication should be practiced not
only because it forms a part of a good medical practice; it also reduces
legal problems. Although the problem of litigation in Nepal is not very
high, there recently seems to be an increasing trend in this direction.
Table 1. Educational Level of Patients-Participants, n = 100
Level of Formal Education Number of Patients per Level
No formal education
Primary/High School
Certificate
Baccalaureate
Masters
TOTAL
10
56
23
9
2
100
Table 2. Patient Awareness of the Informed Consent Process, n =100
Level of Formal Education Aware
No formal education
Primary/High School
Certificate
Baccalaureate
Masters
TOTAL
5
56
23
9
2
95
Not Aware
5
0
0
0
0
5
Total
10
56
23
9
2
100
Table 4. Patient Preference for Mode of Delivery of Information , n=100.
Table 3. Patient Satisfaction with Information Provided by the Doctor, n=100.
Level of Formal Education Satisfied
No formal education
Primary/High School
Certificate
Baccalaureate
Masters
TOTAL
10
56
17
6
1
90
Not Satisfied
0
0
6
3
1
10
Total
10
56
23
9
2
100
Table 5. Other Sources of Information Accessed by the Patients-Participants, n=100
Level of Formal Education Other
Patients
No formal education
Primary/High School
Certificate
Baccalaureate
Masters
TOTAL
-
-
10
-
-
10
Magazines
-
-
2
1
-
3
Internet
-
-
-
8
2
10
Total
-
-
12
9
2
23
Level of Formal Education Mode of Delivery
No formal education
Primary/High School
Certificate
Baccalaureate
Masters
TOTAL
-
46
23
9
2
80
Spoken
8
10
-
-
-
18
No particular preference
2
-
-
-
-
2
Total
10
56
23
9
2
100
Written
PhiliPPine Journal of otolaryngology-head and neck Surgery Vol. 25 no. 2 July – december 2010
ORIGINAL ARTICLES
PhiliPPine Journal of otolaryngology-head and neck Surgery 21
Interestingly, our results showed that patients were not satisfied
with self-gathered information compared to information provided by
doctors, reminiscent of findings by Georgalas et al.14 It may be because
they believe more in the information provided by doctors rather than
that acquired from other sources. Moreover, the risk with this self-
gathered type of information is that it frequently is of variable quality,
and patients in another study graded it as the worst quality among all
the information sources.14
Also consistent with the literature12 were our findings that 70% of
patients believed it was very important for them to be informed about
their procedure and 70% of patients were completely convinced about
what they consented to. This may be because our patients had trust in
their doctors.
Almost half (49%) of our patients, mainly those with no formal
education and educational levels of primary/high school could not list
even a single complication while 33% who listed one complication only
mainly had primary/high school and certificate level education. Only
3% listed 3 complications and they had either master or baccalaureate
level education, consistent with the findings of Gongal et al.9 and
Hekkenberg et al.15 which showed better levels of understanding in
patients who had higher education.
Defining which risks are significant is arguably the most crucial
aspect of informed consent law.6,16 Adhikari et al.11 showed that 90%
expected to know all complications, while Burns et al.6 showed that
73.0% of those questioned expected to be informed of all known
complications, even if the incidence was less than one percent. Our
study showed that only 19% who were among the more educated
expected to know all complications even if rare. It may be because our
patients had less enthusiasm and more anxiety about knowing the
rarest complications. Most patients incorrectly believe that informed
consent serves only to protect a physician’s right but the process of
informed consent gives patients an understanding of a procedure17 so
that they can adequately make an informed decision. While mention of
extremely rare complications such as death may only serve to unjustly
increase patient anxiety; the argument that stating uncommon risks
may cause undue patient anxiety has been disproved.17 When discussing
complications with a patient, it is not clear whether one should present
his or her incidence of a complication or that found in the literature.
Though only few of our patients wish to be informed of all known
complications, we must raise awareness of patients and improve our
communication regarding most major complications.
We should not underestimate the importance of the outpatient
consultation, the importance of written material and non-medical
information sources. It is up to us to understand and use these
Table 6. Satisfaction with Self-Gathered Information, n=100
Level of Formal Education Satisfied
Certificate
Baccalaureate
Masters
TOTAL
2
0
0
2
Not Satisfied
10
9
2
21
Total
12
9
2
23
Table 8. Impact of Information Provided by the Doctor on Decision-Making, n = 100
Level of Formal Education Completely
convincing
No formal education
Primary/High School
Certificate
Baccalaureate
Masters
TOTAL
-
36
23
9
2
70
Partly
Convincing
10
20
-
-
-
30
Not
Convincing
-
-
-
-
-
Total
10
56
23
9
2
100
Table 7. Importance Given by Patients to the Information Provided
by Doctors, n = 100
Level of Formal
Education
Very
Important
No formal education
Primary/High School
Certificate
Baccalaureate
Masters
TOTAL
-
36
23
9
2
70
Important
9
20
-
-
-
29
Somewhat
important
1
-
-
-
-
1
Not
Important
-
-
-
-
-
-
Total
10
56
23
9
2
100
Table 9. Patient recall of the possible complications explained by the doctor,
n=100.
Level of Formal
Education
Cannot
recall any
No formal education
Primary/High School
Certificate
Baccalaureate
Masters
TOTAL
10
39
-
-
-
49
Can recall
only 1
-
17
16
-
-
33
Can recall
2
-
-
7
8
-
15
Can recall
at least 3
-
-
-
1
2
3
Total
10
56
23
9
2
100
Recall of Complications
Table 10. Number of Patients who would like to be told of surgical complications
whose Incidence rates fall within a certain range only, n = 100.
Level of Formal
Education
50-75%
No formal education
Primary/High School
Certificate
Baccalaureate
Masters
TOTAL
-
41
15
-
-
56
25-50%
5
15
-
-
-
20
10-25%
4
-
-
-
-
4
All
-
-
8
9
2
19
Total
10
56
23
9
2
100
Incidence Rate of Complications
5-10%
1
-
-
-
-
1
PhiliPPine Journal of otolaryngology-head and neck Surgery Vol. 25 no. 2 July – december 2010
ORIGINAL ARTICLES
22 PhiliPPine Journal of otolaryngology-head and neck Surgery
alternative information channels appropriately. Patients’ expectations
are quite high and the majority of them want to be informed about
most complications. We should also find ways to improve the provision
of patient information where possible and appropriate as per specific
patient groups.
REFERENCES
1. Mark JS, Spiro H. Informed consent for colonoscopy. A prospective study. Arch Intern Med. 1990
Apr;150(4):777-80.
2. Lidz CW, Appelbaum PS, Meisel A. Two models of implementing informed consent. Arch Intern
Med. 1988 Jun; 148(6):1385-9.
3. Hopper KD, TenHave TR, Hartzel J. Informed consent forms for clinical and research imaging
procedures: how much do patients understand? AJR Am J Roentgenol. 1995 Feb;164 (2):493-6.
4. Braddock CH 3rd, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision
making in outpatient practice: time to get back to basics. JAMA. 1999 Dec 22-29; 282(24):2313-
20
5. Wolf JS, Chiu AG, Palmer JN, O’Malley BW Jr, Schofield K, Taylor RJ. Informed consent in
endoscopic sinus surgery: the patient perspective. Laryngoscope. 2005 Mar; 115(3):492-494.
6. Burns P, Keogh I, Timon C. Informed consent: a patient’s perspective. J Otolaryngol. 2005 Jan;
119(1):19-22.
7. Baker CH. Comment: Informed Consent: Obligation on opportunity. J Health Hosp Law. 1993 Jul;
26(7):214-215.
8. Kuyper AR. Patient counseling detects prescription errors. Hosp Pharm. 1993 Dec;28 (12):1180-
1, 1184-9.
9. Gongal R, Bhattarai P. Informed consent: Is it really understood? Kathmandu Univ Med J (KUMJ).
2005 Jul-Sep; 3(3):271-73.
10. Falagas ME, Akrivos PD, Alexiou VG, Saridakis V, Moutos T, Peppas G et al. Patients’ perception of
quality of pre-operative informed consent in Athens, Greece: A pilot study. PLoS One. 2009 Nov
26;4(11):e8073.
11. Adhikari P, Pradhananga RB. Patients’ expectation on informed consent before ENT surgery.Intl.
Arch. Otorhinolaryngol.2007;11(1):51-53.
12. Albera R, Argentero P, Bonziglia S, De Andreis M, Preti G, Palonta F, et al. Informed consent in
ENT: patients’ judgement about a specific consensus form. Acta Otorhinolaryngol Ital. 2005 Oct;
25(5):304-11.
13. Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ
1993 Apr 3; 306(6882):885-90.
14. Georgalas C, Ganesh K, Papesch E. The information and consent process in patients undergoing
elective ENT surgery: A cross sectional survey. BMC Ear Nose Throat Disord. 2008 Sep 17;8:5.
15. Hekkenberg RJ, Irish JC, Rotstein LE, Brown DH, Gullane PJ. Informed consent in head and neck
surgery: how much do patients actually remember? J Otolaryngol.1997 Jun;26(3):155-9.
16. Palisano DJ, Lauve R. Informed Consent update for Louisiana: reducing the risk of malpractice
suits.J La State Med Soc.1994 Sep; 146(9):399-401.
17. Stanley BM, Walter DJ, Maddern GJ. Informed consent: how much information is enough? Aust
N Z J Surg.1998 Nov; 68(11):788-91.
APPENDIx
Questionnaire
Name:
Age:
Sex:
Religion:
Education:
Guardian name (if children): Relation:
Operation name: Date:
1. Were you satisfied by the information given to you by the doctors
about your operation?
Yes ( ) No ( )
2. Have you looked for any further information regarding your opera-
tion?
Yes ( ) No ( ) List: other patients ( ), Magazines ( ), Internet ( )
3. Were you satisfied with self-gathered information?
Yes ( ) No ( )
4. Do you know what informed consent is?
Yes ( ) No ( )
5. Did your doctor explain the complications of your procedure?
Yes ( ) No ( )
6. Can you list any of complications regarding your operations?
Yes ( ) No ( ) List:
7. How frequent the complications you expect to know from your doc-
tors?
<1%, 1-5%, 5-10%, 10-25%, 25-50%, 50-75%, ALL.
8. How important is it for you to be informed about:
a. Very much b. Enough c. A little d. Not at all
9. Were you convinced about what you consented to?
a. Yes, completely b. yes, partly c. No
10. Would you prefer to receive written or spoken information from the
doctor?
a. Written b. spoken c. it’s the same.