International Journal of Scientific and Research Publications, Volume 10, Issue 9, September 2020 368

ISSN 2250-3153

Pictorial Consent in Cardiac Surgery: A far better option

rather than Standard Informed Written Consent

Dr Debmalya Saha, Dr Pawan Singh, Dr Soumyaranjan Das, Dr Ravi Kumar Gupta, Dr Satyajit Samal,

Dr Muhammad Abid Geelani

Department of Cardiothoracic & Vascular Surgery, G.B. Pant Institute of Postgraduate Medical Education & Research (GIPMER), New Delhi-
110002, India

DOI: 10.29322/IJSRP.10.09.2020.p10544
http://dx.doi.org/10.29322/IJSRP.10.09.2020.p10544

Abstract- Because of the complexity of the procedures, high level and interactive power-point presentations are much more effective
of clarification for the patients as well as their attendants while than the conventional standard consent (7,8). Numerous studies,
taking consent is a must as cardiac surgery is associated with planning, work-up, follow-up have been made for improving the
significant morbidity and mortality. Pictorial consent with pre- consent process, as the regular update in the consent process is
operative education is a far better option in this regard. We mandatory in the present day of global digitalization. Several
randomly took a total of 150 patients within the age group of 18 to guidelines and recommendations have come but with a similar
70 years, and they were explained with standard consent followed basis (9,10). The process of taking consent is truly based upon the
by pictorial consent and vice versa by the same informant. And strong Doctor-patient relationship. Just signing on a consent paper
they were given a preset questionnaire format after both consents. does not signify that patient has fully understood the fact (11).
Later, based on their answers, comparison in relation to the level
of clarity was done. Questionnaire was formatted after rigorous
modification from the reviews of literature. II. MATERIALS & METHODS
We randomly took a total of 150 patients within the age
Key words: Consent, Informed, Pictorial, Cardiac, Legal group of 18 to 70 years, and they were explained with standard
consent followed by pictorial consent and vice versa by the same
informant. And they were given a preset questionnaire format after
both consents. Later, based on their answers, comparison in
I. INTRODUCTION relation to the level of clarity was done. Questionnaire was

A New York Court gave a verdict in 1914 that `every human

has a right to know what shall be done with his body&
without proper consent he will be liable for damages(1).The
formatted after rigorous modification from the review of
literatures.

concept of “consent” was first given by Salgo V. in 1957 as an one

of the most important aspects of legal, ethical and fundamental III. RESULTS
documentation in the context of medical practice(2). Proper After the explanation of both consents, a questionnaire
communication, justified explanation of benefit-risk & possible (table 1) was given and the result is depicted in table 2. Age group
alternative options of the planned procedure are actually neglected of the study population was 18-70 years. Level of literacy was
while focusing just on taking signature on written standard defined as per Gov Of India.
consent(3).In the current era, the process of consent is not Table 3 shows the time taken for explaining the two
adequate(4,5,6). Other interactive tools such as freehand consent. Enrolled patients are summarized in table 4. The result is
diagrams, leaflet, booklet, audiovisual tapes, computer programs noticeably clear as we can see here; and the level of clarity was
much better after the pictorial consent.

This publication is licensed under Creative Commons Attribution CC BY.

http://dx.doi.org/10.29322/IJSRP.10.09.2020.p10544 www.ijsrp.org
International Journal of Scientific and Research Publications, Volume 10, Issue 9, September 2020 369
ISSN 2250-3153

TABLE 1.

Serial No Knowledge Standard Consent/Pictorial Consent

1. Diagnosis of the disease Yes/No

2. Operative procedure planned Yes/No
3. Alternative options Yes/No
4. Approaches/incisions Yes/No
5. Monitoring lines/devices Yes/No
6. Pacing wires/temporary pacemaker Yes/No
7. Drains Yes/No
8. Comorbidities increasing the risk Yes/No
9. Blood products & complications Yes/No
10. Cardioversion Yes/No
11. ICU stay Yes/No
12. Post-operative events Yes/No
13. Long-term outcomes-survival/morbidity/mortality Yes/No

TABLE 2.

SERIAL NO. KNOWLEDGE STANDARD PICTORIAL

CONSENT CONSENT

1. Diagnosis of the disease 80 145

2. Operative procedure planned 51 142
3. Alternative options 71 138
4. Approaches/incisions 91 148
5. Monitoring lines/devices 48 132
6. Pacing wires/temporary pacemaker 61 129
7. Drains 101 141
8. Comorbidities increasing the risk 78 123
9. Blood products & complications 78 141
10. Cardioversion 41 129
11. ICU stay 96 131
12. Post-operative events 79 137
13. Long-term outcomes- 68 128
survival/morbidity/mortality

TABLE 3.

TIME TAKEN STANDARD CONSENT PICTORIAL CONSENT

(minutes)

Maximum 12 29
Minimum 7 13
Average 10 21

This publication is licensed under Creative Commons Attribution CC BY.

http://dx.doi.org/10.29322/IJSRP.10.09.2020.p10544 www.ijsrp.org
International Journal of Scientific and Research Publications, Volume 10, Issue 9, September 2020 370
ISSN 2250-3153

TABLE 4.

PATIENTS MALE FEMALE

AGE GROUPS 18 - 35 26 38
36 - 55 32 23
56 - 70 21 10
LITERATE 45 15
ILLITERATE 34 56

IV. DISCUSSION 7.Cardioversion and its possible complications were

In clinical ground “informed consent” is the legal and ethical explained.
conceptual process by which the patient is provided with 8.Blood product transfusion and its complications: They had
information relevant to a proposed diagnostic or therapeutic a few queries regarding their preoperative donated blood, and it
intervention; and should be elaborated sufficiently that the patient may give better recovery if transfused, but they were explained
can come to a decision for making a rational choice among the about the complications of unnecessary transfusions.
possible available options. In actual clinical scenario the informed 9.Diet: Dietary modification is an important aspect in post-
consent has just become a process of taking signature on consent operative CABG patients; and food stuffs were better understood
form due to huge and increasing work load in the in pictorial form for the illiterate.
hospital(12).Because of global digital advancements, the patients People must understand that there is no procedure that is
are now much aware ,and they come to clinic or hospital with risk-free (12). Although the level of clarity is far improved for the
different queries regarding different therapeutic options, after patients after being explained the pictorial consent.
exploring their problems in the internet; as a result the process of
consent has been complex(13,14,15).
That is why the decision making must be customized V. LIMITATIONS
according to the patient`s ability to understand (16). It should The pictorial consent we tried to utilize had its own
involve active contribution of both the doctor and the patient but limitations. The questionnaire format, that was used to assess the
choice making must be done voluntarily without any external level of clarity, did not cover so many significant aspects of the
influence to avoid legal conflicts(17,18).Another important issue surgical plans.
while taking standard written consent is language barrier when
both the informant and the patient are from two different
geographical areas; in that situation self-explanatory pictorial VI. CONCLUSIONS
consent is a better option(19,20). As patient can understand and remember a very few
While explaining the pictorial consent, the facts were information provided during informed consent, the standard
more easily clarified and understood such as: consent in cardiac surgery should be improved with the
1.Diagnosis: Perception level was far better after simple implementation of interactive and self-explanatory measures such
illustrations while disclosing the diagnosis. as simple pictures, diagrams, illustrations, audiovisual tapes. It is
2.Proposed treatment plan and possible alternative: Patient not assured that the patient will go through the facts in the written
was satisfied after being explained in pictorial form, power-point consent completely even it may contain the detailed information,
presentation including audiovisual clips. while the pictorial consent being interactive in nature involves the
3.Approaches/incisions: Confusion of leg wounds in post- patient for active participation for achieving possible highest level
operative CABG patients were cleared when they were explained of clarity in understanding. A good consent process would help
with free-hand diagrams prior to surgery. better in avoiding ethical and legal conflicts. More studies should
4.Monitoring devices/pacing wire/drains: The necessity of be carried out to improve and standardize the concept of pictorial
neck lines, invasive(arterial) blood pressure monitoring, infusion consent as it is a newer advancement in the field of medical
pumps with inotropes or supporting medications, basics of all practice.
parameters projected on the monitors were explained in a
simplified manner with the help of illustrations. It was also
explained that the pacing wire that come out from the body is for
REFERENCES
temporary pacing to treat the transient heart blocks, and it will be
[1] Herz DA, Looman JE, Lewis SK. Informed consent: is it a myth?
cut before discharge. The functions of both mediastinal and chest Neurosurgery 1992; 30:453–458.
drains were explained along with the probable time of its removal. [2] Berg JW, Appelbaum PS. Informed consent: legal theory and clinical
6.Cardiopulmonary bypass: It was better understood in practice. 2nd ed. Oxford: Oxford University Press;2001
pictorial form.
This publication is licensed under Creative Commons Attribution CC BY.
http://dx.doi.org/10.29322/IJSRP.10.09.2020.p10544 www.ijsrp.org
International Journal of Scientific and Research Publications, Volume 10, Issue 9, September 2020 371
ISSN 2250-3153

[3] Shubha Dathatri, PhD, Luis Gruberg, MD, Jatin Anand. Informed Consent [19] Hopper KD, TenHave TR, Tully DA, et al. The readability of currently used
for Cardiac Procedures: Deficiencies in Patient Comprehension With Current surgical/procedure consent forms in the United States. Surgery 1998;
Methods Department of Surgery, Baylor College of Medicine, Houston, 123:496-503.
Texas; Division of Cardiovascular Diseases, Department of Medicine, and [20] Weston J, Hannah M, Downes J. Evaluating the benefits of a patient
Department of Surgery, Stony Brook School of Medicine, Stony Brook, New information video during the informed consent process. Patient Educ Couns
York; and The Texas Heart Institute, Houston, Texas Ann Thoracic Surg 1997; 30:239-45.
2014;97:1505–12)_ 2014 by The Society of Thoracic Surgeons
[4] Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of
informed consent. BMJ 1993;306:885–90.
[5] Leclercq WK, Keulers BJ, Scheltinga MR, Spauwen PH, van der Wilt GJ. A
review of surgical informed consent: past, present, and future. A quest to help
patients make better decisions. World J Surg 2010;34:1406–15.
[6] Braddock CH III, Edwards KA, Hasenberg NM, Laidley TL, Levinson W.
Informed decision making in outpatient practice: time to get back to basics.
JAMA 1999;282:2313–20.
[7] Tait AR, Voepel-Lewis T, Moscucci M, Brennan- Martinez CM, Levine R. AUTHORS
Patient comprehension of an interactive, computer-based information First Author – Dr Debmalya Saha, MCh Senior Resident,
program for cardiac catheterization: a comparison with standard information.
Arch Intern Med 2009; 169:1907–14. Department of Cardiothoracic & Vascular Surgery, G.B. Pant
[8] Morgan MW, Deber RB, Llewellyn-Thomas HA, et al. Randomized, Institute of Postgraduate Medical Education & Research
controlled trial of an interactive videodisc decision aid for patients with (GIPMER), New Delhi-110002, India
ischemic heart disease. J Gen Intern Med 2000; 15:685–93. Second Author – Dr Pawan Singh, MCh Senior Resident,
[9] General Medical Council. Seeking patient’s consent. The ethical Department of Cardiothoracic & Vascular Surgery, G.B. Pant
considerations. London: GMC; 1998. Institute of Postgraduate Medical Education & Research
[10] Department of Health. Reference guide to consent for examination or (GIPMER), New Delhi-110002, India
treatment. London: Department of Health; 2001. p10.
Third Author – Dr Soumyaranjan Das, MCh Senior Resident,
[11] Pankaj Kumar Mishra, Faruk Ozalp, Roy S. Gardner Informed consent in
cardiac surgery: is it truly informed? Journal of Cardiovascular Medicine Department of Cardiothoracic & Vascular Surgery, G.B. Pant
2006, 7:675–681 Institute of Postgraduate Medical Education & Research
[12] Daniel E. Hall MD MDiv, Allan V. Prochazka MD MSc, Aaron S. Fink MD (GIPMER), New Delhi-110002, India
Informed consent for clinical treatment CMAJ, March 20, 2012, 184(5) p533- Fourth Author – Dr Ravi Kumar Gupta, MCh Senior Resident,
540
Department of Cardiothoracic & Vascular Surgery, G.B. Pant
[13] Newton-Howes PAG, Dobbs B, Frizelle F. Informed consent: What do
patients want to know? N Z Med J 1998; 111:340-2.
Institute of Postgraduate Medical Education & Research
[14] Sulmasy DP, Lehmann LS, Levine DM, et al. Patients’ perceptions of the
(GIPMER), New Delhi-110002, India
quality of informed consent for common medical procedures. J Clin Ethics Fifth Author – Dr Satyajit Samal, MCh Senior Resident,
1994; 5:189-94. Department of Cardiothoracic & Vascular Surgery, G.B. Pant
[15] Schneider CE. The practice of autonomy: patients, doctors, and medical Institute of Postgraduate Medical Education & Research
decisions. New York (NY): Oxford University Press; 1998. p. 35-75, 92-9. (GIPMER), New Delhi-110002, India
[16] Leeper-Majors K, Veale JR, Westbrook TS, et al. The effect of standardized Sixth Author – Dr Muhammad Abid Geelani, Director &
patient feedback in teaching surgical residents informed consent: results of a
pilot study. Curr Surg 2003; 60: 615-22. Professor, Head of the Department, Department of
[17] Schenker Y, Fernandez A, Sudore R, et al. Interventions to improve patient Cardiothoracic & Vascular Surgery, G.B. Pant Institute of
comprehension in informed consent for medical and surgical procedures: a Postgraduate Medical Education & Research (GIPMER), New
systematic review. Med Decis Making 2011; 31:151-73. Delhi-110002, India
[18] Fink AS, Prochazka AV, Henderson WG, et al. Enhancement of surgical
informed consent by addition of repeat back: a multicenter, randomized
controlled clinical trial. Ann Surg 2010; 252: 27-36.
Correspondence Author – Email: [email protected]

This publication is licensed under Creative Commons Attribution CC BY.

http://dx.doi.org/10.29322/IJSRP.10.09.2020.p10544 www.ijsrp.org