INFORMED CONSENT FOR SURGERY IN NIGERIA: IS THE PRACTICE ADEQUATE?

To evaluate the adequacy of the use of informed consent in surgical practice from the patients’ perspective. The study was carried out in the department of Surgery, University of Calabar Teaching Hospital, Calabar, over a six-month period. A structured questionnaire was administered post operatively on patients, and parents/guardians of minors, who agreed to participate in the exercise. Data obtained included sociodemographic characteristics, description of surgery they had, whether surgical procedure was explained to them pre operatively or not, who gave the explanation, their level of understanding and their opinion on the process of obtaining the consent. Ninety one patients participated in the study. Male to female ratio was 3.8:1, with average age of 33.6 years (SD ± 13). Most of them (94.6%) had some level of formal education. Seventy nine patients (86.8%) knew the description of the surgical procedure. Pre operative explanation of the surgical procedure was given to 70.3% of the patients but 27.5% of these did not understand the explanation. A significant number of the patients (51.6%) were not satisfied with the explanation given. Even though all the patients had the consent form signed either by themselves or on their behalf by a close relative, 46.2% of them did not understand the content of the consent form and 67.1% did not understand the implication of what they had signed. The practice of informed consent for surgery is not adequate. Surgeons need to be further educated to improve their practice in this regard. The consent process needs to be simplified to enhance patients’ understanding and participation.


INTRODUCTION
Surgical treatment often involves violation of the integrity of the patient's tissues and organs. Complications are not uncommon. For many centuries, the belief had been that it is the professional duty of the physician to do what is best for the patient. Consequently, the patient assumed an attitude of respect and gratitude, complying with the treatment without requesting any explanations about the therapeutic effects.
The physician also refrained from taking any initiative to inform the patient or his/her family (Mallardi, 2005). In the recent past, a surgeon only needed to obtain the patient's permission to carry out a procedure on him or her (Jones, et al, 2005). This practice has changed dramatically over the years. It is now generally accepted and agreed that a patient scheduled to undergo any surgical procedure must give consent before such a procedure is carried out. In minors and adult patients incapable of giving consent, a parent/guardian or a close adult relative recommended by law can give the consent on their behalf. Currently, the concept of consent has shifted from simple consent mentioned above to informed consent with serious medical, ethical and legal implications (Jones, et al, 2005 andBhattacharyya, et. al. 2005) Informed consent for surgery implies that a patient be given all necessary information about the procedure to be carried out, benefits, alternatives and possible complications including death, to enable him or her decide voluntarily whether to accept to undergo the procedure or not. The Medical Protection Society handbook states: "There is more to consent than getting a patient's signature on a consent form. Misinformed consent or consent given without proper understanding of what is involved, is of little legal value" (Bhattacharyya, et. al. 2005). The practice of informed consent is thought to have originated from the United States of America in an attempt to make sure that the dignity of the patient's independence is preserved at the time of decision-making and choice of medical options (Mallardi, 2005). In the light of this, the era of the patient not being informed of the details of the intended procedure is gone. In Nigeria, however, the practice of obtaining informed consent before surgical procedures appears not to be fully entrenched in our surgical practice. This study, which was done at the University of Calabar Teaching Hospital, Calabar, aims at finding out from patients the adequacy of the use of informed consent before surgical operations.

PATIENTS AND METHODS
All patients who had surgery in the Department of Surgery of the University of Calabar Teaching, Calabar over a six-month period, August 2006 to February 2007, who agreed to participate, were enrolled into the study. This included patients who had elective or emergency surgery as day-case or in-patient.
A questionnaire was administered to the patients post operatively, on the fourth day, when they had stabilized reasonably enough to respond appropriately to enquiries and on the first post operative clinic visit for patients who had day-case surgery. Parent/guardians completed the questionnaire for minors. Information obtained included sociodemographic details of the patient, type of surgery done, when consent for the procedure was obtained, whether the procedure carried out was adequately explained to the patient or not, the person who gave the explanation, patients' or relations' understanding of the explanation given by staff, understanding of the content of the consent form as well as their satisfaction or otherwise with the way the consent was obtained. Data so obtained was analysed using EPI-INFO (version 2002) computer software.

RESULTS
Ninety one patients entered the study. Their average age was 33.6years (range; 15 to 86years, SD ±13). There were 72 males and 19 females giving a male to female ratio of 3.8:1. Eighty six patients (94.6%) had some level of formal education: primary -24 (26.4%), secondary -33 (36.3%) and tertiary -29 (31.9%). The patients included 33 Businessmen/ women (36.3%), 24 Civil Servants (26.4%), 21 Students/Apprentices (23.1%), 11 Farmers (12.1%) and 2 Housewives (2.2%). Fifty nine surgical operations (64.8%) were elective while thirty two (35.2%) were emergencies consisting of thirty major (33.0%), forty three intermediate (47.3%) and eighteen minor procedures (19.8%). Most of the surgical procedures commonly carried out in the Department of Surgery of this hospital were represented. Seventy nine patients (86.8%) knew the description of the intended surgical procedure while 12 (13.2%) did not. The intended surgical procedure was explained to 64 (70.3%) of the patients but 25 (27.5%) did not understand the pre operative explanation given them by the surgical team. The proposed procedure was discussed with the patient and/or relations by the resident doctor most of the time (62.6% of cases) and Consultant in 23.1% of cases. Forty two patients (46.2%) did not understand the content of the consent form they were given to sign. A significant proportion of the patients and relations who signed the consent forms (67.1%) did not understand the implications, especially legal, of what they had signed. Majority of the patients (51.6%) were not satisfied with the pre operative explanation given them about the intended procedure by the surgical staff. Twenty three percent (21 patients/relations) felt that the information given them about the intended procedure was grossly inadequate. In most elective surgical procedures (71.5%), consent forms were given to the patients and/or relations to sign a day to surgery or in the morning of surgery but only 3 patients/relations (3.3%) felt that the consent was obtained rather late. Doctors administered the consent forms in 89% of cases and Nurses in 11%.

DISCUSSION
Today's patients are much more educated and interested in participating in taking decisions that affect their care especially as they now have almost unlimited access to information. This has necessitated an upgrading of the method of obtaining consent, from simple consent to informed consent. That up to 13.2% of the patients did not know the descriptions of the surgical procedure to be performed on them or their children/wards/relatives is rather noteworthy especially as most of the patients had some level of formal education. Even though this figure is low compared with the findings of a similar study done elsewhere in Nigeria (Kidmas, et. al, 2003), it could indicate inadequate interaction between the patients and the surgical team. The lack of understanding of the pre operative discussion of the intended surgical procedure by 27.5% of the patients in this study contrasts with results of another study (Kusec, et. al., 2006). This lack of understanding may be due to the use of very technical language by the surgical team during the discussion with the patient as well as insufficient time spent in this interaction especially in emergency cases. The finding from this study that resident doctors do the pre operative discussion with the patient in most cases (62.6%) could also be a factor in poor patient understanding because the resident doctor may not have all the information about the planned procedure especially in highly specialized cases. The involvement of Consultants in this aspect of surgical care is critical to improving the informed consent process. Recently, it has been suggested that the process of obtaining informed consent, including the pre operative explanation to the patient or relative, should be done by the Surgeon who will perform the procedure (Kidmas, et. al, 2003 andAgu, K A., 2003). The understanding of the patients can be further enhanced by introduction of leaflets containing necessary information, written in a language the patient can read, that the patient keeps for further reference (Aunan, E., 2003).
In our hospital, the content of the consent form is grossly inadequate. Its content is very technical and provides no room for the patient to make any modifications. It is therefore not surprising that up to 46.2 % of the patients did not understand its content. Inadequate or lack of explanation by the surgical staff at the time of administration of the consent form may also be contributory. It is important for the consent process, including the consent forms, to be simplified using 'layman's language' that the patient can understand. The need for further improvement in the consent process is underscored by the finding that 51.6% of the patients were not satisfied with the explanation given them, stating that the information provided by their doctors was grossly inadequate. They desired more detailed discussion about their surgical N. E. NGIM, W. O. NDIFON, M. S. UMOH and A. OGUNKEYEDE condition and the intended surgical procedure by their doctors. Even though 67.1% of the patients and close relatives, who signed the forms, did not understand the implication of their signing the consent forms, they were not bothered as they were primarily concerned with recovering form the diseases condition and they trusted their doctors to do the right thing. This also indicates lack of interest of the patients in our society in medical litigations. However, this is rapidly changing as more patients are getting enlightened about their rights. As many more patients become aware of their legal rights, the rate of medical litigations and malpractice suits is bound to increase.

CONCLUSION
From the results of this study, it would appear that the practice of informed consent by Surgeons is not adequate. Even though the primary purpose of emphasizing the importance of practicing informed consent by doctors is not as a defense against litigation, there is a need for Surgeons in Nigeria to be educated on the best practices as regards obtaining informed consent from their patients. This would not only improve their practice, it would enhance patient confidence in them and compliance with surgical treatment (Onche, et. al, 2004), as the patient would have taken part in the decision-making process. There is also the need to simplify the consent process to encourage and enhance patient participation.

ACKNOWLEDGEMENT
We are grateful to all Consultants in the Department of Surgery, University of Calabar Teaching Hospital, Calabar, for allowing their patients to be enrolled in the study. The cooperation of the Nursing staff, in the Surgical Wards of the hospital, in ensuring the smooth administration of the questionnaire to the patients is also appreciated.