Attitude of Surgeons Working in General Governmental Hospitals Towards Informed Consent , Kuwait

Background: Informed consent in medical practice means an acceptance of a medical or surgical intervention by the patient during hospital care. It helps patients to discuss with treating doctors about their conditions. Informed consent is considered crucial. It is a mutual understanding and agreement between care providers and patients. During informed consent process the patient is required to be informed about everything of the proposed intervention and this depends on the knowledge of the care provider in collecting and providing information to patient. Objective(s): To assess the attitude of surgeons working in General Governmental hospitals towards informed consent in Kuwait. Methods: A cross-sectional study was conducted from January to June 2016 in secondary health care hospitals. A self-administered questionnaire about informed consent for surgery was completed by 353 randomly selected surgeons working at various surgical specialties in five governmental general hospitals in Kuwait. The questionnaire was developed to examine the surgeons' attitudes towards informed consent. They were asked to respond to each question by Yes (agreeing) or No (disagreeing) or Unsure. The responses of the surgeons to each statement were calculated using Statistical package SPSS version 21. Results: Public surgeons considered informed consent routinely achieved in their current practice (87.8%). They thought that all doctors should receive formal training on informed consent (79.3 %), while only 35.7% of them actually received training on informed consent. On the other hand, most public surgeons thought that written information leaflets should be provided for patients during informed consent (82.2%). However, only 41.1% of them provided their patients with leaflets during informed consent. Furthermore, 83% of public surgeons thought that the main purpose of informed consent is to provide the surgeon with greater protection against litigation. Similarly, 89.5% public surgeons thought that the main purpose of informed consent is to respect the patient’s right of autonomy. The majority of surgeons thought that the main purpose of informed consent is to improve the doctor patient relationship (83.0 %), and 81.0% of public surgeons thought that the main purpose of informed consent is to improve the patient’s compliance with medical care. Lower percentages thought that informed consent may be unnecessary because most patients depend on their doctor to make the decision for them (24.4%). Finally, 85.6% of public surgeons thought that the doctor who is going to perform the operation, should do the informed consent. More than half of the surgeons thought that the patients age, level of education, the patient’s clinical presentation whether emergency or elective, the complexity and duration of surgery, social class and the need for referral to another doctor or hospital, affects the amount of information given during informed consent. Conclusion: Surgeons in general public hospitals should be more aware of the informed consent guidelines and they should adhere to them. In addition, introduction of formal training on informed consent in all hospitals is recommended and making written information more widely available is important.


INTRODUCTION
nformed consent is a legal form that expresses the idea that each has the right to make decisions affecting his well-being.It is related to selfpreservation and considered as religious value. (1)nformed consent has become a topic within the medical profession and public media. Increasing awareness resulted in considerable amount of medical research into the consent process.(5)(6)(7)(8) Surgery has been practiced for long time in Kuwaiti governmental hospitals at the level of secondary and tertiary health I Original Article care.The ministry of health in Kuwait has introduced compulsory medical consent to be given by patients before any procedure.According to this document, doctors should inform patients about medical protocols and options available for the case before getting patient signature prior to any medical procedure.
Doctors also should provide all information, including possible risks.This would be mandatory in public as well as private hospitals and clinics. (9)This has been documented by Ministerial Decree No.307/2015. (10)Yet there have been no research studies examining the surgeons' attitudes towards informed consent.Most of the studies that looked at doctors' attitudes towards consent were performed outside Kuwait and none of them looked at the opinions of doctors in relation to their specialty (11)(12)(13)(14) .In addition, there are scarce if not studies in the literature that have looked at how the informed consent process is viewed by surgeons working in governmental general hospitals in Kuwait.In this study, the authors examine the attitudes towards informed consent of a group of surgeons working in general public hospitals.Therefore, the objective of this study was to assess the attitude of surgeons working in general governmental hospitals towards informed consent in Kuwait.

METHODS
A cross-sectional study was conducted from January to June 2016 in five governmental general hospitals located in different regions of Kuwait state (one in each health region).A questionnaire about informed consent for surgery derived from different published studies dealing with the same topic as well as from our own experience was designed.(5) The questionnaire was distributed on 518 randomly selected surgeons from the manpower lists of the studied hospitals, however only 353 completed it.The questionnaire was included 30 questions that were developed to assess the surgeons' attitudes towards informed consent.The participants who were working as consultants and registrars in the various surgical specialties of these hospitals were made aware that the emphasis was on the verbal or written information about the operation they provide their patients with and not merely about the signing of the consent form which could take place at the same time or later.They were asked to respond to each question by Yes (agreeing) or No (disagreeing) or Unsure.

Statistical analysis
The number of surgeons in all the five studied governmental general hospitals was equal to 790 surgeons, the calculated sample size was determined for opinion survey at 5% level of significance, 80% power, 0.05 margin of error and 50% response rate, it was found to reach 518.The sample size was calculated using Check market online sample size calculator. (15)The responses of the surgeons to each statement were calculated using descriptive statistics in which, description of qualitative variables was performed by frequency tables and quantitative variables by calculation of mean ± standard deviation.Statistical analysis was done using SPSS version 21.

Ethical considerations
All ethical issues related to research were addressed according to the guidelines of standard and universal research ethical review.All the required approvals for conducting the study were obtained as that of Ethical Committee, the Kuwait Ministry of Health.The permissions of the Undersecretary of Ministry of Health as well as managers of each selected hospital were obtained.A written informed consent was prepared and signed by respondents after clarification of the aim and process of the study.Confidentiality of collected information was ensured.Filled questionnaires were kept in the central office of the researcher.
Table 2 reveals responses of the surgeons to the general informed consent questions.The majority (87.8%) of the surgeons indicated that informed consent was routinely achieved in their current practice.More than three-quarters (79.3%) thought that all doctors should receive formal training on informed consent.Moreover, 35.7% have received formal training on informed consent, while 64.3% were not trained at all.On the other hand, 82.2% of surgeons thought that written information leaflets should be provided for patients during informed consent.Only 41.1% of surgeons mentioned that they provide their patients with leaflets during informed consent.Table 3 shows responses of the surgeons to questions related to the main purpose of informed consent.88.4% of surgeons thought that the main purpose of informed consent is to ensure that the patient has been informed of all potential complications.More than four-fifths (83.0%) of surgeons thought that the main purpose of informed consent is to provide the surgeon with greater protection against litigation.Similarly, 83% thought that the main purpose of informed consent is to improve the doctor patient relationship.Most surgeons (89.5%) thought that the main purpose of informed consent is to respect the patient's right of autonomy and 81.0% of surgeons thought that the main purpose of informed consent is to improve the patient's compliance with medical care.Table 4 shows the surgeons' attitude towards the necessity of informed consent.Lower percentages (24.4%) thought that informed consent may be unnecessary because most patients depend on their doctor to make the decision for them.Less than twofifths (36.3%) of surgeons thought that informed consent may be unnecessary because disclosing information to patients about potentially harmful risks may be worrying for them.Furthermore 32.3% of surgeons thought that informed consent may be unnecessary because disclosing information about potentially harmful risks may dissuade patients from undergoing the operation.Just more than two-fifths (41.4%) of surgeons thought that informed consent may be unnecessary because most patients do not usually remember all the information given to them.
When surgeons were asked about who should do the informed consent and what should they disclose during the process, the majority (85.6%) of them thought that the doctor who is going to perform the operation, should do the informed consent while 57.2% of surgeons thought that the responsible consultant should take the informed consent and, 43.6% of surgeons thought that a junior doctor, who is going to help in the operation, should take the informed consent.More than three-quarters (76.8%) of surgeons thought that they should disclose the possibility of death if present.The majority (86.4%) of surgeons thought that they should disclose all major risks with incidence more than 1%.Just less than 7 in 10 (68.0%) of surgeons thought that they should disclose all minor risks with incidence more than 5% (Table 5).
Table 6 shows the responses of the surgeons to questions on what affects the amount of information given during informed consent.Just 7 in 10 (70.5%) of surgeons thought that the patients age affects the amount of information and only 41.1% of surgeons thought that the patients gender affects the amount of information while, 70.3% of them thought that the patients level of education affects the amount of information given during informed consent.Just less than a half (49.9%) of surgeons also thought that the patients social class affects the amount of information and 39.4% of surgeons thought that the patients source of funding for treatment affects the amount of information given during informed consent.On the other hand, 68.6% of surgeons thought that the patient's clinical presentation whether emergency or elective affects the amount of information.Just more than three-fifths (62.3%) of surgeons thought that the complexity and duration of surgery affects the amount of information given during informed consent.Less than a half (44.2%) of surgeons thought that the timing of surgery affects the amount of information.Moreover, 28.9% of surgeons thought that how busy you are at the time, affects the amount of information given during informed consent.Just less than a half (49.6%) of surgeons thought that the need for referral to another doctor or hospital affects the amount of information given during informed consent.

DISCUSSION
The participating surgeons in this study were representative of all governmental general hospitals.
In addition, we arguably believe that the responding surgeons could be considered fair representatives of surgeons practicing in each hospital because they were randomly chosen, of varied level of seniority, of broad spectrum of surgical specialties and different training background.Based on our study findings, the level of awareness and adherence to guidelines of the informed consent by surgeons working in general governmental hospitals in Kuwait are unclear.Most public surgeons stated that informed consent was routinely achieved in their practice; nevertheless, they felt that all doctors should receive formal training on informed consent and about a third of them (35.7%) reported that they had such training.They also agreed that written information (leaflets) should be given to patients during informed consent; however, 41.1% of them indicated that they were doing that already.This means that either surgeons do not adhere to the ministry policy guidelines or unavailability of leaflets during informed consent.Written information is useful as they promote the patients learning process, and the consent process should include an explanation of what the procedure entails.The main purpose of the consent process is to respect patients' right to autonomy.However, a minority of surgeons with an apparently paternalistic attitude towards the consent process thought that the consent process is inappropriate as information disclosed may be confusing to patients.Such belief is against policy guidelines indicating that the patient should be told. (16,17)ost public surgeons agreed that the main purpose of informed consent is to ensure that the patient is informed of all potential complications.They believed that informed consent provides the surgeon with greater protection against litigation.Similarly, they felt that the main purpose of informed consent includes, improving the doctor-patient relationship and improving the patients' compliance with medical care.This was supported by studies reporting that advance information about a procedure and its risks improves patients' compliance and post-procedure progress, in addition to reducing post-operative medication use. (18,19)Studies have shown that patients are different in terms of the amount of information they want and are able to understand and remember. (4,7,20,21) Sme patients may not want to know such details. (22)his study showed that most surgeons agreed that the informed consent is better to be done by the doctor himself who is going to operate the patient because he can provide all necessary information to the patient.This is logical as junior doctors may not be able to provide all the information necessary.The levels of risk to be disclosed during informed consent have been a matter of debate for years.Many surgeons have taken the 1-2% risk as the cutoff point to which operative risks should be discussed during informed consent.(18) The participating surgeons shared a similar opinion with regards to levels of risk disclosure, this agrees with pre-existing practice.It seems that most surgeons agreed with the need to disclose to patients the risk of death if present, to disclose all major risks with incidence >1% and all minor risks with incidence >5%.Our findings confirm that this attitude remains for a vast majority of surgeons and are consistent with the widely accepted policy. (2,18) r results showed that the amount of information Kuwaiti surgeons gave to their patients during informed consent was significantly influenced by several factors, which were patient and non-patient related.These included; the patient's age, gender, level of education, social class, source of funding for treatment, clinical presentation whether emergency or elective, complexity and duration of surgery, timing of surgery, how busy the surgeon is at the time and the need for referral to another doctor or hospital.This observation is another indication of paternalistic attitude by the public surgeons.Such findings are unjustifiable, though the variation in patient age, the levels of patient education and the level of social class of the patients may be relevant.

CONCLUSIONS & RECOMMENDATIONS
The present study showed that public surgeons tend to look at informed consent as not only an ethical and legal obligation, but also of benefit to patients.Public surgeons' approach to consent is paternalistic.However, public surgeons should become aware of the medical informed consent guidelines introduced by the Ministry of Health.Furthermore, introduction of formal training on informed consent in studied hospitals is recommended and making written information more widely available, since less than half of public surgeons mentioned that they provide their patients with leaflets for informed consent.