Knowledge and perception of surgical informed consent and associated factors among adult surgical patients in Gondar University Comprehensive and Specialized Hospital, Ethiopia

Introduction: there are many studies regarding informed consent in clinical trials, however, only few studies have assessed adult patient’s knowledge and perception of surgical informed consent in clinical practice. Therefore, the purpose of this study was to assess knowledge and perception of surgical informed consent and associated factors among adult surgical patients in Gondar University Comprehensive and Specialized Hospital, Northwest Ethiopia, 2018 Methods: responses from 312 postoperative adult surgical patients was taken using pretested structured interviewer administered questionnaires for one month. Result: there were a total of 302 respondents, (40% males and 60% females). More than half, 178 (59%) were in age groups of 31-43 years. Of the study participants, 193(63.91%) of them had poor knowledge and 155(51.3%) had poor perception about surgical informed consent in the study area. On the other hand, living in urban, being higher educational status and having past history of surgery were positively associated with good knowledge of patients towards surgical informed consent while being urban, higher education, being ophthalmologic patient & receiving consent from physician were positively associated with perception of patients regarding surgical informed consent. Conclusion: majority of the study participants had limited knowledge and poor perception about surgical informed consent. Adequate preoperative health education for patients should improve patients’ knowledge and perception.

necessary information about health care and subsequent treatment plans, risk, and alternatives. An informed consent is built by competent patient to make decision about his/her surgical procedure with enough information which is clear and understandable and valid unless the patient's disease has not been changed, and or no new findings that may change the planned procedure are revealed (1). Whatever it is, the patient has still full right to refuse the treatment, called informed refusal, but the reality is not true in clinical practice (2,3).
Informed consent is an ethical and legal obligation for the physicians to communicate to the patient and results in the patient's agreement to undergo a medical procedure. It is taken as a safety tool for both patient and the surgical team and Informed consent originated from legal and ethical principles ;this is done by improving patients' knowledge and perception about informed consent process that enables the patient to decide on their surgical procedure freely and intentionally without enforcement (4).
However, now a day (starting from 20 th Century) informed consent had been recognized as an issue in surgical health care services (5). Evidence shows that Patients often feel powerless and vulnerable and it is a proven fact that patient's awareness of legal and ethical issues related to the consent process is often limited. The informed consent process should be seen as an invitation to him to participate in his health care decisions (6).
Patients' perceptions of what constitutes informed consent are diverse and many patients undergo surgery without knowledge of even the identity of the surgeon or the reason for the surgery. Based on this literature poor knowledge and perception about surgical informed consent process leads to poor patients' participation in informed decision making leads to loss of patient autonomy (7).
Signing a surgical informed consent has many benefits including increase patient cooperation, protects patient's autonomy thus minimizing surgical complications and increasing the chances of successful defense against possible medico-legal cases (7)(8)(9).
However, a systemic review on surgical informed consent revealed that substantial weaknesses and omissions of SIC are evident and the current elements of the SIC process are largely neglected in daily practice. Based on this evidence preconditions are ignored, information is incomplete, and the consent itself is not an accurate reflection of the patient's authorization; in the media surgeons are blamed for making mistakes and people are encouraged to ''sue for every fault their surgeons make,'' leading to an increase in medico legal claims. However, it should be realized that most legal cases are not due to failures in treatment but due to failure in communication during consent before surgery is undertaken (10).
Some literatures stated that patients had poor knowledge and perception about surgical informed consent process and they have to be informed of the reason for operation, success of the operation, alternatives of the treatment, what would happen during the operation, for how much the operation would take, precautions after the operation and information on post treatment/post-operative/ care and free and willingness of the overall consent before consent is signed (11,12).
Lack of patient's knowledge and poor perception on surgical informed consent compromise shared decision making between the physician and the patient, increase the likelihood of a patient safety incident, patient anxiety and generally result in postoperative patient dissatisfaction (13).
Literature shows that patients with no formal education are unable to understand the information provided during informed consent process this indicates the presence of gap in health education during consent process (4). Even though evidence suggested that every surgical patient should be informed by the surgeon about the proposed surgery prior to obtaining consent form, but still patients are not aware and the reality is not true in clinical set up especially in developing countries (14). Therefore, informed consent for surgery is expected to be more detailed as compared to general medical care and the appropriate pre-operative counselling during informed consent process fills the gap of patients' knowledge & perception towards consent and this will not only help to strengthen the patient-doctor relationship but also protect the doctor against medico-legal risks (8,15).
According to Ethiopian guidelines developed in Addis Ababa in April, 2016 of Medical Ethics for doctors in Ethiopia, under article 26, recommends that "It is the duty of the doctor to inform the patient about the treatment (Including surgical procedures), she/he intends to carry out. The doctor is always obliged to obtain a written consent of the patient before carrying out procedures. In the case of minors or persons who are unconscious or of unsound mind, the necessary consent should be obtained from parents or legal guardians, if there is no other legal provision" (16), but in practice, patients are not well informed about their overall treatments as result of suspicion of health care workers about patients against consent if their treatment risks were informed as result of poor knowledge and perception about informed consent.
In the study area there is poor perception and limited knowledge regarding surgical informed consent among patients, during the clinical practice, that patients sign the informed consent as a medical obligation for surgery and thought that the decision making regarding their treatment is the physician deal rather than their own rights.
Although studies showed that an informed consent during a surgical procedure leads to positive postoperative outcome, but to the researcher, the patient's knowledge and perception and factors towards the surgical informed consent is not known in Ethiopia. Therefore, this study will assess patient's knowledge and perception towards informed consent for surgical procedures in Gondar University Referral comprehensive and specialized hospital.

Methods
The study was carried out in Gondar University Comprehensive Specialized Hospital, found in Gondar, Ethiopia. Gondar is one of the ancient city in Ethiopia, located 750 km Northwest of Addis Ababa. According to the 2007 Ethiopian census report, it has a total population of 206,987 and more than half (108,902) of them were female (31). The town is divided in to 12 administrative areas; there are two hospitals (1 referral and 1 defense hospital), eight health centers and one NGO clinic. The study was conducted at Gondar University Comprehensive and Specialized Hospital (GUCSH) (surgical ward, orthopedics ward, trauma unit, ophthalmology unit, Fistula center and Gynecologic (Maternity) wards).
The Hospital is a referral and teaching hospital found in Gondar town, Ethiopia. The actual sample size for the study was determined using single population proportion formula taking assumption 50% proportion to maximize the sample size (and since this study is new and the first time in the area even in Ethiopia); with 95% confidence interval (1.96); α=0.05 ;5% marginal of error (5%). n=(Z α/2 ) 2 p(1-p); Therefore, n=384 Section B: -Knowledge questions. The response was rated on yes/No question whereby the one who answers yes was considered as correct and had good knowledge otherwise poor knowledge. The overall score was calculated in percentage.
Section C: -Perception Questions, the response was rated on a Likert scale whereby the most favorable answer gets a higher score and less favorable a lower score and the overall score was calculated in percentage. The minimum possible total score for level of perception will be 10 and the maximum possible score is 40.

Section D: -Clinical related factor questions
Section E: -information and health care worker related factors Data was collected by using a pretested structured interviewer administered questionnaire in surgical ward, orthopedics ward, trauma ward, Gynecologic & obstetrics ward, Fistula center and ophthalmology unit at GUCSH. A total of three clinical Nurses were participated for data collection in the study and was supervised by one Bsc nurse.
To ensure quality of data, the questionnaire was prepared in English and translate in to Amharic and then back to English to maintain consistency. To achieve the reliability, a closed ended questionnaire with the same words, same structure and same format for each participant, was used to ensure consistency and accuracy of data. Two-day training was given for data collectors and supervisor on data collection technique. Pretest was done on 5%(16) of sample size outside study area at Debark Hospital. The data collection process was supervised by supervisor and principal investigator daily.
Data was cleaned manually, entered by EPI INFO version 7 and was exported to SPSS version 20 for further analysis. The result was expressed by number, percentage, mean and standard deviation. Descriptive statistics were presented by table, graph (pie chart) and text. Bivariable analysis was used primarily to check which variable have association with the dependent variable and variables found to have p value of < 0.2 was entered into multivariable analysis for controlling the possible effects of confounders. The adjusted Odds ratios together with their 95% CI and p-value were computed to measure the association b/n the dependent and independent variables. Finally, in multivariable analysis, a p-value < 0.05 was considered as statistically significant in this study.
Ethical clearance was obtained from school of nursing, College of medicine and Health Sciences, and University of Gondar ethical review committee. Permission letter was obtained from Gondar University Comprehensive and Specialized Hospital. The purpose and the importance of the study were explained and informed consent was secured.
Confidentiality was maintained at all level of the study. Participants' involvement in the study were on voluntary bases and that they could withdraw at any time if they want. All the information given by the respondents was used for research purposes only.

Results
A total of 312 post-surgical patients were involved in this study with 302(97%) response rate. Out of the total of respondents, more than half, 181(60%), of them were females. On the other hand, 178 (59%) were 31-43 years and only 44(15%) of patients were age >57 years. One hundred and ninety-nine (65.9%) of patients were married and 61(20.2%) were single. more than half, 157(52%) were came from urban area. Regarding the educational status of the study participants, 138(45.7%) of patients were illiterates (Table 1) When we see knowledge of study participants, 238(78.8%) of them responded that signing an informed consent is a legal requirement for every surgical procedure. On  where the participant gets information, from whom they had taken surgical consent process, and the time given for consent process were associated with perception of surgical informed consent at p<0.2. When these variables were adjusted by using a multivariable analysis, to avoid the confounding effect of variables, a total of four variables (residence, educational status of patients, type of surgery and HCWs who gives consent process) were statistically associated with the outcome variable. Based on these result, study participants living in urban area were two times [AOR=2.07; (95%CI (1.06, 4.04); p=0.033] more likely having Good perception than rural dwellers. (Table 5) A result of this study's binary logistic regression analysis also showed that a study participant who had completed a secondary (grades 9-10) school had two times In this study, we demonstrated that 36.1% (95% CI (30.8, 41.4) of post-surgical patients had good knowledge about surgical informed consent. This finding was higher than the study done in Cairo University Hospital, Egypt where 27.3% of surgical patients were knowledgeable about surgical informed consent (17). This variation might be differences in educational status of the study participants that unlike this study majority of participants (61%) in the above study were illiterate. Our finding was also different from the study done in Rwanda by Mbonera F. et.al (15) such that eighty-three percent (83%) had low knowledge, 12% had moderate and only 5% had high level of knowledge towards informed consent in surgical procedures. The possible explanation for this difference might be the difference in study setting and sample size (147) difference. This result was lower than study's done in Nigeria by Sulaiman A. et al (2), where knowledge of patients about surgical informed consent in Nigeria was high (97.5%). The reason behind these difference might be difference in study setting, population difference and majority of the respondents (89.4%) had formal education in the above study.
Findings of this result was also different from the studies done in Croatia, by Vucemilo L. et al (20) and England studied by Akkad A. et al (13), in which half of study population were knowledgeable about surgical informed consent. The reason for this difference might be sample size (3329) and all study participants were literate in Vucemilo's study, sociodemographic variation might also be a possible explanation for this difference with studies at England; in India by Singh A. et al (14) where the overall understanding was poor in 17%, unsatisfactory in 33%, satisfactory in 32%, and good in 18% of the patients. This difference might be as a result of differences in sociodemographic characteristics (educational status 20% illiterate) as compared to our study setting) and or variation in sample size (n=582). On the other hand, the findings of this study regarding knowledge of patients about surgical informed consent was higher than the study done in south Africa by Kalala T. et al (6)  On the other hand, this finding was different from studies done:-in India by Rajesh A. et al.(9) and America by Fink A.et al (26) reported as looking at the values the level of understanding is not different between those who had a primary level of education and those who did not had formal education, but it was significantly better in those who had higher education. The justification for this difference might be sample size (555). A study in Saudi Arabia ,by EL-Nasser, (11) showed that education was not a predictor variable for knowledge of patients towards SIC. The possible explanation might be difference in  Findings in this result also reported that educational status of the study participants was significantly associated with perception of patients regarding surgical informed consent.
But, it was confirmed that there was no perception difference between patients with educational status of primary school, preparatory and illiterate patients. Based on this finding, those patients with educational level of college and above were nearly nine times [AOR=8.9; 95%CI (8.25, 9.82); p=0.000] more likely having good perception than illiterate participants. This finding was similar in studies done in Rwanda by Mbonera F. et al (15) and in south Africa by Kalala Tshimanga (6) where formal education had positive association with better perception of informed consent.
The type of surgery was still another factor that affects patients' perception towards surgical informed consent. Based on these finding, the odds of having good perception about surgical informed consent in orthopedic patients was decreased by 91% [AOR=0.09; 95% CI (0.03, 0.32); p=0.000] than ophthalmologic surgical patients. It might be due to difference in preoperative health education. This finding was consistent with study done in The result of this finding still reported that there was a significant association between HCW profession from whom the patient had taken informed consent process and patients' perception regarding SIC (surgical informed consent). Based on this finding, the odds of having good perception about SIC in patients who had taken SIC process from intern practitioner were decreased by 55% [AOR=0.45;95%CI (0.26,0.96); p=0.024] than patients received from physicians. This is supported by studies done in Croatia by Vucemilo L.et al (22). and in Saudi Arabia by Abolfotohu M. et al (23), stated as higher quality was predicted when the physician was the one who explained the informed consent. This implies that perception of patients about surgical informed consent should increase as consent process was explained by physicians.
The strength of this study was since there were no similar studies so far in our country, therefore this study shows index of knowledge and perception of patients towards surgical informed consent in our context, and being a base line for future researchers. The study was also tried to include study participants in all surgery disciplines and as it was conducted at tertiary care Hospital, so diversity of patients was obtained.
Our study has the following limitations: Lack of triangulation (data source and methodological triangulation might provide the investigator with better insight towards knowledge of patients towards surgical informed consent among adult surgical patients if there were qualitative data); the study was conducted in a single referral hospital and Institution based study, not generalizable for the community as whole.

Conclusion
This study revealed that the patient's knowledge towards surgical informed consent for

Ethics approval and consent to participate
Ethical clearance was obtained from school of nursing, College of medicine and Health Sciences, and University of Gondar ethical review committee. Permission letter was obtained from Gondar University Referral Hospital. The purpose and the importance of the study were explained and informed consent was secured.
Confidentiality was maintained at all level of the study. Participants' involvement in the study were on voluntary bases and that they could withdraw at any time if they want. All the information given by the respondents was used for research purposes only.
Confidentiality and privacy was maintained by omitting personal identifier of the respondents during data collection procedure