Satisfaction of Surgical Informed Consent and Associated Factors Among Women Undergone Obstetric and Gynecologic Surgery at Jimma Medical Center, Jimma, Oromia Region, Ethiopia 2020.

Background: Informed consent is a process in which a healthcare provider obtains permission from an individual before delivering a certain health intervention. Patient satisfaction towards informed consent process is one main indicator of patient experience on health care services and mirror image of quality health care. The objective of this study was to assess the level of women satisfaction towards surgical informed consent and its associated factors at Jimma Medical Center, Ethiopia, 2020. Method: Facility based cross-sectional study was conducted from April 1 to May30, 2020 at Jimma Medical Center. A total of 372 surgical patients were selected using a systematic random sampling method. The collected data was coded, entered into Epi data version 3.1 and analyzed using SPSS version 25. Bivariate and multivariate regression was carrying out to determine the association between outcome variable and independent variable. Result: A total of 372 study participants were interviewed and giving a response rate of 97.8 %. Of this majority respondents were 167(44.9%) between 28-37 years old, married 310(83.3%), Urban residence 242 (65.1%) and housewife 168 (45%). Patients’ satisfaction towards surgical informed consent was 43%. Multivariate logistic regression analysis showed that residence (AOR: 2.279, 95% CI: 1.257-4.131), current referred history (AOR: 1.856, 95% CI: 1.033-3.337), language of the written consent form (AOR: 2.076, 95% CI: 1.143-3.773), time taken for informed consent provision (AOR: 5.227, 95% CI: 2.499-10.936) and patient to health provider relationship (AOR: 5.419, 95% CI: 3.103-9.464) were positively associated with patient satisfaction. Conclusion: In this study, the level of patient towards surgical informed consent process was low compared with with

Conclusion: In this study, the level of patient satisfaction towards surgical informed consent process was relatively low compared with previous studies. Health care professionals need to give emphasize on way of delivering informed consent, patients' need and obey a standard informed consent process with evidence based practice to improve patient satisfaction.

Background
Patients' surgical informed consent for the operation is one vital part of preoperative care (1). Informed consent is the process in which a healthcare provider obtains permission from an individual before delivering a certain health intervention such as therapy, treatment and surgery. It is agreement on propose surgery perform between patient with health care providers (2).
The process of informed consent contains more than signing a prescribed form. It involves basic elements including the nature of the procedure; reasonable of operation, alternatives to the proposed intervention; the relevant risks, bene ts and uncertainties with sharing a satisfactory amount of information to the consenting individual, addressing their concerns, fears, questions and discussing possible outcomes (3,4). However, the habitual informed consent form content of information didn't consider the patients' needs and right (5). Patient satisfaction has been de ned as the degree of meeting between a patients' expectations of ideal care with their perception of the real care received (6,7). It is an important measure of healthcare quality (8). Patient satisfaction towards informed consent is increase when offer the written informed consent combine with verbal informed consent information during the preoperative period (9). Satis ed patients are more likely to obey treatment, take an active role in their own care and continue using health care services, voluntary involvement in decision making and stays within a healthcare provider (10).
Common reasons for postoperative patients dissatisfaction and usual complain by surgical patients were deformities, scars, asymmetry and infections (11). It would have mitigated or reduce if proper and su cient patient center preoperative informed consent delivered about indication of operation, alternative, advantage, consequence and complication of surgery.
The ultimate goal of offering surgical informed consent include improve client understanding of the proposed procedure, maintain trust between patient to healthcare providers, increase patient satisfaction and minimize litigation issues related to surgical procedure (3). However, the status of patient satisfaction towards informed consent provision still low, especially in African countries compare with high income country (12)(13)(14)(15)(16). It shows that value given to what patient expectation and as well type of service being patient to satisfy while provision of informed consent has huge variation at clinical area.
Generally; patients satisfaction depends on the difference between expectation and perception, so that it seems advisable to analyze in depth which aspects of the health services provide greatest satisfaction to surgical patients. The primary signi cant of this study shows the degree of patient satisfaction towards surgical informed consent provided and to know the factors which lead the patient dissatis ed.

Study design & setting
A cross-sectional study was conducted in Jimma Medical Center located in Jimma town, Ethiopia.
Jimma Medical Center is a referral hospital for the south west part of Ethiopia. It is a teaching tertiary hospital with four major clinical departments including internal medicine, surgery, pediatrics, and gynecology/obstetrics in which Fistula rooms are contained and also has other clinical departments, dentistry, ophthalmology, Orthopedics, psychiatry, Reproductive health center, dermatology and ART clinic.
Obstetrics and gynecology wards had 76 available beds for postoperative care. Around 1,461 and 900 patients were undergone obstetric and gynecological related surgery within past six month respectively (the previous 6 month report). Averagely around 787 patients were done surgery within two month. The study period was from April 1 to May 30, 2020.

Study participants
Women who undergone obstetrics and gynecologic surgeries were study participants of this study.
Surgical patients who undergone Ob-Gyn surgery age of 18 year old and above was include in this study. However, these women who had repeated surgery at the same admission, critically ill and known psychiatric illness were excluded from the study.

Sample size determination
The sample size was determined using single population proportion formula by considering 62 % proportion (P) which took from research done in Hawassa (17); with 95% con dence interval (1.96); α=0.05 and 5% marginal of error. By adding a non-response rate of 5%, the nal sample size was 380.

Sampling technique
Systematic sampling technique was employed to select study participant from 787 total two month surgical cases after determining the interval (K value). The k-value was determined by dividing total two month surgical case (787) to the nal sample size (380) that given approximately 2. The rst study participant was selected by simple random technique from the rst two individual and then the next participant was chosen every two interval from the registration book until the nal sample size reached.

Data collection measurement tool
The data collection measurement tool was adapted from different literatures developed for similar purpose (4,12). The body questioners have six parts. The rst part about general socio-demographic consist of 8 items, the second part deals with patient related factors consist 7 items; third one about service related factors consist 8 item, the fourth part deal with patient to healthcare provider relationship consist 9 items, adopted from validation of the patient to doctor relationship questionnaire (PDRQ-9) study done in German (19), the fth part deal about patients' knowledge towards surgical informed consent and the last part deal about the satisfaction of surgical informed consent it contain 10 items with ve Likert scale option (range from 1 completely dissatis ed to 5 completely satis ed). Data was collected using structured closed ended questionnaire. The data collection method was using interviewer administered questionnaire and document review. Two BSc and one MSc nurses were recruited as data collectors and supervisor respectively.

Dependent Variable
Satisfaction of surgical informed consent Independent Variables Social-demographic characteristics: Age, educational status, occupation, marital status, income and residence.
Patient related factors: Parity, knowledge, type of surgery, previous medical history and previous surgery.
Health care providers related factors: Patient to health care provider relationship Service related factors: Referred history, language of the written consent form, profession who request informed consent, timing of consent, time taken to provide of informed consent, time taken to decision making and person who signed on informed consent.

Operational de nition & de nition of terms
Surgical patients: mean elective-emergency surgery and obstetrics, gynecology patients who operated during the study period.
Patient satisfaction: de ne as meeting someone's expectations hence enjoyment from received services and product.
Satis ed: In this study refer study participants who have acquiring the overall satisfaction above mean satisfaction scores (33.3) on the given items to measure respondents' satisfaction (13).
Dissatis ed: In this study refer participants who have acquiring the overall satisfaction below mean score (33.3) on the given items to measure respondents' satisfaction.
Knowledge on surgical informed consent: about surgical informed consent if women answered knowledge questions with above mean score consider good knowledge otherwise having poor knowledge (18).
Patient to doctor relationship: The patient to doctor relationship can be seen as the perception of the patient concerning the caring shown by the doctor and the attitude and behavior of the doctor towards the patient. The PDRQ contain 9 items with yes/no option. When the patients choose greater than 7 items with yes response, considered as good PDR (19).

Data analysis procedure
The collected data was coded and entered to Epi data version 3.1 and exported to SPSS version 25. Hosmer and lemeshow test was done to con rm the model tness; its p-value was 0.072; so the model has been tted. Bivariate and Multivariate analysis were done between satisfaction of surgical informed consent and explanatory variables. In bivariate logistic regression the variables which had p-value less than 0.25 was considered as candidate variable for multivariable logistic analysis. In multivariable analysis those variables which had p-value less than 0.05 were considered as statistically signi cant with outcome variable. The nding of the data was presented by using tables, gures and graphs.

Data Quality Assurance
The questionnaire was initially prepared in English then translated to local language Afaan Oromo and Amharic, then translated back to English. Prior to actual data collection, pretesting of the questionnaire was conducted on 5% of the total samples (19 women) undergone surgery in Shenen Gibe Hospital. After that appropriate corrections and mandate the questionnaire were made. One day training was given for the supervisor and data collectors. During data collection period, the data was checked for completeness and consistency of information. Any error, ambiguity, incompleteness or other problems was addressed through communication with data collectors before beginning of the next day data collection activities. The reliability of the patients' satisfaction tool was done by using Cronbach Alpha, it was 0.83.

Patient related factors
Among study participants half (52.2%) of them were multipara. Around three fourth of study participants (74.5%) had undergone emergency surgical procedure. Majority study participants 319 (86%) underwent operation with reason of pregnancy related case followed by 20 (5.4%) gynecological cancer, 12(3.2%) gynecological benign tumor and 11 (3%) pelvic organ disorder. One hundred three (27%) respondents had previous history of surgery, among those 60 (58.3%) of them had once time surgical history while the rest 43 (41.7%) patients had more than one time surgical history (Table 2) Respondents' knowledge on surgical informed consent Women were asked to assess their knowledge towards surgical informed consent. Majority (77.1%) of women had poor knowledge; and the rest around one quarter (22.9%) of them had good knowledge to wards surgical informed consent (Figure 1).

Service related factors
Two hundred fty eight (69.4%) study participants were referred from other health facilities. Above half 62.9% women were responding that the consent form written with in their mother tongue. The majority 302 (81.2%) study participants reported that surgical informed consent was taken by GP/resident, followed by obstetrician-gynecologists 44 (11.8%) and nurse/midwives 26 (7%). More than half 208 (56%) respondents reported that they received informed consent counseling immediately before surgery. The consent form was signed by the patients themselves 352 (94.6%) while the rest 20 (5.4%) were signed by their relatives (Table 3) Women were asked to assess patient to health care providers while they received provision informed consent. Out of total interviewed study participants 179 (48 %) of women had good patient to health providers' relationship ( Figure 2).

Women satisfaction on surgical informed consent
Women were scored highest satisfaction value on three satisfaction measurement items; i.e. on awareness of bene t of operation, involvement in the discussion about operation and involvement in decision making its accounts 79.1%, 89.5% and 91.2% respectively. In contrast to this the respondents scored lowest satisfaction value on ve patient satisfaction measurement items; i.e. on alternative of operation, chance to express opinions, the chance to ask questions, the amount of information provided about operation and the explanation about operation its accounts 24.7%, 30.1%, 33.3%, 44.9%, and 46.2% respectively (Table 4) Women were asked to assess their level of satisfaction with the SIC they received prior to their surgical procedure on a ve-point scale. The nding of this study showed that 160 (43%) of respondents were satis ed and the rest 212 (57%) of respondents were dissatis ed on informed consent provision ( Figure  6).

Factors associated with Satisfaction of informed consent
In bivariate logistic regression 15 variables which had p-value less than 0.25 was considered as candidate variable for multivariate logistic analysis. These variables were age, educational status, residence, marital status, occupation, parity, type of surgery, referred history from other health facility, language of written consent form, timing of consent, time taken to provide informed consent, person signing the consent form, professional request the operation, knowledge to wards SIC and patient to healthcare providers relationships (Table 5).
In multivariable logistic analysis 5 variables had p-value less than 0.05. These variables were residence, referred history from other hospital, language of written consent form, time spent while provided SIC and patient to healthcare provider relationship statistically signi cant with outcome variable ( Table 6).
The result of multivariable logistic regression analysis showed that the respondents who came from urban setting 2.2 times (AOR: 2.279, 95% CI: 1.257-4.131) more likely satis ed than those who came from rural residence. Respondents who haven't referred history from other health setting were 1.8 times (AOR: 1.856, 95% CI: 1.033-3.337) more likely satis ed towards provision of informed consent compared to those who have referred history from other health facility.
Women received written informed consent with their mother tongue were two times (AOR: 2.076, 95% CI: 1.143-3.773) more likely satis ed towards informed consent than counterpart. Patients who had received information about surgical informed consent for 10 minutes duration were 5.2 times (AOR: 5.227, 95% CI: 2.499-10.936) more likely satis ed on provision of informed consent than patients who have received the information for less than 5 minute.
Furthermore women had good patient to health care providers relationship were 5.4 times (AOR: 5.419, 95% CI: 3.103-9.464) more likely satis ed towards informed consent process than counterpart.

Discussion
The result of the study revealed that women satisfaction level towards surgical informed consent was 43% (95% CI: 38.2% to 48.7%). The nding of this result in line with study done in Egypt and Eritrea its accounted 48.4% and 45% patients satis ed with SIC provision respectively (16,20). However this study nding of women satisfaction level lower than study conducted in Netherland, Israel, Ethiopia, Rwanda and Pakistan on patients satisfaction towards informed consent which accounted 80.8%, 80 %, 62.1% , 67.4% and 48.9% respectively (13,15,17,21,22). Patients' satisfaction towards provision of surgical informed consent varies from country to country; the possible reason might be due to health care service quality and patients ow rate variation.
The nding of this study showed women who came from urban residence were two times more likely satis ed towards informed consent process as compared to respondents who came from rural residence. It supported by study conducted in Eritrea; patients who came from urban settings were more satis ed on consent information compared to patients those who came from a rural setting (16). This might be due to the fact that the urban livings populations have been know patient autonomy and competent to raise questions for healthcare providers to told them about their current condition, progress and the plan of intervention that will be done.
According to this study nding; surgical patients who hadn't referred history from other health setting were 1.8 times more likely satis ed compared to those who had referred history from other health facility. The possible reason might be due to patients who had referred history from other health facility have be worries on their case or diseases because their case beyond the service given by local health facility and they came to seeking further investigation and intervention. They also have being anxious and stressful in new hospital environment and healthcare provider since they came from other hospital.
Women satisfaction on surgical informed consent was statistically signi cant with language of written informed consent. Women who received written informed consent with mother tongue were two times more likely satis ed towards informed consent than counterpart. It supported by study done in Switzerland the consent form written in a simple layman language and simpler wording improve patients' ability to understand the information provided and strongly associated with patients' satisfaction (12). Simply provision of information doesn't guarantee to say a patient understood what healthcare providers told to them unless we provided the information within their mother tongue due to the fact that patients belonged to various ethnic groups that speak different languages (17). This might be due to delivering of clear information to women within their mother tongue, lead them to easily understand the information given by health care providers and have being satis ed.
Furthermore, time spent while provision of surgical informed consent was positively associated with women satisfaction towards surgical informed consent. Patients who had received information about surgical informed consent for greater than 10 minutes time duration were 5 times more likely satis ed than patients who received the information for less than 5 minute. It support by study done in Nigeria revealed that; time spent in explaining surgery procedure and possible outcome could calm patients and reduce level of anxiety (23). This might be due to adequate time provided to women during informed consent process allow them to easily understand the information provision. When health care providers explaining proposed surgery with adequate time, then the women coped from their anxiety and they have been satis ed.
Furthermore women satisfaction towards informed consent was signi cantly associated with patient to health care provider relationship. According to this study the respondents who had good relationship with health care providers were 5.4 times more likely satis ed towards informed consent process than counterpart. It supported by study done in Netherland reported that a better perceived patient to doctor relationship was related to higher patient satisfaction (24). Similarly, study conducted in Australia revealed that patient centered health care service with effective communications skills result trust between patient and healthcare provider and improved patient satisfaction (25). This might be due to good patient to health care providers relationship build trust between them; then the patients have been ready to open their mind to receive the information provided by health care providers.

Limitation of the study
Generalizability issue because of this study done on women who undergone on obstetrics and gynecologic related case it didn't address major surgery and other surgical case. Social desirability biases also other limitation on this study.

Strength of the study
The strength of this study; it used probable sampling technique and had high response rate.

Conclusion
According to this study nding the level of patient satisfaction with in the surgical informed consent services was relatively low compared with previous studies conducted in the country and other countries in the world. The patient satisfaction is one indicator of health service quality. Residence, language of written informed consent, time spent while provision of SIC, utilization of the recommend component of SIC and patient to healthcare provider relationship were the determinant factors for women satisfaction towards informed consent.

Recommendation
The Jimma Medical Center should develop informed consent form based on patient case to surgery department. Fixed and uninform printed consent form for all case is not valid it should be speci c to patient and disease or case oriented.
Jimma Medical Center should prepare training session for health professionals to strength patient to health provider relationship and to improve way of delivering informed consent service.
Healthcare provider needs to give emphasis to their way of informed consent provision; patients need and follow standard informed consent guideline to come up with evidence based practice.
The health care providers should give enough time while provision of surgical informed consent to patients. It should not be just rush to signed consent form rather give adequate time and information until patients understood the information provided to them and ready themselves to decision making.
The forthcoming researcher should be emphasized the perspective of health care providers of surgical informed consent process.

Declarations
Ethical approval and consent to participate.
Ethical letter was obtained from institutional review board of Jimma University. After obtain the ethical review board support letter, it was submitted to Jimma Medical Center. Then after getting permission from the hospital, verbal consent was obtained from individual participants. Moreover, study participants were informing about aim of the study and the data used only research purpose. The data collection was done using anonymously to con rm the respondents' con dentiality. All the participants were told that their participation would be on voluntary basis and their information will be kept con dential.

Consent of Publication
Not applicable

Availability of data and materials
The datasets used for this study could be deposited in publicly available repositories where appropriate and upon reasonable request. All relevant raw data supporting the ndings and conclusions of this study can also be freely available from the corresponding author through E-mail-tsegabiya54@gmail.com or with other means to any scientist wishing to use them for non-commercial purposes without breaching participant con dentiality upon reasonable request. There will not be any concern on ethical aspect for this as participant data was de-identi ed.

Competing interests
The authors declare that they have no competing interest AT: Participate in analyzing and interpreting the data, discussing the ndings of the study and drafting the manuscript. YB: Participate in analyzing and interpreting the data, discussing the ndings of the study. All authors have read and approved the manuscript.