The practice of obtaining informed consent for elective surgery and anesthesia from patients’ perspective: An institutional based cross-sectional study

Introduction Informed consent is a body of shared decision-making process and voluntary authorization of patients to receive medical or surgical intervention. There are limited studies conducted so far to examine the practice of informed consent in Ethiopia. This study aimed to assess the practice of informed consent process for surgery and Anesthesia. Method A cross-sectional study was conducted from March to May 2019. The data were collected using interviewer-administered structured questionnaire and analyzed in SPSS version 23. Results A total of 139 patients were interviewed in this study. Most 42(30.2%) of patients were in the age group of 29–38 years. Nearly half 68 (48.9%) of the patients were informed the benefits of the surgical procedure and 78(56.1%) of the patients were informed on the type of anesthesia to be administered while 65 (46.8%) were not informed on any complication related to the anesthesia. About 66 (47.5%) of patients were informed on alternatives to the surgery. Of these patients, 39(59%) were not informed of any benefits and possible risks associated with the alternative modes of treatment. About half (54%) of the patients were reported as they were understood the information provided during the pre-operative informed consent process. Conclusion This research revealed that patients were inadequately informed on the complications of proposed procedure, alternative forms of treatment, risks and benefits of the proposed procedure. Therefore, healthcare providers should provide adequate information regarding the proposed procedure and make sure whether patients understood the risks and benefits before the consent.


Introduction
Informed consent is an essential requirement in the health care practice which considers the patient's capacity to be involved in the decision making process concerning their care which ensures the care received reflects their goals, preferences, and values. Currently, the importance of obtaining informed consent before any surgical procedure is well established in all hospitals. However, the practice and understanding of informed consent process are not uniform among health professionals and patients. It is stated that any adult patient with the capability of making decisions concerning his/her own body has the right to get adequate information and there should be a shared decision on the proposed treatment. 1 It is an ethical obligation of health care professionals to uphold patients' autonomy and let them decide on the proposed medical, surgical or other health care and research interventions. 2 Therefore, health professionals must provide appropriate information for patients to the level of the patient's understanding and decision-making skills. In other words, it does not mean to the single moment of an agreement, but to the whole complex process of gaining information, shared decision and consenting. 3,4 A patient's decision to consent to a surgical procedure needs to be grounded on an adequate and relevant information. Without such explanation, a patient's decision to consent to surgery and anesthesia is not effective informed consent. The effectiveness of the informed consent process in satisfying the patients' needs and rights and the patients' perception of how the process should be, is an essential element in the process of obtaining informed consent. 5 Currently, patient education and patient-oriented care are important topics, thus for a clinical activity with high-risk clinical procedures like anesthesia and surgery, it is essential to assess the status of informed consent and health literacy among patients and direct service providers. There is a growing body of evidence showing that compassionate care has been associated with improved health outcomes, increased patient satisfaction, and better adherence to treatment recommendations, fewer malpractice claims and reduced healthcare expenditure. 6 Medical ethics and informed consent are an integral part of Compassionated, Respectful and Caring (CRC) package.
Informed consent for medical or surgical procedures is a legally required process in Ethiopia, however in most surgical centers its requirement is not complete. Informed consent is a process of communication between healthcare provider and patient or client which often leads to agreement or permission for care, treatment or service. 7 Every patient has the right to get information and ask questions before procedures and treatments. If adult patient is mentally able to make his/her own decisions, medical or surgical care cannot begin unless he/she gives informed consent. Healthcare professionals are expected to disclose information to all surgical patients requiring major surgery under general or regional anesthesia regarding their disease condition, name and type of procedure, type of anesthesia to be administered, risks and benefits of the proposed intervention, alternative options and recommendations so that shared decision can be made before signing the consent form. 8 According to a study conducted in UK on the knowledge and attitude of anesthetists and surgeons towards informed consent, the majority of respondents appear to hold attitudes in standing with current guidelines on informed consent however there was still a significant minority who held more paternalistic views to the consent process bringing into question the need for further training in the area. 9 A study conducted in one of Ethiopian hospital to assess the knowledge and perception of surgical patients regarding informed consent revealed that 69.4% of patients were reported that informed consent is a requirement before surgery and anesthesia however more than half had no information on the right to change their mind after signed surgical informed consent. In this study, only 10.5% of the respondents had a good level of knowledge, and it was significant in those with some level of formal education and in patients who live in an urban area than their respective groups. 10 In Ethiopia, the adequacy and type information provided to surgical patients in satisfying the patients' needs and rights is not assessed yet. Evidence-based information regarding the practice of obtaining informed consent is lacking in Ethiopian hospitals.
Therefore, we aimed to assess the practice of taking informed consent because the information obtained from this research could help patients, clinicians, health system leaders, and policymakers and thereby improve the quality of health care services towards the medical ethics and informed consent for surgery and anesthesia. The study also tries to probe health care providers to implement the standard requirements of informed consent and patient safety practice and to keep the ethical norm of informed consent. It will not only strengthen efforts in improving the process of obtaining informed consent, but also provide a basis for further studies, and practical ways of improving the current informed consent process in the hospitals.

Study design and population
An institutional-based cross-sectional study was conducted. All elective surgical patients aged above 18 years who underwent major surgical procedures as elective surgery and who had given written informed consent were participated. Patients who were undergoing elective surgeries but who were considered too ill to consent for surgery, for instance, senile or comatose patients were excluded. The sample size was determined by taking the following assumption: since there is no previous study in the area we assumed the proportion as 50%, confidence interval of 95% and margin of error to be tolerated 0.05. The sample size taken for the study was determined using a single population formula. By applying a finite population correction formula, the final sample size was determined as, Whereas, Nf ¼ the minimum sample size n ¼ sample size N ¼ the number of elective cases in the study area for January, February and March 2019 was 200 excluding pediatric elective cases and emergency cases. Nf 5 132 we are obtained by adding a 5% nonrespondent rate and gave the final n 5 132 1 7 5 139; therefore, the total sample size of 139 elective surgical patients participated in this study.
Sampling technique and data collection procedure All patients who underwent elective surgery during the data collection period were involved. The data was collected using a structured questionnaire after obtaining informed consent. The questionnaire was developed in a local language (Amharic) after reviewing different literatures and local guidelines regarding information to be disclosed during informed consent process. Data was collected by assigned nurses at the workplace, supervised by one responsible senior anesthetist. Information on the socio-demographic and clinical characteristics of patients and the practice of informed consent were taken from the participants.

Operational definition
Adult patient: a patients with the age of 18 years and above.
Pediatric patient: a patient who is below the age of 18 years.
Informed consent: the practices of providing the necessary information that allows the informed person to make autonomous authorization.

Data quality assurance and analysis procedures
Microsoft excels and Statistical Package for Social Sciences (SPSS) version 23 was used to analyze the data. Descriptive analysis using frequency and other summary measures were used to analyze the data. Tables, figures and text narrations were used to present the findings. To maintain the quality of data, a questionnaire was developed in a simple and easily understandable and in the local language. The training was given for two days for data collectors before the actual data collection. Then the questionnaire was checked for its accuracy, clarity, and consistency. The data collectors were nurses who are working at the surgical unit and have more than two years of work experience. Monitoring and supervision were done during the data collection period by the supervisors and the completeness of the data was checked daily.

Socio-demographic characteristics of patients
Respondents of this research were adult patients scheduled for elective surgery under general or regional anesthesia in the study area. A total of 139 patients were interviewed. The majority 74(53.2%) of the participants were females and about 114(82.8%) are orthodox religious followers. Most 85 (61.2%) of the patients were from rural areas.
Most 42(30.2%) patients are were in the 29-38 year age group. Regarding the level of education of the respondents,41(29.5%) had unable to read and write while 37(26.6%) had attended college and above ( Table 1).
The following figure (Figure 1) showed that 69 (49.6%) of the patients underwent elective general surgery while the least, 18(12.9%) of the study participants underwent urology procedures. Regarding the preoperative counseling/informed consent for surgery and anesthesia, almost all (91.4%) of the patients had got their preoperative counseling in the admission ward and 12 (8.6%) in the pre-anesthesia clinic. The majority 122(87.8%) of the study participants did not know who conducted the counseling and 9(6.5%) of the study participants had counseled by nursing officer and 8(5.8%) had received counseling by anesthetist (Figure 2).
About 68(48.9%) and 78(56.1%) of the study participants have got information on the benefits of surgery and benefits of anesthesia respectively. Only 51 (36.7%) of the patients have got counseling on possible complications of anesthesia and 78(56.1%) of the patients have got counseling on the possible complications of surgery (Figure 3).
During pre-operative counseling, 51(36.7%) of the patients were given an opportunity to ask questions prior to the signing of the consent. More than half 75 (54%) of the study participants understood well the information provided to them prior to signing the consent form while 80 (46%) of them partially understod the information.

Discussion
During this study, 139 patients were interviewed, with the percentage of female patients being higher than male patients, which is consistent with the fact that there are more female surgical patients in the hospital than male patients. The study participants were aged between 18 years to over 59 years with the highest percentage of patients being between 29-38 years (30.2%). This could be attributed to the respondents in the study area who were undergoing surgery in four units or departments (General surgery, Gynecology, obstetrics, and urology). A similar trend was observed in a study done by Mohammed Amir et al. on surgical informed consent where the majority of the patients were aged between 25-35 years, therefore, the majority of surgical patients are in the younger age group. 11 The majority of the patients had varying levels of formal education and 29.5% of the patients had no formal education. Establishing the literacy level of patients during pre-operative counseling is important   as patients may fail to understand the medical terminology often used by the physicians and anesthetists. If the patient has had little or no formal education, reading the written consent form may be difficult and this curtails on the patient's autonomy. Besides patients with less formal education are likely to be influenced by other people when deciding whether to proceed with the surgery or not, regardless of their knowledge of the procedure. A study conducted by Mohammed Amir et al. found that 81(58%) of patients did not read the consent form due to low literacy levels. 11 This warrants healthcare professionals to explain about the proposed procedure to the level of patients understanding and avoiding medical jargons before letting them to sign on the informed consent form.
Regarding the type of surgical procedure, the majority of the patients interviewed were scheduled to undergo general surgery procedures 69(49.6%) while the least number of patients were scheduled to undergo urology procedures 18(12.9%). About 9 (6.5%) had their pre-operative counseling for surgery conducted by nursing staff in surgery. Even though, healthcare professionals are expected to introduce their name and role before taking the informed consent, this study revealed that about 122 (87.8%) of the patients did not know who provided pre-operative counselling to obtain the informed consent.
In our study setting, students and senior staffs may conduct pre-anesthetic counseling. When students conduct the informed consent, they are required to consult with the senior staffs supervising them.
A study that looked at the surgeons' and anesthetists' attitudes towards informed consent in the United Kingdom found that 97% of the surgeons agreed on informing the patient on the surgery, its risks and benefits and educating the patient on alternative treatment options. 9 In the current study, about 68(48.9%) of the patients interviewed were informed of the benefits of surgery but only 78(56.1%) of the patients were informed of the possible complications that may arise following surgery. Sixty-five (46.8%) of the patients were not informed of the possible complications associated with the type of anesthesia to be administered. This may be due to the fear that disclosure of complications related to the procedure and anesthesia may increase the patients' anxiety levels and dissuade them from the surgery or the health care professional carrying out the counseling may be inadequately trained on what is required to be told to the patient. 12,13 A study on the surgeons' and anesthetists' attitudes towards informed consent conducted in the United Kingdom found that 50% of the surgeons and anesthetists felt that major risks with an incidence of >1 in 1000 or more should be disclosed to patients as part of the consent process. And seventy percent of both surgeons and anesthetists felt that minor risks with an incidence of >1 in 20 should be disclosed to the patient when obtaining consent. 9 However, evidences are lacking regarding the perception of surgeons and anesthetists towards the extent of information to be disclosed for patients during informed consent process requiring research on the area.
During pre-operative counseling, patients should be also informed on alternative forms of treatment, their risks, and benefits in addition to the proposed surgical procedure or type of anesthesia to be administered by the surgeon or anesthetist respectively. In this study, 66 (47.5%) of the patients were informed of the alternative forms of treatment for the elective surgery to be done. Of these patients, only 23 (16.5%) were informed about the benefits and possible complications of the alternative forms of treatment.
A study on the surgical informed consent in the Royal Sussex County Hospital in the United Kingdom by White and Walton et al. showed that the factors that affect the amount of information conveyed to the patient during the consent process include: patient's age, level of education, inquisitiveness and complexity of the procedure. 9 Once information regarding the proposed form of treatment has been relayed, patients should be provided the opportunity to have their questions answered. This also helps in assessing the patient's level of understanding of the information provided and also assesses the patient's level of satisfaction with the consent process. Patients' perception of satisfaction appears to be dependent upon the engagement in the discussion and decision-making process. In our study, about 75 (54%) of the patients stated that they understood all the information. However, a trend observed in a study conducted in Pakistan on informed consent for surgical patient where that despite the poor understanding of the information and other inadequacies, the majority of the patients 130 (93.5%) still felt satisfied with the process of informed consent. 14 This study is the first study in the area in providing information on the practice of obtaining informed consent, although the study has certain limitations like smaller sample size, descriptive and a singleinstitution study limiting its inference.

Conclusion
In conclusion, the current practice of obtaining informed consent only addresses certain aspects of informed consent such as nature and indication for surgery and the type of anesthesia to be administered. Patients are inadequately informed on the complications related to surgery and anesthesia, alternative forms of treatment, risks, and benefits. The detailed informed consent form that addresses all the key aspects of informed process which include the nature of proposed procedure, its benefits and possible risks, reasonable alternatives to the proposed intervention, as well as relevant risks and benefits related to each alternative, should be developed and well communicated with patients. The departments of surgery and anesthesia should develop standards of practice for obtaining informed consent for surgery and anesthesia.
Ethical approval and consent to participate Ethical clearance was obtained from a Research Ethics Committee of College of Health Sciences, Debre Tabor University. The permission and agreement consent was taken from Debre Tabor General hospital before the study and written consent was taken from patients after a brief explanation of the purpose of the study.

Consent for publication
Not applicable.

Availability of data and materials
The datasets are obtained from the corresponding author upon reasonable request

Authors' contributions
Mr. Tadese T and Mr. Aragaw T were involved in write up of the proposal, data entry, data analysis and final manuscript write up. The final manuscript is read and approved by both authors.

Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.