International

African Journal of Medicine and Surgery ISSN 2756-3324, Vol. 10(1), pp. 001-12, May, 2023. Available Online at
www.internationalscholarsjournals.com © International Scholars Journals
Author(s) retain the copyright of this article.

Research Article

Practice and factors associated with pre-operative informed consent

for major surgical procedures among health care workers, in
Wachemo university, Nigist Eleni Mohamed Memorial comphrensive
specialized hospital, Hosanna Southern Ethiopia, 2022.
Tibebu Tilahun Worku1*, Bezawit Abeje Alemayehu1, Fekadu Waltenigus Sendeku1, Eshetie
Amare1, Almaz Nibret1
Department of Midwifery, Bahir Dar University, Bahir Dar, Ethiopia
Received: 08-Mar-2023, Manuscript No. AJMSOA-23-91123; Editor assigned: 10-Mar-2023, Pre QC No. AJMSOA-23-91123 (PQ); Reviewed: 24-Mar-2023,
QC No. AJMSOA-23-91123; Revised: 08-May-2023, Manuscript No. AJMSOA-23-91123 (R); Published: 16-May-2023

ABSTRACT

Background: Informed consent is the process of communication between a patient and health care provider that results in the
patient’s authorization/agreement to undergo a specific medical/surgical intervention. The practice of surgical informed consent
among health care providers was considered as poor and the health care workers did not meet the minimum standards yet when
they conducted informed consent with patients.
Objective: This study was aimed to assess practice and factors associated with informed consent process for major surgical
procedures among health care workers in Wachemo university, Nigist Eleni Mohamed Memorial comprehensive specialized
hospital, Hosanna Southern Ethiopia. 2022.
Method: Institutional based cross sectional study was conducted among 422 health care workers from 9 August to 21, 2022. Each
study units were selected based on the proportionally allocated sample size from each profession by simple random sampling
method; self-administered pretested questionnaire was used to collect all necessary data. Then data was, entered into epi data
version 3.1, exported to statistical package for social science version 25 for cleaning and analysis. The bivariate logistic regression
model was used to explore factors associated with surgical informed consent practice, variables with p-value of <0.25 became
candidates for final model (multivariable logistic regression model). Then finally, odds ratio with 95% confidence interval and p-
value of <0.005 was used to identify variables which were significantly associated with dependent variable.
Results: A total of 422 sample size with 98.1% response rate, of which 223 (53.9% (CI; 48.3-58.4) had good surgical informed
consent practice. Being age between 31-35 years (AOR=2.392; 95% CI: 1.33-14.467), no language barrier in communication with
patients (AOR=2.011; 95% CI: 1.848-8.511), availability of policy/regulation that support surgical informed consent process
(AOR=3.201; 95% CI: 1.102-9.298), spending more time 21-30 minutes on consent process (AOR=5.006; 95% CI: 1.659-15.100),
patients with history of previous surgery (AOR=3.141; 95% CI: (1.435-6.876), having good knowledge (AOR=3.931; 95% CI:
1.799-8.591) and favorable attitude (AOR=5.690; 95% CI: 2.729-11.862) were significantly and positively associated with good
informed consent practice
Conclusion: The surgical informed consent practice is still inadequate for globally recommended standard among the health care
workers at the comprehensive University Hospital and more emphasis and work up need for quality health service.
Keywords: Health-care workers, Major surgeries, surgical informed consent, Practice, Quality health service
Abbreviations: AOR: Adjusted Odds Ratio; CI: Confidence Interval; CMHS: College of Medicine and Health Science; FMoH: Federal
Minister of Health; ICU: Intensive Care Unit; OR: Operation Room; SIC: Surgical Informed Consent; SNNPR: Southern Nations
Nationality and People’s Region; SPSS: Statistical Package for Social Science; SPHMMC: St, Paul Hospital Millennium Medical
College; SRS: Simple Random Sampling

_____________________________________________________________
*
Corresponding author. Tibebu Tilahun Worku, E-mail: tibebuti@gmail.com
 INTRODUCTION it’s believed that failure to obtain adequate informed consent
renders a physician liable for negligence or battery and
Background constitutes medical malpractice. In Asia (Pakistan), most doctors
think that telling patients about possible complications would
In medicine informed consent is the process of communication discourage them from going ahead with surgery, keeping these
between a patient and health care provider that results in the factors in mind it is essential to formally explore the relationship
patient’s authorization or agreement to undergo a specific of informed consent procedure with the patients' thought
medical/surgical intervention through Informed consent form processes.
which is a document that explains the nature and effect of the act A limited collection of studies from the African continent
and be given to the patients before any procedures so that they reveals, SIC is provided to clients in a highly compromised
can decide to undergo the procedure or choose another option [1- manner, which includes performing surgeries immediately after
3]. obtaining clients’ signatures and without delivering any
The central notion of informed consent is that the patients have information regarding the surgical procedure to be performed,
the proposed procedure explained to them in such a way that this is contrary to international recommendations, which SIC is
each can decide whether he or she can proceed with the one of the pillars of high quality care [10].
treatment. It also requires that the consent comes from the In Ethiopia, informed consent for medical procedures is a legal
patient's own free will without coercion'. In clinical practice, the requirement. It was stated that medical service may not be
signing of a consent form, presumably should be preceded by provided without obtaining the patient’s informed consent under
adequate exchange of information and are only undertaken in the Ethiopian council of minister’s regulation 299/2013, article
some circumstances notably, prior to major invasive procedures 52. It also states, under sub-article 3, “Any health professional
such as radiologic procedures and surgery, in this respect, doctors shall make reasonable effort to obtain the patient’s informed
should follow the principle of beneficence, that is, the duty of consent” [11]. The effectiveness of the informed process in
care [4]. satisfying the patients needs and rights and the patients' own
According to the 1995 world health organization declaration on perception of how the process should be is an essential element
the promotion of patients rights, patients have the right to be in the process of obtaining informed consent [12]. Despite of
fully informed about their health status, including the medical this, In Ethiopia, only 16.5% of surgical patients were informed
facts about their condition; about the proposed medical about the anesthesia to be used, types of surgery, benefits and
procedures, together with the potential risks and benefits of each possible complications of the treatment from their health care
procedure; about alternatives to the proposed procedures, providers [13].
including the effect of non-treatment; and about the diagnosis, Therefore, this study was aimed to assess practice and factors
prognosis and progress of treatment from the care giving health associated with informed consent for major surgical procedures
care professionals [5]. among health care workers in Wachemo university, Nigist Eleni
Despite this, it is inconsistently practiced and rarely achieves the Mohamed Memorial comprehensive specialized Hospital/WCU-
theoretical ideal [6]. Some literatures states patients had poor NEMM/, Hosanna Southern Ethiopia.
knowledge and perception about surgical informed consent/SIC/
and the care providing professionals should provide them with Conceptual framework
the reason for operation, success of the operation, alternatives of
the treatment, what would happen during the operation, for how The conceptual frame work shows the boundary that the study
much the operation would take, precautions after the operation covered and the relationship which was proven after going
and information on post treatment/post-operative/ care and free through all the literature review. The relationship was proposed
and willingness of the overall consent before consent is signed between four categories of independent variables. (Socio-
[7,8]. In Middle East (Saudi Arabia), (47%) of patients believes demographic factors, organizational factors, patient related
that saying no to what the doctors planed would mean losing factors and the HCWs related factors) and the dependent
their good relationship with the doctor [9]. The practice of SIC variable, practice of SIC process. The relation was then depicted
among health care providers was considered as poor and the by one directional effect of independent variables on the
health care workers/HCWs/ did not meet the minimum standards dependent variables (Figure 1).
yet when they conducted informed consent with patients so as,

Figure 1. Conceptual frame work for, practice and factors associated with obtaining surgical informed consent among health care workers in
WCU-NEMM comprehensive specialized hospital Hosanna, southern Ethiopia, 2022 (10-12).
 Objectives
 To determine the proportion of proper pre-operative  Those who had not been working in surgical, labor,
surgical informed consent practice for major surgical obstetrics and gynecology ward, operating room, ICU
procedures among the health-care workers. and emergency OPD for the last 6 months were
 To identify possible factors affecting the excluded as they have less exposure to patients who had
implementation of proper surgical informed consent undergone surgery.
practice among the health care workers.
Sample size determination
MATERIALS AND METHODS
The sample size for proportion of SIC practice was determined
Study area and period by the formula for estimating single population proportion with
assuming confidence interval of 95% and marginal error 5% with
Study was conducted from 9 to 21 August, 2022 at WCU- proportion (p= 50.1% from a previous study done in bale zone
NEMM comprehensive specialized Hospital, which is found in Ethiopia and non-response rate 10% (10). The formula is;
Hadiya zone Hosanna town. Hosanna is a town and separate
woreda in southern Ethiopia and the administrative center of the
Hadiya zone located at 230 km south west of the capital Addis
Ababa in the Southern Nations, Nationalities, and People's
Region (SNNPR) [14]. The hospital has a bed of 474 with an
Then 10% allowance for none responding, and then the total
increasing capacity and renders tertiary care services to a
sample size for the first objective was,
catchment population mainly from Hadiya zone and other
neighboring catchments of the partial Guraghe, Silte, Halaba and
n=384+ (384 × 0.1) =384+38, n= 422.
Kambata zones. It has 713 health care workers (radiologists,
pharmacists, environmental health workers (nurses, midwives,
Sampling procedure
doctors (including General Physicians (GPs), surgeons,
gynecologists and anesthetists)) were working at surgical ward,
Proportional allocation was done to get appropriate
obstetrics and gynecology ward, operating room, labor ward,
representative sample size, from the total of 630 health-care
Intensive Care Unit (ICU) and emergency outpatient department
workers, including medical residence ship students (nurses,
in the hospital. The hospital has 3 major operating rooms, which
midwives, doctors, and anesthetists), found in the surgical ward,
are one obstetrics and gynecology operation room/OR, one
OR, emergency OPD, labor ward, obstetrics and gynecology
general surgery OR and one orthopedic surgery OR. Annually,
ward, and ICU. Specifically, 334 nurse, 106 Midwives, 64
on average, about 3760 patients underwent major surgical
anesthetists, 76 General physicians/Gps/, 14 medical residency
procedures including cesarean deliveries [15].
ship students and 36 specialist doctors, professions that work in 3
different shifts, were found in WCU-NEMM comprehensive
Study design
specialized hospital. Therefore, considering regular staff rotation
between each wards proportional allocation to sample size was
Institutional based, cross sectional study was carried out.
made for each professional, then simple random sampling/SRS/
technique was used to select each participant from their
Study population
respective profession [16].
Proportional allocation for each professions sample size, was
All health care workers who were working in WCU-NEMM
done by the formula;
comprehensive specialized hospital during the study period were
the study populations.
ni=(Ni)*(nf)/((N))
Inclusion criteria: All health care workers who worked at least
Where,
6 months in the hospital were included.
ni= Sample size for each profession.
Ni=Total number of participants in each profession.
Exclusion criteria: Health care workers, who were,
nf= Total sample size of the study participants.
 Sick on bed and couldn’t tolerate to finish the time that
N= Total number of HCWs/source population.
the interview took were excluded from the study.

Therefore, calculated sample size for

Nurse (334) Midwifery (106) Anesthetists (64) General physicians (76) Specialist (24) Residents (14)

ni =224 ni=71, ni=43 ni=51 ni=24, ni=09

 method, then self-administered pretested questionnaire was used
to collect all the necessary data on the practice and factors
Study variable affecting the SIC process. The questionnaire was adapted and
modified from the professional and clinical standards of the
Dependent variable: Surgical informed consent practice. Royal College of Surgeons (RCS) of the UK, South Africa,
Independent variables: Uganda, FMOH, and EMA and were used by Negash et al in the
 Socio-demographic characteristics (age, sex, religion, previous study. The questionnaire had six parts. Part I: Socio-
work experience, language barriers). demographic characteristics of the study participants. Part II:
 Organizational factors (lack of administrative support, Organizational factors that affect practice of informed consent.
time spent on SIC process, lack of in-service training, Part III: Respondents knowledge of the informed consent
lack of adequate content of consent form, lack of policy process. Part IV: Respondents attitude toward the practice of
or regulation in the institution, work load). informed consent, which contained questions with responses
 Health care worker related factors (knowledge, attitude). which ranged from strongly disagree to strongly agree. Part V:
 Patient related factors (anxiety and fear of anesthesia Assessed the respondents’ practice of the informed consent
and surgery, cultural myths about surgery, knowledge of process, and the questions contained response options of “never”,
SIC, influence from relatives, surgical schedules, history “sometimes” and “always”. And part VI: Patient related factors
of previous surgery) that affect practice of informed consent.

Operational definitions Data collectors and data quality control

The practice of SIC was measured using 13 structured Likert To ensure quality of the data, the questionnaires were translated
type questions having options of “never”, “sometimes” and from English in to Amharic and then back to English by bilingual
“always” which scored as 1, 2 and 3, respectively. The total score professionals to maintain consistency. Pretesting was done on a
for practice then dichotomized into good and poor practice using limited number n=22 (5%) of similar health care professionals at
the mean score 26.9976 as the cut point. Worabe compressive specializes hospital which is 60 KMs from
Good practice: A score greater or equal to the mean score for the study area a week before actual data collection time to avoid
the practice questions. information contamination. 3 BSc Midwifery professional data
Poor practice: A score below the mean score for the practice collectors and 1 MSc holder supervisor who participated to
questions. coordinate, facilitate, and supervise the overall activities, were
Knowledge of SIC was measured using 10 structured knowledge recruited outside the study sites to avoid selection and
questions with multiple options, totally 13 items having “yes”, information bias. Two days training was given to them on the
“no” and “I don’t know”. The total score for knowledge then objective of the study, data collection tools (how to maintain
dichotomized into good knowledge and poor knowledge using consistency and completeness of the questionnaire), and when to
the mean score 15.615 as the cut point. start data collection by the principal investigator, then the data
Good knowledge: A score greater or equal to the mean score for collectors were assigned in each ward to distribute and collect
the knowledge questions. back the questionnaire to and from the study participants, by
Poor knowledge: A score below the mean score for the revising each item of the questions, collected data was checked
knowledge questions. for completeness and clarity by the supervisor and the principal
Attitude toward the proper SIC was measured by using 09 Likert investigator.
type attitude questions. A score of 1, 2, 3, 4 and 5 was given for
strongly disagree, disagree, neutral, agree and strongly agree Data processing and analysis
responses, respectively. The total score for attitude then
dichotomized into favorable and unfavorable attitude using the The collected data was checked for completeness and
mean score 35.6 as the cut point. consistency, coded and entered into epi data version 3.1 then was
Favorable attitude: A score greater or equal to the mean score exported to statistical package for social science/SPSS/ version
for the attitude questions. 25 for cleaning and analysis. Data clean up was performed by
Unfavorable attitude: A score below the mean score for the checking for frequencies and missed values and variables,
attitude questions. descriptive statistical analysis was used to show the
Health care workers: In this study, health care workers were characteristics of the participants. Binary logistic regression was
individuals, (nurses, midwives, doctors (GPs, surgeons, used to control for confounder variables and identify factors
gynecologists and anesthetists) those works in frontline clinical associated with the good practice of SIC among HCWs using cut
placements that are in direct contact with patients including point of p-value less than 0.25, then factors with the cut point
health care students. was considered as fit for multivariable analysis. The Hosmer-
Major surgeries: In this study, major surgeries is defined as an Lemeshow goodness of fit test was used to determine model
operative procedure in which more extensive resection to human fitness and the model was adequately fitted for the final analysis
body is performed, like a body cavity is entered, and with (p-value 0.512) which was insignificant and that indicates
organ/tissue manipulation is done. the selected variables were important determinants. The adjusted
odds ratios with their corresponding 95% confidence intervals
Data collection tools and techniques were computed, P-values of less than 0.05 was considered
significant in the final model multivariate logistic regression and
Each study units were selected based on the proportionally the analysis result was presented as frequencies, means, standard
allocated sample size from their respective profession by SRS deviations, and percentages using tables and figures.
RESULTS

Socio-demographic characteristics of the respondents more than half, 238 (57.5%) were Orthodox Christians, about
213 (51.4%) were nurses, 209 (50.5%) of the respondents had 5
A total of 422 sample size, with 98.1% successful response rate. years and less working experience and more than half 259
The respondents’ mean age was 29 years (SD; ± 5.244), ranging (62.6%), had faced a challenge in communication with their
from 21 to 52 years. Almost half, 215 (51.9%) were Females and patients easily due to language barriers (Table 1).

Variables Frequency Percent (%)

Age group (years) 21-25 130 31.4
26-30 years 121 29.2
31-35 years 98 23.7
>35 years 65 15.7
Male 199 48.1
Sex Female 215 51.9
Orthodox 238 57.5
Religion Protestant 127 30.7
Muslim 43 10.4
*
Others 6 1.4
Nurse 213 51.4
Professional status Midwives 71 17.2
Anesthesia 41 9.9
Physicians 64 15.5
**
Others 25 6
Work experience (years) </=5 yrs. 209 50.5
6-10 years 152 36.7
>10 years 53 12.8
Communication challenges (Language barrier) Yes 259 62.6
No 155 37.4
** *
Note: Diploma nurse; Midwives and PHO; Apostolic religion
Table 1. Socio-demographic characteristic of participants in the study of practice and factors associated with surgical informed consent
process among health care workers in WCU-NEMMCS hospital, hosanna southern Ethiopia, 2022. N=414.

Organizational related characteristics of the respondents on the SIC process, and almost all 403 (97.3%) reported that they
had no administrative support (like interpreters available) in their
Out of the total participants, 256 (61.8%) reported that they do institution. 178 (43.0%) of the participants had provided care for
not know if the institution has policy or regulation that supports more than 10 patients in an average per shift, and nearly one
the practice of SIC, 189 (45.7%) of them reported, the contents fourth 94 (22.7%) spends 5-10 minutes on providing information
of the informed consent form is adequate to obtain valid consent, to their patients about the procedure during their professional
only 19 (4.6%) of the participants had attended in service training encounter (Table 2).
Variable Frequency Percent (%)
Adequate content of informed consent Yes 189 45.7
No 73 17.6
Don’t know 152 36.7
Training attended on informed consent (in service training) Yes 19 4.6
No 395 95.4
Policy/regulation in institution Yes 98 23.7
No 60 14.5
Don’t know 256 61.8
Administrative support Yes 11 2.7
 No 403 97.3
Average number of patients cared per shift <5 103 24.9
6-10 133 32.1
>10 178 43
Time spent for consenting process (in minutes) <5 93 22.5
6-10 94 22.7
11-20 67 16.2
21-30 70 16.9
>30 90 21.7
Table 2. Organizational related characteristic of participants in the study of practice and factors associated with surgical informed consent
process among health care workers in WCU-NEMMCS-Hospital, hosanna southern Ethiopia, 2022. N=414.

Patients related characteristics of the respondents that patients and patient relatives are responsible persons to sign
the SIC, and when asked about if they ever faced any patient
Of the total participants, 279 (67.4%) of them reported that, they influenced by someone else to sign SIC, about 192 (46.4%)
have faced surgical patients refused to sign SIC during their responded they have never faced any surgical patient influenced
professional carriers, almost half 209 (50.5%) of them think the by someone else to sign the SIC, 217 (52.4%) participants
reason behind the patients refuse to sign the SIC was anxiety and reported that surgical patients with history of repeated surgery
fear of surgery. 156 (37.7%) of the study participants responded are more easily cooperative to sign the SIC (Table 3).
Variables Frequency Percent (%)
Have you ever faced patient’s refuses to sign SIC form? Yes 279 67.4
No 135 32.6
What do you think the reason for the patients to refuse? Lack of knowledge on sic 130 31.4
Anxiety and fear of surgery 209 50.5
**
Others 75 18.1
Which patients are usually refuses to sign on the SIC form? Patients scheduled for elective surgery 80 19.3
Patients scheduled for emergency surgery 235 56.8
Don't know 99 23.9
Who usually signs on the SIC form The patient themselves 144 34.8
Pts and relatives 156 37.7
Relatives 114 27.5
Have you ever faced patients influenced by someone else Often 91 22
Sometimes 131 31.6
Never 192 46.4
Have you ever faced a patient with history of repeated Yes 276 66.7
surgery? No 138 33.3
Which patients are easily cooperative to sign SIC form? Patients with no previous history of surgery 84 20.5
Patients with history of previous surgery 217 52.4
Don’t know 113 27.3
Table 3. Patient’s related characteristic of participants in the study of practice and factors associated with surgical informed consent
process among health care workers in WCU-NEMMCS hospital, hosanna southern Ethiopia, 2022. N=414.

Knowledge and attitude of health care workers on the SIC Knowledge on SIC (Figure 2). The mean score of study
participants’ attitude was 35.6, and similarly, more than half, 226
The mean score of study participants’ knowledge was 15.615, (54.6% CI; 49.1-59.4), HCWs had favorable attitude towards the
and more than half, 227 (54.8% CI; 49.9-58.7), HCWs had good SIC.
Figure 2. Score value of practice, knowledge and attitude of health care workers in WCU-NEMMCS hospital, hosanna, southern Ethiopia
2022. N=414.

Practice of surgical informed consent process

reported they always discussed the risk/potential complications
Out of the total participants, less than quarter, 57 (13.8%), of of the procedure to their surgical patients. 1/4th, 107 l(25.8%) of
participants reported that, they always obtained informed consent participants discussed the presence of any favorable environment
for major surgical procedures, only 109 (26.3%) informed the and the possibility to say no to the proposed surgery, and nearly,
reason/indication for surgery and nearly 1/4 th, 134 (32.4%) of the 2/3rd 177 (42.8%) had checked that their patients understood the
study participants reported that, they always inform the patients explanations they provided to them (Table 4).
about type of anesthesia to be used. Less than half, 110 (26.6%), The mean score of study participants’ SIC practice was 26.9976,
always informed the patients about the presence/absence of and almost half, 223(53.9% (CI; 48.3-58.4) of the HCWs had
treatment options similarly, less than one third, 119 (28.7%), good SIC practice.

Items Response
Never Sometime Always
N (%) N (%) N (%)
I obtain informed consent from patients for major surgical procedures 68 (16.4) 289 (69.8) 57 (13.8)
I inform the patients why the surgery will be performed 75 (18.1) 230 (55.6) 109 (26.3)
I inform the patients about presence/absence of alternative treatment option/s 98 (23.7) 206 (49.8) 110 (26.6)
to surgery
I inform the patients about type of anesthesia to be used 213 (51.4) 67 (16.2) 134 (32.4)
I explain the benefit of the procedure to the patient 78 (18.8) 210 (50.7) 126 (30.4)
I explain the risks or potential complication/s related to the procedure to the 100 (24.2) 195 (47.1) 119 (28.7)
patient
I explain favorable environment to say no to the proposed surgery 145 (35) 162 (39.1) 107 (25.8)
I inform the patients about consequences of refusing the proposed surgery 83 (20) 200 (48.3) 131 (31.6)
I provide counseling aids including the recommended treatment which assist 136 (32.9) 171 (41.3) 107 (25.8)
in decision making to the patients
I provide adequate time for decision to sign on the informed consent form 48 (11.6) 266 (64.3) 100 (24.2)
I provide an opportunity to ask questions to the patients 40 (9.7) 252 (60.9) 122 (29.5)
I assess the competence of my patients to give consent to treatment/procedure 20 (4.8) 214 (51.7) 180 (43.5)
I check that my patients understand the explanations I provided to them 18 (4.3) 219 (52.9) 177 (42.8)
Note: N represents frequency.
Table 4. Practice of participants in the study of practice and factors associated with surgical informed consent process among health care
workers in WCU-NEMMCS hospital, hosanna southern Ethiopia, 2022. N=414.

Factors associated with surgical informed consent practice content of consent form (standardized format), presence of
policy/regulations in the institution, on site training, patients
In the bivariate analysis, variables male sex, categorical age 26- scheduled for emergency surgery, when both the patients and
30 and 31-35 years, working experience above 10 years, no relatives sign the SIC, when patients were not influenced by
language barrier for communication with patients, number of relatives/someone else to sign SIC, patients with history of
patients seen per day/shift, Time spent 21-30 and >30 minutes to previous surgery, good knowledge and favorable attitude of
provide information on SIC-process to the patients, adequate health care workers, showed a p-value of <0.25 and became
candidates for multivariable analysis. In multivariable binary than 5 minutes to provide information on SIC to their patients
logistic regression, categorical age 31-35 years, no challenges in (AOR=5.006; 95% CI: 1.659-15.100) and HCWs who were
communication with patients due to language barrier, time spent, aware of availability of policy or regulation that supports SIC
21-30 minutes to provide information on SIC process to the practice in the institution were 3.2 times had good SIC practice
surgical patients, availability of policy/regulation that supports than, those who do not aware of whether there is
SIC process, patients with history of previous surgery, good policy/regulation or not in the institution that supports SIC
knowledge and favorable attitude of HCWs were statistically, practice (AOR=3.201; 95% CI: 1.102-9.298). Likewise, odds of
and positively associated with good SIC-practice of the health good SIC practice were 3 times higher when they treated surgical
care workers at a p-value< 0.05. patients with history of previous surgery than when they never
Odds of good SIC practice for the health care workers in age treated neither of surgical patients with history of previous
group of 31-35 years were nearly 2.4 times higher than those surgery nor patients with no previous history of surgery
HCWs who were in the age group of 21-25 years (AOR=2.392; (AOR=3.141; 95% CI: (1.435-6.876).
95% CI: 1.330-14.467). And HCWs workers who never faced Furthermore, HCWs who have good SIC knowledge were 3.9
challenge in communication with their patients due to language times likely to have had good SIC practice when compared to
barrier were almost 2 times more likely to have good SIC- those who have poor SIC knowledge (AOR=3.931; 95% CI:
practice, when compared to those who faced challenge in 1.799-8.591) and at last but not least, HCWs with favorable
communication with their patients due to language barrier attitude towards SIC were 5.69 times had good SIC practice than
(AOR=2.011; 95% CI: 1.848-8.511). those with unfavorable attitude towards SIC (AOR=5.690; 95%
Health care workers who spent 21-30 minutes to provide CI: 2.729-11.862) (Table 5).
information on SIC to their surgical patients were 5 times had
good SIC-practice compared to those who spent a time of less

Variables Practice of SIC Binary logistic regression Multivariable

logistic regression
Good N (%) Poor N (%) COR (95% CI) P-value AOR (95% CI)
Age group in years 21-25 40 (30.8) 90 (69.2) 1
26-30 79 (65.3) 42 (34.7) 4.232 0.353 3.003 (2.550-18.685)
31-35 61 (62.2) 37 (37.7) 3.709 0.011 2.392 (1.330-14.467)*
>35 43 (66.2) 22 (33.8) 4.398 0.023 2.289 (0.472-11.088)
Sex of the participants Male 135 (67.8) 64 (32.2) 3.044 0.172 1.038 (0.516-2.090)
Female 88 (40.9) 127 (59.1) 1
Work experience in years ≤5 84 (40.2) 125 (59.8) 1
6-10 103 (67.8) 49 (32.2) 3.128 0.033 2.306 (0.859-6.159)
>10 36 (67.9) 17 (32.1) 3.151 0.028 4.173 (0.857-20.312)
Faced communication Yes 115 (44.4) 144 (55.6) I
challenges with pats due to No 108 (69.7) 47 (30.3) 2.877 0 2.011 (1.848-8.511)*
Language barrier
Time spent on SIC process. <5 39 (39.4) 60 (60.6) 1
6-10 53 (46.6) 61 (53.5) 0.984 0.957 0.563 (0.204-1.551)
11-20 48 (60.8) 31 (39.2) 2.242 0.314 1.498 (0.540-4.153)

21-30 32 (68.1) 15 (31.9) 6.136 0.003 5.006 (1.659-15.100) **

>30 51 (68.0) 24 (32.0) 5 0.031 2.013 (0.736-5.506)
Adequate content of Yes 108 (57.1) 81 (42.8) 2.161 0.001 1.324 (0.619-2.829)
consent form No 57 (78.1) 16 (21.9) 5.774 0.042 1.506 (0.466-4.870)
Don’t 58 (38.2) 94 (61.8) 1
know
Policy regulations support Yes 85 (86.7) 13 (13.3) 9.556 0 2.846 (1.081-7.491)*
SIC? No 34 (56.7) 26 (43.3) 1.911 0.025 0.504 (0.181-1.404)
Don’t 104 (40.6) 152 (59.4) 1
know
Had training on the SIC Yes 16 (84.2) 3 (15.8) 4.844 0.013 0.684 (0.086-5.428)
practice? No 207 (52.4) 188 (47.6) 1
 Which patients usually Elective 33 (41.3) 47 (58.1) 1.177 0.597 0.767 (0.265-2.215)
refuses to sign on the SIC Emergency 153 (65.1) 82 (34.9) 3.127 0 1.442 (0.548-3.794)
form?
Don’t 37 (37.4) 62 (62.6) 1
know
Who usually signs SIC? Patients 73 (50.7) 71 (49.3) 2.321 0.241 2.004 (1.162-5.838)
only
Pts and 115 (73.7) 41 (26.3) 6.331 0.013 4.194 (3.849-21.961)
relatives
Relatives 35 (30.7) 79 (69.3) 1
only
Faced pts influenced by Often 29 (31.9) 62 (68.1) 1
relatives to sign SIC? Sometimes 62 (47.3) 69 (52.7) 1.921 0.022 1.656 (0.515-5.322)

Never 132 (68.8) 60 (31.3) 4.703 0 1.776 (0.553-5.704)

Faced a patient with Yes 170 (61.6) 106 (38.4) 2.572 0 1.085 (0.418-2.82)
previous surgical history? No 53 (38.4) 85 (61.6) 1
Which pts easily give SIC? With no 13 (15.5) 71 (84.5) 0.298 0.031 0.237 (0.083-0.679)
Hx
With 167 (77) 50 (23.0) 5.437 0.013 3.141 (1.435-6.876)**
history
Don’t 43 (38.1) 70 (61.9) 1
know
Knowledge Good 161 (70.9) 66 (29.1) 4.918 0 3.931 (1.799-8.591)**
Poor 62 (33.2) 125 (66.8) 1
Attitude Favorable 167 (73.9) 59 (26.1) 6.672 0 5.690 (2.729-11.862)***
Unfavorable 56 (29.8) 132 (70.2) 1

Table 5. Factors associated with good surgical informed consent practice among the study participants in WCU-NEMMCS hospital,
hosanna southern Ethiopia, 2022. N=414.

the same number of people in Europe.

DISCUSSION In this study, only 13.8% of the respondents always obtain
informed consent from patients for major surgical procedures.
This study, founds 223 (53.9%; CI:48.3-58.4) of HCWs had good This is very low than the finding in similar study conducted in
SIC practice, this finding was in agreement with the study done our country bale zone where 55.2% of HCWs always obtains SIC
in Ethiopia, bale zone hospitals 50.01%. But is higher than study for major surgeries. The discrepancy might be that, lack of
done in Uganda and SPHMMC Addis Ababa that were 48% and formally documented policy/regulation that clearly supports SIC
8.1% respectively. The variation might be due to that, this study process in the institution, this is supported by the finding in this
was carried out at a single study area where the study participants study, where majority 256 (61.8%) of the study participants do
unfortunately might share similar features. However, it is lower not know if the hospital had policy/regulation that supports SIC
result as compared to those studies done at Sat tam bin Abdul- process.
Aziz university Al-Kharj city (Saudi Arabia) and Brazil where Regarding factors associated with SIC practice, odds of good SIC
69.7% and 59.6%, HCWs had good SIC practice respectively. practice for the HCWs who were in age group of 31-35 years
This might be due to events like Saudi Arabia and Brazil are were 2.4 times higher than those who were in age group of 21-25
countries with middle per capital income thus, their health care years, this finding was congruent with the study conducted in
system varies from our country (sub-Saharan Africa) where Ethiopia bale zone and Aga Khan university hospital, Karachi,
demands and supply (health care system, workforce particularly, Pakistan. This could be explained as age increases, their work
surgeons) were further disproportionate in which one surgeon experience increases, increasing exposure to training and shared
might obligated to treat so many patients, that can affect the experience as a result, HCWs increase their knowledge and
quality of SIC practice. Or might be due to the different data attitude, leading to improved SIC practice.
collection method, an online questionnaire based data collection In this study, health care workers who never faced challenge in
method used in Saudi Arabia, the small sample size (133) and communication with their patients due to language barrier were 2
regression models (Back ward LR) used in Uganda. The times more likely had good SIC practice than their counter parts,
justification is further supported by evidence found in WHO data this finding is similar with the finding in the study conducted at
2000–2007, where on average, across sub-Saharan Africa, a Aga Khan university hospital, Karachi, Pakistan. Possible
population of 10,000 is served by two doctors and 11 nursing and explanation for this could be that, when there is shared language
midwifery personnel, compared to 32 and 79 respectively serving between patients and their health care providers it results in
common understanding among them that lead HCWs to have informed participants of any medical or surgical procedures
good SIC practice. happening to their body. Patient with previous history of surgery,
HCWs that spent more time (21-30 minutes) on providing when both patient and patient relatives sign SIC form, age,
information about SIC process to their surgical patients were 5 language, working experience, time spent for the consenting
times more likely to have good SIC practice than those HCWs process availability of policy/regulation that supports process of
who spent five minutes and less time. This finding is similar to SIC in the institution, Knowledge, attitude of the health care
study done in Ethiopia bale zone and Addis Ababa. The rational workers had a statistically significant positive association with
for this might be that, taking more time in providing information the surgical informed consent practice.
to patients gives the patient more time space to ask more Even if the finding of SIC practice in this study was 53.9% but
questions on their doubts and provide both the HCWs and still, it is low for quality service and looks as it is theoretical
patients with wider discussion period which finally leads to have ideal, which needs more emphasis and work up. Therefore, it is
common understandings and shared decision and results HCWs suggested that, Similar study should be done on different public
in good SIC practice. and private hospitals to compare the result to know which
This study revealed that, HCWs who were aware of availability hospital health professionals have had better SIC practice from
of policy/regulation that supports SIC process in the hospital had public and private sectors in the area, Supervision manual on SIC
3.2 times higher odds of good SIC practice than those who do not should be developed that could be applied to monitor the health
know if institution has policy/regulation that supports SIC professional’s performance, The hospital also should avail the
process. The finding is in line with the study done in our country standardized policy/regulation drafts in the institution that
bale zone, hospitals. Justification for this might be that, when regulates work of every health care professional in the hospital
there is regular supervision and control of activity in working and find away all professionals aware of it, further studies/
environment from the higher officials according the available preferably observational study should be done to assess SIC
policy/regulation, the employee’s commitment and effectiveness professionals for improved validity and more robust evidence on
of work implementation increases. This is supported by findings SIC.
from study done in USA which shows, mid level managerial
involvement/supervision influences effective implementation of STRENGTH OF THE STUDY
work.
This study also found that, there is a significant association  Since similar studies were very rare so far in our
between good SIC practice among HCWs and treating surgical country, therefore this study tried to show index of
patients with history of previous surgery, based on the finding, practice of SIC for major surgical procedures among
odds of good SIC practice for health care workers were 3 times HCWs in my context, and being a base line for future
higher when they treated patients with history of previous researchers.
surgery is higher than when they treated neither of patients with  This study addressed new variables (pts’ related factors)
no previous surgical history nor patients with previous history of which significantly associated.
repeated surgery, it is congruent with finding in the study done at
Jima University medical center, and Hawassa university, referral LIMITATIONS OF THE STUDY
hospital southern Ethiopia, shows a significant association
between patients previous exposure to surgery and easily  Since practice need more observational study and this
signing of SIC in recent schedules. Possible reason might be due study was cross sectional, it lacks proven validity and
to preoperative health education of patients in their previous more robust evidence on practice of SIC process.
surgery and the patients already experienced the reality of  As the study was conducted in a single referral hospital,
surgical treatment. even though it’s a tertiary health facility it could not
In this study, the health care workers who had well SIC generalizable for the health care workers in other health
knowledge were 3.9 times more likely to practice adequate SIC facility that are usually below the level of this institution
than those who had poor knowledge. This finding was similar as a whole.
with the study conducted in bale zone Ethiopia, which might  Self-reporting bias might also affect the outcome of the
know the informed consenting process helps integrate each study, since some respondents may not report what they
component of consent into practice quickly and thoughtfully. It is actually practice.
a fact that without the basic understanding of the elements of the
consenting process, the approach of informed consent will not be ETHICAL APPROVAL
optimal. Similarly, those HCWs with favorable attitudes toward
SIC were 5.69 times more likely to practice adequate informed Ethical clearance approval was obtained from the Institutional
consent than those with unfavorable attitudes. This finding is Review Bord of Bahir Dar university (IRB-CMHS), college of
comparable with the study in bale zone Ethiopia and Pakistan. medicine, and health sciences before the actual data collection
The possible explanation might be that a favorable attitude started, permissions letter was secured from the study hospital.
towards informed consent practice is fundamental and enhances
motivation for practice. CONSENT

During the distribution of questionnaires, informed consent was

CONCLUSION taken from study participants and information was provided
53.9% of health care workers had good surgical informed about the purpose and the benefit of the study along with their
consent practice which is inadequate for globally (WHO) full right to refuse or completely reject to participation in the
recommended standard that stated as, all patients have right to be
study. Considering their safety, explanation of the potential risk 3. Lloyd A, Hayes P, Bell PR, Naylor AR (2001). The role
towards taking their time during interview and informing that no of risk and benefit perception in informed consent for
incentives or other benefits are given to participate in the study. surgery. Med Decis Making. 21(2):141-149.
Finally, all eligible health care workers were allowed to involve 4. Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK,
in the interview and confidentiality or privacy of information was Peppas G (2009). Informed consent: How much and what
maintained. do patients understand? Am J Surg. 198(3):420-435.
5. Agnew J, Jorgensen D (2012). Informed consent: A study
CONFLICTS OF INTEREST of the OR consenting process in New Zealand. AORN J.
95(6):763-70.
Authors declare that they have no conflicts of interest. 6. Abd El-Nasser G, Mohamed N (2013). Patient satisfaction
with perioperative care and its relationship with patient
ETHICAL CONSIDERATION characteristics. Med J Cairo Univ. 81(2).
7. Abolfotouh MA, Adlan AA (2012). Quality of informed
Ethical clearance approval was obtained from the Institutional consent for invasive procedures in central Saudi Arabia.
Review Bord of Bahir Dar university (IRB-CMHS), college of Int J Gen Med. 5:269.
medicine, and health sciences. Before the actual data collection 8. Negash W, Assefa N, Baraki N, Wilfong T (2021).
started, permissions letter was obtained from the study hospital. Practice and factors associated with informed consenting
During the distribution of questionnaires, informed consent was process for major surgical procedures among health care
taken from study participants and information was provided workers, South Eastern Ethiopia. Int J Gen Med. 14:7807.
about the purpose and the benefit of the study along with their 9. Ochieng J, Ibingira C, Buwembo W, Munabi I, Kiryowa
full right to refuse or completely reject to participation in the H, Kitara D. (2014). Informed consent practices for
study. Considering their safety, explanation of the potential risk surgical care at university teaching hospitals: A case in a
towards taking their time during interview and informing that no low resource setting. BMC Med Ethics. 15(1):1-5.
incentives or other benefits are given to participate in the study. 10. Assefa Y, Hill PS, Gilks CF, Admassu M, Tesfaye D,
Finally, all eligible health care workers were allowed to involve Van Damme W. Primary health care contributions to
in the interview and confidentiality or privacy of information was universal health coverage, Ethiopia. Bulletin of the World
maintained. Health Organization. 2020;98(12):894.
11. Chane W BB, Suga Y (2020). Quality of informed
AUTHORS’ CONTRIBUTIONS consent among patients who underwent major surgical
procedure in a Tertiary Care Hospital, Addis Ababa,
TTW*, BAA, FWS, EA, and AN contributed to the conception, Ethiopia. Open Access Surgery. 13:27. [Google Scholar]
designed the study, supervised the data, carried out the analysis, 12. Alsaidan MS, Abuyassin AH, Alammar HS, Hussien G
interpreted the data, and revised the work for important (2021). Prevalence and quality of informed consent for
intellectual content. TTW and BAA participated in framing the patients undergoing cosmetic procedures: A cross
method and wrote the manuscript for publication. All authors sectional study. Acta Bioethica. 27(1):37-48.
read and approved the final manuscript. 13. Jahan F, Roshan R, Nanji K, Sajwani U, Warsani S, Jaffer
S, et al. (2014). Factors affecting the process of obtaining
ACKNOWLEDGMENTS informed consent to surgery among patients and relatives
in a developing country: results from Pakistan. East
Our grateful thank goes to Bahir Dar university, college of Mediterr Health J. 20(9):569-577.
medicine and health science, department of Midwifery for giving 14. Birken SA, Lee S-YD, Weiner BJ, Chin MH, Schaefer CT
us this golden and educative opportunity. We would also like to (2013). Improving the effectiveness of health care
extend our deepest gratitude to WCU-NEMM comprehensive innovation implementation: Middle managers as change
specialized hospital management and medical staff for providing agents. Med Care Res Rev. 70(1):29-45.
us with the necessary information. 15. Teshome M, Wolde Z, Gedefaw A, Asefa A (2019).
Last, but not least we would like to express our special gratitude Improving surgical informed consent in obstetric and
to the data collectors, supervisors study participants and all who gynaecologic surgeries in a teaching hospital in Ethiopia:
helped and supported us during this work. A before and after study. BMJ open. 9(1):023408.
16. O’Connor P, Reddin C, O’Sullivan M, O’Duffy F, Keogh
DATA AVAILABILITY I (2013). Surgical checklists: The human factor. Patient
Saf Surg. 7(1):1-7.
All related data have been presented within the manuscript. The
data set supporting the conclusion of this article can be obtained
from the corresponding author upon reasonable request.

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