ARBA MINCH UNIVERSITY

COLLEGE OF MEDICINE AND HEALTH SCIENCES

Title of the Knowledge and Attitude towards legal nature of surgical informed consent
research and associated factors among adult surgical patients in Arba Minch
proposal General Hospital and Jinka General Hospital, southern Ethiopia, 2021

Principal Dr. Tigabu Daniel (General Surgeon, Assistant Professor)

investigator
1. Menaye Yihune (MPH, Assistant Professor)
Co-investigators
2. Dr. Yonas Abera (General Surgeon, Assistant Professor)
Duration of the
Eight months ( August, 2021 to March, 2022)
study

Place of the study Arbaminch general hospital and Jinka General Hospital, Ethiopia
Total budget of
149,300 Ethiopian Birr
the study
Budget source Arba Minch University
Address of the Email; [email protected]
principal Tel(cell);+251 964-04-11-60/913452078
investigator
Address of the 1. Email; [email protected]
co- investigators Tel(cell); +251 911-00-87-59
2. Email; [email protected]
Tel(cell);+251 920-03-25-09
 ACKNOWLEDGEMENT

First of all, we gratefully thank Arba Minch University, College of Medicine and Health
Sciences research coordination office for giving us this incredible chance and support to prepare
this research proposal. We also want to thank Arba Minch and Jinka General Hospital
administrative staff for providing us base line data pertinent to the proposal.

Finally, our sincere thank goes to all those, who in one way or another have contributed to the
success of this research proposal.

TABLE OF CONTENTS
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ACKNOWLEDGEMENT...............................................................................................................ii
LIST OF TABLES...........................................................................................................................v
LIST OF FIGURES........................................................................................................................vi
ABBREVIATIONS AND ACRONYMS......................................................................................vii
SUMMARY.................................................................................................................................viii
1. INTRODUCTION.......................................................................................................................1
1.1. Background...........................................................................................................................1
1.2. Statement of the problem......................................................................................................2
1.3. Significance of the study.......................................................................................................4
2. LITERATURE REVIEW............................................................................................................5
2.1. Knowledge and attitudes of surgical informed consent........................................................5
2.2. Factors associated with patients’ Knowledge and attitudes towards surgical informed
consent.........................................................................................................................................6
2.3. Conceptual framework..........................................................................................................7
3. OBJECTIVES OF THE STUDY.................................................................................................8
3.1. General Objective.................................................................................................................8
3.2. Specific Objectives...............................................................................................................8
4. METHODS AND MATERIALS................................................................................................9
4.1. Study Setting and period.......................................................................................................9
4.2. Study Design.........................................................................................................................9
4.3. Populations............................................................................................................................9
4.3.1. Source population...........................................................................................................9
4.3.2. Study population.............................................................................................................9
4.3.3. Study Unit.......................................................................................................................9
4.4. Inclusion and Exclusion criteria..........................................................................................10
4.4.1. Inclusion criteria...........................................................................................................10
4.4.2. Exclusion Criteria.........................................................................................................10
4.5. Sample size determination, sampling technique and procedure.........................................10
4.5.1. Sample size determination............................................................................................10
4.5.2. Sampling technique and procedures.............................................................................11
4.6. Data collection methods......................................................................................................12

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 4.6.1. Data collection instruments..........................................................................................12
4.6.2. Pre-testing.....................................................................................................................13
4.6.3. Data Collection.............................................................................................................13
4.7. Variables in the study..........................................................................................................13
4.7.1. Dependent variable.......................................................................................................13
4.7.2. Independent variables...................................................................................................13
4.8. Operational definition of terms...........................................................................................13
4.9. Data quality assurance........................................................................................................14
4.10. Data processing and analysis............................................................................................14
4.11. Ethical consideration.........................................................................................................15
4.12. Benefits and beneficiaries.................................................................................................15
4.13. Dissemination of findings.................................................................................................16
5. PLAN OF ACTIVITIES............................................................................................................17
6. BUDGET...................................................................................................................................18
7. REFERENCES..........................................................................................................................19
8. ANNEXES.................................................................................................................................22
8.1. Annex I: Information sheet and informed consent form.....................................................22
8.2. Annex II: Data Collection Tool..........................................................................................25

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 LIST OF TABLES

Table 1: Sample size determination for a study on knowledge and attitude towards legal nature of
surgical informed consent and associated factors among adult surgical patients in Arba
Minch General Hospital and Jinka General Hospital southern
Ethiopia……………………………………11

Table 2: Plan of activities for a study on knowledge and attitude towards legal nature of surgical
informed consent and associated factors among adult surgical patients in Arba Minch
General Hospital and Jinka General Hospital southern
Ethiopia……………………………………………...17

Table 3: Budget break down for a study on knowledge and attitude towards legal nature of
surgical informed consent and associated factors among adult surgical patients in Arba
Minch General Hospital and Jinka General Hospital southern Ethiopia…………...
…………………………………18

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 LIST OF FIGURES

Figure 1: Conceptual framework of relationships between different explanatory variables with

Patients’ Knowledge and attitudes towards surgical informed consent..........................................7

Figure 2: Diagrammatic presentation of sampling technique for the study on knowledge and
attitude towards legal nature of surgical informed consent and associated factors among adult
surgical patients in Arba Minch and Jinka General Hospital and Jinka General Hospital southern
Ethiopia..........................................................................................................................................12

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 ABBREVIATIONS AND ACRONYMS

AMGH Arba Minch General Hospital

AOR Adjusted Odds Ratio

CDC Communicative Disease Control

COR Crude Odds Ratio

COI Co-Investigator

CI Confidence Interval

ICU Intensive Care Unit

IRB Institutional Research Ethics Review Board

PI Principal Investigator

SNNPR Southern Nations, Nationalities and Peoples' Region

SPHMMC Saint Paul Hospital Millennium Medical College

USA United States of America

WHO World Health Organization

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SUMMARY

Introduction: Surgical informed consent is a document that protects surgeons as well as patients
and hospital from legal accountability. It gives autonomous power for the patients either to
proceed or reject the operation for whatever the outcome. There are many studies regarding
informed consent in clinical trials, however, only few studies have assessed adult patient’s
knowledge and attitude of surgical informed consent in clinical practice. Therefore, the purpose
of this study is to assess knowledge and attitude towards legal nature of surgical informed
consent and associated factors among adult surgical patients in Arba Minch General Hospital and
Jinka General Hospital Southern Ethiopia, 2021

Methods: An institution based cross sectional study will be employed among a total of 384 adult
post-surgical patients From December 01, 2021 to February 28, 2022 at Arba Minch and Jinka
General Hospital, southern Ethiopia. A pretested semi-structured interviewer administered
questionnaire will be used to collect data from study participants. Stratified sampling technique
will be used to select study participants. The collected data will be entered into EPI-data version
3.1 and exported to SPSS (version 25) software for statistical analyses. A binary logistic
regression model will be used to identify factors associated with the outcome variable. Variables
with p-value <0.25 in the bi-variable logistic regression analysis will be interred and checked for
association in a multivariable logistic regression model. The level of statistical significance will
be declared at p-value <0.05. The association between the outcome and independent variables
will be reported using the adjusted odds ratio with 95% CI and p-value. Ethical clearance will be
obtained from institutional research ethics review board of Arba Minch University College of
Medicine and Health Sciences

Expected outcome of the study: A study is expected to assess knowledge and attitude towards
legal nature of surgical informed consent and associated factors among adult surgical patients in
Arba Minch and Jinka General Hospital, Southern Ethiopia.

Budget and study duration: A minimum of 149,300 Ethiopia Birr is requested to finalize this
study from August, 2021 to March, 2022.

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 1. INTRODUCTION

1.1. Background

According to American cancer society definition, informed consent is a legal agreement between
patient and health care provider that often leads to agreement or permission for care, treatment or
services. Every patient has the right to get information and ask questions before any procedures
and treatment. For adult patients that is able to decide, medical care cannot be given unless the
patient signed informed consent. Even the patient has right to cancel the intervention completely,
partially or in mid of the procedure after signing informed consent. According to informed
consent guide line 2019 there are four principles there should be open dialogue between patient
and health care provider, delivery of adequate information for the patients, respect and clarity to
the patients and legality. Based on 1995 WHO declaration on promotion of patients’ rights,
patients has the right to be fully informed about their health status in detail. According to
multiple review of studies, surgical informed consent is underestimated part of surgery and both
surgeon and patient are giving little place for it (1).

There is huge difference between best legal practice and daily practice of surgical informed
consent (1). Effective performance on surgical informed consent avoids unnecessary
expectations, increases patient satisfaction and reduces legal claims (1). There is limited
literatures on quality and informed consent processes both globally and nationally (1). Based on
progress of surgical informed consent, it’s initially created to protect the surgeon from legal
accountability around 14th century (1). The modern structure of surgical informed consent
started in around 20th century after introduction of anesthesia and more invasive surgery. The
way of delivering surgical informed consent is not uniform in different countries (1).

Currently the informed consent is the direct reflection of patients’ authorization (1). Currently
surgeons are commonly accused on Medias and increasing medico legal claims. Most of the
claims are not due to failure of the treatment but is mostly due to failed communication (1). Most
of legal (70%) files are on minor surgeries probably because of giving attention to major

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operations but not for minor by the surgeons (1). The authority of patient on procedure should be
100% but patient satisfactory level of understanding of his/her authority is only 32% and 88% of
patients considered as if they have no right to change their decision after signing informed
consent (2). Globally there is no well-formed uniform surgical informed consent and it’s
different from country to country (1, 3, 4, 5).

1.2. Statement of the problem

Globally there is no well-formed uniform surgical informed consent and it’s different from
country to country (1, 3, 4, 5). There is limited literature on surgical informed consent globally
(1). Currently surgeons are becoming commonly accused on Medias publicly and also increasing
legal claims because of mainly failed surgical informed consent process but not failed procedure
(1). The authority of patient on procedure should be 100% but patient satisfactory level of
understanding of his/her authority is only 32% and 88% of patients considered as if they have no
right to change their decision after signing informed consent (2).

In USA only 30% of surgical informed consent has well described procedure name, only 11%
described how the procedure will be done and only 2% of the consent documents showed risk of
the procedure which shows significant area of gap (4). In Kuwait 69.9% of patients do not know
as surgical informed consent is a legal document and requirement (9).

One study done in India showed 88% of patients believed as if they have no right to change their
mind after signing consent and 61.6% of them lost their autonomy (2). Only 32% of the patients
have satisfactory level of understanding (2). Most of informed consents are not obtained by
operating surgeon but at time of admission by other health care providers (3). Most consent
forms are in adequate (3) of 2480 informed consent collected from 25 hospitals in USA showed
only 30% procedure describing language, only 11% contain how the procedure will be done,
only 2% list risks of procedure, only for 5% benefits of the procedure described, in 80% of
documents procedure name written by hand, only 46% of patients are told 1 day prior to
procedure (over all poor quality of informed consent process) (4). It’s not only patients but also
there is gap on proper processing of consent by the surgeons and some associated factors (5, 6,

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7). To achieve adequate level of patient autonomy still the current format of consent is needs
significant modification (8).

A study done in Kuwait only 69.9% of patients consider informed consent as a legal requirement
and only 72.3% of patients perceived as consent protect their right (9). 59.5% of patients
considered as consent is for the protection of doctors (9). Only 15.9% of patients relay on their
doctors and did not consider the information is necessary (9). The same study reached to the
point that the consent process is insufficient and the current format is not enough to exercise
patient autonomy that needs revision (9).

A study done in India showed that 59.7% of patients have high knowledge regarding patients’
rights (10). Only 38.9% of patients adequately informed about their medical condition in Egypt
(11). Another study in Egypt showed that there is significant discrepancy between patient
attitude and consent goal need to be achieved (12). Awareness, rate of satisfaction and
knowledge was high on one study done in Nigeria (13). 66% of elective patients reported as if
they get adequate in formation to give informed consent in Ghana but they did not know what
procedure has been done and over all the consent is not satisfactory and needs to be amended too
(14). In Ethiopia, all studies showed that there is decreased level of awareness, knowledge,
attitudes of patients to wards surgical informed consent and also the format itself is not fulfilling
the legal requirement of the standard consent (15, 16, 17, 18).

In Egypt still there is insufficiency of surgical informed consent process and only 38.9% of
patients informed about their medical conditions (11). In our country also showing decreased
awareness, knowledge and practice with insufficient and varying formats of surgical informed
consent ( 15, 16, 17, 18). No study was done in our setup regarding surgical informed consent.

As we see from different literatures there is wide gap in practice and attitude of surgical
informed consent that needs active research and implementation on surgical informed consent.
That is why this study is designed to assess knowledge and attitude towards legal nature of
surgical informed consent and associated factors among adult surgical patients in Arba Minch
General Hospital and Jinka General Hospital, Southern Ethiopia.

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 1.3. Significance of the study

The result of this study may help to draw the attention of the study area public health authorities
and other stake holders on improving surgical informed consent process which will be
fundamental to increases patient satisfaction, to increase expectation of reasonable outcome of
procedure and to decreases medico-legal issues.

Most of patients are not fully exercising their autonomy and this study will add input for
empowerment of our patients. Also there are limited papers on this area of patient attitude that
this paper will dig our patient level of attitude and knowledge.

There are increasing medico legal issues on surgeons that are usually failure of informed consent
but not because of failure of procedure which needs empowerment of surgical informed consent
as a legal agreement between surgeon and patient.

Now a day surgeon centered surgical informed consent should be changed to patient autonomy
based on consent evaluation in detail. Specifically nothing was done in our setup with regard to
surgical informed consent and this study will be used as a base for our setup and as reference for
others in our country.

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 2. LITERATURE REVIEW

2.1. Knowledge and Attitude of surgical informed consent

Regarding knowledge, 63.8% of patients they do not try to know about what procedure to be
done but they only relay on their doctors (2). Study done in Rupandehi hospital showed overall
59.72% of patients have knowledge about their right (10). There is significant variety of level of
knowledge regarding right to informed consent, right to leave medical advice and the right to
change mind after signing informed consent (2, 10). There is significant knowledge gap between
physician and patient regarding surgical informed consent (3, 5, 6, 10, 11). Only 49.4% of
physicians informed in detail about the procedure done and only 38.9% of patients being
informed in detail about their procedure (11).

Only one study done in Nigeria showed increased level of knowledge and positive attitude
regarding surgical informed consent among obstetric patients (13). In study done in one of
teaching hospital in Ghana 71.4% of patients have knowledge about their diagnosis but only 41%
have knowledge about the procedure done (14).Study done in Jimma university teaching hospital
showed 77.8% and 22.8% poor knowledge and good knowledge regarding surgical informed
consent respectively (15). Study done in SPHMMC teaching hospital showed 55.6% disclosed
about their benefit of procedure, 60.7% disclosed about consequence of cancelling surgery, only
26.7% explained about risk of procedure and only 44.6% have knowledge about alternative
treatment options and lastly only 10.5% of patients had good knowledge (16, 18). The other
study done in Gondar university teaching hospital showed 61.9% of respondents had poor
knowledge regarding surgical informed consent (17).

Surgical informed consent is one of underestimated part of surgery by surgeons and patients that
needs especial training to surgeons (1). As history of development of surgical informed consent

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shows, the initial intension of it was to protect the operating surgeon. After 20th century as more
invasive surgery and anesthesia began, the patient autonomy based surgical informed consent
was introduced to decrease legal claims that would be corrected by the proper process of
informed consent (1). According to 1995 WHO declaration patients have full right to know about
their disease, possible intervention and its consequences with full ability to proceed or cancel the
intervention. A surgeon who did operation beyond the consent given extent is doing assault (1).

So currently the informed consent should be as patient point of view for whatever outcome of the
disease (1). The current surgical informed consent should pass the three steps: precondition like
competent patient and surgeon also voluntarism, adequate information delivery to patient and
signing consent (1).

About 88% of patients believed that they have no right to change their mind after signing
informed consent (2). Only 61.6% of patients trusted on their doctor (2). Even though they sign
informed consent, 75% of patients believe surgical informed consent as a legal requirement
falsely (2). 75.2% of patients believed as if they will die if they do not sign the consent (2).only
35% real change in attitude of doctors with regard to recent surgical informed consent processing
(5). Only one study done in Nigeria showed positive attitude towards signing informed consent
as a legal document the others are un satisfactory (2, 5,13).

In the past surgical informed consent was perceived as if it is for the mere protection of health
care provider and hospital (1, 2, 7). There is vast difference in patient and physician attitude, still
most being unsatisfactory and there is inadequate consent procedure that strongly needs revision
(2, 6, 9, 11, 18). Study done in Gondar university teaching hospital showed 51.3% had poor
attitude towards surgical informed consent (17).

2.2. Factors associated with patients’ Knowledge and attitudes towards

surgical informed consent

Patient related factors: like parity, previous operation, previous medical history, satisfaction
level affect level of knowledge regarding surgical informed consent (15).

Service related factors: most of patients got insufficient surgical informed consent by low profile
professionals (15). Educated patients have 1.22times higher knowledge than for those low levels

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of education. Those patients satisfied with the service of hospital are 1.8 times high knowledge
on surgical informed consent than others (16). Another study done in Gondar showed there is
significant effect relationship between education level, marital status, residency, occupation, past
surgical history of participants, source of information and time given for explaining surgical
informed consent process and level of knowledge on surgical informed consent (17). The other
study done in SPHMMC showed good level of knowledge from those educated and living in
urban than others but other factors are not statistically significant (18).

2.3. Conceptual framework

Socio-demographic factors
 Age
 Residence
 Educational status
Outcome variable
o Attitude towards surgical
informed consent

Outcome variable
o Knowledge towards
surgical informed consent
Health care related factors
o Level of satisfaction of patients on hospital
services
o Previous surgery exposure
o Time given for explaining the procedure
o Profile of service deliverer

Source: Adapted from different peer reviewed literatures (17, 18).

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Figure 1: Conceptual framework of relationships between different explanatory variables with
Patients’ Knowledge and attitudes towards surgical informed consent.

3. OBJECTIVES OF THE STUDY

3.1. General Objective

F To assess knowledge and attitude towards legal nature of surgical informed consent and
associated factors among adult surgical patients in Arba Minch General Hospital and Jinka
General Hospital, southern Ethiopia, 2021

3.2. Specific Objectives

F To determine patients’ knowledge towards legal nature of surgical informed consent

F To determine patients’ attitude towards legal nature of surgical informed consent
F To identify factors associated with patients’ knowledge towards legal nature of surgical
informed consent
F To identify factors associated with patients’ attitude towards legal nature of surgical
informed consent

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 4. METHODS AND MATERIALS

4.1. Study Setting and period

A study will be conducted in Arba Minch General Hospital, southern Ethiopia and Jinka General
Hospital, southern Ethiopia. Arbaminch General Hospital is found in Arba Minch town which is
the administrative center of Gamo zone. Arba Minch town is located 505 km southwest from
Addis Ababa, the capital city of Ethiopia and 275 km southwest of Hawassa, capital city of
SNNPR.Jinka General Hospital is located in Jinka town South Omo zone that is located in
southwest of Hawassa and Addis ababa, Ethiopia. Study participants will be included from
surgical ward, orthopedics ward, plastic ward, ophthalmology unit and OBGY wards of the two
hospitals.

A study will be conducted from December 01, 2021 to February 28, 2022 among adult surgical
patients in in Arba Minch General Hospital and Jinka General Hospital, southern Ethiopia.

4.2. Study Design

An institution based cross sectional study will be carried out to assess knowledge and attitude
towards legal nature of surgical informed consent and associated factors among adult surgical
patients in Arba Minch General Hospital and Jinka General Hospital, southern Ethiopia.

4.3. Populations

4.3.1. Source population

The source population will be all adult surgical patients in Arba Minch General and Jinka
General Hospitals, southern Ethiopia.

4.3.2. Study population

The study population will be all adult post-surgical patients admitted in Arba Minch and Jinka
General Hospital surgery performing wards mentioned above during the data collection period.

4.3.3. Study Unit

Each selected adult post-surgical patient.

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 4.4. Inclusion and Exclusion criteria

4.4.1. Inclusion criteria

All adult post-surgical patients admitted in Arba Minch General Hospital and Jinka General
Hospital during the data collection period.

4.4.2. Exclusion Criteria

Those adult post-surgical patients who are not fully conscious, psychiatric uncooperative
patients.

4.5. Sample size determination, sampling technique and procedure

4.5.1. Sample size determination

For first specific objective:
The sample size for the first specific is determined using the p-value 10.5% from study done in
SPHMMC (18), Ethiopia; with 95% confidence interval (1.96); α=0.05 ;5% marginal of error
(5%).
N = (Zα/2)2 p(1-p); Therefore, N=144
d2

For second specific objective:

The sample size for the second specific objective is determined using single population
proportion formula taking assumption 50% proportion to maximize the sample size (and since
this study is new and the first time in the area even in Ethiopia); with 95% confidence interval
(1.96); α=0.05 ;5% marginal of error (5%).
N = (Zα/2)2 p(1-p); Therefore, N=384
d2
For third specific objective:
To determine the required sample size for the third and fourth specific objective various factors
significantly associated with the outcome variable (Knowledge and attitude) will be considered
and Epi-Info-7 StatCalc will be used for sample size calculation. The possible calculated sample
size is shown in table 1(see table 1).

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Table 4: Sample size determination for a study on knowledge and attitude towards legal nature of
surgical informed consent and associated factors among adult surgical patients in Arba
Minch General Hospital and Jinka General Hospital, southern Ethiopia.

living in urban (18) being higher educational

Predictors consider status (18)
Confidence level 95% 95%
Power 80% 80%
Ratio 1:1 1:1
% Of outcome in unexposed 3.4722 3
group
Adjusted odd Ratios 4.72 4.82
Sample size 244 270

Final sample size for the study:

After calculated the required sample size for those specific objectives then the maximum sample
size is taken, which is 384.

4.5.2. Sampling technique and procedures

Stratified sampling technique will be used as sampling strategy and the study participants will be
divided into different strata according to the surgical specialties. By allocating the sample size
proportionally in each surgery wards of Arba Minch General Hospital and Jinka General
Hospital(surgical, orthopedic, obstetrics and gynecology, ophthalmology and plastic and
reconstructive), a Systematic random sampling technique will be used as sampling strategy to
collect the study participants in each ward by calculating a constant ‘k’ skip interval.

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 Arba Minch General Hospital and Jinka General Hospital

Surgical Orthopedic Obstetrics and Plastic

gynecology Ophthalmology
(400*), (150**) (150*), (55**) (100*), (0**) (50*), (0**)
(300*), (105**)

Proportional to size allocation

44*, 16** 88*, 31**

117*, 44** 29* 15*

Total Sample size = 384

Key
*Arba Minch G/hospital
**Jinka G/hospital

Figure 2: Diagrammatic presentation of sampling technique for the study on knowledge and
attitude towards legal nature of surgical informed consent and associated factors among
adult surgical patients in Arba Minch General Hospital and Jinka General Hospital,
southern Ethiopia.

4.6. Data collection methods

4.6.1. Data collection instruments

A structured interviewer administered questionnaires in surgical ward, orthopedics ward, plastic

and reconstructive, Gynecologic & obstetrics ward and ophthalmology unit adapted from St.
Paul’s Hospital Millennium Medical College, Befekadu Lemmu1 . et al in Ethiopia (18) will be used as
a standard tool; English version. The tool consists of socio-demographic data which includes the
personal descriptive data of participations, Knowledge and Attitude questions, Clinical related
factor questions and health care worker related factors.

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 4.6.2. Pre-testing

To ensure the quality of data to be collected from adult surgical patients, first data collection
tools will be pre-tested on 5% of the sample in Chencha Hospital, which is not selected as a
study area in this study, one week before the actual data collection period. After pre-testing the
tool necessary modifications will be made based on the nature of gaps identified in the tool.

4.6.3. Data Collection

Six clinical Nurses will be participated for data collection in the study and will be supervised by
two experienced BSc nurses. Each data collector will undergo in the assigned surgery ward to
conduct face to face interview using a structured tool prepared for the study. On site supervision
will be carried out during the whole period of data collection on daily basis by site supervisor,
principal and co- investigators. At the end of each data collection day questionnaire will be
reviewed and cross checked for completeness, accuracy and consistency by site supervisor,
principal and co- investigators and corrective measures will be under taken if necessary.

4.7. Variables in the study

4.7.1. Dependent variable

 Knowledge (Good / Poor)

 Attitude (Favourable / Unfavourable)

4.7.2. Independent variables

o Socio-demographic data: age, marital status, education, place of residence, etc.
o Patient related data: previous surgery, level of satisfaction by hospital service, etc.
o Health care deliverer related data: profile of health care deliverer, time given to consent
process, etc.

4.8. Operational definition of terms

F Knowledge: The response will be rated on Yes/No question whereby: Good Knowledge
(a higher mean score), Poor (a Lower mean score).

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 F Attitude: the response will be rated on a Yes/No whereby: favourable (a higher mean
score), Unfavourable (a Lower mean score).

4.9. Data quality assurance

To assure the quality of data, different mechanisms will be used including pre-testing of the tool
with 5% sample size, recruiting data collectors and site supervisor who had data collection
experience, a total of two days of intensive training on how to administer the data collection
process and on the ethical issues will be given for all data collectors during the process of data
collection.

The principal and co- investigators will perform the immediate supervision on a daily bases
during data collection. They will be checking each and every completed questionnaire. The
overall activity will be monitored by the principal and co-investigators. Data entry software Epi
Data version 3.1 will be used for data entry.

4.10. Data processing and analysis

All the collected data will be checked visually, and standard categorization will be made within
which the circumstances surrounding Knowledge and Attitude. Data will be coded, entered and
cleaned using Epi-Data version 3.1software. Double entry will be made to cross check the data
for completeness and consistency before analysis. Errors related to inconsistency will be verified
using data cleansing method. The entered data will be exported to SPSS (version 25) software for
statistical analyses.

The analyses will be conducted at several steps. First, the Socio-demographic data and other
characteristics of the study participants will be described in terms of mean/median or percentage,
as appropriate. At the second step, bivariate logistic regression will be performed (at p<0.25) for
each independent and outcome of interest to screen out potentially significant variables for
consideration in the multivariable logistic regression.

Upon the completion of the bivariate analysis, variables will be selected for the multivariable
analysis to control confounding and interaction effect. Any variable whose bivariate test has a p-
value <0.25 will be a candidate for multivariable model along with all variables. Additionally,

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context and previous studies will be also considered to make a variables candidate for
multivariable analysis. Once the variables will be identified, multivariable analysis will be begun
with a model containing all of the selected variables. Efforts will be made to assess whether the
necessary assumptions for the application of multivariable model will be fulfilled. Model
fattiness will be checked with Hosmer and Lemeshow test.
Finally, in order to decide whether or not a variable is significant, the p-value associated with
each parameter will be estimated and variables that have p-value < 0.05 will be considered as
important variables and hence, will be included in the final model. Crude and adjusted Odd
Ratios (COR and AOR) together with their corresponding 95% confidence intervals will be
computed to see the strength of association and interpreted accordingly.

4.11. Ethical consideration

Ethical clearance will be obtained from Institutional Research Ethics Review Board (IRB) of
Arba Minch University college of Medicine and Health Sciences before conducting the study.
After securing ethical clearance from IRB of Arba Minch University, Arba Minch General
Hospital and Jinka General Hospital will be informed about the objective of the study through a
support letter, research coordination office and written permission will be obtained from the
hospital administrations before starting data collection. Oral consent will be obtained from the
study participants. No personal identifiers will be used to collect the data, to maintain the
confidentiality of the information and privacy.

4.12. Benefits and beneficiaries

This study will benefit public health authorities and other stake holders on the need to re-
evaluate legal nature of surgical informed consent. There are increasing medico legal issues on
surgeons that are usually failure of informed consent but not because of failure of procedure
which needs empowerment of surgical informed consent as a legal agreement between surgeon
and patient. Additionally, this paper-work will enrich literatures available on the issue and
reference for other studies and finally the general community will be benefited from effective
programs.

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 4.13. Dissemination of findings

The result of this study will be disseminated to Arba Minch General Hospital, Jinka General
Hospital, Arba Minch University research coordination office and other concerned bodies. After
incorporating comments the finalized document will be send to reputable journals for possible
publication.

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 5. PLAN OF ACTIVITIES

Table 5: Plan of activities for a study on knowledge and attitude towards legal nature of surgical
informed consent and associated factors among adult surgical patients in Arba Minch
General Hospital, Jinka General Hospital, southern Ethiopia

Time period (months) during 2021/2022.

Activities Responsibl

Sept.
Aug.

Nov.

Dec.

Mar.
Feb.
Oct.

Jan.
e bodies
Proposal PI and
development and CI
submission
Proposal defense PI and CI
Ethical clearance IRB and
and finance
Budget approval
Prepare for field PI and
work CI
Recruit and train DC PI and
and supervisors CI
Pre-test the checklist PI and
and adjustment CI
Data collection DC
Data entry and PI and
processing CI
Data analysis and PI and
report write up CI
Submission of final PI and
report CI
Monitoring the PI and CI
overall activities

Key;
PI = Principal Investigator, CI= Co-Investigator, IRB = Institutional Research Ethics Review
Board, DC = Data Collectors

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 6. BUDGET

Table 6: Budget break down for a study on knowledge and attitude towards legal nature of
surgical informed consent and associated factors among adult surgical patients in Arba
Minch General Hospital, southern Ethiopia

1. Personnel costs

S. Activity Responsibility Unit Cost/Birr Duration Total Remar

No cost k
1 Training Investigators 3 339/day 1days 1017

Data collectors 6 339/day 1 days 2034

Pre-test Investigators 3 288/day 2 days 1728

Data collectors 2 288/day 1 days 576

2 Data Data collectors 6 288/day 60days 103,680

collection
3 upervision Investigators 3 339/day 20days 20,340

Driver 1 288/day 20 days 5760

Sub total 135,135

Glove ,sanitizer, mask 6119
2. Transport cost
Activities Multiplier Variable / Total unit Unit Estimate
persons/da in litter cost d Cost
1 Arba Minch to Fuel/km 50 litters 5 27.0 6,750
Jinka
2 Arba Minch to Fuel/km 24 litters 2 27.0 1296
Chencha
Sub totals ------------------------------------------------------------------------------8,046

Grand total Ethiopian birr 149,300

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 7. REFERENCES

1. Wouter K. G. Leclercq • Bram J. Keulers • Marc R. M. Scheltinga • Paul H. M. Spauwen

• Gert-Jan van der Wilt, A Review of Surgical Informed Consent: Past, Present, and
Future. A Quest to Help Patients Make Better Decisions, World J Surg (2010) 34:1406–
1415.
2. Rajesh DR, **Abhishek Singh, *Mukul Chopra, *Gaurav P Singh, *Venkteshan M,
***Anu Bhardwaj, ****Balbir Kaur, *****OP Aggarwal, Patient’s Awareness, Attitude,
Understanding and Attitudes towards Legal Nature of Informed Consent, J Indian Acad
Forensic Med. Jan-March 2013, Vol. 35, No. 1.
3. Joseph Ochieng1*, Charles Ibingira1 , William Buwembo1 , Ian Munabi1 , Haruna
Kiryowa1 , David Kitara2 , Paul Bukuluki3 , Gabriel Nzarubara4,5 and Erisa Mwaka1,
Informed consent practices for surgical care at university teaching hospitals: a case in a
low resource setting, Ochieng et al. BMC Medical Ethics 2014, 15:40.
4. Spatz ES, Bao H, Herrin J, et al. Quality of informed consent documents among US.
hospitals: a cross sectional study. BMJ Open 2020;10:e033299. doi:10.1136/ bmjopen-
2019-033299.
5. Chris McKinnona,b,∗ , Dafydd Loughranc , Roísín Finna , Madeline Coxwell-
Matthewmand , Deva Sanjeeva Jeyaretnaa,b , Adam P. Williamsa,e, Surgical consent
practice in the UK following the Montgomery ruling: A national cross-sectional
questionnaire study, International Journal of Surgery 55 (2018) 66–72.
6. F. Jahan,1 R. Roshan,2 K. Nanji,3 U. Sajwani,4 S. Warsani5 and S. Jaffer6, Factors
affecting the process of obtaining informed consent to surgery among patients and
relatives in a developing country: results from Pakistan, EMHJ • Vol. 20 No. 9 •
2014.
7. SYLVESTER CHIDI CHIMA, AN INVESTIGATION OF INFORMED CONSENT IN
CLINICAL PRACTICE IN SOUTH AFRICA, February 2018.
8. Saadoun Faris Al Azmi1 , Bashair Abdullah Almutairi1 , Ahmad Mousa Al Jafar2, A
COMPARATIVE STUDY OF PATIENTS’ ATTITUDE TOWARDS INFORMED
CONSENT IN PUBLIC AND PRIVATE HOSPITALS, Z.U.M.J.Vol. 24; No.3
May .;2018.

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 9. Saadoun Faris Alazmi, Patients’ Attitude of Informed Consent for Surgical Operations in
Kuwait, Journal of High Institute of Public Health 2018;48(2):92-96.
10. Saraj Gurung, Ritika Sapkota, AWARENESS REGARDING PATIENT RIGHTS
AMONG HOSPITALIZED PATIENTS IN A HOSPITAL OF RUPANDEHI, Journal of
Universal College of Medical Sciences (2019) Vol.07 No.01 Issue 19.
11. Yasmine S. Galal*, Knowledge, practice and attitude towards the informed consent
process among physicians and patients in General Surgical Departments at Cairo
University Hospitals, The Egyptian Journal of Community Medicine Vol. 34 No. 2 April
2016.
12. Samar A. Ahmed1 , Sahar Dewedar2, OBSTETRIC PATIENT ATTITUDES OF
WRITTEN CONSENT FORMS: A MIDDLE EAST HOSPITAL STUDY, Vol. 3. No.1.
January, 2011, Part II .
13. Abubakar Idris Sulaiman, Rabiu Ayyuba, Ibrahim Garba Diggol, Iman Usman Haruna,
Knowledge, attitude and attitude of patients towards informed consent in obstetric
surgical procedures at Aminu Kano Teaching Hospital, Nigerian Journal of Basic and
Clinical Sciences / Jan-Jun 2015 / Vol 12 | Number 1.
14. Nsaful J 1 , Umuago R 2 , Dedey F 1 , Adjei F 2 , Clegg-Lamptey JNA 1, AN AUDIT
OF THE INFORMED CONSENT PROCESS AT THE SURGICAL DEPARTMENT OF
KORLE BU TEACHING HOSPITAL, ACCRA, Postgraduate Medical Journal of Ghana
March 2018 Vol. 7 No.1.
15. Belete Fenta Kebede (  [email protected] ) Jimma Institute of Health Sciences:
Jimma University Tsegaw Biazin Tesfaye Jimma Institute of Health Sciences: Jimma
University Aynalem Yetwale Hiwot Jimma Institute of Health Sciences: Jimma
University, Knowledge of Surgical Informed Consent and Associated Factors among
Patients Undergone Obstetric and Gynecologic Surgery at Jimma Medical Center, Jimma,
Oromia Region, Ethiopia, 2020. An Institutional Based Cross-Sectional Study, DOI:
https://doi.org/10.21203/rs.3.rs-607203/v1.
16. Wuletaw Chane 1 Bethlehem Birhanu2 Yisihak Suga1, Quality of Informed Consent
Among Patients Who Underwent Major Surgical Procedure in a Tertiary Care Hospital,
Addis Ababa, Ethiopia, Open Access Surgery 2020:13.

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 17. Nurhusien Nuru Yesuf university of gondar [email protected]
Author ORCiD: https://orcid.org/0000-0002-5431-8212 Anteneh Yehuala Belay
University of Gondar Senetsehuf Melkamu Jemberie University of Gondar Henok
Biresaw Netsere Bahir Dar University, DOI: 10.21203/rs.2.13568/v1
18. Befekadu Lemmu1 Abebe Megersa2 Engida Abebe1 Kirubel Abebe 1, Knowledge and
Attitude of Ethiopian Surgical Patients to Informed Consent Practice for Surgical
Procedures, Open Access Surgery 2020:13 65–70.

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 8. ANNEXES

8.1. Annex I: Information sheet and informed consent form

My name is Dr Tigabu Daniel. I am working as a principal investigator for the study being
conducted in this health facility. I kindly request you to lend me your attention to explain you
about the study and study participants in general.

Title: Knowledge and attitude towards legal nature of surgical informed consent and associated
factors among adult surgical patients in Arba Minch General Hospital and Jinka General
Hospital, southern Ethiopia, 2021.

Name of the organization: Arba Minch University, Ethiopia

Name of the sponsor: Arba Minch University, Ethiopia

Introduction: This information sheet and consent form is prepared by the investigators whose
aim is to assess knowledge and attitude towards legal nature of surgical informed consent and
associated factors among adult surgical patients in Arba Minch General Hospital and Jinka
General Hospital, southern Ethiopia, 2021

Purpose: The main purpose of the research is to fill the information gap and provide pertinent
evidence for decision makers and implementers on knowledge and attitude towards legal nature
of surgical informed consent and associated factors among adult surgical patients in Arba Minch
General Hospital and Jinka General Hospital, southern Ethiopia, 2021

Procedure and duration: The data collectors will collect the necessary information from study
participants using structured interviewer administered questioner to have pertinent data that is
helpful for this study. The duration of data collection will be 90 days from December 01, 2021 to
February 28, 2022.

Risk and/or Discomfort: Participating in this study does not have any risk or harm on study
participants.

Benefits: If you participate in this research, you may not get direct benefit. But the correct
information that you provide us in combination with information we obtain from other sources

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have great importance in designing and implementing effective surgical informed consent by fill
the information gap of decision makers and implementers.

Incentives: You will not be provided any incentives to take part in this study.

Confidentiality and Anonymity: The information acquired from patient will be confidential.
There will be no information that will identify in particular. The findings of the study will be
general for the study population and will not reflect anything particularly of individual persons.
The checklist will be coded to exclude showing names and other personal identifiers’. No
reference will be made in oral or written reports that could link participants to the study.

Right to Refuse or Withdraw: Giving permission for this study is fully voluntary. You have the
right to permit or not for this study. If you decide to permit the study, you have the right to
terminate the study at any time if you consider something related to the study is wrong.

Contact address: If there are any questions or enquires any time about the study or procedures,
please contact in this address.

Principal investigator: Dr Tigabu Daniel, email: [email protected]

Mobile No: +251964041160/913452078.

IRB; Office phone: ---------------

P.O. Box 21, Arba Minch University, Ethiopia

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Declaration of informed voluntary consent:

I have read the participant information sheet. I have clearly understood the purpose of the
research, the procedures, the risks and benefits, issues of confidentiality, the right of participation
and the contact address for any queries. I have been given the opportunity to ask any questions
for things that may have been unclear. I was informed that I can terminate the study at any time.
Therefore, I declare my voluntary consent to participate in this study.

Signature of the participant _____________________ Date_______________________

Signature of Data collector_______________________ Date_______________________

Thank you for your cooperation!

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 8.2. Annex II: Data Collection Tool

Name of the facility: ______________ Format code (coded by the data collectors): –––––––––

Section I: Socio-demographic characteristics of the study participants

S. No Socio-demographic Coding categories Chose Remark

characteristics code

101 Sex ----------------

102 Age ----------------(Years)

103 Residence 1. Urban

2. Rural

104 Ethnicity 1. Gamo

2. Gofa
3. Wolayita
4. Amhara
5. Oromo
6. Other(specify)_____

105 Religion 1. Orthodox

2. Protestant
3. Muslim
4. Catholic
5. Other(Specify)________

106 Marital status 1. Single

2. Married
3. Widowed
4. Divorced
5. Separated
1. Unable to read & write
107 Educational status 2. Able to read & write but no
formal education
3. Grade 1-4
4. Grade 4-8
5. Grade 9-12
6. Above grade 12

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Section II: Questions on Patient knowledge

SN Items Yes No.

1. Did you know legal ground of signing consent
2. Did you know your extent of right on decision of the
surgery even to reject after signing consent?
3. Did you Know the surgeon?
4. Did you Know Reason for operation?
5. Have you Signed before?
6. Did you read the consent paper?
7. Did you Know time surgery going to take?
8. Did you know Anesthesia risks?
9. Did you Know Risks and complication of surgery?
10. Did you Know Postop care?
11. Did you know what to eat and not to eat post-surgery?

12. Did you Know Cost of your surgery?

13. Did you know when to start post-operative feeding?
14. Did you know when you Resume to work?
15. Did you know surgeon role on your disease?

Section III: Questions about Patients attitude

SN Variables YES NO Don’t know

1. Did you think consent remove Compensation?
2. Did you think it’s a Protection for hospital and
surgeon?
3. Did you think you could change your mind after
you signed?
4. Did you allow your Relatives can sign?
5. With Alon
Did you decide alone or with surgeon?
surgeon e

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 DECLARATION FORM

Assurance of Investigators

We, the undersigned, declare that this proposal is our own original work and it has not been

presented in other universities, colleges or other institutions for similar or other purposes. We

agree to accept responsibility for the scientific ethical and technical conduct of the research

project and for the provision of required progress reports as per terms and conditions of the

College of Medicine and Health Science in effect at the time of grant is forwarded as the result of

this application.

Name of the Investigators Signature Date

Dr. Tigabu Daniel (General Surgeon, Assi/Professor) __________ ____________

_____________ ____________
1. Menaye Yihune (MPH, Assi/professor)
2. Dr. Yonas Abera (General Surgeon, Assi/Prof) ____________ ____________

3. Firdawek Getahun (MPH, Assistant Professor) _____________ ____________

Signature Date

1. Department Head ______________ ______________

2. Head of college RCO ______________ ______________

3. Research and community service directorate ______________ ______________

4. Chief executive Director ______________ ______________

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