GULU UNIVERSITY

FACULTY OF MEDICINE
VENOUS THROMBOEMBOLISM RISK STRATIFICATION AND THROMBO-
PROPHYLAXIS OF PATIENTS HOSPITALISED IN GULU UNIVERSITY
TEACHING HOSPITALS

RESEARCH TEAM

NAME REGISTRATION NUMBER

OTILE CLEOPAS EDWIN 19/U/0007/GUM
MUKHWANA MEDI 19/U/0023/GUM
BAKYAYITA STEVEN 19/U/0041/GUM
LASALANDA CHRISTOPHER 19/U/0028/GUM

SUPERVISOR

DR. FELIX BONGOMIN, M.Med, MSc., MB ChB, FECMM

A RESEARCH PROPOSAL FOR A DISSERTATION TO BE SUBMITTED IN

PARTIAL FULFILMENT OF THE REQUIREMENT FOR THE AWARD OF THE
DEGREE OF BACHELOR OF MEDICINE AND BACHELOR OF SURGERY OF
GULU UNIVERSITY

SEPTEMBER 2022
DECLARATION
We the members of this group declare to the best of our knowledge that the information
contained in this research proposal entitled “ VENOUS THROMBOEMBOLISM RISK
STRATIFICATION AND THROMBO-PROPHYLAXIS OF PATIENTS HOSPITALISED
IN GULU UNIVERSITY TEACHING HOSPITALS” is original and we have not copied
from any other source except where due reference or acknowledgement is made in the text.

Name Reg number Signature Date

1. Otile Cleopas Edwin ………………… ……………. ……/……/2022
2. Mukhwana Medi ………………… ……………. ……/……/2022
3. Bakyayita Steven ………………… ……………. ……/……/2022
4. Lasalanda Christopher ………………… ……………. ……/……/2022

APPROVAL
Confirm that this research proposal has been written under my guidance and supervision

SUPERVISOR

Dr. Felix Bongomin ……………………… ……/……/2022

(MB ChB, M.Sc., M.Med (Int.Med), FECMM)
ABBREVIATIONS AND ACRONYMS
OPERATIONAL DEFINITIONS
1.8 DEFINITION OF TERMS.

Venous thromboembolism: is a condition referring to blood clots in the veins.

Risk stratification: it’s a process of assigning all patients in a practice a particular risk
status.

Prophylaxis: it’s an action or treatment taken by an individual to prevent a disease

Missed opportunity in thromboprophylaxis: A patient with moderate or high-risk scores

not initiated on chemoprophylaxis
TABLE OF CONTENTS

Contents
ABSTRACT...............................................................................................................................7
Background:............................................................................................................................7
Objective:................................................................................................................................7
Methods:.................................................................................................................................7
CHAPTER ONE: INTRODUCTION........................................................................................9
1.1 BACKGROUND..............................................................................................................9
1.2 PROBLEM STATEMENT.............................................................................................10
1.3 JUSTIFICATION...........................................................................................................11
1.4 RESEARCH QUESTIONS............................................................................................11
1.5 RESEARCH OBJECTIVES...........................................................................................11
1.6 THEORETICAL FRAMEWORK.................................................................................12
1.7 Scope of study.................................................................................................................13
1.7.1 Geographical scope..................................................................................................13
1.7.2 Time scope................................................................................................................14
1.7.3 Contextual scope......................................................................................................14
CHAPTER 2: LITERATURE REVIEW.................................................................................15
2.1 Introduction.....................................................................................................................15
2.2 Prevalence.......................................................................................................................16
CHAPTER THREE: METHODS............................................................................................20
3.1 Study design....................................................................................................................20
3.2 Study Setting...................................................................................................................20
3.3 Target Population............................................................................................................20
3.4 Accessible population.....................................................................................................20
3.5 Study Population.............................................................................................................20
3.6 Eligibility Criteria...........................................................................................................20
3.6.1 Inclusive Criteria......................................................................................................20
3.6.2 Exclusion Criteria.....................................................................................................21
3.7 Sample size Estimation...................................................................................................21
3.8 Sampling Procedure........................................................................................................21
3.9 Study variables................................................................................................................21
3.9.1 Dependent variables.................................................................................................21
3.9.2 Independent variables...............................................................................................22
3.10 Data collection procedure.............................................................................................22
3.12 Data analysis.................................................................................................................24
 3.13 Quality Control.............................................................................................................24
3.14 Ethical considerations...................................................................................................24
3.15 Dissemination...............................................................................................................25
3.16 Limitations....................................................................................................................25
APPENDICES..........................................................................................................................26
References.............................................................................................................................26
APPENDIX II: INFORMED CONSENT (ENGLISH)........................................................29
APPENDIX III: INFORMED CONSENT (ACHOLI VERSION)......................................32
APPENDIX IV: STUDY TIMELINE..................................................................................34
APPENDIX V: BUDGET....................................................................................................35
DATA COLLECTION TOOL..............................................................................................36
Caprini risk assessment model for venous thromboembolism......................36
REVISED GENEVA RISK ASSESSMENT MODEL FOR VENOUS
THROMBOEMBOLISM..................................................................................................37
Recommended interveon risk of VTE......................................................................37
APPENDIX VII : MITIGATION PLAN..........................................................................38
ABSTRACT
Background:

Venous thromboembolism (VTE) is a preventable and potentially life-threatening disease that

frequently complicates the admission of hospitalized patients.
Risk factors for developing VTE include prolonged immobility during and after surgery,
major trauma, malignancy, inherited thrombophilia’s, old age, and obesity.
VTE can be prevented through the provision of appropriate non-pharmacological and/or
pharmacological prophylaxis following individualized patient screening with a structured risk
assessment model (RAM) or through clinical evaluation.
Objective:

To assess VTE risk categories and the magnitude of missed opportunities for
thromboprophylaxis of patients hospitalized in the gynecology, medical and surgical wards of
GUTHs
Methods:

This will be a hospital-based, descriptive, cross-sectional study with a quantitative, quality

improvement approach. A sample size of 422 participants (211 in GRRH and 211 in LH)
among patients admitted to surgical, Medical and Gynecological wards between January and
May 2023; Descriptive statistics will be used to summarize the data into percentages and
proportions: The data will be analyzed with Statistical Package for Social Scientists (SPSS)
where risk-assessment data recorded as per Caprini RAM, and Revised Geneva Score will be
stratified as very low, low, moderate, and high risk; Missed opportunities for VTE
thromboprophylaxis will be expressed as
Number of patients withmoderate∨highrisk scores whodid not receivethromboprophylaxis
¿ x 100
Total number of elegible participants enrolled

Bland and Altman methods will be used to assess for agreement between numerical scores of
Caprini RAM and Revised Geneva Score meanwhile McNemar’s test will be used to
compare risk strata in the two RAMs. Cohen’s Kappa will be used to compare inter-observer
agreement for both RAMs.

Utility:
The recommendations from this study will help reduce on the general burden of death,
disability and complications and ensure patients recover well following hospitalization in
gynecology, medical, and surgical wards at GRRH and LH.

The results of this study will provide basis for other researchers: Once the risk factors
associated with VTE in hospitalized patients in GUTHs are properly established, effective
prophylaxis can be used to improve recovery of such patients even in other parts of the world.
CHAPTER ONE: INTRODUCTION
1.1 BACKGROUND

Venous thromboembolism (VTE) is a preventable and potentially life-threatening disease that

frequently complicates the admission of hospitalized patients. VTE can manifest as deep-vein
thrombosis (DVT) and/or pulmonary embolism (PE), which are both associated with
increased morbidity and mortality (Wehmeyer et al., 2022; Zhou et al., 2018).

Although the exact incidence of VTE is unknown, an estimated 1 million people in the
United States are affected each year (Bartholomew, 2017). Findings from multinational
ENDORSE found that a greater proportion of medical inpatients were at risk for VTE
(62.3%) compared with surgical patients (43.8%) (Wehmeyer et al., 2022; Zhou et al., 2018).
Orthopedic patients particularly are at higher risk of developing VTE. The absolute risk of
VTE is estimated 0.6-2.2 per 1000 deliveries(Tsikouras et al., 2017).Pulmonary embolism
(PE) is a potentially lethal sequela of venous thromboembolism (VTE) with a reported 30-
day mortality rate varying between 14% and 44% (Esiéné et al., 2019), approximately 10% of
inpatient hospital deaths (Ismail et al., 2022), 12% of deaths annually in Europe(Johnson &
Kumar, 2015). Persons aged ≥65years account for over 60% of VTE with higher mortality
and VTE related morbidities like anticoagulation related bleeding and post thrombotic
syndrome (Tritschler & Aujesky, 2017). Risk of developing DVT after hip fracture surgery
was 50%, in the absence of thromboprophylaxis (Johnson & Kumar, 2015).

Risk factors for developing VTE include prolonged immobility during and after surgery,
major trauma, malignancy, inherited thrombophilia’s, old age, and obesity (Johnson &
Kumar, 2015). VTE is a common cardiovascular disease associated with significant
morbidity ranging from painful leg swelling, chest pain, shortness of breath, and even death.
Long-term complications include recurrent VTE, post pulmonary embolism syndrome,
chronic thromboembolic pulmonary hypertension after PE (0.1%-3.8% incidence). , and post
thrombotic syndrome (PTS) after DVT (20%-50% incidence)(Bartholomew, 2017; Cronin et
al., 2019).

VTE can be prevented through the provision of appropriate non-pharmacological and/or

pharmacological prophylaxis following individualized patient screening with a structured risk
assessment model (RAM) or through clinical evaluation. Low-molecular-weight heparin
(LMWH) and unfractionated heparin have proved to be safe, effective, and cost-effective
agents for VTE prophylaxis in medical inpatients. Mechanical thromboprophylaxis, including
intermittent pneumatic compression (IPC) and graduated compression stockings (GCSs), are
advocated for use in patients who have contraindications to anticoagulants (Johnson &
Kumar, 2015; Wehmeyer et al., 2022).

The barriers to prophylaxis use include natural resistance to change, fear of side effects, lack
of effective institutional policies and even lack of knowledge regarding the guidelines or
difficulties in remembering the recommendations (Vono Alckmin et al., 2013). Hospitalized
patients are often multi-morbid and thus are at an increased risk of developing VTEs,
however, they are no studies in Uganda particularly in Gulu that have been conducted to
assess risk factors and VTE thromboprophylaxis. Therefore, this study aims to assess the risk
stratification and prophylaxis of venous thromboembolism in hospitalized medical, surgical,
and gynecological patients in Gulu University Teaching Hospitals (GUTHs), that is, Gulu
Regional Referral Hospital (GRRH) and St. Mary’s Hospital – Lacor (LH).

1.2 PROBLEM STATEMENT.

VTE is regarded as the most preventable cause of inpatient death in hospital settings
globally(Wehmeyer et al., 2022). A thrombus or blood clot that originates in the lower limbs
or pelvic circulation, termed DVT, may propagate to the lungs and cause blockage of a blood
vessel. The resulting condition, PE, is potentially life threatening.(Johnson & Kumar, 2015)
According to (Barco et al., 2021) prevalence of PE was (40.6%) Europeans, (31.7%)
American, (10.6%)Eastern Mediterranean, 13 (10.6%) Western Pacific, 3 (2.4%) Southeast
Asian, and (1.6%) African. according to population income, (49.1%) were high income, 42
(36.2%) upper-middle income, (12.1%) lower-middle income, and (2.6%) low income and
death attributed to PE was 0.46%. In Uganda, the prevalence of DVT among HIV positive
patients was found was to be 9.1%(Vululi et al., 2018). Risk factors for developing VTE
include prolonged immobility during and after surgery, major trauma, malignancy, inherited
thrombophilia’s, old age, and obesity.(Johnson & Kumar, 2015). The problem of venous
thromboembolism can be prevented by administering low-molecular-weight heparin
(LMWH) and unfractionated heparin which have proved to be safe, effective, and cost-
effective agents for VTE prophylaxis in medical inpatients. Mechanical thromboprophylaxis,
including intermittent pneumatic compression (IPC) and graduated compression stockings
(GCSs), are advocated for use in patients who have contraindications to anticoagulants
(Johnson & Kumar, 2015; Wehmeyer et al., 2022). Therefore, this study seeks to assess the
risk stratification and prophylaxis of venous thromboembolism among medical, surgical, and
gynecological hospitalized patients in Gulu University Teaching Hospitals (GUTHs).

1.3 JUSTIFICATION

Since VTE is among the preventable causes of death in hospitalized patients yet is less
diagnosed and undocumented in Gulu university teaching hospitals and no report and
research about this study has been conducted in Gulu regional referral and Lacor this study is
aimed at addressing this phenomenon. The study will benefit mainly hospitalized patients in
gynecology, medical, and surgical wards at GRRH and LH. This will reduce on the general
burden of death, disability and complications and ensure patients recover well following
hospitalization. The results of this study once successful will provide basis for other
researchers who would like to carry out a similar study in the same region and other hospitals
in Uganda. Once the risk factors associated with VTE in hospitalized patients in Gulu is
properly established, effective prophylaxis be used to improve recovery of such patients even
in other parts of the world, other researchers can base on the most common factors from the
results of this study and carry out other detailed studies.

1.4 RESEARCH QUESTIONS

1. What are the VTE risk strata of patients hospitalized in the gynecology, medical and
surgical wards of GUTHs ?
2. What is the magnitude of missed opportunities for VTE thromboprophylaxis of
patients hospitalized in the gynecology, medical and surgical wards of GUTHs ?
3. What is level of diagnostic agreement between the Caprini and the simplified revised
Geneva VTE risk assessment models ?

1.5 RESEARCH OBJECTIVES

1.5.1 General objectives

To assess VTE risk categories and the magnitude of missed opportunities for
thromboprophylaxis of patients hospitalized in the gynecology, medical and surgical wards of
GUTHs.

1.5.2 Specific objectives

1. To assess VTE risk of patients hospitalized in the gynecology, medical and surgical
wards of GUTHs
2. To determine the magnitude of missed opportunities for VTE thromboprophylaxis of
patients hospitalized in the gynecology, medical and surgical wards of GUTHs
3. To evaluate the level of diagnostic agreement between the Caprini and the simplified
revised Geneva VTE risk assessment models

1.6 THEORETICAL FRAMEWORK

FIGURE 1: THEORETICAL FRAMEWORK

Theoretical framework narrative

Endothelial injury, Venous Stasis, and hypercoagulability in a patient are strong association
factors with venous thromboembolism in the following ways,

Endothelial injury

Damage to the endothelial wall of a vessel alters the dynamics of blood flow. Endothelial
disturbance can result from insults such as smoking, chronically elevated blood pressure, and
atherosclerotic disease secondary to hyperlipidemia. When an insult to the wall occurs, loss
of protective molecules and expression of adhesive molecules, procoagulants and mitogenic
factors occurs, leading to development of thrombosis.

Venous Stasis

Venous stasis is more likely to occur in patients with atrial fibrillation, valvular heart disease:
prolonged immobility such as bedridden patients or prolonged travel, surgery, and trauma.
Exposure to cell proteins triggers anticoagulant pathways on the surface of endothelial cells.
The thinking is that as blood flow slows through vascular beds, flow reduces, and the natural
anticoagulant properties from interaction with surface proteins are affected, resulting in
thrombi production.

Hypercoagulability

Hypercoagulability can occur due to a variety of clinical statuses such as pregnancy, use of
oral contraceptive medications, cancer, chemotherapy drugs, and inherited thrombophilias.
Thrombophilias can include disease states such as protein C deficiency, protein S deficiency,
antithrombin deficiency, hyperhomocysteinemia and homocystinuria, and antiphospholipid
syndrome

All these factors eventually lead to VTE

VTE can manifest as deep-vein thrombosis (DVT) and/or pulmonary embolism (PE),
which are both associated with increased morbidity and mortality
1.7 Scope of study

1.7.1 Geographical scope

This study will be carried out in Gulu district, Gulu University Teaching Hospitals (Gulu
Regional Referral Hospital and St Mary’s hospital Lacor)

1.7.2 Time scope

This study will occur between 20th/October /2022 to 30th/May/2023. Because the researcher
believes that within this time, they will have collected all the data and analyzed the results of
the study.

1.7.3 Contextual scope

This study will focus on mainly fully consented hospitalized patients, both male and female
of all ages, admitted to GRRH and LH during the period of the study.
 CHAPTER TWO: LITERATURE REVIEW

CHAPTER 2: LITERATURE REVIEW

2.1 Introduction

Venous thromboembolism (VTE) refers to a pathophysiological state of the

haemocoagubility pathway where blood clots form in veins. It is a multifactorial disease
provoked by clinical risk factors and acquired or inherited predispositions to thrombosis. It is
seen as a continuum of deep vein thrombosis (DVT), thrombus in transit, acute pulmonary
embolism (PE), and chronic sequela. Current treatment strategies mainly focus on prevention
and treatment of acute events and largely neglect the sequelae of thrombosis: postthrombotic
syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH). (Winter et
al., 2017) associated with high morbidity and mortality. Pulmonary embolism poses one of
the most challenging diagnoses in medicine. Resolving these diagnostic difficulties is more
crucial in emergency departments where fast and accurate decisions are needed for a life-
saving purpose(Esiéné et al., 2019). According to (Ismail et al., 2022), venous
thromboembolism is a complication among admitted medical and surgical patients.
International guidelines recommend patients are assessed upon admission and appropriate
thromboprophylaxis should be initiated. However, studies have shown that
thromboprophylaxis for patients at risk of venous thromboembolism is underutilized. A
thrombus or blood clot that originates in the lower limbs or pelvic circulation, termed deep
vein thrombosis (DVT), may propagate to the lungs and cause blockage of a blood vessel.
Resulting into a condition termed as, pulmonary embolism (PE) which is potentially life
threatening.(Johnson & Kumar, 2015). According to(Vono Alckmin et al., 2013) Although
venous thromboembolism (VTE) is the main preventable cause of death in hospitalised
patients, VTE prophylaxis is still not routinely administered in most hospitals . There are
numerous barriers to prophylaxis use, especially the natural resistance to change, fear of side
effects, lack of effective institutional policies, and as well lack of knowledge regarding the
guidelines or difficulties in remembering the recommendations.
2.2 Prevalence

Despite the use of routine prophylaxis, VTE remains a significant risk, occurring in almost
3% of patients undergoing orthopaedic surgery.(Johnson & Kumar, 2015)

A total of 42.4% of the medical patients are at a risk for VTE. This rate is similar to the value
found in the ENDORSE study, which evaluated patients admitted from 32 countries and
found that 41.5% of the hospitalised medical patients were at risk for VTE. According to the
Brazilian Guidelines,42.4% of inpatients are considered to be at risk for VTE. Surgical
inpatients are at particular risk of developing VTE. Data from eight prospective studies
estimate the total rate of DVT after hip fracture surgery to be 50%, in the absence of
thromboprophylaxis.(Johnson & Kumar, 2015). DVT was shown in nearly 10% of HIV
patients attending an out-patient clinic in an urban setting in Uganda. Risk factors included
protease inhibitors in their ART regimen, prolonged immobility, and low CD4 count (< 200
cells/µl). (Vululi et al., 2018)

Pulmonary embolism is associated with approximately 10% of inpatient hospital

deaths(Ismail et al., 2022). The mortality rate of PE in medical patients varies in the current
review between 40% and 69.5%, whereas the case-fatality rate after surgery was 60% in a
single study. These values are higher than those reported in studies in USA. (Danwang et al.,
2017). The risk of VTE is increased after surgery, in the peripartum period, in women using
oral (Danwang et al., 2017). Contraception, in active cancer patients, and in conditions
leading to prolonged immobilization. (Danwang et al., 2017).

Epidemiologic studies have shown that between one quarter and one half of all clinically
recognized symptomatic VTEs occur in individuals who are neither hospitalized nor
recovering from a major illness. (Anderson & Spencer, 2003)

A research carried out in Tanzania in 2021 showed that Orthopaedic patients particularly
were at higher risk of developing VTE.(Ismail et al., 2022)

During a research in South Africa in 2020 ,findings from the multinational ENDORSE
(Epidemiologic International Day for the Evaluation of Patients at Risk for Venous
Thromboembolism in the Acute Hospital Care Setting) study revealed that more than half of
all hospitalised patients were at risk for VTE, and 41.5% of these were medical inpatients. A
multinational, cross-sectional survey conducted across five countries in sub-Saharan Africa
found that a greater proportion of medical inpatients were at risk for VTE (62.3%) compared
with surgical patients (43.8%). (Wehmeyer et al., 2022)

In a research in the UK in 2014, Risk factors for VTE included prolonged immobility during
and after surgery, major trauma, malignancy, inherited thrombophilias, old age, and obesity.
Surgical inpatients were at particular risk of developing VTE. (Johnson & Kumar, 2015)

During a research conducted in Brazil in 2013,the risk factors found most often were as
follows: age 55 years or older (26.6%), infection (11.3%), cancer (11.0%), tobacco use
(10.0%), heart failure (functional class III or IV; 7.3%), severe respiratory disease (6.0%),
and nephrotic syndrome (5.3%). (Winter et al., 2017)

In the UK in 2003, in a review of 1231 consecutive patients treated for VTE, 96% had ≥1
recognized risk factor. Also, there was convincing evidence that risk increased in proportion
to the number of predisposing factors. Only one quarter to one half of VTEs were diagnosed
in patients who were or had been recently hospitalized. ...(Anderson & Spencer, 2003)

VTE is a common disease (approximately 700 per 100000) that is associated with significant
risk of recurrence, chronic complications and substantial mortality with reported death rates
of up to 40% at 10years. While PTS occurs in up to 50% of patients after symptomatic DVT,
only a small and poorly defined number of patients are diagnosed with CTEPH after PE.
(Vululi et al., 2018)
In Europe, venous thromboembolism (VTE) is the third most common cause of vascular
death after myocardial infarction and stroke (Johnson & Kumar, 2015)

In Uganda, like in many other countries in the East African region, DVT is not prioritized as
a major problem among postoperative patients and the general sense is that the rate of
postoperative DVT is not high. Prophylaxis against DVT is therefore not common practice.
There is paucity of data about the prevalence of this potentially major cause of morbidity and
mortality in Uganda. (Muleledhu et al., 2013)
Prophylaxis of VTE

It involves general, mechanical and pharmacological measures having assessed the patient
risk using clinical probability scores and contraindications
General measures include early ambulation, leg elevation and exercise and maintenance of
hydration. In medical inpatients at high bleeding risk who require prophylaxis, mechanical
prophylaxis is preferred over blood-thinning medications. In medical inpatients at high VTE
risk but acceptable bleeding risk, blood thinning medication is preferred over mechanical
prophylaxis, however, in medical inpatients, when medication is used to prevent VTE, low-
molecular-weight heparin is preferred over unfractionated heparin because it is only
administered once a day and has fewer complications (Tseng, 2018)

Management
Accurate diagnosis of VTE is important due to the morbidity and mortality associated with
missed diagnoses and the potential side effects, patient inconvenience, and resource
implications of anticoagulant treatment given for VTE. These guidelines are intended to
support patients, clinicians, and health care professionals in VTE diagnosis. A D-dimer test is
the best first step to check for VTE in patients with low pre-test probability; if results are
negative, no further testing is required.
Prompt recognition and treatment are potentially lifesaving, external cardiac massage may be
successful in the moribund patient by dislodging and breaking up a large central embolus.
(Goddard & Turner, 2014)
Use thrombolytic therapy to treat patients with pulmonary embolism who are
hemodynamically compromised, use anticoagulant therapy to treat patients in secondary
prevention, use indefinite anticoagulation therapy to treat patients with recurring VTE (ASH
Recommendations for Treatment of Deep Vein Thrombosis and Pulmonary Embolism, 2020)
Conclusion:
The prevalence of VTE and associated mortality are high following surgery, and in pregnant
and postpartum women in Africa and at least one-quarter of patients who are at risk for VTE
in Africa are not receiving prophylaxis, with results generated from studies with a small
sample size (Danwang et al., 2017). Appearing as a continuum of deep vein thrombosis
(DVT), thrombus in transit, acute pulmonary embolism (PE), and chronic sequela. (Winter et
al., 2017) and according to (Muleledhu et al., 2013) Prospective study conducted at mulago
hospital on general surgical ward, DVT is not priotised as a major problem and thus
prophylactic medication for DVT isn’t a common practice. According to (Danwang et al.,
2017) the mortality and case fatality rates that have been reported in Africa are higher
compared to developed countries that have utilized the risk assessment tools and appropriate
prophylaxes against VTE, In Uganda no documented studies have been published about the
risk assessment and thromboprophylaxis against VTE, exposing an enlarged gap which
requires much study to improve the living.
CHAPTER THREE: METHODS
3.1 Study design

This will be hospital-based, descriptive, cross-sectional study with a quantitative, quality

improvement approach. The study will be conducted at GRRH and LH between January and
May 2023. This design will be optimal to collect a snapshot of data to allow the
determination of VTE risks and adequacy of thromboprophylaxis among patients admitted to
surgical, Medical and Gynecological.

3.2 Study Setting

The study will be carried out in the two Gulu university medical teaching hospitals that is St.
Mary’s hospital Lacor (LH) and Gulu Regional Referral Hospital (GRRH). The average
number of inpatients in the medical ward, Surgical ward, and Gynecological ward in both
hospitals averages 200 per day. All the three wards run from Monday to Sunday. The
inpatients are mainly from the Northern region of Uganda especially Gulu and neighboring
districts.

3.3 Target Population.

Hospitalized patients in Uganda.

3.4 Accessible population

Patients hospitalized in the gynecology, medical and surgical wards of GUTHs.

3.5 Study Population

Patients hospitalized in the gynecology, medical and surgical wards of GUTHs who will meet
the eligibility criteria

3.6 Eligibility Criteria

3.6.1 Inclusive Criteria

1. Aged 18 years or older

2. Able and willing to provide written informed consent
 3. Patients hospitalized in the gynecology, medical and surgical wards of GUTHs

3.6.2 Exclusion Criteria

1. Those with contraindications to pharmacological thromboprophylaxis

2. The patients with pre-established DVT or PE upon admission
3. Patients admitted to high-risk isolation units.

3.7 Sample size Estimation

The sample size will be estimated using the Kish Leslie formula (1965)

Z 2 P ( 1−P )
N=
d²

Where Z= score for 95% confidence interval = 1.96

P= Proportion of patients evaluated for VTE risks, a modest proportion of 50% (0.5) has been
chosen since no previous studies in the selected study sites.

d= Precision/acceptable error (5%) = 0.05

2
1.96 x 0.5 x (1.0−0.5 )
N= 2
(0.05)

= 384.16; approximately 384 Participants

Factoring in a non-response rate on 10% gives.

N= 384 + (384×0.1)

N= 422.4; Approximately 422 participants (211 each from LH and GRRH)

3.8 Sampling Procedure

This will be achieved through the randomization of a list of medical, surgical and
gynecological folder numbers obtained from each facility’s inpatients records.
3.9 Study variables

3.9.1 Dependent variables

The dependent variable in this study will be VTE risk strata.

3.9.2 Independent variables

The independent variables in this study will be socio-demographic factors like age and sex.
Obstetric factors like pregnancy or postpartum, gynecological factors like history of
unexplained or recurrent spontaneous abortion, oral contraceptives or hormone replacement,
Comorbidities like serious lung disease, abnormal pulmonary function, acute myocardial
infarction, varicose veins, swollen legs, sepsis, congestive heart failure, history of
inflammatory bowel disease, others like medical patients at bed rest, malignancy,
laparoscopic surgery, and arthroscopic surgery.

3.10 Data collection procedure

A data collection form is to be designed and data filled in from the patients’ admission
details, patients’ demographics, inpatient medical files, documented individual patients’ risk
factors, assessment based on the CAPRINI Risk Assessment Model (RAM) and Revised
Geneva Score plus the pharmacological VTE prophylaxis offered.

Caprini score VTE risk category

0 Very low risk

1-2 Low risk

3-4 Moderate risk

≥5 High risk
 Revised Geneva Score

The revised score uses 8 parameters, but does not include figures which require an arterial
blood gas sample to be performed:

Variable Score
Age 65 years or over 1
Previous DVT or PE 3
Surgery or fracture within 1 month 2
Active malignant condition 2
Unilateral lower limb pain 3
Haemoptysis 2
Heart rate 75 to 94 beats per minute 3
Heart rate 95 or more beats per minute 5
Pain on deep palpation of lower limb and unilateral oedema 4

The score obtained relates to probability of PE:

 0 - 3 points indicates low probability (8%)

 4 - 10 points indicates intermediate probability (28%)

 11 points or more indicates high probability (74%)

The probabilities derived from the scoring systems can be used to determine the need for,
and nature of, further investigations such as D-dimer, ventilation/perfusion scanning and
CT pulmonary angiography to confirm or refute the diagnosis of PE

3.11 Data management

The data will be fed into Microsoft Excel Spread Sheet for analysis.

The data collection forms will be cross-checked by the research assistants to ensure that all
the necessary information is filled from the available records. The data will be fed into
Microsoft Excel Spread Sheet 2016 and secured with a password. The consent forms will be
kept under lock and key. The data will then be coded, cleaned and exported for analysis using
STATA 2017.

3.12 Data analysis

Descriptive statistics will be used to summarize the data into percentages and proportions.

Objective 1: The data will be analyzed with Statistical Package for Social Scientists (SPSS)
where risk-assessment data recorded as per Caprini RAM, and Revised Geneva Score will be
stratified as very low, low, moderate, and high risk.

Objective 2: Missed opportunities for VTE thromboprophylaxis will be expressed as

Number of patients withmoderate∨highrisk scores whodid not receivethromboprophylaxis
¿ x 100
Total number of elegible participants enrolled

Objective 3: Bland and Altman methods will be used to assess for agreement between
numerical scores of Caprini RAM and Revised Geneva Score meanwhile McNemar’s test
will be used to compare risk strata in the two RAMs. Cohen’s Kappa will be used to compare
inter-observer agreement for both RAMs.

3.13 Quality Control

The data collection forms will be prepared by the researchers then thereafter submitted to the
supervisor for approval and modification. The researchers will then be trained and briefed
about proper filling of the required data. The data collection forms will finally be represented
to the supervisor for further scrutiny.

3.14 Ethical considerations

Approval will be sought from Gulu University Research Ethics Committee (GUREC) and the
Uganda National Council for Science and Technology.

Administrative clearance will be sought from the management of Gulu Regional Referral
Hospital (GRRH) and St. Mary’s Hospital Lacor to access their patients’ records.
Informed consent will be sought from all study participants

Confidentiality will be exercised as the data will be entered in anonymity before analysis.

3.15 Dissemination

The results will be compiled into a report that will be presented to GURECC and copies
delivered to GRRH and St.Mary’s Hospital Lacor; Efforts will be made to publish the report
in Gulu University Medical Journal and other publication Manuscripts.

3.16 Limitations

This is a retrospective study. The quality of data collected will be solely dependent on that in
the medical records.

The research will be carried out in higher level facilities (hospitals) and the findings do not
fully reflect what is done in the lower-level health centers and rural settings.
APPENDICES
References

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Circulation, 107(SUPPL. 23). https://doi.org/10.1161/01.CIR.0000078469.07362.E6
ASH Recommendations for Treatment of Deep Vein Thrombosis and Pulmonary Embolism.
(2020). 4(19), 4738.
Barco, S., Valerio, L., Gallo, A., Turatti, G., Mahmoudpour, S. H., Ageno, W., Castellucci, L.
A., Cesarman-Maus, G., Ddungu, H., De Paula, E. V., Dumantepe, M., Goldhaber, S. Z.,
Guillermo Esposito, M. C., Klok, F. A., Kucher, N., McLintock, C., Ní Áinle, F.,
Simioni, P., Spirk, D., … Konstantinides, S. V. (2021). Global reporting of pulmonary
embolism-related deaths in the World Health Organization mortality database: Vital
registration data from 123 countries. Research and Practice in Thrombosis and
Haemostasis, 5(5), e12520. https://doi.org/10.1002/rth2.12520
Bartholomew, J. R. (2017). Update on the management of venous thromboembolism.
Cleveland Clinic Journal of Medicine, 84(12 Suppl 3), 39–46.
https://doi.org/10.3949/ccjm.84.s3.04
Cronin, M. A., Dengler, N., Krauss, E. S., Segal, A., Wei, N., Daly, M., Mota, F., & Caprini,
J. A. (2019). Completion of the Updated Caprini Risk Assessment Model (2013
Version). Clinical and Applied Thrombosis/Hemostasis, 25.
https://doi.org/10.1177/1076029619838052
Danwang, C., Temgoua, M. N., Agbor, V. N., Tankeu, A. T., & Noubiap, J. J. (2017).
Epidemiology of venous thromboembolism in Africa: a systematic review. Journal of
Thrombosis and Haemostasis, 15(9), 1770–1781. https://doi.org/10.1111/jth.13769
Esiéné, A., Owono Etoundi, P., Tochie, J. N., Mbengono Metogo, J. A., & Ze Minkande, J.
(2019). Validity of four clinical prediction scores for pulmonary embolism in a sub-
Saharan African setting: A protocol for a Cameroonian multicentre cross-sectional
study. BMJ Open, 9(10). https://doi.org/10.1136/bmjopen-2019-031322
Goddard, J., & Turner, A. (2014). Davidson ’ s. In Davidson’s principles and practice of
medicine.
Ismail, A., Jadawji, N., Adebayo, P., Jusabani, A., Hameed, K., Zehri, A. A., Kiviri, W., &
Ali, A. (2022). Evaluation of venous thromboembolism (VTE) risk assessment and
thrombo-prophylaxis practices in hospitalized medical and surgical patients at Aga Khan
Hospital Dar es Salaam: single-centre retrospective study. Pan African Medical Journal,
42, 1–8. https://doi.org/10.11604/pamj.2022.42.160.28278
Johnson, O., & Kumar, S. (2015). Risk assessment and prophylaxis of venous
thromboembolism in surgical inpatients: improving adherence to national guidelines.
BMJ Quality Improvement Reports, 4(1), u206691.w2692.
https://doi.org/10.1136/bmjquality.u206691.w2692
Muleledhu, A. L., Galukande, M., Makobore, P., Mwambu, T., Ameda, F., & Kiguli-
Malwadde, E. (2013). Deep venous thrombosis after major abdominal surgery in a
Ugandan hospital: a prospective study. International Journal of Emergency Medicine,
6(1), 43. https://doi.org/10.1186/1865-1380-6-43
Tritschler, T., & Aujesky, D. (2017). Venous thromboembolism in the elderly: A narrative
review. Thrombosis Research, 155, 140–147.
https://doi.org/10.1016/j.thromres.2017.05.015
Tseng, E. (2018). Prophylaxis for Hospitalized and Non-Hospitalized Medical Patients.
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Tsikouras, P., von Tempelhoff, G.-F., & Rath, W. (2017). [Epidemiology, Risk Factors and
Risk Stratification of Venous Thromboembolism in Pregnancy and the Puerperium].
Zeitschrift Fur Geburtshilfe Und Neonatologie, 221(4), 161–174.
https://doi.org/10.1055/s-0043-107618
Vono Alckmin, C. A., Garcia, M. D., Petilo Bricola de Carvalho, S. A., de Martins, M. A.,
Lichtenstein, A., & de Paiva, E. F. (2013). Venous thromboembolism risk assessment in
hospitalised patients: A new proposal. Clinics, 68(11), 1416–1420.
https://doi.org/10.6061/clinics/2013(11)06
Vululi, S. T., Bugeza, S., Zeridah, M., Ddungu, H., Openy, A. B., Frank, M., & Parkes-
Ratanshi, R. (2018). Prevalence of lower limb deep venous thrombosis among adult HIV
positive patients attending an outpatient clinic at Mulago Hospital. AIDS Research and
Therapy, 15(1), 3. https://doi.org/10.1186/s12981-018-0191-1
Wehmeyer, A., Coetzee, R., & McCartney, J. (2022). Venous thromboembolism risk
assessment and prophylaxis in hospitalised medical patients in the Cape Town
metropole, South Africa. South African Medical Journal, 112(2), 117–123.
https://doi.org/10.7196/SAMJ.2022.v112i2.16040
Winter, M.-P., Schernthaner, G. H., & Lang, I. M. (2017). Chronic complications of venous
thromboembolism. Journal of Thrombosis and Haemostasis, 15(8), 1531–1540.
https://doi.org/10.1111/jth.13741
APPENDIX II: INFORMED CONSENT (ENGLISH)

Title of the study:

VENOUS THROMBOEMBOLISM RISK STRATIFICATION AND THROMBO-
PROPHYLAXIS OF PATIENTS HOSPITALISED AT GULU UNIVERSITY
TEACHING HOSPITALS
Investigators:
Otile Cleopas Edwin, Bakyayita Steven, Lasalanda Christopher, Mukhwana Medi

Supervisor: Dr. Felix Bongomin, MBChB, MSc, M. Med, FECMM

Tel. +256 784 523 395.
E-mail: drbongomin@gmail.com
Department of Microbiology and Department of internal medicine
Faculty of Medicine, Gulu University.
Introduction
We are a team of four medical students from Faculty of medicine - Gulu university
conducting a study to assess venous thromboembolism risk stratification and thrombo-
prophylaxis of patients hospitalized at Gulu University Teaching Hospitals.
This informed consent explains the study to you. After the study has been explained, any
questions you may have are answered, and you have decided to participate in the study, you
will be asked to sign a consent, which you will be given a copy to keep.

Purpose
The study seeks to assess Venous Thrombo Embolism risk categories and the magnitude of
missed opportunities for thromboprophylaxis of patients hospitalized in the gynecology,
medical and surgical wards of Gulu University Teaching Hospitals. Recommendations based
on findings of this research will help to reduce on the general burden of death, disability and
complications and ensure patients recover well following hospitalization.

Procedure
Your participation in this study will involve being asked some questions about yourself and
permitting us to access your medical records. If you agree to participate in the study, you will
sign a letter of acceptance

Who will participate in the study?

 Patients hospitalized in the gynecology, medical and surgical wards of Gulu University
Teaching Hospitals aged 18 years and above, able and willing to provide written informed
consent but without contraindications to pharmacological thromboprophylaxis, pre-
established Deep Venous Thrombosis or Pulmonary Embolism upon admission and not
admitted to high-risk isolation units.
The interview will last for approximately 15minutes and 422 participants will take part in the
study.

Risks/discomforts:

There is no foreseeable risk of harm or discomfort that will arise from your participation in
this study. The only risk or discomfort will be the inconvenience in terms of time spent
during the interview.

Benefits:
Recommendations based on findings of this research will help to reduce on the general
burden of death, disability and complications and ensure patients recover well following
hospitalization.

Confidentiality:
Your identity will not be revealed to any one as we shall only use codes to identify
participants. Information obtained will only be accessible by the research team. Soft copies of
the data will be protected by password and hard copy files will be kept under lock and key.
Confidential information will only be accessed by the principal investigator.

Alternatives:
You do not have to participate in this study if you are not interested. You will not lose any
benefit in case of no participation.

Cost:
There will not be any additional cost incurred as a result of participating in this study.

Questions:
If you have any questions related to the study as a research participant, you can contact
The principal investigator,
Otile Cleopas Edwin 0778575970 cleopasoe@gmail.com
Bakyayita Steven 0770899894 bakyaibrambazz@gmail.com
Mukhwana Medi
Lasalanda Christopher 0708736791 chrislas1900@gmail.com

Statement of voluntariness:
Participation in the research study is voluntary and you may join on your own free will. You
have a right to withdraw from the study at any time without penalty.
If you have any issues pertaining to your rights and participation in the study, please contact
the Chairperson, Gulu University Research Ethics Committee, Dr. Gerald Obai Tel: No.,
0772305621; email: lekobai@yahoo.com/lekobai@gmail.com; or the Uganda National
Council for Science and Technology, on plot 6 Kimera road, Ntinda, Kampala on Tel
0414705500.
Statement of consent
........................................................................... has described to me what is going to be done,
the risks, the benefits involved and my rights as a participant in this study. I understand that
my decision to participate in this study will not affect me in any way. In the use of this
information, my identity will be concealed. I am aware that I may withdraw at any time. I
understand that by signing this form, I do not waive any of my legal rights but merely
indicate that I have been informed about the research study in which I am voluntarily
agreeing to participate. A copy of this form will be provided to me.

Name ……………………………………………………
Signature of participant…………………Date…………………

Name……………………………………..
Signature of investigator………………Date…………………………
APPENDIX III: INFORMED CONSENT (ACHOLI VERSION)

WATYE KATIMO KIKWEDO I KOM NGO MA WEKO POTO PAREMO IN LEE I

KOM LUTWO MA KIGENGOGI I OT YAT MEPWONYE PALUTINO GWAN MA
KWANO BEDO DOCTO YOT KI DONG YOO MEGENGO POTO PAREMO I LEE I
KOM LUTWO MA KIGENGO GI I WI KITANA

Lukwed:
Otile Cleopas Edwin, Bakyayita Steven, Lasalanda Christopher, Mukhwana Medi
Lulub kor tic:
Dr. Felix Bongomin, MBChB, MSc, M. Med, FECMM
Tel. 0784 523 395.
E-mail: drbongomin@gmail.com
Department of Microbiology and Department of internal medicine
Faculty of Medicine, Gulu University.

Lanyut.
Watye lutino kwan daktari ma romo agwen ki ii Faculty of medicine- Gulu University
kikweda ma dongo me nongo go matwero kelo poto pareme in lee I kom lutwo ma kiyengo gi
I wi kitana ki dong keto gi I gurep ma pat pat lubu kero ne.
Waraga me yeyo ni nyutu miti me kwed ni boti. Inge niang miti me kwed ni,lapyem ni mo
keken kibi gamo ne,ki bene kibi legi me keto cingi i waraga eni,copy ne bene kibi mini me
agwoka.

Pingo ki bitimo kwed ma

kikweda man miti ne aye me yinyo jami ma pat pat ma kelo poto pa remo ilee; yaka jami ma
dano cayo woko pi gengo poto pa remo ilee ikom lutwo ma ki gengo lwi kitana i ot-yat ma
lutino kwan me university me Gulu gi pwonye iyee; ngec ikom kikweda man,obikonyo me
gengo too,ngolo,ki jomi ma raco ma poto remo twero keto ikom deno.
Kit ma obiwoto kede.
Bedoni I kikweda ni wabi penyi lapeny ma lupe ki in kidong yee ni weg wa nongo lagam
mogo ki I file megi me ot yat.
Ka iye bedo ii kwed man, ibi keto cingi ii waraga me yeyo.

Jo mene ma bibedo ii kwed man?

Kikweda ni mito lutwo ma mwaka gi aparaboro ocito kede malo ma kigengogi I wod pa
mon kidong medical wod ci lutwo ma ku ye bedo i kikweda ni biteko cingi I karatach wek wa
nong lagam kibot gi ma lubo petye ki tyen lokmo ma gengo in gama yat ma gengo poto
paremo I lee, pud pe onogo two ma remo poto I lee madongo ki lee ma cito I oboo, pe tye I
wod matwo two gitek ma no myeko ki get gi irum ma pat ki me pa lutwo mukene ni.
Lapeny nye romo bedo pii dakika maromo 15 dak bene dano maromo 442 obibedo ii kwed
eni.

Ayela yela:
Lanen moo marac onyo gimo maromo balo ber bedo pee maromo aa ki ikom bedo ii kwed
man. Gwok gin marac maromo bedo tye en aye kwok cawa maa ibi tero ii gamo Lapeny.
Ber ne:
Dano weng ka cel acel ma obi bedo ii kwed eni binongo adwogi me kero me cam gi ki bene
ki bi pwonyo gi I kit me yilo kero me cam gi.

Mungu lok:
Nga ma in ibedo pe ki bikelo kamaleng ki ngat moo keken pien wabitiyo ki codes me ngeyo
dano matye ii kwed man. Ngec weng ma ki nongo joo ma loyo kwed man aye romo neno ne.
Ngec ma ii gin ma munu ki bi gwoko ne ki gin me mung ki ma gicoyo acoyo ki bi pungu
wiye ki kupulu. Ngec me mung ladit me kwed man aye obineno.

Onyo:
Pe iromo bedo ii kwed man ka cwinyi pe mito. Pe ibi rwenyo ber moo keken ka pe ibedo ii
kwed man.
Cul:
Cul moo bibedo peke pii bedo ii kwed man.

Lapeny:
Ka itye ki Lapeny moo keken ii kwed man macalo ngat ma tye ii kwed eni, iromo lok ki
lukwed madongo magi, , Otile Cleopas Edwin 0778575970 cleopasoe@gmail.com
Bakyayita Steven 0770899894 bakyaibrambazz@gmail.com
Mukhwana Medi
Lasalanda Christopher 0708736791 chrislas1900@gmail.com

Nyig lok pa joo ma oyee labongo dic:

Bedo ii kwed man tye labongo dic dak bene iromo donyo iye ki imiti ni. Itye ki twero me
weko bedo ii kwed man labongo pwod moo keken.
Ka itye ki lok ikom twero ki bedo ii kwed man, Tim ber lok ki won kom, Gulu University
Research Ethics Committee, Dr. Gerald Obai Tel: No., 0772305621; email:
lekobai@yahoo.com/lekobai@gmail.com; or the Uganda National Council for Science and
Technology, on plot 6 Kimera road, Ntinda, Kampala on Tel 0414705500.

Nyig lok me yeyo

........................................................................... Dong ki tyeko nianga ikom ngo me atima,
racce, ber ma iye karacel ki twero na macalo ngat ma tye ii kwed man. Aniang ni yee pa an
mi bedo ii kwed eni pe ki adwoki moo ikoma. Itic ki ngec man, ki bi mungu nga ma an
abedo. Angeyo bene ni aromo weko kwed man cawa moo keken. Aniang bene ni keto cinga
ii karatac man, pe aloko twero na moo keken ento nyutu mere ni ki tyeko mina ngec ikom
kwed man ma an ayee bedo iye labongo dic ni. Karac ma cal ki man abinongo ne.

Nying ……………………………………………………………………….
Cing lami tam…………………Nino dwe……………………...

Nying…………………………………………………………
Cing bipeny peny……………Nino dwe………………………...
 APPENDIX IV: STUDY TIMELINE

PROPOSED TIME FRAME

Activity September October November Decembe January Februar March

2022 2022 2022 r 2023 y 2023
2022 2023
Topic selection,
proposal writing
and submission.
Approval of
proposal from
GUREC
Pretesting of
research tools

Data collection and

data entry

Data analysis and

interpretation

Report writing and

submission

Disseminatin of
results

Defending of
dessertation
 APPENDIX V: BUDGET

S/N ITEM QUANTITY No. of DAYS UNIT PRICE AMOUNT

1. Ruled papers 1 ream 1 27000 27000

2 Transport for pretesting 4 10 4000 160000
3 Printing fees for letters to city and 6 1 500 3000
hospital leaders
4 Printing informed consent 422 1 500 211000
5 Data collection tool printing 422 1 500 211000
6 Pens 10 1 1000 10000
7 Research assistants 2 30 10000 600000
8 Transport to and fro the data 4 30 4000 480000
collection areas
9 Printing of spiral bound copies 6 copies (180 1 500 90000
pages)
10 Airtime 4 60 1000 240000
11 Printing hard cover copies 6 1 5000 30000
12 Binding 6 1 10000 60000
13 Sanitizers 8 bottles 1 10000 80000
14 Face masks 4 30 1000 120000
TOTAL 2322000
DATA COLLECTION TOOL

Caprini score

Caprini risk assessment model for venous

thromboembolism

Complete the risk assessment to determine your patients’ risk level for venous thromboembolism (VTE).

1 point 2 points 3 points 5 points

per risk factor per risk factor per risk factor per risk factor
Age 41–60 years Age 61–74 years Age 75 years Stroke (<1 month)
Minor surgery Arthroscopic surgery History of VTE Elective arthroplasty
BMI >25 kg/m 2
Major open surgery Family history of VTE Hip, pelvis or leg fracture
Swollen legs Varicose (>45 minutes) Factor V Leiden Acute spinal cord injury
veins Laparoscopic surgery Prothrombin 20210A Lupus (<1 month)
(>45 minutes)
Pregnancy or postpartum anticoagulant
Malignancy
History of unexplained Anticardiolipin antibodies
Confined to bed (>72 hours)
or recurrent spontaneous abortion Elevated serum
Immobilizing plaster cast
Homocysteine
Oral contraceptives Central venous access Heparin-induced
or hormone replacement thrombocytopenia
Sepsis (<1 month) Other congenital or acquired
thrombophilia
Serious lung disease,
If yes: Type
including pneumonia (<1
month)
Abnormal pulmonary function
Acute myocardial infarction
Congestive heart failure (<1
month)
History of inflammatory
bowel disease
Medical patient at bed rest
Other risk factors:

Subtotal: Subtotal: Subtotal: Subtotal:

TOTAL RISK FACTOR SCORE:

 Caprini score

REVISED GENEVA RISK ASSESSMENT MODEL FOR VENOUS

THROMBOEMBOLISM
R
1 POINT PER 2 POINTS PER 3 POINTS PER 4 POINTS PER 5 POINTS PER
RISK RISK FACTOR RISK FACTOR RISK FACTOR RISK FACTOR
FACTOR

Age 65 years Surgery or Previous DVT Pain on deep Heart rate 95

or over fracture within 1 or PE palpation of or more beats per
month lower limb and minute
Active malignant Unilateral unilateral oedema
condition lower limb pain

Heart rate 75
to 94 beats per
Haemoptysis
minute
Subtotal:…….. Subtotal: Subtotal: Subtotal:………. Subtotal:
…………. ………. ……….
TOTAL RISK SCORE:………………………………………………………………………….

Recommended interveon risk of VTE

 APPENDIX VII : MITIGATION PLAN.

Measures for the Prevention and control of risk of spread of COVID-19 during the
implementation of research

Study Title:. VENOUS THROMBOEMBOLISM RISK STRATIFICATION AND

THROMBO-PROPHYLAXIS OF PATIENTS HOSPITALISED IN GULU
UNIVERSITY TEACHING HOSPITALS

Research team
Name Title Qualificati Role on Affiliation
ons research
team
Dr. Felix Bongomin Physician/ MBChB, Supervisor Gulu University
drbongomin@gmail.com Lecturer MSc,
0784 52 33 95 MMed,
FECMM
Otile Cleopas Edwin Student MBChB Principle Gulu University
cleopasoe@gmail.com investigator
+256778575970
Mukhwana Medi Student MBChB Principle Gulu University
investigator

Bakyayita Steven Student MBChB Principle Gulu University

bakyaibrambazz@gmail.co investigator
m
+256770899894
Lasalanda Christopher Student MBChB Principle Gulu University
Chrislas1900@gmail.com investigator
+256708736791

Introduction:
The novel Coronavirus is transmitted from human to human through droplets and direct or
close personal contact with an infected individual

Novel Coronavirus signs of infection include respiratory symptoms, fever, cough, shortness
of breath and breathing difficulties. In more severe cases, infection can cause pneumonia,
severe acute respiratory syndrome, kidney failure and even death
Implementation of the prevention and control measures
In the implementation of the research activities, the investigators are committed to ensuring
the safety of its research team, research participants and occupants of the hospitals where the
study will be conducted. The study team undertakes to comply with the Standard Operating
Procedures issued by the Ministry of Health, and presidential directives to mitigate against
the risk of infection of COVID-19, rapidly detect and effectively respond to any COVID-19
case that may occur in the process of carrying out the study, screening, face covering,
physical distancing, and good hand hygiene.

Procedures to be followed during the implementation of the research.

Prior to data collection and Training

1. Health guidance: There will be training sessions dedicated for COVID-19

sensitization and awareness, to equip the research team with knowledge of signs and
symptoms of the COVID-19, and preventive measures such as hand hygiene before
placing and removing the mask, as well as storage of the mask, social distancing. The
research team will circulate notices, posters, charts on common signs and symptoms
of COVID-19 as provided by the Ministry of Health, and develop and/or use existing
plan for the appropriate referral pathway for identified and/or suspected cases.
2. Personal Screening: All researchers, research assistants, research participants and
any other individuals engaged in research activities will screen temperature daily for
fever. Screening for temperature will be carried out during planning meetings,
trainings, community outreach. Any individual found with COVID 19 symptoms will
be withdrawn and referred to the COVID – 19 task force for further assessment and
management. The withdrawn individual will be allowed to return only if they present
a valid certification of their COVID-19 status showing negative result
3. Wearing face coverings: All researchers and research assistants and any other
individuals engaged in research activities that require interaction with fellow
researchers or research participants or the community member will have to wear a
face mask that fully covers the mouth and nose at all times. The study will provide
face masks for individuals who do not have.
4. Physical Distancing: There will be social distancing during the training, meetings,
community outreach of at minimum of 2 metres. During breaks, the team will not be
allowed to congregate in common areas.
5. Good hygiene: All team members will be required to wash their hands or use hand
sanitizers before and after entering the training room, and other common areas. Hand
washing equipment shall be supplied and made available at all times. All surfaces and
equipment shall be sanitised frequently.
During data collection
1. Personal Protective Equipment (PPE): All research assistants involved in tracing of
respondents and in in-person interviews and research participants will use PPE
including a properly fitted face mask. Enumerators/Researchers and research
participants will wash hands with soap and water or use hand sanitizer prior to the
interview. Handshakes and hugging are prohibited. Physical distancing of at least 2
metres in all research related activities shall be observed.
 2. Consent Process: The Researcher /Research assistants will observe social distancing
when taking consent (while 2 metres apart) upon arrival to the participant.
Enumerators/Researchers and research participants will wash hands with soap and
water or use hand sanitizer prior to the interview. Participant will then be sensitized
on covid-19 and presented with preventive measures.
3. Equipment sanitization: shared devices used to record or capture data shall be
sanitized regularly.
During Dissemination/Community engagement
1. Community Engagement: The research team shall carry educational materials on
prevention of COVID-19 in a language understood by the participants. These
materials shall also have visual images to support understanding.
Enumerators/Researchers and research participants will wash hands with soap and
water or use hand sanitizer prior to the interview. Screening for temperature will be
carried out prior to conducting community engagements.
4. Equipment sanitization: shared devices used during community engagements to
shall be sanitized regularly.
The preventive and control measures will continuously be reviewed based on new
information and guidelines communicated by the ministry of health (MOH).