A Cross-sectional Study Assessing the Agreement Between Sonographer Based Assessment of the Fatty Liver Using Conventional Ultrasound and Attenuation Imaging Scoring.
Conditions: Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non-alcoholic Steatohepatitis, Steatosis of Liver
Sponsor: Hywel Dda Health Board

 
 
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Protocol: Ultrasound and Attenuation Imaging, Version 1.4, 21/03/2024 
 
 
Research Protocol (Version 1.4, 21/03/2024) 
 
 
Study Title: A cross-sectional study assessing the agreement between 
sonographer based assessment of the fatty liver using conventional 
ultrasound and attenuation imaging scoring. 
 
 
Acronym/Short Title: Ultrasound and Attenuation Imaging 
 
 
 
Study ID (IRAS No.): 329847 
 
REC Reference:23/WA/0332 
 
 
 
 
Protocol Version No. & date: (Version 1.4, 21/03/2024) 
 
Author(s) & Designation(s): Laura Mundy, Sonographer, Researcher  
 
 
 
 
 
 
 
 
 

 
 
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Protocol: Ultrasound and Attenuation Imaging, Version 1.4, 21/03/2024 
Study Summary 
 
 
Study Outline 
Non-alcoholic fatty liver disease (NAFLD) affects almost a 3rd of the 
population of the UK and current best practice is to evaluate this using 
Magnetic Resonance Imaging proton density fat fraction (MRI PDFF), 
however, this is inaccessible to many patients due to limited availability, 
cost and a large exclusion criteria. Ultrasound offers an affordable, 
faster and more inclusive method of liver evaluation but only subjective 
assessment of fatty liver disease until a recent development- 
Attenuation Imaging. Attenuation imaging gives a numerical score for 
fatty liver disease. Attenuation imaging has previously only been 
compared to MRI PDFF, however, when many patients do not have 
MRI PDFF it is essential to compare it to common practice, 
conventional ultrasound. This study aims to assess the agreement 
between conventional ultrasound assessment of the liver and 
attenuation imaging using a cross-sectional method. Convenience 
sampling will be used to select 95 participants who will have their 
attenuation imaging score carried out alongside their routine ultrasound 
scan with the sonographer blinded to the attenuation imaging results. 
The inter-rater agreement will be determined using Kappa statistics. 
The results will demonstrate the strength of relationship between the 
two methods. A strong agreement between the two may facilitate further 
investigation into the uses of attenuation imaging, such as use as a 
screening tool, in teaching trainee ultrasound operators or in aiding 
decisions in cases that Sonographers find more difficult to assess such 
as those patients with a high BMI. 
Lay Summary 
Fatty liver disease affects almost a 3rd of the UK population. Currently, 
this is being investigated using a type of Magnetic Resonance Imaging 
(MRI) scan that reports how fatty or not a person’s liver is, with a liver 
fat score, but many patients cannot have this type of scan due to time, 
cost or because they have a condition which makes MRI an unsafe 
scan for them to have. An ultrasound scan is cheaper, faster and safer 
for a wider variety of patients. New developments in ultrasound 
technology mean that instead of a Sonographer, or ultrasound operator, 
deciding whether your liver is fatty or not based on what they see on the 
scan, the ultrasound machine gives a liver fat score. This study will look 
at the relationship between the Sonographers' view on how fatty the 
liver is, compared with the liver fat score given by the new development 
in ultrasound technology.  
  
Key Words 
‘Ultrasound’ ‘Non-alcoholic Fatty Liver Disease’ ‘Metabolic Liver 
Disease’ ‘Attenuation Imaging’  
Objectives 
To assess the agreement between Sonographer based 
ultrasound assessment of fatty liver disease and attenuation 
imaging scoring.  
Sample Size  
95 
Duration 
1 year 
 
Glossary / Definitions / Acronyms 
 
EASL  
 
European Association for the Study of the Liver  

 
 
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GDPR  
 
General Data Protection Regulation 
HDUHB 
 
Hywel Dda University Health Board 
IRAS  
 
Integrated Research Application System 
MRI 
 
 
Magnetic Resonance Imaging 
MRI-PDFF 
 
Magnetic Resonance Imaging- Proton Density Fat Fraction 
NAFLD 
 
Non-alcoholic Fatty Liver Disease 
NHS  
 
National Health Service 
NICE  
 
National Institute for Health and Care Excellence 
PIS 
 
 
Participant Information Sheet 
R&D  
 
Research and Development 
REC  
 
Research Ethics Committee 
 
 

 
 
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Protocol: Ultrasound and Attenuation Imaging, Version 1.4, 21/03/2024 
 
Statement of Compliance 
The study as detailed within this Protocol (Version 1.4, 21/03/2024) or any subsequent 
amendments will be conducted in accordance with the International Conference for 
Harmonisation of Good Clinical Practice (ICH-GCP, E6), and the UK Policy Framework for 
Health and Social Care Research (2017), the World Medical Association Declaration of 
Helsinki (1996) and the current applicable regulatory requirements and any subsequent 
amendments of the appropriate Regulations. 
 

 
 
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Protocol: Ultrasound and Attenuation Imaging, Version 1.4, 21/03/2024 
Signature Page 
The signature below constitutes the approval of this Protocol and the attachments and 
provides the necessary assurances that this research study will be conducted according to 
all stipulations of the Protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements. 
 
Chief / Principal Investigator: 
Signed: 
 
Date 
(dd/mm/yyyy): 
21/03/2024 
 
Name: Laura Mundy 
 
 
Title: Chief Investigator  
 
Designation: 
Sonographer 
 
 
Affiliated organisation(s) : Hywel Dda University Health Board 
University of the West of England. 
 
 
Study sponsor: Hywel Dda University Health Board 
 
 
 
 
 
 
 

 
 
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Protocol: Ultrasound and Attenuation Imaging, Version 1.4, 21/03/2024 
Contact Details 
 
 
Chief Investigator 
Name: Laura Mundy 
Role: Sonographer 
Site: Bronglais Hospital, Caradoc Rd, Aberystwyth, SY23 1ER 
Email: Laura.mundy2@wales.nhs.uk 
Tel: 07849148369 
 
 
Collaborator(s) 
Name: Glenda Toach 
Role: Supervisor and collaborator 
Site: University of the West of England, Glenside Campus,  Blackberry Hill, Stapleton, Bristol 
BS16 1DD 
Email: glenda.toach@uwe.ac.uk 
Tel: 01173287723 
 
 

 
 
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Protocol: Ultrasound and Attenuation Imaging, Version 1.4, 21/03/2024 
Contents 
Study Summary .......................................................................................................... 3 
Statement of Compliance ........................................................................................... 5 
Signature Page .......................................................................................................... 6 
Contact Details ........................................................................................................... 7 
1. 
Introduction ....................................................................................................... 10 
1.1. Background ................................................................................................... 10 
1.2. Research Question ........................................................................................ 11 
2. 
Study Outline..................................................................................................... 11 
2.1. Aims and Objectives ...................................................................................... 11 
2.2. Method .......................................................................................................... 11 
2.2.1. 
Study Type .......................................................................................... 11 
2.2.2. 
Study Overview ................................................................................... 11 
2.2.3. 
Study Populations, Subject Selection, Recruitment and Study Schedule
 
12 
2.2.4. 
Eligibility Criteria ................................................................................. 12 
2.2.5. 
Power Calculation ............................................................................... 13 
2.2.6. 
Statistical Analysis Plan ...................................................................... 13 
2.3. Study Outcomes ............................................................................................ 14 
2.4. Timescale ...................................................................................................... 14 
2.5. Publication Policy .......................................................................................... 14 
3. 
Screening, Consent and Withdrawal ................................................................. 15 
3.1. Screening Duties ........................................................................................... 15 
3.2. Informed Consent Procedures and withdrawal .............................................. 15 
4. 
Risk, Ethical Considerations and Confidentiality ............................................... 15 
4.1. Risk and Benefits ........................................................................................... 15 
4.2. Ethical Considerations ................................................................................... 16 
4.3. Patient & Public Involvement ......................................................................... 16 
4.4. Confidentiality ................................................................................................ 16 
4.5. Premature Termination or Suspension of Study ............................................ 16 
4.6. Record Retention and Archiving .................................................................... 16 
4.7. Study Oversight ............................................................................................. 16 
4.8. Study Reporting ............................................................................................. 16 
4.9. Safety Reporting ............................................................................................ 16 
5. 
Appendix 1. ....................................................................................................... 18 
6. 
References ........................................................................................................ 21 
 

 
 
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1. Introduction 
Non-alcoholic fatty liver disease (NAFLD) has a prevalence of 20-30% in the UK 
population (National Institute for Health and Care Excellence, 2016) 80% of these 
patients will have normal results from routine liver tests (NICE, 2016), meaning that 
diagnosis often requires several further tests. The term NAFLD represents a scale of 
fatty liver disease incorporating non-alcoholic steatohepatitis (NASH) and cirrhosis 
(British Liver Trust, 2022). However, in the earlier stages, the liver can, to an extent, 
repair itself without expensive drugs or procedures, as treatment at this stage is 
predominantly a combination of diet and exercise, meaning that an early diagnosis 
can easily prevent the progression to cirrhosis (British Liver Trust, 2022). 
 
1.1. 
Background 
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI PDFF) is 
recommended by the European Association for the Study of the Liver as the gold 
standard for assessing fatty liver disease (EASL et al., 2016). MRI PDFF gives a 
complete evaluation of the liver enabling assessment for other pathology and 
quantification of the fatty infiltration for segments of the liver. MRI is non-invasive but 
expensive, with multiple exclusion criteria, long waiting times and limited availability 
(Gatos et al., 2022). Most MRI scanners are unsuitable for patients with a larger 
body habitus (Reynolds, 2011), who would naturally make up a significant proportion 
of those with NAFLD due to its causative factors- most commonly poor diet and lack 
of exercise. They are also poorly tolerated by patients due to noise and 
claustrophobia. In addition, it excludes patients with artificial heart valves, recent 
surgery or dental work, and internal electronic devices such as pacemakers or 
insulin pumps (Medicines and Healthcare Products Regulatory Agency, 2021). 
Insulin pumps are a particular issue for this population as there is a 53% prevalence 
of NAFLD within the type 2 diabetic population (NICE, 2016). 
Ultrasound is recommended as a first-line test for NAFLD (EASL et al., 2016). It is 
easily accessible, well tolerated by most patients, more cost-effective than MRI, 
gives a complete overview to assess for other liver pathology and is non-invasive 
(Ballestri et al., 2021). However, conventional ultrasound relies on a subjective liver 
assessment by the operator, which research shows is open to inter-observer 
variation (Straus et al., 2007) and image quality can also be limited by patient obesity 
(Reynolds, 2011). It also has a low detection rate of mild steatosis, or steatosis 
involving less than 30% of the liver parenchyma (Ballestri et al., 2021). In current 
practice, sonographers grade the fatty appearance of the liver subjectively as 
normal, mild, moderate or severe through assessment of the echogenicity of the 
liver, hepato-renal contrast, visualisation of the intra-hepatic veins and visualisation 
of the liver parenchyma (Hernaez et al., 2011, Ballestri et al. 2021). Ultrasound is 
also recommended for monitoring those with advanced fatty liver disease, where 
there are often fibrotic changes with progression to cirrhosis and an increased risk of 
hepatocellular carcinoma (EASL et al., 2016).  
A new advance in ultrasound technology, attenuation imaging, permits quantitative 
measurement of liver fat, which poses no additional risk to the patient than regular 
ultrasound and can be carried out as a part of a routine ultrasound scan (Bae et al., 
2019). As attenuation imaging is not hindered by the subjectivity of conventional 
ultrasound assessment, it has potential as a more specific way to monitor the 
progress of fatty liver disease and to aid more inexperienced sonographers as an 
adjunct to their subjective assessment. Most of the literature compares attenuation 

 
 
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Protocol: Ultrasound and Attenuation Imaging, Version 1.4, 21/03/2024 
imaging to MRI-PDFF as the gold standard, and multiple studies suggest that 
attenuation imaging has reasonable specificity and sensitivity (Ferraioli et al., 2021, 
Jeon et al., 2019). However, as previously stated, MRI is not suitable for an 
extensive range of patients and long waits for MRI scans and reports make it 
unfeasible as a method of choice for assessing and monitoring the fatty liver locally, 
especially in the early stages when the risk of hepatocellular carcinoma is much 
lower. Consequently, whilst the literature compares attenuation imaging to MRI 
PDFF, as the gold standard, it is essential to evaluate the use of attenuation imaging 
against current ultrasound practice, which at this location is a more common method 
of liver evaluation than MRI PDFF. Furthermore, this study will provide a base of 
evidence to allow further research in the future to find answers to questions such as 
‘How does knowing these scores affect patients attitudes to treatment?’ or ‘At which 
stage is treatment most effective?’. 
 
1.2. Research Question 
What is the level of agreement between sonographer based assessment of the fatty 
liver using conventional ultrasound and attenuation imaging scoring?  
 
2. Study Outline 
 
2.1. 
Aims and Objectives 
Evaluate the agreement between a sonographer-based assessment of the fatty liver 
using conventional ultrasound and attenuation imaging scoring.  
Describe any disagreement between sonographer-based assessment of the fatty 
liver and attenuation imaging scoring.  
Assess if there is any variation in agreement at different grades of fatty liver disease. 
 
2.2. 
Method  
 
2.2.1. Study Type 
This study will be carried out using a cross-sectional quantitative methodology. 
 
2.2.2. Study Overview 
A cross-sectional design will be used for this study. The Sonographer appraisal and 
attenuation imaging score will be collected from observations made at a single point 
in time during the ultrasound scan to look at the agreement between the two factors. 
These features, data collected through the sample being observed at a single point 
in time to assess agreement, make this an appropriate design for this study (Ellis, 
2019). Evidence of agreement may point towards further areas for research such as 
use as a screening tool or point of care ultrasound. However, as an inexpensive 
method of collecting and comparing a large quantity of data, a cross-sectional study 
is a pragmatic choice (McClean, 2020).  
The data will be obtained from a population of patients having abdominal or liver 
scans in Bronglais Hospital, Aberystwyth, until sufficient data has been collected in 
line with calculated sample size. Establishing criteria for inclusion and exclusion 
allows exclusion of patients who may be clinically unsuitable or unable to consent. 
The inclusion and exclusion criteria with justification for these decisions are set out in 
table 1. Identifying patients eligible for inclusion in the study should be achievable 
from the assessment of patient referral forms. Most exclusion criteria should also be 

 
 
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detected from the referral form; however, patients with unknown large or multiple 
liver masses may be identified during the scan. Patients will be informed via the PIS 
that if it is found for any reason that they do not meet the criteria that they will be 
informed that this is the case, and we will collect no further data from them. Their 
care will continue as normal.  Patients identified in this way will be excluded from the 
results. 
There will be no randomisation all participants will undergo the same study 
procedure, which will be carried out during a single, routine hospital visit, avoiding 
the need for participants to attend additional appointments. The assessment will be 
carried out by two experienced sonographers with a minimum of 10years of 
abdominal scanning experience. Sonographer 1 will scan each participant, with 
Sonographer 2 reviewing the images later in the same conditions to avoid variation 
caused by lighting conditions. Both sonographers will be blind to the participant’s 
history before completing the liver assessment to avoid any bias from past medical 
history. They will assess the liver using routine ultrasound, making their decision 
based on hepato-renal contrast, visualisation of the walls of the intra-hepatic veins 
and visualisation of the liver parenchyma (Hernaez et al., 2011, Ballestri et al. 2021). 
The sonographers will individually grade the liver as normal, mild, moderate or 
severely fatty, recording this on a case report form. The attenuation imaging function 
will then be switched on and the ultrasound machine will calculate the attenuation 
imaging scores, according to manufacturer guidance, which will be recorded on the 
case report form along with the participant’s age, gender, and diagnosis. The BMI 
measurement will also be taken in the time around the participant’s appointment and 
recorded on the case report form as BMI has an impact on image quality (Reynolds, 
2011).  
 
2.2.3. Study Populations, Subject Selection, Recruitment and Study 
Schedule 
Convenience sampling permits all patients scanned in the time frame who meet the 
inclusion criteria to be included in a study reducing time and cost (Walliman, 2011) 
making this a realistic choice for this study. However, this type of sampling is not 
representative of the population, which limits the ability to generalise the findings 
(Walliman, 2011). This method is widely used in clinical research and convenience 
sampling at a single site is common in healthcare as data protection issues limit data 
transport across multiple sites (Kahn et al. 2012). 
Eligible patients will be identified in line with the eligibility criteria described below. 
Informed consent will be obtained from all participants prior to any study procedures. 
A study schedule and participant flow chart are attached in Appendix 1. 
 
2.2.4. Eligibility Criteria 
Hepatic steatosis appears in different sexes at different ages and is linked to obesity 
and metabolic disease, such as diabetes mellitus (EASL et al., 2016) and so it is 
important to include this in the study. Large liver masses impede both sonographic 
assessment and attenuation imaging and so will be excluded. Inpatients will also be 
excluded as these are often difficult to scan due to poor mobility but also are often 
too unwell to be in the department for any length of time. Patients with complex 
anatomy due to congenital or surgical reasons or who due to body type are not 
suitable for conventional ultrasound will also be excluded. Fatty livers are unusual in 
the younger population unless drug induced and participants need to be able to 

 
 
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Protocol: Ultrasound and Attenuation Imaging, Version 1.4, 21/03/2024 
consent so only an adult population will be included. Patients with normal livers will 
be included as livers can be graded as normal, mild, moderate or severely fatty.  
Table 1 
Variable 
Measure 
Age 
Inclusion:18< years 
Exclusion: <18 years 
Patient group 
Inclusion: GP and OP referrals. 
Exclusion: Inpatients 
Clinical history Inclusion: NAFLD,  Unknown, 
Diabetes, Other metabolic 
disease 
Exclusion: Known large liver 
mass. Poor visualisation of the 
liver due to body type or unusual 
anatomy. 
 
2.2.5. Power Calculation 
The statistical test to determine inter-rater agreement when data are at the ordinal 
level is kappa (McHugh, 2012). The degree of agreement ranges between -1 and 
1.0; 1.0 infers complete agreement, and 0 less agreement than random chance, with 
negative values indicating disagreement. Assessment of the strength of agreement 
will be based on the limits described by Landis and Koch (1977) where ≤0=poor, 
0.01–0.20=slight, 0.21–0.40=fair, 0.41–0.60=moderate, 0.61–0.80=substantial, and 
0.81–1=almost perfect agreement. 
The sample size for kappa is calculated based on the need to detect a difference 
between levels of agreement. McHugh (2005) acknowledges that an agreement of 
0.80 or above is more widely accepted in healthcare as the minimum interrater 
agreement, and a kappa of 0.59 and below an inadequate agreement. Using these 
values with a power of 90% and alpha set at 0.05, the sample size will be 95. 
 
2.2.6. Statistical Analysis Plan  
Initially, descriptive statistics will be used to analyse the data collected. The 
categorical data, gender and diagnosis, will be described using a frequency 
distribution able. Distribution of ratio data will be assessed using the Shapiro-Wilk 
test. Normally distributed ratio data will be described using mean and standard 
deviation, whereas non-normally distributed data will be described using median and 
interquartile range. Finally, the ordinal data, attenuation imaging score and 
sonographer appraisal will be described using a frequency distribution table with 
numbers and percentages, with the mode used to describe the central tendency. 
Inferential statistics will determine the agreement between the sonographer appraisal 
and attenuation imaging score, with the manufacturer cut-off values being used to 
create ordinal-level data. The statistical test to determine inter-rater agreement with 
ordinal data is kappa (McHugh, 2012). Weighted kappa will be used as this takes 

 
 
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Protocol: Ultrasound and Attenuation Imaging, Version 1.4, 21/03/2024 
into account the level of inter-rater disagreement (Sim and Wright, 2005), which in 
this study could be a minor inter-rater disagreement such as mild steatosis versus 
moderate steatosis rating as opposed to normal versus severe steatosis rating which 
would be a more significant inter-rater disagreement. 
The previously stated values recommended by Landis and Koch (1977) will be used 
to evaluate the level of agreement. The magnitude of kappa can be affected by the 
weighting scheme used (Sim and Wright, 2005); linear weighting will be used as 
quadratic weighting attaches too much importance to near agreements. 
 
2.3. 
Study Outcomes 
The value of Kappa will be used to assess the agreement. An interrater agreement 
of 0.80, a value widely accepted in healthcare as the minimum interrater agreement 
(McHugh, 2005) so this value will be used to confirm or reject the hypothesis. 
 
2.4. 
Timescale 
Please see attached Gantt chart in Appendix 1. 
 
2.5. 
Publication Policy  
A copy will be made available for all participants, sponsors, collaborators, and 
research and development department.  
The study will also be submitted for inclusion in the academic journal Ultrasound and 
results may be shared for learning within and outside the health board at 
conferences and events. 
Data will be anonymised on collection so no individual will be able to be identified at 
publication. The study will form part of an MSc thesis submission. 

 
 
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3. Screening, Consent and Withdrawal 
 
3.1. 
Screening Duties 
Laura Mundy, as the researcher and a member of the clinical team, will be 
responsible for screening potential research participants.  All ultrasound requests are 
vetted for suitability by a Sonographer as part of their clinical role. The researcher 
will review requests for abdominal scanning during the normal vetting procedure.  
 
3.2. 
Informed Consent Procedures and withdrawal 
Any patient identified who meets the criteria will be sent a participant information 
leaflet with the appointment letter. The study will be discussed with patient during 
their appointment visit and written consent can be obtained, if the patient agrees to 
take part. Any patients given short notice appointments will be given a patient 
information leaflet on attendance at the department to read whilst waiting to be called 
in for their examination. They will then be asked to sign an informed consent form if 
they’re willing to take part. The sonographer undertaking the scan, who will have 
undertaken training in informed consent, will receive consent from the patient rather 
than the researcher to avoid coercion. 
If the participant wishes to be withdrawn, then they can do so at any time up until the 
data is pseudonymised for analysis.  
If for whatever reason the measurements cannot be taken (due to body habitus, liver 
lesions, etc) then the reason will be recorded, and from this point, no further data will 
be collected. The other data will be retained to look for patterns in patient 
demographics in reject analysis.  
 
4. Risk, Ethical Considerations and Confidentiality 
 
4.1. 
Risk and Benefits 
Risks to patients: 
Attenuation imaging uses the same principles as conventional ultrasound. 
Ultrasound is considered a generally safe imaging modality and details of the British 
Medical Ultrasound Society ‘Statement for the General Public on the Safety of 
Ultrasound’ (2017) will be made available in the information leaflet. Standard 
ultrasound safety practice will be adhered to as per the British Medical Ultrasound 
guidelines (2009). Bae et al. (2019) found that the attenuation imaging scoring 
increased the scan time by approximately two minutes, so the scan time should 
remain within the safe level and minimally impact the patient’s time.  
The only further impact on the patient’s time will be in measuring the patients BMI 
which is not a time-consuming process.  
The ultrasound scan will be reported in the usual manner using the sonographer's 
initial assessments. So, the attenuation imaging scoring will have no impact on the 
report produced for the referring clinician and, consequently, no impact on the 
patient’s treatment or pathway.  
Risks to staff: 
Increased scan times, high patient BMI and repetitive exam types in a single session 
can also impact sonographers, causing work-related musculoskeletal disorders 
(Harrison and Harris, 2015). These factors are accounted for in site risk 

 
 
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assessments based on advice from the Society & College of Radiographers (2019) 
and in the project risk assessment (Appendix 1.); these will be followed to minimise 
risk to the operators. 
 
 
4.2. 
Ethical Considerations 
NHS REC approval will be sought for this study and confidentiality, anonymity and 
informed consent will be ensured throughout.  
4.3. 
Patient & Public Involvement 
Patients will not be involved in the development and dissemination of this study but 
will contribute to its conduct as participants and will be informed of the potential for 
dissemination of results via non identifiable reports and publications. 
 
4.4. 
Confidentiality 
Participants’ signed informed consent forms and research data will be securely stored 
at all times. Research data will be pseudo-anonymised. GDPR regulations will be 
adhered to throughout and information governance approval will be sought prior to 
study commencement 
 
4.5. 
Premature Termination or Suspension of Study 
If premature study termination is required (eg due to insufficient protocol adherence 
or inability to recruit participants and collect study data), HDUHB R&D (as sponsor), 
RECx, and academic supervisors will be notified in writing. 
 
4.6. 
Record Retention and Archiving 
In line with health board policy for sponsored studies, study records will be archived 
for five years at the designated archiving facility. 
 
4.7. 
Study Oversight 
Laura Mundy, as CI will be responsible for study oversight and will report any issues 
to HDUHB R&D (as sponsor), Wales REC 6 and academic supervisor. 
 
4.8. 
Study Reporting 
The CI will provide regular updates to the academic supervisor and HDUHB R&D 
team and will submit an end of study report to Wales REC 6 
4.9. 
Safety Reporting 
Any adverse events or serious adverse events occurring during the study visit will be 
recorded and reported to HDUHB R&D in line with standard procedures.  
 
 

 
 
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5. Appendix 1.  
Participant flow chart. 
 
 
 
 

 
 
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Project Timeline
3 10 17 24
1
8 15 22 29
5 12 19 26
3 10 17 24 31
7 14 21 28
4 11 18 25
2
9 16 23 30
6 13 20 27
4 11 18 25
Discussion with Supervisor
Ethics HDD
Ethics UWE
Introduction
Literature review-Research
Literature review-Write up
Data collection 
Data Analysis
Results-Conclusion
Draft 1
Condense to article
Submission
Deadlines
1
8 15 22 29
5 12 19 26
4 11 18 25
Discussion with Supervisor
Ethics HDD
Ethics UWE
Introduction
Literature review-Research
Literature review-Write up
Data collection 
Data Analysis
Results-Conclusion
Draft 1
Condense to article
Submission
Deadlines
1
Jan-24
Feb-24
Mar-24
Apr-24
Sep-23
Oct-23
Nov-23
Dec-23
Apr-23
May-23
Jun-23
Jul-23
Aug-23

 
 
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6. References 
 
 
Bae, J.S., Lee, D.H., Lee, J.Y., Kim, H., Yu, S.J., Lee, J.H., Cho, E.J., Lee, Y.B., 
Han, J.K., Choi, B.I. (2019) Assessment of hepatic steatosis by using attenuation 
imaging: a quantitative, easy-to-perform ultrasound technique. European Radiology. 
[online].  29 (12), pp.6499–6507. [Accessed 01 October 2022].   
 
Ballestri, S., Zona, Mantovani, A., Byrne, C.D., S., Lonardo, A., and Targher, G. 
(2021) Diagnostic accuracy of ultrasonography for the detection of hepatic steatosis: 
an updated meta-analysis of observational studies. Metabolism and Target Organ 
Damage [online].  1 (7), pp. 1-15 [Accessed 01 October 2022].   
 
Berman Brown, R. and Saunders, M. (2007) Dealing with Statistics [online].   
Buckingham: McGraw-Hill Education. [Accessed 10 October 2022]. 
British Liver Trust (2022) Non-alcohol related fatty liver disease [online]. Available 
from: https://britishlivertrust.org.uk/wp-content/uploads/NAFLD_web_MAR22.pdf 
[Accessed 10 October 2022]. 
British Medical Ultrasound Society Safety Group (2009) The British Medical Ultra-
sound Society. Guidelines for the safe use of diagnostic ultrasound equipment 
[Online] Available from: https://www.bmus.org/static/uploads/resources/BMUS-
Safety-Guidelines-2009-revision-FINAL-Nov-2009.pdf [Accessed 01 October 2022].   
British Medical Ultrasound Society and Society and College of Radiographers (2020) 
SCoR/BMUS Guidelines for Professional Ultrasound Practice. [Online] Available 
from: https://www.bmus.org/static/uploads/resources/2020_Guidelines_for_Profes-
sional_Ultrasound_Practice.pdf [Accessed 01 October 2022]. 
https://www.bmus.org/static/uploads/resources/Statement_for_the_General_Pub-
lic_on_the_Safety_of_Medical_Ultrasound_Imaging_Sept_2017.pdf 
Ellis, P. (2019) Understanding research for nursing students. [online]. 4th Edition. 
London: Learning Matters. [Accessed 01 October 2022].   
European Association for the Study of the Liver (EASL), European Association for 
the Study of Diabetes (EASD) and European Association for the Study of Obesity 

 
 
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(EASO) (2016) EASL–EASD–EASO Clinical Practice Guidelines for the 
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