Gastroenterology Today Spring 2023
Gastroenterology Today Spring 2023
Gastroenterology Today Spring 2023
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Volume 33 No. 1<br />
<strong>Spring</strong> <strong>2023</strong><br />
Padlock Clip ®<br />
system<br />
Viper ®<br />
hemoclip<br />
Time,<br />
Control,<br />
Prevention<br />
GI bleed treatment devices<br />
and irrigation accessories<br />
to address your GI bleed<br />
management needs.<br />
Carr-Locke<br />
injection needle<br />
a STERIS company<br />
HaemoCer<br />
Endoscopic Applicator<br />
SmartBand ® multi-band<br />
ligation system
TRIAGE GASTROSCOPY<br />
REFERRALS WITH<br />
GASTROPANEL®<br />
A first-line test for the stomach<br />
BIOHIT HealthCare’s GastroPanel® is a simple<br />
and effective non-invasive test to diagnose<br />
advanced atrophic gastritis and Helicobacter<br />
pylori (<br />
H. pylori) in patients presenting with<br />
dyspepsia and upper abdominal symptoms.<br />
Atrophic gastritis – a chronic condition of the gastric mucosa,<br />
is considered to be the greatest independent risk factor for<br />
developing gastric cancer and current guidance recommends<br />
that individuals with extensive gastric atrophy undergo<br />
regular endoscopic surveillance to closely monitor their<br />
disease progression. Early detection of those individuals with<br />
a significant risk of developing gastric cancer is the key to<br />
effective patient management, helping to reduce unnecessary<br />
referrals, and improving survival rates through earlier<br />
diagnoses.<br />
GastroPanel measures three stomach-specific biomarkers,<br />
enabling a thorough and objective investigation of the whole<br />
gastric mucosa, non-invasively, and offers clinicians more<br />
confidence in their diagnoses or referrals.<br />
GastroPanel is a simple, effective and low cost blood test<br />
that, through extensive validation, has consistently proven<br />
to be effective in the determination of chronic atrophic<br />
gastritis, acid output disorders, and other diseases of the<br />
gastric mucosa resulting from a H. pylori<br />
infection. When<br />
GastroPanel is positive, it helps direct appropriate and<br />
effective treatment plans, including, eradication therapy,<br />
surveillance gastroscopy, and antacid prescription.<br />
Where endoscopy resources and capacity are<br />
stretched, GastroPanel helps select cases for<br />
gastroscopy.<br />
Figure 1. GastroPanel measures plasma concentrations of<br />
Pepsinogen I, Pepsinogen II, Gastrin-17 and H. pylori<br />
IgG.<br />
This patient-friendly blood test can help transform the<br />
referral pathway for upper GI investigations by identifying<br />
those who need enhanced endoscopy with biopsies.<br />
Implementing GastroPanel could help to relieve the burden<br />
on overstretched gastroscopy services, streamline referrals<br />
for higher-risk patients, and effectively rule-out atrophic<br />
gastritis for others.<br />
Scan to find out more or visit www.biohithealthcare.co.uk<br />
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info@biohithealthcare.co.uk<br />
www.biohithealthcare.co.uk
CONTENTS<br />
CONTENTS<br />
4 EDITORS COMMENT<br />
11 FEATURE Quality assessment of Clinical Practice Guidelines<br />
(CPG) for the diagnosis and treatment of<br />
infl ammatory bowel disease using the AGREE II<br />
instrument: a systematic review<br />
24 FEATURE The cost of illness analysis of infl ammatory bowel<br />
disease<br />
31 COMPANY NEWS<br />
This issue edited by:<br />
Aaron Bhakta<br />
c/o Media Publishing Company<br />
Greenoaks<br />
Lockhill<br />
Upper Sapey, Worcester, WR6 6XR<br />
ADVERTISING & CIRCULATION:<br />
Media Publishing Company<br />
Greenoaks, Lockhill<br />
Upper Sapey, Worcester, WR6 6XR<br />
Tel: 01886 853715<br />
E: info@mediapublishingcompany.com<br />
www.MediaPublishingCompany.com<br />
PUBLISHING DATES:<br />
March, June, September and December.<br />
COVER STORY<br />
a STERIS company<br />
In the UK, at least 1 acute upper GI bleeding case is presented every 6<br />
minutes (1). It is vital that therapeutic devices facilitate treatments that can stop<br />
bleeding and reduce the risk of re-bleeding. STERIS offers a broad portfolio of<br />
hemostasis solutions which provide innovative products for GI emergency and<br />
advanced procedures.<br />
The SmartBand ® multi-band ligation system offers both a complete<br />
endoscopic ligation kit and a reloading pack for those cases where extra<br />
bands are required. These are designed bands to provide greater compression<br />
and gripping force than select competition.[1] Bands manufactured with and<br />
without natural rubber latex are available.<br />
The Viper hemoclip offers 1:1 rotation to ensure a precise placement with the<br />
ability to re-open and close the clip. The Viper hemoclip is now also available<br />
with a 12.5mm deployed length, allowing for maneuverability when deploying<br />
additional GI clips. Available in 11mm, 13mm and 16mm clip opening width.<br />
Padlock Clip ® Defect Closure System: Over-the-scope clip is designed to<br />
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HaemoCer PLUS is plant-based polymer which enhances the natural<br />
clotting cascade and forms a robust gelled matrix adhering to bleeding site.<br />
Endoscopic and Surgical delivery systems available. 2<br />
Carr-Locke Injection Needle: Available in 23Ga and 25Ga with 4mm and 5mm<br />
projection options, designed to minimise sheath kinking and ensure consistent<br />
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1<br />
Testing data on fi le<br />
2<br />
Haemocer Plus Brochure. BioCer Entwicklungs-GmbH Innovative Medical Devices<br />
Reference (1) https://www.researchgate.net/publication/42806793_Use_of_endoscopy_for_management_<br />
of_acute_upper_gastrointestinal_bleeding_in_the_UK_Results_of_a_nationwide_audit<br />
COPYRIGHT:<br />
Media Publishing Company<br />
Greenoaks<br />
Lockhill<br />
Upper Sapey, Worcester, WR6 6XR<br />
PUBLISHERS STATEMENT:<br />
The views and opinions expressed in<br />
this issue are not necessarily those of<br />
the Publisher, the Editors or Media<br />
Publishing Company.<br />
Next Issue Summer <strong>2023</strong><br />
Subscription Information – <strong>Spring</strong> <strong>2023</strong><br />
<strong>Gastroenterology</strong> <strong>Today</strong> is a quarterly<br />
publication currently sent free of charge to<br />
all senior qualifi ed Gastroenterologists in<br />
the United Kingdom. It is also available<br />
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GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
3
EDITORS COMMENT<br />
EDITORS COMMENT<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
“With the<br />
number of<br />
people in<br />
the UK living<br />
with multiple<br />
long-term<br />
conditions<br />
on the rise<br />
and an<br />
increasing life<br />
expectancy,<br />
the economic<br />
and social<br />
burden of<br />
chronic<br />
conditions<br />
is more<br />
apparent than<br />
ever.”<br />
The cost of chronic disease<br />
Chronic conditions such as diabetes mellitus, rheumatoid arthritis and inflammatory bowel<br />
disease to name a few, all have a considerable impact on healthcare resources.<br />
With the number of people in the UK living with multiple long-term conditions on the rise<br />
and an increasing life expectancy, the economic and social burden of chronic conditions is<br />
more apparent than ever.<br />
In this edition of <strong>Gastroenterology</strong> <strong>Today</strong>, we feature a study analysing the economic burden<br />
of inflammatory bowel disease in Iran. This appears to be wide-ranging, from the direct<br />
costs of treatment to productivity losses at work.<br />
The global prevalence of inflammatory bowel disease is increasing, and clinicians and policy<br />
makers alike are looking for innovative ways to tackle the burden of this disease. Home<br />
faecal calprotectin tests for monitoring treatment response are one such technology and we<br />
include an article on the patients’ perspectives.<br />
Aaron Bhakta<br />
St George’s Hospital<br />
4
ADVERTORIAL FEATURE<br />
ADVERTORIAL FEATURE<br />
INFECTION PREVENTION AND<br />
HIGH-QUALITY PULMONARY<br />
CARE IN OPERATING THEATRES<br />
Infection prevention and control are crucial for guaranteeing patient safety<br />
in operating theatres. When it comes to endoscopy, meticulous cleaning<br />
and high-level disinfection is needed to ensure clean and safe use of<br />
endoscopes, on subsequent patients.<br />
In particular, bronchoscopy has a high risk of infection, making the need for<br />
sterile, accessible instruments vital. Single use consumables can address<br />
the main concerns for potential infection risk: the distal tip/elevator, the<br />
valves, and the channels. They are ready-to-use, with no hospital sterilisation<br />
needed. Although single-use scopes cannot be re-used, resulting in more<br />
waste and sustainable challenges, specific settings such as the Intensive<br />
Care Unit (ICU) cannot afford to completely avoid disposable parts. They are<br />
needed to provide the hygiene level necessary for high-risk patients.<br />
Enabling doctors to assess each situation and choose what is best for the<br />
patient on a case-by-case basis, is at the core of what PENTAX Medical<br />
believes in. The ultimate goal is to empower doctors with the Power of Choice<br />
(PoC) to best treat each patient and minimise the risk of infection, instead of<br />
letting the product decide what’s best for the patient – and the planet.<br />
In this way, they can ultimately make smarter and more sustainable choices.<br />
the picture quality is also very good. It is important to note that most of the<br />
time we work in the afternoon, at night or during weekends and holidays –<br />
when access to sterilization is limited. We use single-use equipment and<br />
the PENTAX Medical ONE Pulmo meets our requirements perfectly.<br />
It has been designed in a way that it can be used as identically and intuitively<br />
as multiple-use equipment. Anyone with any experience in using multiple-use<br />
bronchoscopes can work with PENTAX Medical ONE Pulmo.<br />
When do you believe PENTAX Medical ONE Pulmo<br />
best supports patients in bronchoscopy and in the ICU?<br />
Protecting patients from catching infections from others is very important and<br />
we know that in general, ICU patients suffer from infections. When the patient<br />
is deteriorating rapidly and we need to perform a bronchoscopy straight<br />
away, single-use equipment is essential. PENTAX Medical ONE Pulmo<br />
comes in sterile packaging, which is easy to open; we can use it in any part<br />
of the operating theatre very quickly. It also ensures microbiological safety.<br />
From a workflow perspective, where do you see<br />
the most benefit for single use bronchoscopes,<br />
such as PENTAX Medical ONE Pulmo for the ICU?<br />
The PENTAX Medical ONE Pulmo meets every demand when it comes to<br />
diagnostic procedures in the ICU. The main applications in the ICU in terms<br />
of diagnostic work are diagnosing atelectasis, bronchial anastomosis or, in<br />
case of surgery, the condition of a graft after a lung transplant.<br />
One way of intubating difficult respiratory tracks is using a scope. In my<br />
experience, PENTAX Medical ONE Pulmo does the job very well and<br />
is an essential element of safety concerning difficult respiratory tracts.<br />
For example, adjusting the placement of the double-lumen tube via<br />
bronchoscopy is very important on a daily basis in the operating theatre.<br />
We have used PENTAX Medical ONE Pulmo with the 3.4 mm diameter.<br />
This bronchoscope is narrow enough to be used when placing the tube<br />
assessing both the tracheal and bronchial lumen. For double-lumen tubes,<br />
sizes between 35 and 41 French work in 99% of the cases of adult patients.<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
6<br />
Dr Mariusz Skrzypczak and the PENTAX Medical ONE Pulmo<br />
Providing innovative endoscopic solutions means understanding clinicians’<br />
needs to optimally treat patients, based on their specific condition – be it<br />
reusable, semi-disposable or single use solutions. The PENTAX Medical<br />
ONE Pulmo single-use bronchoscope was developed to enhance infection<br />
prevention without compromising on high-quality pulmonary care, especially<br />
for situations where a risk patient is involved – either immunocompromised<br />
or with a disease. We spoke to Dr Mariusz Skrzypczak, MD, Head of<br />
the Department of Anaesthesiology and Intensive Care, Pulmonology<br />
and Thoracic Surgery Center in Poznań, Poland, who shared his clinical<br />
experience with this solution in the ICU.<br />
What, in your opinion, are urgent unmet<br />
clinical needs that PENTAX Medical ONE Pulmo<br />
addresses for surgeons and staff in the ICU?<br />
We expect intensive care equipment to be easily accessible, always at hand<br />
and reliable. The PENTAX Medical ONE Pulmo has all these features and<br />
matches our expectations. Its monitor is light, its battery life is excellent, and<br />
Medical device manufacturers must act as smart innovators in endoscopy,<br />
offering intelligent solutions for the best possible treatment of patients,<br />
adapted to each situation. In the operating theaters, single-use<br />
bronchoscopes provide a safer way to perform procedures and can be<br />
easily added into the pre-existing solutions within a clinician’s endoscopy<br />
suite to simplify workflow, providing an alternative that can be used on a<br />
case-by-case basis. PENTAX Medical is committed to address the hygiene<br />
challenges in endoscopy by offering solutions that minimize risks of infection,<br />
improve clinical outcomes, enhance provider experience, and increase<br />
healthcare productivity, all the while incorporating sustainable thinking in<br />
every aspect of its value chain.<br />
Scan the QR code<br />
to get the full story.
ADVERTORIAL FEATURE<br />
CALPROTECTIN HOME TESTING -<br />
WHAT DO THE PATIENTS THINK?<br />
By Amanda Appleton, Senior Diagnostics Product Manager, Alpha Laboratories Ltd.<br />
The demands on healthcare resources continue<br />
to escalate, with the COVID pandemic having<br />
exacerbated the existing pressures from an aging<br />
population living longer and with more complex<br />
health conditions. Changes to traditional practices<br />
are essential if healthcare services are to keep pace<br />
with the increased demands.<br />
Developments in digital App technology have the ability not only to<br />
improve the health of patients, but also to save money, through rapid<br />
optimisation of treatment. They enable early interventions through<br />
monitoring, before conditions get too serious and reduce the need<br />
for routine check-up appointments and procedures. This frees up<br />
limited resources in both pathology and the clinic.<br />
The BÜHLMANN IBDoc was the fi rst calprotectin home test to be<br />
introduced to the market back in 2015. Since then, there have been<br />
numerous publications demonstrating the correlation of the IBDoc<br />
result from the test performed by the patient in their own home, to<br />
the results of professional laboratory analyses. More importantly there<br />
is also evidence of the correlation to the IBDoc calprotectin results to<br />
the endoscopic and histologic fi ndings of disease status. From the<br />
clinical perspective the test undoubtedly fi ts the bill.<br />
Dr Pushpakaran Munuswamy, Department Lead. <strong>Gastroenterology</strong>,<br />
Basildon University Hospital introduced the IBDoc to support their<br />
IBD patients in the summer of 2020 commented that:<br />
“Anecdotally, it seems to be the older patients that are more engaged<br />
with the home testing, and even the more senior patients which<br />
has been surprising, but maybe it is to be expected. These are the<br />
patients that have lived with the consequences of the disease for<br />
longer and are keen for things not to deteriorate.”<br />
Patients’ Experience of the IBDoc Assay<br />
Overall satisfaction with the test was high:<br />
% of % of patients Patients mildly mildly to to strongly satisfied with the the IBDoc to:<br />
Time to perform the test<br />
Recording & display of the results in the App<br />
Reading the test result with the App<br />
% of Patients mildly to strongly satisfied with the IBDoc<br />
Getting the sample onto the test cassette<br />
Collecting the sample in the CALEX<br />
Time Installation to perform of the the test Ap<br />
Recording & display of the Instructions results in the for App use<br />
Reading the test result with the App78% 80% 82% 84% 86% 88% 90% 92% 94% 96%<br />
Getting the sample onto the test cassette<br />
Collecting the sample in the CALEX<br />
Installation of the Ap<br />
This high level of Instructions satisfaction for use<br />
% of patients mildly was to strongly also refl satisfied ected in that the the results IBDoc and<br />
aftercare with the IBDoc:<br />
Monitor treatment success<br />
Predicted early disease relapse<br />
78% 80% 82% 84% 86% 88% 90% 92% 94% 96%<br />
“From my perspective I am seeing a difference already, because<br />
we can escalate treatment within a day or two of requesting the<br />
calprotectin test. Previously there was a wait of around 4 – 6 weeks<br />
or even longer depending on when the sample is taken and the<br />
capacity in the labs. Hopefully, in the future we will see the benefi ts<br />
of this rapid response in terms of reduced hospitalisations and clinic<br />
visits because patients have had timely interventions. It will also<br />
reduce calls to the helpline because we know the results and have<br />
been able to act quickly.”<br />
But, how do the patients feel about the changes that have been<br />
introduced? Kezia Allen Pathology project specialist conducted a<br />
survey after the IBDoc had been in use for 2 years, with around 250<br />
patients actively using the system in Basildon.<br />
Responses to the survey were received from 22% of eligible patients<br />
with two thirds being female and a third being male. Roughly two<br />
thirds had Crohn’s disease and a third had Ulcerative colitis. The<br />
mean age of the respondents was 43 years ranging from 22 to 75<br />
years.<br />
% of % Results patients of reflected mildly the mildly clinical to status to strongly satisfied with that the the IBDoc to:<br />
Good understanding of what the result meant for their<br />
disease Monitor state treatment success<br />
Results reflected the clinical status<br />
Good understanding of what the result meant for their<br />
disease state<br />
Patient comments included:<br />
70% 75% 80% 85% 90% 95%<br />
Predicted early disease relapse<br />
70% 75% 80% 85% 90% 95%<br />
“Having the result straight away, instead of weeks waiting, is so<br />
benefi cial as you can start on the medication you require.”<br />
“Absolutely love it! I actually get upset when they send out a normal<br />
stool sample test and not the IBDoc.”<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
Continued on next page > > ><br />
7
ADVERTORIAL FEATURE<br />
Aftercare<br />
The survey showed that 94% of patients would feel satisfied with a<br />
phone consultation, rather than a face-to-face appointment, following a<br />
high result, compared to 43% who feel some level of dissatisfaction at<br />
receiving no clinical contact following a negative result.<br />
Patients know what the plan is if a high result is obtained, they will get<br />
their medication increased or switched or have further investigations so<br />
they are happier with a phone consultation.<br />
You would think a negative result would be reassuring, but possibly<br />
the worry is that with a low result they will be told nothing is wrong<br />
even though they may be feeling unwell. A low result means that<br />
the symptoms are unlikely to be caused by their IBD and need to be<br />
managed in another way. This highlights that patients do not know what<br />
to do and would still need clinical advice or better educational materials<br />
explaining the potential causes and treatments of the symptoms if they<br />
aren’t caused by IBD.<br />
The patients on the biologics verses non-biologic treatments seemed<br />
happier knowing when to use the IBDoc and knowing how to manage<br />
their condition. This is probably fairly intuitive because to get to the<br />
stage of being on biologics they have had the disease a while and it<br />
hasn’t been very easy to manage and therefore they have had to be<br />
more engaged.<br />
Improvements<br />
Some of the things that were cited by the patients that would make<br />
things easier were:<br />
accurate correlation to the laboratory results. This is continuous<br />
addressed but there is inevitably a delay.<br />
The Future<br />
I think it is a genuine candidate for patient self-management but we<br />
need to do more in educating patients and personalising the care that<br />
surrounds this. There are easier point of care tests than calprotectin<br />
testing, but the patients want it enough that they are prepared to do it<br />
and it works for them. Some have even changed phones so that they can<br />
use the system – this shows the level of engagement within the patient<br />
population and the desire to be able to access the new technology.<br />
Remote monitoring and patient self-management will be key to<br />
managing services going forwards, we just need to get the education<br />
aspect right. The IBDoc home testing works so well for a large number<br />
of our patients which means it can work well for most of them, we just<br />
have to get better at the support side so that patients are confident<br />
they understand the results and their condition and are being managed<br />
appropriately. There is probably a lot we can learn from other chronic<br />
conditions that have been historically remotely managed like diabetes,<br />
which must also have to cope with different patient groups and different<br />
levels of engagement.<br />
Whilst this type of test will never be for everyone (let’s be honest there<br />
are some patients who will just never do a stool test regardless of<br />
where it is completed), for many this type of technology is appreciated.<br />
It has the potential to help patient engagement and support remote<br />
management and personalised care.<br />
Find out more at www.calprotectin.co.uk/ibdoc<br />
• More regular contact from the IBD team, especially when starting a<br />
new treatment<br />
• More information on what causes a flare and how to control them<br />
• Access to a nutritionist/dietary advice<br />
• Better communication between the primary and secondary care<br />
providers<br />
• Access available on a wider selection of phones<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
Fundamentally the patients seem to like the actual test, most of<br />
the points raised relate to the educational and support functions<br />
that need to underpin the adoption of new technologies. The wider<br />
selection of phones is a continuously moving goalpost as new<br />
phones are released they need to be validated for use to ensure<br />
“Using the IBDoc has increased the engagement from both the patients and the clinical<br />
team, and the speed of the results really makes a big impact in decision making and<br />
patient management. It doesn’t really add more work because you save work in chasing<br />
results and additional support for patients whilst they are waiting for results.”<br />
Dr Pushpakaran Munuswamy<br />
8
ADVERTORIAL FEATURE<br />
THE MOBILE AND MODULAR SOLUTION: HOW ON-<br />
SITE THEATRES ARE TACKLING NHS WAITING LISTS<br />
Cancer waiting lists soared above record levels<br />
As of November 2022, 110,000 people were waiting for a colonoscopy,<br />
and the median wait was 4.2 weeks, double the median wait in<br />
November 2019. The referrals for lower gastrointestinal cancer on the<br />
two weeks pathway soared from 39,000 in November 2019 to 52,000<br />
in November 2022 (HSJI). To tackle the soaring cancer waiting lists,<br />
the NHS has been implementing various diagnostic services and<br />
facilities, including one-stop clinics for tests and symptom hotlines.<br />
One of the most successful initiatives has been the use of mobile and<br />
modular theatre units, which has helped to reduce waiting lists while<br />
keeping procedures separate from main hospital buildings to ensure<br />
infection control.<br />
What to expect when working in a mobile endoscopy suite<br />
Dr. Matthew Banks, <strong>Gastroenterology</strong> Clinical Lead for 18 Week<br />
Support, states that the experience of endoscopists working in a<br />
stand-alone ‘cold site’ can be rapid and relatively straightforward.<br />
Carrying out endoscopy procedures in a mobile or semi-permanent<br />
endoscopy suite requires flexibility and adaptability, and staff need<br />
to be familiar with the unit, layout, equipment, and IT. Once familiar,<br />
the experience is very much like scoping in any endoscopy unit.<br />
However, staff need to be aware of the limitations and that complex<br />
therapeutics and high-risk patients are usually avoided.<br />
Working with mobile theatre units to support the rising waiting<br />
times<br />
Here at 18 Week Support, the UK’s #1 insourcing provider, we provided<br />
specialist endoscopy teams for several Trusts where they staff and<br />
operate mobile theatre units contracted from specialist providers.<br />
We have helped over 55 Trusts across the UK carry out a full range of<br />
endoscopy procedures, either in-house or in mobile theatres, during<br />
and after the COVID-19 pandemic. The success of these mobile and<br />
modular theatre suites has led many Trusts to include them in their<br />
planning to reduce waiting lists, adding new theatre capacity quickly and<br />
cost-effectively.<br />
Final thoughts<br />
In conclusion, mobile and modular theatre units have proven to be a<br />
successful initiative in reducing waiting lists while keeping procedures<br />
separate from main hospital buildings. Working in a stand-alone ‘cold<br />
site’ requires flexibility and adaptability, and staff need to be aware<br />
of the limitations. Good leadership and clinical knowledge and skills<br />
are essential for working in this environment. Finally, the quality and<br />
performance of the endoscopy teams are critical to achieving high<br />
patient satisfaction and safety, especially when working for third-party<br />
organizations like 18 Week Support.<br />
Those working in insourcing teams like 18 Week Support will often<br />
find themselves working with different nurses throughout the week.<br />
Leadership, patience, and understanding are needed to ensure<br />
constant quality delivery. Each unit team typically has a Nurse<br />
in Charge (NIC) who runs the day and the lists. For consultants,<br />
focusing on their role as the endoscopist is key, and working as a<br />
team is essential in ensuring all patients are managed appropriately.<br />
Another difference arises from working for a third-party organization<br />
within an NHS Trust framework. This relationship means that patients<br />
are not followed up by the endoscopist, histology is often not<br />
available to review after the event, and sometimes clinical information<br />
can be quite limited. Moreover, because of the COVID pandemic,<br />
the endoscopist is often the first ‘face-to-face’ consultation the<br />
patient has had in two years.<br />
The pre-procedure process is therefore crucial to understanding the<br />
patient’s concerns and ensuring the correct procedure is completed<br />
or occasionally no procedure performed at all. The quality and<br />
performance of the 18 Week Support teams are reflected in their JAG<br />
data and patient satisfaction scores, which are exemplary across the<br />
UK. Recruiting high-performing endoscopists that are passionate<br />
about their work helps ensure 18 Week Support’s JAG safety and<br />
quality data is above the national average. On December 10th-11th<br />
2022, 18 Week Support carried out 387 colonoscopies across 14<br />
Trusts, recording a patient comfort score of 99%, with a 97% score<br />
on ERS.<br />
Reference: Stubborn cancer backlog at record high | HSJ Intelligence -<br />
https://www.hsjintelligence.co.uk/news/stubborn-cancer-backlogrecord-high<br />
If you want to help clear the NHS backlog and provide high quality<br />
care to patients, please reach out to us at:<br />
recruitment.team@18weeksupport.com.<br />
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FEATURE<br />
QUALITY ASSESSMENT OF CLINICAL PRACTICE<br />
GUIDELINES (CPG) FOR THE DIAGNOSIS AND<br />
TREATMENT OF INFLAMMATORY BOWEL<br />
DISEASE USING THE AGREE II INSTRUMENT:<br />
A SYSTEMATIC REVIEW<br />
R. Zambrano-Sánchez 1 , P. Alvarez-Mena 1 , D. Hidalgo 2 , C. M. Escobar Liquitay 3 , J. V. A. Franco 4 , R. W. M. Vernooij 5 , D.<br />
Simancas-Racines 6 , A. Viteri-García 6 and C. Montesinos-Guevara 6*<br />
BMC <strong>Gastroenterology</strong> (2022) 22:447 https://doi.org/10.1186/s12876-022-02539-9<br />
Abstract<br />
Background<br />
The incidence and diagnosis of infl ammatory bowel disease (IBD)<br />
has increased considerably in recent years. Many clinical practice<br />
guidelines (CPG) have been developed for the management of this<br />
disease across different clinical contexts, however, little evidence exists<br />
on their methodological quality. Therefore, we aimed to systematically<br />
evaluate the quality of CPGs for the diagnosis and treatment of IBD<br />
using the Appraisal of Guidelines for Research and Evaluation (AGREE<br />
II) instrument.<br />
Methods<br />
We identifi ed CPGs by searching databases (MEDLINE - PubMed,<br />
EMBASE, CINAHL, LILACS) and other sources of gray literature on<br />
January 2022. We included guidelines with specifi c recommendations<br />
for the diagnosis and treatment of IBD and evaluated them with<br />
the AGREE II instrument to assess their methodological quality. Six<br />
independent reviewers assessed the quality of the guidelines and<br />
resolved confl icts by consensus. We assessed the degree of agreement<br />
using the intraclass correlation coeffi cient (ICC) and change in quality<br />
over time was appraised in two periods: from 2012 to 2017 and from<br />
2018 to 2022.<br />
Keywords<br />
Infl ammatory bowel disease, Crohn disease, Ulcerative colitis, Clinical<br />
practice guidelines, Systematic review.<br />
Introduction<br />
Ulcerative colitis and Crohn’s disease are the main forms of infl ammatory<br />
bowel disease (IBD). Both pathologies involve chronic infl ammation of<br />
the gastrointestinal tract and show heterogeneity in terms of symptoms,<br />
which mainly include abdominal pain and diarrhea associated with<br />
malabsorption, weight loss and fever [1]. IBD involves periods of<br />
relapse and remission [2]. Although its etiology is unknown, it has been<br />
considered a multifactorial disease due to its association to genetic<br />
factors [3], immune mediators [4], changes in the intestinal microbiome<br />
[5] and exposure to various environmental agents [6].<br />
The onset of IBD generally occurs around the third decade of life, but<br />
25% of cases begin during childhood and adolescence [7]. The peak<br />
age of onset for Crohn’s disease is generally between 20 and 30 years<br />
of age, while Ulcerative Colitis usually begins at around 30 and 40 years<br />
of age [8].<br />
Results<br />
We analyzed and evaluated 26 CPGs that met the inclusion criteria. The<br />
overall agreement among reviewers was moderate (ICC: 0.74; 95% CI<br />
0.36 - 0.89). The mean scores of the AGREE II domains were: “Scope<br />
and purpose” 84.51%, “Stakeholder involvement” 60.90%, “Rigor of<br />
development” 69.95%, “Clarity of presentation” 85.58%, “Applicability”<br />
26.60%, and “Editorial independence” 62.02%. No changes in quality<br />
were found over time.<br />
Conclusions<br />
The quality of the CPGs evaluated was generally good, with a large<br />
majority of the assessed guidelines being “recommended” and<br />
“recommended with modifi cations”; despite this, there is still room<br />
for improvement, especially in terms of stakeholder involvement and<br />
applicability. Efforts to develop high quality CPGs for IBD need to be<br />
further optimized.<br />
The incidence and prevalence of IBD vary according to the geographic<br />
location, environment and ethnicity [9]. The latest reported data on the<br />
incidence of Ulcerative Colitis in North America and Europe ranged<br />
from 0 to 19.2 per 100,000 and 0.6 to 24.3 per 100,000, respectively<br />
[10]; whereas the prevalence of Ulcerative Colitis was 37.5 to 248.6 per<br />
100,000 in North America and 4.9 to 505 per 100,000 in Europe [11].<br />
For Crohn’s disease, the incidence varied from 0 to 20.2 per 100,000<br />
in North America and from 0.3 to 12.7 per 100,000 in Europe [10].<br />
In Latin America these data have considerable differences, however,<br />
in the last decades there has been a progressive increase with a<br />
prevalence of 0.99 to 44.3 per 100,000 inhabitants for Ulcerative Colitis<br />
and 0.24 to 16.7 per 100,000 inhabitants for Crohn’s disease [12, 13].<br />
Epidemiological data suggest that the global incidence of IBD presents<br />
a marked increase, implying that the health systems of developing<br />
countries do not have the resources, health staff and infrastructure<br />
necessary for the diagnosis and treatment of the pathology.<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
* Correspondence: camila.montesinos@ute.edu.ec<br />
6<br />
Centro de Investigación en Salud Pública y Epidemiologia Clínica, (CISPEC), Facultad de Ciencias de la Salud Eugenio Espejo. Universidad UTE, Rumipamba and Bourgeois, Universidad<br />
UTE, 170147 Quito, Ecuador. Full list of author information is available at the end of the article<br />
© The Author(s) 2022.<br />
11
FEATURE<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
Considering the increasing prevalence of IBD and its impacts in terms<br />
of health, society and economy (direct and indirect costs for the health<br />
systems and out-of-pocket expenses) [13], it is important to ensure high<br />
quality tools that facilitate its systematized treatment. For this reason,<br />
in the last decade, there have been important advances in terms of<br />
therapies for the management of IBD through pharmacological, nonpharmacological<br />
and surgical interventions [14, 15], these advances<br />
have been translated into several Clinical Practice Guidelines (CPG),<br />
which quality has not yet been assessed.<br />
CPGs are systematically developed statements intended to help<br />
physicians and patients to make decisions about appropriate medical<br />
care in specific circumstances based on high-quality scientific<br />
evidence [16]. Their recommendations are intended to improve the<br />
quality of patient care by encouraging interventions of proven benefit<br />
and discouraging ineffective or potentially harmful interventions [16].<br />
Several tools currently exist to assess the quality of a CPG and its<br />
implementation [17]; the AGREE (Appraisal of Guidelines, Research,<br />
and Evaluation) collaboration developed the AGREE II tool which is<br />
the most validated and widely used tool [18, 19]. This tool is helpful to<br />
assess the transparency in guidelines development and their quality,<br />
it provides a methodological strategy for guidelines development,<br />
and establishes a scheme for their reporting [20]. The AGREE II tool<br />
can be applied in Clinical Practice Guidelines (CPG) for diagnosis and<br />
medical interventions as well as for the evaluation of guidelines on health<br />
promotion, public health, among others [20].<br />
Therefore, the main objective of this study is to systematically evaluate<br />
CPG for the diagnosis and treatment of IBD using the AGREE II tool, to<br />
provide evidence on their methodological quality and to assess changes<br />
in guideline quality over time.<br />
Methods<br />
Data Search<br />
A systematic search was performed up to January 2022 to look for<br />
CPG on the diagnosis and treatment of IBD. CPGs were searched<br />
on databases (MEDLINE - PubMed, EMBASE, CINAHL, LILACS),<br />
professional societies (CAG, British Society of <strong>Gastroenterology</strong>,<br />
AGA, Brazilian Society of <strong>Gastroenterology</strong>), registries and guideline<br />
developers’ websites (NICE, SIGN). The full search strategy is detailed<br />
in Additional file 1: https://static-content.springer.com/esm/art%3A1<br />
0.1186%2Fs12876-022-02539-9/MediaObjects/12876_2022_2539_<br />
MOESM1_ESM.docx<br />
Inclusion and exclusion criteria<br />
We included: 1.- CPGs with specific recommendations for the diagnosis<br />
and treatment of IBD, both for Crohn’s disease (CD) and ulcerative colitis<br />
(UC); 2.- CPGs on IBD that included pediatric, young, adult, and elderly<br />
populations; 3. - CPGs that provide the full search strategy that was<br />
conducted; 4.- CPGs that mentioned the process how they reached<br />
recommendations; 6.- CPGs published without date restriction until January<br />
2022; and 6.- Last published available version of CPGs. The following<br />
documents were excluded: 1.- CPGs exclusively dealing with other clinical<br />
scenarios such as diagnostics (e.g. endoscopic, imaging), nutrition,<br />
immunological or surgical interventions for IBD; 2.- secondary publications<br />
(e.g., systematic reviews and meta-analyses) and 3.- abstracts from CPGs.<br />
Data Collection<br />
Five reviewers working in pairs (DH, CMG, PA, RZ, RV) independently<br />
peer-screened the guidelines by title and abstract following the above<br />
inclusion and exclusion criteria. If the inclusion criteria were met, the<br />
full-text article were retrieved and screened by pairs for eligibility. All<br />
the screening process was performed using Rayyan (Rayyan Systems<br />
Inc) [21]. Two reviewers independently extracted the following data<br />
for each CPG: title, year of publication, submitting organization, type<br />
of funding, method used to collect evidence, number of sources<br />
documented, methods used to assess the quality and validity of the<br />
evidence, methods used to formulate the recommendations, country,<br />
and language. In case of disagreement, a third reviewer (VA, DSR)<br />
was involved.<br />
Quality assessment<br />
The AGREE II instrument [18-20, 22] was used to evaluate the quality<br />
of the included CPGs. This instrument provides criteria for assessing<br />
the quality of the clinical practice guidelines through 23 items or<br />
questions, divided into 6 domains or categories; including: 1.- scope<br />
and purpose, 2.- stakeholder involvement, 3.- rigor of development,<br />
4.- clarity of presentation, 5.- applicability, and 6.- editorial<br />
independence. The first domain evaluates the general objective of<br />
the CPG, specific health aspects and the target population; the<br />
second domain refers to the degree to which the guideline has been<br />
developed by the appropriate stakeholders and represents the views<br />
of intended users; the third domain refers to the process used to<br />
gather and synthesize evidence, the methods used to formulate<br />
and update recommendations; the fourth domain focuses on the<br />
language, structure and format of the guideline; the fifth domain<br />
refers to barriers and facilitators to CPG implementation, strategies<br />
for its adoption and resource considerations; and finally, the sixth<br />
domain is about the formulation of recommendations, to understand<br />
whether they are biased by conflicts of interest [19].<br />
Each of the 23 items or questions is classified on a 7-point Likerttype<br />
scale, 7 being the maximum score corresponding to “strongly<br />
agree” and 1 the minimum score corresponding to “strongly<br />
disagree”.<br />
For the global guideline evaluation, we used a 3-point scale: 1<br />
“not recommended”, 2 “recommended with modifications” and 3<br />
“recommended”. Six reviewers (DH, CMG, PA, RZ, JAF, RV), with<br />
clinical and methodological expertise, independently peer-scored<br />
each of the 23 items of the 6 domains of the AGREE II instrument<br />
for each CPG that was included. In case of disagreements with the<br />
assessment, a consensus was reached with the support of a third<br />
reviewer (AV, DSR).<br />
Statistical analysis<br />
A descriptive analysis of the CPGs was performed using the general<br />
characteristics of each CPG from the extracted data. To calculate<br />
the score for each domain of the AGREE II tool, all item scores were<br />
summed up and the total value was standardized as a percentage of the<br />
maximum possible score for that domain, using the following formula:<br />
Standardized score (SP) = score obtained - lowest possible score<br />
highest possible score - lowest possible score<br />
× 100<br />
12
FEATURE<br />
Table 1 General characteristics of the CPGs<br />
Guideline Country Organization Year Method used to asses quality and strength of<br />
evidence<br />
AGA Clinical Practice Guidelines on the Management of<br />
Mild-to-Moderate Ulcerative Colitis [28]<br />
ESPGHAN Revised Porto Criteria for the Diagnosis of<br />
Inflammatory Bowel Disease in Children and Adolescents<br />
[29]<br />
ACG Clinical Guideline: Management of Crohn’s Disease<br />
in Adults [30]<br />
European evidence based consensus on surgery for<br />
ulcerative colitis [31]<br />
Updated German Clinical Practice Guideline on “Diagnosis<br />
and treatment of Crohn’s disease” 2014 [32]<br />
Consensus guidelines of ECCO/ESPGHAN on the medical<br />
management of pediatric Crohn’s disease [33]<br />
Management of paediatric ulcerative colitis, Part 1: ambulatory<br />
care- an evidence-based guideline from ECCO and<br />
ESPGHAN [34]<br />
Evidence-based clinical practice guidelines for Crohn’s<br />
disease, integrated with formal consensus of experts in<br />
Japan [35]<br />
Diagnosis and treatment of inflammatory bowel disease:<br />
First Latin American Consensus of the Pan American<br />
Crohn’s and Colitis Organisation [36]<br />
Mexican consensus for the diagnosis and treatment of<br />
idiopathic chronic ulcerative colitis [37]<br />
Crohn’s disease Management in adults, children and<br />
young people [38]<br />
Second Korean guidelines for the management of ulcerative<br />
colitis [39]<br />
AGA Clinical Practice Guidelines on the Management of<br />
Moderate to Severe Ulcerative Colitis [40]<br />
Evidence-based clinical practice guidelines for inflammatory<br />
bowel disease [41]<br />
USA American Gastroenterological Association (AGA) 2019 GRADE a<br />
UK European Society of Pediatric <strong>Gastroenterology</strong>, Hepatology<br />
and Nutrition (ESPGHAN)<br />
USA American College of <strong>Gastroenterology</strong> 2018 GRADE<br />
2013 Oxford Centre for Evidence-Based Medicine<br />
Multinational European Crohn’s and Colitis Organization (ECCO) 2014 Oxford Center for Evidence-Based Medicine<br />
Germany German Society for gastroenterology, digestive and<br />
metabolic diseases (DGVS) with the participation of<br />
Deutsche Gesellschaft for General and Visceral Surgery<br />
(DGAV), German Society of Surgery (DGCh), German<br />
Society for Internal Medicine (DGIM), German Society<br />
for Coloproctology (DGK), German Morbus Crohn’s /<br />
ulcerative colitis association (DCCV), Society for pediatric<br />
gastroenterology and nutrition (GPGE), Competence<br />
Network for Inflammatory Bowel Diseases.<br />
Multinational European Crohn’s and Colitis Organization (ECCO /<br />
ESPGHAN)<br />
Israel Shaare Zedek Medical Center, The Hebrew University of<br />
Jerusalem, Israel.<br />
Japan Japanese Society of <strong>Gastroenterology</strong> and the Research<br />
group of Intractable Bowel Disease subsidized by the<br />
Ministry of the Health, Labour and Welfare of Japan<br />
2014 Oxford Center for Evidence-Based Medicine<br />
2014 Oxford Center for Evidence-Based Medicine<br />
2018 Oxford Centre for Evidence-Based Medicine<br />
2013 Self-grading scheme used to assess the quality of the<br />
evidence<br />
Mexico Pan American Crohn’s and Colitis Organization 2016 Oxford Center for Evidence-Based Medicine<br />
Mexico Mexican Association of <strong>Gastroenterology</strong> 2017 GRADE<br />
UK NICE National institute for health care and excellence 2012 GRADE<br />
Korea Korean Association for the Study of Intestinal Diseases 2017 GRADE<br />
(KASID)<br />
USA AGA American Gastroenterological Association 2020 GRADE<br />
Japan The Japanese Society of <strong>Gastroenterology</strong> (JSGE) 2018 GRADE<br />
Ulcerative colitis - treatment with biologicals [42] Brazil Brazilian Study Group on Inflammatory Bowel Disease,<br />
Brazilian Medical Association<br />
2018 GRADE<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
13
FEATURE<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
Table 1 (continued)<br />
Guideline Country Organization Year Method used to asses quality and strength of<br />
evidence<br />
British Society of <strong>Gastroenterology</strong> consensus guidelines<br />
on the management of inflammatory bowel disease in<br />
adults [43]<br />
Canadian Association of <strong>Gastroenterology</strong> Clinical Practice<br />
Guideline for the Medical Management of Pediatric<br />
Luminal Crohn’s Disease [44]<br />
Clinical Practice Guideline for the Medical Management<br />
of Perianal Fistulizing Crohn’s Disease: The Toronto<br />
Consensus [45]<br />
Crohn’s disease - treatment with biological medication<br />
[46]<br />
Canadian Association of <strong>Gastroenterology</strong> Clinical Practice<br />
Guideline for the Management of Luminal Crohn’s<br />
Disease [47]<br />
Evidence-based clinical practice guidelines for inflammatory<br />
bowel disease 2020 [48]<br />
AGA Clinical Practice Guidelines on the Medical Management<br />
of Moderate to Severe Luminal and Perianal Fistulizing<br />
Crohn’s Disease [49]<br />
WSES-AAST guidelines: management of inflammatory<br />
bowel disease in the emergency setting [50]<br />
The Medical Management of Paediatric Crohn’s Disease:<br />
an ECCO-ESPGHAN Guideline Update [51]<br />
Guidelines for the management of patients with Crohn’s<br />
disease. Recommendations of the Polish Society of<br />
<strong>Gastroenterology</strong> and the Polish National Consultant in<br />
<strong>Gastroenterology</strong> [52]<br />
ECCO Guidelines on Therapeutics in Crohn’s Disease:<br />
Medical Treatment [53]<br />
UK British Society of <strong>Gastroenterology</strong> and others 2019 GRADE<br />
Canada Canadian Association of <strong>Gastroenterology</strong> (CAG) 2019 GRADE<br />
Canada Canadian Association of <strong>Gastroenterology</strong> (CAG) 2018 GRADE<br />
Brazil Brazilian Study Group on Inflammatory Bowel Disease, Brazilian <strong>Gastroenterology</strong> Federation, Brazilian Coloproctology<br />
Society, Brazilian Medical Association<br />
2018 GRADE<br />
Canada Canadian Association of <strong>Gastroenterology</strong> (CAG) 2019 GRADE<br />
Japan The Japanese Society of <strong>Gastroenterology</strong> (JSGE) 2021 GRADE<br />
USA AGA American Gastroenterological Association 2021 GRADE<br />
Netherlands The World Society of Emergency Surgery WSES 2021 GRADE<br />
Multinational European Crohn’s and Colitis Organization [ECCO] and<br />
the Paediatric IBD Porto group of the European Society<br />
of Paediatric <strong>Gastroenterology</strong>, Hepatology and Nutrition<br />
[ESPGHAN]<br />
Poland The Polish Society of <strong>Gastroenterology</strong> and the Polish<br />
National Consultant in <strong>Gastroenterology</strong><br />
2021 Oxford Center for Evidence-Based Medicine<br />
2021 GRADE<br />
Multinational The European Crohn’s and Colitis Organization [ECCO] 2020 GRADE<br />
a GRADE Grading of Recommendations, Assessment, Development and Evaluation<br />
14
FEATURE<br />
Fig. 1 PRISMA flow diagram showing the flow of records that were obtained and reviewed throughout the different phases of the quality<br />
assessment<br />
With this method, the standardized score for each domain ranged from<br />
0 to 100%. The result of the standardized score for each domain for all<br />
the guidelines is presented through the mean, median, first quartile (Q1),<br />
third quartile (Q3), interquartile range (IQR) and a boxplot. The degree<br />
of agreement between reviewers was assessed through the intraclass<br />
correlation coefficient (ICC) with a 95% confidence interval (CI). To<br />
visualize and compare the mean AGREE II scores obtained by the 26<br />
CPGs assessed in this study, we generated a hexagonal radar graph<br />
where each domain is represented on a radial axis centered at 0 and<br />
the maximum score of each domain corresponds to each vertex of the<br />
hexagon. Finally, for the analysis of quality change over time, Student’s<br />
t-test was used to compare the means and categorize the CPGs<br />
into two periods: 2012 to 2017 and 2018 to 2022. Data analysis was<br />
performed in the statistical software RStudio v.1.4 [23] using the libraries<br />
ggplot2 [24], irr [25], tidyverse [26] and Table 1 [27].<br />
Results<br />
Guideline characteristics<br />
Eight thousand seven hundred twenty-three records were retrieved from<br />
the search strategy and 8165 remained after deduplication. 203 records<br />
were subsequently screened by full-text, of which 26 CPGs were<br />
included for data extraction after meeting the inclusion criteria (Fig. 1).<br />
Details on the characteristics of the included CPGs are shown in Table<br />
1 [28-53].<br />
Of the 26 included CPGs, four were from the United States (15.38%)<br />
and four were developed by an international collaboration (15.38%);<br />
three were from the United Kingdom, three from Canada and three<br />
from Japan (11.53% each), two were from Brazil and two from<br />
Mexico (7.69% each); one was from Germany, Israel, South Korea,<br />
the Netherlands and Poland (3.84% each). Included guidelines were<br />
published between 2012 and 2021 (see Table 1).<br />
Three of the 26 guidelines focused exclusively on the pediatric<br />
population while the others were mainly focused on adults [29, 33,<br />
51]. In terms of the scope of the CPGs, 22 dealt with diagnosis and<br />
clinical management [28–30, 32–41, 43–45, 47–49, 51–53], two with<br />
the use of biologic drugs only [42, 46], one with surgical management<br />
in the emergency setting [50] and one with the surgical management<br />
of ulcerative colitis [31]. All guidelines were considered evidence-based<br />
according to our a priori criteria.<br />
Eighteen guidelines (69.23%) used the Grading of Recommendations<br />
Assessment, Development and Evaluation (GRADE) methodology<br />
to assess the quality of evidence and grade the strength of<br />
recommendations. Seven guidelines (26.92%) used the Oxford Centre<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
15
FEATURE<br />
Table 2 Intraclass correlation coefficients (ICC) by peer reviewers<br />
Pair of reviewers ICC 95% CI *P-value a ICC interpretation<br />
RZ + PA 0.69 0.02 - 0.90 0.020 Moderate<br />
CM+JF Table 2 Intraclass 0.74correlation −0.07 - 0.97 coefficients 0.065 (ICC) Moderate by peer reviewers<br />
DH+RV Pair of reviewers 0.03 ICC −0.03 95% - CI 0.74 0.292 *P-value Poor a ICC interpretation<br />
DH+JF 0.69 −0.15 - 0.99 0.093 moderate<br />
RZ+PA 0.69 0.02 - 0.90 0.020<br />
Global 0.74 0.36 - 0.89 6.83e −4 Moderate<br />
moderate<br />
CM+JF 0.74 −0.07 - 0.97 0.065 Moderate<br />
*Significance level < 0.05<br />
DH+RV 0.03 −0.03 - 0.74 0.292 Poor<br />
a<br />
ICC interpretation following Ko and Li 2016 [53]<br />
DH+JF 0.69 −0.15 - 0.99 0.093 moderate<br />
Global 0.74 0.36 - 0.89 6.83e −4 moderate<br />
for Evidence-Based *Significance level < Medicine 0.05 criteria, and one guideline (3.84%) used a<br />
a<br />
ICC interpretation following Ko and Li 2016 [53]<br />
self-grading system to assess the quality of evidence (Table 1).<br />
Quality assessment<br />
The agreement between the 6 reviewers was moderate with an ICC of<br />
0.74 (95% CI: 0.36-0.89, p-value=6.83e −4 ). A summary of the ICCs<br />
achieved by each pair of reviewers is shown in Table 2.<br />
Figure 2 shows a boxplot summarizing the statistical analysis of the<br />
standardized scores for each domain assessed with the AGREE II<br />
tool. In addition, Table 3 shows the standardized scores for all domain<br />
assessed in each clinical practice guideline.<br />
Domain 1: Scope and purpose<br />
This domain evaluates the general objective of the CPG, specific health<br />
aspects and the target population [19]. The mean score was 84.51%<br />
(median: 90.27%, Q1: 78.47%, Q3: 94.44% and IQR=15.97%; Fig. 2).<br />
Twenty-four CPGs (92.30%) scored above 60% in this domain [28, 29,<br />
31–36, 38–53]. See Table 3 for details on domain 1.<br />
Domain 2: Stakeholder involvement<br />
This domain refers to the degree to which the guideline has been<br />
developed by the appropriate stakeholders and represents the views<br />
of intended users [19]. The mean score was 60.90% (median: 66.67%,<br />
Q1: 36.11%, Q3: 83.33% and IQR=47.22%; Fig. 2). Fourteen CPGs<br />
(53.84%) scored above 60% in this domain [32, 38, 40, 41, 43–45,<br />
47–53]. See Table 3 for details on domain 2.<br />
Domain 3: Rigor of development<br />
This domain refers to the process used to gather and synthesize<br />
evidence, the methods used to formulate and update recommendations<br />
[19]. The mean score was 69.95% (median: 69.79%, Q1: 58.07%, Q3:<br />
86.20% and IQR=28.12%; Fig. 2). Nineteen CPGs (73.07%) scored<br />
above 60% in this domain [28, 32–34, 36, 38–41, 43–45, 47–53]. See<br />
Table 3 for details on domain 3.<br />
Domain 4: Clarity of presentation<br />
This domain focuses on the language, structure and format of the<br />
guideline [19]. The mean score was 85.58% (median: 91.67%, Q1:<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
Fig. 2 Distribution of standardized scores by domain for the 26 CPGs<br />
Fig. 2 Distribution of standardized scores by domain for the 26 CPGs<br />
16
FEATURE<br />
Table 3 Standardized scores by domains of AGREE II<br />
Guideline<br />
Scope and<br />
Purpose<br />
Stakeholder<br />
Involvement<br />
Rigour of<br />
Development<br />
Clarity of<br />
Presentation<br />
Applicability<br />
Editorial<br />
Independence<br />
Overall Recommendation<br />
AGA Clinical Practice Guidelines<br />
on the Management of Mild-to-<br />
Moderate Ulcerative Colitis [28]<br />
ESPGHAN Revised Porto Criteria<br />
for the Diagnosis of Inflammatory<br />
Bowel Disease in Children<br />
and Adolescents [29]<br />
ACG Clinical Guideline: Management<br />
of Crohn’s Disease in<br />
Adults [30]<br />
European evidence based<br />
consensus on surgery for<br />
ulcerative colitis [31]<br />
Updated German Clinical<br />
Practice Guideline on “Diagnosis<br />
and treatment of Crohn’s<br />
disease” 2014 [32]<br />
Consensus guidelines of ECCO/<br />
ESPGHAN on the medical management<br />
of pediatric Crohn’s<br />
disease [33]<br />
Management of paediatric<br />
ulcerative colitis, Part 1: ambulatory<br />
care- an evidence-based<br />
guideline from ECCO and<br />
ESPGHAN [34]<br />
Evidence-based clinical practice<br />
guidelines for Crohn’s disease,<br />
integrated with formal consensus<br />
of experts in Japan [35]<br />
Diagnosis and treatment of<br />
inflammatory bowel disease:<br />
First Latin American Consensus<br />
of the Pan American Crohn’s<br />
and Colitis Organisation [36]<br />
Mexican consensus for the<br />
diagnosis and treatment of<br />
idiopathic chronic ulcerative<br />
colitis [37]<br />
Crohn’s disease Management<br />
in adults, children and young<br />
people [38]<br />
Second Korean guidelines for<br />
the management of ulcerative<br />
colitis [39]<br />
AGA Clinical Practice Guidelines<br />
on the Management of<br />
Moderate to Severe Ulcerative<br />
Colitis [40]<br />
Evidence-based clinical practice<br />
guidelines for inflammatory<br />
bowel disease [41]<br />
Ulcerative colitis - treatment<br />
with biologicals [42]<br />
British Society of <strong>Gastroenterology</strong><br />
consensus guidelines on<br />
the management of inflammatory<br />
bowel disease in adults [43]<br />
Canadian Association of <strong>Gastroenterology</strong><br />
Clinical Practice<br />
Guideline for the Medical Management<br />
of Pediatric Luminal<br />
Crohn’s Disease [44]<br />
94.44 30.56 60.42 83.33 25.00 75.00. Recommended, with modifications<br />
75.00 36.11 57.29 86.11 18.75 33.33 Recommended, with modifications<br />
44.44 5.56 35.42 72.22 4.17 29.17 Not recommended<br />
75.00 36.11 50.00 66.67 6.25 29.17 Recommended, with modifications<br />
91.67 86.11 83.33 61.11 12.50 91.67 Recommended, with modifications<br />
72.22 52.78 61.46 83.33 12.50 12.50 Recommended, with modifications<br />
83.33 27.78 67.71 83.33 6.25 66.67 Recommended, with modifications<br />
91.67 52.78 56.25 94.44 16.67 79.17 Recommended, with modifications<br />
75.00 30.56 60.42 69.44 12.50 50.00 Recommended, with modifications<br />
36.11 19.44 50.00 63.89 6.25 62.50 Not recommended<br />
94.44 83.33 94.79 100.00 83.33 75.00 Recommended<br />
80.55 58.33 71.88 100.00 22.92 29.17 Recommended, with modifications<br />
100.00 80.56 91.67 100.00 56.25 83.33 Recommended<br />
91.66 75.00 82.29 88.89 58.33 83.33 Recommended, with modifications<br />
88.88 33.33 45.83 55.56 6.25 0.00 Not recommended<br />
100.00 100.00 91.67 100.00 45.83 100.00 Recommended<br />
100.00 94.44 85.42 100.00 25.00 95.83 Recommended<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
17
FEATURE<br />
Table 3 (continued)<br />
Guideline<br />
Scope and<br />
Purpose<br />
Stakeholder<br />
Involvement<br />
Rigour of<br />
Development<br />
Clarity of<br />
Presentation<br />
Applicability<br />
Editorial<br />
Independence<br />
Overall Recommendation<br />
Clinical Practice Guideline for the 86.11 91.67 79.17 100.00 14.58 95.83 Recommended, with modifications<br />
Medical Management of Perianal<br />
Fistulizing Crohn’s Disease:<br />
The Toronto Consensus [45]<br />
Crohn’s disease - treatment 80.55 44.44 34.38 44.44 4.17 0.00 Not recommended<br />
with biological medication [46]<br />
Canadian Association of <strong>Gastroenterology</strong><br />
100.00 91.67 90.63 100.00 37.50 91.67 Recommended<br />
Clinical Practice<br />
Guideline for the Management<br />
of Luminal Crohn’s Disease [47]<br />
Evidence-based clinical practice<br />
77.78 66.67 66.67 91.67 18.75 87.50 Recommended, with modifications<br />
guidelines for inflamma-<br />
tory bowel disease 2020 [48]<br />
AGA Clinical Practice Guidelines<br />
94.44 83.33 87.50 100.00 52.08 91.67 Recommended<br />
on the Medical Manage-<br />
ment of Moderate to Severe<br />
Luminal and Perianal Fistulizing<br />
Crohn’s Disease [49]<br />
WSES-AAST guidelines: 86.11 69.44 63.54 91.67 25.00 50.00 Recommended, with modifications<br />
management of inflammatory<br />
bowel disease in the emergency<br />
setting [50]<br />
The Medical Management of 91.67 66.67 86.46 100.00 39.58 100.00 Recommended, with modifications<br />
Paediatric Crohn’s Disease: an<br />
ECCO-ESPGHAN Guideline<br />
Update [51]<br />
Guidelines for the management<br />
94.44 72.22 71.88 91.67 33.33 0.00 Recommended, with modifications<br />
of patients with Crohn’s<br />
disease. Recommendations<br />
of the Polish Society of<br />
<strong>Gastroenterology</strong> and the<br />
Polish National Consultant in<br />
<strong>Gastroenterology</strong> [52]<br />
ECCO Guidelines on Therapeutics<br />
91.67 94.44 92.71 97.22 47.92 100.00 Recommended<br />
in Crohn’s Disease: Medical<br />
Treatment [53]<br />
Mean Score 84.51 60.90 69.95 85.58 26.60 62.02<br />
Median 90.27 66.67 69.79 91.67 20.83 75.00<br />
75.00%, Q3: 100.00% and IQR=25%; Fig. 2). Twenty-four CPGs<br />
(92.30%) scored above 60% in this domain [28–41, 43–45, 47–53].<br />
See Table 3 for details on domain 4.<br />
CPGs, 15 guidelines (57.7%), were “recommended with modifications”<br />
[28, 29, 31–36, 39, 41, 45, 48, 50–52]. Finally, 4 CPGs (15.4%) were<br />
“not recommended” (see Table 3) [30, 37, 42, 46].<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
Domain 5: Applicability<br />
This domain refers to barriers and facilitators to CPG implementation,<br />
strategies for its adoption and resource considerations [19]. The mean<br />
score was 26.60% (median: 20.83%, Q1: 12.50%, Q3: 39.06% and<br />
IQR=26.56%; Fig. 2). Only one CPG (3.84%) scored above 60% in this<br />
domain [38]. See Table 3 for details on domain 5.<br />
Domain 6: Editorial Independence<br />
This domain is about the formulation of recommendations, understand<br />
whether they are biased by conflicts of interest [19]. The mean<br />
score was 62.02% (median: 75.00%, Q1: 30.21%, Q3: 91.67% and<br />
IQR=61.45%; Fig. 2). Sixteen CPGs (61.53%) scored above 60% in<br />
this domain [28, 32, 34, 35, 37, 38, 40, 41, 43–45, 47–49, 51, 53]. See<br />
Table 3 for details on domain 6.<br />
Overall assessment<br />
Seven out of the 26 evaluated CPGs (26.9%) were “recommended”<br />
by the independent reviewers [38, 40, 43, 44, 47, 49, 53]. Most of the<br />
Combined assessment<br />
Finally, in the radar plot analysis we observe that domains “scope and<br />
purpose”, “stakeholder involvement”, “rigor of development”, “clarity<br />
of presentation” and “editorial independence” show similar areas in<br />
the scores achieved; however, the domain “applicability” is notoriously<br />
deficient in all the evaluated guidelines (Fig. 3).<br />
Quality assessment over time<br />
With respect to quality change over time, no statistically significant<br />
differences were found for the means of the standardized scores for each<br />
AGREE II domain between the guidelines published during the 2012-2017<br />
period and those published between 2018 and 2022 (Table 4).<br />
Discussion<br />
What do the findings of this study mean?<br />
18
FEATURE<br />
Fig. Fig. 3 3Radar chart chart of of the the mean standardized scores by by domains of of the the 26 26 IBD IBD CPGs CPGs assessed<br />
Table 4 4Quality changes over over time time<br />
Domain<br />
Guidelines<br />
Guidelines<br />
**P-value<br />
from from 2012-<br />
from from 2018-<br />
2017 2017 2022 2022<br />
Scope and and purpose 81.9 81.9 (9.15) (9.15) 85.6 85.6 (17.9) (17.9) 0.5868<br />
Stakeholder involvement 54.5 54.5 (21.0) (21.0) 63.7 63.7 (29.4) (29.4) 0.4336<br />
Rigour of of development 66.9 66.9 (15.3) (15.3) 71.3 71.3 (19.6) (19.6) 0.5817<br />
Clarity of of presentation 82.6 82.6 (15.3) (15.3) 86.9 86.9 (17.0) (17.0) 0.5521<br />
Applicability 23.2 23.2 (24.8) (24.8) 28.1 28.1 (19.0) (19.0) 0.5815<br />
Editorial independence 50.0 50.0 (28.7) (28.7) 67.4 67.4 (36.3) (36.3) 0.2444<br />
*Data *Data given given as as mean mean +/− +/− (SD) (SD) of of standardized scores<br />
**Significance level level < 0.05, < 0.05, p-value with with Student’s t method t for for the the difference of of<br />
two two means<br />
This review showed that the evaluated IBD CPGs had an acceptable<br />
quality based on the AGREE II instrument since 7 out of the 26<br />
evaluated guidelines were “recommended”, 15 were “recommended<br />
with modifications” and only 4 were “not recommended”. The domains<br />
with the highest scores were “clarity of presentation” and “scope and<br />
purpose”, which reached values over 60%, indicating that most of the<br />
assessed guidelines had well-defined general and specific objectives,<br />
the population to which the guideline was intended to apply was<br />
well defined, and the recommendations were clearly described and<br />
identifiable. Rigor of development was the domain that received the<br />
third best score with 69.95%; this domain could be argued to have<br />
the greatest effect on the quality of a clinical practice guideline, since it<br />
has to do with the entire process used to formulate and construct the<br />
recommendations and it is the one that comprises the most items within<br />
AGREE II for its evaluation [54]. We consider that a score over 60% is<br />
more than acceptable for “rigor of development”, which achieved this<br />
score due to most guidelines were partly penalized for being unclear<br />
with the description of external experts’ assessment and for not having<br />
an explicit updating statement.<br />
The domains “stakeholder involvement” and “editorial independence”<br />
obtained scores slightly over 60% (60.90 and 62.02%, respectively;<br />
Fig. 3), which indicates that the views and preferences of patients still<br />
need to be considered when the CPG is drafted and that an expert<br />
methodologist/epidemiologist should be included in the guideline<br />
drafting group. In addition, both domains achieved low scores due to<br />
the limited information most guidelines provided in terms of funding and<br />
its influence on the guidelines’ content, as well as the lack of detail they<br />
included regarding conflicts of interest and how these conflicts were<br />
dealt. Considering these limitations on the development of CPGs could<br />
contribute to their improvement.<br />
The “applicability” domain was the worst scored domain in this review<br />
with an average score of 26.60% (Fig. 3), well below the 60% cut-off<br />
point for this domain. The main reason for this is that most guideline<br />
developers do not fully consider guideline’s implementation in terms of<br />
facilitators and barriers for guidelines’ applicability or they do not fully<br />
consider the resources and tools that are available in a specific context.<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
19
FEATURE<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
We also noted that most of the guidelines did not consider the<br />
economic impact of their recommendations on resources and health<br />
budgets, for example, most guidelines did not include health economists<br />
in the guideline development group or did not perform cost-benefit<br />
analysis. The limitations and omissions that have been observed in the<br />
included guidelines restraint the translation of these documents into<br />
clinical practice, thus hindering its operability.<br />
Regarding quality change over time, this study failed to demonstrate<br />
statistically significant differences between guidelines published during<br />
the 2012-2017 period versus guidelines published between 2018 and<br />
2022 (see Table 4) for any domain covered by AGREE II. This finding<br />
may be due to the small sample size in this study, which is associated to<br />
the specific inclusion criteria applied in the selection of CPGs as well as<br />
the large variety of CPGs for IBD (clinical, surgical, preventive, etc.) we<br />
encountered when screening. In addition, the time ranges we compared<br />
were too short since guidelines’ development in terms of IBD and our<br />
study’s criteria has been an early activity. However, one point to highlight<br />
is the implementation and dissemination of the GRADE methodology<br />
in the development of guidelines, especially in those produced in the<br />
last 4years; our study found that 17 out of the 26 included CPGs had<br />
used this methodology as a framework for grading the evidence and<br />
formulating their recommendations.<br />
The context of this review with other literature<br />
While this review is not the first to evaluate clinical practice guidelines<br />
on inflammatory bowel disease, it is the first to evaluate a large sample<br />
of CPGs as there was no date restriction in its search, which gave us<br />
a much broader picture of what has been produced in the past and<br />
current time. Thus, in line with other reviews of CPG for IBD conducted<br />
by other investigators, and addressing different contexts of inflammatory<br />
bowel disease, the domains with the highest scores were “clarity of<br />
presentation” and “scope and purpose” and the domains with the<br />
lowest scores were “stakeholder involvement” and “applicability”<br />
[55–57]. These results are also similar to previous CPG evaluations for<br />
other clinical-surgical areas such as interventional radiology, pediatrics or<br />
dermatology [58–60].<br />
In addition, other studies that investigated quality changes over time<br />
for clinical practice guidelines in other specialties did not find evidence<br />
of significant changes in quality in the different evaluated periods of<br />
time [61–63]. These results are consistent with the findings of this<br />
study. However, studies by Bhatt et al. [64] for pediatric type II diabetes<br />
CPG and Acuña-Izcaray et al. [65] for asthma CPG, found statistically<br />
significant differences in quality over time for the selected periods for<br />
each individual domain, while a statistical significance has not been<br />
found for all domains at the same time.<br />
Strengths and limitations<br />
Although a strength of our systematic review was the broad and<br />
exhaustive approach of our search – carried out in databases, compiling<br />
entities and guideline developers, with a sensitive strategy designed<br />
for this purpose – it is possible that our review may have missed<br />
some CPGs that were not adequately indexed or that dealt with other<br />
contexts related to inflammatory bowel disease. Likewise, our study only<br />
included CPGs published in English or Spanish, factors that could have<br />
contributed to a potential selection bias.<br />
Likewise, having chosen CPGs with well-defined inclusion criteria, it is<br />
likely that our results have overestimated the score obtained by selecting<br />
guidelines that would score higher than the entire possible universe of<br />
CPGs for IBD. Therefore, our conclusions acquire more relevance when<br />
evaluating this type of guidelines.<br />
On the other hand, although the degree of agreement reached by the<br />
reviewers was moderate (ICC=0.74), this may be due to the fact that<br />
the AGREE II instrument weights each item with a 7-point Likert-type<br />
scale, where only the extreme values of this scale are well defined, but<br />
it is prone to subjectivity for intermediate values 3, 4 and 5 on the scale.<br />
As our research had a large number of reviewers (six), reaching a higher<br />
value for the intraclass correlation coefficient (ICC) to improve reliability<br />
was difficult. However, we consider that the value achieved does provide<br />
adequate reliability [66].<br />
In addition, since the implementation of the AGREE II tool in 2010, it<br />
has become the most widely used and popular resource for assessing<br />
the quality of CPGs, choosing a cut-off point above which a guideline<br />
can be defined as having good quality is subjective and this selection<br />
will depend on the context in which the review is being performed.<br />
As Brouwers et al. [67] noted, “there is no evidence that if a guideline<br />
exceeds a certain score, the recommendations are easier to adopt,<br />
or improve processes of care, or lead to better patient outcomes than<br />
guidelines that do not achieve that score”. ( [67] , p.195) That is, the validity<br />
of the overall assessment may be limited, as there are no clear rules<br />
yet on how to weigh the different domain scores to make a decision on<br />
whether or not to recommend guidelines.<br />
What is new and conclusion<br />
Overall, this study determined that the quality of clinical practice<br />
guidelines for the diagnosis and treatment of inflammatory bowel<br />
disease is acceptable and that there is still room for improvement,<br />
especially in terms of stakeholder participation (inclusion of patients,<br />
expert methodologists/epidemiologists) and applicability (enablers,<br />
barriers, optimization of resources, external review). It is desirable that<br />
guideline developers consider these shortcomings in the future for the<br />
overall improvement of guidelines’ quality to reduce clinical practice<br />
heterogeneity in IBD.<br />
Abbreviations<br />
CPG: Clinical practice guideline; AGREE: Appraisal of Guidelines,<br />
Research, and Evaluation; GRADE: Grading of Recommendations,<br />
Assessment, Development and Evaluation; NPRISMA: Preferred<br />
Reporting Items for Systematic Reviews and Meta-Analyses; IBD:<br />
Inflammatory bowel disease; CD: Crohn’s disease; UC: Ulcerative colitis;<br />
ICC: Intraclass correlation coefficient; IQR: Interquartile range; SD:<br />
Standard deviation; Qi: Quartile; CI: Confidence interval.<br />
Supplementary Information<br />
The online version contains supplementary material available at<br />
https://doi.org/10.1186/s12876-022-02539-9.<br />
Acknowledgements<br />
We thank the University UTE and the Center for Research in Public<br />
Health and Epidemiology (CISPEC) for their support, collaboration and<br />
work in the editorial process of this publication.<br />
20
FEATURE<br />
Authors’ contributions<br />
DH, AV-G and CM-G conceived the idea for this research and designed<br />
the study. RZ-S, PA-M, CM-G and CME-L searched the literature.<br />
DH, CM-G, RZ-S, PA-M and RV screened and selected the guidelines<br />
according to the inclusion criteria. DH, CM-G, RZ-S, PA-M, JAF and RV<br />
rated and evaluated the guidelines with the AGREE II tool. RZ-S and<br />
PA-M conducted the statistical analysis and interpreted the results. RZ-<br />
S, PA-M and CM-G wrote the first draft of the report. CM-G, JAF, DS-R,<br />
CME-L, RV, AV-G contributed to the review and approved the final<br />
manuscript. The author(s) read and approved the final manuscript.<br />
Funding<br />
This research study has not received any funding from the public or<br />
private sector or from any non-profit entity.<br />
Availability of data and materials<br />
The datasets used and/or analysed during the current study are<br />
available from the corresponding author on reasonable request.<br />
Declarations<br />
Ethics approval and consent to participate<br />
Not applicable.<br />
Consent for publication<br />
Not applicable.<br />
Competing interests<br />
The authors declare that they have no competing interests<br />
Author details<br />
1<br />
Maestría en Epidemiología con mención en Investigación Clínica<br />
Aplicada. Facultad de Ciencias de la Salud Eugenio Espejo, Universidad<br />
UTE, Quito, Ecuador. 2 Internal medicine service, NMMC Hamilton,<br />
Hamilton, AL, USA. 3 Research Department. Instituto Universitario<br />
Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. 4 Institute<br />
of General Practice, Heinrich-Heine-University Düsseldorf, Düsseldorf,<br />
Germany. 5 Department of Nephrology and Hypertension, University<br />
Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.<br />
Julius Center for Health Sciences and Primary Care, University Medical<br />
Center Utrecht, Utrecht University, Utrecht, The Netherlands. 6 Centro<br />
de Investigación en Salud Pública y Epidemiologia Clínica (CISPEC),<br />
Facultad de Ciencias de la Salud Eugenio Espejo. Universidad UTE,<br />
Rumipamba and Bourgeois, Universidad UTE, 170147 Quito, Ecuador.<br />
Received: 13 June 2022 Accepted: 14 October 2022<br />
Published online: 05 November 2022<br />
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GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
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GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
23
FEATURE<br />
THE COST OF ILLNESS ANALYSIS OF<br />
INFLAMMATORY BOWEL DISEASE<br />
Majid Pakdin, Leila Zarei, Kamran Bagheri Lankarani and Sulmaz Ghahramani *<br />
Pakdin et al. BMC <strong>Gastroenterology</strong> (<strong>2023</strong>) 23:21 https://doi.org/10.1186/s12876-023-02648-z<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
Abstract<br />
Background<br />
Inflammatory bowel disease (IBD) is a chronic inflammatory condition<br />
involving individuals across all age groups. Recent data suggests the<br />
increase in the prevalence of IBD and the surge in applying the biologic<br />
drugs in which both change the cost of IBD in recent years. Comprehensive<br />
assessment of direct and indirect cost profiles associated with IBD in our<br />
area is scarce. This study aimed to determine the economic burden of IBD<br />
in Iran from a societal perspective, using cost diaries.<br />
Methods<br />
Patients available on clinic registry and hospital information system (HIS),<br />
who were diagnosed with IBD, were invited to take part in this study.<br />
Demographic and clinical data, the healthcare resource utilization or cost<br />
items, absenteeism for the patients and their caregivers were obtained.<br />
The cost of the used resources were derived from national tariffs. The<br />
data regarding premature mortality in IBD patients was extracted from<br />
HIS. Productivity loss was estimated based on the human capital method.<br />
Then, cost date were calculated as mean annual costs per patient.<br />
Results<br />
The cost diaries were obtained from 240 subjects (Ulcerative colitis:<br />
n=168, Crohn’s disease, n=72). The mean annual costs per patient<br />
were 1077 US$ (95% CI 900–1253), and 1608 (95% CI 1256, 1960)<br />
for the patients with ulcerative colitis and Crohn’s disease, respectively.<br />
Of the total costs, 58% and 63% were in terms of the indirect costs<br />
for the patients with ulcerative colitis and Crohn’s disease, respectively.<br />
The cost of illness for country was found to be 22,331,079 US$ and<br />
15,183,678 US$ for patients with ulcerative colitis and Crohn’s disease,<br />
respectively. Highest nationwide economic burden of IBD was found for<br />
patients older than 40 years were estimated to be 8,198,519 US$ and<br />
7,120,891 US$, for ulcerative colitis and Crohn’s disease, respectively.<br />
Conclusion<br />
The medication was found to be the greatest contributor of direct medical<br />
costs. Productivity loss in terms of long-term disability and premature<br />
mortality were major components of IBD’s economic burden in Iran.<br />
Keywords<br />
Inflammatory bowel disease, Crohn’s disease, Ulcerative colitis, Cost of<br />
illness, Health economics<br />
Introduction<br />
Ulcerative colitis (UC) and Crohn’s disease (CD) are included in the<br />
spectrum of disorder defined as inflammatory bowel disease (IBD), the<br />
relapsing–remitting and chronic inflammatory condition in which the<br />
gastrointestinal tract is affected [1]. IBD has lower prevalence compared<br />
to other common gastrointestinal-related disorders, such as irritable<br />
bowel syndrome, gastroesophageal reflux, and colorectal cancer;<br />
however, it is one of the gastrointestinal-related disorders with the<br />
most economic burden [1]. Data from many countries, including India<br />
[2], China [3], Scotland [4], and Turkey [5] showed an unprecedented<br />
growth of IBD worldwide. Concurrently, the incidence of the disease<br />
is increasing in Asia [6] and Iran [7]. Low mortality of the disease,<br />
the diagnosis at early ages, and its chronic nature have driven this<br />
increase in the disease’s prevalence. Using biological medications in the<br />
treatment of IBD changed the need for hospitalization and surgeries and<br />
also changed the cost of the disease in recent years. So, these highlight<br />
the importance of the economic burden evaluation of the disease [8, 9].<br />
As stated before, in Iran, the IBD incidence is rising while information<br />
on its cost is scarce. Two studies have evaluated direct medical cost<br />
and hospitalization cost of the disease [10, 11]. Nevertheless, health<br />
policy makers should have reliable information regarding the cost of<br />
illness to quantify the impact of the disease on a society. This can inform<br />
healthcare cost projection, as well as resource allocation [12]. Regarding<br />
the mentioned points, it is necessary to assess the cost of IBD, including<br />
direct medical costs, direct non-medical costs, and indirect costs to<br />
determine the economic burden of IBD in Iran. In our study, we aim to<br />
evaluate the cost of IBD in a multicenter setting.<br />
Methods<br />
Participants and data collection<br />
This cost of illness analysis was conducted on the patients diagnosed<br />
with IBD in 2021. For data collection, we used the phone records<br />
available in Shiraz’ hospital information systems (HIS) and IBD clinic<br />
at Faghihi hospital, which is referral IBD clinic affiliated to the Shiraz<br />
University of Medical Sciences. Using the convenient sampling method,<br />
patients were invited to take part the study through phone calls. Then,<br />
the data was obtained through a face-to-face interview while the<br />
patients were referred to the clinic. This clinic and referral hospitals all<br />
provide the care to the IBD patients, mostly from Fars province and<br />
sometimes from neighboring provinces. Our study as a partial economic<br />
evaluation technique, aimed to calculate the total costs of IBD in<br />
Iran from the society perspective. The IBD diagnosis was confirmed<br />
based on clinical, endoscopic, and histological criteria, as described<br />
elsewhere [13]. Demographic data (including sex, age, marital status,<br />
educational level, educational level, income, and hours of paid work),<br />
clinical data (including disease duration, disease progression, and extraintestinal<br />
involvement) were obtained from all participants, and they<br />
were interviewed to fill out the cost diary. The disease progression was<br />
defined by calculating Mayo score and Crohn’s disease activity index<br />
24<br />
* Correspondence: Sulmaz Ghahramani, suli.ghahraman@gmail.com, Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Iran<br />
© The Author(s) <strong>2023</strong>.
FEATURE<br />
(CDAI) in patients with UC, and CD, respectively. To obtain an estimated<br />
prevalence of IBD in Fars province, the population ratio of Fars province<br />
in Iran was multiplied by an estimated prevalence of IBD in Iran in 2021<br />
[14, 15], which found to be 1800. The sample volume was determined<br />
to be 233 patients for estimation of costs of illness based on 95%<br />
CI, margin error of 6%, and the estimated prevalence of IBD in Fars<br />
province (http://www.raosoft.com/samplesize.html).<br />
Cost diary<br />
Cost diary is an instrumental method which is developed by Goosens et<br />
al. and is used to estimate the cost of a condition. Since no significant<br />
difference has been found among the patients’ report and medical<br />
records, there is no need to check medical reports when the cost diary<br />
is used [16].<br />
In order to prevent recall bias, the number of physician visits,<br />
physiotherapy, purchased drugs dosage, and all other related disease<br />
‘s costs during 3-month prior to the interview were asked from<br />
patients, which were scaled up by a factor of four to extrapolate to<br />
the mean number of each item during 1-year. Only for hospitalization<br />
and surgeries, the duration of 1- year was considered in cost diary.<br />
To minimize missing information and partial responses, telephone<br />
contacts were made after the initial visit, whenever it was needed.<br />
We had a protocol for phone calls. We made phone calls, in case of<br />
none- response we considered maximum number of three phone<br />
calls in different hours of day and variable days of week to make<br />
telephone contacts. Diary records were used to estimate resource<br />
used. The cost of the used resources were derived from national<br />
tariffs. The costs were recorded in Rial and then we converted to<br />
US dollars based on the moving average of the exchange rate in the<br />
2021 252,000:1 (Rial:US) (Additional file 1: Table S1: https://staticcontent.springer.com/esm/art%3A10.1186%2Fs12876-023-02648-z/<br />
MediaObjects/12876_<strong>2023</strong>_2648_MOESM1_ESM.xlsx).<br />
Death registration database<br />
We extracted death data of patients with IBD, who were died because<br />
of IBD-related causes, from HIS during 2013–2021 to estimate<br />
economic burden of premature mortality for UCCD.<br />
Direct medical costs<br />
Direct medical costs included physician visits, physiotherapy sessions,<br />
nutrition sessions, purchased medication, surgeries, and para-clinical<br />
tests. The cost of each item expected on medication was estimated by<br />
the mean number of each item, multiplied by the contemporary tariff of the<br />
Ministry of Health and Medical Education (MoHME). The contemporary<br />
tariff is defined for each unit of healthcare service item by the MoHME<br />
annually in two forms of private and public services. In our study, we<br />
used the weighted average of these two forms based on the last national<br />
utilization survey [17]. The cost of purchased medication was calculated<br />
by the number of each item, multiplied by the unit cost of each item<br />
defined by Food and Drug Administration (http://irc.fda.gov.ir/nfi#).<br />
Direct nonmedical costs<br />
Transportation, self-help group, hours of paid household help, and<br />
goods-related to the condition (including alternative medicine, assistive<br />
devices, special diet, and books) were considered the components of<br />
direct nonmedical costs. Transportation cost was obtained from the<br />
sum of public and personal transportation. Public transportation cost<br />
was calculated based on the mean number of public transportation<br />
service use multiplied by the tariff of transportation defined by Municipal.<br />
Personal transportation and other items were calculated based on the<br />
real reported costs by patients in the cost diary.<br />
Indirect costs<br />
The human capital approach was used to estimate indirect costs.<br />
Productivity losses because of disability and premature mortality were<br />
considered components of indirect costs in our study. We divided<br />
disability into short- and long-term disability.<br />
Productivity losses due to short-term disability<br />
Productivity losses in terms of short-term disability were obtained from<br />
temporary absenteeism from work for patients with the disease, and<br />
the caregivers. To calculate productivity loss because of temperament<br />
absenteeism of patients from work for therapy appointments, the<br />
hourly wage of lowest-paid unskilled government workers (LPUGW) of<br />
the Ministry of Labor was multiplied by the number of absence hours<br />
for each patient. For calculation of the productivity loss because of<br />
absenteeism of the caregiver the number of hospitalization days for the<br />
patients who were hospitalized during 1-year was added to 14 days<br />
per hospitalization. Then, the calculated number was multiplied by the<br />
LPUGW. It was assumed that work productivity loss was experienced<br />
by caregivers during hospitalization days to fulfill the responsibility of<br />
caregiving.<br />
Productivity losses due to long-term disability<br />
Early retirement of patients, permanent absenteeism from work because<br />
of disability, and unpaid household work for caregivers of disabled<br />
patients were considered estimating productivity losses due to long-term<br />
disability. To estimate the cost of early retirement, the amount of lost<br />
pension, compared to the full pension, was calculated for any patient<br />
who had early retired. To calculate the cost of permanent absenteeism<br />
from work, the annual wage of LPUGW was considered for patients who<br />
completely could not work, and were not paid a defined benefit pension.<br />
To estimate unpaid household work for caregivers of disabled patients,<br />
the number of patients who could not take care of themselves were<br />
multiplied by the annual wage of LPUGW because of unpaid permanent<br />
caregiver responsibility.<br />
Premature mortality<br />
Standard expected years of life lost (SEYLL) was used to predict the<br />
productivity loss due to premature mortality. We used the following<br />
formula to estimate SEYLL [18]:<br />
SEYLL = N × L x<br />
where N identifies the number of deaths at a certain age, and L x<br />
refers<br />
to the remaining life-expectancy at the age of death. Based on many<br />
arguments and the last update of global health estimates by WHO, we<br />
decided not to take into account time discounting and age-weighting<br />
[19–22]. We obtained mean number of annual deaths by age, gender,<br />
and type of disease. The gender-specific remaining life-expectancy<br />
at the age of death was calculated based on the 2020 Iran lifetable<br />
from World Health Organization [23], and subsequently SEYLL for<br />
each disease was calculated by the sum of the two obtained genderspecific<br />
SEYLL for the type of disease. Then, the calculated SEYLL<br />
was multiplied by gross domestic production (GDP) per capita for Iran,<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
25
FEATURE<br />
Table 1 Patients’ characteristics<br />
Costs were reported as mean costs with 95% CI estimated using nonparametric<br />
boodstrap sampling.<br />
Characteristic<br />
Ulcerative<br />
colitis<br />
(n=168)<br />
Crohn’s disease (n=72)<br />
Results<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
Age, mean (SD), years 40.64 (12.90) 39.11 (14.04)<br />
Age groups<br />
0–29 34 [20.2] 19 [26.4]<br />
30–39 55 [32.7] 18 [25.0]<br />
≥ 40 79 [47.0] 35 [48.6]<br />
Sex<br />
Female 81 [48.2] 30 [41.7]<br />
Male 87 [51.8] 42 [58.3]<br />
Marital status<br />
Single 36 [21.4] 25 [34.7]<br />
Married 125 [74.4] 43 [59.7]<br />
Widowed 5 [3] 0<br />
Divorced 2 [1.2] 4 [5.6]<br />
Employment status<br />
Non-employed 81 [48.2] 40 [55.6]<br />
Employed 70 [41.7] 22 [30.6]<br />
Disabled 8 [4.8] 7 [9.7]<br />
Retired 9 [5.4] 3 [4.2]<br />
Educational level<br />
Illiterate 21 [12.5] 7 [9.7]<br />
Diploma 87 [51.8] 42 [58.3]<br />
Bachelor degree or higher 60 [35.7] 23 [32]<br />
Residence<br />
City 136 [81.0] 54 [75]<br />
Village 32 [19.0] 18 [25]<br />
Disease duration, years 9.49 (7.98) 7.86 (6.69)<br />
Disease progression<br />
Continuously active 44 [26.2] 15 [20.8]<br />
Intermittently active 81 [48.2] 41 [56.9]<br />
Inactive 43 [25.6] 16 [22.2]<br />
Extra-intestinal involvement<br />
Liver involvement 23 [13.7] 13 [18.1]<br />
Oral involvement 38 [22.6] 18 [25.0]<br />
Skin involvement 37 [22.0] 14 [19.4]<br />
Vertebra involvement 12 [7.1] 11 [15.3]<br />
Eye involvement 42 [25.0] 21 [29.2]<br />
Joint involvement 59 [35.1] 30 [41.7]<br />
Lung involvement 5 [3.0] 3 [4.2]<br />
Fistula 4 [2.4] 14 [19.4]<br />
SD, standard deviation<br />
Data are presented as n [%] or mean (SD)<br />
which is defined by World Bank [24], to estimate the total economic<br />
burden of premature mortality for each disease. To obtain the mean<br />
cost per patient, the total cost of premature mortality was divided by the<br />
estimated prevalence of the disease in Fars Province.<br />
Statistical analysis<br />
All statistical analyses were performed using SPSS 26.0. Mean, and<br />
the standard deviation was used to present continuous variables,<br />
while categorical variables were shown as frequency and percentage.<br />
Demographic characteristics<br />
Among 286 patients who were initially invited, 240 patients accepted to<br />
take part. The mean±Standard deviation (SD) age of participants was<br />
41±13 and 39±14 for UC and CD, respectively. Majority of patients<br />
were married, and reside in the cities. The gender was approximately<br />
equal between males and females in the both diseases, and UC was<br />
predominant disease among participants. Descriptive results based<br />
on gender, marital status, employment status, disease type, and other<br />
variables are summarized in Table 1.<br />
Direct medical costs<br />
Cost items are categorized in Table 2. Number [%] of participants using<br />
resources, and mean annual cost for each category are shown in the<br />
table for UC and CD, separately.<br />
Drugs, which were taken by patients, are classified into six categories<br />
(Table 3). Number [%] of participants taking each medication’s type, and<br />
mean annual cost for each type are shown in the table based on the<br />
disease type.<br />
Medication had the greatest share of direct medical costs in both<br />
types of IBD, accounting for 31.6% and 23.0% of the total costs in<br />
the patients with UC and CD, respectively (445.52$ per patient in<br />
UC, and 586.96$ per patient in CD). Among types of medication,<br />
aminosalicylates contributed to the most prescription proportion in<br />
both diseases (66.2% in UC and 63.9% in CD). It shared the highest<br />
cost of medication types in patients with UC, accounting for 244.63$<br />
per patient. Less than twenty percent of patients consumed biological<br />
agent; however, this type of medication accounted for the highest and<br />
the second highest medication costs in patients with CD (235.11$),<br />
and UC (100.72$), respectively (Table 3). Hospitalization was another<br />
important contributor of direct medical costs, especially in the patients<br />
with CD, responsible for 10% of the total costs (161.29$) per patient.<br />
Physiotherapy and nutrition consult almost did not impose cost to the<br />
studied IBD patients (Table 2).<br />
Direct nonmedical costs<br />
Although the proportion of using nonmedical resources were high by<br />
participants, the related costs accounted for less than 1% of the total<br />
costs in both diseases (8.92$ per patient in UC, and 4.67$ per patient in<br />
CD). They were mostly driven by transportation (Table 2).<br />
Indirect costs<br />
Indirect costs were major contributors of the total costs, responsible for<br />
more than a half of the costs (622.46$ per patient in UC, and 1016.62$<br />
per patient in CD). Productivity losses induced by short-term disability<br />
were more frequent among participants, as compared with the losses<br />
due to long-term disability, and were almost equally formed by two<br />
components of temporary absenteeism for patients and caregivers.<br />
Despite the lower frequency of productivity losses due to long-term<br />
disability (13.7% in UC patients, and 19.4% CD patients), they imposed<br />
a large share of the total costs (266.50$ per patient in UC, and 436.40$<br />
26
FEATURE<br />
Table 2 Resource utilization and costs per patient<br />
Cost categories<br />
Participants using resources,<br />
n [%]<br />
Mean annual costs in US$ (SD) [% of total costs]<br />
UC: Ulcerative colitis; CD: Crohn’s disease; SD: standard deviation<br />
UC (n=168) CD (n=72) UC (n=168) CD (n=72)<br />
Total costs 168 [100.0] 72 [100.0] 1076.89 (1159.14) [100.0] 1608.24 (1497.11) [100.0]<br />
Direct medical cost 157 [93.5] 72 [100.0] 445.52 (691.76) [41.4] 586.96 (629.74) [36.5]<br />
Physician visit 131 [78.0] 68 [94.4] 15.93 (31.52) [1.5] 21.56 (27.34) [1.3]<br />
General physician 12 [7.1] 7 [9.7] 1.24 (7.82) [0.1] 2.16 (9.63) [0.1]<br />
Specialist 14 [8.3] 3 [4.2] 1.60 (11.73) [0.1] 0.38 (2.13) [0.0]<br />
Subspecialist 123 [73.2] 66 [91.7] 12.87 (16.19) [1.2] 18.81 (25.04) [1.2]<br />
Psychiatrist 4 [2.4] 2 [2.8] 0.21 (1.45) [0.0] 0.20 (1.18) [0.0]<br />
Physiotherapy 4 [2.4] 0 [0.0] 0.13 (1.01) [0.0] 0.00 (0.00) [0.0]<br />
Nutritionist consult 0 [0.0] 0 [0.0] 0.00 (00.00) [0.0] 0.00 (0.00) [0.0]<br />
Hospitalization 24 [14.3] 25 [34.7] 64.64 (251.35) [6.0] 161.29 (380.94) [10.0]<br />
Para-clinic 124 [73.8] 62 [86.1] 22.93 (37.64) [2.1] 27.04 (50.00) [1.7]<br />
Laboratory 116 [69.0] 60 [83.3] 7.59 (9.93) [0.7] 10.64 (11.10) [0.7]<br />
Imaging 48 [28.6] 29 [40.3] 15.33 (31.79) [1.4] 16.41 (34.07) [1.0]<br />
Medication 152 [90.5] 69 [95.8] 340.38 (633.18) [31.6] 369.97 (441.22) [23.0]<br />
Surgeries 7 [4.2] 8 [11.1] 1.51 (7.59) [0.1] 7.10 (25.40) [0.4]<br />
Direct nonmedical cost 140 [83.3] 65 [90.3] 8.92 (36.29) [0.8] 4.67 (7.69) [0.3]<br />
Transportation<br />
Public transportation 62 [39.1] 33 [45.8] 0.42 (0.86) [0.0] 0.56 (1.21) [0.0]<br />
Personal transportation 82 [48.8] 34 [47.2] 4.80 (24.02) [0.4] 3.03 (6.36) [0.2]<br />
Medical related goods (including assistive devices, alternative 9 [5.4] 6 [8.3] 2.07 (18.68) [0.2] 0.98 (4.12) [0.1]<br />
medicine, special diet, related books)<br />
Paid household help 1 [0.6] 1 [1.4] 0.09 (1.10) [0.0] 0.10 (0.84) [0.0]<br />
Self-help group 0 [0.0] 0 [0.0] 0.00 (0.00) [0.0] 0.00 (0.00) [0.0]<br />
Indirect costs 58 [34.5] 33 [45.8] 622.46 (808.61) [57.8] 1016.62 (1169.81) [63.2]<br />
Short-term disability 42 [25.0] 30 [41.7] 88.49 (221.46) [8.2] 193.00 (472.27) [12.0]<br />
Temporary absenteeism for patients 22 [13.1] 8 [11.1] 51.62 (175.87) [4.8] 88.11 (378.42) [5.5]<br />
Temporary absenteeism for caregivers 24 [14.3] 25 [34.7] 36.87 (126.52) [3.4] 104.89 (217.58) [6.5]<br />
Long-term disability 23 [13.7] 14 [19.4] 266.50 (745.37) [24.7] 436.40 (980.39) [27.1]<br />
Early retirement 7 [4.2] 12 [2.8] 42.01 (216.60) [3.9] 28.99 (201.20) [1.8]<br />
Permanent absenteeism 14 [8.3] 9 [12.5] 174.60 (580.82) [16.2] 261.91 (697.80) [16.3]<br />
Unpaid household work for caregivers of disabled patients 4 [2.4] 5 [6.9] 49.89 (320.39) [4.6] 145.50 (536.37) [9.0]<br />
Premature death – – 276.47 [24.8] 387.22 [24.1]<br />
Table 3 Frequency and costs of purchased medication<br />
Drug category Participants taking medication, n [%] Mean annual costs in US$ (SD) [% of total medication<br />
costs]<br />
UC (n=168) CD (n=72) UC (n=168) CD (n=72)<br />
Aminosalicylates 128 [66.2] 46 [63.9] 244.63 (554.37) [71.9] 100.72 (205.08) [25.4]<br />
Biological agents 14 [8.3] 19 [26.4] 74.46 (264.97) [21.9] 235.11 (425.19) [59.3]<br />
Corton 47 [28.0] 24 [33.3] 1.86 (4.23) [0.5] 2.03 (4.36) [0.5]<br />
Immunomodulators 48 [28.6] 35 [48.6] 6.17 (22.09) [1.8] 12.96 (47.79) [3.3]<br />
Supplementary 68 [40.5] 37 [51.4] 5.25 (10.77) [1.5] 7.82 (15.49) [2.0]<br />
Psychotropic drugs 11 [6.5] 9 [12.5] 0.40 (2.05) [0.1] 0.82 (3.89) [0.2]<br />
Miscellaneous 53 [31.5] 25 [34.7] 7.60 (16.92) [2.2] 10.51 (20.19) [2.6]<br />
Miscellaneous drug groups include analgesics, gastrointestinal associated drugs, and others<br />
UC: Ulcerative colitis; CD: Crohn’s disease; SD: standard deviation<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
27
FEATURE<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
per patient in CD). Permanent absenteeism from work was predominant<br />
compartment of productivity losses induced by long-term disability in<br />
both disease types (174.60$ per patient in UC, and 261.91$ per patient<br />
in CD). Productivity loss because of premature death was another<br />
important contributor of the total costs, accounting for almost a quarter<br />
of the costs in both diseases (276.47$ per patient in UC, and 387.22$<br />
per patient in CD) (Table 2).<br />
Cost of illness for country<br />
The characteristics of participants, including age, sex, disease type<br />
and age at diagnosis were almost equivalent to those described for the<br />
recent pilot feasibility study of first nation-wide IBD registry in Iran, which<br />
enabled us to extrapolate the mean annual total costs regarding disease<br />
type and age group for the country [17]. An estimated prevalence of IBD<br />
in Iran in 2021 was used for the calculation [15]. The cost of illness for<br />
country was found to be 22,331,079 and 15,183,678 for UC and CD,<br />
respectively (Table 4).<br />
Discussion<br />
In this retrospective cohort study, we aimed to determine the economic<br />
burden of IBD, and to compare the profiles of costs in UC and CD<br />
patients. There are barriers to study the economic burden of specific<br />
diseases in Iran, as diagnostic data is not ordinarily coded for outpatient<br />
visits, and the patients’ resource utilization are not recorded. Thus,<br />
there is the paucity of information on resource utilization consumed by<br />
patients with specific diseases. However, to the best of our knowledge<br />
this study is among the first comprehensive studies in Iran assessing<br />
both direct and indirect cost profiles associated with IBD.<br />
Several studies have evaluated the economic burden of IBD in other<br />
countries [25–37]. Consistent with their findings, we found that the CD<br />
patients’ resource utilization was higher than that of UC patients, and<br />
this difference was more considerable in hospitalization, surgeries, and<br />
laboratory sectors. Variations in the pathogenesis of the two diseases<br />
can explain this difference, as UC might not lead to irreversible and<br />
systemic damage observed in CD patients [38]. However, the amount<br />
of difference among the annual mean costs of UC and CD differs from<br />
a study to another, based on the design and population of study, as<br />
inconsistencies are created in the results of cost of illness studies when<br />
comparing one to another due variations in method [30]. Annual mean<br />
costs per patient for UC and CD were between 6217–11,477 US$, and<br />
11,034–18,932 US$ in the USA, respectively. The corresponding ranges<br />
were 8949–10,395 euros, and 2898–6742 euros in European countries<br />
[39, 40]. In our study, annual mean costs per patient for UC and CD<br />
were found to be 1077 US$ (95% CI 900–1253), and 1068 (95% CI<br />
1256, 1960) respectively, which is in line with the results of studies in<br />
Table 4 Mean annual total costs in US$ for country<br />
Age group (year) Ulcerative colitis Crohn’s disease<br />
0–29 6,454,537 2,422,262<br />
30–39 7,678,023 5,640,525<br />
≥ 40 8,198,519 7,120,891<br />
All age groups 22,331,079 15,183,678<br />
UK and Germany in terms of CD: UC costs ratio [25, 34]. These two<br />
studies have applied a similar method of using patient-reported resource<br />
utilization to estimate economic burden of the disease (bottom-up<br />
approach). The difference of total costs per patient between Iran and<br />
European countries could be explained by the fluctuations in Iran’s<br />
currency exchange rate to dollar in the last few years.<br />
According to our findings, the medication use represents the major<br />
source of direct medical costs (76.4% and 63.0% of direct medical<br />
costs in UC and CD patients), while costs related to surgery and<br />
hospitalization have not a large share of direct cost. The results of more<br />
recent studies are consistent with our results [30–33]. The widespread<br />
application of biological agents in the treatment of IBD patients has<br />
changed the healthcare outlook, leading to a substantial shift in cost<br />
profiles [33]. The effect of this type of medication was significant on the<br />
reduction of colectomy in UC patients [41–43]. According to findings,<br />
despite the relatively low proportion of patients who received biological<br />
agents (8.3% and 26.4% of UC and CD patients); they shaped a<br />
significant contributor of the total costs in both diseases. This highlights<br />
the importance of better insurance coverage for such drugs to make<br />
them affordable. According to results, none of the participants used the<br />
nutritional consultation and assessment. Considering the importance of<br />
supportive nutritional therapy in the clinical care of IBD patients [44, 45],<br />
routine assessment and monitoring of nutritional status in IBD patients in<br />
Iran is highly encouraged.<br />
Direct nonmedical costs were minor contributors to the total costs,<br />
as compared with direct medical and indirect costs. Based on our<br />
findings, none of participants had been a member of self-help groups.<br />
In these groups, patients share their own experiences, which can lead<br />
to applying executable strategies for management of chronic disease by<br />
other patients [46]. Therefore, it is pivotal to design self-help groups for<br />
IBD patients in Iran which fit for their need; subsequently, they should be<br />
encouraged to enroll in such groups.<br />
Short- and long-term productivity losses because of disability were<br />
also evaluated. We found that productivity losses because of disability<br />
handled 33.0% and 39.1% of the total costs in UC and CD, respectively.<br />
According to a German study, long term productivity losses shared<br />
32% and 49% of the total costs in UC and CD, respectively [34]. In<br />
a more recent study in the Netherlands, productivity losses due to<br />
IBD-related absenteeism were found to be 16% and 39% of the total<br />
costs, respectively [33]. It seems that biological agents have had an<br />
effective role in reducing productivity losses because of disability in<br />
CD patients. However, due to different methodologies in measurement<br />
of productivity losses due to disability, we have limitations for a more<br />
detailed comparison with the results of other studies. In our study, we<br />
considered absenteeism and unpaid household work for caregivers,<br />
which were important contributors to costs for CD patients, accounting<br />
for 6.5% and 9.0% of the total costs, respectively. We did not evaluate<br />
presenteeism in our study, since no validated questionnaire is available<br />
to evaluate presenteeism with a recall time of over 7 days [33].<br />
The premature mortality was another major contributor of costs in both<br />
diseases, which is in line with findings of systematic analysis of the<br />
global burden of inflammatory bowel disease. It shows the fact that<br />
IBD-associated premature mortality forms a great share of disease<br />
burden in countries with low socio-demographic index (SDI) [47].<br />
28
FEATURE<br />
There is insufficient population-based data evaluating the causes of<br />
premature mortality in IBD patients in Iran. In a study assessing the<br />
trend of colectomy in the country, colorectal cancer was found to be<br />
the leading cause of death in IBD patients undergoing colectomy. In this<br />
regard, cancer screening protocols should be routinely performed in<br />
IBD patients [9]. Cancer and cardiovascular disease were found to be<br />
leading causes of mortality in IBD patients in the USA. Therefore, healthy<br />
lifestyle behaviors should be routinely assessed in IBD patients, and<br />
adherence to such lifestyle should be encouraged to reduce contributing<br />
risk for cancer and cardiovascular disease, and subsequently the risk of<br />
premature mortality and related costs in IBD patients [48].<br />
Supplementary Information<br />
The online version contains supplementary material available at<br />
https://doi.org/10.1186/s12876-023-02648-z.<br />
Additional file 1: Table S1. Unit Costs of Medical Resources<br />
Consumed by Patients/*: For Nurition Consult, Imaging, Laboratory, and<br />
Surgery constant of k should be multipled by given data; k = 13600.<br />
Acknowledgements<br />
We are grateful to all patients who participated in this study.<br />
Limitations<br />
This study provided a more comprehensive view of the costs of illness for<br />
IBD in the Iran. However, this study was limited by the small sample size<br />
and prevalence approach for cost diaries. Furthermore some aspects of<br />
estimation might be affected by purchasing power of participants.<br />
Author contributions<br />
Conceptualization, Visualization, and Methodology: KBL, LZ, SG.<br />
Supervision, and Project administration: KBL, SG. Investigation: MP, SG.<br />
Writing, reviewing, and editing: MP, LZ, SG. Data curation, and Software:<br />
MP. All authors read and approved the final manuscript.<br />
Conclusion<br />
The medication was found to be the greatest contributor to direct<br />
medical costs. Productivity loss due to long-term disability and<br />
premature mortality were major components of inflammatory bowel<br />
disease burden in Iran.<br />
Funding<br />
This study was funded by Shiraz University of Medical Sciences (SUMS).<br />
Availability of data and materials<br />
The data that support the findings of this study are available from the<br />
corresponding author upon reasonable request.<br />
Find out more at www.faecal-immunochemical-test.co.uk<br />
Faecal Immunochemical Testing<br />
A framework of recommendations for<br />
maximising the benefits of FIT<br />
Based on evidence, updated recommendations for FIT<br />
by the Association of Coloproctology of Great Britain<br />
and Ireland and the British Society of <strong>Gastroenterology</strong><br />
(BSG) (2022), offer guidelines for identifying patients<br />
requiring further investigation for bowel disease *.<br />
■ FIT to stratify patients younger than 50 years<br />
with bowel symptoms suspicious of CRC<br />
■ FIT to be used as triage tool for further colorectal<br />
investigation at primary care level<br />
■<br />
FIT threshold of fHb ≥10 µg Hb/g for urgent referral for CRC investigation<br />
■ Safety-netting for symptomatic patients if fHb
FEATURE<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
Declarations<br />
Ethics approval and consent to participate<br />
Informed consent was obtained from all participants, their anonymity<br />
was guaranteed, and the study protocol was approved by approved by<br />
Ethical Committee of Shiraz University of Medical Sciences approved<br />
with Reg. No: IR.SUMS.REC.1400.637. The study protocol followed the<br />
ethical guidelines of the 2013 Declaration of Helsinki.<br />
Consent for publication<br />
Not applicable.<br />
Competing interests<br />
The authors confirm that there is no conflict of interest to declare.<br />
Received: 10 August 2022 Accepted: 10 January <strong>2023</strong><br />
Published online: 19 January <strong>2023</strong><br />
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Publisher’s Note<br />
<strong>Spring</strong>er Nature remains neutral with regard to jurisdictional claims in<br />
published maps and institutional affiliations.<br />
30
COMPANY NEWS<br />
PENTAX MEDICAL TO LAUNCH NEW PREMIUM<br />
VIDEO PROCESSOR AND ENDOSCOPE SERIES<br />
PENTAX Medical INSPIRA video processor (EPK-i8020c) and the<br />
i20c endoscope generation obtain CE marks<br />
TOKYO, 16 January <strong>2023</strong> – PENTAX Medical, a division of HOYA<br />
Group, has obtained CE marks for two of its latest innovations;<br />
PENTAX Medical INSPIRA, the new premium video processor,<br />
and the i20c video endoscope series. Developed with a focus on<br />
healthcare provider’s needs, the new video processor maintains<br />
compatibility with PENTAX Medical’s recent endoscope models [1],<br />
and sets new standards in combination with the new i20c video<br />
endoscope generation.<br />
Optimum image quality<br />
PENTAX Medical INSPIRA video processor delivers striking image<br />
quality with any PENTAX Medical endoscope [2]. Compatible with<br />
two connection types, it allows for upgrading the legacy endoscopy<br />
portfolio1 to the latest imaging standards. As a result, the image quality<br />
of current endoscope generations meets high-class clinical needs, for an<br />
extended duration of time. This smart feature thus extends the lifecycle<br />
of each endoscope for greater sustainability, while continuing to meet<br />
the highest standards of modern imaging and visualization.<br />
Enhanced user experience<br />
PENTAX Medical INSPIRA video processor was developed with<br />
a focus on healthcare providers’ needs. It combines cutting-edge<br />
functionalities in one plug-and-play solution with intuitive usability. It is<br />
controlled via a customisable, state-of-the-art touch panel, equipped<br />
with innovative image enhancement functionalities and 4K image<br />
processing. This ultimately enables physicians to focus on what is really<br />
important; achieving optimal clinical outcomes.<br />
Next generation endoscopes with superior ergonomics<br />
The i20c endoscopes are designed with superior ergonomics for<br />
healthcare professionals and exceptional imaging for the highest<br />
quality of procedures. Physicians instantly benefi t from outstanding<br />
manoeuvrability, angulation and handling, combined with further<br />
improved vision. The unique control body and light-weight connector<br />
of the i20c video endoscopes are designed to further optimize the<br />
endoscopic workfl ow.<br />
Rainer Burkard, Global President at PENTAX Medical, comments: “The<br />
PENTAX Medical INSPIRA video processor not only upgrades legacy<br />
instruments’ imaging capabilities, in combination with our new i20c<br />
endoscope generation, it is a milestone for endoscopy. In line with our<br />
commitment to continually innovate products, this cutting-edge solution<br />
provides a future-proof platform and we are proud of the groundbreaking<br />
image quality it brings.”<br />
Both the INSPIRA video processor and i20c endoscopes will be<br />
exclusively showcased during the ESGE Days <strong>2023</strong> in Dublin (or online)<br />
from April 20 – 22, <strong>2023</strong>. Please let us know if you would be interested<br />
in attending, we would be happy to organise an interview with one or<br />
more of the speakers.<br />
[1] 90i, i10, J10, 90K and i10c series endoscopes. Not all models are<br />
compatible. For detail, contact your local PENTAX Medical service<br />
facility.<br />
[2] 90i, i10, J10, 90K, i10c and i20c series endoscopes. Not all models<br />
are compatible. For detail, contact your local PENTAX Medical service<br />
facility.<br />
WHY NOT WRITE FOR US?<br />
<strong>Gastroenterology</strong> <strong>Today</strong> welcomes the submission of<br />
clinical papers and case reports or news that<br />
you feel will be of interest to your colleagues.<br />
Material submitted will be seen by those working within all<br />
UK gastroenterology departments and endoscopy units.<br />
All submissions should be forwarded to info@mediapublishingcompany.com<br />
If you have any queries please contact the publisher Terry Gardner via:<br />
info@mediapublishingcompany.com<br />
GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />
31
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