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




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 />

BIOHIT HealthCare Ltd<br />

Pioneer House, Pioneer Business Park, North Road,<br />

Ellesmere Port, Cheshire, United Kingdom CH65 1AD<br />

Tel. +44 151 550 4 550<br />

info@biohithealthcare.co.uk<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 />


This issue edited by:<br />

Aaron Bhakta<br />

c/o Media Publishing Company<br />

Greenoaks<br />

Lockhill<br />

Upper Sapey, Worcester, WR6 6XR<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 />


March, June, September and December.<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 />

encircle, lift, close, and heal tissue defects.<br />

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 />

endoscopic needle projection every time.<br />

1<br />

Testing data on fi le<br />

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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 />


Media Publishing Company<br />

Greenoaks<br />

Lockhill<br />

Upper Sapey, Worcester, WR6 6XR<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 />

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GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><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 />







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.




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 />



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 />





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 />

Alternatively, if you would like to have more information on how<br />

to work with your Trust, please email us at:<br />

busdev@18weeksupport.com.<br />

18 Week Support<br />

www.18weeksupport.com<br />

Dr Matthew Banks<br />

<strong>Gastroenterology</strong> Clinical Lead<br />

18 Week Support<br />

London<br />

WeWork, 51 Eastcheap, London EC3M 1DRT 020 8038 0447<br />

Birmingham<br />

Charter House, Sandford Street, Lichfield WS13 6QA 01543 226967<br />

GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><br />

Follow us: 18-week-support 18 Week Support @18WeekSupport<br />



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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 />



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 />



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 />



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 />



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 />



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 />



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 />



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 />



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 />



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 />



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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implementation of appropriate treatment pathways and<br />

prioritisation of valuable resources.<br />

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histologic findings<br />

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■ Positive patient experience<br />

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GASTROENTEROLOGY TODAY - SPRING <strong>2023</strong><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>.


(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 />



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 />



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 />



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 />



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


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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32. van der Valk ME, Mangen M-JJ, Severs M, van der Have M, Dijkstra G, van Bodegraven AA, et al.<br />

Evolution of costs of inflammatory bowel disease over two years of follow-up. PLoS ONE. 2016;11(4):<br />

e0142481.<br />

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costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNFα<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 />





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 />


<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 />


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