Gastroenterology Today Spring 2023

Volume 33 No. 1 

Spring 2023 

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CONTENTS 

CONTENTS 

4 EDITORS COMMENT 

11 FEATURE Quality assessment of Clinical Practice Guidelines 

(CPG) for the diagnosis and treatment of 

infl ammatory bowel disease using the AGREE II 

instrument: a systematic review 

24 FEATURE The cost of illness analysis of infl ammatory bowel 

disease 

31 COMPANY NEWS 

This issue edited by: 

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c/o Media Publishing Company 

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GASTROENTEROLOGY TODAY - SPRING 2023 

3

EDITORS COMMENT 

EDITORS COMMENT 


“With the 

number of 

people in 

the UK living 

with multiple 

long-term 

conditions 

on the rise 

and an 

increasing life 

expectancy, 

the economic 

and social 

burden of 

chronic 

conditions 

is more 

apparent than 

ever.” 

The cost of chronic disease 

Chronic conditions such as diabetes mellitus, rheumatoid arthritis and inflammatory bowel 

disease to name a few, all have a considerable impact on healthcare resources. 

With the number of people in the UK living with multiple long-term conditions on the rise 

and an increasing life expectancy, the economic and social burden of chronic conditions is 

more apparent than ever. 

In this edition of Gastroenterology Today, we feature a study analysing the economic burden 

of inflammatory bowel disease in Iran. This appears to be wide-ranging, from the direct 

costs of treatment to productivity losses at work. 

The global prevalence of inflammatory bowel disease is increasing, and clinicians and policy 

makers alike are looking for innovative ways to tackle the burden of this disease. Home 

faecal calprotectin tests for monitoring treatment response are one such technology and we 

include an article on the patients’ perspectives. 

Aaron Bhakta 

St George’s Hospital 

4

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6 

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CALPROTECTIN HOME TESTING - 

WHAT DO THE PATIENTS THINK? 

By Amanda Appleton, Senior Diagnostics Product Manager, Alpha Laboratories Ltd. 

The demands on healthcare resources continue 

to escalate, with the COVID pandemic having 

exacerbated the existing pressures from an aging 

population living longer and with more complex 

health conditions. Changes to traditional practices 

are essential if healthcare services are to keep pace 

with the increased demands. 

Developments in digital App technology have the ability not only to 

improve the health of patients, but also to save money, through rapid 

optimisation of treatment. They enable early interventions through 

monitoring, before conditions get too serious and reduce the need 

for routine check-up appointments and procedures. This frees up 

limited resources in both pathology and the clinic. 

The BÜHLMANN IBDoc was the fi rst calprotectin home test to be 

introduced to the market back in 2015. Since then, there have been 

numerous publications demonstrating the correlation of the IBDoc 

result from the test performed by the patient in their own home, to 

the results of professional laboratory analyses. More importantly there 

is also evidence of the correlation to the IBDoc calprotectin results to 

the endoscopic and histologic fi ndings of disease status. From the 

clinical perspective the test undoubtedly fi ts the bill. 

Dr Pushpakaran Munuswamy, Department Lead. Gastroenterology, 

Basildon University Hospital introduced the IBDoc to support their 

IBD patients in the summer of 2020 commented that: 

“Anecdotally, it seems to be the older patients that are more engaged 

with the home testing, and even the more senior patients which 

has been surprising, but maybe it is to be expected. These are the 

patients that have lived with the consequences of the disease for 

longer and are keen for things not to deteriorate.” 

Patients’ Experience of the IBDoc Assay 

Overall satisfaction with the test was high: 

% of % of patients Patients mildly mildly to to strongly satisfied with the the IBDoc to: 

Time to perform the test 

Recording & display of the results in the App 

Reading the test result with the App 

% of Patients mildly to strongly satisfied with the IBDoc 

Getting the sample onto the test cassette 

Collecting the sample in the CALEX 

Time Installation to perform of the the test Ap 

Recording & display of the Instructions results in the for App use 

Reading the test result with the App78% 80% 82% 84% 86% 88% 90% 92% 94% 96% 

Getting the sample onto the test cassette 

Collecting the sample in the CALEX 

Installation of the Ap 

This high level of Instructions satisfaction for use 

% of patients mildly was to strongly also refl satisfied ected in that the the results IBDoc and 

aftercare with the IBDoc: 

Monitor treatment success 

Predicted early disease relapse 

78% 80% 82% 84% 86% 88% 90% 92% 94% 96% 

“From my perspective I am seeing a difference already, because 

we can escalate treatment within a day or two of requesting the 

calprotectin test. Previously there was a wait of around 4 – 6 weeks 

or even longer depending on when the sample is taken and the 

capacity in the labs. Hopefully, in the future we will see the benefi ts 

of this rapid response in terms of reduced hospitalisations and clinic 

visits because patients have had timely interventions. It will also 

reduce calls to the helpline because we know the results and have 

been able to act quickly.” 

But, how do the patients feel about the changes that have been 

introduced? Kezia Allen Pathology project specialist conducted a 

survey after the IBDoc had been in use for 2 years, with around 250 

patients actively using the system in Basildon. 

Responses to the survey were received from 22% of eligible patients 

with two thirds being female and a third being male. Roughly two 

thirds had Crohn’s disease and a third had Ulcerative colitis. The 

mean age of the respondents was 43 years ranging from 22 to 75 

years. 

% of % Results patients of reflected mildly the mildly clinical to status to strongly satisfied with that the the IBDoc to: 

Good understanding of what the result meant for their 

disease Monitor state treatment success 

Results reflected the clinical status 

Good understanding of what the result meant for their 

disease state 

Patient comments included: 

70% 75% 80% 85% 90% 95% 

Predicted early disease relapse 

70% 75% 80% 85% 90% 95% 

“Having the result straight away, instead of weeks waiting, is so 

benefi cial as you can start on the medication you require.” 

“Absolutely love it! I actually get upset when they send out a normal 

stool sample test and not the IBDoc.” 


Continued on next page > > > 

7


Aftercare 

The survey showed that 94% of patients would feel satisfied with a 

phone consultation, rather than a face-to-face appointment, following a 

high result, compared to 43% who feel some level of dissatisfaction at 

receiving no clinical contact following a negative result. 

Patients know what the plan is if a high result is obtained, they will get 

their medication increased or switched or have further investigations so 

they are happier with a phone consultation. 

You would think a negative result would be reassuring, but possibly 

the worry is that with a low result they will be told nothing is wrong 

even though they may be feeling unwell. A low result means that 

the symptoms are unlikely to be caused by their IBD and need to be 

managed in another way. This highlights that patients do not know what 

to do and would still need clinical advice or better educational materials 

explaining the potential causes and treatments of the symptoms if they 

aren’t caused by IBD. 

The patients on the biologics verses non-biologic treatments seemed 

happier knowing when to use the IBDoc and knowing how to manage 

their condition. This is probably fairly intuitive because to get to the 

stage of being on biologics they have had the disease a while and it 

hasn’t been very easy to manage and therefore they have had to be 

more engaged. 

Improvements 

Some of the things that were cited by the patients that would make 

things easier were: 

accurate correlation to the laboratory results. This is continuous 

addressed but there is inevitably a delay. 

The Future 

I think it is a genuine candidate for patient self-management but we 

need to do more in educating patients and personalising the care that 

surrounds this. There are easier point of care tests than calprotectin 

testing, but the patients want it enough that they are prepared to do it 

and it works for them. Some have even changed phones so that they can 

use the system – this shows the level of engagement within the patient 

population and the desire to be able to access the new technology. 

Remote monitoring and patient self-management will be key to 

managing services going forwards, we just need to get the education 

aspect right. The IBDoc home testing works so well for a large number 

of our patients which means it can work well for most of them, we just 

have to get better at the support side so that patients are confident 

they understand the results and their condition and are being managed 

appropriately. There is probably a lot we can learn from other chronic 

conditions that have been historically remotely managed like diabetes, 

which must also have to cope with different patient groups and different 

levels of engagement. 

Whilst this type of test will never be for everyone (let’s be honest there 

are some patients who will just never do a stool test regardless of 

where it is completed), for many this type of technology is appreciated. 

It has the potential to help patient engagement and support remote 

management and personalised care. 

Find out more at www.calprotectin.co.uk/ibdoc 

• More regular contact from the IBD team, especially when starting a 

new treatment 

• More information on what causes a flare and how to control them 

• Access to a nutritionist/dietary advice 

• Better communication between the primary and secondary care 

providers 

• Access available on a wider selection of phones 


Fundamentally the patients seem to like the actual test, most of 

the points raised relate to the educational and support functions 

that need to underpin the adoption of new technologies. The wider 

selection of phones is a continuously moving goalpost as new 

phones are released they need to be validated for use to ensure 

“Using the IBDoc has increased the engagement from both the patients and the clinical 

team, and the speed of the results really makes a big impact in decision making and 

patient management. It doesn’t really add more work because you save work in chasing 

results and additional support for patients whilst they are waiting for results.” 

Dr Pushpakaran Munuswamy 

8


THE MOBILE AND MODULAR SOLUTION: HOW ON- 

SITE THEATRES ARE TACKLING NHS WAITING LISTS 

Cancer waiting lists soared above record levels 

As of November 2022, 110,000 people were waiting for a colonoscopy, 

and the median wait was 4.2 weeks, double the median wait in 

November 2019. The referrals for lower gastrointestinal cancer on the 

two weeks pathway soared from 39,000 in November 2019 to 52,000 

in November 2022 (HSJI). To tackle the soaring cancer waiting lists, 

the NHS has been implementing various diagnostic services and 

facilities, including one-stop clinics for tests and symptom hotlines. 

One of the most successful initiatives has been the use of mobile and 

modular theatre units, which has helped to reduce waiting lists while 

keeping procedures separate from main hospital buildings to ensure 

infection control. 

What to expect when working in a mobile endoscopy suite 

Dr. Matthew Banks, Gastroenterology Clinical Lead for 18 Week 

Support, states that the experience of endoscopists working in a 

stand-alone ‘cold site’ can be rapid and relatively straightforward. 

Carrying out endoscopy procedures in a mobile or semi-permanent 

endoscopy suite requires flexibility and adaptability, and staff need 

to be familiar with the unit, layout, equipment, and IT. Once familiar, 

the experience is very much like scoping in any endoscopy unit. 

However, staff need to be aware of the limitations and that complex 

therapeutics and high-risk patients are usually avoided. 

Working with mobile theatre units to support the rising waiting 

times 

Here at 18 Week Support, the UK’s #1 insourcing provider, we provided 

specialist endoscopy teams for several Trusts where they staff and 

operate mobile theatre units contracted from specialist providers. 

We have helped over 55 Trusts across the UK carry out a full range of 

endoscopy procedures, either in-house or in mobile theatres, during 

and after the COVID-19 pandemic. The success of these mobile and 

modular theatre suites has led many Trusts to include them in their 

planning to reduce waiting lists, adding new theatre capacity quickly and 

cost-effectively. 

Final thoughts 

In conclusion, mobile and modular theatre units have proven to be a 

successful initiative in reducing waiting lists while keeping procedures 

separate from main hospital buildings. Working in a stand-alone ‘cold 

site’ requires flexibility and adaptability, and staff need to be aware 

of the limitations. Good leadership and clinical knowledge and skills 

are essential for working in this environment. Finally, the quality and 

performance of the endoscopy teams are critical to achieving high 

patient satisfaction and safety, especially when working for third-party 

organizations like 18 Week Support. 

Those working in insourcing teams like 18 Week Support will often 

find themselves working with different nurses throughout the week. 

Leadership, patience, and understanding are needed to ensure 

constant quality delivery. Each unit team typically has a Nurse 

in Charge (NIC) who runs the day and the lists. For consultants, 

focusing on their role as the endoscopist is key, and working as a 

team is essential in ensuring all patients are managed appropriately. 

Another difference arises from working for a third-party organization 

within an NHS Trust framework. This relationship means that patients 

are not followed up by the endoscopist, histology is often not 

available to review after the event, and sometimes clinical information 

can be quite limited. Moreover, because of the COVID pandemic, 

the endoscopist is often the first ‘face-to-face’ consultation the 

patient has had in two years. 

The pre-procedure process is therefore crucial to understanding the 

patient’s concerns and ensuring the correct procedure is completed 

or occasionally no procedure performed at all. The quality and 

performance of the 18 Week Support teams are reflected in their JAG 

data and patient satisfaction scores, which are exemplary across the 

UK. Recruiting high-performing endoscopists that are passionate 

about their work helps ensure 18 Week Support’s JAG safety and 

quality data is above the national average. On December 10th-11th 

2022, 18 Week Support carried out 387 colonoscopies across 14 

Trusts, recording a patient comfort score of 99%, with a 97% score 

on ERS. 

Reference: Stubborn cancer backlog at record high | HSJ Intelligence - 

https://www.hsjintelligence.co.uk/news/stubborn-cancer-backlogrecord-high 

If you want to help clear the NHS backlog and provide high quality 

care to patients, please reach out to us at: 

recruitment.team@18weeksupport.com. 

Alternatively, if you would like to have more information on how 

to work with your Trust, please email us at: 

busdev@18weeksupport.com. 

18 Week Support 

www.18weeksupport.com 

Dr Matthew Banks 

Gastroenterology Clinical Lead 

18 Week Support 

London 

WeWork, 51 Eastcheap, London EC3M 1DRT 020 8038 0447 

Birmingham 

Charter House, Sandford Street, Lichfield WS13 6QA 01543 226967 


Follow us: 18-week-support 18 Week Support @18WeekSupport 

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FEATURE 

QUALITY ASSESSMENT OF CLINICAL PRACTICE 

GUIDELINES (CPG) FOR THE DIAGNOSIS AND 

TREATMENT OF INFLAMMATORY BOWEL 

DISEASE USING THE AGREE II INSTRUMENT: 

A SYSTEMATIC REVIEW 

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. 

Simancas-Racines 6 , A. Viteri-García 6 and C. Montesinos-Guevara 6* 

BMC Gastroenterology (2022) 22:447 https://doi.org/10.1186/s12876-022-02539-9 

Abstract 

Background 

The incidence and diagnosis of infl ammatory bowel disease (IBD) 

has increased considerably in recent years. Many clinical practice 

guidelines (CPG) have been developed for the management of this 

disease across different clinical contexts, however, little evidence exists 

on their methodological quality. Therefore, we aimed to systematically 

evaluate the quality of CPGs for the diagnosis and treatment of IBD 

using the Appraisal of Guidelines for Research and Evaluation (AGREE 

II) instrument. 

Methods 

We identifi ed CPGs by searching databases (MEDLINE - PubMed, 

EMBASE, CINAHL, LILACS) and other sources of gray literature on 

January 2022. We included guidelines with specifi c recommendations 

for the diagnosis and treatment of IBD and evaluated them with 

the AGREE II instrument to assess their methodological quality. Six 

independent reviewers assessed the quality of the guidelines and 

resolved confl icts by consensus. We assessed the degree of agreement 

using the intraclass correlation coeffi cient (ICC) and change in quality 

over time was appraised in two periods: from 2012 to 2017 and from 

2018 to 2022. 

Keywords 

Infl ammatory bowel disease, Crohn disease, Ulcerative colitis, Clinical 

practice guidelines, Systematic review. 

Introduction 

Ulcerative colitis and Crohn’s disease are the main forms of infl ammatory 

bowel disease (IBD). Both pathologies involve chronic infl ammation of 

the gastrointestinal tract and show heterogeneity in terms of symptoms, 

which mainly include abdominal pain and diarrhea associated with 

malabsorption, weight loss and fever [1]. IBD involves periods of 

relapse and remission [2]. Although its etiology is unknown, it has been 

considered a multifactorial disease due to its association to genetic 

factors [3], immune mediators [4], changes in the intestinal microbiome 

[5] and exposure to various environmental agents [6]. 

The onset of IBD generally occurs around the third decade of life, but 

25% of cases begin during childhood and adolescence [7]. The peak 

age of onset for Crohn’s disease is generally between 20 and 30 years 

of age, while Ulcerative Colitis usually begins at around 30 and 40 years 

of age [8]. 

Results 

We analyzed and evaluated 26 CPGs that met the inclusion criteria. The 

overall agreement among reviewers was moderate (ICC: 0.74; 95% CI 

0.36 - 0.89). The mean scores of the AGREE II domains were: “Scope 

and purpose” 84.51%, “Stakeholder involvement” 60.90%, “Rigor of 

development” 69.95%, “Clarity of presentation” 85.58%, “Applicability” 

26.60%, and “Editorial independence” 62.02%. No changes in quality 

were found over time. 

Conclusions 

The quality of the CPGs evaluated was generally good, with a large 

majority of the assessed guidelines being “recommended” and 

“recommended with modifi cations”; despite this, there is still room 

for improvement, especially in terms of stakeholder involvement and 

applicability. Efforts to develop high quality CPGs for IBD need to be 

further optimized. 

The incidence and prevalence of IBD vary according to the geographic 

location, environment and ethnicity [9]. The latest reported data on the 

incidence of Ulcerative Colitis in North America and Europe ranged 

from 0 to 19.2 per 100,000 and 0.6 to 24.3 per 100,000, respectively 

[10]; whereas the prevalence of Ulcerative Colitis was 37.5 to 248.6 per 

100,000 in North America and 4.9 to 505 per 100,000 in Europe [11]. 

For Crohn’s disease, the incidence varied from 0 to 20.2 per 100,000 

in North America and from 0.3 to 12.7 per 100,000 in Europe [10]. 

In Latin America these data have considerable differences, however, 

in the last decades there has been a progressive increase with a 

prevalence of 0.99 to 44.3 per 100,000 inhabitants for Ulcerative Colitis 

and 0.24 to 16.7 per 100,000 inhabitants for Crohn’s disease [12, 13]. 

Epidemiological data suggest that the global incidence of IBD presents 

a marked increase, implying that the health systems of developing 

countries do not have the resources, health staff and infrastructure 

necessary for the diagnosis and treatment of the pathology. 


* Correspondence: camila.montesinos@ute.edu.ec 

6 

Centro de Investigación en Salud Pública y Epidemiologia Clínica, (CISPEC), Facultad de Ciencias de la Salud Eugenio Espejo. Universidad UTE, Rumipamba and Bourgeois, Universidad 

UTE, 170147 Quito, Ecuador. Full list of author information is available at the end of the article 

© The Author(s) 2022. 

11

FEATURE 


Considering the increasing prevalence of IBD and its impacts in terms 

of health, society and economy (direct and indirect costs for the health 

systems and out-of-pocket expenses) [13], it is important to ensure high 

quality tools that facilitate its systematized treatment. For this reason, 

in the last decade, there have been important advances in terms of 

therapies for the management of IBD through pharmacological, nonpharmacological 

and surgical interventions [14, 15], these advances 

have been translated into several Clinical Practice Guidelines (CPG), 

which quality has not yet been assessed. 

CPGs are systematically developed statements intended to help 

physicians and patients to make decisions about appropriate medical 

care in specific circumstances based on high-quality scientific 

evidence [16]. Their recommendations are intended to improve the 

quality of patient care by encouraging interventions of proven benefit 

and discouraging ineffective or potentially harmful interventions [16]. 

Several tools currently exist to assess the quality of a CPG and its 

implementation [17]; the AGREE (Appraisal of Guidelines, Research, 

and Evaluation) collaboration developed the AGREE II tool which is 

the most validated and widely used tool [18, 19]. This tool is helpful to 

assess the transparency in guidelines development and their quality, 

it provides a methodological strategy for guidelines development, 

and establishes a scheme for their reporting [20]. The AGREE II tool 

can be applied in Clinical Practice Guidelines (CPG) for diagnosis and 

medical interventions as well as for the evaluation of guidelines on health 

promotion, public health, among others [20]. 

Therefore, the main objective of this study is to systematically evaluate 

CPG for the diagnosis and treatment of IBD using the AGREE II tool, to 

provide evidence on their methodological quality and to assess changes 

in guideline quality over time. 

Methods 

Data Search 

A systematic search was performed up to January 2022 to look for 

CPG on the diagnosis and treatment of IBD. CPGs were searched 

on databases (MEDLINE - PubMed, EMBASE, CINAHL, LILACS), 

professional societies (CAG, British Society of Gastroenterology, 

AGA, Brazilian Society of Gastroenterology), registries and guideline 

developers’ websites (NICE, SIGN). The full search strategy is detailed 

in Additional file 1: https://static-content.springer.com/esm/art%3A1 

0.1186%2Fs12876-022-02539-9/MediaObjects/12876_2022_2539_ 

MOESM1_ESM.docx 

Inclusion and exclusion criteria 

We included: 1.- CPGs with specific recommendations for the diagnosis 

and treatment of IBD, both for Crohn’s disease (CD) and ulcerative colitis 

(UC); 2.- CPGs on IBD that included pediatric, young, adult, and elderly 

populations; 3. - CPGs that provide the full search strategy that was 

conducted; 4.- CPGs that mentioned the process how they reached 

recommendations; 6.- CPGs published without date restriction until January 

2022; and 6.- Last published available version of CPGs. The following 

documents were excluded: 1.- CPGs exclusively dealing with other clinical 

scenarios such as diagnostics (e.g. endoscopic, imaging), nutrition, 

immunological or surgical interventions for IBD; 2.- secondary publications 

(e.g., systematic reviews and meta-analyses) and 3.- abstracts from CPGs. 

Data Collection 

Five reviewers working in pairs (DH, CMG, PA, RZ, RV) independently 

peer-screened the guidelines by title and abstract following the above 

inclusion and exclusion criteria. If the inclusion criteria were met, the 

full-text article were retrieved and screened by pairs for eligibility. All 

the screening process was performed using Rayyan (Rayyan Systems 

Inc) [21]. Two reviewers independently extracted the following data 

for each CPG: title, year of publication, submitting organization, type 

of funding, method used to collect evidence, number of sources 

documented, methods used to assess the quality and validity of the 

evidence, methods used to formulate the recommendations, country, 

and language. In case of disagreement, a third reviewer (VA, DSR) 

was involved. 

Quality assessment 

The AGREE II instrument [18-20, 22] was used to evaluate the quality 

of the included CPGs. This instrument provides criteria for assessing 

the quality of the clinical practice guidelines through 23 items or 

questions, divided into 6 domains or categories; including: 1.- scope 

and purpose, 2.- stakeholder involvement, 3.- rigor of development, 

4.- clarity of presentation, 5.- applicability, and 6.- editorial 

independence. The first domain evaluates the general objective of 

the CPG, specific health aspects and the target population; the 

second domain refers to the degree to which the guideline has been 

developed by the appropriate stakeholders and represents the views 

of intended users; the third domain refers to the process used to 

gather and synthesize evidence, the methods used to formulate 

and update recommendations; the fourth domain focuses on the 

language, structure and format of the guideline; the fifth domain 

refers to barriers and facilitators to CPG implementation, strategies 

for its adoption and resource considerations; and finally, the sixth 

domain is about the formulation of recommendations, to understand 

whether they are biased by conflicts of interest [19]. 

Each of the 23 items or questions is classified on a 7-point Likerttype 

scale, 7 being the maximum score corresponding to “strongly 

agree” and 1 the minimum score corresponding to “strongly 

disagree”. 

For the global guideline evaluation, we used a 3-point scale: 1 

“not recommended”, 2 “recommended with modifications” and 3 

“recommended”. Six reviewers (DH, CMG, PA, RZ, JAF, RV), with 

clinical and methodological expertise, independently peer-scored 

each of the 23 items of the 6 domains of the AGREE II instrument 

for each CPG that was included. In case of disagreements with the 

assessment, a consensus was reached with the support of a third 

reviewer (AV, DSR). 

Statistical analysis 

A descriptive analysis of the CPGs was performed using the general 

characteristics of each CPG from the extracted data. To calculate 

the score for each domain of the AGREE II tool, all item scores were 

summed up and the total value was standardized as a percentage of the 

maximum possible score for that domain, using the following formula: 

Standardized score (SP) = score obtained - lowest possible score 

highest possible score - lowest possible score 

× 100 

12

FEATURE 

Table 1 General characteristics of the CPGs 

Guideline Country Organization Year Method used to asses quality and strength of 

evidence 

AGA Clinical Practice Guidelines on the Management of 

Mild-to-Moderate Ulcerative Colitis [28] 

ESPGHAN Revised Porto Criteria for the Diagnosis of 

Inflammatory Bowel Disease in Children and Adolescents 

[29] 

ACG Clinical Guideline: Management of Crohn’s Disease 

in Adults [30] 

European evidence based consensus on surgery for 

ulcerative colitis [31] 

Updated German Clinical Practice Guideline on “Diagnosis 

and treatment of Crohn’s disease” 2014 [32] 

Consensus guidelines of ECCO/ESPGHAN on the medical 

management of pediatric Crohn’s disease [33] 

Management of paediatric ulcerative colitis, Part 1: ambulatory 

care- an evidence-based guideline from ECCO and 

ESPGHAN [34] 

Evidence-based clinical practice guidelines for Crohn’s 

disease, integrated with formal consensus of experts in 

Japan [35] 

Diagnosis and treatment of inflammatory bowel disease: 

First Latin American Consensus of the Pan American 

Crohn’s and Colitis Organisation [36] 

Mexican consensus for the diagnosis and treatment of 

idiopathic chronic ulcerative colitis [37] 

Crohn’s disease Management in adults, children and 

young people [38] 

Second Korean guidelines for the management of ulcerative 

colitis [39] 

AGA Clinical Practice Guidelines on the Management of 

Moderate to Severe Ulcerative Colitis [40] 

Evidence-based clinical practice guidelines for inflammatory 

bowel disease [41] 

USA American Gastroenterological Association (AGA) 2019 GRADE a 

UK European Society of Pediatric Gastroenterology, Hepatology 

and Nutrition (ESPGHAN) 

USA American College of Gastroenterology 2018 GRADE 

2013 Oxford Centre for Evidence-Based Medicine 

Multinational European Crohn’s and Colitis Organization (ECCO) 2014 Oxford Center for Evidence-Based Medicine 

Germany German Society for gastroenterology, digestive and 

metabolic diseases (DGVS) with the participation of 

Deutsche Gesellschaft for General and Visceral Surgery 

(DGAV), German Society of Surgery (DGCh), German 

Society for Internal Medicine (DGIM), German Society 

for Coloproctology (DGK), German Morbus Crohn’s / 

ulcerative colitis association (DCCV), Society for pediatric 

gastroenterology and nutrition (GPGE), Competence 

Network for Inflammatory Bowel Diseases. 

Multinational European Crohn’s and Colitis Organization (ECCO / 

ESPGHAN) 

Israel Shaare Zedek Medical Center, The Hebrew University of 

Jerusalem, Israel. 

Japan Japanese Society of Gastroenterology and the Research 

group of Intractable Bowel Disease subsidized by the 

Ministry of the Health, Labour and Welfare of Japan 

2014 Oxford Center for Evidence-Based Medicine 


2018 Oxford Centre for Evidence-Based Medicine 

2013 Self-grading scheme used to assess the quality of the 

evidence 

Mexico Pan American Crohn’s and Colitis Organization 2016 Oxford Center for Evidence-Based Medicine 

Mexico Mexican Association of Gastroenterology 2017 GRADE 

UK NICE National institute for health care and excellence 2012 GRADE 

Korea Korean Association for the Study of Intestinal Diseases 2017 GRADE 

(KASID) 

USA AGA American Gastroenterological Association 2020 GRADE 

Japan The Japanese Society of Gastroenterology (JSGE) 2018 GRADE 

Ulcerative colitis - treatment with biologicals [42] Brazil Brazilian Study Group on Inflammatory Bowel Disease, 

Brazilian Medical Association 

2018 GRADE 


13

FEATURE 


Table 1 (continued) 

Guideline Country Organization Year Method used to asses quality and strength of 

evidence 

British Society of Gastroenterology consensus guidelines 

on the management of inflammatory bowel disease in 

adults [43] 

Canadian Association of Gastroenterology Clinical Practice 

Guideline for the Medical Management of Pediatric 

Luminal Crohn’s Disease [44] 

Clinical Practice Guideline for the Medical Management 

of Perianal Fistulizing Crohn’s Disease: The Toronto 

Consensus [45] 

Crohn’s disease - treatment with biological medication 

[46] 

Canadian Association of Gastroenterology Clinical Practice 

Guideline for the Management of Luminal Crohn’s 

Disease [47] 

Evidence-based clinical practice guidelines for inflammatory 

bowel disease 2020 [48] 

AGA Clinical Practice Guidelines on the Medical Management 

of Moderate to Severe Luminal and Perianal Fistulizing 

Crohn’s Disease [49] 

WSES-AAST guidelines: management of inflammatory 

bowel disease in the emergency setting [50] 

The Medical Management of Paediatric Crohn’s Disease: 

an ECCO-ESPGHAN Guideline Update [51] 

Guidelines for the management of patients with Crohn’s 

disease. Recommendations of the Polish Society of 

Gastroenterology and the Polish National Consultant in 

Gastroenterology [52] 

ECCO Guidelines on Therapeutics in Crohn’s Disease: 

Medical Treatment [53] 

UK British Society of Gastroenterology and others 2019 GRADE 

Canada Canadian Association of Gastroenterology (CAG) 2019 GRADE 


Brazil Brazilian Study Group on Inflammatory Bowel Disease, Brazilian Gastroenterology Federation, Brazilian Coloproctology 

Society, Brazilian Medical Association 

2018 GRADE 


Japan The Japanese Society of Gastroenterology (JSGE) 2021 GRADE 

USA AGA American Gastroenterological Association 2021 GRADE 

Netherlands The World Society of Emergency Surgery WSES 2021 GRADE 

Multinational European Crohn’s and Colitis Organization [ECCO] and 

the Paediatric IBD Porto group of the European Society 

of Paediatric Gastroenterology, Hepatology and Nutrition 

[ESPGHAN] 

Poland The Polish Society of Gastroenterology and the Polish 

National Consultant in Gastroenterology 


2021 GRADE 

Multinational The European Crohn’s and Colitis Organization [ECCO] 2020 GRADE 

a GRADE Grading of Recommendations, Assessment, Development and Evaluation 

14

FEATURE 

Fig. 1 PRISMA flow diagram showing the flow of records that were obtained and reviewed throughout the different phases of the quality 

assessment 

With this method, the standardized score for each domain ranged from 

0 to 100%. The result of the standardized score for each domain for all 

the guidelines is presented through the mean, median, first quartile (Q1), 

third quartile (Q3), interquartile range (IQR) and a boxplot. The degree 

of agreement between reviewers was assessed through the intraclass 

correlation coefficient (ICC) with a 95% confidence interval (CI). To 

visualize and compare the mean AGREE II scores obtained by the 26 

CPGs assessed in this study, we generated a hexagonal radar graph 

where each domain is represented on a radial axis centered at 0 and 

the maximum score of each domain corresponds to each vertex of the 

hexagon. Finally, for the analysis of quality change over time, Student’s 

t-test was used to compare the means and categorize the CPGs 

into two periods: 2012 to 2017 and 2018 to 2022. Data analysis was 

performed in the statistical software RStudio v.1.4 [23] using the libraries 

ggplot2 [24], irr [25], tidyverse [26] and Table 1 [27]. 

Results 

Guideline characteristics 

Eight thousand seven hundred twenty-three records were retrieved from 

the search strategy and 8165 remained after deduplication. 203 records 

were subsequently screened by full-text, of which 26 CPGs were 

included for data extraction after meeting the inclusion criteria (Fig. 1). 

Details on the characteristics of the included CPGs are shown in Table 

1 [28-53]. 

Of the 26 included CPGs, four were from the United States (15.38%) 

and four were developed by an international collaboration (15.38%); 

three were from the United Kingdom, three from Canada and three 

from Japan (11.53% each), two were from Brazil and two from 

Mexico (7.69% each); one was from Germany, Israel, South Korea, 

the Netherlands and Poland (3.84% each). Included guidelines were 

published between 2012 and 2021 (see Table 1). 

Three of the 26 guidelines focused exclusively on the pediatric 

population while the others were mainly focused on adults [29, 33, 

51]. In terms of the scope of the CPGs, 22 dealt with diagnosis and 

clinical management [28–30, 32–41, 43–45, 47–49, 51–53], two with 

the use of biologic drugs only [42, 46], one with surgical management 

in the emergency setting [50] and one with the surgical management 

of ulcerative colitis [31]. All guidelines were considered evidence-based 

according to our a priori criteria. 

Eighteen guidelines (69.23%) used the Grading of Recommendations 

Assessment, Development and Evaluation (GRADE) methodology 

to assess the quality of evidence and grade the strength of 

recommendations. Seven guidelines (26.92%) used the Oxford Centre 


15

FEATURE 

Table 2 Intraclass correlation coefficients (ICC) by peer reviewers 

Pair of reviewers ICC 95% CI *P-value a ICC interpretation 

RZ + PA 0.69 0.02 - 0.90 0.020 Moderate 

CM+JF Table 2 Intraclass 0.74correlation −0.07 - 0.97 coefficients 0.065 (ICC) Moderate by peer reviewers 

DH+RV Pair of reviewers 0.03 ICC −0.03 95% - CI 0.74 0.292 *P-value Poor a ICC interpretation 

DH+JF 0.69 −0.15 - 0.99 0.093 moderate 

RZ+PA 0.69 0.02 - 0.90 0.020 

Global 0.74 0.36 - 0.89 6.83e −4 Moderate 

moderate 

CM+JF 0.74 −0.07 - 0.97 0.065 Moderate 

*Significance level < 0.05 

DH+RV 0.03 −0.03 - 0.74 0.292 Poor 

a 

ICC interpretation following Ko and Li 2016 [53] 

DH+JF 0.69 −0.15 - 0.99 0.093 moderate 

Global 0.74 0.36 - 0.89 6.83e −4 moderate 

for Evidence-Based *Significance level < Medicine 0.05 criteria, and one guideline (3.84%) used a 

a 

ICC interpretation following Ko and Li 2016 [53] 

self-grading system to assess the quality of evidence (Table 1). 

Quality assessment 

The agreement between the 6 reviewers was moderate with an ICC of 

0.74 (95% CI: 0.36-0.89, p-value=6.83e −4 ). A summary of the ICCs 

achieved by each pair of reviewers is shown in Table 2. 

Figure 2 shows a boxplot summarizing the statistical analysis of the 

standardized scores for each domain assessed with the AGREE II 

tool. In addition, Table 3 shows the standardized scores for all domain 

assessed in each clinical practice guideline. 

Domain 1: Scope and purpose 

This domain evaluates the general objective of the CPG, specific health 

aspects and the target population [19]. The mean score was 84.51% 

(median: 90.27%, Q1: 78.47%, Q3: 94.44% and IQR=15.97%; Fig. 2). 

Twenty-four CPGs (92.30%) scored above 60% in this domain [28, 29, 

31–36, 38–53]. See Table 3 for details on domain 1. 

Domain 2: Stakeholder involvement 

This domain refers to the degree to which the guideline has been 

developed by the appropriate stakeholders and represents the views 

of intended users [19]. The mean score was 60.90% (median: 66.67%, 

Q1: 36.11%, Q3: 83.33% and IQR=47.22%; Fig. 2). Fourteen CPGs 

(53.84%) scored above 60% in this domain [32, 38, 40, 41, 43–45, 

47–53]. See Table 3 for details on domain 2. 

Domain 3: Rigor of development 

This domain refers to the process used to gather and synthesize 

evidence, the methods used to formulate and update recommendations 

[19]. The mean score was 69.95% (median: 69.79%, Q1: 58.07%, Q3: 

86.20% and IQR=28.12%; Fig. 2). Nineteen CPGs (73.07%) scored 

above 60% in this domain [28, 32–34, 36, 38–41, 43–45, 47–53]. See 

Table 3 for details on domain 3. 

Domain 4: Clarity of presentation 

This domain focuses on the language, structure and format of the 

guideline [19]. The mean score was 85.58% (median: 91.67%, Q1: 


Fig. 2 Distribution of standardized scores by domain for the 26 CPGs 

Fig. 2 Distribution of standardized scores by domain for the 26 CPGs 

16

FEATURE 

Table 3 Standardized scores by domains of AGREE II 

Guideline 

Scope and 

Purpose 

Stakeholder 

Involvement 

Rigour of 

Development 

Clarity of 

Presentation 

Applicability 

Editorial 

Independence 

Overall Recommendation 

AGA Clinical Practice Guidelines 

on the Management of Mild-to- 

Moderate Ulcerative Colitis [28] 

ESPGHAN Revised Porto Criteria 

for the Diagnosis of Inflammatory 

Bowel Disease in Children 

and Adolescents [29] 

ACG Clinical Guideline: Management 

of Crohn’s Disease in 

Adults [30] 

European evidence based 

consensus on surgery for 

ulcerative colitis [31] 

Updated German Clinical 

Practice Guideline on “Diagnosis 

and treatment of Crohn’s 

disease” 2014 [32] 

Consensus guidelines of ECCO/ 

ESPGHAN on the medical management 

of pediatric Crohn’s 

disease [33] 

Management of paediatric 

ulcerative colitis, Part 1: ambulatory 

care- an evidence-based 

guideline from ECCO and 

ESPGHAN [34] 

Evidence-based clinical practice 

guidelines for Crohn’s disease, 

integrated with formal consensus 

of experts in Japan [35] 

Diagnosis and treatment of 

inflammatory bowel disease: 

First Latin American Consensus 

of the Pan American Crohn’s 

and Colitis Organisation [36] 

Mexican consensus for the 

diagnosis and treatment of 

idiopathic chronic ulcerative 

colitis [37] 

Crohn’s disease Management 

in adults, children and young 

people [38] 

Second Korean guidelines for 

the management of ulcerative 

colitis [39] 


on the Management of 

Moderate to Severe Ulcerative 

Colitis [40] 


guidelines for inflammatory 

bowel disease [41] 

Ulcerative colitis - treatment 

with biologicals [42] 

British Society of Gastroenterology 

consensus guidelines on 

the management of inflammatory 

bowel disease in adults [43] 

Canadian Association of Gastroenterology 

Clinical Practice 

Guideline for the Medical Management 

of Pediatric Luminal 


94.44 30.56 60.42 83.33 25.00 75.00. Recommended, with modifications 

75.00 36.11 57.29 86.11 18.75 33.33 Recommended, with modifications 

44.44 5.56 35.42 72.22 4.17 29.17 Not recommended 








94.44 83.33 94.79 100.00 83.33 75.00 Recommended 


100.00 80.56 91.67 100.00 56.25 83.33 Recommended 



100.00 100.00 91.67 100.00 45.83 100.00 Recommended 

100.00 94.44 85.42 100.00 25.00 95.83 Recommended 


17

FEATURE 

Table 3 (continued) 

Guideline 

Scope and 

Purpose 

Stakeholder 

Involvement 

Rigour of 

Development 

Clarity of 

Presentation 

Applicability 

Editorial 

Independence 

Overall Recommendation 

Clinical Practice Guideline for the 86.11 91.67 79.17 100.00 14.58 95.83 Recommended, with modifications 

Medical Management of Perianal 

Fistulizing Crohn’s Disease: 

The Toronto Consensus [45] 

Crohn’s disease - treatment 80.55 44.44 34.38 44.44 4.17 0.00 Not recommended 

with biological medication [46] 

Canadian Association of Gastroenterology 

100.00 91.67 90.63 100.00 37.50 91.67 Recommended 

Clinical Practice 

Guideline for the Management 

of Luminal Crohn’s Disease [47] 



guidelines for inflamma- 

tory bowel disease 2020 [48] 


94.44 83.33 87.50 100.00 52.08 91.67 Recommended 

on the Medical Manage- 

ment of Moderate to Severe 

Luminal and Perianal Fistulizing 


WSES-AAST guidelines: 86.11 69.44 63.54 91.67 25.00 50.00 Recommended, with modifications 

management of inflammatory 

bowel disease in the emergency 

setting [50] 

The Medical Management of 91.67 66.67 86.46 100.00 39.58 100.00 Recommended, with modifications 

Paediatric Crohn’s Disease: an 

ECCO-ESPGHAN Guideline 

Update [51] 

Guidelines for the management 


of patients with Crohn’s 

disease. Recommendations 

of the Polish Society of 

Gastroenterology and the 

Polish National Consultant in 

Gastroenterology [52] 

ECCO Guidelines on Therapeutics 

91.67 94.44 92.71 97.22 47.92 100.00 Recommended 

in Crohn’s Disease: Medical 

Treatment [53] 

Mean Score 84.51 60.90 69.95 85.58 26.60 62.02 

Median 90.27 66.67 69.79 91.67 20.83 75.00 

75.00%, Q3: 100.00% and IQR=25%; Fig. 2). Twenty-four CPGs 

(92.30%) scored above 60% in this domain [28–41, 43–45, 47–53]. 

See Table 3 for details on domain 4. 

CPGs, 15 guidelines (57.7%), were “recommended with modifications” 

[28, 29, 31–36, 39, 41, 45, 48, 50–52]. Finally, 4 CPGs (15.4%) were 

“not recommended” (see Table 3) [30, 37, 42, 46]. 


Domain 5: Applicability 

This domain refers to barriers and facilitators to CPG implementation, 

strategies for its adoption and resource considerations [19]. The mean 

score was 26.60% (median: 20.83%, Q1: 12.50%, Q3: 39.06% and 

IQR=26.56%; Fig. 2). Only one CPG (3.84%) scored above 60% in this 

domain [38]. See Table 3 for details on domain 5. 

Domain 6: Editorial Independence 

This domain is about the formulation of recommendations, understand 

whether they are biased by conflicts of interest [19]. The mean 

score was 62.02% (median: 75.00%, Q1: 30.21%, Q3: 91.67% and 

IQR=61.45%; Fig. 2). Sixteen CPGs (61.53%) scored above 60% in 

this domain [28, 32, 34, 35, 37, 38, 40, 41, 43–45, 47–49, 51, 53]. See 

Table 3 for details on domain 6. 

Overall assessment 

Seven out of the 26 evaluated CPGs (26.9%) were “recommended” 

by the independent reviewers [38, 40, 43, 44, 47, 49, 53]. Most of the 

Combined assessment 

Finally, in the radar plot analysis we observe that domains “scope and 

purpose”, “stakeholder involvement”, “rigor of development”, “clarity 

of presentation” and “editorial independence” show similar areas in 

the scores achieved; however, the domain “applicability” is notoriously 

deficient in all the evaluated guidelines (Fig. 3). 

Quality assessment over time 

With respect to quality change over time, no statistically significant 

differences were found for the means of the standardized scores for each 

AGREE II domain between the guidelines published during the 2012-2017 

period and those published between 2018 and 2022 (Table 4). 

Discussion 

What do the findings of this study mean? 

18

FEATURE 

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 

Table 4 4Quality changes over over time time 

Domain 

Guidelines 

Guidelines 

**P-value 

from from 2012- 

from from 2018- 

2017 2017 2022 2022 

Scope and and purpose 81.9 81.9 (9.15) (9.15) 85.6 85.6 (17.9) (17.9) 0.5868 

Stakeholder involvement 54.5 54.5 (21.0) (21.0) 63.7 63.7 (29.4) (29.4) 0.4336 

Rigour of of development 66.9 66.9 (15.3) (15.3) 71.3 71.3 (19.6) (19.6) 0.5817 

Clarity of of presentation 82.6 82.6 (15.3) (15.3) 86.9 86.9 (17.0) (17.0) 0.5521 

Applicability 23.2 23.2 (24.8) (24.8) 28.1 28.1 (19.0) (19.0) 0.5815 

Editorial independence 50.0 50.0 (28.7) (28.7) 67.4 67.4 (36.3) (36.3) 0.2444 

*Data *Data given given as as mean mean +/− +/− (SD) (SD) of of standardized scores 

**Significance level level < 0.05, < 0.05, p-value with with Student’s t method t for for the the difference of of 

two two means 

This review showed that the evaluated IBD CPGs had an acceptable 

quality based on the AGREE II instrument since 7 out of the 26 

evaluated guidelines were “recommended”, 15 were “recommended 

with modifications” and only 4 were “not recommended”. The domains 

with the highest scores were “clarity of presentation” and “scope and 

purpose”, which reached values over 60%, indicating that most of the 

assessed guidelines had well-defined general and specific objectives, 

the population to which the guideline was intended to apply was 

well defined, and the recommendations were clearly described and 

identifiable. Rigor of development was the domain that received the 

third best score with 69.95%; this domain could be argued to have 

the greatest effect on the quality of a clinical practice guideline, since it 

has to do with the entire process used to formulate and construct the 

recommendations and it is the one that comprises the most items within 

AGREE II for its evaluation [54]. We consider that a score over 60% is 

more than acceptable for “rigor of development”, which achieved this 

score due to most guidelines were partly penalized for being unclear 

with the description of external experts’ assessment and for not having 

an explicit updating statement. 

The domains “stakeholder involvement” and “editorial independence” 

obtained scores slightly over 60% (60.90 and 62.02%, respectively; 

Fig. 3), which indicates that the views and preferences of patients still 

need to be considered when the CPG is drafted and that an expert 

methodologist/epidemiologist should be included in the guideline 

drafting group. In addition, both domains achieved low scores due to 

the limited information most guidelines provided in terms of funding and 

its influence on the guidelines’ content, as well as the lack of detail they 

included regarding conflicts of interest and how these conflicts were 

dealt. Considering these limitations on the development of CPGs could 

contribute to their improvement. 

The “applicability” domain was the worst scored domain in this review 

with an average score of 26.60% (Fig. 3), well below the 60% cut-off 

point for this domain. The main reason for this is that most guideline 

developers do not fully consider guideline’s implementation in terms of 

facilitators and barriers for guidelines’ applicability or they do not fully 

consider the resources and tools that are available in a specific context. 


19

FEATURE 


We also noted that most of the guidelines did not consider the 

economic impact of their recommendations on resources and health 

budgets, for example, most guidelines did not include health economists 

in the guideline development group or did not perform cost-benefit 

analysis. The limitations and omissions that have been observed in the 

included guidelines restraint the translation of these documents into 

clinical practice, thus hindering its operability. 

Regarding quality change over time, this study failed to demonstrate 

statistically significant differences between guidelines published during 

the 2012-2017 period versus guidelines published between 2018 and 

2022 (see Table 4) for any domain covered by AGREE II. This finding 

may be due to the small sample size in this study, which is associated to 

the specific inclusion criteria applied in the selection of CPGs as well as 

the large variety of CPGs for IBD (clinical, surgical, preventive, etc.) we 

encountered when screening. In addition, the time ranges we compared 

were too short since guidelines’ development in terms of IBD and our 

study’s criteria has been an early activity. However, one point to highlight 

is the implementation and dissemination of the GRADE methodology 

in the development of guidelines, especially in those produced in the 

last 4years; our study found that 17 out of the 26 included CPGs had 

used this methodology as a framework for grading the evidence and 

formulating their recommendations. 

The context of this review with other literature 

While this review is not the first to evaluate clinical practice guidelines 

on inflammatory bowel disease, it is the first to evaluate a large sample 

of CPGs as there was no date restriction in its search, which gave us 

a much broader picture of what has been produced in the past and 

current time. Thus, in line with other reviews of CPG for IBD conducted 

by other investigators, and addressing different contexts of inflammatory 

bowel disease, the domains with the highest scores were “clarity of 

presentation” and “scope and purpose” and the domains with the 

lowest scores were “stakeholder involvement” and “applicability” 

[55–57]. These results are also similar to previous CPG evaluations for 

other clinical-surgical areas such as interventional radiology, pediatrics or 

dermatology [58–60]. 

In addition, other studies that investigated quality changes over time 

for clinical practice guidelines in other specialties did not find evidence 

of significant changes in quality in the different evaluated periods of 

time [61–63]. These results are consistent with the findings of this 

study. However, studies by Bhatt et al. [64] for pediatric type II diabetes 

CPG and Acuña-Izcaray et al. [65] for asthma CPG, found statistically 

significant differences in quality over time for the selected periods for 

each individual domain, while a statistical significance has not been 

found for all domains at the same time. 

Strengths and limitations 

Although a strength of our systematic review was the broad and 

exhaustive approach of our search – carried out in databases, compiling 

entities and guideline developers, with a sensitive strategy designed 

for this purpose – it is possible that our review may have missed 

some CPGs that were not adequately indexed or that dealt with other 

contexts related to inflammatory bowel disease. Likewise, our study only 

included CPGs published in English or Spanish, factors that could have 

contributed to a potential selection bias. 

Likewise, having chosen CPGs with well-defined inclusion criteria, it is 

likely that our results have overestimated the score obtained by selecting 

guidelines that would score higher than the entire possible universe of 

CPGs for IBD. Therefore, our conclusions acquire more relevance when 

evaluating this type of guidelines. 

On the other hand, although the degree of agreement reached by the 

reviewers was moderate (ICC=0.74), this may be due to the fact that 

the AGREE II instrument weights each item with a 7-point Likert-type 

scale, where only the extreme values of this scale are well defined, but 

it is prone to subjectivity for intermediate values 3, 4 and 5 on the scale. 

As our research had a large number of reviewers (six), reaching a higher 

value for the intraclass correlation coefficient (ICC) to improve reliability 

was difficult. However, we consider that the value achieved does provide 

adequate reliability [66]. 

In addition, since the implementation of the AGREE II tool in 2010, it 

has become the most widely used and popular resource for assessing 

the quality of CPGs, choosing a cut-off point above which a guideline 

can be defined as having good quality is subjective and this selection 

will depend on the context in which the review is being performed. 

As Brouwers et al. [67] noted, “there is no evidence that if a guideline 

exceeds a certain score, the recommendations are easier to adopt, 

or improve processes of care, or lead to better patient outcomes than 

guidelines that do not achieve that score”. ( [67] , p.195) That is, the validity 

of the overall assessment may be limited, as there are no clear rules 

yet on how to weigh the different domain scores to make a decision on 

whether or not to recommend guidelines. 

What is new and conclusion 

Overall, this study determined that the quality of clinical practice 

guidelines for the diagnosis and treatment of inflammatory bowel 

disease is acceptable and that there is still room for improvement, 

especially in terms of stakeholder participation (inclusion of patients, 

expert methodologists/epidemiologists) and applicability (enablers, 

barriers, optimization of resources, external review). It is desirable that 

guideline developers consider these shortcomings in the future for the 

overall improvement of guidelines’ quality to reduce clinical practice 

heterogeneity in IBD. 

Abbreviations 

CPG: Clinical practice guideline; AGREE: Appraisal of Guidelines, 

Research, and Evaluation; GRADE: Grading of Recommendations, 

Assessment, Development and Evaluation; NPRISMA: Preferred 

Reporting Items for Systematic Reviews and Meta-Analyses; IBD: 

Inflammatory bowel disease; CD: Crohn’s disease; UC: Ulcerative colitis; 

ICC: Intraclass correlation coefficient; IQR: Interquartile range; SD: 

Standard deviation; Qi: Quartile; CI: Confidence interval. 

Supplementary Information 

The online version contains supplementary material available at 

https://doi.org/10.1186/s12876-022-02539-9. 

Acknowledgements 

We thank the University UTE and the Center for Research in Public 

Health and Epidemiology (CISPEC) for their support, collaboration and 

work in the editorial process of this publication. 

20

FEATURE 

Authors’ contributions 

DH, AV-G and CM-G conceived the idea for this research and designed 

the study. RZ-S, PA-M, CM-G and CME-L searched the literature. 

DH, CM-G, RZ-S, PA-M and RV screened and selected the guidelines 

according to the inclusion criteria. DH, CM-G, RZ-S, PA-M, JAF and RV 

rated and evaluated the guidelines with the AGREE II tool. RZ-S and 

PA-M conducted the statistical analysis and interpreted the results. RZ- 

S, PA-M and CM-G wrote the first draft of the report. CM-G, JAF, DS-R, 

CME-L, RV, AV-G contributed to the review and approved the final 

manuscript. The author(s) read and approved the final manuscript. 

Funding 

This research study has not received any funding from the public or 

private sector or from any non-profit entity. 

Availability of data and materials 

The datasets used and/or analysed during the current study are 

available from the corresponding author on reasonable request. 

Declarations 

Ethics approval and consent to participate 

Not applicable. 

Consent for publication 


Competing interests 

The authors declare that they have no competing interests 

Author details 

1 

Maestría en Epidemiología con mención en Investigación Clínica 

Aplicada. Facultad de Ciencias de la Salud Eugenio Espejo, Universidad 

UTE, Quito, Ecuador. 2 Internal medicine service, NMMC Hamilton, 

Hamilton, AL, USA. 3 Research Department. Instituto Universitario 

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. 4 Institute 

of General Practice, Heinrich-Heine-University Düsseldorf, Düsseldorf, 

Germany. 5 Department of Nephrology and Hypertension, University 

Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. 

Julius Center for Health Sciences and Primary Care, University Medical 

Center Utrecht, Utrecht University, Utrecht, The Netherlands. 6 Centro 

de Investigación en Salud Pública y Epidemiologia Clínica (CISPEC), 

Facultad de Ciencias de la Salud Eugenio Espejo. Universidad UTE, 

Rumipamba and Bourgeois, Universidad UTE, 170147 Quito, Ecuador. 

Received: 13 June 2022 Accepted: 14 October 2022 

Published online: 05 November 2022 

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en. 2019;68(3):1–106. https://doi.org/10.1136/gutjnl-2019-318484. 

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FEATURE 


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23

FEATURE 

THE COST OF ILLNESS ANALYSIS OF 

INFLAMMATORY BOWEL DISEASE 

Majid Pakdin, Leila Zarei, Kamran Bagheri Lankarani and Sulmaz Ghahramani * 

Pakdin et al. BMC Gastroenterology (2023) 23:21 https://doi.org/10.1186/s12876-023-02648-z 


Abstract 

Background 

Inflammatory bowel disease (IBD) is a chronic inflammatory condition 

involving individuals across all age groups. Recent data suggests the 

increase in the prevalence of IBD and the surge in applying the biologic 

drugs in which both change the cost of IBD in recent years. Comprehensive 

assessment of direct and indirect cost profiles associated with IBD in our 

area is scarce. This study aimed to determine the economic burden of IBD 

in Iran from a societal perspective, using cost diaries. 

Methods 

Patients available on clinic registry and hospital information system (HIS), 

who were diagnosed with IBD, were invited to take part in this study. 

Demographic and clinical data, the healthcare resource utilization or cost 

items, absenteeism for the patients and their caregivers were obtained. 

The cost of the used resources were derived from national tariffs. The 

data regarding premature mortality in IBD patients was extracted from 

HIS. Productivity loss was estimated based on the human capital method. 

Then, cost date were calculated as mean annual costs per patient. 

Results 

The cost diaries were obtained from 240 subjects (Ulcerative colitis: 

n=168, Crohn’s disease, n=72). The mean annual costs per patient 

were 1077 US$ (95% CI 900–1253), and 1608 (95% CI 1256, 1960) 

for the patients with ulcerative colitis and Crohn’s disease, respectively. 

Of the total costs, 58% and 63% were in terms of the indirect costs 

for the patients with ulcerative colitis and Crohn’s disease, respectively. 

The cost of illness for country was found to be 22,331,079 US$ and 

15,183,678 US$ for patients with ulcerative colitis and Crohn’s disease, 

respectively. Highest nationwide economic burden of IBD was found for 

patients older than 40 years were estimated to be 8,198,519 US$ and 

7,120,891 US$, for ulcerative colitis and Crohn’s disease, respectively. 

Conclusion 

The medication was found to be the greatest contributor of direct medical 

costs. Productivity loss in terms of long-term disability and premature 

mortality were major components of IBD’s economic burden in Iran. 

Keywords 

Inflammatory bowel disease, Crohn’s disease, Ulcerative colitis, Cost of 

illness, Health economics 

Introduction 

Ulcerative colitis (UC) and Crohn’s disease (CD) are included in the 

spectrum of disorder defined as inflammatory bowel disease (IBD), the 

relapsing–remitting and chronic inflammatory condition in which the 

gastrointestinal tract is affected [1]. IBD has lower prevalence compared 

to other common gastrointestinal-related disorders, such as irritable 

bowel syndrome, gastroesophageal reflux, and colorectal cancer; 

however, it is one of the gastrointestinal-related disorders with the 

most economic burden [1]. Data from many countries, including India 

[2], China [3], Scotland [4], and Turkey [5] showed an unprecedented 

growth of IBD worldwide. Concurrently, the incidence of the disease 

is increasing in Asia [6] and Iran [7]. Low mortality of the disease, 

the diagnosis at early ages, and its chronic nature have driven this 

increase in the disease’s prevalence. Using biological medications in the 

treatment of IBD changed the need for hospitalization and surgeries and 

also changed the cost of the disease in recent years. So, these highlight 

the importance of the economic burden evaluation of the disease [8, 9]. 

As stated before, in Iran, the IBD incidence is rising while information 

on its cost is scarce. Two studies have evaluated direct medical cost 

and hospitalization cost of the disease [10, 11]. Nevertheless, health 

policy makers should have reliable information regarding the cost of 

illness to quantify the impact of the disease on a society. This can inform 

healthcare cost projection, as well as resource allocation [12]. Regarding 

the mentioned points, it is necessary to assess the cost of IBD, including 

direct medical costs, direct non-medical costs, and indirect costs to 

determine the economic burden of IBD in Iran. In our study, we aim to 

evaluate the cost of IBD in a multicenter setting. 

Methods 

Participants and data collection 

This cost of illness analysis was conducted on the patients diagnosed 

with IBD in 2021. For data collection, we used the phone records 

available in Shiraz’ hospital information systems (HIS) and IBD clinic 

at Faghihi hospital, which is referral IBD clinic affiliated to the Shiraz 

University of Medical Sciences. Using the convenient sampling method, 

patients were invited to take part the study through phone calls. Then, 

the data was obtained through a face-to-face interview while the 

patients were referred to the clinic. This clinic and referral hospitals all 

provide the care to the IBD patients, mostly from Fars province and 

sometimes from neighboring provinces. Our study as a partial economic 

evaluation technique, aimed to calculate the total costs of IBD in 

Iran from the society perspective. The IBD diagnosis was confirmed 

based on clinical, endoscopic, and histological criteria, as described 

elsewhere [13]. Demographic data (including sex, age, marital status, 

educational level, educational level, income, and hours of paid work), 

clinical data (including disease duration, disease progression, and extraintestinal 

involvement) were obtained from all participants, and they 

were interviewed to fill out the cost diary. The disease progression was 

defined by calculating Mayo score and Crohn’s disease activity index 

24 

* Correspondence: Sulmaz Ghahramani, suli.ghahraman@gmail.com, Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Iran 

© The Author(s) 2023.

FEATURE 

(CDAI) in patients with UC, and CD, respectively. To obtain an estimated 

prevalence of IBD in Fars province, the population ratio of Fars province 

in Iran was multiplied by an estimated prevalence of IBD in Iran in 2021 

[14, 15], which found to be 1800. The sample volume was determined 

to be 233 patients for estimation of costs of illness based on 95% 

CI, margin error of 6%, and the estimated prevalence of IBD in Fars 

province (http://www.raosoft.com/samplesize.html). 

Cost diary 

Cost diary is an instrumental method which is developed by Goosens et 

al. and is used to estimate the cost of a condition. Since no significant 

difference has been found among the patients’ report and medical 

records, there is no need to check medical reports when the cost diary 

is used [16]. 

In order to prevent recall bias, the number of physician visits, 

physiotherapy, purchased drugs dosage, and all other related disease 

‘s costs during 3-month prior to the interview were asked from 

patients, which were scaled up by a factor of four to extrapolate to 

the mean number of each item during 1-year. Only for hospitalization 

and surgeries, the duration of 1- year was considered in cost diary. 

To minimize missing information and partial responses, telephone 

contacts were made after the initial visit, whenever it was needed. 

We had a protocol for phone calls. We made phone calls, in case of 

none- response we considered maximum number of three phone 

calls in different hours of day and variable days of week to make 

telephone contacts. Diary records were used to estimate resource 

used. The cost of the used resources were derived from national 

tariffs. The costs were recorded in Rial and then we converted to 

US dollars based on the moving average of the exchange rate in the 

2021 252,000:1 (Rial:US) (Additional file 1: Table S1: https://staticcontent.springer.com/esm/art%3A10.1186%2Fs12876-023-02648-z/ 

MediaObjects/12876_2023_2648_MOESM1_ESM.xlsx). 

Death registration database 

We extracted death data of patients with IBD, who were died because 

of IBD-related causes, from HIS during 2013–2021 to estimate 

economic burden of premature mortality for UCCD. 

Direct medical costs 

Direct medical costs included physician visits, physiotherapy sessions, 

nutrition sessions, purchased medication, surgeries, and para-clinical 

tests. The cost of each item expected on medication was estimated by 

the mean number of each item, multiplied by the contemporary tariff of the 

Ministry of Health and Medical Education (MoHME). The contemporary 

tariff is defined for each unit of healthcare service item by the MoHME 

annually in two forms of private and public services. In our study, we 

used the weighted average of these two forms based on the last national 

utilization survey [17]. The cost of purchased medication was calculated 

by the number of each item, multiplied by the unit cost of each item 

defined by Food and Drug Administration (http://irc.fda.gov.ir/nfi#). 

Direct nonmedical costs 

Transportation, self-help group, hours of paid household help, and 

goods-related to the condition (including alternative medicine, assistive 

devices, special diet, and books) were considered the components of 

direct nonmedical costs. Transportation cost was obtained from the 

sum of public and personal transportation. Public transportation cost 

was calculated based on the mean number of public transportation 

service use multiplied by the tariff of transportation defined by Municipal. 

Personal transportation and other items were calculated based on the 

real reported costs by patients in the cost diary. 

Indirect costs 

The human capital approach was used to estimate indirect costs. 

Productivity losses because of disability and premature mortality were 

considered components of indirect costs in our study. We divided 

disability into short- and long-term disability. 

Productivity losses due to short-term disability 

Productivity losses in terms of short-term disability were obtained from 

temporary absenteeism from work for patients with the disease, and 

the caregivers. To calculate productivity loss because of temperament 

absenteeism of patients from work for therapy appointments, the 

hourly wage of lowest-paid unskilled government workers (LPUGW) of 

the Ministry of Labor was multiplied by the number of absence hours 

for each patient. For calculation of the productivity loss because of 

absenteeism of the caregiver the number of hospitalization days for the 

patients who were hospitalized during 1-year was added to 14 days 

per hospitalization. Then, the calculated number was multiplied by the 

LPUGW. It was assumed that work productivity loss was experienced 

by caregivers during hospitalization days to fulfill the responsibility of 

caregiving. 

Productivity losses due to long-term disability 

Early retirement of patients, permanent absenteeism from work because 

of disability, and unpaid household work for caregivers of disabled 

patients were considered estimating productivity losses due to long-term 

disability. To estimate the cost of early retirement, the amount of lost 

pension, compared to the full pension, was calculated for any patient 

who had early retired. To calculate the cost of permanent absenteeism 

from work, the annual wage of LPUGW was considered for patients who 

completely could not work, and were not paid a defined benefit pension. 

To estimate unpaid household work for caregivers of disabled patients, 

the number of patients who could not take care of themselves were 

multiplied by the annual wage of LPUGW because of unpaid permanent 

caregiver responsibility. 

Premature mortality 

Standard expected years of life lost (SEYLL) was used to predict the 

productivity loss due to premature mortality. We used the following 

formula to estimate SEYLL [18]: 

SEYLL = N × L x 

where N identifies the number of deaths at a certain age, and L x 

refers 

to the remaining life-expectancy at the age of death. Based on many 

arguments and the last update of global health estimates by WHO, we 

decided not to take into account time discounting and age-weighting 

[19–22]. We obtained mean number of annual deaths by age, gender, 

and type of disease. The gender-specific remaining life-expectancy 

at the age of death was calculated based on the 2020 Iran lifetable 

from World Health Organization [23], and subsequently SEYLL for 

each disease was calculated by the sum of the two obtained genderspecific 

SEYLL for the type of disease. Then, the calculated SEYLL 

was multiplied by gross domestic production (GDP) per capita for Iran, 


25

FEATURE 

Table 1 Patients’ characteristics 

Costs were reported as mean costs with 95% CI estimated using nonparametric 

boodstrap sampling. 

Characteristic 

Ulcerative 

colitis 

(n=168) 

Crohn’s disease (n=72) 

Results 


Age, mean (SD), years 40.64 (12.90) 39.11 (14.04) 

Age groups 

0–29 34 [20.2] 19 [26.4] 

30–39 55 [32.7] 18 [25.0] 

≥ 40 79 [47.0] 35 [48.6] 

Sex 

Female 81 [48.2] 30 [41.7] 

Male 87 [51.8] 42 [58.3] 

Marital status 

Single 36 [21.4] 25 [34.7] 

Married 125 [74.4] 43 [59.7] 

Widowed 5 [3] 0 

Divorced 2 [1.2] 4 [5.6] 

Employment status 

Non-employed 81 [48.2] 40 [55.6] 

Employed 70 [41.7] 22 [30.6] 

Disabled 8 [4.8] 7 [9.7] 

Retired 9 [5.4] 3 [4.2] 

Educational level 

Illiterate 21 [12.5] 7 [9.7] 

Diploma 87 [51.8] 42 [58.3] 

Bachelor degree or higher 60 [35.7] 23 [32] 

Residence 

City 136 [81.0] 54 [75] 

Village 32 [19.0] 18 [25] 

Disease duration, years 9.49 (7.98) 7.86 (6.69) 

Disease progression 

Continuously active 44 [26.2] 15 [20.8] 

Intermittently active 81 [48.2] 41 [56.9] 

Inactive 43 [25.6] 16 [22.2] 

Extra-intestinal involvement 

Liver involvement 23 [13.7] 13 [18.1] 

Oral involvement 38 [22.6] 18 [25.0] 

Skin involvement 37 [22.0] 14 [19.4] 

Vertebra involvement 12 [7.1] 11 [15.3] 

Eye involvement 42 [25.0] 21 [29.2] 

Joint involvement 59 [35.1] 30 [41.7] 

Lung involvement 5 [3.0] 3 [4.2] 

Fistula 4 [2.4] 14 [19.4] 

SD, standard deviation 

Data are presented as n [%] or mean (SD) 

which is defined by World Bank [24], to estimate the total economic 

burden of premature mortality for each disease. To obtain the mean 

cost per patient, the total cost of premature mortality was divided by the 

estimated prevalence of the disease in Fars Province. 

Statistical analysis 

All statistical analyses were performed using SPSS 26.0. Mean, and 

the standard deviation was used to present continuous variables, 

while categorical variables were shown as frequency and percentage. 

Demographic characteristics 

Among 286 patients who were initially invited, 240 patients accepted to 

take part. The mean±Standard deviation (SD) age of participants was 

41±13 and 39±14 for UC and CD, respectively. Majority of patients 

were married, and reside in the cities. The gender was approximately 

equal between males and females in the both diseases, and UC was 

predominant disease among participants. Descriptive results based 

on gender, marital status, employment status, disease type, and other 

variables are summarized in Table 1. 

Direct medical costs 

Cost items are categorized in Table 2. Number [%] of participants using 

resources, and mean annual cost for each category are shown in the 

table for UC and CD, separately. 

Drugs, which were taken by patients, are classified into six categories 

(Table 3). Number [%] of participants taking each medication’s type, and 

mean annual cost for each type are shown in the table based on the 

disease type. 

Medication had the greatest share of direct medical costs in both 

types of IBD, accounting for 31.6% and 23.0% of the total costs in 

the patients with UC and CD, respectively (445.52$ per patient in 

UC, and 586.96$ per patient in CD). Among types of medication, 

aminosalicylates contributed to the most prescription proportion in 

both diseases (66.2% in UC and 63.9% in CD). It shared the highest 

cost of medication types in patients with UC, accounting for 244.63$ 

per patient. Less than twenty percent of patients consumed biological 

agent; however, this type of medication accounted for the highest and 

the second highest medication costs in patients with CD (235.11$), 

and UC (100.72$), respectively (Table 3). Hospitalization was another 

important contributor of direct medical costs, especially in the patients 

with CD, responsible for 10% of the total costs (161.29$) per patient. 

Physiotherapy and nutrition consult almost did not impose cost to the 

studied IBD patients (Table 2). 

Direct nonmedical costs 

Although the proportion of using nonmedical resources were high by 

participants, the related costs accounted for less than 1% of the total 

costs in both diseases (8.92$ per patient in UC, and 4.67$ per patient in 

CD). They were mostly driven by transportation (Table 2). 

Indirect costs 

Indirect costs were major contributors of the total costs, responsible for 

more than a half of the costs (622.46$ per patient in UC, and 1016.62$ 

per patient in CD). Productivity losses induced by short-term disability 

were more frequent among participants, as compared with the losses 

due to long-term disability, and were almost equally formed by two 

components of temporary absenteeism for patients and caregivers. 

Despite the lower frequency of productivity losses due to long-term 

disability (13.7% in UC patients, and 19.4% CD patients), they imposed 

a large share of the total costs (266.50$ per patient in UC, and 436.40$ 

26

FEATURE 

Table 2 Resource utilization and costs per patient 

Cost categories 

Participants using resources, 

n [%] 

Mean annual costs in US$ (SD) [% of total costs] 

UC: Ulcerative colitis; CD: Crohn’s disease; SD: standard deviation 

UC (n=168) CD (n=72) UC (n=168) CD (n=72) 

Total costs 168 [100.0] 72 [100.0] 1076.89 (1159.14) [100.0] 1608.24 (1497.11) [100.0] 

Direct medical cost 157 [93.5] 72 [100.0] 445.52 (691.76) [41.4] 586.96 (629.74) [36.5] 

Physician visit 131 [78.0] 68 [94.4] 15.93 (31.52) [1.5] 21.56 (27.34) [1.3] 

General physician 12 [7.1] 7 [9.7] 1.24 (7.82) [0.1] 2.16 (9.63) [0.1] 

Specialist 14 [8.3] 3 [4.2] 1.60 (11.73) [0.1] 0.38 (2.13) [0.0] 

Subspecialist 123 [73.2] 66 [91.7] 12.87 (16.19) [1.2] 18.81 (25.04) [1.2] 

Psychiatrist 4 [2.4] 2 [2.8] 0.21 (1.45) [0.0] 0.20 (1.18) [0.0] 

Physiotherapy 4 [2.4] 0 [0.0] 0.13 (1.01) [0.0] 0.00 (0.00) [0.0] 

Nutritionist consult 0 [0.0] 0 [0.0] 0.00 (00.00) [0.0] 0.00 (0.00) [0.0] 

Hospitalization 24 [14.3] 25 [34.7] 64.64 (251.35) [6.0] 161.29 (380.94) [10.0] 

Para-clinic 124 [73.8] 62 [86.1] 22.93 (37.64) [2.1] 27.04 (50.00) [1.7] 

Laboratory 116 [69.0] 60 [83.3] 7.59 (9.93) [0.7] 10.64 (11.10) [0.7] 

Imaging 48 [28.6] 29 [40.3] 15.33 (31.79) [1.4] 16.41 (34.07) [1.0] 

Medication 152 [90.5] 69 [95.8] 340.38 (633.18) [31.6] 369.97 (441.22) [23.0] 

Surgeries 7 [4.2] 8 [11.1] 1.51 (7.59) [0.1] 7.10 (25.40) [0.4] 

Direct nonmedical cost 140 [83.3] 65 [90.3] 8.92 (36.29) [0.8] 4.67 (7.69) [0.3] 

Transportation 

Public transportation 62 [39.1] 33 [45.8] 0.42 (0.86) [0.0] 0.56 (1.21) [0.0] 

Personal transportation 82 [48.8] 34 [47.2] 4.80 (24.02) [0.4] 3.03 (6.36) [0.2] 

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] 

medicine, special diet, related books) 

Paid household help 1 [0.6] 1 [1.4] 0.09 (1.10) [0.0] 0.10 (0.84) [0.0] 

Self-help group 0 [0.0] 0 [0.0] 0.00 (0.00) [0.0] 0.00 (0.00) [0.0] 

Indirect costs 58 [34.5] 33 [45.8] 622.46 (808.61) [57.8] 1016.62 (1169.81) [63.2] 

Short-term disability 42 [25.0] 30 [41.7] 88.49 (221.46) [8.2] 193.00 (472.27) [12.0] 

Temporary absenteeism for patients 22 [13.1] 8 [11.1] 51.62 (175.87) [4.8] 88.11 (378.42) [5.5] 

Temporary absenteeism for caregivers 24 [14.3] 25 [34.7] 36.87 (126.52) [3.4] 104.89 (217.58) [6.5] 

Long-term disability 23 [13.7] 14 [19.4] 266.50 (745.37) [24.7] 436.40 (980.39) [27.1] 

Early retirement 7 [4.2] 12 [2.8] 42.01 (216.60) [3.9] 28.99 (201.20) [1.8] 

Permanent absenteeism 14 [8.3] 9 [12.5] 174.60 (580.82) [16.2] 261.91 (697.80) [16.3] 

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] 

Premature death – – 276.47 [24.8] 387.22 [24.1] 

Table 3 Frequency and costs of purchased medication 

Drug category Participants taking medication, n [%] Mean annual costs in US$ (SD) [% of total medication 

costs] 

UC (n=168) CD (n=72) UC (n=168) CD (n=72) 

Aminosalicylates 128 [66.2] 46 [63.9] 244.63 (554.37) [71.9] 100.72 (205.08) [25.4] 

Biological agents 14 [8.3] 19 [26.4] 74.46 (264.97) [21.9] 235.11 (425.19) [59.3] 

Corton 47 [28.0] 24 [33.3] 1.86 (4.23) [0.5] 2.03 (4.36) [0.5] 

Immunomodulators 48 [28.6] 35 [48.6] 6.17 (22.09) [1.8] 12.96 (47.79) [3.3] 

Supplementary 68 [40.5] 37 [51.4] 5.25 (10.77) [1.5] 7.82 (15.49) [2.0] 

Psychotropic drugs 11 [6.5] 9 [12.5] 0.40 (2.05) [0.1] 0.82 (3.89) [0.2] 

Miscellaneous 53 [31.5] 25 [34.7] 7.60 (16.92) [2.2] 10.51 (20.19) [2.6] 

Miscellaneous drug groups include analgesics, gastrointestinal associated drugs, and others 

UC: Ulcerative colitis; CD: Crohn’s disease; SD: standard deviation 


27

FEATURE 


per patient in CD). Permanent absenteeism from work was predominant 

compartment of productivity losses induced by long-term disability in 

both disease types (174.60$ per patient in UC, and 261.91$ per patient 

in CD). Productivity loss because of premature death was another 

important contributor of the total costs, accounting for almost a quarter 

of the costs in both diseases (276.47$ per patient in UC, and 387.22$ 

per patient in CD) (Table 2). 

Cost of illness for country 

The characteristics of participants, including age, sex, disease type 

and age at diagnosis were almost equivalent to those described for the 

recent pilot feasibility study of first nation-wide IBD registry in Iran, which 

enabled us to extrapolate the mean annual total costs regarding disease 

type and age group for the country [17]. An estimated prevalence of IBD 

in Iran in 2021 was used for the calculation [15]. The cost of illness for 

country was found to be 22,331,079 and 15,183,678 for UC and CD, 

respectively (Table 4). 

Discussion 

In this retrospective cohort study, we aimed to determine the economic 

burden of IBD, and to compare the profiles of costs in UC and CD 

patients. There are barriers to study the economic burden of specific 

diseases in Iran, as diagnostic data is not ordinarily coded for outpatient 

visits, and the patients’ resource utilization are not recorded. Thus, 

there is the paucity of information on resource utilization consumed by 

patients with specific diseases. However, to the best of our knowledge 

this study is among the first comprehensive studies in Iran assessing 

both direct and indirect cost profiles associated with IBD. 

Several studies have evaluated the economic burden of IBD in other 

countries [25–37]. Consistent with their findings, we found that the CD 

patients’ resource utilization was higher than that of UC patients, and 

this difference was more considerable in hospitalization, surgeries, and 

laboratory sectors. Variations in the pathogenesis of the two diseases 

can explain this difference, as UC might not lead to irreversible and 

systemic damage observed in CD patients [38]. However, the amount 

of difference among the annual mean costs of UC and CD differs from 

a study to another, based on the design and population of study, as 

inconsistencies are created in the results of cost of illness studies when 

comparing one to another due variations in method [30]. Annual mean 

costs per patient for UC and CD were between 6217–11,477 US$, and 

11,034–18,932 US$ in the USA, respectively. The corresponding ranges 

were 8949–10,395 euros, and 2898–6742 euros in European countries 

[39, 40]. In our study, annual mean costs per patient for UC and CD 

were found to be 1077 US$ (95% CI 900–1253), and 1068 (95% CI 

1256, 1960) respectively, which is in line with the results of studies in 

Table 4 Mean annual total costs in US$ for country 

Age group (year) Ulcerative colitis Crohn’s disease 

0–29 6,454,537 2,422,262 

30–39 7,678,023 5,640,525 

≥ 40 8,198,519 7,120,891 

All age groups 22,331,079 15,183,678 

UK and Germany in terms of CD: UC costs ratio [25, 34]. These two 

studies have applied a similar method of using patient-reported resource 

utilization to estimate economic burden of the disease (bottom-up 

approach). The difference of total costs per patient between Iran and 

European countries could be explained by the fluctuations in Iran’s 

currency exchange rate to dollar in the last few years. 

According to our findings, the medication use represents the major 

source of direct medical costs (76.4% and 63.0% of direct medical 

costs in UC and CD patients), while costs related to surgery and 

hospitalization have not a large share of direct cost. The results of more 

recent studies are consistent with our results [30–33]. The widespread 

application of biological agents in the treatment of IBD patients has 

changed the healthcare outlook, leading to a substantial shift in cost 

profiles [33]. The effect of this type of medication was significant on the 

reduction of colectomy in UC patients [41–43]. According to findings, 

despite the relatively low proportion of patients who received biological 

agents (8.3% and 26.4% of UC and CD patients); they shaped a 

significant contributor of the total costs in both diseases. This highlights 

the importance of better insurance coverage for such drugs to make 

them affordable. According to results, none of the participants used the 

nutritional consultation and assessment. Considering the importance of 

supportive nutritional therapy in the clinical care of IBD patients [44, 45], 

routine assessment and monitoring of nutritional status in IBD patients in 

Iran is highly encouraged. 

Direct nonmedical costs were minor contributors to the total costs, 

as compared with direct medical and indirect costs. Based on our 

findings, none of participants had been a member of self-help groups. 

In these groups, patients share their own experiences, which can lead 

to applying executable strategies for management of chronic disease by 

other patients [46]. Therefore, it is pivotal to design self-help groups for 

IBD patients in Iran which fit for their need; subsequently, they should be 

encouraged to enroll in such groups. 

Short- and long-term productivity losses because of disability were 

also evaluated. We found that productivity losses because of disability 

handled 33.0% and 39.1% of the total costs in UC and CD, respectively. 

According to a German study, long term productivity losses shared 

32% and 49% of the total costs in UC and CD, respectively [34]. In 

a more recent study in the Netherlands, productivity losses due to 

IBD-related absenteeism were found to be 16% and 39% of the total 

costs, respectively [33]. It seems that biological agents have had an 

effective role in reducing productivity losses because of disability in 

CD patients. However, due to different methodologies in measurement 

of productivity losses due to disability, we have limitations for a more 

detailed comparison with the results of other studies. In our study, we 

considered absenteeism and unpaid household work for caregivers, 

which were important contributors to costs for CD patients, accounting 

for 6.5% and 9.0% of the total costs, respectively. We did not evaluate 

presenteeism in our study, since no validated questionnaire is available 

to evaluate presenteeism with a recall time of over 7 days [33]. 

The premature mortality was another major contributor of costs in both 

diseases, which is in line with findings of systematic analysis of the 

global burden of inflammatory bowel disease. It shows the fact that 

IBD-associated premature mortality forms a great share of disease 

burden in countries with low socio-demographic index (SDI) [47]. 

28

FEATURE 

There is insufficient population-based data evaluating the causes of 

premature mortality in IBD patients in Iran. In a study assessing the 

trend of colectomy in the country, colorectal cancer was found to be 

the leading cause of death in IBD patients undergoing colectomy. In this 

regard, cancer screening protocols should be routinely performed in 

IBD patients [9]. Cancer and cardiovascular disease were found to be 

leading causes of mortality in IBD patients in the USA. Therefore, healthy 

lifestyle behaviors should be routinely assessed in IBD patients, and 

adherence to such lifestyle should be encouraged to reduce contributing 

risk for cancer and cardiovascular disease, and subsequently the risk of 

premature mortality and related costs in IBD patients [48]. 

Supplementary Information 

The online version contains supplementary material available at 

https://doi.org/10.1186/s12876-023-02648-z. 

Additional file 1: Table S1. Unit Costs of Medical Resources 

Consumed by Patients/*: For Nurition Consult, Imaging, Laboratory, and 

Surgery constant of k should be multipled by given data; k = 13600. 

Acknowledgements 

We are grateful to all patients who participated in this study. 

Limitations 

This study provided a more comprehensive view of the costs of illness for 

IBD in the Iran. However, this study was limited by the small sample size 

and prevalence approach for cost diaries. Furthermore some aspects of 

estimation might be affected by purchasing power of participants. 

Author contributions 

Conceptualization, Visualization, and Methodology: KBL, LZ, SG. 

Supervision, and Project administration: KBL, SG. Investigation: MP, SG. 

Writing, reviewing, and editing: MP, LZ, SG. Data curation, and Software: 

MP. All authors read and approved the final manuscript. 

Conclusion 

The medication was found to be the greatest contributor to direct 

medical costs. Productivity loss due to long-term disability and 

premature mortality were major components of inflammatory bowel 

disease burden in Iran. 

Funding 

This study was funded by Shiraz University of Medical Sciences (SUMS). 

Availability of data and materials 

The data that support the findings of this study are available from the 

corresponding author upon reasonable request. 

Find out more at www.faecal-immunochemical-test.co.uk 

Faecal Immunochemical Testing 

A framework of recommendations for 

maximising the benefits of FIT 

Based on evidence, updated recommendations for FIT 

by the Association of Coloproctology of Great Britain 

and Ireland and the British Society of Gastroenterology 

(BSG) (2022), offer guidelines for identifying patients 

requiring further investigation for bowel disease *. 

■ FIT to stratify patients younger than 50 years 

with bowel symptoms suspicious of CRC 

■ FIT to be used as triage tool for further colorectal 

investigation at primary care level 

■ 

FIT threshold of fHb ≥10 µg Hb/g for urgent referral for CRC investigation 

■ Safety-netting for symptomatic patients if fHb

FEATURE 


Declarations 

Ethics approval and consent to participate 

Informed consent was obtained from all participants, their anonymity 

was guaranteed, and the study protocol was approved by approved by 

Ethical Committee of Shiraz University of Medical Sciences approved 

with Reg. No: IR.SUMS.REC.1400.637. The study protocol followed the 

ethical guidelines of the 2013 Declaration of Helsinki. 

Consent for publication 


Competing interests 

The authors confirm that there is no conflict of interest to declare. 

Received: 10 August 2022 Accepted: 10 January 2023 

Published online: 19 January 2023 

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30

COMPANY NEWS 

PENTAX MEDICAL TO LAUNCH NEW PREMIUM 

VIDEO PROCESSOR AND ENDOSCOPE SERIES 

PENTAX Medical INSPIRA video processor (EPK-i8020c) and the 

i20c endoscope generation obtain CE marks 

TOKYO, 16 January 2023 – PENTAX Medical, a division of HOYA 

Group, has obtained CE marks for two of its latest innovations; 

PENTAX Medical INSPIRA, the new premium video processor, 

and the i20c video endoscope series. Developed with a focus on 

healthcare provider’s needs, the new video processor maintains 

compatibility with PENTAX Medical’s recent endoscope models [1], 

and sets new standards in combination with the new i20c video 

endoscope generation. 

Optimum image quality 

PENTAX Medical INSPIRA video processor delivers striking image 

quality with any PENTAX Medical endoscope [2]. Compatible with 

two connection types, it allows for upgrading the legacy endoscopy 

portfolio1 to the latest imaging standards. As a result, the image quality 

of current endoscope generations meets high-class clinical needs, for an 

extended duration of time. This smart feature thus extends the lifecycle 

of each endoscope for greater sustainability, while continuing to meet 

the highest standards of modern imaging and visualization. 

Enhanced user experience 

PENTAX Medical INSPIRA video processor was developed with 

a focus on healthcare providers’ needs. It combines cutting-edge 

functionalities in one plug-and-play solution with intuitive usability. It is 

controlled via a customisable, state-of-the-art touch panel, equipped 

with innovative image enhancement functionalities and 4K image 

processing. This ultimately enables physicians to focus on what is really 

important; achieving optimal clinical outcomes. 

Next generation endoscopes with superior ergonomics 

The i20c endoscopes are designed with superior ergonomics for 

healthcare professionals and exceptional imaging for the highest 

quality of procedures. Physicians instantly benefi t from outstanding 

manoeuvrability, angulation and handling, combined with further 

improved vision. The unique control body and light-weight connector 

of the i20c video endoscopes are designed to further optimize the 

endoscopic workfl ow. 

Rainer Burkard, Global President at PENTAX Medical, comments: “The 

PENTAX Medical INSPIRA video processor not only upgrades legacy 

instruments’ imaging capabilities, in combination with our new i20c 

endoscope generation, it is a milestone for endoscopy. In line with our 

commitment to continually innovate products, this cutting-edge solution 

provides a future-proof platform and we are proud of the groundbreaking 

image quality it brings.” 

Both the INSPIRA video processor and i20c endoscopes will be 

exclusively showcased during the ESGE Days 2023 in Dublin (or online) 

from April 20 – 22, 2023. Please let us know if you would be interested 

in attending, we would be happy to organise an interview with one or 

more of the speakers. 

[1] 90i, i10, J10, 90K and i10c series endoscopes. Not all models are 

compatible. For detail, contact your local PENTAX Medical service 

facility. 

[2] 90i, i10, J10, 90K, i10c and i20c series endoscopes. Not all models 

are compatible. For detail, contact your local PENTAX Medical service 

facility. 

WHY NOT WRITE FOR US? 

Gastroenterology Today welcomes the submission of 

clinical papers and case reports or news that 

you feel will be of interest to your colleagues. 

Material submitted will be seen by those working within all 

UK gastroenterology departments and endoscopy units. 

All submissions should be forwarded to info@mediapublishingcompany.com 

If you have any queries please contact the publisher Terry Gardner via: 

info@mediapublishingcompany.com 


31

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Gastroenterology Today Spring 2023

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