Gastroenterology Today Spring 2024

Volume 34 No. 5 Spring 2024

CONTENTS
CONTENTS
Gastroenterology Today
Developed to support patient
acceptance 1–3
Shape
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of mild to moderate ulcerative proctitis 1
4 EDITOR’S COMMENT
7 FEATURE The impact of endoscopist performance and patient
factors on distal adenoma detection and colorectal
cancer incidence
21 FEATURE The cost of illness analysis of inflammatory
bowel disease
31 COMPANY NEWS
This issue edited by:
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OCTASA 1g Suppositories (mesalazine) - Prescribing Information
Presentation: Suppository containing 1g mesalazine. Indications: Treatment
of acute mild to moderate ulcerative proctitis. Maintenance of remission of
ulcerative proctitis Dosage and administration: Adults and older people:
Acute treatment - one Octasa 1 g Suppository once daily (equivalent to 1
g mesalazine daily) inserted into the rectum. Maintenance treatment - one
Octasa 1 g Suppository once daily (equivalent to 1 g mesalazine daily) inserted
into the rectum. Children: Limited experience and data for use in children.
Method of administration: for rectal use, preferably at bedtime. Duration of
use to be determined by the physician. Contra-indications: Hypersensitivity
to salicylates or any of the excipients, severe impairment of hepatic or renal
function. Warnings and Precautions: Blood tests and urinary status (dip
sticks) should be determined prior to and during treatment, at discretion of
treating physician. Caution in patients with impaired hepatic function. Do not
use in patients with impaired renal function. Consider renal toxicity if renal
function deteriorates during treatment. Cases of nephrolithiasis have been
reported with mesalazine treatment. Ensure adequate fluid intake during
treatment. Monitor patients with pulmonary disease, in particular asthma, very
carefully. Patients with a history of adverse drug reactions to sulphasalazine
should be kept under close medical surveillance on commencement of
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abdominal cramps, acute abdominal pain, fever, severe headache and rash).
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eosinophilia and systemic symptoms (DRESS), Stevens-Johnson Syndrome
(SJS) and toxic epidermal necrolysis (TEN) have been reported. Stop treatment
immediately if signs and symptoms of severe skin reactions are seen.
Mesalazine may produce red-brown urine discoloration after contact with
sodium hypochlorite bleach (e.g. in toilets cleaned with sodium hypochlorite
contained in certain bleaches). Interactions: No interaction studies have
been performed. May increase the myelosuppressive effects of azathioprine,
6-mercaptopurine or thioguanine. May decrease the anticoagulant activity
of warfarin. Fertility, pregnancy and lactation: Only to be used during
pregnancy and lactation when the potential benefit outweighs the possible
risk. No effects on fertility have been observed. Adverse reactions: Rare:
Headache, dizziness, myocarditis, pericarditis, abdominal pain, diarrhoea,
flatulence, nausea, vomiting, constipation, photosensitivity, Very rare: Altered
blood counts (aplastic anaemia, agranulocytosis, pancytopenia, neutropenia,
leukopenia, thrombocytopenia), peripheral neuropathy, allergic and fibrotic
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pulmonary eosinophilia, lung infiltration, pneumonitis), acute pancreatitis,
impairment of renal function including acute and chronic interstitial nephritis
and renal insufficiency, alopecia, myalgia, arthraligia, hypersensitivity
reactions (such as allergic exanthema, drug fever, lupus erythematosus
syndrome, pancolitis), changes in liver function parameters (increase in
transaminases and parameters of cholestasis), hepatitis, cholestatic hepatitis,
oligospermia (reversible). Not known: Nephrolithiasis, Drug reaction with
eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic
epidermal necrolysis. Consult the Summary of Product Characteristics in
relation to other adverse reactions. Marketing Authorisation Numbers,
Package Quantities and basic NHS price: PL36633/0011; packs of 10
suppositories (£9.87) and 30 suppositories (£29.62). Legal category: POM.
Marketing Authorisation Holder: Tillotts Pharma UK Ltd, The Larbourne
Suite, The Stables, Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX, UK.
Octasa is a trademark. © 2021 Tillotts Pharma UK Ltd. Further Information
is available from the Marketing Authorisation Holder. Date of preparation of
PI: November 2022
Adverse events should be reported.
Reporting forms and information can be found at
https://yellowcard.mhra.gov.uk. Adverse events
should also be reported to Tillotts Pharma UK Ltd.
(address as above) Tel: 01522 813500.
References
1. Octasa ® 1g Suppositories – Summary of Product Characteristics.
2. Ghosh S, Daperno M. Gastroenterology 2015; 148(4): 701–704.
3. Andus T et al. Inflamm Bowel Dis 2010; 16(11): 1947–1956.
4. Data on file. Tillotts Pharma UK Limited. [Pharmaceutical
Development Information: Octasa ® 1g suppositories] – January 2022.
Date of preparation: December 2022. PU-00987.
Journal: Gastroenterology Today Tillotts: Octasa Range Ad Job no: 04994
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of post procedure bleeding. 2,3
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the clip multiple times prior to deployment, opening widths of 9, 11, 13, 16, and 18
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GASTROENTEROLOGY TODAY – SPRING 2024
3

EDITOR’S COMMENT
EDITOR’S COMMENT
BMA v Government
“After 5 years
the system
has managed
to produce
a cohort of
intelligent,
qualified and
motivated
doctors who
within a very
short timescale
are fed up”
Something has gone very wrong in medical undergraduate and postgraduate training. Anyone involved in
medical school admissions or with a friend or family member applying for medical school will be aware of
the hoops that need to jumped through, the numbers wanting to study medicine and the competitive nature
of the entire process. And yet, after 5 years the system has managed to produce a cohort of intelligent,
qualified and motivated doctors who within a very short timescale are fed up, willing to strike and looking to
leave medicine or the UK.
The media reports suggest this all boils down to pay but it is clearly much more complex. There are
significant financial issues which start on day one at medical school. New students can only dream of no
fees, student grants, housing benefit and 12 months accommodation provided on qualification. The erosion
of all of these feed into the pay issue.
When qualifying with huge debt all future expenses come under the spotlight: post graduate professional
exams, GMC fees and indemnity fees to name but a few. None of these are optional.
Aspiration to become a senior doctor is further dampened by the ongoing negotiations between the BMA
and government on the consultant contract, a pension scheme that has become so complex barely anyone
seems to truly understand it and primary care under more pressure than ever before.
The solution has to be more than just a pay rise. Unless all aspects of the costs associated with
undergraduate and postgraduate medicine are addressed any single solution is likely to be a temporary
band aid.
A Poullis
GASTROENTEROLOGY TODAY – SPRING 2024
Publishers Comment
On behalf of everyone involved with the publishing of Gastroenterology Today I would like to say a big
thank you to our contributors for their input and a special thank you to our advertisers as without their
ongoing support we would not be able to print and despatch copies of this very unique publication to all
Gastroenterology Departments and Endoscopy Units. Wishing you all a prosperous 2024.
Terry Gardner
Publisher
4

FEATURE
EyeMAX
Enhanced Clarity,
Improved Diagnoses
THE IMPACT OF ENDOSCOPIST
PERFORMANCE AND PATIENT FACTORS
ON DISTAL ADENOMA DETECTION AND
COLORECTAL CANCER INCIDENCE
Sharon Power 1* , Kate Wooldrage 1 , Brian P. Saunders 2,3 and Amanda J. Cross 1
Power et al. BMC Gastroenterology (2024) 24:44 https://doi.org/10.1186/s12876-024-03125-x
RESEARCH
Abstract
Background High quality endoscopy is key for detecting and removing
precursor lesions to colorectal cancer (CRC). Adenoma detection
rates (ADRs) measure endoscopist performance. Improving other
components of examinations could increase adenoma detection.
Introduction
Colorectal cancer (CRC) is the fourth most common cancer with over
42,000 cases diagnosed in the UK annually [1]. Effective screening for
CRC enables the removal of precursor lesions, preventing CRC, and
the detection of CRC at an earlier stage, significantly improving patient
outcomes [2, 3].
Experience Superior
Image Quality
120° Angle of HD Vision
Aims To investigate how endoscopist performance at flexible
sigmoidoscopy (FS) affects adenoma detection and CRC incidence.
Methods Among 34,139 participants receiving FS screening by the
main endoscopist at one of 13 centres in the UK FS Screening Trial,
median follow-up was 17 years. Factors examined included family
history of CRC, bowel preparation quality, insertion and withdrawal
time, bowel segment reached, patient pain and ADR. Odds ratios (OR)
for distal adenoma detection were estimated by logistic regression.
Hazard ratios (HR) for distal CRC incidence were estimated by
Cox regression.
Flexible sigmoidoscopy (FS) involves inserting a thin tube into
the rectum to visualise ~ 60 cm of the distal colorectum [4]. FS
screening reduces CRC incidence and mortality [5–8]; in the UK
Flexible Sigmoidoscopy Screening Trial (UKFSST), CRC incidence
and mortality was reduced by 35% and 41%, respectively, in those
screened compared to controls [9].
Endoscopic examination accuracy is dependent on endoscopist skill
and experience, with higher quality exams associated with better
patient outcomes [10]. Adenoma detection rates (ADRs) are used to
assess endoscopist performance [11]. Low ADRs are associated with
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Results At screening, 4,104 participants had distal adenomas
detected and 168 participants developed distal CRC during follow-up.
In multivariable models, a family history of CRC (yes vs. no: OR 1.40,
95%CI 1.21–1.62), good or adequate bowel preparation quality (vs.
excellent: OR 0.84, 95%CI 0.74–0.95; OR 0.56, 95%CI 0.49–0.65,
respectively) and longer insertion and withdrawal times (≥ 4.00 vs. <
2.00 min: OR 1.96, 95%CI 1.68–2.29; OR 32.79, 95%CI 28.22– 38.11,
respectively) were associated with adenoma detection. Being screened
by endoscopists with low or intermediate ADRs, compared to high
ADRs, was positively associated with CRC incidence (multivariable:
HR 4.71, 95%CI 2.65–8.38; HR 2.16, 95%CI 1.22–3.81, respectively).
Conclusions Bowel preparation quality and longer insertion and
withdrawal time are key for improving distal adenoma detection. Higher
ADRs were associated with a lower risk of distal CRC.
Keywords Colorectal cancer, Endoscopic screening, Adenoma
detection, Key performance indicators, Flexible sigmoidoscopy
*Correspondence:
Sharon Power
s.power18@imperial.ac.uk
Full list of author information is available at the end of the article
higher rates of interval CRCs [12] and post-colonoscopy CRC mortality
[13]. Large variability exists in ADRs between endoscopists [14–16],
with quality of bowel preparation [17, 18], depth of endoscope insertion,
segment of bowel reached and withdrawal time all related to ADRs [14].
Higher quality withdrawal techniques are associated with lower miss
rates for adenomas [19].
The Joint Advisory Group on gastrointestinal endoscopy, the British
Society of Gastroenterology and the Association of Coloproctology of
Great Britain and Ireland have developed key performance indicators
(KPIs) for endoscopy, which include ADRs, bowel preparation quality,
withdrawal time, comfort and completeness of examination [20]. These
KPIs are accompanied by quality assurance measures, which provide
minimal standards and aspirational targets for endoscopists [20].
However, there is a lack of data on KPIs and long-term outcomes. The
UKFSST offers the opportunity to examine KPIs in relation to adenoma
detection and distal CRC incidence.
GASTROENTEROLOGY TODAY – SPRING 2024
7

FEATURE
Power et al. BMC Gastroenterology (2024) 24:44
Page 3 of 13
FEATURE
Methods
Study design
Between November 1994 and March 1999, the UKFSST recruited men
and women aged 55–64 years from general practices serving 14 UK
hospitals; details reported previously [9]. Adenoma incidence increases
after the age of 50 years but levels out before 60 years [15, 21];
screening around 60 years of age offered the optimum opportunity to
detect adenomas [21]. Participants were excluded if they were unable
to provide consent; had a history of CRC, adenomas or inflammatory
bowel disease; had severe/terminal disease, life expectancy of < 5
years, or a sigmoidoscopy/colonoscopy within the previous 3 years.
Eligible individuals were randomised to either the intervention (n =
57,237, invitation to once-only FS screening), or control arm (n =
113,195, no screening and no further contact) (Fig. 1).
UKFSST endoscopists were previously ranked by their ADR (estimated
as the proportion of participants that had ≥ 1 distal adenoma detected)
into high-, intermediate-, or low-detectors, with corresponding
ADRs of 15%, 12% and 9%, respectively [15]; these groups were
used in this analysis. The order in which participants were screened
revealed a learning effect for the endoscopists’ ADR [15]; thus, we
created a variable that grouped participants according to the order of
examination occurrence: the first 500 participants examined by each
endoscopist and those examined later.
Outcome ascertainment
Information on date, site and morphology of cancers and date of
emigrations and deaths were collected from National cancer registries,
the National Health Service (NHS) Central Register, National Services
Scotland, NHS Digital and the Office for National Statistics.
GASTROENTEROLOGY TODAY – SPRING 2024
We excluded those who died or were diagnosed with CRC prerandomisation,
those in a family history study receiving colonoscopy
screening, those screened by an endoscopist other than the main
endoscopist at each centre, those in the pilot centre, those screened
within the first two months at one centre where the pathologist was
over-diagnosing adenomas, those diagnosed with CRC at baseline
and those with incomplete exams (Fig. 1). Of the 34,139 participants
remaining, 1,810 received multiple FS examinations (89% repeated due
to poor bowel preparation quality; Supplementary Table 1). Only one
exam per participant was included in the analysis; if FS was repeated
due to poor bowel preparation, the last complete exam was included,
but if FS was repeated for other reasons, the earliest complete exam
was used. If any exams had polyps detected, these rules were applied
within exams with polyps only.
Endoscopists were registrar-level gastroenterologists/surgeons with
3–8 years of experience post-basic medical qualification and must
have performed a minimum of 50 supervised and 100 unsupervised
endoscopies [15]. Participants were to administer a single phosphate
enema (Fletchers’ phosphate enema; Forest Laboratories UK Ltd.,
Bexley, Kent), one hour before leaving home for their examination
[15]. Sedation was not routinely used during FS examination [15]. All
endoscopists were to advance the scope (60 cm Olympus videoendoscope
(CF-200S)) as far as possible without causing undue
discomfort (normally to the sigmoid colon/descending colon junction)
and to remove polyps < 10 mm, leaving intact polyps < 3 mm deemed
to be hyperplastic in the distal 4 cm of the rectum [15]. Follow-up
colonoscopy was arranged for participants at high risk (≥ 3 adenomas,
a polyp ≥ 10 mm, an adenoma with villous/tubulovillous histology, or
high-grade dysplasia, malignant disease, or ≥ 20 hyperplastic polyps
above the distal rectum) [15].
Exposures
We examined endoscopist-reported variables of bowel preparation
quality (Supplementary Table 2), time to maximum point of insertion,
withdrawal time from maximum point of insertion, and segment of
bowel reached. A pre-examination questionnaire assessed family
history of CRC in first-degree relatives and a post-examination
questionnaire assessed the level of pain experienced (none, mild,
quite a lot, severe) during FS.
Primary outcomes were distal adenomas and distal CRC incidence.
Distal adenomas included adenomas detected at FS or any distal
adenoma detected at follow-up colonoscopy (endoscopists were
to leave polyps ≥ 10 mm for removal at colonoscopy). Distal CRCs,
defined by the International Classification of Diseases 10th revision
(ICD-10) and ICD for Oncology 2nd edition [22], included sites C18.7,
C19 and C20 (rectum and sigmoid colon) and morphologies for
invasive adenocarcinomas and carcinomas not otherwise specified
for cancers diagnosed on clinical grounds only. The earliest distal
CRC diagnosed per patient was included and follow- up time was not
censored at diagnosis of proximal or unspecified site CRC.
Statistical analysis
Univariable and multivariable logistic regression was used to estimate
odds ratios (OR) and 95% confidence intervals (CIs) for associations
with distal adenoma detection. For distal CRC incidence, Cox models
were used to estimate hazard ratios (HR) and 95% CIs. Time-at-risk
started from baseline FS examination and was censored at emigration,
death or the end of 2014. Non-proportionality was assessed using the
Schoenfeld test; no violations were identified.
Initial univariable analyses included everyone with complete data
on each variable, referred to as “full dataset” analyses. Multivariable
analyses required data for all variables in the model, referred to as
“complete-case” analyses; see Tables 1 and 2 for details. Insertion and
withdrawal times were missing in ~ 40% of participants as this was not
recorded until partway through the trial. Further sensitivity analyses
were conducted excluding participants with multiple FS examinations.
Multivariable models were constructed based on a-priori plans using
previous research [14, 23] and included: age, sex, family history of
CRC, bowel preparation quality, insertion time, withdrawal time,
segment of bowel reached and patient-reported pain. The multivariable
model for distal adenoma detection also included centre while that for
distal CRC incidence included endoscopist ADR group and centre was
omitted due to collinearity with ADR group. Kaplan–Meier estimates
show time to distal CRC diagnosis.
Negative examinations were those with no findings in the colorectum
(no lesions detected, no biopsies performed). Among those with
negative examinations, we examined variation in KPIs, the associations
between insertion time and pain and segment reached, and the
Fig. 1 Study Profile. † 784 patients whose FS screening was performed by an endoscopist other than the main endoscopist at that centre, 536
patients screened at one pilot centre that had far fewer participants than the other centres and where there were two main endoscopists rather
than one, 367 patients who were screened within the first two months at one centre where the pathologist was found to be over-diagnosing
adenomas, 93 participants with CRC diagnosed at baseline and 4,361 participants whose exam was classed as incomplete by the endoscopist. ‡ Four
patients had incident CRC diagnosed at both sub-sites. § Three patients had CRC as the underlying cause of death but the sub-site specific cause
could not be determined as CRC was diagnosed at both sub-sites
associations between bowel preparation quality and pain and reaching
the splenic flexure (SF). To examine if KPIs were associated with
of 15%, 12% and 9%, respectively [15]; these groups Outcome permission ascertainment to obtain and process patient data (PIAG 4–07(j)/2002). All
complexity of findings at FS, we investigated associations with the
were used in this analysis. The order in which participants
were screened revealed a learning effect for the and date of emigrations and deaths were collected from
Information methods were on carried date, out site according and morphology to the relevant of guidelines. cancers
outcome of detection of multiple adenomas and/or any advanced
adenoma (defined as adenomas 10 mm, with high-grade dysplasia,
endoscopists’ ADR [15]; thus, we created a variable that National Results cancer registries, the National Health Service
or with villous/tubulovillous histology).
grouped participants according to the order of examination
occurrence: the first 500 participants examined NHS The Digital median and age the at FS Office was 60 for years, National 53% of Statistics. participants were males
(NHS) Central Register, National Services Scotland,
by Analyses each endoscopist were performed and using those STATA/IC examined V.13.1 (StataCorp later. LP, 2013;
and 11% had ≥ 1 first degree relative with CRC (Table 1). Bowel
Stata Statistical Software: Release 13; Texas, USA). Two-sided p-values
< 0.05 were considered statistically significant. Ethical approval was
preparation quality was excellent for 43%. Median insertion and
obtained from local research ethics review committees for each centre withdrawal times were 2.4 (IQR 1.7–3.4) and 1.9 (IQR 1.2–3.4) minutes,
(Multicentre Research Ethics Committee reference: 03/01/22). Trial respectively. Most examinations reached the descending colon or
registration: ISRCTN28352761. All individuals who underwent FS further (78%) and 29% of participants reported feeling no pain during
provided written informed consent prior to examination. The Patient
Information Advisory Group (now Confidentiality Advisory Group) granted
the examination (Table 1).
GASTROENTEROLOGY TODAY – SPRING 2024
8 9

FEATURE
Power et al. BMC Gastroenterology (2024) 24:44
FEATURE
Page 5 of 13
GASTROENTEROLOGY TODAY – SPRING 2024
Variables were examined by centre, synonymous with endoscopist,
among the 70% of participants with negative examinations
(Supplementary Table 3). ‘Excellent’ bowel preparation quality varied
between 9.6% (centre 9) and 68.2% (centre 4). Median insertion time
varied from 1.45 (IQR 1.03–2.07; centre 4) to 3.88 (IQR, 2.92–5.50;
centre 10) minutes and median withdrawal time varied from 0.88
(IQR 0.65–1.27; centre 4) to 2.38 (IQR 1.90–3.06; centre 5) minutes.
Examinations reaching the descending colon varied between 27.7%
(centre 13) and 84.1% (centre 8) and participants reporting severe
pain varied between 0.2% (centre 4) and 4.1% (centre 8). Despite
these differences between centres, there were no clear associations
between these factors and endoscopist ADR when examining by
ascending order of ADR (Supplementary Table 3).
Among negative examinations, the proportion of participants reporting
quite a lot/severe pain tended to decrease with further segment reached
(p-trends < 0.001). Females were more likely to report quite a lot/severe
pain than males (15.5% vs. 8.0%, respectively, among exams reaching a
maximum of the SF) and to have a longer time to maximum insertion for
each section of the bowel reached (SF: median 2.37 min (IQR 1.75–3.45)
vs. 2.14 min (IQR 1.58–2.90)) (Supplementary Table 4).
In complete-case analyses, 3,349 (14.4%) negative examinations
reached at least the SF. Females were less likely to have an
examination reaching the SF (10.9%) than males (18.2%) (multivariable:
OR 0.57, 95%CI 0.53– 0.62). Among those with negative exams, the
odds of reaching the SF were 75% lower with ‘poor’ bowel preparation
compared to ‘excellent’ (multivariable: OR 0.25 95%CI 0.13–0.50)
and 47% lower with the reporting of severe pain compared to no pain
(multivariable: OR 0.53 95%CI 0.38–0.73) (Supplementary Table 5).
Distal adenoma detection
There were 4,104 (12.0%) participants with ≥ 1 distal adenoma
detected (Table 1). In all models, there were increased odds of distal
adenoma detection with increasing age (multivariable: OR 1.03, 95%CI
1.01–1.04) (Table 1), with a family history of CRC, compared to without
(multivariable: OR 1.40, 95%CI 1.21–1.62), and decreased odds in
females compared to males (multivariable: OR 0.62, 95%CI 0.56–0.69).
Although there was no association in the full dataset, in complete-case
models there were increased odds of distal adenoma detection for those
with ‘poor’ bowel preparation compared to ‘excellent’ (multivariable:
OR 2.88, 95%CI 1.25–6.60; Table 1), and lower odds for those with
‘good’ (multivariable: OR 0.84, 95%CI 0.74–0.95) or ‘adequate’ bowel
preparation (multivariable: OR 0.56, 95%CI 0.49–0.65).
In all models, increasing insertion and withdrawal times were
associated with distal adenoma detection (multivariable: OR ≥ 4.00
vs. < 2.00 min: 1.96, 95%CI 1.68–2.29; 32.79, 95%CI 28.22–38.11,
respectively). In comparison to reaching the sigmoid/descending
junction, reaching more proximally was associated with higher odds
of distal adenoma detection in univariable models (full dataset,
descending colon: OR 1.43, 95%CI 1.31–1.56; SF: OR 1.66, 95%CI
1.47–1.88); however, this attenuated in multivariable models.
In complete-case univariable models, there were lower odds of distal
adenoma detection with increasing pain (severe compared to none: OR
0.69, 95%CI 0.51–0.95; Table 1) but this was not evident in the other
models. In the full dataset, individuals whose FS screening occurred
after their endoscopist’s first 500 examinations had increased odds of
distal adenoma detection compared to those whose took place earlier
(OR 1.32, 95%CI 1.20–1.45); multivariable models were not possible
due to missing data.
Advanced and/or multiple adenomas
There were 919 (4.8%) participants with multiple and/ or advanced
distal adenomas in the complete-case dataset (Supplementary Table
6). Age, sex, family history, bowel preparation quality, insertion and
withdrawal time, segment reached, patient pain and the order of FS
occurrence were similarly associated with the detection of advanced
and/or multiple adenomas as of any distal adenoma.
Distal CRC incidence
During a median follow-up of 17 years, 168 (0.5%) distal CRCs were
diagnosed (Table 2). In the full dataset, females had a lower risk of
distal CRC than males (HR 0.62, 95%CI 0.45–0.85) and those with a
family history of CRC had a higher risk than those without (HR 1.65,
95%CI 1.09–2.50) (Table 2, Supplementary Fig. 1A-B); these effects
attenuated in complete-case models.
Age, bowel preparation quality, segment of bowel reached, patientreported
pain, and order of examination occurrence were not
associated with distal CRC incidence (Table 2, Supplementary Fig. 1C–
F). Although overall the associations for insertion and withdrawal times
were not statistically significant, those in the top category of ≥ 4.00 min
(versus < 2.00 min) had an increased risk of distal CRC (multivariable:
HR 1.81, 95%CI 1.00–3.27; HR 1.93, 95%CI 1.14–3.24, respectively)
(Table 2, Supplementary Fig. 1G-H).
Compared to those examined by high-detectors, individuals examined
by low-detectors had an increased risk of distal CRC (multivariable:
HR 4.71, 95%CI 2.65–8.38), as did those examined by intermediatedetectors
in complete- case models only (multivariable: HR 2.16,
95%CI 1.22–3.81) (Table 2, Supplementary Fig. 1I).
Excluding participants with multiple FS examinations (n = 1,810) did not
materially alter the results for distal adenoma detection or long-term
colorectal cancer incidence in any of the models.
Discussion
We investigated factors that could improve the quality of FS
examinations, increase adenoma detection, and reduce CRC
incidence. We found that multiple variables were associated with
adenoma detection, including patient age, sex, family history of CRC,
bowel preparation quality, insertion time and withdrawal time. For longterm
outcomes, patients who were examined by endoscopists with
higher ADRs had a lower risk of distal CRC incidence.
Individuals with a family history of CRC or its precursor lesions are
at increased risk of CRC compared to those without [24]; similarly,
we found a positive association between family history of CRC and
distal adenoma detection at FS screening [25]. Participants provided
family history information on the pre-screening questionnaire, which
the endoscopist may have accessed, potentially motivating them to
conduct a more thorough FS examination.
Table 1 Detection of any distal adenoma by patient factors and endoscopist variables
All eligible participants: Full dataset analysis (n = 34 139) Participants with complete data on all variables: Complete-case analysis (n = 19 333) a
p-value Multivariable OR p-value
(95%CI) c
Univariable OR
(95%CI)
p-value n (%) b Participants
with ≥ 1 adenoma
detected at
baseline n (%)
Univariable OR
(95%CI)
n (%) b Participants
with ≥ 1 adenoma
detected at
baseline n (%)
Total 34 139 (100) 4 104 (12.0) 19 333 (100) 2 415 (12.5)
Age (IQR), years 60.3 (57.9–62.8) 4 104 (12.0) 1.03 (1.02–1.04) < 0.001 60.5 (58.0–62.9) 2 415 (12.5) 1.03 (1.01–1.05) < 0.001 1.03 (1.01–1.04) 0.002
Sex 34 139 (100) 4 104 (12.0) < 0.001 < 0.001 < 0.001
Male 18 127 (53.1) 2 817 (15.5) 1 10 315 (53.4) 1 665 (16.1) 1 1
Female 16 012 (46.9) 1 287 (8.0) 0.48 (0.44–0.51) 9 018 (46.6) 750 (8.3) 0.47 (0.43–0.52) 0.62 (0.56–0.69)
32 356 (94.8) 3 926 (12.1) < 0.001 < 0.001 < 0.001
Family history of
CRC
No 28 663 (88.6) 3 381 (11.8) 1 17 123 (88.6) 2 077 (12.1) 1 1
Yes 3 693 (11.4) 545 (14.8) 1.29 (1.17–1.43) 2 210 (11.4) 338 (15.3) 1.31 (1.15–1.48) 1.40 (1.21–1.62)
Centre 34 139 (100) 4 104 (12.0) < 0.001 < 0.001 < 0.001
1 2 413 (7.1) 207 (8.6) 1 1 607 (8.3) 139 (8.6) 1 1
2 d 3 438 (10.1) 302 (8.8) 1.03 (0.85–1.23) - - - -
3 2 674 (7.8) 249 (9.3) 1.09 (0.90–1.33) 1 452 (7.5) 135 (9.3) 1.08 (0.84–1.39) 0.91 (0.67–1.23)
4 2 131 (6.2) 209 (9.8) 1.16 (0.95–1.42) 1 452 (7.5) 146 (10.1) 1.18 (0.93–1.51) 1.55 (1.14–2.09)
5 2 466 (7.2) 271 (11.0) 1.32 (1.09–1.59) 1 844 (9.5) 189 (10.2) 1.21 (0.96–1.52) 0.41 (0.31–0.54)
6 2 733 (8.0) 306 (11.2) 1.34 (1.12–1.62) 1 579 (8.2) 163 (10.3) 1.22 (0.96–1.54) 1.23 (0.92–1.65)
7 2 516 (7.4) 282 (11.2) 1.35 (1.11–1.62) 1 741 (9.0) 205 (11.8) 1.41 (1.12–1.77) 1.19 (0.89–1.58)
8 2 839 (8.3) 362 (12.8) 1.56 (1.30–1.86) 1 486 (7.7) 190 (12.8) 1.55 (1.23–1.95) 0.77 (0.58–1.03)
9 2 493 (7.3) 349 (14.0) 1.73 (1.45–2.08) 1 617 (8.4) 236 (14.6) 1.80 (1.45–2.25) 1.39 (1.06–1.83)
10 2 532 (7.4) 370 (14.6) 1.82 (1.52–2.18) 1 578 (8.2) 215 (13.6) 1.67 (1.33–2.09) 0.57 (0.43–0.76)
11 2 324 (6.8) 347 (14.9) 1.87 (1.56–2.25) 1 202 (6.2) 185 (15.4) 1.92 (1.52–2.43) 0.65 (0.49–0.86)
12 2 799 (8.2) 421 (15.0) 1.89 (1.58–2.25) 2 214 (11.5) 348 (15.7) 1.97 (1.60–2.43) 1.11 (0.86–1.44)
13 2 781 (8.1) 429 (15.4) 1.94 (1.63–2.32) 1 561 (8.1) 264 (16.9) 2.15 (1.73–2.67) 0.71 (0.54–0.92)
33 609 (98.4) 3 925 (11.7) 0.05 0.001 < 0.001
Bowel preparation
quality
Excellent 14 573 (43.4) 1 690 (11.6) 1 7 819 (40.4) 924 (11.8) 1 1
Good 11 692 (34.8) 1 431 (12.2) 1.06 (0.99–1.15) 6 922 (35.8) 918 (13.3) 1.14 (1.03–1.26) 0.84 (0.74–0.95)
Adequate 7 060 (21.0) 769 (10.9) 0.93 (0.85–1.02) 4 553 (23.6) 561 (12.3) 1.05 (0.94–1.17) 0.56 (0.49–0.65)
Poor 284 (0.8) 35 (12.3) 1.07 (0.75–1.53) 39 (0.2) 12 (30.8) 3.32 (1.67–6.57) 2.88 (1.25–6.60)
Insertion time 20 371 (59.7) 2 630 (12.9) < 0.001 < 0.001 < 0.001
< 2.00 mins 7 357 (36.1) 795 (10.8) 1 7 014 (36.3) 727 (10.4) 1 1
2.00–2.59 mins 6 198 (30.4) 759 (12.2) 1.15 (1.04–1.28) 5 894 (30.5) 702 (11.9) 1.17 (1.05–1.31) 1.18 (1.04–1.35)
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Table 1 (continued)
All eligible participants: Full dataset analysis (n = 34 139) Participants with complete data on all variables: Complete-case analysis (n = 19 333) a
n (%) b Participants
with ≥ 1 adenoma
detected at
baseline n (%)
Univariable OR
(95%CI)
p-value n (%) b Participants
with ≥ 1 adenoma
detected at
baseline n (%)
Univariable OR
(95%CI)
p-value Multivariable OR p-value
(95%CI) c
3.00–3.59 mins 3 412 (16.7) 466 (13.7) 1.31 (1.16–1.48) 3 221 (16.7) 424 (13.2) 1.31 (1.15–1.49) 1.37 (1.18–1.61)
≥ 4.00 mins 3 404 (16.7) 610 (17.9) 1.80 (1.61–2.02) 3 204 (16.6) 562 (17.5) 1.84 (1.63–2.07) 1.96 (1.68–2.29)
Withdrawal time 20 326 (59.5) 2 621 (12.9) < 0.001 < 0.001 < 0.001
< 2.00 mins 10 625 (52.3) 295 (2.8) 1 10 204 (52.8) 262 (2.6) 1 1
2.00–2.59 mins 3 672 (18.1) 295 (8.0) 3.06 (2.59–3.61) 3 479 (18.0) 266 (7.6) 3.14 (2.64–3.74) 3.85 (3.21–4.62)
3.00–3.59 mins 1 837 (9.0) 311 (16.9) 7.14 (6.03–8.44) 1 740 (9.0) 289 (16.6) 7.56 (6.34–9.01) 9.47 (7.88–11.38)
≥ 4.00 mins 4 192 (20.6) 1 720 (41.0) 24.36 (21.37–27.78) 3 910 (20.2) 1 598 (40.9) 26.23 (22.84–30.12) 32.79 (28.22–38.11)
Segment reached 34 075 (99.8) 4 098 (12.0) < 0.001 < 0.001 0.79
RM/RS/SC 128 (0.4) 16 (12.5) 1.43 (0.84–2.44) 53 (0.3) 8 (15.1) 1.63 (0.76–3.48) 1.12 (0.46–2.69)
SD 7 510 (22.0) 680 (9.1) 1 4 447 (23.0) 437 (9.8) 1 1
DC 21 327 (62.6) 2 660 (12.5) 1.43 (1.31–1.56) 11 840 (61.2) 1 519 (12.8) 1.35 (1.21–1.51) 1.00 (0.87–1.14)
SF 3 462 (10.2) 491 (14.2) 1.66 (1.47–1.88) 2 062 (10.7) 310 (15.0) 1.62 (1.39–1.90) 1.12 (0.92–1.38)
TC/HF/AC/CM/TI 1 648 (4.8) 251 (15.2) 1.80 (1.54–2.11) 931 (4.8) 141 (15.1) 1.64 (1.33–2.01) 1.01 (0.79–1.28)
Patient pain 33323 (97.6) 3 989 (12.0) 0.66 0.003 0.48
None 9 563 (28.7) 1 164 (12.2) 1 4 937 (25.5) 685 (13.9) 1 1
Mild 17 859 (53.6) 2 139 (12.0) 0.98 (0.91–1.06) 10 561 (54.6) 1 292 (12.2) 0.87 (0.78–0.96) 0.92 (0.82–1.03)
Quite a lot 5 224 (15.7) 613 (11.7) 0.96 (0.86–1.06) 3 378 (17.5) 392 (11.6) 0.81 (0.71–0.93) 0.92 (0.78–1.07)
Severe 677 (2.0) 73 (10.8) 0.87 (0.68–1.12) 457 (2.4) 46 (10.1) 0.69 (0.51–0.95) 0.86 (0.60–1.25)
FS occurrence e 34 139 (100) 4 104 (12.0) < 0.001 - -
First group 500 5 410 (15.8) 526 (9.7) 1 - - - -
Later groups 500 28 729 (84.2) 3 578 (12.5) 1.32 (1.20–1.45) - - - -
Abbreviations: AC ascending colon, CI confidence interval, CM caecum, DC descending colon, FS flexible sigmoidoscopy, HF hepatic flexure, Mins minutes, OR odds ratio, RM rectum, RS recto sigmoid, SC sigmoid colon, SD
sigmoid descending, SF splenic flexure, TC transverse colon, TI terminal ileum
P-values were calculated with the likelihood ratio test
a 1 783 missing values on family history of CRC; 530 missing values on bowel preparation quality; 13 768 missing values on insertion time; 13 813 missing values on withdrawal time; 64 missing values on segment
reached; 816 missing values on patient-reported pain (these values are not mutually exclusive)
b All n and percentage except the entry for age, which is median and interquartile range
c Multivariable model includes age, sex, family history of CRC, centre, bowel preparation quality, insertion time, withdrawal time, segment reached and patient-reported pain
d
Centre 2 was omitted from the complete-case analyses due to a lack of recorded information for insertion or withdrawal times, as this information was not required until partway through the trial at which time centre 2
had already completed recruitment
e Order of occurrence of FS examination was omitted from the complete-case analyses due to a lack of recorded information for insertion and withdrawal times for the category ‘first group 500’; this information was not
required until partway through the trial at which time each endoscopist had already completed 500 examinations
Table 2 Long-term distal colorectal cancer incidence by patient factors and endoscopist variables
All eligible participants: Full dataset analysis (n = 34 139) Participants with complete data on all variables: Complete-case analysis (n = 19 294) a,b
n (%) c Number of
distal CRCs, n
Incidence rate
per 100,000
person-years
(95% CI)
Univariable HR
(95%CI)
p-value n (%) c Number of
distal CRCs, n
Incidence rate
per 100,000
person-years
(95% CI)
Univariable HR
(95%CI)
p-value Multivariable p-value
HR (95%CI) d
Total 34 139 (100) 168 31.4 (27.0–36.5) 19 294 (100) 91 30.8 (25.1–37.9)
Age (IQR), years 60.3 (57.9–62.8) 168 - 1.03 (0.98–1.09) 0.23 60.5 (58.0–62.9) 91 - 1.00 (0.93–1.08) 0.98 1.00 (0.93–1.08) 0.96
Sex 34 139 (100) 168 0.003 0.06 0.12
Male 18 127 (53.1) 106 38.1 (31.5–46.1) 1 10 294 (53.4) 56 36.2 (27.9–47.1) 1 1
Female 16 012 (46.9) 62 24.1 (18.8–31.0) 0.62 (0.45–0.85) 9 000 (46.7) 35 24.9 (17.9–34.7) 0.67 (0.44–1.03) 0.71 (0.45–1.09)
Family history
of CRC
32 356 (94.8) 156 0.026 0.23 0.24
No 28 663 (88.6) 129 28.8 (24.2–34.2) 1 17 087 (88.6) 77 29.4 (23.5–36.8) 1 1
Yes 3 693 (11.4) 27 47.1 (32.3–68.7) 1.65 (1.09–2.50) 2 207 (11.4) 14 42.0 (24.9–70.9) 1.44 (0.81–2.54) 1.43 (0.81–2.52)
Bowel preparation
quality
33 609 (98.4) 164 0.19 0.45 0.16
Excellent 14 573 (43.4) 62 26.8 (20.9–34.4) 1 7 819 (40.5) 33 27.4 (19.5–38.5) 1 1
Good 11 692 (34.8) 56 30.7 (23.6–39.9) 1.15 (0.80–1.65) 6 922 (35.9) 32 30.3 (21.4–42.9) 1.11 (0.69–1.81) 1.24 (0.76–2.03)
Adequate 7 060 (21.0) 44 40.5 (30.1–54.4) 1.53 (1.04–2.25) 4 553 (23.6) 26 37.8 (25.7–55.5) 1.40 (0.83–2.33) 1.72 (0.99–2.97)
Poor b 284 (0.8) 2 44.8 (11.2–178.9) 1.65 (0.40–6.74) - - - - -
Insertion time 20 371 (59.7) 93 0.53 0.42 0.20
< 2.00 mins 7 357 (36.1) 31 27.6 (19.4–39.2) 1 7 006 (36.3) 30 28.0 (19.6–40.1) 1 1
2.00–2.59 mins 6 198 (30.4) 27 28.5 (19.5–41.6) 1.03 (0.62–1.73) 5 885 (30.5) 27 30.0 (20.6–43.7) 1.07 (0.63–1.79) 1.09 (0.64–1.84)
3.00–3.59 mins 3 412 (16.7) 14 26.7 (15.8–45.1) 0.96 (0.51–1.81) 3 216 (16.7) 13 26.3 (15.3–45.3) 0.93 (0.49–1.79) 0.95 (0.49–1.86)
≥ 4.00 mins 3 404 (16.7) 21 40.6 (26.5–62.3) 1.47 (0.84–2.55) 3 187 (16.5) 21 43.3 (28.2–66.4) 1.54 (0.88–2.69) 1.81 (1.00–3.27)
Withdrawal
time
20 326 (59.5) 93 0.24 0.27 0.09
< 2.00 mins 10 625 (52.3) 42 25.8 (19.1–34.9) 1 10 190 (52.8) 42 26.9 (19.9–36.4) 1 1
2.00–2.59 mins 3 672 (18.1) 15 26.5 (16.0–44.0) 1.02 (0.56–1.83) 3 469 (18.0) 15 28.1 (16.9–46.6) 1.03 (0.57–1.86) 1.00 (0.55–1.82)
3.00–3.59 mins 1 837 (9.0) 9 32.0 (16.7–61.5) 1.23 (0.60–2.52) 1 738 (9.0) 8 30.1 (15.1–60.2) 1.11 (0.52–2.36) 1.19 (0.55–2.57)
≥ 4.00 mins 4 192 (20.6) 27 42.7 (29.3–62.3) 1.64 (1.01–2.67) 3 897 (20.2) 26 44.2 (30.1–64.9) 1.63 (1.00–2.66) 1.93 (1.14–3.24)
Segment
reached
34 075 (99.8) 167 0.50 0.42 0.45
RM/RS/SC/SD 7 638 (22.4) 36 30.0 (21.7–41.7) 1 4 484 (23.2) 18 26.2 (16.5–41.6) 1 1
DC 21 327 (62.6) 111 33.2 (27.6–40.0) 1.11 (0.76–1.61) 11 822 (61.3) 62 34.2 (26.7–43.9) 1.30 (0.77–2.20) 0.99 (0.57–1.71)
SF/TC/HF/AC/
CM/TI
5 110 (15.0) 20 25.1 (16.2–39.0) 0.84 (0.49–1.46) 2 988 (15.5) 11 24.3 (13.5–43.9) 0.93 (0.44–1.98) 0.67 (0.31–1.44)
Patient pain 33 323 (97.6) 163 0.25 0.49 0.81
None 9 563 (28.7) 55 36.7 (28.2–47.9) 1 4 929 (25.5) 28 37.4 (25.8–54.1) 1 1
Mild 17 859 (53.6) 85 30.4 (24.6–37.6) 0.83 (0.59–1.16) 10 541 (54.6) 47 29.1 (21.9–38.8) 0.78 (0.49–1.24) 0.87 (0.54–1.40)
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Table 2 (continued)
All eligible participants: Full dataset analysis (n = 34 139) Participants with complete data on all variables: Complete-case analysis (n = 19 294) a,b
p-value Multivariable p-value
HR (95%CI) d
Univariable HR
(95%CI)
Incidence rate
per 100,000
person-years
(95% CI)
p-value n (%) c Number of
distal CRCs, n
Univariable HR
(95%CI)
Incidence rate
per 100,000
person-years
(95% CI)
n (%) c Number of
distal CRCs, n
Quite a lot/ 5 901 (17.7) 23 24.8 (16.5–37.3) 0.68 (0.42–1.10) 3 824 (19.8) 16 27.2 (16.7–44.4) 0.73 (0.39–1.34) 0.83 (0.44–1.58)
severe e
FS occurrence f 34 139 (100) 168 0.18 - - - -
First group 500 5 410 (15.8) 35 39.8 (28.5–55.4) 1 - - - - - -
28 729 (84.2) 133 29.8 (25.1–35.3) 0.77 (0.53–1.12) - - - - - -
Later groups
500
34 139 (100) 168 0.001 < 0.001 < 0.001
Endoscopist’s
ADR ranking
group
High 12 929 (37.9) 44 21.8 (16.2–29.3) 1 8 161 (42.3) 22 17.5 (11.5–26.6) 1 1
Intermediate 10 554 (30.9) 51 30.9 (23.5–40.7) 1.42 (0.95–2.13) 6 626 (34.3) 32 31.5 (22.3–44.5) 1.81 (1.05–3.12) 2.16 (1.22–3.81)
Low 10 656 (31.2) 73 43.5 (34.6–54.7) 1.99 (1.37–2.90) 4 507 (23.4) 37 54.8 (39.7–75.6) 3.24 (1.91–5.49) 4.71 (2.65–8.38)
Abbreviations: AC ascending colon, ADR adenoma detection rate, CI confidence interval, CM caecum, CRC colorectal cancer, DC descending colon, FS flexible sigmoidoscopy, HF hepatic flexure, HR hazard ratio, Mins
minutes, RM rectum, RS recto sigmoid, SC sigmoid colon, SD sigmoid descending, SF splenic flexure, TC transverse colon, TI terminal ileum
P-values were calculated with the likelihood ratio test
a
1 783 missing values on family history; 530 missing values on bowel preparation quality; 13 768 missing values on insertion time; 13 813 missing values on withdrawal time; 64 missing values on segment reached; 816
missing values on patient-reported pain (these values are not mutually exclusive)
b Participants with the ‘poor’ category of bowel preparation quality (n = 39) were excluded from the complete-case analyses due to a lack of cases
c
All n and percentage except the entry for age, which is median and interquartile range
d
Multivariable model includes age, sex, family history of CRC, bowel preparation quality, insertion time, withdrawal time, segment reached, patient-reported pain and endoscopist’s ADR ranking group
e
Participants with the ‘severe’ category of patient-reported pain were combined with the category ‘quite a lot’ due to a lack of cases
Order of occurrence of FS examination was omitted from the complete-case analyses due to a lack of recorded information for the variables of insertion and withdrawal time for the category ‘first group 500’; this
information was not required until partway through the trial at which time each endoscopist had already completed 500 examinations
Bowel preparation plays a crucial role in the quality and completeness reached, insertion time and withdrawal time. Quality of bowel
of endoscopic examinations, with higher levels of cleanliness
preparation has been associated with longer insertion times [30, 31].
associated with optimum views of the colon [26] and improved ADRs Advancing a sigmoidoscope through a bowel with poorer preparation
[23]. Compared to having ‘excellent’ bowel preparation, we found lower requires more cleaning to obtain good views of the mucosa, potentially
odds of adenoma detection among those having ‘good’ or ‘adequate’ increasing insertion times. However, in our multivariable model
and increased odds among those having ‘poor’. Among participants including both insertion time and bowel preparation quality, the
with poor bowel preparation at first FS, those who had adenomas association between insertion time and adenoma detection remained.
detected that triggered referral to colonoscopy would not have had a
repeat FS to improve the bowel preparation quality; however, those Higher quality withdrawal techniques are associated with fewer missed
without high-risk adenomas detected would have undergone a repeat adenomas. Colonoscopists with lower miss rates for adenomas had
FS, likely improving the bowel preparation quality. This could contribute longer examination times compared to those with higher miss rates
to poor bowel preparation being positively associated with adenoma [19]. We found that longer withdrawal times were associated with
detection. We were unable to examine poor bowel preparation quality increased adenoma detection, which is unsurprising due to the time
and distal CRC incidence due to a lack of cases, attributed to the fact taken to remove lesions < 10 mm during FS. Although larger lesions
that we only included complete examinations.
would not have been removed during FS, they would likely increase
the examination time. For distal CRC incidence, only the longest
In contrast to previous findings, which either reported no correlation withdrawal time category was associated with increased risk; this
between adenoma detection and longer insertion time [27] or
can likely be attributed to patients with long withdrawal times having
decreased adenoma detection with longer insertion times [28, 29], more advanced pathology and inherently being at higher risk rather
we found that longer insertion time was associated with greater than reflecting the quality of the endoscopist’s withdrawal. There is no
adenoma detection. Within the UKFSST, endoscopists were to
minimum recommended withdrawal time for FS, unlike for colonoscopy
remove polyps ≤ 5 mm during insertion to avoid difficulties relocating [20]. A previous study suggested a FS withdrawal time of at least 3.25
them on withdrawal, remove polyps 6-9 mm during withdrawal, and min from the SF and, to maximise ADRs, specified an aim of 3.5–4.0
leave polyps ≥ 10 mm for removal at colonoscopy. Therefore, longer minutes [14]; although this has not been validated, our data supports
insertion times in this study could be associated with the presence this recommendation.
of numerous polyps ≤ 5 mm requiring resection and/or very large
adenomas needing endoscopic assessment/ photo-documentation. FS with a 60 cm maximum scope insertion distance can reach the
We also found increased odds of detecting multiple and/or advanced SF and sometimes beyond [32]. In our study, the majority (78%) of
adenomas in those with longer insertion times. In our study there examinations were judged by the endoscopist to have reached at least
was no fixed endpoint for FS examinations and further reach of the the descending colon with 15% reaching at least the SF. It is important
sigmoidoscope during an examination would naturally lead to longer that the sigmoidoscope reaches as high as comfortably possible
insertion and withdrawal times and a higher chance of adenoma to maximise the mucosa examined, increasing the effectiveness of
detection. However, in multivariable models we adjusted for segment the examination [33, 34]. In our univariable analyses, the chance of
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FEATURE
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detecting an adenoma was greater when at least the descending colon
was reached, although this effect attenuated in multivariable models.
Previously, inadequate examinations (e.g., insertion of the scope <
50 cm) were associated with female sex and advancing age, with the
majority of incomplete examinations due to patient discomfort [34].
In agreement with this, we found decreased odds of reaching the SF
for females, those who reported more pain, and those with poorer
bowel preparation quality among those with negative examinations
[14]. However, we found no clear association between patient-reported
pain and adenoma detection or distal CRC incidence. Identifying
factors that could reduce levels of pain could result in more complete
examinations, lessening the chances of negative experiences that
could compromise attendance at future examinations.
We found that adenomas were more likely to be detected at
examinations conducted after an endoscopist’s first 500 examinations,
suggesting a learning effect, consistent with previous analyses [15];
although we cannot be certain that participants examined within an
endoscopist’s first 500 examinations had adenomas missed at baseline.
It has been reported that for each 1% increase in the ADR, there is an
associated 3% decreased risk of post-colonoscopy CRC [13] and that
greater long-term protection from CRC is observed when FS screening
is conducted by endoscopists with higher ADRs [35]. We found an
almost five-fold increase in distal CRC incidence for individuals screened
by low-detectors compared to those screened by high-detectors;
this suggests an ADR of 15%, observed among the high-detectors,
should be considered as a minimal standard. Other factors could
account for differences in ADR, including variations in equipment,
screening protocols or endoscopists’ prior experience; these factors
were controlled for in the study design/analysis, which lends more
weight to the difference in ADRs reflecting real variability in endoscopist
performance and consequent effects on CRC incidence [5].
Although seven variables were associated with adenoma detection,
only endoscopist ADR group was associated with distal CRC, in
addition to insertion and withdrawal times in the top categories only.
These differences potentially demonstrate the importance of certain
factors in adenoma detection but not necessarily cancer prevention,
but differences in findings could be due to a lack of power for the distal
CRC analyses.
Strengths of our study include the large, high-quality dataset with
multiple KPI measures and long follow-up period. Participants were
recruited throughout the UK, resulting in good generalisability of our
findings. Complete endoscopic examinations are crucial as incomplete
examinations are associated with higher numbers of interval cancers
[36, 37]; we only included examinations classed by the endoscopist as
complete. In addition, we only included examinations performed by the
main endoscopist at each centre, which removed heterogeneity within
centres introduced by multiple endoscopists. There were limitations,
including missing data for insertion and withdrawal times, potential
inaccuracy in classifying depth of insertion since imaging systems
were not used and limited statistical power for distal CRC analyses.
We were unable to exclude examination time used for polyp removal
or endoscopic assessment/photo documentation of polyps, which
may have contributed to the association between adenoma detection
and longer insertion and withdrawal times. Additionally, since the trial
screening was conducted there have been advances in the quality of
endoscopic equipment and improvements in endoscopist training and
monitoring; therefore, the number of adenomas detected today would
likely be higher.
In conclusion, there is a lack of published data on KPIs and long-term
CRC outcomes. Examining the impact of KPIs on adenoma detection
and distal CRC incidence, we identified several variables associated
with patient outcomes. Examinations with good or adequate bowel
preparation quality had lower odds of adenoma detection, and longer
insertion and withdrawal times had increased odds of adenoma
detection. Patients examined by endoscopists with high ADRs had the
lowest risk of distal CRC. We suggest an ADR of 15% should be set as
a minimal standard. The importance of the detection and removal of
adenomas cannot be understated; early detection of abnormalities is
key in providing long-term protection against CRC. It is vital that each
endoscopic procedure is conducted to the highest standard, so all
patients receive the optimum benefit that screening can offer.
Parts of the reported results have been presented as a poster
presentation [38].
Abbreviations
AC Ascending colon
ADR Adenoma detection rate
CI Confidence interval
CM Caecum
CRC Colorectal cancer
DC Descending colon
FS Flexible sigmoidoscopy
HF Hepatic flexure
HR Hazard ratio
ICD-10 International Classification of Diseases 10th revision
ISRCTN International Standard Randomised Controlled Trial Number
IQR Interquartile range
KPIs Key performance indicators
Mins Minutes
NHS National Health Service
OR Odds ratio
PIAG Patient Information Advisory Group
RM Rectum
RS Rectosigmoid
SC Sigmoid colon
SD Sigmoid descending
SF Splenic flexure
TC Transverse colon
TI Terminal ileum
UKFSST UK Flexible Sigmoidoscopy Screening Trial
Supplementary Information
The online version contains supplementary material available at
https://doi.org/10.1186/s12876-024-03125-x.
Additional file 1: Supplementary Table 1. Reasons for repeat flexible
sigmoidoscopy. Supplementary Table 2. Protocol guidelines for the
categorisation of bowel preparation quality. Supplementary Table 3.
Endoscopist variables by endoscopist for negative examinations*.
Supplementary Table 4. Patient-reported pain and insertion time
by extent of examination in negative examinations*. Supplementary
Table 5. Reaching the splenic flexure in negative examinations*
by age, sex, bowel preparation quality, and pain. Supplementary
Table 6. Detection of multiple and/or advanced distal adenomas by
patient factors and endoscopist variables. Supplementary Figure 1.
Cumulative distal colorectal cancer incidence in all eligible participants
by patient factors and endoscopist variables (the full dataset).
Acknowledgements
CSPRG: Wendy Atkin, Mariano Perdices Kalfors, Paul Greliak, Iain
Stenson, Salman Shahrezaei. Trial Steering Committee: M Parmar
(Chair), R Valori, A Gray, J Patnick, A Mackie, L Berkman. We thank the
general practitioners, hospital staff, and the men and women who took
part in this study.
Authors’ contributions
SP, KW and AJC: conception and design; analysis and interpretation of
the data; drafting of the article; All authors: critical revision of the article
for important intellectual content and final approval of the article.
Funding
Currently, this trial is funded by the National Institute for Health
Research (NIHR) Health Technology Assessment (HTA) ref: 16/65/01.
The work of the Cancer Screening and Prevention Research Group
(CSPRG) at Imperial College London is also supported by Cancer
Research UK (C53889/A25004). SP is funded by a Cancer Research
UK studentship award (A27007).
Availability of data and materials
The data used in this current study is not available as it uses individuallevel
identifiable data, which is confidential. Requests regarding data
should be directed to the corresponding author.
Declarations
Ethics approval and consent to participate
Ethical approval was obtained from local research ethics review
committees for each centre (Multicentre Research Ethics Committee
reference: 03/01/22). Trial registration: ISRCTN28352761. All
individuals who underwent FS provided written informed consent
prior to examination. The Patient Information Advisory Group (now
Confidentiality Advisory Group) granted permission to obtain and
process patient data (PIAG 4–07(j)/2002). All the methods were carried
out according to the relevant guidelines.
Consent for publication
Not applicable.
Competing interests
BPS has done consultancy work, been a speaker for, had loan
equipment and a research grant from Olympus in the last 3 years; all
other authors report no conflicts of interest.
Author details
1
Cancer Screening and Prevention Research Group (CSPRG),
Department of Surgery and Cancer, St Mary’s Hospital, Imperial
College London, London W2 1NY, UK. 2 Department of Surgery
and Cancer, Imperial College London, London, UK. 3 Department
of Gastroenterology, St Mark’s Hospital and Academic Institute,
London, UK.
Received: 28 June 2023 Accepted: 2 January 2024
Published online: 23 January 2024
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38. jurisdictional Power S, claims Wooldrage in published K, Cross maps A. and P190 institutional The impact affi of liations. endoscopist
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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
RESEARCH
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
*Correspondence:
Sulmaz Ghahramani
suli.ghahraman@gmail.com
Health Policy Research Center, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Iran
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 nonmedical
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
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GASTROENTEROLOGY TODAY – SPRING 2024

FEATURE
Pakdin et al. BMC Gastroenterology (2023) 23:21
FEATURE
GASTROENTEROLOGY TODAY – SPRING 2024
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
extra-intestinal 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
(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) .
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,
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.
Costs were reported as mean costs with 95% CI estimated using nonparametric
boodstrap sampling.
Results
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
Table 1 Patients’ characteristics
Characteristic
SD, standard deviation
Ulcerative
colitis
(n = 168)
Age, mean (SD), years 40.64 (12.90) 39.11 (14.04)
Age groups
Sex
0–29 34 [20.2] 19 [26.4]
30–39 55 [32.7] 18 [25.0]
≥ 40 79 [47.0] 35 [48.6]
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]
Data are presented as n [%] or mean (SD)
Crohn’s disease (n = 72)
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.
Drug
six cate
ing eac
type ar
Med
cal cos
23.0%
respect
patient
icylates
in both
the hig
accoun
percen
this ty
the sec
(235.11
pitaliza
medica
sible fo
Physio
impose
Direct n
Althou
were h
less tha
patient
mostly
Indirec
Indirec
respon
patient
tivity l
frequen
due to
formed
for pat
of prod
in UC
large s
and 43
from w
ity loss
types (
in CD
was an
accoun
eases (
in CD)
GASTROENTEROLOGY TODAY – SPRING 2024
22 23

Pakdin et al. BMC Gastroenterology (2023) 23:21
FEATURE
Table 2 Resource utilization and costs per patient
Cost categories
Participants using resources,
n [%]
Page 5 of 8
Mean annual costs in US$ (SD) [% of total costs]
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
medicine, special diet, related books)
9 [5.4] 6 [8.3] 2.07 (18.68) [0.2] 0.98 (4.12) [0.1]
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]
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 shortterm
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$ 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).
ers 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 FEATURE
information
on resource utilization consumed by patients with specific
diseases. However, to the best of our knowledge this
study among the first comprehensive studies in Iran
Discussion
assessing both direct and indirect cost profiles associated
In
with
this
IBD.
retrospective cohort study, we aimed to determine the
economic
Several
burden
studies
of IBD,
have
and
evaluated
to compare the
the
profiles
economic
of costs
burden
in UC
and
of IBD
CD patients.
in other
There
countries
are barriers
[25–37].
to study
Consistent
the economic
with
burden
their
of
specific
findings,
diseases
we found
in Iran,
that
as diagnostic
the CD
data
patients’
is not ordinarily
resource
coded
utilization
was visits, higher and than the patients’ that of resource UC patients, utilization and are not this recorded. differ-
for
outpatient
Thus, ence there was is more the paucity considerable of information in hospitalization, on resource utilization surgeries,
consumed and laboratory by patients sectors. with specific Variations diseases. in However, the pathogenesis to the best of of
our the knowledge two diseases this study can is explain among the this first difference, comprehensive as UC studies might
in not Iran lead assessing to irreversible both direct and and indirect systemic cost profiles damage associated observed
with in CD IBD. patients [38]. However, the amount of difference
among the annual mean costs of UC and CD differs from
Several a study studies to another, have evaluated based the on economic the design burden and of IBD population in other
countries of study, [25–37]. as inconsistencies Consistent with their are findings, created we in found the that results the CD of
patients’ cost of resource illness utilization studies was when higher comparing than that of one UC patients, to another and
this due difference variations was more in method considerable [30]. in Annual hospitalization, mean surgeries, costs per and
laboratory patient for sectors. UC Variations and CD in were the pathogenesis between 6217–11,477 of the two diseases US$,
can and explain 11,034–18,932 this difference, US$ as UC in might the not USA, lead to respectively. irreversible and The
systemic corresponding damage observed ranges in were CD patients 8949–10,395 [38]. However, euros, the amount and
of 2898–6742 difference among euros the in annual European mean costs countries of UC and [39, CD 40]. differs In our
study, annual mean costs per patient for UC and CD
from a study to another, based on the design and population of
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
spread
IBD pa
ing to a
this typ
of cole
ings, de
receive
CD pat
total c
tance o
them a
ipants
Consid
therapy
tine as
IBD pa
Direc
the tota
rect co
had be
patient
applyin
disease
design
for the
to enro
Shor
disabili
ity loss
of the
to a Ge
32% an
tively [
produc
found
[33]. It
role in
UC: Ulcerative colitis; CD: Crohn’s disease; SD: standard deviation
Table 3 Frequency and costs of purchased medication
GASTROENTEROLOGY TODAY – SPRING 2024
Drug category Participants taking medication, n [%] Mean annual costs in US$ (SD) [% of total medication
costs]
Miscellaneous drug groups include analgesics, gastrointestinal associated drugs, and others
UC: Ulcerative colitis; CD: Crohn’s disease; SD: standard deviation
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]
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GASTROENTEROLOGY TODAY – SPRING 2024
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FEATURE
FEATURE
GASTROENTEROLOGY TODAY – SPRING 2024
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 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].
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].
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.
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.
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.
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.
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.
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
Not applicable.
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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