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Population-based screening for early detection and treatment of colorectal cancer (CRC) and precursor lesions, using evidence-based methods, can be effective in populations with a significant burden of the disease provided the services are of high quality. Multidisciplinary, evidence-based guidelines for quality assurance in CRC screening and diagnosis have been developed by experts in a project co-financed by the European Union. The 450-page guidelines were published in book format by the European Commission in 2010. They include 10 chapters and over 250 recommendations, individually graded according to the strength of the recommendation and the supporting evidence. Adoption of the recommendations can improve and maintain the quality and effectiveness of an entire screening process, including identification and invitation of the target population, diagnosis and management of the disease and appropriate surveillance in people with detected lesions. To make the principles, recommendations and standards in the guidelines known to a wider professional and scientific community and to facilitate their use in the scientific literature, the original content is presented in journal format in an open-access Supplement of Endoscopy. The editors have prepared the present overview to inform readers of the comprehensive scope and content of the guidelines.
European guidelines for quality assurance in colorectal cancer screening and
diagnosis: Overview and introduction to the full Supplement publication
Authors L. von Karsa1, J. Patnick2,3, N. Segnan1,4, W. Atkin5, S. Halloran6,7, I. Lansdorp-Vogelaar8, N. Malila9, S. Minozzi4,
S. Moss10, P. Quirke11, R. J. Steele12, M. Vieth13, L. Aabakken14, L. Altenhofen15, R. Ancelle-Park16, N. Antoljak17,18,
A. Anttila9, P. Armaroli4, S. Arrossi19, J. Austoker20,, R. Banzi21, C. Bellisario4, J. Blom22, H. Brenner23, M. Bretthauer24,
M. Camargo Cancela25,26 , G. Costamagna27, J. Cuzick28,M.Dai
29, J. Daniel26,30, E. Dekker31, N. Delicata32, S. Ducarroz1,
H. Erfkamp33, J. A. Espinàs34, J. Faivre35, L. Faulds Wood36, A. Flugelman37, S. Frkovic-Grazio38, B. Geller39, L. Giordano4,
G. Grazzini40, J. Green20, C. Hamashima41, C. Herrmann26, 42, P. Hewitson20, G. Hoff43,44, I. Holten45, R. Jover46,
M. F. Kaminski47, E. J. Kuipers8, J. Kurtinaitis48,, R. Lambert1, G. Launoy49, W. Lee50, R. Leicester51, M. Leja52, D. Lieber-
man53, T. Lignini1, E. Lucas1, E. Lynge54, S. Mádai55, J. Marinho56,J.Maučec Zakotnik57, G. Minoli58, C. Monk59, A. Mor-
ais60, R. Muwonge1, M. Nadel61, L. Neamtiu62, M. Peris Tuser63, M. Pignone64,C.Pox
65, M. Primic-Zakelj66, J. Psaila32,
L. Rabeneck67, D. Ransohoff64, M. Rasmussen68, J. Regula47, J. Ren26, G. Rennert37,J.Rey
69, R. H. Riddell70, M. Risio71,
V. Rodrigues72, H. Saito41, C. Sauvaget1, A. Scharpantgen73, W. Schmiegel65, C. Senore4, M. Siddiqi74, D. Sighoko26, 75,
R. Smith30, S. Smith76, S. Suchanek77, E. Suonio1, W. Tong78, S. Törnberg79, E. Van Cutsem80, L. Vignatelli81, P. Villain20,
L. Voti26,82, H. Watanabe83, J. Watson20, S. Winawer84, G. Young85, V. Zaksas86, M. Zappa40, R. Valori87
Institutions Institutions are listed at the end of the article.
submitted 10. October 2012
accepted after revision
26. October 2012
Published online: 4.12.2012
Endoscopy 2013; 45: 5159
© Georg Thieme Verlag KG
Stuttgart · New York
ISSN 0013-726X
Corresponding author:
L. von Karsa, MD
Quality Assurance Group,
Early Detection and
Prevention Section
International Agency for
Research on Cancer
150 cours Albert Thomas
69372 Lyon Cedex 08
Fax: +33472738351
European Colorectal Cancer Screening Guidelines Working Group:
Link to the
guideline supplement:
Co-Funded by the
Health Programme of
the European Union
Guidelines 51
According to recent estimates by the International
Agency for Research on Cancer [1], colorectal can-
cer (CRC) is the most common cancer in Europe
with 432 000 new cases reported annually in
men and women combined. It is the second most
common cause of cancer deaths in Europe with
212 000 deaths reported in 2008. Worldwide,
CRC ranks third in incidence and fourth in mortal-
ity with an estimated 1.2 million cases and 0.6
million deaths annually. In the 27 Member States
of the European Union (EU), CRC ranks first in in-
cidence and second in mortality, with approxi-
mately 334 000 new cases and 149 000 deaths es-
timated in 2008.Even in those Member States in
the lower range for age-standardized rates of
CRC, the burden of disease is significantly greater
when compared with many other regions of the
world (see reference [1]). CRC is therefore an im-
portant health problem across the EU.
Screening can be effective in cancer control in po-
pulations with a significant burden of CRC,
provided the services are of high quality [2]. The
aim of CRC screening is to lower the burden of
cancer in the population by discovering disease
in its early, latent stages [3]. Evidence-based
methods permit treatment that is more effective
than if disease is diagnosed later when symptoms
have occurred. Early treatment of invasive lesions,
for example by endoscopic resection of early CRC,
can also be less detrimental for quality of life. The
endoscopic removal of pre-malignant lesions also
reduces the incidence of CRC by avoiding the pro-
gression to cancer. Randomized trials in people of
average risk invited to participate in screening
have shown a reduction in CRC incidence [47]
and mortality [4,7 10].
The EU recommends population-based screening
for breast, cervical and colorectal cancer using
evidence-based methods with quality assurance
of the entire screening process [11]. The EU policy
takes into account the principles of cancer screen-
ing developed by the World Health Organization
[12] and the extensive experience in the EU in pi-
loting and implementing population-based can-
cer screening programmes [13]. Comprehensive
European quality assurance guidelines for breast
and cervical cancer screening have been devel-
von Karsa L et al. Overview: European guidelines for qualit y assurance in CRC screening and diagnosis Endoscopy 2013; 45: 5159
Population-based screening for early detection
and treatment of colorectal cancer (CRC) and pre-
cursor lesions, using evidence-based methods,
can be effective in populations with a significant
burden of the disease provided the services are
of high quality. Multidisciplinary, evidence-based
guidelines for quality assurance in CRC screening
and diagnosis have been developed by experts in
a project co-financed by the European Union. The
450-page guidelines were published in book for-
mat by the European Commission in 2010. They
include 10 chapters and over 250 recommenda-
tions, individually graded according to the
strength of the recommendation and the support-
ing evidence. Adoption of the recommendations
can improve and maintain the quality and effec-
tiveness of an entire screening process, including
identification and invitation of the target popula-
tion, diagnosis and management of the disease
and appropriate surveillance in people with de-
tected lesions. To make the principles, recom-
mendations and standards in the guidelines
known to a wider professional and scientific com-
munity and to facilitate their use in the scientific
literature, the original content is presented in
journal format in an open-access Supplement of
Endoscopy. The editors have prepared the present
overview to inform readers of the comprehensive
scope and content of the guidelines.
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
oped by experts and published by the EU [14,15]. The new Euro-
pean guidelines for quality assurance in colorectal cancer screen-
ing and diagnosis [3, 16 27] make similar principles, standards
and recommendations available to healthcare professionals, sci-
entists, decision-makers and other stakeholders seeking to estab-
lish or improve CRC screening programmes.
The content of the evidence-based multidisciplinary guidelines is
presented in 13 articles in a recent Supplement to Endoscopy.
Each article covers one of the 10 chapters of the guidelines [3,
1624], the annex of the chapter dealing with quality assurance
in pathology [25], the section on principles of evidence assess-
ment and methods for reaching recommendations [28], or the
executive summary [26]. The results section of each chapter arti-
cle begins with a list of key recommendations with a dual grading
showing the strength of each recommendation and the support-
ing evidence. The annotation of each recommendation also indi-
cates the places in the text where the evidence pertaining to each
recommendation is explained, including cross-references to
other chapters. This enables the reader to rapidly review the key
content of the guidelines and to identify places in the volume
likely to be of interest for further reading. In total, 750 references
are cited and more than 250 graded recommendations are ex-
plained. In addition, some statements of advisory character con-
sidered to be good practice but not sufficiently important to war-
rant formal grading are provided in each chapter.
The guidelines address the quality issues in screening of the aver-
age-risk population in which most CRC develops. Given the mod-
erate geographic variation in the population risk of CRC across
the EU [1], no attempt was made to develop recommendations
tailored to people with moderate risk due to family history of
CRC. However, people identified with a family history of CRC,
but not presenting with a hereditary syndrome should be inclu-
ded in the average-risk screening; see Chapter 2 [16]. High-risk
individuals should be referred for alternative and more intensive
protocols if those are available. The potential benefit and harm of
screening recommendations tailored to people with a family his-
tory should be examined in greater depth in the preparation of
the next edition of the EU guidelines.
The methods used in developing the guidelines are described in
greater detail elsewhere [28, 29]. Briefly, a multidisciplinar y
group of authors and editors experienced in quality assurance in
CRC screening, programme implementation and guideline devel-
opment collaborated with a literature groupconsisting of epide-
miologists with special expertise in the field of CRC and in sys-
tematic literature review. The literature groupsystematically re-
trieved, evaluated and synthesized relevant publications accord-
ing to clinical questions defined by the authors and editors. Bib-
liographic searches were performed using MeSH terms and free-
text words. For most clinical questions searches were limited to
the years 2000 to 2008 and were performed on Medline, and in
many cases also on Embase and the Cochrane library databases.
Additional searches were conducted without date restrictions or
starting before 2000 if the authors or editors who were experts in
the field knew that there were relevant articles published before
2000. Articles of adequate quality recommended by authors be-
cause of their clinical relevance were also included. In selected
cases references not identified by the literature groupwere in-
cluded in the evidence base, i. e., when authors found relevant ar-
ticles published after 2008 during the period up to October 2010
when the chapter manuscripts were drafted and revised prior to
publication. The methodological quality of the retrieved publica-
tions was assessed using the criteria obtained from published
and validated checklists [30 35]. Preliminary versions of the
draft guidelines were repeatedly reviewed and revised through
multidisciplinary meetings attended by the authors, editors and
the literature group, as well as in pan-European network meet-
ings with participants from all of the 27 EU Member States. Prior
to finalization of the guidelines, all of the chapters except the in-
troduction were reviewed by external experts from Australia, Ca-
nada, France, Japan, Norway, Poland, Switzerland, the United
Kingdom and the United States of America.
An extensive body of scientific evidence was systematically col-
lected and reviewed in the preparation of the guidelines. Ap-
proximately two years have passed since work on the first edit ion
was completed and knowledge in the field of CRC screening con-
tinues to expand. In our appraisal, more recent literature would
justify revision of the grading of the evidence for some recom-
mendations, and in some cases the strength of a recommenda-
tion could be increased. A continuous update of the scientific evi-
dence on colorectal cancer screening is therefore needed in order
to provide timely changes to the recommendations on quality as-
surance for colorectal cancer screening.
The authors and editors welcome comments, suggestions and re-
porting of any errors noticed by the reader. They are a valuable
source of information for preparation of the next guidelines edi-
Overview of the guidelines content
Throughout the text emphasis is placed on best practice at each
step in the multidisciplinary screening process. The guidance in-
cludes both methods for avoiding and practical approaches to
solving medical, organizational and technical problems in the se-
lection and use of faecal occult blood tests, in endoscopy for diag-
nosis or screening, in pathology, and in the clinical management
and surveillance of people with lesions detected in screening.
Cross-cutting themes, such as communication, documentation,
evaluation and training, that are crucial to ensuring high quality
in the provision of screening services are also covered. The nu-
merous guiding principles, evidence-based recommendations
and conclusions presented in the guidelines cannot all be pres-
ented here. The following points are highlighted to illustrate the
scope and depth of the first edition.
Evidence for the effectiveness of CRC screening
The first chapter presents the evidence that was available in late
2010 for the effectiveness and costeffectiveness of CRC screen-
ing and for key operational parameters such as age range, inter val
between two negative screening examinations and some combi-
nations of tests [3]. The 17 graded recommendations and conclu-
sions reflect the large body of evidence on the primary screening
method that is recommended by the EU (faecal occult blood test-
ing, FOBT) [11]. Most of the FOBT randomized trials were per-
formed with guaiac-based tests, but the EU guidelines confirm
that faecal immunochemical testing (FIT) also fulfils the require-
ments of the EU for primary screening [3, 11]. At the time of the
original publication, reasonable evidence for the efficacy of flex-
ible sigmoidoscopy screening was available from a large random-
ized trial, and there was limited evidence for the efficacy of colo-
noscopy screening. There is now good evidence from large ran-
domized trials involving over 300 000 men and women that
screening with flexible sigmoidoscopy can substantially reduce
colorectal cancer incidence [4, 6, 7] and mortality [4, 7].
von Karsa L et al. Overview: European guidelines for qualit y assurance in CRC screening and diagnosis Endoscopy 2013; 45: 5159
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Organization of a colorectal screening programme
The 29 recommendations and conclusions in the second chapter
cover the key organizational aspects that influence the quality
and effectiveness of a CRC screening programme [16]. They re-
flect the broad consensus in the EU on the fundamental principle
that a CRC screening programme is a multidisciplinary process.
The effectiveness of a programme is a function of the quality of
each of the individual components of the process. Organized
screening as opposed to spontaneous case-finding is essential to
achieve and maintain appropriate quality.
The provision of a screening service must take into account the
values and preferences of individuals concerned as well as public
health considerations. The public health perspective in the plan-
ning and provision of screening services requires commitment to
ensuring equity of access and sustainability of the programme
over time. Adequate consideration for the perspective of the indi-
vidual requires commitment to promoting informed participa-
tion and to providing a high-quality, safe service.
Successful implementation of a screening programme entails
more than simply carrying out the screening tests and referring
individuals to assessment where indicated. Specific protocols
such as those used in call and recall systems must be developed
for identifying and inviting the target population to attend
screening or assessment of screen-detected abnormalities, and
for monitoring cause of death. Protocols are also required for pa-
tient management in the diagnosis, treatment and surveillance
phases to ensure that all individuals have timely access to appro-
priate diagnostic and treatment options. In addition, irrespective
of the organizational approach, political and financial support is
crucial to the successful implementation of any screening pro-
Evaluation and interpretation of screening outcomes
The third chapter contains 20 graded recommendations on the
processes and procedures required for effective monitoring and
evaluation of CRC screening programmes [17]. Of fundamental
importance is the complete and accurate recording of all relevant
data on each individual and every screening test performed. This
includes both the information needed for the invitation system,
which is best provided by an accurate population database, as
well as individual test results, further diagnostic procedures and
the final outcome of screening, and serious adverse effects. CRC
incidence and mortality must be monitored and comprehensive
systems must be developed to document the screening process,
monitor data completeness and quality, and accurately compile
and report results. Key measures, indicators and standards for
monitoring programme performance and evaluating screening
impact are recommended, some of which require linkage of
screening data with data from other sources, such as cancer re-
gistries. The standards are based on an overview of performance
measures available from published trial results and population-
based screening programmes.
Performance indicators are essential for the supervision of a pro-
gramme and for the provision of regular information to decision
makers. The authors stress the importance of incorporating eval-
uation of the programme into the protocols adopted for the
screening process before screening begins. This should ensure
that the evaluation components are implemented from the very
start of the programme.
Faecal occult blood testing
The fourth chapter includes 21 detailed recommendations con-
cerning the design, application and selection of appropriate
FOBTs in CRC screening [18]. The ideal biochemical test for popu-
lation screening of CRC would use a biomarker, specific and sen-
sitive for cancer and advanced pre-cancer, with an easily collec-
ted sample that could be safely and cheaply transported to a cen-
tralized laboratory for accurate, reproducible and inexpensive
automated analysis. Although none of the currently available
tests are ideal, the faecal immunochemical test (FIT) for haemo-
globin and the guaiac-based faecal occult blood test (gFOBT) for
men and women aged 50 74 years fulfil the criteria for screen-
ing recommended by the Council of the EU.
Immunochemical tests have improved test characteristics com-
pared with conventional guaiac-based tests. They are both analy-
tically and clinically more sensitive and specific for the detection
of haemoglobin. Their measurement can be automated and the
user can determine the concentration at which a result is desig-
nated positive. By changing the designated cut-offconcentra-
tion, the proportion of false-positive tests and the number of co-
lonoscopies performed can be adjusted to meet local require-
ments. Quantitative immunochemical tests are currently the test
of choice for population screening; however, individual device
characteristics, including ease of use by the participant and la-
boratory, suitability for transport, sampling reproducibility and
sample stability are all important when selecting the FIT most
appropriate for an individual screening programme.
Guaiac-based FOBTs have proven characteristics that make them
suitable for population screening. However, they lack the specifi-
city and sensitivity of immunochemical tests for the detection of
haemoglobin, their analysis cannot be automated and the con-
centration at which they turn from negative to positive cannot
be adjusted by the user. For these reasons guaiac-based tests are
not the preferred test for new population screening programmes,
although, depending on local labour costs, the mechanism of kit
distribution and collection and the reduced sample stability in
immunochemical tests, they might prove more practicable and
affordable than immunochemical testing.
The authors and editors of the EU guidelines also stress the im-
portance of centralized laboratory processing of screening tests
and participation in laboratory external quality assurance
Quality assurance of endoscopy in CRC screening
and diagnosis
A comprehensive view of the many-faceted aspects of quality as-
surance of endoscopy used for follow-up examinations as well as
for primary screening is presented in Chapter 5 [19]. The com-
plexity of the subject is reflected by the comparatively large
number of specific recommendations (50 in total) that deal with
planning and location of endoscopic services, infrastructure and
equipment, preparation of the patient and aftercare, endoscopic
technique, endoscopistsperformance, quality improvement, po-
licies and processes. Provision of the service must take into ac-
count the perspectives of endoscopists and public health to en-
sure that the experience is high-quality, safe and efficient as
well as people-oriented. Furthermore, historic development
within different local and cultural contexts should be taken into
account. The organization of the chapter reflects the patient jour-
ney through screening and follow-up.This approach reflects the
consensus of the authors and editors that screening and sympto-
matic (diagnostic) services should achieve the same minimum
von Karsa L et al. Overview: European guidelines for qualit y assurance in CRC screening and diagnosis Endoscopy 2013; 45: 5159
Guidelines 53
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levels of quality and safety. Wherever possible, the quality assur-
ance required for screening should have an enhancing effect on
the quality of endoscopy performed for symptomatic patients.
All people undergoing endoscopy, whether for primary screen-
ing, for assessment of abnormalities detected through screening,
for assessment of symptoms or for surveillance, should have as
good an experience as possible. They should be confident enough
in the quality of the procedure developed to be able to recom-
mend screening, assessment and surveillance of appropriate
quality to their friends, family and colleagues.
Professional requirements and training
The 23 graded recommendations in Chapter 6 deal with profes-
sional and other requirements for screening staff [20]. Special
training of the multidisciplinary team that is involved in the
screening programme is required. The team includes administra-
tive and clerical staff, epidemiologists, laboratory staff, primary
care physicians, endoscopists, radiologists, pathologists, sur-
geons, nurses and public health specialists.
All staff involved in the delivery of a CRC screening programme
should know the basic principles of CRC screening. The need for
specialist training in screening differs between the various disci-
plines and is most important for those involved in the planning
and delivery of the service and diagnosis, e.g. epidemiologists,
laboratory staff, endoscopists, radiologists, pathologists and
Quality assurance in pathology in CRC
screening and diagnosis
The pathology service plays a crucial role in CRC screening be-
cause the clinical and subsequent management of participants
in the programme depends on the quality and accuracy of the di-
agnosis. Pathology affects the decision to undergo further local
and/or major resection as well as surveillance after screening.
Chapter 7 contains 23 graded recommendations for pathology,
concentrating on areas of clinical importance within a screening
programme [21]. The associated annex discusses some of the
more difficult areas and suggests topics for future research. The
authors recognize that this is the first edition of what will be a
continuing process of revision as new data emerge on the pathol-
ogy, screening and management of CRC. It is also hoped that by
setting minimum standards, these will be followed in all pro-
grammes and hence encourage the development of higher stand-
ards amongst the pathology community and screening pro-
grammes. Guidelines for the reporting and management of re-
sected specimens have been included in an attempt to also
move towards agreed minimum European standards of patholo-
gy in these areas. This will improve the clinical relevance of infor-
mation obtained through evaluation and monitoring and should
also facilitate the exchange of information and experience be-
tween programmes by making data and results more compar-
The authors and editors of the EU guidelines also stress the im-
portance of participation in external quality assurance schemes
for pathology services.
Management of lesions detected in CRC screening
The screening process can only be successful if timely and appro-
priate management follows early detection of lesions. Chapter 8
contains 32 graded recommendations on management of lesions
detected in CRC screening [22]. In essence, the management of
screen-detected adenomas and carcinomas does not differ, stage
for stage, from that required for symptomatic disease. However,
screening detects a different spectrum of disease compared with
that diagnosed in the symptomatic population (i. e., there is a
higher proportion of early disease). Some considerations in the
management of screen-detected disease are therefore empha-
sized in this chapter of the guidelines.
Of prime importance is the wide consensus on the principle that
colorectal neoplasia is best managed by a multidisciplinary team.
The relevant disciplines include surgery, endoscopy, pathology,
radiology, radiotherapy, medical oncology, specialist nursing, ge-
netics and palliative care [36]; these should work in close colla-
boration with primary care. Furthermore, it is recognized that
the interval between the diagnosis of screen-detected disease
and the start of definitive management is a time of anxiety for
the patient and, if prolonged, presents the opportunity for dis-
ease progression. For these reasons, standards have been set
which aim at minimizing delay [37]. Also of relevance in this re-
gard is the recognition that colonoscopy is not merely a diagnos-
tic procedure, but has therapeutic capacity [38], and it is essential
that the endoscopist carrying out screening colonoscopy has the
necessary expertise to remove all but the most demanding le-
Colonoscopic surveillance following adenoma removal
The primary aims of colonoscopic surveillance are to reduce the
morbidity and mortality from CRC by removing high-risk adeno-
mas before they have had a chance to become malignant and by
detecting invasive cancers at an early, curable stage. However, co-
lonoscopy is a costly, invasive and scarce resource and should be
undertaken only in people at increased risk, and at the lowest fre-
quency deemed adequate to provide protection against the de-
velopment of cancer. If colonoscopy surveillance is undertaken,
it should be performed to the highest standard.
Chapter 9 includes 24 graded recommendations dealing with
surveillance after removal of adenomas and a comprehensive
strategy suitable for surveillance of patients attending screening
programmes anywhere in the EU [23]. The recommendations re-
flect the fact that patients with previous adenomas are at in-
creased risk for recurrent adenomas and hence CRC. The risk is
thought to be linked to the number, size and histological grade
of adenomas found and removed during baseline colonoscopy.
On this basis, patients can be divided into low-, intermediate-
and high-risk groups, and the interval to the first follow-up ex-
amination can vary accordingly. A reassessment can be made
based on findings at the first and subsequent follow-up examina-
tions. The risk stratification is predicated on an assumption that
the initial and subsequent colonoscopies are of high quality and
that there is complete removal of any detected lesions. The indi-
cation and interval for surveillance is determined primarily by
the presumed risk for recurrence of advanced adenomas and can-
cer, but also by age, co-morbidity and patient wishes.
Because surveillance colonoscopy consumes considerable resour-
ces, countries that have difficulty meeting the demand might not
be able to sustain reasonable waiting times. Screening pro-
grammes should therefore have a policy on surveillance with a
hierarchy of action for different risk groups based on resource
availability. The policy may limit surveillance to the high-risk
group if sufficient resources are not available to include people
with lower risk.
von Karsa L et al. Overview: European guidelines for qualit y assurance in CRC screening and diagnosis Endoscopy 2013; 45: 5159
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Chapter 10 provides 35 recommendations dealing with commu-
nication [24]. CRC screening programmes can only be successful
if they ensure that as many people as possible in the target popu-
lation receive the relevant information to enable them to make
an informed decision about attending screening. People using
CRC screening services should receive accurate and accessible in-
formation, based on the most recent available evidence about the
test proposed and its potential contribution to reduce illness, as
well as information about potential risks, side-effects and limita-
tions. Achieving this goal is challenging, because of the complex-
ity of CRC screening programmes compared with other estab-
lished programmes such as breast cancer or cervical cancer
screening. This complexity may be an additional cause of anxiety
for participants and therefore needs to be addressed in the com-
munication strategy. People invited to screening therefore also
need specific and clear instructions on how to use the FOBT kit
or perform the bowel cleansing procedure.
The recommendations include information strategies, tools and
interventions that can be used in current or future CRC screening
programmes. They provide guidance specifically for screening
programmes based on the FOBT, which is also the most frequent-
ly used test in programmes implemented in the EU. However,
most of the recommendations can also be applied to pro-
grammes based on other tests.
Performance standards
Numerous measures, indicators and standards of performance
are provided in the chapters dealing with evaluation and inter-
pretation of screening outcomes [17], and quality assurance of
endoscopy [19] and pathology [21] in CRC screening and diagno-
sis. The extensive consensus documented in the guidelines on
relevant definitions and standards was facilitated by discussions
in the International Colorectal Cancer Screening Network that
demonstrated the need for further progress in programme mon-
itoring and evaluation [39]. The executive summary includes a ta-
ble of the performance standards [26]. All targets should be con-
stantly reviewed in the light of experience and revised according-
ly with regard to results achieved and best clinical practice. As far
as possible, the targets given refer to men a nd women aged 50
74 years invited to and/or attending a CRC screening programme.
Quality assurance aims to ensure that an endeavour leads to the
outcome for which it is intended. This principle also applies to
complex systems, such as screening programmes designed to
lower the burden of colorectal cancer (CRC) in the population.
Over 100 million men and women in the European Union (EU)
are in the age range currently recommended by the Council of
the EU for CRC screening (5074 years). By 2007, CRC screening
programmes were running or being established in 12 EU coun-
tries [13, 40]. Since then, screening programmes have been ex-
panded or initiated in several EU countries. At any given time,
only a relatively small proportion of those attending screening
will have latent disease and can therefore directly benefit from
early detection and treatment, However, all participants are ex-
posed to the risks of screening such as anxiety and morbidity
due to false-positive screening results, and the risk of invasive
procedures for detection and/or removal of suspicious colorectal
tissue. Although the risks may be slight, they add up in the large
number of people exposed to screening. Effective quality assur-
ance ensures that the balance between the collective risk and
the achieved benefit remains acceptable.
Experience gained from piloting and implementing numerous
cancer screening programmes in the EU confirms the well-
known observation that overall screening outcome depends on
the level of performance at each step in the process of screening
[3,13 16, 41 43]; see also [44]. To maximize the benefit and
minimize the risk of CRC screening, quality must be optimal
throughout the process, and that includes the identification and
personal invitation of the target population, the performance of
the screening test and, if necessary, the diagnostic work-up of
screen-detected lesions, and treatment, surveillance and after-
care [2,3].
Implementation of organized screening programmes, as opposed
to opportunisticcase-finding is recommended because they in-
clude an administrative structure responsible for service deliv-
ery, quality assurance and evaluation. Population-based pro-
grammes generally require a high degree of organization in order
to identify and personally invite each person in the eligible target
population. Personal invitation aims to give each eligible person
an equal chance of benefiting from screening and thereby reduce
health inequalities. As with evidence-based screening for breast
or cervical cancer, the population-based approach to programme
implementation is also recommended for CRC screening because
it provides an organizational framework conducive to effective
management and continuous improvement of the screening pro-
cess, such as through linkage with population and cancer regis-
tries for optimization of invitation to screening and for evaluation
of screening performance and impact [3, 1317]. Nationwide im-
plementation of population-based screening programmes makes
services performing to high standards available to the entire pop-
ulation eligible to attend screening. Large numbers of profession-
als undertake further specialization in order to meet the screen-
ing standards. Consequently, these nationwide efforts also con-
tribute to widespread improvement in diagnosis and manage-
ment of symptomatic disease [2, 3, 13].
A number of internationally recognized guidelines and recom-
mendations for best practice in CRC screening have been pub-
lished elsewhere in recent years [45 52]. Numerous screening
programmes, or scientific societies in their respective countries,
have developed or recommended evidence-based guidelines
and standards dealing with key elements of the screening pro-
cess; see for example [53 57]. The EU guidelines are unique,
however, because of their broad scope and detail and because
they do not focus on indicating which methods can be recom-
mended for screening. Although faecal occult blood testing for
men and women in the age range 50 74 years is the only CRC
screening method currently recommended by the EU [11], the
European guidelines do not indicate a preference for this or any
other method for use in CRC screening. Instead they provide
comprehensive guiding principles and detailed, evidence-based
recommendations on quality assurance that should be followed
when implementing the screening methods currently employed
in publicly mandated programmes in EU countries (FOBT, flexible
sigmoidoscopy and colonoscopy).
The new EU guidelines are the first internationally developed,
evidence-based, comprehensive guidelines dealing with the en-
tire process of CRC screening. While all of the innovative ele-
ments in the new EU screening guidelines cannot be mentioned
here, a few examples show how recent developments have been
taken into account.
von Karsa L et al. Overview: European guidelines for qualit y assurance in CRC screening and diagnosis Endoscopy 2013; 45: 5159
Guidelines 55
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Differing levels of endoscopist competence have implications for
planning the location of endoscopy services for a CRC screening
programme, and this is one of the many new elements in the
chapter dealing with quality assurance in endoscopy; see Chapter
5 [19].
The inclusion of recommendations dealing with non-polypoid
colorectal lesions and serrated lesions, some of which are diffi-
cult to detect due to their non-polypoid morphology, is another
innovative aspect of the guidelines; see Chapter 7 [21] and the
annex to Chapter 7 [25]. Although the existence of these lesions
had been reported earlier, their appreciable prevalence and po-
tential significance in diagnosis and management of CRC attrac-
ted attention in the western literature during the development
of the EU guidelines [58, 59]. Sessile ser rated lesions are often
found in the proximal colon [25]. In a non-population-based
screening setting in North America, interval cancers have been
associated with proximal location and molecular traits, such as
CpG island methylation phenotype (CIMP) [60], that occur in
most sessile serrated lesions and traditional serrated adenomas
[25]. Under-detection of non-polypoid and serrated lesions may
therefore play a role in study results that have not shown a pro-
tective effect of colonoscopy against CRC mortality in the right
colon [61, 62]. The international discussions on the significance
of these lesions, during the development of the guidelines, stim-
ulated further efforts to clarify appropriate methods of histologic
reporting and clinical management [59] and led to related re-
commendations in the guidelines [21, 25]. Since then, recent
findings at two academic endoscopy units in North America
have indicated that the prevalence of proximal colon serrated le-
sions in patients undergoing screening colonoscopy in a clinical
setting may be higher than previously reported [63] and a signif-
icant proportion of proximal serrated lesions may be missed dur-
ing colonoscopy [64]. Interval cancers have also been associated
with proximal location in a population-based screening setting
in Europe [65]. These findings also illustrate the importance of
the recommendations in the guidelines for routine documenta-
tion of the morphology and topography of lesions detected in
CRC screening [19, 21].
The European guidelines also include the first comprehensive
classification for the histology of lesions detected in CRC screen-
ing; that is applicable worldwide; see Chapter 7, Table7.1 [21]. A
selection of images and digital slides showing the histopathology
of lesions commonly detected in screening programmes, as well
as some images illustrating pitfalls in histopathological interpre-
tation, has also been established [66]. This depository for instruc-
tive images will facilitate the exchange of experience between
programmes and professionals within and beyond the borders
of the EU.
Another example of the innovative character of the new EU
guidelines is the first European protocol for surveillance of peo-
ple found to be at elevated risk for development of CRC because
of detection of adenomas at screening; see Chapter 9 [23]. Gui-
dance on surveillance was deemed to be important by the editors
and authors because surveillance on an inappropriate scale has
the potential to expose patients to unnecessary risks and to pro-
hibit implementation of nationwide CRC screening programmes
because of unnecessary consumption of limited colonoscopy re-
sources; see also [45, 67].
The detailed recommendations on communication, particularly
on the essential elements to be included in invitation letters and
information brochures for CRC screening, are an additional re-
source in the guidelines that can help to lower barriers to partici-
pation and thereby help to make high quality screening available
to all EU citizens; see Chapter 10 [24].
The comprehensive recommendations in the European guide-
lines are based on an extensive body of evidence; nevertheless,
any aspect in the process of CRC screening could be improved
through additional research and further exchange of experience
between countries, programmes and other stakeholders. The au-
thors, editors, contributors and reviewers who have participated
in the development of the first edition of the guidelines therefore
recommend that these efforts continue and that the evidence
base and content of the guidelines is continuously updated. But
keeping recommendations up to date is no guarantee that they
will be followed or that effective CRC screening programmes
will be implemented where they are needed. A number of cr iteria
for successful implementation of cancer screening programmes
have been identified in the chapter on organization [16]. This is
an important area in which knowledge is expanding [68 71]
and should be further developed to make effective use of CRC
screening as a tool of cancer control.
In a state-of-the-art process, wide consensus has been achieved
on a comprehensive package of evidence-based recommenda-
tions for quality assurance in CRC screening in the EU. Given the
universally applicable guiding principles on which the guidelines
are based and the broad spectrum of cultural and economic
health care settings in the EU, the recommendations are relevant
to any country or region with a burden of disease appropriate for
screening in the coming years. Application of the recommenda-
tions and standards in these guidelines will facilitate quality
management and promote the international exchange of infor-
mation and experience between programmes that is essential
for continuous quality improvement. Over time this will help to
prevent deaths due to CRC and will improve the quality of life of
many of the millions of people potentially affected by one of the
most common cancers in Europe and the world.
It would be short-sighted, however, to assume that all of the
problems of quality assurance in CRC screening and diagnosis
have been solved. Coordinated additional resources are required
for continuous updating of the evidence-based recommenda-
tions and standards, including resources for additional research
and collaboration between countries, regions and programmes
in implementation of the guidelines. Resources are also needed
for capacity building in screening, diagnosis and therapy of CRC,
to reduce waiting times. Appropriate political commitment and
investment at an early stage is likely to save considerable resour-
ces later on, when the full impact of these improvements will be-
come discernible.
The activities described in this publication were co-funded by the
European Union through the EU Public Health Programme (grant
agreement no. 2005317: Development of European Guidelines
for Quality Assurance of Colorectal Cancer Screening). Co-fund-
ing in the framework of the grant agreement was also provided
by the following partner institutions: Oxford University Cancer
Screening Research Unit, Cancer Epidemiology Unit, University
of Oxford, Oxford, United Kingdom; Unit of Cancer Epidemiology,
von Karsa L et al. Overview: European guidelines for qualit y assurance in CRC screening and diagnosis Endoscopy 2013; 45: 5159
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Centre for Cancer Epidemiology and Prevention, CPO Piemonte,
AO Città della Salute e della Scienza di Torino, Turin, Italy; Public
Association for Healthy People, Budapest, Hungary; European
Cancer Patient Coalition (ECPC), Utrecht, Netherlands; Quality
Assurance and Screening Groups, Section of Early Detection and
Prevention, International Agency for Research on Cancer, Lyon,
France. Additional financial support was received from the Public
Affairs Committee of the United European Gastroenterology Fed-
eration, and from a cooperative agreement between the Ameri-
can Cancer Society and the Division of Cancer Prevention and
Control at the Centers for Disease Control and Prevention, Atlan-
ta, Georgia, United States of America.
The views expressed in this document are those of the authors
and do not necessarily represent the official position of the Euro-
pean Commission or the Centers for Disease Control and Preven-
tion. Neither the European Commission nor any other organisa-
tion, or person can be held responsible for any use that may be
made of the information in this document.
Competing interests: Dr. Wendy Atkin has received significant
non-monetary research support from Eiken Chemicals for re-
agents and machine lease for processing immunochemical faecal
occult blood tests. The support is ongoing and will total less than
£80 000.Dr Hermann Brenner is employed by The German Can-
cer Research Center (DKFZ) that has received significant research
support from Eiken Chemicals (less than 40 000) for previously
and currently running studies on colorectal cancer detection. The
following companies have provided the DKFZ with faecal occult
blood tests free of charge for previously and currently running
evaluation studies: ulti med, Ahrensburg, Germany; DIMA, Got-
tingen, Germany; Beckman Coulter, Krefeld, Germany; CARE-
diagnostica, Voerde, Germany; Preventis, Bensheim, Germany;
Quidel, San Diego, California. The total value of the non-monetary
support is less than 100 000. The German Cancer Research Cen-
ter (DKFZ) has received significant research support from Epige-
nomics (less than 125 000).Dr Michael Bretthauers research
unit at the Oslo University Hospital has received research grants
and non-monetary research support of less than 25 000from
the companies Olympus and Falk.Dr David Liebermann has
served on the advisory board of Exact Sciences. He received less
than 3000for this activity to date.Dr Christian Pox has received
lecture honoraria and travel support of less than 9000from the
following manufacturers of pharmaceuticals, diagnostics, medi-
cal equipment and other health products: Dr Falk Pharma, Hita-
chi and Roche. He has also received consultancy fees of 1500for
attending an Advisory Board Meeting of the Abbot company, a
broad-based health care manufacturer, and 2100from the
AQUA Institute, Germany, a private entity dedicated to quality as-
surance research and implementation that is mandated by the
Federal Committee of the German Statutory Health Insurance
System to implement a nationwide quality assurance scheme.Dr
Wolff Schmiegel is the holder of one patent and the co-holder of
three patents covering technologies related to screening and di-
agnosis of colorectal tumours. He is also co-holder of a patent
covering substances potentially suitable for prevention and treat-
ment of colorectal polyps. He has received consultancy fees of
less than 2000from Astra Zeneca and consultancy fees, lecture
honoraria and travel support totalling less than 16 000from
Roche. He has also received lecture honoraria from Abbott, Pfizer
and Falk. The Medical Faculty of the Ruhr University in Germany
where he works has received institutional research funding of
less than 160 000from Roche and the pharmaceutical manufac-
turer Sanofi Aventis for studies in colorectal cancer screening and
diagnosis.Dr Schmiegel is the sole shareholder (25 000) of Med-
motive GmbH, a holding that until 2010 controlled 25 % of the
company Westdeutsches Darm-Centrum GmbH with a capital in-
vestment of 25 000. The aim of these companies is to develop
and coordinate a quality-assured network in colorectal oncology
through such activities as consulting, development of therapeutic
standards, specialized training and lobbying key stakeholders.Dr
Schmiegel has received consultancy fees of less than 15 000
from Amgen, Apceth, Astra Zeneca, Merck and Roche.Dr Nereo
Segnan has received consultancy fees of less than 1500from
Roche Diagnostics Ltd for his participation at an Advisory Board
Meeting on CRC screening.Dr Graeme Young has received consul-
tancy fees (less than 10 000) from Quidel Corporation, a manu-
facturer of diagnostic products. Eiken Chemicals has provided
Flinders University where he works with faecal occult blood tests
free of charge for studies (total value less than 10 000).
1International Agency for Research on Cancer, Lyon, France
2NHS Cancer Screening Programmes Sheffield, United Kingdom
3Oxford University Cancer Screening Research Unit, Cancer Epidemiology Unit,
University of Oxford, Oxford, United Kingdom
4CPO Piemonte, AO Città della Salute e della Scienza di Torino, Turin Italy
5Imperial College London, London, United Kingdom
6Bowel Cancer Screening Southern Programme Hub, Royal Surrey County
Hospital NHS Foundation Trust, Guildford, United Kingdom
7University of Surrey, Guildford, United Kingdom
8Erasmus MC, Rotterdam, the Netherlands
9Finnish Cancer Registry, Helsinki, Finland
10 The Institute of Cancer Research, Royal Cancer Hospital, Sutton, United
11 Leeds Institute of Molecular Medicine, St JamesUniversity Hospital, Leeds,
United Kingdom
12 Ninewells Hospital and Medical School, Dundee, United Kingdom
13 Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany
14 Department of Medical Gastroenterology, Stavanger University Hospital,
Stavanger, Norway
15 Central Research Institute of Ambulatory Health Care, Berlin, Germany
16 Direction Générale de la Santé, Paris, France
17 Croatian National Institute of Public Health, Zagreb, Croatia
18 University of Zagreb School of Medicine, Zagreb, Croatia
19 CONICET/CEDES, Buenos Aires, Argentina
20 University of Oxford, Oxford, United Kingdom
21 Mario Negri Institute for Pharmacological Research, Milan, Italy
22 Karolinska Institutet, Stockholm, Sweden
23 German Cancer Research Center, Heidelberg, Germany
24 Institute of Health and Society, University of Oslo, Oslo, Norway
25 National Cancer Registry, Cork, Ireland
26 Formerly International Agency for Research on Cancer, Lyon, France
27 A. Gemelli University Hospital, Rome, Italy
28 Wolfson Institute of Preventive Medicine, Queen Mary University of London,
United Kingdom
29 Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing,
30 American Cancer Society, Atlanta, Georgia, United States of America
31 Academic Medical Centre, Amsterdam, the Netherlands
32 National Health Screening Services, Ministr y of Health, Elderly & Community
Care, Valletta, Malta
33 University of Applied Sciences FH Joanneum, Graz, Austria
34 Catalan Cancer Strategy, LHospitalet de Llobregat, Spain
35 Digestive Cancer Registry of Burgundy, INSERM U866, University and CHU,
Dijon, France
36 Lynns Bowel Cancer Campaign, Twickenham, United Kingdom
37 National Israeli Breast and Colorectal Cancer Detection, Haifa, Israel
38 Department of Gynecological Pathology and Cytology, University Medical
Center Ljubljana, Slovenia
39 University of Vermont, Burlington, Vermont, United States of America
40 Cancer Prevention and Research Institute (ISPO), Florence, Italy
41 National Cancer Centre, Tokyo, Japan
42 Cancer League of Eastern Switzerland, St. Gallen, Switzerland
von Karsa L et al. Overview: European guidelines for qualit y assurance in CRC screening and diagnosis Endoscopy 2013; 45: 5159
Guidelines 57
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
43 Cancer Registry of Norway, Oslo, Norway
44 Telemark Hospital, Skien, Norway
45 Danish Cancer Society, Copenhagen, Denmark
46 Hospital General Universitario de Alicante, Alicante, Spain
47 Maria Sklodowska-Curie Memorial Cancer Centre and Medical Centre
for Postgraduate Education, Warsaw, Poland
48 Lithuanian Cancer Registry, Vilnius, Lithuania
49 U1086 INSERM UCBN, CHU Caen, France
50 The Catholic University of Korea College of Medicine, Seoul, Republic
of Korea
51 St. Georges Hospital, London, United Kingdom
52 University of Latvia, Riga, Latvia
53 Oregon Health & Science University, Portland, Oregon, United States of
54 University of Copenhagen, Copenhagen, Denmark
55 MaMMa Healthcare Institute, Budapest, Hungary
56 Health Administration Central Region Portugal, Aveiro, Portugal
57 National Public Health Institute, Ljubljana, Slovenia
58 Gastroenterology Unit, Valduce Hospital, Como, Italy
59 GlaxoSmithKline Pharma Europe, London, United Kingdom
60 Regional Health Administration, Coimbra, Portugal
61 Centers for Disease Control and Prevention, Atlanta, Georgia, United States
of America
62 Prof. Dr Ion Chiricuţă, Cluj-Napoca, Romania
63 Catalan Institute of Oncology, LHospitalet de Llobregat, Spain
64 University of North Carolina, Chapel Hill, North Carolina, United States of
65 Ruhr Universität, Bochum, Germany
66 Epidemiology and Cancer Registry, Institute of Oncology Ljubljana, Slovenia
67 University of Toronto and Cancer Care Ontario, Toronto, Canada
68 Bispebjerg University Hospital, Copenhagen, Denmark
69 Institut Arnault Tzanck, St Laurent du Var, France
70 Mount Sinai Hospital, Toronto, Canada
71 Institute for Cancer Research and Treatment, Candiolo-Torino, Italy
72 Faculdade de Medicina Universidade de Coimbra, Coimbra, Portugal
73 Ministry of Health, Luxembourg, Luxembourg
74 Cancer Foundation of India, Kolkata, India
75 The University of Chicago, Department of Medicine, HematologyOncology
Section, Center for Clinical Cancer Genetics, Global Health, Chicago, United
States of America
76 University Hospitals Coventry & Warwickshire NHS Trust, Coventry, United
77 Charles University and Military Universit y Hospital, Prague, Czech Republic
78 Chinese Academy of Medical Sciences, Beijing, China
79 Department of Cancer Screening, Stockholm Gotland Regional Cancer
Centre, Stockholm, Sweden
80 University of Leuven, Leuven, Belgium
81 Agenzia Sanitaria e Sociale RegionaleRegione Emilia-Romagna, Bologna,
82 University of Miami, Miami, Florida, United States of America
83 Niigata University, Niigata, Japan
84 Memorial SloanKettering Cancer Center, New York, United States of
85 Gastrointestinal Services, Flinders University, Adelaide, Australia
86 State Patient Fund, Vilnius, Lithuania
87 NHS Endoscopy, Leicester, United Kingdom
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Guidelines 59
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... NORCCAP research demonstrated benefits of CO2 gas insufflation rather than using standard air. This was instrumental for the EU Commission Guidelines in 2010 recommending CO2 insufflation during colonoscopy [21]. A major benefit of CO2 insufflation is reduced pain and discomfort after the examination. ...
... early intervention. On average, this approach is assumed to lead to a better prognosis, as well as to fewer and less severe side effects of treatment [2][3][4][5]. In the Netherlands, the screening tests of the CSPs are offered free of charge by the government to all citizens of a specific age and gender. ...
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Background The Netherlands hosts, as many other European countries, three population-based cancer screening programmes (CSPs). The overall uptake among these CSPs is high, but has decreased over recent years. Especially in highly urbanized regions the uptake rates tend to fall below the minimal effective rate of 70% set by the World Health Organization. Understanding the reasons underlying the decision of citizens to partake in a CPS are essential in order to optimize the current screening participation rates. The aim of this study was to explore the various perspectives concerning cancer screening among inhabitants of The Hague, a highly urbanized region of the Netherlands. Methods A Q-methodology study was conducted to provide insight in the prevailing perspectives on partaking in CSPs. All respondents were inhabitants of the city of The Hague, the Netherlands. In an online application they ranked a set of 31 statements, based on the current available literature and clustered by the Integrated Change model, into a 9-column forced ranking grid according to level of agreement, followed by a short survey. Respondents were asked to participate in a subsequent interview to explain their ranking. By-person factor analysis was used to identify distinct perspectives, which were interpreted using data from the rankings and interviews. Results Three distinct perspectives were identified: 1). “Positive about participation”, 2). “Thoughtful about participation”, and 3). “Fear drives participation”. These perspectives provide insight into how potential respondents, living in an urbanized region in the Netherlands, decide upon partaking in CSPs. Conclusions Since CSPs will only be effective when participation rates are sufficiently high, it is essential to have insight into the different perspectives among potential respondents concerning partaking in a CSP. This study adds new insights concerning these perspectives and suggests several ideas for future optimization of the CSPs.
... Screening should start for everyone at the age of 50 and be performed in 1 to 2-year intervals up to 75 years of age. [17][18][19] Recently, updated guidelines published in the U.S. have included CRC screening for young people. [15,16,20,21] The American guidelines [15] suggest that adults aged >45-75 years with an average risk for CRC should undergo non-invasive screening using either a high sensitivity stool based test or an invasive diagnostic method such as structural (visual) examination (e.g. ...
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Background: The Al-Kharj colorectal cancer (CRC) screening program was implemented for five years (2017-2022) in a central urban area of Riyadh Province, Saudi Arabia, to assess the participation and impact of the program in average-risk individuals. Methods: The high sensitivity-guaiac based-fecal occult blood test (HSgFOBT) was used as a first-line investigation to identify asymptomatic patients, aged 45-75 years, requiring CRC screening using colonoscopy. The program was run in three tertiary hospitals in the area. Results: The five-year participation rate was 73% (35,640/48,897). The average age was 53 years (range 45-75), 49% were female (17,464/35,640), all were asymptomatic, and 77% had adequate bowel preparation. The HSgFOBT (+) rate was 6.3% (n = 2245), and 76% (n = 1701) of these underwent colonoscopy. The prevalence of findings were as follows: CRC, 4.8% (81/1701); advanced adenoma, 9.5% (162/1701); adenoma, 15.9% (270/1701); non-adenomatous polyps, 7.9% (135/1701); and no polyps or tumors, 25.4% (432/1701). Among participants aged 45-50 years, early onset-CRC had female predominance, while those ≥50 years with late onset-CRC were predominantly male. CRC was more prevalent in the left colon (P < 0.005). Conclusions: Approximately one-third of the participants diagnosed with CRC had early-onset CRC. Screening participation was desirable for the defined target population. Public education is necessary along with expanded colonoscopy resources to continue further citizen participation.
... Therefore, the organisation recommends choosing the FIT method over gFOBT [36]. The analysis of the European Colorectal Cancer Screening Guidelines Working Group guidelines currently points to FIT being the test of choice for population screening [52]. ...
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Introduction: The colorectal cancer prognosis depends on the stage of the neoplasm; therefore, its early detection plays an important role. The aim of the study is evaluation of the sensitivity, specificity, and clinical effectiveness of the faecal immunochemical test in the early colorectal cancer detection. Methods: The clinical analysis was based on the results of the studies included in a systematic review conducted in accordance with the Cochrane Collaboration guidelines. The following medical information sources were searched: Medline (via PubMed), Embase (via Ovid), The Cochrane Library. Results: From 241 citations, 13 studies were included in this review. All included studies had a low risk of bias. The faecal immunochemical test is highly specific in all analysed populations ranging from 85% to 97%. In most of the found studies, sensitivity is over 75%. The faecal immunochemical test screening also determines a reduction in death (10–59%) due to colorectal cancer. Conclusions: The faecal immunochemical test is an effective and cost-effective method of conducting population-wide colorectal cancer screening. It is an alternative or complementary to other screening tests, including colonoscopy.
... Colon screening programs designed to detect adenomas and early-stage cancer have been widely adopted and the optimal age to initiate screening has progressively decreased, adding to demand for screening services. Current consensus recommends that for average-risk individuals, screening should start after the age of 45 or 50 years, varying between different governing bodies and scientific societies [64][65][66][67][68][69][70]. Annual or biennial guaiac or fecal occult blood testing (FOBT), colonoscopy every 10 years, or flexible sigmoidoscopy every 5 years are the most recommended modalities, with CTC offering another option. ...
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Colon screening programs have reduced colon cancer mortality. Population screening should be minimally invasive, safe, acceptably sensitive, cost-effective, and scalable. The range of screening modalities include guaiac or immunochemical fecal occult blood testing and CT colonography and colonoscopy. A number of carefully controlled studies concur that second-generation capsule endoscopy has excellent sensitivity for polyp detection and a high negative predictive value. Colon capsules fulfill the screening expectation of safety, high sensitivity for polyp detection, and patient acceptance, and appear to straddle the divide between occult blood testing and colonoscopy. While meeting these criteria, there remains the challenges of scaling, capsule practitioner training, resource allocation, and implementing change of practice. Like CT colonography, capsule screening presents the clinician with a decision on the threshold for colonoscopy referral. Overall, colon capsules are an invaluable tool in polyp detection and colon screening and offer a filter that determines “who needs a colonoscopy?”.
Purpose: Korea has implemented an early screening for colorectal cancer since 2004. However, it is not known whether this has translated into improved survival over the years.Methods: We acquired colorectal cancer mortality data from the Cause of Death Statistics in Korea from 2000 to 2020. We characterized the data into year of death, cancer-specific loci, and age group. We analyzed age-standardized mortality rates (ASMR) according to year of death, age group, and primary location to find trends in colorectal cancer mortality over a 20-year period.Results: The crude mortality rate of colorectal cancer increased from 8.78 per 100,000 in 2000 to 17.27 per 100,000 in 2020. The second decade was slower in increments compared to the first decade. ASMR showed a decrease over the second decade after an initial increase in the first decade. The decrease was primarily from the lowering of ASMR for rectosigmoid cancers. Age group analysis showed a lowering of ASMR mainly in the 45–59-year, 60–74-year, and ≥ 75-year age groups; however, 0–29-year and 30–44-year age groups showed generally unchanged ASMR over the total period.Conclusion: After a brief incline of age-specific mortality of colorectal cancers during the early 2000s, colorectal cancer mortality has gradually been decreasing in the past decade. This was mainly due to decreased mortalities in rectosigmoid colon cancers especially in the age groups that were the target of early screening.
Introduction: We aimed to systematically evaluate quality of shared decision-making (SDM) in colorectal cancer (CRC) screening clinical practice guidelines (CPGs) and consensus statements (CSs). Methods: Search for CRC screening guidances was from 2010 to November 2021 in EMBASE, Web of Science, MEDLINE, Scopus and CDSR, and the World Wide Web. Three independent reviewers and an arbitrator rated the quality of each guidance using a SDM quality assessment tool (maximum score: 31). Reviewer agreement was 0.88. Results: SDM appeared in 41/83 (49.4%) CPGs and 9/19 (47.4%) CSs. None met all the quality criteria, and 51.0% (52/102) failed to meet any quality items. Overall compliance was low (mean 1.63, IQR 0-2). Quality was better in guidances published after 2015 (mean 1, IQR 0-3 vs. mean 0.5, IQR 0-1.5; p = 0.048) and when the term SDM was specifically reported (mean 4.5, IQR 2.5-4.5 vs. mean 0.5, IQR 0-1.5; p < 0.001). CPGs underpinned by systematic reviews showed better SDM quality than consensus (mean 1, IQR 0-3 vs. mean 0, IQR 0-2, p = 0.040). Conclusion: SDM quality was suboptimal and mentioned in less than half of the guidances, and recommendations were scarce. Guideline developers should incorporate evidence-based SDM recommendations in guidances to underpin the translation of evidence into practice.
Colorectal carcinoma (CRC) is the third most common cancer worldwide and ranks second as a cause of cancer mortality. CRC screening is carried out in many countries for detection early-stage CRC and its prevention by removing precancerous lesions, and includes fecal occult blood testing and colonoscopy. Different countries use their own approach to screening, including methods of detection of fecal occult blood. The strategy for fecal occult blood testing is based on the fact that already in the early stages the tumor can bleed, and small traces of blood in the stool are detected before the onset of clinical symptoms of the disease. Different countries use their own approach to the CRC screening, including methods for fecal occult blood testing. Chemical and immunochemical methods are used to determine occult blood in the feces. The chemical method is based on the detection of heme peroxidase activity. The immunochemical method detects human globin using specific antibodies. The immunochemical method can be qualitative and quantitative. The sensitivity of a quantitative immunochemical test depends on the selected threshold and the stage of CRC. The lower the threshold value, the higher the sensitivity, but the lower the specificity due to false positive results. CRC screening programs use different thresholds for quantitative immunochemical testing in different countries, which is caused by the availability of colonoscopy in a positive test result, as well as the rate of CRC in this population. To increase the sensitivity of the immunochemical test, some programs suggest using it in combination with other methods: detection of DNA in stool, examination of other proteins in feces (transferrin, haptoglobin). This review presents the methods used in the world for fecal occult blood testing, their advantages and limitations; recommendations for reporting the results of a quantitative immunochemical test; thresholds recommended in screening programs in different countries for quantitative immunochemical tests. The results of pilot screening for fecal occult blood testing in some regions of the Russian Federation are also presented.
Backgrounds The value of colorectal cancer (CRC) screening program in a population with a limited participation rate is debated. This study assesses the real-life performances of different screening tests in a population benefiting from an organized program and included in a cancer registry. Methods Patients who participated in at least one screening campaign between 2004 and 2016 were included. Four screening procedures were used: Hemoccult II, Magstream, Hemoccult and Magstream combined, and OC Sensor. Data were crossed with the Digestive Cancer Registry of Calvados to detect CRCs diagnosed during this period. The main outcomes were CRC detection and the incidence rate of interval cancers. Results Screening consisted of 325,083 tests in 134,498 patients. Of the 2580 CRCs detected in patients aged 50–74, 534 (20.7 %) were screen-detected. OC Sensor had the highest sensitivity for CRC detection (83.7 %, 95 % CI [76.8–89.1 %]) and the lowest interval cancer rate (2.0 per 10,000 person-years, 95 % CI [1.4–2.7]) compared with other screening tests, excluding combinations. The overall participation rate was 28.9 %. Conclusion Real-life differences in performance between different screening tests exist, and OC Sensor appears to be the best. The low participation rate suggests that the rate of screen-detected CRC could be higher.
The Asia-Pacific region has the largest number of cases of colorectal cancer (CRC) and one of the highest levels of mortality due to this condition in the world. Since the publishing of two consensus recommendations in 2008 and 2015, significant advancements have been made in our knowledge of epidemiology, pathology and the natural history of the adenoma-carcinoma progression. Based on the most updated epidemiological and clinical studies in this region, considering literature from international studies, and adopting the modified Delphi process, the Asia-Pacific Working Group on Colorectal Cancer Screening has updated and revised their recommendations on (1) screening methods and preferred strategies; (2) age for starting and terminating screening for CRC; (3) screening for individuals with a family history of CRC or advanced adenoma; (4) surveillance for those with adenomas; (5) screening and surveillance for sessile serrated lesions and (6) quality assurance of screening programmes. Thirteen countries/regions in the Asia-Pacific region were represented in this exercise. International advisors from North America and Europe were invited to participate.
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The fourth edition of the European guidelines for quality assurance in breast cancer screening and diagnosis was published by the European Commission in 2006. The present supplements to the fourth edition have been produced by the same groups of experts originally established under the Europe Against Cancer programme that have developed and updated the guidelines since the early 1990s. Over the years, the scope and the depth of the multidisciplinary guidelines have expanded, and recommendations and protocols have been updated to keep pace with developments in the field. The present supplements lay a cornerstone for a new, completely revised fifth edition of the guidelines
Background: The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). Methods: The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. Findings: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with "trial flow", study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. Interpretation: We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.
Colorectal cancer (CRC) is the most common cause of non-tobaccorelated cancer deaths in Canadian men and women, accounting for 10% of all cancer deaths. An estimated 7800 men and women will be diagnosed with CRC, and 3250 will die from the disease in Ontario in 2007. Given that CRC incidence and mortality rates in Ontario are among the highest in the world, the best opportunity to reduce this burden of disease would be through screening. The present report describes the findings and recommendations of Cancer Care Ontario’s Colonoscopy Standards Expert Panel, which was convened in March 2006 by the Program in Evidence-Based Care. The recommendations will form the basis of the quality assurance program for colonoscopy delivered in support of Ontario’s CRC screening program.
In the era of evidence based medicine, with systematic reviews as its cornerstone, adequate quality assessment tools should be available. There is currently a lack of a systematically developed and evaluated tool for the assessment of diagnostic accuracy studies. The aim of this project was to combine empirical evidence and expert opinion in a formal consensus method to develop a tool to be used in systematic reviews to assess the quality of primary studies of diagnostic accuracy. METHODS: We conducted a Delphi procedure to develop the quality assessment tool by refining an initial list of items. Members of the Delphi panel were experts in the area of diagnostic research. The results of three previously conducted reviews of the diagnostic literature were used to generate a list of potential items for inclusion in the tool and to provide an evidence base upon which to develop the tool. RESULTS: A total of nine experts in the field of diagnostics took part in the Delphi procedure. The Delphi procedure consisted of four rounds, after which agreement was reached on the items to be included in the tool which we have called QUADAS. The initial list of 28 items was reduced to fourteen items in the final tool. Items included covered patient spectrum, reference standard, disease progression bias, verification bias, review bias, clinical review bias, incorporation bias, test execution, study withdrawals, and indeterminate results. The QUADAS tool is presented together with guidelines for scoring each of the items included in the tool. CONCLUSIONS: This project has produced an evidence based quality assessment tool to be used in systematic reviews of diagnostic accuracy studies. Further work to determine the usability and validity of the tool continues