Disclaimer
This information collection is a core HTA, i.e. an extensive analysis of one or more health technologies using all nine domains of the HTA Core Model. The core HTA is intended to be used as an information base for local (e.g. national or regional) HTAs.

Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening

Fecal Immunochemical Test (FIT) for colorectal cancer screening compared to CRC screening with Guaiac –based fecal occult blood test (gFOBT) in the screening of Adenomas, as non-malignant precursor lesions of ColoRectal Cancer (CRC). in healthy and/or asymptomatic adults and elderly Any adult over 50 years old, both men and women, with average risk of CRC.

(See detailed scope below)

HTA Core Model Application for Screening Technologies 1.0
Core HTA
Published
Tom Jefferson (Agenas - Italy), Marina Cerbo (Agenas - Italy), Nicola Vicari (Agenas - Italy)
Mirjana Huic (AAZ), Agnes Männik (UTA - Estonia), Jesus Gonzalez (ISCIII - Spain), Ingrid Rosian (GÖG - Austria), Gottfried Endel (HVB - Austria), Valentina Rupel (IER - Slovenia), Alessandra Lo Scalzo (Agenas - Italy), Ingrid Wilbacher (HVB - Austria)
Agenas - Agenzia nazionale per i servizi sanitari regionali
AAZ (Croatia), AETSA (Spain), A. Gemelli (Italy), Avalia-t (Spain), CEIS (Italy), CEM (Luxembourg), GÖG (Austria), HAS (France), HVB (Austria), IER (Slovenia), ISCIII (Spain), Laziosanità (Italy), NCPHA (Bulgaria), NIPH (Slovenia), NSPH (Greece), NSPH MD (Romania), Osteba (Spain), Regione Veneto (Italy), SBU (Sweden), SNHTA (Switzerland), THL (Finland), UTA (Estonia).
5.4.2013 13.07.00
31.7.2014 9.21.00
Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 3 October 2022]. Available from: http://corehta.info/ViewCover.aspx?id=206

Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening

<< Collection summaryDescription and technical characteristics of technology >>

Health Problem and Current Use of the Technology

Authors: Mirjana Huic, Eleftheria Karampli, Silvia Florescu, Cipriana Mihaescu-Pintia

Summary

Aim To give broad overview on the health problem of colorectal carcinoma (CRC), the screening population and the current use of different CRC screening methods in Europe, as well as FIT use, an alternative name for Immunochemical faecal occult bleeding test (iFOBT), a class of occult blood tests which represents one out of few different screening options CRC.

Methods The Project scope is applied in this Domain. Results cards are covered by evidence gathered from basic literature search, hand searched literature, manufacturers web sites, company brochures and information for use, and survey (questionnaire) results. No quality assessment tool was used, but multiple sources were used in order to validate individual, possibly biased, sources. Descriptive analysis was performed on different information sources. The assessment elements questions are answered by cooperation of Domain investigators.

Results Colorectal cancer (CRC) is the 3rd most common cancer worldwide, and the second most frequent in developed countries. Most colon cancers arise from non-malignant adenomas in form of adenomatous polyps. Due such natural course, CRC is particularly suitable for screening. The aim of population-based screening for CRC is to reduce morbidity and mortality from CRC through both prevention (by the removal of adenomas before they become malignant) and earlier diagnosis of CRC (at early, curable stage). In developed countries, approximately, 40.50% of the population develop one or more adenomas in a lifetime, but the majority of these adenomas will never develop into CRC. Only 5.6% of the population actually develop CRC. The average duration of the development of an adenoma to CRC is unobserved, but is estimated to take at least 10 years. Focusing on Europe, in 2008, CRC accounted for 12.4% of deaths caused by malignancy in European countries (11.5% and 13.5% of total cancer deaths in men and women respectively). In Europe, an increasing trend in average incidence of CRC has been observed in recent years, and in the future, the number of new cases and deaths related to CRC are expected to increase. In specific, the International Agency on Research for Cancer (IARC) estimates the number of new CRC cases in Europe (in all ages) to rise to 502,000 in 2020, whereas the annual deaths from CRC in Europe are expected to rise to 248,000.

Target population for CRC screening includes asymptomatic people at average risk, of both genders, age 50-74. There are various methods available for colorectal cancer screening. They can be broadly divided into endoscopic and radiologic methods (for example colonoscopy) and stool-based tests (guaiac-based or immunochemical Faecal occult blood tests - FOBTs, Faecal DNA testing). Routine screening of stool for occult blood may facilitate early detection. Guaiac-based Faecal Occult Blood (gFOBT) tests are those mostly studied in RCTs as screening test for CRC and are an established screening strategy for CRC. Several large randomized studies have demonstrated a reduction in cancer-related mortality. FIT (Faecal Immunochemical test) is an alternative name for Immunochemical Faecal Occult Blood Test (iFOBT), a class of occult blood tests which represents one out of few different screening options for colorectal cancer (CRC). A number of countries have organised CRC screening programmes utilising different strategies. FOB testing is a widely implemented strategy, however there are differences in the type of tests used (gFOBT or iFOBT). From the information provided via the EUnetHTA member survey, use of immunochemical testing (FIT) was reported in 5 out of 11 responded (i. e. Austria, Russia, Luxembourg, Lithuania, Italy, Scotland, Spain, Romania, France, Croatia and Slovenia) European countries. In specific, FIT is used in the Regions of Veneto and Lazio in Italy, Lithuania, Russia, Slovenia and Spain. In Austria, FIT is used only in one province (Burgenland). According to data (May 2008) from the International Cancer Screening Network, CRC screening programmes utilising immunochemical techniques had been implemented in Hungary (2 pilots) and Italy. In Italy, the majority of programmes use FIT, a limited number offer flexible sigmoidoscopy (FS) once in a lifetime and FIT for non-responders to FS. Participation rates in various CRC screening programmes (pilot programmes, established programmes) in Europe and abroad broadly varies from 14.4%-63.8%. Various technologies are available for the diagnosis of adenomas and CRC. Colonoscopy is the gold standard and allows biopsy for histology.

Several different types and brands of FOB tests are available, with different performance characteristics. Potential advantages of gFOBT, as main comparator in this Core HTA, are: the collection card and reagent are cheap, the card based collection system is easy to pack using automated machinery and easy to send by post, easy to print patients details on the cards, the samples are considered to be stable on the cards for up to 21 days, the system has been validated in numerous RCTs, has been implemented in a number of bowel cancer screening programmes and work successfully. Disadvantages of gFOBT are: testing is not automated, test is labour intensive and involves subjective visual reading, the participants is required to prove samples from three separate bowel motions, it is not specific for human Hb, it is not possible to adjust the cut-off Hb concentration of the test.

According the EU Guideline 2010, "iFOBT have improved test characteristics than gFOBT, and they are currently the test of choice for population CRC screening. In different settings, individual device characteristics like ease of use by participant and laboratory, suitability for transport, sampling reproducibility and sample stability are important and should be all taken into account when selecting the iFOBT most appropriate for CRC screening programme (Level of evidence II, Grade of recommendation A). Adoption of test device and the selection of a cut-off concentration should follow a local pilot study to ensure that chosen test, test algorithm and transport arrangements work together to provide a positivity rate that is clinically, logistically and financially acceptable (Level of evidence VI, Grade of recommendation A). Maximum period between collection and analysis is significantly shorter  than for gFOBT (14-21 days), and screening programmes should adopt the conditions and period of storage described in manufacturer’s Instructions for use and should be appropriate for local conditions which might expose samples to high temperatures for long period of time (Level of evidence III, Grade of recommendation A). Despite the fact that dietary constituents present potential interference in gFOBT, dietary restriction has not been demonstrated to significantly increase screening specificity and risks reducing participation rate. The potential for dietary interference is significantly less for iFOBT. Some drugs which could cause GI bleeding like aspirin, NSAIDs and anticoagulants present potential interference in gFOBT and iFOBT, drug restriction is not recommended for population screening programmes using either gFOBT or iFOBT.“

The most clinically and cost-effective CRC screening method still should be determine in additional comparative effectiveness research. When making decision between different FOB tests (gFOBT or FIT) should be used for CRC screening, their analytical performance should be keep in mind as well as compliance and general acceptance of the test by the public.

Introduction

Colorectal cancer (CRC) is the 3rd most common cancer worldwide, and the second most frequent in developed countries. In the US, CRC accounts for 10% of cancer-related deaths; focusing on Europe, in 2008, CRC accounted for 12.4% of deaths caused by malignancy in European countries (11.5% and 13.5% of total cancer deaths in men and women respectively); incidence increases above age 50, the average age at diagnosis is 60-65 years. Different factors could increase or decrease risk for colorectal cancer. Factor which increased risk for CRC are: environmental factors (prevalence is increased in developed countries, urban areas); advantaged socioeconomic groups; hypercholesterolemia; coronary artery diseases; low-fiber, high-animal-fat diets; obesity; smoking; acromegaly; sugar consumption; family history (risk is increased in first-degree relatives of patients, families with increased prevalence of cancer, patients with breast or gynecologic cancer, familial polyposis syndromes);>10-year history of ulcerative colitis or Crohn's colitis;>15-year history of uretherosygmoidostomy. Risk is decreased with long term dietary calcium supplementation, vegetable, garlic, exercise, daily aspirin ingestion (after 5 years daily aspirin there is a 35% reduction in all GI cancers) and other NSAIDs.

Most colon cancers arise from non-malignant adenomas in form of adenomatous polyps. Due such naturale course, CRC is particularly suitable for screening.

The aim of population-based screening for CRC is to reduce morbidity and mortality from CRC through both prevention (by the removal of adenomas before they become malignant) and earlier diagnosis of CRC (at early, curable stage). Different screening tests for CRC are available, classified according to three categories:

 

Stool-based techniques: Fecal occult blood test (FOBT) (either guaiac, so called gFOBT and immunochemical, so called FIT); Fecal DNA testing.   Endoscopic techniques: Optical colonoscopy; Flexible sigmoidoscopy (FS).   Imaging techniques: Virtual colonoscopy techniques using: a) Computed tomographic colonography (CT colonography), b) Magnetic resonance colonography (MR colonography); Wireless capsule endoscopy; Double-contrast barium enema.   The aim of this Domain is to give broad overview on the health problem of colorectal carcinoma, the screening population and the current use of different CRC screening methods in Europe, as well as FIT, an alternative name for Immunochemical faecal occult bleeding test (iFOBT), a class of occult blood tests introduced in US market in 2001, which represents one out of few different screening options for colorectal cancer (CRC).

Methodology

Frame

The collection scope is used in this domain.

TechnologyFecal Immunochemical Test (FIT) for colorectal cancer screening
Description

FITs use an antibody (immunoglobulin) specific to human globin, the protein component of haemoglobin, to detect fecal occult blood. Immunochemical tests have improved test characteristics compared to conventional guaiac-based tests for fecal occult blood. FIT should not be subject to interference from dietary blood and it is more specific to bleeding from the distal gastrointestinal tract. They could be analytically and clinically more sensitive and specific, Their measurement can be automated and the user can adjust the concentration at which a positive result is reported. A wide range of qualitative and quantitative tests is presently available, with varying levels of sensitivity and specificity (like Hem-SP/MagStream H, Fujirebio Inc. Japan ; OC-Sensor, Eiken Chemical Co., Tokyo, Japan;    FOB Gold, Medinostics Products Supplier; Sentinel Diagnostics SpA, Milan, Italy).

Intended use of the technologyScreening

CRC screening with faecal inmunochemical test (FIT) for detection of occult blood in the stool associated with colorectal lesions (adenomas and CRC).

The use of the test is considered under conditions of population based colorectal cancer screening, in the context of organised cancer screening programmes as recommended by the EU. Early detection and treatment of colorectal lesions before they become symptomatic has the potential to improve control of the disease, reducing morbidity and mortality associated to CRC. Early treatment of invasive lesions can be generally less detrimental for quality of life. The endoscopic removal of pre-malignant lesions also reduces the incidence of CRC by stopping the progression to cancer. Colorectal cancers and adenomatous polyps bleed has providing fecal blood haemoglobin as the biomarker of choice for current screening programmes. Stool samples could be periodically taken and analyzed for the presence of occult blood, as an early sign of colorectal lesions (adenoma or CRC).

Target condition
Adenomas, as non-malignant precursor lesions of ColoRectal Cancer (CRC).
Target condition description

CRC is the third most common in incidence and the fourth most common cause of cancer death worldwide. CRC is particularly suitable for screening. The disease is believed to develop in a vast majority of cases from non-malignant precursor lesions called adenomas. Adenomas can occur anywhere in the colorectum after a series of mutations that cause neoplasia of the epithelium. At some time , the adenoma may invade the submucosa and become malignant. Initially, this malignant cancer is not diagnosed and does not give symptoms  (preclinical phase). It can progress from localised (stage I) to metastasised (stage IV) cancer, until it causes symptoms and is diagnosed. Only 5–6% of the population actually develop CRC. The average duration of the development of an adenoma to CRC is estimated to be  at least 10 years. This long latent phase provides a window of opportunity for early detection of the disease.

Target population

Target population sex: Any. Target population age: adults and elderly. Target population group: Healthy and/or asymptomatic people.

Target population description

Adults, average risk of CRC, aged 50 years or over.

The best age range for offering gFOBT or FIT screening has not been investigated in trials. Circumstantial evidence suggests that mortality reduction from gFOBT is similar in different age ranges between 45 and 80 years .The age range for a national screening programme should at least include people aged 60 to 64 years in which CRC incidence and mortality are high and life-expectancy is still considerable. Only the FOBT for men and women aged 50–74 years has been recommended todate by the EU (Council Recommendation and the European guidelines for quality assurance in CRC screening and diagnosis).

Members of families with hereditary syndromes, previous diagnosis of CRC or pre-malignant lesions should follow specific surveillance protocols and are not included in the target population

ComparisonCRC screening with Guaiac –based fecal occult blood test (gFOBT)
Description

CRC screening with Guaiac–based fecal occult blood test (gFOBT)

The guaiac-based FOBT is still a commonly used method for detecting blood in faeces. To detect hemoglobin the test uses guaiac gum and its efficacy as a colorectal cancer screening test has been analyzed in several randomised controlled trials. The test detects the haem component of haemoglobin, which is identical across human and animal species and is chemically robust and only partially degraded during its passage through the gastrointestinal tract. gFOBTs cannot distinguish between human blood and blood residues from the diet.

Many guaiac-based tests are currently on the market (like Coloscreen, Helena Laboratories,Texas,USA; Hema-screen Immunostics Inc.; Hemoccult, Beckman Coulter Inc.; Hemoccult SENSA, Beckman Coulter Inc.; MonoHaem, Chemicon Europe Ltd; Hema-Check, Siemens PLC; HemaWipe, Medtek Diagnostics LLC)

The use of the test is considered under conditions of population based colorectal cancer screening, in the context of organised cancer screening programmes as recommended by the EU. Population-based programmes have been rolled out nationwide in several European countries. Many member states  haveestablished nationwide non-population-based programmes. Some states are planning or piloting a nationwide population-based programme. These have  adopted only FOBT, some only FIT, some a mix between FOBT and endoscopy, or only colonoscopy.

Outcomes

CUR and TEC

  • Health problems (target condition)
  • Epidemiology
  • Burden of disease
  • Target population
  • Current management of the condition
  • Features of the technology
  • Life-Cycle
  • Regulatory status
  • Utilization
  • Investments and tools required to use the technology
  • Training and information needed to use the technology

SAF

  • Colonoscopy probability of perforation
  • Colonoscopy with polypectomy probability of perforation
  • Colonoscopy probability of death following perforation
  • Probability of bleeding following colonoscopy
  • Psychological harms from false-negatives and false-positives (and generally from participating in screening program)

EFF

  • Test (FIT and gFOBT) sensitivity for adenomas
  • Test (FIT and gFOBT) sensitivity for cancer
  • Test (FIT and gFOBT) specificity for adenomas
  • Test (FIT and gFOBT) specificity for cancer 
  • Adenoma incidence (detection rates)
  • Rectal cancer incidence (detection rates)
  • Colon cancer incidence (detection rates)
  • CRC incidence (detection rates)
  • Stage distribution of detected cancers
  • Rectal cancer specific mortality
  • CRC specific mortality
  • Overall mortality
  • Life years saved

ECO:

  • Model/template for  national pilots  to assess the costs and benefits of the two alternative  technologies FIT and gFOBT  and also no-programmed-screening
  • Systematic literature search of   available models and/or economic  evaluation for screening colorectal cancer with FIT and gFOBT and no screening programme
  • Resource Utilization: Publicly funded health care payer costs (screening tests, further examinations e.g. labor, colonoscopy  and treatments and administration and organisation costs of screening programme) for FIT and gFOBT (in cooperation with ORG)
  • Cost per Case detected (average, marginal, incremental) =  intermediate outcome – optional, not decided yet (relevant for deciding how often a test should be carried out and what are the incremental costs for a “new” detected case
  • Indirect Costs: not for the Core modell (should be decided later on)
  • Test accuracy: from SAF
  • Cost effectiveness analysis: HRQoL measures (both generic and context specific) (EFF and SAF for help, own Lit.research), ICER

 ORG:

  • Responsiveness of target population to invitation
  • Invitation-reminder system
  • Competence of human resources – health professionals
  • Investments needed (material,equipment)
  • Costs of using both tests (FIT, gFOBT)
  • Timeliness of results and future phases
  • Use of tools for process monitoring (completed check lists)
  • Model for Budget Impact Analysis from perspective of the payer

SOC

  • Compliance with the tests (FIT, gFOBT)
  • Anxiety and any psychological effects of using  one test or another
  • Information, counseling, communication (quality of) for the use of tests
  • Satisfaction  
  • Quality of life
  • Equity of access

LEG

  • Information as baseline for an informed consent
  • Harms or inequities that can be taken to court

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
A0001Target ConditionWhich disease/health problem/potential health problem will the technology be used for?yesWhich disease/health problem/potential health problem will FIT be used for?
A0002Target ConditionWhat, if any, is the precise definition/ characterization of the target disease? Which diagnosis is given to the condition and according to which classification system (e.g. ICD-10)?yesWhat, if any, is the precise definition/ characterization of adenomas and/or colorectal carcinoma (CRC)? Which diagnosis is given to the condition and according to which classification system (e.g. ICD-10)?
A0003Target ConditionWhich are the known risk factors for acquiring the condition?yesWhich are the known risk factors for acquiring adenomas and/or CRC?
A0004Target ConditionWhat is the natural course of the condition?yesWhat is the natural course of CRC?
A0005Target ConditionWhat are the symptoms at different stages of the disease?yesWhat are the symptoms at different stages of adenomas and/or CRC?
A0006Target ConditionWhat is the burden of the condition?yesWhat is the burden of CRC?
A0009Target ConditionWhat aspects of the burden of disease are targeted by the technology?yesWhat aspects of the burden of CRC are targeted by CRC screening with FIT?
A0007Target PopulationWhat is the target population of the technology?yesWhat is the target population for colorectal carcinoma screening with FIT?
A0023Target PopulationHow many people belong to the target population?yesHow many people belong to the target population in Europe?
A0011UtilisationHow much is the technology being used?yesWhich countries use FIT for CRC screening?
Which percentage of target population is accually screened in countries with CRC screening program with FIT?
A0012UtilisationWhat kind of variations in use are there across countries/regions/settings?yesWhat kind of variations in use of CRC screening methods are there across countries/regions/settings?
A0013Current Management of the ConditionHow is the disease/health condition currently diagnosed or screened?yesHow are adenomas/CRC currently diagnosed?
How are adenomas/CRC currently screened?
A0014Current Management of the ConditionHow should the condition be diagnosed or screened according to published algorithms/guidelines?yesHow should adenomas/CRC be diagnosed or screened according to published algorithms/guidelines?
A0015Current Management of the ConditionHow is the condition currently managed?yesHow are adenomas/CRC currently managed?
A0016Current Management of the ConditionHow should the condition be managed according to published algorithms/guidelines?yesHow should adenomas/CRC be managed according to published algorithms/guidelines?
A0017Current Management of the ConditionWhat are the differences in the management for different stages of disease?yesWhat are the differences in the management for different stages of CRC?
A0018Current Management of the ConditionWhat are the other evidence-based alternatives to the current technology?yesWhat are the other evidence-based alternatives to CRC screening with FIT?
What are the technical characteristics and analytical validity of guaiac-based fecal occult blood test (FOBT), as main CRC screening comparator in this assessment?
A0019Life-CycleIn which phase is the development of the technology?yesIn which phase is the development of FIT?
A0020Regulatory StatusWhich market authorization status has the technology in other countries, or international authorities?yesWhich market authorization status (CE mark) has FIT in other countries, or international authorities?
A0021Regulatory StatusWhat is the reimbursement status of the technology across countries?yesWhat is the reimbursement status of CRC screening with FIT across countries?

Methodology description

Domain frame

The Project scope is applied in this domain.

 

Information sources

- Basic systematic search. Common (basic) literature search strategy was used, run for the whole project and described in COL Appendix 1;

- Hand search;

- Additional search for published literature in PubMed and internet search of grey literature using Google search engine;

- Review of the reference lists and bibliographies of studies identified through the basic systematic search;

- International Organisations’ websites (OECD, WHO, NICE etc.);

- Manufacturers web sites;

- Company brochures and Information for use;

-  Survey: two questionnaires were administered, to EUnetHTA Partners and Manufacturers (more information in COL Appendix 2), with aim to get further information about primary CRC screening methods and tests in different EU countries; please see in COL Appendix 2.

Quality assessment tools or criteria

No quality assessment tool was used, but multiple sources were used in order to validate individual, possibly biased, sources.

Analysis and synthesis

Descriptive analysis was performed on different information sources. The assessment elements questions are answered by cooperation of Domain investigators.

Results cards are covered by evidence gathered from basic search (COL Appendix 1), hand searched literature, manufacturers web sites, company brochures and information for use, and survey (questionnaire) results.

 

Result cards

Target Condition

Result card for CUR1: "Which disease/health problem/potential health problem will FIT be used for?"

View full card
CUR1: Which disease/health problem/potential health problem will FIT be used for?
Result

Importance: Critical

Transferability: Completely

Result card for CUR2: "What, if any, is the precise definition/ characterization of adenomas and/or colorectal carcinoma (CRC)? Which diagnosis is given to the condition and according to which classification system (e.g. ICD-10)?"

View full card
CUR2: What, if any, is the precise definition/ characterization of adenomas and/or colorectal carcinoma (CRC)? Which diagnosis is given to the condition and according to which classification system (e.g. ICD-10)?
Result

Importance: Critical

Transferability: Completely

Result card for CUR4: "Which are the known risk factors for acquiring adenomas and/or CRC?"

View full card
CUR4: Which are the known risk factors for acquiring adenomas and/or CRC?
Result

Importance: Important

Transferability: Partially

Result card for CUR6: "What is the natural course of CRC?"

View full card
CUR6: What is the natural course of CRC?
Result

Importance: Critical

Transferability: Completely

Result card for CUR8: "What are the symptoms at different stages of adenomas and/or CRC?"

View full card
CUR8: What are the symptoms at different stages of adenomas and/or CRC?
Result

Importance: Critical

Transferability: Completely

Result card for CUR9: "What is the burden of CRC?"

View full card
CUR9: What is the burden of CRC?
Result
Comment

Importance: Critical

Transferability: Partially

Result card for CUR11: "What aspects of the burden of CRC are targeted by CRC screening with FIT?"

View full card
CUR11: What aspects of the burden of CRC are targeted by CRC screening with FIT?
Result

Importance: Critical

Transferability: Completely

Target Population

Result card for CUR10: "What is the target population for colorectal carcinoma screening with FIT?"

View full card
CUR10: What is the target population for colorectal carcinoma screening with FIT?
Result

Importance: Critical

Transferability: Partially

Result card for CUR26: "How many people belong to the target population in Europe?"

View full card
CUR26: How many people belong to the target population in Europe?
Result

Importance: Critical

Transferability: Not

Utilisation

Result card for CUR12: "Which countries use FIT for CRC screening?" and CUR13: "Which percentage of target population is accually screened in countries with CRC screening program with FIT?"

View full card
CUR12: Which countries use FIT for CRC screening?
Method
Result

Importance: Important

Transferability: Partially

CUR13: Which percentage of target population is accually screened in countries with CRC screening program with FIT?
Result

Importance: Critical

Transferability: Partially

Result card for CUR14: "What kind of variations in use of CRC screening methods are there across countries/regions/settings?"

View full card
CUR14: What kind of variations in use of CRC screening methods are there across countries/regions/settings?
Result
Comment

Importance: Important

Transferability: Partially

Current Management of the Condition

Result card for CUR15: "How are adenomas/CRC currently diagnosed?" and CUR16: "How are adenomas/CRC currently screened?"

View full card
CUR15: How are adenomas/CRC currently diagnosed?
Result

Importance: Important

Transferability: Partially

CUR16: How are adenomas/CRC currently screened?
Result

Importance: Important

Transferability: Partially

Result card for CUR17: "How should adenomas/CRC be diagnosed or screened according to published algorithms/guidelines?"

View full card
CUR17: How should adenomas/CRC be diagnosed or screened according to published algorithms/guidelines?
Result

Importance: Important

Transferability: Partially

Result card for CUR18: "How are adenomas/CRC currently managed?"

View full card
CUR18: How are adenomas/CRC currently managed?
Result

Importance: Important

Transferability: Partially

Result card for CUR20: "How should adenomas/CRC be managed according to published algorithms/guidelines?"

View full card
CUR20: How should adenomas/CRC be managed according to published algorithms/guidelines?
Result

Importance: Important

Transferability: Partially

Result card for CUR21: "What are the differences in the management for different stages of CRC?"

View full card
CUR21: What are the differences in the management for different stages of CRC?
Result

Importance: Important

Transferability: Partially

Result card for CUR22: "What are the other evidence-based alternatives to CRC screening with FIT?" and CUR27: "What are the technical characteristics and analytical validity of guaiac-based fecal occult blood test (FOBT), as main CRC screening comparator in this assessment?"

View full card
CUR22: What are the other evidence-based alternatives to CRC screening with FIT?
Result

Importance: Important

Transferability: Partially

CUR27: What are the technical characteristics and analytical validity of guaiac-based fecal occult blood test (FOBT), as main CRC screening comparator in this assessment?
Result

Importance: Important

Transferability: Partially

Life-Cycle

Result card for CUR23: "In which phase is the development of FIT?"

View full card
CUR23: In which phase is the development of FIT?
Result

Importance: Important

Transferability: Completely

Regulatory Status

Result card for CUR24: "Which market authorization status (CE mark) has FIT in other countries, or international authorities?"

View full card
CUR24: Which market authorization status (CE mark) has FIT in other countries, or international authorities?
Result

Importance: Critical

Transferability: Completely

Result card for CUR25: "What is the reimbursement status of CRC screening with FIT across countries?"

View full card
CUR25: What is the reimbursement status of CRC screening with FIT across countries?
Result

Importance: Important

Transferability: Completely

Discussion

Few limitations were observed during assessment of domain questions. Detailed comparisons were difficult due the fact that not all countries maintain population and cancer registers. Data on incidence and mortality were extracted from the database of the GLOBOCAN project (International Agency for Research on Cancer), which provides contemporary estimates of these measures {6}. The most recent estimates are for 2008. Incidence data also derive from population-based cancer registries. More information on the GLOBOCAN data and sources are available on the project’s website. Regarding CRC survival, results of the EUROCARE project were preferred as it is a project that aims to describe and interpret differences in cancer patient survival in Europe. However, there are limitations to the project, already acknowledged by the researchers {21}. The reader should keep in mind that not all European countries are involved in the EUROCARE project. Furthermore, for several countries cancer registration covers only a fraction of the total national population. The first round (EUROCARE-1) included 30 cancer registry populations diagnosed from 12 European countries. During the rounds that followed more regional and national registries participated. The current, fifth round (EUROCARE-5) includes data from 116 Cancer Registries in 30 European countries and for patients diagnosed during 2000-2007 {39}. Strengths, limitations and the value of findings are discussed in detail by the researchers {21,40}.

Differences among MSs on screening methods, adherence rates, marketing authorization and reimbursement status of the tests were not fully established since in the Survey applied to MSs Partner only 11 countries were answered, and in Survey applied to Manufacturers only one responded.

The most clinically and cost-effective CRC screening method still should be determine in additional comparative effectiveness research. Analytical performance of different FOB tests (gFOBT or FIT) should be keep in mind when make decision on which FOB test should be used for CRC screening as well as compliance and general acceptance of the test by the public.

References

 

1.             Gallagher C, Lister T, Smith M. Malignant disease. In: Kumar P, Clark M, editors. Clinical Medicine 8th ed. Edinburgh: Elsevier; 2012. p. 431-83.

2.             Segnan N, Patnick J, von Karsa L, editors. European guidelines for quality assurance in colorectal cancer screening and diagnosis - First Edition. 1st ed. Luxembourg: Publications Office of the European Union; 2010.

3.             Longo D, Fauci A, Kasper D, Hauser S, Jameson J, Loscalzo J. Colorectal cancer.  Harrison’s manual of medicine. 18th ed. New York: McGraw-Hill; 2013. p. 453-57.

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