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

<< Ethical analysisSocial aspects >>

Organisational aspects

Authors: Principal investigators: Valentina Prevolnik Rupel, Nika Berlic Investigators: Dominika Novak Mlakar, Taja Čokl, Plamen Dimitrov, Marta López de Argumedo

Summary

The manner in which CRC screening is carried out varies significantly from country to country within the EU, both in terms of organization and the screening test chosen. A screening program of one sort or another has been implemented in 19 of 27 EU countries. Results have shown that some countries have organized screening and some countries have the opportunistic one. European guidelines compared those two screening types and, according to the reviewed evidence, showed that organised screening programmes achieve better coverage of the target population including hard to- reach or disadvantaged groups that opportunistic. It is also more cost-effective and provides greater protection against the harms of screening, including over screening, poor quality and complications of screening, and poor follow-up of participants with positive test results.

The most frequently applied method in Europe is testing stool for occult bleeding (fecal occult blood test, FOBT). In 2007, gFOBT (which in 2003 was the only test recommended by the Council of the European Union) was used as the only screening method in twelve countries (Bulgaria, Czech Republic, Finland, France, Hungary, Latvia, Portugal, Romania, Slovenia, Spain, Sweden, and United Kingdom). In six countries, two types of tests were used: FIT and FS in Italy, and gFOBT and colonoscopy in Austria, Cyprus, Germany, Greece, and Slovak Republic. Since then FIT is becoming increasingly popular. For example: Slovenia, since 2009, when national CRC screening programme FIT has been adopted, uses FIT technology. According to the survey, implemented among 11 European countries (i. e. Austria, Russia, Luxembourg, Lithuania, Italy, Scotland, Spain, Romania, France, Croatia and Slovenia), it is seen that only 6 countries (Russia, Lithuania, Italy, Scotland, Spain and Slovenia) out of 11 uses FIT technology. Other countries, which participated to the survey, use gFOBT technology, with exception of Austria (excluding the Burgenland that uses FIT technology), who uses colonoscopy as a primary screening method. In addition to that Luxembourg indicated that FIT is relatively new technology and isn't widely accepted in their country. All countries stated that FIT and gFOBT screening are free of charge for target population and founded by the country.

FIT screening, like other screening methods, have to follow specific procedure: from identifying target population, sending invitation, re-invitation where it is necessary, delivering kits (The test kit may be delivered by mail, at GPs’ offices or outpatient clinics, by pharmacists, or in other community facilities, and in some cases with the support of volunteers.), collecting samples (via e-mail, or through volunteers for example – like in some countries), laboratory examination and follow up.

National screening programme gives criteria based on risk information about who should receive screening invitations. The target population for a CRC screening programme includes all people eligible to attend screening on the basis of age and geographical area of residence. According to Table 1 and Table 2 (see ORG1), some differences about the target population exist between European countries. In general, people who are between 50 and 75 are invited to the screening. Table 1 offers also information on operational characteristics.

Several studies found FIT as a better option in comparison to gFOBT, due to the fact that FIT:

·         Has no need for dietary restriction that results in better screening participation;

·         Needs a smaller number of stool samples than gFOBT;

·         Shows a greater relative sensitivity than gFOBT;

·         Shows a greater sensitivity for the detection of advanced adenomas than gFOBT;

·         Has a higher recall rate than most gFOBTs;

·         Has a PPV similar to those obtained with most gFOBTs;

·         Provides an opportunity of using a numeric threshold to find the most appropriate balance between sensitivity and specificity (i.e. between detection rate and positivity to the test); and

·         Allows the opportunity to balance recall and detection rates providing each country with the tools to implement a colorectal cancer screening programme that will meet local healthcare expectations within available resources.

·         But still, it has a major problem with sample instability, and collected samples should preferably be kept cool and returned immediately for analysis;

As regarding the participants’ and important others’ involvement into screening process and their own care and treatment, it has been showed (according to one study) that the attitudes towards CRC screening are strongly correlated with participation. Some other studies revealed participants' low awareness of the faecal occult blood test before they received the invitation for screening. Two of the major factors that influence the participation in screening programme are therefore an increasing knowledge and provision of more accessible screening programmes.

The success of a colorectal cancer screening programme depends on specially trained individuals committed to implementation, provision and evaluation of a high quality, efficient service. The multidisciplinary team that is responsible for a colorectal screening programme within FIT screening method includes:

·         Administrative, clerical staff,

·         Epidemiologists,

·         Laboratory staff,

·         Primary care physicians,

·         Nurses and also

·         Public health specialists.

Where screening tests are positive and further examination, treatment or care are necessary, the team also includes:

·         Endoscopists,

·         Radiologists,

·         Pathologists and

·         Surgeons.

But quality assurance cannot be achieved without a proper communication – in all levels. Cancer and screening communication messages must be therefore designed and delivered to match the communication skills, needs, and pre-dispositions of specific audiences. A key component of CRC screening programmes is, therefore, the information and education provided about CRC and CRC screening tests and procedures.

Communication among professionals is essential in order to ensure that all the information coming from the prognostic tests is available quickly and is correctly interpreted. To achieve and maintain an effective communication between the various professionals of a colorectal multidisciplinary team it is essential that they participate to different training courses, which should be focused on good inter-professional communication. Joint courses given for the multidisciplinary team may facilitate this goal. Good communication should be carried out between the members of the screening team with agreed terminology, regular meetings and clinical discussions.

Although colorectal cancer screening is recommended by major policy-making organizations, rates of screening remain low. Studies examine different communication tool options to increase knowledge on colorectal cancer screening and also to its participation. Studies also examine how communication factors influence CRC screening.

Literature provided little information on the impact of de-centralisation/ centralisation on implementation of FIT. Nevertheless some general conclusions about advantages and disadvantages of centralized and/or decentralized systems could be drawn; studies reveals that decentralized clinics and activities provide better access to health campaigns, who offers more information and knowledge to the participants and therefore influences on individuals participation to the screening. In the other hand in the centralized services the development of teams of different disciplines are more easily to arrange, they achieve economies of scale and can make better efficient use of a scarce resource and they also provide better outcomes for patients under the care due to the larger team of specialist professionals, for example – for cancer survival.

For implementation of FIT several investments are needed: a) material: e.g. equipment for screening, premises, office material for posting invitations and re-invitations, IT equipment and other office devices such as printers, and b) human resources: administrative and health personnel, investment in education of personnel and their training. Every country needs to assess their costs independently using cost-effectiveness analyses or other economic evaluation method. Investments that are needed for implementation of FIT are therefore country specific.

Data of budget impact of the implementation of FIT for the different payers were, by the literature review, not found. The existing studies examine only cost-effectiveness of performing FIT. The study of cost-effectiveness is important due to its impact on the payers’ decision about budget allocation and about the amount of financial resources that they will invest in the national screening programme and into a new technology. Although it has been expected that the information on the budget impact is going to be obtained through a survey, it can be concluded that information obtained from the survey were not sufficient for the budget impact analysis. In addition to that only two countries have indicated the costs that are related to the screening (i.e. Lithuania and Slovenia). We believe that further research and in-depth studies would be necessary to indicate the budget impact of the implementation of FIT for the payers.

According to the insight that was gained through the literature review, it can be concluded that the most critical points in management are:

·         To ensure that all eligible target population is invited and well informed about the colorectal cancer, colorectal cancer screening and the screening process;

·         To ensure that screening process is conducted strictly according to the rules of procedure (the quality of process depend also on the communication, coordination etc.);

·         To ensure an adequate and timely follow-up or treatment for those, who needs it;

·         To ensure the availability of data (data management system);

FIT method has been, among patients, well accepted. The studies have shown that FIT slightly outperforms gFOBT with a lower level of reported discomfort and overall burden. There are little information about the acceptance of FIT by health personnel and the organization. Nevertheless it has been demonstrated that the higher acceptability of FIT among patients is an important argument for choosing FIT in preference to gFOBT as the screening method for a nation-wide screening programme, apart from additional arguments regarding test performance characteristics. The additional information from the survey is going to enhance and backed the data on acceptance of FIT by health personnel and the organization.

Wide spectrums of stakeholders are engaged in planning and implementation of FIT. Usually stakeholders, involved in that process, vigorously defend their many interests, including patients, health professionals, politicians and industry. Little information exists about the interest groups/ stakeholders, who are or have to be taken into account in the planning / implementation of FIT. Only two reports were found – UK and Australian – to be relevant to this question. In addition, some information was gained through the survey.

For reaching quality assurance of FIT testing a consistency in analytical performance must be assured by the adoption and application of rigorous quality assurance procedures. Manufacturer’s Instructions for Use must be followed. Laboratories should perform daily checks of analytical accuracy and precision across the measurement range with particular emphasis at the selected cut-off limit. Rigorous procedures need to be agreed and adopted on how internal quality control data is interpreted and how the laboratory responds to unsatisfactory results. Performance data, both internal quality control and external quality assessment data, should be shared and reviewed by a Quality Assurance team working across the programme. Sufficient instrumentation should be available to avoid delays in analysis due to instrument failure or maintenance procedures.

Whilst an immunochemical test is recommended, programmes that adopt a traditional guaiac test need to apply additional laboratory quality procedures.

The prime importance of quality assurance should also be included in basic training of the staff that is engaged in screening process.

Quality assurance is strongly connected to the monitoring. All aspects of the cancer screening programme should be monitored and evaluated. Quality standards need to be set for every step along the screening pathway and an appropriate monitoring framework is required to determine if the standards are being met. Standards will apply at a number of levels: to procedures; individuals; teams; institutions and overall systems.

In the case of FIT cancer screening programme, where screening is based on a laboratory test, it is self-evident that an adequate monitoring system should be present in laboratories.

All laboratories providing screening services should be associated with a laboratory accredited to ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence. The laboratories should perform Internal Quality Control (IQC) procedures and participate in an appropriate External Quality Assessment Scheme (EQAS).

Of fundamental importance is also the complete and accurate recording of all relevant data on each individual and every screening test performed - including the test results, the decisions made as a consequence, diagnostic and treatment procedures and the subsequent outcome, including cause of death.

In order to be able to evaluate the effectiveness of screening, the data must be linked at the individual level to several external data sources including population register, cancer or pathology registries, and registries of cause of death in the target population. Therefore, legal authorisation should be put in place when the screening programme is introduced in order to be able to carry out programme evaluation by linking the above-mentioned data for follow-up.

Introduction

The organisational domain considers what types of resources (material, human skills, knowledge, money, etc.) must be mobilised and organised when implementing a technology, and what changes or consequences the use can cause in an organisation and a health care system as a whole. The issues include e.g. quality and sustainability assurance, centralization, communication, managerial structure and acceptance. There are three levels to consider regarding organizational aspects: intra-organizational, inter-organizational and health care system level. The levels of approach can also be divided into micro level (patient interaction), mezzo level (health care organization and community) and macro level (health policy).

The growing focus of organizational issues in health technology assessment (HTA) indicates a recognition that many decisions on resource allocation in provision of technologies are of crucial importance. Organizational aspects in HTA influence the behaviour of managers and health professionals. Also policy makers on the national level need knowledge on organizational aspects, when making decisions on the use of technologies. Organizational aspects in HTA may clarify challenges and barriers in implementing health technologies {1}.

In this core HTA the objective is to assess the organisational effects of FIT (Fecal immunochemical Test) for colorectal cancer screening, also called as iFOBT (immunochemical FOBT) screening, compared with the guaiac-based fecal occult blood test (gFOBT) for colorectal cancer screening, both within organized screening program. 

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
G0001ProcessWhat kind of work flow, participant flow and other processes are needed?yesWhat kind of work flow, participant flow and other processes are needed?
G0002ProcessWhat kind of involvement has to be mobilized for participants and important others?yesWhat kind of involvement has to be mobilized for participants and important others?
G0003ProcessWhat kind of staff, training and other human resources are required?yesWhat kind of staff, training and other human resources are required?
G0004ProcessWhat kind of co-operation and communication of activities have to be mobilised?yesWhat kind of co-operation and communication of activities have to be mobilised?
G0012ProcessWhat kind of quality assurance is needed and how should it be organised?yesWhat kind of quality assurance is needed and how should it be organised?
G0005StructureHow does de-centralisation or centralization requirements influence the implementation of the technology?yesHow does de-centralisation or centralization requirements influence the implementation of FIT?
G0006StructureWhat kinds of investments are needed (material or premises) and who are responsible for those?yesWhat kinds of investments are needed (material or premises) and who are responsible for those?
G0007StructureWhat is the likely budget impact of the implementation of the technology for the payers (e.g. government)?yesWhat is the likely budget impact of the implementation of FIT for the payers (e.g. government)?
G0008ManagementWhat management problems and opportunities are attached to the technology?yesWhat management problems and opportunities are attached to FIT?
G0013ManagementWhat kind of monitoring requirements and opportunities are there for the technology?yesWhat kind of monitoring requirements and opportunities are there for FIT?
G0009ManagementWho decides which people are eligible for the technology and on what basis?noIn comapring gFOBT and FIT in organized screening the eligibility of the population is the same as it is based on incidence and prevalence.
G0010CultureHow is the technology accepted?yesHow is FIT accepted?
G0011CultureHow are the other interest groups taken into account in the planning / implementation of the technology?yesHow are the other interest groups taken into account in the planning / implementation of FIT?

Methodology description

Domain frame

The project scope is applied in this domain.

Technology

FIT for colorectal cancer screening vs. gFOBT colorectal cancer screening in organized screening program

Description

Procedure of gFOBT: the standard fecal occult blood (FOBT) test can detect small amounts of blood in the stool by submitting a portion of three consecutive bowel movements for testing. The test cannot identify polyps and some diet restrictions need to be considered, as the test is not specific for human blood alone. gFOBT is used for more than 30 years in routine, is widely available and inexpensive. If the test is positive, a colonoscopy will be needed to find the reason for the bleeding {2, 3}.

Procedure of FIT: FIT (Fecal Immunochemical Test) for colorectal cancer screening, also called as iFOBT (immunochemical FOBT) screening, is more accurate than FOBT as it only identifies human blood. It needs only one stool sample, thus is more simple to complete. If the test is positive, a colonoscopy will be needed to find the reason for the bleeding {2, 3}.

Colorectal cancer (CRC) screening with faecal inmunochemical test (FIT) for detection of occult blood in the stool associated with colorectal lesions (adenomas and CRC) 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. Stool samples could be periodically taken and analyzed for the presence of occult blood, as an early sign of colorectal lesions (adenoma or CRC).

To ensure effectiveness, the screening interval in a national screening programme should not exceed two years for gFOBT and three years for FIT {4}.

Purpose of use: detect cancer, polyps, nonpolypoid lesions, which are flat or slightly depressed areas of abnormal cell growth and can also develop into colorectal cancer.

Intended use of the technology

Screening

CRC screening with faecal immunochemical test (FIT)

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. Adenoma may invade the submucosa and become malignant. Initially, this malignant cancer is not diagnosed and does not cause 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 general 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: 50-74 years. Target population group: Asymptomatic people.

Target population description

Adults (both men and women), 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. EU Council Recommendations suggests only the faecal occult blood test (gFOBT or FIT) for men and women aged 50–74 for CRC screening {4}.

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.

 

Comparison

CRC 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 analysed 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 have established nationwide non-population-based programmes. Some states are planning or piloting a nationwide population-based programme. These have adopted only gFOBT, some only FIT, some a mix between FOBT and endoscopy, or only colonoscopy.

 

ASSESSMENT ELEMENTS

Question number

ID

Topic

Issue

Relevant

Research questions or rationale for irrelevance

ORG1

G0001

Process

What kind of work flow, participant flow and other processes are needed?

yes

What kind of work flow, participant flow and other processes are needed?

ORG2

G0002

Process

What kind of involvement has to be mobilized for participants and important others?

yes

What kind of involvement has to be mobilized for participants and important others?

ORG3

G0003

Process

What kind of staff, training and other human resources are required?

yes

What kind of staff, training and other human resources are required?

ORG4

G0004

Process

What kind of co-operation and communication of activities have to be mobilised?

yes

What kind of co-operation and communication of activities have to be mobilised?

ORG5

G0005

Structure

How does de-centralisation or centralization requirements influence the implementation of the technology?

yes

How does de-centralisation or centralization requirements influence the implementation of FIT?

ORG6

G0006

Structure

What kinds of investments are needed (material or premises) and who are responsible for those?

yes

What kinds of investments are needed (material or premises) and who are responsible for those?

ORG7

G0007

Structure

What is the likely budget impact of the implementation of the technology for the payers (e.g. government)?[1]

yes

What is the likely budget impact of the implementation of FIT for the payers (e.g. government)?

ORG8

G0008

Management

What management problems and opportunities are attached to the technology?

yes

What management problems and opportunities are attached to the FIT?

ORG9

G0010

Culture

How is the technology accepted?

yes

How is FIT accepted?

ORG10

G0011

Culture

How are the other interest groups taken into account in the planning / implementation of the technology?

yes

How are the other interest groups taken into account in the planning / implementation of FIT?

ORG11

G0012

Process

What kind of quality assurance is needed and how should it be organised?

yes

What kind of quality assurance is needed and how should it be organised?

ORG12

G0013

Management

What kind of monitoring requirements and opportunities are there for the technology?

yes

What kind of monitoring requirements and opportunities are there for FIT?

 

Information sources

Organisational aspects are rarely covered in clinical studies or HTA reports so the current analysis required several activities. Systematic review of the literature was not enough to answer the research question of this domain. So grey literature and national guidelines were added. Since some organizational aspects are very much linked to country contexts, it is useful to integrate results with the experience of local experts in the area. For this purpose the results of the survey was used.

Quality assessment tools or criteria

In the systematic literature review, only studies with organizational aspect, published in peer reviewed journals were selected. Reviews, letters, comments, etc., were not considered for inclusion in the analysis of evidence. These studies are often highly context specific (i.e., specific to the country, population, health-care system).

Hereinafter exclusion and inclusion criteria are presented in more detail:

Exclusion criteria:

a)     Formal exclusion criteria

·         Studies not published in English

·         Duplicates

·         Studies irrelevant for the European context

b)     Thematic exclusion criteria

·         Different research question

·         Different disease or clinical focus (e.g. other diseases than colorectal cancer)

·         Other intervention (i.e. no comparison between FIT and gFOBT)

c)      Study design

·         Congress presentation, posters, „Comments“, „Letters“ etc. (i.e.. „Abstracts“, not based on any actual primary study)

·         Case studies

·         Studies not focusing on human medicine (e.g. animal studies) or in-vitro Studies

 

Inclusion criteria:

·         Basic requirements fulfilled (none of the above exclusion criteria is applicable)

·         HTA / systematic Review

·         Study presents an organizational aspect

 

To summarize,  inclusion criteria for ORG domain were:

1.      The studies compared a guaiac-based faecal occult blood test (gFOBT) with an immunochemical based faecal occult blood test (FIT),

2.      The studies considered the organizational aspect,

3.      The studies were relevant for the European context.

 

Analysis and synthesis

Literature search was conducted in May 2013. Descriptive analysis was performed on different information sources. The assessment elements questions were answered by Principal investigator and complemented and reviewed by investigators.   Literature search was specifically aimed at identifying peer-reviewed literature containing organizational aspect on population based colorectal cancer screening using FIT and gFOBT. After systematic literature was completed, non-systematic searching for other literature (grey literature) and survey were conducted. The details of all three steps in this process of information searching are described below:

1.      A literature search and review of the results

A systematic literature search was conducted in May 2013. Published literature was obtained by searching: ACADEMIC SEARCH COMPLETE (EBSCO), WILEY ONLINE LIBRARY, SCIENCE DIRECT, SPRINGER LINK, ERIC (EBSCO) and JSTOR. Additional searches were done through the Internet engine Google, where guidelines, reports and some free articles/ studies on Oxford journals, PubMed etc. were found.

The search was performed using key words of each identity card (i.e. each research question). More detailed description of literature (key words) are described in Appendix 1 (i.e. search strategies).

pdf10936.ORG Methodology-Figure 1

2.      Grey literature and national guidelines searches

Grey literature was searched for the ORG1, ORG5, ORG6, ORG10 and ORG12 assessment elements. Details of the searches are covered in those elements and the identified literature is included in the domain references. Grey literature was not searched for any other assessment element.

32 relevant articles/studies were found, one international guidelines and two international reports. In addition, two publications were found, one national report and one national guidelines (through an Internet engine Google). Six other grey resources ware found through an Internet engine Google. We also used EUnetHTA WP4 CORE HTA basic document, published on EUnetHTA intranet, as a background document.

3.      A survey

The survey for retrieving information on the use of technology in European countries has been implemented. 11 European countries have participated to the survey: Austria, Russia, Luxembourg, Lithuania, Italy, Scotland, Spain, Romania, France, Croatia and Slovenia.

Institutions that participated to the survey are listed in table below (Table 1):

Table 1: Institutions that participated to the survey

CountryInstitution

Austria

Ludwig Boltzmann Institute for Health Technology Assessment

Russia

National Center for Health Technology Assessment - NCHTA

Luxembourg

Cellule d'expertise médicale

Lithuania

State Health Care Accreditation Agency under the Ministry of Health

Italy

•             Laziosanità – ASP (Agenzia di Sanità Pubblica della Regione Lazio è l'organo strumentale della Regione in materia sanitaria)

•             Veneto Region

Scotland

Healthcare Improvement Scotland

Spain

Andalusian Agency for Health Technology Assessment  - AETSA

Romania

National School of Public Health, Management and Professional Development - NSPHMPD

France

HAS

Croatia

Agency for Quality and Accreditation in Health Care and Social Welfare

Slovenia

National Institute of Public Health

A survey gives answers on question ORG7 and the supplement to the answers on following questions: ORG5, ORG6 and ORG10. The survey gives additional information also to the questions ORG1 and ORG9.

  [1] This question should be included in the ECO domain.

Result cards

Process

Result card for ORG1: "What kind of work flow, participant flow and other processes are needed?"

View full card
ORG1: What kind of work flow, participant flow and other processes are needed?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Completely

Result card for ORG2: "What kind of involvement has to be mobilized for participants and important others?"

View full card
ORG2: What kind of involvement has to be mobilized for participants and important others?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Completely

Result card for ORG3: "What kind of staff, training and other human resources are required?"

View full card
ORG3: What kind of staff, training and other human resources are required?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Completely

Result card for ORG4: "What kind of co-operation and communication of activities have to be mobilised?"

View full card
ORG4: What kind of co-operation and communication of activities have to be mobilised?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Completely

Result card for ORG11: "What kind of quality assurance is needed and how should it be organised?"

View full card
ORG11: What kind of quality assurance is needed and how should it be organised?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Partially

Structure

Result card for ORG5: "How does de-centralisation or centralization requirements influence the implementation of FIT?"

View full card
ORG5: How does de-centralisation or centralization requirements influence the implementation of FIT?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Partially

Result card for ORG6: "What kinds of investments are needed (material or premises) and who are responsible for those?"

View full card
ORG6: What kinds of investments are needed (material or premises) and who are responsible for those?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Partially

Result card for ORG7: "What is the likely budget impact of the implementation of FIT for the payers (e.g. government)?"

View full card
ORG7: What is the likely budget impact of the implementation of FIT for the payers (e.g. government)?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Partially

Management

Result card for ORG8: "What management problems and opportunities are attached to FIT?"

View full card
ORG8: What management problems and opportunities are attached to FIT?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Partially

Result card for ORG12: "What kind of monitoring requirements and opportunities are there for FIT?"

View full card
ORG12: What kind of monitoring requirements and opportunities are there for FIT?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Partially

Culture

Result card for ORG9: "How is FIT accepted?"

View full card
ORG9: How is FIT accepted?
Method
Frame
Result
Comment

Importance: Critical

Transferability: Partially

Result card for ORG10: "How are the other interest groups taken into account in the planning / implementation of FIT?"

View full card
ORG10: How are the other interest groups taken into account in the planning / implementation of FIT?
Method
Frame
Result
Comment

Importance: Important

Transferability: Not

Discussion

Based on the European Guidelines for Quality Assurance in Colorectal Cancer Screening and Diagnosis - First Edition and on the Report on the implementation of the Council Recommendation on cancer screening – First Report, sufficient overview of organizational aspect of FIT has been given. We have substantiated and strengthen the answers with several studies and also other resources that have been found on the web site. However those two documents on all the other resources were not enough to gain a complete insight into countries’ specific organizational situation and also for gaining an insight into the budgetary issues.

The current overview can be therefore used as a starting point for further – country specific – examination. For this purpose an international survey was executed.

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Appendices

Appendix 1: pdf10936.ORG-Appendix 1

Appendix 2: pdf10936.ORG-Appendix 2

 

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