FIT (Faecal immunochemical test) is an alternative name for Immunochemical faecal occult blood test (iFOBT), a class of faecal occult blood tests. Faecal Occult Blood Tests (FOBTs) are tests for blood or blood products. They use blood as an indicator of the presence of tumour {1}.

A wide range of qualitative and quantitative iFOBT tests is presently available, with varying levels of sensitivity and specificity. They all use antibodies raised against human haemoglobin (Hb) to detect human blood present in faeces.

Similar to g FOBT, participants collect one or more stool samples. The sampling procedure varies: different sampling systems are available (wooden sticks, brushes) and samples may be applied either to a card (dry method) or to place into a vial (wet method). Samples can be analysed either using automated systems in the laboratory (for some manufacturers) or are read by the naked eye with a positive result indicated by a colour change on a strip {2}. The automated systems can be quantitative or qualitative. Qualitative tests produce a dichotomous result, with individuals categorized as either positive or negative if the amount of Hb in the faecal sample is above or below a specific analytical detection limit set by the manufacturers. In quantitative tests, specificity can be determined by the user {3}. The most frequently used values are 75 or 100 ng/mL. This is important due the fact that by increasing the positive cut-off limit, the test sensitivity and positivity rate decreases and specificity and positive predictive values for CRC detection increase. FIT kits with a visual result are designed as point-of-care devices and are qualitative. They can be adopted for use in clinical laboratories for population-based screening; however they retain a more manual approach than the automated systems.

In their report on the comparison of FITs vs. g FOBTs for population-based colorectal cancer screening in Ontario, CA {4} the FIT Guidelines Expert Panel has considered test processing in laboratories more suitable that point-of-care systems for a population-based screening program. Similarly, the NHS Centre for Evidence-based Purchasing in the UK adopted certain criteria that the iFOBTs had to meet in order to be evaluated for the CRC screening programme in the UK {5}. Only automated systems were included in the evaluation. Regarding staff requirements, more technical knowledge will be required than for gFOB tests. If the increased packing material is required to meet postal regulation, unpacking of iFOBT liquid sampling devices may take longer than for gFOBT.

Potential advantages and disadvantages of iFOBT are given in Table 1.

Table 1. Potential advantages and disadvantages of iFOBT (5)

Three iFOBT are presented here, as three analytical platforms using the three sample collection devices: OC-Sensor/OC-Sensor Diana & OC-Sensor Micro, Hem-SP/MagStream HT, FOB Gold/SENTiFOB analyser.  In brief {6}:

•  OC-Sensor measures human Hb concentration in faeces samples by latex agglutination using polystyrene latex particles coated with polyclonal anti haemoglobin Ao antibodies. One sample only is recommended as number of separate samples used for assessment. The Diana has a memory capacity for 100 000 test results, with speed of 280 samples per hour analysis. Ten mg of faeces is recommended as quantity that should be collected by sampling device. Advantage is that this test is CE marked for a user defined cut-off (default setting 100 ng/mL), with 20 ng/mL in buffer as limit of detection. The faecal sample is collected into the OC-Auto sampling bottle 3. Analysis should be performed as soon as possible after sample collection; in case of any delay the sample collection bottles should be stored at 2-10C;
• Hem-SP/MagStream HT (MagStream Hem-Sp®) is based on magnetic particle agglutination (the magnetic particles are coated with rabbit anti-human Hb antibodies). Two samples are recommended as number of separate samples used for assessment. One disadvantage is that this method is qualitative, and has a non-adjustable cut-off at a Hb concentration equal to or greater than 20 ng/ml. In the presence of human haemoglobin, the particles remain aggregated in a spot with minimal change (positive result). In the absence of human haemoglobin, particles flow down the slope (negative result).  MagStream HT, an automated instrument which holds 400 samples has a memory capacity of 2 million test results, with speed of analysis of 960 tests per hour (MagStream HT). 0.3 mg of faeces is recommended as quantity should be collected by sampling device. The faecal sample is collected into the NEW HEMTUBE. Analysis should be performed as soon as possible after sample collection; in case of any delay the sample collection bottles should be stored at 2-10C. Freezing must be avoided;

The FOB Gold use an antigen-antibody agglutination reaction between human haemoglobin and polyclonal anti-human haemoglobin antibodies coated on polystyrene particles. The total reading time is 8 minutes, with speed of analyses of 75 tests/hr

• (SentiFOB). The FOB Gold reagents can be used on any suitable immunoassay automated analyser although the manufacturer provides the SENTiFOB analyser. Advantages of this test is that this test is CE marked for a user defined cut-off, with limit of detection of 14 ng/mL buffer, and measuring range of 15-1000 ng/ml. The faecal sample is collected into the FOB Gold tube. Analysis should be performed as soon as possible after sample collection; in case of any delay the sample tubes should be stored at 2-8 C.

Some of products characteristics are presented in Table 2.

 Table 2. Product characteristics of OC-Sensor/OC-Sensor Diana & OC-Sensor Micro, Hem-SP/MagStream HT, FOB Gold/SENTiFOB analyser {5-9}.

Different authors {5-8} have compared the analytical performance of 3 iFOB tests: OC-Sensor/OC-Sensor Diana & OC-Sensor Micro, Hem-SP/MagStream HT, FOB Gold/SENTiFOB analyser. With regard to reproducibility and temperature stability, OC-Sensor performed better than Magstream and far better than FOB Gold. For all tests, variability was essentially related to sampling. Detected Hb levels were substantially lower for all tests at temperatures above 20 C. This loss is more important for FOB Gold than for other two tests. Some suggestion are made, like delay between sampling and test processing should be reduced to 3 days, or CRC screening programs should be stopped during the summer in countries with long period of very high temperatures >30 C. Patients should be advised to store faecal samples in the refrigerator at home before forwarding them by post.

Rossum et al. {10} reported that delay in sample return increased false negative iFOBT because of Hb degradation. Compared with no-delay, the adenoma detection rate was significantly decreased after >5 days delay (OR 0.6; 95% CI 0.4-0.9).

Sentinel Diagnostic Spa, manufacturer of FOB Gold NG test was only one who responded on our Survey for Manufacturer and sent documentation for their FIT products. The product leaflet of SENTiFIT pierce Tube (collection tube) writes that the human haemoglobin extracted from the feces sample and obtained according to the recommended collection procedure is stable for 14 days at 2-8 C or 7 days at 15-30 C protected from direct light.

The authors of the NHS Centre Evaluation report in 2009 {5}, concluded that the OC-Sensor/DIANA analyser was the most suitable system for the English CRC population-based screening programme. They reported that even when the faecal collection devices were used by experienced evaluation staff, none of the sampling devices gave reproducible results, contributing to the overall imprecision of the methods. Manufacturers claims for stability of the Hb in faecal samples added to the collection devices and stored at room temperature (23C-26C) prior the analysis were confirmed for the OC-Sensor/DIANA method only. Analytical methods comparisons are presented in Table 3.

Table 3. Analytical methods comparisons for 3 iFOB tests: OC-Sensor/OC-Sensor Diana & OC-Sensor Micro, Hem-SP/MagStream HT, FOB Gold/SENTiFOB analyser {5}

According the authors of this report {5}, all 3 analytical platforms are easy to operate and maintain once appropriate training has been received. For all three tests, the liquid samples stored at room temperature for more than three days are not suitable for analysis, due to deterioration of any Hb present. This should be taken in account when sending samples via different MSs postal systems (should be returned within this time). The OC-Sensor/DIANA analyser was the most suitable system for the UK bowl cancer screening programme, despite limited reagent, wash and waste capacity (regular attention will be required in a busy screening laboratory). The FOB Gold/SENTiFOB analyser has a very low sample throughput. The HemSp/MagStream HT has a non-adjustable cut-off, the method is not CE marked for quantitative measurement of human Hb. The system gave negative results for samples that were positive by other methods.

For all three tests sample collection devices should be stored between 2 and 10 C in case of any delay in analysis, so refrigerated storage space is required. The number of analysers required will depend on the laboratory workload; number required for a 5,000 sample per day workload will be 1 for HemSp/MagStream HT; 5 for OC-Sensor/DIANA, and 15 SentiFOB and 1 chemistry analyser for FOB Gold/SENTiFOB. Specialist training is provided by the manufacturers (instructions on routine use and maintance of the analyser). Staff will be required to authorise each batch of results generated from the iFOBT analysers and transfer the data to the bowel cancer screening programme database, if such exists {5}.

Results {5-8}

FITs /iFOBTs are a class of faecal occult blood tests and one out of few different screening options for colorectal cancer (CRC). The aim of population-based screening for CRC is to reduce mortality through both, prevention (by the removal of adenomas) and earlier diagnosis of CRC.

Overall, the advantages of FIT in contrast to gFOBT are: specificity for human Hb, reducing the number of false positive results and no dietetic restrictions are necessary; increased sensitivity to human Hb; automated analysis and the possibility to set cut-off limits (the latter applies only to quantitative FIT tests).

According to the EU Guidelines for quality assurance in CRC screening and diagnosis (2010) {6}:

-“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);

-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 manufacturers. Instructions for use 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);

-The potential for dietary interference is significantly less for iFOBT. With the qualification that a diet peculiar to a particular country or culture may not have been tested or reported, dietary restriction is not indicated for programmes using either gFOBT or iFOBT (Level of evidence II, Strength of recommendation  D)“.

FITs are a newer class of Faecal Occult Blood tests (the first FOBTs developed and marketed were gFOBTs). According the EU Guideline 2010(6), iFOBTs have improved test characteristics than gFOBT. iFOBTs have been used for population CRC screening in Japan since 1992. In the US, iFOBTs have been approved by the FDA (Food and Drug Administration) since 2001 (OC-Sensor).

Today, a wide range of qualitative and quantitative tests is available worldwide. Over time, manufacturers have developed new sampling methods (brush-sampling vs stick-sampling FIT) with the aim of increasing simplicity of use and acceptability of test by participants {11}.

According to Lin et al. {12}, a new generation DNA test for colorectal cancer screening will combine genetic markers with an immunochemical assay for haemoglobin. A multi-marker faecal DNA test plus FIT, Cologuard has been developed by Exact Sciences Corp.  They announced results of preliminary analysis of recently completed DeeP-C pivotal clinical trial in April 2013 (13), registered in ClinicalTrial.gov {14}. No study results posted on ClinicalTrials.gov yet. This study compared “the performance of the Cologuard test to colonoscopy and faecal immunochemical testing or FIT” (according the ClinicalTrial.gov, Primary outcome was Sensitivity and Specificity of the Exact CRC screening test with comparison to colonoscopy, both with respect to cancer; Secondary outcome was to compare the performance of the Exact CRC screening test to a commercially available FIT, both with respect to cancer and advanced adenoma). Exact Sciences planned to submit data from the DeeP-C study to the U.S. Food and Drug Administration as part of its pre-market approval (PMA) submission, and will submit the study's complete data set for publication in a peer-reviewed journal, presentation at a major medical meeting or both.

Apart of health professionals (primary care physicians and nurses, laboratory staff), people invited to screening will use this technology.

The EU guidelines for quality assurance in CRC screening and diagnosis {6} state that “people invited to screening need specific and clear instructions on how to use the kit. Factors that enhance accessibility and uptake are the design of a test kit, and simple and clear instructions which should be provided with the test kit. Effective sample collection is critical to the success of a screening programme with FOBT, so the process of collection should be as simple as possible. Physical and mental disabilities in the screened age group could be one of the reasons for non-participation.

Laboratory staff is necessary in settings where a screening programme is based on a FOBT. The training and skills required are dependent on the type of the test (gFOBT or iFOBT, qualitative or quantitative); staffs require supervision by appropriately qualified individual with expertise in clinical biochemistry, and the day-to-day running of the laboratory must be managed by an appropriate skilled scientific officer. Laboratory staff required training in good laboratory practice, training in the performance of the FOBT, and training in the use of the IT system used to record results, in addition to basic understanding of the CRC process. Laboratory Manager required training on managerial skills, internal quality control and external quality assurance; interactions between the laboratory process and the whole screening programme. Individual with expertise in clinical biochemistry which is responsible for the operation of laboratory required training  on in-depth understanding of CRC, screening process, performance characteristics of different type of FOBT; in-depth understanding of the technology required to perform the FOBT.

Primary care physicians and nurses in primary care should be informed about national CRC screening programme, to be able to help people invited to screening, if they asked for, in form of answering questions on screening and tests, but not to perform FOBT on an individual basis”.

FIT is used in population-based screening for CRC. Faecal occult blood testing for men and women in the range of 50-74 years is the only CRC screening method currently recommended by the EU {15}.

Results {5-9}

iFOBT have improved test characteristics than gFOBT. 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.

In contrast to gFOBT, iFOBT requires shorter transportation time frame due instability on room temperature (this should be taken in account when sending samples via different MSs postal systems, should be returned within 3 days); new investments in laboratory; staff education (instructions on routine use and maintance of the analyser is provided by manufacturers);  all three tests sample collection devices should be stored between 2 and 10 C in case of any delay in analysis, so refrigerated storage space are required. The number of analysers required will depend on the laboratory workload. iFOBT sample collection tubes will require disposal in rigid bins to contain any liquid, which requires different procedure and more manual handling.

FIT is used in the population targeted for colorectal carcinoma screening (CRC). The target group is asymptomatic people at average risk, of both genders. Regarding the age-range, there is evidence endorsing the provision of CRC screening to average-risk individuals, beginning at age 50, to detect cancers at a favourable stage before they have advanced to a potentially lethal disease state. According the Ontario HTA Report {16} persons in whom age is the only risk factor for CRC are considered to be at average risk. Factors that place individuals at higher risk include a family history of CRC or adenoma, personal history of CRC or adenoma, and inflammatory bowel disease. There are other protocols for screening of individuals at higher risk for CRC.

In the European guidelines for quality assurance in CRC screening {6} it is suggested that “in the absence of additional evidence, the age range for a screening programme with iFOBT can be based on the limited evidence for the optimal age range in gFOBT trials. The best age range for offering gFOBT 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 (Level of the evidence IV). The age range for a national screening programme should at least include 60 to 64 years in which CRC incidence and mortality are high and life-expectancy is still considerable. From there the age range could be expanded to include younger and older individuals, taking into account the balance between risk and benefit and the available resources (Level of the evidence VI - B). “

This field of faecal tests for CRC screening is changing fast according literature data. In addition to faecal DNA tests, new area of research is use of RNA markers in stool, as well as the use of DNA or RNA in plasma, serum and urine. Much work is still ongoing on use of protein biomarkers in blood for CRC screening and early detection.

For phase of FIT please see Result card TEC 3.

Faecal DNA tests represent new group of faecal tests designed to detect molecular abnormalities in cancer or precancerous lesion that are shed into the stool. Two faecal DNA tests were commercially available: PreGen Plus, from 2003 to 2008, and ColoSure (single marker faecal DNA assay for methylated vimentin) the only commercially available test in the US, intended for individuals who are not eligible for more invasive CRC screening. New test showed evolution in the composition of the test, as well in pre-analytical factors and analytic factors in comparison with older faecal DNA tests. Authors of the 2012 AHRQ HTA Report {12} concluded that faecal DNA tests have insufficient evidence about its diagnostic accuracy to screen for colorectal cancer in asymptomatic, average-risk patients; insufficient evidence for the harms, analytic validity, and acceptability of testing in comparison to other screening modalities. Existing evidence has little or no applicability to currently available faecal DNA testing.

At its website, Epigenomics stated that Septin9 test, the world's first blood-based IVD test for CRC screening, has been available as a CE-marked test kit in Europe and the Middle East since October 2009. For the improved Septin9 test, Epi proColon 2.0, according to the company’s press release {17}, the fourth module of the PMA was submitted to FDA, which contained the clinical data generated with the test, including the results of the recently reported head-to-head comparative study of the performance of the Epi proColon® to FIT(18) (with no study results posed yet), previously announced data from a clinical validation study in a cohort of prospectively collected samples and other clinical study results generated during the development of Epi proColon®. On 15 05 2013 they also announced that results of the head-to-head comparative study between its blood-based CRC detection test Epi proColon and FIT will be presented at the workshop of the WEO CRC Screening Committee during conference in Orlando, May 17, 2013 {19}.

Results {5-8,20}

Cut-off limits are important in CRC screening due the fact that, by increasing the positive cut-off limit, the test sensitivity and positivity rate decreases and specificity and positive predictive values for CRC detection increase.

European guidelines {6} state that “the choice of a cut-off concentration to be used in an immunochemical test to discriminate between a positive and negative result will depend on the test device chosen, the number of samples used and the algorithm adopted to integrate the individual test results. Whilst an increasing number of studies are reporting the experience of different algorithms, local conditions, including the effect on sample stability of transport conditions, preclude a simple prescribed algorithm at this time. Adoption of a test device and the selection of a cut-off concentration should follow a local pilot study to ensure that the chosen test, test algorithm and transport arrangements work together to provide a positivity rate that is clinically, logistically and financially acceptable (VI - A)”.

Two out of three iFOBT are quantitative tests and have adjustable or user defined cut-off values (OC-Sensor and The FOB Gold); Hem-SP/MagStream HT is qualitative, and has a non-adjustable cut-off value:

• OC-Sensor is CE marked for a user defined cut-off (default setting 100 ng/mL), with 20 ng/mL in buffer as limit of detection.;
• Hem-SP/MagStream HT is qualitative, and has a non-adjustable cut-off at a Hb concentration equal to or greater than 20 ng/ml;
• The FOB Gold is CE marked for a user defined cut-off, with limit of detection of 14 ng/mL buffer, and measuring range of 15-1000 ng/ml.

Van Rossum at al. {20}, using OC-Sensor collection and OC-Micro analyser  concluded that cut-off of 75 ng/ml brought optimal results and may be recommended for population screening in Netherlands. They concluded also in settings where colonoscopy capacity is insufficient, a cut-off up to 200ng/ml would result in minimal false negative results for cancer although more for advance adenoma.

iFOBTs are around 10-fold more expensive than gFOBT. In an evaluation of three automated analytical iFOB methods in the UK {5}, investments made by a laboratory for use of FIT, include:

-Analytical platforms (automated analysers): The number of analysers required will depend on the laboratory workload; number required in the evaluation for a 5,000 sample per day workload will be 1 for HemSp/MagStream HT; 5 for OC-Sensor/DIANA, and 15 SentiFOB and 1 chemistry analyser for FOB Gold/SENTiFOB. All analysers required routine prentative maintance visits (part of the service contract, annualy, but depend on the workload). All analysers required a 13 amp power suplly and purified water to wash the cuvettes (OC-Sensor/DIANA) or for preparation of wash solutions (all three) and system solution (SentiFOB). All three have RS 232-C serial interface ports.

-Sample collection devices: for OC-Sensor the faecal sample was collected into the OC-Auto sampling bottle 3; for Hem-SP/MagStream HT (MagStream Hem-Sp®) the faecal sample was collected into the NEW HEMTUBE; for the FOB Gold the faecal sample was collected into the FOB Gold tube.

- Refrigerated storage space

- Clinical waste disposal.  iFOBT sample collection tubes required disposal in rigid bins to contain any liquid, which required different procedure and more manual handling.

- End of life disposal: end of life disposal of the products may have financial and/or environmental costs, depending on the regulations in place (e.g. Waste Electrical and Electronic Equipment regulation in the UK).

Please see Result card TEC 6.

Please see  Result card TEC 7.

The data and records needed that are described refer to the entire CRC screening process, not only for testing with iFOBT.

According the European guidelines (2010) {6}, relevant data on each individual and every screening test performed must be recorded, including the test results, the decision made as a consequence, diagnostic and treatment procedures and the subsequent outcome, including cause of death, should be ensured. 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, to be able to evaluate the effectiveness of screening.

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 (VI - A).

A database consisting of individual records (one record per person for each screening episode) is essential in order to produce results on screening performance (VI - A).

Quality control procedures for the database should be available and run regularly to check the quality of the data and to correct any data entry errors. (VI - A).

A table should be made to present the test results (positive, negative, or inadequate) by gender and age.

Following Process variables in screening with the faecal occult blood test (FOBT) and other in vitro tests should be applied: Screened/tested; Inadequate test; Positive test; Referral to follow-up colonoscopy.

Following Outcomes variables should be applied to CRC screening performed with any of the currently available primary screening tests; follow-up colonoscopy; lesions; adenomas; advanced adenoma; cancers; severe complications required hospitalizations; 30-day mortality.

Following data tables should be produced: target, eligible, invited, screened/tested at 1^st screening and at subsequent screening episodes; inadequate test; positive test or screening; follow-up colonoscopy examination attended; negative follow-up colonoscopy examination; positive follow-up colonoscopy examination; lesion detected; adenoma detected; non-advanced adenoma detected; advanced/high-risk adenoma detected; cancer detected by stage.

The registers needed are described in detail in the European guidelines for quality assurance in CRC screening {6}: “Relevant data on each individual and every screening test performed must be recorded, including the test results, the decision made as a consequence, diagnostic and treatment procedures and the subsequent outcome, including cause of death, should be ensured. 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, to be able to evaluate the effectiveness of screening.

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.”

The qualification, training and quality assurance processes are described in detail in the respective European guidelines {6}:

“Laboratory staff is necessary in settings where a screening programme is based on a FOBT. The training and skills required are dependent on the type of the test (gFOBT or iFOBT, qualitative or quantitative); staffs require supervision by appropriately qualified individual with expertise in clinical biochemistry, and the day-to-day running of the laboratory must be managed by an appropriate skilled scientific officer.

Laboratory staff required training in good laboratory practice, training in the performance of the FOBT, and training in the use of the IT system used to record results, in addition to basic understanding of the CRC process.

Laboratory Manager required training on managerial skills, internal quality control and external quality assurance; interactions between the laboratory process and the whole screening programme.

Individual with expertise in clinical biochemistry which is responsible for the operation of laboratory required training  on in-depth understanding of CRC, screening process, performance characteristics of different type of FOBT; in-depth understanding of the technology required to perform the FOBT.

All laboratories providing population screening should be led by a qualified clinical chemist trained and experienced in the techniques used for analysis and with clinical quality assurance procedures (Level of evidence VI, Grade of recommendation B).

All laboratories providing screening service should be associated with a laboratory accredited to ISO 15189:2007 Medical laboratories-Particular requirements for quality and competence. Also they should perform Internal Quality Control procedures and participate in appropriate External Quality Assessment Scheme (Level of evidence VI, Grade of recommendation B).

Automated check protocols should be implemented to ensure correct identification of the screen population and complete and accurate recording of individual screening participation and test results.  Protocols should be implemented to ensure standardised and reliable classification of the test results (Level of evidence VI, Grade of recommendation A).

Quality assurance of iFOBT

Manufacturer’s Instructions for Use must be followed. Daily checks of analytical accuracy and precision across the measurement range with particular emphasis at the selected cut-off limit should be performed. Sufficient instrumentation should be available to avoid delays in analysis due to instrument failure or maintenance procedures. 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. (Level of evidence VI, Grade of recommendation B).

All laboratory performance outcomes like uptake, undelivered mail, time from collection to analysis, analytical performance, positivity rates, lots and spoilt kits and technical failure rate, technical performance variability and bias should be each subject to rigorous monitoring (Level of evidence VI, Grade of recommendation A).“

Please see Result card TEC 12.

According the Manufacturer of FOB Gold NG assay, simple training is required in order to inform the users about the use of the product and results interpretation. The typical professional laboratory operator is able to use the test in a very short time.

Information and education provided about CRC and CRC screening test and procedures is a key component of CRC screening programmes. Three phases in which information can be provided to participants are: Invitation phase (invitation for screening through invitation letters and leaflets); Reporting results page (screening test results are communicated to the participants), and Follow up phase (for people with positive FOBT results).

Personal invitation letters, preferably signed by the GP, should be used. Specific instructions on how to use FOBT kit or perform the bowel cleansing procedure need to be communicated to the patient. Patient should be able to understand written instructions how to perform these procedures. Written material should be clear, visually appealing and motivating.

 Recommendations from EU Guidelines {6} on different screening process steps are (see also TEC 14-Appendix 1):

“To communicate CRC screening information, including written instructions on how to use the FOBT kit or perform the bowel cleansing procedure, the language and text format used should be easy to understand and illustrations may be used. Ideally, written information (including written instructions) should not be the only source of information and should be complemented by visual communication instruments and/or oral interventions (VI - A).

Primary health care providers should be involved in the process of conveying information to people invited for screening (II - A).

In the context of an organised programme, personal invitation letters, preferably signed by the GP,

should be used. A reminder letter should be mailed to all non-attenders to the initial invitation (I - A).

Clear and simple instruction sheets should be provided with the kit (V - A).

Use of a non-tailored leaflet for the general population is advised; the leaflet should be included with the invitation letter. Information about CRC screening risks and benefits, CRC risks (incidence and risks factor), meaning of test results, potential diagnostic tests and potential treatment options should be included (VI - A).

Illustrations may be used, which would be particularly useful for minorities, the elderly or low-literacy participants (II - A).

Video/DVD may be a useful component in a multi-modal intervention in addition to written information, and would be particularly useful for the elderly, minorities and low literacy participants (I - B).

For the elderly, increasing the number of components of the multi-modal intervention and the period over which these components are provided may be more effective (I - B).

A computer-based decision aid could be used to help both the general population and specific groups to make informed decisions about CRC screening (I - B). The computer-based decision aid should be “user-friendly” and designed to fit with the computer abilities of the target population (general or specific groups).

If possible, all information provided by the screening programme should be available on a specific web site. This information should be regularly updated (VI - A).

Patient navigation could be used within CRC screening programmes, particularly to reach subgroups of the population such as the elderly, those with low literacy, and medically underserved patients. When used with minorities, the patient navigator should be from a similar ethnic background and/or live in the same community as the participant (I - B).

Verbal face-to-face interventions with a nurse or physician could be used to improve knowledge and participation. They would be useful to reach subgroups of the population such as the elderly, minorities and those with low literacy (I - A).

Nurses and primary care practitioners (GPs) should receive adequate training to be able to help people make informed decisions about CRC screening (VI - A).

CRC screening programmes should work closely with advocacy groups and the media and provide them with up-to-date, accurate and comprehensive information about CRC and CRC screening (VI - A).

A telephone or ideally a verbal face-to-face intervention, e.g. nurse or physician intervention, should be used to inform a patient of a positive screening test result, as obtaining such a result could be a source of psychological distress for the patient. A letter informing the patient should not be used as the only way of notifying a positive result (VI - A).

To increase endoscopy follow-up after a positive FOBT and facilitate communication, CRC

screening programmes should, where possible:

- Use a reminder-feedback and an educational outreach intervention targeted to the primary

care physician (II - A);

- Provide patients with a written copy of their screening report (II - A);

- Facilitate patient consultation with a gastroenterologist (V - B);

- Describe the follow-up procedure, make the follow-up testing more convenient and

accessible (VI - A); and

- Use direct contact intervention to address psychological distress and other specific barriers.

(V - B).

Each endoscopy service must have a policy for pre-assessment that includes a minimum data set relevant to the procedure. There should be documentation and processes in place to support and monitor the policy (III - B).

The endoscopy service must have policies that guide the consent process, including a policy on withdrawal of consent before or during the endoscopic procedure (VI - B).

Before leaving the endoscopy unit, patients should be informed about the outcome of their procedure and given written information that supports a verbal explanation (VI - A).

The outcome of screening examinations should be communicated to the primary care doctor (or equivalent) so that it becomes part of the core patient record (VI - B).

Ideally, the invitation letter and the letter used for notification of a positive result should be sent with a leaflet and should encourage participants to read it (VI - A).

Certain basic information, e.g. logistic/organisational information, description of the screening test, harms and benefits of screening, information about the FOBT kit and the bowel cleansing procedure, must be included in the invitation/result letter in case a person reads only the letter and not the leaflet (VI - A). ”

General information on CRC burden and CRC screening clinical importance and CRC screening methods available.