The domain methodology was used for this question (analysis of selected studies extracted from the basic literature search). Two reports, one document with guidelines and four articles were found to be relevant to this question. We found additional information by an internet search of grey literature performed on 21 June 2013 via the search engine Google. It was performed by investigator using the phrase: “Slovenian colorectal cancer screening programme”. One grey literature source is referred to in these results, more precisely a presentation, prepared by Institute of Public Health of Slovenia.

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With FOBT, stool samples are analysed for the presence of occult blood. FOBTs are either guaiac-based (gFOBT) or immunochemical tests (FIT). gFOBTs investigate the presence of any blood, whereas FIT are specific for human blood {4}.

The specific policy of a screening programme determines the target age and gender and possibly the geographical area, the screening test and screening interval, and further diagnostics and treatment for those who need them. European guidelines compare opportunistic screening and organized screening. The evidence shows that organised screening programmes achieve better coverage of the target population including hard to- reach or disadvantaged groups. 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 {4}.

Organized screening should generally include a regional or national team responsible for the implementation, quality assurance and reporting of results. Comprehensive guidelines, rules and a quality assurance structure should be available. Population-based screening requires the identification and personal invitation of each person in the eligible target population (by an office or special agency) {5, 6}.

Organised CRC screening is a multi-step process including {4}:

·         Identification of the target population;

·         Recruitment of eligible subjects;

·         Delivery of screening test;

·         Reporting of screening test results;

·         Reassurance of people with negative results and information on the timing of the next test;

·         Recall of people with unsatisfactory/inadequate screening test

·         Follow-up of people with positive tests, i.e. diagnostic procedures and treatment needed, including a fail-safe system to make sure this actually happens; and

·         Registration, monitoring and evaluation of the entire programme.

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. The target group contains approximately 136 million individuals suitable for CRC screening (aged 50 to 74 years). Of this number, 43% individuals come from 12 countries where CRC population screening is performed or being prepared on either national or regional levels (i.e. Cyprus, Finland, France, Hungary, Italy, Poland, Portugal, Romania, Slovenia, Spain, Sweden and the United Kingdom) {4, 5, 6}.

Testing stool for occult bleeding (fecal occult blood test, FOBT) is the most frequently applied method. 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). According to the data of European Guidelines {4}, EU report on implementation of the Council Recommendation on cancer screening {5} and Zavoral et. al. {6}, two types of tests was used in six countries: 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 (which is followed by colonoscopy in case of positive screening results) {7}.

Another study, executed by the International Colorectal Cancer Screening Network, also compares screening programs on international level. The study identifies 43 organized screening programs, of which 28 of them used FOBT as their primary screening modality. Of these, 16 used guaiac tests, 9 used immunochemical tests and 3 used both kinds of tests. The country comparison in this study, which observed 15 European countries – 13 of them are part of EU 27 –, reveals that there are 10 EU countries who used gFOBT and 3 EU countries, which used FIT (Italy, Netherlands and Hungary) {8}. The report on colorectal cancer in Europe and Australia {9} confirms that FIT method is used in Italy, Netherlands and Hungary, furthermore, this report indicates that FIT is also used in 2 more European countries (Czech Republic and Spain), including Australia {9}. According to Spanish study of Ascunce et al. (2010) it can be confirmed that Spain is using gFOBT, as well as FIT technology for CRC screening. In more detail the data from the study indicated that CRC screening had been implemented in 6 regions (out of 17), {10}

The survey, implemented among 11 European countries (i. e. Austria, Russia, Luxembourg, Lithuania, Italy, Scotland, Spain, Romania, France, Croatia and Slovenia), indicated that only 5 countries (Russia, Lithuania, Italy, Spain and Slovenia) out of 11 uses FIT technology. Other countries, which participated to the survey, use gFOBT technology, with exception of Scotland who uses gFOBT and FIT only in case if individuals are required to repeat the test or do the retest. One of the exceptions is also 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 requires no additional costs for target population and is founded by the country.

Most programs using gFOBt collected six stool samples (two samples from three consecutive bowel movements), whereas programs using FIT collected only one or two stool samples (one sample per bowel movement). Regardless of the number of samples taken, most programs defined a test as positive when any of the samples was considered positive. However, England and Spain defined gFOBT test as positive when at least five of the six samples were positive on first tests, or for borderline tests (1–4 samples positive), on repeat testing (any of 12 samples positive on two further tests). Scotland defined a test as positive when at least five of the six samples taken were positive, or when 1–4 of the six samples and a subsequent FIT were positive {8}.

In the following eight states: Belgium, Denmark, Estonia, Ireland, Lithuania, Luxembourg, Malta, and the Netherlands, CRC screening has not been implemented yet, but according to the data of  European guidelines Denmark and the Netherlands are currently in the decision process for implementing a CRC screening programme {4, 5, 6}.

Identifying a target population (see Figure 2)

Participation in screening (see Figure 3)

Testing protocol

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. The studies review in European guidelines shows no evidence that any of these strategies may have an impact on the proportion of inadequate samples, provided that clear and simple instruction sheets are included in the kit {4}.

The choice of the provider should aim to maximise accessibility, taking into account local conditions, settings and cultural factors {4}.

According to study review, mailing of the FOBT kit with instructions, together with the invitation letter and the information leaflet, is effective in increasing participation rates. These results are consistent with previous reports indicating that the GP’s letter and mailing of FOBT kits represent the most important factors for improving compliance. Mailing of the FOBT kit might not always represent a cost-effective strategy, if the baseline participation rate and the expected increase in participation are low. Compared to mailing a second FOBT kit to all non-responders, mailing a recall letter with a test order coupon resulted in a substantial decrease in the programme costs, but also in a significant decrease in participation. The authors of the trial suggested, however, that the spared costs might be allocated more efficiently to communication interventions that might have a higher impact on compliance. Several test providers close to the target population should be available when the subject is required to reach health or community facilities to get the kit {4}.

Volunteers or non-health professionals may also be involved in the distribution and collection of kits. Delivery of kits may represent in this case an additional opportunity for counselling, for conveying information about the programme and for providing instructions for test utilisation. Subjects contacted at home by a trained non-health professional, who delivered the kit and collected the sample from the participant’s home showed a substantially higher completion rate of FIT, as compared to the group who received the kit by mail with an invitation from their primary care physician {4}. Programs Using Mailed Contact and Screening Kit include those that make direct contact with individuals who are determined to be eligible for CRC screening, and place a screening kit in the hands of potential respondents. Countries that are using this method are, according to the study of Swan et. al., the following: Croatia, Finland, France, Italy, Spain and UK. Programs Using Office Visit Contact, which rely on providers in

the health system to offer CRC screening to individuals who are determined to be eligible for CRC screening, are implemented in Latvia, Czech Republic, Germany and Poland {11}.

Community volunteers, who have received some general training by the programme staff, have been involved in the kit distribution in the context of ongoing organised programmes and their involvement has been consistently associated with high participation rates. As no randomised comparison is available, it is difficult to dissociate their specific effect from other characteristics of the communities or target populations involved. Sustainability over time represents an important issue to be taken into account when planning to use volunteer support. The modalities adopted for stool collection, storage and shipping of the sample to the laboratory are mainly dependent on the characteristics of the test adopted, i.e. its stability at environment temperature. Based on these considerations mailing of the samples may be an option that can be implemented more easily for guaiac than for immunochemical tests, which need to be processed faster.  The haem moiety used in gFOBTs is more stable than the globin moiety used in FITs. Transport of a dried sample, which is used for most guaiac test kits, provides greater stability than that in wet buffer which is usually used for immunochemical tests. The acceptable time period between sampling and testing is defined by the product manufacturers in their Instructions For Use (IFU). For gFOBTs the maximum time period is usually between 14 and 21 days; for FIT it is much less {4}.

Accessibility of the collection facilities remains an important goal, but the logistics of the sample handling may promote reducing the number of collection facilities in order to ensure an appropriate storage or timely shipping to the laboratories {4}.

When samples are collected, they are sent to the laboratory examinations. Laboratories must strictly follow the procedure’s protocol, under the constant monitoring, in order to reach quality assurance standards.

Detailed protocols on handling the stool samples must be available and followed through the whole process. Identification and tracing of the sample through the entire process should be ensured by adopting appropriate labelling allowing the sample and patient’s ID code to be linked. Automated check protocols should be implemented in order to avoid mismatching of the results. All data, including test results, should have a regular backup system. An operational definition for an inadequate screening test should be made explicit in the programme protocol, taking into account the characteristics of the test (i.e. the stability and the storage requirements of the tests) as well as the testing procedure adopted (i.e. the number of samples or of cards required). Protocols should be in place to define the appropriate test and the algorithm used to classify a test result (as negative or positive). For quantitative or semi-quantitative [1]FITs, an explicit definition of cut-off levels for haemoglobin concentration should be defined. Protocols or rules for combining results when using multiple samples, the number of samples that are needed to evaluate the test result, etc. must be in place. When using a quantitative test, provision should be made to record the information concerning the actual amount of haemoglobin, both for tests classified as negative and for those classified as positive. Some people may present with clinical conditions such as inflammatory bowel disease (Crohn’s disease or haemorrhagic recto-colitis), which may explain a positive FOBT result. In such cases, if no cancers were detected, then the screening results should be classified as negative for the purposes of the screening programme. These patients should then be referred for treatment in the appropriate clinical setting {4}.

There are some differences between FIT and gFOBT. Nevertheless European experts agree it is difficult to draw simple conclusions from the variety of different tests and study settings, it can be concluded that FIT in comparison with gFOBT:

•          Has no need for dietary restriction;

•          Has a major problem with sample instability, and collected samples should preferably be kept cool and returned immediately for analysis;

•          Provides a greater participation rate than gFOBT;

•          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 (positive predictive value) 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 {4}.

Several providers of  bowel preparation close to the target population should be available when the subject is required to reach health or community facilities to get the preparation. Organisational options include the possibility of having the enema administered at the endoscopy unit. Clear and simple instruction sheets should be provided with the preparation {4}.

The potential reduction of mortality through cancer screening can only be achieved if subjects with abnormal findings receive timely and appropriate follow-up for detected abnormalities. The ascertainment of interval cancers represents a key component of the evaluation of a screening programme. The documentation and evaluation process requires forward planning and linkage between screening registries and cancer registries, including data on causes of death, with no losses to follow-up. Data collection and reporting should cover information on colorectal cancer appearing in the target population. Methods of ascertainment and follow-up may differ across countries and screening programmes depending on the availability and accessibility of data and of existing data sources: cancer/pathology registries, clinical or pathology records or death records/registries {4}.

Defining the relevant healthcare professionals

Depending on each country’s health system and culture, different health professionals can be involved in kit delivery and stool sampling collection or in delivering bowel preparation for endoscopy screening (i.e. GPs, nurses, paramedics, pharmacists, volunteers from no-profit organisations, etc.), as well as in performing colonoscopy, sigmoidoscopy when offered as a screening test (i.e. GPs, nurses gastroenterologists,). Each country should follow quality assurance standards for the facilities and establish minimum training requirements for each type of professional, fulfilling the present guidelines {4}.

  [1] Quantitative FIT - adjustable cutoff point and high throughput analysis; Semi-quantitative nature of test  permits adjust ment of the cutoff value for the detection of colorectal cancer (CRC) in an effort to optimise screening programmes for specific populations and health-care practices;  

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Analysis of selected studies extracted from the basic literature search. Two articles and one document with guidelines were relevant to this question.

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A Netherlands study found that attitudes towards CRC screening strongly correlated with participation. People who considered screening to be ineffective, those expressing anxiety and those who are not familiar with CRC screening tests were less likely to participate. Knowledge of CRC and screening is therefore a positive predictor of participation. According to the study, having acquaintances affected by CRC increased screening participation. Researches also indicated that CRC screening participants are more often engaged in other health-promoting interventions, such as regular dental visits and other forms of cancer screening; those who are more familiar with health prevention are more likely to participate in screening. Italian study also indicates that physical health below average was a positive predictor of FOBT screening participation. A possible explanation may be that those of worse physical health may worry more about their health or are more familiar with health care and therefore are more inclined to participate. The fact that the absence of abdominal complaints is the main reason for non-participation in FOBT screening, and that insufficient knowledge significantly correlates with non-participation highlights the need of adequately informing the target population, including making individuals aware that CRC symptoms mostly occur late in the course of the disease and CRC can be present without symptoms. This Netherlands study reveals that only 12% of non-participants had made an informed choice on non-participation. So, screening organisations should focus on adequate information provision to the target population by for example suitable information brochures, information meetings, and media coverage, as this will affect the two of the most important parameters for the success of screening: informed choice and participation {13}.

Another study showed participants' low awareness of the faecal occult blood test before they received the invitation for screening. Awareness of bowel cancer was mainly through past experience or family history or was work-related. Data suggested that demography and cultural issues such as age, sex, taboo, attitudes, altruism, so-called ostrich syndrome, and stoicism can affect behaviour and decisions. Knowledge and awareness were identified as factors in breaking some of the cultural barriers affecting uptake {14}.

According to several studies one of the major factors that influence the participation in screening programme is increasing knowledge. Therefore it is highly important to make a screening programmes and information about screening easily accessible. Different strategies for making screening programme easily accessible are used. The most widely used strategy is to consider the size of the population and the patients’ geographic distribution and to establish local screening centres for better availability. Also mobile screening vans can be used for more distant areas.

Selection and management of the participants through the screening process needs to be well organized. Participants must receive complete information about benefits and risks, as well as pros and cons of participation in screening programme. Patient, who decides to participate in the screening process, needs to be aware and consider the screening protocol. According to the data of European guidelines 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, who can deliver the kits and collect samples {4}.

In order to reduce the probability of a false positive result, dietary restrictions are usually recommended when guaiac-based tests are used. More recent randomised trials have demonstrated that better compliance can be achieved using FIT compared to a gFOBT test, because FIT does not require modification of a subject’s diet and sampling is limited to one or two bowel movement. In order to enhance compliance European guidelines therefore recommend testing procedures that require no or only minor dietary restrictions {4}.

Distribution of task is also presented in the picture below (i.e. Figure 4):

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Analysis of selected studies extracted from the basic literature search. One report and one document with guidelines were relevant to this question.

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Depending on each country’s health system and culture, different health professionals can be involved in kit delivery and stool sampling collection or in delivering bowel preparation for endoscopy screening (i.e. GPs, nurses, paramedics, pharmacists, volunteers from no-profit organisations, etc.). Each country should follow quality assurance standards for the facilities and establish minimum training requirements for each type of professional, fulfilling the present guidelines {4}.

All staff involved in the delivery of a colorectal cancer screening programme must have knowledge of the basic principles of colorectal cancer screening. To achieve this it would be appropriate for them to attend a course of instruction at an approved training centre prior to the commencement of the programme. Updating knowledge as part of continuing medical education should be encouraged. Participation in training courses should be documented and certificates of attendance issued based on the levels of skill attained and evaluated. Specific training requirements in terms of quality and volume should determine eligibility for any certification or accreditation process which must be applied only to centres with sufficiently skilled personnel {4}.

The success of a colorectal cancer screening programme is dependent 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 includes {4}:

• Administrative and clerical staff (A colorectal screening programme can be run under the umbrella of a screening programmes division associated with the national or regional health department where this exists. This allows the colorectal screening programme staff to benefit from the experience gained from other screening programmes. In the UK, the organisation of the colorectal screening programmes is overseen by a programme manager who reports to a national or regional screening coordinator responsible for all screening programmes. In addition to a programme manager each centre that is responsible for sending out invitations and/or organising screening tests for those who accept the invitations is overseen by a screening manager who is responsible for the efficient operation of the screening programme and managing the staff of the screening centre. The staffing of the screening centre depends on the structure of the programme itself; e.g. if it is a centralised programme, staff are required for identifying individuals to be invited, sending out invitations, replying to those who have undergone testing and, where appropriate, organising further investigations for those with positive tests.);

• Epidemiologists (As many disciplines contribute to providing data required for monitoring and evaluating of a colorectal screening programme it is essential that a designated individual with relevant epidemiological expertise oversees the collection and analyses the data required for evaluation. Assessing a programme’s impact on colorectal cancer mortality is only possible if adequate provision has been made in the planning process for adequate collection and analysis of data. Basic Training: The individual overseeing data collection and analysis requires training in clinical epidemiology and statistics. Specific training: Training for epidemiologists involved in a colorectal cancer screening programme focuses on:

  • Colorectal cancer epidemiology (incidence, prevalence, mortality, trends);

  • Screening theory (pre-clinical disease, lead time, selection, length bias);

  • Colorectal cancer screening terminology (sensitivity, specificity, positive predictive value etc);

  • The colorectal screening programme (organisation, current screening modalities);

  • Ethical and confidentiality issues;

  • Setting up a colorectal cancer screening programme (identification and an invitation of target population, call-recall system, follow-up system);

  • Strategies for data collection and management (use of appropriate databases, individual files,

  • computerised archives, linkage to appropriate registries, classification of screening outcomes, quality control procedures and data collection);

  • Statistical analysis and interpretation of results (performance indicators for evaluation, predictors of the impact of screening, assessing screening impact and effectiveness, cost-effectiveness calculations); and

  • Presentation of data and report writing.);

• Laboratory staff (In the case of FOBT cancer screening programme, where screening is based on a laboratory test, it is self-evident that an adequately staffed laboratory is necessary. It is similarly self-evident that the training and skills required by the laboratory staff are dependent on the type of test (guaiac or immunochemical, qualitative or quantitative). The laboratory staff require supervision by an appropriately qualified individual with expertise in clinical biochemistry, and the day-to-day running of the laboratory must be managed by an appropriately skilled scientific officer. When faecal occult blood testing is being used as the primary test for a colorectal screening programme it is essential that this be done with appropriate internal quality control (IQC) and external quality assurance (EQAS); and this requires centralisation, either on a national or regional basis, of the testing process. Delegation to individual practitioners is not appropriate. The training required for the laboratory staff should include the following:

  • A basic understanding of colorectal cancer and the benefits of early diagnosis (a basic understanding of the colorectal cancer screening process);

  • Training in good laboratory practice;

  • Training in the performance of the faecal occult blood test (the specific training will depend on whether a guaiac or immunochemical test is used and whether it is a qualitative or quantitative test); and

  • Training in the use of the IT system used to record results.

In addition, the training required by the Laboratory Manager includes:

• Managerial skills;

• An appreciation of internal quality control and external quality assurance; and

• A thorough understanding of the interactions between the laboratory process and the whole screening programme.

An individual with expertise in clinical biochemistry is ultimately responsible for the operation of the laboratory and requires training in the following:

• An in-depth understanding of colorectal cancer (diagnosis, treatment, prognosis, staging and the importance of stage at diagnosis);

• An in-depth understanding of the colorectal cancer screening process (including screening theory and especially the potential benefits and harms of screening and the prime importance or quality assurance);

• Extensive knowledge of performance characteristics of different types of faecal occult blood test; and

• An in-depth understanding of the technology required to perform the faecal occult blood test.;

• Primary care physicians (There is ample evidence for the importance of involving primary care physicians in the implementation of colorectal cancer screening programmes. The role of primary care physicians in colorectal cancer screening will vary widely from one European country to another. In some instances the general practitioner (GP) is required to invite the target population, in some instances they are required to encourage their patients to participate in a centrally organised screening programme and in some instances they may not play a direct role in the screening programme but will clearly be required to answer questions on screening posed by their patients. It must be emphasised however, that general practitioners should not be encouraged to perform faecal occult blood tests on an individual basis as it is impossible to ensure adequate quality assurance for the performance of the test. The training required of general practitioners working in an area where there is an active screening programme should include the following:

  • A thorough knowledge of colorectal cancer (diagnosis, treatment, prognosis, staging and importance of stage at diagnosis);

  • An in-depth understanding of the colorectal screening process (including screening theory and particularly the potential benefits and harms of screening, and the prime importance of quality assurance); and

  • A thorough knowledge of the organisation of the local screening programme and the role of GPs within the programme.

• Endoscopists (Endoscopists carrying out colonoscopy as the investigation following a positive primary screening test, are central to the delivery of a successful screening programme. It is essential that they be skilled in complete examination of the colonic mucosa and in recognising both cancers and pre-cancerous lesions (i.e. adenomas). It is also essential that they be skilled in biopsy and polypectomy technique such that they can carry out lower gastrointestinal endoscopy safely and effectively. Different countries will employ different types of health professionals to undertake endoscopy, including medically qualified gastroenterologists, medically qualified surgeons, nurse endoscopists and, in some instances, endoscopists who have neither a formal medical nor a nursing qualification);

• Radiologists (While the majority of European countries will employ colonoscopy as either the main investigative technique for a positive test or as the primary screening test, radiology expertise is required to investigate the colon in those individuals in whom a complete follow-up or surveillance colonoscopy is not achievable.);

• Pathologists (Pathologists working within a colorectal cancer screening programme require full training in the histopathology of gastrointestinal disease with specific emphasis on colorectal cancer. These pathologists should be skilled in the following areas:

  • The interpretation of biopsies taken from benign and malignant tumours of the colon and rectum;

  • The preparation and histological interpretation of endoscopic polypectomy specimens; and

  • The preparation and histological interpretation of surgical resection specimens.

They also need the following training requirements:

• Good knowledge of the disease processes that can affect the colon and their histological appearances;

• An ability to distinguish between benign and malignant biopsy specimens;

• An ability to distinguish between benign and malignant polypectomy specimens;

• An ability to access the risk factors associated with recurrence after endoscopic excision of malignant polyps;

• An appreciation of immunohistochemistry where it relates to histological interpretation of colorectal tumours; and

• The ability to prepare a colorectal resection specimen, with particular emphasis on harvesting lymph nodes and assessing the circumferential resection margin.

• Surgeons (Most cancers and a small proportion of large adenomas detected within a colorectal screening programme will require surgical excision, and it is important that this be carried out as effectively and safely as possible. The beneficial effect of early detection of colorectal cancer is dependent on low mortality and morbidity rates associated with the subsequent surgery. It is now recognised that both short- and long-term results of surgery for both rectal and colon cancer are highly surgeon-dependant and there is now good evidence that specialisation associated with high volume is associated with improved results. It is therefore mandatory that all screen-detected cancers requiring surgery are treated by surgeons who specialise in colorectal surgery, preferably with a particular interest in cancer. It is also essential that these surgeons work in multidisciplinary teams with access to oncologists experienced in both adjuvant and palliative treatment of colorectal cancer. It follows that surgeons treating patients with screen-detected colorectal cancer should be fully trained and possess the appropriate qualifications for a colorectal surgeon. In addition to the specialist training that this entails, surgeons working within a colorectal screening programme have the following training requirements:

  • An understanding of the basic principles of screening, with particular reference to colorectal cancer; and

  • An understanding of the significance of pT1 cancers with reference to the need for completion surgery.

Screen-detected cancers may be particularly suitable for laparoscopic resection, and it is essential that any surgeon utilising this technique is fully trained and, where appropriate, accredited. While some surgeons may be in a position to obtain appropriate training for laparoscopic surgery within their own institutions, this may not always be the case; and it is essential that surgeons wishing to carry out laparoscopic colorectal surgery should attend the appropriate courses and obtain the appropriate training wherever this is available.;

• Nurses (Nurses have important roles throughout the colorectal screening pathway, from the initial contact with the screening invitees through diagnostic endoscopy both as an endoscopy nurse or as a nurse endoscopist, to the care of the patient requiring surgery. The importance of these roles will vary from country to country and indeed from region to region within countries. The nursing skills required to care for screening patients are essentially the same as those required to care for symptomatic colorectal patients in many situations. However, the specialist colorectal nurse may have a specific role to play, particularly in counselling individuals with positive screening tests. Such nurses are fully qualified and have experience in specialist colorectal nursing. The training requirements for nurses in a colorectal cancer screening programme include the following:

  • An in-depth understanding of colorectal cancer (diagnosis, treatment, prognosis, staging and importance of stage at diagnosis);

  • An in-depth understanding of the colorectal screening process (including screening theory and particularly the potential benefits and harms of screening, and the prime importance of quality assurance); and

  • Advanced communication skills.

Appropriate courses should be available for nurses involved specifically in colorectal cancer screening programmes to address these issues, including adequate training to be able to help people make informed decisions about CRC screening.

• Public health specialists (Considering the different healthcare environments, public health specialists with adequate epidemiological knowledge or equivalent expertise are recommended. These professionals are needed from the onset, to ensure that the programme includes a population-based information system that monitors each step of the screening process. They will then be responsible for gathering data and for ongoing monitoring in order to identify problems that need intervention. These public health specialists can be based at a national or regional level, whereas the other health professionals who are providing screening services are needed in each area.. The role of the public health specialist in a colorectal cancer screening programme is to ensure coordination of the component parts of the screening programme in such a way as to optimise delivery of the programme to the target population. This will include endeavouring to maximise uptake by means of health promotion initiatives and addressing inequality issues. The role of the public health physician may vary from country to country and from region to region within countries, but public health specialists are well placed to act in a coordinating role. Public health specialists engaging in colorectal cancer have the following training requirements:

  • An in-depth understanding of colorectal cancer (diagnosis, treatment, prognosis, staging and the importance of stage at diagnosis);

  • An in-depth understanding of the colorectal cancer screening process (including screening theory and particularly the potential benefits and harms of screening, and the prime importance of quality assurance);

  • A full understanding of the mechanisms whereby colorectal cancer screening is delivered in their population; and

  • Training in effective health promotion.

Public health specialists should therefore have training in and an understanding of basic epidemiology, statistics and communication. Courses or the ability to visit screening centres can provide this specific training.

Criteria for personnel and training

All staff involved in the delivery of a colorectal cancer screening programme requires knowledge of the basic principles of colorectal cancer screening. The need for specialist training in screening differs between the different disciplines and is most important for those involved in the delivery of the service and diagnosis, e.g. laboratory staff, endoscopists, radiologists, pathologists and nurses. The surgical treatment of screen-detected cancer and post-operative treatment is not performed differently according to whether a cancer is screen detected or symptomatic, but there are certain considerations for the surgeon to take into account when treating a screen-detected cancer. Professional requirements of oncologists are not discussed in this chapter because; stage for stage, their role in the treatment of screen-detected disease is no different from that in symptomatic disease {4}.

According to the Report on the implementation of the Council Recommendation on cancer screening, very high level of adequate training is reported in the European level. Twenty (i.e. Austria, Belgium, Cyprus, Czech Republic, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Netherland, Poland, Slovakia, Slovenia, Spain, Sweden, UK) out of 22 responding Member States (91%) reported that screening programme personnel is adequately trained at all levels to ensure that they are able to deliver high quality screening{5}.

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Analysis of selected studies extracted from the basic literature search. Seven articles were found to be relevant to this question and one document with guidelines. 

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Communication is the primary tool for educating people about cancer risks and motivating them to seek out screening for early detection of cancer. Promotion of early cancer detection and screening often involves the use of communication campaigns, educational materials, and behavioural intervention programs {14}. There are positive effects of intrapersonal, interpersonal, group, organizational, and societal communications on cancer screening behaviours {15}.

Within the communication it is extremely important that the information is transferred and communicated to the information’s receiver in a proper way. Cancer communication messages must be therefore designed and delivered to match the communication skills, needs, and pre-dispositions of specific audiences. To influence entrenched health behaviours, messages need to be relevant and compelling, with health information that provides direction and rationale for making the best health-related decisions and adopting health-preserving behaviours {14}. A key component of CRC screening programmes, therefore, is the information and education provided about CRC and CRC screening tests and procedures: people who use CRC screening services should receive, through an appropriate communication, accurate and accessible information that reflects the most current evidence about the CRC screening test and its potential contributions to reducing illness as well as information about its risks and limitations {4}.

Co-operation and communication activities take place at different levels and between several actors. If we focus only on screening process itself, the following two relationships are the most important: a) patient/ participant and health personnel (i.e. medical and administration personnel), b) health personnel in intra- and inter-organizational level.

Provision of balanced, unbiased and quantified information about CRC (e.g. incidence, risk factors and symptoms) and CRC screening (benefits, harms and risk factors) is crucial for helping patients in making informed decisions. It is important that scientific evidence is used to develop patient information materials, and that this evidence is easily accessible for public consultation {4}. Several countries have patient information materials available on the national institution's web site. Receiving balanced, unbiased and quantified information related to CRC and CRC screening may be not sufficient for patients to make informed decisions; patients need also to be able to understand the information provided, to make a decision and to carry out their decision. Barriers/obstacles to informed decision making (IDM) may exist and may be related to:

·         the setting and the organisation of the CRC screening programme, such as the access and the availability of the screening service and the access and the availability of the screening information,

·         the knowledge, attitudes and practice of the CRC screening provider(s) and

·         the patient themselves: age, gender, physical or mental health problems, occupation, education or abilities to read or understand information.

To ensure participation in screening process and its suitable embodiment, with adequate communication process, European guidelines highlight the following recommendations {4}:

·         Developing communication strategies for an organised CRC screening programme is important to ensure that as many of the target population as possible receive the relevant information to be able to make informed decisions about whether or not they wish to attend for CRC screening.

·         Any framework developed to communicate CRC screening information must enable subjects to make an informed decision and should be underpinned by the four ethical principles of autonomy, non-maleficence, beneficence and justice;

·         CRC screening programmes should provide balanced, quantified and unbiased information about CRC (e.g. incidence, risk factors and symptoms) and CRC screening (benefits, harms and risks). Scientific evidence should be used to develop patient information materials and should be easily accessible for public consultation.

·         CRC screening programmes should identify the barriers, needs and facilitators to informed decision making of their target population (including specific groups). The information materials produced, including written instructions on how to use the FOBT kit or perform the bowel cleansing procedure, and the intervention(s) used must conform to these identified information needs and facilitators. The public should be involved in the entire process; from identifying barriers, needs and facilitators to developing information materials.

·         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.

Organised screening programmes generally have three distinct "communication" phases throughout the CRC screening process, where information (general or person-specific information) can be provided to participants. For a CRC FOBT screening programme the following figure illustrates these three phases and the corresponding communication tools {4}:

·         The invitation phase: people are invited to participate in screening. Information for this screening phase is generally provided through invitation letters and leaflets. Written instructions on how to use the FOBT kit are usually provided with the kit;

·         The reporting results phase: people are notified of the results of their screening test. Information conveyed during this phase may be very sensitive and the communication tools must be carefully crafted to address the people‘s information needs;

·         The follow-up phase: only for people with a positive FOBT result, who require further assessment (colonoscopy). Usually information about colonoscopy is notified at the same time as positive results. This phase also involves information about management of the colonoscopy procedure;

In the invitation phase different contact strategies can be used: mailed contacts, mailed contacts and screening kits, office visit or all three together.

Figure 5: Communication tools in FOBT-CRC screening

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 {4}. What is also extremely important is that the tasks among health personnel are clearly organized. The study of Rowe et al. indicates that the lack of communication and teamwork between the nurses and residents highly affected the rates of implementation of colorectal cancer screening {16}.

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.

The study of Yoo et. al. {15} utilizes the Health Belief Model (HBM) that predicts individuals’ cancer screening behaviours. Building on the HBM, the study investigated how communication factors influence CRC screening. They have found out that media use for health information and interpersonal health communication had direct effects on both perceived CRC threat and positive expectations for CRC screening. The mass media has the capacity to disseminate effective, large scale, strategic messages for the promotion of cancer prevention. While mass communication is relatively more important in increasing awareness and knowledge of cancer-related risks, interpersonal communication channels provide rapid and continuous feedback, making them instrumental in persuading people to engage in a specific behaviour, including cancer-preventive behaviours. New communication technologies, especially the Internet, can be understood as integrated communication outlets that combine the broad reach of mass communication with the persuasive capabilities of interpersonal communication. The result of this study reveals that although communication factors were not found to have a direct impact on the stool blood test, they indirectly influenced the stool blood test through their influence on key components of the HBM. The use of mass media for obtaining health information positively affected perceived CRC threat that, in turn, led to positive expectations for CRC screening which finally resulted in the use of the stool blood test. In addition, mass media use for obtaining health information positively influenced the use of new media for seeking health information which, in turn, created positive expectations for colon cancer screening. The positive expectations ultimately resulted in the use of the stool blood test. Because communication factors are crucial determinants of these perceptions, it is essential to produce effective communication messages, which outline the risk of CRC as well as the benefits of CRC screening. The lack of awareness of the need for CRC screening and lack of knowledge about CRC is still the greatest barriers that make individuals do not be screened. Thus, health care providers need to be educated regarding appropriate communication approaches to encourage people to get screened for CRC. In addition, health campaign researchers should develop a variety of risk communication strategies to promote CRC screening. Irrespective of the evidence of positive impact of mass media and new media on individual’s behaviour, certain concerns about effective communication of colon cancer still persist. With the explosive growth of communication channels and the subsequent abundance of health information available to the general public, it may be difficult for people to judge the quality of the information they are exposed to. The Internet, in particular, has a strong potential to disseminate inaccurate or misleading cancer information. On the Internet, half of the links on CRC are commercially oriented – containing information on goods or private health services – while less than 1% of the available colon cancer information is being provided by healthcare professionals. The problem of cancer information overload is as overwhelming for the general public as well as physicians or patients. Because of the overwhelming amount of cancer information, individuals who paid less attention to, and who are less trusting of cancer information may overlook critical cancer information, and may not believe important or credible information. Therefore, those who are overwhelmed with cancer prevention information may require cancer messages that are structured as clearly, and as accurately as possible.

Kim et. al. in their study developed a patient-directed, computer-based decision aid about colorectal cancer screening and investigate whether it could increase patient interest in screening. A computer-based aid, which they have developed, differs from several other decision aids for CRC screening in that patients were able to interact with the aid via its modular format and choose to view information based on their knowledge needs. It is interactive and takes approximately 25 minutes of patient time. This computer-based decision aid on colorectal cancer screening increased patient interest in screening and subjectively improved knowledge about screening options {17}. The exactly same results were found from the study of Miller et. al. Through a randomized controlled trial they have measured the effectiveness of a web-based colorectal cancer screening in a mixed-literacy population. The results have shown that the CRC screening decision aid, called CHOICE (Communicating Health Options through Interactive Computer Education) increased test preferences and patients’ readiness to receive screening, irrespective of literacy level {18}.

A study of Cueva et. al. {19} reveals interesting interpersonal communication tool to provide CRC screening information, model ways to talk about CRC screening, increase comfort with talking about CRC, and encourage healthy lifestyle choices. It is called: “Readers’ Theatre”, a 25 minutes long script that was developed with and for Alaska Native and American Indian Community Health Workers (CHWs) and the people in their communities. Readers’ Theatre, within the context of this study, was the coming together of a group of adults to read aloud a written theatre script. Participants eagerly embraced this CRC Readers’ Theatre as a cancer communication tool. Readers’ Theatre created a comfortable, supportive environment of trust for adult learners to ask questions and discuss concerns, making learning relevant and meaningful. As reported by participants, Readers’ Theatre increased their knowledge, comfort talking about CRC, and appeared to serve as a catalyst for positive intent to change behaviour. The power of Readers’ Theatre as an innovative health communication tool lies in its ability to connect with people both affectively and cognitively, to share information in culturally respectful ways, to offer diverse perspectives, to actively engage participants in cancer-related conversations, and to serve as a springboard for action.

As already mentioned, patients are more likely to be screened, if this is recommended by the primary health provider. Therefore it is of great importance that providers have the information and access to the latest screening guidelines. The results, presented in the study of Redmond et. al. on effective communication of colorectal cancer screening information to primary care providers suggests that an effective dissemination of colorectal cancer screening information requires multiple approaches, which includes: e-mail from a trusted source, scientific journal articles, professional conferences and media campaigns. In addition, the information is well received when delivered periodically by trusted sources, such as medical colleagues, professional organizations and societies, and national research and advocacy agencies. Importantly, providers indicated that they would prefer receiving colorectal cancer screening update prior to the public to be best prepared for questions they receive from their patients. An ideal partner to venue and disseminate information is through comprehensive national programmes {20}.

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Analysis of selected studies extracted from the basic literature search. One article, one report and one document with guidelines were found to be relevant to this question.

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Adequate quality assurance requires substantial efforts, due to the complexity of the screening process which extends from identification and invitation of the target population, to performance of the screening test and, if necessary, diagnostic work-up and treatment of screen detected lesions; and aftercare {5}.

According to the European guidelines {4}, European external quality assessment scheme should be developed to facilitate Europe-wide quality assurance of occult blood testing and enhance the reproducibility of testing within and between countries providing population screening.

Rigorous analytical quality assurance procedures must be adopted by laboratories providing gFOBT and FIT analysis for population screening. To minimise analytical and procedural variability, the number of laboratories used for population screening should be small {4}.

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 laboratory should be led by a qualified clinical chemist who is trained and experienced in the techniques used for analysis and in clinical quality assurance procedures. The laboratory staff should be appropriately trained and competent in the use of the analytical device/ instrumentation, quality control and assessment procedures and associated information technology {4}.

Quality assurance of FIT testing

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 {4}.

Nevertheless prevention of delays of return samples to laboratory is one of the factors that contributes to quality assurance of FIT testing, Roon et al. (2011) in their study indicated that both positivity rate and detection rate of FITs do not decrease with prolonged sample return times up to 10 days. This means that a delay in sending the FIT back to the laboratory, of ups to at least 1 week, does not necessitate repeat sampling in case of negative result. this data also supports the use of FIT-based screening as a reliable tool for nationwide CRC screening programs {45}.

Quality assurance of gFOBT testing

Whilst an immunochemical test is recommended, programmes that adopt a traditional guaiac test need to apply additional laboratory quality procedures. To minimise variability and error associated with visual test reading, including manual results input, the following procedures should be considered {4}:

•             Use of appropriate temperature for artificial lighting and neutral-coloured walls in the reading laboratory;

•             Use of a national laboratory training programme to prosper consistency of interpretation;

•             A blinded internal QC check each day for each analyst prior to commencing testing;

•             Adoption of a monitoring programme to identify operator related analytical performance (e.g. positivity variability and bias); and

•             Double entry of test results.

Analytical quality assurance – Internal Quality Control (IQC) and External Quality Assessment Schemes (EQAS)

For those laboratories using visually read gFOBTs, the design of the test kit will influence the reliability of analysis. Reproducibility in detecting the blue gFOBT colour in the presence of dark faecal pigments depends on good staff training and experience but can be improved by other factors. The visual acuity and colour perception of the reader should be professionally checked and monitored. The colour of the test card surrounding the sample, the colour of surrounding walls and the colour temperature and brightness of artificial lighting all should be considered. The opportunity for errors due to operator fatigue should be minimised by enforcing periodic work breaks. The competence of staff to perform visual tests should be checked before they commence each batch of analysis, typically using preloaded test kits with known positivity that is hidden from the operator. A rigorous monitoring system should be adopted to identify staff, who has spot positivity rates which are markedly different to the mean or who exhibit marked variability {4}.

Most gFOBTs and point-of-care FIT devices have a means of checking the integrity of the device and reagents by way of a quality control check integral to the device. For gFOBT, this control can check whether guaiac has been applied across the whole of the test area and whether the hydrogen peroxide reagents are working correctly. Point-of-care FIT devices provide a similar check of reagent integrity but are unsuitable for population screening {4}.

The case for automation in population screening programmes is a strong one, and should significantly influence the choice of an acceptable occult blood testing system. Automated FIT analysis will require internal quality control procedures appropriate to the chosen technique and instrument. As a minimum, laboratories should adopt the manufacturers’ instructions for use, and give consideration to what additional internal quality control measures can be used to check instrument accuracy and imprecision throughout the period of analysis. Good analytical performance is particularly important at the selected cut-off concentration, and quality control measures should reflect that requirement {4}.

Participation in an external quality assessment scheme (EQAS) is seen as mandatory for tests performed in a clinical laboratory. Participation in an EQAS enables assessment of bias between participating laboratories, and is particularly important for a national screening programme utilising several laboratories. The availability of an EU-wide EQAS is desirable. National population screening programmes should have quality assurance procedures that enable oversight of the analytical performance of all screening laboratories. Satisfactory performance in an EQAS provides an objective criterion of competence {4}.

Quality assurance and staff

The prime importance of quality assurance should also be included in basic training of other staff involved in screening process, not just those in laboratories: public health specialists, administrative and clerical staff, general practitioners, nurses, endoscopists, who must be strongly engaged in quality assurance, and also radiologist. In addition, quality control of surgery is particularly important within a screening programme, as it is essential that individuals with lesions detected at screening are afforded the highest possible standards of care. The pathologist has an essential role in the quality assurance of surgery by assessing the completeness of tumour excision in surgical resection specimens {4}.

Achieving and maintaining high quality at every step in the screening process requires an integrated, population-based approach to health service delivery. This approach is essential in order to make screening accessible to those in the population who may benefit and in order to adequately monitor, evaluate and continuously improve performance {5}.

In the case of positive FOBT result the follow-up phase is necessary. Participants with positive feedback require further assessment (colonoscopy). Usually information about colonoscopy is notified at the same time as positive results. The information provider is usually so called patients navigator (PN). This is an individual whose role has been described as providing individualized assistance (by telephone and/or by direct contact) to a patient to both educate and help them overcome healthcare system barriers related to, for example, doctors’ offices, clinics, hospitals, outpatient centres, payment systems. Social and logistical services provided by patient navigators could be for example facilitating communication among patients/family members/survivors/healthcare providers, coordinating care among providers, facilitating appointments and follow-up appointments, and facilitating access and transportation to services facilities. Patient navigators could be trained community health workers/advisors who have close ties to the local community or trained social workers/health professional/volunteers or belong to a specific organization {4}.

According to the manufacturer’s information on the FIT technology (FOB Gold/ SENTiFOB analyser), the FOB Gold® NG assay is a IVD laboratory test for professionals use, so a 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.

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Analysis of selected studies extracted from the basic literature search. Four articles were found to be relevant to this question and one publication. We found additional information by an internet search of grey literature performed on 16 May 2013 via the search engine Google. It was performed by investigator using key words specific to this question (“impact of centralization/ dencetralization on colorectal cancer screening”, “centralized vs. decentralized health care environments”, “centralized vs. decentralized health care system”, “centralized or decentralized health services”, “impact of centralization/ decentralization on health preventive programmes”). One grey literature source is referred to in these results.

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The factors that speak in favor of centralized services are the following {21}:

a) development of teams of different disciplines are easily to arrange in larger establishments,

b) large units achieve economies of scale and can make most efficient use of a scarce resource and

c) better outcomes for patients under the care of more specialized professionals.

Although the organizational theory includes several disadvantages of decentralization: (a) the risk of sub-optimality as decentralized entities focus on their own performance rather than the entire organization, b) lack of coordination, c) inappropriate diversity in practices and standards especially in personnel management and d) reduced comparability and predictability at the system level) {22}, there is still a significant advantage for the basic interventions as screening. Decentralized clinics and activities provide better access to health campaigns, which offer more information and knowledge to the participants {23}. Regarding implementation of  FIT and participation in screening, centralization might reduce participation in screening, especially in countries with practices like in France {24}, where the individuals from the target population are first invited to consult their family physician before they receive the screening test by mail. Centralization might also reduce the awareness of screening meaning for health, because the access to information is not as good as in decentralized system. There is consistent evidence that centralisation of cancer screening services increased patient travel costs, time and distance {25}. The negative impact is mostly felt by those with low incomes, poor access to transport, by elderly and disabled {21}. Centralization impact that is related to access of the information about the screening could easily be overcome with mobile screening vans, which can be used for more distant areas.

Survey, implemented among 11 European countries, has shown that countries have its health system organized in a different way. Austria, Italy (i.e. decentralized in regional level) and Spain have decentralised health system. In Spain, every single region has its own organization. The Spain also indicated that they don’t have information about the influence of each Regional Health System on the screening phases. The Russian healthcare system is a mixture of centralized and decentralized features. The decision making regarding health policy issues, key national health and reimbursement programs is centralized and supported by significant federal budget funds. Implementation of important health programs is the obligation of regional and municipal health authorities. Centralization of the healthcare system affects all CRC screening phases. Lithuania has semi-centralized health-care system. Lithuania indicated that there is a national legislation act, concerning the CRC screening programme, defining screening services and implementation procedures. The implementation results of this programme are provided by the Colon Cancer Early Detection Program Funding Coordination Group. The Coordination Group indicates results of the programme at least once a year. Programme implementation reports are provided to the Ministry of Health and to the National Health Insurance Fund under the Ministry of Health. Scotland indicated that the advice on screening programmes is provided to all devolved administrations by the UK National Screening Committee. Screening policy is set by the Scottish Government Health Directorates. Romania has stated that National Unit for the Management of Screening Programmes under Ministry of Health is responsible for the planning, implementation and monitoring. The tests are performed by Accredited Laboratories. National screening programme in France is organized around departmental management structures that coordinate all activities, provide training to general practitioners, manage invitations based on data of the national health insurance, track results and assure transmission of data to the In VS (Institute national de Veille Sanitaire - French Institute for Public Health Surveillance). Slovenia has a centrally organized program. Preparations started in 2006, when the Ministry of Health has approved the national program and has been granted funding of public funds through the Health Insurance (Health Insurance Institute of Rep. Slovenia). In 2008 a pilot study was made and in 2009 the program became operational at the state level. The Central Unit, at the Institute of Public Health of Slovenia, is responsible for the planning, organization, implementation, tracking, monitoring and data collection. The colonoscopy preparation and implementation is performed by clinics/health centres and colonoscopy authorized centres (this is decentralized).

Program organization in Croatia is related to their country division into 20 counties plus the capital city of Zagreb. There is one public health institute in each county and city. In each local public health institute there is a coordinator nominated for the National Screening Program. At the national level, a coordinator from the Croatian National Public Health Institute has been nominated, and all 22 coordinators are members of the Committee for Program Performance. An Expert Committee has also been nominated by the Minister of Health and Social Welfare with the main task to evaluate professional qualification of colonoscopists included in the National Program and to attend to other issues during the program performance {26}.

Literature provides little information on the impact of de-centralisation or centralisation on implementation of FIT.

Analysis of selected studies extracted from the basic literature search. Four articles were found to be relevant to this question. We found additional information by an internet search of grey literature performed on 19 May 2013 via the search engine Google. It was performed by investigator using key words specific to this question (“health expenditure for colorectal cancer screening in Europe”, “cost for colorectal cancer screening in Europe”, “financial investment in colorectal cancer screening in Europe” etc.). One grey literature source is referred to in these results.

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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.

Screening programs are usually financed by central or local government – depends from a country {27}.

Explicit allocation of resources from the national budget to adult screening seemed to be standard within countries offering colorectal screening programmes. LSE Health (London School of Economics in Health) in 2008 concluded in their report that of countries, who participated in some form of screening, explicit funding allocation was noted in Australia, France, Netherlands, Poland, Romania and the UK. Concrete values were only reported for six countries. In the Netherlands, spending for the 2005 IKA pilot was reported to be €700,000; this was based on a population of 32,000. CRC screening expenditure was €4.2 million in Poland (2005- 2006), while the pilot programme in Romania was allocated €185,000. Finally, although explicit CRC resource allocation was reported in Germany and the Czech Republic, no information was available regarding funding amounts {9}.

The Netherland’s study of van Rossum et. al. (2010) indicates the actual costs of FIT and gFOBT screening. The participation-independent costs of the FOBTs were: €5.20 for G-FOBT and €4.39 for I-FOBT. Compared with the manually operated and evaluated G-FOBT, the automated analyser (OC-Sensor micro) reduced operation and evaluation time for the I-FOBT with more than 90%. When assuming 100% participation, one G-FOBT overall cost €9.63 and one I-FOBT cost €8.50. The actual participation was 47% for G-FOBT and 60% for I-FOBT. Therefore, the overall cost according to intention to screen for one G-FOBT was €7.06 and for one I-FOBT €6.22 {28}.

University of Nottingham made a study on the cost of screening for colorectal cancer. They have concluded that one clerical officer and two clerical assistants (at a total cost of £18 909 per annum) would be sufficient to handle the necessary administration in a more general setting, assuming the appropriate computer software were to be available. In addition, a consultant surgeon acts as overseer to the entire screening project, and would presumably continue to do so in the general setting. This input amounts to one session per week and is accordingly costed at one tenth of the cost of employing the consultant (£38 400 per annum). Again, they initially presumed that the furnished office accommodation at zero opportunity cost, and free access to the existing mainframe computer should be provided. There would be an additional requirement for a local IT budget, covering, for example, the purchase of terminals, a printer, disks and tapes, and lines to the mainframe. Experience suggests that a test processing rate of 60 tests per hour is feasible, and employing the nurse for the necessary length of time is necessary (total annual cost of state registered nurse = £9132). The current cost of a three day Haemoccult test is £1-13, including reagent (based on the purchase price of one pack of 50 tests). Each test costs £0-41 to send (including postage, stationery, and instruction leaflet). Returned unused tests are assumed to be discarded rather than reused. According to this study the computing equipment necessary to operate the screening system would entail an expenditure of the order of £25 000. Administrative staff would need to be in post for perhaps six months before the programme became operationalized, at a cost of some £10 000, and the nurse responsible for test development would require a short period of training (costing, perhaps £2000) {29}. According to another UK study, performed by Sharp et. al. (2012), the cost for FIT kit (cost per kit dispatched (i.e., cost per individual invited to participate in screening) is 3.75 €, the cost for FIT processing/analysis (cost per kit completed and returned (i.e., cost per screening participant)) amounts 11.60 €. Study reveals that for biennial FIT implementation at age 55–74 40.17 € per person is required {30}. Screening process also requires some other health personnel: laboratory staff and general practitioner, who give appropriate information about the screening to the patients.

International survey, implemented among 11 European countries, also indicates some information about the screening costs. Only two countries out of 11 reported on screening cost, i.e. Lithuania and Slovenia.

Lithuania indicated that the unit cost of FIT kit is 8,57 LTL, which implies that for 111,366 number of kits (the data refers for the period from July 2011 until July 2012) they have spent 954.406.62 LTL. They have indicated that FIT processing/analysis per participating person (completed and returned kit) amounts 23,20 LTL, which, for the number of 111,366, amounts 2.583.947,34 LTL. In case of positive screening results: 40.091.803 colonoscopies examinations without anaesthesia (per participating person), 2.206 colonoscopies examinations with anaesthesia and 1.392 colonoscopy biopsy examination and evaluation have been performed in above mentioned time period. The unit cost for colonoscopy examination was 124,22 LTL (without anaesthesia), 202,83 LTL (with anaesthesia) and 126,09 LTL (colonoscopy biopsy examination and evaluation). They have also indicated the costs of cancer treatment for different cancer stages. Unit cost for stage I has been estimated to 2.543,80 LTL, while 199 numbers of treatments have been necessary in above mentioned time period. Unit cost for stage II has been estimated to 4.076,49 LTL, while 311 numbers of treatments have been necessary in above mentioned time period. Unit cost for stage III has been estimated to 5.073,03 LTL, while 364 numbers of treatments have been necessary in above mentioned time period.  Unit cost for stage IV has been estimated to 7.459,48 LTL, while 399 numbers of treatments have been necessary in above mentioned time period. 

Slovenia provided data for year 2012. They have indicated that in 2012 - 280.686 individuals have been invited to the screening. The unit cost for the invitation letter amounts 2,12 €, which amounted in total 597.727,96 € for the invitation letters. The unit cost for FIT kit costs 6,54 €, which for 126.971 screening participants amounted 830.390,34 €. They have also indicated labour costs (total per year for all employees) in GP’s office, which amounted 310.645,05 €. Material costs (total per year) in GP’s office was estimated to 57.023,64 €, while laxatives (Movi Prep) amounted to 116.991.30 € (the unit cost of laxative is 13,64 €; 8.577 number of laxatives have been used in 2012). Labour costs in laboratory was estimated to 155.322,52 € per year 2012. FIT processing/analysis per participating person was estimated to 261.243,38 € (the unit cost of FIT processing/analysis is 1,60 €; 163,114 number of FIT kits was analysed in 2012). After a positive screening result 9016 number of colonoscopies was implemented in 2012. A unit cost for colonoscopy examination per participating person amounts 217,21 €, which in 2012 amounted 1.958.350,82 € in total. They have also reported on 35 DRG (diagnosis related group) cases, which in 2012 amounted 146.982,84 € (unit cost of DRG case ranges between 0,58 to 7,01 €). In 2012 also 6.004 pathohistologic medical tests was performed, which amounted 643.628,80 € (the unit cost is 107,20 €).

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Analysis of selected studies extracted from the basic literature search. Two articles were identified to be relevant to this question. Survey gave additional information on this question.

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Budget impact analysis (BIA) of the implementation of FIT as a new technology was not found by the literature review. On the other hand literature search did provide information on importance of BIA and guidance for developing BIA. It was noticed that countries on their national level have already perform some BIA of a new technology but since those reports were note prepared precisely for FIT technology they weren’t included into this document.

Budget impact analysis in combination with cost study and economic evaluation play a crucial part in the comprehensive assessment of a health technology and may inform reimbursement decisions. Reimbursement may be withheld from a cost-effective health technology if it has a high budgetary impact. Conversely, a cost-ineffective technology may receive reimbursement if its budgetary impact is limited. This is because the opportunity cost of adopting such a technology is low (little other activity would need to be displaced) and the adoption may meet other important objectives of a decision-maker such as equity {31}. The methodology of budget impact analysis is still developing. While cost-effectiveness analyses (CEAs) are well accepted, the same progress has not been made for BIA. In 2005 Task Force was established by International Society for Pharmacoeconomics and Outcomes Research (ISPOR) to develop and present guidance on methodologies for those undertaking such analyses or for those reviewing the results of such analyses. The BIA is important, along with the CEA, as part of a comprehensive economic evaluation of a new health technology.  A BIA starts with providing all relevant epidemiological, clinical and economic information of the disease. More precisely, it should be performed using data that reflect, for a specific health condition, the size and characteristics of the population, the current and new treatment mix, the efficacy and safety of the new and current treatments, and the resource use and costs for the treatments and symptoms as would apply to the population of interest. The Task Force recommended that budget impact analyses be generated as a series of scenario analyses in the same manner that sensitivity analyses would be provided for CEAs. In particular, the input values for the calculation and the specific cost outcomes presented (a scenario) should be specific to a particular decision-maker’s population and information needs. Sensitivity analysis should also be in the form of alternative scenarios chosen from the perspective of the decision-maker. The primary data sources for estimating the budget impact should be published clinical trial estimates and comparator studies for efficacy and safety of current and new technologies as well as, where possible, the decision-maker’s own population for the other parameter estimates. Suggested default data sources also are recommended. These include the use of published data, well-recognized local or national statistical information and in special circumstances, expert opinion. Finally, the Task Force recommended that the analyst use the simplest design that will generate credible and transparent estimates. If a health condition model is needed for the BIA, it should reflect health outcomes and their related costs in the total affected population for each year after the new intervention is introduced into clinical practice. The model should be consistent with that used for the CEA with regard to clinical and economic assumptions {32}.

The survey, implemented among 11 European countries (i. e. Austria, Russia, Luxembourg, Lithuania, Italy, Scotland, Spain, Romania, France, Croatia and Slovenia), indicated that only 6 countries (Russia, Lithuania, Italy, Scotland, Spain and Slovenia) out of 11 uses FIT technology. 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 screening is free of charge for target population and founded by the country. Not all country indicated the payers. In Spain for example the payer are Regional Health Services; Russia has stated that reimbursement is provided under the program for Mandatory health Checks. CRC checks in high risk population and patients with CRC symptoms are covered under the Health Service State Guaratees Program. In Scotland FIT is supplied by NHS (National Health Service). Slovenia also stated that FIT is covered by compulsory Health insurance. In addition, only two countries indicated the costs that were related to the screening (i.e. Lithuania and Slovenia).

Unfortunately information obtained from the survey was not sufficient for the budget impact analysis. Data from the survey could present only one part of BIA. In addition, BIA is very country specific and therefore one general model of BIA of FIT couldn’t be applicable to all countries.  Nevertheless there are some general guidance that each country should stick to, when preparing their own BIA.

We believe that further research and countries’ in-depth studies would be necessary to indicate the budget impact of the implementation of FIT for the payers.

Data of budget impact of the implementation of FIT for the different payers was, by the literature review, not found.

Analysis of selected studies extracted from the basic literature search. Three articles were found to be relevant to this question and one document with guidelines.

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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 depends also on the communication, coordination etc.);

•             To ensure an adequate and timely follow-up or treatment for those who need it;

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

i-FOBT requires assurance of consistency in analytical performance 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 {4}.

The problem can occur in relation to the inappropriate implementation of screening, which can result in grossly misleading results {4}. Another challenge is related to an insufficient participation to an appropriate follow-up diagnostic evaluation in cases with a positive fecal occult blood test (FIT) result {33}.

The problem can also represent a limited amount of financial, technical, staff and time resources.

Therefore in an organized screening program, besides a health care team, a management team acts an important role for its implementation {8, 27}. In colorectal cancer, multidisciplinary management is strongly recommended. In the UK for example (already mentioned in ORG3), the organisation of the colorectal screening programmes is overseen by a programme manager, who reports to a national or regional screening coordinator responsible for all screening programmes {4}.

The professional and organisational managers of a screening programme must have sufficient authority and autonomy, including an identified budget and sufficient control over the use of resources to effectively control the quality, effectiveness and cost-effectiveness of the programme and the screening service. The institutional structure must facilitate effective management of quality and performance {4}.

One of the management opportunities could also be located within the development of a European external quality assessment scheme that would facilitate Europe-wide quality assurance of occult blood testing and enhance the reproducibility of testing within and between countries providing population screening {4}.

Literature provides little information about European countries’ perspective on the management problems and opportunities attached to FIT.

Analysis of selected studies extracted from the basic literature search. Three studies, one document with guidelines and one international report were found to be relevant to this question. We found additional information by an internet search of grey literature performed on 23 May 2013 via the search engine Google. It was performed by investigator using the key words, specific to this question: “colorectal cancer screening and monitoring”, “monitoring in colorectal cancer screening” etc. Two additional sources have been found: one report and one document with national guidelines.

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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. These standards, and their monitoring, are an essential ethical requirement for all screening programmes, to ensure that harms are minimised and benefits are maximised for participants {39}.

Maintaining high-quality of the screening service requires continuous supervision and rigorous scientific reporting. Attention must be paid to performance at each step in the screening process from information and invitation to performance of the screening test, assessment of abnormalities, and diagnosis and treatment of lesions detected in screening {46}.

Key points at this stage are {46}:

•             Supervision of all steps in the screening process.

•             Ability to exclude bad performers.

•             Testing grounds for new technologies.

•             Monitoring the benefits and harms of screening.

•             Scientific publication of outcome.

European Council Recommendations on cancer screening (2003) indicates that all countries should {5}:

(a) regularly monitor the process and outcome of organised screening and report these results quickly to the public and the personnel providing the screening;

(b) adhere to the standards defined by the European Network of Cancer Registries in establishing and maintaining the screening databases in full accordance with relevant legislation on personal data protection;

(c) monitor the screening programmes at adequate intervals.

Regular, systematic monitoring, evaluation and EU-wide status reporting would promote the exchange of information on successful developments between Member States and would identify weak points requiring improvement {5}.

With regard to specific recommendation 3 (a) in the Council Recommendation (i.e. to regularly monitor the process and outcome of organised screening and report these results quickly to the public and the personnel providing the screening), only 55% of the responding Member States reported that the process and outcome of organised screening is monitored regularly by an independent peer review and 59% indicated that the results are reported quickly to the general public and to screening staff {5}.

Monitoring programme performance in UK

UK have designed a national IT system – the bowel cancer screening system (BCSS) – has been designed and built by to support the BCSP (bowel cancer screening programme). The system offers a range of functions that enable programme hubs and screening centres to manage the programme. These functions include: a) selection of screening subjects, b) call and recall, c) logging receipt of test kits and test kit results, d) booking SSP clinic appointments, e) recording of colonoscopy and histopathology results, f) letter production, g) reporting programme activity {41}.

The BCSS provides a series of strategic reports that contain statistics about programme activity (e.g. count of letter types sent, FOB test results count). Programme hubs are expected to report regularly to the national office on programme activity {41}.

All screening centres are required to use this system, which is provided free of any licensing charge. Programme hubs and screening centres will be required to work towards meeting the national standard for cancer waiting times (the 62 day wait) for patients who are diagnosed with bowel cancer through the screening programme. All patients diagnosed with cancer are included in the 31 day wait target {41}.

France

The France’s program established monitoring centres that are responsible for program implementation within specified districts. Individuals in the national health registry who are eligible for CRC screening receive biennial mailed screening invitations from local monitoring centres. Initially, recipients are directed to visit their primary care physician for a free in office FOBT. If the test is not completed within three months of invitation, the program sends a reminder with an FOBT kit {11}.

Laboratory accreditation and quality monitoring

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.

One of the reasons of FITs development is to provide for large scale development in the laboratory where quality assurance of test development is much easier to monitor and control. Laboratory development is preferred in many countries, especially for mass screening when many tests must be done and quality assurance is vital {34}.

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) {4}.

Outcome monitoring: All aspects of laboratory performance in respect of the screening test should be part of a rigorous quality assurance system. Uptake, undelivered mail, time from collection to analysis, analytical performance (internal QC and external QA), positivity rates, lost & spoilt kits and technical failure rate, technician performance variability and bias should each be subject to rigorous monitoring {4}.

Data collection and monitoring

There is a special need to monitor performance of programmes using new tests. The monitoring and evaluation of the programme therefore require that adequate provision has to be made in the planning process for the complete and accurate recording of all the relevant data. Achieving this goal is dependent on the development of comprehensive systems for documentation of the screening process, monitoring of data acquisition and quality, and accurate compilation and reporting of the results. The information system should be designed to support the implementation of the different steps of screening, to record screening findings of each individual, to identify those detected with abnormalities, to monitor that the recommended action has been taken and to collect information about assessments and treatment. For the purposes of impact evaluation this information should be linked to several external data sources, and legal authorisation to be able to achieve this should be secured: population registries, for estimating population coverage and to identify people in the target population in relation to their screening history; cancer or pathology registries, for cancer follow-up and for quality assurance purposes and feed-back to clinicians; and cause of death register for individuals in addition to population statistics, for assessing vital status and cause of death for final effectiveness evaluation {4}.

The design of the information system should take into account the views and data requirements of all groups involved in the screening programme. A wide range of consultation and participatory planning is important to improve programme evaluation, through common definition of data elements, indicators and standards. The programme should ensure that professionals involved in screening receive timely feedback on programme and individual performance. Rapid publication of the monitoring results is important as screening units and other actors need the information to run their activity and to implement quality assurance and training efforts {4}.

For monitoring the programme, tables presenting performance indicators should be produced at regular intervals (at least annually) by age and gender and by type of screening test using the collected data {4}.

Screening organization

A number of indicators can be used to monitor the organizational performance of a screening programme {4}:

•             Time interval between completion of test and receipt of results: The time interval between performing a test and receipt of results will affect patient outcomes in terms of anxiety and potentially screening outcomes in terms of stage of diagnosis of disease. The time interval between completion of test and receipt of results by the subject should be as short as possible, (acceptable standard: >90% within 15 days).

•             Time interval between positive test and follow-up colonoscopy: timely procedure is not critical in the context of primary screening but it is very important when endoscopy is performed following a previous positive screening test. A delayed procedure may not be critical biologically, but it can cause unnecessary anxiety for the screenee. To ensure that patient anxiety is not unnecessarily increased, it is recommended that follow-up colonoscopy after positive screening be performed as soon as reasonably possible but no later than within 31 days of referral. Follow-up colonoscopy after positive screening (any modality) should be scheduled within 31 days of referral (an acceptable standard is >90%, >95% is desirable).

•             Time interval between positive endoscopy (CS or FS) and start of definitive management: The interval between the diagnosis of screen-detected disease and the start of definitive management is a time of anxiety for the patient and affords the opportunity, if prolonged, for disease progression. For these reasons, standards aimed at minimising delay have set the maximum interval at 31 days. The time interval between the diagnosis of screen-detected disease and the start of definitive management should be minimised. Acceptable standard: >90%, desirable >95% within 31 days.

•             Time interval between consecutive primary screening tests: The time interval between two consecutive primary screening tests will affect the coverage of the programme by invitation/screening. The interval between two consecutive primary screening tests should be monitored to remain within an acceptable level (depending on the screening interval). People should be re-invited according to the date of their last test and not that of their last invitation.

Management of people with positive test results and fail-safe mechanism

In order to ensure timely and appropriate assessment, an active follow-up of people with an abnormal screening test result should be implemented, using reminders and computerised systems for tracking and monitoring management of these patients {4}.

In order to achieve these aims it is recommended to identify a coordination board that is responsible for regularly auditing the programme and taking necessary actions (including indications about the specific organisational changes which are necessary to meet the desired quality standards) {4}.

Considering the different healthcare environments, public health specialists with adequate epidemiological knowledge or equivalent expertise are recommended. These professionals are needed from the onset, to ensure that the programme includes a population-based information system that monitors each step of the screening process. They will then be responsible for gathering data and for ongoing monitoring in order to identify problems that need intervention. These public health specialists can be based at a national or regional level, whereas the other health professionals who are providing screening services are needed in each area. Public health specialists should have training in and an understanding of basic epidemiology, statistics and communication. A European training programme on monitoring and evaluation of screening programmes would be desirable {4}.

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Analysis of selected studies extracted from the basic literature search. Five articles were found to be relevant to this question.

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Acceptance of FIT by patients

Young and Cole in their study (2007) found out that FITs overcome most of the disadvantages presented by gFOBT, are superior to gFOBT in terms of participation as well as performance and concluded that  FIT should replace gFOBT in two-step screening. FIT technology simplifies the testing process, removes the need for diet and drug restrictions, provides for preferred and more acceptable stool-sampling tools such as brushes or probes rather than a wooden spatula, and is possible with collecting fewer fecal samples. Most branded versions of FIT require fewer than three fecal samples, the recommended number for gFOBT {33}. In study of Cole et. al. (2003) the removal of dietary restrictions has been shown to enhance participation in screening with FIT relative to gFOBT, by 28% {35}. Changing to a brush-sampling method also simplifies the process and enhances participation by 30%. Together, these two advances increase population participation by 66% {34}.

Another population-based study compares perceived test burden and willingness to return for a successive screening round among gFOBT, FIT and FS (flexible sigmoidoscopy) in an average-risk population. All three screening tests were well accepted among participants, given the large proportion of screenees willing to return for successive screening rounds and the positive recommendation for screening that most subjects intended to give their family and/or friends. FIT was perceived as slightly less burdensome than gFOBT screening due to less reported discomfort during faecal collection and test performance. The number of faecal samples required may explain the difference in discomfort during faecal collection, as gFOBT had to be performed on three consecutive bowel movements and FIT was a one-sample test. The authors concluded that gFOBT, FIT and FS are well accepted screening tests among participants. FIT slightly outperforms gFOBT with a lower level of reported discomfort and overall burden. Both FOBTs were better accepted than FS screening {36}. Better acceptance of FIT in comparison to gFOBT was also observed in Allison’s study {37}.

Acceptance of FIT by personnel and organization

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. Therefore, the Dutch Health Council recently recommended introducing a nation-wide FIT-based CRC screening programme {36}.

The survey result gave additional information. Scotland indicated that FIT test is new in the country and not widely accepted by doctors. Therefore patients can choose between FOBT and colonoscopy.

There are little information about the acceptance of FIT by health personnel and the organization.

Analysis of selected studies extracted from the basic literature search. Two articles were found to be relevant to this question. We found additional information by an internet search of grey literature performed on 23 May 2013 via the search engine Google. It was performed by investigator using key words specific to this question (“professional involved in FIT screening”, “stakeholders’ participation in FIT screening”, “stakeholders’ engagement in FIT screening”, “partners’ participation in FIT screening”, “the role of manufacturers in FIT screening”, “the role of municipalities in FIT screening”, “the role of pharmacists in FIT screening” etc.). Five grey literature sources are referred to in these results.

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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 {38}. New Zeland’s report from University of Otago agrees that the relevant stakeholders have to be included already in the early process, when screening program is in stage of designing. Key stakeholders in their specific area include Consumers, Maori, Pacific people, Surgeons, Gastroenterologists, Pathologists, Laboratories, Academics, radiation specialists, oncologists, Potential providers of any services such as laboratories, private specialists, FOBT manufacturers General practitioners, National Screening Unit Cancer NGOs, DHBs, Ministry of Health, Treasury, Minister of Health {39}. That involvement of a wide range of stakeholders is essential, confirms also a study of Geddies et. al., who claim that those, who participate in health policy decision making may range from senior government and administrative officials, trained methodologists and clinicians, program managers, or community stakeholders {40}. UK has also defined roles and responsibilities of stakeholders in their bowel cancer screening programme. Main stakeholders that have been mentioned are:

•             national office (for example: they develop quality assurance (QA), develop and monitor the effectiveness of QA etc.),

•             strategic health authorities (SHAs), who have the role of coordination of the process of selection of screening centres and recommendation of potential centres to the national office to ensure that their responsible populations are included in the screening programme,

•             primary care trusts (PCTs), who are involved in the process of selecting proposed screening centres and are responsible for securing and funding the treatment of cancers detected by the screening programme,

•             general practice (screening centres are responsible for disseminating information about the screening programme to primary care teams, e.g. through PCTs, practice visits or regular GP/practice manager meetings; once screening has begun, some people receiving invitations and test kits may want the opportunity to discuss the screening process with their GPs),

•             program hubs (their main roles are: manage call and recall for the screening programme, provide a telephone helpline for people invited for screening, despatch and process test kits, send test result letters and notify GPs, book the first appointment at an SSP (specialist screening practitioner) clinic for patients with an abnormal test result),

•             screening centres (their roles are: arrange colonoscopy appointments for patients with an abnormal test result or who are scheduled for polyp surveillance, ensure appropriate follow up or treatment for patients after colonoscopy etc. and also provide information about the screening programme for the local health community, promote the screening programme to the general public in their locality, provide information and support for local people in completing the FOB test (on referral from the programme hub), ensure that data are collected to enable audit and evaluation of the screening programme) and

•             acute trusts (provide endoscopy services, but which will not be developing into screening centres) {41}.

Spanish study of Carballo and Munoz-Navas (2012) indicated that one of the main reasons of thriving and active population based screening of high quality in Spain was also a good collaboration between key institutions, which are integrated in pre-existing Cancer Screeing Program Network (CSPN). The CSPN is formed by the people in charge of cancer screening programs in the Autonomous regions, who are experts in Public Health; its main objective is the exchange of experiences between managers of population based programs of early cancer detection. They organize the CSPN annual meeting, to which specialists in digestive disorders, pathologists, radiologists, surgeons, primary care physicians and oncologists participate. In 2007 this special meeting was dedicated to establish the necessary recommendations for the planning and setting up of demographically-based organized programs for the prevention of CRC {42}.

Some literatures have also been found on the importance and the role of pharmacists. In Canada pharmacists help those, who do not have a health care provider to access screening for colorectal cancer by: dispensing program-branded FOBT kits to eligible unattached participants, providing information about the importance of screening for colorectal cancer etc. {43, 44}.

Survey, implemented among 11 European countries, has also provided some important results. Only 5 countries indicated the stakeholder’s involvement (Austria, Italy, Scotland, France and Slovenia). Only 3 countries out of those five mentioned use FIT technology (Scotland, Italy and Slovenia). Scotland indicated that stakeholders in their country include NHS Education Scotland, Healthcare Improvement Scotland, 14 territorial NHS Boards, NHS National Services Scotland, Central Legal Office, Information Services Division, National Services Division, Health Facilities Scotland, Bowel Cancer UK. Italy only mentioned the important role of GPs, who advise the target population about the relevance/importance of screening. Slovenia indicated the following 5 important stakeholders:

1.            NIPH (National Institute of Public Health) Slovenia as Svit leading program.

2.            Authorized contractual partners: Histopatological centres, colonoscopy centres.

3.            Payer: Health Insurance Institute of Rep. Slovenia.

4.            Tenders for promotions program (web pages, IT support).

5.            Pharmaceutical industry: Tenders for iFOBT, laxative Movi Prep, laboratory materials.

Little information exists about the interest groups/ stakeholders, who are or have to be taken into account in the planning / implementation of FIT. No study was found that would indicate general information on each stakeholder’s involvement or their interaction that could be referred to all European countries. Stakeholders’ involvement and role are, naturally, country specific due to specific countries programme, but little information was found also among grey literature.