Result card

  • ORG1: What kind of work flow, participant flow and other processes are needed?
English

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

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

Internal reviewers: Americo Cicchetti, Daniela D'Angela, Marco Marchetti

Acknowledgments: /

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)

pdf10936.ORG-1 Figure 2

Participation in screening (see Figure 3)

pdf10936.ORG-1 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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Critical
Completely
Rupel P et al. Result Card ORG1 In: Rupel P et al. Organisational aspects In: Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=206

References