Result card

  • ORG12: What kind of monitoring requirements and opportunities are there for FIT?
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What kind of monitoring requirements and opportunities are there for FIT?

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: /

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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Critical
Partially
Rupel P et al. Result Card ORG12 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

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