EVALUATION AND INTERPRETATION OF SCREENING OUTCOMES

Evaluation and interpretation of screening outcomes are essential to recognising whether a colorectal cancer screening programme is achieving the goals for which it has been established. It is recognised that the context and logistics of screening programmes will differ by country and even by region. For example, the prior existence of a population register facilitates issuing personalised invitations, whereas the absence of such a register may lead to recruitment by open invitation. Many of these contextual differences will affect the measured outcomes.

The effectiveness of a programme is a function of the quality of its individual components. Success of the programme is measured not only by its impact on public health, but also by its organisation, implementation, and acceptability. 

To determine whether a programme has been effective with regard to its impact on morbidity and mortality requires continuous follow-up of the target population over an extended time-frame. Therefore early-performance indicators using standard definitions, available early in the lifetime of a screening programme are essential to measure the quality of the programme and its potential longer-term impact

A key component in the evaluation of population screening programmes is data collection. Colorectal cancer screening can be performed using various tests or techniques. Data collection necessary for evaluation can be common to all tests or specific to particular tests. The examples given in these Guidelines refer to in vitro stool tests based on detection of faecal occult blood (FOBT) that are currently the most widely used, and to endoscopic tests i.e. flexible sigmoidoscopy (FS) or colonoscopy (CS). In the text, gFOBT refers to guaiac-based FOBTs, and iFOBT to immunological FOBTs. 

It should be noted that in a setting where opportunistic screening (for example by colonoscopy) has been taking place for some time, the uptake and performance of an organised programme may differ markedly from those in a setting where no such screening has been taking place. The majority of the values of the indicators described below will relate to the latter setting. 

Data items necessary for evaluation  

Programme conditions 

Programme type 

As mentioned above, the organisational aspects of a screening programme influence the evaluation and interpretation of screening outcomes. Population-based programmes are recommended because they require an infrastructure that is conducive to implementation of quality assurance and evaluation, such as through linkage of screening data and cancer registry data (Karsa et al. 2010). It is therefore important to document the type of programme (population-based or non-population-based) and to describe the sources of population data used for identification and invitation of the eligible target population (e.g. population registry). Data on screening outcomes should be linked with data from other registries in order to monitor and evaluate the programme. 

Primary screening test 

Currently only the faecal occult blood test (FOBT) is recommended by the EU for CRC screening. However endoscopic screening programmes with flexible sigmoidoscopy (FS) or colonoscopy (CS) as primary screening tests are currently running in a number of Member States. Given the potential impact of the type of primary screening test or tests used in a programme on the respective results and performance, the type of primary screening test should always be indicated when documenting results and reporting. 

Population base 

A screening programme is population based when every member of the target population in the area designated to be served by the programme is known to the programme, and when the eligible members of the target population are individually invited to participate. 

The availability and reliability of target population data will depend on the existence, quality and accessibility of population registers in the region where the programme is being set up. Population registers are not always available and demographic data for identifying the target population might be obtained from various sources, e.g. census data, electoral registers, private or statutory health care registers or health insurance funds registers. The choice of the target population database for issuing invitations will depend on the completeness of the database and on the individuals or variables included, e.g. electoral registers might not include eligible foreigners or dates of birth.

A database consisting of individual records (one record per person for each screening episode) is essential in order to produce results on organisational aspects of the programme (coverage, participation) and screening performance. The data collected should respect a logical order and follow the development of the screening process (identification of person [date of birth, gender], date of invitation, date of reminder, date of test, test results, date of the examination performed during assessment, results, colonoscopy date, results, adverse effects, treatment). The location in the bowel of any detected lesions or cancers (Tumour site) should also be recorded [Rectum, sigmoid, descending colon (distal colon) transverse colon, splenic flexure, ascending colon]. 

Each variable should be precisely defined. All data collected for each round should be kept and updated information should not overwrite data provided during preceding rounds. All information on the timing of events during each screening episode, including invitation history, should be recorded as calendar dates. This ensures maximal flexibility of the database for future evaluation efforts and participation in multi-centre studies. It also permits distinguishing between the first and subsequent screening episodes and between participants with different patterns of attendance 

Self registrations 

Self registrations are defined as eligible residents of the designated area served by the programme, who request screening but who are not identified by the target population register used to generate invitations. Their number should be reported separately.  

Self referrals 

Self referrals are defined as people requesting screening before receipt of an invitation or outside the invited age-range. They should not be included in coverage by invitation, or in participation rate if in the relevant age range, but their number should be reported separately.