Report in English with a Dutch summary (KCE reports 45A)

Report in English with a Dutch summary (KCE reports 45A) Report in English with a Dutch summary (KCE reports 45A)

10.08.2013 Views

16 Screening for Colorectal Cancer KCE reports vol.45 1 GENERAL INTRODUCTION TO CANCER SCREENING 1.1 DEFINITION OF SCREENING In medicine, screening is typically a strategy used to identify disease in a primarily unsuspecting population. Unlike in curative medicine, in screening a test or intervention is performed on individuals without any known clinical indication of disease. The intention is to identify disease in an earlier stage, thus enabling earlier intervention and management in the hope to reduce mortality and suffering from disease. However, there remains a certain overlap with pre-emptive searching for disease in suspected population subgroups at more than average risk and surveillance of those with confirmed disease or genetic predisposition, as we will discuss further on. 1.2 PRINCIPLES OF SCREENING The principles underlying an effective screening intervention were originally developed by Wilson and Jungner in 1968 1, and these are summarized below: 1. The condition should be an important health problem for the individual and community. 2. There should be an accepted treatment or useful intervention for patients with the disease. 3. Facilities for diagnosis and treatment should be available. 4. There should be a recognizable latent or early symptomatic stage. 5. There should be a suitable test or examination. 6. The test should be acceptable to the population. 7. The natural history of the condition, including development for latent to declared disease, should be adequately understood. 8. There should be an agreed policy for referring for further examination and whom to treat as patients. 9. The cost of case-finding (including diagnosis and treatment of patients diagnosed) should be economically balanced in relation to possible expenditure on medical care as a whole. 10. Case finding should be a continuing process and not a "once and for all" project. The essence of these principles is that the target disease process should be a common problem that has a better outcome when treated at an early stage, and that the test employed is acceptable and sufficiently sensitive, specific, and inexpensive to be cost-effective. Although these original principles remain largely valid, other considerations are to be made. In its Report on the Dutch consensus development meeting for implementation and further development of population screening for colorectal cancer based on FOBT 2, the Dutch National Health Council 3 extended the

KCE reports vol.45 Screening for Colorectal Cancer 17 Wilson & Jungner criteria, adding additional criteria on practical 4 and ethical 5 issues: 11. Treatment started at an early stage should be of more benefit than treatment started later. 12. The time between test and result and between result and treatment must be as short as possible. 13. The recruitment procedure should not limit people in their freedom to participate or not in the screening program. 14. Potential participants should receive adequate information about pro and cons of participation. Benefits and risks should also be well known to health care providers 6. 15. Public education should promote a broad accessibility of the program. It should however not include a moral pressure effect. 16. There should be quality assurance (QA) and quality control (QC) procedures for the whole screening program. 17. Screening programs are concerted actions meeting organisational and managerial requirements. 1.3 PITFALLS AND POSSIBLE HARMS 1.3.1 Biases To many people, screening intuitively seems an appropriate thing to do, because catching disease earlier seems better. However, no screening test is perfect. There will always be problems with incorrect results and adverse effects. Before a screening program is implemented, it should thoroughly be studied to ensure that putting it in place would do more good than harm. Various factors can cause the screening test to appear more successful than it really is. A number of different biases can distort the results 7-13: 1. Length-time bias arises from the fact that intermittent screening tests will tend to pick up slow-growing, indolent disease that is likely to have a better prognosis than the rapidly advancing disease, which is more likely to appear with symptoms between screening intervals. As a consequence, screening in general may tend to detect some cancers that would not have killed the patient or even not have been detected prior to death from other causes. 2. Lead-time bias arises from early diagnosis itself. By screening, we intend to diagnose a disease earlier than it would be without screening. Even if in both cases a person dies at the same time, the survival time since diagnosis is longer with screening, simply because in the latter case we diagnosed disease earlier. No additional life has been gained but, looking at raw statistics, screening will appear to increase survival time: this gain is called lead time. If we do not pay attention to what survival time actually means in this context, we might attribute success to a screening test that does nothing but advance diagnosis. 3. Selection bias can arise from the fact that not everyone necessarily will participate in a screening program. There can be factors that differ between those willing to get tested and those

<strong>KCE</strong> <strong>reports</strong> vol.45 Screen<strong>in</strong>g for Colorectal Cancer 17<br />

Wilson & Jungner criteria, add<strong>in</strong>g additional criteria on practical 4 and ethical 5<br />

issues:<br />

11. Treatment started at an early stage should be of more benefit<br />

than treatment started later.<br />

12. The time between test and result and between result and<br />

treatment must be as short as possible.<br />

13. The recruitment procedure should not limit people <strong>in</strong> their<br />

freedom to participate or not <strong>in</strong> the screen<strong>in</strong>g program.<br />

14. Potential participants should receive adequate <strong>in</strong>formation about<br />

pro and cons of participation. Benefits and risks should also be<br />

well known to health care providers 6.<br />

15. Public education should promote a broad accessibility of the<br />

program. It should however not <strong>in</strong>clude a moral pressure effect.<br />

16. There should be quality assurance (QA) and quality control<br />

(QC) procedures for the whole screen<strong>in</strong>g program.<br />

17. Screen<strong>in</strong>g programs are concerted actions meet<strong>in</strong>g<br />

organisational and managerial requirements.<br />

1.3 PITFALLS AND POSSIBLE HARMS<br />

1.3.1 Biases<br />

To many people, screen<strong>in</strong>g <strong>in</strong>tuitively seems an appropriate th<strong>in</strong>g to do, because<br />

catch<strong>in</strong>g disease earlier seems better. However, no screen<strong>in</strong>g test is perfect.<br />

There will always be problems <strong>with</strong> <strong>in</strong>correct results and adverse effects.<br />

Before a screen<strong>in</strong>g program is implemented, it should thoroughly be studied to<br />

ensure that putt<strong>in</strong>g it <strong>in</strong> place would do more good than harm.<br />

Various factors can cause the screen<strong>in</strong>g test to appear more successful than it<br />

really is. A number of different biases can distort the results 7-13:<br />

1. Length-time bias arises from the fact that <strong>in</strong>termittent screen<strong>in</strong>g<br />

tests will tend to pick up slow-grow<strong>in</strong>g, <strong>in</strong>dolent disease that is<br />

likely to have a better prognosis than the rapidly advanc<strong>in</strong>g<br />

disease, which is more likely to appear <strong>with</strong> symptoms between<br />

screen<strong>in</strong>g <strong>in</strong>tervals. As a consequence, screen<strong>in</strong>g <strong>in</strong> general may<br />

tend to detect some cancers that would not have killed the<br />

patient or even not have been detected prior to death from<br />

other causes.<br />

2. Lead-time bias arises from early diagnosis itself. By screen<strong>in</strong>g, we<br />

<strong>in</strong>tend to diagnose a disease earlier than it would be <strong>with</strong>out<br />

screen<strong>in</strong>g. Even if <strong>in</strong> both cases a person dies at the same time,<br />

the survival time s<strong>in</strong>ce diagnosis is longer <strong>with</strong> screen<strong>in</strong>g, simply<br />

because <strong>in</strong> the latter case we diagnosed disease earlier. No<br />

additional life has been ga<strong>in</strong>ed but, look<strong>in</strong>g at raw statistics,<br />

screen<strong>in</strong>g will appear to <strong>in</strong>crease survival time: this ga<strong>in</strong> is called<br />

lead time. If we do not pay attention to what survival time<br />

actually means <strong>in</strong> this context, we might attribute success to a<br />

screen<strong>in</strong>g test that does noth<strong>in</strong>g but advance diagnosis.<br />

3. Selection bias can arise from the fact that not everyone<br />

necessarily will participate <strong>in</strong> a screen<strong>in</strong>g program. There can be<br />

factors that differ between those will<strong>in</strong>g to get tested and those

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