Screening Programmes Flashcards

1
Q

What is screening?

A

Screening is the examination of asymptomatic people to identify early disease or the precursors of disease with the usual aim of preventing or reducing mortality or morbidity. Screening can be defined as ‘The systematic application of a test or inquiry, to identify individuals at sufficient risk of a specific disorder to warrant further investigation or direct preventive action, amongst persons who have not sought medical attention on account of symptoms of that disorder.’ It can be directed at the whole population (mass screening) or at specific groups of people considered to be at high risk of developing the disease (selective screening). Whilst screening is usually undertaken to reduce mortality and morbidity, through effective, early treatment of identified cases of disease, some screening programmes are undertaken for slightly different reasons. For example, antenatal screening for Downs Syndrome or Spina Bifida, where the purpose of screening is to allow parents the possibility of terminating the pregnancy (and thereby preventing future morbidity). In screening for communicable disease such as HIV, the aim is not only to reduce mortality and morbidity of the person who is HIV positive, but also to prevent the mortality or morbidity of their at risk contacts.

Screening can also be done pro-actively or opportunistically. In pro-active screening members of a target population are invited to attend for testing in a systematic programme which will cover the whole of that population over a defined period of time. For example, women between 20 and 64 are targeted for regular cervical screening test every 3 to 5 years. Opportunistic screening occurs when a test for an unsuspected disorder at a time when a person presents to the doctor for another reason. For example, most people have blood pressure check when they visit their GP for any medical concern and this could identify people at the risk of heart disease.

Much attention is focused on screening tests, for example the cervical smear test or blood pressure measurement, but it is inappropriate to think of screening as simply a test. A screening programme consists of all those activities from the identification of the population likely to benefit right through to definitive diagnosis and treatment.

There is sometimes confusion over the terminology used in screening and clinical case finding. Identification of people with a specific disease in clinical practice or research is sometimes referred to as screening (for example, screening for depression). This is misleading because case finding relies on the identification of people with known disease whereas the aim of screening is to identify people in the early stages (pre-clinical phase) of disease before they are aware that they have the disease.

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2
Q

How can screening be defined?

A

‘The systematic application of a test or inquiry, to identify individuals at sufficient risk of a specific disorder to warrant further investigation or direct preventive action, amongst persons who have not sought medical attention on account of symptoms of that disorder.’

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3
Q

What is screening directed at a whole population called?

A

Mass screening (e.g. PKU)

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4
Q

What is screening directed at specific groups of people considered to be at high risk of developing the disease called?

A

Selective screening (e.g. Coal miners)

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5
Q

What is the purpose of screening?

A

Whilst screening is usually undertaken to reduce mortality and morbidity, through effective, early treatment of identified cases of disease, some screening programmes are undertaken for slightly different reasons. For example, antenatal screening for Downs Syndrome or Spina Bifida, where the purpose of screening is to allow parents the possibility of terminating the pregnancy (and thereby preventing future morbidity). In screening for communicable disease such as HIV, the aim is not only to reduce mortality and morbidity of the person who is HIV positive, but also to prevent the mortality or morbidity of their at risk contacts.

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6
Q

What is proactive screening?

A

In pro-active screening members of a target population are invited to attend for testing in a systematic programme which will cover the whole of that population over a defined period of time. For example, women between 20 and 64 are targeted for regular cervical screening test every 3 to 5 years.

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7
Q

What is opportunistic screening?

A

Opportunistic screening occurs when a test for an unsuspected disorder at a time when a person presents to the doctor for another reason. For example, most people have blood pressure check when they visit their GP for any medical concern and this could identify people at the risk of heart disease.

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8
Q

Is a screening programme simply a test?

A

Much attention is focused on screening tests, for example the cervical smear test or blood pressure measurement, but it is inappropriate to think of screening as simply a test. A screening programme consists of all those activities from the identification of the population likely to benefit right through to definitive diagnosis and treatment.

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9
Q

What criteria are used to assess whether certain diseases are suitable for screening?

A

Not all diseases are appropriate for screening. General criteria for screening have been proposed by the World Health Organisation (WHO) and expanded to account for current available evidence and concerns about the adverse effects of health care.

The criteria for appraising the viability, effectiveness and appropriateness of a screening programme include assessment of the condition, the test, the treatment, and the screening programme.

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10
Q

Describe the characteristics of a condition that may be suitable for inclusion in a screening programme.

A

1) . The condition should be an important health problem.
2) . The epidemiology and natural history of the condition, including development from latent to declared disease, should be adequately understood and there should be a detectable risk factor, disease marker, latent period or early symptomatic stage.

3). All the cost-effective primary prevention interventions should have been implemented as far as practicable.

The disease should be an important health problem. That is, it should be fairly prevalent and result in significant mortality or morbidity if untreated. Population screening for rare disease is not efficient but is sometimes undertaken (for example in phenylketonuria), when there is a good screening test available that is cheap, easy to administer, is not associated with significant risk and where the health consequences of non-treatment in the early stages of the disease are serious.

The natural history of the disease should be well understood. Many screening tests detect a range of abnormalities from slightly to severely abnormal. Some knowledge of the prognosis of different grades of abnormality is needed to inform decisions about when to offer treatment. In many cases there is poor understanding of the natural history of disease. The assumption is that the disease will inevitably progress to a stage where it causes mortality of significant morbidity. However, this is not always the case. Even in serious disease some cases either spontaneously resolve or fail to progress and this may happen in the pre-clinical phase. In other words, without screening, such people would be completely unaware that they had ever had the disease. Even within the same disease, there is often considerable variability in the rates of progression ease in different people. For example, in lung cancer, the size of the tumour does not necessarily correlate with prognosis. Patients with 3cm masses have the same outcomes as those with masses less than 1cm.

The disease must pass through a detectable pre-clinical phase. Since the purpose of screening is the detection and early treatment of disease, there is little point in screening for a disease that cannot be detected before the onset of symptoms as this would not result in earlier treatment.

Primary prevention of the disease should be implemented. If there is any primary prevention of disease, this would be important to have in place to prevent disease before it occurs.

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11
Q

Describe the characteristics for a test that may be suitable for inclusion in a screening programme.

A

1) . There should be a simple, safe, precise and validated screening test. Must have high sensitivity and high specificity. Sensitivity should be almost perfect but also want specificity to be high.
2) . Need t understand the range of test values we might get in the population. The distribution of test values in the target population should be known and a suitable cutoff level defined and agreed.
3) . The test should be acceptable to the population you are screening and to the health care service providing these tests - e.g. shouldn’t produce too many false positives, in genetic testing we should consider whether the presence of the variant means a person will actually develop the disease etc.
4) . There should be an agreed policy on the further diagnostic investigation of individuals with a positive test result and on the choices available to those individuals.

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12
Q

Describe the characteristics for a treatment that may be suitable for inclusion in a screening programme.

A

1) . There should be an effective treatment or intervention for patients identified through early detection, with evidence of early treatment leading to better outcomes than late treatment.
2) . There should be agreed evidence based policies covering which individuals should be offered treatment and the appropriate treatment to be offered. Clinical management of the condition and patient outcomes should be optimised by all health care providers prior to participation in a screening programme.

There must be effective treatment available for the disease. It would be unethical and a waste of resources to identify people with pre-clinical disease for which there was no effective treatment. This has been one of the dilemmas in screening for prostate cancer where the treatment most frequently offered to men positively identified as having prostate cancer is invasive surgery which is associated with a high risk of incontinence and impotence, despite the lack of evidence that this is more effective than ‘watchful waiting’ (i.e. no intervention) in most men.

Assuming the treatment is effective, early treatment must offer some advantage over later treatment. Screening is based upon the assumption that treatment in the early stages of the disease will be more effective in reducing/preventing mortality and morbidity than treatment when the disease is more established. For example, in most cases of cancer, it is accepted that early treatment of smaller, localised tumours is more likely to reduce mortality than treatment of metastatic disease.

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13
Q

Describe the evaluations that should be made of a screening programme.

A

1) . There should be high quality evidence from Randomised Controlled Trials that the screening programme is effective in reducing mortality or morbidity.
2) . There should be evidence that the complete screening programme (test, diagnostic procedures, treatment/ intervention) is clinically, socially and ethically acceptable to health professionals and the public.
3) . The benefit from the screening programme should outweigh the physical and psychological harm (caused by the test, diagnostic procedures and treatment).
4) . The opportunity cost of the screening programme (including testing, diagnosis and treatment) should be economically balanced in relation to expenditure on medical care as a whole.
5) . There should be a plan for managing and monitoring the screening programme and an agreed set of quality assurance standards.
6) . Adequate staffing and facilities for testing, diagnosis, treatment and programme management should be available prior to the commencement of the screening programme.
7) . All other options for managing the condition should have been considered (e.g. improving treatment, providing other services).

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14
Q

Describe the characteristics of screening tests.

A

The purpose of screening is to detect pre-clinical disease i.e. disease that is asymptomatic. Most screening tests, therefore are physiological, biochemical or anatomical and include x-rays, CT scans, mammography, cervical cytology, measures of blood pressure and so on. Suitable screening tests should be acceptable to the target population (otherwise there will be poor uptake), inexpensive, easy to use and interpret, safe, reliable, valid and have good sensitivity and specificity.

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15
Q

Describe possible sources of error in screening tests.

A

1) . Inherent error (e.g. x-ray resolution)
2) . Application error (x-ray wrong exposure)
3) . Interpretations error (x-ray reading)

There are several sources of error in screening tests, some of which are inherent in the tests themselves and others in their application and interpretation. For example, x-rays may be badly performed or not taken in a standardised way, smears may fail to capture the malignant cells that were present, some biochemical markers may be very unstable and the results of all tests are potentially open to misinterpretation or misclassification. In screening, the sensitivity and specificity of the tests are of particular importance.

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16
Q

What is meant by the sensitivity of a test?

A

Sensitivity of the test is the probability that it will correctly classify people with pre-clinical disease as positive (i.e. the proportion of true positives correctly identified) or the sensitivity of the test is the proportion of individuals classed as positives by the gold standard who are correctly identified by the study test. A high sensitivity means the test is correctly identifying a high proportion of the true positives (ie true exposed or true diseased).

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17
Q

What is meant by the specificity of a test?

A

Specificity is the probability that the test will classify people who are not diseased as negative (i.e. the proportion of true negatives correctly identified) or the specificity of the test is the proportion of individuals classed as negatives by the gold standard who are correctly identified by the study test. A high specificity means the test is giving few positive results in the unexposed or non-diseased. For the test to be valid, a high sensitivity and a high specificity are needed. The use of sensitivity and specificity can be used for screening as well as questionnaire as shown below.

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18
Q

What is the easiest way to calculate values for sensitivity and specificity?

A

The easiest way to calculate these values is to put the numbers in a cross tabulation of a reference (gold standard) test and our screening test.

True positives = a
False positives = b
False negatives = c
True negatives = d

Sensitivity = a/(a+c)

Specificity = d/(b+d)

True prevalence = (a+c)/(a+b+c+d)

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19
Q

Why do we need a good specificity in a screening test?

A

A good specificity means few false positive. This means there will be few false positives and less people worried unnecessarily.

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20
Q

Why do we need a good sensitivity in a screening test?

A

Good sensitivity means few false negatives i.e. fewer mistakes.

21
Q

Describe positive and negative predictive values.

A

The positive predictive value (PPV) is the likelihood that people with a positive test result have the disease.

Positive predictive = _a__
a +b

The negative predictive value (NPV) is the likelihood that someone with a negative test result does not have the disease.

Negative predictive value = _d__
c+d

Both the positive and negative predictive values are determined by the sensitivity and specificity of the test and the prevalence of pre-clinical disease in the target population. The lower the prevalence of a disease, then the lower the PPV is. Specificity determines the number of false positives, which are derived from people without the disease (i.e the majority of the people who are screened), so that even a small loss of specificity, can result in a significant increase in the numbers of false positives and a large decline in PPV. Conversely, an increase in sensitivity results in a larger number of true positives and therefore a higher PPV. PPV can be increased by increasing the specificity of the test or by increasing the prevalence of pre-clinical disease in the target population.

Specificity can be increased by changing the test criterion of positivity, that is, by making the criteria for classification as positive more stringent (for example, by requiring a higher level of abnormality on the test for classification as positive for the disease). The problem with this is that doing so may reduce the sensitivity of the test.

22
Q

How can specificity be increased?

A

Specificity can be increased by changing the test criterion of positivity, that is, by making the criteria for classification as positive more stringent (for example, by requiring a higher level of abnormality on the test for classification as positive for the disease). The problem with this is that doing so may reduce the sensitivity of the test.

23
Q

When should sensitivity be increased at the expense of specificity and when should specificity be increased at the expense of sensitivity?

A

In general, sensitivity should be increased at the expense of specificity when:

  • the disease is communicable,
  • the disease is serious and an effective treatment is available,
  • and when subsequent confirmatory diagnostic tests are inexpensive and low risk.

i.e. we really need to detect all individuals with these people.

If it is going to be a trade off between the two we should increase the sensitivity and just accept that we are going to have to follow up a few more false positives. The benefit is identifying everyone with the disease.

When the costs or risks of further diagnostic tests are substantial (such as in biopsy), specificity is more important than sensitivity.

One way of overcoming the problem of the balance between sensitivity and specificity is to use more than one screening test for each disease but this will have its own problems of increased costs and problems of interpretation.

The sensitivity and specificity of a screening test also raise ethical issues. A test with poor sensitivity would fail to identify some people who really do have disease (the false negatives) whilst a test with poor specificity would erroneously identify some people as having the disease (the false positives). Such people would suffer unnecessary anxiety as a result.

24
Q

What is positive predictive value?

A

Positive predictive value is the likelihood that people with a positive test result have the disease.

The lower the prevalence of the disease the lower the positive predictive value.

25
Q

What is negative predictive value?

A

Negative predictive value is the likelihood that people with a negative test result do not have the disease.

26
Q

What are both positive predictive and negative predictive values both influenced by?

A

Both are influenced by the sensitivity and specificity.

e.g. if we have a low specificity that will lead to a significant increase in the numbers of false positives and therefore a large decline in the PPV.

An increase in sensitivity results in a larger number of true positives and therefore a higher PPV.

27
Q

Describe how you calculate sensitivity, specificity, positive predictive value and negative predictive value.

A

True positives = a
False positives = b
False negatives = c
True negatives = d

Sensitivity = number of true identified positives/actual total positives present = a/(a+c)

Specificity = number of true identified negatives/actual total negatives present = d/(b+d)

True prevalence = (a+c)/(a+b+c+d)

Positive predictive = number of true identified positives / number of true and false identified positives= a/(a+b)

Negative predictive value = number of true identified negatives / number of true and false identified negatives = d/(c+d)

28
Q

Other than sensitivity and specificity what are PPVs and NPVs also influenced by?

A

Both the PPVs and NPVs are determined by the sensitivity and specificity of the test and the prevalence of the pre-clinical disease in the target population.

The lower the prevalence, the lower the PPV.

29
Q

Describe the relationships between PPV, specificity, sensitivity and prevalence.

A

PPV and NPV depend on the prevalence of disease.

Lower disease prevalence = lower PPV.

Decrease in specificity leads to an increase in the numbers of false positives and a large decline in PPV.

Increase in sensitivity results in a larger number of true positives and therefore a higher PPV.

30
Q

What effect will an increase in sensitivity have on the PPV?

A

Increase in sensitivity results in a larger number of true positives and therefore a higher PPV.

31
Q

Describe how to assess or estimate the extent or magnitude of measurement error for a screening test or questionnaire (assess the performance of a test).

A

Clearly we want a situation where the test/questionnaire performs well, so that measurement error is minimised. The performance of our tool/measure can be assessed in terms of:

Validity: does it measure what it is supposed to measure?

Reliability: does it give the same result on repeated application?

It is important to make some assessment of the performance of the measures used in a study in terms of their reliability and validity, so that the likely impact of errors on the study findings can be determined.

32
Q

What is validity?

A

Validity: does it measure what it is supposed to measure?

Am i measuring what I really want to measure?

A test must be reliable to be valid but reliable tests are not necessarily valid.

33
Q

What is reliability?

A

Reliability: does it give the same result on repeated application?

Reliability does not mean that the answer is right, but a test cannot be sensitive or specific without also being reliable.

34
Q

How often should people be screened?

A

For some conditions, such as genetic or congenital conditions, a one-off screening at an identifiable time (for example, at birth or in utero) is sufficient. However, for the majority of diseases that can develop at any time over the life course a one-off screening would only detect a small proportion of potential cases. The question is how frequently should people be screened? Decisions about screening intervals are based on information about the interval rates of disease that can be derived from the false negative rate and the length of the pre-clinical phase of the disease (during which it can be detected by screening). Case control studies can provide this information by allowing comparison of the number and interval between screens in cases and controls but will only give accurate information if the screening histories of cases and controls are fully ascertained.

  • genetic or congenital conditions = once
  • most diseases need repeat screening
  • frequency derived from false negative data
35
Q

Give a summary of the criteria for screening.

A
  • The disease being screened for should be an important health problem
  • The natural history of the disease should be well understood
  • It should have a detectable pre-clinical phase
  • There should be effective treatment available
  • Early treatment should have significant advantages over later treatment
  • A test should be available that is capable of detecting the disease in its pre-clinical phase
  • The test should be acceptable to the target population
  • The benefits should outweigh the risks (physical and psychological)
  • The interval for repeating the test should be determined
  • There should be appropriate diagnostic tests for people who have screened positive
  • There should be adequate resources to perform diagnostic tests and provide treatment for identified cases
  • It should be cost-effective
36
Q

What are the advantages and disadvantages of screening?

A

Advantages:

  • Improved prognosis for some cases
  • Less radical treatment
  • Resource savings
  • Reassurance for negative test results

Disadvantages:

  • Longer morbidity for cases where prognosis is unaltered
  • Overtreatment of questionable abnormalities
  • Resource costs
  • False assurance (false negatives)
  • Adverse effects (false positives)
  • Hazards of the test and subsequent diagnostic tests
37
Q

How do we evaluate if screening is effective?

A

1) . Ecological studies
2) . Case-control studies
3) . Cohort studies
4) . RCTS

Often difficult due to bias.

38
Q

What are the 4 potential sources of bias in evaluating the effectiveness of screening?

A

1) . Volunteer bias
2) . Lead-time bias - disease diagnosed earlier
3) . Length bias - screening detects more slowly progressive disease
4) . Overdiagnosis bias - would the lesion result in disease - e.g. cervical screening

39
Q

Describe volunteer bias in evaluating the effectiveness of screening.

A

Volunteer bias: Selection or volunteer bias can occur because specific groups of people with specific risk of disease may be more attracted to screening than groups with a very different risk. Socio-economic class is a strong determinant of the uptake of screening but is also associated with differential risk for many diseases. For example, middle class women are more likely to attend breast cancer screening but their risk for breast cancer is higher than that of other social classes, less likely to attend screening. In other cases, screening may attract people who are generally more healthy and at reduced risk of disease.

40
Q

Describe lead-time bias in evaluating the effectiveness of screening.

A

Lead-time bias: Lead-time bias occurs because the diagnosis of disease is made earlier in screened populations than in those who present symptomatically and can artificially increase the apparent survival time although the actual time from the onset of disease to death is identical (see figure 1). Lead-time bias can be overcome by comparing age-specific death rates in the screened and unscreened groups, or if the lead-time is known, it can be taken into account.

41
Q

Describe length bias in evaluating the effectiveness of screening.

A

Length bias: Length bias also gives an artificially increased survival to the screened group compared with those who present symptomatically. This occurs because the probability of detecting disease through screening depends upon the length of the pre-clinical phase; a longer pre-clinical phase gives more opportunity for detection before symptoms develop. In some disease, such as some cancers, the duration of the pre-clinical phase is related to the severity of disease (more aggressive tumours have shorter pre-clinical phases). This means that people with more aggressive disease (with a poorer prognosis) are more likely to present symptomatically than be detected through screening. Screening is therefore likely to detect a higher proportion of non-aggressive disease (with a better prognosis).

42
Q

Describe overdiagnosis bias in evaluating the effectiveness of screening.

A

Overdiagnosis bias: This is an extreme form of length-time bias and occurs because some cases detected by screening will have very mild disease which either does not progress to significant morbidity or does not affect their life expectancy. This results in an overestimation of the benefit of screening. An example of this occurs in prostate cancer in which only a small proportion of cancers known to be present become clinically evident and more men die with prostate cancer than because of it.

43
Q

Explain how we can assess the effectiveness of screening.

A

A variety of study designs have been used to evaluate the effectiveness of screening programmes and include observational studies, ecological studies, case control studies and randomised controlled trials. Effective evaluation of screening is problematic because most study designs are subject to one or more of the following biases: volunteer (selection) bias, lead-time bias, length bias and over diagnosis bias.

1) . Volunteer bias: Selection or volunteer bias can occur because specific groups of people with specific risk of disease may be more attracted to screening than groups with a very different risk. Socio-economic class is a strong determinant of the uptake of screening but is also associated with differential risk for many diseases. For example, middle class women are more likely to attend breast cancer screening but their risk for breast cancer is higher than that of other social classes, less likely to attend screening. In other cases, screening may attract people who are generally more healthy and at reduced risk of disease.
2) . Lead-time bias: Lead-time bias occurs because the diagnosis of disease is made earlier in screened populations than in those who present symptomatically and can artificially increase the apparent survival time although the actual time from the onset of disease to death is identical (see figure 1). Lead-time bias can be overcome by comparing age-specific death rates in the screened and unscreened groups, or if the lead-time is known, it can be taken into account.
3) . Length bias: Length bias also gives an artificially increased survival to the screened group compared with those who present symptomatically. This occurs because the probability of detecting disease through screening depends upon the length of the pre-clinical phase; a longer pre-clinical phase gives more opportunity for detection before symptoms develop. In some disease, such as some cancers, the duration of the pre-clinical phase is related to the severity of disease (more aggressive tumours have shorter pre-clinical phases). This means that people with more aggressive disease (with a poorer prognosis) are more likely to present symptomatically than be detected through screening. Screening is therefore likely to detect a higher proportion of non-aggressive disease (with a better prognosis).
4) . Overdiagnosis bias: This is an extreme form of length-time bias and occurs because some cases detected by screening will have very mild disease which either does not progress to significant morbidity or does not affect their life expectancy. This results in an overestimation of the benefit of screening. An example of this occurs in prostate cancer in which only a small proportion of cancers known to be present become clinically evident and more men die with prostate cancer than because of it.

44
Q

What study types can we use to assess the effectiveness of our screening programmes?

A

1) . Ecological studies
2) . Case control studies
3) . Cohort studies
4) . Randomised controlled trials

45
Q

Describe the study types that can be used to assess the effectiveness of our screening programmes.

A

1). Ecological studies:

Ecological studies can take two forms. They either look at trends in disease in populations before and after screening has been introduced (so that each population acts as its own control) or they compare frequencies of screening and disease rates for different populations. Results are used to suggest a relationship between screening and a reduction in mortality or morbidity. The general drawback of these studies is that because the information is derived from populations, it is difficult to relate it to individuals. For example, it is not possible to determine whether the reduction in mortality occurred in individuals who were screened. Nor is it possible to determine the optimal screening strategy for an individual because the measure of frequency of screening is an average value so that an area in which half the population were screened twice a year, would appear to have the same screening experience as an area where the entire population was screened once a year.

2). Case control studies:

Case control studies compare people with and without disease (outcome) with respect to their screening history (exposure). They are essentially comparisons of morbidity or mortality between people who accept or refuse screening. Good screening histories and careful selection of cases and controls are essential. If mortality is the end point, the controls may include patients who have the disease as well as people who do not.

3). Cohort studies:

Cohort studies compare survival times in screen detected and non-screen detected cases. These studies are susceptible to lead-time and length biases.

4). Randomised controlled trials:

Randomised controlled trials overcome many of the biases and problems of confounding but are difficult to perform in screening. The population to be screened is randomised to one of two groups. One group is screened, the other is not. All participants are followed up and the number of deaths or people experiencing severe morbidity in the whole of the study population is recorded. One of the problems is that the length of follow-up may have to extend over many years to reflect the natural history of the disease (for example, long enough to observe most of the change in death rate from early treatment), making the study logistically difficult, expensive and increasing the chance that standard screening tests will evolve and change during the course of the study. Another problem is that because the subjects most likely to benefit from screening are those who have their disease detected in its preclinical phase, who are a small proportion of the total population, screening trials often need to be very large. For example, in the Health Insurance Study of breast cancer screening, 20,000 women had to have 62,000 examinations in order for 132 women to be treated early. Moreover, randomised controlled trials (where the control is no screening) may not be ethically acceptable in situations where screening has become routinely available.

46
Q

Describe ecological studies for assessing the effectiveness of screening programmes.

A

Ecological studies can take two forms. They either look at trends in disease in populations before and after screening has been introduced (so that each population acts as its own control) or they compare frequencies of screening and disease rates for different populations. Results are used to suggest a relationship between screening and a reduction in mortality or morbidity. The general drawback of these studies is that because the information is derived from populations, it is difficult to relate it to individuals. For example, it is not possible to determine whether the reduction in mortality occurred in individuals who were screened. Nor is it possible to determine the optimal screening strategy for an individual because the measure of frequency of screening is an average value so that an area in which half the population were screened twice a year, would appear to have the same screening experience as an area where the entire population was screened once a year.

47
Q

Describe case control studies for assessing the effectiveness of screening programmes.

A

Case control studies compare people with and without disease (outcome) with respect to their screening history (exposure). They are essentially comparisons of morbidity or mortality between people who accept or refuse screening. Good screening histories and careful selection of cases and controls are essential. If mortality is the end point, the controls may include patients who have the disease as well as people who do not.

48
Q

Describe cohort studies for assessing the effectiveness of screening programmes.

A

Cohort studies compare survival times in screen detected and non-screen detected cases. These studies are susceptible to lead-time and length biases.

49
Q

Describe randomised control trials for assessing the effectiveness of screening programmes.

A

Randomised controlled trials overcome many of the biases and problems of confounding but are difficult to perform in screening. The population to be screened is randomised to one of two groups. One group is screened, the other is not. All participants are followed up and the number of deaths or people experiencing severe morbidity in the whole of the study population is recorded. One of the problems is that the length of follow-up may have to extend over many years to reflect the natural history of the disease (for example, long enough to observe most of the change in death rate from early treatment), making the study logistically difficult, expensive and increasing the chance that standard screening tests will evolve and change during the course of the study. Another problem is that because the subjects most likely to benefit from screening are those who have their disease detected in its preclinical phase, who are a small proportion of the total population, screening trials often need to be very large. For example, in the Health Insurance Study of breast cancer screening, 20,000 women had to have 62,000 examinations in order for 132 women to be treated early. Moreover, randomised controlled trials (where the control is no screening) may not be ethically acceptable in situations where screening has become routinely available.