Annex: Criteria for appraising the viability,
effectiveness and appropriateness of a screening programme
UK National Screening Committee
Criteria
The Condition
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.
4. If the carriers of a mutation are identified
as a result of screening the natural history of people with this
status should be understood, including the psychological implications.
The Test
5. There should be a simple, safe, precise and
validated screening test.
6. The distribution of test values in the target
population should be known and a suitable cut-off level defined
and agreed.
7. The test should be acceptable to the population.
8. 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.
9. If the test is for mutations the criteria
used to select the subset of mutations to be covered by screening,
if all possible mutations are not being tested, should be clearly
set out.
The Treatment
10. 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.
11. There should be agreed evidence based policies
covering which individuals should be offered treatment and the
appropriate treatment to be offered.
12. Clinical management of the condition and
patient outcomes should be optimised in all health care providers
prior to participation in a screening programme.
The Screening Programme
13. There should be evidence from high quality
Randomised Controlled Trials that the screening programme is effective
in reducing mortality or morbidity. Where screening is aimed solely
at providing information to allow the person being screened to
make an "informed choice" (eg. Down's syndrome, cystic
fibrosis carrier screening), there must be evidence from high
quality trials that the test accurately measures risk. The information
that is provided about the test and its outcome must be of value
and readily understood by the individual being screened.
14. 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.
15. The benefit from the screening programme
should outweigh the physical and psychological harm (caused by
the test, diagnostic procedures and treatment).
16. The opportunity cost of the screening programme
(including testing, diagnosis and treatment, administration, training
and quality assurance) should be economically balanced in relation
to expenditure on medical care as a whole (ie. value for money).
Assessment against this criteria should have regard to evidence
from cost benefit and/or cost effectiveness analyses and have
regard to the effective use of available resource.
17. All other options for managing the condition
should have been considered (eg. improving treatment, providing
other services), to ensure that no more cost effective intervention
could be introduced or current interventions increased within
the resources available.
18. There should be a plan for managing and monitoring
the screening programme and an agreed set of quality assurance
standards.
19. Adequate staffing and facilities for testing,
diagnosis, treatment and programme management should be available
prior to the commencement of the screening programme.
20. Evidence-based information, explaining the
consequences of testing, investigation and treatment, should be
made available to potential participants to assist them in making
an informed choice.
21. Public pressure for widening the eligibility
criteria for reducing the screening interval, and for increasing
the sensitivity of the testing process, should be anticipated.
Decisions about these parameters should be scientifically justifiable
to the public.
22. If screening is for a mutation the programme
should be acceptable to people identified as carriers and to other
family members.[270]
270 UK National Screening Committee, 'Criteria for appraising the viability, effectiveness and appropriateness of a screening programme',
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