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1. The condition
- 1. The condition should be an important health problem as judged by its frequency and/or severity. The epidemiology, incidence, prevalence and natural history of the condition should be understood, including development from latent to declared disease and/or there should be robust evidence about the association between the risk or disease marker and serious or treatable disease.
- 2. All the cost-effective primary prevention interventions should have been implemented as far as practicable.
- 3. 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.
2. The test
- 4. There should be a simple, safe, precise and validated screening test.
- 5. The distribution of test values in the target population should be known and a suitable cut-off level defined and agreed.
- 6. The test, from sample collection to delivery of results, should be acceptable to the target population.
- 7. 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.
- 8. If the test is for a particular mutation or set of genetic variants the method for their selection and the means through which these will be kept under review in the programme should be clearly set out.
3. The intervention
- 9. There should be an effective intervention for patients identified through screening, with evidence that intervention at a pre-symptomatic phase leads to better outcomes for the screened individual compared with usual care. Evidence relating to wider benefits of screening, for example those relating to family members, should be taken into account where available. However, where there is no prospect of benefit for the individual screened then the screening programme should not be further considered.
- 10. There should be agreed evidence based policies covering which individuals should be offered interventions and the appropriate intervention to be offered.
4. The screening programme
- 11. 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” (such as Down’s syndrome or 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.
- 12. 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.
- 13. The benefit gained by individuals from the screening programme should outweigh any harms, for example from overdiagnosis, overtreatment, false positives, false reassurance, uncertain findings and complications.
- 14. 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 (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.
5. Implementation criteria
- 15. Clinical management of the condition and patient outcomes should be optimised in all health care providers prior to participation in a screening programme.
- 16. All other options for managing the condition should have been considered (such as improving treatment or providing other services), to ensure that no more cost effective intervention could be introduced or current interventions increased within the resources available.
- 17. There should be a plan for managing and monitoring the screening programme and an agreed set of quality assurance standards.
- 18. Adequate staffing and facilities for testing, diagnosis, treatment and programme management should be available prior to the commencement of the screening programme.
- 19. Evidence-based information, explaining the purpose and potential consequences of screening, investigation and preventative intervention or treatment, should be made available to potential participants to assist them in making an informed choice.
- 20. 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.
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