Screening

1. Screening Jo Pollott 31st May 2006

3. Outline Why do we need to screen? Who decides what conditions should be screened for? How is it done? When is it done? When screening can do more harm than good Current UK screening programmes Conditions specifically not screened for

4. Definition Screening is a public health service in which members of a defined population, who do not necessarily perceive they are at risk of, or are already affected by a disease or its complications, are asked a question or offered a test, to identify those individuals who are more likely to be helped than harmed by further tests or treatment to reduce the risk of a disease or its complications. As per UK National screening committeeAs per UK National screening committee

5. UK National Screening Committee chaired by one of the Chief Medical Officers advises Ministers, the devolved national Assemblies and the Scottish Parliament on all aspects of screening policy has Fetal Maternal and Child Health Co-ordinating Group (FMCH) which deals with antenatal and child health screening issues draws on the latest research evidence and the skills of specially convened multi-disciplinary expert groups, which always include patient and service user representatives assesses proposed new screening programmes against a set of internationally recognised criteria ensures that they do more good than harm at a reasonable cost 1996 - NHS was instructed not to introduce any new screening programmes until the NSC had reviewed their effectiveness

6. Criteria for screening Defined by WHO 1968 Wilson-Jungner criteria Defined by WHODefined by WHO

7. Wilson-Jungner Criteria The condition being screened for should be an important health problem The natural history of the condition should be well understood There should be a detectable early stage Treatment at an early stage should be of more benefit than at a later stage A suitable test should be devised for the early stage The test should be acceptable Intervals for repeating the test should be determined Adequate health service provision should be made for the extra clinical workload resulting from screening The risks, both physical and psychological, should be less than the benefits The costs should be balanced against the benefits The Wilson-Jungner criteria for appraising the validity of a screening programme Principles and practices of screening for disease by Wilson JM, and Jungner YG. Geneva, World Health Organization, 1968 The Wilson-Jungner criteria for appraising the validity of a screening programme Principles and practices of screening for disease by Wilson JM, and Jungner YG. Geneva, World Health Organization, 1968

8. Criteria for appraising the viability, effectiveness and appropriateness of a screening programme 2003 - the Condition The condition should be an important health problem 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 All the cost-effective primary prevention interventions should have been implemented as far as practicable 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. March 2003 NSC 22 point criteria take into account both the more rigorous standards of evidence required to improve effectiveness, and the greater concern about the adverse effects of screening March 2003 NSC 22 point criteria take into account both the more rigorous standards of evidence required to improve effectiveness, and the greater concern about the adverse effects of screening

9. Criteria for appraising the viability, effectiveness and appropriateness of a screening programme 2003 - the Test There should be a simple, safe, precise and validated screening test The distribution of test values in the target population should be known and a suitable cut-off level defined and agreed The test should be acceptable to the population 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 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 for, should be clearly set out

10. Criteria for appraising the viability, effectiveness and appropriateness of a screening programme 2003 - the Treatment 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 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 in all healthcare providers prior to participation in a screening programme.

11. Criteria for appraising the viability, effectiveness and appropriateness of a screening programme 2003 - the Screening programme 1 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' (for example, Down's syndrome and 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 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 The benefit from the screening programme should outweigh the physical and psychological harm (caused by the test, diagnostic procedures and treatment) 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) There should be a plan for managing and monitoring the screening programme and an agreed set of quality assurance standards

12. Criteria for appraising the viability, effectiveness and appropriateness of a screening programme 2003 - the Screening programme 2 Adequate staffing and facilities for testing, diagnosis, treatment, and programme management should be available prior to the commencement of the screening programme All other options for managing the condition should have been considered (for example, improving treatment and providing other services), to ensure that no more cost-effective intervention could be introduced or current interventions increased within the resources available 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 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 If screening is for a mutation, the programme should be acceptable to people identified as carriers and to other family members

13. Limitations of screening not a fool-proof process can reduce the risk of developing a condition or its complications but it cannot offer a guarantee of protection irreducible minimum of false positive results and false negative results

14. When screening can do more harm than good Whole body CT Whole body MRI Exercise ECG PSA testing for prostate cancer Mammography if <50 yrs old

15. Current NHS Screening Programmes Antenatal Neonatal Child Adult Breast cancer Cervical cancer

16. Antenatal � maternal screening Anaemia (early pregnancy + 28 wks) Blood group + Rhesus status (early pregnancy) Atypical alloantibodies (early pregnancy + 28 wks) Asymptomatic bacteriuria Hepatitis B virus HIV Rubella Syphilis

17. Antenatal �fetal screening Structural anomalies (USS 18-20 wks) Down�s syndrome Nuchal translucency (NT) Combined test (NT, hCG, PAPP-A) Triple test (hCG, AFP, uE3) Quadruple test (hCG, AFP, uE3, inhibin A) Integrated test (NT, PAPP-A + hCG, AFP, uE3, inhibin A) Serum integrated test (PAPP-A + hCG, AFP, uE3, inhibin A) Down's - Currently, all women should be offered test with detection rate of 60% with false-positive rate >5% From april 2007, test should have 75% detection rate and 3% false postive therefore rules out NT alone NT + CT � 11-14 wks TT and QT � 14-20 wks IT + SIT � 11-20 wks Down's - Currently, all women should be offered test with detection rate of 60% with false-positive rate >5% From april 2007, test should have 75% detection rate and 3% false postive therefore rules out NT alone NT + CT � 11-14 wks TT and QT � 14-20 wks IT + SIT � 11-20 wks

18. Neonatal screening - newborn check (<72 h) Congenital malformations Eyes Heart Hips Testes Hearing Otoacoustic Emissions (OAE) Automated Auditory Brainstem Response test (AABR)

19. Neonatal screening � bloodspot 1 Phenylketonuria (PKU) Congenital hypothyroidism Sickle cell & thalassaemia Heel prick test day 5-8 Over 600,000 newborns screened per year Approx 250 affected babies identified per year >99% coverage PKU � since 1969 CH � since 1981 SC - 2005 Baby DOB = day 0 Ideally day 5PKU � since 1969 CH � since 1981 SC - 2005 Baby DOB = day 0 Ideally day 5

21. Neonatal screening � bloodspot 2 Cystic Fibrosis IRT (immuno-reactive trypsinogen) followed by two-stage DNA screen if IRT>99.5 centile if one mutation found or no mutation but v high initial IRT, blood taken for further IRT measurement currently ~20% of newborns screened in England all newborns in Northern Ireland, Wales and Scotland screened April 2007 - all newborns in UK to be screened currently � in areas served by laboratories in East Anglia, Trent, Northampton and Leeds.currently � in areas served by laboratories in East Anglia, Trent, Northampton and Leeds.

23. Child screening Physical examination (6-8 wks) Eyes Hips Heart Testes School entry Hearing Height, weight and growth Vision

24. Adult screening Chlamydia (oppurtunistic) Diabetic retinopathy Vascular Breast cancer Cervical screening Colorectal cancer DR � yearly if aged 11 or aboveDR � yearly if aged 11 or above

25. Breast screening - background 1988 � set up by DoH following recommendations of a working group, chaired by Professor Sir Patrick Forrest 1986 - report Breast Cancer Screening was published, became known as The Forrest Report First of its kind in the world 1990 - began inviting women for screening Mid 1990s - national coverage achieved

26. Breast screening � why? 14 million women screened so far 80000 cancers detected Report by DoH Advisory Committee published in 1991 suggested programme would save 1,250 lives by 2010 Latest research shows screening saves 1400 lives per year in England 35% decreased mortality (for every 500 women aged 50 � 69 yrs screened, 1 life saved)

27. Breast screening � who and how? All women aged 50 to 70 years Invited every 3 years ~1.5 million screened per year Method = 2 view mammography

28. Breast screening � how much? 80 breast screening units across the UK Nationally coordinated Budget for programme (in England) is approximately �75 million =�37.50 per woman invited or �45.50 per woman screened

29. Cervical screening - background Mid-1960s - cervical screening began in Britain Mid-1980s - concern that those at greatest risk were not being tested, and that those who had positive results were not being followed up and treated effectively 1988 - The NHS Cervical Screening Programme was set up ? DoH instructed all health authorities to introduce computerised call-recall systems and to meet certain quality standards

30. Cervical Screening � why? Detects early abnormalities which, if left untreated, could lead to cervical cancer Almost 4 million women screened per year In 2001/2002- 81.6% eligible women screened ? possible 95% reduction in mortality long term

31. Cervical Screening � who? All women aged 25 to 64 years Every three to five years depending on age (as per advice by Cancer Research UK) National recommendations will be changed as follows:

32. Cervical Screening � how? Smear test Spatula swept around cervix Cells �smeared� onto slide Examined under microscope Liquid Based Cytology (LBC) Brush inserted into cervix Head of brush either placed in vial of preservative fluid or cells washed of into fluid Cells spun down and obscuring material removed Thin film on slide inspected by microscope Reduction in inadequate tests ? reduced patient anxiety, workload and cost

33. Cervical Screening � how much? Estimated cost �157 million per year in England Changeover to LBC estimated to cost �10 million Nationally coordinated PCTs commission cervical screening from the overall allocation received from the DoH Regional directors of public health responsible for quality assurance of network in their region 1. But will save money in long run due to fewer tests and smaller workforce 2. national office of the NHS Cancer Screening Programmes, based in Sheffield 1. But will save money in long run due to fewer tests and smaller workforce 2. national office of the NHS Cancer Screening Programmes, based in Sheffield

34. Colorectal cancer screening - background national programme to be phased in from 2006 over 3 years Wolverhampton to have first screening centre 14 centres by spring 2007 will eventually be >90 screening centres across the country administered from 5 regional programme hubs

35. Colorectal cancer screening � why? major public health problem - second most common cause of cancer deaths in UK aim to reduce death rates by finding and treating bowel cancer early deaths from bowel cancer could drop by 15% as a result of screening nationally, screening for bowel cancer could save approximately 1,200 lives each year patients whose cancer is discovered early have more treatment options and better long term outlook

36. Colorectal cancer screening � who? All men and women aged 60�69 years Every 2 years

37. Colorectal cancer screening � how? Faecal Occult Blood Sample taken at home then sent to lab for analysis

38. Colorectal cancer screening � how much? FOB test costs �5 2% of all tests are positive ? subsequent diagnostic colonoscopy = �127

39. Vascular National Service Framework for Coronary Heart Disease in England recommends priority given to the identification of people at high risk of coronary heart disease so can be given systematic follow-up and offered advice and treatment to reduce the risk of recurrent infarction screening is not recommended for people at low risk of coronary heart disease. National Screening Committee has integrated these recommendations with those of the NSF for Diabetes to create the Diabetes, Heart Disease and Stroke Prevention Project (being piloted in�8 inner city primary care trusts, where need is greatest) This project aimed to identify people at high risk for heart disease and diabetes, based on the presence of existing cardiovascular disease or diabetes, and offered preventive measures. The project has been piloted in 8 inner city Primary Care Trusts. This project aimed to identify people at high risk for heart disease and diabetes, based on the presence of existing cardiovascular disease or diabetes, and offered preventive measures. The project has been piloted in 8 inner city Primary Care Trusts.

40. Conditions not screened for 1 Antenatal Bacterial vaginosis Chlamydia Cystic Fibrosis CMV Diabetes Domestic violence Familial dysautonomia Fragile X Genital Herpes Hepatitis C HTLV-1 Postnatal depression Preterm labour Streptococcus B Thrombocytopenia Thrombophilia Toxoplasmosis Newborn Amino acid metabolism disorders Biliary atresia Biotidinase deficiency Cannavans diseased Congenital adrenal hyperplasia Fatty-acid oxidation disorders Galactosemia Gauchers disease Medium Chain Acyl CoA Dehydrogenase Deficiency (MCADD) Muscular dystrophy Neuroblastoma Organic metabolism disorders Thrombocytopenia

41. Conditions not screened for 2 Child Autism Dental Disease Development & Behaviour Hypertension Hypertrophic cardiomypathy Hyperlipidaemia Iron deficiency anaemia Lead poisoning Obesity Speech & Language delay Scoliosis Adult AAA Alcohol problems Alzheimer�s disease Atrial fibrillation Cancers: Anal, Bladder, Lung, Oral, Ovarian, Prostate, Stomach, Testicular Deafness Depression Diabetes Domestic violence Glaucoma Haemochromatosis Hepatitis C Hyperlipidaemia Osteoporosis Renal disease Thrombophilia Thyroid disease Vision

42. References www.screening.nhs.uk Screening for Breast Cancer in England: Past and Future, Advisory Committee on Breast Cancer Screening, 2006 (NHSBSP Publication no 61) Breast Cancer Screening 1991: Evidence and Experience since the Forrest Report, Department of Health Advisory Committee, NHS Breast Screening Programme 1991 7th Handbook on Cancer Prevention, IARC, Lyons 2002 P Sasieni, J Adams and J Cuzick, Benefits of cervical screening at different ages: evidence from the UK audit of screening histories, British Journal of Cancer, July 2003 http://www.cancerscreening.nhs.uk http://www.rcog.org.uk/resources/Public/pdf/Antenatal_Care_summary.pdf