New Developments In the Cervical Screening Programme

What's New In Cervical Screening The impact of the previous changes to the programme Two week turnaround for results Pathology workforce review HPV Vaccination HPV Testing Ceasing of Reporting infections on Cervical Screening results Changes to the recall status of women having vault samples

Recommendations for the England Age-group Frequency of cytological screening Under 25 Don’t screen 25-49 Three-yearly screening 50-64 Five-yearly screening Based on the research from Professor Sasieni: the research showed that screening made little impact on the outcome of cancers in the under 25 age range. Although abnormalities were frequently picked up many would resolved without intervention. The Artistic trial has provided further evidence for this by showing that there are abnormalities but the majority are cleared by age 25.

Changes to the Cervical Screening Programme The Age Range For Screening National Audit of Cervical Cancers Liquid Based Cytology implementation Large reductions in inadequate rates? Age change most unpopular decision in the programme. Many remain opposed to the decision. The National Office for Cancer Screening has advised that if further evidence can be collected to disprove the original findings they would change the programme back. Hence National Cancer audit. GP’s will be wrote to regarding any interim cancers that develop for further details. Multi-disciplinary approach laboratory colp co-ordinated by HBPC. The benefits of LBC are already becoming apparent. Of the four million tests taken each year, the number of inadequate tests fell from 370,000 (9%) in 2004-05 to 173,000 (4.7%) in 2006-07. As a result around 200,000 women did not have to attend a repeat test, with all the anxiety that this involves for women, the additional expense for the NHS and the unnecessary workload for the programme LBC implementation North West first to implement in the country has both systems in North West. Surepath users have seen much larger reductions in inadequate rates. In some areas of Liverpool Cytyc inadequate rates have risen. Cytyc working with the practices and Laboratory to improve this.

Cancer Reform Strategy The cervical screening programme will ensure that all women receive the results of their screening tests within two weeks by 2010 First mentioned in the government manifesto in 2005. Initially suggested a 7 day turnaround but options appraisal agreed that this would be unattainable without significant investment. The Cervical screening process will need complete mapping from start to result. Logistics will need to be considered. Smear taken in a Family Planning setting late on a Friday evening will not leave until Monday morning. The Two week will be measured from Sample being taken to result being available from screening office to the woman Viewed very much as a Political move as screening well women it is not imperative that the results should be returned in 2 weeks

Reduction of Cancer Screening Waiting Times Better use of information Technology More advanced Biomedical Scientist Practitioners in Cervical Cytology Reconfiguring laboratories to make them more efficient North West Specialist commissioning Report Larger call/recall agencies to reduce turnaround times to allow better facilities to improve coverage such as telephone help lines

Two Week Turnaround Limit processing of samples to only those women eligible within the national standards Implement an electronic link from the laboratory to the call/recall office Despatch results letters by first class post on Monday Tuesday and Wednesday mornings Workforce redesign- training of advanced practitioners Merge workload from small laboratories ScHARR recommended that local screening programmes should not process samples taken from women who fall outside the programme (ie only screen women aged 25 to 49 every three years and women aged 50 to 64 every five years). Many women are currently screened “opportunistically” outside national standards. Currently 24.7% of samples are provided by women and their doctors at an inappropriate interval in the call and recall programme. Some units already strictly adhere to this policy, and show it can be achieved. Initial national costs would be £100,000, with potential savings of over £10 million per year. In discussions with stakeholders, there was some concern about the reaction of the service to not processing out of programme samples. The Advisory Committee on Cervical Screening (ACCS) has recommended that there should be a flexible period of six months prior to tests becoming due at which samples can be reported. Evidence from local screening programmes who operate strict policies on reporting out of programme samples has shown that primary care practitioners soon cease sending inappropriate samples for reporting. Local education programmes for GPs would be an important part of The Cervical screening process will need complete mapping from start to result. Logistics will need to be considered. Smear taken in a Family Planning setting late on a Friday evening will not leave until Monday morning. The Two week will be measured from Sample being taken to result being available from screening office Viewed very much as a Political move as screening well women it is not imperative that the results should be returned in 2 weeks

Coverage by age, England 1999 & 2005, North West 2005 Main concerns for the programme at present is the poor coverage in the cervical screening programme. In the North West there are some coverage initiatives taking place. Manchester and Liverpool Blackpool have the poorest nationally in with London. QA would welcome any suggestions to improve coverage. Coverage worker training has been very enlightening. Cultural issues discussed. Female circumcision. Cultural beliefs.

Be Cervix Savvy

Achievements in the Cervical Screening Programme The NHS Cervical Programme saves up to 4,500 lives in England ever year In 2006/07 3.4 million women were screened and laboratories examined 3.7 million samples In 2006/07 over 40,000 women had high grade abnormalities detected and treated through the programme

Classification of HPV Genotypes 100 + Different Genotypes Cutaneous Mucosal – (Anogenital types) Non-genital Skin warts – 1,2,3,4 Low Risk 6,11,42,43,44 High Risk 16,18,31,33,35,39,45, 51,52,56,58,59,68

Human Papilloma Virus (HPV) HPV is a necessary cause of cervical cancer 99.7% of cervical cancers contain HPV DNA Persistent infection with high-risk or oncogenic sub-types High-risk subtypes associated with high-grade pre-invasive and invasive disease - 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 Low-risk subtypes associated with genital warts and low-grade cytological abnormalities – 6, 11, 40, 42, 43, 44

HPV Transmission Intimate contact Studies have shown that infection in virgins was rare although any type of non-penetrative sexual contact was associated with an increased risk Condoms have only a degree of protection due to HPV field effect all over genitalia therefore condoms are not comprehensive or complete in protecting. Studies clearly demonstrate that the number of sexual partners is the key risk factor for acquiring the HPV infection

HPV Transmission HPV is almost a normal consequence of having sex 80% of the population have had HPV at some point in their lives In most women HPV will cause no long term harm and be eradicated by their immune system

Public Awareness of HPV Research shows little evidence of HPV Awareness Sample takers have a role in giving informed choice The association between knowledge of HPV and feelings of stigma, shame and anxiety This study has been produced by Laura Marlow and Dr Jo Waller at Cancer Research 2007 and demonstrates that there is little awareness and although there had been a three fold increase in the number of women who were able to list HPV as a cause of the disease since 2002 the figure is still ‘extraordinarily low’. Although there was an increase in the proportion of respondents who mentioned virus/infection as a risk factor there was no increase in mention of ‘a sexually transmitted’ virus/infection. The respondents used in the study were age 50 years on average and most were white (94%)…….. not very representative. The conclusion was that Public understanding of HPV is necessary to ensure informed consent for vaccination and testing. There is an urgent need for educational programmes. A further study by Dr Jo Waller and Laura Marlow regarding the association between knowledge of HPV and feelings of stigma, shame and anxiety was a web based survey. The results showed great differences were observed in emotional reactions to testing HPV positive: Knowledge of the prevalence was associated with lower levels of stigma, shame and anxiety. Knowledge that HPV is sexually transmitted was associated with higher levels of stigma and shame, but not anxiety. Women who knew that HPV is sexually transmitted but not that it is highly prevalent had the highest scores for stigma and shame. The conclusions: Raising public awareness of the sexually transmitted nature of HPV has the potential to increase women’s feeling of stigma and shame if they test positive for the virus. However the findings suggest that ensuring women’s awareness of HPV being common may reduce the feelings and also reduce anxiety, perhaps by ‘normalising’ the infection.

Consent to Cancer Screening New publication series No:4 January 2008 Women should be informed of the benefits and disadvantages of the test. Women should be informed of the procedure by the sample taker who must also be able to accurately and honestly answer any questions she may have.

Informed choice As a general principle , women should understand the limitations and consequences of screening or of not having screening, and should make an informed decision about whether or not to accept the invitation to participate in the programme.

HPV SENTINEL SITES HPV TESTING HPV Triage Sites in Manchester, Liverpool, Bristol, Norwich, and Sheffield and London Samples will be tested for high risk HPV following a borderline or mild dyskaryosis result.

What is HPV Triage? All cervical samples with first BNC or mild dyskaryosis test result will be tested for high risk HPV to distinguish between women who need referral to colposcopy and women who can be safely returned to routine recall. Women who test positive for high risk HPV will be referred to colposcopy. Women who are HPV negative will be returned to routine recall.

HPV Triage

Test of Cure Protocol (Follow up of treated CIN) HPV testing will be used following treatment for all grades of CIN. If cytology positive: Managed as per current guidelines No HPV test

Test of cure continued If cytology negative: HPV test Women who are cytology negative and HPV negative will proceed to a three year recall period – avoiding the need for 10 years of annual tests. If HPV positive patient managed as per current guidelines i.e. 3 x neg for L/G or 10 x neg for H/G abnormalities

HPV Vaccines – potential impact Reduce high grade CIN and invasive cancer by approximately 70-80% Reduce low grade CIN by 25-30% Still have significant volume of disease present but implications will be different Assumes 100% compliance with full vaccination schedule Would need to continue screening to cover other oncotypes – by HPV testing May see shift in genotypes after period of vaccination Duration of effectiveness and protection unknown Will not eliminate need for cytology in the unvaccinated or in those who test HPV positive

Infection Reporting on Cervical Screening Debate regarding if this is appropriate Good versus harm Informed Consent Infections incorrect term as many are comensals Consequences of these reports not realised by laboratory staff Cervical Screening is not an appropriate test High false positives for TV

Changes to Recall Status for Women having Vault Samples Letter produced from John Tidy (Chair Of National Colposcopy Professional Advisory Group) advising ‘ with effect from 1/4/08 it has been decided that due to problems with the recall of women for vault cytology it would be best managed by ceasing the recall of these patients from the national screening programme.

Issues to be agreed Women who undergo a Sub total hysterectomy will still require screening and therefore need to be identified. Ensuring that the correct information is sent to Primary Care Clinician from the gynaecologists following patient discharge Identifying who will be undertaking the vault smears in the future. Ensure appropriately trained staff are undertaking the vault sample taking Identifying responsibilities for failsafe

North West Cervical Screening QA Regional Guidance for Good Practice in Primary Care Available on the QA website: www.nwcsqarc.org.uk

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