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COLPOSCOPY AND PROGRAMME MANAGEMENT
Guidelines for the NHS Cervical Screening Programme NHSCSP Publication No 20 NHS Cancer Screening Programmes The Manor House 260 Ecclesall Road South Sheffield S11 9PS Tel: 0114 271 1060 Fax: 0114 271 1089 Email: nhs.screening@sheffield-ha.nhs.uk Website: www.cancerscreening.nhs.uk NHS Cancer Screening Programmes 2004 The contents of this document may be copied for use by staff working in the public sector but may not be copied for any other purpose without prior permission from the NHS Cancer Screening Programmes.
ISBN 1 84463 014 5 Further copies of this publication can be ordered from the Department of Health Publications Orderline, quoting NHSCSP Publication No 20: Tel: 08701 555 455 Fax: 01623 724 524 Email: [email protected] A copy is also available as a PDF file on the NHS Cancer Screening Programmes website.
Typeset by Prepress Projects Ltd, Perth (www.prepress-projects.co.uk) Printed by Cambrian Printers Colposcopy and Programme Management
ACKNOWLEDGEMENTS Evidence based guidelines How were these guidelines developed? Changes from previous guidelines SCREENING PROGRAMME POLICY Frequency of screening Age at starting screening Age at finishing screening Unscheduled cervical screening Cervical sampling in genitourinary medicine clinics Summary of standards SCREENING STRATEGIES Current screening method Liquid based cytology Colposcopic screening Other screening strategies REFERRAL GUIDELINES FOR COLPOSCOPY Inadequate samples Borderline nuclear change Abnormal results of any grade Mild dyskaryosis Moderate dyskaryosis Severe dyskaryosis Possible invasion Glandular neoplasia 4.10 Women with symptoms 4.11 Previous treatment for CIN 4.12 Waiting times for colposcopy 4.13 Summary of standards NHSCSP April 2004
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QUALITY STANDARDS FOR COLPOSCOPY CLINICS Good working practices Reducing anxiety for women Colposcopy equipment Clinic staffing Liaison with other units Training and certification of colposcopists Summary of standards DIAGNOSTIC STANDARDS FOR COLPOSCOPY Cytology results Colposcopic examination Invasive disease Local destruction Colposcopically directed punch biopsy Accuracy of colposcopic diagnosis Summary of standards INFECTIONS AND COLPOSCOPY Asymptomatic women Actinomyces-like organisms Incidental infections TREATMENT OF CERVICAL INTRAEPITHELIAL NEOPLASIA Treatment standards Surgical techniques ‘See and treat' policy Summary of standards FOLLOW-UP OF WOMEN ATTENDING FOR COLPOSCOPY Standards for follow-up of treated women Duration of follow-up Frequency of follow-up Samples for follow-up cytology Follow-up after hysterectomy Role of HPV testing during post-treatment follow-up Follow-up of untreated women Summary of standards NHSCSP April 2004
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PREGNANCY, CONTRACEPTION, MENOPAUSE AND HYSTERECTOMY 10.1 Pregnant women 10.2 Use of contraceptives 10.3 Menopause and the use of hormone replacement therapy 10.4 Hysterectomy 10.5 Summary of standards SCREENING AND MANAGEMENT OF IMMUNOSUPPRESSED WOMEN 11.1 Immunosuppressed women 11.2 Women with renal failure requiring dialysis 11.3 Women taking maintenance immunosuppression medication post transplantation 11.4 Women with multifocal disease 11.5 Women receiving cytotoxic drugs for rheumatological disorders 11.6 Other women who are immunosuppressed 11.7 HIV positive women 11.8 Summary of standards MANAGEMENT OF GLANDULAR ABNORMALITIES 12.1 Cervical glandular epithelial abnormalities 12.2 Reporting of abnormal glandular samples 12.3 Clinical management of cervical glandular intraepithelial neoplasia 12.4 Hysterectomy for cervical glandular intraepithelial neoplasia 12.5 Summary of standards APPENDIX 1: SUMMARY OF STANDARDS APPENDIX 2: GUIDANCE ON WORKING PRACTICES FOR COLPOSCOPY UNITS APPENDIX 3: EXAMPLE JOB DESCRIPTION FOR LEAD COLPOSCOPISTS NHSCSP April 2004
Colposcopy and Programme Management
David Luesley, Simon Leeson Ian Duncan, Henry Kitchener, Julietta Patnick, Charles Redman, Peter Smith, Patrick Soutter, Patrick Walker Caroline Bradbeer, Maggie Cruickshank, John Cullimore, Gabrielle Downey, Paola Dey, Grainne Flannelly, Theresa Freeman-Wang, Tito Lopez, Pierre Martin-Hirsch, Antonia Moore, John Murdoch, Peter Saseini, Tracy Smith, Glyn Teale, John Tidy NHSCSP April 2004
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Evidence based
Guidelines are a means of attempting to set standards of care. By defi- nition they are a form of guidance and are not intended to be rules for practice. Not only will new information become available, which will necessitate change, but also there will be local or regional factors that may have a strong influence on practice.
Ideally, guidelines for practice should be based on robust evidence. In this particular area of healthcare, as in most others, evidence is patchy and incomplete and there remains a heavy reliance on professional con-sensus. In this publication, we have attempted to use as much evidence as possible and have indicated where we have relied on consensus. These weaknesses should serve as stimuli for research to provide the evidence that may allow successive editions to become more evidence based.
How were these
Two previous publications have formed the basis for practice until now: Guidelines for Clinical Practice and Programme Management1 and Standards and Quality in Colposcopy.2 These publications have been amalgamated and the resulting hybrid constituted the starting point. An editorial group was convened to decide upon content and structure. Areas of previous omission were identified and areas of possible duplication removed. Contributions were commissioned from individuals or groups known to be active or recently active in the field of interest. These con-tributors worked closely with one of the editorial team to produce an individual guideline, as evidence based as is possible. All of the reference material has been included. The guidelines also include standards that can be used for audit purposes. These standards are shown throughout the text in bold and are also summarised in Appendix 1. Prior to the final draft being formatted, a wider consensus was invited by making the penultimate draft available on the internet. These additional comments have, where possible, been included.
Guidelines are at best transient and have a limited life span. It is also recognised that the clinical skills required to deliver high quality care in this area are very subjective and do not lend themselves easily to quanti-fication. There is no such thing as a standard colposcopy service but, with positive guidance and commitment from those charged with delivering the service, a high quality service can be maintained and improved. This was one of the objectives.
A second and equally important goal was to ensure that the colposcopy service becomes more focused on women with abnormalities. Women who are at very low risk of developing cervical cancer should not be brought into the colposcopy service. The guidelines have been developed with the aim of ensuring that these women are either not referred to col-poscopy clinics or at the very least returned to community surveillance as quickly as possible. This not only is an efficient use of resources but also recognises the possible negative health impact of unnecessary colposcopy in women who have a very low risk of developing cervical cancer.
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Changes from previous
Sections have been included to address issues that have generated constant query over the last decade. Such areas include hysterectomy, contraception and the menopause, immunosuppression and human immu-nodeficiency virus (HIV) infection. There is also a separate section on glandular abnormalities.
The major changes in the core of the programme include a recommenda-tion for referral after one mildly dyskaryotic sample. This might be seen as increasing the workload and thus jeopardising one of the objectives. It is important to take this particular change of practice in context. A rapid return to community based cytology surveillance is also recommended for all women who have normal colposcopy and low grade abnormali-ties. Taken together, it is judged that this strategy offers both safety and eventually efficiency.
The concept of linking risk to practice continues in the changes in follow-up policy that are proposed. Patients at low risk will be returned to routine recall more quickly, whereas those at high risk will be maintained on follow-up for up to 10 years after treatment.
The value of training, audit and team working has been emphasised and standards have been set. Previous standards that relate to quality in the colposcopy clinic such as changing facilities, privacy, etc. have been made more stringent. A modern colposcopy service should not only be delivered in an environment that is properly designed and equipped but also take into account the views of women. This, and some of the other changes, may have resource implications, but if healthcare is to be quality driven then this is unavoidable in some cases. This document will have a posi-tive effect in terms of quality on the NHS Cervical Screening Programme (NHSCSP) and will lay a solid foundation for future development.
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2. SCREENING PROGRAMME POLICY
Frequency of screening
2.1.1 Screening intervals Recently published evidence has indicated that a more effective screen-ing programme can be offered to women by changing the frequency of screening according to a woman's age.3 The recommendations made have been accepted by the Advisory Committee on Cervical Screening and by Ministers and will be implemented in the national programme. The recommendations are as follows: Age group (years)
Frequency of screening
Only screen those who have not been screened since age 50 or those who have had recent abnormal tests Evidence: Although, the meta-analysis4 carried out by the IARC
(International Agency for Research on Cancer) would suggest that
five-yearly screening is almost as effective as three-yearly screen-
ing, this has not been borne out by more recent studies from the
UK.5,6 These two studies both suggest that three-yearly screening
could prevent substantially more cancers than five-yearly screening
and that the cost per cancer prevented may be no greater. Evidence
from the recent UK audit of screening histories3 stresses the value
of screening in middle-aged women and recommends that the fre-
quency of screening should depend on a woman's age.
2.1.2 Maximum screening Cytological screening should be undertaken at least every five years.
Evidence: Cytological screening in the UK has always been offered
at least every five years, and there is no new evidence to suggest that
longer intervals would be as safe. However, there was no evidence
in the study4 carried out by the IARC to suggest that six-yearly
screening is any less effective than five-yearly screening.
2.1.3 Invitations for All letters of routine invitation should be sent to women three months routine screening and before the date that the test is due, and in no case later than the test due date; ie three months before a woman's twenty-fifth birthday, 33 months after a previous test for women aged 25–49, and 57 months after the previous test for women aged 50–64.
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Evidence: There is (unpublished) evidence that a delay of sev-
eral months may occur between inviting women and their actual
screening test.
2.1.4 Monitoring the The actual screening interval should be monitored.
Evidence: Good practice. The numbers of women screened within
the previous three and five years do not correspond to the number
regularly screened at intervals of three and five years. As a pro-
portion of women will be screened just once in their lifetime, or
less frequently than every screening round, the number of women
screened in the last 3–5 years does not necessarily correspond to
the number undergoing regular screening. Estimation of the propor-
tion of the population screened at different intervals should also
be undertaken.
2.1.5 Screening interval of Routine screening at intervals of less than three years should not be less than three years considered without strong evidence to support such a move.
Evidence: Screening every two years is approximately 50% more
expensive than screening every three years, and there is little evi-
dence to support such a move. The IARC meta-analysis4 found
no significant difference in the rate of cancers diagnosed 12–23
months and 24–35 months after a negative smear. A more recent UK
study6 found a small advantage of two-yearly screening in women
aged under 40, but it was not sufficient to warrant the extra cost and the greater number of insignificant abnormalities that would be identified. A recent US study7 concluded that, in well screened women, three-yearly screening would prevent virtually all cancers prevented by annual screening: an additional 70 000 smears and 4000 colposcopies are needed to prevent one extra cancer.
Age at starting
Recently published research and experience from the cervical screening programme have shown that screening women under the age of 25 years may do more harm than good.3 Cervical cancer is very rare in women under 25. In 2002, five deaths from cervical cancer were registered among women aged between 15 and 24. In total, 26 cases of cervical cancer were registered. By contrast, there were 55 000 women aged 20–24 with abnormal (borderline or worse) smears.8 Evidence: The incidence of cervical cancer in the under 25 age
group is low,9 and the prevalence of transient human papillomavirus
(HPV) infection after coitarche is high.10 One in six smears taken
in this age group is abnormal. Much of this prevalent low grade
disease would resolve spontaneously if screening were started at
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a later age.11 Hence, screening in this age group would result in unnecessary attendances at colposcopy, with the resultant possible negative consequences of increased anxiety and possible overtreat-ment. In addition, screening has not been shown to be effective at reducing the incidence of invasive cancer in women under the age of 2012 or indeed under the age of 25.
The evidence confirms that women aged under 25 should not be screened in the context of a national programme with computerised call and recall. Women under 25 who are concerned about their sexual health or who are at risk of developing cervical cancer should contact their GP or the local genitourinary medicine (GUM) clinic.
Age at finishing
In England and Wales, routine screening ends at the age of 65 years. Although it is possible that it may be safe to withdraw well screened women with a negative smear history (three consecutive negative screen-ing smears) from the cervical screening programme at age 50 years, there is insufficient robust evidence to withdraw this level of healthcare.13 The effectiveness of screening women over the age of 50 years will continue to be kept under review. It is clear that screening women aged 50–64 who have had at most one or two previous smears is an extremely effective policy.3 Evidence: The exit age of 65 has been questioned particularly on
reducing the age of screening to 50 in women who have been well
screened with a satisfactory negative history. Cervical screening is
less efficient at detecting cervical intraepithelial neoplasia 3 (CIN
3) in older women – more smears are required to detect a case of
CIN 3 after the age of 50,14 but it is more efficient at preventing
invasive cancer.3
The prevalence of CIN 3 and invasive cancer in women over the age of 50 is low: 11 in 100 000 in well screened women compared with a prevalence rate of 59 in 100 000 women in the population as a whole.15 Women who were diagnosed with invasive cancer after the age of 50 had not participated adequately in the cervical screen-ing programme.16 Evidence from the USA suggests that screening women over the age of 65 who have been poorly screened previ-ously still results in a reduction in the subsequent rate of cervical cancer.17 Early withdrawal of women from the cervical screening programme could lead to a substantial reduction in the resources devoted to screening, which could be channelled more effectively into other aspects of healthcare. However, this is likely to increase the overall incidence of cervical cancer unless other steps are taken to com-pensate.18 NHSCSP April 2004
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HPV tests may be a useful adjunct. A combined screening test offers the possibility of greater protection and/or longer screen-ing intervals, which could reduce the overall cost of the screening programme.19 No study has shown that cervical cancer rates in women aged 60–70 years would not increase dramatically if screening were only offered up to the age of 50.
Unscheduled cervical
Additional cervical screening is not justified in any of the following situations, providing that the woman is in the age group to be screened and has had a screening test within the previous 3–5 years: • on taking or starting to take an oral contraceptive• on insertion of an intrauterine contraceptive device (IUCD)• on taking or starting to take hormone replacement therapy• in association with pregnancy – either antenatally or postnatally or after termination unless a previous screening test was abnormal (see section 10.1.1) • in women with genital warts• in women with vaginal discharge• in women with infection• in women who have had multiple sexual partners• in women who are heavy cigarette smokers.
In a mathematical simulation model, the practice of routinely taking a second smear one year after the first ever smear conferred no additional benefit in terms of person–years life saved.20 This practice should not be pursued providing that the first smear was negative and it was taken in a quality controlled programme.
Evidence: There is no available evidence to suggest that social or
behavioural risk factors reduce the length of the preclinical detect-
able phase of cervical neoplasia. The strength of the association
with sociosexual correlates is insufficient to reliably predict women
with high grade CIN.21,22 More intensive screening of women with
a history of multiple sexual partners and early onset of first inter-
course is not cost-effective.22
The issue of cervical screening in HIV positive women receiving antiretroviral treatment and in chronically immunosuppressed women has not been fully evaluated and is covered elsewhere in this document.
Cervical sampling
Cervical cytology in GUM clinics should be reserved for those with a in genitourinary
cytological indication or those who have not been screened in the previous routine screening interval (three years for women under the age of 50).
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Evidence: A case–control study of women attending GUM clinics
in the UK suggested that they were as likely to attend for routine
screening as women in the general population.23 Higher rates of
cytological abnormality were mainly due to an excess of smears
containing low grade abnormalities. This has been confirmed in a
survey of UK sexually transmitted infection clinics.24,25 Audits of
cervical screening in GUM clinics suggest that a greater propor-
tion of smears are reported as inadequate or exhibit inflammatory
changes owing to the presence of infection.26–28 A cervical smear is
an inappropriate test for the detection of genital infection.29–31
Summary of standards
1. Cervical screening should take place between the ages of 25 and 64 years, at intervals of three or five years depending on the woman's age.
2. Women must be called on or around their 25th birthday and subsequently recalled at three-yearly intervals between the ages of 25 and 49 years, and at five-yearly intervals between the ages of 50 and 64 years.
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3. SCREENING STRATEGIES
Current screening
Cervical cytology on samples obtained using conventional smear taking techniques is the current standard method of screening in the NHS Cervi-cal Screening Programme (NHSCSP).
Evidence: A recent systematic review32 has reported that, in 12
studies with the least biased estimates, sensitivity ranged from 30%
to 87% and specificity from 86% to 100%. This means that there
is a need to identify new methods that may increase the sensitivity
and specificity and hence improve performance in the detection of
cancer precursors. Any change in screening modalities must show
an improvement in effectiveness and/or cost-effectiveness before
the NHSCSP will recommend its use.
Liquid based cytology
Liquid based cytology (LBC) is a technology whereby a Cervex® brush sample (or other broom-like device) is suspended in buffer and processed such that a thin layer of cells is produced in a slide without contamina-tion by blood cells and debris. It achieves ‘cleaner' preparations, which are generally easier to read. Its advantage is a reduction in inadequate samples and there may be gains in reducing borderline results and increasing sensitivity.
In 2000, the National Institute for Clinical Excellence (NICE) recom-mended that NHS funded pilot studies should be set up to evaluate the use of LBC for cervical screening in England and Wales. A pilot study in Scotland had already been completed and liquid based cytology is now being implemented there. The NICE appraisal of the pilot studies in England was published in October 2003.33 It recommended that LBC should be introduced as the primary means of processing samples in the cervical screening programme in England and Wales. Arrangements are now being put in place to implement the recommendation in the NHSCSP. The timescale is determined by the need to train laboratory staff and primary care sample takers and to install the necessary equipment in laboratories. This will take up to five years to complete nationally.
There are a few circumstances in which colposcopic screening should replace cytology for routine cervical screening. Certain very high risk groups of women who are at increased risk of CIN, particularly immuno-suppressed women such as transplant recipients and HIV positive women, could be considered for colposcopic screening (see Chapter 11). Women whose samples are repeatedly reported as inadequate should be referred for colposcopy as part of routine screening (see Chapter 4).
Evidence: There is evidence that in HIV positive women there
is an increased risk of false negative cytology34 and colposcopic
screening could be recommended. In other high risk groups, for
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example women with genital warts or cigarette smokers, there is no evidence to suggest that three-yearly cervical cytology is less protective than for other women, but in HIV positive women annual screening by cytology is recommended.
Other screening
Other screening strategies are being researched and the following tech- nologies are under investigation: • human papillomavirus (HPV) testing as a form of risk assessment• immunoenhanced testing using antibodies to cell cycle proteins• electro-optical technologies.
Only HPV testing is being evaluated for implementation into the NHSCSP.
HPV testing
3.5.1 HPV triage for The potential for the introduction of HPV testing to triage women with borderline and mildly borderline and mildly abnormal results is under investigation.
abnormal results Evidence: A systematic review35 commissioned by the Health Tech-
nology Assessment (HTA) programme recommended controlled
introduction of HPV testing as a triage for women with borderline
and mildly abnormal screening results. This is being assessed by
means of a large pilot study in England. The rationale is that women
with borderline and mildly abnormal results will be divided into
those at very low risk (HPV negative) and those at higher risk
(HPV positive) for whom colposcopy would be appropriate.36 This
secondary screening role for HPV testing could potentially reduce
the increasing number of women being referred for colposcopy
with borderline or mildly abnormal results. This could be highly
cost-effective, reduce the burden on colposcopy clinics and reduce
patient anxiety associated with colposcopy.
HPV testing in this setting is also being evaluated in the Medi-cal Research Council (MRC) Trial of Management of Borderline and Other Low grade Abnormal smears (TOMBOLA), which is expected to report in 2006.
3.5.2 HPV testing for follow There is the potential for women who are both cytology negative and up of treated CIN HPV negative at six-month follow-up to be returned to routine recall. Before this can be recommended, there needs to be evidence of success-ful implementation of a suitable protocol for the NHSCSP. A pilot study is in progress.
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Evidence: A number of non-randomised studies have been reported
which have shown that HPV testing may improve the prediction
of treatment failure.37 This is probably based on the fact that HPV
testing will have a high negative predictive value for any residual
disease, which is the commonest reason for treatment failure. One
of the published studies controlled for margin status and HPV was
still significantly associated with treatment failure.38
3.5.3 Population screening The high sensitivity of HPV testing for detecting high grade CIN makes with HPV testing it a candidate for improving population cervical screening. Sensitivity with cytology alone is probably not greater than 70% and this could rise significantly with HPV testing. Randomised trials are being undertaken in Sweden and the Netherlands, neither of which has yet reported, and a randomised trial began in mid-2001 in Manchester. Non-randomised studies suggest that HPV testing will improve the detection of underly-ing CIN. Longer term follow-up of these screened cohorts will provide further evidence of the effectiveness of HPV testing, particularly its nega-tive predictive value. It is likely that HPV testing will prove sufficiently cost-effective to play a role in the NHSCSP, but any introduction into the national programme requires rigorous evaluation and a convincing evidence base. HPV testing is not recommended for routine use.
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4. REFERRAL GUIDELINES FOR
Women should be referred for colposcopy after three consecutive inad-equate samples.
Evidence: Professional consensus. Invasive cancers may be asso-
ciated with inflammatory processes and bleed on contact. Women
with persistent inadequate samples should undergo colposcopy to
exclude invasive cancer.
Borderline nuclear
change
4.2.1 Squamous cell changes Women should be referred for colposcopy after three tests in a series reported as borderline nuclear change in squamous cells without the woman being returned to routine recall.
Evidence: In a randomised trial of women with an atypical squa-
mous cells of undetermined significance (ASCUS) smear, per-
formed in the USA, the incidence of high grade CIN after a single
smear reporting borderline nuclear change was low (11%).39 In a
UK prospective series, the incidence of CIN 2/3 was 36%.40 Women
with persistent borderline nuclear change are at increased risk of
developing high grade CIN over time.41
4.2.2 Endocervical cell Women should be referred for colposcopy after one test reported as borderline nuclear change in endocervical cells.
Evidence: Case series of women with smears reported as border-
line glandular cells have increased rates of malignant (4–16%) and
preinvasive disease (17–40%).42–45
Abnormal results of
Women should be referred for colposcopy if they have had three tests any grade
reported as abnormal at any grade in a 10-year period, even if returned to routine recall on one or more occasions in that period.
Evidence: Professional consensus.
Ideally, women should be referred for colposcopy after one test reported as mild dyskaryosis, but it remains acceptable to recommend a repeat test. Women must be referred after two tests reported as mild dyskaryosis without a return to routine recall.
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Evidence: There are no reported randomised trials triaging women
to immediate colposcopy or community based cytological follow-
up. A randomised trial in the hospital based management of mild
dyskaryosis comparing four periods of surveillance, which included
immediate colposcopy, found 68% of women with high grade CIN
after a single mild or moderately dyskaryotic smear.46 Other case
series have shown the percentage of women found with high grade
CIN after a mild dyskaryotic smear is about 40%.40,47 Retrospective
case series of women followed in the community report varying
rates of referral to colposcopy (14–64%) and these women are
at increased risk of developing invasive cancer.48 There is a high
non-attendance rate for women who are followed up for more
than 24 months.49 An economic model suggested that immediate
colposcopy was cheaper that cytological follow-up.50 Since this
publication, the recommendations for cytological follow-up after
a mild dyskaryotic smear have changed: three normal results are
required before return to routine screening instead of two.51 This
change will make cytological surveillance more expensive and
make immediate colposcopy a better option. In two studies, only
25% of women with a smear showing mild dyskaryosis achieved
regression to a normal smear.49,52
Women with a mild dyskaryotic result should be seen and assessed but not necessarily treated. To prevent possible overtreatment, they should not be managed in a ‘see and treat' scenario. There will be an initial increase in referral to colposcopy clinics as a result of this guideline but with time this should decrease.
This guideline should not alter the management of women enrolled in studies that will further improve our understanding of management of minor cytological abnormalities. The debate about this area of practice needs to be informed by the outcomes of those studies.
Women must be referred for colposcopy after one test reported as moder-
ate dyskaryosis (100%).
Evidence: A randomised trial of the management of women with
a moderate dyskaryotic smear found 74% of women to have CIN
2/3.46 Case series also report a high incidence (74–77%) of CIN
2/3 at time of colposcopy.47,53
Women must be referred for colposcopy after one test reported as severe
dyskaryosis (100%).
Evidence: Case series report a high incidence (80–90%) of CIN
2/3 at time of colposcopy.48,53
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Women must be referred for colposcopy after one test reported as pos-
sible invasion (100%). They should be seen urgently within two weeks
of referral (90%).
Evidence: The correlation between a smear showing features
of invasion and the histological diagnosis of invasive cancer is
high. The positive predictive value in one series was 56% for all
cancers.54
Women must be referred for colposcopy after one test reported as glan-
dular neoplasia (100%). They should be seen urgently within two weeks
of referral (90%).
Evidence: The natural history of this condition remains unclear.
Case series of women referred to colposcopy with a single smear
reporting glandular neoplasia are associated with high levels of
invasive (40–43%) and preinvasive (20–28%) disease. 42,55
Women with an abnormal cervix should be referred for gynaecological examination and onward referral for colposcopy if cancer is suspected.
Evidence: Professional consensus. An abnormal cervix may be
associated with invasive cancer.
4.10 Women with
Women presenting with symptoms of cervical cancer, ie postcoital bleeding in women over 40 years, intermenstrual bleeding and persistent vaginal discharge, should be referred for gynaecological examination and onward referral for colposcopy if cancer is suspected.
Referral of younger women with postcoital bleeding to GUM clinics should be considered.
Contact bleeding at the time of cervical sampling may often occur and is not an indication for referral for colposcopy in the absence of other symptoms or an abnormal result.
Evidence: Professional consensus. A case series reported a high
incidence of cervical neoplasia in women with postcoital bleed-
ing.56
Although postcoital bleeding is a significant symptom with regard to cervical neoplasia, the majority of cases are not malignant. In younger women, chlamydial infection and problems with family planning are more likely causes. These women require appropriate assessment and referral for colposcopy if cancer is suspected.
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4.11 Previous treatment for
Women should be referred for colposcopy if they have been treated for CIN and have not been returned to routine recall and a subsequent test
is reported as mild dyskaryosis or worse (100%).
Evidence: Women treated for CIN are at increased risk of develop-
ing cervical cancer.57
4.12 Waiting times for
At least 90% of women with an abnormal test result should be seen in
a colposcopy clinic within eight weeks of referral.
Evidence: Professional consensus.
At least 90% of women with a test result of moderate or severe dyskaryo-
sis should be seen in a colposcopy clinic within four weeks of referral.
Evidence: Professional consensus.
4.13 Summary of standards
1. Women should be referred for colposcopy after three consecutive inadequate samples.
2. Women should be referred for colposcopy after three tests reported as borderline nuclear change in squamous cells in a series, without the woman being returned to routine recall.
3. Women should be referred for colposcopy after one test reported as borderline nuclear change in endocervical cells.
4. Women should be referred for colposcopy if they have had three tests reported as abnormal at any grade in a 10-year period.
5. Ideally, women should be referred for colposcopy after one test reported as mild dyskaryosis, but it remains acceptable to recommend a repeat test. Women must be referred after two tests reported as mild dyskaryosis without a return to routine recall.
6. Women must be referred for colposcopy after one test reported as moderate dyskaryosis (100%).
7. Women must be referred for colposcopy after one test reported as severe dyskaryosis (100%).
8. Women must be referred for colposcopy after one test reported as possible invasion (100%). They should be seen urgently within two
weeks of referral (90%).
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9. Women must be referred for colposcopy after one test reported as glandular neoplasia (100%). They should be seen urgently within
two weeks of referral (90%).
10. Women should be referred for colposcopy if they have been treated for CIN and have not been returned to routine recall and a subsequent
test is reported as mild dyskaryosis or worse (100%).
11. At least 90% of women with an abnormal test result should be seen
in a colposcopy clinic within eight weeks of referral.
12. At least 90% of women with a test result of moderate or severe
dyskaryosis should be seen in a colposcopy clinic within four weeks of referral.
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5. QUALITY STANDARDS FOR
Good working
practices
5.1.1 Quality assurance Colposcopy should be organised as a quality assured service whatever the setting, whether in a gynaecological clinic or GUM clinic or in pri-mary care. A protocol that gives guidance on good working practices is in Appendix 2. The colposcopy service should be run by a team, using protocols based on these guidelines, and should aim to meet the quality standards outlined in this document. Any problems arising in connec-tion with colposcopy practice should be addressed in a confidential and supportive manner.
The team should be led by a lead colposcopist. The role of the lead colposcopist is to ensure good practice, compliance with protocols, data collection to comply with KC65 and audit. It is also a responsibility of the lead colposcopist to ensure that the quality standards in this docu-ment are attained. An example job description for lead colposcopists is shown in Appendix 3.
The attainment of quality assured colposcopy in the UK has been a considerable achievement and requires continued efforts to ensure that standards remain uniformly high. The mandatory Department of Health (DoH) return, KC65, is one task that underpins this process. This return is required quarterly but will probably become an annual return in the future. This return requires clinics to have and to maintain computerised data based on the British Society for Colposcopy and Cervical Pathology (BSCCP) minimum dataset.
A hospital based programme coordinator should be identified. He or she should take responsibility for ensuring that quality assurance targets are monitored, including non-attendance.
All colposcopists in the team should be certificated through the BSCCP/Royal College of Obstetricians and Gynaecologists (RCOG) scheme and should comply with the recertification process every three years, thus indicating continued practice of a sufficient caseload. It is considered by the NHSCSP that independent colposcopy should not be conducted in the NHS unless by certificated practitioners.
It is a requirement of recertification that continued medical education (CME) is pursued by all colposcopists in order to keep abreast of sci-entific knowledge and clinical practice developments. Suitable CME opportunities are available from advanced colposcopy courses and the BSCCP Annual Meeting (see section 5.7).
5.1.3 Clinic staffing and The service requires at least one colposcopy nurse whose duties are to ensure smooth running of the clinic and provision of support to the patient. NHSCSP April 2004
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A second nurse will be needed to assist in the preparation between patients for cervical sampling, biopsies and treatment (see section 5.4).
The colposcopy service requires adequate clerical and secretarial support to ensure timely communication with patients and the GP. In addition, this support is required for data collection and ensuring that failsafe mechanisms are effective.
The clinic's facilities should protect the patient's dignity, and patients should be given time to discuss their care both before and after the col-poscopy examination and/or treatment.
5.1.4 Team meetings The colposcopy team should meet at least twice a year to discuss clinic policy, any protocol problems that may have arisen and the findings of audit and peer review visits as well as comparing any shortcom-ings against quality standards. Multidisciplinary meetings that include cytopathology, histopathology and colposcopy staff should be held at least twice a year to discuss operational issues relevant to the colposcopy service (see section 5.6).
Reducing anxiety for
women
5.2.1 Information and Reducing anxiety – information and communication: • each woman should be offered verbal information and should be sent written information before and after a cervical sampling and before
colposcopy (95%)
• counselling must be available as an integral part of colposcopy• women must be sent an appropriately worded invitation with a contact name, telephone number and clinic times • information with regard to visits and results of investigations should be communicated to the patient within four weeks of her attendance
(best practice 90%) or eight weeks (minimum standard 100%)
• results and management plans should be communicated to the referring practitioner within four weeks of the patient's attendance at
the clinic (best practice 90%) or eight weeks (minimum standard
100%)
• information leaflets should be individualised to each clinic.
Evidence: There is compelling evidence58–64 that many women
suffer significant negative psychological effects from receiving
an abnormal smear result and the need for subsequent investiga-
tion and psychological sequelae is often more likely to discour-
age compliance with subsequent screening and follow-up. The
provision of accurate and clear information reduces anxiety and
improves patients' experiences.
5.2.2 Ethnic minority groups Culturally appropriate information should be made available for ethnic minority groups.
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Evidence: Coverage is low among many ethnic minority and
refugee groups. There are significant differences in awareness
about cervical cancer across different ethnic groups. Providing
information and visiting community centres to explain the concept
of screening improves compliance.65–67
5.2.3 ‘See and treat' clinics Clinics providing a ‘see and treat' policy must ensure that women who
are offered treatment at their first visit are sent adequate and appropriate
information in advance of their appointment (100%).
Evidence: Anxiety is greater in women attending ‘see and treat'
clinics if they are not adequately informed of the potential for treat-
ment at their first visit.68–70
5.2.4 History taking Appropriate and sensitive enquiries regarding sexual history may be made only if there is a specific indication with regard to presentation or under the auspices of an ethically approved study.
Evidence: Questions regarding sexual history may cause embar-
rassment, resentment and distress to women. This may result in
poor compliance if the woman feels she is being judged.59,71
5.2.5 Clinic facilities With respect to clinic facilities, there must be: • a private area with changing facilities
• toilet facilities
• a permanently sited room specifically used for colposcopy (100%)
• refreshments available
• separate waiting and recovery areas.
Evidence: Professional consensus and patients' opinions.
5.2.6 Visitors to the clinic Visitors to the unit should be limited as follows: • women should be able to have a friend or relative present if they • the woman's permission should be sought prior to colposcopy if any additional staff non-essential for the purposes of performing colposcopy are present (ie trainees, undergraduates, visitors).
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Evidence: Women have strong negative reactions to the intru-
siveness of a gynaecological examination. Those attending for
colposcopy are often particularly anxious. Being sensitive to
their concerns helps to improve their experience of the serv-
ice.59,62
With regards to equipment for the colposcopy clinic, there must be: • a permanent couch and colposcope• appropriate sterilising facilities in accordance with local and national health and safety recommendations • automatic referral (in units offering a diagnostic service) to a unit where treatment is available if required • clinic staff familiarity with the treatment method(s) used (100%)
• adequate safety guidelines if laser or diathermy equipment is in
use, with all staff trained in their use and clearly written and easily available emergency guidelines in each clinic in line with individual trust recommendations • adequate resuscitation equipment immediately available and staff involved in the clinical care of patients must be familiar with its use • suitable information technology equipment and software to facilitate collection of data for the BSCCP minimum dataset and for submission of the statutory quarterly KC65 • television monitoring facilities for patients who wish to watch the procedure are desirable.
Evidence: Professional consensus.
With respect to staffing of the colposcopy unit: • all clinics must have a named colposcopist with appropriate skills who leads the service, with a specialist team specific to the colposcopy unit; the named lead colposcopist must have a job description • there must be at least two nurses for each clinic – the primary nurse should be a registered nurse trained in counselling; she/he should be the named nurse dedicated to the unit and should not have other concurrent outpatient duties – the second nurse should be for the support of the patient, and would not need to be a fully trained nurse • nurse colposcopists working in a clinic role must be supported by another registered nurse • there must be adequate dedicated clerical support for the clinic.
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Evidence: Having a specialist team specific to the colposcopy
unit provides continuity of care and allows women to gain con-
fidence in individual members of staff.59 This in turn helps to
reduce their anxiety and improves both attendance and their
satisfaction with the service. The extended role of the nurse in
respect to nurse colposcopy may be of particular benefit in this
regard.69,72
With respect to patient non-attendance: • there must be written protocols for the management of non- • audit should include analysis of the records of defaulters to discern any patterns that could be addressed to reduce the default rate • the default rate should be less than 15%.
Evidence: In total, 20% of women fail to attend for fear of
cancer or the procedure. There are multiple other reasons why
women default on their appointments, including forgetting the
appointment, menstruation, work, childcare, transport constraints
and long waiting times.
There is an administrative cost to departments in terms of wasted appointments. Following reminders, most women will eventually be seen within one year of their first non-attendance. Strategies to improve patterns of attendance should be explored.73–78 Liaison with other
Liaison with other units: • colposcopy clinics in GUM must have established protocols for liaison with gynaecological services79 (100%)
• multidisciplinary audit must be an integral part of the service• there should be well established clinical and computer links with cytological and histological services to support multidisciplinary working • details of the referral cytology report (if performed) should be available at time of colposcopy • colposcopy clinics in gynaecology should have established protocols for liaison with GUM services.
Multidisciplinary meetings should include histopathology, cytopathol-ogy and colposcopy and should be held at least twice a year to discuss difficult cases, cases where there is significant mismatch between cytopathology, histology and colposcopy, and borderline glandular and glandular smears.
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Training and
certification of
colposcopists
5.7.1 Training requirements All practising colposcopists must be able to demonstrate that they have received an adequate training. The evidence required depends on when training commenced: • for those who commenced training after April 1998: BSCCP/RCOG Diploma in Colposcopy • for those who commenced training prior to April 1998 but had not completed training by the end of April 1998: BSCCP Completion of Training Certificate • for those who completed training before April 1998: self- Training must be conducted according to the requirements determined by the BSCCP Certification and Training Committee. The BSCCP/RCOG training programme is the only recognised colposcopy training and certification programme for colposcopists wishing to practise within the NHSCSP and who commenced training after April 1998.
5.7.2 Maintenance of clinical Colposcopists practising within the NHSCSP must see at least 50 new skill and continued abnormal cytology referrals per year. All colposcopists must attend at medical education least one BSCCP recognised colposcopy meeting every three years.
Summary of standards
1. Each woman should be offered verbal information and should be sent written information before and after cervical sampling and
before colposcopy (95%).
2. Counselling must be available as an integral part of colposcopy.
3. Women must be sent an appropriately worded invitation with a contact name, telephone number and clinic times.
4. Information with regard to the visit and results of investigations should be communicated to the patient within four weeks of her
attendance (best practice 90%) or eight weeks (minimum stand-
ard 100%).
5. Results and management plans should be communicated to the referring practitioner within four weeks of the patient's attendance at
the clinic (best practice 90%) or eight weeks (minimum standard
100%).
6. Clinics providing a ‘see and treat' policy must ensure that women who are offered treatment at their first visit are sent adequate and
appropriate information in advance of their appointment (100%).
7. There must be a private area with changing facilities. There must also be toilet facilities.
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8. There must be a permanently sited room specifically used for 9. Refreshments must be available.
10. There must be separate waiting and recovery areas.
11. There must be a permanent couch and colposcope.
12. Appropriate sterilising facilities must be available in accordance with local and national health and safety recommendations.
13. In units offering a diagnostic service there must be automatic referral to a unit where treatment is available if required.
14. Clinic staff must always be familiar with the treatment method(s) used (100%).
15. If laser or diathermy equipment is in use, there must be adequate safety guidelines in place with all staff trained in their use; emergency guidelines must be available in each clinic.
16. Adequate resuscitation equipment must be immediately available and staff involved in the clinical care of patients must be familiar with its use.
17. There must be suitable information technology equipment and software to facilitate collection of data for the BSCCP minimum dataset and for submission of the statutory quarterly KC65.
18. All clinics must have a named colposcopist with appropriate skills who leads the service, with a specialist team specific to the colpos-copy unit. The named lead colposcopist must have a job descrip-tion.
19. There must be at least two nurses for each clinic.
20. Nurse colposcopists working in a clinic role must be supported by another registered nurse.
21. There must be adequate dedicated clerical support for the clinic.
22. There must be written protocols for the management of non- 23. The default rate should be less than 15%.
24. Colposcopy clinics in GUM must have established protocols for liaison with gynaecological services (100%).
25. Multidisciplinary audit must be an integral part of the service.
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26. All colposcopists in the team should be certificated through the BSCCP/RCOG scheme and should comply with the recertification process every three years.
27. All practising colposcopists must be able to demonstrate that they have received adequate training.
28. Colposcopists practising within the NHSCSP must see at least 50 new abnormal cytology referrals per year.
29. All colposcopists must attend at least one BSCCP recognised colposcopy meeting every three years.
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6. DIAGNOSTIC STANDARDS FOR
The cytology result should be available to the colposcopist prior to com-mencing the colposcopic examination.
Evidence: Knowledge of the cytological result improves the iden-
tification of colposcopic images of high grade CIN80 and, when
combined with colposcopic findings, improves the sensitivity of
diagnosis of high grade CIN.81,82
Colposcopic
The following data should be recorded at the colposcopic examina- • reason for referral (100%)
• grade of cytological abnormality (90%)
• whether the examination is satisfactory; this is defined as the entire
squamocolumnar junction having been seen and the upper limit of
any cervical lesion also being seen (100%)
• the presence or absence of vaginal and/or endocervical extension• the colposcopic features should be recorded• the colposcopic impression of lesion grade.
Care should be taken not to overlook invasive disease. An excisional form
of biopsy is recommended (95%) in the following circumstances:
• when colposcopic appearances indicate high grade abnormality• when low grade colposcopic change is associated with severe dyskaryosis or worse • when a lesion extends into the canal (sufficient canal must be removed in these situations).
In the situations mentioned above, punch biopsies are not considered to be reliably informative. The colposcopist should be cognisant of the small risk of inappropriate or inadvertent destruction of invasive or glandular lesions. This situation is most often encountered in association with high grade cytological or colposcopic change (CIN 3).
There may be pressing reasons for delay in biopsy, such as pregnancy.
Reasons for not performing a biopsy must be recorded (100%).
Evidence: The evidence sources are one systematic review83 and
further subsequent retrospective reviews84,85 of cases of invasion
identified through cervical screening and colposcopic examination.
The relevant findings were that 56% of microinvasive and 30%
of invasive lesions are missed by colposcopy.83 The retrospective
reviews84,85 suggest that approximately two-thirds of missed cancers
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are due to colposcopist error, whereas one-third are due to the limita-tions of technique. Common cytological and colposcopic findings in cases of missed disease included one or more of the following: • high grade cytological abnormality • endocervical extension of lesions, even when examination was • large, complex lesions with raised irregular surfaces • underevaluation of lesions by colposcopically directed Systematic review has shown that unsatisfactory colposcopy is a more frequent finding in invasive disease (61% of microinvasive, 71% of invasive disease) than CIN (14% of CIN). Atypical vessels are found in 44% of microinvasion and 84% of invasion.83,89 All patients must have a biopsy or biopsies taken prior to local destructive
treatment (100%). Unless there are special circumstances, the result of
the biopsy should be available (best practice).
Evidence: Accepted practice dictates that the decision to perform
destructive treatments should only be reached after the available
cytological, colposcopic and directed biopsy evidence indicate a
high degree of confidence that invasion is absent. Retrospective
studies of invasive disease presenting after destructive treatments
indicate that failure to exclude invasive carcinoma prior to treat-
ment is the most important aetiological factor.90,91 Nevertheless,
large observational studies of local destructive therapies conducted
in regional centres with rigorous colposcopic assessment indicate
high success rates with only a small risk of inadvertent/inappropri-
ate treatment of invasive or glandular lesions.92–94
Biopsy should be carried out unless an excisional treatment is planned, directed punch biopsy
when the cytology indicates persisting moderate dyskaryosis or worse
and always when a recognisably atypical transformation zone is present
(100%). Pregnancy is an exception.
Low grade cytological abnormality (mild dyskaryosis or less) and nega-
tive colposcopic examination may not require colposcopic biopsy.
Evidence: A retrospective study95 showed that in women with low
grade cytological abnormalities and a normal colposcopic examina-
tion only 7.8% had CIN 2 or 3 on loop excision.
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6.5.1 Treatment decisions In deciding on treatment (and especially if destructive methods are being considered) associated cytological and colposcopic findings are as important as the result of directed biopsy.83,86,96 Evidence: Colposcopically directed biopsy (CDB) can only be
considered as a sampling of the lesion, by convention the most
atypical area, and thus can only give a provisional histological
diagnosis. Systematic review83 of studies comparing CDB with
reference histology from cones or hysterectomy specimens shows
a lower positive predictive value (PPV) for CIN 1 and 2 (16% and
32% respectively) than for CIN 3 (86%). PPV for microinvasion
was 59% and for invasion 83%. Additional retrospective studies
show that, although CDB may correctly ‘overestimate' the grade of
lesion compared with reference histology when the lesion is small,
CDB has been shown frequently to underestimate the severity of
the lesion. High grade CIN is underestimated in 4.3–57.1% of
cases.81,97–100 Cases of early invasive disease have been underevalu-
ated as CIN 3.85,86,97 Subjectivity in colposcopic opinion is also
reflected in selection of site for biopsy.101
6.5.2 Destructive treatment Of all biopsies taken (directed and excisional) > 90% should be suitable
for histological interpretation.
The colposcopist should analyse the results of cytology, colposcopy and biopsy before selecting a destructive method for treatment.
Evidence: Good practice dictates that the decision to perform
destructive treatments should only be reached after the available
cytological, colposcopic and directed biopsy evidence indicate a
high degree of confidence that invasion is absent.
If colposcopically directed biopsy is reported as inadequate for histologi-
cal interpretation, it should be repeated if there is a residual colposcopic
lesion (95%).
Evidence: Good practice.
Accuracy of
For those with satisfactory colposcopic examination, the predictive value of a colposcopic diagnosis of a high grade lesion (CIN 2 or worse) should
be at least 65%.
It is desirable that colposcopists should be able to differentiate high grade (CIN 3 and CIN 2) lesions (intraepithelial or otherwise) from low grade in order to avoid missing advanced disease and to reduce overtreatment NHSCSP April 2004
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for low grade lesions. A variety of factors influence the precision of colposcopic diagnosis.
Specific colposcopic appearances such as acetowhite epithelium, puncta-tion and mosaicism, and glandular cuffing have been related to histology in few studies83 and any statistical analysis is unreliable. Furthermore, punctation and mosaicism are noted in benign circumstances.83 Scoring systems have been published but these are not recommended for routine clinical use. They do not readily facilitate the confirmation or exclusion of high grade disease, which is the most important and reproducible colposcopic criterion (see below). Among experienced colposcopists, there is a lower level of agreement for diagnosing low grade lesions (CIN 1) compared with high grade,80,101 and for low grade abnormalities agreement is poor.80 Not all CIN lesions may demonstrate colposcopic abnormality.102 There is an association between increasing severity of CIN and lesion size. Furthermore, the accuracy of colposcopic diagnosis in women with proven ‘high grade' CIN is related to lesion size.82 Invasive cancer and high grade CIN are usually accepted as reproducible endpoints for sig-nificant disease in assessing cervical screening and diagnosis. Although it has been noted that there is considerable subjectivity and interobserver variability in the grading of CIN by expert pathologists, this is less so for high grade lesions. The histological presence or absence of high grade CIN seems the most valid way of assessing the performance of colposcopic diagnosis (colposcopic impression).
For guidance in relation to cervical glandular intraepithelial neoplasia, see Chapter 12.
Evidence: One meta-analysis103 of the ability of colposcopy to dif-
ferentiate high grade lesions (CIN 2/3) from all others (normal and
low grade). Additional retrospective studies were identified from
which sensitivity and positive predictive value (PPV) for high grade
lesions could be calculated.81,86,104 One systematic review calculated
the PPV of colposcopic impression.83 Meta-analysis suggests high
sensitivity of colposcopy, with average weighted sensitivity 85%,
but low specificity, average weighted specificity 69%, confirming
a high rate of false positive diagnosis of high grade lesions. Further
analysis showed that high grade lesions had colposcopic character-
istics that allowed them to be reasonably accurately separated from
low grade lesions. However, attempting to distinguish low grade
lesions from benign was much less accurate.103 Analysis of three
other retrospective studies indicated broadly similar results. One
study showed improvement in diagnostic sensitivity of 8%81 by
considering the cytology result, at the expense of a similar reduc-
tion in specificity. The systematic review demonstrated a PPV of a
colposcopic impression of CIN 3 of 78%. PPV declined as severity
of CIN decreased.83
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Summary of standards
1. The following data should be recorded at the colposcopic • reason for referral (100%)
• grade of cytological abnormality (90%)
• whether the examination is satisfactory; this is defined as the
entire squamocolumnar junction having been seen, and the upper
limit of any cervical lesion also being seen (100%).
2. An excisional form of biopsy is recommended (95%):
• when colposcopic appearances indicate high grade abnor- • when low grade colposcopic change is associated with severe dyskaryosis or worse • when a lesion extends into the canal (sufficient canal must be removed in these situations).
3. Reasons for not performing a biopsy must be recorded (100%).
4. All patients must have a biopsy or biopsies taken prior to local destructive treatment (100%). Unless there are special circumstances,
the result of the biopsy or biopsies should be available (best
practice).
5. Biopsy should be carried out unless an excisional treatment is planned, when the cytology indicates persisting moderate dyskaryosis
or worse, and always when a recognisably atypical transformation
zone is present (100%). Pregnancy is an exception.
6. Of all biopsies taken (directed and excisional), > 90% should be
suitable for histological interpretation.
7. If colposcopically directed biopsy is reported as inadequate for histological interpretation, it should be repeated if there is a residual
colposcopic lesion (95%).
8. For those with satisfactory colposcopic examination, the predictive value of a colposcopic diagnosis of a high grade lesion (CIN 2 or
worse) should be at least 65%.
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7. INFECTIONS AND COLPOSCOPY
There is no indication to routinely test for Chlamydia and other infec-tions in asymptomatic patients when attending for colposcopy. If a patient complains of vaginal discharge or soreness then high vaginal and endocervical sampling is indicated after gaining verbal consent for Chlamydia/Gonococcus testing.
Evidence: Screening for Chlamydia has been recommended for
women attending genitourinary clinics (prevalence 16%), having
termination of pregnancy (prevalence 8%), for sexually active
women under 25 years of age or those with a new partner or more
than two partners in the previous year. Prevalence of asymptomatic
infection in general practice and family planning clinics is 5%.105,106
Colposcopy clinics have not been included as a high risk group but
a prevalence rate of 3–10% has been quoted in studies of women
attending for cervical smears in general practice in Wales and a low
risk urban population in the USA.107,108 Similarly, evidence fails to
support testing for Gonococcus in asymptomatic women.108
Actinomyces-like organisms (ALOs) require no specific intervention in the vast majority of patients and are usually seen in patients using an intrauterine contraceptive device (including the Mirena IUS).
If asymptomatic then: • the coil does not need to be removed and antibiotics are not • the patient should have an abdominal and pelvic examination• the patient should be warned of the small possibility of developing pelvic actinomycosis and advised to return should she develop symptoms • family planning follow-up should be arranged every six months and should include enquiry regarding new symptoms and a pelvic examination • repeat cytology is not required unless the smear was graded • if the asymptomatic patient wishes the device to be removed or it is due for removal then it need not be sent for culture.
If the patient complains of specific symptoms the device may need to be removed, after first ensuring that the patient has not had sexual intercourse in the preceding five days.
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• vaginal discharge, dysuria or significant pelvic tenderness.
If the device is removed because the woman has any of the above symp-toms: • the device should be sent for culture and alternative contraception • a course of antibiotics (such as amoxicillin 250 mg three times daily for two weeks in penicillin sensitive patients or erythromycin 500 mg three times daily for two weeks in penicillin resistant patients) should be given and a gynaecological opinion arranged to ensure that the symptoms or signs have resolved.109 Evidence: Good practice.
Incidental infections may be detected in cervical samples. Some may require specific treatment or defined management.
Bacterial vaginosisIf the patient does not complain of a vaginal discharge and is not pregnant then treatment is not required.
Candidiasis (moniliasis)This should be treated if symptomatic.
Herpes simplexPatients with a herpes simplex virus infection may present with symp-toms long before the cervical cytology report is available. All patients should be referred to a local GUM clinic. Aciclovir (200 mg five times daily for five days) is started if active infection is suspected. There is no evidence that this drug is teratogenic, so it can be safely prescribed in pregnancy.110 Trichomonas vaginalis (TV)Asymptomatic detection of this protozoon merits treatment in all cases. All patients should be referred to a local GUM clinic. The patient and her partner should be treated with metronidazole (400 mg three times daily for one week). Samples with Trichomonas present may often be unsatisfactory owing to the marked inflammation. TV should be first treated if a repeat test is required.
Evidence: Good practice.
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8. TREATMENT OF CERVICAL
• All women needing treatment must be informed that treatment will be required and their consent, either written or verbal, recorded
(100%).
• All women needing treatment must have had a colposcopic • All treatments must be recorded (100%).
• All women must be treated in properly equipped and staffed clinics
• All women must have had their histological diagnosis established prior to destructive therapy (100%).
• The proportion of women treated at the first visit that have evidence of CIN on histology must be ≥ 90%.
• Proportion of treatment associated with primary haemorrhage that requires a haemostatic technique in addition to the treatment method
applied (< 5%).
• The proportion of cases admitted as inpatients due to treatment complications (< 2%).
There is no obviously superior conservative surgical technique for treat-ing and eradicating cervical intraepithelial neoplasia (CIN). However ablative techniques are only suitable when: • the entire transformation zone is visualised (100%)
• there is no evidence of glandular abnormality (100%)
• there is no evidence of invasive disease (100%)
• there is no major discrepancy between cytology and histology.
Evidence: Cochrane review of 28 randomised controlled trials
comparing seven surgical techniques, namely knife cone biopsy,
laser conisation, large loop excision of the transformation zone
(LLETZ), laser ablation, cryocautery, cold coagulation and radi-
cal diathermy.111 One recent prospective randomised trial of exci-
sion versus destruction has indicated a lower rate of moderately
dyskaryotic smears after excision.112
CIN 1 does not necessarily require treatment. If CIN 1 is not
treated, cytological and colposcopic follow-up should be per-
formed until spontaneous regression has occurred or treatment is
required.
Cryocautery should only be used for low grade CIN, and a double freeze
thaw–freeze technique must be used (100%).
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Evidence: The rate of clearance of CIN 3 is poor.113,114 The double
freeze technique has a lower incidence of residual disease compared
with a single freeze technique.115,116
8.4.1 Removal of specimen When excision is used, at least 80% of cases should have the specimen
removed as a single sample. Removing the transformation zone in multi-
ple fragments can increase the difficulties encountered in histopathologi-
cal assessment. Furthermore, if microinvasive disease is present, it may
be impossible to allocate a substage or define completeness of excision
in fragmented excisional specimens.
Evidence: Good practice.
8.4.2 Histology report The histology report should record the dimensions of the specimen and the status of the resection margins with regard to intraepithelial or invasive disease.
Evidence: Professional consensus.
8.4.3 Ectocervical lesions For ectocervical lesions, excisional techniques should remove tissue to
a depth of greater than 7 mm (95%).
Evidence: Histological assessment of the depth of crypt involve-
ment by CIN 3 has shown a mean depth of 1–2 mm with a maxi-
mum of 5.22 mm and a mean ± three standard deviations (99.7%)
of 3.80 mm.117,118
‘See and treat' policy
Treatment at first visit for a referral of borderline or mild dyskaryosis
should only be used in exceptional cases, and only when audit has identi-
fied that CIN is present in ≥ 90% of the excised specimens.
Evidence: It is inappropriate to adopt ‘see and treat' if the propor-
tion of specimens with no CIN is high, as these women will have
received unnecessary treatment. Clinics undertaking treatment at
the first visit must audit the proportion of cases with CIN. A target
of ≥ 90% can be achieved with a selective policy.119
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8.6.1 CIN extending to CIN extending to the margins at excision results in a higher incidence of recurrence but does not justify routine repeat excision as long as: • there is no evidence of glandular abnormality• there is no evidence of invasive disease• the woman is under 50 years of age.
Evidence: CIN extending to the resection margins of a LLETZ has
been shown to be a risk factor for recurrent CIN both in the short
and long term.120–122 This risk appears to be predominantly due
to the presence of CIN at the endocervical margin.123 Despite the
increased incidence of recurrence, the majority of women in the
above studies had no evidence of residual disease and the recom-
mendation is that these women have colposcopy and cytology at
first follow-up.
8.6.2 Women over the age of All women over the age of 50 who have CIN 3 at the endocervical margin and in whom satisfactory cytology and colposcopy cannot be guaranteed
must have a repeat excision performed to try and obtain clear margins
(100%).
Evidence: In a series of 3426 LLETZ procedures, women aged
≥ 50 with CIN at the margins of excision constituted a minority high
risk group. It was suggested that these women should be offered
retreatment rather than surveillance.123
8.7.1 Women with Women with adenocarcinoma in situ/cervical glandular intraepithelial adenocarcinona in neoplasia (cGIN) can be managed by local excision for those wishing to situ/cervical glandular retain fertility. Incomplete excision at the endocervical margin requires a further excisional procedure to obtain clear margins and exclude occult
invasive disease (95%) (see Chapter 12).
Evidence: Several studies have shown that women with adenocar-
cinoma in situ with negative margins can be managed conserva-
tively.124–127 One study has suggested that up to 15% of these women
will require further treatment by four years because of recurrent
cytological abnormalities.126
8.7.2 Microinvasive squamous Microinvasive squamous cancer FIGO stage Ia1 can be managed by local cancer FIGO stage Ia1 excisional techniques if: • the excision margins are free of CIN and invasive disease NHSCSP April 2004
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• the gynaecological cancer centre pathologist and multidisciplinary team have reviewed the histology.
If the invasive lesion is excised but CIN extends to the excision margin then a repeat excision should be performed to confirm excision of the CIN and to exclude further invasive disease. This should be performed even in those cases planned for hysterectomy to exclude an occult invasive lesion requiring radical surgery.
Evidence: Several studies have suggested that FIGO stage Ia1 dis-
ease can be managed conservatively.119,128 Variation in histological
diagnosis of microinvasive disease is well recognised and all cases
should be reviewed by an independent pathologist with an interest
in gynaecological oncology.
Treatment should be performed with adequate pain control and should
include pretreatment counselling. Treatment should be offered with local
analgesia but, when this is inappropriate, general anaesthesia should
be offered. Reasons for treating under general anaesthesia should be
recorded in the colposcopy record. The proportion of women managed
as outpatients with local analgesia should exceed 80%.
Summary of standards
1. All women needing treatment must be informed that treatment will be required and their consent, either written or verbal, recorded
(100%).
2. All women needing treatment must have had a colposcopic 3. All treatments must be recorded (100%).
4. All women must be treated in properly equipped and staffed clinics 5. All women must have had their histological diagnosis established prior to destructive therapy (100%).
6. The proportion of women treated at the first visit who have evidence of CIN on histology must be ≥ 90%.
7. The proportion of treatment associated with primary haemorrhage that requires a haemostatic technique in addition to the treatment
method applied must be < 5%.
8. The proportion of patients admitted as inpatients owing to treatment complications must be < 2%.
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9. Ablative techniques are only suitable when: • the entire transformation zone is visualised (100%)
• there is no evidence of glandular abnormality (100%)
• there is no evidence of invasive disease (100%).
10. Cryocautery should only be used for low grade CIN and a double freeze thaw–freeze technique must be used (100%).
11. When excision is used, at least 80% of cases should have the
specimen removed as a single sample.
12. For ectocervical lesions, excisional techniques should remove tissue to a depth of greater than 7 mm (95%).
13. Treatment at first visit for a referral of borderline or mild dyskaryosis should only be used in exceptional cases, and only when audit has
identified that CIN is present in ≥ 90% of the excised specimens.
14. All women over the age of 50 years who have CIN 3 at the endo- cervical margin and in whom satisfactory cytology and colposcopy
cannot be guaranteed must have a repeat excision performed to try
and obtain clear margins (100%).
15. Among women with adenocarcinoma in situ/cGIN, those wishing to retain fertility can be managed by local excision. Incomplete excision
at the endocervical margin requires a further excisional procedure to
obtain clear margins and exclude occult invasive disease (95%).
16. The proportion of women managed as outpatients with local analgesia should exceed 80%.
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9. FOLLOW-UP OF WOMEN
ATTENDING FOR COLPOSCOPY
All women remain at risk following treatment and must be followed up
(100%).
There is no obviously superior conservative surgical technique for the treatment of cervical intraepithelial neoplasia.111 Excisional treatments permit histological assessment of biopsy and can determine risk fac-tors for residual disease. Women at increased risk of residual/recurrent disease should be considered for more intensive surveillance following treatment.
Evidence: Several retrospective studies120,123,129–137 of residual dis-
ease rates after LLETZ or knife cone biopsy have demonstrated
that negative excision margins are associated with lower risk of
residual disease and positive excision margins are associated with
higher risk of residual disease. Studies have demonstrated that
disease at the endocervical resection margin is associated with
increased risk of residual disease compared with involved ectocer-
vical margins.120,123,136,138,139 Women aged 50 years or more123,140 are
particularly at risk of persistent/recurrent disease.
Standards for follow-
• Follow-up should start at six months following treatment and not up of treated women
later than eight months following treatment (> 90%).
• Cytology alone is recommended for follow-up and samples should be taken by appropriately trained staff.
• Initial follow-up cytology (six month test) is ideally performed in the treatment centre (best practice); alternatively, follow-up cytology can be performed in the primary care sector (minimum standard).
• All women who do not have negative test results after treatment should be recolposcoped at least once within 12 months (100%).
• The proportion of treated women with no dyskaryosis six months after treatment should exceed 90%.
• The proportion of confirmed histological treatment failures should not exceed 5% within 12 months of treatment.
Duration of follow-up
Women should have annual follow-up for at least 10 years after the treatment of CIN 2 or worse before returning to the routine screening interval. Women treated for CIN 1 can be returned to routine recall after two years of negative post-treatment cytology.
Evidence: The majority of persistent/recurrent disease is detected
within the first 24 months.123,141 However, there is clear evidence
that there is persistent long term risk of invasive cancer for at least
10 years after treatment and possibly for 20 years.57,142 Annual
follow-up cytology is therefore justified after the treatment of CIN
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2 or worse. Although the risk of invasive recurrence is likely to be greater after treatment of high grade disease, there are no reliable data that examine the relative risks for different grades of CIN.
Frequency of follow-
Recommendations for follow-up protocols have to be determined by expert consensus opinion: • women treated with high grade disease (CIN 2, CIN 3, cGIN) require 6 and 12 month follow-up cytology and annual cytology for the subsequent nine years at least, before returning to screening at the routine interval (high risk follow-up) • women treated for low grade disease require 6, 12 and 24 month follow-up cytology. If all results are negative, then women may be returned to screening at the routine interval (low risk follow-up).
Evidence: There is no clear evidence suggesting that diagnostic
performance of cytology in combination with colposcopy for the
detection of persistent disease after treatment for CIN is superior
to cytology alone.
Current opinion is mixed on the value of cytology combined with colposcopy for follow-up. Some authors suggest that colposcopy does not increase the detection of disease.133,143 Other authors144–147 suggest that an initial follow-up colposcopy marginally enhances early detection of disease and reduces the false negative rate.
Women treated for cGIN are at somewhat higher risk of developing recurrent disease than those with high grade CIN.126 In addition, recurrent disease is more difficult to detect cytologically. Cytology should continue for the same duration with the same frequency as after treatment of CIN 2 and CIN 3 (minimum standard). Ideally, six-monthly samples would be taken for five years followed by annual samples for a further five years (best practice).
Samples for follow-up
Extended tip sampling devices should be used for taking samples for follow-up by conventional cytology; brush devices such as the Cervex-Brush® should be used for liquid based samples: • after surgical treatment, particularly excisional treatment, the squamocolumnar junction can retract into the cervical canal; ideally, a cervical sample should be taken with an extended tip device • after treatment for cGIN, follow-up samples must contain endo- cervical cells (see section 12.3).
Follow-up after
Women who have had a hysterectomy with CIN present are potentially at risk of developing vaginal intraepithelial neoplasia (VaIN) and invasive vaginal disease. There is no clear evidence that colposcopy increases the detection of disease on follow-up. Expert consensus opinion recom-mends that: NHSCSP April 2004
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• for women on routine recall for at least 10 years prior to hysterectomy and no CIN in the sample at hysterectomy, no vault cytology is required • for women with less than 10 years' routine recall and no CIN at hysterectomy, a sample should be taken from the vault six months after surgery and there should be no further cytology follow-up if it is negative • for women with completely excised CIN at hysterectomy, a sample should be taken from the vault at 6 and 18 months after surgery and there should be no further cytology follow-up if both are negative • for women with incomplete or uncertain excision of CIN, follow-up should be conducted as if the cervix were still in situ (ie as for low and high risk follow-up in section 9.4 above).
It should be emphasised that these clinical guidelines for follow-up of women treated by hysterectomy are not part of the cervical screening programme and data on cytology from vault samples are not collected routinely.
Evidence: The incidence of VaIN after hysterectomy diagnosed
with CIN was in the order of 1% in a series of 341 women,148 with
no subsequent cases of invasive disease. In a similar series of 177
women,149 4% developed VaIN, with 0.6% developing subsequent
invasive disease. A meta-analysis of long term results suggests
that, although recurrent intraepithelial disease is less common
after hysterectomy for CIN than after local treatments of the cervix
(522 versus 1587 per 100 000 woman–years), the risk of invasive
recurrence is similar in both groups (57 versus 67 per 100 000
woman–years).150
It is accepted that, even after hysterectomy, there is a risk of developing cancer similar to that after conisation or local destruction. It is not clear whether this is due to incomplete treatment or recurrent disease, although the latter would seem unlikely if the whole cervical transformation zone (along with the cervix) has been removed. Although supporting evidence is lacking, it seems reasonable to assume that if there is complete exci-sion with no transformation zone remaining and two follow-up cytology tests confirm no dyskaryosis then the risk of developing cancer must be very small indeed and does not justify surveillance beyond the suggested 18 months.
Role of HPV testing
HPV testing after treatment has the potential to enhance the detection during post-treatment
of persistent/recurrent disease.37,38,151–155 These preliminary studies sug- gest that there is a role for HPV DNA testing during follow-up. These studies suggest that: • a positive HPV test, even in the presence of normal cytology, can detect treatment failure more quickly and more accurately • some treatment failures have a negative HPV test in the presence of abnormal cytology; a combined cytological evaluation together with NHSCSP April 2004
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an HPV test will significantly increase the safety of the follow-up surveillance • a proportion of women have a positive HPV test in the presence of normal cytology, without eventually developing failure/recurrence; as it is not possible to distinguish which of them is likely to be a failure, they should undergo colposcopic evaluation • further larger studies are required to assess the true diagnostic accuracy of HPV testing during the follow-up period.
Follow-up of untreated
women
9.8.1 Women referred with Women referred with moderate or severe dyskaryosis (high grade) on moderate or severe their test result are at significant risk of CIN 2 or 3, even in the pres- ence of normal colposcopy. Biopsy should be undertaken in > 95% of
women with high grade abnormalities (see section 6.3). If treatment is not
undertaken, close surveillance with colposcopy and cytology every six
months is advised. If at follow-up a high grade cytological abnormality
persists, excisional treatment is recommended (90%).
Evidence: The overall specificity for distinguishing normal from
abnormal tissue at colposcopy in a meta-analysis was only 48%.156
The specificity of high grade cytology is over 90% in several
studies.157,158 This evidence suggests that high grade cytological
abnormalities have a high likelihood of being associated with CIN
2 or CIN 3. Follow-up studies159,160 also support the relatively high
likelihood of CIN 2 or CIN 3 in this group, and thus the presence
of persistent high grade abnormalities, even in the face of normal
colposcopy, warrants treatment.
9.8.2 Women referred with Women referred with moderate dyskaryosis or worse cytological abnor- moderate dyskaryosis or malities who have a colposcopically low grade lesion and who are not treated should have multiple biopsies (90%). If CIN 1 or less is con-
firmed, close colposcopic and cytological follow-up is advised. Cases
with unexplained severe dyskaryosis should be discussed at multidisci-
plinary meetings.
Evidence: The positive predictive value of colposcopy for distin-
guishing low grade from high grade lesions is only 57%.156 As the
specificity of high grade cytology is over 90%, the likelihood of an
underlying high grade lesion in this situation is extremely high. If
treatment is not undertaken as a result of colposcopic diagnosis of
a low grade lesion, histological assessment is recommended by way
of multiple directed biopsies.158,161 If there is high grade cytology
at follow-up, treatment is recommended.
9.8.3 Women referred with Women referred with mild dyskaryosis or less who have a satisfactory mild dyskaryosis or less and normal colposcopic examination are at low risk of developing cervi- NHSCSP April 2004
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cal cancer. Their management is best determined by repeat cytological assessment six months after the referral sample: • if this is normal they can be returned to recall• if this is borderline, repeat test in 12 months• if this is mild dyskaryosis, a colposcopy with another test within 12 months is recommended • any other test result warrants further colposcopy with or without Evidence: Three studies159,160,162 indicate that the risk of significant
disease is extremely small when low grade cytology (mild dyskaryo-
sis or less) is associated with normal colposcopy. The risk probably
does not warrant intensive surveillance with its attendant costs and
anxieties. In each of these studies, follow-up cytology identified
women with significant disease and this should form the main part
of follow-up. In one study,162 the smear at first colposcopy visit dis-
tinguished those who were at risk. If this repeat smear was normal
or borderline, the risk was minimal and referral back to community
screening was advised. There is evidence to suggest that the routine
practice of repeating smears at first attendance at the clinic does not
add significantly to management and certainly repeating a smear
within three months of an index smear is unlikely to be helpful.
However, in the face of a low grade referral smear there is a 50%
chance of normal colposcopy, and in this group the repeat smear
at first visit offers the chance of discharging the woman to her GP
if the result is normal or borderline.
9.8.4 Women referred Women referred with a result of mild dyskaryosis or less who have a with a report of mild colposcopically low grade lesion may be treated or followed up at six- dyskaryosis or less monthly intervals in the colposcopy clinic.
If the lesion has not resolved within two years of referral to colposcopy,
at least a biopsy is warranted (> 90%). In practice, many women are
offered treatment at this point, as persistent surveillance risks default.
Evidence: Approximately 50% of women with a low grade cyto-
logical abnormality who are not treated at first visit will eventually
revert to normal cytology and colposcopy.162 Those who are identi-
fied to have a colposcopically low grade lesion may be followed
up.1 Prospective randomised data suggest that such a policy does
not alter the number of women with high grade lesions who are
treated but does reduce the number of low grade lesions treated.52
However, in this study over one-fifth of women defaulted from
follow-up. Therefore, the decision to follow up rather than treat
in the presence of an apparent low grade lesion must incorporate
analysis of the likelihood of default. Furthermore, the positive pre-
dictive value for distinguishing low grade from high grade lesions
is only 57%.156 Therefore, follow-up is warranted as a result of the
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inherent poor colposcopic discrimination between high and low grade lesions. The ongoing management decisions for this group will often be influenced by the woman's choice.
Summary of standards
1. All women remain at risk following treatment and must be followed up (100%).
2. Follow-up should start at six months following treatment and not later than eight months following treatment (> 90%).
3. All women who do not have negative test results after treatment must be recolposcoped at least once within 12 months (100%).
4. The proportion of treated women with no dyskaryosis six months following treatment should exceed 90%.
5. The proportion of confirmed histological treatment failures should not exceed 5% within 12 months of treatment.
6. Biopsy should be undertaken in > 95% of women with high grade
7. If at follow-up a high grade cytological abnormality persists, excisional treatment is recommended (90%).
8. Women referred with moderate dyskaryosis or worse cytological abnormalities who have a colposcopically low grade lesion and who
are not treated should have multiple biopsies (90%).
9. If a low grade lesion has not resolved within two years of referral to colposcopy, at least a biopsy is warranted (> 90%).
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10. PREGNANCY, CONTRACEPTION,
MENOPAUSE AND HYSTERECTOMY
10.1 Pregnant women
10.1.1 Cervical screening in • Unless a pregnant woman with negative history has gone beyond three years without having cervical screening then the test should be postponed.
• If a woman has been called for routine screening and she is pregnant then the test should be deferred.
• If a previous test was abnormal, and in the interim the woman becomes pregnant, then the test should not be delayed but should be taken in mid-trimester unless there is a clinical contraindication.
10.1.2 Colposcopy in A woman who meets the criteria for colposcopy still needs colposcopy if she is pregnant. The primary aim of colposcopy for pregnant women is to exclude invasive disease and to defer biopsy/treatment until the woman has delivered. Women seen in early pregnancy may require a further assessment in the late second trimester at the clinician's discretion.
Evidence: The safety of delaying treatment of pregnant women has
been shown in a number of cohort and retrospective uncontrolled
studies.163,165 The incidence of invasive cervical cancer in pregnancy
is low and pregnancy itself does not have an adverse effect on the
prognosis.166
If colposcopy has been performed during pregnancy, postpartum
assessment of women with an abnormal smear or biopsy proven CIN is
essential (100%). Excision biopsy in pregnancy cannot be considered
therapeutic and these women should be seen for colposcopy post partum.
This requires a system to ensure that women are given an appointment
after delivery.
Evidence: Regression rates for preinvasive cervical disease during
pregnancy and following delivery are low from retrospective uncon-
trolled studies and regression is not related to mode of delivery.167 A
retrospective study of pregnant women treated by cone biopsy for
high grade CIN and microinvasion reported high rates of disease
persistence.168
10.1.3 Colposcopic evaluation Colposcopic evaluation of the pregnant woman requires a high degree of the pregnant woman • if CIN 1 or less is suspected, repeat the examination three months following delivery NHSCSP April 2004
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• if CIN 2 or 3 is suspected, repeat colposcopy at the end of the second trimester or, if the pregnancy has already advanced beyond that point, three months following delivery • if invasive disease is suspected clinically or colposcopically, a biopsy adequate to make the diagnosis is essential (100%). Cone, wedge and
diathermy loop biopsies are all associated with a risk of haemorrhage
and such biopsies should be taken where appropriate facilities to deal
with haemorrhage are available. Punch biopsy suggesting only CIN
cannot reliably exclude invasion.
Evidence: Case series of biopsies taken by diathermy loop in
pregnancy have shown that the risk of haemorrhage is in the
order of 25%.169
10.2 Use of contraceptives
10.2.1 Women with abnormal Women with abnormal cervical screening results should not be advised cervical screening to change from the oral contraceptive pill (OCP) if it is a successful method of contraception. An abnormal result should not influence the choice of contraception.
Evidence: Nested case–control studies indicate a small increase in
the relative risk of CIN after compensating for HPV infection with
long term use of the OCP.170–172 However, we do not have evidence
that stopping the OCP will alter the natural history of the disease. A
large prospective cohort study confirms no significant association
between the use of the OCP ever and cervical cancer.173
10.2.2 Women with an IUCD It is not necessary to remove an intrauterine contraceptive device (IUCD) to perform local treatment. Women with an IUCD should be given clear information on the clinic's management policy regarding whether her IUCD will be removed or not. She will need to know if she has to use alternative methods of contraception and if she has to schedule her treat-ment to coincide with the first half of her cycle.
Evidence: Professional consensus.
10.3 Menopause and
the use of hormone
replacement therapy
10.3.1 Postmenopausal women The incidence of abnormal cytology is low in postmenopausal women with previous normal results. The use of systemic hormone replacement therapy (HRT) is not known to alter the risk of cervical disease.
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Evidence: One randomised controlled trial and two case–control
studies demonstrated no increase in relative risk from the use of
systemic HRT.174–176
10.3.2 Postmenopausal In an adequately screened woman, postmenopausal bleeding (PMB) is NOT an indication to take a cervical sample. The investigation of abnor-mal bleeding after the menopause must include direct visual inspection of the cervix. A cervical sample is not an appropriate test for investigating PMB. All unexplained bleeding should be referred to a gynaecologist.
Evidence: Professional consensus.
10.4.1 Women undergoing a All women in the cervical screening age range undergoing a hysterectomy hysterectomy for other for other gynaecological reasons should have a negative test result within the screening interval. Otherwise, a cervical sample should be taken as
part of their preoperative investigations (100%).
Evidence: Professional consensus.
10.4.2 Women being considered All patients being considered for hysterectomy who have an undiagnosed for hysterectomy abnormal test result or symptoms attributable to cervical cancer should
have diagnostic colposcopy and an appropriate biopsy177 (100%).
Evidence: Professional consensus suggests that the nature and
extent of cervical neoplasia is defined to avoid inadvertent non-
radical treatment of cervical cancer or inadvertent inadequate
excision of VaIN.177,178
10.4.3 Hysterectomy as treatment Hysterectomy is a recognised treatment for histologically proven CIN if for histologically proven there are coexisting conditions appropriately treated by hysterectomy.
cervical intraepithelial neoplasia Evidence: Professional consensus.
10.4.4 Hysterectomy as Hysterectomy is an acceptable form of treatment of persistent abnormal treatment of persistent endocervical cytology despite a prior excisional biopsy of adequate size. abnormal endocervical This is provided that all measures to exclude occult invasion have been Evidence: Professional consensus.
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10.4.5 Mapping vaginal Patients with CIN should have any abnormality on the vagina mapped by colposcopy or Lugol's iodine at the time of surgery to ensure that any coexisting VaIN is recognised and excised at the time of the hys-terectomy.179 Evidence: Observational data.
10.4.6 Correlation of histology The histology of the resected uterus should be correlated with prior with cytology cervical cytology as part of the quality assurance process.
Evidence: Professional consensus.
10.4.7 Follow-up after After hysterectomy, follow-up is advised as suggested in section 9.6.
Evidence: Professional consensus.
10.5 Summary of standards
1. If colposcopy has been performed during pregnancy, postpartum assessment of women with an abnormal cervical sample or biopsy
proven CIN is essential (100%).
2. Colposcopic evaluation of the pregnant woman requires a high degree of skill. If invasive disease is suspected clinically or colposcopically,
a biopsy adequate to make the diagnosis is essential (100%).
3. The investigation of abnormal bleeding after the menopause must include direct visual inspection of the cervix.
4. All patients in the cervical screening age range undergoing a hysterectomy for other gynaecological reasons should have a negative
test result within the screening interval or as part of their preoperative
investigations (100%).
5. All patients being considered for hysterectomy who have an undiagnosed abnormal sample or symptoms attributable to cervical
cancer should have diagnostic colposcopy and an appropriate biopsy
(100%).
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11. SCREENING AND MANAGEMENT
OF IMMUNOSUPPRESSED WOMEN
11.1 Immunosuppressed
This includes women on immunosuppressing medication, transplant recipients and all other forms of immunosuppression. The screening and management of the immunosuppressed woman is a complex area of assessment and management. All patients who are immunosuppressed must be managed in a centre with demonstrable skill and expertise, with sufficient access to patient numbers to maintain that expertise. There must be a compromise between the increased risk of CIN and the additional psychological and physical trauma of assessment and treatment, with due consideration to the comorbidity of the underlying disease process.
11.2 Women with renal
All women aged 25–65 years with renal failure requiring dialysis must failure requiring
have cervical cytology performed at, or shortly after, diagnosis.
Colposcopy should be performed if resource permits. Any cytological abnormality should be treated as a high grade abnormality requiring prompt colposcopic referral. All women about to undergo renal trans-plantation should have had cervical cytology performed within one year. Coexisting CIN should be managed according to national guidelines.
Evidence: There is good evidence that women who have renal fail-
ure requiring dialysis or renal transplantation are at an increased risk
of CIN and cervical cancer.180,181 The range of incidence of abnor-
mal cervical cytology in the renal transplant population has been
quoted as between 8.7% and 70%; a realistic figure of around 15%
represents a fivefold increase from that of the normal population.182
There is some evidence that cervical cytology is relatively insensi-
tive and coexisting CIN could be missed, hence early recourse to
colposcopy.183,184 Most publications inform on cytology taken in a
research/colposcopy clinic setting and thus there is no information
regarding cytology obtained on routine screening.
11.3 Women taking
Women taking maintenance immunosuppression medication post trans- maintenance
plantation, who have no history of CIN, should have cervical screening as per the national guidelines for the non-immunosuppressed.
medication post
transplantation
Any abnormal cervical cytology result should prompt colposcopic refer-ral. Any woman with a previous history of CIN should have routine follow-up as recommended for the immunocompetent population.
Evidence: There are insufficient data on the assessment and
management of these patients long term. All studies bar one were
cross-sectional, whereas the only published longitudinal study has
insufficient numbers to be useful in dictating national guidelines.185
There is no evidence that women who are immunosuppressed after
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renal transplantation have an accelerated natural history of CIN, and thus decreasing the screening interval has no demonstrable benefit.
11.4 Women with
Patients with multifocal disease will require expert assessment and management in a centre with expertise in this area. The patients should be assessed by cytology, colposcopy, vulvoscopy and biopsy where indicated, at least six-monthly.
Evidence: In renal patients, the risk of intraepithelial disease,
and therefore cancer, appears to be temporally related, ie the risk
increases with time. There is little information in the literature
regarding multifocal disease and renal transplantation. The only
longitudinal study demonstrated the presence of ‘high risk' onco-
genic HPV type infection in all patients with vulval intraepithelial
neoplasia (VIN).185 There is good evidence that infection with ‘high
risk' HPV types and persistence of viral infection increases the risk
of subsequent CIN and cervical cancer.186–188 However, the value of
HPV screening has yet to be determined.
11.5 Women receiving
Women receiving long term cytotoxic drugs for rheumatological disorders cytotoxic drugs for
should have regular cytological screening as per national guidelines.
If the screening history is incomplete at commencement of cytotoxic drugs then a cervical sample should be taken with referral to colposcopy for any cytological abnormality.
Evidence: There is an increased incidence of CIN in women with
systemic lupus erythematosus treated with long term chemother-
apy.189,190 The data in other rheumatological disorders are lacking
but safe practice dictates adequate screening histories as a minimum
requirement.
11.6 Other women who are
There is no indication for increased surveillance in the following situ- • women receiving cytotoxic chemotherapy for non-genital cancers• women receiving long term steroids• women receiving oestrogen antagonists such as tamoxifen.
Such women should have cytological screening in accordance with national guidelines.
Evidence: There is a theoretical risk that folate deficiency acts as
a cocarcinogen during the initiation of cervical dysplasia. Folic
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acid supplements neither alter the course of established disease nor decrease the risk of developing CIN.191 There is no evidence to suggest that women who receive chemotherapy with cytotoxic drugs or tamoxifen are at increased risk of CIN.192–194 11.7 HIV positive women
All women newly diagnosed with HIV should have cervical surveil-lance performed by, or in conjunction with, the medical team managing the HIV infection. Annual cytology should be performed with an initial colposcopy if resources permit. Subsequent colposcopy for cytological abnormality should follow national guidelines. The age range screened should be the same as for HIV negative women.
Despite the higher cervical treatment failure rate, high grade CIN should be managed according to national guidelines. Lesions less severe than CIN 2 should probably not be treated as these are likely to represent persistent HPV infection of the cervix, which may ultimately clear and responds poorly to treatment. Regular cytological surveillance will detect progression.
Evidence: Whereas the estimated prevalence of cervical disease
in HIV seronegative women is approximately 3%,195 a number of
reports including cross-sectional, case–control and cohort studies
have indicated a greatly increased prevalence of squamous intraepi-
thelial lesions, ranging from 20% to 40%,196–199 and increased inci-
dence in HIV infected women.200 Furthermore, regression of low
grade lesions is rare and high grade lesions may respond poorly to
standard therapies.201,202 In one study, the recurrence rate in women
with CD4 counts < 200/mm3 was 87%,202 compared with less than
10% in immunocompetent women.
The reason for this high incidence of CIN and recurrence after treat-ment is thought to be the lack of immune activity against HPV. Even in cohorts with a high use of highly active antiretroviral therapy (HAART), there is a high risk of abnormal cytology, although HAART may increase the regression of low grade lesions.203 Early data from a European cohort study show a 33% prevalence of abnor-mal cytology, ASCUS or worse, among 859 women recruited so far. This was despite the fact that a large proportion of the women were on HAART (Mach 1 Study Group).
Use of HAART reduces HIV viral load, and may reduce HPV viral load. As a consequence, the prevalence and incidence of cervical abnormal-ity may also be reduced. However, the evidence for this is inconsistent to date and thus there is a need for more intense surveillance of these women to detect preinvasive cervical lesions.
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11.8 Summary of standards
1. All patients who are immunosuppressed must be managed in a centre with demonstrable skill and expertise, with sufficient access to patient numbers to maintain that expertise.
2. All women aged 25–65 years with renal failure requiring dialysis must have cervical cytology performed at or shortly after diagnosis.
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12. MANAGEMENT OF GLANDULAR
12.1 Cervical glandular
Cervical cytological screening can predict the presence of cervical glan- epithelial
dular intraepithelial abnormalities, including cervical adenocarcinoma and high grade intraepithelial glandular neoplasia.
Evidence: Observational studies of women with abnormal glan-
dular cytology with histological correlation. The data indicate that
premalignancy and malignancy account for a variable proportion of
pathology, with high grade CIN, cervical adenocarcinoma, endome-
trial cancer and high grade glandular intraepithelial neoplasia being
the pathological conditions most commonly diagnosed.42,55,204,205
12.2 Reporting of abnormal
12.2.1 Written reports Reporting of any abnormal glandular sample must be supplemented by
a written descriptive report (100%).
Evidence: The written report should indicate the likely source of
the glandular cells wherever possible. Although not expected to
be 100% accurate, the finding of abnormal endometrial cells can
facilitate the diagnosis of endometrial carcinoma.
12.2.2 Colposcopic assessment Colposcopic assessment is essential in the presence of cytological glan-
dular abnormality (100%).
Evidence: There is a high prevalence of invasive adenocarcinoma,
cGIN and CIN in this population.42,43 Although there are no specific
colposcopic indicators of glandular abnormality, villous fusion
and acetowhite changes proximal to the squamocolumnar junction
have been noted.42,206 However, colposcopy lacks sensitivity for the
diagnosis of glandular lesions207 and punch biopsy has little role
in their precise diagnosis. Colposcopy demonstrates concomitant
CIN in 50% of cases, provides an assessment of the anatomy of
the cervix and vagina, and helps to decide on the most appropriate
method and extent of biopsy.
12.2.3 Further investigation of Women with samples reported as ?glandular neoplasia should be referred for urgent investigation by colposcopy to exclude significant cervical and endometrial neoplasia.
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Evidence: For high grade glandular cytological abnormality, reports
suggest variations in positive predictive value (PPV) between 17%
and 96% for premalignant or malignant pathology.42,55,204,205,208
Furthermore, the predictive value of abnormal glandular cytology
is compromised by the occurrence of several benign conditions
that mimic cervical glandular neoplasia cytologically.209 Endocer-
vical brush artefact can give rise to such samples.210 Other non-
cervical/endometrial neoplastic lesions of the genital tract and
intraperitoneal organs sometimes present in this way. Although
larger datasets are desirable, expert opinion and the limited data
available support a rigorous investigative protocol for this grade
of abnormality.42,52,204,205
12.2.4 Borderline glandular Women with borderline glandular samples should be referred promptly for investigation by colposcopy, any appropriate cervical biopsy and selective use of endometrial biopsy.
Evidence: For predictions with less certainty of glandular neoplasia,
the borderline classification is used. Most available studies, how-
ever, report atypical glandular cells of undetermined significance
(AGUS) samples representing the Bethesda convention,212 which
differs from the UK in respect of glandular samples. Although
the data are somewhat unreliable, high grade squamous intraepi-
thelial lesions are those most commonly diagnosed in 27–37% of
cases.210,213 However, invasive lesions have been noted to present
in this way.214 Limited UK data indicate that a borderline classifi-
cation of those examples of abnormal glandular cells is associated
with a low, but still significant, incidence of pathology (33–57%).
Intraepithelial glandular lesions very infrequently present with this
grade of abnormality.42,43
The above guideline conforms with the suggestions of a Joint College working party,215 which did not suggest a need for radical excision of the endocervix.
12.2.5 Punch biopsy Punch biopsy is an unreliable investigation in the management of high grade cytological glandular abnormality.
Evidence: Invasive neoplasia cannot be excluded on the basis of
a punch biopsy.216 Punch biopsy is of low sensitivity for diagnosis
of glandular lesions.217,218 Expert opinion indicates that a reli-
able diagnosis of high grade cGIN and distinction from invasive
adenocarcinoma can only be achieved in the histopathology labora-
tory, and an excisional biopsy including the endocervical canal is
required for this purpose. Endometrial carcinoma has been detected
through the screening process under the circumstances described
above.42,43,214
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12.2.6 Endometrial biopsy Selective use of endometrial biopsy is recommended for women of peri-menopausal age and above, or for those with irregular vaginal bleeding or if the atypical cells appear to be of endometrial origin. Postmenopausal women with atypical endometrial cells on a sample must be referred to a gynaecologist. Although it is accepted that cervical assessment may be required in such cases, the majority do not have cervical disease and should have an endometrial assessment in the first instance.
Evidence: Professional consensus.
12.3 Clinical management
of cervical glandular
intraepithelial
neoplasia
12.3.1 Conservative Cervical glandular intraepithelial neoplasia (cGIN) often occurs in young management of cervical women who wish to retain fertility. The weight of expert opinion has glandular intraepithelial moved from radical towards conservative methods. In selected cases, a neoplasia lesions conservative cone type excision (using a cylindrical rather than a conical specimen) is considered appropriate. Expert histopathological opinion216 favours techniques that either avoid or minimise thermal artefact to improve assessment of the excision margins.
For women with suspected cGIN or early invasive adenocarcinoma, the extent of cervical excision can be individualised. In younger women and/or women desirous of fertility who have a colposcopically visible squamocolumnar junction (SCJ), a cylindrically shaped cervical exci-sional biopsy including the whole transformation zone (TZ) and at least 1 cm of endocervix above the SCJ is appropriate. In older women, or where the SCJ is not visible at colposcopy, cylindrical biopsy includ-ing all of the visible TZ and about 20–25 mm of the endocervical canal should be removed.
Evidence: Retrospective and prospective clinical studies207,217–222
and histomorphometric studies218,222 support the use of cone biopsy
for the management of cGIN, provided that the conditions below
are met.
Despite columnar cell origins, this lesion is found in the TZ in 85% of cases.219,223 TZ involvement is usually accompanied by endocervi-cal columnar disease. Bertrand et al219 emphasised that deep clefts of up to 5 mm from the margin of the canal could be involved with disease. Although theoretically any site within the endocervix can be affected, multifocal disease is found in only 13–17% of cases and the lesion is usually contiguous with the SCJ, extending up the canal as a unicentric lesion for variable distances. A similar distribution of early invasive adenocarcinoma has been described.224 Overall, 95% of cGIN extends within 25 mm of the anatomical external os.219 Further data225 show a relationship between age and NHSCSP April 2004
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proximal linear extent of disease, suggesting that more limited exci-sion of the endocervix, ie 1 cm above the SCJ, may be reasonable in women aged < 36 years. Such an approach would also allow accurate diagnosis of early invasive adenocarcinoma.224 A trend for a greater extent of glandular disease has been noted in older women.125 Similarly, it is well established that the SCJ retreats into the canal with increasing age and thus older women require deeper excisions. Thus, colposcopic examination can help to individualise the requisite extent of the excisional specimen.
In advising expectant management for cGIN, the clinician should be satisfied that: • the margins of the specimen are free of disease; if the margins of the first excision are not free, it is reasonable to offer a further attempt at conservative excision in order to confidently exclude invasion and obtain negative margins • the specimen submitted has been thoroughly sampled in the Women to be managed conservatively after cone biopsy should be coun-selled that expectant management appears safe if careful follow-up is car-ried out (see below). Recent data indicate a recurrence rate of 15% at four years, although a slightly higher proportion will require further surgical investigation for abnormalities detected during follow-up. Follow-up of conservatively treated cGIN should consist of cytology and such follow-up is best managed in the colposcopy clinic (see section 9.4).
Evidence: Follow-up cytology must include endocervical cells
(see section 9.5).218 Such samples can detect the presence of
residual glandular lesions.218 There are recognised difficulties in
assessing atypical glandular cells in samples after cone biopsy
for cGIN. Lower segment sampling has been misinterpreted as
glandular abnormality, leading to further surgical intervention.225
The increased awareness of the possibility of glandular neoplasia
introduces bias into the diagnosis with increased risks of false posi-
tive reporting due to benign mimics.226
Although evidence is lacking, colposcopy may be indicated because of the need to monitor the possible recurrence of cGIN, CIN and invasion. However, some form of heightened surveillance and easy access to cytologists is required.
If cervical histology is negative, consider other gynaecological/non-gynaecological conditions that could yield abnormal glandular cells.
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12.4 Hysterectomy for
Simple hysterectomy might be considered in the following circum- cervical glandular
• if fertility is not required• if there are positive margins after an adequate excisional • if treatment by cone biopsy is followed by further high grade cytological abnormality • for those who are unwilling to undergo conservative management• failure to achieve adequate cytological follow-up, eg because of cervical stenosis • for those with other clinical indications for the procedure• only when invasive disease has been confidently excluded.
12.5 Summary of standards
1. Reporting of any abnormal glandular sample must be supplemented by a written descriptive report (100%).
2. Colposcopic assessment is essential in the presence of cytological glandular abnormality (100%).
3. Postmenopausal women with atypical endometrial cells on a sample must be referred to a gynaecologist.
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APPENDIX 1: SUMMARY OF
STANDARDS
1. To ensure that women are adequately informed about colposcopy and treatment• Each woman should be offered verbal and be sent written information before and after a smear and before colposcopy
(95%) (section 5.2.1).
• Counselling must be available as an integral part of colposcopy (section 5.2.1).
• Women must be sent an appropriately worded invitation with a contact name, telephone number and clinic times (section 5.2.1).
• Information with regard to visit and results of investigations should be communicated to the patient within four weeks of
her attendance (best practice 90%) or eight weeks (minimum
standard 100%) (section 5.2.1).
• Clinics providing a ‘see and treat' policy must ensure that women who are offered treatment at their first visit are sent adequate and
appropriate information in advance of their appointment (100%)
(section 5.2.3).
• All women needing treatment must be informed that treatment will be required and their consent, either written or verbal,
recorded (100%) (section 8.1).
2. To provide an adequate clinic environment • There must be a private area with changing facilities. There must also be toilet facilities (section 5.2.5).
• There must be a permanently sited specific room for colposcopy (100%) (section 5.2.5).
• Refreshments must be available (section 5.2.5).
• There must be separate waiting and recovery areas (section • There must be a permanent couch and colposcope (section • Appropriate sterilising facilities must be available in accordance with local and national health and safety recommendations (section 5.3).
• In units offering a diagnostic service, there must be automatic referral to a unit where treatment is available if required (section 5.3).
• If laser or diathermy equipment is in use, there must be adequate safety guidelines in place with all staff trained in their use and emergency guidelines must be available in each clinic (section 5.3).
• Adequate resuscitation equipment must be immediately available and staff involved in the clinical care of patients must be familiar with its use (section 5.3).
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3. To provide appropriate clinic staff • All clinics must have a named colposcopist with appropriate skills who leads the service with a specialist team specific to the colposcopy unit. The named lead colposcopist must have a job description (section 5.4).
• There must be at least two nurses for each clinic (section 5.4).
• Nurse colposcopists working in a clinic role must be supported by another registered nurse (section 5.4).
• There must be adequate dedicated clerical support for the clinic (section 5.4).
4. To ensure appropriate and accurate data collection • There must be suitable information technology equipment and software to facilitate collection of data for the BSCCP minimum dataset and for submission of the statutory quarterly KC65 (section 5.3).
• Multidisciplinary audit must be an integral part of the service (section 5.6).
5. To reduce default • There must be written protocols for the management of non- attenders (section 5.6).
• The default rate should be less than 15% (section 5.6).
6. To reduce failure of diagnosis of early cancers • All women needing treatment must have had a colposcopic assessment (100%) (section 8.1).
• An excisional form of biopsy is recommended (95%) (section
6.3):– when colposcopic appearances indicate high grade – when low grade colposcopic change is associated with severe dyskaryosis or worse – when a lesion extends into the canal (sufficient canal must be removed in these situations).
• Reasons for not performing a biopsy must be recorded (100%)
(section 6.3).
• All measures including biopsy must be taken to exclude invasion prior to treating with local destruction (100%) (section 6.4).
7. To improve the quality, accuracy and timeliness of diagnosis • Cervical screening should take place between the ages of 25 and 64 at intervals of three or five years, depending on the woman's age (section 2.1.1).
• Women must be called on or around their 25th birthday and subsequently recalled at three-yearly intervals between the ages of 25 and 49 years, and at five-yearly intervals between the ages of 50 and 64 years (section 2.1.3).
• Women should be referred for colposcopy after three consecutive inadequate samples (section 4.1).
• Women should be referred for colposcopy after three tests in a series reported as borderline nuclear change in squamous cells NHSCSP April 2004
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without the woman being returned to routine recall (section 4.2.1).
• Women should be referred for colposcopy after one test reported as borderline nuclear change in endocervical cells (section 4.2.2).
• Women should be referred for colposcopy if they have had three tests reported as abnormal of any grade in a 10-year period (section 4.3).
• Ideally, women should be referred for colposcopy after one test reported as mild dyskaryosis, but it remains acceptable to recommend a repeat test. Women must be referred after two tests reported as mild dyskaryosis without a return to routine recall (section 4.4).
• Women must be referred for colposcopy after one test reported as moderate dyskaryosis (100%) (section 4.5).
• Women must be referred for colposcopy after one test reported as severe dyskaryosis (100%) (section 4.6).
• Women must be referred for colposcopy after one test reported as possible invasion (100%). They should be seen urgently within
two weeks of referral (90%) (section 4.7).
• Women must be referred for colposcopy after one test reported as glandular neoplasia (100%). They should be seen urgently
within two weeks of referral (90%) (section 4.8).
• Women should be referred for colposcopy if they have been treated for CIN and have not been returned to routine recall
and a subsequent test is reported as mild dyskaryosis or worse
(100%) (section 4.11).
• At least 90% of women with an abnormal test result should be
seen in a colposcopy clinic within eight weeks of referral (section 4.12).
• At least 90% of women with a test result of moderate or severe
dyskaryosis should be seen in a colposcopy clinic within four weeks of referral (section 4.12).
• The following data should be recorded at the colposcopic examination (section 6.2):
– reason for referral (100%)
– grade of cytological abnormality (90%)
– whether the examination is satisfactory; this is defined as
the entire SCJ having been seen, and the upper limit of any
cervical lesion also being seen (100%).
• Of all biopsies taken (directed and excisional), > 90% should be
suitable for histological interpretation (section 6.5.2).
• If a colposcopically directed biopsy is reported as inadequate for histological interpretation, it should be repeated if there is a
residual colposcopic lesion (95%) (section 6.5.2).
• For those with satisfactory colposcopic examination, the predictive value of a colposcopic diagnosis of a high grade lesion
(CIN 2 or worse) should be at least 65% (section 6.6).
• Biopsy should be undertaken in > 95% of women with high
grade abnormalities (section 9.8.1).
• Women referred with moderate dyskaryosis or worse cytological abnormalities who have a colposcopically low grade lesion and NHSCSP April 2004
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who are not treated should have multiple biopsies (90%) (section
9.8.1).
• All patients who are immunosuppressed must be managed in a centre with demonstrable skill and expertise, with sufficient access to patient numbers to maintain that expertise (section 11.1).
• All women aged 25–65 years with renal failure requiring dialysis must have cervical cytology performed at or shortly after diagnosis (section 11.2).
• Reporting of any abnormal glandular smear must be supplemented by a written descriptive report (100%) (section 12.2.1).
• Postmenopausal women with atypical endometrial cells on a smear must be referred to a gynaecologist (section 12.2.6).
• The investigation of abnormal bleeding after the menopause must include direct visual inspection of the cervix (section 10.3.2).
• Colposcopic assessment is essential in the presence of cytological glandular abnormality (100%) (section 12.2.2).
• If colposcopy has been performed during pregnancy, postpartum assessment of women with an abnormal smear or biopsy proven
CIN is essential (100%) (section 10.1.2).
• Colposcopic evaluation of the pregnant woman requires a high degree of skill. If invasive disease is suspected clinically or
colposcopically, a biopsy adequate to make the diagnosis is
essential (100%) (section 10.2.3).
• All patients in the cervical screening age range undergoing a hysterectomy for other gynaecological reasons should have a
negative smear within the screening interval or as part of their
preoperative investigations (100%) (section 10.4.1).
• All patients being considered for hysterectomy who have an undiagnosed abnormal smear or symptoms attributable to
cervical cancer should have diagnostic colposcopy and an
appropriate biopsy (100%) (section 10.4.2).
8. To ensure appropriate selection for and quality of treatment • Colposcopy clinics in GUM must have established protocols for liaison with gynaecological services (100%) (section 5.6).
• Clinic staff must always be familiar with the treatment method(s) used (100%) (section 5.3).
• Biopsy should be carried out unless an excisional treatment is planned, when the cytology indicates persisting moderate
dyskaryosis or worse, and always when a recognisably atypical
TZ is present (100%). Pregnancy is an exception (section
6.5).
• All patients must have a biopsy or biopsies taken prior to local destructive treatment (100%). Unless there are special
circumstances, the result of the biopsy should be available (best
practice) (section 6.5.2).
• All women needing treatment must be informed that treatment will be required and their consent, either written or verbal,
recorded (100%) (section 8.1).
• All women needing treatment must have had a colposcopic assessment (100%) (section 8.1).
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• All treatments must be recorded (100%) (section 8.1).
• All women must be treated in properly equipped and staffed
clinics (100%) (section 8.1).
• All women must have had their histological diagnosis established prior to destructive therapy (100%) (section 8.1).
• The proportion of women treated at the first visit who have evidence of CIN on histology must be ≥ 90% (section 8.1).
• The proportion of treatment associated with primary haemorrhage that requires a haemostatic technique in addition to the treatment
method applied must be < 5% (section 8.1).
• The proportion of patients admitted as inpatients owing to treatment complications must be < 2% (section 8.1).
• Ablative techniques are only suitable when (section 8.2): – the entire transformation zone is visualised (100%)
– there is no evidence of glandular abnormality (100%)
– there is no evidence of invasive disease (100%)
• Cryocautery should only be used for low grade CIN and a double freeze thaw–freeze technique must be used (100%) (section
8.3).
• When excision is used, at least 80% of cases should have the
specimen removed as a single sample (section 8.4.1).
• For ectocervical lesions, excisional techniques should remove tissue to a depth of greater than 7 mm (95%) (section 8.4.3).
• Treatment at first visit for a referral of borderline or mild dyskaryosis should only be used in exceptional cases, and only
when audit has identified that CIN is present in ≥ 90% of the
excised specimens.
• All women over the age of 50 years who have CIN 3 at the endocervical margin, and in whom satisfactory cytology and
colposcopy cannot be guaranteed, must have a repeat excision
performed to try and obtain clear margins (100%) (section
8.6.2).
• Women with adenocarcinoma in situ/cGIN can be managed by local excision for those wishing to retain fertility. Incomplete
excision at the endocervical margin requires a further excisional
procedure to obtain clear margins and exclude occult invasive
disease (95%) (section 8.7.1).
• The proportion of women managed as outpatients with local analgesia must be > 80% (section 8.8).
9. To ensure appropriate and adequate follow-up • All women are at risk after treatment and must be followed up (100%) (section 9.1).
• Follow-up should start at six months after treatment and not later than eight months after treatment (> 90%) (section 9.2).
• All women who do not have negative test results after treatment must be recolposcoped at least once within 12 months (100%)
(section 9.2).
• The proportion of treated women with no dyskaryosis six months after treatment should exceed 90% (section 9.2).
• The proportion of confirmed histological treatment failures should not exceed 5% within 12 months of treatment (section
9.2).
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• If at follow-up a high grade cytological abnormality persists, excisional treatment is recommended (90%) (section 9.8.1).
• If a low grade lesion has not resolved within two years of referral to colposcopy, at least a biopsy is warranted (> 90%) (section
9.8.4).
10. To ensure adequate communications with the referring practitioner • Results and management plans should be communicated to the referring practitioner within four weeks of the patient's
attendance at the clinic (best practice 90%) or eight weeks
(minimum standard 100%) (section 5.2.1).
11. To maintain skill levels • All practising colposcopists must be able to demonstrate that they have received an adequate training (section 5.7.1).
• All colposcopists in the team should be certificated through the BSCCP/RCOG scheme and should comply with the recertification process every three years (section 5.7.1).
• Colposcopists practising within the NHSCSP should see at least 50 new abnormal cytology referrals per year (section 5.7.2).
• All colposcopists must attend one colposcopy meeting recog- nised by the BSCCP every three years (section 5.7.2).
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APPENDIX 2: GUIDANCE ON WORKING
PRACTICES FOR COLPOSCOPY UNITS
The following guidance has been agreed by the NHSCSP Colposcopy Quality Assurance (QA) Group.
1. There needs to be a clear structure for managing NHS colposcopy services, whatever the setting. There should be a designated lead colposcopist, ideally at consultant level, who is a practising colposcopist certificated through the BSCCP/RCOG scheme.
2. The lead colposcopist will be required to ensure that the defined standards are being met and maintain data collection, which will allow audit to be conducted against these standards. The agreed national minimum dataset and the required quarterly return should be collected. The required annual return will be the responsibility of the lead colposcopist.
3. The data collected will serve as a means of comparing performance between colposcopy units. All colposcopic practice, whether in trusts or in the community, should be measured against uniform national standards. Regional arrangements should be in place to ensure that colposcopy clinics are running effectively. A scheme of regular visits (eg every 3–4 years) may provide an effective process for identifying deficiencies before problems arise and encourage good practice.
4. Where concerns arise about colposcopic practice, there must be a means of open discussion between colleagues. The best way of ensuring this is a culture of audit within the unit. This should comprise regular multidisciplinary meetings. Quality assurance is a means of ensuring that standards are improved, where necessary, using a constructive approach rather than a critical one.
5. Where concerns arise about an individual's clinical performance in colposcopy, these require to be handled sensitively and should be the responsibility of the lead colposcopist. There must be a speedy resolution and if this fails, or the lead colposcopist is under scrutiny, the medical director (or equivalent) should take responsibility. The regional QA colposcopy representative should also be involved at this stage.
6. Individual practice often cannot be judged on the basis of a small sample of cases with poor outcomes, unless these are extreme. Large truly representative samples may be required using valid outcomes in order to reach reliable conclusions. Only when matters cannot be satisfactorily resolved ‘in house' should consideration be given to the need for external review. The external reviewer should assist in determining the extent and nature of the review. Under these circumstances the regional QA director will be informed.
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7. All NHS colposcopy units must comply with the nationally agreed QA measures, and trusts and primary care trusts (PCTs) should regard maintenance of quality in colposcopy as an essential part of the framework of clinical governance.
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APPENDIX 3: EXAMPLE JOB
DESCRIPTION FOR LEAD
COLPOSCOPISTS
The NHSCSP requires that each hospital trust providing colposcopy services should have a named lead colposcopist. In trusts where more than one colposcopy unit provides services, there should be one lead colposcopist to coordinate the KC65 statutory return, but there may be lead clinicians in separate colposcopy clinics within a single trust.
The National Quality Assurance Group in Colposcopy of the NHSCSP and the Royal College of Obstetricians and Gynaecologists (RCOG) have published guidance previously on the roles and responsibilities for lead colposcopists.
The national quality assurance group has devised this job description for lead colposcopists. Both the RCOG and the NHSCSP Quality Assurance Group believe that the roles and responsibilities of the lead colposcopist should be recognised by a sessional commitment of at least one notional half day per week (or programmed activity). The lead colposcopist should be supported by at least one session of designated administrative/secre-tarial time for the tasks associated with the position.
Responsibilities of the post
The lead colposcopist is responsible for: • Ensuring that written protocols are in place for the service and that these include recommended national guidelines.
• Ensuring that the protocols are regularly reviewed so that the needs of the commissioners and the users of the service are met. The lead colposcopist will be required to ensure that the defined quality assurance standards are being met. The agreed national minimum dataset and the required quarterly KC65 return should be collected.
• Ensuring that regular audit of the service takes place to compare practice with the local protocols and national targets.
• Liaising with those within the trust responsible for providing the facilities for the service to ensure that the service is adequately staffed by appropriately trained individuals (medical and non-medical) in order that the service needs can be met in a timely and consumer sensitive fashion.
• Coordinating training and liaising with the BSCCP Certification and Training Committee as appropriate.
• Facilitating the maintenance of continued certification of practising colposcopists within the unit.
• Informing those in the trust management about the need to ensure that procedures are in place to facilitate care and rapid communication with patients, other hospital departments, primary care agencies and cytopathology and histopathology services.
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• With the hospital based programme coordinator, convening regular multidisciplinary meetings, including cytology and histology services for case discussion and protocol review.
• Working with the hospital based programme coordinator to alert the PCT screening commissioner of any shortcomings of any aspect of the ability of the colposcopy services to respond to issues in primary care.
• Conducting regular dialogue with users, providers and purchasers of care to ensure that service and development are both appropriate and meet with the needs of the local population.
• BSCCP/RCOG certification• commitment to the colposcopy service and readiness to take responsibility for it • organisational skills• team management skills• training skills • information technology• data analysis• conducting research NHSCSP April 2004
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abnormal cervix 13 data collection 56 abnormal endocervical cytology 44 destructive treatment 26 abnormal results 11, 43 diagnosis failure 56 accuracy of diagnosis 26–7 diagnostic standards 24–8, 56–8 Actinomyces-like organisms 29 duration of follow-up 36–7 adenocarcinoma in situ 33 dyskaryosis 11–12, 39–41 Advisory Committee on Cervical Screening 3age at finishing screening 5–6 ectocervical lesions 32 age at starting screening 4–5 endocervical cell changes 11, 44 endometrial biopsy 52 anxiety, reduction of 17–19 endometrial cancer 50 ASCUS smear 11, 48 ethnic minority groups 17–18 atypical glandular cells of undetermined significance evidence based guidelines 1 bacterial vaginosis 30 facilities 16–17 borderline glandular samples 51 folate deficiency 47–8 borderline nuclear change 11 follow-up 36–41, 59–60 BSCCP Certification and Training Committee 21 follow-up after hysterectomy 37–8 BSCCP Completion of Training Certificate 21 follow-up cytology 37 BSCCP/RCOG Diploma in Colposcopy 21 frequency of follow-up 37frequency of screening 3–4 candidiasis 30certification 16 cervical adenocarcinoma 50 genitourinary medicine clinics 6–7, 13, 16, 29, 30 cervical glandular intraepithelial abnormalities 50 glandular abnormalities 50–4 cervical glandular intraepithelial neoplasia (cGIN) 33, glandular neoplasia 13, 50–1 Gonococcus 29 cervical intraepithelial neoplasia (CIN) 5, 8, 11, 31–5, good working practices 16–17 Guidelines for Clinical Practice and Programme cervical sampling 6–7 Chlamydia 29clinic facilities 18, 55 cold coagulation 31 Health Technology Assessment (HTA) programme 9 colposcopic examination 24 herpes simplex 30 colposcopic examination of glandular abnormalities 50 colposcopic examination in pregnancy 42–3 histology report 32 colposcopically directed biopsy 25–6 history taking 18 colposcopists, job description 63–4 colposcopy equipment 19 HIV positive women 48 colposcopy in pregnancy 42 hormone replacement therapy 43–4 communication with patients 17, 55 human papillomavirus 4, 9, 38–9 continued medical education 16, 21, 60 hysterectomy 2, 37–8, 44–5, 54 contraception 2, 43counselling 55 immunosuppression 2, 46–9 cryocautery 31, 31–2 immunosuppression medication 46–7 current screening method 8 inadequate samples 11 cytology 24, 44, 45 infections 29–30 cytotoxic drugs 47 information for patients 17, 55 NHSCSP April 2004
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International Agency for Research on Cancer 3 punch biopsy 25–6, 51 intrauterine contraceptive device 6, 29–30, 43invasive disease 24–5 quality assurance 16, 61–2 invitations for screening 3–4 KC65 return 16, 63 knife cone biopsy 31, 36 repeat excision 33reports 32, 50 large loop excision of the transformation zone 31, 36 rheumatological disorders 47 laser ablation 31 Royal College of Obstetricians and Gynaecologists 63 laser conisation 31liaison between units 20 screening for Chlamydia 29 liquid based cytology 8 screening, colposcopic 8–9 local destruction 25 screening intervals 3–4 local excision 33–4 screening in pregnancy 42see and treat policy 18, 32 maximum screening interval 3 severe dyskaryosis 12, 39 menopause 2, 43–4 squamous cell changes 11 staffing 16–17, 19–20, 56 microinvasive squamous cancer FIGO stage Ia1 33–4 standards for follow-up 36 mild dyskaryosis 11–12, 39–40 Standards and Quality in Colposcopy 1 moderate dyskaryosis 12, 38 symptomatic women 13 systemic lupus erythematosus 47 monitoring of screening interval 4multifocal disease 47 tamoxifen 47team meetings 17 National Institute for Clinical Excellence 8 National Quality Assurance Group in Colposcopy 63 treatment decisions 26 NHS Cervical Screening Programme 2, 8 treatment standards 31 NHSCSP Colposcopy Quality Assurance Group 61 Trial of Management of Borderline and Other Low non-attendance 20 grade Abnormal smears (TOMBOLA) 9 Trichomonas vaginalis 30 objectives 1oestrogen antagonists 47 unscheduled screening 6 oral contraceptive pill 43 untreated women 39–41 population screening 10 vaginal abnormalities 45 positive predictive value 13, 26, 27, 39, 40, 51 vaginal intraepithelial neoplasia (VaIN) 37, 38, 44, 45 possible invasion 13 vulval intraepithelial neoplasia (VIN) 47 postmenopausal bleeding 44 visitors to clinic 18–19 pregnant women 42–3previous treatment 14 primary care trusts 62 working practices for colposcopy units 61–2 NHSCSP April 2004

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