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Colposcopy and programme management guidelines
ARTICLE IN PRESS Current Obstetrics & Gynaecology (2005) 15, 139–141
www.elsevier.com/locate/curobgyn
Colposcopy and programme management guidelines Kay Welton, Mahmood I. Shafi Addenbrooke’s Hospital, P.O. Box 224, Hills Road, Cambridge CB2 2QQ, UK
KEYWORDS Colposcopy; Programme management; Cervical screening; Follow up
Summary The aim of this article is to promote awareness of the new, revised ‘Colposcopy and programme management guidelines, 2004’. In order to have a more effective, evidence based method of care, best practice standards and their implications are discussed. The principles applied will ensure that colposcopy clinics and Primary care will collaborate in applying practices that ensure women requiring referral to colposcopy will be managed appropriately and those without significant abnormality are returned to the community. & 2005 Elsevier Ltd. All rights reserved.
Introduction
Guideline development
The National Health Service (NHS) cervical screening programme, ‘Colposcopy and Programme Management Guidelines’, published in 2004, is a means of setting standards of care as a form of guidance for those working within the NHS. Significant changes are included from previous guidance. Overall, the aim of the new guidelines is to ensure that colposcopy clinics focus on those women with cancer precursors, and to return all others back to the community as soon as possible.
Previous publications (Standards for Quality in Colposcopy, 1996; Guidelines for Clinical Practice and Programme Management, 1997) have formed the basis for the development of these new guidelines. Following their amalgamation, a starting point for the new guidelines was developed in order to bring about the structure and content that is set out, allowing for omissions to be identified and duplications to be removed. Where possible, the guidelines are evidence based, and where this evidence was lacking, professional consensus was used. Contributions were commissioned from individuals or groups known to be active in the field of interest.
Corresponding author. Tel.: +44 1223 216603.
E-mail address: [email protected] (M.I. Shafi).
0957-5847/$ - see front matter & 2005 Elsevier Ltd. All rights reserved. doi:10.1016/j.curobgyn.2005.01.005
ARTICLE IN PRESS 140
K. Welton, M.I. Shafi
Standards are set out throughout the document. This will allow audit to take place linking good practice and evidence-based care. If health care is to be quality driven, resource implications are unavoidable and should be identified.
Relevant changes to practice A number of changes to practice are included. These include screening guidance, liquid-based cytology (LBC), unnecessary cervical smears, referral criteria and follow-up policies.
Frequency of screening The screening programme including LBC was the subject of a National Institute of Clinical Excellence (NICE) review published in 2003. Screening will commence from the age of 25 years, as cervical cancer below this age is extremely rare. The age change for first invitation to screening was taken from research evidence and experience having shown that screening women under the age of 25 years may potentially do more harm than good. Three-yearly screening will occur from 25 until 49 years of age. After this, a 5-yearly programme is suggested until screening ceases at 64 years of age. These changes will need to be monitored to make sure that the screening programme continues to have the desired effect of reducing the incidence of and mortality from cervical cancer, as well as limiting any harmful effects of screening. Table 1 shows the screening intervals for the national cervical screening programme.
Liquid-based cytology Smears have traditionally been performed as originally described by Papanicolaou in the mid1940s. The recent NICE recommendation is that LBC should be introduced throughout the UK. Using this technique, a cervical brush sample is suspended in buffer and processed as a thin layer without contamination with blood cells and debris. The major advantage is that the unsatisfactory smear Table 1
rate is reduced from the usual 9–10% for Pap smears to 1–2%. If required, reflex testing for human papillomavirus can occur without recourse to further samples. This may have a role in the triage of women with minor cervical cytological abnormalities. Arrangements to introduce LBC, through a roll-out programme, are being put in place by the NHS cervical screening programme. Nationally, this will take up to 5 years.
Unnecessary smears There is no justification for additional cervical screening in women based on social or behavioural risk factors, provided the woman is in the age group to be screened and has had a screening test within the previous 3–5 years. There is no available evidence to suggest that these factors reduce the length of the pre-clinical detectable phase of cervical neoplasia. Moreover, intensive screening of women with a history of multiple sexual partners and early onset of first intercourse is not effective. Cervical screening is not justified in the following circumstances:
on taking or starting to take an oral contraceptive, on insertion of an intra-uterine contraceptive device, on taking or starting to take hormone replacement therapy, in association with pregnancy—antenatally, postnatally or after termination unless a previous screening test was abnormal, in women with genital warts, in women with vaginal discharge, in women with infection, in women who have had multiple sexual partners, and in women who are heavy cigarette smokers.
Referral guidance A major change to the programme is the recommendation that women should be referred to colposcopy following one mildly dyskaryotic smear.
Screening intervals for national cervical screening programme.
Age group (years)
Frequency of screening
25 25–49 50–64 65+
First invitation Three yearly Five yearly Only screen those who have not been screened since 50 years of age or those who have had recent abnormal tests
ARTICLE IN PRESS Colposcopy and programme management guidelines This is deemed to be the best practice, although referral after two mildly abnormal smears is considered to be an acceptable practice. Early referral allows identification of those with potential significant cancer precursors requiring further investigation and treatment. Those without significant abnormality can be returned to the community as they are at low risk of progression to significant abnormality. Women with symptoms, i.e. post-coital bleeding in women over the age of 40 years, intermenstrual bleeding and persistent vaginal discharge, should be referred for gynaecological assessment and colposcopy where indicated. The majority of these women do not have a malignancy even though the symptoms are significant. Younger women with post-coital bleeding should be referred to a genito-urinary medicine clinic in order to exclude causes such as chlamydia.
Follow-up Following treatment for cervical intra-epithelial neoplasia (CIN), women remain at risk for recurrent disease for up to 10 years. Those following treatment for low-grade CIN are at much lower risk of recurrent disease. It is recommended that a
141 follow-up smear should be performed 6 and 12 months following treatment. If the lesion was lowgrade CIN, a further smear is performed at 24 months; if this is also normal, routine screening can be continued. In those where the lesion was highgrade CIN, annual cervical smear should be performed until the 10th anniversary of treatment. If the smears remain normal, the woman can return to routine screening. Women having had a hysterectomy with CIN present are at potential risk of developing vaginal intra-epithelial neoplasia and vaginal disease. Follow-up should consist of a vault smear at 6 and 18 months post surgery. If both tests are negative, no further follow-up is required. If there is incomplete or uncertain excision of CIN, follow-up should be conducted as if the cervix was still in situ.
Further reading 1. Luesley D, Leeson S. Colposcopy and programme management: guidelines for the NHS cervical screening programme. NHSCSP Publication 20. Sheffield: NHS; 2004. 2. National Institute for Clinical Excellence. Guidance on the use of liquid-based cytology for cervical screening. Technology Appraisal Guidance 69. National Institute for Clinical Excellence; 2003.
www.elsevier.com/locate/curobgyn
Colposcopy and programme management guidelines Kay Welton, Mahmood I. Shafi Addenbrooke’s Hospital, P.O. Box 224, Hills Road, Cambridge CB2 2QQ, UK
KEYWORDS Colposcopy; Programme management; Cervical screening; Follow up
Summary The aim of this article is to promote awareness of the new, revised ‘Colposcopy and programme management guidelines, 2004’. In order to have a more effective, evidence based method of care, best practice standards and their implications are discussed. The principles applied will ensure that colposcopy clinics and Primary care will collaborate in applying practices that ensure women requiring referral to colposcopy will be managed appropriately and those without significant abnormality are returned to the community. & 2005 Elsevier Ltd. All rights reserved.
Introduction
Guideline development
The National Health Service (NHS) cervical screening programme, ‘Colposcopy and Programme Management Guidelines’, published in 2004, is a means of setting standards of care as a form of guidance for those working within the NHS. Significant changes are included from previous guidance. Overall, the aim of the new guidelines is to ensure that colposcopy clinics focus on those women with cancer precursors, and to return all others back to the community as soon as possible.
Previous publications (Standards for Quality in Colposcopy, 1996; Guidelines for Clinical Practice and Programme Management, 1997) have formed the basis for the development of these new guidelines. Following their amalgamation, a starting point for the new guidelines was developed in order to bring about the structure and content that is set out, allowing for omissions to be identified and duplications to be removed. Where possible, the guidelines are evidence based, and where this evidence was lacking, professional consensus was used. Contributions were commissioned from individuals or groups known to be active in the field of interest.
Corresponding author. Tel.: +44 1223 216603.
E-mail address: [email protected] (M.I. Shafi).
0957-5847/$ - see front matter & 2005 Elsevier Ltd. All rights reserved. doi:10.1016/j.curobgyn.2005.01.005
ARTICLE IN PRESS 140
K. Welton, M.I. Shafi
Standards are set out throughout the document. This will allow audit to take place linking good practice and evidence-based care. If health care is to be quality driven, resource implications are unavoidable and should be identified.
Relevant changes to practice A number of changes to practice are included. These include screening guidance, liquid-based cytology (LBC), unnecessary cervical smears, referral criteria and follow-up policies.
Frequency of screening The screening programme including LBC was the subject of a National Institute of Clinical Excellence (NICE) review published in 2003. Screening will commence from the age of 25 years, as cervical cancer below this age is extremely rare. The age change for first invitation to screening was taken from research evidence and experience having shown that screening women under the age of 25 years may potentially do more harm than good. Three-yearly screening will occur from 25 until 49 years of age. After this, a 5-yearly programme is suggested until screening ceases at 64 years of age. These changes will need to be monitored to make sure that the screening programme continues to have the desired effect of reducing the incidence of and mortality from cervical cancer, as well as limiting any harmful effects of screening. Table 1 shows the screening intervals for the national cervical screening programme.
Liquid-based cytology Smears have traditionally been performed as originally described by Papanicolaou in the mid1940s. The recent NICE recommendation is that LBC should be introduced throughout the UK. Using this technique, a cervical brush sample is suspended in buffer and processed as a thin layer without contamination with blood cells and debris. The major advantage is that the unsatisfactory smear Table 1
rate is reduced from the usual 9–10% for Pap smears to 1–2%. If required, reflex testing for human papillomavirus can occur without recourse to further samples. This may have a role in the triage of women with minor cervical cytological abnormalities. Arrangements to introduce LBC, through a roll-out programme, are being put in place by the NHS cervical screening programme. Nationally, this will take up to 5 years.
Unnecessary smears There is no justification for additional cervical screening in women based on social or behavioural risk factors, provided the woman is in the age group to be screened and has had a screening test within the previous 3–5 years. There is no available evidence to suggest that these factors reduce the length of the pre-clinical detectable phase of cervical neoplasia. Moreover, intensive screening of women with a history of multiple sexual partners and early onset of first intercourse is not effective. Cervical screening is not justified in the following circumstances:
on taking or starting to take an oral contraceptive, on insertion of an intra-uterine contraceptive device, on taking or starting to take hormone replacement therapy, in association with pregnancy—antenatally, postnatally or after termination unless a previous screening test was abnormal, in women with genital warts, in women with vaginal discharge, in women with infection, in women who have had multiple sexual partners, and in women who are heavy cigarette smokers.
Referral guidance A major change to the programme is the recommendation that women should be referred to colposcopy following one mildly dyskaryotic smear.
Screening intervals for national cervical screening programme.
Age group (years)
Frequency of screening
25 25–49 50–64 65+
First invitation Three yearly Five yearly Only screen those who have not been screened since 50 years of age or those who have had recent abnormal tests
ARTICLE IN PRESS Colposcopy and programme management guidelines This is deemed to be the best practice, although referral after two mildly abnormal smears is considered to be an acceptable practice. Early referral allows identification of those with potential significant cancer precursors requiring further investigation and treatment. Those without significant abnormality can be returned to the community as they are at low risk of progression to significant abnormality. Women with symptoms, i.e. post-coital bleeding in women over the age of 40 years, intermenstrual bleeding and persistent vaginal discharge, should be referred for gynaecological assessment and colposcopy where indicated. The majority of these women do not have a malignancy even though the symptoms are significant. Younger women with post-coital bleeding should be referred to a genito-urinary medicine clinic in order to exclude causes such as chlamydia.
Follow-up Following treatment for cervical intra-epithelial neoplasia (CIN), women remain at risk for recurrent disease for up to 10 years. Those following treatment for low-grade CIN are at much lower risk of recurrent disease. It is recommended that a
141 follow-up smear should be performed 6 and 12 months following treatment. If the lesion was lowgrade CIN, a further smear is performed at 24 months; if this is also normal, routine screening can be continued. In those where the lesion was highgrade CIN, annual cervical smear should be performed until the 10th anniversary of treatment. If the smears remain normal, the woman can return to routine screening. Women having had a hysterectomy with CIN present are at potential risk of developing vaginal intra-epithelial neoplasia and vaginal disease. Follow-up should consist of a vault smear at 6 and 18 months post surgery. If both tests are negative, no further follow-up is required. If there is incomplete or uncertain excision of CIN, follow-up should be conducted as if the cervix was still in situ.
Further reading 1. Luesley D, Leeson S. Colposcopy and programme management: guidelines for the NHS cervical screening programme. NHSCSP Publication 20. Sheffield: NHS; 2004. 2. National Institute for Clinical Excellence. Guidance on the use of liquid-based cytology for cervical screening. Technology Appraisal Guidance 69. National Institute for Clinical Excellence; 2003.