Technical Guidelines on Unaided Visual Inspection of the Cervix
"Clinical Downstaging"
Saloney Nazeer
WHO Collaborating Centre in Education and Research in Human Reproduction
DEFINITION:
Downstaging for cervical cancer is defined as "the detection of the disease in an earlier, curable stage, in asymptomatic women, using a simple speculum for visual examination of the cervix".
HISTORICAL BACKGROUND:
This strategy was proposed by WHO in 1985, as an alternative approach in the developing countries where a meaningful coverage of all at risk women by cervical cytology would not be possible for decades to come.
It is important to recognise that earlier detection of cancer of the cervix was achieved in a number of developed countries prior to the introduction of cervical cytology screening. The evidence for this is indirect, but relates to data on downstaging of cancer of the cervix and reduction in mortality from the disease, from the historical records in Sweden and Canada. This downstaging arose not from a deliberate policy, but from programmes of public and professional education which made women and their health care providers aware of the symptoms and signs of the disease and its potential curability if detected early. These programmes therefore appeared to be successful of themselves, while also preparing the population for the successful introduction and acceptance of cervical cytology screening.
RATIONALE FOR CLINICAL DOWNSTAGING OF CANCER OF THE CERVIX:
Organised cytology screening is the mainstay of early detection of cervical cancer. Unfortunately in developing countries, where the load of the disease is heavy and the populations are virtually unscreened, nation-wide cytology screening programmes are not possible in fore-seeable future because of paucity of economic and manpower resources.
At present, in the developing countries, 80-85% of women with cervical cancer present to the treatment centres at advanced stages, when treatment no matter how sophisticated, fails to improve survival time. The objective of the "downstaging" approach is to improve the stage distribution of cervical cancer at the time of diagnosis with the aim of improving prognosis. Several pilot studies have proven that upto 50-70% of cases of cervical cancer can be detected on visual examination, not only overt cases but also some cases of CIN.
Though visual screening is a sub-optimal approach in comparison to the cytological screening, it is relevant in areas where there is a heavy load of prevalent cancer and screening by cytology is not yet feasible but adequate treatment facilities are available. Such a strategy is not expected to decrease the incidence of invasive cancer, but would decrease morbidity and mortality from the disease through early detection.
APPROACH TO CLINICAL DIAGNOSIS:
Approaches to visual screening currently being evaluated include;
1. Unaided visual inspection of the cervix, referred to as "Downstaging" by WHO. It involves looking at the cervix during a speculum examination to detect early stage cancer.
2. Unaided visual inspection of the acetic acid treated cervix:
Visual inspection of cervix treated with 3-5% acetic acid could serve as a "helpful supplement" in aiming to detect CIN.
3. Aided visual inspection of the acetic acid treated cervix:
This approach involves the use of a small, lightweight, low-powered (2-4X), monocular telescope to view acetic acid treated tissues. This technique is currently being evaluated in several Asian countries, but its sensitivity, specificity and any advantage that it confers in comparison with unaided visual inspection is yet to be determined.
4. Speculoscopy:
In this method an additional fluorescent light source aids in the detection of white lesions in acetic acid treated cervix. Information regarding its efficacy as a screening tool is limited.
5. Cervicography:
Cervicography involves the inspection, by trained personnel, of photographs of the cervix taken at the time of speculum examination. Its sensitivity and specificity in comparison with cervical cytology has not been established. Special cameras are required and special readers have to be available to assess the photographs.
HEALTH EDUCATION:
Health education is a pre-requisite of any screening programme. Adequate programmes of public and professional education to make them aware of the symptoms and signs of the disease and of its potential curability if detected early, should be organised to accompany, and preferably precede, introduction of the screening programme. This will encourage the women to willingly (voluntarily) join the screening programme, which will go a long way in improving patient compliance. On the other hand the health personnel involved should possess adequate knowledge about the disease to be able to anticipate a woman's worries and questions and be prepared to deal with them in a professional and reassuring manner.
WOMEN TO BE SCREENED:
As for cervical cytological screening, it is important that the age groups examined are those where the incidence of cervical cancer is high. The maximum age range can be considered to be 30-35 years and above.
PERSONNEL NEEDED FOR THE EXAMINATION:
Female primary health care workers should be employed to do the clinical examination. These health workers should be trained for a period of at least one-week, in the gynaecology department of a district hospital, on how to perform a speculum examination of the cervix. By the end of the training they should be well acquainted with the symptoms and signs of the disease and be able to distinguish a clinically normal cervix from a cervix with simple erosion or one with a suspected invasive cancer. They should also be trained on how to take a specimen for culture and a cervical smear for diagnostic purposes. During the training an adequate exposure of the health worker to women with clinically normal and abnormal findings will have to be ensured by the training gynaecologist. Some primary health care workers may already have performed speculum examinations of the cervix as part of family planning programme, however, such workers should still be specially trained to recognise the signs of invasive cervical cancer.
EQUIPMENT REQUIRED:
Visual examination should be preferably performed at the primary health clinics but if need be can be done at woman's residence, provided adequate facilities are available.
- Examination table, preferably with stirrups.
- Sterile speculae, preferably Cusco's.
- Sterile rubber gloves
- Source of light, a lamp or a torch.
- Stationary.
THE EXAMINATION:
- The procedure and the reason for it should be carefully explained to the woman to be examined and she should be made as comfortable as possible.
- Privacy of the patient is important female relative or friend maybe of assistance in providing reassurance. Good visualisation of the cervix is essential, therefore adequate light is important.
- Speculum should be lubricated with warm water only, prior to insertion.
- Woman should not be using any intravaginal medication at the time of the examination.
- The examination should not be performed during menstrual period.
REPORTING VISUAL INSPECTION FINDINGS:
Objective of the visual examination is solely, to be able to recognise clinically normal from abnormal cervix and refer abnormal looking cases for further evaluation and diagnosis.
All findings should be carefully recorded in the provided printed forms (see fig.1 for reference)
The gross appearance of the cervix should be classified into;
- Normal
- Abnormal
- Suspicious of Malignancy
NORMAL CERVIX:
A normal cervix appears smooth, round, pink, lubricated with clear mucoid secretion and has a central hole the 'external os'. The shape of the external os varies with parity, being round in a nulliparous woman and slit like or cruciate in a multipara. Cervix in postmenopausal women appears atrophic.
ABNORMAL CERVIX:
This category will include all benign looking lesions, such as;
- Hypertrophy
- Redness or Congestion
- Irregular surface
- Distortion
- Simple erosions (that do not bleed on touch)
- Cervical polyps (with smooth surface)
- Abnormal discharge (foul smelling, dirty/greenish, white/cheesy, blood stained)
- Nabothian follicles
- Prolapsed uterus
These appearances usually accompany following clinical conditions;
- Infections
- Ectopy (Erythroplasias)
- Benign tumours
SUSPICIOUS OF MALIGNANCY:
Malignancy should be suspected when there is;
- An erosion that bleeds on touch
- A growth with an irregular surface
Both of these lesions may be friable and bleed on touch or may be accompanied with an offensive discharge.
FREQUENCY OF EXAMINATION:
For clinical diagnosis there are no data as yet to suggest an appropriate frequency of screening, though different intervals selected according to available resources in different projects may eventually provide guidance. Every two or three year planned examinations would be appropriate in the absence of an abnormality. The women should be advised to return to the clinic if symptoms develop between scheduled examinations.
REFERRAL PROTOCOL:
- A woman with normal findings should be called back for a repeat examination after 2 or 3 years, according to the decided policy.
- For women with abnormal findings but not suspected to have cervical cancer, a number of clinical conditions may be relevant, including infections. If necessary facilities are available a swab should be taken for culture at the time of examination and sent to the laboratory. The patient should be referred to the Primary Health Clinic for further evaluation and treatment by the physician.
- Women suspected to have malignant lesions should be directly referred to the oncology centre for further assessment.
ASSESSMENT AND EVALUATION OF THE PROGRAMME:
In areas where downstaging programmes have been initiated every measure should be taken to assess the efficiency of the staff and evaluate effectiveness of the approach.
The staff of the gynaecology department at the oncology referral centre should make field visits to randomly examine the women already been examined by the Primary Health Care workers to assess false positive and false negative rates of visual inspection. Furthermore, the field staff should be given refresher course when and where possible.
With regards to the evaluation of effectiveness of the programme, it is important to remember that the programme should not be expected to have immediate impact on improving the stage distribution of cases in an area but only after it has been in operation for several years will it be possible to judge its effectiveness.
Thus it is advisable to base evaluation of the programme on the following measures:
SHORT TERM MEASURES:
- Change in background knowledge of the target population. Two random sampling surveys should be performed. The first prior to the introduction of the health education campaign and the second, one year after the campaign has been completed.
- Proportion of women in the target population screened. For this (as well as some of the other evaluation measures) it will be necessary to procure accurate estimates of the numbers of women in the target population.
- Proportion of women screened found to be abnormal.
- Proportion of women screened abnormal who attend for diagnosis and therapy.
- Utilisation of treatment services and proportion of cases treated by surgery, radiotherapy and palliative care. It is to be expected that the proportion of cases that can only be treated by palliative care will diminish with time, and thus this can also be regarded as an additional long-term evaluation measure.
- Rates of detection of CIN (by degree) and invasive cancer.
- Determination of the economic costs of the programme.
LONG TERM MEASURES:
- Change in stage distribution of invasive cancers. It is unlikely that a stage shift indicative of true effectiveness would be seen in less than three years and possibly would not be seen for five or more. Screening can be expected to bring to light disease that is detectable, but which has not yet been recognised because the symptoms are not intrusive this will increase the apparent incidence in the areas and indeed the stage distribution may shift as such disease is likely to have a better prognosis than disease that presents between screens or that with more severe symptoms.
- Change in rate of advanced disease. This, if calculated on an annual basis, should begin to fall with effective programmes after about three to four years, if not before, for a highly effective programme with rapid and almost complete screening of the target population.
- Change in mortality from the disease. With an effective programme, mortality from the disease will fall. This effect should be detectable within one or two years of a significant reduction in the rate of advanced disease.
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VISUAL EXAMINATION REPORTING FORM PATIENT'S PROFILE Name Last : First : Middle : Age : Address : Date of marriage : No. of children : Menstrual cycles : REG : IRREG : Intermenstrual bleeding : YES : NO : Contact bleeding : YES NO : Pregnant : YES : NO : Last menstrual period : Contraceptives : YES : NO : If yes, specify : Cytological examination : YES : NO : If yes, Date : Result : HUSBAND'S MEDICAL HISTORY : (If ever been treated for STD) PER-SPECULUM EXAMINATION OF THE CERVIX : Discharge : Normal : Bloody : Dirty / greenish : Foul smelling : White / cheesy : Appearance of cervix :
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