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All district health authorities have recently introduced call and recall schemes for cervical cytology screening. Little attention has been given to the implications of these schemes for diagnostic colposcopy, and treatment services. This paper describes the steps necessary to estimate the likely increase in demand on these services.
The purpose of this study was to evaluate the clinical use of the Hybrid Capture (HC)-II system for the detection of human papillomavirus (HPV) DNA to identify women at risk of progression to high grade squamous intraepithelial lesions (HGSIL) and carcinomas by differentiating low risk (LR) HPV types (6, 11, 42, 43, 44) and high/intermediate risk (HR) HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68). Five hundred and ninety-six women were enrolled in the study. Among them, 466 attended the hospital for routine cytologic screening and 130 were referred for colposcopy because of an abnormal Pap smear. The presence of HPV DNA was tested in cervical samples collected with the Digene Cervical Sampler in Digene Specimen Transport Medium (Digene Corporation, Silver Spring, MD, U.S.A.) using the HC-II assay. Results were compared with those obtained by polymerase chain reaction (PCR) using the MY09-MY11 primers followed by several hybridizations with specific probes. The overall HPV positivity was 32.9% by HC-II and 37.8% by PCR. Among cytologically normal smears, 19.5% were positive by HC-II (14.3% HR) and 25.1% by PCR. Of the atypical squamous cells of undetermined significance samples, 52.9% were positive by HC-II (41.1% HR) and 55.9% by PCR. Of the low grade SIL, 64.5% were positive by HC-II (59.4% HR) and 68.7% by PCR. The HPV positivity rate was found identical by both techniques in high grade smears (81.6%) and squamous cervical carcinomas (100%). By using PCR as the reference method, the sensitivity of HC-II was higher among women with abnormal cytology than with normal cytology (87.3% vs. 70%). Specificity was 80.8% and 97.5%, respectively. In summary, these results indicate that the HC-II method and MY-PCR identified nearly equivalent prevalences of HPV in cervical smear specimens.
OBJECTIVE: To determine if sites selected for colposcopic biopsy and histologically proven cervical intraepithelial neoplasia are distributed randomly across the cervix. MATERIALS AND METHODS: Data were evaluated from all patients who visited the Walter Reed Army Medical Center Colposcopy Clinic during a 20-month period. chi analysis was performed to assess the randomness of distribution of biopsies and cervical intraepithelial neoplasia. RESULTS: In 303 patients, 479 biopsies were performed. The 11-, 12-, and 1-o'clock positions were selected for 190 of 479 (40%) of biopsies, whereas the 6- and 12-o'clock positions were chosen for 186 of 479 (39%) of biopsies (p < 0.0001). Of 479 specimens, 161 (34%) were diagnosed as low-grade and 57 (12%) were diagnosed as high-grade. The 6-, 11-, and 12-o'clock positions accounted for 32 of 57 (56%) high-grade biopsies (p < 0.0001). The 6- and 12-o'clock positions accounted for 61 of 161 (38%) low-grade biopsies (p < 0.0001). CONCLUSIONS: Loci selected for biopsy and histologically confirmed cervical intraepithelial neoplasia are not randomly distributed across the cervix. There is a predilection for the locations anterior and posterior to the cervical os.
OBJECTIVE: To determine whether the sensitivity of screening tests that miss small cervical intraepithelial neoplasia (CIN) 2 or worse (e.g., acetic acid-aided visual inspection) is inflated when the criterion standard (colposcopic-directed biopsy) misses the same small CIN 2 or worse. MATERIALS AND METHODS: One thousand nine hundred twenty-eight women were screened using acetic acid-aided visual inspection, self-tests, and direct tests for high-risk human papillomavirus, and using liquid-based cytologic screening. All women underwent colposcopy with biopsy. If a cervical quadrant had no lesion, a random biopsy at the squamocolumnar junction within that quadrant was obtained. All patients underwent endocervical curettage (ECC). Differences in sensitivity for CIN 2 or worse of screening tests were compared with criterion standards of colposcopically directed biopsy and colposcopically directed biopsy, random biopsy, plus ECC. RESULTS: Sixty-two of 83 women with CIN 2 or worse were diagnosed by colposcopically directed biopsy, 19 by random biopsy, and 2 solely by ECC. Fifty-six of the 83 women had CIN 2 or worse involving 0 to 2 quadrants (2 with 0 quadrants were diagnosed solely by positive ECC) and 27 of 83 had CIN 2 or worse results involving 3 to 4 quadrants. Colposcopically directed biopsy detected 35 of 56 women (62.5%) with CIN 2 or worse involving 0 to 2 cervical quadrants and 27 of 27 women (100%) with CIN 2 or worse involving 3 to 4 quadrants (p < .005). Acetic acid-aided visual inspection and cytologic analysis of high-grade squamous intraepithelial lesion or cancer detected 35 of 56 (62.5%) and 36 of 56 (64.3%) lesions involving 0 to 2 quadrants and 27 of 27 (100%) (p < .005) and 24 of 27 (88.9%; p < .05) lesions involving 3 to 4 quadrants. The sensitivity of direct human papillomavirus tests (97.6%) and cytologic analysis of atypical squamous cells of undetermined significance or worse (94.0%) for CIN 2 or worse were high and unaffected by lesion size. When the criterion standard was changed from colposcopically directed biopsy, random biopsy, plus ECC to colposcopically directed biopsy, the sensitivity of acetic acid-aided visual inspection and cytologic analysis of high-grade squamous intraepithelial lesion or worse for CIN 2 or worse increased from 75.9% to 85.5% (p > .1) and from 71.1% to 79.0% (p > .25). Sensitivities of other screening tests were unaffected by changing the criterion standard. CONCLUSIONS: Criterion standards that miss the same CIN 2 or worse as the screening tests likely cause inflation of the sensitivity of those tests.
Systematic observation of the gland(crypt) openings of the uterine cervix is essential to colposcopy.
OBJECTIVE: To describe knowledge of the cervical cancer prevention process among rural and urban women referred for evaluation of abnormal cytology. MATERIALS AND METHODS: Women with abnormal screening cervical cytology attending university colposcopy clinics (n = 178) were asked about demographic factors and knowledge of Pap testing, human papillomavirus (HPV) infection, and risk factors for cervical cancer. Responses were tabulated, and correlations assessed. RESULTS: Only 131 (74%) of 176 responding women understood that Pap tests evaluate the cervix, whereas 137 (78%) understood that Pap tests should be repeated at intervals of 1-3 years. The cancer screening function of a Pap test was identified by 122/177 (69%), but only 99 (56%) knew HPV is sexually transmitted and causes warts and premalignant changes. Rural residence was not associated with knowledge, but older women were more likely to know the nature of the Pap test (p =.005) and the meaning of an abnormal Pap test (p = .04). Women in higher income strata were more likely to understand the meaning of an abnormal Pap test (p = .03), the nature of HPV (p = .005), and risk factors for cervical cancer (p = .03). College graduates were better (p = .0005), and women of greater parity were less (p = .02) able than others to identify the nature of HPV, although neither differed from others in ability to answer other questions correctly (p > .1). CONCLUSIONS: Income and education are better predictors of knowledge of the cervical cancer prevention process than rural residence. Higher rates of cervical cancer in rural areas may reflect lower educational attainment and lower income.
OBJECTIVE: It was hypothesized that music or guided imagery versus usual care would result in less anxiety and perceived pain for colposcopy patients. MATERIALS AND METHODS: Patients were randomized to music, guided imagery, or usual care after completing a baseline questionnaire. All patients completed a postprocedure questionnaire. RESULTS: Study participants (N=170) had a mean age of 28.4 years (SD=9.6; range 18-60) and formed a racially diverse group. Education/income levels were low. No between-group differences were found for postprocedure anxiety or pain rating. CONCLUSIONS: Mind-body interventions had no statistically significant impact on reported anxiety, perceived pain, or satisfaction with care, even for those who anticipated the most pain or started with high anxiety.
The quantitative measurement of areas on the cervix is of interest to researchers studying the natural history of human papilloma viral lesions. Measurement of areas from images obtained through a colposcope are, however, inherently in error due to the image being a two-dimensional projection of a three-dimensional object. The ability to correct for these errors through use of digital imaging colposcopy and a practical application of a shape from shading algorithm was developed in this study. The shape from shading technique requires empirical measurement of the relationship between observed light intensity and the viewing angle (referred to as a reflection map). It was found that a population mean reflection map provided a correction that was about as accurate as using an individual's own reflection map (making it unnecessary to measure a map for each exam). Digital red filtering of the images increased accuracy and precision of measurement.
We present 2 years data on direct booking in our colposcopy clinic. The new booking system has improved our efficiency and helped us to achieve the national quality standards on clinic waiting time. The non-attendance (DNA) rate has also improved.
This is retrospective cohort study of women who were recommended for further assessment or treatment after their first visit to a gynaecologist for an abnormal Pap smear. The sample included women who first attended a private outpatient colposcopy service in Canberra between 1 January 1989 and 30 April 1990. Only women who had never previously seen a gynaecologist for an abnormal Pap smear were included in the sample. The nonattendance rate was 2.2 women per 100 women-months (n = 493). Cox proportional hazards modelling was used to examine the relationships between sociodemographic and clinic variables and nonattendance. After adjusting for age and the degree of abnormality on presenting smear, women without private health insurance and women who had had treatment were less likely to continue attending. The current focus on identifying barriers to screening services needs to be broadened to consider attendance at all points along the screening pathway.
A group of 118 women underwent laser cone biopsy. Data were collected routinely on proforma case notes and entered into a computerized database. The histology of the cone biopsies was compared with that of previous, colposcopically directed punch biopsies, with the cytology of smears taken in the clinic and with the colposcopic diagnosis. The punch biopsy had a 54% false negative rate and neither of the two microinvasive carcinomas biopsied in this way were detected by the biopsy. Ten of 24 women with negative punch biopsies had CIN III in the cone. When the punch biopsy showed CIN II or worse, the cone biopsy confirmed the presence of CIN in 86%. There was some evidence of false negative cone biopsies. The data suggest that management should not be based solely upon the punch biopsy result but should include consideration of the cytology and colposcopy findings. Excisional methods of treatment are more likely to reveal early invasion and adenocarcinoma-in-situ.
The first phase of a paperless computer record has been developed at Hammersmith Hospital. The system was designed around the work practices of the clinic staff. In this phase the data are collected on forms which replace the normal case notes. This information is entered onto an IBM compatible computer by the secretary using a quick, user-friendly program written in a dBASE dialect and compiled with Quicksilver. The program produces letters to patients and their doctors and a printed record of the clinic findings for the case sheet to replace the handwritten form. When funding for hardware becomes available the data will be entered directly into the system by the medical staff in the clinic. Clinic appointment lists are maintained and patients "lost to follow-up' can be identified. Ad hoc enquiries can be made using dBASE III Plus or any similar program. This approach has integrated the computerized recording of data in a colposcopy clinic with the normal work of the staff involved so that no extra effort is required from medical or secretarial staff. The immediate accessibility of patient data and the ability to audit the work of the clinic have been particularly useful.
OBJECTIVE: To study the significance of the presence of high risk human papillomavirus (HPV) in women with initially normal cervical cytology for the development of abnormal cytology and an abnormal colposcopic impression. DESIGN: Prospective, observational study PARTICIPANTS AND METHODS: Sixty-eight women with cytomorphologically normal smears and at least one positive HPV test result were evaluated every six months by cytology, colposcopy and HPV testing. The endpoint of the study was abnormal cervical cytology. RESULTS: The median time of follow up from the first positive HPV test was 34 months. A total of 17 women developed abnormal cytology, of whom 16 (94%) had persistence of a high risk HPV infection. Women with persistent high risk HPV were more likely to develop abnormal cervical cytology than women without high risk HPV (hazard ratio 28.2, 95% CI 3.72-215.2); they also had an increased risk of developing an abnormal colposcopic impression (hazard ratio 4.4, 95% CI 1.69-11.7). Among the 17 women with abnormal cytology, high grade dysplasia was histopathologically demonstrated in eight women. CONCLUSION: Persistent presence of high risk HPV in normal cervical smears is associated with a significantly increased risk of developing abnormal cytology and to a lesser degree with developing an abnormal colposcopic impression.
We evaluated the effectiveness of local anaesthetic spray prior to injection of local anaesthetic before biopsy or large loop excision of the transformation zone of the cervix at colposcopy. This was a prospective, randomised, double-blind placebo-controlled study involving 51 women. Pain or discomfort was measured using a four-point categorical scale and a visual analogue score. Our results show that the use of local anaesthetic spray has no effect on the pain or discomfort experienced by patients having local anaesthetic injections to the cervix, and cannot be recommended.
An analysis of a group of predominantly Caucasian women with cervical intraepithelial neoplasia grade 3 lesions seen at the Dunedin Hospital Colposcopy Clinic during a period when it was the only colposcopic service in the region, showed that patients in the lowest socioeconomic class, as judged by two parameters unique in New Zealand were overrepresented. This finding is in agreement with the social class gradient for cervical cancer and precursor lesions observed in other countries. Poverty, more liberal sexual activity and smoking may be factors in the genesis of cervical neoplasia amongst the women studied. In providing cervical smear facilities for at-risk women, special provision should be made for women in the lowest social stratum.
This study validated a self-reported smoking prevalence questionnaire against urinary cotinine levels among women referred to a Sydney based public hospital colposcopy clinic over the period November 1997 to June 1998. Of 213 eligible women, 160 (75%) agreed to participate. Of these, 151 (94%) completed the smoking prevalence item and 130 (86%) also provided a urine specimen. 40% (95% CI: 33%-49%) of respondents self-reported as current smokers. Observed agreement between self-reported and biochemically validated smoking status was 94% compared with 52% chance agreement (kappa = 0.87, p<0.001). This high level of agreement was also robust to sensitivity analyses using a more conservative cutoff for the urinary cotinine levels. We conclude that self-reported smoking status provides valid estimates of actual rates of smoking among women referred with abnormal cervical smears.
AIM: To determine whether there is any benefit in repeating the Pap smear at the time of colposcopy in women referred to a teaching hospital dysplasia clinic. METHODS: Analysis of a computerised database, and review of literature. RESULTS: Repeating the Pap smear potentially changed management in 2% of women referred with low-grade lesions, and in 7% of those with high-grade lesions. CONCLUSION: Although the literature suggests that the repeat smear may directly affect the quality of the colposcopic examination, repeating the smear in women referred with high-grade squamous intraepithelial (HSIL) smears may be beneficial.
AIMS: To determine whether the detection of high risk human papillomavirus (HPV) types is more predictive for high grade CIN than the current cervical smear test, and whether the production and measurement of HPV type 16 (HPV-16) and cellular survivin and telomerase transcripts can be used to discriminate between cervical HPV infections that self cure and those that induce high grade lesions. METHODS: Three hundred and fifty four cervical smear samples from women attending the colposcopy clinic were tested by the polymerase chain reaction (PCR) for the presence of HPV. Transcripts for HPV-16 E6, E6*I, E6*II, E7, and L1 as well as cellular survivin, telomerase RNA component, and telomerase reverse transcriptase were measured using fluorogenic probe (Taqman) assays. RESULTS: Referral smear grades of severe or moderate showed greater positive predictive values for CIN 2/3 than did the detection of high or moderate risk HPV types. HPV-16 transcripts from E6, E6*I, E6*II, and E7 showed high predictive values for CIN 2/3, but low sensitivity. The telomerase RNA component was detected in 53 of 57 samples and telomerase reverse transcriptase was only detected in one sample, whereas survivin transcripts were detected in 40% of samples. CONCLUSIONS: The detection of HPV-16 or cellular survivin or telomerase transcripts did not accurately predict the grade of CIN in the samples. The detection of HPV risk types correlated well with the grade of CIN; however, the referral grade smear was the most accurate predictor of the severity of the lesion. Of the 35 different HPV types detected, 18 are not included in the HPV hybrid capture II commercial test kit. The use of such kits would have missed HPV infection in 4.3% of clinic patients with CIN 2/3 lesions and 15.4% with CIN 0/1.