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Collection devices for obtaining cervical cytology samples.

OBJECTIVES: The false-negative rate of cervical smears varies between 1.5% and 55%. This variation may be partly due to differences in sampling device and technique. The objective of this review was to assess different cervical sampling devices for collecting endocervical cells, which are thought to be a surrogate for detection of abnormal cells and adequate smear rates. SEARCH STRATEGY: We searched the Cochrane Gynaecological Cancer Group trials register and MEDLINE up to July 1997. We also handsearched 16 journals. SELECTION CRITERIA: Randomised and quasi-randomised trials and non-randomised comparative studies comparing cervical smear collection devices in women attending for primary screening, colposcopy following an abnormal smear or colposcopy after treatment. DATA COLLECTION AND ANALYSIS: Two reviewers independently abstracted data. Study quality was assessed. MAIN RESULTS: Thirty-four trials and six observational comparative studies were included. The Ayre spatula was shown to be less effective compared with extended tip spatulas for collecting endocervical cells in eight trials (odds ratio 2.25, 95% confidence interval 2.06 to 2.44). Use of a spatula with the cytobrush was more effective than spatula alone at collecting endocervical cells (odds ratio 3.33, 95% 3.05 to 3.63) and the same effect was present for adequate smear rates (odds ratio 1.51 95% 1.19-1.92). Extended tip spatulas were also superior for the detection of dyskaryosis in seven trials (odds ratio 1.21, 95% confidence interval 1.10 to 1.33). Based on data from two trials and three observational studies, smears that contained endocervical cells were more likely to detect dyskaryosis, particularly in severe disease. The proportion of smears with endocervical cells present increased with increasing severity of the disease. REVIEWER'S CONCLUSIONS: Extended tip spatulas of various designs appear to be better for collecting endocervical cells than the commonly used Ayre spatula. The most effective combination appears to be the cytobrush with an extended tip spatula. The rate of detection of endocervical cells appears to be a valid and convenient surrogate for the ability to detect dyskaryosis and for adequate smear rates. The ability of the extended tip spatula with the cytobrush compared with the extended tip spatula alone to detect disease, needs to be evaluated in a trial.

Female↗

Loop electrosurgical excision procedure for squamous intraepithelial lesions of the cervix: advantages and potential pitfalls.

OBJECTIVE: to evaluate the advantages and pitfalls of the loop electrosurgical excision procedure as applied to the diagnosis and treatment of cervical cancer precursors. METHODS: Loop electrosurgical excision procedure using local anesthesia and colposcopic guidance was performed in an outpatient clinical setting in 1189 consecutive patients referred for colposcopy for an abnormal Papanicolaou smear during a period of 4 years. RESULTS: Of the 1189 patients, 915 (77%) were managed in one sitting with the "see and treat" approach, and in 274 patients endocervical curettage and cervical biopsies preceded loop electrosurgical excision procedure. One hundred nineteen (10%) patients were lost to follow-up. Twenty-one patients had either adenocarcinoma in situ (15) or microinvasive squamous cell carcinoma (six) in the loop electrosurgical excision procedure specimen, whereas the electroexcised specimens contained no lesional tissue in 166 (14%) patients. Cure (ie, disease-free at 6 months or longer) was observed in 92% of the 883 evaluable patients after a single treatment and 95% after a repeat loop electrosurgical excision procedure. High-grade squamous intraepithelial lesion was successfully treated with loop electrosurgical excision procedure in 287 (93%) of 309 patients. Complications, mainly intra- and postoperative bleeding, occurred in 7% of the patients. In most loop electrosurgical excision procedure-negative cases, the referral cytologic diagnosis or colposcopy and/or history were false-positive on review, or the biopsies performed before loop electrosurgical excision procedure removed smaller areas of abnormal tissue. CONCLUSION: Loop electrosurgical excision procedure using the see and treat approach should be limited to cytologically and colposcopically unequivocal intraepithelial lesions, and depth of excision should be controlled by colposcopy using loop electrodes of appropriate size. In doubtful cases, particularly in the young patient, disease should be ascertained by expert histology and colposcopy before definite therapy. Loop electroexcision represents an attractive means of diagnosing and treating cervical cancer precursors.

Adenocarcinoma↗

Performance of the Roche AMPLICOR human papillomavirus (HPV) test in prediction of cervical intraepithelial neoplasia (CIN) in women with abnormal PAP smear.

OBJECTIVES: To assess the performance of a novel PCR-based assay (Roche AMPLICOR HPV test) in detection of cervical pathology as a part of management for abnormal PAP smear (MAPS) and in women participating in cervical cancer screening. STUDY DESIGN: Altogether, 504 women comprising 270 patients referred for colposcopy due to an abnormal Pap smear and another 234 women participating in cervical cancer screening (tested for comparison) were analyzed for oncogenic (HR) Human papillomavirus (HPV) types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 using the Roche AMPLICOR HPV test in cervical samples collected in PreservCyt liquid media. Colposcopic biopsy and/or LEEP cone biopsy was used as the gold standard in the triage group, while liquid-based cytology (LBC) was the reference test in the screening group. RESULTS: The prevalence of HPV was significantly higher in the MAPS group (65.9%) than in the screening group (31.2%) (P = 0.0001). There was a poor concordance between the referral PAP and the current LBC, being only moderate in the screening series, ICC (weighted kappa) = 0.291 (95%CI 0.070-0.459) (P = 0.007), and almost poor in the MAPS Series, with ICC = 0.217 (95%CI 0.04-0.384) (P = 0.023). AMPLICOR HPV positivity increased linearly with the increasing grade of cervical lesions. In detecting high-grade (CIN2-3), colposcopy was the most sensitive test (96.5%), very similar to AMPLICOR (95.2%) (P = 0.731), while LBC with HSIL cutoff was by far the most specific test (99.5%) and showed the highest PPV (96.1%). NPV of colposcopy (97.2%) and AMPLICOR (96.7%) were similar (P = 0.839). Together with abnormal colposcopy and HSIL cytology, the AMPLICOR HPV test is a powerful independent predictor of high-grade CIN2-3, and as such suitable to replace cervical cytology in management of women with abnormal PAP test (MAPS). CONCLUSIONS: The Roche AMPLICOR HPV test is comparable to other HPV tests (HCII, PCR) in detecting CIN in MAPS. However, more data are clearly needed on the performance of AMPLICOR test in management of abnormal PAP and particularly as a screening tool.

Adolescent↗

Screening for squamous intraepithelial lesions with fluorescence spectroscopy.

OBJECTIVE: To evaluate the accuracy of fluorescence spectroscopy in screening for squamous intraepithelial lesions (SILs) and to compare its performance with that of Papanicolaou smear screening, colposcopy, cervicoscopy, cervicography, and human papillomavirus (HPV) testing. DATA SOURCES: Receiver operating characteristic (ROC) curve analysis was used to analyze performance by fluorescence spectroscopy (primary data) and other methods (secondary data). METHODS OF STUDY SELECTION: In our search, 275 articles were identified in MEDLINE (1966-1996). Articles were included if the investigators had studied a population in whom low disease prevalence was expected; used either Papanicolaou smear screening and colposcopy or colposcopically directed biopsy as a standard against which the screening technique was measured, and included enough data for recalculation of reported sensitivities and specificities. TABULATION, INTEGRATION, AND RESULTS: Receiver operating characteristic curves for fluorescence spectroscopy were calculated using a Bayesian algorithm, and ROC curves for the other screening methods were constructed using metaanalytic techniques. Areas under the ROC curves and Q points were calculated. Screening colposcopy had the highest area under the curve (0.95), followed by screening cervicography (0.90), HPV testing (0.88), cervicoscopy (0.85), fluorescence spectroscopy (0.76), and Papanicolaou smear screening (0.70). CONCLUSION: In terms of screening for SILs, fluorescence spectroscopy performed better than the standard technique, Papanicolaou smear screening, and less well than screening colposcopy, cervicography, HPV testing, and cervicoscopy. The promise of this research technique warrants further investigation.

Female↗

Comparison of HPV-based assays with Papanicolaou smears for cervical cancer screening in Morelos State, Mexico.

OBJECTIVE: To compare the performance of human papillomavirus (HPV) assays with conventional Pap cytology for cervical cancer (CC) screening in Mexico. METHODS: Pap smears, self-collected vaginal specimens (SS) for HPV testing, and clinician-collected cervical specimens (CS) for HPV testing were obtained from 7868 women, aged 15-85 years old, attending CC screening at the Mexican Institute of Social Security (IMSS) between May and October, 1999. SS and CS specimens were screened for oncogenic HPV DNA by Hybrid Capture 2. Women who received cytological interpretations of atypical squamous cells of undetermined significance (ASCUS), and/or a positive HPV test were referred for colposcopy and histologic studies. The relative estimates for sensitivity, specificity and predictive values of each test were calculated using histological diagnoses of cervical intraepithelial neoplasia (CIN) grades 2 or 3, or CC histological diagnosis. RESULTS: Oncogenic HPV detection rate was 11.6% for SS, and 9.3% for CS. Pap smear abnormalities were observed in 2.4% of the women. Of 1147 women who had at least one abnormal test result, 88.5% underwent colposcopy, and 101 biopsy-confirmed CIN2/3 or cancer cases were identified. The relative sensitivity estimates for the Pap test, SS and CS were 59.4% (95% CI: 49.2-68.9), 71.3% (95% CI: 61.3-79.6), and 93.1% (95% CI: 85.8-96.9), respectively, while the specificities were 98.3% (95% CI: 98.0-98.6), 89.2% (95% CI: 88.5-89.9), and 91.8% (95% CI: 91.2-92.4), respectively. The positive predictive values of Pap, SS and CS were 36.1, 9.1 and 14.9, the colposcopy referrals needed to detect a case of CIN2/3 or cancer were 2.8, 11.0 and 6.7, respectively. DISCUSSION: Both HPV assays detected more cases of CIN2/3 or CC than Pap cytology alone. However, the HPV assays increased the number of colposcopy referrals. Our study suggests that HPV testing could be an effective way to improve the performance of CC screening.

Adolescent↗

Use of semi-quantitative PCR for human papillomavirus DNA type 16 to identify women with high grade cervical disease in a population presenting with a mildly dyskaryotic smear report.

The aim of this study was to assess whether qualitative or semi-quantitative detection of human papillomavirus type 16 (HPV 16) can help to identify women with major grade cervical intraepithelial neoplasia (CIN 2 and CIN 3) among those referred with a smear suggesting mild dyskaryosis. The study population consisted of 200 women sequentially attending the Royal Free Hospital colposcopy clinic. All women were investigated by cytology, colposcopy and, where appropriate, histopathology, and HPV 16 DNA was detected in cervical scrape samples using the polymerase chain reaction (PCR). A final clinical diagnosis of normal, wart virus infected (WVI), CIN 1, CIN 2 or CIN 3 was made in 179 women. On the basis of the qualitative PCR data, the presence of HPV 16 DNA was of borderline use in identifying women with high grade cervical disease [63/113 (normal/WVI/CIN 1) vs 46/66 (CIN 2/CIN 3); P = 0.065]. However, semi-quantitative PCR analysis showed that a high/medium HPV 16 result was significantly associated with high-grade disease [29/113 (normal/WVI/CIN 1) vs 38/66 (CIN 2/CIN 3); P = 0.0001]. Furthermore, semi-quantitative PCR and cytology were performed on the repeat smear taken immediately prior to colposcopy. The combined laboratory results show that 53/60 women with biopsy proven high-grade disease were identified, as were 26/95 women who were either normal or who had low grade cervical disease. The possibility of using such an approach for selecting women for more rapid or for routine colposcopy appointments in the two groups respectively is discussed.

Adult↗

Management of the minimally abnormal papanicolaou smear in pregnancy.

OBJECTIVE: To evaluate the effectiveness of colposcopy of the uterine cervix in pregnant patients with minimally abnormal Papanicolaou smears. METHODS: Two hundred, indigent, pregnant patients with atypical cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LGSIL) on Papanicolaou smear underwent colposcopy and endocervical evaluation. Directed biopsies were performed on 64 patients. One hundred thirty-five patients were compliant with postpartum Papanicolaou smears or colposcopy with endocervical evaluation. RESULTS: One hundred eighty-seven pregnant patients had satisfactory prenatal Papanicolaou smears, colposcopy and endocervical brushings. High-grade intraepithelial lesions were found in 2.1% of prenatal endocervical brushings, 4.7% of prenatal biopsies, 0.8% of postpartum Papanicolaou smears, 2.2% of postpartum endocervical brushings, and 7.9% of postpartum biopsies. No invasive cervical cancer was detected. CONCLUSION: Antepartum colposcopic evaluation did not add in the management of minimally abnormal Papnicolaou smears in this population of pregnant women.

Journal Article↗

Screening for cervical cancer in HIV-infected women receiving care in the United States.

OBJECTIVE: We examined the sociodemographic, clinical and provider factors associated with screening for cervical cancer among HIV-infected women. METHODS: We studied a national sample representing 43,490 women receiving treatment of HIV infection who completed first follow-up surveys of the HIV Cost and Service Utilization Study (HCSUS). All women were asked, "In the past 12 months, have you had a Pap test?" Women reporting an abnormal Pap test result were asked whether they had been told antibiotics could cure abnormal cells, and whether they were scheduled for another Pap test or for a colposcopy within 3 months. RESULTS: Of the population represented, 81% had had a Pap test in the past 12 months. Women who reported having a gynecologist and primary care physician at the same clinical site were almost twice as likely (odds ratio, 1.9; 95% confidence interval, 1.3-3.0) as other women to report Pap testing. Among women who reported abnormal Pap test results and were not told antibiotics could cure abnormal cells, 95% were scheduled for a repeat Pap test or colposcopy, but 15% of the women had not received their repeat Pap test or colposcopy. CONCLUSION: Although Pap test rates and appropriate referral for abnormal findings were high among HIV-tested women, many women with initially abnormal Pap test results did not actually receive follow-up Pap testing or colposcopy. Providing gynecologic care at the same site as primary HIV care would likely improve delivery of needed gynecologic care for women.

Adolescent↗

Using patient history to predict high-grade cervical dysplasia and cancer in women with borderline cervical cytologic results.

OBJECTIVE: To determine whether demographic and lifestyle factors can be used to triage women with borderline cervical cytologic results. MATERIALS AND METHODS: Demographic and medical information were collected from women undergoing colposcopy for a cytologic result read as atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion in the gynecology clinic of an urban public hospital between July 1, 1996, and December 1, 1999. Colposcopy and subsequent histologic results were reviewed. Multivariate analysis was used to define predictors of high-grade cervical disease. RESULTS: From among 1725 eligible women, 283 women (16%) with ASCUS or low-grade squamous intraepithelial lesion results were found to have high-grade cervical disease (113 women with ASCUS results [13%] and 170 women with low-grade squamous intraepithelial lesion results [21%]). In multivariate analysis, pregnant women were less likely to have high-grade disease (odds ratio, 0.36; 95% CI, 0.17-0.79). Women with three or more lifetime sexual partners were more likely to have high-grade disease (odds ratio, 1.75; 95% CI, 1.31-2.34). However, a triage scheme tracking pregnant women with fewer than three lifetime partners to observation without colposcopy would have excluded only 51 of the 1725 women eligible (3%). Other combinations of risk factors had inadequate sensitivity or specificity for high-grade disease. Separate models for ASCUS showed that only having fewer than three lifetime sexual partners was associated with lower risk of high-grade histologic results (odds ratio, 0.56; 95% CI, 0.36-0.89), but excluding women with fewer partners would have missed 27 of 110 cases (25%) of high-grade disease. CONCLUSIONS: History and demographic information are inadequately sensitive for use in triage of women with borderline cytologic findings. Colposcopy or triage using human papillomavirus DNA tests remain indicated.

Journal Article↗

Psychologic morbidities prior to loop electrosurgical excision procedure in the treatment of cervical intraepithelial neoplasia.

The objective of this study was to assess and compare anxiety and distress in patients undergoing colposcopic examinations and loop electrosurgical excision procedure (LEEP). Patients seen for evaluation of cervical intraepithelial neoplasia (CIN) and LEEP were recruited. All patients received further teaching with respect to their abnormality right after the colposcopic evaluation by nursing staff. The Hospital anxiety and Depression Scale (HADS) and the Psychosocial Effects of Abnormal Pap Smears (PEAPS) questionnaires were used to measure and compare distress between the two groups. Linear regression models were built to identify significant predictive variables for psychologic morbidities. Twenty-one colposcopy and 20 LEEP patients participated in this study. No significant demographic differences were noted. Eighty-one percent of patients having colposcopy and 65% of those undergoing LEEP can be classified as having significant anxiety and depression based on the HADS questionnaire. Patients undergoing LEEP scored significantly better than colposcopy patients on the mean total PEAPS score and on the self-belief/cancer concern and effects on sexual relationship dimension scores. Significant psychologic morbidities exist in patients diagnosed with CIN. Face-to-face individualized education and support after colposcopy can decrease patients' distress at subsequent treatment visits.

Adult↗

Conization with a carbon dioxide laser as a uterine-preservation operation for patients with preinvasive cervical carcinoma.

Preinvasive cervical carcinoma (PCC) is a disease entity of the uterine cervix resulting from carcinoma in situ and various degrees of dysplasia. These cases are conventionally treated by a total abdominal hysterectomy. Effective management that can preserve the uterus is more desirable than hysterectomy. In this report, we present the results and complications of laser conization as a uterine-preservation treatment. At our dysplasia clinic, cases of reproductive age diagnosed with PCC can voluntarily undergo laser conization. From June 1985 to May 1988, there were 26 cases who received this treatment. After treatment, they were regularly followed up for more than three years. Before and after surgery, these cases were evaluated by a Pap smear for cytology, colposcopy, a cervical punch biopsy and endocervical curettage for histopathology. Eighteen cases with a satisfactory colposcopy were treated by laser vaporizing conization. Eight cases with an unsatisfactory colposcopy were treated by laser excisional conization. Their mean age was 35.8 (SD 7.7) years, and parity was 1.5 (SD 0.9). The instrument used was a Sharplan CO2 laser model 720. The power density was around 1,000 W/cm2 for vaporization, and 1,500 W/cm2 for excisional conization. During the operations, there was little bleeding. No case required a blood transfusion. The vaginal discharge decreased within four days after treatment. The cervical epithelium on the operated wound began growing after the second week, and the cervix healed well in four to six weeks. After healing, the squamocolumnar junction in each case was visible on colposcopy. No case suffered from cervical stenosis.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Screening of cervical neoplasia by using pap smear with speculoscopy compared with pap smear alone.

OBJECTIVE: The objective was to compare the sensitivity and specificity of Pap smear plus speculoscopy with Pap smear alone. MATERIAL AND METHOD: The study was conducted in the Gynecology Clinic, Rajavithi hospital, Thailand between February 1st and July 31st 2003. Women who made a request for cervical screening underwent a Pap smear, speculoscopy and colposcopy. Colposcopically directed biopsies were obtained from women who had a positive colposcopy. Analytical methods were applied. RESULTS: Of 257 women recruited to the study, Pap smear plus speculoscopy could increase sensitivity from 6.67% with Pap smear alone and to 33.33% when Pap smear plus speculoscopy is used. The false negative rate was reduced from 93.33% with Pap alone and to 66.67% with Pap smear plus speculoscopy. In using Pap smear alone compared with combination of two tests, the specificity decreased from 97.52% to 77.68% and false positive rate increased from 2.48% to 22.31%, respectively. CONCLUSION: Adding speculoscopy to the Pap smear is able to significantly increase the sensitivity of the cervical screening. It also reduces the 'false negative" result. However, as expected, the specificity slightly decreases, due to the false positive from speculoscopy itself. One solution is to defer colposcopy for 6 months and to perform colposcopy only if either Pap smear or speculoscopy is positive.

Adolescent↗

Sensitivity of the Papanicolaou smear in human immunodeficiency virus-infected women.

OBJECTIVE: To determine the sensitivity of the Papanicolaou smear in human immunodeficiency virus (HIV)-infected women. METHODS: Fifty-two HIV-seropositive women underwent colposcopy and had cytologic and histologic specimens obtained. Eighty-five consecutive women seen in our colposcopy clinic who stated that they were HIV-seronegative formed the comparison group. Demographic features of the groups and cytology and histology findings were compared. RESULTS: In HIV-infected patients, the prevalence of cervical dysplasia was 50%. An additional 15% had vulvar lesions alone. The sensitivity of cytologic smears for cervical dysplasia was 63% and specificity was 84%. These findings were not significantly different from those of a control group of women undergoing colposcopy for standard indications (P > .05). Twelve of 38 seropositive women for whom future appointments were scheduled were lost to follow-up. CONCLUSIONS: The sensitivity of the Papanicolaou test does not appear to be diminished in HIV-seropositive women. Screening colposcopy may be justified in view of the high prevalence of cervical and vulvar dysplasia, as well as the high noncompliance rate observed in this patient population.

Adult↗

Cryosurgery. Its use for the abnormal Pap smear.

During a two-and-one-half year period, 317 women were seen in the Colposcopy Clinic for evaluation of an abnormal Pap smear. Seventy-four (23%) desired to maintain their childbearing potential and were treated conservatively. Ten (14%) had inadequate colposcopy and underwent cold knife conization of the cervx. The remaining 64 were treated by adequate colposcopy, combined with cryosurgery; they are discussed in detail. All were managed economically as outpatients without anesthesia and no serious complications occurred. To date, only four have recurrent abnormal cervical cytology and several have delivered children. Adequate colposcopic examination combined with biopsies must proceed all cryosurgical procedures performed for abnormal cervical cytology.

Adolescent↗

Atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion: diagnostic performance, human papillomavirus testing, and follow-up results.

BACKGROUND: Current guidelines recommend colposcopy rather than high-risk human papillomavirus (HPV) testing for the evaluation of abnormal cervical cytology interpreted as "atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion" (ASC-H) based on data from the Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion (ASCUS/LSIL) Triage Study (ALTS), which indicated that ASC-H had a significantly greater frequency of high-risk HPV positivity and underlying high-grade squamous intraepithelial lesions (HSIL) compared with ASCUS. The cytologic interpretations in the ALTS were expert consensus diagnoses rather than routine, single-pathologist readings. METHODS: The authors conducted a comparative analysis of Hybrid Capture 2 high-risk HPV positivity and frequency of histologically diagnosed HSIL for ASC-H and ASCUS to evaluate the performance of ASC-H as a cytologic interpretation subcategory and the potential utility of HPV testing for colposcopy triage of ASC-H in routine practice. RESULTS: Sixty-four of 96 patients with ASC-H (66.7%) were HPV-positive compared with 484 of 1079 patients with ASCUS (44.9%). Among the patients who had histologic follow-up, HSIL was identified in 18 of 45 patients (40.0%) with HPV-positive ASC-H compared with 27 of 266 patients (10.2%) with HPV-positive ASCUS (P < 0.0001) and 1 of 22 patients (4.5%) with HPV-negative ASC-H (P = 0.003); the latter result was similar to the finding of HSIL in 5 of 85 patients (5.9%) with HPV-negative ASCUS. The frequency of HPV-positive ASC-H in the current study (67%) was lower than that obtained in the ALTS for ASC-H (86%) but higher than that for ASCUS in both this study (45%) and in the ALTS (51% for all ASC; 63% for ASCUS, equivocal for LSIL). Underlying HSIL was detected in a similar percentage of patients with HPV-positive ASC-H in this study and in the ALTS (41%). CONCLUSIONS: The greater frequency of HPV positivity and the significantly increased risk of underlying HSIL for ASC-H compared with ASCUS indicated that ASC-H category utilization and performance are appropriate in this routine clinical practice setting. The lower frequency of HPV positivity for ASC-H compared with the ALTS data and the similar low risk of HSIL in HPV-negative ASC-H and HPV-negative ASCUS indicate that HPV testing for triage of ASC-H in routine practice has the potential to reduce the number of women who are referred for colposcopy without an increased risk of failure to detect HSIL among HPV-negative women, similar to its triage role for ASCUS.

Adolescent↗

Clinical impact (cost-effectiveness) of qualifying atypical squamous cells of undeterminate significance (ASCUS) in cases favoring a reactive or dysplastic process.

The cost-effectiveness of qualifying ASCUS cases into two different subcategories, favoring a reactive (ASCUS-R) or dysplastic process (ASCUS-S), was evaluated at the Centro per lo Studio e la Prevenzione Oncologica of Florence in a prospective study. The study determined the positive predictive value (PPV) for histologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2) or more (CIN>) severe lesion of the two ASCUS subgroups. ASCUS-S had a PPV (10.78%) comparable to low-grade squamous intraepithelial lesions (LSIL) (11.40%). For ASCUS-R cases, the recommendation of 6-mo repeat cytology prompting colposcopy in cases of persistent ASCUS or more severe cytology was also effective, as it selected a subgroup with a relatively high PPV (10.34%). The cost-effectiveness of a protocol based on ASCUS qualification was compared with two other possible options for nonqualified ASCUS cases: immediate colposcopy and colposcopy in persistent ASCUS at 6-mo repeat cytology. The detection rate of CIN2> was substantially higher using ASCUS qualification (35.9 vs 14.8 or 17.1). The cost per ASCUS subject was euro 24.99, 27.11, or 25.14 and that per CIN2> detected was euro 697, 1,831 or 1,470 for the three options, respectively. The evidence that ASCUS detection option implies a higher detection rate of CIN2> and subsequently a lower cost per CIN2> detection must be considered with caution and deserves confirmation by other comparative studies.

Cervix Uteri↗

Effect of Bethesda 2001 on reporting of atypical squamous cells (ASC) with special emphasis on atypical squamous cells-cannot rule out high grade (ASC-H).

We compared the overall ASC rate and the outcomes for women with different categories of ASC before and after TBS 2001 to evaluate the impact of TBS 2001. Our laboratory reported ASC in four subcategories before TBS 2001; ASC, favor reactive (ASC-R), favor low-grade squamous intraepithelial lesion (SIL) (ASC-L), undetermined significance (ASC-US), and ASC-H. Since the implementation of TBS 2001, we have been reporting ASC as ASC-US and ASC-H. After TBS 2001, our ASC rate decreased from 6.2% to 4% (P < 0.0001). Before TBS 2001, ASC-R carried the same risk as ASC-US for underlying condyloma/CIN 1. Moreover, ASC-R was rarely associated with CIN 2 or 3. Before TBS 2001, ASC-H captured more low-grade (condyloma/CIN 1) and less high-grade (CIN 2, 3, and SCC) lesions compared to after TBS 2001. More women with ASC-H after TBS 2001 underwent colposcopy (80% vs. 71%, P < 0.05). Twenty-two percent of women with ASC-H required 2-4 colposcopies to identify the high-grade lesion. Our results confirm that consistent application of TBS 2001 terminology for ASC reduces the ASC rate, and better identifies women at high risk for CIN 2, 3, and SCC. In addition, ASC-H requires very close clinical follow-up as a significant percentage of women require more than one colposcopy to identify the high-grade lesion.

Colposcopy↗

Usefulness of concurrent Papanicolaou smear at time of cervical biopsy.

The reliability and cost-effectiveness of a repeat Papanicolaou (Pap) smear performed at the time of colposcopic biopsy is uncertain. To evaluate the usefulness of this practice, Pap smear and biopsy results of 718 patients were reviewed and compared: 619 patients had Pap smears performed prior to colposcopy with a 1.1% false-negative rate, 97.5% sensitivity, and 83.6% positive predictive value. Ninety-nine patients had Pap smears performed at the time of colposcopy with a 19.1% false-negative rate, 56.8% sensitivity, and 92.6% positive predictive value. Repeat Pap smear at the time of colposcopy resulted in significant changes in the management of only 2 patients (2%) and more careful follow-up in one (1%). Pap smears performed at colposcopic biopsy are less sensitive than those done prior to biopsy (P < 0.001). The clinical benefit of this practice is marginal, considering the added costs and potential detrimental effects to the colposcopic examination, provided patients receive adequate follow-up.

Biopsy↗