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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Costa et al. evaluated 992 women who underwent Pap smears and simultaneous cervicography and HPV DNA testing (Costa, 2000). Colposcopy was used as a reference tool. The combination of Pap testing and cervicography resulted in an increase of sensitivity but a decrease in specificity.

Moscicki et al. compared cytology with cervicography in 334 HIV-infected and uninfected adolescent females (Moscicki, 2003). Although the sensitivity of a single Pap smear increased when cervicography was used as an adjunct test, a low positive predictive value (33% and 15% for the HIV-infected and uninfected group, respectively) suggests that cervicography has limited use for screening in high-risk adolescents.

A study was performed to determine whether cervicography and HPV testing would improve the detection of CIN 2 or 3 in 304 women with low-grade cytologic lesions (Howard, 2004). The sensitivity of cytology for identifying CIN 2 or 3 was 73% and increased by 22% to 95% with the addition of cervicography. These gains were reduced to 8% and 11% above the sensitivities expected if the additional test were performed randomly. The authors concluded that HPV testing or cervicography provide similar gains in sensitivity, but this can be misleading if chance increases are not taken into account.

Cervical cancer is a leading cause of cancer-associated death in women of the developing world and in low-resource settings, where successful cervical cancer screening programs have been difficult to implement. Cronje et al. compared the results of 4 screening methods (cytologic examination, cervicography, direct acetic acid test, and speculoscopy) with the results of histological examination in 1286 women (Cronje, 2003). The investigators concluded that these screening methods were not individually suited for screening in developing countries because of the low sensitivity of cytology and the low specificity of the other tests. Cervicography demonstrated a sensitivity of 49% and a specificity of 88%. Denny et al. reported on 2-stage cervical screening of 1423 women in South Africa (Denny, 2000). Direct visual inspection, cytologic testing, HPV deoxyribonucleic acid testing, and cervicography when used alone, detected 24, 26, 23, and 23 cases of disease per 1000 women respectively. Two-stage screening with direct visual inspection performed first, followed by cytologic testing, HPV deoxyribonucleic acid testing, or cervicography detected 18, 16, and 18 cases per 1000 women respectively and reduced the number of women without disease who were classified as having abnormal results. Another study of 264 patients in rural Georgia concluded that telecolposcopy detected more cervical neoplasms than cervicography (Ferris, 2003). DeVuyst et al.

evaluated the quality of 4 screening methods to detect CIN in 653 women in an urban African setting (De Vuyst, 2005).

They found that the Pap smear had the highest specificity (95%) and HPV testing had the highest sensitivity (94%). Visual inspection with acetic acid (VIA) and cervicography demonstrated accuracy between the former two tests.

In a study by Bomfim et al., 1292 women were submitted to both cytological and VIA tests to obtain a sample of 301 positive VIA cases (23.3%) which have had the Digital Cervicography (DC) taken and evaluated (Bomfim, 2006). Just cases considered positive by DC (149/301 cases--49.5%) and/or positive Pap smear tests were referred to colposcopy and biopsy whenever indicated. The results showed that the cervical smear was positive in 5.4%, including LSIL (4%), HSIL (1%) and one case of invasive cancer (0.4%), and 1.6% of ASCUS or AGUS). DC identified 81 positive cases (74 LSIL; 5 HSIL; 2 cancers). The sensitivity of cytology was 14.8%, and the DC was 100%. Corresponding specificities were 95.4% and 69.1%, respectively. The NPV and PPV for DC were 100% and 54.4%. That study concluded that DC increases sensitivity, specificity and positive predictive value of VIA, becoming a valid adjunctive screening test for cervical cancer in low resource settings.

Cervical Cancer Screening - Commercial Medical Management Guideline Professional Societies and Organizations United States Preventive Services Task Force (USPSTF): According to a 1996 report from the USPSTF, cervicography compares in sensitivity to the Pap smear (approximately 60%); however, it demonstrates a lower specificity (approximately 50%). This conclusion was based on a combination of studies that were conducted in 1985 to 1993. It was concluded that there was insufficient evidence to recommend for or against routine cervicography (or colposcopy) screening for cervical cancer in asymptomatic women. (USPSTF, 1996) American College of Obstetricians and Gynecologists (ACOG): Currently ACOG does not have a guideline that addresses the use of cervicography.

Magnified Chemiluminescent Visual Exam (Speculoscopy) Overall, results of the reviewed medical literature suggests that when speculoscopy is added to the conventional Pap test for cervical cancer screening, a higher percentage of patients with biopsy-proven cervical pathology are identified compared with use of the Pap testing alone. For Pap test and speculoscopy combined, sensitivities and specificities ranged from 93% to 100% and 23% to 88%, respectively. However, this increase in sensitivity was associated with a reduction in specificity and thus, an increase in false-positive test results. The reduction in specificity introduced by the addition of speculoscopy to the Pap test in cervical cancer screening programs could result in patients without cervical pathology being referred for further testing by colposcopy and biopsy and possibly in unnecessary treatment. There also remain questions about the follow-up of patients with a negative Pap test result and a positive speculoscopy result. While specificity might be improved by deferring colposcopy for selected patients, the effectiveness of this strategy depends upon whether the patients are reliable enough to return for follow-up testing.

None of the studies discussed or evaluated patient outcomes, i.e., whether use of speculoscopy as an adjunct screening tool reduces cervical cancer morbidity or mortality. Furthermore, no studies were identified in the published, peer-reviewed literature that compare the efficacy of speculoscopy with other cancer screening methods such as liquid cytology, HPV DNA testing, and automated methods for reading cytological slides.

The clinical effectiveness of speculoscopy as an adjunct to Pap testing for cervical cancer screening must be evaluated in large, well-designed studies in which primary care providers (the health professionals for whom this test was designed) perform testing, and in which all test results are confirmed by the gold standard of colposcopy and biopsy. The optimal role of speculoscopy in a cervical cancer-screening program has not been determined. If this test is to be used as part of a series of tests, an algorithm must be developed so that it is used appropriately and judiciously. The impact of speculoscopy upon relevant outcomes, particularly cervical cancer morbidity (e.g., reduction in hysterectomy) and mortality must be studied.

In the largest trial involving more than 5692 patients undergoing routine cervical cancer screening by primary care providers in the United States, the addition of speculoscopy to the Pap test increased sensitivity since more patients with cervical pathology were detected by PPS compared with the Pap test alone (Wertlake, 1997). Patients with a positive result on either screening test were referred for colposcopy and biopsy. A total of 799 patients were positive using one or both screening tests. However, only 410 (51.3%) of these patients returned for colposcopy and biopsy; the remaining patients were lost to follow-up. Of 410 biopsies performed, 32 were diagnosed as HSIL, 191 as LSIL, 145 as reparative or reactive changes, and 42 as normal. The addition of speculoscopy to the Pap test resulted in the identification of 11 of 32 (34%) patients with HSIL and 154 of 191 (81%) with LSIL; all of these patients had had negative Pap test results. Interpretation of the study findings is hampered by the high attrition rate for colposcopy (~50%), which would result in an underestimation of the prevalence of cervical pathology.

An Italian multicenter trial known as the GISPE involved 3300 asymptomatic patients presenting for cervical cancer screening (Loiudice, 1998). In addition to the Pap test and speculoscopy, all patients in this study had colposcopy. The 646 women with positive colposcopy underwent biopsy. Of 267 (41%) patients with positive biopsies, 25 had HSIL and 242 had LSIL. The Pap test alone identified 76% of the women with HSIL, speculoscopy identified 84%, and the combination approach, PPS, detected 100%. Among patients with LSIL, the Pap test alone detected 37%, speculoscopy alone detected Cervical Cancer Screening - Commercial Medical Management Guideline 54%, and PPS detected 91% of LSIL compared with the reference standard of colposcopy. Diagnostic sensitivity increased from 40% to 92% with the expected trade-off in specificity (reduced from 94% to 23%).

Edwards et al. conducted a multicenter trial in the setting of a U.S. health maintenance organization that involved 689 patients undergoing routine cervical cancer screening (Edwards, 1997). The patients had speculoscopy immediately after a Pap test was completed. Patients with positive findings (ASCUS or SIL) on either the Pap test or speculoscopy were referred for colposcopy. A total of 68 (9.9%) patients had normal Pap test results but positive findings on speculoscopy. Colposcopy and biopsy showed 3 patients with HSIL, 28 with LSIL, and 37 with normal findings. The PPS detected 33% more cases of HSIL and 400% more cases of LSIL than the Pap test alone. However, the false-positive rate for referral for colposcopy increased from 2.6% to 5.4% by the PPS approach. Not all patients had colposcopy and biopsy so the true prevalence of cervical pathology in this population is unknown.

In an Italian healthcare setting, Boselli and colleagues evaluated whether the addition of speculoscopy to conventional Pap testing would improve the detection of cervical precancers and cancers compared with the Pap test alone among 1000 patients undergoing cervical cancer screening (Boselli, 2000). Women with a positive Pap test and/or positive speculoscopy test result underwent colposcopy and biopsy for positive colposcopy examination. Ten (10%) patients had a positive Pap test result and 144 (14.4%) had a positive speculoscopy test. Speculoscopy diagnosed 56 CIN 1 and HPV lesions and 4 CIN 3 lesions that were missed by cytology. The PPV of speculoscopy was 89.5%.

In a study conducted in South Africa, Cronj et al. compared four cervical cancer screening methods in 1286 women in a primary care facility (Cronj, 2003). All women had a Pap test, speculoscopy, cervicography, and a direct acetic acid test (AAT). Of the women screened, 1093 (85%) were eligible for analysis; only 468 (56%) returned for colposcopy.

Sensitivities for the screening tests were 53.3% for the Pap test, 76.7% for speculoscopy, 48.9% for cervicography, and 78.9% for the direct AAT. The corresponding specificities were 94.6%, 44.6%, 87.5%, and 48.9%, respectively. The PPVs for the screening tests were 47.1% for the Pap test, 11% for speculoscopy, 26% for cervicography, and 12.2% for the direct AAT. The corresponding NPVs were 95.7%, 95.5%, 95%, and 96.3%, respectively. While these screening tests were compared with the gold standard, colposcopy, the incremental value of adding speculoscopy to the Pap test was not determined.

In another large study conducted in Taiwan, Yu et al. compared the efficacy of Pap testing alone with PPS for cervical cancer screening among 1717 patients who all underwent colposcopy (reference standard) as well from a total population of 1829 (71 women did not meet the eligibility criteria and 41 were lost to follow-up) (Yu, 2003). Among the 1717 patients evaluated, the addition of speculoscopy significantly increased the sensitivity compared with the Pap test alone (92.9% versus 45.2%, respectively; P In a relatively small study in Thailand (n=257) in which all patients had colposcopy, with biopsy reserved for colposcopypositive results, Boonlikit et al. found that the combination of speculoscopy and Pap testing for cervical cancer screening increased sensitivity to 33.3% from 6.7% for the Pap test alone; however, the specificity decreased from 97.5% for Pap testing to 77.7% for PPS, which would result in a number of false positive diagnoses (Boonlikit, 2005).

In an attempt to improve the diagnostic yield of PPS, Parham and colleagues compared outcomes after immediate or deferred colposcopy among patients with negative Pap test results but positive speculoscopy results. More than 80% of patients in the immediate colposcopy group had positive colposcopy results and 64.9% had biopsy-confirmed LSIL or HSIL. The percentage of biopsy-confirmed LSIL or HSIL increased to 90% among 45 of 67 patients with Pap test-negative, speculoscopy-positive patients who returned for follow-up. During this time, the speculoscopy results of 29% converted from positive to negative, indicating possible regression of low-grade lesions. However, this approach would have to be employed carefully since its effectiveness and safety depends upon patient reliability; the loss to follow-up rate approached 33% and could prove to be detrimental in cases of progressive disease. (Parham, 2000) The evidence is insufficient to recommend speculoscopy as an adjunct to the Pap test (PapSure) for routine cervical cancer Cervical Cancer Screening - Commercial Medical Management Guideline screening. While it has been shown that the addition of speculoscopy to Pap testing results in higher sensitivity for the detection of cervical precancers and cancers, the combined test has lower specificity than the Pap test alone, which results in significant numbers of patients being subjected to unnecessary biopsies and treatment. No studies have systematically evaluated diagnostic performance and/or the impact of the addition of speculoscopy to the Pap test on clinical decision making, patient management, or health outcomes. Therefore, it remains unknown whether adding speculoscopy to screening reduces cervical cancer morbidity and mortality.

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