Cost-Effectiveness Analysis Based on the Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study (ALTS)

Kulasingam, Shalini; Kim, Jane J.; Lawrence, William; Mandelblatt, Jeanne S.; Myers, Evan R.; Schiffman, Mark; Solomon, Diane; Goldie, Sue J.; Partridge, Edward E.; Kilgore, Larry C.; Hester, S.; Walker, Joan L.; Johnson, Gary A.; Yadack, A; Guido, Richard S.; McIntyre‐Seltman, Kathleen; Edwards, Robert P.; Gruss, Judy; Kiviat, Nancy B.; Koutsky, Laura A.; Mao, Constance; Ferris, Daron G.; Cox, J. Thomas; Burke, Louis; Wheeler, Cosette M.; Peyton-Goodall, C.; Manos, M. Michele; Kurman, Robert J.; Rosenthal, Dorothy L.; Sherman, Mark E.; Stoler, Mark H.; Harper, Diane M.; Rosenthal, Jeanne F.; Dunn, Marsha; Quarantillo, J.; Robinson, D.; Lörincz, Attila T.; Kramer, Barnett S.

doi:10.1093/jnci/djj009

Cited by 88 publications

(41 citation statements)

References 15 publications

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“…HPV testing was used to identify the 13 known high-risk HPV types (16,18,31,33,35,39,45,51,52,56,58,59, and 68). Women with abnormal screening results were referred for follow-up colposcopies or repeat screening, and the presence of a cervical lesion was confirmed using colposcopy and biopsy [29][30][31]39,40]. The number of clinic visits varied from 1 to 3 visits, based on screening strategy and test results.…”

Section: Screening Strategies and Diagnostic Follow Upmentioning

confidence: 99%

Cost effectiveness of high-risk HPV DNA testing for cervical cancer screening in South Africa

Vijayaraghavan

Efrusy

Lindeque

et al. 2009

Gynecologic Oncology

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a b s t r a c t a r t i c l e i n f oObjective. To determine the cost effectiveness of several cervical cancer screening strategies utilizing HPV testing in South Africa.Methods. We developed a lifetime Markov model of the costs, quality of life, and survival associated with screening and treating cervical cancer and its precursors. Screening strategies evaluated included: 1) conventional cytology, 2) cytology followed by HPV testing for triage of equivocal cytology, 3) HPV testing, 4) HPV testing followed by cytology for triage of HPV-positive women, and 5) co-screening with cytology and HPV testing. Primary outcome measures included quality-adjusted life-years saved (QALYs), incremental cost-effectiveness ratios, and lifetime risk of cervical cancer. Costs are in 2006 South African Rand (R).Results. In a cohort of 100,000 women, starting at age 30 and screening once every 10 years reduced the lifetime risk of cervical cancer by 13-52k depending on the screening strategy used, at an incremental cost of R13,000-R42,000 per QALY. When strategies were compared incrementally, cytology with HPV triage was less expensive and more effective than screening using cytology alone. HPV testing with the use of cytology triage was a more effective strategy and costs an additional R42,121 per QALY. HPV testing with colposcopy for HPV-positive women was the next most effective option at an incremental cost of R1541 per QALY. Simultaneous HPV testing and cytology co-screening was the most effective strategy and had an incremental cost of R25,414 per QALY.Conclusions. In our model, HPV testing to screen for cervical cancer and its precursors is a cost-effective strategy in South Africa.

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Section: Screening Strategies and Diagnostic Follow Upmentioning

confidence: 99%

Cost effectiveness of high-risk HPV DNA testing for cervical cancer screening in South Africa

Vijayaraghavan

Efrusy

Lindeque

et al. 2009

Gynecologic Oncology

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“…21,22 For women with ASCUS, the ALTS trial suggested that the sensitivities of HPV testing and repeat cytology in the detection of CIN3 or worse were similar but that HPV testing (in combination with cytology) would result in fewer referrals to colposcopy, 23 and was considered to be an economically viable strategy. 24 The generalisability of the findings of ALTS is uncertain, particularly to populations in which the prevalence of infection with HPV in women with mild dyskaryosis or LSIL is lower, 4 as reported in the UK. [25][26][27] In a Canadian trial in women with ASCUS or LSIL, addition of HPV testing to repeat cytology resulted in higher sensitivity for detection of CIN2 or worse, but with a substantial loss of specificity.…”

Section: Introductionmentioning

confidence: 99%

The role of human papillomavirus testing in the management of women with low‐grade abnormalities: multicentre randomised controlled trial

Cotton

Sharp

Little

et al. 2010

BJOG

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Objective To assess the value of a single human papillomavirus (HPV) test in making decisions on management of women with cervical cytology showing borderline nuclear abnormality (BNA) or mild dyskaryosis. In particular, to determine whether information on high-risk (hr) HPV status would be valuable in the choice between (1) cytological surveillance versus immediate referral to colposcopy, and (2) at colposcopy, between biopsy and recall versus immediate large loop excision of the transformation zone (LLETZ).Design Multicentre individually randomised controlled trial, nested within the NHS Cervical Screening Programmes, investigating the value of HPV testing by testing for interactions between HPV status and (1) cytological surveillance versus colposcopy, and (2) biopsy and recall versus immediate LLETZ.Setting Grampian, Tayside and Nottingham.Population Women (n = 4439), aged 20-59 years, with a cytology test showing borderline nuclear abnormalities or mild dyskaryosis during October 1999 to October 2002.Methods High-risk HPV status was determined at recruitment using the polymerase chain reaction assay with the GP5+/6+ general primer system. The results of this HPV testing were not disclosed to either the participating women or to those involved in their management. Women were randomised to either (1) 6-monthly cytological screening in primary care or (2) referral for colposcopy. Human papillomavirus status was used to stratify both randomisations. All women were followed for 3 years, concluding with an invitation to an exit appointment at which colposcopic examination was undertaken. In addition, in women who were randomised to initial colposcopy and underwent colposcopy, the association between hrHPV status and presence of cervical intraepithelial neoplasia (CIN) grade 2 or more severe disease (henceforth CIN2 or worse) was examined.Main outcome measures Sensitivity, specificity, positive and negative predictive values of the HPV test for predicting CIN2 or worse and the implications for the choice of management between cytological surveillance and immediate referral for colposcopy.Results There were no significant interactions between management and HPV status. Hence, in women with mild dyskaryosis or BNA who are HPV positive, there is no advantage of (1) immediate colposcopy over cytological surveillance (P = 0.76) or (2) immediate LLETZ over biopsy and recall (P = 0.27). The sensitivity of HPV testing for detection of CIN2 or worse was 75.2% (95% CI 68.8-81.0%) among women with mild dyskaryosis and 69.9% (95% CI 61.7-77.3%) among those with BNA. Specificity was higher in those with BNA (71.3%; 95% CI 68.5-74.1%) than in those with mild dyskaryosis (46.9%; 95% CI 42.2-51.6%). Sensitivity decreased with increasing age whereas specificity increased. The negative predictive value was high, particularly among women with BNA (94.5%; 95% CI 92.9-96.0%). Across all ages, 22% of women who had CIN2 or worse were HPV negative. Conversely, 40% of those who were HPV positive did not have CIN. HPV was a much more relia...

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“…Repeat cytology examinations were as sensitive as HPV DNA testing for detecting CIN3+, but would require more follow-up visits. Kulasingam et al (2006) conducted a cost-effectiveness analysis of the ALTS trial to determine whether HPV DNA testing is a cost-effective alternative to immediate colposcopy or conservative management (Kulasingam et al, 2006). Their results confirmed that the triage based on a positive HPV DNA test detected more CIN3+ cases and was less costly than immediate colposcopy or conservative management with up to three repeat cytology visits with HSIL+ as the threshold for referral to colposcopy.…”

Section: Discussionmentioning

confidence: 90%

Cost and Effectiveness Comparison of Immediate Colposcopy Versus Human Papillomavirus DNA Testing in Management of Atypical Squamous Cells of Undetermined Significance in Turkish Women

Kececioglu¹,

Seckin²,

Başer³

et al. 2013

Asian Pacific Journal of Cancer Prevention

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Background: A small but significant proportion of cases with atypical squamous cells of undetermined significance (ASCUS) may harbour CIN 2-3, or even invasive carcinoma. Although immediate colposcopy, HPV-DNA testing or expectant management are three recommended options in ASCUS triage, a consensus does not currently exist on which one of these approaches is the most efficient. In this study, we aimed to compare the performance and cost of immediate colposcopy and colposcopy based on the human papillomavirus (HPV) testing for detecting histologically confirmed high-grade cervical intraepithelial neoplasia (CIN) in women with ASCUS. Materials and Methods: Records of 594 women with an index Papanicolaou smear showing ASCUS were retrospectively analyzed. Women in the immediate colposcopy arm were referred directly to colposcopy (immediate colposcopy group, n=255) and those in the HPV triage arm were proceeded to colposcopy if the high-risk HPV (hrHPV) test was positive (HPV triage group, n=339). High grade CIN (CIN2+) detection rate and treatment costs were compared between the groups. Results: The detected rate of CIN2+ was higher in the HPV triage group compared to immediate colposcopy group (8% vs. 1.6%, p=0.011). In the HPV triage group, the total cost, cost per patient, and the cost for detecting one case of high grade CIN were higher than the immediate colposcopy group (p<0.001). Conclusions: In women with ASCUS cytology, HPV DNA testing followed by colposcopy is more costly than immediate colposcopy, but this approach is associated with a higher rate of CIN2+ detection. This findings suggest that HPV DNA testing combined with cervical cytology could reduce the referral rate to colposcopy

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Cost-Effectiveness Analysis Based on the Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesion Triage Study (ALTS)

Abstract: HPV DNA testing is an economically viable strategy for triage of ASCUS cytology. The less than perfect sensitivity of colposcopy and biopsy needs to be accounted for in future clinical guidelines and policy analyses.

Cited by 88 publications

References 15 publications

Cost effectiveness of high-risk HPV DNA testing for cervical cancer screening in South Africa

Cost effectiveness of high-risk HPV DNA testing for cervical cancer screening in South Africa

The role of human papillomavirus testing in the management of women with low‐grade abnormalities: multicentre randomised controlled trial

Cost and Effectiveness Comparison of Immediate Colposcopy Versus Human Papillomavirus DNA Testing in Management of Atypical Squamous Cells of Undetermined Significance in Turkish Women

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