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  • Article: Cost and logistics of alternative roll-out options for implementing human papillomavirus testing as a triage in cervical screening: results of the sentinel sites study.
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    ABSTRACT: Background:Previous studies have indicated that human papillomavirus (HPV) testing as a triage for managing equivocal cytology is cost-effective. The aim of this study was to assess the costs of alternative roll-out options.Methods:Detailed cost estimates were collected from six laboratories where HPV triage had been implemented. Costs were assessed for the two different service delivery models that were implemented; a 'hub and spoke model' of central HPV testing in a microbiology laboratory with separate cytology laboratories, and an 'integrated model' where HPV testing was conducted within the cytology laboratory.Results:Comparison of alternative delivery models indicated that setting up HPV processing within existing cytology laboratory, i.e., an 'integrated cytology/HPV laboratory' generated savings in staff time amounting to between £2.54 and 4.86 per sample processed. Running full HPV testing batches was also an important consideration. For full batches to be run on a twice weekly basis requires having no more than two laboratories per Strategic Health Authority.Conclusions:To be cost-efficient, and to meet turn-around times, HPV testing needs to be conducted at integrated cytology/HPV testing centres with sufficient throughput to run full batches of HPV tests.
    British Journal of Cancer 10/2012; 107(9):1574-9. · 5.04 Impact Factor
  • Article: Cost effectiveness of human papillomavirus test of cure after treatment for cervical intraepithelial neoplasia in England: economic analysis from NHS Sentinel Sites Study.
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    ABSTRACT: To evaluate the cost effectiveness of human papillomavirus testing after treatment for cervical intraepithelial neoplasia (CIN). Economic analysis using a Markov modelling approach to combine cost and epidemiological data from the NHS Sentinel Sites Study with data from previous studies of post-treatment recurrence rates. English NHS Cervical Cancer Screening Programme. Management guidelines after treatment of CIN involving annual cytology follow-up for 10 years, compared with alternative protocols using the human papillomavirus test to reduce the amount of post-treatment surveillance. Cases of underlying CIN3+ averted at 10 years and costs per 1000 women treated. Model predictions indicated that, at observed levels of compliance with post-treatment recommendations, management with only cytological follow-up would result in 29 residual cases of recurrent CIN3+ by 10 years and would cost £358 222 (€440 426; $574 910) (discounted) per 1000 women treated. Implementation of human papillomavirus test of cure in cytologically negative women according to the sentinel sites protocol would avert an additional 8.4 cases of CIN 3+ and reduce costs by £9388 per 1000 women treated. Human papillomavirus test of cure would be more effective and would be cost saving compared with cytology only follow-up. The results of this evaluation support the full scale implementation of human papillomavirus test of cure after treatment of CIN within the NHS Cervical Screening Programme.
    BMJ (Clinical research ed.). 01/2012; 345:e7086.
  • Article: Women's preferences regarding options for management of atypical, borderline or low-grade cervical cytological abnormalities: a review of the evidence.
    M Z Sadique, R Legood
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    ABSTRACT: To review the evidence on women's preferences for and valuation of alternative management pathways following identification of low-grade cytological abnormalities as part of routine cervical cancer screening. The aim was to identify empirical studies evaluating women's preferences regarding alternative management pathways and to compare the impact of alternative elicitation methods on results. A systematic review of the literature was conducted using the online bibliographic information service PubMed database. Empirical studies were identified that elicited general preferences, utilities or valuations based on willingness to pay (WTP) with respect to management of low-grade cytology results. Data were extracted on the methodology used and the empirical results. Where quality of life data were elicited directly from patients that were undergoing management of low-grade abnormalities utilizing direct elicitation techniques such as WTP, general preference questionnaires and the Euroqol, the studies tended towards a preference in favour of HPV testing (and colposcopy referral if HPV positive) rather than repeat cytology. In contrast, where studies included the general population and presented hypothetical scenarios of treatment pathways, and explicitly tried to incorporate assessment of process utility, the evidence indicated a slight tendency to favour repeat cytology. Consideration of patient preferences in the management of low-grade cytology is important for designing screening protocols. The reviewed studies indicate that potentially different conclusions may be drawn depending on the elicitation methodology and selection of participants in the research.
    Cytopathology 06/2011; 23(3):161-6. · 1.59 Impact Factor
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    Article: MAVARIC - a comparison of automation-assisted and manual cervical screening: a randomised controlled trial.
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    ABSTRACT: The principal objective was to compare automation-assisted reading of cervical cytology with manual reading using the histological end point of cervical intraepithelial neoplasia grade II (CIN2) or worse (CIN2+). Secondary objectives included (i) an assessment of the slide ranking facility of the Becton Dickinson (BD) FocalPoint™ Slide Profiler (Becton Dickinson, Franklin Lakes, NJ, USA), especially 'No Further Review', (ii) a comparison of the two approved automated systems, the ThinPrep® Imaging System (Hologic, Bedford, MA, USA) and the BD FocalPoint Guided Screener Imaging System, and (iii) automated versus manual in terms of productivity and cost-effectiveness. A 1 : 2 randomised allocation of slides to either manual reading or automation-assisted paired with manual reading. Cytoscreeners were blinded to whether samples would be read only manually or manually paired with automated. Slide reading procedures followed real-life laboratory protocol to produce a final result and, for paired readings, the worse result determined the management. Costs per event were estimated and combined with productivity to produce a cost per slide, per woman and per CIN2+ and cervical intraepithelial neoplasia grade III (CIN3) or worse (CIN3+) lesion detected. Cost-effectiveness was estimated using cost per CIN2+ detected. Lifetime cost-effectiveness in terms of life-years and quality-adjusted life-years was estimated using a mathematical model. Liquid-based cytology samples were obtained in primary care, and a small number of abnormal samples were obtained from local colposcopy clinics, from different women, in order to enrich the proportion of abnormals. All of the samples were read in a single large service laboratory. Liquid residues used for human papillomavirus (HPV) triage were tested (with Hybrid Capture 2, Qiagen, Crawley, UK) in a specialist virology laboratory in Edinburgh, UK. Histopathology was read by a specialist gynaecological pathology team blinded to HPV results and type of reading. Samples were obtained from women aged 25-64 years undergoing primary cervical screening in Greater Manchester, UK, with small proportions from women outside this age range and from women undergoing colposcopy. The principal intervention was automation-assisted reading of cervical cytology slides which was paired with a manual reading of the same slide. Low-grade cytological abnormalities (borderline and mild dyskaryosis) were triaged with HPV testing to direct colposcopy referral. Women with high-grade cytology were referred for colposcopy and those with negative cytology were returned to recall. The principal outcome measure was the sensitivity of automation-assisted reading relative to manual for the detection of CIN2+. A secondary outcome measure was cost-effectiveness of each type of reading to detect CIN2+. The study was powered to detect a relative sensitivity difference equivalent to an absolute difference of 5%. The principal finding was that automated reading was 8% less sensitive relative to manual, 6.3% in absolute terms. 'No further review' was very reliable and, if restricted to routine screening samples, < 1% of CIN2+ would have been missed. Automated and manual were very similar in terms of cost-effectiveness despite a 60%-80% increase in productivity for automation-assisted reading. The significantly reduced sensitivity of automated reading, combined with uncertainty over cost-effectiveness, suggests no justification at present to recommend its introduction. The reliability of 'no further review' warrants further consideration as a means of saving staff time. Current Controlled Trials ISRCTN66377374. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 3. See the HTA programme website for further project information.
    Health technology assessment (Winchester, England). 01/2011; 15(3):iii-iv, ix-xi, 1-170.
  • Article: Cervical cancer screening among HIV-infected women: an economic evaluation in a middle-income country.
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    ABSTRACT: Due to the recent widespread availability of highly active antiretroviral therapy (HAART) in middle-income countries, there has been an increase in life expectancy for women on HAART, but no corresponding decrease in cervical cancer incidence. This study evaluates the optimal cervical cancer screening strategy for HIV-infected women in a middle-income country. We developed a mathematical model, which simulates the natural history of the HPV infection, as well as the HIV-mediated immunosupression among women in Brazil. Our model was calibrated using data from the IPEC/FIOCRUZ Women's HIV-infected cohort. The model compares the lifetime effects, costs and cost-effectiveness of strategies combining cytology, HPV DNA test and colposcopy at different screening intervals for different CD4 count strata (27 strategies in total). We found that the strategy with the best cost-effectiveness profile (cost-effectiveness ratio-U$4,911/year of life saved [YLS] and probability of being cost-effective-86%) was HPV testing followed by cytology triage every year for all HIV infected women, considering a very cost-effective threshold given by Brazil's GDP per capita (US$8,625/YLS). The results were robust to changes in the input parameters as demonstrated in one-way, scenario, threshold and probabilistic sensitivity analysis. Our study indicates that annual HPV testing followed by cytology triage for all HIV-infected women is likely to be very cost-effective in a middle-income country like Brazil. The results reflect the synergic effect of using a highly sensitive screening test (HPV DNA test) in sequence with a highly specific test (cytology).
    International Journal of Cancer 09/2011; 131(2):E96-104. · 5.44 Impact Factor

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