Primary HPV testing versus cytology-based cervical screening in women in Australia vaccinated for HPV and unvaccinated: effectiveness and economic assessment for the National Cervical Screening Program.

BACKGROUND: Australia's National Cervical Screening Program currently recommends cytological screening every 2 years for women aged 18-69 years. Human papillomavirus (HPV) vaccination was implemented in 2007 with high population coverage, and falls in high-grade lesions in young women have been reported extensively. This decline prompted a major review of the National Cervical Screening Program and new clinical management guidelines, for which we undertook this analysis. METHODS: We did effectiveness modelling and an economic assessment of potential new screening strategies, using a model of HPV transmission, vaccination, natural history, and cervical screening. First, we evaluated 132 screening strategies, including those based on cytology and primary HPV testing. Second, after a recommendation was made to adopt primary HPV screening with partial genotyping and direct referral to colposcopy of women positive for HPV16/18, we evaluated the final effect of HPV screening after incorporating new clinical guidelines for women positive for HPV. Both evaluations considered both unvaccinated and vaccinated cohorts. FINDINGS: Strategies entailing HPV testing every 5 years and either partial genotyping for HPV16/18 or cytological co-testing were the most effective. One of the most effective and cost-effective strategies comprised primary HPV screening with referral of women positive for oncogenic HPV16/18 direct to colposcopy, with reflex cytological triage for women with other oncogenic types and direct referral for those in this group with high-grade cytological findings. After incorporating detailed clinical guidelines recommendations, this strategy is predicted to reduce cervical cancer incidence and mortality by 31% and 36%, respectively, in unvaccinated cohorts, and by 24% and 29%, respectively, in cohorts offered vaccination. Furthermore, this strategy is predicted to reduce costs by up to 19% for unvaccinated cohorts and 26% for cohorts offered vaccination, compared with the current programme. INTERPRETATION: Primary HPV screening every 5 years with partial genotyping is predicted to be substantially more effective and potentially cost-saving compared with the current cytology-based screening programme undertaken every 2 years. These findings underpin the decision to transition to primary HPV screening with partial genotyping in the Australian National Cervical Screening Program, which will occur in May, 2017. FUNDING: Department of Health, Australia.

Choosing between competing technologies in the cytology laboratory.

Technological change often is internal to anatomic pathology services. When new technology requires collaborative development with clinical staff, it is important to systematically approach the rationale for the new technology, and be prepared to deal with its medical, financial, and, sometimes, even personal implications. Such a systematic approach involves sequentially evaluating the acceptability and the potential benefits of technologic alternatives among the laboratory leadership, with each potential vendor, the laboratory staff, and the clinical and institutional leadership, and must ultimately include effective communication with the entire clinical community. Among the benefits of such a systematic approach are resiliency of the process when challenged, and credibility of its leadership, within and outside of the laboratory.

Cost-effective evaluation of indeterminate urinary cytology.

PURPOSE: We reviewed our management of indeterminate urinary cytologies to determine which patients warrant urological evaluation. Our goal was to develop a cost-effective evaluation scheme that detects the most cancers. MATERIALS AND METHODS: We analyzed case histories of 389 patients with indeterminate urinary cytology who had undergone complete urological evaluations. Upper urinary tract imaging and cystoscopy were required to exclude malignancy, and tissue biopsy results were recorded in all individuals diagnosed with cancer. Multivariate analysis was used to assess the significance of clinical factors that would suggest the necessity of complete urinary system evaluation. Marginal cost-effectiveness rates were applied to various clinical scenarios. RESULTS: Of 389 patients 60 (15%) had urinary tract malignancy. A history of urothelial malignancy and hematuria were the only significant factors that suggested complete evaluation was necessary. If smoking history were included 59 of the 60 malignancies would have been detected. CONCLUSIONS: Patients with indeterminate urinary cytology who are nonsmokers and have neither hematuria nor a history of urothelial cancer are at low risk for malignancy and do not warrant complete evaluation.

Impact of automated technology on the cervical cytologic smear. A comparison of cost.

The cervical cytologic screening test for cervical cancer is the largest-volume cancer screening test currently conducted predominantly without the advantage of process automation. Much attention has been directed toward commercial application of automated technology to support both quality enhancement and productivity gain in cervical cytology screening. Several systems are now available for clinical application that address various aspects of cervical cytologic screening automation. These include specimen-preparation devices and image-based automated screeners. Each system provides a different mix of benefits and impacts cost differently as well. This, coupled with the fact that few systems are in broad clinical use as yet, makes it difficult to conduct parallel cost-benefit analysis. A comparison is presented on the impact of system use on the laboratory's cost to conduct the test. Although there is a demand for technology that can support improvements in quality and/or productivity of cervical cytologic screening, there is also a responsibility for fiscal prudence in technology implementation. Products that dramatically increase the cost of service, and thus perhaps limit access to care for some patients, may have an impact on patient outcomes quite apart from that intended.

Automated screening of cervical cytology specimens.

After more than four decades of research into automation of the process of screening Papanicolaou (Pap) smears, attempts to develop commercially viable automated screening machines have increased in recent years. These developments have been made possible in part because of the improving price-to-performance ratios in computers and other electronics. Although the Pap smear has been responsible for a very significant decrease in mortality of cervical cancer over the past 40 years, concern has arisen over false-negative cases, with their effects on patients, and the associated legal liability, particularly in the United States. In addition, shortages of cytotechnologists, which have been exacerbated by new regulations limiting the number of slides that may be examined per day, have caused concern about handling the workload, which will probably increase as more individuals gain access to preventive health care. Automated screening machines can potentially allow detection of abnormal cases that are missed with conventional screening, although they may substantially increase the cost of Pap smears. The use of automated screening machines represents a change in the way cervical cytology specimens are processed, and with some machines, a significant change in the operation of the cytology laboratory. Current methods for processing and evaluating Pap smears have not changed significantly for the past four decades. This review discusses some of the principles of operation and practical aspects of automated screening machines.

Cytotechnology manpower assessment.

The shortages of cytotechnologists in the state of South Carolina are 43 percent, representing an extreme urgency to fill these vacant positions (national average 28 percent). Furthermore, the shortage is expected to rise (52 percent) thereby demanding a solution to the problem.

New federal regulations and the future practice of cytology.

An explanation of the new federal economic initiatives (the Tax Equity and Fiscal Responsibility Act; diagnosis-related groups) is offered as they currently pertain to the practice of cytopathology. Future trends are discussed, and means to deal with them are recommended. The cytology community can wait no longer to come to grips with changing economic times.