Clinical and epidemiological background of combined strategy for cervical screening of women in Ukraine
Keywords:
diagnostic screening strategy, cervical cancer, utility function, HPV testing, cytological smear.Abstract
Background: cervical cancer (CC) ranks second place among cancers of women of reproductive age in Ukraine, accounting for more than 2000 deaths annually. Virtually all cases of CCs are caused by persistent infection with Human Papillomaviruses (HPVs). Two main methods of diagnosis in screening for cervical pathology are cytological test (Pap-test) and molecular-genetic (HPV-test) tests. Implementation of efficient cervical cancer screening programs, based on Pap- and HPV-tests, might significantly decrease CC incidence rates. Issue of effective combination of the two diagnostic methods and development of optimal screening strategies is essential. The primary need is the development and application of pharmacoeconomic models to compare two or more diagnostic techniques (methods). This approach could be used as a tool to select more appropriate strategy given its cost and effectiveness, or utility. The main criterion of the "cost - utility" method is utility function of each diagnostic technology. The first step in constructing this model should be the definition of its basic parameters, that is the probability of HPV infection and the presence of subclinical or clinical manifestations in women at a certain age and to identify the utility function for each diagnostic test and their combinations thereof. Objective of the study was the definition of utility functions of combined strategy using HPV- and cytological tests based on clinical and epidemiological research data.
Materials and methods: 1257 cervical smears from Ukrainian women aged 19 – 65 were tested (HPV typing test and cytological testing). "Cost-utility"-based analysis and evaluation are based on the results of own clinical and laboratory studies of 1257 cervical samples (HPV DNA tests and cytological diagnostics) from women aged 19 – 65 (mean age 30.68 (±7.72)), living in different regions of Ukraine. Statistical and mathematical methods are used for modeling the utility function of a number of diagnostic strategies. Obtained results of laboratory testing formed the basis for developing screening strategies, with HPV test only, cytological test only or both tests depending on the differences in clinical and epidemiological history of the patient were evaluated.
Results: According to the results of clinical and epidemiological studies defined utility function for each test as components of a comprehensive strategy, the first step in developing an optimal algorithm for screening of HPV-associated cervical diseases in Ukraine. Simulation shows maximum of diagnostic utility for HPV test, as a single screening strategy, in women aged 29-30 years. Screening with cytological test only increases its utility with the increase of patients’ age. Combined screening strategy based on both HPV and cytological tests shows maximum of utility for HPV test when using it among younger women (<21 years old) and for cytological test when using it with women aged >21. The results will be the basis for further comprehensive assessment of screening strategies for HPV-associated lesions of the cervix.
Conclusions: Obtained results compose the first step in the development of an optimal algorithm for HPV-associated cervical screening in Ukraine. The results will form the basis for further comprehensive assessment of screening strategies.
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