PREDNOST TESTIRANJA NA OKUŽBO Z ONKOGENIMI HUMANIMI PAPILOMSKIMI VIRUSI DOMA PRI NEODZIVNICAH V PROGRAMU ZORA

Ivanuš, Urška (author), Poljak, Mario (mentor)

Uvod: Z randomizirano raziskavo smo preverili različne pristope, s katerimi bi lahko povečali pregledanost v Državnem programu za zgodnje odkrivanje predrakavih sprememb materničnega vratu ZORA. Neodzivnicam rednega programa ZORA smo ponudili možnost, da si doma same odvzamejo vzorec za testiranje na prisotnost okužbe z onkogenimi humanimi papilomskimi virusi (HPV). Zanimalo nas je, ali je vrsta pripomočka za samoodvzem vzorca doma (odvzemnika) povezana z odzivnostjo in ali je odziv povezan z možnostjo izbire med presejanjem s samoodvzemom vzorca doma za test HPV in presejanjem z odvzemom brisa materničnega vratu za citološki pregled pri ginekologu. Ženske v primerjalni skupini niso imele možnosti izbire (skupina P), medtem ko so ženske v skupini brez obveznega naročila odvzemnika (skupina I2) in v skupini z obveznim naročilom odvzemnika (skupina I1) to možnost imele. Preiskovanke in metode: V randomizirano nadzorovano raziskavo smo vključili 26.556 neodzivnic iz mariborske in celjske zdravstvene regije, stare od 30 do 64 let, ki smo jih naključno razporedili v skupine P (n = 2.600), I1 (n = 14.400) in I2 (n = 9.556). Neodzivnice v I2 smo naključno razporedili v tri skupine glede na vrsto odvzemnika, ki so ga prejele po pošti: I2-Q (n = 3.284, Qvintip), I2-H (n = 3.284, HerSwab) and I2-D (n = 2.988, Delphi Screener). V I1 smo uporabili samo odvzemnik Qvintip. Samoodvzete vzorce so ženske po pošti vrnile v laboratorij, kjer smo jih testirali na prisotnost okužbe s HPV z metodo Hybrid Capture 2, in ženske o rezultatu obvestili po pošti. Tiste s pozitivnim izvidom testa HPV smo povabili na ustrezno nadaljnjo obravnavo. Glavni opazovani izid je bil odziv žensk na povabilo na presejalni pregled glede na vse vključene ženske. Z multivariatno logistično regresijo smo preverili morebitne neodvisne napovedne dejavnike za odziv (vrsta pristopa &#8210; študijske skupine, vrsta odvzemnika v skupini I2, starost, presejalna zgodovina in regija stalnega bivališča). Rezultati: Od 26.556 vključenih žensk si je 8.972 (33,8 %) žensk vzorec za test HPV v enem letu odvzelo doma ali so opravile presejalni pregled pri ginekologu. Odzivnost med skupinami je bila statistično značilno različna in je bila 37,7-odstotna v skupini I2, 34,0-odstotna v skupini I1 in 18,4-odstotna v skupini P (p < 0,001). V skupini I2-D je bila odzivnost (33,4 %) statistično značilno manjša kot v skupinah I2-Q (39,1 %) in I2-H (40,1 %) (p < 0,001). Značilni napovedni dejavniki za odziv so bili tudi starost ženske, regija stalnega bivališča in predhodna udeležba v presejalnem programu. Zaključek: Ženske, ki se ne udeležujejo redno presejalnih pregledov, se značilno bolje odzovejo, če imajo možnost izbire med samoodvzemom vzorca doma za test HPV ali pregledom z brisom materničnega vratu pri ginekologu, in sicer ne glede na to, ali morajo odvzemnik naročiti ali ne. Vrsta odvzemnika je značilni napovedni dejavnik za odziv.

• Language: Slovenian
• Keywords: rak materničnega vratu, presejalni program, neodzivnice, HPV, samoodvzem vzorca
• Work type: Doctoral dissertation
• Organization: MF - Faculty of Medicine
• Year: 2019
• PID: 20.500.12556/RUL-107103
• COBISS.SI-ID: 299563264
• Publication date in RUL: 28.03.2019

Secondary language

• Language: English
• Title: BENEFITS OF SELF-SAMPLING FOR HIGH-RISK HUMAN PAPLLOMAVIRUS DETECTION IN NON-RESPONDERS TO PROGRAMME ZORA

Abstract

Introduction: To overcome obstacles for screening attendance within the Slovenian organised cervical cancer screening programme ZORA, a randomised pilot study of human papillomavirus (HPV) self-sampling among non-attenders was performed, aiming to assess three different screening approaches. We were interested whether a choice between HPV self-sampling and cytological screening at gynaecologist as well as self-sampling device are significant prognostic factors for response. Choice of test was available in opt-in (study group I1) and opt-out (study group I2) HPV self-sampling approach, but not in the control group (study group P), where women could perform only cytology screening at personal gynaecologist. Participants and methods: All together 26,556 non-attenders aged 30&#8210;64 years from two Slovenian regions were enrolled into a randomised controlled traial and randomised to two HPV self-sampling groups (&#8201;opt-in I1; n = 14,400 and opt-out I2; n = 9,556), with a control group (P; n = 2,600). Women in I2 were randomly allocated to three different self-sampling devices: I2-Q (Qvintip; n = 3,284), I2-H (HerSwab; n = 3,248) and I2-D (Delphi Screener; n = 2988). In I1 only Qvintip was used. Self-collected samples were mailed to the laboratory where they were analysed using the Qiagen Hybrid Capture 2 assay. HPV-positive women were invited to a colposcopy. The main outcomes were overall and type-specific intention-to-screen response rates. We used multiple logistic regression to assess the following possible prognostic factors for the response: the women’s age, the screening approach, the screening history and the region of residence. Results: Of the 26,556 women enrolled, 8,972 (33.8%) responded with self-sample for HPV testing and/or traditional cytology within one year of enrolment. Response rates were 37.7%, 34.0% and 18.4% (p <0.001) for opt-out I2, opt-in I1 and control P groups, respectively. In the opt-out I2 group the response rates were 33.4 % for I2-D, 39.1 % for I2-Q and 40.1 % for I2-H (p < 0.001). Age of women, screening history, region of residence were also significant predictor for a response. Conclusion: The results of our study show that non-attenders to regular cervical screening programmes respond significantly better if they have a choice to perform HPV-self sampling at home or cytology screening at personal gynaecologist, the response was significantly higher in opt-in and opt-out HPV self sampling approach compared to the control group. Self-sampling device can be a significant prognostic factor for a response in opt-out approach.

• Keywords: cervical cancer prevention, screening programme, non-attenders, cytology, HPV, self-sampling