6 research outputs found
Randomized implementation of a primary human papillomavirus testing-based cervical cancer screening protocol for women 34 to 69 years in Norway
Background:
Cervical cancer screening programs are facing a programmatic shift where screening protocol based on human papillomavirus testing (HPV-Screening protocol) is replacing the liquid-based cytology (LBC-Screening protocol). For safe technology transfer within the nationwide screening programme in Norway, HPV-Screening protocol was implemented randomized to compare the real-world effectiveness of HPV-Screening protocol and LBC-Screening protocol at the first screening round.
Methods:
Among 302,295 women ages 34 to 69 years scheduled to attend screening from February 2015 to June 2017, 157,447 attended. A total of 77,207 were randomly allocated to the HPV-Screening protocol and 80,240 were allocated to the LBC-Screening protocol. All women were followed up for 18 months.
Results:
The HPV-Screening protocol resulted in a relative increase of 60% in the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse [risk ratio (RR) = 1.6, 95% confidence interval (CI) = 1.5â1.7], 40% in CIN grade 3 or worse (RR = 1.4, 95% CI = 1.3â1.6), 40% in cancer (RR = 1.4, 95% CI = 1.0â2.1), and 60% in colposcopy referrals (RR = 1.6, 95% CI = 1.5â1.6) compared with LBC-Screening. The performance of both protocols was age dependent, being more effective in women ages under 50 years.
Conclusions:
The HPV-Screening protocol was well accepted by women in Norway and detected more CIN2, CIN3, and cancers compared with the LBC-Screening protocol.
Impact:
A randomized implementation of the HPV-Screening protocol with real-world assessment enabled a gradual, quality assured, and safe technology transition. HPV-based screening protocol may further be improved by using HPV genotyping and age-specific referral algorithms.publishedVersio
Additional file 1: Table S1. of Accuracy of cervical cytology: comparison of diagnoses of 100 Pap smears read by four pathologists at three hospitals in Norway
Diagnoses per pathologist (P2âP5) in samples with Normal cytology at UNN. Table S2. Diagnoses per pathologist (P2âP5) in samples with ASC-US cytology at UNN. Table S3. Diagnoses per pathologist (P2âP5) in samples with LSIL cytology at UNN. Table S4. Diagnoses per pathologist (P2âP5) in samples with ASC-H cytology at UNN. Table S5. Diagnoses per pathologist in samples with HSIL cytology at UNN. Figure S1. Distribution of high-grade cytology (ASC-H+) diagnoses by observer (P2âP5) in women with at least one high-grade cytology (N=61). Figure S2. Distribution of high-grade cytology (ASC-H+) diagnoses by observer (P2âP5) in women with histological CIN2+ in follow-up (N=32). (PDF 100 kb
Triaging HPV-Positive Cervical Samples with p16 and Ki-67 Dual Stained Cytology within an Organized Screening ProgramâA Prospective Observational Study from Western Norway
The implementation of high-risk human papillomavirus testing (hrHPV testing) as a screening method in substitute for cytology has evoked the need for more sensitive and less objective tests for the triage of HPV-positive women. In a cohort of 1763 HPV-positive women, the potential of immunocytochemical p16 and Ki-67 dual staining as compared to cytology, alone or in combination with HPV partial genotyping, was tested for triage of women attending a cervical cancer screening program. Performance was measured using sensitivity, specificity, and positive and negative predictive values. Comparisons were assessed using logistic regression models and the McNemar test. Dual staining was evaluated in a prospectively collected study cohort of 1763 HPV-screened women. For triage of CIN2+ and CIN3+, NPV and sensitivity, 91.8% and 94.2% versus 87.9% and 89.7%, respectively, were significantly higher using dual staining together with HPV 16/18 positive, as compared to cytology (p < 0.001). The specificities, however, were lower for dual staining as compared to cytology. Conclusions: Dual staining is safer for decision-making regarding HPV-positive womenâs need for follow-up with colposcopy and biopsy, as compared to cytology
Randomized implementation of a primary human papillomavirus testing-based cervical cancer screening protocol for women 34 to 69 years in Norway
Background:
Cervical cancer screening programs are facing a programmatic shift where screening protocol based on human papillomavirus testing (HPV-Screening protocol) is replacing the liquid-based cytology (LBC-Screening protocol). For safe technology transfer within the nationwide screening programme in Norway, HPV-Screening protocol was implemented randomized to compare the real-world effectiveness of HPV-Screening protocol and LBC-Screening protocol at the first screening round.
Methods:
Among 302,295 women ages 34 to 69 years scheduled to attend screening from February 2015 to June 2017, 157,447 attended. A total of 77,207 were randomly allocated to the HPV-Screening protocol and 80,240 were allocated to the LBC-Screening protocol. All women were followed up for 18 months.
Results:
The HPV-Screening protocol resulted in a relative increase of 60% in the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse [risk ratio (RR) = 1.6, 95% confidence interval (CI) = 1.5â1.7], 40% in CIN grade 3 or worse (RR = 1.4, 95% CI = 1.3â1.6), 40% in cancer (RR = 1.4, 95% CI = 1.0â2.1), and 60% in colposcopy referrals (RR = 1.6, 95% CI = 1.5â1.6) compared with LBC-Screening. The performance of both protocols was age dependent, being more effective in women ages under 50 years.
Conclusions:
The HPV-Screening protocol was well accepted by women in Norway and detected more CIN2, CIN3, and cancers compared with the LBC-Screening protocol.
Impact:
A randomized implementation of the HPV-Screening protocol with real-world assessment enabled a gradual, quality assured, and safe technology transition. HPV-based screening protocol may further be improved by using HPV genotyping and age-specific referral algorithms
Prosjektforslag hjemmetest: Implementering av hjemmeprĂžvetaking i Livmorhalsprogrammet
Effektiv forebygging av livmorhalskreft fordrer at kvinner deltar i Livmorhalsprogrammet som anbefalt. I dag er deltakelsen pĂ„ 71%, mens anbefalt deltakelse er minimum 80% ifĂžlge internasjonale retningslinjer. Over halvparten av livmorhalskrefttilfellene diagnostisert i Norge er blant kvinner som ikke har tatt livmorhalsprĂžver som anbefalt. I tillegg fĂ„r de som aldri eller sjelden screener seg, oftere pĂ„vist livmorhalskreft pĂ„ et hĂžyere stadium enn de som screener seg som anbefalt. En ny norsk studie viser at tilbud om hjemmetest til denne gruppen avdekker et betydelig antall forstadier til kreft og kreft som ikke ville blitt avdekket ved ordinĂŠr pĂ„minnelse om Ă„ ta screeningprĂžve hos lege. BĂ„de internasjonale og norske studier har vist at man pĂ„ en kostnadseffektiv mĂ„te kan oppnĂ„ en betydelig forbedret deltakelse i screeningprogrammet blant kvinner dersom de fĂ„r tilbud om hjemme-prĂžvetaking (= hjemmetest). Helsedirektoratet har bedt Kreftregisteret om Ă„ utrede hjemmetest som et tiltak for Ă„ Ăžke deltakelsen i Livmorhalsprogrammet blant kvinner som ikke har mĂžtt til screening pĂ„ mer enn ti Ă„r. Forslaget skulle ogsĂ„ inkludere bruk av hjemmetest for kvinner som ikke har tatt livmorhalsprĂžve pĂ„ grunn av covid-19 pandemien, og eventuelle andre grupper. Denne rapporten skisserer hvordan hjemmetest kan innfĂžres i Livmorhalsprogrammet. Anbefalt strategi er Ă„ gi tilbud om hjemmetest til tre grupper. Den fĂžrste gruppen er kvinner med betydelig Ăžkt risiko for alvorlige celleforandringer i livmorhalsen pĂ„ grunn av manglende deltakelse over lengre tid. Spesifikt anbefales det at kvinner uten registrert livmorhalsprĂžve i lĂžpet av ti Ă„r eller mer fĂ„r hjemmetest tilsendt i posten (opt-out). Den andre gruppen er kvinner uten registrert livmorhalsprĂžve de siste Ă„tte eller ni Ă„r, denne gruppen anbefales Ă„ fĂ„ mulighet til Ă„ bestille hjemmetest (opt-in). Den siste gruppen er kvinner som av fysiske eller psykiske Ă„rsaker vegrer seg for Ă„ ta en livmorhalsprĂžve hos legen. Det planlegges at disse kvinnene fĂ„r tilbud om hjemmetest via lege. Hjemmetesting er enda mer aktuelt nĂ„ pĂ„ grunn av covid-19 pandemien. Normalt registrerer Livmorhalsprogrammet cirka 450 000 prĂžver per Ă„r. Grove estimater viser at det ble registrert 50 000 fĂŠrre livmorhalsprĂžver enn forventet i 2020. En ny smittebĂžlge av covid-19 i november 2020, som fĂžrte til en ny sosial nedstenging av samfunnet i Oslo-regionen i januar 2021, ser ogsĂ„ ut til Ă„ ha pĂ„virket antall registrerte prĂžver i januar 2021. Hjemmetest i seg selv er et mer kostnadseffektivt alternativ enn legetatt prĂžve, ettersom helsepersonell ikke involveres i selve prĂžvetakingen. De helseĂžkonomiske modellene inkludert i rapporten viser at tilbud om hjemmetest gir en helsegevinst ved at andelen kvinner som deltar i screeningprogrammet vil Ăžke, og dermed reduseres deres livstidsrisiko for Ă„ utvikle livmorhalskreft. Ăkt deltakelse vil imidlertid medfĂžre en Ăžkt kostnad for screeningvirksomheten, men for samfunnet som en helhet vil det vĂŠre lĂžnnsomt. Dette tilbudet vil resultere i samfunnsmessige besparelser fordi fĂŠrre kvinner vil mĂ„tte behandles for livmorhalskreft. Kvinner som rammes av livmorhalskreft fĂ„r Ăžkte kvalitetsjusterte leveĂ„r (pĂ„ engelsk: quality-adjusted life years -QALYs). I vĂ„r forenklede modell-baserte analyse ble det estimert at opt-out hjemmetesting, sammenlignet med pĂ„minnelsesbrev, kunne gi mer enn 1 365 ekstra (diskontert) QALYs blant de 217 000 kvinnene som kvalifiserer til hjemmetest i lĂžpet av fem Ă„r. Dette er langt flere QALYs enn de 155 som behĂžves for Ă„ vĂŠre kostnadseffektiv, gitt at myndighetenes betalingsvillighet for et ekstra leveĂ„r er 385 000 kroner. Samlet viser ogsĂ„ beregningsmodellene som er gjennomfĂžrt, at kostnaden per tilfelle av alvorlige celleforandringer som oppdages, er lavere ved hjemmetest sammenlignet med vanlig pĂ„minnelse og prĂžvetaking hos lege