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  • 1
    Online Resource
    Online Resource
    Accuracy of colposcopy‐directed biopsy vs dynamic spectral imaging directed biopsy in correctly identifying the grade of cervical dysplasia in women undergoing conization: A methodological study
    Wiley ; 2020
    In:  Acta Obstetricia et Gynecologica Scandinavica Vol. 99, No. 8 ( 2020-08), p. 1064-1070
    Details
    In: Acta Obstetricia et Gynecologica Scandinavica, Wiley, Vol. 99, No. 8 ( 2020-08), p. 1064-1070
    Abstract: Dynamic spectral imaging (DSI) colposcopy has previously been found to improve sensitivity of CIN2+ detection. The aim of this study was to compare the histological diagnosis of colposcopic‐directed biopsies (CDB) with that of DSI‐directed biopsies in women undergoing conization, using the histological diagnosis of the conization specimen as gold standard. Material and methods Women referred for colposcopy were included in a prospective cohort study at Randers Regional Hospital, Denmark, from January 2016 to February 2019. All women had four cervical punch biopsies taken. The first biopsy was taken from the area that appeared most abnormal by conventional colposcopy (ie, CDB) and the second biopsy from the area that appeared most abnormal using the DSI map. An additional two biopsies were taken either from other visible lesions or as random biopsies. Biopsies were analyzed separately. If any biopsies revealed cervical dysplasia of such a degree that excisional treatment was recommended, the patient was referred for conization. Subsequently, we compared the histological diagnosis of CDB and DSI‐directed biopsies with that of the cone biopsy. Results A total of 573 women were enrolled, 170 of which underwent conization. In women with an adequate colposcopy and representative biopsies (n = 124) there was an overall agreement rate between the worst biopsy diagnosis (of any four) and the conization diagnosis in 95.2% (95% CI 89.8‐98.2) of women. CDB diagnosis agreed with the cone diagnosis in 80.6% (95% CI 72.6‐87.2) of women. DSI‐directed biopsy agreed with the cone diagnosis in 83.9% (95% CI 76.2‐89.9) of women. The difference in detection rate between the CDB and the DSI‐directed biopsy was, however, not significant ( P  = .54). Taking four biopsies increases the detection rate of cervical dysplasia to 95.2%, which was a significant increase from both CDB alone ( P  = .0008) and DSI‐directed biopsy alone ( P  = .0053). Conclusions We found no significant difference in the ability to identify the cervical dysplasia grade between CDB and DSI‐directed biopsies. A higher detection rate of cervical dysplasia was achieved with four biopsies than with one CDB biopsy or one DSI‐directed biopsy.
    Type of Medium: Online Resource
    ISSN: 0001-6349 , 1600-0412
    URL: Issue
    URL: Article
    DOI: 10.1111/aogs.v99.8
    DOI: 10.1111/aogs.13832
    RVK:
    YM 6500
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2024554-3
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  • 2
    Online Resource
    Online Resource
    Cervical screening in Denmark – a success followed by stagnation
    Informa UK Limited ; 2018
    In:  Acta Oncologica Vol. 57, No. 3 ( 2018-03-04), p. 354-361
    Details
    In: Acta Oncologica, Informa UK Limited, Vol. 57, No. 3 ( 2018-03-04), p. 354-361
    Type of Medium: Online Resource
    ISSN: 0284-186X , 1651-226X
    URL: Article
    DOI: 10.1080/0284186X.2017.1355110
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2018
    detail.hit.zdb_id: 1492623-4
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  • 3
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    Online Resource
    Danish method study on cervical screening in women offered HPV vaccination as girls (Trial23): a study protocol
    BMJ ; 2018
    In:  BMJ Open Vol. 8, No. 5 ( 2018-05), p. e020294-
    Details
    In: BMJ Open, BMJ, Vol. 8, No. 5 ( 2018-05), p. e020294-
    Abstract: The first birth cohorts of women offered human papillomavirus (HPV) vaccination as girls are now entering cervical screening. However, there is no international consensus on how to screen HPV vaccinated women. These women are better protected against cervical cancer and could therefore be offered less intensive screening. Primary HPV testing is more sensitive than cytology, allowing for a longer screening interval. The aim of Trial23 is to investigate if primary HPV testing with cytology triage of HPV positive samples is a reasonable screening scheme for women offered HPV vaccination as girls. Methods Trial23 is a method study embedded in the existing cervical screening programme in four out of five Danish regions. Without affecting the screening programme, women born in 1994 are randomised to present screening with liquid-based cytology every third year (present programme arm) or present screening plus an HPV test (HPV arm). The study started 1 February 2017 and will run over three screening rounds corresponding to 7–8 years. Analyses The primary endpoint is cervical intraepithelial neoplasia grade 3 or above. The trial is undertaken as a non-inferiority study including intention-to-treat and per-protocol analyses. The potential effect of primary HPV screening with a 6-year interval will be calculated from the observed data. Ethics and dissemination The study protocol has been submitted to the ethical committee and deemed a method study. All women are screened according to routine guidelines. The study will contribute new evidence on the future screening of HPV vaccinated birth cohorts of women. All results will be published in open-access journal. Trial registration NCT03049553 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2017-020294
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 2599832-8
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  • 4
    Online Resource
    Online Resource
    HrHPV testing vs liquid-based cytology in cervical cancer screening among women aged 50 and older: a prospective study
    BMJ ; 2020
    In:  International Journal of Gynecologic Cancer Vol. 30, No. 11 ( 2020-11), p. 1678-1683
    Details
    In: International Journal of Gynecologic Cancer, BMJ, Vol. 30, No. 11 ( 2020-11), p. 1678-1683
    Abstract: Evidence supports high-risk human papilloma virus (HPV) testing as the primary cervical cancer screening tool. However, benefits and harms should be carefully considered before replacing liquid-based cytology. In women age 50 and older, we evaluated how a commercially available DNA amplification HPV test compares with routine liquid-based cytology. Methods This prospective study included 4043 patients who had a cervical sample analyzed from September 2011 to September 2012. Patients were followed between 64 and 76 months (median: 70 months). Samples were analyzed using both liquid-based cytology and the Cobas 4800 HPV DNA test. We calculated the diagnostic efficacy of liquid-based cytology and HPV, with or without the opposite test as triage, using cervical intraepithelial neoplasia (CIN2+/CIN3+) as reference. Results The patients had a median age of 58 years, (range; 50–90). At baseline, HPV prevalence was 8.0%: a total of 3.7% of patients had atypical squamous cells of undetermined significance or worse (ASCUS+). Positive test results were 1.9% for liquid-based cytology with HPV triage and 3.0% for HPV with liquid-based cytology triage. The cumulative incidence of CIN3+ was 1.0% (40/4043). Sensitivities for CIN3+ were: liquid-based cytology 47.5% (31.5%–63.9%); liquid-based cytology with HPV triage 45.0% (29.3%–61.5%); HPV 90.0% (76.3%–97.2%); and HPV with liquid-based cytology triage 67.5% (50.9%–81.4%). Corresponding specificities were: liquid-based cytology 96.6% (96.0%–97.2%); liquid-based cytology with HPV triage 98.5% (98.0%–98.8%); HPV 92.8% (92.0%–93.6%); and HPV with liquid-based cytology triage 97.7% (97.2%–98.1%). At baseline, HPV testing overlooked five cases of gynecological cancer other than cervical cancer. Five cervical cancers were detected, two had been overlooked at baseline by liquid-based cytology and two by HPV testing Conclusion HPV screening using DNA amplification is a promising alternative to liquid-based cytology in women age 50 and older, but evaluation of alternative triage methods is warranted. The risk of overlooking cancers needs consideration when replacing liquid-based cytology with HPV testing as a method for primary screening.
    Type of Medium: Online Resource
    ISSN: 1048-891X , 1525-1438
    URL: Article
    DOI: 10.1136/ijgc-2020-001457
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2009072-9
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  • 5
    Online Resource
    Online Resource
    Management of low-grade cervical cytology in young women. Cohort study from Denmark
    Informa UK Limited ; 2021
    In:  Acta Oncologica Vol. 60, No. 4 ( 2021-04-03), p. 444-451
    Details
    In: Acta Oncologica, Informa UK Limited, Vol. 60, No. 4 ( 2021-04-03), p. 444-451
    Type of Medium: Online Resource
    ISSN: 0284-186X , 1651-226X
    URL: Article
    DOI: 10.1080/0284186X.2020.1831061
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2021
    detail.hit.zdb_id: 1492623-4
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  • 6
    Online Resource
    Online Resource
    Dynamic Spectral Imaging Colposcopy Versus Regular Colposcopy in Women Referred With High-Grade Cytology: A Nonrandomized Prospective Study
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of Lower Genital Tract Disease Vol. 25, No. 2 ( 2021-4), p. 113-118
    Details
    In: Journal of Lower Genital Tract Disease, Ovid Technologies (Wolters Kluwer Health), Vol. 25, No. 2 ( 2021-4), p. 113-118
    Abstract: The aim of the study was to evaluate the sensitivity of dynamic spectral imaging (DSI) colposcopy compared with regular colposcopy for women referred with high-grade cervical cytology. Methods In a prospective, nonrandomized, multicenter study, we included women referred for colposcopy at hospital gynecology clinics with high-grade cytology. Women were examined using either a regular or DSI colposcope. In both groups, colposcopists located 1 area viewed as most suspicious. In the DSI group, this was done before viewing the DSI map. Subsequently, an area was chosen based on the worst color of the DSI map, and further additional biopsies were taken. All women had 4 cervical biopsies taken, all analyzed separately. The main outcome was sensitivity to find cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Results A total of 261 women were examined using DSI colposcopy, and 156 women were examined using regular colposcopy. The sensitivity for finding CIN2+ when using the DSI technology as an adjunctive technology was found to be 82.2% (95% CI = 75.9–87.4), based on an average of 1.4 biopsies. This was corresponding in sensitivity to 2 biopsies taken using regular colposcopy (80.3%; 95% CI = 72.3–86.8). There was no difference in sensitivity for CIN+ between the groups when 3 or more biopsies were taken. Conclusions We found that the DSI colposcope may help direct biopsy placement; however, the improvement is based on small differences in needed biopsies and the clinical significance of this may be small. Multiple biopsies were still superior.
    Type of Medium: Online Resource
    ISSN: 1526-0976
    URL: Article
    DOI: 10.1097/LGT.0000000000000586
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2006922-4
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  • 7
    Online Resource
    Online Resource
    Can the dynamic spectral imaging (DSI) color map improve colposcopy examination for precancerous cervical lesions? A prospective evaluation of the DSI color map in a multi-biopsy clinical setting
    Springer Science and Business Media LLC ; 2021
    In:  BMC Women's Health Vol. 21, No. 1 ( 2021-12)
    Details
    In: BMC Women's Health, Springer Science and Business Media LLC, Vol. 21, No. 1 ( 2021-12)
    Abstract: Colposcopy serves as a subjective examination of the cervix with low sensitivity to detect cervical intraepithelial dysplasia (CIN) grade 2 or worse (CIN2 +). Dynamic spectral imaging (DSI) colposcopy has been developed to provide an objective element to cervix examinations and has been proven to increase sensitivity of detecting CIN2 + . We aimed to assess the performance of the DSI color map and compared it to histological diagnoses of cervical biopsies in determining the CIN grade present. Methods Women were included in a consecutive, prospective manner at Randers Regional Hospital, Denmark. Women were eligible to participate if they were referred for colposcopy due to abnormal cervical smear (threshold:  ≥ ASCUS) or follow-up after previously diagnosed CIN. All women had four biopsies taken, one directed by colposcopists alone prior to viewing the DSI color map, one directed by the worst color on the respective DSI color map, and two additional biopsies. All biopsies were analyzed separately. We calculated sensitivity, specificity, positive predictive values, and negative predictive values (NPVs) with 95% confidence intervals (CIs). Results A total of 800 women were recruited. Of these, 529 (66.1%) were eligible for inclusion. The sensitivity of the DSI color map was found to be 48.1% (95% CI 41.1–55.1) in finding CIN grade 2 or worse (CIN2 +) when compared to the histological diagnosis of the DSI directed biopsy. This was 42.5% (95% CI 36.7–48.5) when compared to the final histological diagnosis of all four cervical biopsies and with an NPV of 53.5% (95% CI 50.5–56.5). Conclusion The worst color indicated by the DSI map might not consistently reflect the true grade of cervical dysplasia present. Thus, even though the DSI color map indicates low-grade changes, colposcopists should still consider taking biopsies from the area as high-grade changes might be present. Trial registration : NCT04249856, January 31 2020 (retrospectively registered).
    Type of Medium: Online Resource
    ISSN: 1472-6874
    URL: Article
    DOI: 10.1186/s12905-020-01169-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2050444-5
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  • 8
    Online Resource
    Online Resource
    HPV-prevalence in elderly women in Denmark
    Elsevier BV ; 2019
    In:  Gynecologic Oncology Vol. 154, No. 1 ( 2019-07), p. 118-123
    Details
    In: Gynecologic Oncology, Elsevier BV, Vol. 154, No. 1 ( 2019-07), p. 118-123
    Type of Medium: Online Resource
    ISSN: 0090-8258
    URL: Article
    DOI: 10.1016/j.ygyno.2019.04.680
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
    detail.hit.zdb_id: 1467974-7
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  • 9
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    Prevalence of high‐risk human papillomavirus after HPV ‐vaccination in Denmark
    Wiley ; 2020
    In:  International Journal of Cancer Vol. 147, No. 12 ( 2020-12-15), p. 3446-3452
    Details
    In: International Journal of Cancer, Wiley, Vol. 147, No. 12 ( 2020-12-15), p. 3446-3452
    Abstract: What's new? Vaccination against human papillomavirus (HPV) has been introduced as a public health initiative in many countries. However, data on HPV infection prevalence at screening age in HPV‐vaccinated birth cohorts remain scarce. This study found that HPV‐16 and 18 were almost eliminated in a population aged 23‐24 years where 92% of women received quadrivalent HPV vaccination at age 14. Prevalence of HPV 16 and 18 was lower in non‐vaccinated women than in previous birth cohorts not offered HPV‐vaccination. Nonetheless, one third of vaccinated women were positive for high‐risk HPV other than 16/18, with potential implications for cervical cancer prevention and screening programs.
    Type of Medium: Online Resource
    ISSN: 0020-7136 , 1097-0215
    URL: Issue
    URL: Article
    DOI: 10.1002/ijc.v147.12
    DOI: 10.1002/ijc.33157
    RVK:
    XA 10000
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 218257-9
    detail.hit.zdb_id: 1474822-8
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  • 10
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    A cervical screening initiative for elderly women in Denmark
    Wiley ; 2023
    In:  Acta Obstetricia et Gynecologica Scandinavica Vol. 102, No. 6 ( 2023-06), p. 791-800
    Details
    In: Acta Obstetricia et Gynecologica Scandinavica, Wiley, Vol. 102, No. 6 ( 2023-06), p. 791-800
    Abstract: To assess outcome of a one‐time human papillomavirus (HPV)‐screening in 2017 of Danish women aged 70+. Material and methods Women born 1947 or before were personally invited to have a cell‐sample collected by their general practitioner. Screening‐ and follow‐up samples were analyzed in hospital laboratories in the five Danish regions and registered centrally. Follow‐up procedures varied slightly across regions. Cervical intraepithelial neoplasia 2 (CIN2) was recommended treatment threshold. Data were retrieved from the Danish Quality Database for Cervical Cancer Screening. We calculated CIN2+ and CIN3+ detection rates per 1000 screened women, and number of biopsies and conizations per detected CIN2+ case. We tabulated annual number of incident cervical cancer cases in Denmark for the years 2009–2020. Results In total, 359 763 women were invited of whom 108 585 (30% of invited) were screened; 4479 (4.1% of screened, and 4.3% of screened 70–74 years) tested HPV‐positive; of whom 2419 (54% of HPV‐positive) were recommended follow‐up with colposcopy, biopsy and cervical sampling, and 2060 with cell‐sample follow‐up. In total, 2888 women had histology; of whom 1237 cone specimen and 1651 biopsy only. Out of 1000 screened women 11 (95% confidence interval [CI]: 11–12) had conization. In total, 579 women had CIN2+; 209 CIN2, 314 CIN3, and 56 cancer. Out of 1000 screened women five (95% CI: 5–6) had CIN2+. Detection rate of CIN2+ was highest in regions where conization was used as part of first‐line follow‐up. In 2009–2016, number of incident cervical cancers in women aged 70+ in Denmark fluctuated around 64; in 2017 it reached 83 cases; and by 2021 the number had decreased to 50. Conclusions The prevalence of high‐risk HPV of 4.3% in women aged 70–74 is in agreement with data from Australia, and the detection of five CIN+2 cases per 1000 screened women is in agreement with data for 65–69 year old women in Norway. Data are thus starting to accumulate on primary HPV‐screening of elderly women. The screening resulted in a prevalence peak in incident cervical cancers, and it will therefore take some years before the cancer preventive effect of the screening can be evaluated.
    Type of Medium: Online Resource
    ISSN: 0001-6349 , 1600-0412
    URL: Issue
    URL: Article
    DOI: 10.1111/aogs.v102.6
    DOI: 10.1111/aogs.14574
    RVK:
    YM 6500
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2024554-3
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