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Objective: In 2017, Australian's National Cervical Screening Program changed from 2-yearly cytology to 5-yearly primary human papillomavirus (HPV) testing. The Stakeholder Opinions of Renewal Implementation and Experiences Study (STORIES) aimed to capture stakeholder perspectives during implementation of the renewed National Cervical Screening Program., Materials and Methods: Qualitative semistructured interviews were conducted with key National Cervical Screening Program stakeholders 11-20 months following the change, either face-to-face, online, or via phone. Data related to colposcopy services were thematically analyzed using Proctor's conceptual framework for implementation outcomes., Results: The authors identified 4 overarching themes: non-adherence to guidelines, lack of preparedness, unintended consequences, and mitigation strategies. While an initial increase in colposcopy referral was expected following transition, many stakeholders found increased referrals to be inequitably spread across services and exacerbated by confusion about, or overuse of testing for, symptoms., Conclusions: The study provides the first assessment of stakeholder perceptions and experiences relating to colposcopy services during a transition from cytology to HPV screening. Significant preparation is required to ensure equitable and timely access to colposcopy when transitioning cervical screening programs, including wide stakeholder communication to build confidence; clear guidelines, especially around symptoms; and adequate resourcing for colposcopy services to meet projected referral rates., Competing Interests: Declaration of interests: The C4 CRE is a collaborative network led by the Daffodil Centre (a joint venture between Cancer Council NSW (CCNSW) and University of Sydney), Australian Centre for the Prevention of Cervical Cancer (ACPCC), University of Melbourne and Kirby Institute. Cancer Council NSW, ACPCC and University of Melbourne have received contract funding from Commonwealth Department of Health for work related to the NCSP outside the current analysis. ACPCC has received self-collection tests for research outside this current analysis without charge from Abbott, BD, Roche, Seegene, Cepheid. ACPCC has received equipment and funding for the Compass trial from Roche Molecular Systems and Ventana USA. Researchers are/were employees of CCNSW and ACPCC who were involved in the rNCSP. Employees of ACPCC were invited to participate in the study in their role as key stakeholders. In any instances where potential conflicts of interest were apparent, the interview was performed by a researcher without conflicts., (Copyright © 2024, ASCCP.)

Aims: To assess colposcopic performance and determine indicators for competency within the new Australian primary human papillomavirus (HPV) cervical screening program., Materials and Methods: A retrospective observational study of 4542 women seen at The Royal Women's Hospital Colposcopy Clinic in Melbourne, from 1 December 2017 to 31 July 2020 after a higher-risk cervical screening test (CST) result., Results: Histological CIN2+ was detected in 25.1% up to two years from first colposcopy visit (FCV). The majority (86.7%) of CIN2+ was detected early within the first six months of presentation. Biopsy rate overall was 96.1% with abnormal colposcopic impression. Of four colposcopists with a lower biopsy rate, only one was able to achieve this early detection rate. Biopsy was also taken in over 30% of cases with negative reflex cytology and normal colposcopy, with CIN2+ detected in 5.0% among positive HPV16/18 and 3.8% with non-16/18 HPV. Positive predictive value of high-grade colposcopic impression at FCV averaged 66.4% (range: 54.9-81.6% among our colposcopists) and is poorly correlated with early detection rate of CIN2+. Overall accuracy of colposcopy is 84.5% (range: 78.7-90.3%), buoyed by high true negative colposcopic predictions secondary to high rates of negative reflex cytology referral with the new screening algorithm and is also unlikely to be a useful colposcopy indicator., Conclusions: Early detection rate of CIN2+ within the first six months of presentation is a useful measure of colposcopy competency and we would encourage our National Cancer Screening Register to explore this with the participating colposcopists., (© 2024 Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Aims: To examine outcomes in women aged 50-74 years after detection of oncogenic human papillomavirus (HPV) at cervical screening., Materials and Methods: A retrospective observational study of 464 women seen in the Royal Women's Hospital Colposcopy Clinic from 1 January 2018 to 31 July 2020, 292 (62.9%) were positive for HPV16/18 and 172 (37.1%) for HPV (not 16/18)., Results: Fifty-four women (11.6%) had histologically proven CIN2+ including seven cancers, up to two years after first colposcopy visit (FCV): 48 (88.9%) detected at FCV or at excisional treatment (Excision) arranged after no CIN2+ detected at FCV. There was no significant difference (P = 0.14) in proportion of CIN2+ detected between the two groups, 'HPV16/18' (9.9%) or 'HPV (not 16/18)' (14.5%), nor with reflex cytology types. The positive predictive value (PPV) of high-grade impression at colposcopy was 63.6%. There were 243 (52.4%) who had Type 3 transformation zone (TZ3) with 20 CIN2+ detected, 13 at FCV including all three cancers and five at Excision. There were 214 (73.3%) with positive HPV16/18 who had reflex negative cytology, of which seven had CIN2+ including one cancer but only two (1.4%) CIN2+ when their repeat cytology at colposcopy was negative., Conclusions: Most CIN2+ were detected at first colposcopy or at subsequent excision. We would encourage high biopsy rates at colposcopy and vigilance in selection for excisional treatment in TZ3 cases if there is no significant suspicion of high-grade abnormality. There is a need to refine the algorithm for management of persistent HPV16/18 infections with reflex negative cytology to reduce colposcopy referrals in women aged 50 and above., (© 2023 Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Aim: To examine outcomes in women following cervical screening detection of oncogenic human papillomavirus (HPV), with reflex cytology showing possible high-grade squamous intraepithelial lesion (pHSIL)., Materials and Methods: A retrospective observational study of 523 women seen in the Royal Women's Hospital Colposcopy Clinic from 1 January 2018 to 31 July 2020., Results: Two hundred eighty-two (53.9%) women had histology-confirmed HSIL, encompassing CIN2 or worse (CIN2+), including seven cancers (1.3%) and two adenocarcinoma in situ (AIS) (0.4%). In 81.2% (229/282) of women with CIN2+, this was detected on cervical biopsy at initial colposcopy, with another 8.9% (25/282) of CIN2+ detected at cervical excision following initial colposcopy and the remaining 9.9% (28/282) at follow-up colposcopy thereafter. When discordant cervical biopsy results were discussed at multidisciplinary meeting (MDM), 66.7% of women with pHSIL cytology upgraded to definite HSIL were found to have CIN2+, but only 20.8% when pHSIL cytology was retained and none when downgraded to low-grade (LSIL) or normal. No significant difference was found in the proportion of CIN2+ based on patient age above or below 40, HPV16 and/or 18 versus non 16/18, or whether discordant findings were reviewed at MDM., Conclusions: We propose a pathway for management of women with positive oncogenic HPV and reflex pHSIL cytology. MDM review is recommended when CIN2+ is not identified on cervical biopsy at initial colposcopy. Conservative management is safe with low risk of CIN2+ when LBC prediction of pHSIL is confirmed or downgraded at MDM with no high-grade change on colposcopy or repeat cytology., (© 2021 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Background: Primary human papillomavirus (HPV) screening was introduced in Australia in December 2017., Aims: Outcomes for women after positive HPV in their cervical screening test (CST)., Materials and Methods: A retrospective observational study of 4458 women seen at the Royal Women's Hospital Colposcopy Clinic from 1 January 2018 to 31 July 2020., Results: HPV16/18 was positive (considered higher-risk CST) in 42.2% of women in the study, 16.6% with reflex possible with high-grade squamous intraepithelial lesions (pHSIL) or worse and 54.9% with normal cytology. There were 24.8% of women with positive HPV16/18 who had histological confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+), 10.3% CIN2+ (including six cancers) among women with reflex negative cytology and 87.7% CIN2+ among women with reflex HSIL cytology. In women with positive HPV (not 16/18), CIN2+ was found in 60.2% with reflex pHSIL or worse cytology (higher risk) and 10.2% with reflex low-grade SIL (LSIL) or normal cytology (intermediate risk). Median waiting time to colposcopy with the intermediate-risk group went up to 181 days. Our colposcopists were able to achieve a positive predictive value (PPV) for CIN2+ of 69.9%, higher than 57.8% PPV in the National Cervical Screening Program (NCSP) 2020 monitoring report. Women with type 3 transformation zone on colposcopy could be followed up with CST if no HSIL was suspected on screening or at colposcopy as their risk of CIN2+ was only 2.5%., Conclusions: Our findings support direct referral to colposcopy for women with higher-risk CST, with all cancers confined to this group. The NCSP recommendation to refer for colposcopy only after three intermediate-risk CST will need monitoring with the LSIL triage group., (© 2021 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Background: Colposcopy has been recommended for all women with recurrent post-coital bleeding (PCB) even if their cervical cytology or co-test (involving oncogenic human papillomavirus (HPV) DNA testing and cytology) are negative., Aims: To determine the risk of cervical cancer and its precursors among women with recurrent PCB with negative cytology or co-test., Materials and Methods: A retrospective analysis of two cohorts of women with PCB referred to a tertiary colposcopy clinic. Cohort (1) (n = 1846) between 1 January 2000 and 31 December 2016 (cytology-based screening) and Cohort (2) (n = 215) from 1 January 2018 to 31 December 2019 after introduction of primary HPV screening., Results: In 1217 (65.9%) women in Cohort (1) referred with negative cytology, there was one cancer (0.08%) and 22 high-grade squamous intraepithelial lesions (HSIL (cervical intraepithelial neoplasia 2/3)) on histopathology. In Cohort (2), there was no cancer or HSIL in 83 women with negative co-tests (negative for oncogenic HPV and cytology). False-negative cytology after a negative referral cytology or co-test was low with 2% of repeat cytology at initial colposcopy showing possible HSIL or worse., Conclusions: Women presenting with PCB and negative cytology alone have a low risk of cancer and could have HPV testing before being triaged to colposcopy. We showed that with the assurance of a negative co-test and the low likelihood of false-negative cytology, these women could avoid colposcopy unless cervical cancer is clinically suspected. There is a need for a larger cohort study to substantiate our findings with more precision., (© 2020 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Objective: Adenocarcinoma in situ (AIS) of the cervix is a precursor to cervical adenocarcinoma. When AIS is detected by cervical screening an excision biopsy is mandatory to exclude invasion. We aimed to compare margins status, specimen size and fragmentation after loop electrosurgical excision procedure (LEEP) and 'cold knife cone biopsy' (CKC)., Methods: The EXCISE Trial was an investigator-initiated, multicenter, open-label, parallel-group, phase 2, randomized study. Patients were enrolled at seven hospitals in Australia and New Zealand. We randomly assigned women aged ≥18 to ≤45 years with screen detected AIS to LEEP or CKC. Co-primary endpoints were margin status, specimen size and fragmentation. Analysis was by intention-to-treat., Results: Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. Margin status was evaluable in 36 cases. The proportion of patients with involved margins did not differ between groups. 25 of 26 LEEP and all 14 CKC biopsies were excised as single specimens (p = 1·00). There were no differences in specimen dimensions. Patients in the CKC group had more post-operative complications (64.3% compared to 15.4% for LEEP p = ·00). There were no differences in grade three complications (p = ·65)., Conclusions: LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol. However, the study was not powered to establish non-inferiority of LEEP and a definitive phase 3 trial to compare margin status and rates of treatment failure after LEEP and CKC is warranted., Competing Interests: Declaration of Competing Interest PAC and CDHW have received honoraria from Seqirus unrelated to this work. MRS has received grants from Astellas, Amgen, Astra Zeneca, Bayer, Bionomics, Bristol-Meyers-Squibb, Celgene, Medivation, Merck Sharp & Dohme, Pfizer, Roche, Sanofi, Specialised Therapeutics and Tilray unrelated to this work. All other authors declare no competing interests., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Autoimmune conditions (AICs) and/or their treatment may alter risk of human papilloma virus (HPV) infection and females with AICs are therefore at an increased risk of cervical dysplasia. However, inclusion of these at-risk populations in cervical cancer screening and HPV-vaccination guidelines, are mostly lacking. This study aimed to determine the prevalence of cervical dysplasia in a wide range of AICs and compare that to HIV and immunocompetent controls to support the optimisation of cervical cancer preventive health measures., Methods: Data linkage was used to match cervical screening episodes to emergency department records of females with AICs or HIV to immunocompetent controls over a 14-year period. The primary outcome was histologically confirmed high-grade cervical disease. Results, measured as rates by cytology and histology classification per 1,000 females screened, were analysed per disease group, and intergroup comparisons were performed., Results: Females with inflammatory bowel disease (2,683), psoriatic and enteropathic arthropathies (1,848), multiple sclerosis (MS) (1,426), rheumatoid arthritis (1,246), systemic lupus erythematosus and/or mixed connective tissue disease (SLE/MCTD) (702), HIV (44), and 985,383 immunocompetent controls were included. SLE/MCTD and HIV groups had greater rates of high-grade histological and cytological abnormalities compared to controls. Increased rates of low-grade cytological abnormalities were detected in all females with AICs, with the exception of the MS group., Conclusions: Females with SLE/MCTD or HIV have increased rates of high-grade cervical abnormalities. The increased low-grade dysplasia rate seen in most females with AICs is consistent with increased HPV infection. These findings support expansion of cervical cancer preventative programs to include these at-risk females., Competing Interests: Dr Foster, Dr Malloy, A/Prof Van Doornum, Dr Unglik and A/Prof Brotherton have no conflict of interest to declare. Dr Jokubaitis has received speaker’s honoraria from Biogen, and conference travel support from Merck. She receives research funding from MS Research Australia, and the Australian National Health and Medical Research Council (NHMRC). Mr. Wrede has received Honoraria and Sponsorship from Biogen and Seqirus. He is Deputy Chairman of the Board of VCS Foundation Pty Ltd. He is a member of the Clinical Expert Panel reviewing the Australian Cervical Screening Program. Prof Butzkueven serves as the Director of the MSBase foundation. He serves on steering committees and advisory boards for Biogen, Roche, Merck, Sanofi, Novartis. He has received speaker’s honoraria, travel support and receives research grant support from Roche, Biogen, Merck, Sanofi, Novartis and Teva. Prof Sasadeusz has been on advisory boards for Merck. Prof Macrae is on advisory committee for Pfizer and receives funding for the conduct of multiple clinical trials in inflammatory bowel disease. He receives funding from Cancer Australia, Cancer Council NSW, and NHMRC for investigator-initiated studies. A/Prof van der Walt has received speaker’s honoraria, travel support and served on advisory boards for Biogen, Merck, Sanofi, Novartis and Teva. She receives funding from the NHMRC Australia. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Australian guidelines for cervical cancer screening are being revised under the "renewal program". Physicians' willingness to accept these changes will play a pivotal role in its success., Objective: To understand the willingness and acceptance of, as well as barriers and facilitators for Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) affiliates to screening using human papillomavirus (HPV) testing, starting at 25 years of age, every 5 years., Study Design: An electronic survey of RANZCOG affiliates was undertaken April-June 2014, while renew was announced April 28th 2014. Responses used a 7 point Likert scale, which was dichotomized as ≤4, indicating 'unwilling' and >4, indicating 'willing' to adopt revised practices., Results: Response rate was 22% (n=956): 60% were obstetricians and gynaecologists (OG); 27% general practitioner diplomates; 13% OG trainees. Overall, 60% (n=526/874) were willing to revise their screening practice. This correlated with awareness of new guidelines (p=<0.001). Fifty percent (n=438/869) of respondents were concerned about delaying to 25 years, and 48% (n=421/869) concerned cervical cancers would be missed. Reasons respondents gave for wishing to continue screening from 18 years contrary to guidelines included: women not being vaccinated (65.6%), immunosuppressed women (92.2%) and women who had been victims of childhood sexual assault (73.9%)., Conclusions: The majority of RANZCOG affiliates were willing to change screening practice however, a number of barriers to delaying onset of screening age to age 25 years were reported. Effective change management strategies will need to be implemented to address the concerns raised to ensure best practice for cervical screening., (Copyright © 2015 Elsevier B.V. All rights reserved.)