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Objective: To report detailed age‐specific outcomes from the first round of an English pilot studying the implementation of high‐risk human papillomavirus (HR‐HPV) testing in primary cervical screening. Design: Observational study with screening in 2013–2016, followed by two early recalls and/or colposcopy until the end of 2019. Setting: Six NHS laboratory sites. Population: A total of 1 341 584 women undergoing screening with HR‐HPV testing or liquid‐based cytology (LBC). Methods: Early recall tests and colposcopies were recommended, depending on the nature of the screening‐detected abnormality. Main outcome measures: We reported standard screening process indicators, e.g. proportions with an abnormality, including high‐grade cervical intraepithelial neoplasia (CIN2+) or cancer, and the positive predictive value (PPV) of colposcopy for CIN2+, by screening test and age group. Results: Among unvaccinated women screened with HR‐HPV testing at age 24–29 years, 26.9% had a positive test and 10.4% were directly referred to colposcopy following cytology triage, with a PPV for CIN2+ of 47%. At 50–64 years of age, these proportions were much lower: 5.3%, 1.2% and 27%, respectively. The proportions of women testing positive for HR‐HPV without cytological abnormalities, whose early recall HR‐HPV tests returned negative results, were similar across the age spans: 54% at 24–29 years and 55% at 50–64 years. Two‐thirds of infections at any age were linked to non‐16/18 genotypes. Among women with CIN2, CIN3 or cervical cancer, however, the proportion of non‐16/18 infections increased with age. As expected, the detection of abnormalities was lower following screening with LBC. Conclusions: These data provide a reliable reference for future epidemiological studies, including those concerning the effectiveness of HPV vaccination. Data from the English pilot study provide a comprehensive overview of abnormalities detected through HPV screening. Data from the English pilot study provide a comprehensive overview of abnormalities detected through HPV screening. [ABSTRACT FROM AUTHOR]

BACKGROUND: Overcalling of abnormalities has been a concern for using cytology triage after positive high‐risk human papillomavirus (HPV) tests in cervical screening. METHODS: The authors studied the detection of cytological and histological abnormalities at age 24 to 64 years, using data from the English HPV pilot. The pilot compared routine implementation of primary cervical screening based on cytology (N = 931,539), where HPV test results were not available before cytology reporting, with that based on HPV testing (N = 403,269), where cytology was only required after positive HPV tests. RESULTS: Revealed HPV positivity was associated with a higher direct referral to colposcopy after any abnormality (adjusted odds ratio [ORadj], 1.16; 95% confidence interval [CI], 1.14‐1.18). Laboratories with higher direct referral referred fewer persistently HPV‐positive women after early recall. The detection of high‐grade cervical intraepithelial neoplasia (CIN2+) after direct referral increased with an ORadj of 1.17 (95% CI, 1.13‐1.20) for informed versus uninformed cytology. Generally, the positive predictive value (PPV) of colposcopy for CIN2+ remained comparable under both conditions of interpreting cytology. In women 50 to 64 years old with high‐grade dyskaryosis, however, the PPV increased from 71% to 83% after revealing HPV positivity (ORadj, 2.05; 95% CI, 1.43‐2.93). CONCLUSIONS: Quality‐controlled cervical screening programs can avoid inappropriate overgrading of HPV‐positive cytology.; These population‐based data show that the interpretation of triage cytology informed by a positive human papillomavirus (HPV) test can contribute to a higher overall detection of high‐grade cervical intraepithelial neoplasia without a concomitant increase in overreferral of low‐risk women. The practices used in England, where the national cervical screening program is quality‐assured using rigorous national standards, may serve as a model for screening settings where revealing HPV positivity has led to overgrading of cytology. [ABSTRACT FROM AUTHOR]

Objectives: Many countries are now using primary human papillomavirus (HPV) testing for cervical screening, testing for high-risk HPV and using cytology as triage. An HPV-positive result can have an adverse psychological impact, at least in the short term. In this paper, we explore the psychological impact of primary HPV screening over 12 months.Methods: Women were surveyed soon after receiving their results (n=1133) and 6 (n=762) and 12 months (n=537) later. Primary outcomes were anxiety (Short-Form State Anxiety Inventory-6) and distress (General Health Questionnaire-12). Secondary outcomes included concern, worry about cervical cancer and reassurance. Mixed-effects regression models were used to explore differences at each time point and change over time across four groups according to their baseline result: control (HPV negative/HPV cleared/normal cytology and not tested for HPV); HPV positive with normal cytology; HPV positive with abnormal cytology; and HPV persistent (ie, second consecutive HPV-positive result).Results: Women who were HPV positive with abnormal cytology had the highest anxiety scores at baseline (mean=42.2, SD: 15.0), but this had declined by 12 months (mean=37.0, SD: 11.7) and was closer to being within the 'normal' range (scores between 34 and 36 are considered 'normal'). This group also had the highest distress at baseline (mean=3.3, SD: 3.8, scores of 3+ indicate case-level distress), but the lowest distress at 12 months (mean=1.9, SD: 3.1). At 6 and 12 months, there were no between-group differences in anxiety or distress for any HPV-positive result group when compared with the control group. The control group were less concerned and more reassured about their result at 6 and 12 months than the HPV-positive with normal cytology group.Conclusions: Our findings suggest the initial adverse impact of an HPV-positive screening result on anxiety and distress diminishes over time. Specific concerns about the result may be longer lasting and efforts should be made to address them. [ABSTRACT FROM AUTHOR]

Several international cervical screening guidelines advise against using high‐risk human papillomavirus (HR‐HPV) testing in women younger than 30. The rationale for this in young women, lies in the potential for additional detection of both low‐grade and high‐grade cervical intraepithelial neoplasia (CIN) leading to unnecessary treatments without reducing the burden of cervical cancer. We studied 56 544 women screened at 24 to 29 with HR‐HPV testing and 116 858 screened with liquid‐based cytology (LBC) in the English HPV screening pilot. They were compared to 528 460 women screened at the age of 30 to 49. We studied the detection of cervical cancer and CIN2/3 across two consecutive screening rounds 3 years apart. At 24 to 29, a positive HR‐HPV test detected more cases of cervical cancer in the prevalence round than did a positive LBC test (1.36/1000 screened vs 0.82/1000, ORadj: 1.61, 95% CI: 1.18‐2.19). In women with a negative HR‐HPV test, cervical cancer was diagnosed before or at the incidence round in 0.07/1000. After a negative LBC test, cancer detection reached 0.47/1000 and 40% of these cases were diagnosed at FIGO stage IB+. HR‐HPV testing increased the detection of CIN2/3 diagnoses in two consecutive rounds combined by 30% (71.9/1000 vs 55.2/1000). The patterns of detection of cervical cancer and CIN2/3 were almost identical at older ages. These data support using HR‐HPV testing for screening of women younger than 30, which not only accelerates the diagnosis of cervical cancer but leads to a similar relative increase in CIN2/3 diagnosis to that found in women aged 30 to 49. [ABSTRACT FROM AUTHOR]

Objective: To report detailed age-specific outcomes from the first round of an English pilot studying the implementation of high-risk human papillomavirus (HR-HPV) testing in primary cervical screening., Design: Observational study with screening in 2013-2016, followed by two early recalls and/or colposcopy until the end of 2019., Setting: Six NHS laboratory sites., Population: A total of 1 341 584 women undergoing screening with HR-HPV testing or liquid-based cytology (LBC)., Methods: Early recall tests and colposcopies were recommended, depending on the nature of the screening-detected abnormality., Main Outcome Measures: We reported standard screening process indicators, e.g. proportions with an abnormality, including high-grade cervical intraepithelial neoplasia (CIN2+) or cancer, and the positive predictive value (PPV) of colposcopy for CIN2+, by screening test and age group., Results: Among unvaccinated women screened with HR-HPV testing at age 24-29 years, 26.9% had a positive test and 10.4% were directly referred to colposcopy following cytology triage, with a PPV for CIN2+ of 47%. At 50-64 years of age, these proportions were much lower: 5.3%, 1.2% and 27%, respectively. The proportions of women testing positive for HR-HPV without cytological abnormalities, whose early recall HR-HPV tests returned negative results, were similar across the age spans: 54% at 24-29 years and 55% at 50-64 years. Two-thirds of infections at any age were linked to non-16/18 genotypes. Among women with CIN2, CIN3 or cervical cancer, however, the proportion of non-16/18 infections increased with age. As expected, the detection of abnormalities was lower following screening with LBC., Conclusions: These data provide a reliable reference for future epidemiological studies, including those concerning the effectiveness of HPV vaccination., Tweetable Abstract: Data from the English pilot study provide a comprehensive overview of abnormalities detected through HPV screening., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)