Operator Sex and Experience Do Not Influence Conization Outcomes in Terms of Cone Volume, Depth or Resection Margins.

BACKGROUND/AIM: Conization in patients with cervical intraepithelial neoplasia is associated with longer time required to conceive, a higher risk of preterm delivery, and a myriad of obstetric complications. This study assessed whether operator sex and experience correlate with cone volume, depth, and resection margins in patients wishing to conceive and the general patient population. PATIENTS AND METHODS: This retrospective single center cohort study included 141 women who had undergone conization for cervical dysplasia in 2020 and 2021. Loop size selection was guided by the preoperative colposcopy report and intraoperative diluted Lugol staining. The hemiellipsoid cone volume was compared for subgroups in three categories: patients operated on by residents vs. board-certified gynecologists; patients operated on by female vs. male surgeons; patients who wished to pursue future pregnancy after conization vs. those who did not. RESULTS: Female surgeons excised insignificantly less cervical tissue compared with their male counterparts (p=0.08). In the subgroup of patients without the wish to conceive, male surgeons tended to excise significantly bigger volumes during conization (p=0.008). No significant difference (p=0.74) regarding volume of resected tissue was evidenced when comparing residents to board-certified surgeons, both in patient subgroups with (p=0.58) and without (p=0.36) a wish to conceive. Male surgeons tended to resect higher volumes (p=0.012) if board-certified compared to their board-certified female colleagues. CONCLUSION: There were insignificant differences regarding cone depth and volume or incomplete resection when stratified by operator experience and sex. However, male gynecologists removed significantly larger cone volumes in the subgroup of patients who did not pursue future pregnancy.

The European Society of Gynaecological Oncology (ESGO), the International Society for the Study of Vulvovaginal Disease (ISSVD), the European College for the Study of Vulval Disease (ECSVD), and the European Federation for Colposcopy (EFC) Consensus Statement on the Management of Vaginal Intraepithelial Neoplasia.

ABSTRACT: The European Society of Gynaecological Oncology (ESGO), the International Society for the Study of Vulvovaginal Disease (ISSVD), the European College for the Study of Vulval Disease (ECSVD), and the European Federation for Colposcopy (EFC) developed consensus statements on pre-invasive vulvar lesions in order to improve the quality of care for patients with vaginal intraepithelial neoplasia (VaIN). The management of VaIN varies according to the grade of the lesion: VaIN 1 (low grade vaginal squamous intraepithelial lesions (SIL)) can be subjected to follow-up, while VaIN 2-3 (high-grade vaginal SIL) should be treated. Treatment needs individualization according to the patient's characteristics, disease extension and previous therapeutic procedures. Surgical excision is the mainstay of treatment and should be performed if invasion cannot be excluded. Total vaginectomy is used only in highly selected cases of extensive and persistent disease. Carbon dioxide (CO2) laser may be used as both an ablation method and an excisional one. Reported cure rates after laser excision and laser ablation are similar. Topical agents are useful for persistent, multifocal lesions or for patients who cannot undergo surgical treatment. Imiquimod was associated with the lowest recurrence rate, highest human papillomavirus (HPV) clearance, and can be considered the best topical approach. Trichloroacetic acid and 5-fluorouracil are historical options and should be discouraged. For VaIN after hysterectomy for cervical intraepithelial neoplasia (CIN) 3, laser vaporization and topical agents are not the best options, since they cannot reach epithelium buried in the vaginal scar. In these cases surgical options are preferable. Brachytherapy has a high overall success rate but due to late side effects should be reserved for poor surgical candidates, having multifocal disease, and with failed prior treatments. VaIN tends to recur and ensuring patient adherence to close follow-up visits is of the utmost importance. The first evaluation should be performed at 6 months with cytology and an HPV test during 2 years and annually thereafter. The implementation of vaccination against HPV infection is expected to contribute to the prevention of VaIN and thus cancer of the vagina. The effects of treatment can have an impact on quality of life and result in psychological and psychosexual issues which should be addressed. Patients with VaIN need clear and up-to-date information on a range of treatment options including risks and benefits, as well as the need for follow-up and the risk of recurrence.

Efficacy of optical coherence tomography in the triage of women with minor abnormal cervical cytology before colposcopy.

OBJECTIVES: To evaluate the efficacy of Optical Coherence Tomography (OCT) for detecting cervical lesions in women with minor abnormal cytology results (atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesion (LSIL)). METHODS: A prospective study was conducted at gynecologic clinic from Mar 2021 to Sep 2021. The recruited women with cervical cytological findings of ASC-US or LSIL were inspected with OCT before colposcopy-directed cervical biopsy. The diagnostic performance of OCT, alone and in combination with high-risk human papillomavirus (hrHPV) testing were evaluated to detect cervical intraepithelial neoplasia of grade 2 or worse (CIN2+)/CIN3 or worse (CIN3+). The rate of colposcopy referral and the immediate risk of CIN3+ of OCT were calculated. RESULTS: A total of 349 women with minor abnormal cervical cytology results were enrolled. For detection of CIN2+/CIN3+, the sensitivity and NPV of OCT were lower than those of hrHPV testing (CIN2+: 71.3% vs. 95.4%, 89.0% vs. 91.1%, P < 0.001; CIN3+: 75% vs. 93.8%, 96.5% vs. 95.6%, P < 0.001), but the specificity, accuracy and PPV were higher than those of hrHPV testing (CIN2+: 77.5% vs. 15.6%, 75.9% vs. 35.5%, 51.2% vs. 27.3%, P < 0.001; CIN3+: 69.4% vs. 13.6%, 69.9% vs. 20.9%, 19.8% vs. 9.9%, P < 0.001). OCT combined with hrHPV testing (CIN2+: 80.9%; CIN3+: 72.6%) showed higher specificity than that of OCT alone (P < 0.001). The colposcopy referral rate base on OCT classification was lower than that based on hrHPV testing (34.7% vs. 87.1%, P < 0.001). Patients with hrHPV-positive ASC-US and hrHPV-negative LSIL cytology, the immediate CIN3+ risk in OCT negative cases was less than 4%. CONCLUSIONS: OCT alone or combination with hrHPV testing shows good performance for detecting CIN2+/CIN3+ in patients with ASC-US/LSIL cytology. OCT is an effective method for colposcopy triage in women with hrHPV-positive ASC-US and hrHPV-negative LSIL cytology.

[Lugol as a rare cause of anaphylactic reaction after colposcopy. Case report]. / Lugol como causa inusual de anafilaxia después de la colposcopia. Reporte de un caso clínico.

INTRODUCTION: Lugol is a solution composed of elemental iodine (5%) and potassium iodide (10%) together with distilled water, used during colposcopic assessment to identify possible cervical cell alterations. CASE REPORT: A 31-year-old female who presents an episode suggestive of anaphylaxis ninety minutes after a colposcopy exploration, successfully treated with intramuscular hydrocortisone and desclorfeniramine. During colposcopy Lugol solution and acetic acid was applied. Skin prick test (SPT) with Lugol solution was positive (papule 9x7 mm). Four control tests were negative. Intradermal tests (IDT) were positive with Lugol and elemental iodine, the last one turned-out irritant. It was ruled out possible cross-reactivity with other iodine preparations (Betadine®) and potassium iodide (Yoduk®). CONCLUSIONS: Our report demonstrates a rare case of allergy to Lugol solution with positive SPT and a clinical suggestive reaction, with tolerance to other iodine preparations and potassium iodide.

INTRODUCCIÓN: El lugol es una solución compuesta por yodo elemental (5%), yoduro de potasio (10%) y agua destilada, utilizada durante las colposcopias para detectar alteraciones celulares en el cérvix. REPORTE DE CASO: Paciente femenina de 31 años, que tuvo un evento de anafilaxia noventa minutos después de la colposcopia, tratada exitosamente con hidrocortisona por vía intramuscular y desclorfeniramina. Durante la colposcopia se aplicó lugol y ácido acético. La prueba de prick con lugol resultó positiva, con formación de una pápula de 9 x 7 mm, al igual que las pruebas intradérmicas para lugol y yodo elemental. Cuatro controles fueron negativos, excepto para yodo elemental, que resultó irritante en intradermorreacción. Se descartó reactividad cruzada con otras soluciones yodadas (Betadine®) y (Yoduk®). CONCLUSIONES: Reportamos un caso raro de alergia a lugol con prick positivo y una reacción clínica sugerente, con tolerancia a otras preparaciones yodadas y a yoduro de potasio.

Cervical intraepithelial neoplasia in non-16/18 high-risk human papilloma virus positive/cytology negative women: An alternative approach in poor resource areas.

OBJECTIVE: Because the specific prevalence and carcinogenesis of non-16/18 high-risk (hr) Human Papillomavirus (HPV) is not fully understood, we designed a study with aim of evaluating the risk of high-grade cervical intraepithelial neoplasia (CIN) in non-16/18 hr-HPV positive/cytology negative cases and assessing the distribution of non-16/18 hr-HPV subtypes. MATERIALS AND METHODS: This cross-sectional study was conducted on 138 non-16/18 hr-HPV positive/cytology negative women, who were referred to the gynecologic oncology clinic of Yas hospital, affiliated with Tehran University of Medical Sciences, January 2021 to 2022. RESULTS: Among the detected types, HPV 31 was the most frequent type. 63 cases underwent biopsy as indicated based on colposcopic examination with acetic acid 3% application among which 34 had normal results. In the remaining 29 cases, 25 had insignificant findings. CIN2 was reported in 2 cases, one with HPV 31, 45, 58, and the other with HPV 58. CIN3 was also detected in 2 cases, one with HPV 31 and the other with HPV 35, 45. The overall incidence of high-grade CIN was 2.8%. A statistically significant (P-value = 0.046) difference was detected between patients with high-grade CIN compared with the others regarding the Hookah usage. CONCLUSION: The risk of CIN among non-16/18 hr-HPV positive/cytology negative cases is noticeably low. Based on ASCCP guidelines return testing at 1 year without immediate colposcopy seems sufficient; however, because of many reasons doing immediate colposcopy rather than 1-year follow-up may be a more accessible approach in resource poor, low-income countries such as ours.

Predictors factors of the absence of high-grade intraepithelial lesion in excisional therapy specimen.

OBJECTIVES: To identify predictive factors of the absence of high-grade intraepithelial lesion (HGSIL) in cervical excisional therapy specimen. METHODS: Data from 835 women who underwent excisional therapy for a cervical intra epithelial lesion at the department of Gynaecology from two university hospitals, between January 2015 and December 2020 were reviewed. Demographic data, referral cytology, colposcopic findings, results of cervical biopsy and endocervical curettage were retrieved. Primary outcome was the absence of HGSIL on cervical excisional specimen analysis defined by the identification of no intraepithelial lesion or of low-grade lesion only. RESULTS: The absence of HGSIL on specimen was observed in 137 (16.4%) cases. Three factors were identified to have a significant and independent impact on the probability of the absence of HGSIL on specimen: age higher than 40 years (aOR: 1.8; 95%CI: 1.1-3.0; p=0.024), a small abnormal transformation zone (TZ) (aOR: 2.3; 95%CI: 1.4-3.7; p=0.001) and the result of the cervical biopsy at the time of colposcopic assessment not showing HGSIL (aOR: 8.6; 95%CI: 4.7-15.5; p < 0.001). No significant impact of the referral cytology nor of the colposcopic impression were observed. CONCLUSION: Although the result of cervical biopsy performed at the time of colposcopic assessment is the key risk factor for the absence of HGSIL on excisional specimen, age over 40 and a small abnormal TZ are the two other identified risk factors. Practitioners should consider these findings when deciding for excisional therapy.

Colposcopic accuracy in diagnosing squamous intraepithelial lesions: a systematic review and meta-analysis of the International Federation of Cervical Pathology and Colposcopy 2011 terminology.

BACKGROUND: Colposcopy is an important tool in diagnosing cervical cancer, and the International Federation of Cervical Pathology and Colposcopy (IFCPC) issued the latest version of the guidelines in 2011. This study aims to systematically assess the accuracy of colposcopy in predicting low-grade squamous intraepithelial lesions or worse (LSIL+) / high-grade squamous intraepithelial lesions or worse (HSIL+) under the 2011 IFCPC terminology. METHODS: We performed a systematic review and meta-analysis, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched for studies about the performance of colposcopy in diagnosing cervical intraepithelial neoplasia under the new IFCPC colposcopy terminology from PubMed, Embase, Web of Science and the Cochrane database. Data were independently extracted by two authors and an overall diagnostic performance index was calculated under two colposcopic thresholds. RESULTS: Totally, fifteen articles with 22,764 participants in compliance with the criteria were included in meta-analysis. When colposcopy was used to detect LSIL+, the combined sensitivity and specificity were 0.92 (95% CI 0.88-0.95) and 0.51 (0.43-0.59), respectively. When colposcopy was used to detect HSIL+, the combined sensitivity and specificity were 0.68 (0.58-0.76) and 0.93 (0.88-0.96), respectively. CONCLUSION: In accordance with the 2011 IFCPC terminology, the accuracy of colposcopy has improved in terms of both sensitivity and specificity. Colposcopy is now more sensitive with LSIL+ taken as the cut-off value and is more specific to HSIL+. These findings suggest we are avoiding under- or overdiagnosis both of which impact on patients' well-being.

Provider- and Facility-Level Variation in Precancerous Cervical Biopsy Diagnoses.

OBJECTIVES: Reproducibility of cervical biopsy diagnoses is low and may vary based on where the diagnostic test is performed and by whom. Our objective was to measure multilevel variation in diagnoses across colposcopists, pathologists, and laboratory facilities. METHODS: We cross-sectionally examined variation in cervical biopsy diagnoses within the 5 sites of the Population-Based Research Optimizing Screening through Personalized Regimens (PROSPR I) consortium within levels defined by colposcopists, pathologists, and laboratory facilities. Patients aged 18 to 65 years with a colposcopy with biopsy performed were included, with diagnoses categorized as normal, cervical intraepithelial neoplasia grade 1 (CIN1), grade 2 (CIN2), and grade 3 (CIN3). Using Markov Chain Monte-Carlo methods, we fit mixed-effects logistic regression models for biopsy diagnoses and presented median odds ratios (MORs), which reflect the variability within each level. Median odds ratios can be interpreted as the average increased odds a patient would have for a given outcome (e.g., CIN2 or CIN3 vs normal or CIN1) when switching to a provider with higher odds of diagnosing that outcome. The MOR is always 1 or greater, and a value of 1 indicates no variation in outcome for that level, with higher values indicating greater variation. RESULTS: A total of 130,110 patients were included who received care across 82 laboratory facilities, 2,620 colposcopists, and 489 pathologists. Substantial variation in biopsy diagnoses was found at each level, with the most occurring between laboratory facilities, followed by pathologists and colposcopists. Substantial variation in biopsy diagnoses of CIN2 or CIN3 (vs normal or CIN1) was present between laboratory facilities (MOR: 1.26; 95% credible interval = 1.19-1.36). CONCLUSIONS: Improving consistency in cervical biopsy diagnoses is needed to reduce underdiagnosis, overdiagnosis, and unnecessary treatment resulting from variation in cervical biopsy diagnoses.

Developing a predictive nomogram for colposcopists: a retrospective, multicenter study of cervical precancer identification in China.

BACKGROUND: Colposcopic examination with biopsy is the standard procedure for referrals with abnormal cervical cancer screening results; however, the decision to biopsy is controvertible. Having a predictive model may help to improve high-grade squamous intraepithelial lesion or worse (HSIL+) predictions which could reduce unnecessary testing and protecting women from unnecessary harm. METHODS: This retrospective multicenter study involved 5,854 patients identified through colposcopy databases. Cases were randomly assigned to a training set for development or to an internal validation set for performance assessment and comparability testing. Least Absolute Shrinkage and Selection Operator (LASSO) regression was used to reduce the number of candidate predictors and select statistically significant factors. Multivariable logistic regression was then used to establish a predictive model which generates risk scores for developing HSIL+. The predictive model is presented as a nomogram and was assessed for discriminability, and with calibration and decision curves. The model was externally validated with 472 consecutive patients and compared to 422 other patients from two additional hospitals. RESULTS: The final predictive model included age, cytology results, human papillomavirus status, transformation zone types, colposcopic impressions, and size of lesion area. The model had good overall discrimination when predicting HSIL + risk, which was internally validated (Area Under the Curve [AUC] of 0.92 (95%CI 0.90-0.94)). External validation found an AUC of 0.91 (95%CI 0.88-0.94) across the consecutive sample, and 0.88 (95%CI 0.84-0.93) across the comparative sample. Calibration suggested good coherence between predicted and observed probabilities. Decision curve analysis also suggested this model would be clinically useful. CONCLUSION: We developed and validated a nomogram which incorporates multiple clinically relevant variables to better identify HSIL + cases during colposcopic examination. This model may help clinicians determining next steps and in particular, around the need to refer patients for colposcopy-guided biopsies.

CIN2 + detection in high-risk HPV patients with no or minor cervical cytologic abnormalities: a clinical approach validated by machine learning.

PURPOSE: To evaluate the feasibility and diagnostic value of the combination of colposcopy, cytology and hrHPV (high-risk human papilloma virus) PCR (polymerase chain reaction) testing in patients with no or minor cytologic abnormalities and HPV high risk infection and to find the best predictors for the presence of CIN2 + in this patient collective. METHODS: Three hundred and thirty-four hrHPV patients with normal cytology or minor cytologic abnormalities who had a colposcopic examination at the center of colposcopy at the university hospital Aachen in 2021 were enrolled in this retrospective cohort analysis. Multivariate logistic regression and a machine-learning technique (random forests, leave-one-out analysis) were used. RESULTS: The overall risk for CIN2 + in hrHPV-positive patients with normal cytology was 7.7% (N = 18) (5% for CIN3 +), 18% (N = 16) (10.1% for CIN3 +) in patients with PAP IIp (ASC-US) and 62.5% (N = 5) (25% for CIN3 +) in patients with PAP IIg (AGC). Variables that show a statistically significant influence for the CIN-status are 'major change' as the result of colposcopy, transformation zone type T1, PAP IIg upon referral (AGC) and hrHPV category 1a (HPV 16/18) detection. Using machine learning (random forests) techniques, the main influencing variables were confirmed. A monotonously decreasing risk for CIN2 + from hrHPV category 1a to 3 (in accordance to the IACR guidelines) was found. CONCLUSION: In the collective of hrHPV patients with no or minor cytologic abnormalities, the result of colposcopy and HPV PCR status are key predictors for the detection of CIN2 + with a monotonously decreasing risk for CIN2 + from hrHPV category 1a to 3.

Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study.

BACKGROUND: Colposcopy, currently included in WHO recommendations as an option to triage human papillomavirus (HPV)-positive women, remains as the reference standard to guide both biopsy for confirmation of cervical precancer and cancer and treatment approaches. We aim to evaluate the performance of colposcopy to detect cervical precancer and cancer for triage in HPV-positive women. METHODS: This cross-sectional, multicentric screening study was conducted at 12 centres (including primary and secondary care centres, hospitals, laboratories, and universities) in Latin America (Argentina, Bolivia, Colombia, Costa Rica, Honduras, Mexico, Paraguay, Peru, and Uruguay). Eligible women were aged 30-64 years, sexually active, did not have a history of cervical cancer or treatment for cervical precancer or a hysterectomy, and were not planning to move outside of the study area. Women were screened with HPV DNA testing and cytology. HPV-positive women were referred to colposcopy using a standardised protocol, including biopsy collection of observed lesions, endocervical sampling for transformation zone (TZ) type 3, and treatment as needed. Women with initial normal colposcopy or no high-grade cervical lesions on histology (less than cervical intraepithelial neoplasia [CIN] grade 2) were recalled after 18 months for another HPV test to complete disease ascertainment; HPV-positive women were referred for a second colposcopy with biopsy and treatment as needed. Diagnostic accuracy of colposcopy was assessed by considering a positive test result when the colposcopic impression at the initial colposcopy was positive minor, positive major, or suspected cancer, and was considered negative otherwise. The main study outcome was histologically confirmed CIN3+ (defined as grade 3 or worse) detected at the initial visit or 18-month visit. FINDINGS: Between Dec 12, 2012, and Dec 3, 2021, 42 502 women were recruited, and 5985 (14·1%) tested positive for HPV. 4499 participants with complete disease ascertainment and follow-up were included in the analysis, with a median age of 40·6 years (IQR 34·7-49·9). CIN3+ was detected in 669 (14·9%) of 4499 women at the initial visit or 18-month visit (3530 [78·5%] negative or CIN1, 300 [6·7%] CIN2, 616 [13·7%] CIN3, and 53 [1·2%] cancers). Sensitivity was 91·2% (95% CI 88·9-93·2) for CIN3+, whereas specificity was 50·1% (48·5-51·8) for less than CIN2 and 47·1% (45·5-48·7) for less than CIN3. Sensitivity for CIN3+ significantly decreased in older women (93·5% [95% CI 91·3-95·3] in those aged 30-49 years vs 77·6% [68·6-85·0] in those aged 50-65 years; p<0·0001), whereas specificity for less than CIN2 significantly increased (45·7% [43·8-47·6] vs 61·8% [58·7-64·8]; p<0·0001). Sensitivity for CIN3+ was also significantly lower in women with negative cytology than in those with abnormal cytology (p<0·0001). INTERPRETATION: Colposcopy is accurate for CIN3+ detection in HPV-positive women. These results reflect ESTAMPA efforts in an 18-month follow-up strategy to maximise disease detection with an internationally validated clinical management protocol and regular training, including quality improvement practices. We showed that colposcopy can be optimised with proper standardisation to be used as triage in HPV-positive women. FUNDING: WHO; Pan American Health Organization; Union for International Cancer Control; National Cancer Institute (NCI); NCI Center for Global Health; National Agency for the Promotion of Research, Technological Development, and Innovation; NCI of Argentina and Colombia; Caja Costarricense de Seguro Social; National Council for Science and Technology of Paraguay; International Agency for Research on Cancer; and all local collaborative institutions.

Cervical Cancer Screening and Follow-Up Practices in U.S. Prisons.

INTRODUCTION: The objective of this study is to better understand cervical cancer screening and follow-up practices in U.S. prisons. METHODS: A 29-question survey examining cervical cancer screening practices, education, and facility/patient characteristics was disseminated to state-prison medical directors. RESULTS: A total of 70% (35/50) of state medical directors completed the survey between August 2021 and January 2022. All prison systems provided cervical cancer screening both at intake and specified intervals. A total of 36% provided colposcopy on site, and 9% performed excisional procedures on site. A total of 11 states identified 1‒5 cases of cervical cancer within the last year. Frequently cited challenges included a perceived lack of patient interest, delays in community referral, and lack of follow-up of abnormal results after release. CONCLUSIONS: This study found relatively high rates of screening with a perceived lack of patient interest as the most reported barrier. Follow-up care was also often affected by reported lack of patient interest, delays in community referral for diagnostic procedures, and patient release before follow-up. There is room for further optimization of screening and surveillance among incarcerated women by understanding and addressing systems-based challenges. By understanding patient barriers to primary screening, expanding access to onsite testing and community referral for abnormal results, and streamlining post-release follow-up, disparities in care among incarcerated women can be reduced.

The Future Role of Cytology in Cervical Cancer Screening in the Era of HPV Vaccination.

BACKGROUND: Up until recently, cervical cytology was the mainstay for cervical cancer screening. However, the established association between human papillomavirus (HPV) infection and cervical cancer has led to changes in preventive strategies, with cytology being replaced by the use of high-risk HPV (hrHPV) testing and primary prevention being achieved by HPV vaccination. In this context, the role of cervical cytology is shifting to secondary triage of HPV-positive women. As vaccination is leading to decreased HPV infections and significant cervical abnormalities (CIN2+), data on the impact of HPV vaccination on cervical cytology metrics, including positive predictive value (PPV) and negative predictive value (NPV), are starting to emerge. SUMMARY: This is a review of updates in cervical cancer screening, including the use of primary HPV testing and the impact of HPV vaccination on cytology as part of cervical cancer screening. KEY MESSAGES: Cervical cancer screening and prevention are undergoing significant changes as there is widespread implementation of HPV vaccination and hrHPV testing is becoming the entry point for secondary prevention. Optimal screening approaches and intervals in this setting are currently being analyzed including the use of cytology and other ancillary techniques for triage of positive cases, as well as the effect of vaccination on the PPV and NPV of cytology in the detection of CIN2+.

Endocervical sampling using brush versus curette: a single centre experience and literature review.

Endocervical sampling is performed traditionally with an endocervical curette (ECC). The current study objective is to compare the histopathological performance of endocervical brush (ECB) and endocervical curette (ECC). A retrospective review was performed including patients included that underwent colposcopy with endocervical sampling using either method. A total of 127 samples were obtained with ECC and 98 with ECB. Histopathological diagnosis was obtained in 124 (97.6%) ECC samples and in 94 (95.9%) ECB samples (p = 0.46). The incidence of benign results was similar between ECC and ECB (117 (92.1%) versus 88 (89.8%) respectively (p = 0.28)). When combining information from endocervical sampling with cervical biopsies, the detection rate of high-grade pathologies was similar between the groups with 14 cases (17.7%) for ECC and 8 cases (17.0%) for ECB (p = 0.43). A scope review of the topic was performed, illustrating that studies favour either method. In conclusion, ECB and ECC perform similarly for providing a histopathological diagnosis on endocervical samples.IMPACT STATEMENTWhat is already known on this subject? Endocervical samples in colposcopy were traditionally obtained using an endocervical curette. Similarly, a brush can be used for histological sampling of the endocervical canal. However, it is unclear how the ability to obtain a histopathological diagnosis compares between the two techniques.What do the results of this study add? This single-institution experience with using endocervical brush and curette for endocervical sampling finds that both methods are acceptable and have a high ability to provide a histopathological diagnosis. Precisely, 4.1% of brush and 2.4% of curette samples had insufficient tissue.What are the implications of these findings for clinical practice and further research? The endocervical brush is an adequate sampling method for colposcopy, and can be safely used instead of the curette, based on clinician preference. Further studies could investigate how these methods compare from a patient perspective.

Evaluation of the feasibility of human papillomavirus sponge-type self-sampling device at Japanese colposcopy clinics.

AIM: Self-sampling human papillomavirus (HPV) testing has been introduced for cervical cancer screening worldwide. In Japan, there are two types (brush and sponge) of HPV self-sampling devices. However, the recommended type for cervical cancer screening remains unclear. This study aimed to evaluate the feasibility of the HPV self-sampling device-sponge type (HSD-ST). Additionally, we aimed to examine the positive rate (sensitivity) for cervical intraepithelial neoplasia (CIN) 2 or worse using the HSD-ST. Finally, we aimed to perform a questionnaire survey regarding the usability of the HSD-ST. METHODS: We included 165 women who underwent HPV testing at one of three gynecologic clinics. First, the women used the HSD-ST and completed a questionnaire regarding its usability. Subsequently, they underwent physician-sampling HPV testing and cytology. We examined the agreement rate of HPV positivity between self- and physician-sampling HPV testing. RESULTS: The HPV-positive rates of self- and physician-collected samples were 59.4% and 62.4%, respectively, with an overall concordance rate of 88.5% and a calculated kappa coefficient of 0.76, indicating high concordance. Moreover, the positive (sensitivity) rates for CIN2 or worse were 81.4% and 89.8% in the self- and physician-collected samples, respectively. CONCLUSIONS: Our findings demonstrated the feasibility and usability of the HSD-ST.

Clinical utility of p16/Ki67 dual-stain cytology for detection of cervical intraepithelial neoplasia grade two or worse in women with a transformation zone type 3: A cross-sectional study.

OBJECTIVE: To evaluate the clinical utility of p16/Ki67 dual-stain (DS) compared with cytology for detecting cervical intraepithelial lesion grade two or worse (CIN2+) in women with a transformation zone type 3 (TZ3). DESIGN: Cross-sectional study. SETTING: Colposcopy clinics in Central Denmark Region. POPULATION: Women aged 45 years or older referred for colposcopy because of an abnormal screening test. METHODS: All women had a cervical sample collected for cytology and DS testing and underwent large-loop excision of the transformation zone (LLETZ). MAIN OUTCOME MEASURE: Sensitivity, specificity and negative (NPV) and positive (PPV) predictive values of DS for CIN2+ detection were compared to those of cytology. RESULTS: Of 166 women eligible, 93 (56.0%) were included in the final analysis. Median age was 68 years (interquartile range [IQR] 63.4-70.5 years). Most women were postmenopausal (95.7%) and referred based on a positive human papillomavirus screening test (86.0%). Fifty-two women (55.9%) were DS-positive, 29 (55.8%) of whom had CIN2+ detected. Twenty-seven (29.0%) women had atypical squamous cells of undetermined significance or worse (ASC-US+), and CIN2+ was detected in 21 women (77.8%). DS had a higher sensitivity (96.7% versus 70.0% p = 0.021) and NPV (97.6% versus 86.4%, p = 0.018) compared with cytology for CIN2+ detection. In contrast, the specificity (63.5% versus 90.5% p < 0.001) and PPV (55.8% versus 77.8%, p = 0.001) were lower for DS compared with cytology. CONCLUSIONS: Dual stain may be a valuable risk marker to guide clinical management of women with a TZ3. The superior NPV of DS suggests that a diagnostic excision may safely be avoided in DS-negative women.

The added value of digital imaging to reflex cytology for triage of high-risk human papillomavirus positive self-sampled material in cervical cancer screening: A prospective cohort study.

OBJECTIVE: Cytology performed directly on hrHPV-positive self-samples (reflex cytology) is feasible and for women with abnormal cytology, an additional cytology test at the general practitioner could be omitted. The aim of this study is to assess the added value of digital imaging (ThinPrep® Imaging System) on the clinical utility of reflex cytology by reducing screening error. DESIGN: A secondary analysis of a prospective cohort study. SETTING: One of five Dutch screening laboratories. POPULATION: Women tested hrHPV-positive on self-samples between December 2018 and August 2019. METHODS: Self-samples were used for reflex cytology with and without digital imaging. The follow-up data (cytological and histological results within 1 year of follow-up) were obtained through the Dutch Pathology Registry (PALGA). MAIN OUTCOME MEASURES: Test performance of the reflex cytology was determined by comparing it with physician-collected follow-up results. RESULTS: The sensitivity for detecting abnormal cells by reflex cytology on self-samples increased significantly from 26.3% (42/160; 95% confidence interval [CI] 19.6-33.8) without digital imaging to 35.4% (56/158; 95% CI 28-43.4) with digital imaging (P < 0.05) without compromising specificity. Importantly, 41.7% of women with ≥CIN2 (35/84) and 45.6% with ≥CIN3 (26/57) were detected by reflex cytology with digital imaging on hrHPV-positive self-samples. CONCLUSION: Digital imaging is of added value to reflex cytology on hrHPV-positive self-samples with a 9% increase in sensitivity. If reflex cytology on self-samples analysed with digital imaging had been implemented in the screening programme, 35.4% of the hrHPV-positive women with abnormal cytology on additional physician-collected samples could have been referred directly for colposcopy.

Clinical performance of primary HPV screening cut-off for colposcopy referrals in HPV-vaccinated cohort: Observational study.

OBJECTIVE: To understand the effect of changing from cytology-based to primary HPV screening on the positive predictive value (PPV) of colposcopy referrals for cervical intraepithelial neoplasia (CIN) in a cohort offered HPV vaccination. DESIGN: Retrospective pre/post observational cohort study. SETTING: Scotland. POPULATION OR SAMPLE: 2193 women referred to colposcopy between September 2019 and February 2020 from cytology-based screening and between September 2020 and February 2021 from primary high-risk HPV (hrHPV) screening. METHODS: Calculating positive predictive values (PPVs) for two cohorts of women; one having liquid-based cytology screening and the other, the subsequent hrHPV cervical screening as a pre/post observational study. MAIN OUTCOME MEASURES: Positive predictive values of LBC and hrHPV cut-offs for colposcopy referral for CIN at colposcopy. RESULTS: Three papers fitted our criteria; these reported results only for cytology-based screening. The PPV was lower for women in HPV-vaccinated cohorts indicating a lower prevalence of disease. Vaccination under the age of 17 had the lowest PPV reported. Scottish colposcopy data concerning hrHPV and cytology showed a non-significant difference between PPV (17.5%, 95% CI 14.3-20.7, and 20.6, 95% CI 16.7-24.5, respectively) for referrals with a cut-off of low grade dyskaryosis (LGD); both met the standard set of 8-25%. The hrHPV PPV (66.7, 95% CI 56.8-76.6) was comparable to cytology (64.1, 95% CI 55.8-72.4) for referrals with a cut-off of high grade dyskaryosis (HGD) but neither met the standard set of 77-92%. CONCLUSIONS: Current literature only provides PPVs for LBC and, overall, the vaccinated cohort had lower PPVs. Only LG dyskaryosis met PHE criteria. The PPV for HPV-vaccinated women undergoing either LBC or HR-HPV screening were not statistically different. However, similar to papers in the current literature, HG dyskaryosis (HGD) PPVs of both techniques did not meet the PHE threshold of 76.6-91.6% outlined in the cervical standards data report.