Journal of Lower Genital Tract Disease最新文献

Objective: The Alinity m HR HPV assay is a qualitative molecular assay that simultaneously detects high-risk human papillomavirus (hr HPV) genotypes HPV16, 18, and 45 and reports the 11 other hr HPV genotypes in 2 aggregates as other HR HPV A (HPV31, 33, 52, 58) and other HR HPV B (HPV35, 39, 51, 56, 59, 66, 68). Here, the authors describe the prevalence of hr HPV genotypes in the Alinity m HR HPV assay US clinical trial population stratified by age, cytology, and cervical disease status.

Methods: This study included 11,532 women undergoing routine cervical cancer screening.

Results: Overall hr HPV positivity decreased with age. Other HR HPV B genotypes had the highest positivity followed by other HR HPV A, HPV16, HPV45, and HPV18. In the population with ≥atypical squamous cells of undetermined significance cytology, other HR HPV A and other HR HPV B genotypes had the highest positivity rates. HPV16 and other HR HPV A positivity rates were highest in specimens with ≥cervical intraepithelial neoplasia 3 by histology.

Conclusions: This analysis of primary screening participants in the Alinity m HR HPV assay US clinical trial demonstrates the benefits of including genotype-specific testing in cervical cancer screening programs.

Abstract: The American Society for Colposcopy and Cervical Pathology (ASCCP) provides practice guidance for clinicians caring for patients with lower genital tract conditions. The ASCCP wants to ensure that its library of guidance documents is current, evidence based, and easy for clinicians to use. Guidance documents should present clear, actionable evidence-based management recommendations where the quality of the evidence and the strength of the recommendation are clearly identified. This document explains ASCCP's new standard document types and the processes for their development and maintenance, as well as the process for selecting new topics.

Objectives: This study assessed the feasibility and acceptability of Human Papillomavirus (HPV) self-swab collection at a Hawaii-based Federally Qualified Health Center in the United States with low cervical cancer screening rates.

Methods: Patients with an indication for cervical cancer screening were approached during their scheduled primary care visit. Consenting participants self-collected a sample for primary HPV testing. After sample collection, participants completed a 5-minute written survey concerning their experience collecting the sample and knowledge of cervical cancer.

Results: From August 2023 through May 2024, 20 participants enrolled and completed the study, including 5 participants who had never undergone any prior cervical cancer screening and 7 participants over the age of 65. The HPV analysis confirmed 1 positive result. Most (17 of 20) of the participants described the self-collection process as very easy or easy. Knowledge of HPV and cervical cancer prevalence was low with only 2 of 20 participants (10%) correctly identifying the prevalence of these conditions.

Conclusions: Self-swab screening for HPV is feasible with high patient satisfaction in the studied population.

Objective: Labial adhesion (LA) lacks a clear etiology but is associated with low estrogen levels and lichen sclerosus (LS). Genitourinary Syndrome of Menopause is a contributor due to low estrogen, needing surgical resection if symptoms persist after topical estrogen use. Early diagnosis and treatment of LS can decrease the risk of development of LA. The objective is to investigate LS prevalence as an etiological factor and evaluate the necessity for enhanced biopsy rates in LA patients.

Methods: TrinetX provided data from 80 global health care centers, focusing on patients with LA using ICD-10-CM coding. The cohort was stratified based on vulva surgery 2 years post-LA diagnosis to establish a causal relationship.

Results: A total of 11,875 women over the age of 18 were diagnosed with LA from 2000 to 2023. Of those, 3,673 (30.93%) underwent a surgical procedure on the female genital system within 2 years. Demographic data included a mean age of 45 years, 67.9% identified as White, 6.53% as Black/African American, 20.52% unknown, and 2.45% other races. Of the 3,673 total women, 11% had a documented biopsy prior to or with the surgery, leading to 11% (395 women) being diagnosed with LS. Limitations include inconsistent medical coding, uncertain causality between conditions, and potential data inconsistencies from the national database.

Conclusions: Labial adhesion has a complex etiology, yet is associated with LS, emphasizing the need for biopsy in management when the first-line estrogen cream approach fails. Future studies on LA etiologies can improve approaches to female sexual health care disorders, enhancing patient care.

Objective: To estimate the proportion of participants with high-grade cervical intraepithelial neoplasia (CIN 2/3) who completed indicated therapeutic procedures.

Methods: This was a retrospective observational cohort study of the National Institutes of Health's All of Us database enriched for racial and ethnic minorities historically underrepresented in biomedical research. The study included female participants aged 25 and older with a diagnosis of CIN 2/3 only, excluding invasive malignancy. The authors conducted both univariate and multivariate logistic regression to identify background characteristics associated with guideline-concordant ablative and excisional procedures.

Results: Of 1,764 participants with CIN 2/3, only 27.7% of participants underwent a therapeutic procedure in the 12 months following a diagnosis of CIN 2/3. The study found that Hispanic participants had a 1.48 increased odds ratio (OR) (95% CI = 1.18-1.85) of undergoing therapeutic procedures (compared to non-Hispanic). Participants residing in the Midwest had a 2.04 OR (95% CI = 1.6-2.6) of undergoing a therapeutic procedure compared to the Northeast. After adjustment for race, ethnicity, region, and smoking status, Hispanic ethnicity remained associated with therapeutic excision (OR = 2.37, 1.13-4.78). Geography was significant with 2.37 (95% CI = 1.17-3.29) increased odds of therapy completions for Midwest residents but 0.52 (95% CI = 0.27-0.96) decreased odds for Western residents.

Conclusion: In this large US national database enriched for racial and ethnic minorities, the authors found that 3 of 4 participants with cervical precancer did not undergo a therapeutic procedure in the 12 months following their first diagnosis. Increased efforts to promote access to and completion of treatment of CIN 2/3 are needed to prevent cancer.

Objective: The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for the use of self-collected vaginal specimens for human papillomavirus (HPV) testing in health care settings.

Methods: A comprehensive literature search was performed, external systematic reviews were evaluated, and HPV genotype agreement between self-collected vaginal and clinician-collected cervical specimens was summarized. Recommendations considered available data, public comments, and expert consensus. Recommendations were ratified through a vote by the Consensus Stakeholder Group.

Results: Clinician-collected cervical specimens are preferred and self-collected vaginal specimens are acceptable for primary HPV screening of asymptomatic average-risk individuals. Repeat testing in 3 years is recommended following HPV-negative screens using self-collected vaginal specimens. Colposcopy with collection of cytology and biopsies is recommended following positive tests for HPV types 16 and 18. Clinician-collected cytology or dual stain for triage testing is recommended following positive tests for HPV 45, 33/58, 31, 52, 35/39/68, or 51 or for pooled HPV other types but negative for HPV 16 or 18. Repeat HPV testing in 1 year is recommended following a positive test for HPV types 56/59/66 and no other carcinogenic types. Minimal data exist on use of self-collected vaginal specimens for surveillance following abnormal screening test results, colposcopy or treatment, and therefore, clinician-collected cervical specimens are preferred.

Conclusions: Human papillomavirus testing of self-collected vaginal specimens expands cervical cancer screening options and has potential to increase access for currently underscreened individuals. Laboratory and clinical workflows will need to be modified to ensure adequate specimen processing and follow-up.