Population-based norms for the human papillomavirus-quality of life (HPV-QoL) questionnaire: A cross-sectional multicenter study.

INTRODUCTION: Human papillomavirus (HPV) diagnosis has a considerable emotional and psychological impact on women. To evaluate the impairment this infection leads to regarding quality of life (QoL), several scales have been suggested, such as the human-papillomavirus-quality-of-life (HPV-QoL) questionnaire. This has been validated for the Spanish population and measures the impact of HPV on health-related-quality-of-life (HR-QoL). However, normative values are yet to be developed. Thus, the objective was to describe the population-based norms of the HPV-QoL for Spanish women aged 25-65 years and to test the questionnaire's construct validity. MATERIAL AND METHODS: This was a cross-sectional nationwide multicenter study. Women from outpatient clinics in Spain aged 25-65 years, with a diagnosis of past or active HPV infection were recruited. The central tendency, dispersion, and percentiles were calculated for the total score and its dimensions for each age group. Construct validity was tested by analyzing age groups and their correlations with other related scales (12-Item General Health Questionnaire [GHQ-12], Female Sexual Function Index [FSFI], and Hospital Anxiety and Depression Scale [HADS]). RESULTS: A total of 1352 women were included in the study. The norms showed moderate and significant coefficients of correlation with other related scales. Significant differences between age strata groups were found according to educational level, sexual dysfunction, sexual activity, mental deterioration, and severity of anxiety and depression symptoms (p < 0.001 in all cases). The total score differed significantly between the groups (p = 0.006). Significant differences in the contagiousness, health, and sexuality dimensions (p < 0.05) were found among the groups. It was seen that HPV infection impaired women's QoL. Dimensions within all test age groups (p < 0.001 in all cases) were significantly different, with the health dimension being the highest contributor to women's QoL impairment, whereas social well-being was the main determinant of QoL. CONCLUSIONS: Population-based norms for the novel HPV-QoL questionnaire showed adequate validity and could be a useful tool for assessing the impact of QoL among women with HPV in Spain.

Development and psychometric properties of the human papillomavirus-quality of life (HPV-QoL) questionnaire to assess the impact of HPV on women health-related-quality-of-life.

PURPOSE: The HPV-Quality-of-Life (HPV-QoL) questionnaire was developed to determine the impact of Human-Papillomavirus (HPV) infection and related interventions on women health-related quality-of-life. This study provides the development and preliminary psychometric properties of a novel HPV-QoL questionnaire for adult women with HPV. METHODS: After reviewing literature and cognitive debriefing interviews in women who had experienced HPV-related conditions, instrument items and domains were developed. A draft questionnaire was pilot tested for comprehension and ease of completion. Psychometric evaluation of the final HPV-QoL scale was conducted in a psychometric study including 252 adult women derived to our centre by a positive HPV test in the cervical cancer screening program and/or presenting genital warts. RESULTS: The present study reveals that the HPV-QoL questionnaire, structured in four domains: general well-being [including psychological well-being and social well-being subdomains], health, contagiousness and sexuality, showed good metric properties of feasibility irrespective of age or educational level, and time to administer was less than 5 min. Internal consistency and temporal stability (reliability) showed values above the acceptable standards. The instrument showed its concurrent validity by means of a significant correlation with mental and sexual existing instruments; GHQ-12 and FSFI questionnaires, respectively, and also known groups validity showing significant differences among the subgroups regarding either sexual dysfunction or mental deterioration. CONCLUSION: This study provides an HPV-QoL questionnaire with an innovative patient-reported outcomes specific measurement tool to assess HRQoL in women with HPV infection. The present study suggests this questionnaire has satisfactory psychometric properties, including validity and reliability. Results support the use of the HPV-QoL questionnaire as a HRQoL measurement instrument for daily medical practice and clinical research.

Comparative pilot study about HPV test with partial genotyping in primary screening versus other strategies for cervical cancer population screening, CRYGEN 16/18 study.

INTRODUCTION: The early detection of cervical cancer requires the implementation of molecular screening programmes for human papillomavirus (HPV). However, there are discrepancies in the optimization of screening protocols. The performance of 10 primary screening strategies based on molecular, cytological or combined techniques is now evaluated. MATERIAL AND METHODS: A blind, prospective, and interventional study was designed in 1.977 35-year-old women. The molecular determination was carried out by the Cobas 4800 HPV platform. Cytological analysis were performed on the same samples without knowledge of the result of the molecular assay. All women in whom HPV-16/HPV-18 was detected or presented cytological alteration together with detection of other high-risk genotypes (HPVhr) were referred to colposcopy. RESULTS: The molecular assay detected the presence of HPVhr genotypes in 12.5% of the women, while only 8.1% of the cytologies were pathological. Among the patients referred to colposcopy, in 19.5% high-grade lesions were observed, being HPV-16 present in 65.3% of them. In six of these high-grade lesions (associated with HPV-16 in all cases), cytology was reported as normal. The follow-up one year later, of women with normal cytology and HPVhr detection a HSIL/CIN2+ lesion was detected (associated to HPV-33). In the comparative study with other strategies, the protocol called CRYGEN 16/18 yielded the best balance of sensitivity and specificity with the least referral to colposcopy. CONCLUSIONS: Performing molecular detection of HPVhr with partial first-line genotyping of at least HPV-16, with direct referral to colposcopy, increases the detection rate of HSIL/CIN2+ lesions.

Effectiveness of Prophylactic Human Papillomavirus Vaccine in the Prevention of Recurrence in Women Conized for HSIL/CIN 2-3: The VENUS Study.

Background: Recent data have shown that the human papillomavirus (HPV) vaccine could impact on a decrease in high-grade cervical intraepithelial lesions (HSIL) in women who have undergone surgical treatment. This study aimed to evaluate the efficacy of human papilloma virus (HPV) vaccination against persistent/recurrent disease in patients undergoing conization for high-grade squamous intraepithelial lesion/cervical intraepithelial neoplasia-grade 2-3 (HSIL/CIN 2-3). Methods: From January 2009 to March 2019, 563 patients with HSIL/CIN 2-3 underwent conization. The population was divided into two groups according to vaccination status: vaccinated-group (V-Group) and non-vaccinated-group (NV-Group). Bivalent or quadrivalent vaccines were administered indiscriminately. A follow-up was scheduled every 6-12 months according to clinical guidelines. The mean follow-up was 29.6 vs. 36.5 months in the V-group and NV-group, respectively. Results: 277 (49.2%) women were vaccinated, while 286 (50.8%) were not. Overall, persistent/recurrent HSIL/CIN 2-3 was presented by 12/277 (4.3%) women in the V-Group and 28/286 (9.8%) in the NV-Group (HR: 0.43, 95% Confidence interval 0.22-0.84, p = 0.014). Vaccination was associated with a 57% reduction in HSIL persistence/recurrence after treatment. When no disease was present in the first 6-month follow-up visit, persistence/recurrence rates were very low in both groups: 1.1% in the V-Group vs. 1.5% in the NV-Group (p > 0.05). The factor associated with a high-risk of HSIL persistence/recurrence was the presentation of a positive co-test in the first control after treatment (p < 0.001). Conclusions: Our results corroborate the benefit of HPV vaccination in woman treated for HSIL/CIN 2-3, showing a reduction of persistent/recurrent HSIL/CIN 2-3.

Risk Factors Associated with CIN2+ in Spanish Patients with L-SIL/ASCUS Cytology Collected from a Madrid Hospital.

The management of patients with L-SIL/ASCUS cytology is controversial and not clearly standardized. OBJECTIVE: To analyze the risk factors associated with H-SIL/CIN2+ in a cohort of patients with ASCUS or L-SIL in a Pap smear. METHODS: Between 2012 and 2022, 1259 eligible women with ASCUS/L-SIL were referred for colposcopy. The risk factors associated with H-SIL/CIN2+ were analyzed. The colposcopic study, conventional or assisted with dynamic spectral imaging (DSI), was performed in all cases. Guided biopsies were performed in cases of abnormal examination or random biopsies when no lesions were found. A LEEP was performed in H-SIL/CIN2+ results or persistent LSIL/CIN. RESULTS: A normal or metaplastic specimen was found in 750 women (63.2%), LSIL/CIN1 in 346 (29.1%), and H-SIL/CIN2+ in 92 (7.7%). The presence of HR-HPV (OR = 2.1; IC 95% = 1.4-3.2), smoking habits (OR = 2.2; IC 95% = 1.4-3.5), and the performance of DSI combined with colposcopy (OR = 0.6; IC 95% = 0.37-0.83) were the factors associated with the detection of H-SIL/CIN2+. A summative effect of HR-HPV and smoking habit (OR = 2.9; IC 95% = 1.7-5.0) was observed in the detection of H-SIL/CIN2+. In multivariate analysis, the presence of HPV 16/18 was the unique independent factor associated with H-SIL/CIN2+. CONCLUSION: In women carrying an ASCUS/LSIL in the Pap smear, the unique independent factor predictive of H-SIL/CIN2+ is the presence of the HPV 16/18 genotype. Smoking women carrying ASCUS/LSIL with HR-HPV should be targeted for stricter follow-up to avoid an unsuspected H-SIL/CIN2+.

Quadrivalent Human Papillomavirus Vaccine Effectiveness after 12 Years in Madrid (Spain).

A fully government-funded human papillomavirus (HPV) vaccination program started in 2007 in Spain (only 11-14-year-old girls). The first of those vaccinated cohorts, with the quadrivalent vaccine (Gardasil), turned 25 years old in 2018, the age at which cervical cancer screening begins in Spain. The current study could provide the first evidence about the effectiveness of the quadrivalent vaccine against HPV in Spain and the influence of age of vaccination. The present ambispective cohort study, which was conducted on 790 women aged 25 and 26 years old, compares the rate of HPV prevalence and cytologic anomaly according to the vaccination status. The overall infection rate was 40.09% (vaccinated group) vs. 40.6% (non-vaccinated group). There was a significant reduction in the prevalence of HPV 6 (0% vs. 1.3%) and 16 (2.4% vs. 6.1%), and in the prevalence of cytological abnormalities linked to HPV16: Atypical Squamous Cells of Undetermined Significance (ASCUS) (2.04% vs. 14%), Low-grade Squamous Intraepithelial Lesions (LSIL) (2.94% vs. 18.7%) and High-grade Squamous Intraepithelial Lesion (HSIL) (0% vs. 40%), in the vaccinated group vs. the non-vaccinated group. Only one case of HPV11 and two cases of HPV18 were detected. The vaccine effectively reduces the prevalence of vaccine genotypes and cytological anomalies linked to these genotypes.

Comparative pilot study about HPV test with partial genotyping in primary screening versus other strategies for cervical cancer population screening, CRYGEN 16/18 study. / Estudio piloto comparativo del test VPH con genotipado parcial en primera línea frente a otras estrategias de cribado poblacional del cáncer de cérvix. Estudio CRYGEN 16/18.

INTRODUCTION: The early detection of cervical cancer requires the implementation of molecular screening programs for human papillomavirus (HPV). However, there are discrepancies in the optimization of screening protocols. The performance of 10 primary screening strategies based on molecular, cytological or combined techniques is now evaluated. MATERIAL AND METHODS: A blind, prospective, and interventional study was designed in 1977 35-year-old women. The molecular determination was carried out by the Cobas 4800 HPV platform. Cytological analysis was performed on the same samples without knowledge of the result of the molecular assay. All women in whom HPV-16/HPV-18 was detected or presented cytological alteration together with detection of other high-risk genotypes (HPVhr) were referred to colposcopy. RESULTS: The molecular assay detected the presence of HPVhr genotypes in 12.5% of the women, while only 8.1% of the cytologies were pathological. Among the patients referred to colposcopy, in 19.5% high-grade lesions were observed, being HPV-16 present in 65.3% of them. In six of these high-grade lesions (associated with HPV-16 in all cases), cytology was reported as normal. The follow-up one year later, of women with normal cytology and HPVhr detection a HSIL/CIN2+ lesion was detected (associated to HPV-33). In the comparative study with other strategies, the protocol called CRYGEN 16/18 yielded the best balance of sensitivity and specificity with the least referral to colposcopy. CONCLUSIONS: Performing molecular detection of HPVhr with partial first-line genotyping of at least HPV-16, with direct referral to colposcopy, increases the detection rate of HSIL/CIN2+ lesions.

[Overexpression and prognostic value of p53 and HER2/neu proteins in benign ovarian tissue and in ovarian cancer]. / Grado de expresión y valor pronóstico de las proteínas p53 y HER2/neu en el tejido ovárico benigno y en el cáncer de ovario.

BACKGROUND AND OBJECTIVE: To investigate the prognostic value of p53 and HER2/neu overexpression in epithelial ovarian cancer (EOC). PATIENTS AND METHOD: p53 and HER2/neu immunostaining were performed in 198 tissue samples, 124 EOC, 44 benign ovarian tumors and 30 normal ovaries. Nuclear p53 and membranous HER2/neu immunostaining were evaluated. RESULTS: Neither p53 nor HER2/neu overexpression was seen in the benign ovarian tumors. HER2/neu immunostaining was observed in one normal ovary. P53 overexpression was found in 25% EOC and was related with advanced stage, endometrioid, clear cell and undifferentiated types, grade G3, and sub-optimal surgery. HER2/neu immunostaining was observed in 24.2% and it was associated with advanced stage, clear cell and undifferentiated types, and suboptimal surgery. Both, p53 and HER2/neu overexpression decreased overall and progression-free survival, but in the multivariant analysis, only HER2/neu overexpression was an independent prognostic factor of overall survival (RR = 2.8; 95% confidence interval [CI], 1.2-5.6) and recurrence (RR = 2.8; 95% CI, 1.1-7.1). Simultaneous p53 and HER2/neu overexpression made the prognosis worse (p < 0.01). CONCLUSIONS: HER2/neu overexpression (but not p53 overexpression) is a major prognostic factor in EOC.

Vulvitis de Zoon en mujer en edad fértil. Reporte de un caso / Zoon vulvitis in a woman of childbearing age. A case report / Zoon vulvitis in a woman of childbearing age. A case report

RESUMEN La vulvitis de Zoon o vulvitis de células plasmáticas es una enfermedad inflamatoria crónica infrecuente, caracterizada por placas eritematosas bien delimitadas y brillantes que pueden afectar cualquier localización de la vulva. Suele presentarse en mujeres posmenopáusicas y plantea un difícil diagnóstico diferencial. Se insiste en la necesidad de realizar biopsia vulvar para obtener un diagnóstico histológico de certeza. Se presenta el caso de una paciente de 36 años y se comenta las opciones terapéuticas actuales descritas en la literatura.

ABSTRACT Zoon vulvitis or vulvitis circumscripta plasmacellularis is a rare chronic inflammatory disease characterized by well-delimited and shiny erythematous plaques that can affect any location of the vulva. It usually occurs in postmenopausal women and poses a difficult differential diagnosis. The need for a vulvar biopsy is emphasized to obtain a certain histological diagnosis. The case of a 36-year-old patient is presented and the current therapeutic options described in the literature are discussed.

Úlcera vulvar aguda de Lipschütz / Acute vulvar ulcer of Lipschütz

RESUMEN La úlcera de Lipschütz es una entidad poco frecuente e infradiagnosticada. Se presenta el caso de una paciente de 24 años sin antecedente de contacto sexual que consultó por aparición súbita de úlceras vulvares dolorosas, en el contexto de un cuadro pseudogripal. Se discuten los principales diagnósticos diferenciales, dado que es una enfermedad no relacionada con enfermedades de transmisión sexual y poco reconocida por los profesionales de la salud, que precisa de manejo conservador.

ABSTRACT Lipschütz ulcer is a rare underdiagnosed entity. We present the case of a 24-year-old patient without history of sexual contact who consulted for sudden occurrence of painful vulvar ulcers, in the context of flu-like symptoms. The main differential diagnoses are discussed, as it is a disease unrelated to sexually transmitted diseases and little recognized by health professionals, which requires conservative management.