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

Recommendations for a standardised educational program in robot assisted gynaecological surgery: consensus from the Society of European Robotic Gynaecological Surgery (SERGS)

Background: the Society of European Robotic Gynaecological Surgery (SERGS) aims at developing a European consensus on core components of a curriculum for training and assessment in robot assisted gynaecological surgery. Methods: a Delphi process was initiated among a panel of 12 experts in robot assisted surgery invited through the SERGS. An online questionnaire survey was based on a literature search for standards in education in gynaecological robot assisted surgery. The survey was performed in three consecutive rounds to reach optimal consensus. The results of this survey were discussed by the panel and led to consensus recommendations on 39 issues, adhering to general principles of medical education. Results: on review there appeared to be no accredited training programs in Europe, and few in the USA. Recommendations for requirements of training centres, educational tools and assessment of proficiency varied widely. Stepwise and structured training together with validated assessment based on competencies rather than on volume emerged as prerequisites for adequate and safe learning. An appropriate educational environment and tools for training were defined. Although certification should be competence based, the panel recommended additional volume based criteria for both accreditation of training centres and certification of individual surgeons. Conclusions: consensus was reached on minimum criteria for training in robot assisted gynaecological surgery. To transfer results into clinical practice, experts recommended a curriculum and guidelines that have now been endorsed by SERGS to be used to establish training programmes for robot assisted surgery

Risk factors for recurrence after robot-assisted radical hysterectomy for early-stage cervical cancer: a multicenter retrospective study

This retrospective analysis aimed to assess the risk factors for recurrence in patients diagnosed with early-stage cervical cancer (≤IB1 or IIA1, FIGO 2009) undergoing robot-assisted radical hysterectomy in Spain and Portugal between 2009 and 2018. A second primary objective was to audit the oncological outcomes according to quality indicators (QI) proposed by the European Society of Gynecology Oncology (ESGO). The study population included 239 women. After a median follow-up of 51 months, recurrence occurred in 26 patients (10.9%). Independent factors for recurrence were clinical tumor size > 20 mm (hazard ratio (HR) 2.37), adenocarcinoma as histological type (HR 2.51), positive pelvic lymph nodes (HR 4.83), tumor grade 2 (HR 4.99), tumor grade 3 (HR 8.06), and having not performed sentinel lymph node biopsy (SLNB) (HR 4.08). All 5 QI selected were surpassed by our results. In patients with early-stage cervical cancer undergoing robotic radical hysterectomy, clinicians should be aware that tumor grade 2 and 3, tumor size > 20 mm, adenocarcinoma, positive pelvic nodes, and lack of performance of SLNB are risk factors for recurrence. Fulfillment of QI targets of the ESGO might be considered as an objective oncological outcome indicator supporting the minimally invasive approach for early-stage cervical cancer treatment. KEYWORDS: early-stage cervical cancer; oncological outcome; radical hysterectomy; recurrence; robotic surgery

Eficacia del gel vaginal de coriolus versicolor en mujeres con lesiones cervicales asociadas al virus del papiloma humano. El estudio Paloma

Objetivo: el objetivo del estudio fue determinar la eficacia de un gel vaginal con Coriolus versicolor, Papilocare®, en la reparación de las lesiones cervicales de bajo grado causada por el virus del papiloma humano (VPH). Material y métodos: estudio multicéntrico, abierto, aleatorizado y controlado que implicó 91 mujeres positivas en VPH con alteraciones de bajo grado en citología cervical y colposcopia concordante. Resultados: el porcentaje de mujeres con citología normal y colposcopia concordante después de tres y seis meses de tratamiento con el gel fue significativamente mayor (78,0% y 84,9%) que en el grupo control (54,8% y 64,5%), principalmente en pacientes con VPH de alto riesgo (79,5% y 87,8% frente a 52,0% y 56,0%). A los seis meses, el aclaramiento de VPH fue mayor en pacientes que recibieron tratamiento respecto a las que no lo recibieron (59,6% frente a 41,9%), especialmente en las de alto riesgo (62,5% frente a 40,0%). En comparación con basal, el estrés percibido por las pacientes se redujo en el grupo de tratamiento (de 21,1 a 19,0), mientras que se incrementó en el grupo control (de 17,7 a 20,7). Se describieron siete posibles/probables efectos adversos relacionados con el tratamiento; la mayoría de severidad leve o moderada. Conclusión: el tratamiento con el gel vaginal con Coriolus versicolor ha demostrado un mayor beneficio clínico que la conducta clínica habitual, espera vigilante, tanto en la muestra total como en el subgrupo de alto riesgo, respecto a su eficacia para el tratamiento de las lesiones cervicales de bajo grado y el aclaramiento de las cepas de VPH después de seis meses de tratamiento. El gel vaginal ha presentado además un perfil de seguridad y tolerabilidad alto y ha conferido adicionalmente una importante mejora de la reepitelización cervical, una reducción del estrés percibido y una alta adherencia terapéutica.2021-2

Central Pathology Review in SENTIX, a Prospective Observational International Study on Sentinel Lymph Node Biopsy in Patients with Early-Stage Cervical Cancer (ENGOT-CX2)

The quality of pathological assessment is crucial for the safety of patients with cervical cancer if pelvic lymph node dissection is to be replaced by sentinel lymph node (SLN) biopsy. Central pathology review of SLN pathological ultrastaging was conducted in the prospective SENTIX/European Network of Gynaecological Oncological Trial (ENGOT)-CX2 study. All specimens from at least two patients per site were submitted for the central review. For cases with major or critical deviations, the sites were requested to submit all samples from all additional patients for second-round assessment. From the group of 300 patients, samples from 83 cases from 37 sites were reviewed in the first round. Minor, major, critical, and no deviations were identified in 28%, 19%, 14%, and 39% of cases, respectively. Samples from 26 patients were submitted for the second-round review, with only two major deviations found. In conclusion, a high rate of major or critical deviations was identified in the first round of the central pathology review (28% of samples). This reflects a substantial heterogeneity in current practice, despite trial protocol requirements. The importance of the central review conducted prospectively at the early phase of the trial is demonstrated by a substantial improvement of SLN ultrastaging quality in the second-round review

Glycyrrhizinic Acid as an Antiviral and Anticancer Agent in the Treatment of Human Papillomavirus

Human papillomavirus (HPV), like any other virus, needs to penetrate the host cell and make use of its machinery to replicate. From there, HPV infection can be asymptomatic or lead to benign and premalignant lesions or even different types of cancer. HPV oncogenesis is due to the ability of the viral oncoproteins E6 and E7 to alter the control mechanisms for the growth and proliferation of host cell. Therefore, the use of agents with the ability to control these processes is essential in the search for effective treatments against HPV infections. Glycyrrhizinic acid (Gly), the active ingredient in liquorice, has been shown in numerous preclinical studies to have an antiviral and anticancer activity, reducing the expression of E6 and E7 and inducing apoptosis in cervical cancer cells. In addition, it also has antioxidant, anti-inflammatory, immunomodulatory or re-epithelializing properties that can be useful in HPV infections. This review includes the different antiviral and anticancer mechanisms described for Gly, as well as the clinical studies carried out that position it as a potential therapeutic strategy against HPV both through its topical application and by oral administration.CatalysisDepto. de Salud Pública y Materno - InfantilFac. de MedicinaTRUEpubDescuento UC

TSPAN13 expression in ovarian cancer

Vicerrectorado de Investigación UF

Lymphovascular Space Invasion in Early-Stage Endometrial Cancer (LySEC): Patterns of Recurrence and Predictors. A Multicentre Retrospective Cohort Study of the Spain Gynecologic Oncology Group

In patients with early-stage endometrioid endometrial cancer, the presence of lymph vascular space involvement (LVSI) correlates with nodal metastases, shorter disease-free survival and overall survival. However, the effect of LVSI on recurrence patterns of these patients has been poorly studied, and the optimal adjuvant treatment remains unclear. Additionally, positive LVSI is indicative for nodal assessment, however, this parameter is usually not Known until a final pathology report. The main aim of our study was to analyze oncological outcomes and patterns of recurrence of these patients according to LVSI status, as well as to determine preoperative predictors of positive LVSI. We confirmed in a large multi-institutional cohort of patients (3546 participants), that positive LVSI is an independent prognostic factor for distant recurrences (HR 2.37) but not for local recurrence. In addition, deep myometrial invasion, high-grade tumors, cervical stroma invasion, and tumor diameter ≥ 2 cm are independent predictors of positive LVSI.The main aim is to compare oncological outcomes and patterns of recurrence of patients with early-stage endometrioid endometrial cancer according to lymphovascular space invasion (LVSI) status. The secondary objective is to determine preoperative predictors of LVSI. We performed a multicenter retrospective cohort study. A total of 3546 women diagnosed with postoperative early-stage (FIGO I-II, 2009) endometrioid endometrial cancer were included. Co-primary endpoints were disease-free survival (DFS), overall survival (OS), and pattern of recurrence. Cox proportional hazard models were used for time-to-event analysis. Univariate and multivariate logistical regression models were employed. Positive LVSI was identified in 528 patients (14.6%) and was an independent prognostic factor for DFS (HR 1.8), OS (HR 2.1) and distant recurrences (HR 2.37). Distant recurrences were more frequent in patients with positive LVSI (78.2% vs. 61.3%, p < 0.01). Deep myometrial invasion (OR 3.04), high-grade tumors (OR 2.54), cervical stroma invasion (OR 2.01), and tumor diameter ≥ 2 cm (OR 2.03) were independent predictors of LVSI. In conclusion, in these patients, LVSI is an independent risk factor for shorter DFS and OS, and distant recurrence, but not for local recurrence. Deep myometrial invasion, cervical stroma invasion, high-grade tumors, and a tumor diameter ≥ 2 cm are independent predictors of LVSI.Depto. de Salud Pública y Materno - InfantilFac. de MedicinaTRUEpubDescuento UC

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&ndash;3.2), smoking habits (OR = 2.2; IC 95% = 1.4&ndash;3.5), and the performance of DSI combined with colposcopy (OR = 0.6; IC 95% = 0.37&ndash;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&ndash;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+