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

Nicht-präsentiale lehre in Geburtshilfe und Gynäkologie

Se ha realizado un proyecto docente con la finalidad de rediseñar la asignatura de Obstetricia y Ginecología del Hospital Clinico San Carlos en no presencial. Se crearon nuevos contenidos usando la plataforma virtual de la UCM. Se presentaron las clases magistrales y casos clínicos usando presentaciones de PowerPoint o pdf en “streaming” forma directa. Como complemento se usó contenido multimedia según la naturaleza de la clase. Durante las sesiones se permitía interacción con el alumno usando el chat o dando paso a intervenciones según convenía. No se pudo realizar seminarios de índole inminentemente practica como son los relacionados a la exploración, habilidades y manejo endoscópico. En estos casos se realizaron de forma presencial siguiendo las medidas recomendadas. La evaluación de conocimiento no pudo realizarse de forma virtual siguiendo las recomendaciones de la UCM ante la imposibilidad de monitorizar un numero de alumnos mayor de 100. Los resultados de las calificaciones brutas de las clases no presenciales fueron peores que los obtenidos en las clases presenciales. Los alumnos consideran las clases no presenciales como peores, se quejan del poco contacto entre compañeros y no ven diferencias respecto al profesorado. El profesorado también valora peor las clases no presenciales y se sienten menos cómodos. La mayoría de los profesores ven bien un futuro con formato híbrido (presencial y on line simultáneo).A teaching project has been carried out with the aim of redesigning in non-presential the Obstetrics and Gynecology subject at Hospital Clinico San Carlos. New content was created using the UCM virtual platform. Lectures and clinical cases were presented using streaming PowerPoint or pdf presentations. As a complement, multimedia content was used according to the type of class. During the sessions, students interacted using chat or live streaming when appropriate. It was not possible to carry out on hands seminars, such as those related to exploration, skills, and endoscopic management. In these cases, they were carried out in a presidential way following the recommended health measures. The exams could not be carried out in a virtual way following the recommendations of the UCM due to the impossibility of monitoring more than 100 students. The results of the raw grades of the non-face-to-face classes were worse than those obtained in the face-to-face classes. Students considered non-face-to-face classes worse, they complained about little contact between classmates and they saw non-differences in relation to the teaching staff. Teachers also value non-contact classes worse and feel less comfortable. Most teachers see possible a hybrid format (face-to-face and online simultaneously) in the future.Depto. de Salud Pública y Materno - InfantilFac. de MedicinaFALSEningunasubmitte

Validación del Cuestionario de Conocimientos sobre Infecciones del Tracto Genital Inferior en farmacia comunitaria; Validation of Knowlegde Questionnaire about Lower Genital Tract Infections in Community Pharmacy

Objetivos:Diseñar y validar un cuestionario de conocimientos sobre infecciones del tracto genital inferior, de no transmisión sexual, destinado a las pacientes que acuden a las farmacias comunitarias y han sufrido infecciones vaginales al menos una vez. Material y métodos: Validación y diseño del cuestionario de conocimientos se basó en la revisión bibliográfica, valoración por el panel de expertos (método Delphi) y el análisis estadístico correspondiente.Se determinó la fiabilidad de la escala mediante el índice de consistencia interna (alfa de Cronbach), se realizó un análisis factorial de componentes principales con rotación Varimax y se verificó la sensibilidad del cuestionario al cambio a través del Test de Wilcoxon y McNemar. El cuestionario se autoadministró dentro de las oficinas de farmacia antes de la intervencióneducativa mediante folletos especialmente elaborados y se volvió a aplicar pasados 6 meses. Resultados: La valoración por 30 expertos fue superior a 4 sobre 5 en escala Likert. En el estudio participaron 105 mujeres entre 18 y 65 años de 11 farmacias comunitarias de Madrid. La consistencia interna antes y después de depuración de ítems fue 0,713 y 0,738 respectivamente. El análisis factorial confirmó la multidimensionalidad del cuestionario. Mediante el Test de Wilcoxon se demostró la sensibilidad del cuestionario a la intervención educativa. El 28,6% de las pacientes contestó correctamente a más del 75% de los ítems. Conclusiones. Los conocimientos sobre infecciones vaginales se consideran insatisfactorios por lo tanto se ve necesaria la implementación de educación sanitaria en las oficinas de farmacia. Gracias a la fiabilidad de la escala y la óptima validez del contenido, el cuestionario diseñado puede ser considerado una buena base para futuras investigaciones y una herramienta recomendable en la práctica profesional. Objectives: To design and validate a questionnaire of knowledge about infections of the lower genital tract, of non-sexual transmission, intended for patients who visit community pharmacies and have suffered vaginal infections at least once.   Material and methods: The validation and design of the knowledge questionnaire was based on bibliographic review, evaluation by the panel of experts (Delphi method) and the corresponding statistical analysis. The reliability of the scale was determined using the internal consistency index (Cronbach's alpha), a factorial analysis of the main components with Varimax rotation was carried out, and the sensitivity of the questionnaire to the change was verified through the Wilcoxon and McNemar test. The questionnaire was self-administered within the pharmacies before the educational intervention through specially prepared brochures and was re-applied after 6 months.   Results: The evaluation by 30 experts was superior to 4 out of 5 on the Likert scale. The study involved 105 women between 18 and 65 years old from 11 community pharmacies in Madrid. The internal consistency before and after the item screening was 0,713 and 0,738 respectively. The factorial analysis confirmed the multidimensionality of the questionnaire. The Wilcoxon test demonstrated the sensitivity of the questionnaire to the educational intervention. Only 28,6% of the patients correctly answered more than 75% of the items.   Conclusions: The knowledge about vaginal infections is considered unsatisfactory, therefore it is necessary to implement health education in the community pharmacies. Thanks to the reliability of the scale and the optimal validity of the content, the designed questionnaire can be considered a good basis for future research and a recommended tool in professional practice

Validación del Cuestionario de Conocimientos sobre Infecciones del Tracto Genital Inferior en farmacia comunitaria; Validation of Knowlegde Questionnaire about Lower Genital Tract Infections in Community Pharmacy

Objetivos:Diseñar y validar un cuestionario de conocimientos sobre infecciones del tracto genital inferior, de no transmisión sexual, destinado a las pacientes que acuden a las farmacias comunitarias y han sufrido infecciones vaginales al menos una vez. Material y métodos: Validación y diseño del cuestionario de conocimientos se basó en la revisión bibliográfica, valoración por el panel de expertos (método Delphi) y el análisis estadístico correspondiente.Se determinó la fiabilidad de la escala mediante el índice de consistencia interna (alfa de Cronbach), se realizó un análisis factorial de componentes principales con rotación Varimax y se verificó la sensibilidad del cuestionario al cambio a través del Test de Wilcoxon y McNemar. El cuestionario se autoadministró dentro de las oficinas de farmacia antes de la intervencióneducativa mediante folletos especialmente elaborados y se volvió a aplicar pasados 6 meses. Resultados: La valoración por 30 expertos fue superior a 4 sobre 5 en escala Likert. En el estudio participaron 105 mujeres entre 18 y 65 años de 11 farmacias comunitarias de Madrid. La consistencia interna antes y después de depuración de ítems fue 0,713 y 0,738 respectivamente. El análisis factorial confirmó la multidimensionalidad del cuestionario. Mediante el Test de Wilcoxon se demostró la sensibilidad del cuestionario a la intervención educativa. El 28,6% de las pacientes contestó correctamente a más del 75% de los ítems. Conclusiones. Los conocimientos sobre infecciones vaginales se consideran insatisfactorios por lo tanto se ve necesaria la implementación de educación sanitaria en las oficinas de farmacia. Gracias a la fiabilidad de la escala y la óptima validez del contenido, el cuestionario diseñado puede ser considerado una buena base para futuras investigaciones y una herramienta recomendable en la práctica profesional. Objectives: To design and validate a questionnaire of knowledge about infections of the lower genital tract, of non-sexual transmission, intended for patients who visit community pharmacies and have suffered vaginal infections at least once.   Material and methods: The validation and design of the knowledge questionnaire was based on bibliographic review, evaluation by the panel of experts (Delphi method) and the corresponding statistical analysis. The reliability of the scale was determined using the internal consistency index (Cronbach's alpha), a factorial analysis of the main components with Varimax rotation was carried out, and the sensitivity of the questionnaire to the change was verified through the Wilcoxon and McNemar test. The questionnaire was self-administered within the pharmacies before the educational intervention through specially prepared brochures and was re-applied after 6 months.   Results: The evaluation by 30 experts was superior to 4 out of 5 on the Likert scale. The study involved 105 women between 18 and 65 years old from 11 community pharmacies in Madrid. The internal consistency before and after the item screening was 0,713 and 0,738 respectively. The factorial analysis confirmed the multidimensionality of the questionnaire. The Wilcoxon test demonstrated the sensitivity of the questionnaire to the educational intervention. Only 28,6% of the patients correctly answered more than 75% of the items.   Conclusions: The knowledge about vaginal infections is considered unsatisfactory, therefore it is necessary to implement health education in the community pharmacies. Thanks to the reliability of the scale and the optimal validity of the content, the designed questionnaire can be considered a good basis for future research and a recommended tool in professional practice