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

Women with low quality of life by cervantes-short form scale choose menopausal hormone therapy.

Objectives The aim of the study is to assess whether women who choose to use menopausal hormone therapy (MHT) have lower quality of life (QoL) than those who do not initiate it using Cervantes short form scale (C-SF), and analyze sociodemographic factors associated with lower QoL in women. Study design A cross-sectional descriptive observational study was made in four hundred and eighty women with climacteric symptoms. Results Mean age was 51.1 years. Two hundred and sixty-one women (54.3 %) started MHT. The sample´s global mean in C-SF score was 51.3 ± 13.9. Women who choose to use MHT have higher score in C-SF (lower QoL) than women who reject it (58.7 ± 15.9 vs 46.7 ± 12.8; p 30 BMI) (52.8 ± 13.5 vs 41.0 ± 8.2; p = 0.002); with previous malignancies (56.2 ± 18.2 vs 50.2 ± 13.5; p = 0.020) and without sexual activity (58.0 ± 25.4 vs 50.4 ± 13.1; p = 0.009. No differences were found in C-SF score with respect to tobacco habits or physical activity. In the multivariate analysis, the variable independently associated to lower QoL by C-SF (high score) was to be a woman who want to initiate MHT (p = 0.004). Conclusions Women who choose to use MHT due to menopausal symptoms have lower quality of life measured by C-SF scale. Women with early menopause, with no obesity (<30 BMI), without sexual activity and with previous malignances have lower quality of life measured by C-SF scale. Women with early menopause have more psychic symptoms like nervousness, fatigue and sleep complaints by C-SF scale than women with natural menopause.pre-print726 K

Pharmacological interactions and menopausal hormone therapy a review

Importance and Objective: Menopausal hormone therapy (HT) is widely used, and there are several statements of international scientific societies to guide prescribers; however, a summary of existing literature about possible drug interactions with HT does not exist, although many midlife women take medications for other conditions. Therefore, our objective was to create a document that presents and synthesizes the most relevant interactions. The impact of the interaction itself and the number of candidates for HTwho are likely to use other treatments are considered based on the best available evidence. Methods: A systematic review was performed to determine the best evidence of interaction effects on relevant outcomes of interest for decision making. Aworking framework was developed to formulate explicit and reasoned recommendations according to four predefined categories for coadministration: (1) can be used without expected risks, (2) acceptable use (no evidence of negative interaction), (3) alternative treatment should be considered, and (4) nonuse without express justification. The project protocolwas registered in the Open Science Framework platform (doi: 10.17605/OSF.IO/J6WBC) and in PROSPERO (registration number CRD42020166658). Results: Studies targeting our objective are scarce, but 23 pharmacological groups were assigned to one of the predefined categories of recommendation for concomitant use of HT. Vaginal HTwas assigned to category 1 for 21 of the analyzed pharmacological groups. For oral and transdermal HT (estrogen-only or combined) and tibolone, there were 12 pharmacological groups assigned to category 1, 12 to category 2, 5 to category 3, and 4 to category 4. Results are shown in crossed-tables that are useful for counseling and prescription. Discussion and conclusions: Available evidence of HT interactions with other drugs is scarce and mainly indirect. It comes from biological plausibility, knowledge of extensive concomitant use without reported incidents, and/or extrapolation from hormonal contraception, but there are pharmacological groups in all categories showing that information is useful. These eligibility criteria summarize it and can help in the decision process of HT coadministration with other drugs. Decisions should be taken based on these recommendations but also individualized risk/benefit evaluation, according to underlying pathology, patient's clinical requirements, and the existence or nonexistence of alternatives

Tumoral volume measured preoperatively by magnetic resonance imaging is related to survival in endometrial cancer.

Background. The aim of the study was to determine if the endometrial tumor volume (TV) measured by magnetic resonance imaging (MRI-TV) is associated with survival in endometrial cancer and lymph nodes metastases (LN+). Patients and methods. We evaluated the MRI imaging and records of 341 women with endometrial cancer and preoperative MRI from 2008 to 2018. The MRI-TV was calculated using the ellipsoid formula measuring three perpendicular tumor diameters. Tumor myometrial invasion was also analyzed. Results. Higher MRI-TV was associated with age ≥ 65y, non-endometrioid tumors, grade-3, deep-myometrial invasion, LN+ and advanced FIGO stage. There were 37 patients with LN+ (8.8%). Non-endometrioid tumors, deep-myometrial invasion, grade-3 and MRI-TV ≥ 10 cm3 were the factors associated with LN+. Using a receiver operating characteristic [ROC] curve, the MRI-TV cut-off for survival was 10 cm3 (area under curve [AUC] = 0.70; 95% CI: 0.61–0.73). 5 years disease-free (DFS) and overall survival (OS) was significantly lower in MRI-TV ≥ 10 cm3 (69.3% vs. 84.5%, and 75.4% vs. 96.1%, respectively). MRI-TV was considered an independent factor of DFS (HR: 2.20, 95% CI: 1.09–4.45, p = 0.029) and OS (HR: 3.88, 95% CI: 1.34–11.24, p = 0.012) in multivariate analysis. Conclusions. MRI-TV was associated with LN+, and MRI-TV ≥ 10 cm3 was an independent prognostic factor of lower DFS and OS. The MRI-TV can be auxiliary information to plan the surgery strategy and predict the adjuvant treatment in women with endometrial cancer.post-print403 K

Predictive and criterion validity of the Cervantes-SF menopause quality of life questionnaire.

pre-print384 K

Health-related quality of life and resilience in peri- and postmenopausal women during Covid-19 confinement.

Objective To assess the impact of confinement due to the coronavirus (Covid-19) pandemic on health-related quality of life (HRQoL) and resilience in peri- and postmenopausal women. Material and Methods We used an online questionnaire which was sent between April 30th and May 13th, 2020 to women aged 40–70 years who were peri- or postmenopausal according to STRAW criteria. We used the 16-item Cervantes short-form scale (Cervantes-SF) to measure HRQoL, and the 14-item Wagnild and Young Resilience Scale (RS-14) to measure resilience. High scores on the Cervantes-SF indicate low HRQoL and high scores on the RS-14 indicate high levels of resilience. Covid-19 status, sociodemographic descriptors, and lifestyle variables were also evaluated. Results We included 2430 peri- and postmenopausal women with valid questionnaires. All items of the Cervantes-SF were completed in 2151 cases, whilst the RS-14 was completed in 2413 cases. There was a negative correlation between scores on the Cervantes-SF and RS-14 scales (Rho -0.350; p < 0.0001). Multiple linear regression analysis revealed a statistically significant association between Cervantes-SF scores and living with others (β-coefficient -10.2; p < 0.001), use of antidepressants (β 9.3; p < 0.001), physical activity (β -8.6; p < 0.001) and sexual activity (β -2.7; p < 0.001). Resilience was associated with the use of antidepressants (β -5.9; p < 0.001), physical activity (β 3.2; p < 0.001) and sexual activity (β 1.7; p = 0.005). According to the multivariate analysis, there were no associations between either Covid-19 or menopausal status and HRQoL or resilience scores. Conclusions During the period of mandatory Covid-19 confinement, peri- and postmenopausal women who engaged in physical and sexual activity had higher HRQoL and higher levels of resilience, whilst women who were using antidepressants had lower HRQoL and lower levels of resilience. HRQoL was greater in women who lived with others.pre-print185 K

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.pre-print927 K

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