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.

Lymph node dissection in uterine leiomyosarcomas: A matched-pair study.

OBJECTIVE: To assess the impact of the lymph node dissection (LND) in the disease-free (DFS) and overall survival (OS) of the women treated surgically of uterine leiomyosarcoma (ULMS). MATERIAL AND METHODS: A multicentric retrospective study was conducted among European countries collecting patients diagnosed of uterine sarcoma (SARcoma of the UTerus - SARCUT study). A total of 390 ULMS were selected for the present study to compare patients who underwent LND and those who did not. A further matched-pair subanalysis identified 116 women, 58 pairs (58 with LND and 58 without it) comparable in age, tumor size, surgical procedures, extrauterine disease and adjuvant treatment. Demographic data, pathology results and follow-up were abstracted from medical records and analyzed. Disease-free (DFS) and overall survival (OS) were studied using Kaplan-Meier curves and Cox regression analysis. RESULTS: Among the 390 patients, the 5-year DFS was significantly higher in no-LDN group comparing to the LDN group (57.7% vs. 33.0%; HR 1.75, 95% CI 1.19-2.56; p = 0.007), but not the 5-year OS (64.6% vs. 64.3%; HR 1,10 95% CI 0,77-1,79; p = 0.704). In the matched-pair subanalysis, there were no statistical differences between the study groups. The 5- year DFS was 50.5% in the no-LND and 33.0% in the LND group (HR 1.38; 95% CI 0,83-2.31; p = 0,218) and the 5-year OS was 59.7% and 64.3% respectively (HR 0.81; 95% CI 0,45-1,49; p = 0,509). CONCLUSIONS: LND performed in women diagnosed of ULMS have no impact neither in the disease-free nor in the overall survival compared to patients without LDN in a complete homogeneous group.

Sensitivity-to-change and predictive validity of the Cervantes Short-Form (C-SF) questionnaire in postmenopausal women.

OBJECTIVES: To explore, for the first time, the ability of the Cervantes Short-Form (C-SF) questionnaire to detect and to predict meaningful changes (sensitivity-to-change and predictive validity) in women with menopausal symptoms receiving any therapeutic management under routine medical care. METHODS: Postmenopausal women included in a registry study were the source of data. Sensitivity-to-change was explored by assessing the responses of C-SF to different type of treatment management: no treatment, natural therapies or systemic hormonal therapy (SHT). Predictive validity assessed the ability of baseline score to predict the reduction in the impact of menopausal symptoms in C-SF scoring equal or higher than one time its minimally important difference (MID) of improvement (response rate). RESULTS: A total of 245 women were enrolled. C-SF score was significantly reduced (better QoL) with SHT by 10.62 points versus no change or 2.32 point by natural therapies or no treatment, respectively (p < 0.001 in both cases). Women declaring better improvement after treatment showed higher significant reduction in C-SF score versus those with no self-perceived improvement or impairment: -12.49 point versus +1.06 and +12.71, respectively (p < 0,01 in both cases). Responder rate showed a significant lineal growing trend with higher C-SF scoring at baseline in women who received SHT: higher scoring showed higher response rates (lineal Chi2 = 15.9, p < 0.001), but not in the case of receiving natural therapies or no treatment. CONCLUSIONS: C-SF was shown to be sensitive-to-change when postmenopausal QOL status changes due to mainly systemic hormonal treatment, therefore, supporting the utilization of this instrument to monitor response to treatment. Likewise, pre-treatment scoring in C-SF was able to predict woman's QOL meaningful response with hormonal treatment.

Oncological safety of hysteroscopy in endometrial cancer.

OBJECTIVE: It has been suggested that the manipulation of neoplastic tissue during hysteroscopy may lead to dissemination of tumor cells into the peritoneal cavity and worsen prognosis and overall survival. The goal of this study was to assess the oncological safety comparing hysteroscopy to Pipelle blind biopsy in the presurgical diagnosis of patients with endometrial cancer. METHODS: We performed a retrospective multicentric study among patients who had received primary surgical treatment for endometrial cancer. A multivariate statistical analysis model was used to compare relapse and survival rates in patients who had been evaluated preoperatively either by hysteroscopy or Pipelle biopsy. The relapse rate, disease-free survival, and overall survival were assessed as the main outcomes. The histological type, tumor size, myometrial invasion, International Federation of Gynecology and Obstetrics (FIGO) stage, surgical approach, use of a uterine manipulator, and adjuvant treatment were also included in the analysis. RESULTS: A total of 1731 women from 15 centers were included: 1044 in the hysteroscopy group and 687 in the Pipelle sampling group. 225 patients relapsed during the 10 year follow-up period: 139 (13.3%) in the hysteroscopy group and 86 (12.4%) in the Pipelle sampling group. There is no evidence of an association between the use of hysteroscopy as a diagnostic method and relapse rate (HR 1.24, 95% CI 0.92 to 1.66; p=0.16), lower disease-free survival (HR 1.23, 95% CI 0.92 to 1.66; p=0.15), or overall survival (HR 0.95, 95% CI 0.70 to 1.29; p=0.76). CONCLUSION: Hysteroscopy is a safe diagnostic method for patients with endometrial cancer with no impact on oncological outcomes when compared with sampling by Pipelle.

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.

Voiding recovery after radical parametrectomy in cervical cancer patients: An international prospective multicentre trial - SENTIX.

OBJECTIVE: Voiding dysfunctions represent a leading morbidity after radical hysterectomy performed in patients with early-stage cervical cancer. The aim of this study was to perform ad hoc analysis of factors influencing voiding recovery in SENTIX (SENTinel lymph node biopsy in cervIX cancer) trial. METHODS: The SENTIX trial (47 sites, 18 countries) is a prospective study on sentinel lymph node biopsy without pelvic lymphadenectomy in patients with early-stage cervical cancer. Overall, the data of 300 patients were analysed. Voiding recovery was defined as the number of days from surgery to bladder catheter/epicystostomy removal or to post-voiding urine residuum ≤50 mL. RESULTS: The median voiding recovery time was three days (5th-95th percentile: 0-21): 235 (78.3%) patients recovered in <7 days and 293 (97.7%) in <30 days. Only seven (2.3%) patients recovered after >30 days. In the multivariate analysis, only previous pregnancy (p = 0.033) and type of parametrectomy (p < 0.001) significantly influenced voiding recovery >7 days post-surgery. Type-B parametrectomy was associated with a higher risk of delayed voiding recovery than type-C1 (OR = 4.69; p = 0.023 vs. OR = 3.62; p = 0.052, respectively), followed by type-C2 (OR = 5.84; p = 0.011). Both previous pregnancy and type C2 parametrectomy independently prolonged time to voiding recovery by two days. CONCLUSIONS: Time to voiding recovery is significantly related to previous pregnancy and type of parametrectomy but it is not influenced by surgical approach (open vs minimally invasive), age, or BMI. Type B parametrectomy, without direct visualisation of nerves, was associated with longer recovery than nerve-sparing type C1. Importantly, voiding dysfunctions after radical surgery are temporary, and the majority of the patients recover in less than 30 days, including patients after C2 parametrectomy.

A higher quality of life by the Cervantes Short-Form Scale is related to a better sexual desire in postmenopausal women.

OBJECTIVE: Evaluate the association between health relate quality of life and sexual desire in postmenopausal women and the influence of demographic descriptors on sexual desire. METHODS: A observational-cross-sectional study was conducted in 521 postmenopausal women in La Zarzuela Hospital between 2018-2020. Cervantes-short form (Cervantes-SF) scale and Brief profile female sexual function (B-PFSF) scale were filled out in the consultation. High score in Cervantes-SF implies worse health-related quality of life (HR-QoL). If score is lower or equal to 20 in B-PFSF implies diagnosis of hypoactive sexual desire disorder. RESULTS: There is a positive relationship between HR-QoL measured by Cervantes-SF and sexual desire measured by B-PFSF (p < .001; correlation coefficient: .223). The mean score on Cervantes-SF was 30.8 ± 14.9 and on B-PFSF was 18.7 ± 7.4. The B-PFSF score was worse in those women using systemic or vaginal hormonal treatment versus using non-hormonal treatment (18.7 ± 7.8 or 17.2 ± 7.4 vs 19.7 ± 6.5; p = .033. Smoking (b exp: .384; p = .029) and using vaginal hormonal treatment (b exp: 1.759; p = .033) are independent factors related to sexual desire. No difference was found in the wellbeing perceived by women in the different treatments (mean of minimal clinically important difference score was 2.9 in systemic vs. 3.0 in vaginal hormonal treatment). CONCLUSIONS: Improvement on HR-QoL is related to improvement on sexual desire. Sexual desire is better in women with non-hormonal treatment than in women with systemic or vaginal hormonal treatment. The vaginal hormonal treatment and being current smoker are independent factors of low and high sexual desire, respectively.

Prognostic factors in patients with vulvar cancer: the VULCAN study.

OBJECTIVE: This study aimed to analyze the prognostic factors for overall and progression-free survival in patients with vulvar cancer. METHODS: This international, multicenter, retrospective study included 2453 patients diagnosed with vulvar cancer at 100 different institutions. Inclusion criteria were institutional review board approval from each collaborating center, pathologic diagnosis of invasive carcinoma of the vulva, and primary treatment performed at the participating center. Patients with intraepithelial neoplasia or primary treatment at non-participating centers were excluded. Global survival analysis and squamous cell histology subanalysis was performed. RESULTS: After excluding patients due to incomplete data entry, 1727 patients treated for vulvar cancer between January 2001 and December 2005 were registered for analysis (1535 squamous, 42 melanomas, 38 Paget's disease and 112 other histologic types). Melanomas had the worse prognosis (p=0.02). In squamous vulvar tumors, independent factors for increase in local recurrence of vulvar cancer were: no prior radiotherapy (p<0.001) or chemotherapy (p=0.006), and for distant recurrence were the number of positive inguinal nodes (p=0.025), and not having undergone lymphadenectomy (p=0.03) or radiotherapy (p<0.001), with a HR of 1.1 (95% CI 1.2 to 1.21), 2.9 (95% CI 1.4 to 6.1), and 3.1 (95% CI 1.7 to 5.7), respectively. Number of positive nodes (p=0.008), FIGO stage (p<0.001), adjuvant chemotherapy (p=0.001), tumor resection margins (p=0.045), and stromal invasion >5 mm (p=0.001) were correlated with poor overall survival, and large case volume (≥9 vs <9 cases per year) correlated with more favorable overall survival (p=0.05). CONCLUSIONS: Advanced patient age, number of positive inguinal lymph nodes, and lack of adjuvant treatment are significantly associated with a higher risk of relapse in patients with squamous cell vulvar cancer. Case volume per treating institution, FIGO stage, and stromal invasion appear to impact overall survival significantly. Future prospective trials are warranted to establish these prognostic factors for vulvar cancer.

Impact of the lymphadenectomy in high-risk histologic types of endometrial cancer: a matched-pair study.

OBJECTIVE: The aim of this study is to assess the impact of lymphadenectomy (LND) on morbidity, survival, and cost for high-risk histologic types of endometrial cancer (EC). MATERIALS AND METHODS: We analyzed a multicenter retrospective cohort of 389 women with high-risk histotypes of EC (poor differenced tumors [G3], clear cell, serous papillary, and mixed mesodermal tumors) preoperatively confined to the corpus and diagnosed between 2000 and 2013. All patients underwent hysterectomy and bilateral salpingo-oophorectomy. A matched-pair analysis identified 97 pairs (97 with LDN and 97 without) equal in age, body mass index, comorbidities, International Federation of Gynecology and Obstetrics stage, and adjuvant treatment. Demographic data, pathologic examination results, perioperative morbidity, and survival were abstracted from medical records. Cost was provided by the cost unit of the local hospital. Disease-free and overall survival were analyzed using the Kaplan-Meier curves and Cox multivariable regression analysis. RESULTS: Both study groups were homogeneous in demographic data and pathologic examination results. At a median follow-up of 24.5 months (range, 5.4-146.3), disease-free survival (hazard ratio, 1.09; 95% confidence interval, 0.70-1.90) and overall survival (hazard ratio, 0.86; 95% confidence interval, 0.56-1.33) were similar in both groups regardless of nodal count. Positive nodes were found in 23.7%. Predictor factors of nodal involvement were advanced age (P = 0.024), deep myometrial invasion (P < 0.001), and high CA 125 levels (P = 0.003). In the LDN group, operating time, late postoperative complications, and surgical cost were higher (P < 0.05). There were no statistical differences between both groups relative to surgical morbidity. Early postoperative complications and hospital stay were lower in the LDN group. The global cost was similar for both groups (6027&OV0556; for the LND group and 5772&OV0556; for the no-LND group). CONCLUSIONS: Lymphadenectomy in high-risk histotypes of EC does not increase perioperative morbidity or global cost and has not benefit on survival.

Comparison of perioperative outcomes and cost between robotic-assisted and conventional laparoscopy for transperitoneal infrarenal para-aortic lymphadenectomy (TIPAL).

STUDY OBJECTIVE: To compare perioperative outcomes and cost of robotic-assisted and laparoscopic transperitoneal infrarenal para-aortic lymphadenectomy (TIPAL) for treatment of gynecologic malignant conditions. DESIGN: Prospective non-randomized study (Canadian Task Force classification II-2). SETTING: Tertiary center for women's health. PATIENTS: Sixty-two patients with gynecologic cancer operated on by the same surgical team. INTERVENTIONS: Thirty-two patients underwent TIPAL via robotic-assisted laparoscopy, and 30 via conventional laparoscopy. Comparison analyses of perioperative outcomes and estimated costs were performed. MEASUREMENTS AND MAIN RESULTS: There were no differences between robotic-assisted and laparoscopy insofar as age, body mass index, presurgical morbidity, operating time (92.5 minutes for robotics vs 96.6 minutes for laparoscopy), number of aortic nodes (12 vs. 12), hospitalization stay (2 vs. 2 days), or rate of complications (12.5% vs. 13.3%). Blood loss tended to be lower in the robotic group (75.0 vs. 92.5 mL; p = .08). Surgical cost was higher in the robotic group ($3.42 vs. $2.55; p < .001), although hospitalization cost was similar. CONCLUSION: Robotic-assisted and laparoscopy provide similar perioperative outcomes. However, the robotic-assisted approach is associated with higher surgical cost.

Correlating the accuracy of colposcopy with practitioner experience when diagnosing cervical pathology using the dynamic spectral imaging system.

BACKGROUND/AIMS: To assess the performance of colposcopists and correlate it with their experience when diagnosing cervical pathology by reviewing conventional colposcopy (CC) digital images and the Dynamic Spectral Imaging System (DySIS) cervical map. METHODS: Images from 50 women with normal and abnormal cervix collected during CC and the corresponding DySIS maps were projected consecutively to 63 participating colposcopists. Participants were asked for their diagnosis (normal, abnormal findings or cancer). The clinical experience of the participants was divided into low (n = 27), medium (n = 18) and high (n = 18), considering the number of colposcopies each one performed routinely. RESULTS: The mean of overall correct diagnoses was significantly higher with DySIS than CC for the low and medium experience group (20.4 vs. 24.4, and 21.9 vs. 26.0, respectively; p < 0.001), but not in the high experience group. The correct diagnosis was significantly higher with DySIS than CC for all experience groups in cases with a normal cervix and cervical intraepithelial neoplasia 2+ (CIN2+), but not for those with CIN1. All groups agreed that DySIS guides biopsies better, offers more information and allows performing colposcopy even without extensive experience. CONCLUSIONS: The results of evaluating projected colposcopy images were more successful with DySIS than with CC in the diagnosis of cervical pathology, especially among less experienced colposcopists.

Prevalence and persistence of nausea and vomiting along the pregnancy.

BACKGROUND/AIMS: Nausea and vomiting of pregnancy (NVP) impact in the pregnant woman´s quality of life, especially when are persistent or severe. The objective is to estimate the prevalence and factors associated with the persistence of NVP in each trimester of pregnancy. METHODS: We studied a cohort of 263 pregnant women with gestational age < 12 weeks. Data were collected using the Gastro- Esophageal Reflux Questionnaire validated for use in the Spanish population. Data were collected through telephone interviews at the end of each trimester of pregnancy. The main variable was the presence of NVP in each trimester and their persistence along the pregnancy. RESULTS: The prevalence of nausea in the each trimester was 63.5 %, 33.8 %, 26.2 %, and vomiting was 29.3 %, 22.1 %, 14.1 %, respectively. Factors associated with nausea in the first trimester were Latin-American origin (OR: 3.60, 95 %IC 1.61- 80.5) and primary education (OR: 0.31; 0.13-0.73); vomiting was associated with Latin-American origin (OR: 13.80, 1.82-104.4) and was inversely associated with weight gain (OR: 0.58, 0.35-0.97). Persistence of NVP were only associated with suffering the symptom in the previous trimester (p < 0.01), and did not find other predictor factors. CONCLUSIONS: NVP´s prevalence declines along pregnancy, is associated with race and inversely with weight gain, and its persistence over time cannot be predicted.

Robotic radical hysterectomy after conization for patients with small volume early-stage cervical cancer.

Laparoscopy and robotics are recommended for managing gynecological cancer, as they are associated with lower morbidity and comparable outcomes to open surgery. However, in the case of early cervical cancer, new evidence suggests worse oncological outcomes with these approaches compared to open surgery, though the limited number of robotic cases makes it challenging to draw definitive conclusions for this particular approach. The prior conization has been proposed as a strategy to reduce the risk of tumor spillage and contamination during minimally invasive (MIS) radical hysterectomy (RH). Retrospective studies have indicated that undergoing conization before RH is linked to a reduced risk of recurrences, especially in cervical tumors measuring less than 2 cm. Nevertheless, these studies lack the statistical power needed to definitively establish conization as a recommended step before RH. Furthermore, these studies do not have enough cases utilizing the robotic approach and specific conclusions cannot be drawn from this technique. The question of whether a subset of cases would benefit from preoperative conization and whether conization should be performed to recommend MIS over open surgery remains unanswered. Prospective clinical trials involving women diagnosed with early-stage cervical cancer <2 cm, randomized between undergoing conization before robotic RH or without prior conization are mandatory to assess the role of conization before robotic RH in cervical cancer.

Eligibility criteria for using menopausal hormone therapy in breast cancer survivors: a safety report based on a systematic review and meta-analysis.

IMPORTANCE: Menopause hormone therapy (MHT) effectively alleviates menopausal symptoms. However, it is generally not recommended for breast cancer survivors, although the scientific evidence is scarce. OBJECTIVE: This study aimed to establish eligibility criteria for use of the MHT in breast cancer survivors based on a systematic review and meta-analysis of the literature. EVIDENCE REVIEW: We conducted exhaustive literature searches until June 2022 in MEDLINE, The Cochrane Library, and EMBASE, using a tailored strategy with a combination of controlled vocabulary and search terms related to breast cancer survivors and MHT. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and assessed the risk of bias using the Cochrane and Risk of Bias in Non-randomized Studies - of Interventions tools. The quality of the evidence was graded according to grading quality of evidence and strength of recommendations criteria (A, high; B, moderate; C, low; and D, very low). We categorized MHT use into four levels: category 1 (no restrictions on use), category 2 (the benefits outweigh the risks), category 3 (the risks generally outweigh the benefits), and category 4 (MHT should not be used). FINDINGS: A total of 12 studies met the eligibility criteria. Analysis of the three randomized clinical trials using combined MHT or tibolone revealed no significant differences concerning tumor recurrence (relative risk [RR], 1.46; 95% CI, 0.99-2.24). A combined analysis of randomized clinical trials, prospective, and retrospective trials found no elevated risk of recurrence (RR, 0.85; 95% CI, 0.54-1.33) or death (RR, 0.91; 95% CI, 0.38-2.19). The eligibility criteria for patients with hormone receptor (HR)-positive tumors fell into categories 3B and 3C for combined MHT or estrogen alone and 4A for tibolone. For HR-negative tumors, the category was 2B and 2C. CONCLUSIONS AND RELEVANCE: Our findings suggest that MHT could be a viable treatment alternative for breast cancer survivors experiencing menopausal symptoms, especially those with HR-negative tumors. Personalized management is recommended for each peri/postmenopausal woman facing a diminished quality of life because of menopause symptoms. Further randomized trials are needed before considering changes to current standards of care.

Menopause in adult women with human papillomavirus: health-related quality of life and determinants.

OBJECTIVE: Human papillomavirus (HPV) infection and menopause entail a considerable impairment in health-related quality of life (HRQoL). The objective of the present study was to analyze the impact of the menopause status on HRQoL in women with HPV infection. METHODS: A cross-sectional, nationwide, multicenter sample of women with HPV infection was conducted throughout clinics of gynecology representative of the Spanish population with regard to age, geographic density, and autonomous regions. Demographic and clinical characteristics and the specific HPV-QoL questionnaire score with its domains were compared according to reproductive status: premenopausal and peri-/postmenopausal. Correlation with other validated patient-reported outcomes measurements was also tested, including General Health Questionnaire-12 (GHQ-12), Female Sexual Function Index (FSFI), and Hospital Anxiety and Depression Scale (HADS). RESULTS: A sample of 1,016 noninstitutionalized women, aged 18-80 y, was recorded, 191 (18.8%) peri-/postmenopausal and 825 (81.2%) premenopausal. Total HPV-QoL scoring was significantly lower in peri-/postmenopausal (38.8, 95% CI [35.2-42.4]) compared to premenopausal (46.4, 95% CI [45.0-47.8]) women, and also in every domain of the scale (P < 0.05), except in social well-being and health domains, with a small effect size of 0.39. In women with sexual dysfunction according to FSFI, adjusted total scoring and domains sexuality, general well-being, and psychological well-being scored significantly higher in premenopause women (P < 0.01), although the magnitude of differences were of small to moderate size. CONCLUSIONS: HRQoL was impaired during menopause in women with HPV infection according to HPV-QoL questionnaire. The sexuality domain was the most differentiating dimension between these populations.

Endometrial cancer: predictors and oncological safety of tumor tissue manipulation.

PURPOSE: The main goal of this study is to assess the impact of tumor manipulation on the presence of lympho-vascular space invasion and its influence on oncological results. METHODS: We performed a retrospective multi-centric study amongst patients who had received primary surgical treatment for apparently early-stage endometrial cancer. A multivariate statistical analysis model was designed to assess the impact that tumor manipulation (with the use of uterine manipulator or preoperative hysteroscopy) has on lympho-vascular development (LVSI) in the final surgical specimen. RESULTS: A total of 2852 women from 15 centers were included and divided into two groups based on the lympho-vascular status in the final surgical specimen: 2265 (79.4%) had no LVSI and 587 (20.6%) presented LVSI. The use of uterine manipulator was associated with higher chances of lympho-vascular involvement regardless of the type used: Balloon manipulator (HR: 95% CI 4.64 (2.99-7.33); p < 0.001) and No-Balloon manipulator ([HR]: 95% CI 2.54 (1.66-3.96); p < 0.001). There is no evidence of an association between the use of preoperative hysteroscopy and higher chances of lympho-vascular involvement (HR: 95% CI 0.90 (0.68-1.19); p = 0.479). CONCLUSION: Whilst performing common gynecological procedures, iatrogenic distention and manipulation of the uterine cavity are produced. Our study suggests that the use of uterine manipulator increases the rate of LVSI and, therefore, leads to poorer oncological results. Conversely, preoperative hysteroscopy does not show higher rates of LVSI involvement in the final surgical specimen and can be safely used.

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 HT who 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. A working 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 protocol was 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 HT was 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.

Development and psychometric properties of a measurement to ascertain the impact of genitourinary symptoms on health-related quality of life in menopausal women: the Cervantes-GSM questionnaire.

OBJECTIVE: The Cervantes-GSM questionnaire is a novel tool currently being developed to examine the impact of genitourinary symptoms on health-related quality of life in adult women with genitourinary syndrome of menopause (GSM). METHODS: A literature review and cognitive debriefing were conducted in women with GSM, which provided the basis for creating a draft questionnaire. This draft version was pilot-tested to check participant comprehension and ease of completion. The initial draft was then refined to obtain a 15-item version with five domains whose initial psychometric properties were analyzed in 130 adult women with GSM. The psychometric properties tested in this study were factorial structure, feasibility, reliability, and construct validity. RESULTS: The Cervantes-GSM 15-item questionnaire consists of five domains: vulvovaginal symptoms, urinary symptoms, psychological (emotions), interference with daily activities, and sexuality. The instrument was shown to be feasible and easy to complete, regardless of age or educational level. Internal consistency was high (Cronbach α = 0.88). Construct validity was supported by convergent-divergent validity showing higher correlation coefficients between items in their own domain (>0.70) than with the other items and domains in the questionnaire. Cervantes-GSM also showed known group validity with significant differences in total score and most domains (13-20 points, P < 0.01) regardless of whether women chose local treatment of their genitourinary symptoms. CONCLUSION: This study presents a novel questionnaire capable of assessing health-related quality of life in menopausal women with GSM. The tool has shown acceptable preliminary psychometric properties, including feasibility, factor structure, construct validity, and internal consistency.

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.