Psychological distress and uterine fibroids: a bidirectional two-sample mendelian randomization study.

BACKGROUND: Observational data indicates a connection between emotional discomfort, such as anxiety and depression, and uterine fibroids (UFs). However, additional investigation is required to establish the causal relationship between them. Hence, we assessed the reciprocal causality between four psychological disorders and UFs utilizing two-sample Mendelian randomization (MR). METHODS: To evaluate the causal relationship between four types of psychological distress (depressive symptoms, severe depression, anxiety or panic attacks, mood swings) and UFs, bidirectional two-sample MR was employed, utilizing single nucleotide polymorphisms (SNPs) associated with these conditions. Both univariate MR (UVMR) and multivariate MR (MVMR) primarily applied inverse variance weighted (IVW) as the method for estimating potential causal effects. Complementary approaches such as MR Egger, weighted median, simple mode, and weighted mode were utilized to validate the findings. To assess the robustness of our MR results, we conducted sensitivity analyses using Cochran's Q-test and the MR Egger intercept test. RESULTS: The results of our UVMR analysis suggest that genetic predispositions to depressive symptoms (Odds Ratio [OR] = 1.563, 95% Confidence Interval [CI] = 1.209-2.021, P = 0.001) and major depressive disorder (MDD) (OR = 1.176, 95% CI = 1.044-1.324, P = 0.007) are associated with an increased risk of UFs. Moreover, the IVW model showed a nominally significant positive correlation between mood swings (OR: 1.578; 95% CI: 1.062-2.345; P = 0.024) and UFs risk. However, our analysis did not establish a causal relationship between UFs and the four types of psychological distress. Even after adjusting for confounders like body mass index (BMI), smoking, alcohol consumption, and number of live births in the MVMR, the causal link between MDD and UFs remained significant (OR = 1.217, 95% CI = 1.039-1.425, P = 0.015). CONCLUSIONS: Our study presents evidence supporting the causal relationship between genetic susceptibility to MDD and the incidence of UFs. These findings highlight the significance of addressing psychological health issues, particularly depression, in both the prevention and treatment of UFs.

Psychosocial Stress and MicroRNA Expression Profiles in Myometrial Tissue of Women Undergoing Surgical Treatment for Uterine Fibroids.

Uterine leiomyomas (fibroids) are the most common non-cancerous tumors affecting women. Psychosocial stress is associated with fibroid risk and severity. The relationship between psychosocial stress and fibroid pathogenesis may involve alterations in microRNAs (miRNAs) although this has yet to be examined. We investigated associations between two psychosocial stress measures, a composite measure of recent stressful life events and perceived social status, with expression levels of 401 miRNAs in myometrium (n = 20) and fibroids (n = 44; 20 with paired fibroid and myometrium samples) among pre-menopausal women who underwent surgery for fibroid treatment. We used linear regressions to identify psychosocial stressors associated with miRNAs, adjusting for covariates (age, body mass index, race/ethnicity, and oral contraceptive use). The association between psychosocial stressors and miRNAs was considered statistically significant at an FDR p < 0.10 and showed a monotonic response (nominal p-trend < 0.05). In the myometrium, 21 miRNAs were significantly associated with a composite measure of recent stressful events, and two miRNAs were associated with perceived social status. No fibroid miRNAs were associated with either stress measure. Pathway analyses revealed miRNA-mRNA targets were significantly enriched (FDR p < 0.05) in pathways relevant to cancer/tumor development. Of the 74 differentially expressed miRNAs between myometrium and fibroids, miR-27a-5p and miR-301b were also associated with stress exposure. Our pilot analysis suggests that psychosocial stress is associated with myometrial miRNA expression and, thus, may have a role in the pathogenesis of fibroids from healthy myometrium.

"I think people should be more aware:" Uterine fibroid experiences among women living in Indiana, USA.

OBJECTIVE: To understand healthcare experiences among patients with uterine fibroids (fibroids) across the continuum of care, from early symptoms through diagnosis, treatment, and management, while also investigating health disparities. METHODS: We conducted 20 semi-structured interviews with patients with fibroids. Interviews were transcribed verbatim and qualitatively analyzed using thematic analysis. Eligible participants were women aged 18 and over, residing within 75 miles of one of the two recruitment locations (Tippecanoe or Marion County) in Indiana, USA. RESULTS: Women experienced myriad physical symptoms, which often manifested into psychological and sexual disturbances and infiltrated all aspects of daily life. Internet searches were frequently mentioned as their main information source. Fertility became a prominent factor in deciding treatment options. However, health disparities prevented some from receiving quality fibroids healthcare. Some women reported staying home during COVID-19 pandemic facilitated the management of physical symptoms. Overall, participants advocated for greater fibroids awareness and education. CONCLUSION: Results highlight barriers and facilitators to fibroids-related decisions, behaviors, and outcomes. Translation of research to practice was guided by a combined Social-Ecological Model and social determinants of health framework for development of strategic interventions. PRACTICE IMPLICATIONS: Interventions should aim to improve fibroids healthcare access, education and awareness, and patient-provider communication for minority, rural, and low socioeconomic status communities disproportionately impacted by fibroids.

Assessing burden, risk factors, and perceived impact of uterine fibroids on women's lives in rural Haiti: implications for advancing a health equity agenda, a mixed methods study.

BACKGROUND: Uterine fibroids, the most common cause of gynecologic surgery, have a reported cumulative incidence of 59% among Black women in the U.S. Uterine fibroids negatively impact the quality of women's lives. No study has been found in the literature about fibroids in Haiti. We conducted a mixed methods study to assess the burden and risk factors of uterine fibroids, as well as their effects on women's quality of life. METHODS: A convergent mixed methods study was conducted between October 1, 2019 and January 31, 2020 at MUH's (Mirebalais University Hospital) OB-GYN outpatient department. Quantitatively, in a cross-sectional study 211 women completed consecutively a structured questionnaire. In-depth interviews with 17 women with fibroids and 7 family members were implemented for the qualitative component. Descriptive statistics were calculated for clinical and social demographic variables. Logistic regression was performed to examine associations between fibroids and related risk factors. An inductive thematic process was used to analyze the qualitative data. A joint display technique was used to integrate the results. RESULTS: Of 193 women analyzed 116 had fibroids (60.1%). The mean age was 41.3. Anemia was the most frequent complication- 61 (52.6%). Compared to women without uterine fibroids, factors associated with uterine fibroids included income decline (AOR = 4.7, 95% CI: 2.1-10.9, p = < 0.001), excessive expenses for transport (AOR = 4.4, 95% CI: 1.6-12.4, p = 0.005), and family history with uterine fibroids (AOR = 4.6, 95% CI: 1.6-13.6, p = 0.005). In contrast, higher level of education and micro polycystic ovarian syndrome were associated with lower prevalence (AOR = 0.3, 95% CI: 0.1-0.9, p = 0.021) and (AOR = 0.2, 95% CI: 0.1-0.97, p = 0.044), respectively. The qualitative findings delineate how contextual factors such as health system failures, long wait times, gender inequality and poverty negatively affect the quality of women's lives. The poverty cycle of uterine fibroids emerged. CONCLUSIONS: A vicious cycle of poverty negatively impacts access to care for uterine fibroids in Haiti. Health insurance, social support, and income generating activities may be keys to promote social justice through access to adequate care for women with uterine fibroids in Haiti.

Improvement in parameters of quality of life and uterine volume reduction after uterine fibroid embolization.

OBJECTIVE: To evaluate improvement in quality of life, reduction of uterine volume, and the correlation between these two variables after uterine fibroid embolization. METHODS: Data on quality of life before and after uterine fibroid embolization were collected from 60 patients using the Uterine Fibroid Symptom - Quality of Life questionnaire. In 40 of these patients, uterine volume information on magnetic resonance imaging examinations performed before and after uterine fibroid embolization was collected, and compared using the nonparametric Wilcoxon test for paired data. Correlation between quality of life and uterine volume before and after procedure was measured using Spearman's correlation coefficient. RESULTS: There was significant improvement in quality of life after uterine fibroid embolization on Uterine Fibroid Symptom - Quality of Life questionnaire, in both subscales scores and the total score. There was a significant median reduction of -37.4% after uterine fibroid embolization, but no correlations between uterine volume and quality of life scores were found before or after embolization. CONCLUSION: Uterine embolization is an alternative to treat uterine fibroids, resulting in relief of symptoms and better quality of life. Although reduction in uterine volume plays an important role in the evaluation of therapeutic success, it does not necessarily have a definitive correlation with relief of symptoms.

A systematic review of the psychosocial impact of fibroids before and after treatment.

OBJECTIVE: Despite the high prevalence of uterine fibroids, the psychosocial impact of fibroids has not been evaluated across different quality of life indicators and compared with other chronic conditions. Here, we rigorously analyzed available evidence pertaining to the psychosocial burden of uterine fibroids in premenopausal women and compared validated quality of life and symptom scores before and after treatment. DATA SOURCES: We searched PubMed, PsycINFO, ClinicalTrials.gov, Embase, and Cochrane Library for publications from January 1990 to January 2020. STUDY ELIGIBILITY CRITERIA: We considered English-language publications that evaluated the association between uterine fibroids diagnosed by imaging studies in premenopausal women and quality of life by standardized and validated questionnaires at baseline and after treatment. We used a detailed list of terms related to quality of life, questionnaires, and uterine fibroids to conduct the search. METHODS: Three reviewers screened titles and abstracts and then obtained full-text articles for further analysis. The reviewers assessed risk of bias using established Cochrane and Newcastle-Ottawa Scale guidelines. The quality of life scores of premenopausal women with fibroids were reviewed at baseline and compared with those of published quality of life scores in other disease populations in addition to after fibroid treatment. RESULTS: A total of 57 studies were included in the review: 18 randomized controlled trials and 39 observational studies. Of note, the 36-Item Short Form Survey and European Quality of Life Five-Dimension Scale questionnaires both indicated a diagnosis of uterine fibroids to have a disability score that was similar to or exceeded (was a greater psychosocial stressor) a diagnosis of heart disease, diabetes mellitus, or breast cancer. Quality of life scores were lower at baseline than after treatment in all instruments measuring these variables in women with uterine fibroids, indicating significantly impaired psychosocial functioning. Uterine fibroids were associated with significant patient-reported health disabilities related to bodily pain, mental health, social functioning, and satisfaction with sex life. CONCLUSION: A diagnosis of uterine fibroids was a significant psychosocial stressor among women at baseline and relative to other diseases. Validated quality of life instruments indicated therapeutic success and the improvement of both physical and emotional symptoms after treatment.

Comparative effectiveness of hysterectomy versus myomectomy on one-year health-related quality of life in women with uterine fibroids.

OBJECTIVE: To compare long-term health-related quality of life (HRQOL) 1 year after hysterectomy or myomectomy for treatment of uterine fibroids (UFs) and to determine whether route of procedure, race, or age affected improvements in HRQOL. DESIGN: Prospective cohort study. SETTING: Eight clinical sites throughout the United States. PATIENT(S): A total of 1,113 premenopausal women with UFs who underwent hysterectomy or myomectomy as part of Comparing Options for Management: Patient-Centered Results for Uterine Fibroids. INTERVENTION(S): None. MAIN OUTCOME MEASURE (S): Self-reported HRQOL measures including Uterine Fibroid Symptom Quality of Life, the European QOL 5 Dimension Health Questionnaire, and the visual analog scale at baseline and 1-year after hysterectomy or myomectomy. RESULT (S): Hysterectomy patients were older with a longer history of symptomatic UF compared with myomectomy patients. There were no differences in baseline HRQOL. After adjustment for baseline differences between groups, compared with myomectomy, patients' HRQOL (95% confidence interval [CI], 5.4, 17.2) and symptom severity (95% CI, -16.3, -8.8) were significantly improved with hysterectomy. When stratified across race/ethnicity and age, hysterectomy had higher HRQOL scores compared with myomectomy. There was little difference in HRQOL (95% CI, 0.1 [-9.5, 9.6]) or symptom severity (95% CI, -3.4 [-10, 3.2]) between abdominal hysterectomy and abdominal myomectomy. CONCLUSION (S): HRQOL improved in all women 1 year after hysterectomy or myomectomy. Hysterectomy patients reported higher HRQOL summary scores compared with myomectomy patients. When stratified by route, minimally invasive hysterectomy had better HRQOL scores than minimally invasive myomectomy. There was little difference in scores with abdominal approaches.

Influence of Ethnicity on Clinical Presentation and Quality of Life in Women With Uterine Fibroids: Results From a Prospective Observational Registry.

OBJECTIVE: This study sought to evaluate ethnic variations in the clinical presentation of women with uterine fibroids. METHODS: A total of 996 premenopausal women with symptomatic uterine fibroids were enrolled in a prospective, non-interventional, observational registry at 19 clinical sites across Canada (CAPTURE Registry). Patient-reported outcomes were assessed using Uterine Fibroid Symptom and Health-Related Quality of Life Symptom Severity questionnaires and the Aberdeen Menorrhagia Severity Scale (Ruta score). Linear and logistic regression models, adjusted for patient and fibroid characteristics, were used to examine differences among ethnicities for continuous and binary outcomes of interest. RESULTS: Black women were 4.9 years younger (P < 0.001), were more likely to be nulligravid (P = 0.046), had a 41% longer duration of symptoms before enrolment (P = 0.01), had a 49% larger fibroid volume (P = 0.01), and were more likely to be anemic (P < 0.001) compared with White women. Black women reported lower health-related quality of life scores (-5.19 points; 95% CI -9.90 to -0.48, P = 0.03) compared with White women. East Asian women were 2.0 years younger (P = 0.01), were more likely to be nulligravid (P < 0.001), had a 53% longer duration of symptoms (P = 0.01), had 67% larger fibroid volume (P = 0.01), and were more likely to be anemic (P = 0.003) compared with White women. East Asian women had lower symptom severity scores (-5.95 points; 95% CI -11.16 to -0.75, P = 0.02). Non-White women preferred uterine-preserving treatment options (P < 0.001). CONCLUSION: Black and East Asian women have an increased burden of disease compared with White women and prefer uterine preservation. There is a discrepancy between disease burden and patient-reported outcomes that may reflect ethnocultural differences in disease experience.

Ulipristal acetate on quality of life and sexual function of women with uterine fibromatosis.

To evaluate quality of life and sexual function of childbearing-age women, affected by uterine fibromatosis undergoing medical treatment with ulipristal acetate. The data obtained by filling the questionnaires European Quality of Life Five-Dimension Scale and modified Female Sexual Function Index, were analyzed to assess UPA usefulness in improving QoL and sexual activity. A total of 139 patients affected by uterine fibromatosis undergoing conservative ulipristal acetate treatment were enrolled in this prospective observational cohort study. Seventy-one women (average age 46.5 years) answered the questionnaires: QoL and sexuality were evaluated before and after ulipristal acetate treatment. 59 patients (83.1%) had an improvement of QoL and general health state, with a reduction of VAS score after ulipristal acetate treatment. EQ-5D-5L showed a statistically significant improvement of usual act impairment, mobility, discomfort, anxiety/depression (p < .0005). There was no difference in personal care management after therapy. Modified FSFI showed a statistically significant improvement (p < .0001) of sexual satisfaction and sexual life. A not statistically significant improvement in dyspareunia was also highlighted. This study provides a clear picture about QoL impact on women and confirms the effectiveness of the ulipristal acetate in improving different aspects of daily and sexual life of patients undergoing medical treatment.

Anxiety of myoma patients: results of standardized interviews with the State Trait Anxiety Inventory and the Kessler 10 questionnaire.

Introduction: The aim of this study was to explore a possible relation between myoma-related anxieties and general state or trait anxiety or psychological distress, to get a better understanding of the impact of anxiety on the patients.Methods: This prospective study was conducted at the myoma clinic of a large university hospital in a major European city from November 2016 to February 2017. Patients completed standardized questionnaires on myoma-related fears, the State Trait Anxiety Inventory (STAI), and the Kessler 10.Results: Eighty-five out of 88 women agreed to participate. State-anxiety on the STAI had a mean of 49.4 (11 points above the norm (p < .001)), and trait-anxiety had a mean of 42.0 (5 points above the norm (p = .001)). Thirty-seven percent of the patients had distress values on the K10 above the norm (defined as <20). More myoma-related fears correlated with higher scores on the Kessler and STAI. The scores were not related to the level of information about myomas or duration of illness.Conclusions: Myoma-related fears correlated with higher mental distress and elevated state and trait anxiety levels. Thus, physicians can contribute to the overall well-being of patients when they relieve them of the myoma-related anxiety. Further research is needed to determine whether treatment has any impact on anxiety or mental distress.

Improvement in parameters of quality of life and uterine volume reduction after uterine fibroid embolization / Melhora em parâmetros de qualidade de vida e redução do volume uterino após embolização de artérias uterinas

ABSTRACT Objective To evaluate improvement in quality of life, reduction of uterine volume, and the correlation between these two variables after uterine fibroid embolization. Methods Data on quality of life before and after uterine fibroid embolization were collected from 60 patients using the Uterine Fibroid Symptom - Quality of Life questionnaire. In 40 of these patients, uterine volume information on magnetic resonance imaging examinations performed before and after uterine fibroid embolization was collected, and compared using the nonparametric Wilcoxon test for paired data. Correlation between quality of life and uterine volume before and after procedure was measured using Spearman's correlation coefficient. Results There was significant improvement in quality of life after uterine fibroid embolization on Uterine Fibroid Symptom - Quality of Life questionnaire, in both subscales scores and the total score. There was a significant median reduction of -37.4% after uterine fibroid embolization, but no correlations between uterine volume and quality of life scores were found before or after embolization. Conclusion Uterine embolization is an alternative to treat uterine fibroids, resulting in relief of symptoms and better quality of life. Although reduction in uterine volume plays an important role in the evaluation of therapeutic success, it does not necessarily have a definitive correlation with relief of symptoms.

RESUMO Objetivo Avaliar a melhora na qualidade de vida e a redução do volume uterino, além da correlação entre essas duas variáveis, após a embolização de artérias uterinas. Métodos Foram coletados dados de 60 pacientes sobre qualidade de vida antes e depois da embolização de artérias uterinas com a aplicação do questionário Uterine Fibroid Symptom - Quality of Life. Informações sobre o volume uterino em exames de ressonância magnética realizada antes e depois do procedimento foram coletadas em 40 dessas pacientes e comparadas por meio de teste não paramétrico de Wilcoxon para dados pareados. A correlação entre qualidade de vida e volume uterino antes e depois do procedimento foi determinada pelo coeficiente de Spearman. Resultados Houve melhora significativa na qualidade de vida das pacientes após embolização de artérias uterinas nos escores do questionário Uterine Fibroid Symptom - Quality of Life, tanto das subescalas como do total. Houve redução mediana significativa (-37,4%) no volume uterino após embolização de artérias uterinas, embora não tenha sido estabelecida qualquer correlação entre volume uterino e escores de qualidade de vida antes e depois da embolização. Conclusão A embolização de artérias uterinas é alternativa para o tratamento de fibroide uterina, resultando na melhora dos sintomas e da qualidade de vida. Embora a redução do volume uterino seja fator importante na avaliação do sucesso terapêutico, não está necessariamente correlacionada com melhora de sintomas.

Uterine Fibroid Symptom and Health-related Quality of Life Questionnaire: a Chinese translation and validation study.

INTRODUCTION: The Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) questionnaire is a validated tool in English language to assess treatment outcomes for women with fibroids. We performed a Chinese (traditional) translation and cultural adaptation of it and evaluated its reliability, validity, and responsiveness. METHODS: Overall, 223 Chinese women aged ≥18 years with uterine fibroids self-administered the UFS-QOL, Short-Form Health Survey-12, pictorial blood loss assessment chart (PBAC), and a visual analogue scale (VAS) on fibroid-related symptom severity. Demographics and haemoglobin levels were recorded; physical examination and ultrasound for size of fibroids were performed. Half of the women were followed up 6 months later for responsiveness. RESULTS: Cronbach's alpha coefficients ranged from 0.706 to 0.937, demonstrating high internal reliability. The intra-class correlation coefficients to measure test-retest reliability implied excellent stability of symptom scores (0.819, P<0.001), health-related quality of life scores (0.897, P<0.001), and all subscales (range 0.721-0.870, P<0.001). Convergent validity was demonstrated by positive correlations between the findings of various symptom severity assessment tools (PBAC, VAS on fibroid-related symptoms severity) and the symptom severity domain of Chinese UFS-QOL. In addition, there were positive correlations between health-related quality of life scores of Chinese UFS-QOL and the corresponding subscales of the Short-Form Health Survey-12. Responsiveness was shown by reduction of symptom severity scores and improvement of health-related quality of life scores after treatment. CONCLUSIONS: The Chinese version of the UFS-QOL is valid, reliable, and responsive to changes after treatment.

The association between chronic psychological stress and uterine fibroids risk: A meta-analysis of observational studies.

The association between chronic psychological stress and uterine fibroids (UFs) risk remains unclear. In this study, a meta-analysis of observational studies was performed to explore the reported association between them. A literature search was performed in PubMed, EMBASE, and Web of Science to identify relevant published articles. A random-effect model was used to examine pooled odds ratio (OR) and 95% confidence interval (CI). Additionally, subgroup analyses and two-stage random-effect dose-response meta-analysis were performed. A total of six articles with seven studies were included in this meta-analysis. For the highest versus lowest category of chronic psychological stress, the pooled OR was 1.24 (95% CI [1.15, 1.34]; p = .000). Through subgroup analyses, we found a positive association between chronic psychological stress and UFs risk especially in non-Hispanic Blacks studies (OR, 1.24, 95% CI [1.14, 1.34], p = .000). When evaluating for a dose-response, we found a weak correlation between chronic psychological stress and UFs risk, especially for the severe (OR, 1.17, 95% CI [1.07, 1.29]) and very severe (OR, 1.23, 95% CI [1.07, 1.41]) categories. Our meta-analysis shows a statistically significant association between chronic psychological stress and UFs risk particularly for non-Hispanic Blacks. Interventions aiming to reduce chronic psychological stress may be useful to decrease the prevalence of UFs.

[Understanding lower gynaecological cancer consultation delay and help-seeking behavior in patients over 65]. / Compréhension du délai de consultation pour les cancers gynécologiques bas chez les patientes âgées de plus de 65 ans.

INTRODUCTION: Delays for consultation of more than six months exist for uterine cancer. Delays in diagnosis of more than five years exist for vulvar cancer. The peak incidence of these neoplasms appear after the age of 65 years. Patient's symptoms are characteristically swelling, vaginal bleeding or itching. This study aims to understand what is happening during this period for women over 65 years old. It also tries to identify triggers during the help-seeking period. METHODS: Qualitative studies using semi-structured interviews with dual analyses (semio-pragmatic and psychodynamic) have been conducted on a population of older (65+) gynaecologic cancer patients, recruited from a French oncology centre. RESULTS: Twelve patients were interviewed. Patients' courses of action were determined by the characteristics of their symptoms, their feelings and their emotions. Representations, subjective beliefs and past experiences were employed to make sense of their symptoms. The patient's friend and family circle had an important role in incentivizing the patient to seek consultation. Multiple factors affected the path towards consulting the doctor. The initial medical contact included several challenges. The patient would consult a doctor earlier if he had more information about his illness and if his relationship with the doctor was better. CONCLUSION: Our findings are similar to those of other cancers. The peculiarity for this population appears to be the different representations of age-related changes in the reproductive system, and the taboo associated with this issue when facing friends and family.

Patient involvement in comprehensive, complex cancer surgery: Perspectives of patients, relatives and health professionals.

We investigated the perspectives of patients, relatives and health professionals on the drivers and barriers to patient involvement (PI) in the treatment of peritoneal carcinomatosis with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). During 2016-2017, individual and focus group interviews were conducted with purposively selected participants during CRS and HIPEC, supplemented by field observations. This material was analysed using meaning condensation (Kvale). Fifteen patients, eight relatives and nine health professionals participated in 31 individual and two focus group interviews, supplemented by 37 observations. The findings were structured into themes concerning treatment decisions, organisation of pathways, knowledge of the patient and life during treatment. Deciding to treat was determined not only by preoperative biomedical information, personal preferences but also findings during surgery. This circumstance put the patients under mental pressure and affected their ability to process the offered information. They furthermore perceived the pathway as complex and occasionally unclear, leading them to attempt to coordinate transitions themselves. The study has highlighted barriers to, rather than drivers of, PI. To promote PI during comprehensive complex cancer surgery, we suggest that patients and relatives are offered patient-centred care, such as support in posing questions, overview of their treatment pathway and coherent transitions.

Health-related quality of life in pregnancy with uterine fibroid: a cross-sectional study in China.

BACKGROUND: Uterine fibroids (UFs) are the most common benign tumors in women. They are likely to cause numerous clinical symptoms, such as pain, menorrhagia, and other obstetric complications in pregnant women. This study aimed to determine the health-related quality of life (HRQoL) during pregnancy with uterine fibroids (UF), thus providing a utility-based case value in pregnant women with UF and understanding of whether HRQoL is associated with clinical outcomes in pregnant women with UFs. METHOD: This study was conducted in a cross-sectional manner. This study was based on questionnaire surveys completed by sequential out- and in-patients and was conducted in a regional university hospital in Guangzhou, China. The EuroQoL five-dimension-five-level (EQ-5D-5 L) questionnaire was used, and demographic data were collected. An electronic record of the clinical outcomes of pregnant women with UF was retrieved from the hospital's electronic medical record system. The association between UF and HRQoL was evaluated by ordered regression. RESULTS: Seven-hundred-sixty-seven pregnant women with a mean age (SD) of 32.7 (4.8) years completed 707 questionnaires. Overall, when comparing the UF with non-UF groups, we detected statistical differences in age, body mass index (BMI), gravidity and abortion times, partner's smoking and alcoholic habits, advanced maternal age, and uterine scars (p <  0.05). Furthermore, pregnant women without UF scored significantly higher than those with UF on the EQ-5D value system (0.84 versus 0.79; p = 0.017). Moreover, pregnant women with UF suffered more health-related problems, especially with respect to self-care (odds ratio [OR] = 3.69, p <  0.01) and usual activity dimensions (OR = 2.11; p = 0.01). CONCLUSION: We found that UF has a negative impact on the HRQoL of pregnant women with respect to self-care and usual activity dimensions. Also, the EQ-5D score was a better index than the EQ-VAS score for HRQoL when evaluating of the QoL of our population of pregnant women.

Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.

OBJECTIVE: To investigate effects of ulipristal acetate on health-related quality of life (QOL) and symptom severity in women with symptomatic uterine leiomyomas and abnormal uterine bleeding. METHODS: Women were randomized to ulipristal (5 mg, 10 mg) or placebo in two phase 3, multicenter, double-blind, placebo-controlled trials (VENUS I and II). Health-related QOL and symptom severity were assessed at baseline, and over one (VENUS I and II) and two (VENUS II) 12-week treatment courses using the Uterine Fibroid Symptom Health-Related Quality of Life questionnaire. In pooled VENUS I and II data, change from baseline to the end of the first course for each Uterine Fibroid Symptom Health-Related Quality of Life scale was analyzed, including a Revised Activities subscale that measured physical and social activities. The proportion of women achieving meaningful change in the Symptom Severity (20 or more points), Health-Related QOL Total (20 or more points), and Revised Activities (30 or more points) scales was calculated. In VENUS II data, change from baseline to the end of each course in each scale was analyzed for each treatment arm. RESULTS: In pooled analyses, the intent-to-treat population included 589 patients (placebo, n=169; ulipristal 5 mg, n=215; ulipristal 10 mg, n=205). Significantly greater improvements from baseline in all Uterine Fibroid Symptom Health-Related Quality of Life scales were observed with both ulipristal doses compared with placebo (P<.001). A meaningful change in Revised Activities was achieved by 51 patients receiving placebo (34.9%), compared with 144 (73.5%; OR 5.0 [97.5% CI 2.9-8.6]) and 141 (80.6%; OR 7.9 [97.5% CI 4.3-14.6]) patients receiving ulipristal 5 mg, and 10 mg, respectively. In VENUS II, at end of courses 1 and 2, both ulipristal doses demonstrated significant improvements from baseline compared with placebo for all Uterine Fibroid Symptom Health-Related Quality of Life scales (P<.01). Mean Revised Activities scores showed that beneficial ulipristal effects were maintained in course 2, and improvements occurred on switching to ulipristal; results for other scales were similar. CONCLUSION: Ulipristal was associated with significant improvements in health-related QOL and symptom severity compared with placebo for women with symptomatic uterine leiomyomas. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02147197 and NCT02147158. FUNDING SOURCE: Allergan plc, Dublin, Ireland.

Chinese Version of the Assessment of Survivor Concerns Scale for Gynecological Cancer Survivors: A Psychometric Study in Taiwan.

BACKGROUND: Most gynecological cancer survivors outlive the acute stage, and many reach permanent survival. However, the fear of cancer recurrence (FCR) is stressful and affects quality of life. PURPOSE: This study was designed to validate a Chinese version of the Assessment of Survivor Concerns (ASC) questionnaire in terms of its ability to assess FCR in gynecological cancer survivors. METHODS: A two-stage study procedure was employed. The first stage involved the translation of the ASC questionnaire from English into Chinese using the methods proposed by Guillemin, which include translation, back-translation, consensus meetings, and a trial of potential users. In the second stage, a pilot study was completed with 37 gynecological cancer survivors followed by a psychometric property study with 287 gynecological cancer survivors. Construct validity was determined using confirmatory factor analysis (CFA) with structural equation modeling. Convergent validity was determined using composite reliability and the average variance extracted values of the ASC model. Discriminant validity was determined by comparing the model fitness of the ASC model against the model fitness of a one-construct model. Concurrent criterion validity was assessed using the European Organization for Research and Treatment of Cancer's Quality-of-Life Questionnaire Core 30 as the auxiliary instrument. Reliability was determined by measuring the internal consistency reliability using Cronbach's α in addition to the 3-week test-retest reliability with a 95% confidence interval of the intraclass correlation coefficient. RESULTS: The process of translation and back-translation was performed to ensure the conceptual equivalence of the Chinese version with the original ASC questionnaire. For CFA, the fit indices of the ASC model (χ = 9.87, p > .05; root mean square error of approximation = .03. comparative fit index = 1, nonnormed fit index = 1) indicated appropriate model fitness. For convergent validity, the composite reliability and average variance extracted values of the ASC model were satisfactory. For discriminant validity, the model fitness of the ASC model was significantly improved over the one-construct model. For concurrent criterion validity, the ASC scores correlated negatively with the scores of the global quality of life and the five functions (physical, role, cognition, emotions, and social) of the European Organization for Research and Treatment of Cancer's Quality-of-Life Questionnaire Core 30, as hypothesized. For reliability, the Cronbach's α and the 95% confidence interval of intraclass correlation coefficient for the ASC model were .91 and [.18, .68], respectively. CONCLUSIONS/IMPLICATIONS FOR PRACTICE: The Chinese version of the ASC questionnaire is a valid and reliable instrument that is suitable for assessing FCR in gynecological cancer survivors in clinical and research settings.

Increasing Awareness of Uterine Cancer Risks and Symptoms by Using Campaign Materials from Inside Knowledge: Get the Facts About Gynecologic Cancer.

Uterine cancer is the fourth most commonly diagnosed cancer among women in the USA. To increase knowledge among women and healthcare providers about uterine cancer, the Centers for Disease Control and Prevention's National Comprehensive Cancer Control Program (NCCCP) partnered with the Inside Knowledge: Get The Facts About Gynecologic Cancer campaign to present facilitated discussions about uterine cancer with women and providers. After standardized training, local NCCCP grantees developed and led community-based, tailored, facilitated discussions for public participants and providers. Pre- and post-session surveys were administered to assess knowledge of risk factors, symptoms, testing, and diagnostic options for uterine cancer. Following the facilitated sessions, significantly, more public respondents identified uterine cancer risk factors (e.g., advanced age, post-menopausal status). However, they also equally identified factors not associated with uterine cancer (e.g., smoking, HPV). Non-OB/GYN provider knowledge increased, significantly for some risks and symptoms, and their confidence with relaying uterine cancer information to patients significantly increased from 51.4 to 91.0% (P < 0.0001). Relatively low proportions of OB/GYNs (19.3%), other primary care providers (46.2%), and public participants (51.8%) knew post-session that genetic testing for Lynch syndrome can help stratify women for uterine cancer risk. Participant knowledge significantly increased for some risk factors and symptoms following Inside Knowledge educational sessions; however, some knowledge gaps remained. Overall, the Inside Knowledge materials are effective for increasing uterine cancer awareness among providers and women. Additional provider education could include specific resources related to uterine cancer genetic associations, as advancements in genetic testing for all uterine cancers are currently being made.