FEMaLe: The use of machine learning for early diagnosis of endometriosis based on patient self-reported data-Study protocol of a multicenter trial.

INTRODUCTION: Endometriosis is a chronic disease that affects up to 190 million women and those assigned female at birth and remains unresolved mainly in terms of etiology and optimal therapy. It is defined by the presence of endometrium-like tissue outside the uterine cavity and is commonly associated with chronic pelvic pain, infertility, and decreased quality of life. Despite the availability of various screening methods (e.g., biomarkers, genomic analysis, imaging techniques) intended to replace the need for invasive surgery, the time to diagnosis remains in the range of 4 to 11 years. AIMS: This study aims to create a large prospective data bank using the Lucy mobile health application (Lucy app) and analyze patient profiles and structured clinical data. In addition, we will investigate the association of removed or restricted dietary components with quality of life, pain, and central pain sensitization. METHODS: A baseline and a longitudinal questionnaire in the Lucy app collects real-world, self-reported information on symptoms of endometriosis, socio-demographics, mental and physical health, economic factors, nutritional, and other lifestyle factors. 5,000 women with confirmed endometriosis and 5,000 women without diagnosed endometriosis in a control group will be enrolled and followed up for one year. With this information, any connections between recorded symptoms and endometriosis will be analyzed using machine learning. CONCLUSIONS: We aim to develop a phenotypic description of women with endometriosis by linking the collected data with existing registry-based information on endometriosis diagnosis, healthcare utilization, and big data approach. This may help to achieve earlier detection of endometriosis with pelvic pain and significantly reduce the current diagnostic delay. Additionally, we may identify dietary components that worsen the quality of life and pain in women with endometriosis, upon which we can create real-world data-based nutritional recommendations.

Laparoscopic natural orifice specimen extraction colectomy versus conventional laparoscopic colorectal resection in patients with rectal endometriosis: a randomized, controlled trial.

BACKGROUND: The conventional laparoscopic approach for the surgical management of deep endometriosis (DE) infiltrating the rectum appears to ensure improved digestive functional outcomes. The natural orifice specimen extraction (NOSE) technique for the treatment of colorectal DE can significantly accelerate postoperative recovery; however, data on gastrointestinal function following conventional laparoscopic segmental bowel resection (CLR) compared with NOSE colectomy (NC) for DE are sparse. MATERIALS AND METHODS: Between 30 September 2019 and 31 December 2020, a randomized, open-label, two-arm, parallel-group controlled trial with women aged 18-45 years was conducted at University Hospital.Ninety-nine patients were randomized to CLR or NC, with DE infiltrating at least the muscular layer, at least 50% of the circumference of the bowel, up to 15 cm from the anal verge, exhibiting pain and bowel symptoms and/or infertility. The primary endpoint was bowel function, represented by low anterior resection syndrome (LARS). Secondary parameters included the Endometriosis Health Profile 30 (EHP30), Gastrointestinal Quality of Life Index (GIQLI), Visual Analog Scale (VAS) scores preoperatively and at set times (1 and 6 months, 1 year) following surgery. RESULTS: No significant differences were observed in the postoperative LARS scores, VAS, EHP30, and GIQLI between the NC and CLR groups. LARS scores did not reveal significant differences 12 months postoperatively compared to the preoperative values in both groups (CLR group P =0.93 versus NC group, P =0.87). GIQLI scores were significantly improved 12 months after the operation compared with baseline values in the CLR group ( P =0.002) and NC group ( P =0.001). Pain symptoms and quality of life scores significantly improved 12 months postoperatively in both groups. CONCLUSIONS: NC is a feasible surgical approach for treating patients with rectal DE. Our study did not show a statistically significant difference between CLR and NC techniques in mid-term digestive and pain outcomes.

Challenges of and possible solutions for living with endometriosis: a qualitative study.

BACKGROUND: Endometriosis as a chronic gynecological disease has several negative effects on women's life, thereby placing a huge burden on the patients and the health system. The negative impact of living with endometriosis (impaired quality of life, diverse medical experiences) is detailed in the literature, however, we know less about patients' self-management, social support, the meaning of life with a chronic disease, and the needs of patients. To implement a proper multidisciplinary approach in practice, we need to have a comprehensive view of the complexity of endometriosis patients' life and disease history. METHODS: Four focus group discussions were conducted between October 2014 and November 2015 by a team consisting of medical and psychological specialists. 21 women (age: 31.57; SD = 4.45) with surgical and histological confirmation of endometriosis were included in the study. Discussions were audiotaped and transcribed verbatim, and a 62,051-word corpus was analyzed using content analysis. RESULTS: Four main themes emerged from the analysis: (1) the impact of endometriosis on quality of life, (2) medical experiences, (3) complementary and alternative treatments, and (4) different coping strategies in disease management. All themes were interrelated and highly affected by a lack of information and uncertainty caused by endometriosis. A supporting doctor-patient relationship, active coping, and social support were identified as advantages over difficulties. Finding the positive meaning of life after accepting endometriosis increased the possibility of posttraumatic growth. Furthermore, women's needs were identified at all levels of the ecological approach to health promotion. CONCLUSIONS: Our results highlight the need for multidisciplinary healthcare programs and interventions to find solutions to the difficulties of women with endometriosis. To achieve this goal, a collaboration of professionals, psychologists, and support organizations is needed in the near future.

Different Characteristics of the Female Sexual Function Index in a Sample of Sexually Active and Inactive Women.

BACKGROUND: The Female Sexual Function Index (FSFI) is a widely used measurement tool to assess female sexual function along the six dimensions of desire, arousal, lubrication, orgasm, satisfaction, and pain. However, the structure of the questionnaire is not clear, and several studies have found high correlations among the dimensions, indicating that a common underlying "sexual function" factor might be present. AIM: To investigate whether female sexual function is best understood as a multidimensional construct or, alternatively, whether a common underlying factor explains most of the variance in FSFI scores, and to investigate the possible effect of the common practice of including sexually inactive women in studies using the FSFI. METHODS: The sample consisted of 508 women: 202 university students, 177 patients with endometriosis, and 129 patients with polycystic ovary syndrome. Participants completed the FSFI, and confirmatory factor analyses were used to test the underlying structure of this instrument in the total sample and in samples including sexually active women only. OUTCOMES: The FSFI is a multidimensional self-report questionnaire composed of 19 items. RESULTS: Strong positive correlations were found among five of the six original factors on the FSFI. Confirmatory factor analyses showed that in the total sample items loaded mainly on the general sexual function factor and very little variance was explained by the specific factors. However, when only sexually active women were included in the analyses, a clear factor structure emerged, with items loading on their six specific factors, and most of the variance in FSFI scores was explained by the specific factors, rather than the general factor. University students reported higher scores, indicating better functioning compared with the patient samples. CLINICAL TRANSLATION: The reliable and valid assessment of female sexual function can contribute to better understanding, prevention, and treatment of different sexual difficulties and dysfunctions. STRENGTHS AND LIMITATIONS: This study provides a rigorous statistical test of the structure of the FSFI and an explicit decision rule for categorizing sexually inactive women. Limitations include a lack of control over the circumstances of data collection. CONCLUSION: This study supports the use of the FSFI as a multidimensional measurement of female sexual function but highlights the need to establish clear decision rules for the inclusion or exclusion of sexually active and inactive respondents. Hevesi K, Mészáros V, Kövi Z, et al. Different Characteristics of the Female Sexual Function Index in a Sample of Sexually Active and Inactive Women. J Sex Med 2017;14:1133-1141.

Physical pain and emotion regulation as the main predictive factors of health-related quality of life in women living with endometriosis.

STUDY QUESTION: To what extent are pain symptoms, psychological variables (anxiety, depression and distress) and emotion regulation associated with women's health in endometriosis? SUMMARY ANSWER: Physical pain symptoms and emotion regulation difficulties via psychological stress negatively affect the health-related quality of life (HRQoL) of women living with endometriosis. WHAT IS KNOWN ALREADY: There are some missing links in the definitive treatment and recovery from endometriosis. Women with chronic pain report a decrease in HRQoL and an increase in the frequency of psychological problems, but little is known about the complex relationship between these variables in the context of endometriosis. STUDY DESIGN, SIZE, DURATION: This cross-sectional study was conducted between October 2014 and October 2015 on 193 women living with endometriosis. PARTICIPANTS/MATERIALS, SETTING, METHODS: The sample consisted of women with a medically confirmed diagnosis of endometriosis who received treatment at the participating clinic. All participants completed the Short Form Health Survey (SF-36), the Hospital Anxiety and Depression Scale, the Perceived Stress Scale and the Difficulties in Emotion Regulation Scale. Spearman's rank correlation was used to explore the associations between the measured variables, and structural equation modeling was used to test the proposed mediation models. MAIN RESULTS AND THE ROLE OF CHANCE: The response rate was 46%. In this study, 54.79% of the participants presented with anxiety and 20.3% with depressive symptoms. Pain symptoms, psychological variables and difficulties in emotion regulation were negatively associated with HRQoL. Mediation models revealed that physical pain, psychological stress and difficulties in emotion regulation explained 55% of the variance in the overall HRQoL, 41% of the variation in physical and 55% of the variation in mental HRQoL. Accordingly, severe physical pain (ß = -0.39, P < 0.001) was directly, and difficulties in emotion regulation (ß = -0.38, P < 0.001) was indirectly related to deterioration in overall HRQoL. Physical pain had a higher direct standardized effect (ß = -0.51, P < 0.001) on physical HRQoL, and had no significant direct effect on mental HRQoL. Furthermore, both physical pain (ß = -0.07, P < 0.001) and difficulties in emotion regulation (ß = -0.46, P < 0.001) had a significant indirect effect on mental HRQoL. LIMITATIONS, REASONS FOR CAUTION: The data were heterogeneous with regard to the severity of endometriosis. The validity of this cross-sectional study is limited to correlations; therefore, further longitudinal studies using a more representative sample are needed to explore valid causal relationships. WIDER IMPLICATIONS OF THE FINDINGS: The results of this study indicate that HRQoL can be improved through pain management and emotion regulation strategies. The authors believe that HRQoL would increase with concomitant application of physical treatment and psychological care. STUDY FUNDING/COMPETING INTEREST(S): There were no external funding sources for this study, and the authors have no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: Not applicable.