The association between violence against women and chronic pain: a systematic review and meta-analysis.

Violence against women is a phenomenon that involves at least 35% of women worldwide. Violence can be sexual, physical, and/or psychological, perpetrated by the partner, another family member, or a stranger. Violence is a public health problem because its consequences include higher morbidity, higher mortality, and short and long-term physical and psychological health diseases. Most studies prove an association between any type of violence and some chronic pain diagnoses but no one has done a complete collection of this evidence. This systematic review and meta-analysis aimed to evaluate whether this association is statistically significant, including the largest number of studies. Through the inclusion of 37 articles, the association has been demonstrated. Compared with no history of violence, women who did experience violence showed 2 times greater odds of developing chronic pain. The impact of violence was significant also on fibromyalgia separately, but not on pelvic pain.PROSPERO registrationPROSPERO CRD42023425477.

Pain and other complications of pelvic mesh: a systematic review of qualitative studies and thematic synthesis of women's accounts.

OBJECTIVES: Synthesis of the experience of women with pain from pelvic or vaginal mesh or its removal, to identify pain-related problems and to formulate psychological aspects of pain. DESIGN: Systematic review and thematic analysis of qualitative studies of pain from pelvic or vaginal mesh, or mesh removal, in women over 18 years, using individual interviews, focus groups, free text, or written or oral contributions to formal enquiries. DATA SOURCES: Medline, Embase and PsycINFO, from inception to 26 April 2023. ELIGIBILITY CRITERIA: Qualitative studies of pain and other symptoms from pelvic or vaginal mesh or its removal; adults; no language restriction. DATA EXTRACTION AND SYNTHESIS: Line-by-line coding of participant quotations and study author statements by one author to provide codes that were applied to half the studies by another author and differences resolved by discussion. Codes were grouped into subthemes and themes by both authors, then scrutinised and discussed by a focus group of mesh-injured women for omissions, emphasis and coherence. Studies were appraised using an amalgamation of the CASP and COREQ tools. RESULTS: 2292 search results produced 9 eligible studies, with 7-752 participants, a total of around 2000. Four recruited patients, four totally or partially from mesh advocacy groups, and two were national enquiries (UK and Australia). Four major themes were as follows: broken body, broken mind; distrust of doctors and the medical industry; broken life and keeping going-a changed future. Psychological content mainly concerned the loss of trust in medical care, leaving women unsupported in facing an uncertain future. Mesh-injured women strongly endorsed the findings. CONCLUSIONS: Pain and other problems associated with pelvic mesh are profound and far-reaching for women affected. Worse, they feel subject to continued gaslighting, including denial of their mesh-related problems and dismissal of their concerns about continued mesh insertion. PROSPERO REGISTRATION NUMBER: CRD42022330527.

Sleep disorders in patients with endometriosis; a cross-sectional study.

BACKGROUND: Endometriosis affects 10-15% of women of reproductive age and is considered a critical gynecological problem. Endometriosis causes pain and infertility, both of which can impair the patient's quality of life. Sleep disorders account for the most bothersome presentation of impaired quality of life. This study investigated the frequency and severity of sleep disorders in women with endometriosis. METHODS: In this analytical cross-sectional study, 665 women referred to three hospitals in Tehran, Rasool-e-Akram, Pars, and Nikan, were included (463 patients with endometriosis and 202 women without endometriosis). All of them were informed about the study design and the aim of the research, and then they were asked to sign the consent form and complete the Pittsburgh Sleep Quality Index (PSQI). After data gathering and entering, they were analyzed by SPSS version 22 and were considered significant with P < 0.05. RESULTS: The study population's mean age was 35.4 ± 7.9 years. The mean global PSQI score in the case group (endometriosis patients) was higher than in the control group (non-endometriosis patients) (10.6 vs. 7.1; P < 0.001). Patients with dyspareunia, dysuria, pelvic pain, and dyschezia had a significantly higher PSQI score (P < 0.05). CONCLUSION: According to the findings of the present study, the sleep quality in endometriosis patients is low, and there is a need to pay greater attention to these patients. This may result in some changes in the therapeutic strategies for this disease.

ACR Appropriateness Criteria® Acute Pelvic Pain in the Reproductive Age Group: 2023 Update.

This review focuses on the initial imaging in the reproductive age adult population with acute pelvic pain, including patients with positive and negative beta-human chorionic gonadotropin (ß-hCG) levels with suspected gynecological and nongynecological etiology. For all patients, a combination of transabdominal and transvaginal pelvic ultrasound with Doppler is usually appropriate as an initial imaging study. If nongynecological etiology in patients with negative ß-hCG is suspected, then CT of the abdomen and pelvis with or without contrast is also usually appropriate. In patients with positive ß-hCG and suspected nongynecological etiology, CT of the abdomen and pelvis with contrast and MRI of the abdomen and pelvis without contrast may be appropriate. In patients with negative ß-hCG and suspected gynecological etiology, CT of the abdomen and pelvis with contrast, MRI of pelvis without contrast, or MRI of pelvis with and without contrast may be appropriate. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

Mindfulness in Facilitating Pelvic Floor Botulinum Toxin Injection in Women with Chronic Pelvic Pain.

Botulinum toxin (BoNT) injection can safely be done as an office-based procedure, but can be painful itself, especially when injecting pelvic floor muscles to treat chronic pelvic pain (CPP). Mindfulness interventions may reduce procedure-associated acute anxiety and pain. We applied mindfulness techniques to increase the tolerability of office-based pelvic floor BoNT injections in women with CPP. Women enrolled in a clinical trial of BoNT for endometriosis-associated CPP were offered a brief, guided mindfulness session before and/or after transvaginal injection. Anxiety, pain, and dysphoria were rated on a 0-10 numerical rating scale (NRS) before and after each mindfulness session. Eight women underwent mindfulness sessions. Five participants had a session before and two after the transvaginal injection. One participant had two sessions: one before and one after separate injections. All six women completing a session prior to injection had at least moderate anxiety, which lessened after the mindfulness session (median NRS change: -3.3/10). All three women reporting injection-associated pain experienced less intense pain following the post-injection session (median NRS change: -3/10). Three women experiencing dysphoria improved after the session (median NRS change: -3/10). A brief, guided mindfulness session may lessen acute pain, anxiety, and dysphoria associated with office-based transvaginal BoNT injection.

Wandering spleen presenting in the form of right sided pelvic mass and pain in a patient with AD-PCKD: a case report and review of the literature.

BACKGROUND: Wandering spleen is a rare clinical entity in which the spleen is hypermobile and migrate from its normal left hypochondriac position to any other abdominal or pelvic position as a result of absent or abnormal laxity of the suspensory ligaments (Puranik in Gastroenterol Rep 5:241, 2015, Evangelos in Am J Case Rep. 21, 2020) which in turn is due to either congenital laxity or precipitated by trauma, pregnancy, or connective tissue disorder (Puranik in Gastroenterol Rep 5:241, 2015, Jawad in Cureus 15, 2023). It may be asymptomatic and accidentally discovered for imaging done for other reasons or cause symptoms as a result of torsion of its pedicle and infarction or compression on adjacent viscera on its new position. It needs to be surgically treated upon discovery either by splenopexy or splectomy based on whether the spleen is mobile or not. CASE PRESENTATION: We present a case of 39 years old female Ethiopian patient who presented to us complaining constant lower abdominal pain especially on the right side associated with swelling of one year which got worse over the preceding few months of her presentation to our facility. She is primiparous with delivery by C/section and a known case of HIV infection on HAART. Physical examination revealed a right lower quadrant well defined, fairly mobile and slightly tender swelling. Hematologic investigations are unremarkable. Imaging with abdominopelvic U/S and CT-scan showed a predominantly cystic, hypo attenuating right sided pelvic mass with narrow elongated attachment to pancreatic tail and absent spleen in its normal position. CT also showed multiple different sized purely cystic lesions all over both kidneys and the pancreas compatible with AD polycystic kidney and pancreatic disease. With a diagnosis of wandering possibly infarcted spleen, she underwent laparotomy, the finding being a fully infarcted spleen located on the right half of the upper pelvis with twisted pedicle and dense adhesions to the adjacent distal ileum and colon. Release of adhesions and splenectomy was done. Her post-operative course was uneventful. CONCLUSION: Wandering spleen is a rare clinical condition that needs to be included in the list of differential diagnosis in patients presenting with lower abdominal and pelvic masses. As we have learnt from our case, a high index of suspicion is required to detect it early and intervene by doing splenopexy and thereby avoiding splenectomy and its related complications.

Is it time to agree upon a standardised approach to the assessment of contributing factors and impacts of adolescent pelvic pain?

BACKGROUND: A biopsychosocial approach to the understanding of pelvic pain is increasingly acknowledged. However, there is a lack of standardised instruments - or their use - to assess risk factors and their impact on pelvic pain in both clinical and research settings. This review aims to identify validated tools used to assess known contributory factors to pelvic pain, as well as the validated tools to measure the impact of pelvic pain in adolescents and young adults, in order to provide a framework for future standardised, adolescent specific assessment and outcome tools. METHODS: Literature searches were performed in MEDLINE, PsycInfo and PubMed. Search terms included pelvic pain, dysmenorrhoea, endometriosis, adolescent, pain measurement, quality of life, sleep, mental health, coping strategies and traumatic experience. RESULTS: We found validated instruments to assess adverse childhood experiences and coping strategies, both known contributing factors to pelvic pain. The impact of pain was measured through validated tools for health-related quality of life, mental health and sleep. CONCLUSIONS: Pelvic pain evaluation in adolescents should include a multi-factorial assessment of contributing factors, such as childhood adversity and coping strategies, and impacts of pelvic pain on quality of life, mental health and sleep, using validated instruments in this age group. Future research should focus on the development of consensus amongst researchers as well as input from young women to establish a standardised international approach to clinical trials involving the investigation and reporting of pelvic pain in adolescents. This would facilitate comparison between studies and contribute to improved quality of care delivered to patients.

Pelvic pain is pain located in the lower abdomen, and includes period pain, which is the most common gynaecologic condition in adolescents and young adults. An approach that includes biological, psychological and social factors is important to understand and manage pelvic pain. Nonetheless, these factors are often poorly assessed in the clinic and research setting. We performed a literature review to identify tools that measure risk factors for pelvic pain, and those that evaluate the impact of pelvic pain. We found instruments that measure exposure to childhood trauma and coping strategies, which are risk factors for developing pelvic pain. We found tools to assess quality of life, mental health and sleep as an impact of pelvic pain. A standardised approach to pelvic pain, including instruments to measure risk factors and impact of pelvic pain, would facilitate comparison between studies and improve quality of care for patients.

CD8 T cells are dispensable for experimental autoimmune prostatitis induction and chronic pelvic pain development.

Introduction: Chronic Pelvic Pain Syndrome or Chronic Prostatitis (CPPS/CP) is the most prevalent urologic affliction among young adult men. It is a challenging condition to treat, which significantly decreases patient quality of life, mostly because of its still uncertain aetiology. In that regard, an autoimmune origin is a prominent supported theory. Indeed, studies in patients and in rodent models of Experimental Autoimmune Prostatitis (EAP) have provided compelling evidence suggesting a key role of CD4 Th1 cells in disease pathogenesis. However, the implication of other prominent effectors of the immune system, such as CD8 T cells, has yet to be studied. Methods: We herein analyzed the induction of prostatitis and the development of chronic pelvic pain in EAP using CD8 T cell-deficient animals. Results: We found similarly elevated PA-specific immune responses, with high frequencies of specific IFNg+CD4+ and IL17+CD4+ T cells in prostate draining lymph nodes from PA-immunized either CD8 KO or wild type animals with respect to controls. Moreover, these peripheral immune responses were paralleled by the development of significant chronic pelvic pain, and accompanied by prostate histological lesions, characterized by hemorrhage, epithelial cell desquamation, marked periglandular leukocyte infiltration, and increased collagen deposition in both, PA-immunized CD8 KO and wild type animals. As expected, control animals did not develop prostate histological lesions. Discussion: Our results indicate that CD8 T cells do not play a major role in EAP pathogenesis and chronic pelvic pain development. Moreover, our results corroborate the previous notion that a CD4 Th1 associated immune response drives the induction of prostate tissue inflammation and the development of chronic pelvic pain.

Endovascular Treatment of Pelvic Venous Congestion Syndrome in Nulliparous Patients-Preliminary Results of 10 Years of Experience.

PURPOSE: The aim of this article is to present our experience with minimally-invasive treatment for nulliparous patients with pelvic venous congestion syndrome (PVCS) with special attention to anatomical considerations, procedural and clinical outcome. MATERIALS AND METHODS: In this retrospective, monocentric study, 21 patients with PVCS treated from January 2014 to June 2023 were included. The preprocedural imaging evaluation of PVCS was based on color Doppler ultrasound, contrast-enhanced CT and/or MRI. In all cases insufficient ovarian veins and/or internal iliac branches were occluded with coils and sclerosant. Procedural and clinical outcomes were measured 30 and 90 days after the procedure. RESULTS: Average duration of pelvic pain was 44.8 ± 54.2 months (from 6 to 200) with the mean VAS-recorded pain intensity of 8.5 ± 1.1 (range from 7 to 10 where 0 was "no pain" and 10 "worst pain possible"). Most common symptoms included dysmenorrhea, dyspareunia and dysuria. Complete embolization was observed in in all cases. Targeted vessels included left ovarian vein (13/21, 62%), both ovarian veins (7/21, 33%) and left pudendal with left ovarian (1/21, 5%). Residual PVCS was noted in 1 patient. Mean VAS at 90-days after the procedure was 2.4 ± 1.4 (range from 0 to 6, p < 0.001). Nineteen patients (90%) were satisfied with the clinical outcome (13 "very satisfied", 6 "satisfied") and reported improvement in quality of life. Two patients (9.5%) reported to be "neutral" as the VAS reduction was less than 50%. CONCLUSION: Our study confirms that endovascular coil embolization is safe and effective in treatment of nulliparous patients with PVCS that provides very high rate of clinical success and overall satisfaction.

Epithelial cells derived exosomal miR-203a-3p facilitates stromal inflammation of type IIIA chronic prostatitis/chronic pelvic pain syndrome by targeting DUSP5 and increasing MCP-1 generation.

Increased proinflammatory cytokines and infiltration of inflammatory cells in the stroma are important pathological features of type IIIA chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS-A), and the interaction between stromal cells and other cells in the inflammatory microenvironment is closely related to the inflammatory process of CP/CPPS-A. However, the interaction between stromal and epithelial cells remains unclear. In this study, inflammatory prostate epithelial cells (PECs) released miR-203a-3p-rich exosomes and facilitated prostate stromal cells (PSCs) inflammation by upregulating MCP-1 expression. Mechanistically, DUSP5 was identified as a novel target gene of miR-203a-3p and regulated PSCs inflammation through the ERK1/2/MCP-1 signaling pathway. Meanwhile, the effect of exosomes derived from prostatic fluids of CP/CPPS-A patients was consistent with that of exosomes derived from inflammatory PECs. Importantly, we demonstrated that miR-203a-3p antagomirs-loaded exosomes derived from PECs targeted the prostate and alleviated prostatitis by inhibiting the DUSP5-ERK1/2 pathway. Collectively, our findings provide new insights into underlying the interaction between PECs and PSCs in CP/CPPS-A, providing a promising therapeutic strategy for CP/CPPS-A.

[Research progress in treatment of chronic prostatitis/chronic pelvic pain syndrome with traditional Chinese medicine].

Chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS) is a common urological disease with complex etiology. The treatment effect of western medicine is not satisfactory, and the course of the disease is protracted, which brings great trouble to patients. Traditional Chinese medicine(TCM) has a variety of treatment methods based on syndrome differentiation and treatment, including internal treatment with TCM, acupuncture and massage, and other external treatment methods for comprehensive treatment, with significant effect. This study summarized the etiology and pathogenesis of CP/CPPS and found that western medicine cannot fully explain the etiology and pathogenesis of CP/CPPS. It was believed that CP/CPPS was mainly related to many factors such as special pathogen infection, voiding dysfunction, mental and psychological abnormalities, neuroendocrine abnormalities, immune abnormalities, excessive oxidative stress, pelvic diseases, and heredity. TCM believed that CP/CPPS was caused by damp heat, blood stasis, Qi stagnation, and poisoning and was closely related to the organs of the liver, spleen, kidney, lung, stomach, bladder, and meridians of Chong and Ren channels and three yin channels of the foot. In the treatment of TCM, multiple comprehensive treatment plans are currently used, including internal treatment with TCM(decoction, proprietary Chinese medicine, and unique therapies of famous doctors), acupuncture and massage treatment, and other external treatment methods(rectal administration, topical application of TCM, and ear acupoint pressure). Comprehensive regulation has significant clinical efficacy and prominent characteristics of TCM, and it is worth clinical promotion. This study aims to provide a reference for clinical prevention and treatment of CP/CPPS and points out potential directions for future research in this field.

Vitamin C and E antioxidant supplementation may significantly reduce pain symptoms in endometriosis: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The primary challenge encountered by individuals diagnosed with endometriosis is the experience of pain. Emerging research indicates that oxidative stress is implicated in the initiation of pain associated with endometriosis. Vitamins C and E are known for their antioxidative properties. The primary objective of this study is to assess the efficacy of antioxidant supplementation, consisting of these vitamins, in the management of pain associated with endometriosis. METHODS: A comprehensive search was conducted on the ClinicalTrials.gov, Scopus, Europe PMC, and Medline databases up until August 23rd, 2023, utilizing a combination of relevant keywords. This review incorporates literature that examines the relationship between antioxidant supplementation and pain in endometriosis. We employed fixed-effect models to analyze the risk ratio (RR) and present the outcomes together with their corresponding 95% confidence intervals (CI). RESULTS: A total of five RCTs were incorporated. The results of our meta-analysis indicated that antioxidant supplementation with vitamin C and E combination was associated with higher proportion of endometriosis patients reporting reduced chronic pelvic pain (RR 7.30; 95%CI: 3.27-16.31, p<0.00001, I2 = 0%), alleviations of dysmenorrhea (RR 1.96; 95%CI: 1.25-3.07, p = 0.003, I2 = 39%), and dyspareunia (RR 5.08; 95%CI: 2.10-12.26, p = 0.0003, I2 = 0%) than patients only receiving placebo. CONCLUSIONS: This study suggests the potential ability of vitamin C and E in alleviating pain symptoms experienced by individuals with endometriosis.

Pain and daily interference among reproductive-age women with myofascial pelvic pain: Serial mediation roles of kinesiophobia, self-efficacy and pain catastrophizing.

BACKGROUND: Myofascial pelvic pain (MFPP), which is identified by tender points in the pelvic floor musculature, is a prevalent source of chronic pelvic pain in women. It may lead to physical and mental exhaustion, reproductive concerns, and coping difficulties in daily life and work than the disease itself. Pain-related cognitive processes can affect pain relief and quality of life. Kinesiophobia, self-efficacy and pain catastrophizing are frequently treated as mediators between pain and its related consequences. Greater kinesiophobia and pain catastrophizing have been shown to be associated with adverse functional outcomes, while higher self-efficacy has been related with improved quality of life. Regarding MFPP in females of childbearing age, it remains unclear whether the effects of kinesiophobia, self-efficacy and pain catastrophizing on daily interference are direct or indirect; the influence on each variable is, therefore, not entirely evident. AIM: The present study aimed to evaluate the relationship between pain and daily interference in reproductive-age women with MFPP through kinesiophobia, self-efficacy and pain catastrophizing, as well as to identify areas for future investigation and intervention based on the data collected from this population. METHODS: This is a multi-center cross-sectional study. The study was conducted from November 15, 2022 to November 10, 2023, 202 reproductive-age women with MFPP were recruited from 14 hospitals in ten provinces of China. The demographic variables, Brief Pain Inventory, Tampa Scale of Kinesiophobia, Pain Self-Efficacy Questionnaire, and Pain Catastrophizing Scale were used to measure the participants' related information. The data was described and analyzed using Descriptive analyses, Pearson correlation analysis, and Serial mediation modeling. RESULTS: Pain not only had a direct positive impact (B = 0.575; SE = 0.081; 95%CI: LL = 0.415, UL = 0.735) on daily interference, but also had an indirect impact on daily interference through the independent mediating role of pain catastrophizing (B = 0.088; SE = 0.028; 95%CI: LL = 0.038, UL = 0.148), the chain mediating of kinesiophobia and catastrophizing (B = 0.057; SE = 0.019; 95%CI: LL = 0.024, UL = 0.098), and the four-stage serial mediating of kinesiophobia, self-efficacy and catastrophizing (B = 0.013; SE = 0.006; 95%CI: LL = 0.003, UL = 0.027). The proposed serial mediation model showed a good fit with the collected data. CONCLUSION: The findings illustrate the significance of addressing pain catastrophizing and kinesiophobia (especially catastrophizing), and increasing self-efficacy in pain therapy, and suggest that functional recovery be integrated into pain therapy for reproductive-age women suffering from MFPP.

Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial.

OBJECTIVES: To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. DESIGN: The PRE-EMPT (preventing recurrence of endometriosis) pragmatic, parallel group, open label, randomised controlled trial. SETTING: 34 UK hospitals. PARTICIPANTS: 405 women of reproductive age undergoing conservative surgery for endometriosis. INTERVENTIONS: Participants were randomised in a 1:1 ratio using a secure internet facility to a long acting progestogen (depot medroxyprogesterone acetate or levonorgestrel releasing intrauterine system) or the combined oral contraceptive pill. MAIN OUTCOME MEASURES: The primary outcome was pain measured three years after randomisation using the pain domain of the Endometriosis Health Profile 30 (EHP-30) questionnaire. Secondary outcomes (evaluated at six months, one, two, and three years) included the four core and six modular domains of the EHP-30, and treatment failure (further therapeutic surgery or second line medical treatment). RESULTS: 405 women were randomised to receive a long acting progestogen (n=205) or combined oral contraceptive pill (n=200). At three years, there was no difference in pain scores between the groups (adjusted mean difference -0.8, 95% confidence interval -5.7 to 4.2, P=0.76), which had improved by around 40% in both groups compared with preoperative values (an average of 24 and 23 points for long acting progestogen and combined oral contraceptive pill groups, respectively). Most of the other domains of the EHP-30 also showed improvement at all time points compared with preoperative scores, without evidence of any differences between groups. Women randomised to a long acting progestogen underwent fewer surgical procedures or second line treatments compared with those randomised to the combined oral contraceptive pill group (73 v 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00). CONCLUSIONS: Postoperative prescription of a long acting progestogen or the combined oral contraceptive pill results in similar levels of improvement in endometriosis related pain at three years, with both groups showing around a 40% improvement compared with preoperative levels. While women can be reassured that both options are effective, the reduced risk of repeat surgery for endometriosis and hysterectomy might make long acting reversible progestogens preferable for some. TRIAL REGISTRATION: ISRCTN registry ISRCTN97865475.

The reporting quality and spin of randomized controlled trials of endometriosis pain: Methodological study based on CONSORT extension on abstracts.

OBJECTIVE: To assess the reporting quality of published RCT abstracts regarding patients with endometriosis pelvic pain and investigate the prevalence and characteristics of spin in these abstracts. METHODS: PubMed and Scopus were searched for RCT abstracts addressing endometriosis pelvic pain published from January 1st, 2010 to December 1st, 2023.The reporting quality of RCT abstracts was assessed using the CONSORT statement for abstracts. Additionally, spin was evaluated in the results and conclusions section of the abstracts, defined as the misleading reporting of study findings to emphasize the perceived benefits of an intervention or to confound readers from statistically non-significant results. Assessing factors affecting the reporting quality and spin existence, linear and logistic regression was used, respectively. RESULTS: A total of 47 RCT abstracts were included. Out of 16 checklist items, only three items including objective, intervention and conclusions were sufficiently reported in the most abstracts (more than 95%), and none of the abstracts presented precise data as required by the CONSORT-A guidelines. In the reporting quality of material and method section, trial design, type of randomization, the generation of random allocation sequences, the allocation concealment and blinding were most items identified that were suboptimal. The total score for the quality varied between 5 and 15 (mean: 9.59, SD: 3.03, median: 9, IQR: 5). Word count (beta = 0.015, p-value = 0.005) and publishing in open-accessed journals (beta = 2.023, p-value = 0.023) were the significant factors that affecting the reporting quality. Evaluating spin within each included paper, we found that 18 (51.43%) papers had statistically non-significant results. From these studies, 12 (66.66%) had spin in both results and conclusion sections. Furthermore, the spin intensity increased during 2010-2023 and 38.29% of abstracts had spin in both results and conclusion sections. CONCLUSION: Overall poor adherence to CONSORT-A was observed, with spin detected in several RCTs featuring non-significant primary endpoints in obstetrics and gynecology literature.

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.