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OBJECTIVE: To assess the frequency and determinants of medical interventions during childbirth without women's consent at the population level. METHODS: The nationwide cross-sectional Enquête Nationale Périnatale 2021 provided a representative sample of women who delivered in metropolitan France with a 2-month postpartum follow-up (n = 7394). Rates and 95% confidence intervals (CI) of interventions during childbirth (oxytocin administration, episiotomy or emergency cesarean section) without consent were calculated. Associations with maternal, obstetric, and organizational characteristics were assessed using robust variance Poisson regressions, after multiple imputation for missing covariates, and weighted to account for 2-month attrition. RESULTS: Women reporting failure to seek consent were 44.7% (CI: 42.6-47.0) for oxytocin administration, 60.2% (CI: 55.4-65.0) for episiotomy, and 36.6% (CI: 33.3-40.0) for emergency cesarean birth. Lack of consent for oxytocin was associated with maternal birth abroad (adjusted prevalence ratio [aPR] 1.20; 95% CI: 1.06-1.36), low education level, and increased cervical dilation at oxytocin initiation, whereas women with a birth plan reported less frequently lack of consent (aPR 0.79; 95% CI: 0.68-0.92). Delivery assisted by an obstetrician was more often associated with lack of consent for episiotomy (aPR 1.46; 95% CI: 1.11-1.94 for spontaneous delivery and aPR 1.39; 95% CI: 1.13-1.72 for instrumental delivery, reference: spontaneous delivery with a midwife). Cesarean for fetal distress was associated with failure to ask for consent for emergency cesarean delivery (aPR 1.58; 95% CI: 1.28-1.96). CONCLUSION: Women frequently reported that perinatal professionals failed to seek consent for interventions during childbirth. Reorganization of care, particularly in emergency contexts, training focusing on adequate communication and promotion of birth plans are necessary to improve women's involvement in decision making during childbirth.
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The ovaries, resembling almonds in shape and size, are vital organs that serve as the female gonads where oocytes, or female gametes, undergo development and where various reproductive hormones are produced. The ovaries receive their arterial blood supply predominately from the ovarian artery but also from the ascending branches of the uterine artery. The arterial anatomy of the ovaries is highly significant in any gynecological surgical procedure, as hemorrhagic complications may be fatal. Therefore, the main objective of the present review is to comprehensively describe the complete anatomy of the arterial blood supply of the ovaries. The arterial blood supply to the ovaries is facilitated by a complex network of arteries, frequently characterized by diverse anastomoses. Notably, the ovarian artery and uterine artery exhibit significant variability, presenting challenges for physicians performing gynecological and endovascular procedures. This study showcased comprehensive and detailed insights into the arterial blood supply of the ovaries, serving as a valuable resource for practitioners navigating the complexities of these procedures. By offering clear and detailed information, the present study aimed to enhance the effectiveness and safety of medical interventions involving the ovaries.
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OBJECTIVE: To assess the impact of an Outpatient Word Catheter Program (OWCP) on outcomes in women presenting with Bartholin cysts or abscesses (BC/BAs). . METHODS: This retrospective cohort study reviewed 408 women presenting with BC/BAs to our tertiary unit from 2017-2022. Analysis of medical records, with subgroup analysis of pregnant patients, and comparative analysis between pre- and post-intervention groups, was completed. Financial impact analysis using national activity-based funding pricing guidance to estimate cost was conducted. RESULTS: Pre-intervention, 65% (n = 34) of procedures were completed in theater, but after the introduction of OWCP, 61% (n = 213) of cases were treated in the day ward (χ2 = 67.43, P <0.001). Similarly, inpatient admissions reduced; 94.2% (n = 49) pre-intervention versus 26% (n = 92) post-intervention (χ2 = 92.25, P <0.001). The mean all patient admission duration decreased from 1.52 ± 0.89 days to 0.69 ± 0.59 days (P <0.001). The mean cost for those women attending in the pre-OWCP period was 4798, versus 2704 in the women who attended post-OWCP introduction (P < 0.001). CONCLUSION: After OWCP introduction, there were significant decreases in inpatient admissions, surgical procedures in theater, general anesthetic exposure, and duration of admission. Financial impact analysis revealed a significant cost reduction of ~2100 per patient. Outpatient or day-care Word catheter programs are feasible, affordable and acceptable services to provide to women presenting with BC/BAs.
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OBJECTIVE: To determine which locoregional techniques are effective in managing post-operative pain in major open oncologic gynecologic surgery in terms of pain scores and opioid consumption when epidural analgesia is not a feasible option. METHODS: A systematic review of the literature, based on the Preferred Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, was conducted. The ROB-2 assessment was used to assess bias. The primary outcomes were opioid consumption and post-operative pain scores. Secondary outcomes included post-operative markers such as time to mobilization and bowel movement. RESULTS: A total of nine studies (n=714) were included in the analysis. Eight studies had a low risk of bias. Five different forms of locoregional analgesia were described. Eight studies compared with placebo and one study compared rectus sheath block with epidural analgesia. Three of the five studies investigating transversus abdominis plane (TAP) blocks showed an improvement in pain scores and opioid consumption when compared with the placebo group. One study investigating rectus sheath blocks and another investigating paravertebral blocks demonstrated significantly less opioid consumption and improved pain scores at certain time points. The studies investigating continuous wound infiltration and superior hypogastric plexus block found no significant effect. No adverse effects of locoregional anesthesia were found. CONCLUSION: Our study showed that TAP blocks, rectus sheath blocks, and paravertebral blocks may decrease opioid consumption and improve pain scores in patients undergoing open abdominal surgery for gynecologic cancer. Additionally, these techniques might serve as a viable alternative for patients with contraindications to epidural analgesia.
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This 10-year retrospective cohort study at a single-center clinic in Germany aimed to analyze the outcomes of endometrial cancer patients and explore the impact of lymphovascular invasion (LV) on patient outcomes and disease-free survival (DFS). Identifying correlations among demographic data, tumor characteristics, treatment modalities, and survival outcomes could enhance patient management and improve survival rates. The study encompassed patients diagnosed and treated for endometrial cancer from January 2010 to December 2020. Clinical and pathological data were extracted from medical records for 311 patients, focusing on variables such as age, histological type, tumor grade, type of surgical treatment, and adjuvant therapies. Survival analysis was conducted using the Kaplan-Meier method and multivariate Cox proportional hazard models to identify factors independently associated with survival. The study demonstrated that lymphovascular invasion significantly impacted survival outcomes on Kaplan-Meier analysis (log-rank p-value = 0.0058). Patients with LV showed a marked decrease in DFS compared to those without LV invasion, with a median DFS of 3.2 years and a hazard ratio of 2.18 (95% CI: 1.56-3.04, p < 0.001). Furthermore, high-grade tumors and p53 positivity were strongly associated with reduced DFS, with hazard ratios of 1.93 (p = 0.001) and 2.11 (p < 0.001), respectively. Patients with distant metastasis exhibited the most significant decline in survival, with a hazard ratio of 5.56 (95% CI: 2.45-10.18, p < 0.001). Despite comprehensive surgical and adjuvant therapies, these high-risk factors dictated poorer outcomes. The presence of lymphovascular invasion, high-grade tumors, and genetic markers like MSI and p53 are pivotal in predicting the course of endometrial cancer. This study underscores the necessity for aggressive management strategies in patients exhibiting these high-risk features to potentially improve prognosis and survival outcomes. The findings advocate for enhanced therapeutic strategies tailored to the biological behavior of the tumor, thereby aiming to elevate the overall survival rates for women diagnosed with endometrial cancer.
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OBJECTIVE: In the surgery-focused field of obstetrics and gynecology (OB-GYN), the development of residents' skills is paramount. This study aims to evaluate the impact of an enhanced Peyton Four-Step Teaching Model on the foundational skill training of first-year OB-GYN residents. METHODS: Utilizing a cohort study design, we assessed 116 first-year residents from the OB-GYN residency program at Shengjing Hospital of China Medical University from June 2021 to June 2023. The 57 residents beginning their training in 2022 were part of the Refined Peyton (RP) group, introduced to the RP method; the 59 residents from 2021 served as the Traditional Teaching-mode (TTM) group, receiving conventional simulation-based instruction. Teaching effectiveness was assessed by comparing theoretical knowledge and skill performance assessments, National Medical Licensing Examination (NMLE) pass rates, direct observation of procedural skills (DOPS) one year post-training, and survey feedback. RESULTS: The theoretical knowledge scores for both groups were comparable at 78.78 ± 4.08 and 78.70 ± 3.83, with no significant difference (P = 0.76). However, the experimental group demonstrated superior performance in skill operation assessments, first-time NMLE pass rates, and DOPS evaluations one year after training [(77.05 ± 5.39) vs. (84.60 ± 5.65), 100.0% (57/57) vs. 86.4% (51/59), and (75.22 ± 3.56) vs. (82.54 ± 3.43)], as well as higher teaching satisfaction scores [(4.63 ± 0.46) vs. (3.92 ± 0.62)], with all differences being statistically significant (P < 0.05). CONCLUSION: The refined Peyton Four-Step Teaching Model significantly improves the immediate acquisition and long-term retention of clinical basic skills among OB-GYN residents, enhancing both teaching efficacy and resident satisfaction.
Subject(s)
Clinical Competence , Gynecology , Internship and Residency , Obstetrics , Humans , Obstetrics/education , Gynecology/education , Female , China , Educational Measurement , Teaching , Cohort Studies , Male , Adult , Education, Medical, GraduateABSTRACT
We discuss lessons learned from the COVID-19 pandemic through an obstetrics and gynecology (OB/GYN) hospitalist lens, with a focus on clinical care considerations, workforce changes, communication and collaboration, and provider wellness. We end with a discussion on the role of OB/GYN hospitalists as leaders. Our goal is to share what worked well for hospital systems and OB/GYN hospitalist teams during COVID-19, along with recommendations to consider for future national emergencies.
Subject(s)
COVID-19 , Gynecologists , Hospitalists , Obstetrics , Female , Humans , Pregnancy , COVID-19/epidemiology , COVID-19/therapy , Leadership , Obstetrics and Gynecology Department, Hospital/organization & administration , Pandemics , SARS-CoV-2ABSTRACT
Obstetrics and gynecology hospitalists play a vital role in reducing maternal morbidity and mortality by providing immediate access to obstetric care, especially in emergencies. Their presence in hospitals ensures timely interventions and expert management, contributing to better outcomes for mothers and babies. This proactive approach can extend beyond hospital walls through education, advocacy, and community outreach initiatives aimed at improving maternal health across diverse settings.
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Gynecologists , Hospitalists , Maternal Mortality , Obstetrics , Female , Humans , Pregnancy , Health Services Accessibility , Maternal Health Services/standards , United States/epidemiologyABSTRACT
STUDY OBJECTIVE: The purpose of this study is to better understand the pediatric and adolescent gynecology (PAG) experience from the obstetrics and gynecology (OBGYN) resident perspective and its impact on physician comfort with caring for younger patients. METHODS: This is a cross-sectional survey study of physicians enrolled in OBGYN residency programs in the United States. For each program, an internet search was also performed to identify the closest PAG providers. Chi-square and Fisher's exact tests were performed to compare categorical variables. This study was IRB approved. RESULTS: 74 resident responses from 42 unique OBGYN training programs were included. The majority (62%) of programs offered no PAG clinical experience. Of programs with no PAG clinical experience, 45% had unaffiliated self-identified PAG providers within 30 miles of their institution. Only 26% of residents reported having a dedicated PAG rotation. 68% of residents felt they did not have enough PAG exposure in training. Residents who had a dedicated PAG rotation were more comfortable caring for patients <7 years old (p=0.016) and patients 8-14 years old (p=0.019) than residents without a rotation. The majority (88%) of residents believe that PAG experience will be useful for their future practice. CONCLUSION: Residents with PAG training are more comfortable in caring for patients <14 years than those in programs who lack this training. Residencies without PAG-trained staff physicians could consider partnering with PAG-practicing community physicians with the aim of broadening clinical experience. Improvement in PAG education helps provide graduating obstetrician-gynecologists with the necessary knowledge to provide needed care to younger patients.
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OBJECTIVE: To assess factors impacting obstetric transport and referral processes for pregnant patients experiencing an emergency in a rural state without a perinatal regionalized system of care. DATA SOURCES AND STUDY SETTING: Data is from Critical Access Hospitals (CAHs) without obstetric units and healthcare providers involved in obstetric care and transport at hospitals with varying levels of obstetric capacity in Montana. STUDY DESIGN: This mixed-methods study involved surveying CAHs without obstetric units about the hospitals' capacity for obstetric emergencies and transport policies. Survey data were collected from 32 of 34 CAHs without obstetric units (94% response rate) in the fall of 2021. Subsequent interviews were conducted in the fall and winter of 2022-2023 with 20 hospital and emergency medical services (EMS) personnel to provide further insights into the referral and transport process during obstetric emergencies. DATA COLLECTION/EXTRACTION METHODS: Survey data were collected using REDCap; interviews were conducted via videoconference. We performed descriptive statistics and Fisher's exact tests for quantitative data. We analyzed qualitative data using a three-phase pragmatic analytic approach. PRINCIPAL FINDINGS: The survey of CAHs found 12 of 32 facilities faced difficulties coordinating transport for pregnant patients. Qualitative data indicated this was often due to the state's decentralized transport system. Challenges identified through both quantitative and qualitative data included weather, securing a receiving facility/provider, and coordinating medical transport. Only 10 CAHs reported having written protocols for transporting pregnant patients; of those, four facilities had formal transfer agreements. Qualitative data emphasized variations in awareness and the utility of obstetric transport policies. CONCLUSIONS: A decentralized transport system in a rural state can exacerbate existing challenges faced by providers arranging transport for pregnant patients during an obstetric emergency. State and interfacility policies could enhance the transport process for increased regionalization as well as increased support for and coordination of existing EMS.
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Background: Modern management of preeclampsia can be optimized by tailoring the targeted treatment of hypertension to an individual's hemodynamic profile. Growing evidence suggests different phenotypes of preeclampsia, including those with a hyperdynamic profile and those complicated by uteroplacental insufficiency. Fetal growth restriction (FGR) is believed to be a result of uteroplacental insufficiency. There is a paucity of research examining the characteristics of patients with severe preeclampsia who do and who do not develop FGR. We aimed to elucidate which hemodynamic parameters differed between these two groups. Methods: All patients admitted to a single referral center with severe preeclampsia were identified. Patients were included if they had a live birth at 23 weeks of gestation or higher. Multiple gestations and pregnancies complicated by fetal congenital anomalies and/or HELLP syndrome were excluded. FGR was defined as a sonographic estimation of fetal weight (EFW) < 10th percentile or abdominal circumference (AC) < 10th percentile. Results: There were 76% significantly lower odds of overall pulse pressure upon admission for those with severe preeclampsia comorbid with FGR (aOR = 0.24, 95% CI = 0.07-0.83). Advanced gestational age on admission was associated with lower odds of severely abnormal labs and severely elevated diastolic blood pressure in preeclampsia also complicated by FGR. Conclusions: Subtypes of preeclampsia with and without FGR may be hemodynamically evaluated by assessing pulse pressure on admission.
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Endometriosis is a debilitating, chronic inflammatory disease affecting ~10% of reproductive age women worldwide with no cure. While macrophages have been intrinsically linked to the pathophysiology of endometriosis, targeting them therapeutically has been extremely challenging due to their high heterogeneity and because these disease-associated macrophages (DAMs) can be either pathogenic or protective. Here, we reported identification of pathogenic macrophages characterized by TET3 overexpression in human endometriosis lesions. We showed that factors from the disease microenvironment upregulated TET3 expression transforming macrophages into pathogenic DAMs. TET3 overexpression stimulated pro-inflammatory cytokine production via a feedback mechanism involving inhibition of let-7 miRNA expression. Remarkably, these cells relied on TET3 overexpression for survival, hence vulnerable to TET3 knockdown. We demonstrated that Bobcat339, a synthetic cytosine derivative, triggered TET3 degradation both in human and mouse macrophages. This degradation was dependent on a VHL E3 ubiquitin ligase whose expression was also upregulated in TET3-overexpressing macrophages. Furthermore, depleting TET3-overexpressing macrophages either through myeloid-specific Tet3 ablation or using Bobcat339 strongly inhibited endometriosis progression in mice. Our results defined TET3-overexpressing macrophages as key pathogenic contributors to and attractive therapeutic targets for endometriosis. Our findings may also be applicable to other chronic inflammatory diseases where DAMs have important roles.
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BACKGROUND: Digital technology and gamified apps can be useful in the health care context. Gamification uses technology to influence users' actions and motivations through experiences that resemble games. Patient adherence to the enhanced recovery after surgery (ERAS) program is crucial for achieving early recovery after surgery and continuous monitoring is essential for obtaining good results. OBJECTIVE: This study aimed to describe the development and validation of a mobile app for enhanced recovery after surgery (MobERAS), a gamified mobile health app for telemonitoring patients in the postoperative period based on the ERAS program, and to evaluate its functionality and usability and the experience of patients, health care professionals, and computer professionals with its use. METHODS: We developed MobERAS for postoperative telemonitoring, with active participation of patients in the process, and offering availability of real-time information for the health team. The app development process included idealization, interdisciplinary team formation, potential needs assessment, and product deployment. Usability tests were conducted throughout the development process with improvements, technical adjustments, and updates. After finalization, comprehensive verification tests were performed. The parameters evaluated are those that can influence the length of hospital stay, such as nausea, vomiting, pain scales, return to normal gastrointestinal function, and thromboembolic events. MobERAS was designed to be downloaded by users on their phones, tablets, or other mobile devices and to provide postoperative data. The app has a GPS that monitors the patient's walking time and distance and is connected to a virtual database that stores the collected data. RESULTS: Women undergoing medium and major gynecologic oncologic surgeries were included. We included 65 patients with an average age of 53.2 (SD 7.4, range 18-85) years. The time of use ranged from 23.4 to 70 hours (mean 45.1, SD 19.2 hours). Regarding adherence to the use of MobERAS, the mean fill rate was 56.3% (SD 12.1%, range 41.7%-100%), and ambulation data were obtained for 60 (92.3%) of the 65 patients. The researcher had access to the data filled out by the patients in real time. There was good acceptance of the use of MobERAS by the patients, with good evaluation of the app's usability. MobERAS was easy to use and considered attractive because of its gamified design. The app was rated as good or very good in all items by health care professionals (n=20) and professionals specializing in technological innovation (n=10). CONCLUSIONS: MobERAS is easy to use, safe, well accepted by patients, and well evaluated by experts. It can be of great use in clinical surgical practice and an important tool for greater engagement of patients and health care professionals with the ERAS program.
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Background: The treatment patterns and clinical outcomes in recurrent/advanced endometrial cancer in Europe are not well known. Materials & methods: Endometrial Cancer Health Outcomes-Europe-First-Line is a multicenter, retrospective chart review study conducted in the UK, Germany, Italy, France and Spain. Patients diagnosed with recurrent/advanced endometrial cancer who initiated first-line systemic therapy between 1 July 2016 and 31 March 2020 were eligible. Results: Among 242 patients, median age was 69 years and 82.2% had stage IIIB-IV disease. In first-line, most patients received platinum-based chemotherapy (78.9%); others received endocrine therapy (6.2%), taxane monotherapy (5.8%) and nonplatinum or taxane-based chemotherapy (4.1%). Median real-world progression-free survival since first-line initiation was 10.8 months and median overall survival was 20.7 months. Conclusion: Poor prognosis with platinum-based first-line chemotherapy suggests significant unmet medical need.
Treatment patterns & survival for recurrent/advanced endometrial cancer patients in Europe who received their first treatmentThe treatments and survival for recurrent/advanced endometrial (uterus lining) cancer patients in real-life European settings are not well known. Endometrial Cancer Health Outcomes-Europe-First-Line is a multicenter study that was conducted in the UK, Germany, Italy, France and Spain and used de-identified information from existing patient medical records. Patients diagnosed with recurrent/advanced endometrial cancer who initiated a first treatment between 1 July 2016 and 31 March 2020 were included. Among 242 included patients, the average age was 69 years and 82.2% had stage IIIB-IV disease (indicating the size and extent of their cancer). As their first treatment, most patients received platinum-based chemotherapy (78.9%), which is a type of drug that kills cancer cells. Overall, patients lived for an average of 20.7 months since their first treatment. The average length of time patients lived without their disease getting worse was 10.8 months since their first treatment. We found that patients who received platinum-based chemotherapy as their first treatment had poor survival, which suggests significant unmet medical need.
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Transmasculine individuals have a poor access to health care, mostly regarding the sexual and reproductive health. Despite a lack of official guidelines, they need a gynecological follow-up, the aim of this review was to describe it. The present study involved an exhaustive search of MEDLINE, 68 articles were included to analyze the impact of hormonal therapy, prevention, and care regarding sexual and reproductive health of transmasculine individuals. Despite a lack of solid data, the global literature agrees that transmasculine individuals require sexual and reproductive health care. Care must be adapted to each pathway and may be impacted by gender-affirming care. The cancer risk does not seem to be increased in this population, particularly in relation to hormonal therapy. Prevention programs do not differ from those offered to cis women in the absence of gender-affirming surgeries. Transmasculine individuals require follow-up and care adapted to their needs and their pathways. Healthcare professionals must be trained to provide such care.
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MRKH syndrome, or Mayer-Rokitansky-Küster-Hauser syndrome, a rare congenital disease, manifests as a complete or partial aplasia of the uterus and the vagina's upper two-thirds with normal external genitalia and functioning ovaries. Mayer-Rokitansky-Küster-Hauser syndrome can occur in isolation (type I) or in conjunction with other congenital extragenital deformities affecting the kidneys, skeleton, heart, eyes, or auditory system (type II). The diagnosis of Mayer-Rokitansky-Küster-Hauser syndrome typically relies on imaging studies, with transabdominal ultrasonography serving as the primary modality. However, magnetic resonance imaging is considered the gold standard for detailed assessment of internal genital anatomy. We present the case of an 18-year-old woman without any notable medical history who exhibited primary amenorrhea. Mayer-Rokitansky-Küster-Hauser syndrome type II was suspected on pelvic ultrasound and subsequently confirmed via magnetic resonance imaging. The patient was provided with psychological assistance and planned for vaginoplasty.
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BACKGROUND: Proper and complete clerkships for patients have long been shown to contribute to correct diagnosis and improved patient care. All sections for clerkship must be carefully and fully completed to guide the diagnosis and the plan of management; moreover, one section guides the next. Failure to perform a complete clerkship has been shown to lead to misdiagnosis due to its unpleasant outcomes, such as delayed recovery, prolonged inpatient stay, high cost of care and, at worst, death. OBJECTIVE: The objectives of the study were to determine the gap in clerkship, the impact of incomplete clerkship on the length of hospital stay, to explore the causes of the gap in clerkship of the patients and the strategies which can be used to improve clerkship of the patients admitted to, treated and discharged from the gynecological ward in Mbale RRH. METHODOLOGY: This was a mixed methods study involving the collection of secondary data via the review of patients' files and the collection of qualitative data via key informant interviews. The files of patients who were admitted from August 2022 to December 2022, treated and discharged were reviewed using a data extraction tool. The descriptive statistics of the data were analyzed using STATA version 15, while the qualitative data were analyzed via deductive thematic analysis using Atlas ti version 9. RESULTS: Data were collected from 612 patient files. For qualitative data, a total of 8 key informant interviews were conducted. Social history had the most participants with no information provided at all (83.5% not recorded), with biodata and vital sign examination (20% not recorded) having the least number. For the patients' biodata, at least one parameter was recorded in all the patients, with the greatest gap noted in terms of recording the nearest health facility of the patient (91% not recorded). In the history, the greatest gap was noted in the history of current pregnancy (37.5% not provided at all); however, there was also a large gap in the past gynecological history (71% not recorded at all), past medical history (71% not recorded at all), past surgical history (73% not recorded at all) and family history (80% not recorded at all). The physical examination revealed the greatest gap in the abdominal examination (43%), with substantial gaps in the general examination (38.5% not recorded at all) and vaginal examination (40.5% not recorded at all), and the vital sign examination revealed the least gap. There was no patient who received a complete clerkship. There was a significant association between clerkships and the length of hospital stay. The causes of the gap in clerkships were multifactorial and included those related to the hospital, those related to the health worker, those related to the health care system and those related to the patient. The strategies to improve the clerkship of patients also included measures taken by health care workers, measures taken by hospitals and measures taken by the government. CONCLUSION AND RECOMMENDATION: There is a gap in the clerkships of patients at the gynecological ward that is recognized by the stakeholders at the ward, with some components of the clerkship being better recorded than others, and no patients who received a complete clerkship. There was a significant association between clerkships and the length of hospital stay. The following is the recommended provision of clerkship tools, such as the standardized clerkship guide and equipment for patient examination, continuous education of health workers on clerkships and training them on how to use the available tools, the development of SOPs for patient clerkships, the promotion of clerkship culture and the supervision of health workers.
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Clinical Clerkship , Quality Improvement , Quality of Health Care , Humans , Female , Adult , Length of Stay/statistics & numerical data , Middle AgedABSTRACT
Endometrial cancer is a leading gynecological malignancy, with obesity being a significant risk factor due to increased estrogen production in body fat. Current treatments often involve hysterectomy, which precludes fertility, thus highlighting the need for fertility-preserving options. This study aims to evaluate the combined efficacy of a levonorgestrel intrauterine device (LNG-IUD), metformin, and liraglutide for treating women with endometrial hyperplasia or early stage endometrial cancer while preserving fertility. The study will enroll 264 women aged 18-45 with a BMI > 30 who desire uterine preservation. Participants will be randomized into three groups: LNG-IUD alone, LNG-IUD plus metformin, and LNG-IUD plus metformin and liraglutide. Primary outcomes will include complete pathological remission, while secondary outcomes will assess histological changes, glucose, insulin levels, and weight changes over a 12-month period. This study protocol hypothesizes that LNG-IUD combined with metformin and liraglutide may potentially lead to higher regression rates of endometrial hyperplasia (EH) and early stage endometrial cancer (EC) compared to LNG-IUD alone. Furthermore, the protocol anticipates that these combination therapies will demonstrate good tolerability with minimal adverse effects, suggesting the potential benefit of integrating metabolic interventions with LNG-IUD to enhance treatment efficacy while preserving fertility in women with EH and EC.