Human ; Research Personnel ; Nurses ; Students

Background: While surgical intervention has been the usual treatment option for leiomyomas, non-surgical methods have been gaining popularity over the years. The levonorgestrel-releasing intrauterine system (LNG-IUS) is said to be effective in alleviating the signs and symptoms brought by uterine leiomyomas. Objective: To determine the effectiveness of LNG-IUS in the treatment of uterine leiomyomas presenting with abnormal uterine bleeding. Methods: The study was conducted using the PRISMA 2020 guidelines. The literature search was performed using the following databases: Medline, Cochrane Library, PubMed, Elsevier, Embase, and Herdin. All identified studies published from January 2015 up to July 2023 were included. Titles and abstracts were screened independently by two reviewers. Data extraction and risk of bias assessment were done independently by two reviewers. Gathered information were managed using Microsoft Excel spreadsheet. Synthesis of study characteristics and findings were conducted using a descriptive narrative review. The main outcomes were uterine volume, fibroid size, menstrual blood loss or bleeding patterns, and serum hemoglobin and hematocrit levels. Secondary outcome was incidence of adverse events. Results: A total of 5 studies were included with two having low methodological quality. One before-and-after cohort study showed that the use of LNG-IUS is effective in reducing menorrhagia with improvement in hematologic parameters. There is no change, however, in uterine volume. Another cohort study showed that the intervention is safe with low incidence of severe adverse events (0.5% in 595 patients). A comparative cohort study showed that LNG-IUS significantly decreased uterine volume and fibroid size, and a good alternative for treatment of heavy menstrual bleeding, as compared to intramuscular progestogen. Another before-and-after cohort study showed a significant decrease in uterine volume in women given LNG-IUS, but not in the control group. Finally, one comparative cross-sectional study showed that LNG-IUS did not effectively reduce heavy bleeding in 32.3% of patients, compared to laparoscopic hysterectomy, which was was 100% effective. Conclusion The use of LNG-IUS resulted in reduced menstrual bleeding and improved hematologic parameters after treatment. LNG-IUS was more effective compared to other hormonal treatments. However, when compared to laparoscopic hysterectomy, LNG-IUS was less effective in managing heavy bleeding. The incidence of adverse events reported in the studies was low.

Objectives: Many developing countries utilize the services of community health volunteers (CHVs) to enhance healthcare services in underserved regions. Evaluating client satisfaction with CHVs’ performance is crucial for ensuring the effective utilization of their services. This study aims to assess clients’ satisfaction with the provision of basic reproductive health services by CHVs in the governorates of Ibb and Al Mahweet, Yemen.Materials and Methods: A cross-sectional study was conducted, collecting data via structured questionnaires administered by trained data collectors to clients of CHVs. A total of 510 households were interviewed, with 255 from each governorate, distributed across 30 clusters (villages). Each governorate comprised 15 clusters in 12 districts (six districts in Ibb and five in Al Mahweet, excluding one district for security reasons). Within each cluster, 17 households were randomly selected for interviews. Descriptive analysis was performed using the SPSS version 22.Results: The majority of the clients were female (84.7%), most were aged 20–39 years (55.7%), and more than half of them had received at least primary education (54.2%). The study findings indicate that a significant proportion of respondents were highly satisfied with CHVs’ performance (93%). Almost all respondents confirmed that CHVs resided in their villages (94%) and were easily accessible for consultation (99%). Most of the respondents (97%) expressed trust in the CHVs, stating that they were helpful to all villagers and treated them well. Additionally, nearly all the respondents reported easy access to services (98.6%), although a considerable percentage experienced a gap of three months or more since their last interaction with a CHV (39.1%).Conclusion: The CHVs contribute to the well-being of the rural populations in Yemen by delivering satisfactory services, particularly regarding family planning. However, ensuring the sustainability of the CHV programs remains a challenge, which requires attention from the program managers and decision makers in the Yemeni healthcare sector.

Objective: To compare the efficacy of the levonorgestrel intrauterine system (LNG-IUS) versus megestrol acetate (MA) in inducing complete regression among women with atypical endometrial hyperplasia (AEH) who declined hysterectomy. Methods: In this single-center, open-label randomized controlled trial, we included 148 women with AEH who declined hysterectomy. We randomized participants to receive either daily oral MA 160 mg (n=74) or apply LNG-IUS (n=74) and scheduled their follow-up by endometrial sampling at 3, 6, 9, 12, 18, and 24 months. The success rate and duration until complete regression were the primary outcomes. Results: The mean duration until complete regression was 5.52 months (95% confidence interval [CI]=4.85–6.18) for the LNG-IUS group versus 6.87 months (95% CI=6.09–7.64) for the megestrol group (log-rank test p-value=0.011). The cumulative regression rate after 12 months was 91.9% with the LNG-IUS versus 77% with MA (p=0.026). Weight gain in the MA group vs LNG-IUS group after one year (4.7±4 kg vs. 2.7±2.6 kg, 95% CI=0.89–3.12; p=0.001) and after two years of therapy (7.8±5.1 kg vs. 4.1±2.9 kg, 95% CI=2.29–5.06; p<0.001). Conclusion Compared to MA, the LNG-IUS was more efficacious in treating AEH in women who declined hysterectomy, especially those with moderate/severe obesity, with fewer adverse effects and less weight gain. Extending therapy to 12 months for persistent cases would improve regression rates with reasonable safety. Alternate hysteroscopic and office sampling seemed convenient for follow-up.

Objective: To compare the efficacy of the levonorgestrel intrauterine system (LNG-IUS) versus megestrol acetate (MA) in inducing complete regression among women with atypical endometrial hyperplasia (AEH) who declined hysterectomy. Methods: In this single-center, open-label randomized controlled trial, we included 148 women with AEH who declined hysterectomy. We randomized participants to receive either daily oral MA 160 mg (n=74) or apply LNG-IUS (n=74) and scheduled their follow-up by endometrial sampling at 3, 6, 9, 12, 18, and 24 months. The success rate and duration until complete regression were the primary outcomes. Results: The mean duration until complete regression was 5.52 months (95% confidence interval [CI]=4.85–6.18) for the LNG-IUS group versus 6.87 months (95% CI=6.09–7.64) for the megestrol group (log-rank test p-value=0.011). The cumulative regression rate after 12 months was 91.9% with the LNG-IUS versus 77% with MA (p=0.026). Weight gain in the MA group vs LNG-IUS group after one year (4.7±4 kg vs. 2.7±2.6 kg, 95% CI=0.89–3.12; p=0.001) and after two years of therapy (7.8±5.1 kg vs. 4.1±2.9 kg, 95% CI=2.29–5.06; p<0.001). Conclusion Compared to MA, the LNG-IUS was more efficacious in treating AEH in women who declined hysterectomy, especially those with moderate/severe obesity, with fewer adverse effects and less weight gain. Extending therapy to 12 months for persistent cases would improve regression rates with reasonable safety. Alternate hysteroscopic and office sampling seemed convenient for follow-up.

Objective: To compare the efficacy of the levonorgestrel intrauterine system (LNG-IUS) versus megestrol acetate (MA) in inducing complete regression among women with atypical endometrial hyperplasia (AEH) who declined hysterectomy. Methods: In this single-center, open-label randomized controlled trial, we included 148 women with AEH who declined hysterectomy. We randomized participants to receive either daily oral MA 160 mg (n=74) or apply LNG-IUS (n=74) and scheduled their follow-up by endometrial sampling at 3, 6, 9, 12, 18, and 24 months. The success rate and duration until complete regression were the primary outcomes. Results: The mean duration until complete regression was 5.52 months (95% confidence interval [CI]=4.85–6.18) for the LNG-IUS group versus 6.87 months (95% CI=6.09–7.64) for the megestrol group (log-rank test p-value=0.011). The cumulative regression rate after 12 months was 91.9% with the LNG-IUS versus 77% with MA (p=0.026). Weight gain in the MA group vs LNG-IUS group after one year (4.7±4 kg vs. 2.7±2.6 kg, 95% CI=0.89–3.12; p=0.001) and after two years of therapy (7.8±5.1 kg vs. 4.1±2.9 kg, 95% CI=2.29–5.06; p<0.001). Conclusion Compared to MA, the LNG-IUS was more efficacious in treating AEH in women who declined hysterectomy, especially those with moderate/severe obesity, with fewer adverse effects and less weight gain. Extending therapy to 12 months for persistent cases would improve regression rates with reasonable safety. Alternate hysteroscopic and office sampling seemed convenient for follow-up.

Purpose: Classification of focal skeleton/bone marrow uptake (BMU) can be challenging. The aim is to investigate whether an artificial intelligence–based method (AI), which highlights suspicious focal BMU, increases interobserver agreement among a group of physicians from different hospitals classifying Hodgkin’s lymphoma (HL) patients staged with [ ­ 18 F]FDG PET/CT. Methods: Forty-eight patients staged with ­[ 18 F]FDG PET/CT at Sahlgenska University Hospital between 2017 and 2018 were reviewed twice, 6 months apart, regarding focal BMU. During the second time review, the 10 physicians also had access to AI-based advice regarding focal BMU. Results: Each physician’s classifications were pairwise compared with the classifications made by all the other physicians, resulting in 45 unique pairs of comparisons both without and with AI advice. The agreement between the physicians increased significantly when AI advice was available, which was measured as an increase in mean Kappa values from 0.51 (range 0.25–0.80) without AI advice to 0.61 (range 0.19–0.94) with AI advice (p = 0.005). The majority of the physicians agreed with the AI-based method in 40 (83%) of the 48 cases. Conclusion An AI-based method significantly increases interobserver agreement among physicians working at different hospitals by highlighting suspicious focal BMU in HL patients staged with ­[ 18 F]FDG PET/CT.

Given that impurities may affect the quality and safety of drug products,impurity identification and profiling is an integral part of drug quality control and is particularly important for newly developed medications such as solriamfetol,which is used to treat excessive daytime sleepiness.Although the high-performance liquid chromatography analysis of commercial solriamfetol has revealed the presence of several impurities,their synthesis,structure elucidation,and chromatographic determination have not been reported yet.To bridge this gap,we herein identified,synthesized,and isolated eight process-related solriamfetol impurities,characterized them using spectroscopic and chromatographic tech-niques,and proposed plausible mechanisms of their formation.Moreover,we developed and validated a prompt impurity analysis method based on ultrahigh-performance liquid chromatography with UV detection,revealing that its selectivity,linearity,accuracy,precision,and quantitation limit meet the acceptance criteria of method validation stipulated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.Thus,the developed method was concluded to be suitable for the routine analysis of solriamfetol substances.

Objective: This study investigated the impact of two stimulation protocols using highly purified human menopausal gonadotropin (HP-hMG) on the endocrine profile, follicular fluid soluble Fas levels, and outcomes of intracytoplasmic sperm injection (ICSI) cycles. Methods: This prospective clinical trial included 100 normal-responder women undergoing ovarian stimulation for ICSI; 55 patients received concomitant follicle-stimulating hormone (FSH) plus HP-hMG from the start of stimulation, while 45 patients received FSH followed by HP-hMG during mid/late follicular stimulation. The primary outcome was the number of top-quality embryos. The secondary outcomes were the number and percentage of metaphase II (MII) oocytes and the clinical pregnancy rate. Results: The number of MII oocytes was significantly higher in the concomitant protocol (median, 13.0; interquartile range [IQR], 8.5–18.0 vs. 9.0 [8.0–13.0] in the consecutive protocol; p=0.009); however, the percentage of MII oocytes and the fertilization rate were significantly higher in the consecutive protocol (median, 90.91; IQR, 80.0–100.0 vs. 83.33 [75.0–93.8]; p=0.034 and median, 86.67; IQR, 76.9–100.0 vs. 77.78 [66.7–89.9]; p=0.028, respectively). No significant between-group differences were found in top-quality embryos (p=0.693) or the clinical pregnancy rate (65.9% vs. 61.8% in the consecutive vs. concomitant protocol, respectively). The median follicular fluid soluble Fas antigen level was significantly higher in the concomitant protocol (9,731.0 pg/mL; IQR, 6,004.5–10,807.6 vs. 6,350.2 pg/mL; IQR, 4,382.4–9,418.4; p=0.021). Conclusion Personalized controlled ovarian stimulation using HP-hMG during the late follicular phase led to a significantly lower response, but did not affect the quality of ICSI.

Cervical cancer is preventable through gynecological screening. To promote participation among non-attending women, self-collected vaginal samples for detection of high-risk human papillomavirus (hr-HPV) is an option. The aims of this study were to investigate the response of self-collected vaginal samples for hr-HPV testing among long-term non-attendees, to explore the attendance at follow-up among HPV-positive women, and to analyze the prevalence of hr-HPV and severe cervical dysplasia or cancer among the responders. A vaginal self-sampling kit was sent to 19,766 women aged 30-70 years who had not provided a cervical screening sample for ≥ 7 years in Skåne, Sweden. The self-sample was analyzed by the Aptima HPV mRNA assay (Hologic). Women testing positive for HPV were invited for follow-up. The response was 18.5% (3,646/19,757). The prevalence of HPV mRNA was 11.3% (412/3,636). Among HPV-positive women, 85.7% (353/412) attended follow-up, and of these, 44.8% (158/353) had HPV in the cervical sample. The HPV mRNA test of self-samples showed a positive predictive value of 9.3% ([33/353], 95% CI = 6.5-12.9) for detection of cytologically severe dysplasia. Histologically severe dysplasia or cancer was detected in 0.88% ([32/3,636], 95% CI = 0.6-1.2) among responders, including two cervical- and one vaginal cancer. In conclusion, almost one fifth of the long-term non-attendees participated in self-collected vaginal hr-HPV sampling. The prevalence of histologically confirmed high grade squamous intraepithelial lesion or cervical cancer was not increased significantly compared to regularly screened women in Sweden. The relatively high HPV prevalence among the self-samples indicates the importance of diagnostic follow-up with cervical HPV testing and reflex-cytology of HPV-positive cases.