Category: Nevin Manimala

Arch Gynecol Obstet. 2025 Jan 25. doi: 10.1007/s00404-024-07916-1. Online ahead of print.

ABSTRACT

PURPOSE: Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age, often leading to anovulatory infertility. Obesity exacerbates the reproductive, metabolic and psychological features of PCOS, making fertility treatment and patient satisfaction difficult. Despite guidelines from the European Society of Human Reproduction and Embryology (ESHRE) emphasizing lifestyle modifications and specific treatments, there remains a significant gap in adherence to these guidelines by both healthcare providers and patients.

METHODS: A cross-sectional online survey was conducted from 1 January to 14 March 2021 among PCOS patients in Germany, Austria and Switzerland. A non-standardized, non-validated questionnaire covering several aspects of reproductive health was distributed via online channels. Data were analyzed using descriptive statistics, chi-squared tests, Student’s t-tests and Jonckheere-Terpstra tests, with significance set at p < 0.05.

RESULTS: Out of 2029 participants, 1902 completed the fertility questionnaire. Of these, 73.9% perceived their fertility to be impaired, with this perception being higher in obese women (80.8% vs. 67.4%, p < 0.001). The analysis focused on 564 childless women with a current desire to have children, 67.0% of whom met WHO criteria for infertility. Obese women (BMI ≥ 30 kg/m²) reported lower satisfaction with fertility treatment (40.9 vs. 47.8, p = 0.009) and were less likely to receive fertility treatment (56.7% vs. 75.8%, p < 0.001). Despite recommendations, only 34.1% reported lifestyle changes as part of their treatment. Letrozole, the recommended first-line treatment, was underused (14.6%) and clomiphene citrate was more commonly prescribed (35.4%). Obese women reported fewer current pregnancies (4% vs. 13.9%, p < 0.001) and were more likely to be infertile for more than one year (77.0% vs. 53.0%, p < 0.001). They also expressed a greater desire for possibilities to ask more questions about PCOS and fertility and to undergo more infertility tests. (56.1% vs. 45.3%, p = 0.013; 69.4% vs. 59.8%, p = 0.020).

CONCLUSIONS: Fertility management in PCOS patients, especially in obese patients, shows significant gaps in adherence to recommended guidelines, highlighting the need for improved patient education, professional training and individualized treatment strategies. Improved health care is essential to address reproductive concerns and improve outcomes in this population.

PMID:39862270 | DOI:10.1007/s00404-024-07916-1

Arch Orthop Trauma Surg. 2025 Jan 25;145(1):146. doi: 10.1007/s00402-025-05767-2.

ABSTRACT

PURPOSE: The adoption of robotic-assisted total hip arthroplasty (THA) is increasingly widespread, yet its influence on outcomes in outpatient surgery remains uncertain. This study aimed to evaluate whether robotic assistance reduces the rate of 90-day postoperative events in patients undergoing outpatient THA, compared to those in inpatient procedures.

METHODS: This historical-prospective cohort study analyzed 706 primary THA cases performed between January 2017 and January 2023 by three senior surgeons. Patients were grouped into outpatient (n = 132) and inpatient (n = 576) cohorts. From December 2019, robotic-assisted THA using the MAKO™ system was implemented. Propensity score matching was used to minimize baseline differences between groups. The primary outcome was the occurrence of any event within 90 days post-surgery, including readmissions, reoperations, and other complications. Secondary outcomes included functional scores, length of hospital stay, and intraoperative factors such as blood loss and Operative Room (OR) time.

RESULTS: No significant differences were found between inpatient and outpatient groups in terms of gender, age, BMI, ASA score, or surgeon. The 90-day event rates were similar between the two groups (8.59% vs. 9.38%, p > 0.999). However, outpatient THA was associated with lower blood loss (p = 0.02) and shorter hospital stays (p < 0.001). Multivariate analysis identified prolonged OR time (> 2 h), BMI ≥ 25, and manual surgical techniques as significant risk factors for 90-day events. Robotic-assisted surgery, although not statistically significant (p = 0.105), showed a trend towards reducing complications in outpatient THA.

CONCLUSION: Outpatient THA is a safe alternative to inpatient surgery, with no significant difference in 90-day postoperative events. Robotic-assisted surgery appears to reduce complications, particularly in the outpatient setting, and may optimize outpatient care pathways. Further research is needed to confirm these findings and explore long-term outcomes.

LEVEL OF EVIDENCE: III.

PMID:39862256 | DOI:10.1007/s00402-025-05767-2

Eur Radiol. 2025 Jan 25. doi: 10.1007/s00330-025-11380-z. Online ahead of print.

ABSTRACT

OBJECTIVES: The Scrotal and Penile Imaging Working Group (SPIWG) of the European Society of Urogenital Radiology (ESUR) aimed to formulate recommendations on the imaging modalities and minimal technical requirements for abdominopelvic imaging in the follow-up of adult patients treated for testicular germ-cell tumors (TGCT).

METHODS: The SPIWG members performed an extensive literature search, reviewed the current clinical practice, and reached a consensus based on the opinions of experts in the field.

RESULTS: Recurrence in patients treated for TGCT mainly occurs in retroperitoneal lymph nodes (LNs). Abdominopelvic CT and MRI are equivalent assessing retroperitoneal LNs. MRI has the advantage of avoiding radiation exposure, and moreover, diffusion-weighted images (DWI) may increase the detection rates without the need for contrast administration. In patients treated for stage I TGCT, the ESUR-SPIWG recommends MRI over CT for the detection of retroperitoneal LNs during the follow-up after treatment. CT, however, remains the follow-up imaging of choice in patients with advanced disease. When MRI is used, the recommended minimal requirements are at least one high-quality anatomical sequence (T1-WI or T2-WI) in axial and coronal planes, and DWI in the same axial plane, ≤ 4 mm contiguous slices from the diaphragm to the perineum. When CT is used, the recommended minimal requirement is a standard-dose contrast-enhanced CT in the portal-venous phase, scanned from the diaphragm to the perineum.

CONCLUSIONS: In this paper, the ESUR-SPIWG provides recommendations on the imaging modalities and minimal technical requirements for abdominopelvic imaging in the follow-up of adult patients treated for TGCT.

KEY POINTS: Question There are no recommendations on the preferred imaging modality or scan sequences required for abdominopelvic imaging in the follow-up after treatment for testicular cancers. Findings The European Society of Urogenital Radiology Scrotal and Penile Imaging Working Group (ESUR-SPIWG) provides recommendations for abdominopelvic imaging in follow-up after treatment for testicular cancers. Clinical relevance Recurrence of testicular germ-cell tumors mainly occurs in retroperitoneal lymph nodes. Both CT and MRI provide similar morphological assessments, but radiation exposure can be avoided by using MRI instead of CT.

PMID:39862250 | DOI:10.1007/s00330-025-11380-z

Eur Radiol. 2025 Jan 25. doi: 10.1007/s00330-025-11373-y. Online ahead of print.

ABSTRACT

OBJECTIVES: Forensic age estimation from orthopantomograms (OPGs) can be performed more quickly and accurately using convolutional neural networks (CNNs), making them an ideal extension to standard forensic age estimation methods. This study evaluates improvements in forensic age prediction for children, adolescents, and young adults by training a custom CNN from a previous study, using a larger, diverse dataset with a focus on dental growth features.

METHODS: 21,814 OPGs from 13,766 individuals aged 1 to under 25 years were utilized. The custom CNN underwent 1000 epochs of training and validation using 16,000 and 4000 OPGs, respectively. The best model was chosen by the least mean absolute error (MAE) and evaluated with an additional test dataset of 1814 independent OPGs. Furthermore, the CNN was applied to OPGs from 15 available forensic age estimations conducted by experts certified by the Study Group on Forensic Age Diagnostics (AGFAD), and the results were compared.

RESULTS: A MAE of 0.93 ± 0.81 years and a mean-signed error (MSE) of -0.06 ± 1.23 years were achieved in the test dataset. 63% of predictions were accurate within 1 year, and 95% within 2.5 years. Results of the CNN were comparable to those obtained by experts, effectively highlighting discrepancies in the reported ages of individuals.

CONCLUSION: Using a large and diverse dataset along with custom deep learning techniques, forensic age estimation can be significantly improved, often providing predictions accurate to within 1 year. This approach offers a reliable, robust, and objective complement to standard forensic age estimation methods.

KEY POINTS: Question The potential of custom convolutional neural networks for forensic age estimation, along with a large, diverse dataset, warrants further investigation, offering valuable support to experts. Findings For 1814 test-orthopantomograms, 63% of predictions were accurate within 1 year and 95% within 2.5 years, similar to expert estimates in 15 forensic cases. Clinical relevance Many individuals’ fates depend on accurate age estimation. Forensic age estimation can benefit from applying CNN-based methods to further enhance reliability and accuracy.

PMID:39862249 | DOI:10.1007/s00330-025-11373-y

Clin Trials. 2025 Jan 25:17407745241309318. doi: 10.1177/17407745241309318. Online ahead of print.

ABSTRACT

BACKGROUND/AIMS: Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research over the past decade and characterized key regulatory and trial design elements with a focus on the primary efficacy endpoint utilized as the basis of approval.

METHODS: Using the Food and Drug Administration’s Data Analysis Search Host database, we identified novel new drug applications and biologics license applications with orphan drug designation that were approved between 2013 and 2022 for non-oncologic indications. From Food and Drug Administration review documents and other external databases, we examined characteristics of pivotal trials for the included drugs, such as therapeutic area, trial design, and type of primary efficacy endpoints. Differences in trial design elements associated with primary efficacy endpoint type were assessed such as randomization and blinding. Then, we summarized the primary efficacy endpoint types utilized in pivotal trials by therapeutic area, approval pathway, and whether the disease etiology is well defined.

RESULTS: One hundred and seven drugs that met our inclusion criteria were approved between 2013 and 2022. Assessment of the 107 drug development programs identified 150 pivotal trials that were subsequently analyzed. The pivotal trials were mostly randomized (80%) and blinded (69.3%). Biomarkers (41.1%) and clinical outcomes (42.1%) were commonly utilized as primary efficacy endpoints. Analysis of the use of clinical trial design elements across trials that utilized biomarkers, clinical outcomes, or composite endpoints did not reveal statistically significant differences. The choice of primary efficacy endpoint varied by the drug’s therapeutic area, approval pathway, and whether the indicated disease etiology was well defined. For example, biomarkers were commonly selected as primary efficacy endpoints in hematology drug approvals (70.6%), whereas clinical outcomes were commonly selected in neurology drug approvals (69.6%). Further, if the disease etiology was well defined, biomarkers were more commonly used as primary efficacy endpoints in pivotal trials (44.7%) than if the disease etiology was not well defined (27.3%).

DISCUSSION: In the past 10 years, numerous novel drugs have been approved to treat non-oncologic rare diseases in various therapeutic areas. To demonstrate their efficacy for regulatory approval, biomarkers and clinical outcomes were commonly utilized as primary efficacy endpoints. Biomarkers were not only frequently used as surrogate efficacy endpoints in accelerated approvals, but also in traditionally approved rare disease drugs. The choice of primary efficacy endpoints varied by therapeutic area, approval pathway, and understanding of disease etiology.

PMID:39862118 | DOI:10.1177/17407745241309318

Health Informatics J. 2025 Jan-Mar;31(1):14604582251315594. doi: 10.1177/14604582251315594.

ABSTRACT

Purpose: In the context of Chinese clinical texts, this paper aims to propose a deep learning algorithm based on Bidirectional Encoder Representation from Transformers (BERT) to identify privacy information and to verify the feasibility of our method for privacy protection in the Chinese clinical context. Methods: We collected and double-annotated 33,017 discharge summaries from 151 medical institutions on a municipal regional health information platform, developed a BERT-based Bidirectional Long Short-Term Memory Model (BiLSTM) and Conditional Random Field (CRF) model, and tested the performance of privacy identification on the dataset. To explore the performance of different substructures of the neural network, we created five additional baseline models and evaluated the impact of different models on performance. Results: Based on the annotated data, the BERT model pre-trained with the medical corpus showed a significant performance improvement to the BiLSTM-CRF model with a micro-recall of 0.979 and an F1 value of 0.976, which indicates that the model has promising performance in identifying private information in Chinese clinical texts. Conclusions: The BERT-based BiLSTM-CRF model excels in identifying privacy information in Chinese clinical texts, and the application of this model is very effective in protecting patient privacy and facilitating data sharing.

PMID:39862116 | DOI:10.1177/14604582251315594

Clin Trials. 2025 Jan 25:17407745241309056. doi: 10.1177/17407745241309056. Online ahead of print.

ABSTRACT

INTRODUCTION: The sequential parallel comparison design has emerged as a valuable tool in clinical trials with high placebo response rates. To further enhance its efficiency and effectiveness, adaptive strategies, such as sample size adjustment and allocation ratio modification can be employed.

METHODS: We compared the performance of Jennison and Turnbull’s method and the Promising Zone approach for sample size adjustment in a two-phase sequential parallel comparison design study. We also evaluated the impact of allocation ratio adjustments using Neyman and Optimal allocation strategies. Various scenarios were simulated to assess the effects of different design parameters, including weight in the test statistic, initial randomization ratio, and interim analysis timing.

RESULTS: The Promising Zone approach demonstrated superior or comparable power to Jennison and Turnbull’s method at equivalent expected sample sizes while maintaining the intuitive property that more promising interim results lead to smaller required follow-up sample sizes. However, the Promising Zone approach may require a larger maximum possible sample size in some cases. The addition of allocation ratio adjustments offered minimal improvements overall, but showed potential benefits when the variance in the treatment group was larger than that in the placebo group. We also applied our findings to a real-world example from the AVP-923 trial in patients with Alzheimer’s disease-related agitation, demonstrating the practical implications of adaptive sequential parallel comparison designs in clinical research.

DISCUSSION: Adaptive strategies can significantly enhance the efficiency of sequential parallel comparison designs. The choice between sample size adjustment methods should consider trade-offs between power, expected sample size, and maximum adjusted sample size. Although allocation ratio adjustments showed limited overall impact, they may be beneficial in specific scenarios. Future research should explore the application of these adaptive strategies to binary and survival outcomes in sequential parallel comparison designs.

PMID:39862109 | DOI:10.1177/17407745241309056

Front Biosci (Landmark Ed). 2025 Jan 20;30(1):26299. doi: 10.31083/FBL26299.

ABSTRACT

BACKGROUND: In this study, we prepared a porous gradient scaffold with hydroxyapatite microtubules (HAMT) and chitosan (CHS) and investigated osteogenesis induced by these scaffolds.

METHODS: The arrangement of wax balls in the mold can control the size and distribution of the pores of the scaffold, and form an interconnected gradient pore structure. The scaffolds were systematically evaluated in vitro and in vivo for biocompatibility, biological activity, and regulatory mechanisms.

RESULTS: The porosity of the four scaffolds was more than 80%. The 50% and 70% HAMT-CHS scaffolds formed an excellent gradient pore structure, with interconnected pores. Furthermore, the 70% HAMT-CHS scaffold showed better anti-compressive deformation ability. In vitro experiments indicated that the scaffolds had good biocompatibility, promoted the expression of osteogenesis-related genes and proteins, and activated the oxidative phosphorylation pathway to promote bone regeneration. Eight weeks after implanting the HAMT-CHS scaffold in rat skull defects, new bone formation was observed in vivo by micro-computed tomographic (CT) staining. The obtained data were statistically analyzed, and the p-value < 0.05 was statistically significant.

CONCLUSION: HAMT-CHS scaffolds can accelerate osteogenesis in bone defects, potentially through the activation of the oxidative phosphorylation pathway. These results highlight the potential therapeutic application of HAMT-CHS scaffolds.

PMID:39862088 | DOI:10.31083/FBL26299

Int J Stroke. 2025 Jan 25:17474930241313301. doi: 10.1177/17474930241313301. Online ahead of print.

ABSTRACT

BACKGROUND: The usual antithrombotic treatment for symptomatic intracranial atherosclerotic stenosis (ICAS) consists of dual treatment with clopidogrel and aspirin for 90 days followed by aspirin alone but the risk of recurrent stroke remains high up to 12 months. The Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial was designed to determine whether other combinations of dual antithrombotic therapy are superior to clopidogrel and aspirin.

METHODS: CAPTIVA is an ongoing, prospective, double-blinded, three-arm clinical trial at over 100 sites in the United States and Canada that will randomize 1683 high-risk subjects with a symptomatic infarct attributed to 70-99% stenosis of a major intracranial artery to 12 months of treatment with (1) ticagrelor (180 mg loading dose, then 90 mg twice daily), (2) low-dose rivaroxaban (2.5 mg twice daily), or (3) clopidogrel (600 mg loading dose, then 75 mg daily). All subjects receive aspirin (81 mg daily), intensive risk factor management, and will undergo blinded CYP2C19 genotype analysis. The primary goal of the trial is to determine whether rivaroxaban or ticagrelor or both are superior to clopidogrel for lowering the primary endpoint (ischemic stroke, intracerebral hemorrhage (ICH), or vascular death) within 12 months. A prespecified interim safety analysis will be conducted when the first 450 randomized subjects have been followed for 12 months to evaluate the risk of major hemorrhage in the rivaroxaban and ticagrelor arms.

RESULTS: Enrollment began in August 2022 and, as of 26 June 2024, the 450th subject was randomized into the study.

CONCLUSION: CAPTIVA is evaluating two alternative dual antithrombotic therapies to clopidogrel and aspirin to maximize the chance of establishing more effective antithrombotic therapy for symptomatic ICAS, one of the most common and high-risk cerebrovascular diseases worldwide.

PMID:39862061 | DOI:10.1177/17474930241313301

Nurs Leadersh (Tor Ont). 2025 Jun;37(3):8-29. doi: 10.12927/cjnl.2025.27506.

ABSTRACT

INTRODUCTION: Black nurses are under-represented in the Canadian nursing workforce. A legacy of discrimination and systemic barriers reinforce the under-representation of Black nurses in the nursing workforce throughout the health system.

OBJECTIVE: The objective of this study was to identify and describe organizational initiatives for the recruitment, retention and advancement of Black nurses in the healthcare system.

METHODS: We conducted a rapid review of peer-reviewed and grey literature regarding the recruitment, retention and advancement initiatives for Black nurses, in North America and the UK.

RESULTS: Thirty-eight sources were included in this review. Majority of the included sources focused on leadership initiatives that described a multi-pronged approach for recruitment, retention or advancement. Examples of useful initiatives included mentorship, dedicated leadership and advancement programs, as well as supportive institutional policies. In addition, several Black nurse-led organizations/initiatives were identified.

CONCLUSION: These findings highlight the importance of multi-pronged approaches to enhance and support the Black nurse workforce. In addition, implementing and evaluating initiatives is critical to understanding how workforce representation and inclusion is strengthened.

PMID:39862050 | DOI:10.12927/cjnl.2025.27506