Inconclusive Results Research Articles

Lower risk of the deterioration of muscle mass and function in oral active vitamin D users among Incident peritoneal dialysis patients: a 12-month follow-up cohort study

Data in terms of how active vitamin D supplementation affects muscle mass and function in end-stage renal disease (ESRD) patients has led to inconclusive results. The main goal of this research was to examine the association of active vitamin D supplementation and risk of the deterioration of muscle mass and function among ESRD patients on peritoneal dialysis (PD). Eligible ESRD patients on PD were prospectively included, and followed up at 3-month intervals in the tertiary care center. Based on the medications during the 12-month follow-up period, the patients were divided into two groups (vitamin D users and non-users). The deterioration of muscle mass and function was identified utilizing the criteria set by the Asian Working Group on Sarcopenia in 2019 (AWGS 2019). Primary outcome was defined as the deterioration of muscle mass and function at the end of the 12-month follow-up. The absolute diffecence and 95% confidence interval (CI) of the incidence of deterioration between vitamin D users and non-users was estimated. The association of vitamin D supplementation with risk of the deterioration of muscle mass and function during the 12-month follow-up period, was examined by employing multivariate logistic regression models. A total of 229 incident PD patients (6 of whom were lost in follow-up) were included. During the entire study period, 54.7% (122/223) of the remaining patients were considered users of oral active vitamin D. The incidence of deterioration in muscle mass and function was 30.5% (68/223) throughout the entire follow-up. In this regard, the rate was 23.0% (28/122) that received oral active vitamin D, while it was 39.6% (40/101) in the group that did not receive it, with an absolute diffecence of -16.6% (95% CI − 4.5, − 28.7) and an estimated relative risk (RR) of 0.784 (95% CI 0.651–0.943). After adjustment for potential confounding factors in logistic regression model, vitamin D users group was still associated with decreased risk of the deterioration of muscle mass and function (OR 0.330, 95% CI 0.159–0.683, P = 0.003). In secondary analysis, the relationship between oral active vitamin D and the deterioration of muscle mass and function remained consistent (≤ 0.25 µg per day vs. non-users; OR 0.300, 95% CI 0.131–0.688, P = 0.004); however, no significant relationship was identified in patients receiving a mean daily dose of > 0.25 µg compared with non-users (OR 0.389, 95% CI 0.146–1.034, P = 0.058). These results indicate that active vitamin D supplementation was significantly associated with a decreased risk of the deterioration of muscle mass and function in incident PD patients with ESRD. However, the amount and type of vitamin D used and the duration of the intervention warrant further randomized controlled trials to confirm the possibility that such medication improves sarcopenia in ESRD patients.

Sample Size Calculation Based on Research Approaches in Animal Studies

Introduction: Sample sizes that are too small can produce inconclusive results, while sample sizes that are too large may raise ethical concerns and produce trivial outcomes. Ethical considerations of sample size calculation in animal studies are essential and researchers should consider the 3R approach. Therefore, accurately calculating the sample size is essential to ensure adequate statistical power and avoid wastage of resources. Methods: The paper presents several innovative approaches for conducting small-scale sampling in animal studies. It includes a comprehensive review of relevant literature, discussing various proposed methods for determining sample size in animal studies Results: In this study, various formulas are available for preparing sample size calculations that are relevant to the research design. These include t-tests (for one sample and two independent/paired samples), ANOVA, ANCOVA, simple/multiple linear regression, as well as proportion studies and studies utilizing correlation coefficients Conclusion: Our aims to equip researchers with formulas for reliable findings and adherence to ethical principles for sample size calculating in animal studies.

The association between changes in muscle mass and function and mortality in individuals receiving peritoneal dialysis.

Data in terms of how dynamic changes of muscle mass and function affect mortality in end-stage kidney disease (ESKD) patients undergoing dialysis have led to inconclusive results. The main goal of this research was to determine the association between dynamic deterioration of muscle mass and function and all-cause mortality in ESKD patient on continuous ambulatory peritoneal dialysis (CAPD). Eligible ESKD patients on CAPD were prospectively included, and followed up at 3-month intervals in the tertiary care center for 2 years. Dynamic deterioration of muscle mass and function during a 12-month follow-up period before patients enrolled was the exposure of interest. The deterioration of muscle mass and function was identified utilizing the criteria set by the Asian Working Group on Sarcopenia in 2019 (AWGS 2019). Primary outcome was defined as the all-cause mortality during the next 2-year follow-up period. Kaplan-Meier analysis with log-rank test was used to compare overall survival between groups. Association of dynamic deterioration of muscle mass and function with all-cause mortality was examined by employing Cox proportional hazards models. A sensitivity analysis was also conducted to examine whether the potential association was modified. A total of 217 eligible patients on CAPD were included. The prevalence of dynamic deterioration of muscle mass and function was 42.9% (93/217), of which that evolving to sarcopenia (nonsevere sarcopenia or severe sarcopenia) from nonsarcopenia was 24.9% (54/217) and that evolving to severe sarcopenia from nonsevere sarcopenia was 18.0% (39/217). A total of 35.0% (76/217) participants died during the 2-year follow-up period, of which the group with deterioration of muscle mass and function was 50.5% (47/93), and the group without deterioration was 23.4% (29/124), with an absolute difference of 27.1% (95%CI 14.5%-39.7%). Kaplan-Meier survival curve revealed that the participants with dynamic deterioration of muscle mass and function had a worse survival rate than those without deterioration (log-rank test, χ2 = 17.46, p < 0.001). After adjustment for potential confounding factors, the dynamic deterioration of muscle mass and function was still significantly associated with increased risk of all-cause mortality (hazard ratio [HR] = 2.40, 95%CI 1.44-4.00, p = 0.001). In sensitivity analysis, the relationship between dynamic deterioration of muscle mass and function (nonsarcopenia to sarcopenia vs without deterioration) and all-cause mortality was consistent (HR = 4.01, 95%CI 2.22-7.22, p < 0.001). Nevertheless, no significant relationship was found in participants who evolved to severe sarcopenia from nonsevere sarcopenia (HR = 1.41, 95%CI 0.72-2.74, p = 0.313). This research demonstrated a significant association between dynamic deterioration of muscle mass and function and higher risk of mortality in ESKD patients on CAPD, and we recommend individualized lifestyle intervention that may be implemented to intervene in the progression of their muscle mass and function across the health care spectrum.

Between gendered walls: Assessing the impact of single-sex and co-education on student achievement, self-confidence, and communication skills

In this study, we investigate the impact of educational environments characterized by single-sex and co-educational settings on students' academic performance, communication skills, and self-confidence. The analysis encompassed 677 research articles, comprising 798 effect sizes, and involving a cumulative sample size of 1,179,558 participants. The existing literature presents inconclusive results regarding the effects of co-education on students' overall educational well-being. This research contributes to this ongoing debate by examining the impact of educational settings, specifically co-educational and single-sex environments, on academic achievement, communication skills, and self-confidence. Our findings indicate that the type of educational setting, whether co-educational or single-sex, does not exert a statistically significant impact on academic achievement, except in countries with a low educational attainment index, where students in co-educational settings achieve higher. Additionally, students in co-educational settings demonstrate better communication skills and higher self-confidence than their counterparts in single-sex schools. These results challenge the prevailing notion that single-sex education enhances girls' achievement and self-confidence while providing a safer environment for self-expression. In contrast, our data suggest that gender-segregated schools may not be the most conducive environments for girls to thrive both socially and academically, potentially due to the promotion of passive femininity within such institutions.

The Value of Reducing Inconclusive and False-Positive Newborn Screening Results for Congenital Hypothyroidism, Congenital Adrenal Hyperplasia and Maple Syrup Urine Disease in The Netherlands.

Inconclusive and false-positive newborn screening (NBS) results can cause parental stress and increase healthcare expenditures. These results can be reduced by improving NBS algorithms. This was recently done for Congenital Hypothyroidism (CH), Congenital Adrenal Hyperplasia (CAH) and Maple Syrup Urine Disease (MSUD) in the Dutch NBS program. The current study estimates the financial consequences of these improved algorithms related to the reduction in inconclusive results and false-positives. For each improved algorithm, the care pathway of an inconclusive/false-positive result was analyzed. The costs associated with the improvements, based on the change in inconclusive results/false-positives, were assessed to estimate the cost reduction per year. The improvements resulted in a reduction of inconclusive results and/or false-positives, without increasing false-negatives. For CH, false positives decreased by 26 per year with a related cost reduction of EUR 31,156. For CAH, 95 second heel punctures and seven false-positives per year were avoided, leading to a related cost reduction of EUR 7340. For MSUD, five false-positives per year were avoided with a related cost reduction of EUR 11,336. The improved screening algorithms led to a cost reduction of EUR 49,832 annually. Together with the known negative psychosocial effects associated with an inconclusive or false-positive NBS result, these results highlight the importance of improving NBS algorithms.

Cutting the Gordian Knot: Rare Presentation of Nodular Fasciitis as Supraclavicular Swelling with Muscular Involvement in 68Ga-FAPI-PET/CT

Background: Nodular fasciitis is a benign, singularly occurring nodular fibroblastic/myofibroblastic neoplasia. Due to the rapid growth and cellular atypia, this rare differential diagnosis in the head and neck region can be mistaken for malignant sarcomas. Methods: We present a 40-year-old female patient with an unclear, rough, and poorly displaceable supraclavicular swelling on the right as part of a medical check-up. Sonographically, the lump was poorly circumscribed with little vascularization. A consecutive core needle biopsy of the lesion yielded inconclusive results showing spindle-shaped tumor cells. 68Ga-FAPI-PET/CT showed an intensive uptake of the right supraclavicular lesion in addition to postoperative changes in the right tonsil. Subsequent operative partial excision of the lesion confirmed the histopathological diagnosis of nodular fasciitis. Results: Nodular fasciitis is the most prevalent pseudosarcoma found in soft tissues. This case is the first description of 68Ga-FAPI-PET/CT in nodular fasciitis. Surgical removal is advised; nevertheless, the tumor frequently diminishes on its own, and recurrence is rare. Extensive surgical therapy is not necessary. Conlcusions: The recognition of nodular fasciitis and its benign characteristics is crucial to prevent diagnostic errors and the subsequent unnecessary operative treatment of the patient.

Impacts of double biopsy and double vitrification on the clinical outcomes following euploid blastocyst transfer: a systematic review and meta-analysis.

Compared to the 'single biopsy + single vitrification' approach, do 'double biopsy + double vitrification' or 'single biopsy + double vitrification' arrangements compromise subsequent clinical outcomes following euploidy blastocyst transfer? Both 'double biopsy + double vitrification' and 'single biopsy + double vitrification' led to reduced live birth/ongoing pregnancy rates and clinical pregnancy rates. It is not uncommon to receive inconclusive results following blastocyst biopsy and preimplantation genetic testing for aneuploidy (PGT-A). Often these blastocysts are warmed for re-test after a second biopsy, experiencing 'double biopsy + double vitrification'. Furthermore, to achieve better workflow, IVF laboratories may choose to routinely vitrify all blastocysts and schedule biopsy at a preferred timing, involving 'single biopsy + double vitrification'. However, in the current literature, there is a lack of systematic evaluation of both arrangements regarding their potential clinical risks in reference to the most common 'single biopsy + single vitrification' approach. A systematic review and meta-analysis were performed, with the protocol registered in PROSPERO (CRD42023469143). A search in PUBMED, EMBASE, and the Cochrane Library for relevant studies was carried out on 30 August 2023, using the keywords 'biopsy' and 'vitrification' and associated variations respectively. Only studies involving frozen transfers of PGT-A tested euploid blastocysts were included, with those involving PGT-M or PGT-SR excluded. Study groups included blastocysts having undergone 'double biopsy + double vitrification' or 'single biopsy + double vitrification', with a 'single biopsy + single vitrification' group used as control. The primary outcome was clinical pregnancy, while secondary outcomes included live birth/ongoing pregnancy, miscarriage, and post-warming survival rates. Random effects meta-analysis was performed with risk ratios (RR) and 95% CIs were used to present outcome comparisons. A total of 607 records were identified through the initial search and nine studies (six full articles and three abstracts) were eventually included. Compared to 'single biopsy + single vitrification', 'double biopsy + double vitrification' was associated with reduced clinical pregnancy rates (six studies, n = 18754; RR = 0.80, 95% CI = 0.71-0.89; I2 = 0%) and live birth/ongoing pregnancy rates (seven studies, n = 20964; RR = 0.72, 95% CI = 0.63-0.82; I2 = 0%). However, no significant changes were seen in miscarriage rates (seven studies, n = 22332; RR = 1.40, 95% CI = 0.92-2.11; I2 = 53%) and post-warming survival rates (three studies, n = 13562; RR = 1.00, 95% CI = 0.99-1.01; I2 = 0%) following 'double biopsy + double vitrification'. Furthermore, 'single biopsy + double vitrification' was also linked with decreased clinical pregnancy rates (six studies, n = 13284; RR = 0.84, 95% CI = 0.76-0.92; I2 = 39%) and live birth/ongoing pregnancy rates (seven studies, n = 16800; RR = 0.79, 95% CI = 0.69-0.91; I2 = 70%), and increased miscarriage rates (five studies, n = 15781; RR = 1.48, 95% CI = 1.31-1.67; I2 = 0%), but post-warming survival rates were not affected (three studies, n = 12452; RR = 0.99, 95% CI = 0.97-1.01; I2 = 71%) by 'single biopsy + double vitrification'. All studies included in this meta-analysis were retrospective with varying levels of heterogeneity for different outcomes. Not all studies had accounted for potential confounding factors. Only one study reported neonatal outcomes. Our data indicated adverse impacts of 'double biopsy + double vitrification' and 'single biopsy + double vitrification' on clinical outcomes following euploid blastocyst transfers. Patients should be carefully consulted about the risks when offered such approaches. The biopsy process should be carried out as carefully and competently as possible to minimize an inconclusive diagnosis. R.W. is supported by a National Health and Medical Research Council Emerging Leadership Investigator Grant (2009767). There is no other external funding to report. All authors report no conflict of interest. CRD42023469143.

8764 A Unique Case of Infertility in a Patient with NCCAH

Abstract Disclosure: M. Paravastu: None. R. Patel: None. Background: Non-Classic Congenital Adrenal Hyperplasia (NCCAH) in women often presents with hirsutism, acne, menstrual dysfunction, or infertility. Subfertility in patients with NCCAH can be attributed to menstrual disorders including oligomenorrhea or secondary amenorrhea. We report a unique case in which a patient with NCCAH with consistently normal menstrual cycles is experiencing infertility. Case Description: A 31 y/o female with no PMH was referred to our Endocrinology Clinic for evaluation of Infertility and elevated 17-Hydroxyprogesterone levels (17OHP). Patient has been having trouble conceiving for the past 2 years, no prior successful pregnancies. She started menstrual cycles at age 17, she reports having regular menstrual cycles. Prior to our evaluation, she was seen in Reproductive Endocrinology who completed hormonal and imaging evaluation. Elevated 17OHP: 286ng/dL. Rest of hormonal workup within normal range. Normal Pelvic Ultrasound. Hormonal workup was repeated in our clinic. 17OHP is elevated at 617.01ng/dL. Rest of lab work returned normal with DHEAS:218.9mcg/dL, TSH: 2.826mcUnits/mL, Free Testosterone: 5.4pg/mL, Prolactin:11.7ng/mL, Beta HCG: negative, LH: 13.5mUnits/mL, FSH: 5.3mUnits/mL, Estradiol 79pg/mL. Cosyntropin stimulation test was completed. Baseline AM 17OHP:469.78ng/dL, Baseline Cortisol: 17.9mcg/dL. 17OHP 30 minutes-post:1216.4ng/dL, Cortisol 30 minutes-post: 18.5mcg/dL. 17OHP 60 min-post: 1051ng/dL, Cortisol 60 minutes post:16.4 mcg/dL. Given Inconclusive Cosyntropin stimulation test results, Genetic Testing was recommended. Genetic testing returned positive for NCCAH, patient’s husband is not a carrier of this gene. She was started on Hydrocortisone therapy for treatment of infertility. Shortly after she started on hydrocortisone therapy, patient did successfully conceive, however the pregnancy later resulted in a miscarriage. Conclusion: Subfertility in patients in NCCAH is thought to be due to menstrual irregularities including oligomenorrhea or secondary amenorrhea. We report the first case of a woman with diagnosis of NCCAH who is experiencing infertility despite having normal menstrual cycles. Presentation: 6/1/2024

Blood flow modulation to improve motor and neurophysiological outcomes in individuals with stroke: a scoping review.

Ischemic Conditioning (IC) is a procedure involving brief periods of occlusion followed by reperfusion in stationary limbs. Blood Flow Restriction with Exercise (BFR-E) is a technique comprising blood flow restriction during aerobic or resistance exercise. Both IC and BFR-E are Blood Flow Modulation (BFM) strategies that have shown promise across various health domains and are clinically relevant for stroke rehabilitation. Despite their potential benefits, our knowledge on the application and efficacy of either intervention in stroke is limited. This scoping review aims to synthesize the existing literature on the impact of IC and BFR-E on motor and neurophysiological outcomes in individuals post-stroke. Evidence from five studies displayed enhancements in paretic leg strength, gait speed, and paretic leg fatiguability after IC. Additionally, BFR-E led to improvements in clinical performance, gait parameters, and serum lactate levels. While trends toward motor function improvement were observed post-intervention, statistically significant differences were limited. Neurophysiological changes showed inconclusive results. Our review suggests that IC and BFR-E are promising clinical approaches in stroke, however high-quality studies focusing on neurophysiological mechanisms are required to establish the efficacy and underlying mechanisms of both in stroke. Recommendations regarding future directions and clinical utility are provided.

A proposed methodology for measuring the effects of binaural beats in music on concentration, working memory, and calmness following the Garcia-Argibay Protocol

Binaural beats are perceived when two different frequencies are presented dichotically to a listener, causing the perception of a beating sound. They have been associated with beneficial effects on cognitive functions such as learning, concentration, and creativity. Studies however often yield incomparable or inconclusive results, due to inconsistent methodologies. Through a systematic examination, following the Garcia-Argibay Protocol, we aim to provide a more detailed understanding of the effects of binaural beats in music on cognitive functions. Specifically, we will compare auditory stimulation with music containing binaural beats of the alpha and gamma frequencies to a control condition presenting music without binaural beats. We will measure the differential effect of 12 Hz and 40 Hz binaural beats on working memory performance, operationalized through the N-back task, and investigate the impact of these frequencies on concentration levels measured via the global-local task. Lastly, heart rate will be used as a continuous measurement throughout the experiment in order to evaluate the effectiveness of the different frequencies in inducing calmness.

Context matters when evacuating large cities: Shifting the focus from individual characteristics to location and social vulnerability

Climate change is driving extreme weather, heat and flooding, which increasingly require evacuations. Recent studies have found inconclusive results on the determinants of evacuation-related decisions and have reported widely varying evacuation rates, especially in high-density areas. We use a large dataset of geotagged evacuation choices in Paris, France (n = 2976) during a flood, to show that while they are rarely addressed, location, social vulnerability, length of residence, and hazard exposure are critical predictors. They can be used to infer the impact of previous experience on evacuation intentions, which is usually difficult to collect at scales relevant to decision-making. We address multiple evacuation choices over time that have previously been overlooked, including gradually self-fueling spontaneous evacuations after observations of peers evacuating or flooding proximity and post-impact evacuation due to infrastructure disruption. Our findings reveal that many people wait until their home is flooded to evacuate. The gap between the initial share of people leaving immediately and the minority refusing to leave in any case even after their housing is flooded gradually fills when considering different evacuation behaviors over time. Such chronology might explain the wide range of evacuation rates reported in the literature. However, people in vulnerable situations and with increased hazard exposure are more likely to declare that they would disregard evacuation instructions. One key implication is that policies aimed at reducing social vulnerability might be more effective than communication campaigns to increase preparedness and support evacuation.

B-218 Inconclusive results in the Fetal Sex Determination from maternal plasma assay may indicate miscarriage

Abstract Background The purpose of this study was to evaluate the miscarriage rates from patients presenting inconclusive results in a cell-free DNA fetal sex determination test at Dasa, a Brazilian laboratory, between 2021 and 2023. Methods In validating the fetal sex determination test, a Ct value range was established to assign the presence of the Y chromosome on maternal plasma and a gray zone for determining an inconclusive result. In this case, our operational procedure is to repeat the analysis from the beginning, due to plasma volume limitation. When the result remains inconclusive upon repetition a new sample is requested.After the 2nd sample collection with inconclusive results, cases are forwarded to specialized medical contact, when patient is informed and potential explanations for the rare situation of a repeat-indeterminate sex determination result are discussed.At the end of 2022, the need to widen the sex-determining range and consequently the inconclusive zone was routinely perceived. The main reason for this change was to reduce unnecessary repetitions. Results The adjustments of range reduced unnecessary repetition, requests for new samples and medical contacts (Table). Between 2021 and 2023 the median gestational age at 1st collect of medical contact was 9 weeks, and in cases of miscarriages was 10 (2022) and 8 weeks (2023). Conclusions The widening of the Y chromosome Ct range proved to be efficient on a routine basis without changing the result error rates, which since 2021 have remained at 0.05%. In addition to providing more precision to the assay, the newly established gray zone increased the positive predictive value for miscarriage. Our results, show that what was thought to be a limitation of the technique in determining the fetal sex may in fact, in many cases, be associated to fetal loss

Re-analysis of Next-generation Sequencing Data in Patients with Hypertrophic Cardiomyopathy: Contribution of Spliceogenic MYBPC3 Variants in an Italian Cohort.

Hypertrophic cardiomyopathy (HCM) is a genetic cardiac muscle disease characterized by clinical and genetic heterogeneity. Genetic testing can reveal the presence of disease-causing variants in genes encoding sarcomere proteins. However, it yields inconclusive or negative results in 40-60% of HCM cases, owing to, among other causes, technical limitations such as the inability to detect pathogenic intronic variants. Therefore, we aimed to increase the diagnostic yield of molecular analysis for HCM by improving the in-silico detection of intronic variants in MYBPC3 that may escape detection by algorithms normally used with tagged diagnostic panels. We included 142 HCM probands with negative results in Illumina TruSight Cardio panel analysis, including exonic regions of 174 cardiomyopathy genes. Raw data were re-analyzed using existing bioinformatics tools. The spliceogenic variant c.1224-80G>A was detected in three patients (2.1%), leading us to reconsider their molecular diagnosis. These patients showed late onset and mild symptoms, although no peculiar phenotypic characteristics were shared. Collectively, rare spliceogenic MYBPC3 variants may play a role in causing HCM, and their systematic detection should be performed to provide more comprehensive solutions in genetic testing using multigenic panels.

Prehospital blood transfusion : Opportunities and challenges for the German emergency medical services

Exsanguination is the leading cause of preventable death in severe trauma. Immediate hemorrhage control and transfusion of blood products are critical to maintain oxygen delivery and address trauma-induced coagulopathy. While prehospital blood product transfusion (PHBT) is established in neighboring countries, the fragmented configuration of Germany's emergency medical service (EMS) infrastructure has delayed the adoption of widespread PHBT programmes. This review aims to provide an updated perspective on the evolution, international practices and research needs of PHBT within the German context. This narrative review is based on aPubMed search using the search terms "prehospital" and "blood*". From an initial 4738 articles, 333 were directly related to PHBT and were subjected to further detailed examination. The literature, including referenced studies, was categorized into areas such as history, rationale, international practices, and evidence, and analyzed for quality. The benefit of early blood transfusion in major trauma has been established since WW1, explaining the efforts to initiate this lifesaving intervention as early as possible in the care pathway, including the prehospital field. Recent randomized trials have faced design and recruitment challenges, reflecting the complexity of the research question. These trials have yielded inconclusive results regarding the survival benefits of PHBT in civilian settings. This scenario raises doubts about the capability of randomized trials to resolve questions concerning survival advantages. Despite these difficulties, there is adiscernible trend indicating potential improvements in patient outcomes. In Germany, the incidence of trauma-associated shock stands at 38per 100,000 individuals per year. It is estimated that between 300 and 1800 patients annually possibly benefit from PHBT. Prehospital Blood Transfusion appears to be promising but identifying patient groups most likely to benefit as well as the most suitable blood products remain unresolved issues. In Germany PHBT programs are not yet widely established. Paradoxically, this situation, paired with the extensive German Trauma Registry, provides aprime opportunity for comprehensive prospective cohort studies, addressing the balance between PHBT benefits, logistical feasibility, and implementation strategies. Such studies are essential for establishing guidelines and integrating PHBT efficiently into German trauma care protocols.

The utility of disc space and vertebral body specimens cell count differential for the diagnosis of native vertebral osteomyelitis: a prospective cohort study.

Diagnostic methods for native vertebral osteomyelitis (NVO) often yield inconclusive results. Image-guided spine biopsies for culture are specific but diagnose NVO in only 50% of cases. Pre-exposure to antimicrobials further reduces diagnostic yield. Our study assesses the value of neutrophil percentage in disc space fluid and vertebral body (DS/VB) samples for diagnosing NVO. Adults referred for spine biopsy at Mayo Clinic from August 2022 to September 2023 were consented and enrolled at the time of biopsy. Following routine specimen collection, the biopsy needle was rinsed in saline into an EDTA tube for cell analysis. NVO diagnosis required organism identification in spine tissue or blood and/or positive histopathology, and consistent symptoms and imaging. Sixty-eight patients were prospectively enrolled, comprising 14 with NVO and 54 with alternative diagnoses. The median biopsy sample polymorphonuclear (PMN) percentage for NVO patients was 80.5% (IQR 72.5-85.2), compared to 64.5% (IQR 54.0-69.0) for those without NVO (p < 0.001). Nine (64.3%) NVO patients received antibiotics within 10 days prior to spine biopsy. As a continuous measure, PMN differential showed a moderately strong ability in classifying NVO status with an area under ROC curve of 0.795; an optimal point on the curve of 71.5% corresponded to a sensitivity of 78.6%, specificity of 79.6%, negative predictive value of 93.5% and positive predictive value of 50.0%. PMN differential in DS/VB biopsies may serve as an effective diagnostic tool in the evaluation of patients with NVO particularly in ambiguous cases with an initially negative spine biopsy. Future efforts will aim to implement these findings within routine clinical practice.

WITHDRAWN: Cervical pessary versus vaginal progesterone in individuals with a singleton pregnancy and a short cervix: a randomized controlled trial

For asymptomatic individuals with a singleton pregnancy and a short cervix, vaginal progesterone significantly decreases the risk of PTB and improves perinatal outcomes. Cervical pessary is another option that has been evaluated with inconclusive results. There is; however, a lack of head-to-head comparisons between pessary and vaginal progesterone in this high risk population. This randomized controlled trial (RCT) aims to compare the effectiveness of pessary and vaginal progesterone for the prevention of PTB in individuals with a singleton pregnancy and a CL ≤25 mm. We conducted an open-label, multi-center, RCT (NCT04300322) at three hospitals in Vietnam. Asymptomatic individuals with a singleton pregnancy and a CL ≤25mm (at 16 to 22 weeks) were randomized (1:1 ratio) to receive either an Arabin® cervical pessary or 200-mg vaginal progesterone daily. Primary outcome was PTB <37 weeks of any cause. Secondary outcomes were maternal and neonatal complications. We planned to recruit 804 women to assess a 10% absolute risk reduction in PTB <37 weeks (alpha-error 0.05, power 80%, 5% lost to follow-up). In view of the potential harm of pessary on perinatal mortality and PTB <28 weeks reported recently in two recent trials, our study was halted on June 2023. Analysis was by intention-to-treat. Between May 2020 and May 2023, we randomized 301 participants to pessary (N=150) or vaginal progesterone (N=151). Seven participants withdrew consent and 13 were lost to follow-up, resulting in 281 participants available for analysis (pessary group N=139; vaginal progesterone group N=142). The primary outcome, any PTB <37 weeks rate, occurred in 15.1% in the pessary group versus 14.1% in the vaginal progesterone group (RR 1.07; 95% CI, 0.61 to 1.9). PTB <28 weeks and perinatal death rates were higher in the pessary group, although these differences did not reach statistical significance (7.9% versus 4.2%, RR 1.87; 95% CI, 0.71 to 4.9 and 4.3% versus 2.8%, RR 1.5; 95% CI, 0.34 to 9.2; respectively). Vaginal discharge was significantly more frequent in the pessary group. In this prematurely halted RCT involving individuals with a singleton pregnancy and a CL ≤25 mm, neither cervical pessary nor vaginal progesterone was found to be superior in the prevention of PTB <37 weeks. However, vaginal progesterone was associated with non-significantly lower rates of PTB <34, <28 weeks and perinatal death.

Effectiveness and clinical relevance of kinesio taping in musculoskeletal disorders: a protocol for an overview of systematic reviews and evidence mapping.

Kinesio taping (KT) has been extensively applied in the management of musculoskeletal disorders (MSDs). Although plentiful systematic reviews (SRs) have evaluated its efficacy, there are no convincing conclusions due to dispersed and inconclusive results, and its clinical relevance remains unclear. Hence, there is a need to summarise all the SRs for comprehensive and consistent evidence. This overview aims to appraise the overall effectiveness of KT in MSDs and provide evidence maps to visualise the findings. Electronic databases (Cochrane Database of Systematic Reviews, MEDLINE, Embase, Epistemonikos, PEDro, Scopus and ISI Web of Science) and reference lists will be searched from inception to September 2024 for the SRs of randomised controlled trials (RCTs). The SRs involving comparisons of the effectiveness between single or adjunctive KT and other interventions for patients with MSDs will be included. The primary and additional outcomes to be considered will be the core outcome set, and the patient-reported outcome measure and patient-important outcome, respectively. Two reviewers will independently screen and select studies, extract the data and evaluate the reporting and methodological quality of eligible SRs as well as the risk of bias of included RCTs. For the SRs without meta-analysis, we will collate the number of RCTs that showed any differences in outcomes. For the SRs with meta-analysis, we will provide the original summary of evidence (eg, pooled effects and heterogeneity) for outcomes with an evaluation of missing results and clinical relevance. The certainty of each outcome will be measured, and user-friendly maps of findings will be presented graphically. Formal ethical approval for this study is not required since the data will be only collected from published literature in public databases. The results will be disseminated in the peer-reviewed academic journal, and relevant datasets will be preserved in the online repository. CRD42024517528.

Robot-assisted T-plasty for recalcitrant bladder neck stenosis: description of technique and initial results.

The aim of this study was to describe the technique and initial outcomes of robot-assisted T-plasty for recalcitrant bladder neck stenosis. Patients who underwent robot-assisted T-plasty for recalcitrant bladder neck stenosis in a single center were included. Presence of bladder neck stenosis was preoperatively confirmed by the combination of retrograde urethrography with voiding cysto-urethrography and flexible urethroscopy. Follow-up visits were performed with history taking, uroflowmetry and echographic residual urine measurement. Complications were graded according to the Clavien-Dindo classification. Patients without urinary symptoms and with a maximum uroflow of no less than 15mL/s were considered as successfully treated. Otherwise, cystoscopy would be performed, and recurrence was defined as the inability to pass a 14 French cystoscope through the bladder neck. Since 2018, seven patients were treated. The etiologies were transurethral resection of the prostate and simple prostatectomy in respectively 6 patients and 1 patient. Cystoscopy was able to diagnose bladder neck stenosis in all cases whereas urethrography was equivocal in 3 out of 7 cases. Median (range) age at surgery was 60 (54-75) years, and median number of prior endoscopic treatment for bladder neck stenosis was 3 (1-16). The median operative time was 123 (110-159) minutes. No intraoperative complications were reported. Three patients suffered a grade 2 complication. After a median follow-up of 27 (4-74) months, the recurrence-free rate was 100% with no evidence of de-novo incontinence or erectile dysfunction. In our series, robot-assisted T-plasty suggests positive and safe outcomes in treating recalcitrant bladder neck stenosis with a good patency rate and low incontinence rate. Additionally, cystoscopy is reliable in the diagnosis of patients with inconclusive urethrography results.

Prediction of feeding difficulties in neonates with hypoxic-ischemic encephalopathy using magnetic resonance imaging-derived radiomics features.

The mechanisms behind brain and spinal cord injuries in hypoxic-ischemic encephalopathy (HIE) and associated feeding difficulties are unclear, with previous magnetic resonance imaging (MRI) attempts yielding inconclusive results. We aim to evaluate an MRI radiomics model for predicting feeding difficulties in HIE infants. Additionally, we investigate changes in predictive capability after incorporating the duration of mechanical ventilation and the timing of MRI examination. Retrospective study with 151 HIE infants (January 2013 to December 2021), randomly divided into training and validation sets. Radiomics features extracted from basal ganglia-thalamus and brainstem in T1-weighted and T2-weighted MRI. Established single-modality, single-site, and multimodality/multisite models. Receiver operating characteristic analysis and area under the curve evaluated models. Decision curve analysis assessed changes in predictive capability. The combined radiomics model of the basal ganglia-thalamus and brainstem regions on the T2-weighted imaging demonstrated superior performance (area under the curve: 0.958 and 0.875 for training and validation, respectively). Combining scores with duration of mechanical ventilation and MRI examination time in a calibration plot model improved and stabilized performance, showing high fitting and clinical utility. Decision curve analysis favored the combined calibration plot model. The MRI-based radiomics model predicts feeding difficulties in HIE infants, with basal ganglia-thalamus and brainstem as relevant factors. The combined calibration plot model exhibits the highest clinical predictive efficacy.

On the Frontlines of Pre-Hospital Care: The Efficacy of Freeze-Dried Plasma

Despite continued developments made in the field of trauma care, hemorrhagic shock resulting from trauma remains the leading cause of preventable death on the battlefield. The current methods being used for the treatment of patients with acute hemorrhage include dressing the wound in an attempt to stop the bleeding, along with intravenous administration of fluids intended to replace the blood loss and treat the accompanying shock. The question of what kind of fluid to use is one that fascinated many throughout history, consequentially leading to the development of physiological crystalloid based solutions on one hand and isolated blood products on the other. With its introduction, plasma was found to have significant clinical benefits, conceivably because plasma replenishes various coagulation proteins that are consumed during the coagulopathy that often accompanies traumatic injuries. In military and remote settings, the logistical limitations of plasma, namely the need to maintain a comprehensive cold-chain infrastructure and the complicated process of thawing the plasma, restricted the use of plasma in these settings. In World War II, these barriers were lifted as Freeze-Dried Plasma (FDP) was invented, not requiring any freezers and soon available. This product was vastly used during the war with hundreds of thousands treated, but then disremembered because of disease transmission issues such as hepatitis found among recipients in the 1960’s. Modern-day advanced techniques have improved the safety and made it possible to produce safe and effective dried plasma solving the previous problems, but still, FDP is currently used by only a few countries worldwide. In line with its unpopularity, little has been published regarding the clinical effects of this product. Purpose of this Study: To shed light on the clinical effectiveness of using freeze-dried plasma as a pre-hospital resuscitation fluid during the treatment of hemorrhagic shock in the pre-hospital setting. Methods: A retrospective analysis of data collected on trauma patients injured in the Syrian civil war and treated by the IDF from 2014 until 2016. Casualties who required long evacuation time (i.e., over 45 minutes) were chosen. Two groups of casualties were allocated according to weather FDP was used (N=29), or standard-care fluids were given (N=83). Results: Using FDP as part of the pre-hospital resuscitation was shown to be associated with an improvement in both vital signs and shock index score. Moreover, among these patients, a lower transfusion volume was needed throughout their hospitalization. However, an increased risk for mortality, increased risk of in-hospital blood transfusion, and increased risk of pre-hospital intubation were observed in the FDP treated group. Conclusions: The effectiveness of FDP presented inconclusive but promising results in lowering the severity of shock and reducing iatrogenic coagulopathy in trauma patients. Further research is needed to disprove the adverse outcomes of this study.