Primary Outcome Measure Research Articles

Prevalence and prognostic value of different iron deficiency definitions in light chain cardiac amyloidosis patients.

Research on iron deficiency (ID) in patients with light chain cardiac amyloidosis (AL-CM) has been limited in previous studies. The purpose of this study was to investigate the prevalence and its association with prognosis of ID based on different definitions in patients with AL-CM. Three different ID definitions were applied: (1) serum ferritin concentration of <100ng/mL, or 100-299ng/mL with transferrin saturation (TSAT)<20% (according to guidelines on heart failure), (2) TSAT<20% and (3) serum iron <13μmol/L. The primary outcome measure was all-cause mortality. Prevalence and outcomes of various ID definitions were evaluated among patients diagnosed with AL-CM at Heart Failure Center, Fuwai Hospital between September 2017 and October 2023. Overall, 149 patients were included with a mean age of 60.71±10.11years, of whom 60 (40.3%) patients were female, 127 (85.2%) patients were in New York Heart Association (NYHA) class III-IV and 136 (91.3%) patients were in the revised Mayo 2012 stage III-IV. Assessments of iron biomarkers revealed the following results: median ferritin levels were 183.68ng/mL (interquartile range [IQR] 95.48, 339.01), median TSAT was 21.80% (IQR 16.34, 29.48), and median serum iron was 10.87μmol/L (IQR 7.38, 13.71). Serum iron were highly correlated with TSAT (r=0.85, P<0.0001). Depending on the definition used, 63 (42.3%) patients, 61 (40.9%) patients and 105 (70.5%) patients were defined as ID, respectively (P<0.0001). ID defined by TSAT and serum iron was associated with the primary outcome [hazard ratio (HR) 2.14, 95% confidence interval (CI) 1.36-3.37, P<0.001, and HR 2.16, 95% CI (1.23-3.80), P<0.01], but the same association was not seen with the guideline definition of ID [HR 1.39, 95% CI (0.88-2.18), P=0.158]. In the multivariable model adjusting for age, gender, haemoglobin, and revised 2012 Mayo staging, the predictive value of TSAT<20% [adjusted HR 2.49, 95% CI (1.54-4.05), P<0.001] and serum iron<13μmol/L [adjusted HR 2.24, 95% CI (1.23-4.09), P<0.01] remained. Different definitions of ID yield inconsistent results in terms of prevalence and prognosis. ID, as defined by TSAT<20% or serum iron<13μmol/L, rather than the guideline definition, emerged as an independent predictor of all-cause mortality in patients with AL-CM.

Palmitoylethanolamide (Levagen+) for acute menstrual pain: a randomized, crossover, double-blind, placebo-controlled trial

ABSTRACT Palmitoylethanolamide (PEA) is a well-tolerated compound effective in reducing pain. This randomized, double-blind, placebo-controlled crossover study investigated PEA for menstrual pain relief. Conducted in Australia from May to December 2023, the study included adults over 18. Participants consumed 300 mg of PEA or a placebo at menstrual pain onset. Pain scores were recorded on the numerical pain rating scale (NRS) every 30 minutes for up to 4 hours. If pain persisted, a second dose was permitted after 2-hours. The primary outcome measure was the reduction in acute menstrual pain scores from the NRS. Secondary outcome measures included the Treatment Satisfaction Questionnaire for Medication, rescue medication use and adverse events. Pain scores were analyzed using repeated measures analysis of variance. PEA resulted in a significant reduction in pain scores at 1 (p = .045), 1.5 (p = .009), 2 (p = .015) and 2.5 (p = .039) hours post dosage compared to placebo. No difference was seen for the Treatment Satisfaction Questionnaire for Medication, rescue medication used, or adverse events. This study demonstrates PEA supplementation is a safe and effective option for reducing menstrual pain compared to a placebo, with significant pain reduction observed at multiple time points post-dosage.

The bergen 4-day treatment for panic disorder: a longer-term follow-up

IntroductionBergen 4-Day treatment (B4DT) is a form of concentrated exposure-based cognitive behavioral therapy (CBT) in which patients receive treatment over four consecutive days. Previous studies have shown B4DT to be a promising treatment format for panic disorder (PD), although the long-term stability of treatment gains requires additional study.AimThe aim of the current study was to evaluate the longer-term effectiveness of B4DT for patients with panic disorder with or without agoraphobia. This study extends a previously published study by providing a long-term follow-up of the same cohort (n = 30), initially assessed at three months post-treatment.MethodThirty patients with panic disorder were consecutively included in a retrospect open trial. The primary outcome measure was the Panic Disorder Severity Scale. The secondary outcome measures were the Generalized Anxiety Disorder-7 and the Patient Health Questionnaire-9. Outcomes were assessed at pretreatment, posttreatment, 3-month follow-up, and longer-term follow-up (with a mean time of 18 months).ResultsThere was a significant reduction in panic disorder symptoms from pretreatment to longer-term follow-up (d = 5.03, 95% CI [18.55, 21.12] to [1.33, 3.87]). The Panic Disorder Severity Scale (PDSS) mean decreased from 19.83 (SD = 0.64, 95% CI [18.55, 21.12]) before treatment, to 4.37 (SD = 0.64, 95% CI [2.98, 5.76]) post-treatment, followed by further decreases at the 3-month follow-up to a mean of 2.84 (SD = 0.64, 95% CI [1.45, 4.22]), and at the longer-term follow-up to 2.60 (SD = 0.64, 95% CI [1.33, 3.87]). There was no significant difference in symptom severity between the 3-month and 18-month assessments, indicating a sustained improvement (p <.001). At the 18-month follow-up, 90% of the patients were classified as being in remission. There were also significant reductions in symptoms of depression (d = 1.44) and generalized anxiety (d = 1.62) that were maintained at the longer-term follow-up assessment.ConclusionThe results from the current study indicated that the treatment effects of B4DT are stable over time and that the treatment format appears to be promising for PD. Confirming these preliminary results in rigorous study designs is needed.Trial registrationThe study was approved by the Regional Committee for Medical and Health Research Ethics of Northern Norway (REK Nord-2021/209619).

A Multi-institutional Study From the United States Resident Operative Experience Consortium Examining Factors Associated With Exposure and Pursuit of Colorectal Fellowship Following General Surgery Residency.

Colon and rectal surgery is a popular fellowship following general surgery residency. The impact of a resident's colon and rectal surgery experience during residency may impact their career trajectory and pursuit of colon and rectal surgery. This study aims to identify individual and program factors associated with matriculation into colon and rectal surgery fellowship compared to other career trajectories. An analysis of case logs and demographic data from graduates of 19 accredited general surgery residency programs from the Accreditation Council for Graduate Medical Education between 2010-2020 was completed utilizing the United States Resident Operative Experience Consortium. The demographics and operative experience of residents who pursued colon and rectal surgery fellowship were compared to those who did not. This study is a retrospective review of resident specialty selection, demographic information, and operative case logs. Graduates of 19 accredited general surgery residency programs from the Accreditation Council for Graduate Medical Education between 2010-2020 participated in the study. Resident demographics, general and colon and rectal surgery-related program-specific characteristics, and resident operative case logs associated with entrance into colon and rectal surgery fellowship served as the primary outcome measures. Those in the colon and rectal surgery cohort were more likely to be female sex and have completed a dedicated research experience. No association was noted with co-location of a colon and rectal surgery fellowship and general surgery residency. Multivariable analysis demonstrated a higher likelihood of colon and rectal surgery fellowship matriculation for female sex residents and residents who completed a clinical fourth-year colon and rectal surgery rotation. Higher logged colon and rectal surgery-specific case volume was associated with those matriculating into colon and rectal surgery. Self-reported case log data, differences in residency structures in offering colon and rectal surgery rotations to clinical fourth-year residents, academic bias of participating residency programs. This study identified individual and program-specific factors associated with matriculating into colon and rectal surgery fellowship, such factors include female sex, colon and rectal surgery-specific rotation in the fourth clinical year, and higher volume of colon and rectal surgery-specific cases. These data may optimize resident colon and rectal surgery experience and strengthen the colon and rectal surgery fellowship pipeline. See Video Abstract.

Prospective study of the duo-hybrid venous stent for treatment of iliac vein obstruction.

Background: This prospective, single center, exploratory study assessed primary patency, clinical performance, and adverse events associated with the DUO-HYBRID Venous Stent used to treat iliac vein obstruction. Materials and methods: Twenty-one patients with symptomatic obstructions were treated with the self-expanding stent designed with varying zones of fatigue and crush resistance to adapt to the challenging iliac vein anatomy. The primary outcome measure was 12-month primary patency, defined as ≤50% residual stenosis, the absence of re-thrombosis or reintervention, and the absence of major adverse events from treatment to discharge. Secondary clinical measures included the Villalta score to assess the symptoms of post-thrombotic syndrome (PTS), and the revised Venous Clinical Severity Score (rVCSS) and Clinical, Etiological, Anatomical, and Pathophysiological (CEAP) score, both used to measure the severity of venous disease. Finally, the number of device- or procedure-related adverse events were recorded. Results: Primary patency was 92.9% at 12 months: one patient exhibited restenosis greater than 50% at 12 months. CEAP scores at baseline were predominantly C3 - C5 (78.9%) while at 12 months, 78.6% of scores were C1 - C2 and 14.3% were C0. The mean rVCSS score was 5.5 ± 2.7 at baseline and 1.1 ± 1.0 at 12 months, an 80% reduction in the mean score from baseline. Pre-procedure, 14.3% of patients had a Villalta score of 0-4 while at 12 months, 100% had scores of 0-4 (i.e., no clinically meaningful signs of post-thrombotic syndrome). Two adverse events were reported as possibly related to the device but neither case required revascularization. Conclusions: Observations from this exploratory study demonstrated a primary patency rate of 92.9%, improvements in rVCSS, CEAP, and Villalta scores from baseline, and no cases of target lesion or vessel revascularization at 12 months. The DUO-HYBRID Venous Stent performed appropriately when used for its intended indication.

Combination of mentor-based and resident-based learning may benefit to improving the ability of clinical practice in resident training

BackgroundMentor-based learning (MBL) is common teaching method in medical resident training and presents many shortcomings such as few practice opportunities and lack of efficiency. This study proposed the combination of mentor-based and resident-based learning (CMRL) and explored the role of CMRL in improving the effect of medical resident training.MethodsSeventy-two residents who participated in standardized resident training (SRT) were recruited and randomly divided into the CMRL and MBL groups. The CMRL group adopted CMRL and MBL group adopted MBL for daily medical teaching for four weeks. The primary outcome measure was the difference in trainee's scores of comprehensive analysis ability between CMRL group and MBL group after teaching. The secondary outcome measures were the differences in trainee's scores of diagnosis ability, prescribing medical orders ability, and incorrect operations, as well as the differences in questionnaire scores of the trainee's communication skills and patient care between CMRL group and MBL group after teaching.ResultsThe ability scores of CMRL group after teaching were higher than those before teaching (ability of diagnosis, 78.75 ± 17.83% vs. 67.08 ± 24.10%, p < 0.05; ability of comprehensive analysis 88.27 ± 10.95% vs. 69.56 ± 13.11%, p < 0.05; ability of prescribing medical orders, 90.03 ± 9.63% vs. 78.31 ± 10.28%, p < 0.05; respectively). In addition, scores of CMRL group in patient's evaluation on trainees after teaching were higher than that before teaching (communication skills 7.78 ± 1.02 scores vs. 6.22 ± 1.62 scores, p < 0.05; patient care 8.69 ± 0.92 scores vs. 6.92 ± 1.65 scores, p < 0.05; respectively). Meanwhile, the scores of CMRL group in ability of comprehensive analysis or prescribing medical orders after teaching were higher than those of MBL group. Moreover, scores of the trainee's communication skills and patient care in CMRL group were higher than those in MBL group after teaching.ConclusionCMRL is beneficial to improving residents' ability of comprehensive analysis and prescribing medical orders as well as residents' ability of communication skills and patient care in SRT. CMRL may be beneficial to improving the ability of clinical practice.

Real-time ultrasound-guided neuraxial puncture in elderly patients: a randomized controlled trial comparing paramedian transverse and parasagittal approaches.

Historically, spinal anesthesia has been performed using anatomical landmarks. This study aimed to compare the efficacy and procedural outcomes of real-time ultrasound-guided parasagittal oblique (RTU-PO) and real-time ultrasound-guided paramedian transverse (RTU-PT) approaches in elderly patients undergoing elective surgery under spinal anesthesia. Seventy-seven elderly patients scheduled for elective surgery under spinal anesthesia were enrolled in this study. Patients were randomized to receive spinal anesthesia using either RTU-PO (38 patients) or RTU-PT (39 patients) technique. The primary measure outcome was the rate of successful dural puncture at the first attempt in both groups. The secondary outcomes included the overall success rate of spinal anesthesia, time to identify the posterior complex on ultrasound, time to perform spinal anesthesia, total procedural time, number of needle redirections and passes, number of separate skin punctures, patients' satisfaction, and incidences of complications in both groups. Baseline demographic and anatomical characteristics were not different between the two groups. The incidence of successful spinal anesthesia at first attempt was 60.5% with RTU-PO and 56.4% with RTU-PT (P=0.71). All other secondary outcomes were comparable between the two groups except for the time to identify posterior complex that was higher in the RTU-PT versus the RTU-PO group (36±18 vs. 20±11 seconds; P=0.0001). In elderly patients undergoing elective surgeries under spinal anesthesia, the RTU-PO and the RTU-PT techniques are comparable in almost all aspects.

A prospective randomised controlled trial investigating the impact of a musculoskeletal injury prevention warm-up program for youth badminton: A preliminary study

ABSTRACT There are warm-up programs designed to reduce injuries for various sports; however, no study has been conducted on the development of a protocol for preventing injuries in badminton. The purpose of this study was to investigate the effectiveness of a prevention warm-up program (PreventiBad) in reducing injury rates among youth badminton players. A cluster randomised controlled trial was conducted, involving 273 youth badminton players (13.81 ± 2.76 years). The intervention group incorporated the program as part of their warm-up during training sessions, while the control group adhered to their usual warm-up. The participants were monitored over an 8 weeks period, with primary outcome measures including the incidence of overall injuries, typology and severity. The rate of adherence to the intervention program was assessed as a secondary outcome. A total of 14 injuries were reported among 147 players in the control group in 3440.50 h of exposure (4.07 injuries/1000 h), and a total of 6 injuries were reported across 126 players within the intervention group in 4865.00 exposure hours (1.23 injuries/1000 h). The Injury Risk Ratio was 0.30 (95%CI 0.12 to 0.75). Results indicated that the use of PreventiBad in the intervention group led to a 70% reduction compared to the control group.

Comparative study of low-power versus high-power holmium laser enucleation of the prostate for large volume benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH) is a prevalent condition among the elderly male population, characterised by prostate enlargement and bothersome urinary symptoms. Holmium Laser Enucleation of the Prostate (HoLEP) is a minimally invasive surgical option that is preferred for larger prostates due to its precision and minimal complications. Although high-power HoLEP is an efficacious procedure, recent studies indicate that low-power settings may offer comparable benefits with diminished postoperative discomfort. This study compares the efficacy of low-power (LP) and high-power (HP) HoLEP in a prospective, multicentre, randomised controlled trial involving 102 men with prostates larger than 80ml. The participants were randomly assigned to either the LP or HP groups and were followed for a period of six months following the operation. The primary outcome measure was the international prostate symptom score (IPSS), with secondary outcomes including perioperative and postoperative parameters and Qmax, PVR, and Clavien-Dindo classification of complications at one, three, and six months post-surgery. Both LP and HP HoLEP resulted in significant improvements in IPSS, Qmax, and PVR compared to the baseline (p < 0.05). The LP group demonstrated a longer laser application time (p < 0.001) and required a greater volume of irrigation fluid (p < 0.001), yet exhibited a reduction in total energy usage (p = 0.01). Additionally, they reported significantly diminished postoperative pain at 24 and 48h (p < 0.05). No significant differences were observed between the groups with regard to the incidence of complications, the duration of catheterisation, or the length of hospital stay. The results demonstrate that LP-HoLEP is as efficacious as HP-HoLEP in improving urinary symptoms, with the additional benefit of reduced postoperative discomfort. These findings support the use of LP-HoLEP as a viable option for the treatment of large prostates, although further research is required to confirm long-term outcomes.

Association between the triglyceride–glucose index and the risk of acute kidney injury in critically ill patients with acute pancreatitis: a retrospective study

BackgroundThe triglyceride–glucose (TyG) index is increasingly recognized for its ability to predict cardiovascular and metabolic risks. This study investigated the correlation between the TyG index and the risk of acute kidney injury(AKI) in critical ill patients with acute pancreatitis(AP).MethodsThe Medical Information Mart for Intensive Care IV database was retrospectively searched to identify AP patients hospitalized in the intensive care unit. The primary outcome measure was the incidence of AKI. The secondary endpoint was in-hospital mortality and the rate of renal replacement therapy(RRT) use. Cox regression analysis and restricted cubic spline were used to analyze TyG index association with AKI risk. Kaplan–Meier survival analysis was performed to assess the incidence of endpoints in the different groups.ResultsA total of 848 patients were enrolled. The incidence of AKI was 61.56%.The in-hospital mortality was 11.69%. Kaplan–Meier analysis showed that the TyG index ≥ 8.78 group has a high incidence of AKI and high risk of requiring RRT (P < 0.001). Multivariable Cox regression analysis showed whether TyG index was a continuous variable (HR, 1.65 [95% CI 1.10–2.48], P = 0.015) or a categorical variable (HR, 1.72 [95% CI 1.09–2.79], P = 0.028), and the TyG index was independently associated with the risk of AKI in AP patients. The restricted cubic splines model illustrated the linear relationship between higher TyG index and increased risk of AKI in this specific patient population.ConclusionsHigh TyG index is an independent risk factor for AKI in critical ill patients with AP. Assessing the TyG index may be beneficial for early stratification and interventions to improve prognosis.

Applying the Kessler Foundation modified Story Memory Technique (KF-mSMT ®) to Improve New Learning in Aging Populations

Introduction: The current study examines the efficacy of the 10-session Kessler Foundation modified Story Memory Technique (KF-mSMT®) to improve new learning in older adults. Methods. This double-blind, placebo-controlled randomized clinical trial included twenty-eight individuals over age 65 randomized to the treatment group (n=17) or placebo control group (n=13). Participants completed a baseline neuropsychological assessment, including questionnaires assessing everyday memory, and a repeat assessment immediately post-treatment. The primary outcome measure was the total learning score from the California Verbal Learning Test II (CVLT II) and the secondary outcome measure was total score from the Memory Functioning Questionnaire. Results: A significant effect of the KF-mSMT® was noted on the CVLT-II total learning score in the treatment group, demonstrating a large effect size. Post-hoc analysis examining benefit from the KF-mSMT in the healthy aging group as compared with the MCI group showed a trend toward significance (p=.069), with a large effect size. With benefit defined as a 10% or greater improvement on the CVLT total learning, 65% of patients in the treatment group showed improvement from baseline to immediate follow-up, compared with 31% of the control group (p=.06). Significant treatment effects were also noted on a self-report measure of memory in daily life, the Memory Functioning Questionnaire. Post-treatment changes in depression or anxiety from before to after treatment were not significant between the groups. Conclusion: The current study presents preliminary evidence in support of the KF-mSMT® for improving learning and memory abilities in older populations of those aging normally and those meeting criteria for MCI.

Retrospective analysis of patients with immediate decannulation in severe acquired brain injury (RAPID-SABI)

Objective: To examine an early decannulation protocol in adult severe acquired brain injury (SABI) patients. Design: Retrospective, observational cohort study. Subjects/patients: Tracheotomized SABI patients ≥ 18 years admitted to a neurorehabilitation unit. Methods: Primary outcome measure was difference in survival rate within first year of discharge. Secondary outcome measures were respiratory infections treated with antibiotics, rate of re-cannulation, time from admission to decannulation, length of stay, difference in rate of re-admission due to pneumonia within first year of discharge and difference in rate of tracheal tube dependency within first year of discharge. Results: No statistical significance in survival rate within the first 12 months from discharge was found. Median time from admission to decannulation was 32 days (interquartile range [IQR] 14–61) vs 9 days (IQR 0–13) in the control and intervention group, respectively (p &lt; 0.0003). Median length of stay was 66 days (IQR 54–92) in the control group vs 60 (IQR 48–75) days in the intervention group (p = 0.168). Conclusion: A new early decannulation protocol omitting evaluation of tolerance to tracheostomy tube capping and fiberoptic endoscopic evaluation of swallowing was non-inferior to previous procedures in survival rate within first year of discharge. The early decannulation protocol allowed for significantly earlier decannulation.

Comparative outcomes of laparoscopic transcystic duct vs traditional laparoscopic bile duct exploration: A multicentre randomised trial

AbstractAimThis multicentre randomised controlled trial aimed to compare post‐operative complications and recovery outcomes between these two approaches.Patients and methodsEighty patients with symptomatic choledocholithiasis were randomly assigned to undergo either laparoscopic transcystic (LTCBDE; n = 40) or traditional (LCBDE; n = 40) common bile duct exploration. The primary outcome measures were post‐operative complications within 3 months, while the secondary outcomes included operative time, intraoperative blood loss, recurrence of bile duct stones, and time to return to activities of daily living (ADLs). Logistic regression models were used to identify predictors of complications and recurrence.ResultsThe LTCBDE group had significantly shorter operative times (117.55 vs 136.05 min, P &lt; .001) and reduced intraoperative blood loss (51.25 vs 61.45 mL, P &lt; .001). Both groups had a 20% rate of post‐operative complications (P = .614). Septic complications were higher in LCBDE compared with LTCBDE (20% vs 7.5%, P = .105). Time to return to ADL was shorter in the LTCBDE group (33.4 vs 39.75 days, P = .007). Diabetes mellitus independently predicted post‐operative complications (adjusted odds ratio 4.397, P = .014) and revision surgery (adjusted odds ratio 22.592, P = .006). Recurrence rates were similar between groups (P = .363).ConclusionLTCBDE is associated with shorter operative times, reduced blood loss, and faster recovery than LCBDE, without an increase in post‐operative complications. LTCBDE may be the preferred option for the treatment of choledocholithiasis.

Validation of the Polish version of the Functional Oral Intake Scale against flexible endoscopic evaluation of swallowing and the International Dysphagia Diet Standardization Initiative Functional Diet Scale

IntroductionThe Functional Oral Intake Scale (FOIS) is a widely used instrument for assessing oral intake in dysphagic patients. Despite its frequent use, a validated version for the Polish population has been lacking.MethodsThis study aimed to validate the Polish adaptation of FOIS (FOIS-PL) by examining its concordance with Fiberoptic Endoscopic Evaluation of Swallowing (FEES) outcomes and the International Dysphagia Diet Standardization Initiative Functional Diet Scale (IDDSI-FDS) scores across patients with diverse clinical profiles. The primary outcome measures included the Penetration-Aspiration Scale (PAS) score from FEES, pharyngeal residue quantification, and IDDSI-FDS scores. A total of 302 participants with varying clinical conditions were recruited. The cohort included individuals with head and neck malignancies, cerebrovascular incidents, neuromuscular disorders, and other dysphagia aetiologies.ResultsPatients with gastroesophageal reflux disease and those post-thyroidectomy consistently exhibited oral food intake with a FOIS-PL score of ≥5. A strong inverse correlation was found between FOIS-PL scores and PAS scores (rho = −0.739; p &amp;lt; 0.001), indicating that reduced oral intake was associated with increased penetration or aspiration risk. Significant differences in FOIS-PL scores were evident across patient subgroups stratified by PAS severity (PAS ≤ 2, PAS 3–5, PAS &amp;gt; 5) and IDDSI levels. Lower FOIS-PL scores corresponded with more impaired swallowing safety (PAS &amp;gt; 5). The median FOISPL score was 5 for individuals with pharyngeal residue and 6 for those without (p &amp;lt; 0.001). Inter-rater reliability between evaluations conducted by a dietitian (FOIS I) and a speech-language pathologist (FOIS II) demonstrated high consistency (tau = 0.995; p &amp;lt; 0.001). Convergent validity was supported by strong correlations between FOIS-PL and IDDSI-FDS scores (FOIS I vs. IDDSI-FDS I: tau = 0.819; p &amp;lt; 0.001; FOIS II vs. IDDSI-FDS II: tau = 0.815; p &amp;lt; 0.001).ConclusionThe Polish version of the Functional Oral Intake Scale (FOIS-PL) is a valid and reliable tool for assessing oral intake in dysphagia. The findings demonstrate high accuracy, reliability, and validity, supporting its use across diverse clinical conditions.

Continuous overnight monitoring of body temperature during embryo transfer cycles as a proxy for establishing progesterone fluctuations by comparison with P4 blood progesterone results: a prospective, observational study

BackgroundA prospective, observational study to identify relationships between body temperature and levels of peripheral P4 blood progesterone, and examine if these differ according to body temperature cycle pattern.Methods62 data points from 18 patients undergoing hormone assisted embryo transfer cycles at IVIRMA IVF clinics in Madrid, Mallorca and Malaga, Spain volunteered to use OvuSense, an intra-vaginal body temperature monitor. Primary outcome measures were OvuSense Raw and Smooth Temperature (ST) (°C), P4 (ng/ml). Secondary outcome measures: Ongoing Pregnancy, Miscarriage or biochemical pregnancy. Graphical time based comparison analyses and multilevel regression analyses using MLwiN 3.10 [Charlton C, Rasbash J, Browne WJ, Healy M, Cameron B. MlwiN Version 3.10. Centre for Multilevel Modelling. University of Bristol; 2024.] software were conducted.ResultsA graphical analysis showed an apparent relationship between P4 levels and Temperature taken on P4 blood draw day. A multilevel regression analysis using MLwiN 3.10 Centre for Multilevel Modelling. University of Bristol software investigated this relationship, allowing between-patient variation to be accounted for and estimated. This established a strong linear relationship between LnP4 and ST, and cross correlation was carried out which identified the optimum predictor of levels of LnP4 was ST measured on the day prior to blood sampling. Further graphical analyses showed an apparent lower luteal level of P4 for cycles flagged as atypical by OvuSense, and for negative outcomes, except on embryo transfer day.ConclusionsThe results provide extremely strong evidence of a linear relationship between LnP4 and Smooth Temperature (ST) measured the day before blood sampling (Z = 15.6, p < 0.0001, 2 sided). This suggests that ST could provide a less invasive, continuous, and more practical method of assessing P4 response. Secondary outcomes may be related to ST pattern established during an embryo transfer cycle. Further investigation is required to establish the value of the ST pattern for improving outcomes.

The numbers of biopsied cells in routine clinical process of preimplantation genetic testing (PGT) do not affect the pregnancy outcomes of embryos

Abstract STUDY QUESTION Does the number of biopsied trophectoderm cells sampled for preimplantation genetic testing for monogenic disease (PGT-M) affect subsequent clinical outcomes for those selected embryos? SUMMARY ANSWER The number of biopsied cells does not affect the pregnancy outcome of preimplantation genetically tested embryos. WHAT IS KNOWN ALREADY The successful execution of PGT relies on the availability of a certain number of high-quality biopsied cells. Evidence in the literature has reported that blastocyst biopsies may have a negative impact on clinical outcomes. STUDY DESIGN, SIZE, DURATION A retrospective cohort study including 850 single-blastocyst transfer cycles from 605 couples between May 2014 and August 2024 was conducted at Peking University Third Hospital. The primary clinical outcome measure was the biochemical pregnancy rate, while other indicators such as the live birth rate, the clinical pregnancy rate, and the miscarriage rate were also recorded. PARTICIPANTS/MATERIALS, SETTING, METHODS This study included 850 blastocysts obtained from routine PGT-M cycles. Based on biopsied cell numbers, data were categorized into four groups: Group 1 (1–5 cells) (n = 234), Group 2 (6–10 cells) (n = 328), Group 3 (11–15 cells) (n = 192), and Group 4 (&amp;gt;15 cells) (n = 96). MAIN RESULTS AND THE ROLE OF CHANCE The number of cells biopsied from the embryo did not significantly affect either the biochemical pregnancy rate or the live birth rate in the routine PGT process (P &amp;gt; 0.05). There were 129 of 234 embryos (55.1%) in the 1–5 biopsied cell group, 183 of the 328 embryos (55.8%) with 6–10 biopsied cells, 92 of 192 embryos (47.9%) with 11–15 biopsied cells, and 48 of 96 (50.0%) embryos with more than 15 biopsied cells which achieved successful pregnancies. The live birth rates were 42.7%, 49.7%, 43.2%, and 43.8% for each of the biopsy groups, respectively. LIMITATIONS, REASONS FOR CAUTION Data for this study were collected from one center only, therefore multicenter, large-scale cohort studies are essential to confirm the accuracy and the reliability of this study. WIDER IMPLICATIONS OF THE FINDINGS The number of biopsied cells in a blastocyst is associated with the embryo quality and hatching status. The conclusion of this study emphasizes that routine procedures during the biopsy process do not affect pregnancy outcomes. It is crucial to strike a balance between minimizing damage to the blastocyst’s developmental potential and achieving the highest possible detection efficiency for PGT-M. STUDY FUNDING/COMPETING INTEREST(S) This project is funded by the National Key Research and Development Program of China (2019YFA0801401, 2019YFA0110001) and the National Natural Science Foundation of China (82125013). The authors declare that they have no competing interests. TRIAL REGISTRATION NUMBER N/A.

Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or

IntroductionAs a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low anterior resection syndrome (LARS) is one such consequence and describes a...

Trends in clinical encounters and management for infertility among women attending Australian general practice: a national longitudinal study using MedicineInsight, 2011 to 2021

ObjectiveTo examine longitudinal trends in infertility management in women attending general practice.DesignCohort study using the national general practice dataset, MedicineInsight.SettingAustralian general practice.Intervention(s)Not applicable.ParticipantsThe cohort included 2 552 339 women aged...

Effectiveness of Powered Hand Exoskeleton on Upper Extremity Function in People with Chronic Stroke

Impairment of upper limb function is common after a stroke and is closely linked to decreased functional independence in activities of daily living. Robot-assisted training has been used in clinical settings to improve hand function in stroke patients; however, many existing devices are costly and require specialized training to operate. This study aimed to propose a novel powered hand exoskeleton (EO) and verify its effectiveness on upper extremity function in people with chronic stroke. Thirty participants were randomly assigned to either the experimental group or the control group. Each participant underwent 30 min interventions twice a week for 8 weeks. The experimental group received 15 min of conventional therapy followed by 15 min of training with the powered hand EO, while the control group received 30 min of conventional therapy. The primary outcome measures included the Fugl-Meyer Assessment for upper extremity function (FMA-UE), the Box and Block Test (BBT), and handgrip dynamometer. Assessments were conducted at baseline and then at 4-week intervals throughout the 8-week period. Results showed that, after the 8-week intervention, the average changes in FMA-UE scores for the experimental group were significantly greater than those for the control group (p &lt; 0.01). A clear upward trend in both FMA-UE and BBT scores was observed in the EO group. Statistical analysis revealed significant improvements in the overall, proximal, and distal components of the FMA-UE scores (all p &lt; 0.01) and in BBT scores (both p &lt; 0.05) in the EO group compared to the control group at 4 and 8 weeks, respectively. However, no significant differences in grip strength were observed between the groups at either time point. Our findings suggest that the proposed powered hand EO is both feasible and safe for training the impaired hand in stroke survivors. Given the characteristics of the device, it has potential for use in hand rehabilitation aimed at regaining upper extremity function.

Effectiveness and safety of transcutaneous auricular vagus nerve stimulation for depression in patients with epilepsy.

Our study aimed to evaluate the effectiveness and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for treating mild to moderate depression in patients with epilepsy (PWE). A single-arm, prospective, multi-center, pre-post controlled study was conducted in Eastern China. After a four-week baseline period, PWE with mild to moderate depression began treatment with taVNS, administered for 30min, three times daily, over a 12-week period. The primary outcome measure was the change in 24-item Hamilton Depression Rating Scale (HAMD) scores from baseline to week 12. Secondary outcomes included the response and remission rates for depression at week 12, as well as changes in the 14-item Hamilton Anxiety Rating Scale (HAMA), the Pittsburgh Sleep Quality Index (PSQI), and the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) scores, and seizure frequency at weeks 4 and 12 compared to baseline. Adverse events (AEs) were recorded to assess the safety of taVNS. Both modified Intention-To-Treat (mITT) and Per-Protocol (PP) analyses were employed. Sixty-nine participants were enrolled in this study. Of these, 61 (88.4%) completed the 4-week treatment phase, and 50 (72.5%) finished the 12-week treatment phase. In the mITT analysis, HAMD scores significantly decreased by 4.54±7.44 (p<0.001) from baseline to week 12, with clinical response in 16 (26.2%) and remission in 15 (24.6%) patients. HAMA scores also decreased significantly by week 4 (3.23±5.18, p<0.001) and week 12 (4.95±6.78, p<0.001). PSQI scores and seizure frequency showed non-significant changes at week 4, but seizure frequency decreased significantly by week 12 (0.03±10.47, p=0.038). In the PP analysis, similar improvements were observed. After 12weeks of taVNS compared to baseline, HAMD scores decreased significantly by 5.32±8.98 (p<0.001), with 32% of patients achieving a clinical response and 24% achieving clinical remission. And HAMA scores also decreased by 5.66±7.54 (p<0.001), seizure frequency by 0.14±11.03 (p=0.018), and PSQI scores by 1.06±4.14 (p=0.076).There was a significant increase in QOLIE-31 scores by 5.17±14.71 (p=0.020). Ten (14.5%) patients experienced non-serious adverse events, the most common of which was ear pain (n=4); one patient withdrew due to tinnitus enhancement; all resolved after reducing the stimulation intensity or stopping the treatment. Our study suggests that taVNS may effectively improve depressive symptoms in PWE. This may be an efficacious and safe treatment for mild to moderate depression in PWE.