Protocol Analysis Research Articles

Early robotic gait training after stroke (ERA Stroke): study protocol for a randomized clinical trial

BackgroundWalking impairment after stroke is associated with substantial limitations in functional independence, quality of life, and long-term survival. People in the subacute phase after stroke who are unable to walk are most likely to benefit the greatest from use of overground robotic gait training (RGT). This study will provide preliminary evidence regarding the clinical use and efficacy of RGT during the subacute phase of stroke recovery as well as observational findings associated with the safety, tolerability, feasibility, and cost of delivering RGT during inpatient stroke rehabilitation.MethodsThis prospectively registered randomized controlled trial will enroll 54 patients admitted to inpatient rehabilitation within six months of stroke. Admitted patients will be screened at admission to inpatient rehabilitation for eligibility. Consented patients will be randomized based on stroke severity to receive either RGT or usual care for 90 minutes per week of gait training intervention during inpatient rehabilitation length of stay. Patients will complete assessments on walking and health outcomes at admission and discharge from inpatient rehabilitation and at 1- and 3-month follow-up. Intent-to-treat and per protocol analysis will be performed to evaluate safety [rate of adverse events, visual analog scale, and treatment completion rate], walking function [gait speed via 10-Meter Walk Test, Functional Ambulation Category, gait endurance via 6-Minute Walk Test] and health outcomes [Modified Rankin Scale, Stroke Rehabilitation Assessment of Movement, Continuity Assessment Record and Evaluation Tool, 5 Times Sit-to-Stand Test, Berg Balance Scale, and Stroke Impact Scale–16], and cost-analysis.DiscussionThis study will provide foundational evidence regarding the clinical use and efficacy of a RGT program during the subacute phase of stroke recovery with specific findings associated with the safety, tolerability, feasibility, and cost-analysis of delivering RGT during inpatient stroke rehabilitation.Trial registrationNCT06430632.

Exploring the Impact of Digital Technologies on Team Collaborative Design

This paper presents the results of a protocol study exploring the impact of various digital technologies on team collaborative design processes. Previous studies have suggested that compared to traditional methods such as sketching, digital technologies can provide further benefits for collaborative processes. However, there persists a lack of understanding about the impacts of digital technologies on such processes, particularly in relation to emerging significant digital technologies such as immersive Virtual Reality (VR). Therefore, this study aims to fill that gap by exploring team collaboration behaviours of two groups of professionals working in two digital design environments—desktop 3D modelling with Revit and immersive VR using Hyve-3D—as well as their behaviours during traditional sketching sessions for benchmarking purposes. Utilising protocol analysis method, the think-aloud data of participants was recorded, transcribed and coded using an adapted collaborative practice model. Team collaboration activities are broadly categorised as ‘Content’ or ‘Process’: content referring to design task-based activities, while process refers to activities related to the organising of group processes. The results suggest that during the design collaboration process, designers allocated the majority of their efforts towards process-oriented design activities. Differences between design environments only had a minor impact on the amount of effort expended on process-oriented activities and content-oriented activities. Moreover, traditional sketching design environments were shown to be potentially beneficial for problem-solution and associated negotiation activities. Additionally, immersive environments were associated with a reduction in the designers’ cognitive effort that was expended on exploring the design environment.

Generalised Entropy Accumulation

Consider a sequential process in which each step outputs a system Ai\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$A_i$$\\end{document} and updates a side information register E. We prove that if this process satisfies a natural “non-signalling” condition between past outputs and future side information, the min-entropy of the outputs A1,⋯,An\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$A_1, \\dots , A_n$$\\end{document} conditioned on the side information E at the end of the process can be bounded from below by a sum of von Neumann entropies associated with the individual steps. This is a generalisation of the entropy accumulation theorem (EAT) (Dupuis et al. in Commun Math Phys 379: 867–913, 2020), which deals with a more restrictive model of side information: there, past side information cannot be updated in subsequent rounds, and newly generated side information has to satisfy a Markov condition. Due to its more general model of side-information, our generalised EAT can be applied more easily and to a broader range of cryptographic protocols. As examples, we give the first multi-round security proof for blind randomness expansion and a simplified analysis of the E91 QKD protocol. The proof of our generalised EAT relies on a new variant of Uhlmann’s theorem and new chain rules for the Rényi divergence and entropy, which might be of independent interest.

Effects of acetazolamide on exercise performance in patients with COPD going to high altitude: randomised controlled trial

BackgroundIn patients with chronic obstructive pulmonary disease (COPD), preventive treatment with acetazolamide reduces adverse health effects during altitude travel. We investigated whether preventive acetazolamide treatment modifies exercise performance in COPD patients going to high altitude.MethodsIn this randomized, double-blind trial, lowlanders with COPD, FEV1 40–80%predicted, were assigned to acetazolamide (375 mg/24 h) or placebo treatment starting 24 h before ascent and while staying at 3100 m. Patients performed progressive cycling exercise to exhaustion at 760 m, before taking the study drug, and within 4 h after arrival at 3100 m. Primary outcome was the maximal power output (Wmax). ClinicalTrials.govNCT03177837.Results103 patients (32 women), mean ±sdage 57.2±8.1y, FEV1 66±11% predicted, were included in per protocol analyses. In 53 patients receiving acetazolamide, Wmax and oxygen uptake (V'O2max) at 760 m and 3100 m were 105±40 and 91±40watts, and 18.0±6.8 and 15.5±6.8 ml·min−1·kg−1(p<0.001, both changes). Corresponding Wmax and V'O2max in 50 patients receiving placebo were 107±41 and 97±41watts, and 18.9±7.0 and 17.2±7.0 ml·min−1·kg−1(p<0.001, both changes). Between-group differences (95%CI) in altitude-induced Wmax-changes were −3.0 watts (−8.7 to +2.7, p=0.305) and in V'O2max-changes were −0.8 ml·min−1·kg−1(−2.1 to +0.5, p=0.213). Acetazolamide mitigated the altitude-induced reduction of end-exercise PaO2by 0.7kPa (0.1 to 1.3, p=0.016). At 3100 m, maximal work rate with respiratory exchange ratio ≤1 was greater with acetazolamide than with placebo by 10.1 watts (4.0 to 16.2, p=0.022).ConclusionsIn lowlanders with COPD, preventive treatment with acetazolamide did not modify the altitude-induced reduction in maximal work rate. However, acetazolamide enhanced arterial oxygenation and submaximal, moderate-intensity work capacity compared to placebo.

Comparative analysis of features extraction protocols for LC-HRMS untargeted metabolomics in mountain cheese ‘identitation’

This study presents a comprehensive metabolomic analysis of Parmigiano Reggiano samples to differentiate between those designated as Mountain Quality Certification (QC) and conventional Protected Designation of Origin (PDO). Despite following the same production protocol, these cheese varieties differ in the cows’ feeding regimes and milk stable locations, with mountain-certified samples adhering to specific requirements regarding milk origin and feed composition. An untargeted approach with Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) was proposed to characterize the cheese metabolome. High-resolution LC-MS data can generate gigabyte-sized files, making data compression essential for manageable multivariate analysis and noise reduction. This study employs the Region of Interest-Multivariate Curve Resolution (ROI-MCR) protocol to achieve effective data compression and chromatographic resolution, thereby extracting the most informative features. This method was compared with a classical approach for feature extraction from chromatographic data, namely Compound Discoverer (CD) software. The features extracted by both methods were analysed through Principal Component Analysis (PCA) and ASCA (ANOVA Simultaneous Component Analysis). The comparison of ROI-MCR and CD approaches demonstrated that while both methods yielded similar overall conclusions, ROI-MCR provided a more streamlined and manageable dataset, facilitating easier interpretation of the metabolic differences. Both approaches indicated that amino acids, fatty acids, and bacterial activity-related compounds played significant roles in distinguishing between the two sample types.

5065 Cyproterone Acetate Versus Spironolactone In Transgender Women Commencing Estradiol: A Randomized Controlled Trial

Abstract Disclosure: L.M. Angus: Advisory Board Member; Self; Kirin Brewery. Speaker; Self; Kirin Brewery. S. Leemaqz: None. A. Kasielska-Trojan: None. M. Mikołajczyk: None. J. Doery: None. J.D. Zajac: None. A.S. Cheung: None. Background: Transgender women commonly use cyproterone acetate or spironolactone as anti-androgens with estradiol to assist with feminization. However, the optimal anti-androgen is unclear. We aimed to assess the effect of these anti-androgens on breast development and hypothesized that cyproterone acetate would result in greater breast development than spironolactone due to greater androgen receptor antagonism and suppression of serum total testosterone. Design: Double-blind, randomised controlled trial Methods: Transgender women newly commencing estradiol were randomized to spironolactone 100mg daily or cyproterone acetate 12.5mg daily for six months. The primary outcome was measurement of breast development via breast chest distance with secondary outcomes of estimated breast volume using the BreastIdea Volume Estimator application and serum total testosterone using LCMS. Results: Fifty-five participants were included in per protocol analysis (cyproterone acetate group n=28, spironolactone group n=27). Baseline age, body mass index, breast indices, serum estradiol and serum total testosterone were comparable. At six months, the mean (standard deviation) breast chest distance was 9.2cm (3.0) in the cyproterone group versus 8.3cm (2.7) in the spironolactone group (p=0.27). The mean (SD) estimated breast volume was 190.25 mL (158.60) in the cyproterone acetate group and 157.84mL (112.03) in the spironolactone group (p=0.39) with significant inter-individual variation (range 20.27 - 787.77 mL). The mean (SD) serum total testosterone was 1.48 nmol/L (3.45) in the cyproterone acetate group and 4.29 nmol/L (5.44) in the spironolactone group (p=0.04). Serum estradiol levels were comparable. Use of cyproterone acetate was associated with mild hyperprolactinaemia and spironolactone with an increase in serum urea and creatinine. Conclusions: Choice of anti-androgen should be individualised based on clinician and patient preference, with consideration of associated side effects. Further research is needed to optimise breast development in transgender women. Presentation: 6/3/2024

Silicone Irregular Hexagon Pessary Versus Polyvinyl Chloride Ring Pessary for Pelvic Organ Prolapse: Randomised Controlled Trial.

Vaginal pessaries are the mainstay of the non-surgical management of pelvic organ prolapse (POP). A flexible silicone irregular hexagonal (SIH) pessary was developed based on the results of a prior vaginal case study. We hypothesised that the SIH pessary would have a higher rate of retention and self-management than the polyvinyl chloride (PVC) pessary. This was a prospective non-blinded, randomised controlled trial with institutional review board approval. Eligible participants were randomised and fitted with the assigned pessary. They were reviewed 1 week, 6 months and 1 year after the initial pessary fitting. Participants who returned for follow-up completed the study questionnaires. The primary outcome was success, defined as continued use of the allocated pessary at 6 months. Secondary outcomes included the ability to perform pessary self-care, treatment satisfaction and pessary-related complications. Statistical tests were performed with alpha or statistical significance defined as a p value of ≤ 0.05, two-tailed. A total of 104 participants were randomised, with 52 subjects in each arm. Primary outcome data were analysed using per protocol analysis. Continuing pessary usage at 6 months was 68.1% for the PVC pessary group and 65.1% for the SIH group, with no statistically significant differences between the two groups (p = 0.765). Subjects with SIH were more likely to perform pessary self-care. There were no significant differences in subjects' satisfaction, quality-of-life scores or treatment complications between groups. The pessary continuation rate between the SIH and the PVC pessary groups was similar at 6 months. Participants with an SIH pessary were more likely to self-manage.

The complexity of agility testing in water polo: Reliability and validity analysis of sport-specific protocols

ABSTRACT This study aimed at evaluating the reliability and discriminant validity of a newly developed in-water agility test through a progression in complexity. Thirty-eight young male water polo players were divided into elite (n = 20; 16.2 ± 0.5 years) and non-elite (n = 18; 15.8 ± 0.6 years) groups. Players performed 20 m Freestyle Sprint Swimming Test (20 m FSST), Change of Direction Speed (CODS), and the Functional Agility Test without (FAT) and with shooting (FATS). The cognitive (CD) and technical deficits (TD) were calculated by subtracting time results of CODS from FAT and of FAT from FATS respectively. Excellent reliability was found for the 20 m FSST, CODS, and FAT (ICC from 0.954 to 0.982) and good reliability for the FATS (ICC = 0.838). Elite players outperformed non-elite players in 20 m FSST (g = 1.25), CODS (g = 1.08), and FAT (g = 1.14). There were no differences in FATS (g = 0.29), CD (g = 0.14), TD (g = 0.50) and shooting efficiency (g = 0.04). Increasing protocol’s complexity resulted in similar performance between groups eliminating differences in physicality. Although designed to mimic in-game performance, the results suggest discriminant validity only for physical attributes among young players, raising the need for further improvements in the testing protocol to better meet the cognitive and technical demands.

The CEP-Conep System in 2020: confronting COVID-19, challenges and lessons learned.

This paper presents the structuring dimensions of the CEP-Conep System in order to understand the actions promoted by the National Research Ethics Commission in response to demands for the processing and ethical analysis of research protocols related to COVID-19 in 2020. Based on CEP-Conep System public documents, an assessment of legislation, from 1988 to 2020, and its extension in terms of the number of Committees, users, and protocols, from 2012 to 2020 was presented. The minutes of Conep's Ordinary Meetings (RO), for 2020, of a confidential nature, were analyzed, to verify adaptations to the pandemic. At the end of 2020, the System had 844 Committees, 854,741 users, and 701,791 analyzed protocols. The Commission centralized the analysis of COVID-19 protocols, in January 2020, and promoted three decentralizations, as more knowledge was generated, with vaccine protocols for COVID-19 remaining centralized. The history of the CEP-Conep System provided ballast for the adoption of management, educational and communication measures that accelerated the approval of protocols and made the process transparent. The absence of indicators made it impossible to evaluate the performance in 2020, which was apparently satisfactory.

Three-Year Effects of Motivational Interviewing–Enhanced Behavior Therapy for Adolescents With ADHD: A Randomized Community-Based Trial

This study reports 3-year effects of a parent-teen cognitive/behavioral treatment for adolescent attention-deficit/hyperactivity disorder (ADHD), blended with Motivational Interviewing (Supporting Teens' Autonomy Daily [STAND]), vs Usual Care (UC) in 4 community clinics. This was a randomized clinical trial with double randomization of adolescents and therapists to STAND vs UC. Participants were 278 culturally diverse adolescents diagnosed with DSM-5 ADHD and 82 community therapists. Long-term effects on outcomes and theorized mechanisms were assessed at approximately 3 years post baseline (mean age= 16.94 years, SD= 1.69): ADHD severity (parent-rated), parent-teen conflict (parent/adolescent-rated), organization, time management, and planning skills (OTP; parent-rated), treatment and school enrollment (parent/adolescent-reported), and ADHD diagnostic persistence (clinician-determined). Therapist licensure was examined as a treatment moderator. Intent-to-treat (ITT) and per protocol analyses (n = 225; participants initiating treatment after agency intake) were conducted. As in the original trial, ITT analyses indicated no long-term group by time effects. However, STAND (vs UC) led to superior long-term outcomes when therapists were licensed (22% of sample) vs unlicensed for parent-rated hyperactivity/impulsivity (d= 0.39; adolescent-rated parent-teen conflict: d= 0.27, and parent-rated OTP skills: d= 0.79). Previously reported post-treatment group differences on medication engagement were non-significant at the 3-year follow-up. Although STAND did not outperform UC overall, group by licensure interactions indicate specific long-term impacts on ADHD symptoms, executive function skills such as OTP, and parent-teen conflict, extending this trial's acute effects and replicating previous findings. Clinicians in community settings might recommend adjunctive cognitive/behavioral treatment to adolescents with ADHD to maximize long-term outcomes. However, additional efforts are needed to facilitate effective implementation by unlicensed clinicians. STAND Community Trial (STAND); https://clinicaltrials.gov; NCT02694939. Long-term Follow-up of MI-based Behavioral Intervention Delivered in Community Mental Health; https://osf.io; h5w6f. We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. One or more of the authors of this paper self-identifies as living with a disability. We actively worked to promote sex and gender balance in our author group. We actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our author group. While citing references scientifically relevant for this work, we also actively worked to promote sex and gender balance in our reference list. The author list of this paper includes contributors from the location and/or community where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work.

Effects of a sedentary behaviour intervention in emergency dispatch centre phone operators: a study protocol for the SECODIS randomised controlled cross-over trial

IntroductionSedentary behaviour is a public health problem. We mainly have sedentary behaviour at work, transforming them into occupational risk. To our knowledge, there is no intervention study on the reduction...

49 Exploring Current Emergency Medical Services Approaches to Manage Agitated Older Adult Patients: A Comprehensive Analysis of Statewide Protocols

49 Exploring Current Emergency Medical Services Approaches to Manage Agitated Older Adult Patients: A Comprehensive Analysis of Statewide Protocols

Progress in Noninvasive Surveillance for Acute Rejection in Pediatric Heart Transplant Recipients: A Real-World Analysis of Donor-Derived Cell-Free DNA-Based Surveillance Protocol.

Acute cellular (ACR) and antibody-mediated (AMR) rejection are risk factors for allograft loss in heart transplant (HT) recipients. Endomyocardial biopsy (EMB), although considered the gold standard for rejection surveillance, is invasive and has high interobserver variability. Noninvasive donor-derived cell-free DNA (dd-cfDNA) sampling has a high negative predictive value (NPV) for rejection in adults and is increasingly used in pediatrics. This single center study aimed to test the performance of dd-cfDNA in screening for acute rejection (AR) and donor-specific antibodies (DSAs) in pediatric HT recipients. Blood samples for dd-cfDNA were obtained per clinical protocol for all eligible HT recipients in our center from July 1, 2022 to December 31, 2023. Primary endpoints were episodes of AR, pathology grading of EMBs temporally related to ddcfDNA sampling (0-150 days), and presence of DSAs. There were 471 interpretable samples, in 192 unique patients. Of those, 199 dd-cfDNA tests were paired with EMB ± DSA in 152 patients. Abnormal dd-cfDNA (> 0.2%) was found in 77 samples (median 0.48%, range 0.21%-11%) and led to EMB, where one sample was positive for ACR (grade 2R), 13 for AMR, yielding an NPV of 97% for AMR. After excluding abnormal ddcfDNA testing associated with AR, 65 abnormal dd-cfDNA tests were paired with DSA testing. The NPV of the test for detection of DSAs was 93%. Implementation of noninvasive rejection surveillance with dd-cfDNA in a pediatric cohort demonstrates high NPV for AR and high DSAs, making it an ideal screening tool for long-term monitoring of allograft health in pediatrics.

Cost-Benefit Analysis of a Pediatric ICU Sedation Weaning Protocol.

A risk stratified sedation weaning protocol improved patient outcomes in a pediatric intensive care unit (PICU). We sought to determine the protocol effect on medication costs. This was a retrospective observational cohort study in an academic tertiary care children's hospital PICU (2018-2020) comparing the cost when weaning benzodiazepine, alpha agonist, and/or opioid infusions in intubated children <18 years of age. There were 84 total sedation weaning instances (pre-protocol n = 41 and post-protocol n = 41); 2 patients had 2 encounters, 1 in each phase. The total cost (in 2022 United States Dollars) of sedation weaning was $400,328.87 ($15,994.44/kg) pre-protocol compared with $170,458.85 ($11,227.52/kg) post-protocol. The median cost of sedation wean per patient for pre-protocol patients was $3197.42 (IQR: $322.66-$12,643.29) and post-protocol patients was $1851.44 (IQR: $425.05-$5355.85; p = 0.275). A linear regression model estimated the expected cost of sedation wean for post-protocol patients to be $5173.20 lower than for pre-protocol patients of the same weight and overall drug risk (p = 0.036). The proportion of withdrawal symptoms in the pre-protocol patients (16%) was not significantly different from the proportion in the post-protocol patients (14%; p = 0.435). Implementation of a PICU sedation weaning protocol in a single-center conferred cost benefit without negatively impacting patient outcomes. A larger multicenter study would provide insight to the applicability to PICUs in varied settings with differing patient populations.

Verbal Mediation During Auditory Equivalence Class Formation Using Go/No-Go Successive Matching-to-Sample

AbstractSuccessive matching-to-sample (S-MTS) with a go/no-go response requirement has previously produced equivalence classes with nonverbal auditory stimuli among college students. When participants are required to talk aloud during posttests (protocol analysis), their verbal behavior tends to match their selection performance. However, in some cases, the protocol analysis seems to interfere with posttests, in that equivalence yields are lower when participants are required to talk aloud. Thus, the current study replicated and extended previous research by requiring participants to complete emergence posttests before introducing training for the protocol analysis. Subsequently, participants completed one additional block of the transitivity/equivalence posttest with the talk-aloud requirement. Additionally, participants completed tact and intraverbal tests following emergence posttests to further assess possible verbal-mediation strategies. The results showed that six of eight college students formed equivalence classes, suggesting that previous failures could have been influenced by the talk-aloud requirement. Further, there was a positive correlation between verbal and nonverbal (selection) responses suggesting the possibility that verbal mediation may have contributed to equivalence-class formation.

Analysis of authentication methods for full-stack applications and implementation of a web application with an integrated authentication system

The subject of research is methods and techniques for secure user authentication in web applications. The goal of the work is to analyse authentication methods and implement a web application with an authentication system integrating JWT tokens and the OAuth v2.0 standard. The article solves the tasks of analysis of the main protocols and methods of user authentication in web applications, implementation of authentication based on the OAuth 2.0 standard and JWT access/refresh token, and analysis of the risks of vulnerabilities and attacks for the implemented web applications. Methods used: comparison, empirical analysis, calculation methods. The next results have been obtained: analysed the protocols and methods of user authentication in web applications; selected authentication methods of JWT token and OAuth v2.0 standard for building modern web applications; created a web application based on the selected authentication methods in web applications; analysed the risks of vulnerabilities and attacks in web applications. Conclusions: The most well-known authentication methods for web applications are analyzed. It is established that most modern authentication methods have many disadvantages, which leads to increased risks when using these authentication methods. It is shown that one of the most reliable methods of web application user data security is the use of a combination of JWT Access/Refresh token and browser fingerprints. The implementation, configuration, and analysis of this methodology have shown that this combination provides the most reliable prevention of token theft and use from another computer. OAuth 2.0 authentication was also implemented. The study found that delegating authentication to services such as Facebook or Google can provide a low risk of attacks and vulnerabilities for a web application. It is noted that authentication using OAuth 2.0 can be compromised only at the beginning of the connection between the client and the server, or rather when the client first sends initial information from the browser fingerprints. This information is sent over the secure HTTPS (Hypertext Transfer Protocol Secure) protocol, so the risk of compromising OAuth 2.0 authentication is low.

Improvement of laboratory markers of anaemia in the treatment of heavy menstrual bleeding with a 19.5-mg intrauterine device: a pilot study

Objectives To evaluate improvements in laboratory markers of anaemia (haemoglobin, haematocrit, serum iron, and ferritin) in women with subjective heavy menstrual bleeding (HMB) treated with the levonorgestrel 19.5-mg intrauterine device. Materials and methods We conducted a pilot study at the Department of Obstetrics and Gynaecology, University of Campinas, Faculty of Medical Sciences, Campinas, SP, Brazil. We compared anaemia markers in 73 women aged 18–48 years suffering from HMB, one year after placement of the IUD. Results The mean age of participants was 30.0 years (range 24–38); more than half were white, and the mean body mass index (kg/m2) was 27.0. Twenty (27.4%) participants exited the study due to loss to follow-up (n = 12; 16.4%), expulsion (n = 7; 9.6%) and uterine perforation (n = 1; 1.4%). One-year post-IUD placement, amenorrhoea was reported by 10 (13.7%) women. According to intention-to-treat and per protocol analyses, the proportion of women with normal haemoglobin levels significantly improved (p = 0.014 in both analyses), as did haematocrit (p < 0.001 in both analyses) and serum iron (p = 0.003 in both analyses) compared to baseline evaluations. The proportion of women with normal ferritin levels also improved (p < 0.001) in both analyses using a cut-off of 15 ng/ml, though no significant difference was observed using a 30 ng/ml cut-off (p = 0.083 in both analyses). Conclusion The levonorgestrel 19.5-mg IUD effectively improved laboratory markers of anaemia one year after placement in women with HMB.

Health-related quality of life with rivaroxaban plus aspirin vs. aspirin alone in chronic stable cardiovascular disease: Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial.

This study aimed to compare the effects of the combination of rivaroxaban and aspirin with aspirin alone on health-related quality of life in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial. Health-related quality of life assessed using the EQ-5D-3L. The treatment effects on health utility and EQ visual analogue scale (EQ VAS) scores were compared between rivaroxaban plus aspirin and aspirin alone in terms of adjusted mean difference in change from baseline and odds ratio of having deterioration events. Nine thousand forty-nine (98.9%) and 6916 (75.5%) completed the EQ-5D-3L at baseline and at final visit, respectively. Nine thousand twenty-eight (98.9%) and 6887 (76.3%) completed the EQ-5D-3L at baseline and final visit, respectively. Mean (standard deviation) health utility and EQ VAS scores at baseline were 0.871 (0.141) and 76.0 (15.3), respectively, for the rivaroxaban plus aspirin group, compared with 0.873 (0.139) and 75.8 (15.1) for the aspirin group. Adjusted mean difference in change from baseline utility was -0.002 [95% confidence interval (CI), -0.006, 0.002, P = 0.30] between the combination therapy group and the aspirin group. The odds ratio (95% CI) of experiencing deterioration in health utility was 1.01 (95% CI, 0.93, 1.10, P = 0.81) between the two groups. Adjusted mean difference in change from baseline EQ VAS was 0.02 (95% CI, -0.43, 0.47, P = 0.93) between the two groups. This analysis of the COMPASS trial demonstrated that the quality of life of patients was similar between the rivaroxaban plus aspirin group and the aspirin alone group. Trial registration number: ClinicalTrials.gov number (NCT01776424). Trial protocol and statistical analysis plan: https://www.nejm.org/doi/full/10.1056/NEJMoa1709118#APPNEJMoa1709118PRO.

Comparative Analysis of Plyometric Training Protocols in Volleyball: A Meta-Analysis

Purpose: This meta-analysis synthesizes findings from 40 research studies to comprehensively examine the impact of plyometric training protocols on overall performance outcomes in volleyball athletes. Method: A systematic search identified relevant studies on plyometrics and volleyball performance. Data on training programs, performance measures, and outcomes were extracted. Statistical analysis assessed the overall effect size and addressed potential variation between studies. Findings: The constant-effects version revealed a giant wonderful common impact (Fisher r-to-z converted correlation coefficient = 0.7531, 95% CI: 0.6952 to 0.8110), affirming the fine relationship between plyometrics and volleyball overall performance. However, the random-effects model indicated giant heterogeneity among authentic effects (I² = 78.53%), prompting a radical exploration of ability sources of variability. Despite diagnosed limitations, inclusive of heterogeneity and ability publication bias, this meta-analysis underscores the want for standardized protocols and in addition studies to refine training strategies. Conclusion: The importance of this analysis lies in its contribution to proof-primarily based practices, providing valuable insights to coaches and practitioners in search of to optimize plyometric training for volleyball athletes. As a complete reference, it courses destiny research endeavors and advances know-how within the nuanced courting between plyometrics and volleyball.

Effects of the Zishen Yutai Pill on live births compared with placebo among infertile women with frozen-thawed embryo transfer cycle: A multicentre double-blind randomized controlled trial

BackgroundZishen Yutai Pill exhibited clinical benefit to infertile women undergoing fresh embryo transfer cycles, improving their pregnancy outcomes. However, as the endometrial environment in frozen embryo transfer (FET) is different from fresh cycles, the effects of ZYP on fresh embryo transfer could not be generalized to FET. ObjectiveWe aimed to explore the effects of ZYP on live birth rate in women's FET cycles. MethodsThis multicentre, double-blind, placebo-controlled, randomized study was conducted at 11 reproductive medical centres in China. Women were recruited and randomly assigned to ZYP or placebo intervention (5 g once, 3 times per day) around the time of FET. The live birth rate was set as the primary outcome. Secondary outcomes included implantation rate, biochemical pregnancy rate, clinical pregnancy rate, pregnancy loss rates. Data was analyzed based on the intention-to-treat principle, with per protocol analysis as sensitivity analysis. ResultsBetween December 2017 and April 2019, 934 women were screened, of whom 880 met all eligibility criteria and were allocated to ZYP (n=441) or placebo (n=439). In ITT analysis, the live birth rates were 38.32% (169/441) in ZYP group and 32.57% (143/439) (absolute difference 5.75%, 95%CI [−0.57%, 12.00%], OR 1.29, 95%CI [0.98, 1.70], P=0.08). The intervention of ZYP did not result in significantly differences in all secondary outcomes compared with placebo (all P>0.05). Similar trends were observed in PP analysis. In post hoc analysis, ZYP resulted in higher rates of live birth than placebo among women in specific subgroups, i.e., with miscarriage history (39.23% vs. 26.45%, P=0.01) or advanced maternal age (33.93% vs. 21.85%, P=0.04). ConclusionIn infertile women undergoing FET cycle, intervention with ZYP led to a trend of live birth rate increment compared with placebo, but without statistical significance. However, women with miscarriage history and advanced age could experience possible benefits from ZYP intervention. RegistrationChiCTR-INR-17010809 (http://www.chictr.org.cn).