Practice of data sharing plans in clinical trial registrations and concordance between registered and published data sharing plans: a cross-sectional study.

Background: The International Committee of Medical Journal Editors (ICMJE) recommends that trial authors must specify data sharing plans when trials are registered and published, yet this uptake remains unclear. We aimed to assess the practice of data sharing plans in trial registration platforms and the concordance between registered and published data sharing plans.

Methods: We included clinical trials published between 2021 and 2023 in six high-profile journals (The Lancet, The New England Journal of Medicine, JAMA, BMJ, JAMA Internal Medicine, and Annals of Internal Medicine) that enrolled participants no earlier than 2019 and registered on clinical trial platforms.

Disparity between statistical significance and clinical importance in published randomised controlled trials: a methodological study.

Objectives: We estimated the extent of the disparity between statistical significance and clinical importance in published randomised controlled trials (RCTs), and explored factors associated with this disparity.

Design: A methodological study of trials published between 2018 and 2022 and indexed in PubMed was conducted. Primary reports of two-arm, phase three, superiority trials of human health interventions were included.

Impact of hepatitis C serostatus on health service utilization for opioid-related harms among individuals prescribed opioid agonist therapy: A longitudinal prospective cohort study.

Objectives: Varied substance use outcomes have been reported among individuals with a hepatitis C viral (HCV) infection on opioid agonist treatment (OAT) for opioid use disorder. Accordingly, the current study sought to evaluate the association between HCV serostatus, among other factors, and opioid-related acute health service utilization (e.g.

Early Rehabilitation Bundle in a Canadian PICU: Cost Analysis of Implementation in 2018-2020.

Objectives: First, to determine the resources and costs required to implement an early rehabilitation (ABCDEF) bundle. Second, to compare the impact of the bundle on costs pre- and post-implementation.

Design And Setting: Cost analysis was conducted as part of an implementation study at McMaster Children's Hospital PICU in 2018-2020.

The association between HIV drug resistance testing, viral suppression and mortality in Ontario: a retrospective cohort study.

Background: Drug resistance compromises the effectiveness of antiretroviral therapy (ART). Resistance testing prior to initiating therapy is recommended in guidelines in many high-income countries, and it has been shown to improve outcomes after first-line ART regimen failure. There is limited evidence on its role in treatment-naïve individuals.

Derivation of Novel Imaging Biomarkers of Neonatal Brain Injury Using Bedside Diffuse Optical Tomography: Protocol for a Prospective Feasibility Study.

Prognostication of neurodevelopmental outcomes for neonates with hypoxic-ischemic encephalopathy (HIE) is primarily reliant on structural assessment using conventional brain magnetic resonance imaging in the clinical setting. Diffuse optical tomography (DOT) can provide complementary information on brain function at the bedside, further enhancing prognostic accuracy. The predictive accuracy and generalizability of DOT-based neuroimaging markers are unknown.

Implementing exercise and self-management for women with breast cancer during treatment: results of the NEXT-BRCA randomized controlled trial.

The purpose of this study was to determine the feasibility (recruitment, retention, and adherence rates) and effectiveness of institution-based exercise and self-management (SM) on physical activity (PA) level, exercise knowledge and intention, health status, functional capacity, patient engagement, and lower extremity strength for individuals with breast cancer receiving treatment. We conducted a hybrid implementation-effectiveness trial (type 1), including female participants with a current diagnosis of breast cancer undergoing treatment. Participants were randomized to (1) exercise and SM (EXSM; 8 in person exercise sessions and SM education), (2) SM only (8 sessions of SM), or (3) usual care (UC; no intervention).

Publication of data sharing statements in clinical trials by cardiovascular journals: a quantitative and qualitative analysis.

Many cardiovascular disease (CVD) journals request data sharing statements upon trial report submission, but their compliance in publishing these statements remains unclear. We therefore performed a quantitative analysis to evaluate the current practice of the publications of data sharing statements in clinical trials by CVD journals, which included 78 CVD journals that published clinical trials from Jan 2019 to Dec 2022 and had data sharing statement request. Multivariable logistic regression analysis was used to examine the association between journal characteristics and journals' publications of statements.

Comparative efficacy and safety of biologics and systemic immunomodulatory treatments for chronic urticaria: Systematic review and network meta-analysis.

Background: Chronic urticaria is a common skin condition characterized by itchy wheals (hives), angioedema, or both, lasting for 6 weeks or more. Beyond antihistamines, multiple systemic treatments are available, but there is uncertainty regarding their comparative effects on chronic urticaria outcomes.

Objective: We systematically synthesized the comparative benefits and harms of systemic treatments for chronic urticaria.

Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial.

Background: Vertebral fractures due to osteoporosis cause significant pain and disability. There is guidance available on the management of osteoporotic vertebral fractures, informed by systematic reviews and a consensus process. However, few studies examine whether implementing pragmatic and patient-oriented rehabilitation interventions can improve outcomes for individuals with a vertebral fracture.

The diagnostic accuracy of point-of-care ultrasound in shock: a systematic review and meta-analysis.

Purpose: We sought to conduct a systematic review to determine the diagnostic test accuracy of point-of-care ultrasound (POCUS) for the specific etiologies and subtypes of shock.

Methods: We searched MEDLINE, Embase, and the grey literature for prospective studies in adult populations with shock. We collected data on study design, patient characteristics, operator characteristics, POCUS protocol, and true and false positives and negatives, and assessed the risk of bias.

Alcohol-Based Versus Aqueous Skin Antisepsis Before Surgical Fixation of Open Fractures: A Combined Analysis of 2 Cluster-Randomized Crossover Trials.

Background: Skin antisepsis remains a vital component in prophylaxis against surgical site infection (SSI); however, for open fractures, it is unclear whether alcohol-based or aqueous solutions should be preferred. The purpose of this study was to compare the use of alcohol-based and aqueous skin antisepsis solutions, using data from the 2 PREP-IT trials, with respect to the risks of SSI and unplanned reoperation following surgery for an open fracture.

Methods: Individual patient data from the 2 cluster-randomized, crossover clinical trials were combined to create a single data set of patients undergoing surgery for an open fracture.

Effectiveness of methadone versus buprenorphine in the treatment of opioid use disorder: secondary analyses of prospective cohort study data.

Objectives: To compare the effectiveness of buprenorphine-naloxone (bup/nal) and methadone maintenance therapy (MMT) in the treatment of patients with opioid use disorder (OUD) during the fentanyl era.

Design: Secondary analysis of prospective cohort study data.

Setting: Data for the study were collected from 54 clinical sites across Ontario, Canada, between May 2018 and January 2023.

Comparative analysis of methods for identifying multimorbidity patterns among people with opioid use disorder: A retrospective single-cohort study.

Background: Multimorbidity, the presence of two or more (2+) chronic conditions, presents significant challenges for healthcare delivery, particularly among populations with opioid use disorder (OUD). Multimorbidity patterns among individuals with OUD are not well established, and minimal research exists examining the impact of clustering methods on identifying these patterns.

Objective: Our study aimed to assess multimorbidity prevalence, explore associated sociodemographic and clinical characteristics, and determine multimorbidity patterns using hierarchical cluster analysis (HCA) and K-means clustering among people receiving treatment for OUD in Ontario, Canada between 2011 and 2021.

AeroVax: study protocol for a randomised, double-blind, placebo-controlled, phase 2 trial to evaluate safety and immunogenicity of a next-generation COVID-19 vaccine delivered by inhaled aerosol to humans.

Background: Coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) continues to have a significant impact worldwide, in part due to a reduction in neutralising antibody protection provided by vaccines targeting monovalent spike antigens related to immune escape. Development of vaccines amenable for respiratory mucosal delivery that provide broad and durable immunity are needed. This study aims to determine the safety and immunogenicity of a single inhaled dose of a replication-deficient chimpanzee adenovirus type 68 vector expressing a trivalent transgene cassette of SARS-CoV-2 S1 domain of spike, nucleocapsid and RNA polymerase genes (ChAd-triCoV/Mac).

Comparison of total event analysis and first event analysis in relation to heterogeneity in cardiovascular trials.

Background: In cardiovascular (CV) trials, analyzing the total number of events, rather than just time-to-first event, enhances understanding of participants' health. Adapting Cox models to account for between-subject heterogeneity in multiple events and understanding its impact plays crucial roles in total event analysis.

Method: This study compares effect sizes from first event and total event analyses in three cardiovascular trials: ORIGIN (N = 12,537, median follow-up of 6.

Protocol for the development of a transdiagnostic core outcome set for mental health disorders in adults: the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative.

Introduction: Mental health problems are important causes of disability and economic costs worldwide. Randomised clinical trials examining the treatment of mental health disorders measure heterogeneous outcomes, causing difficulties in data synthesis, interpretation and translation into clinical practice. The aim of the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative is to develop an overarching, transdiagnostic research-based and consensus-based core outcome set for adult mental health disorders.

Completeness of reporting of simulation studies on responder analysis methods and simulation performance: a methodological survey.

Objectives: To evaluate the completeness of reporting of simulation studies on responder analysis methods and simulation performance.

Design: Systematic methodological survey.

Data Sources: We searched Embase, MEDLINE (via Ovid), PubMed and Web of Science Core Collection from inception to 9 October 2023.

Effect of an Online Mobility Self-Management Program on Walking Speed in Older Adults With Preclinical Mobility Limitation: Protocol for a Randomized Controlled Trial.

Background: Walking difficulties are a common and costly problem. However, disability associated with the decline in walking ability is not an inevitable consequence. With an aging population, it is increasingly important to establish strategies to help older adults preserve the capacity to live independently and function well in late life.

Study protocol for the randomized controlled trial of EMBOLDEN: a multifaceted intervention aimed at Enhancing physical and community MoBility in OLDEr adults with health inequities using commuNity co-design.

Background: Reduced physical mobility is common in older adults and is associated with adverse outcomes, including functional decline, depression, social isolation, and poor nutritional status. Group-based programs focusing on physical activity and nutrition to support healthier lifestyles have demonstrated benefits, particularly when paired with social engagement activities. This paper presents the protocol for a randomized controlled trial (RCT) to test a lifestyle intervention called : a multifaceted intervention aimed at nhancing physical and community oility in r adults with health inequities using commuity co-design.

Master protocol for a series of cohort-based randomized controlled trials to test tools to communicate research results to study participants and others with relevant lived experience: the SPIN-CLEAR Trials.

Background: Research results are often not communicated to study participants or others with relevant lived experience. Effective communication of research results would help study participants understand their contribution to research and could improve trust in research and likelihood of research participation. Few randomized controlled trials (RCTs), however, have compared the effectiveness of research communication tools, and it is not known which tools work best for different people.

Risk Factors for Patient-Important Upper Gastrointestinal Bleeding.

Patient-important gastrointestinal bleeding is an endpoint developed by patients and family members; however, risk factors for this outcome are unknown. We sought to identify risk factors for patient-important upper gastrointestinal bleeding among invasively ventilated adults. This preplanned regression analysis of an international trial database evaluated baseline and time-varying risk factors in the preceding 3 days for patient-important upper gastrointestinal bleeding, accounting for illness severity and the competing risk of death.

SPIRIT 2025 statement: updated guideline for protocols of randomized trials.

The protocol of a randomized trial is the foundation for study planning, conduct, reporting and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols.

SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.

High quality protocols facilitate proper planning, conduct, reporting, and external review of randomised trials, yet their completeness varies and key elements are often not considered. To strengthen good reporting of trial protocols, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement has been updated to incorporate new evidence and emerging perspectives. This SPIRIT 2025 explanation and elaboration document provides users with exemplars of reporting in contemporary trial protocols, contextual elaboration, more detailed guidance on reporting, references to key empirical studies, an expanded checklist, and a link to a website for further information.