Trials

IntroductionAdverse event (AE) reporting transparency is essential for evidence-based surgical practice, yet substantial reporting gaps persist despite Consolidated Standards for Reporting Trials (CONSORT) Harms guidance. The Medical Dictionary for Regulatory Activities (MedDRA) provides standardized terminology for AE classification, but its association with AE reporting quality remains unexplored. ObjectivesThe purpose of this study was to establish the frequency of Medical Dictionary for Reg...

BackgroundExperts across industry, academia, and regulatory bodies increasingly stress the importance of prioritising participant experiences in clinical trials. Simultaneously, the shift towards decentralised approaches is reshaping how trials are designed and conducted, with a direct impact on the experiences of the participants involved. ObjectiveThis study aims to gain a deeper understanding of the experiences of participants taking part in Decentralised Clinical Trials, focusing on the uni...

ObjectiveAntimicrobial resistance (AMR) is an urgent global health threat, resulting in more than 5 million deaths globally in 2019. Timely and complete antimicrobial agent (AMA) clinical trial results reporting is essential to evaluate the safety and efficacy of investigational therapies. The Food and Drug Administration Amendments Act (FDAAA) of 2007 mandated results reporting for applicable clinical trials to ClinicalTrials.gov. After nearly ten years of underreporting, the HHS issued the Fin...

IntroductionPatient populations in Canadian community and academic hospitals may differ with respect to demographic and clinical characteristics, as well as outcomes. Community hospitals may also differ with respect to research capacity and trial performance. The objectives of this study are to examine differences between community and academic hospitals participating in the REVISE trial with respect to: 1) patient characteristics; 2) research capacity, and 3) trial metrics. Methods and analysi...

The terms personalized, individualized and precision medicine are increasingly used to describe health interventions, yet their operational meaning in clinical research remains unclear. Despite extensive conceptual discussion, there is limited empirical evidence on how these labels are applied in randomized controlled trials (RCTs) and whether such trials meet standards of transparency and methodological rigor. We systematically examined 262 RCTs published between 2020 and 2022 that used the ter...

BackgroundThe optimal model for delivering Tele-ICU is still to be determined. Previous clinical trials focused on medical-led daily multidisciplinary rounds (DMRs), showing certain improvements in processes of care but without direct evidence for improvement in clinical outcomes. ObjectiveTo evaluate whether a structured Tele-ICU intervention, comprising DMRs led by an intensivist plus a multidisciplinary care bundle (nursing, physical therapy, pharmacy) and a quality and safety management pac...

BACKGROUNDThe safety and feasibility of telemedicine in intensive care units (ICU) are well established. However, whether tele-ICU exerts a measurable impact on clinically relevant outcomes remains uncertain. METHODS AND ANALYSISThe TELESCOPE 2 is a multicenter, open-label, stepped-wedge cluster randomized controlled trial including 25 ICUs in Brazil from January 2024 to January 2026. In a stepped-wedge assignment, ICUs will be randomized and allocated into one of five sequences. All ICUs will ...

BackgroundThe strength and transparency of clinical trial evidence supporting drug approvals has become increasingly scrutinized, particularly considering the increased use of regulatory flexibility and expedited pathways. While U.S. Food and Drug Administration (FDA) standards have been extensively analyzed, evidence standards at the European Medicines Agency (EMA) remain less well-characterized. Thus, this study aims to systematically assess the design, quality, and outcomes of pivotal efficac...

BackgroundClinical research coordinators play a crucial role in ensuring the scientific rigor, regulatory compliance, and operational integrity of clinical trials. However, in Africa, they often lack access to structured, competency-based training, especially in operational, regulatory, and trial management domains. This study evaluated the effectiveness of a comprehensive training intervention designed to standardize and enhance core competencies of clinical trial coordinators. MethodsWe condu...

IntroductionRecent evidence from randomized controlled trials and meta-analyses in the critically ill suggest small but clinically important differences in death and requirement for renal replacement therapy that favor Ringers lactate as compared to normal saline. To futher contribute to this evidence base, we will perform a secondary analysis of the FLUID trial with a focus on critically ill patients (FLUID - ICU). The FLUID trial was hospital wide cluster randomized cross-over trial that compa...

This study aimed to systematically review and critically evaluate the risk of bias and applicability of surgical site infection (SSI) risk prediction models after spinal surgery. China National Knowledge Infrastructure, Wanfang Database, China Science and Technology Journal Database (VIP), SinoMed, PubMed, Web of Science, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, and Embase were searched from inception to April 10, 2025. The prediction model risk of bias ass...

Withdrawal StatementThe authors have withdrawn this manuscript because We request withdrawal as the current version is incomplete and requires additional experimental data. Therefore, the authors do not wish this work to be cited as reference for the project. If you have any questions, please contact the corresponding author.

BackgroundThe FACE-Q Skin Cancer Module is a condition-specific patient-reported outcome measure for facial skin cancer. While its psychometric properties have been established, normative reference values that enable score interpretation in clinical practice and research are lacking. ObjectiveTo establish normative reference values for the FACE-Q Skin Cancer Module using preoperative patient data and to validate these values by comparison with a demographically matched cohort of healthy partner...

BackgroundAdapted dance is a promising rehabilitation intervention for physical and psychosocial impairments in people with chronic stroke. However, in-person attendance is hindered by limited community ambulation, transportation, and schedule conflicts. At-home participation with a live-streamed dance program could address these issues, but psychosocial benefits may be diminished because of reduced social interactions. The primary objective of this study was to assess the feasibility and safety...

BackgroundThere is growing evidence that individuals with different skin phototypes require tailored approaches to achieve optimal photoprotection. Individuals with darker skin phototypes are more prone to UVA1- and visible light-induced pigmentation, whereas lighter phototypes are more susceptible to shorter wavelengths such as UVB and UVA2. Thus, skin phototype is an important determinant of sunscreen efficacy. In the present study we have asked if ethnicity - independent of phototype - is ano...

Clinical trials shape medical evidence and determine who gains access to experimental therapies. Whether participation in these trials reflects the global burden of disease remains unclear. Here we analyze participation inequality across more than 62,000 randomized controlled trials spanning 16 major disease categories from 2000 to 2024. Linking 36.8 million trial participants to country-level disease burden, we show that global inequality in clinical trials participation is overwhelmingly shape...

IntroductionEngaging individuals with lived experience enhances the rigor and real-world relevance of clinical research. In adolescent idiopathic scoliosis (AIS), where non-surgical evidence remains limited, involving patients and caregivers informs design, recruitment, and retention for future trials. MethodsUsing the Community Engagement (CE) Studio model, we conducted a 1.5-hour virtual session with children aged 10-16 years with AIS and their caregivers residing in North America. Participan...

BackgroundEffective education improves hypertension self-management but is not routinely delivered, and there is limited guidance to overcome barriers to support delivery in primary care. This study aimed to use co-design and an implementation science framework to develop and prioritize implementation strategies for the delivery of patient education to support blood pressure (BP) management across the hypertension journey in primary care. MethodsA two-stage, co-design study using implementation...

BackgroundMedical students represent a critical population for photoprotection education, as future physicians responsible for skin cancer prevention counseling. However, no previous studies have characterized knowledge, attitudes, and practices (KAP) regarding photoprotection among medical students in Central America or the Caribbean. ObjectiveTo assess KAP related to photoprotection and identify associated factors among medical students at a Nicaraguan university. MethodsA cross-sectional st...

BackgroundPsychedelics exert widespread effects on brain activity, but their impact on motor function is unclear. This is clinically relevant given the emerging interest in psychedelic-assisted physical therapy for disorders of motor function. This studys primary objectives examined the feasibility and safety of administering movement tasks following low-to-moderate doses of psilocybin in healthy volunteers. MethodsHealthy participants were randomly assigned three psilocybin doses consisting of...