Trials最新文献

{"title":"Statistical analysis plan for the Prenatal Iodine Supplementation and Early Childhood Neurodevelopment (PoppiE) randomised controlled trial.","authors":"Thomas R Sullivan, Tim J Green, Jacqueline F Gould, Maria M Makrides, Karen P Best","doi":"10.1186/s13063-025-08863-1","DOIUrl":"10.1186/s13063-025-08863-1","url":null,"abstract":"<p><strong>Background: </strong>Observational evidence suggests both low and high iodine intakes in pregnancy are associated with poorer neurodevelopment in children. This raises concern that blanket recommendations for iodine supplementation in pregnancy may negatively impact child neurodevelopment in women with sufficient iodine intake from food alone.</p><p><strong>Methods: </strong>PoppiE (Prenatal Iodine Supplementation and Early Childhood Neurodevelopment) is a multi-centre, parallel, two-arm, clinician, researcher and participant blinded randomised controlled trial. Seven hundred fifty-four consenting pregnant women ≤ 13 weeks of gestation with an iodine intake of > 165 μg/day from food will be randomised to receive a multivitamin and mineral supplement containing 20 µg/day (intervention) or 200 µg/day (control) of iodine from enrolment until delivery. The primary outcome is the developmental quotient of infants at 24 months of age as assessed with the Cognitive Scale Score of the Bayley Scales of Infant Development, 4th Edition, to be analysed using linear regression with generalised estimating equations to account for multiple births. In this article, we comprehensively detail the planned statistical analyses of the PoppiE trial, including approaches to intercurrent events, methods for handling missing data and planned sensitivity analyses.</p><p><strong>Conclusions: </strong>PoppiE is the first trial to examine the effect of prenatal iodine supplementation on early childhood development in women with sufficient iodine intake from food. At the time of writing (February 2025), recruitment into the trial is complete and data collection is due to conclude in July 2026. The statistical analysis plan was finalised before the database lock, which will ensure study conclusions are not subject to bias due to data-driven analyses.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04586348. Registered on October 14, 2020.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"162"},"PeriodicalIF":2.0,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087031/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144102816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of levothyroxine monotherapy in lowering the risk of cardiovascular disease in older adults with subclinical hypothyroidism: research protocols of a multicenter, open-label, randomized controlled trial.","authors":"Chong Xu, Hui Zhou, Xiaofan Lu, Shuhang Xu, Yu Sun","doi":"10.1186/s13063-025-08857-z","DOIUrl":"10.1186/s13063-025-08857-z","url":null,"abstract":"<p><strong>Objective: </strong>This multicenter, open-label, randomized controlled trial (RCT) aims to assess the efficacy and safety of levothyroxine monotherapy in lowering the risk of cardiovascular disease (CVD) in untreated older adults with subclinical hypothyroidism (SCH) who are diagnosed according to population-specific TSH reference values.</p><p><strong>Methods: </strong>A total of 254 patients with SCH who meet the diagnostic criteria will be recruited, and the baseline clinical data of the patients will be collected. Then, a total of 127 patients will be randomly divided into each of the treatment and control groups, and the treatment group will receive daily levothyroxine doses (Merck Euthyrox® levothyroxine 50 mcg tablet). Specifically, 50 µg of levothyroxine per day will be administered to patients in the treatment group (or 25 µg to patients with a body weight < 50 kg) for at least 48 weeks to maintain thyroid-stimulating hormone (TSH) levels within the normal range. The participants in the control group will be subjected only to thyroid status evaluation, and the results will be recorded. The participants will complete five visits before and after the start of the trial, and differences in the change in carotid intima-media thickness (CIMT), maximum mean change in plaque burden, and changes in lipid profiles, bone mineral densities, and incidences of fatal and nonfatal cardiovascular events between the initial visit and the last follow-up visit will be evaluated via vascular ultrasound.</p><p><strong>Discussion: </strong>We will explicitly address whether levothyroxine replacement therapy provides cardiovascular benefits for older adults with subclinical hypothyroidism.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov, No. ChiCTR2400092634. Registered on 30 November 2024. Recruitment for this study began on December 1, 2024, and continues until at least until November 30, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"161"},"PeriodicalIF":2.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083150/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What is the effect of the Informed Health Choices secondary school intervention on the ability of students in Rwanda to think critically about health choices after one-year follow-up? A cluster-randomized trial.","authors":"Michael Mugisha, Laetitia Nyirazinyoye, Dieudonne Kayiranga, Clarisse Marie Claudine Simbi, Faith Chesire, Ronald Senyonga, Matt Oxman, Allen Nsangi, Christopher James Rose, Jenny Moberg, Astrid Dahlgren, Margaret Kaseje, Simon Lewin, Nelson K Sewankambo, Sarah Rosenbaum, Andrew D Oxman","doi":"10.1186/s13063-025-08779-w","DOIUrl":"10.1186/s13063-025-08779-w","url":null,"abstract":"<p><strong>Aim: </strong>The aim of this study was to evaluate the effects of the Informed Health Choices secondary school intervention on the ability of students in Rwanda to think critically and make informed health choices after 1 year.</p><p><strong>Methods: </strong>This was a two-arm cluster-randomized trial conducted in 84 lower secondary schools from 10 districts representing five provinces of Rwanda. We used stratified randomization to allocate schools 1:1 to the intervention or control arm. One class in each intervention school had ten 40-min lessons taught by a trained teacher in addition to the usual curriculum. Control schools followed the usual curriculum. The primary outcome was a passing score (≥ 9 out of 18 questions answered correctly) for students on the Critical Thinking about Health Test completed 1 year after the intervention. We conducted an intention to treat analysis using generalized linear mixed models, accounting for the cluster design using random intercepts.</p><p><strong>Results: </strong>After 1 year, 35 of 42 teachers (83.3%) and 1181 of 1556 students (75.9%) in the control arm completed the test. In the intervention arm, 35 of 42 teachers (83.3%) and 1238 of 1572 students (78.8%) completed the test. The proportion of students who had a passing score in the intervention arm was 625/1238 (50.5%) compared to 230/1181 (19.5%) in the control arm (adjusted odds ratio 7.6 [95% CI: 4.6-12.6], p < 0.0001). The adjusted difference in the proportion of students with a passing score was 32.2% (95% CI 24.5-39.8%).</p><p><strong>Conclusions: </strong>The IHC secondary school intervention was effective after 1 year. However, the size of the effect was smaller than immediately after the intervention (adjusted difference 32.2% vs 37.2%) due to decay in the proportion of students in intervention schools with a passing score (50.5% vs 58.2%).</p><p><strong>Trial registration: </strong>Pan African Clinical Trial Registry (PCTR), trial identifier: PACTR202203880375077. Registered on February 15, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"160"},"PeriodicalIF":2.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12082997/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical trial budgeting approaches in Switzerland-a meta-research study.","authors":"Alexandra Griessbach, Malena Chiaborelli, Klaus Ehrlich, Regina Grossmann, María De Medina Redondo, Aurélie Fayet, Reinhard Maier, Sven Trelle, Angèle Gayet-Ageron, Alessandro Ceschi, Benjamin Speich, Matthias Briel","doi":"10.1186/s13063-025-08855-1","DOIUrl":"https://doi.org/10.1186/s13063-025-08855-1","url":null,"abstract":"<p><strong>Background: </strong>Conducting clinical trials is resource demanding. Mirroring challenges experienced elsewhere, clinical trials conducted in Switzerland often face overoptimistic budget estimations and insufficient funding, leading to trial discontinuation and research waste. As a first step to address this problem, we investigated the current approaches to estimate clinical trial budgets in Switzerland.</p><p><strong>Methods: </strong>We collected and examined the budgeting tools and approaches for clinical trials provided by the seven Swiss clinical trial units (CTUs) and the Swiss National Science Foundation (SNSF). We compared available approaches to the publicly accessible budgeting tool of the Belgian Health Care Knowledge Centre (KCE). For each approach, we collected data about user-testing, the availability of prespecified cost items, and estimates on cost ranges.</p><p><strong>Results: </strong>We found substantial heterogeneity in budget calculation approaches used by Swiss CTUs. None of the currently used tools and approaches provided by the seven CTUs or the SNSF was user-tested and neither supplied cost ranges for investigators to rely on. Five CTU tools included a detailed list of cost items. The SNSF provided a costing template with broad categories and is available for open grant applications only. One CTU tool was publicly available. The publicly available Belgian KCE tool was developed with user feedback and provided a detailed list of cost items, some cost ranges, and an instruction manual.</p><p><strong>Conclusion: </strong>Stakeholders should consider improving budgeting practices in Switzerland by standardizing cost items and user-testing approaches. The continuously improved Belgian KCE tool could provide orientation.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"158"},"PeriodicalIF":2.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving retention of pediatric feeding tubes with a nasal bridle: a randomized controlled trial.","authors":"Megan Foster, Veronica Armijo-Garcia, Jonathan Gelfond, Andrew D Meyer","doi":"10.1186/s13063-025-08867-x","DOIUrl":"https://doi.org/10.1186/s13063-025-08867-x","url":null,"abstract":"<p><strong>Background: </strong>Nasoenteric feeding tubes are necessary in hospitalized children to deliver nutrition and medication. Traditionally, adhesive tape secures these feeding tubes but fails to prevent 40% of tube dislodgements. The nasal bridle, a thin plastic anchor placed around the vomer bone, is an increasingly used method for tube securement. Our objective is to compare AMT Bridle Pro® nasal bridle versus conventional tape to safely reduce tube dislodgement in pediatric patients.</p><p><strong>Methods: </strong>A prospective, open-label randomized controlled trial was carried out between February 2020 and January 2021 at a tertiary pediatric hospital. Infants, children, and adolescents less than 18 years of age with an order to place a nasogastric or post-pyloric feeding tube were approached for enrollment. Exclusion criteria included facial trauma, nasal airway obstruction, or thrombocytopenia. After obtaining consent, patients were randomized to AMT Bridle Pro® nasal bridle or conventional tape to secure the feeding tube. The primary outcome was the frequency of feeding tube dislodgement, defined as unintentional tube removal or change in position. Secondary outcomes included days to feeding tube dislodgement, number of dislodgements per 10 tube days, resource use, and complications from tube securement.</p><p><strong>Results: </strong>A total of 35 patients were randomized and equally split to the bridle (n = 17) and tape arm (n = 18). The primary analysis revealed the rate of feeding tube dislodgement over 30 days was significantly higher in the tape group compared to the bridle group with an attributable risk reduction of 57% (hazard ratio = 6.3, 95% CI 2.4-16.5, p < 0.001). After 30 days, tubes dislodged at a proportion 88% (15) in the tape arm compared to 31% (5) in the bridle arm (risk ratio = 2.82; 95% CI: 1.34-5.96; p = 0.001). There were no serious adverse events. Four patients in the tape group developed erythema and skin breakdown where the tube was secured with tape. One patient was withdrawn from the bridle group because they developed erythema on the nasal septum after placement, which resolved quickly upon removal of the bridle.</p><p><strong>Conclusion: </strong>Securing nasoenteric feeding tubes with the AMT Bridle Pro® can effectively reduce tube dislodgements in hospitalized children.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04621734. Registered on November 3, 2020. https://clinicaltrials.gov/search?cond=NCT04621734 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"159"},"PeriodicalIF":2.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12080054/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A complex behaviour change intervention delivered by dental nurses: mixed-methods fidelity assessment of the RETURN intervention.","authors":"V Lowers, P Christiansen, B Young, J Hennessy, R V Harris","doi":"10.1186/s13063-025-08856-0","DOIUrl":"10.1186/s13063-025-08856-0","url":null,"abstract":"<p><strong>Introduction: </strong>Behaviour change interventions delivered in dental settings could be useful in reducing oral health inequalities. Pragmatic randomised controlled trials testing interventions, however, are vulnerable to problems with internal and external validity. Intervention fidelity strategies are helpful to address methodological problems and to provide scientific assurances about trial results. This paper sets out the intervention fidelity assessment of the RETURN intervention which was delivered in dental settings to promote planned dental visits.</p><p><strong>Methods: </strong>The assessment was guided by the National Institutes of Health Behaviour Change Consortium intervention fidelity framework domains of training and delivery. A mixed-methods design was selected, using quantitative data collected during intervention delivery training, together with qualitative observations (n = 58), interviews (n = 13) and audio-recordings of intervention delivery sessions (n = 472). Data were analysed separately using descriptive statistics and multiple logistic regression for the quantitative data and reflexive thematic analysis for the qualitative data. Data were integrated to provide a comprehensive fidelity assessment.</p><p><strong>Results: </strong>Dental nurses were successfully trained to deliver the RETURN intervention; training was successfully standardised, and skills drift minimised. Training presented challenges, and not all nurses achieved competency sign-off to deliver the intervention independently. Nurse characteristics such as dental nursing experience, wider trial procedures and confidence were all found to impact training success. The RETURN intervention was judged to have been delivered with high levels of fidelity, despite few interventions reaching the pre-determined fidelity threshold. Fidelity levels of between 75% and 85% were achieved across intervention domains. Interventionist, intervention dose and intervention topic (dental visiting barrier) were all found to have a relationship with fidelity levels.</p><p><strong>Conclusions: </strong>Dental nurses can be trained to deliver a brief behaviour change intervention alongside their usual clinical roles, and this can be delivered with a high degree of intervention fidelity. The results from this fidelity assessment provide assurances about the scientific validity of the RETURN trial results. Recommendations about the suitability of dental nurse interventionists within future dental trials are discussed.</p><p><strong>Trial registration: </strong>ISRCTN 84666712. Registered on 12/04/2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"156"},"PeriodicalIF":2.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070712/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144051920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transforming healthcare by prioritizing qualitative and quantitative clinical trial evidence: evaluating the Aging, Community and Health Research Unit's Community Partnership Program for Older Adults (ACHRU-CPP).","authors":"Kathryn Fisher, Soo Chan Carusone, Rebecca Ganann, Maureen Markle-Reid, Melissa Northwood, Diana Sherifali","doi":"10.1186/s13063-025-08839-1","DOIUrl":"10.1186/s13063-025-08839-1","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to test the effectiveness and implementation of a complex integrated care intervention for older adults. We collected both quantitative and qualitative data, which is recommended in evaluating complex interventions to gain a comprehensive understanding of key success factors. Often, congruence is sought and considered desirable when integrating the findings from both data types. However, data are not always congruent, nor is it suboptimal when incongruence occurs, as we illustrate in this case study. We present the divergent findings from a large community-based implementation-effectiveness hybrid type II trial, and how the struggle to reconcile incongruent results yielded rich insights informing the next steps for translational research on the intervention being tested.</p><p><strong>Methods: </strong>Previous foundational research, including a pilot study and randomized controlled trial (RCT), showed promising results and supported proceeding with a multi-site pragmatic hybrid type II effectiveness-implementation RCT. This recent RCT was undertaken and quantitative and qualitative data were collected to inform the effectiveness and implementation evaluation. To synthesize the findings and guide integration of this large body of evidence, we developed a conceptual model which combined two existing frameworks: the Consolidated Framework for Implementation Research and Quintuple Aim. We used this model to identify the evidence and relate it to relevant implementation and intervention determinants/outcomes. We then synthesized the evidence to distall the main messages regarding the future of the intervention, which involved reconciling apparently discrepant findings from the quantitative and qualitative approaches.</p><p><strong>Results: </strong>The current RCT showed no statistically significant effect for participants for the primary (or secondary) outcomes yet the implementation evaluation consistently found perceived benefits of the intervention for patients, providers, and the healthcare system. Qualitative evidence was critical in understanding contextual factors potentially responsible for the absence of a treatment effect (e.g., COVID-19), strategies to overcome challenges experienced in participant engagement and intervention delivery, and recent policy/practice setting changes which showed strong alignment with the intervention and supported its future implementation.</p><p><strong>Conclusions: </strong>With the goal of the hybrid type II effectiveness and implementation study in mind, stakeholders encouraged proceeding with a scalability assessment to consider the evidence from the current trial within the context of our prior research, the broader literature for similar interventions, and the ever-changing policy context.</p><p><strong>Trial registration: </strong>clinicaltrials.gov NCT03664583. Registration date: September 10, 2018.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"154"},"PeriodicalIF":2.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070794/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144012030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Smartphone virtual reality for pain management during pediatric burn care transition: study protocol for a randomized controlled trial.","authors":"Megan Armstrong, Amber Price, Rebecca Coffey, Dana Noffsinger, Rajan K Thakkar, Renata B Fabia, Jonathan I Groner, Samuel Mandell, Ai Ni, Henry Xiang","doi":"10.1186/s13063-025-08860-4","DOIUrl":"10.1186/s13063-025-08860-4","url":null,"abstract":"<p><strong>Background: </strong>Burn injuries severe enough to result in emergency department visits are a large burden for US children. Treatment for these injuries often involves daily dressing changes at home, which can be very painful and anxiety-inducing. This trial aims to evaluate the efficacy of a virtual reality therapeutic for pain and anxiety alleviation during repeated at-home burn dressing changes among pediatric patients.</p><p><strong>Methods: </strong>Two hundred children with burn injuries requiring daily dressing changes will be recruited from two American Burn Association-verified burn centers in the USA for this randomized, controlled, two-arm clinical trial with a 1:1 allocation ratio. During each dressing change at home, the intervention group will play the Virtual Reality Pain Alleviation Therapeutic (VR-PAT) game and answer questions about their pain, anxiety state, pain medication usage, simulator sickness symptoms, and experience playing the game. The control group will perform their dressing as usual without the VR-PAT and answer questions about their pain, anxiety state, and pain medication usage. The primary outcome is the difference in self-reported pain and anxiety between the two groups over their week of dressing changes.</p><p><strong>Discussion: </strong>The transition of burn injury treatment from the medical center to the home can increase anxiety for children and their parents. Virtual reality is a promising digital technology that can improve wound care for these children. Findings from this trial will provide data on the efficacy of the VR-PAT for reducing self-reported pain and anxiety during daily home dressing changes for pediatric burn care. The results from this trial will serve as evidence for a large-scale implementation study.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05673551. Registered on December 21, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"157"},"PeriodicalIF":2.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12076937/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144039873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A review of the statistical analysis of randomised controlled trials conducted within OCTRU.","authors":"Alexander Ooms, Caitlin Waldron, Daphne Kounali, Ioana R Marian, M Sofia Massa, Nicholas Peckham, Matthew Parkes, Elizabeth Conroy, Jonathan A Cook","doi":"10.1186/s13063-025-08764-3","DOIUrl":"10.1186/s13063-025-08764-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Despite a proliferation of statistical methodologies and developments within randomised controlled trials (RCTs) in recent decades, it is unclear which approaches are being implemented in practice. Oxford Clinical Trials Research Unit (OCTRU) is a UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Unit (CTU) that has been operational since 2013 based in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford. We performed a review of all published RCTs conducted within OCTRU, with particular emphasis on trial methodology, statistical study design and statistical analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Studies were considered eligible if they were: RCTs conducted by OCTRU, have been completed and disseminated their primary results. Studies were ineligible if they were: a pilot or feasibility trial, a simulation study, a secondary analysis of an existing RCT, or a phase I trial. Phase II trials were considered if they were randomised. We performed double data extraction of all fields for all eligible trials. General trial information, such as primary disease area, main funding source, sample size, trial design and analysis information (e.g. number of study outcomes and analyses performed), were extracted and summarised. An analysis was defined as any time a statistical model was fit or a corresponding statistical test (e.g. χ&lt;sup&gt;2&lt;/sup&gt; test) and/or estimation of a parameter was performed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 142 OCTRU studies registered & funded (as of June 2023), 70 were completed and written up and 27 were eligible at the time of this review. The rest were ongoing or found to be ineligible. Included studies were published between 2014 and 2023, the majority in the last 5 years (20/27, 74% published between 2020 and 2023). All trials were multi-centre, prospectively designed and referred to both a study protocol and sample size justification (usually a power calculation) in their published results. Most included studies had elements of what could be referred to as a 'standard' RCT; used a parallel group design (93%), powered with superiority question (26/27, 96%), had two randomised groups (23/27, 85%) or used an equal allocation ratio (25/27, 93%). The median sample size was 451 (interquartile range: 238-836). The median total number of analyses performed was 22 (Interquartile range: 14-30) with the most analyses performed within a single trial being 69. Eighty-one per cent (22/27) of trials had a primary outcome with either binary or continuous data. Linear mixed effects, linear regression or logistic regression was used as the primary analysis model in 74% of the 27 trials. All trials that included at least one analysis (26/27) featured at least one additional analysis on the primary outcome, the most popular additional analyses were on an alternative population (for example a per-protocol population), occurring in ","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"153"},"PeriodicalIF":2.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144034106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A brief online mindfulness intervention: study protocol for Indonesian undergraduate students, a randomized controlled trial.","authors":"Ka Yan, Nessa Ikani, Cleoputri Yusainy, Cilia Witteman, Jan Spijker","doi":"10.1186/s13063-025-08858-y","DOIUrl":"10.1186/s13063-025-08858-y","url":null,"abstract":"<p><strong>Background: </strong>Elevated levels of stress, anxiety, and depression persist among undergraduate students in Eastern countries, including Indonesia. Access to mental healthcare resources, however, remains difficult and costly for most young people. Furthermore, there is a strong tendency to avoid seeking professional help. The primary aim of this study is to investigate the effects of a brief 14-day online mindfulness intervention in reducing stress, anxiety, depressive symptoms, and repetitive negative thinking (RNT) among a representative sample of Indonesian undergraduate students. Given the mixed empirical evidence on the role of RNT in mindfulness, the secondary aim is to investigate the mediating role of RNT in the effects of mindfulness on stress, anxiety, and depressive symptoms.</p><p><strong>Methods: </strong>Within this study, participants assigned to the mindfulness intervention will be compared to those allocated to psychoeducational and waitlist conditions. The Depression, Anxiety, and Stress Scale 21 (DASS-21), the Five Facet Mindfulness Questionnaires (FFMQ), and the Perseverative Thinking Questionnaire (PTQ) will be assessed at baseline, post-condition evaluation, and a subsequent follow-up assessment 3 months following the intervention period. Throughout the intervention phase, participants will complete daily questionnaires and have the option to maintain a daily journal.</p><p><strong>Discussion: </strong>The findings from this randomized controlled trial will provide evidence for the possible effectiveness of a brief online mindfulness intervention on stress, anxiety, depression, and RNT. This online intervention could serve as an easily accessible and low-threshold strategy conducive to enhancing mental health and well-being of the Indonesian population.</p><p><strong>Trial registration: </strong>NCT05882565 (ClinicalTrials.gov), retrospectively registered on May 21, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"155"},"PeriodicalIF":2.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070549/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144034104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}