Trials最新文献

{"title":"Effects of opioid-free anesthesia combined with iliofascial nerve block on perioperative neurocognitive deficits in elderly patients undergoing hip fracture surgery: study protocol for a prospective, multicenter, parallel-group, randomized controlled trial.","authors":"Tong Zhi, Shirong Wei, Jiao Kuang, Sitong Zhou, Danhong Yu, Tesheng Gao, Long Lei, Chengfei Xu, Liang Cheng, Qinghe Zhou, Ming Yao, Huadong Ni","doi":"10.1186/s13063-025-08828-4","DOIUrl":"https://doi.org/10.1186/s13063-025-08828-4","url":null,"abstract":"<p><strong>Background: </strong>Perioperative neurocognitive dysfunction (PND), a prevalent complication affecting elderly surgical patients, poses substantial challenges to postoperative rehabilitation and long-term functional independence. Despite growing awareness of its clinical significance, current evidence regarding effective neuroprotective anesthetic strategies remains inconclusive. Where emerging evidence suggests opioid-free anesthesia (OFA) strategies could maintain analgesic efficacy while potentially attenuating opioid-associated neuroinflammatory mechanisms implicated in PND pathogenesis. This multicenter trial investigates the efficacy of OFA combined with ultrasound-guided iliofascial nerve block in mitigating PND among geriatric patients undergoing hip fracture surgery.</p><p><strong>Methods: </strong>This multicenter, randomized controlled trial will enroll 348 patients, who will be randomly assigned to receive either OFA combined with iliofascial nerve block or opioid-based anesthesia (OBA) combined with iliofascial nerve block. All patients will undergo hip fracture surgery under general anesthesia with tracheal intubation. The primary outcome will be the change in composite neurocognitive scores, assessed through a battery of neuropsychological tests from baseline to 3 months postoperatively. Secondary outcomes include alterations in serum protein and inflammatory markers, extubation time, postoperative pain incidence, intraoperative hemodynamic stability, and postoperative recovery parameters. The safety profile of OFA in hip surgery will also be assessed.</p><p><strong>Discussion: </strong>Effective prevention of PND is crucial for optimizing postoperative recovery and long-term functional outcomes in elderly patients. This trial aims to refine and optimize anesthesia management strategies to reduce the incidence of PND, improve postoperative quality of life, and ultimately enhance perioperative neurocognitive outcomes.</p><p><strong>Trial registration: </strong>This trial protocol was registered with the China Clinical Trial Registry on December 14, 2023, under the registration number: ChiCTR2300078647.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"122"},"PeriodicalIF":2.0,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143789242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Time, money, and weight loss: a qualitative study exploring patients' perspectives on randomization for bariatric surgery vs. an intensive non-surgical weight loss program.","authors":"Sofie Amalie Tomova-Olsen, Marius Brostrøm Kousgaard, Katrine Tranberg Jensen, Susanne Reventlow, Ann-Kathrin Lindahl Christiansen, Kirstine Nyvold Bojsen-Møller, Carsten Dirksen, Gritt Overbeck","doi":"10.1186/s13063-025-08816-8","DOIUrl":"https://doi.org/10.1186/s13063-025-08816-8","url":null,"abstract":"<p><strong>Background: </strong>Randomized controlled trials (RCTs) are foundational in advancing medical knowledge and patient care, offering high-quality evidence on the comparative effectiveness of healthcare interventions. However, a common challenge for RCTs is the recruitment of trial participants. To understand and overcome potential obstacles in recruitment for a clinical trial (the LightBAR trial, NCT06309238) comparing the effectiveness of bariatric surgery versus an intensive weight loss program, a qualitative study was conducted.</p><p><strong>Methods: </strong>Nine patients from the public bariatric surgery waiting list participated in focus groups at a hospital in the Capital Region of Denmark. Vignette scenarios were utilized to prompt participants to reflect on barriers and facilitators for participation. Three patients participated in a follow-up interview. Data was analyzed using thematic analysis.</p><p><strong>Results: </strong>Analysis revealed four main themes: (1) having waited long for surgery reduced participants' willingness to be randomized; (2) the cost of weight loss medication was a major concern for participants; (3) participants were concerned about the extra work involved in program participation; and (4) participants weighed the efficacy and potential negative side effects of surgery against those of an intensive weight loss program based on personal beliefs and experiences.</p><p><strong>Conclusions: </strong>Tailoring the recruitment strategy to patients' circumstances and concerns, and providing clear, patient-centered communication about the nature and potential implications of participating in the trial may improve recruitment success.</p><p><strong>Trial registration: </strong>The LightBAR trial (NCT06309238). Registered on ClinicalTrials.gov on May 2, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"121"},"PeriodicalIF":2.0,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143789243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immunoadsorption study Mainz in adults with post-COVID syndrome (IAMPOCO)-a single-blinded sham-controlled crossover trial to evaluate the effect of immunoadsorption on post-COVID syndrome.","authors":"Marco Stortz, Pascal Klimpke, Andreas Kommer, Philipp Gründer, Livia Steenken, Christian Dresel, Daniel Kraus, Irene Schmidtmann, Arndt Weinmann, Julia Weinmann-Menke","doi":"10.1186/s13063-025-08825-7","DOIUrl":"10.1186/s13063-025-08825-7","url":null,"abstract":"<p><strong>Background: </strong>Post-COVID syndrome (PCS) affects up to 43% of all SARS-CoV-2-infected persons and describes ongoing symptoms months after the acute infection. Despite the large number of affected people, there is still very little evidence about therapeutic options. Some studies suggest at least partially a role of autoantibody-mediated autoimmunity. Immunoadsorption is an extracorporeal therapy to remove circulating antibodies which is used successfully in several autoimmune diseases. We conceived the IAMPOCO trial to evaluate the therapeutic effect of immunoadsorption in patients with PCS.</p><p><strong>Methods: </strong>IAMPOCO is a single-center randomized sham-controlled trial with a crossover design which will enroll 40 participants with PCS and a symptom severity of at least 2 on post-COVID functional scale. All participants will undergo 5 immunoadsorption treatments and after a washout period of 8 weeks 5 sham treatments or vice versa. Which modality is conducted first will be randomized. Patients but not providers of therapy are blinded for which modality is conducted. Primary outcome is the efficacy of IA to the severity of PCS measured by the change of several symptom scores and hand grip strength. Secondary outcomes are the frequency of adverse events and the prevalence of relevant autoantibodies in participants with PCS as well as the concentration of autoantibodies before and after therapy and sham treatment.</p><p><strong>Discussion: </strong>The trial addresses the lack of evidence for treatment options in PCS. By using a crossover design and including a sham treatment arm, the study aims to compare the effects of immunoadsorption and sham therapy within the same patients. The trial also benefits from recruiting participants from a cohort study on PCS prevalence, ensuring a thorough evaluation of symptoms. Objective assessments of symptoms are challenging due to their subjective nature, but various scoring systems and tests are being utilized. Despite the lack of data from RCTs, the results of this study have the potential to significantly improve PCS therapy and support evidence-based treatment decisions.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05841498. Registered on May 3, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"119"},"PeriodicalIF":2.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11966871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143773462","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":"Pragmatic clustered randomised control trial to evaluate a self-regulated learning intervention to be implemented in South Australian primary schools-study protocol.","authors":"S A Brinkman, B Lam, S Dawson, R Marrone, D Schunk, K Winkel, H Hermes, F Gabriel, S Fowler, D Engelhardt","doi":"10.1186/s13063-025-08814-w","DOIUrl":"10.1186/s13063-025-08814-w","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Self-regulated learning (SRL) is described as a process whereby learners actively take control of their learning by setting goals, planning, monitoring, evaluating, and adjusting their learning strategies to improve performance and achieve desired outcomes Panadero (Front Psychol 8:422, 2017). SRL proficiency has been shown to predict educational success and lifelong outcomes, such as income and health. While SRL is recognised as a key lifelong competency, there remain questions regarding how educators can best develop and promote SRL in school settings. A scalable, low-cost intervention targeted at grade 1 students (6-7 years old) in Germany was found to have substantial effects on impulse control and self-regulated learning, with sustained impacts on long-term academic success Schunk (Nat Hum Behav 6(12):1680-90, 2022). This study protocol seeks to adapt the Schunk et al. (2022) randomised trial to the Australian content and extend it to grades levels 2, 4 and 6.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will use a standard pragmatic clustered (by school) randomised controlled superiority trial with an additional population-wide matched parallel control arm. Effectively, we will conduct three trials-one for each age/grade level. Each trial will be powered to assess the impact of the intervention on the age/grade groups independently: grade 2 (early primary, 7-8 years), grade 4 (mid primary, 9-10 years), and grade 6 (late primary, 11-12 years). Schools assigned to the treatment group will have all three grade levels (grades 2, 4, and 6) receiving the treatment (at least one class per grade); no classes in the schools assigned to the control group will receive the intervention. A minimum of 56 schools with an average cluster size of 19 children/class will be required to detect a minimum impact of 0.25 SD effect size at 80% power taking into account the clustered design with an intraclass correlation coefficient (ICC) of 0.05. This results in a total sample of 1064 per grade and thus 3192 students in total (56 schools per arm × 19 students in an average-sized class × three grade levels). Randomisation will occur on a 1:1 ratio, such that half of the schools (n = 28), and effectively about half of the students (n = 1596) will receive the intervention. The primary outcome will be improved self-regulation assessed at 6 weeks, 6 months and 12 months post the intervention. Longer-term secondary outcomes will include academic and wellbeing measures obtained through administrative data linkage to the National Assessment Program in Literacy and Numeracy (NAPLAN) outcomes and the Wellbeing and Engagement Collection (WEC) outcomes measures in the year following implementation (grades 3, 5, and 7). Follow-up via the South Australia Data Linkage Systems will allow for longer-term academic outcomes, mental health, school completion, criminal justice, and tax data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;This protocol paper provides a detail","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"120"},"PeriodicalIF":2.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11967115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143781235","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":"Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America.","authors":"Samuel Byiringiro, Juliana K Garcia, Nsenga Farrell, Bunmi Ogungbe, Rifath Ara Alam Barsha, Hailey N Miller, Evans Whitaker, Paul Wang, William E Rosa, Barbara E Bierer, Cheryl R Himmelfarb, Erin D Michos, Koen De Lombaert, Maya Berdichesky, Stephan Busque, Latha Palaniappan, Eldrin Lewis, Fatima Rodriguez, Hannah Valantine","doi":"10.1186/s13063-025-08820-y","DOIUrl":"10.1186/s13063-025-08820-y","url":null,"abstract":"<p><p>The lack of diversity in clinical studies has significant ethical and health consequences, limiting the development of effective treatments for diverse populations. Homogeneous participation in clinical studies contributes to health disparities, particularly among historically underrepresented groups in the United States (US). Racial, ethnic, and other minoritized populations have long been excluded from clinical research. In response, the US Congress mandated the National Institutes of Health to assess the impacts of insufficient diversity in clinical studies. Despite efforts by the government, non-profit organizations, and industry players to improve diversity in clinical studies, progress has been slow due to fragmented approaches. For instance, the new US administration (2025) has recently released executive orders which threaten to reverse the progress made in inclusive clinical research. The Stanford Think Tank on Diversity and Equity in Clinical Trials, held in September 2023, brought together key partners across multiple sectors and professions to discuss barriers and explore potential solutions to participation in clinical studies. In this commentary, we discuss the importance of collaborative, inclusive strategies in clinical study design to advance equitable health outcomes for all. Further, we discuss potential implications of the government's dismissal of diversity, equity, and inclusion initiatives on diverse research participation.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"117"},"PeriodicalIF":2.0,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11963400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143773450","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":"Correction: The PROPHECI trial: a phase II, double-blind, placebo-controlled, randomized clinical trial for the treatment of pseudoxanthoma elasticum with oral pyrophosphate.","authors":"Laetitia Clotaire, Isabelle Rubera, Christophe Duranton, Jocelyn Gal, Emmanuel Chamorey, Hélène Humeau, Samir Yamani, Christine Chiaverini, Serge Willoteaux, Bernard Padovani, Laurie Mourozeau, Adam Mainguy, Stéphanie Baillif, Ludovic Martin, Georges Leftheriotis","doi":"10.1186/s13063-025-08797-8","DOIUrl":"10.1186/s13063-025-08797-8","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"118"},"PeriodicalIF":2.0,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11966807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143773460","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":"ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears.","authors":"Ian A Harris, Richard S Page, Rachelle Buchbinder, Ville Äärimaa, Sam Adie, Graeme Brown, Nancy Cinnadaio, Maurizio Damiani, Joseph Descallar, Manuela L Ferreira, Nadine E Foster, Stephen Gill, Katrina Hutchison, Teppo Järvinen, Oliver Khoo, David Lieu, Christopher G Maher, Justine M Naylor, Geoff Smith, Luke Spencer, Yvana Toh, Andrew Whan, Tim Yeoh","doi":"10.1186/s13063-025-08822-w","DOIUrl":"10.1186/s13063-025-08822-w","url":null,"abstract":"<p><strong>Background: </strong>Degenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment, but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full-thickness degenerative rotator cuff tears.</p><p><strong>Methods: </strong>The study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40-75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4 cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including-as indicated-bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists, study staff and statisticians will be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will be shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery.</p><p><strong>Discussion: </strong>The ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears.</p><p><strong>Trial registration: </strong>The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"116"},"PeriodicalIF":2.0,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11963692/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143773457","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":"Inhaled sedation versus propofol in respiratory failure in the ICU (INSPiRE-ICU2): study protocol for a multicenter randomized controlled trial.","authors":"Brian O'Gara, Alexis L Serra, Joshua A Englert, Alisha Sachdev, Robert L Owens, Steven Y Chang, Pauline K Park, Daniel Talmor, Ida Sverud, Peter Sackey, Jeremy R Beitler","doi":"10.1186/s13063-025-08791-0","DOIUrl":"10.1186/s13063-025-08791-0","url":null,"abstract":"<p><strong>Background: </strong>Patients undergoing invasive mechanical ventilation often require pharmacologic sedation to facilitate tolerance of this life-sustaining intervention, but sedatives currently used in routine care have substantial limitations. Isoflurane is an inhaled volatile anesthetic with pharmacologic properties potentially suitable to sedation of ventilator-dependent critically ill patients, but need for specialized drug administration equipment has limited its use historically to general anesthesia in the operating theatre. This trial will evaluate isoflurane, administered using a novel drug delivery system, for sedation of ventilator-dependent adult intensive care unit (ICU) patients in the United States (US).</p><p><strong>Methods: </strong>The Inhaled Sedation versus Propofol in Respiratory Failure in the ICU (INSPiRE-ICU2) is a phase 3, multicenter, randomized, controlled, assessor-blinded non-inferiority trial that will evaluate efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S, compared to intravenous propofol, for sedation of mechanically ventilated adult ICU patients. At 16 US hospitals, 235 enrolled patients requiring continuous sedation during invasive mechanical ventilation will be randomized in 1.5:1 ratio to inhaled isoflurane or intravenous propofol for sedation. Treatment duration is expected to be at least 12 h and may last up to 48 (± 6) h or until no longer needing continuous sedation, whichever occurs first. The primary endpoint is the percentage of time sedation depth is maintained within the targeted range (Richmond Agitation Sedation Scale - 1 to - 4), in the absence of rescue sedation, during the treatment period. Secondary superiority outcomes include opioid exposure, wake-up time, cognitive recovery after end-of-treatment, and preservation of spontaneous breathing effort.</p><p><strong>Discussion: </strong>The INSPiRE-ICU2 trial will help determine the potential role of isoflurane for sedation of ventilator-dependent adult patients in the ICU. Key trial design features, including adoption of the estimand framework and blinded assessments of sedation depth, pain, and cognitive recovery, will ensure a rigorous evaluation of isoflurane for ICU sedation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05327296. First registered on April 5, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"114"},"PeriodicalIF":2.0,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956472/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754669","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":"Development and evaluation of a school-based bullying prevention program (Bullying&You): study protocol for a cluster randomized trial.","authors":"Vanessa Jantzer, Franziska Neumayer, Stefan Lerch, Michael Kaess","doi":"10.1186/s13063-025-08821-x","DOIUrl":"10.1186/s13063-025-08821-x","url":null,"abstract":"<p><strong>Background: </strong>Bullying victimization affects one in ten schoolchildren in Europe and has far-reaching negative consequences for mental health and school achievement. Although school-based bullying prevention programs seem overall capable of reducing the frequency of bullying, the continuous development, improvement, and rigorous evaluation of bullying prevention programs with enhanced feasibility and efficacy is critical. Consequently, we developed the program Bullying&You, which applies a blended-intervention approach to school-based bullying prevention based on latest empirical knowledge regarding effective program components and program-related facilitators. We aim to test its efficacy within a cluster randomized trial (CRT).</p><p><strong>Methods: </strong>Bullying&You will be implemented and evaluated in 40 schools (estimated total n = 8500 pupils) in Germany. The effectiveness of the program will be investigated in a CRT comparing 20 schools in the intervention group (IG; starting immediately with the program) with 20 schools in the waiting control group (CG; starting with a 1-year delay). The target group of the program are pupils in grades 3-9, as well as the whole school staff. All pupils will be asked to complete questionnaires concerning their bullying experiences (as victims, perpetrators, and bystanders) and mental health at baseline (T0) and two annual follow-ups (T1 and T2). The main endpoint of the trial is the reduction of bullying (prevalence of victims and perpetrators of direct, indirect, and cyberbullying) at 1-year follow-up (T1) in the IG compared to the CG. Secondary endpoints are psychopathology and self-harm behaviour. In addition, further research questions include (a) which specific components of the program prove to be most effective and (b) whether there are certain characteristics that predict program success at the individual level.</p><p><strong>Discussion: </strong>School-based bullying prevention programs still lack rigorous evidence for their efficacy. In addition, dissemination of bullying prevention programs has previously been hampered by the high need of resources required from schools for their implementation. The program's blended-intervention approach allows for a time-efficient and flexible implementation, while the continuous monitoring of the progress ensures program fidelity and strengthens adherence. If proven effective, Bullying&You has the potential to contribute to filling the gap in systematic dissemination of bullying prevention among youth.</p><p><strong>Trial registration: </strong>German Clinical Trials Register DRKS00028183. Registered on 02 March 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"115"},"PeriodicalIF":2.0,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11956421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754664","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":"Tolerating bad health research (part 2): still as many bad trials, but more good ones too.","authors":"Anna Daly, Shaun Treweek, Genevieve Shiely Hayes, Frances Shiely","doi":"10.1186/s13063-025-08747-4","DOIUrl":"https://doi.org/10.1186/s13063-025-08747-4","url":null,"abstract":"<p><strong>Background: </strong>We previously published a study examining the risk of bias of a random selection of Cochrane systematic reviews. The purpose of our current study is to reassess the risk of bias of a cohort of Cochrane reviewed trials to see if our reassessment differs from the original Cochrane assessment and to determine whether the funder, having methodological support, or involving a statistician affected the risk of bias.</p><p><strong>Methods: </strong>We extracted data from 140 of 159 included trials from three countries, the UK, Canada, and Ireland, in our original cohort. The 19 remaining trials were excluded for a variety of reasons. We recorded the number of participants in the trial, the funder, if a statistician was involved in the trial, if there was any methodological support from a trials unit or clinical research facility, the sponsor, and whether the sponsor was involved in the design or conduct of the trial. The risk of bias of the 140 trials was re-assessed using the same tool as that used by the Cochrane authors.</p><p><strong>Results: </strong>Our judgement of overall high risk of bias was broadly consistent with the original Cochrane authors. The proportion of high risk of bias trials remained more or less where it was at 55%, but the proportion of low risk of bias trials increased from 9 to 16%. The proportion of unclear risk of bias trials changed accordingly. Compared to the original assessments, we judged more studies to be low risk of bias across all domains. The greatest variation was in the two blinding categories (participants and personnel; outcome assessor) and 'other bias'.</p><p><strong>Conclusions: </strong>More than half of trials in our UK, Canada, and Ireland cohort were at high risk of bias highlighting significant challenges in ensuring the integrity and reliability of research findings. Addressing bias in clinical trials is essential to uphold the credibility of scientific research and to ensure that healthcare interventions are based on sound evidence, ultimately improving patient outcomes.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"110"},"PeriodicalIF":2.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744060","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}