Trials最新文献

{"title":"Mixed reality-assisted versus landmark-guided spinal puncture in elderly patients: protocol for a stratified randomized controlled trial.","authors":"Lei Gao, Haichao Zhang, Yidi Xu, Yanjun Dong, Lu Sheng, Yongqian Fan, Chunhui Qin, Weidong Gu","doi":"10.1186/s13063-024-08628-2","DOIUrl":"10.1186/s13063-024-08628-2","url":null,"abstract":"<p><strong>Background: </strong>Performing spinal anesthesia in elderly patients with spine degeneration is challenging for novice practitioners. This stratified randomized controlled trial aims to compare the effectiveness of mixed reality-assisted spinal puncture (MRasp) with that of landmark-guided spinal puncture (LGsp) performed by novice practitioners in elderly patients.</p><p><strong>Methods: </strong>This prospective, single-center, stratified, blocked, parallel randomized controlled trial will include 168 patients (aged ≥ 65 years) scheduled for elective surgery involving spinal anesthesia. All spinal punctures will be performed by anesthesiology interns and residents trained at Huadong Hospital. Patients will be randomly assigned to the MRasp group (n = 84) or the LGsp group (n = 84). Based on each intern/resident's experience in spinal puncture, participants will be stratified into three clusters: the primary group, intermediate group, and advanced group. The primary outcome will be the comparison of the rate of successful first-attempt needle insertion between the MRasp group and the LGsp group. Secondary outcomes will include the number of needle insertion attempts, the number of redirection attempts, the number of passes, the rate of successful first needle pass, the spinal puncture time, the total procedure time, and the incidence of perioperative complications. A stratified subgroup analysis will also be conducted for interns/residents at different experience levels.</p><p><strong>Discussion: </strong>The findings from this trial establish the effectiveness of MRasp by novice practitioners in elderly patients. This trial may provide experimental evidence for exploring an effective visualization technology to assist in spinal puncture.</p><p><strong>Trial registration: </strong>Chinese Clinical Trials Registry ChiCTR2300075291. Registered on August 31, 2023. https://www.chictr.org.cn/bin/project/edit?pid=189622 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"780"},"PeriodicalIF":2.0,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11575154/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668759","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":"Can the integration of new rules into a clinical decision support system reduce the incidence of acute kidney injury and hyperkalemia among hospitalized older adults: a protocol for a stepped-wedge, cluster-randomized trial (DETECT-IP).","authors":"Anaïs Payen, Nour Elhouda Tlili, Etienne Cousein, Laurie Ferret, Antoine Le Bozec, Aurélie Lenglet, Romaric Marcilly, Pierre Pilven, Arnaud Potier, Chloé Rousselière, Julien Soula, Laurine Robert, Jean-Baptiste Beuscart","doi":"10.1186/s13063-024-08569-w","DOIUrl":"10.1186/s13063-024-08569-w","url":null,"abstract":"<p><strong>Background: </strong>Clinical decision support systems (CDSSs) enable the automated, real-time detection of situations associated with a risk of adverse drug events (ADEs). However, the effectiveness of CDSS in reducing ADEs has yet to be demonstrated. We have chosen to focus on the detection of ADE such as hyperkalemia and/or acute kidney injury (AKI), which are common among hospitalized older adults. The present study's primary objective is to use a CDSS to reduce the number of ADEs (such as AKI and/or hyperkalemia) that occur in hospitalized older adults.</p><p><strong>Methods: </strong>This is a multicenter, stepped-wedge, cluster-randomized study involving five hospitals. Each hospital will start with a control period (i.e., routine care, during which each center's CDSS is deactivated) and then switch to an intervention period (during which the CDSS is activated). The intervention will be the use of a CDSS and a strategy for managing and transmitting alerts to clinical pharmacists. The rules concerning AKI and hyperkalemia have been drafted and reviewed by a multidisciplinary group. Each rule created in the CDSS is associated with a standardized procedure, based on a review of the literature. Older patients (aged 65 or over) admitted to a participating general medicine ward, a surgical ward, or obstetrics ward will be eligible for inclusion after the provision of verbal informed consent.</p><p><strong>Discussion: </strong>This study will assess the effectiveness of the CDSS in reducing the incidence of AKI and hyperkalemia. The implementation of the CDSS can assist clinical pharmacists in their daily work and is expected to prevent ADEs.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT05923983. Registered February 02, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"779"},"PeriodicalIF":2.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571581/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668850","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":"Permissive weight bearing versus restrictive weight bearing in surgically treated trauma patients with displaced intra-articular calcaneal fractures (the PIONEER study): study protocol for a multicenter randomized controlled trial.","authors":"Coen Verstappen, Mitchell L S Driessen, Pishtiwan H S Kalmet, Lloyd Brandts, Merel Kimman, Michael Edwards, Erik Hermans, Martijn Poeze","doi":"10.1186/s13063-024-08617-5","DOIUrl":"10.1186/s13063-024-08617-5","url":null,"abstract":"<p><strong>Background: </strong>Following successful treatment, displaced intra-articular calcaneal fractures (DIACFs) necessitate an extensive rehabilitation regimen, significantly influencing functional and socio-economic outcomes. Apart from surgical intervention, the implementation of a comprehensive rehabilitation protocol is crucial to optimize foot stability and functional recovery. The objective of this study is to ascertain the optimal rehabilitation protocol for patients with surgically treated DIACFs, either permissive weight bearing (PWB) or Restricted Weight Bearing, focusing on functional outcomes, health-related quality of life (HRQoL), radiographic parameters, cost-effectiveness, and incidence of complications.</p><p><strong>Methods: </strong>Study design: A prospective multicenter randomized controlled trial.</p><p><strong>Study population: </strong>Presence of surgically (extended lateral, sinus tarsi, or percutaneous approach) treated unilateral DIACFs (Sanders type II to IV), aged 18-67 years (labor force). Patients must be able to understand and follow weight bearing instructions. N = 115 patients with DIACFs will be included.</p><p><strong>Interventions: </strong>Patients with DIACFs will be randomly allocated to one of the rehabilitation protocols, either PWB or RWB.</p><p><strong>Primary outcome measure: </strong>Functional outcome, measured with the American Orthopaedic Foot & Ankle Society Score (AOFAS)).</p><p><strong>Secondary outcomes: </strong>Functional outcome (Maryland Foot Score, MFS), HRQoL (EuroQol-5D, EQ-5D), differences in radiographic parameters, cost-effectiveness, and complications. Nature and extent of burden: The PWB protocol is aimed to be non-inferior to the RWB protocol. Previous analysis of this protocol in other lower extremity fractures has shown a safe complication rate. Follow-up is standardized according to current trauma guidelines, namely at time points 2, 6, 12 weeks, and 6 months. The radiation exposure for both groups will differ from standard care (one extra CT scan of the foot will be made). Therefore, the burden for participants is considered minimal, with no significant health risks.</p><p><strong>Discussion: </strong>This study will be the first study to define an optimal rehabilitation regime for surgically treated patients with DIACFs. The limitations of this study include the absence of patient blinding, as this is impossible in rehabilitation. Additionally, the primary outcome measure (AOFAS) has limited validity for DIACFs. However, it is the most commonly used questionnaire in the literature on DIACFs. There is an apparent need since current literature is lacking on this specific topic.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05721378, accepted on February 7, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"778"},"PeriodicalIF":2.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11572059/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668760","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 measures of context in process evaluations: development and use of the Context Tracker tool.","authors":"Joanna Busza, Fortunate Machingura, Cedomir Vuckovic","doi":"10.1186/s13063-024-08623-7","DOIUrl":"10.1186/s13063-024-08623-7","url":null,"abstract":"<p><strong>Background: </strong>Process evaluations are increasingly integrated into randomised controlled trials (RCTs) of complex interventions to document their delivery and interactions with local systems and dynamics, helping understand observed health outcomes. Yet process evaluations often struggle to assess relevant contextual determinants, leaving much of the important role of \"context\" in shaping an intervention's mechanisms opaque in many studies. A lack of easily adapted data collection methods to help define and operationalise indicators of context likely contributes to this.</p><p><strong>Methods: </strong>We present a method to help structure measures of context in process evaluations and describe its use in two very different settings. The \"Context Tracker\" is an innovative tool for use within trials and quasi-experiments to more systematically capture and understand key dimensions of context. It was developed in Zimbabwe as part of a cluster randomised controlled trial and then adapted for a quasi-experimental evaluation in the UK. Both studies provided harm reduction and health services for marginalised and hard-to-reach populations.</p><p><strong>Results: </strong>We developed the Context Tracker to be both standardised (i.e. formatted and applied in the same way across study sites) and flexible enough to allow unique features to be explored in greater detail. Drawing on the Context and Implementation of Complex Interventions (CICI) and Risk Environments frameworks, we mapped 5 domains across micro, meso and macro levels in a simple table and used existing evidence and experience to predict factors likely to affect delivery of and participation in intervention components. We tracked these over time across study sites using routine programme statistics, observation and qualitative methods. The Context Tracker enables identification and comparison of facilitators and barriers to implementation, variations in engagement with interventions, and how mechanisms of action are (or are not) triggered in different settings.</p><p><strong>Conclusions: </strong>The Context Tracker is one example of how evidence-based contextual determinants can be used to guide data collection and analysis within process evaluations. It is relevant in low- and high-income settings and applicable to both qualitative and quantitative analyses. While perhaps most useful to process evaluations of complex interventions targeting marginalised communities, the broader approach would benefit a more general research audience.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"777"},"PeriodicalIF":2.0,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571973/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668856","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 of the preformulated irrigation solution Bactisure® in acute periprosthetic joint infection debridement surgery: study protocol for a randomized controlled trial.","authors":"Rafael Oleo-Taltavull, Matías Vicente Gomà-Camps, Nayana Joshi Jubert, Pablo S Corona","doi":"10.1186/s13063-024-08637-1","DOIUrl":"10.1186/s13063-024-08637-1","url":null,"abstract":"<p><strong>Background: </strong>Despite significant progress in orthopaedic surgery, the prevalence of periprosthetic joint infections (PJIs) remains persistent, and future increases are expected due to the increasing number of joint arthroplasties. PJIs are intricately connected to biofilm-producing bacteria, which encase infected prostheses, impairing the effectiveness of antibiotics and the immune system. Acute PJIs with immature biofilms are traditionally managed with debridement, antibiotics, and implant retention (DAIR). However, to date, there has not been a conclusive direct clinical comparison (in vivo) demonstrating the superiority of one irrigation solution over others. Recently, there has been a growing interest in irrigation solutions with antibiofilm properties demonstrated in in vitro studies, exemplified by the preformulated Bactisure® irrigation solution, which contains ethanol, acetic acid, sodium acetate, benzalkonium chloride, and sterile water. The main objective of this study was to evaluate the effectiveness (infection cure rate) of preformulated Bactisure® irrigation solution in vivo compared with saline solution in a control group of patients with acute knee and/or hip periprosthetic infections treated with DAIR.</p><p><strong>Methods: </strong>Prospective single-centre randomized controlled trial involving patients with acute haematogenous PJI who received standard DAIR surgery from December 2022 to December 2024. The type of irrigation solution used during surgery will include two groups allocated at a 1:1 ratio: a control group (n = 25) with saline solution and an experimental group (n = 25) receiving the Bactisure® preformulated solution. The sample size was calculated based on an expected reduction in reinfection rates from 45% in the control group to 10% in the experimental group. Data on baseline patient characteristics, clinical and radiological information, and healthcare questionnaires will be recorded. All patients will be followed for minimum of 12 months. The infection cure rate at 1 year will be the primary outcome.</p><p><strong>Discussion: </strong>This study is the first to compare the effectiveness of preformulated Bactisure® irrigation solution with that of saline solution in real clinical practice (in vivo) in patients with acute knee and/or hip periprosthetic infections treated with DAIR. Our main hypothesis is that, compared with saline solution, Bactisure® provides a better infection cure rate at 1 year post-DAIR.</p><p><strong>Trial registration: </strong>International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696 . Registered on December 19, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"775"},"PeriodicalIF":2.0,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644752","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":"Effects of ultrasound-guided external oblique intercostal plane block on the postoperative analgesia after open liver surgery: study protocol for a randomised controlled trial.","authors":"Jiali Tang, Qingqing Hua, Yuelun Zhang, Weihua Nie, Songlin Yu, Jinlan Zhang","doi":"10.1186/s13063-024-08449-3","DOIUrl":"10.1186/s13063-024-08449-3","url":null,"abstract":"<p><strong>Background: </strong>Open liver surgery remains a primary surgical approach for complex liver resections and liver transplantation. However, the postoperative pain management is still a major challenge. Ultrasound-guided external oblique intercostal (EOI) plane block is a novel approach of regional anaesthesia and has a great potential to relieve postoperative pain after upper abdominal surgeries. This study aims to investigate the efficacy and safety of ultrasound-guided EOI plane block in managing postoperative pain after open liver surgery.</p><p><strong>Methods: </strong>Seventy-four participants scheduled for open liver surgery will be randomly assigned to either the intervention group, receiving an ultrasound-guided EOI plane block with a single dose of 30 ml 0.375% ropivacaine, or the control group, which will not receive this block. All participants will be provided with opioid-based patient-controlled intravenous analgesia (PCIA) postoperatively. The primary outcome is resting pain score at 3 h postoperatively, assessed using numerical rating scale. Secondary outcomes include pain score at 6, 24, 48, and 72 h postoperatively, perioperative opioid consumption, remedial analgesics within 72 h postoperatively, PCIA usage within postoperative 72 h, postoperative recovery, length of hospital stay, postoperative side effects, block-related complications, and ropivacaine plasma concentration of participants receiving the block.</p><p><strong>Discussion: </strong>This study is a randomised controlled trial to evaluate the efficacy and safety of ultrasound-guided EOI plane block for postoperative analgesia after open liver surgery. As regional anaesthesia plays an important role in the multimodal pain management, EOI plane block may prove to be an effective regional technique for enhancing postoperative pain relief and contributing to enhanced recovery after open liver surgery.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2200065745. Registered on November 14, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"776"},"PeriodicalIF":2.0,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644587","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":"Evaluating effects of community-based social healing model on Ubuntu, mental health and psychosocial functioning in post-genocide Rwanda: protocol for cluster randomized control trial.","authors":"Stefan Jansen, Jean Bosco Niyonzima, Patricia Gerbarg, Richard P Brown, Alice Nsengiyumva, Japhet Niyonsenga, Epaphrodite Nsabimana","doi":"10.1186/s13063-024-08632-6","DOIUrl":"10.1186/s13063-024-08632-6","url":null,"abstract":"<p><strong>Background: </strong>The community-based social healing (CBSH) model, developed by Ubuntu Centre for Peace, aims to support individuals with traumatic experiences and mental health challenges in achieving better mental health. CBSH combines BREATH-BODY-MIND™ (BBM) practices with collective narrative and rituals, facilitated by Community Healing Assistants in therapeutic groups. A previous pilot study involving 1889 Rwandan CBSH participants showed significant mental health improvements, including reductions in depression, anxiety, and PTSD, along with enhanced work productivity, and decreased intimate partner violence. The trial investigates the CBSH model's impact on Ubuntu and mental health. Ubuntu, a concept that encompasses humanness, compassion, and interconnectedness, is deeply rooted in the African philosophy.</p><p><strong>Methods/design: </strong>This cluster randomized controlled trial will involve 54 villages randomly selected in the Kirehe district, with 1080 participants randomly allocated equally to the CBSH intervention or a wait-list control group. While the trial will be conducted at the village (cluster) level, both primary and secondary outcomes will be measured individually for participants within each cluster. The Primary outcome \"Ubuntu\" will be measured using a context-adapted Ubuntu measurement scale. Secondary outcomes include psychosocial indicators which will be assessed through standardized tools such as the Patient Health Questionnaire for depression (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Warwick-Edinburgh Mental Wellbeing scale (WEMWS), Connor-Davidson Resilience scale (CD-RISK-10), Somatic Symptom Severity Scale (PHQ-15), Revised Conflict Tactics scale (CTS2S), and Adapted Social Capital Assessment Tool (SASCAT).</p><p><strong>Conclusion: </strong>This trial aims to evaluate the CBSH model's impacts on Ubuntu, mental health, and social functioning among trauma-affected Rwandans, including those impacted by the 1994 Genocide against the Tutsi, mass killings, sexual abuse, and domestic violence. The findings could be of value to the Ubuntu Centre for Peace, policymakers, healthcare practitioners, and other stakeholders, by highlighting the significance of promoting Ubuntu as a foundation for addressing mental health challenges and the consequences of psychosocial trauma.</p><p><strong>Trial registration: </strong>ISRCTN ISRCTN17659369. Registered on February 09, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"773"},"PeriodicalIF":2.0,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644827","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":"Accuracy of healthcare systems data for identifying cardiovascular outcomes after stroke due to intracerebral haemorrhage in the United Kingdom.","authors":"Alice Hosking, Jacqueline Stephen, Jonathan Drever, William N Whiteley, Cathie L M Sudlow, Rustam Al-Shahi Salman","doi":"10.1186/s13063-024-08631-7","DOIUrl":"10.1186/s13063-024-08631-7","url":null,"abstract":"<p><strong>Background: </strong>Healthcare systems data (HCSD) could improve the efficiency of clinical trials, but their accuracy and validity are uncertain. Our objective was to assess the accuracy of HCSD as the sole method of outcome detection in the REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) compared with adjudicated questionnaire follow-up and compare estimates of treatment effect.</p><p><strong>Methods: </strong>RESTART was a prospective, open, assessor-blind, parallel-group randomised controlled trial (RCT) of antiplatelet therapy after intracerebral haemorrhage (ICH) in the UK. We included 496 (92%) of 537 RESTART participants, who were resident in England or Scotland at randomisation. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. RESTART used annual questionnaires to detect its primary outcome (recurrent ICH) and secondary outcome (a composite of haemorrhagic or ischemic major adverse cardiovascular events [MACE]) over a median of 2.0 years; an independent adjudication committee verified outcomes using medical records and brain imaging. We obtained ICD10-coded HCSD on hospital admissions and deaths in England and Scotland to identify primary and secondary outcomes. We compared HCSD with a reference standard of adjudicated outcomes. We estimated the effects of antiplatelet therapy using HCSD alone in a Cox proportional hazards model adjusted for minimisation variables.</p><p><strong>Results: </strong>In the original RESTART trial, 31 people experienced a primary outcome event. HCSD had sensitivity of 84% (95% CI 66 to 95%) and positive predictive value of 68% (51 to 82%) for recurrent ICH. HCSD estimated an effect of antiplatelet therapy (adjusted hazard ratio [aHR] 0.51, 95% CI 0.27 to 0.98; p = 0.044) that was almost identical to adjudicated outcomes (aHR 0.51, 95% CI 0.25 to 1.03; p = 0.060). HCSD had sensitivity of 84% (76 to 91%) and positive predictive value of 78% (69 to 85%) for MACE, on which HCSD estimated an effect of antiplatelet therapy (aHR 0.81, 95% CI 0.56 to 1.16; p = 0.247) that was similar to adjudicated outcomes (aHR 0.65, 95% CI 0.44 to 0.95; p = 0.025).</p><p><strong>Conclusions: </strong>In a RCT of antiplatelet therapy for people with ICH, HCSD was reasonably accurate and provided similar estimates of treatment effect compared with adjudicated outcomes.</p><p><strong>Trial registration: </strong>ISRCTN71907627 . Registered on 25 April 2013.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"774"},"PeriodicalIF":2.0,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644658","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":"How should trial teams make decisions about the proportions and diversity of the ethnic groups in their trial?","authors":"Shaun Treweek, Katie Gillies, Miles D Witham, Declan Devane, Kamlesh Khunti, Peter Bower, Adwoa Parker, Irene Soulsby, Bārbala Ostrovska, Sarah Prowse, Heidi Green","doi":"10.1186/s13063-024-08625-5","DOIUrl":"10.1186/s13063-024-08625-5","url":null,"abstract":"<p><strong>Background: </strong>The benefits of randomised trials are not shared equally, and people from ethnic minority groups are a key constituency under-served by clinical research and clinical care. The STRIDE project aimed to give trialists practical information about how to decide which ethnic groups should be in their trials, and at what proportion.</p><p><strong>Methods: </strong>We considered trials in six clinical areas: cancer, cardiovascular, diabetes, maternal health, mental health, and smoking cessation. We created a summary for each, including participants-intervention-comparators-outcomes, and data on disease prevalence by ethnicity. These were discussed with panels with clinical expertise, trial and methodology expertise, lived experience, funding, and experience of working with and on behalf of ethnic communities. For each trial, we asked panel members to decide which ethnic groups should have been involved and at what proportion.</p><p><strong>Results: </strong>We discussed 23 trials with 40 individual panel members. Panels found our questions difficult to answer. The lack of publicly available data on prevalence by ethnicity was central to this. Where data were available, decision-making was easier but not simple. The discussions led to eight STRIDE recommendations. We recommend that discussions involve diverse teams and that discussions need time, with access to the best available data. In the absence of data or consensus, we recommend the adoption of 'default' minimum rates of inclusion, with oversampling considered. These discussions should inform site selection, and the practical challenges of recruitment and retention should not determine which groups are to be included. We also suggest five policy initiatives to support implementation of the recommendations. Broadly, these are (1) funders need to signal that ethnic diversity is expected, (2) trial teams need access to better data, (3) funders and others need to signal that ethnic diversity means better science, (4) more funding is needed for evaluation, and (5) Good Clinical Practice training should cover ethnic diversity.</p><p><strong>Conclusions: </strong>Agreeing targets for which ethnic groups to involve in a trial is essential but difficult. Our eight recommendations could help to make trials more ethnically diverse if followed, and we suggest five policy initiatives that would create a supportive environment for their implementation.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"768"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566274/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626826","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":"Evaluation of a multi-component prevention concept for hazardous substance use among refugees in shared accommodations: study protocol for a cluster randomized controlled trial.","authors":"Miriam Hedwig Lorenz, Jonathan Uricher, Markus Iwan Pauzar, Johannes Michalak, Marion Laging, Thomas Heidenreich","doi":"10.1186/s13063-024-08558-z","DOIUrl":"10.1186/s13063-024-08558-z","url":null,"abstract":"<p><strong>Background: </strong>Refugees are exposed to various risk factors in shared accommodations in Germany where they are housed after their arrival. Due to their often traumatic experiences before, during, and after their flight and socio-structural post-migration stressors, refugees are potentially vulnerable to hazardous substance use. They form a structurally disadvantaged group for substance use prevention and intervention. Various barriers make it difficult for them to access the healthcare system and to get health information. Therefore, a participatory multi-component prevention concept for refugees in shared accommodations was developed. The aim of the trial is to evaluate the efficacy of this concept regarding the increase in knowledge about substance use among refugees living in shared accommodations.</p><p><strong>Methods: </strong>Based on a randomized controlled stepped-wedge design, the study will be conducted in a multicenter setting in nine shared accommodations and will aim to include refugees living in shared accommodations as well as social workers and psychologists working there.</p><p><strong>Discussion: </strong>This trial will be one of the first to generate evidence about effective participatory prevention concepts for refugees in shared accommodations. Evidence-based concepts for refugees can improve access to health care and might be helpful for the multidisciplinary workforce in shared accommodations.</p><p><strong>Trial registration: </strong>OSF Registry: osf.io/ebnj3. Registered on May 24, 2024. Registration DOI: https://doi.org/10.17605/OSF.IO/EBNJ3.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"770"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644828","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}