Trials最新文献

{"title":"Implementing palliative care in hepatocellular carcinoma ambulatory clinics-study protocol for Accelerated translational research in PRImary liver CAncer (APRICA) randomised controlled palliative care trial.","authors":"Cameron Gofton, Anna Di Bartolomeo, Rose Boutros, Yvonne A Zurynski, Fiona Stafford-Bell, Kim Caldwell, Geoffrey McCaughan, Amany Zekry, Simone I Strasser, Miriam Levy, Caitlin Sheehan, Stephen Goodall, Jan Maree Davis, Linda Sheahan, Ken Liu, Sally Greenaway, Scott Davison, Thang Du Huynh, Zujaj Quadri, Meera Agar, Jacob George","doi":"10.1186/s13063-024-08603-x","DOIUrl":"10.1186/s13063-024-08603-x","url":null,"abstract":"<p><strong>Background: </strong>Integration of symptom and palliative care for people with advanced cancer is established in many tumour types, but its role in people with hepatocellular carcinoma (HCC) has not been clearly defined. This study aims to evaluate the clinical and cost effectiveness of an intervention involving a suite of strategies designed to assess and treat palliative care symptoms and needs in adult outpatients with HCC attending four New South Wales (NSW) metropolitan tertiary hospitals.</p><p><strong>Methods: </strong>This trial will use a pragmatic cluster-based randomised-controlled design, with ambulatory HCC services as the clusters. HCC patients will be recruited if they have Barcelona Clinical Liver Cancer (BCLC) stage A disease with active tumour or a current or prior diagnosis of BCLC stage B or C disease regardless of tumour activity. Patients with BCLC stage D disease will be excluded as palliative care is the standard of care (SOC) in this group. Cluster sites will be randomised to the study intervention or control where patients are managed according to SOC. All participants will complete the liver-specific Edmonton Symptom Assessment Scale (ESAS) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at regular ambulatory clinic appointments. At intervention sites, patients scoring ≥ 5 on any liver-specific ESAS symptom will be referred to palliative care physicians for consultation. The primary clinical outcome will be improvement in all symptoms scored ≥ 5 on the liver-specific ESAS by 50% within 3 months and the primary implementation outcome will recording the liver-specific ESAS in ≥ 80% of all participants attending clinic appointments. Caregivers of patients enrolled in the trial will be invited to perform Carer Support Needs Assessment Tool at each appointment.</p><p><strong>Discussion: </strong>This trial will inform if earlier palliative care involvement significantly reduces the symptom burden associated with HCC. If found to be effective, earlier implementation of palliative care consultation should be included in HCC treatment guidelines.</p><p><strong>Trial registration: </strong>ACTRN12623000010695. Registered on September 1, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542352/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142591211","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":"Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: update to the statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial.","authors":"Sarah N Dawson, Yi-Da Chiu, Andrew A Klein, Melissa Earwaker, Sofia S Villar","doi":"10.1186/s13063-024-08538-3","DOIUrl":"10.1186/s13063-024-08538-3","url":null,"abstract":"<p><strong>Background: </strong>The NOTACS trial will assess the efficacy, safety and cost-effectiveness of high-flow nasal therapy (HFNT) compared to standard oxygen therapy (SOT) on the outcomes of patients after cardiac surgery.</p><p><strong>Methods/design: </strong>NOTACS is an adaptive, international, multicentre, parallel group, randomised controlled trial, with a pre-planned interim sample size re-estimation (SSR). A minimum of 850 patients will be randomised 1:1 to receive either HFNT or SOT. The primary outcome is days alive and at home in the first 90 days after the planned surgery (DAH90), with a number of secondary analyses and cost-effectiveness analyses also planned. The interim SSR will take place after a minimum of 300 patients have been followed up for 90 days and will allow for the sample size to increase up to a maximum of 1280 patients.</p><p><strong>Results: </strong>This manuscript provides detailed descriptions of the design of the NOTACS trial and the analyses to be undertaken at the interim and final analyses. The main purpose of the interim analysis is to assess safety and to perform a sample size re-estimation. The main purpose of the final analysis is to examine the safety, efficacy and cost-effectiveness of HFNT compared to SOT on the outcomes of patients after cardiac surgery.</p><p><strong>Discussion: </strong>This manuscript outlines the key features of the NOTACS statistical analysis plan and was submitted to the journal before the final analysis in order to preserve scientific integrity under an adaptive design framework. A previous version of this SAP was published prior to the interim analysis (Dawson, 2022). The NOTACS SAP closely follows published guidelines for the content of SAPs in clinical trials (Gamble, 2017).</p><p><strong>Trial registration: </strong>ISRCTN14092678 . (13 May 2020).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11539829/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142591140","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 website for cluster randomised trials including stepped wedge: facilitating quality trials and methodological research.","authors":"Claire L Chan, Clémence Leyrat, James Martin, Jennifer Thompson, Elizabeth L Turner, Sandra M Eldridge","doi":"10.1186/s13063-024-08597-6","DOIUrl":"10.1186/s13063-024-08597-6","url":null,"abstract":"<p><strong>Background: </strong>A cluster randomised trial is a randomised controlled trial in which groups of individuals (clusters) are randomised to treatment arms. Stepped wedge cluster randomised trials are a type of cluster randomised trial where clusters are randomised to sequences. These trial designs are important for impacting decision-making, and it is therefore important that they be well-conducted and reported.</p><p><strong>Main body: </strong>In November 2018, we created a new website dedicated to cluster randomised trials, including stepped wedge designs: https://clusterrandomisedtrials.qmul.ac.uk/ . The idea for the website emerged from the conference on Current Developments in Cluster Randomised Trials and Stepped Wedge Designs held in November 2016 at Queen Mary University of London, with the aim to provide an online resource to facilitate quality trials and methodological research on these types of trial. The website is divided into sections covering Design, Analysis and Reporting for traditional (i.e. parallel two-arm) cluster randomised trials and stepped wedge designs and contains resources in the form of hyperlinks to relevant papers along with brief explanations. A noticeboard page provides details on announcements, events, and past events.</p><p><strong>Conclusion: </strong>We aim to keep the site updated with the latest publications and events related to cluster randomised trials, and welcome suggestions from the research community on further resources or events to add. We hope that the site will facilitate high-quality traditional and stepped wedge cluster randomised trials.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542435/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142591065","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 motivates SARS-CoV-2 vaccine trial participants? A pre- and post-participation survey study.","authors":"Olivia A C Lamers, Meta Roestenberg, Martine C de Vries, Marie-Astrid Hoogerwerf","doi":"10.1186/s13063-024-08582-z","DOIUrl":"10.1186/s13063-024-08582-z","url":null,"abstract":"<p><strong>Background: </strong>Scientific advancement, including the testing and licensing of new drugs, relies heavily on clinical trials with healthy individuals. The motivations of clinical trial participants have been discussed intensively, as some worry that financial compensation may distract from the intrinsic risk of clinical research. Herein, we investigated the motivations and decisional factors influencing SARS-CoV-2 clinical trial participants. Moreover, since most surveys are administered after clinical trial participation, we were interested in whether the results were tainted by recall bias.</p><p><strong>Methods: </strong>This was a cross-sectional observational study. Participants were administered a survey on two occasions, once before and once after participation in a clinical trial. The primary outcomes were the motivations and decisional factors of SARS-CoV-2 vaccine trial participants and the difference between the surveys collected before and after clinical trial participation.</p><p><strong>Results: </strong>The survey response rate was 149/200 (75%). SARS-CoV-2 vaccine trial participants were mostly motivated by the desire to contribute to science and help others. Answers collected before and after the trial were not statistically different, indicating the absence of recall bias.</p><p><strong>Conclusion: </strong>The decision-making process of clinical trial participants is complex and multi-faceted. Previous studies have shown that clinical trial participants have mixed motivations but never to the extent reported in the current survey. Here, we present a theoretical framework that attempts to explain how different motivational factors may contribute to decision forming.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11539315/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142591282","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 multi-country, randomized trial of three nutritional supplements on short-term and sustained anthropometric recovery in children 6-24 months of age with moderate wasting and acute illnesses: the NUTRIMAM study protocol.","authors":"","doi":"10.1186/s13063-024-08390-5","DOIUrl":"10.1186/s13063-024-08390-5","url":null,"abstract":"<p><strong>Background: </strong>Globally, moderate wasting affects approximately 33 million children. Complex bidirectional interactions exist between wasting and infection in children. Children who experience both conditions have an increased risk of adverse outcomes including progression to severe wasting and mortality. Breaking the cycle between moderate wasting and infection could help improve growth and survival in these children. The NUTRIMAM trial will aim to investigate the efficacy of a 12-week regimen of three different nutritional interventions in at-risk young children (i.e., children who are moderately wasted and have one/more acute infections) on anthropometric recovery. Further, the study will explore whether recovery can be sustained with a post-intervention package that includes counseling and food vouchers. Sustaining anthropometric recovery beyond supplement administration will have important implications for programs.</p><p><strong>Methods: </strong>NUTRIMAM is a multi-country, multi-center individually randomized, open-label, trial in five countries including Bangladesh, India, Mali, Pakistan, and Tanzania. A total of 6360 moderately wasted children aged 6 to 24 months with acute illness will be enrolled at health centers. Children will be randomly allocated to receive one of three dietary supplements (locally available foods, ready-to-use supplementary foods, or microbiota-directed supplementary foods) for 12 weeks. Anthropometric recovery will be assessed over this period. Participants who recover will then be re-randomized to a post-recovery support intervention comprising either counseling and food vouchers or routine standard of care for recovered children for an additional 12 weeks to determine if this intervention facilitates sustained recovery at 24 weeks.</p><p><strong>Discussion: </strong>Children who are moderately wasted and have an infection are at higher risk of adverse outcomes. There are very few clinical trials that have been performed among children with moderate wasting with infectious illnesses to investigate if it is possible to break the undernutrition-infection cycle and thereby reduce the risk of nutritional deterioration to severe wasting or mortality and decrease the risk of acute infections. The results of the trial are anticipated to fill important evidence gaps in feeding recommendations for moderately wasted children with acute illness as well as interventions to sustain anthropometric recovery in children beyond the period of the nutritional intervention.</p><p><strong>Trial registration: </strong>ISRCTN registry, ISRCTN53213318 . Registered on April 03, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142584396","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":"Interleukin-6 receptor antibodies (tocilizumab) in acute myocardial infarction with intermediate to high risk of cardiogenic shock development (DOBERMANN-T): study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial.","authors":"Joakim Bo Kunkel, Sarah Louise Duus Holle, Christian Hassager, Redi Pecini, Sebastian Wiberg, Pernille Palm, Lene Holmvang, Lia Evi Bang, Jesper Kjærgaard, Jakob Hartvig Thomsen, Thomas Engstrøm, Jacob Eifer Møller, Jacob Thomsen Lønborg, Martin Frydland, Helle Søholm","doi":"10.1186/s13063-024-08573-0","DOIUrl":"10.1186/s13063-024-08573-0","url":null,"abstract":"<p><strong>Background: </strong>Inflammation and neurohormonal activation play a significant role in the adverse outcome seen in acute myocardial infarction (AMI) and the development of cardiogenic shock (CS), which is associated with a mortality rate up to 50%. Treatment with anti-inflammatory drugs such as tocilizumab, an interleukin-6 receptor antagonist, has been shown to reduce troponin release and reduce the myocardial infarct size in AMI patients and it may therefore have cardioprotective properties.</p><p><strong>Methods: </strong>This is a double-blind, placebo-controlled, single-center randomized clinical trial, including adult AMI patients without CS at hospital arrival, undergoing percutaneous coronary intervention (PCI) within 24 h from symptom onset, and at intermediate to high risk of developing CS (ORBI risk score ≥ 10). A total of 100 participants will be randomized to receive a single intravenous dose of tocilizumab (280 mg) or placebo (normal saline). The primary outcome is peak plasma pro-B-type natriuretic peptide (proBNP) within 48 h, assessed using serial measurements at intervals: before infusion, 12, 24, 36, and 48 h after infusion. Secondary endpoints include the following: (1) cardiac magnetic resonance imaging (CMR) during 24-48 h after admission and at follow-up after 3 months with assessment of left ventricular area at risk, final infarct size, and the derived salvage index and (2) biochemical markers of inflammation (C-reactive protein and leukocyte counts) and cardiac injury (troponin T and creatinine kinase MB).</p><p><strong>Discussion: </strong>Modulation of interleukin-6-mediated inflammation in patients with AMI, treated with acute PCI, and at intermediate to high risk of in-hospital CS may lead to increased hemodynamic stability and reduced left ventricular infarct size, which will be assessed using blood biomarkers with proBNP as the primary outcome and inflammatory markers, troponin T, and CMR with myocardial salvage index as the secondary endpoints.</p><p><strong>Trial registration: </strong>Registered with the Regional Ethics Committee (H-21045751), EudraCT (2021-002028-19), ClinicalTrials.gov (NCT05350592). Study registration date: 2022-03-08, Universal Trial Number U1111-1277-8523.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536892/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142584397","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":"The Platform trial In COVID-19 vaccine priming and BOOsting (PICOBOO) booster vaccination substudy protocol.","authors":"McLeod C, Dymock M, Flanagan Kl, Plebanski M, Marshall H, Marsh J, Estcourt Mj, Ramsay J, Wadia U, Williams Pcm, Tjiam Mc, Blyth C, Subbarao K, Nicholson S, Faust S N, Thornton Rb, Mckenzie A, Snelling T, Richmond P","doi":"10.1186/s13063-024-08456-4","DOIUrl":"10.1186/s13063-024-08456-4","url":null,"abstract":"<p><strong>Background: </strong>Coronavirus-2019 (COVID-19) vaccination in Australia commenced in February 2021. The first vaccines recommended for use were AZD1222 and BNT162b2, both delivered as a two-dose primary schedule. In the absence of sustained immunity following immunisation, recommendations for booster vaccination have followed. It is likely that periodic boosting will be necessary for at least some Australians, but it is unknown what the optimal booster vaccines and schedules are or for whom vaccination should be recommended.</p><p><strong>Methods: </strong>The Platform Trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, multi-arm, randomised, Bayesian adaptive platform trial evaluating different booster vaccine interventions in immunocompetent children and adults, stratified by their primary vaccination schedule and age. Participants are randomised to receive one of three licensed COVID-19 booster vaccines available for use in Australia. PICOBOO aims to generate evidence about the immunogenicity, reactogenicity, and cross-protection of different booster vaccine strategies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants/subvariants. The protocol structure specifying PICOBOO is modular and hierarchical. We have previously published the PICOBOO core (master) protocol. Here, we detail the substudy protocol which outlines the study processes which are specific to PICOBOO participants enrolled in the booster vaccination substudy.</p><p><strong>Discussion: </strong>PICOBOO is an adaptive platform trial evaluating different COVID-19 booster vaccination strategies to generate evidence to inform immunisation practice and policy. The modular and flexible protocol structure is intended to enable investigators to respond with agility to new research questions as they arise, such as immunogenicity targeting emergent virus variants, and the immunogenicity and reactogenicity of new vaccines as they become available for use.</p><p><strong>Trial registration: </strong>Australian and New Zealand Clinical Trials Register ACTRN12622000238774; registered on 10/02/2022. Protocol V8.0_23112023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11529175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142558876","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":"Nurse-led framework to improve the safety and quality of residential aged care (HIRAID® Aged Care): protocol for a stepped-wedge cluster randomised controlled trial.","authors":"Ramon Z Shaban, Kate Curtis, Margaret Fry, Brendan McCormack, Deborah Parker, Mary K Lam, Lee-Fay Low, Yun-Hee Jeon, Donna Waters, Richard I Lindley, Karen Watson, Moira Dunsmore, Julie Considine, Gaynor Squillacioti, Lucy Thompson, Andrea Smith, Manowara Begum, Jo-Ann Dalton, Clair Ramsden, Jasmine Glennan, Catherine Viengkham","doi":"10.1186/s13063-024-08585-w","DOIUrl":"10.1186/s13063-024-08585-w","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The health issues experienced by older people can often be severe and complex, and an increasing number are using residential aged care services to meet their care needs. High-quality nursing care is fundamental to the health and safety of aged care residents and is contingent on nurses' accurate assessment, informed decision-making, and delivery of timely interventions. However, the role of the aged care nurse is often challenging, impeded by factors such as understaffing, high workloads, and a lack of access to clinical infrastructure and resources. When these challenges mount, residents are put at greater risk of adverse outcomes, such as avoidable clinical deterioration and hospital transfers. This study describes the adaptation and implementation of the emergency nursing framework, HIRAID® (History including Infection risk, Red Flags, Assessment, Interventions, Diagnostics, reassessment, communication and plan)-a tool to assist nurses' assessment, decision-making and care in residential aged care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The HIRAID® framework will be adapted for residential aged care using a real-time Delphi and panel of aged care and nursing experts. The co-designed HIRAID® Aged Care framework will be trialled in 23 residential aged care homes in Sydney, Australia, in a modified stepped-wedge cluster randomised controlled trial design. All homes will be randomised into one of four clusters. Outcomes of interest include the rate of clinical deterioration events resulting from nurses' actions, the rate of hospital transfers determined to be inappropriate, performance against the national mandatory aged care quality indicators, resident satisfaction with care, nurse and medical staff satisfaction with communication, and the quality of nursing documentation. These outcomes will be evaluated using a combination of qualitative and quantitative analysis of routinely collected resident data, expert assessments of facility documentation events against validated criteria, and pre- and post-intervention surveys of residents, family carers, nurses, and medical staff.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;This protocol describes a pragmatic trial that aims to translate an evidence-based framework from the emergency care context into residential aged care. The adapted HIRAID® Aged Care framework will be the first of its kind to standardise and guide holistic nursing assessment, decision-making, and documentation in residential aged care in Australia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ethics and dissemination: &lt;/strong&gt;This research has been approved by the Western Sydney Local Health District Human Research Ethics Committee: 2023/ETH00523. A waiver of consent has been approved to access resident health data and nursing documentation at each participating site.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Australian and New Zealand Clinical Trial Registry, ACTRN12623000481673. Registered 12 May 2023.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Protocol version: &lt;/strong","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564443","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":"Effectiveness of Virtual - Compensatory Cognitive Training (V-CCT) for improving cognition in persons with schizophrenia - a multi- centre randomized controlled trial.","authors":"Sonia Sims, Suvarna Jyothi Kantipudi, Yogitha Ashok, B Nisha, Subhashini Gopal, Elsa Joseph, S Amritha, Lakshmi Venkatraman, Pratiksha Venkatasubramanian, Padmavati Ramachandran","doi":"10.1186/s13063-024-08568-x","DOIUrl":"10.1186/s13063-024-08568-x","url":null,"abstract":"<p><strong>Background: </strong>Cognitive deficits are the core component in persons with schizophrenia which impacts their socio-occupational functioning. Also, cognitive deficits cause significant impairment with the person's quality of life [3]. Hence, targeting such a pivotal aspect in persons with schizophrenia through suitable interventions is very important. Developed countries have designed various cognitive remediation programs using computers involving high-end software which cannot be generalized to low-resource settings, like India, due to various factors including sociocultural factors, educational standards, and living standards of the patient population. Compensatory cognitive training (CCT) was developed to be \"brief, practical, low-tech\" and found to be effective in the west [9]. As there are no structured cognitive intervention modules in India, we have adapted the English CCT manual to be used for an urban population in Chennai, India. CCT was found to be feasible in face-to-face group sessions in our setting [12] and is found to be feasible and acceptable as virtual one-one intervention (unpublished data). Therefore, this study aims to evaluate the effectiveness of V-CCT in enhancing cognition and socio-occupational functioning.</p><p><strong>Methods: </strong>The proposed study will be a multicenter assessor-blinded randomized controlled trial at two clinical sites in Chennai, India. The preparatory phase of the study would include translation of the manual to the local language, recruitment and training of research assistants, and pilot testing using the translated manual. The second phase will be the main randomized controlled trial (RCT), during which a total of 160 persons diagnosed with schizophrenia will be recruited from both sites. After obtaining informed consent, baseline assessments will be conducted on cognition, functioning, self-esteem, and quality of life. Participants will be randomly assigned to either the virtual CCT group or the control group using a computer-generated randomization table. End-line assessments will be conducted 6 weeks after the baseline by research assistants who are blinded to the randomization post-intervention.</p><p><strong>Discussion: </strong>If V-CCT is found to be effective, it will be available for use in Tamil for persons with schizophrenia, and it will have an effect on their functioning, quality of life, and self-esteem.</p><p><strong>Trial registration: </strong>The study is registered under Clinical trial registry-India (CTRI), and the registration number is CTRI/2024/04/065267. Registered on April 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528983/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564322","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":"Paclitaxel- or sirolimus-coated balloons used for ArterioVEnous fistulas-2 (PAVE-2): study protocol for a randomised controlled trial to determine the efficacy of paclitaxel- or sirolimus-coated balloons in arteriovenous fistulas used for haemodialysis.","authors":"Narayan Karunanithy, Sam Norton, Francis Calder, Neelanjan Das, Niamh Dooley, Lusine Hakobyan, Robert Jones, Soundrie Padayache, Chloe Spriggs, Kate Steiner, Rebecca Suckling, Michael G Robson","doi":"10.1186/s13063-024-08502-1","DOIUrl":"10.1186/s13063-024-08502-1","url":null,"abstract":"<p><strong>Background: </strong>In view of the conflicting results from previous studies, the benefit of paclitaxel-coated balloons for arteriovenous fistulas is uncertain and equipoise remains. Although an industry-led trial testing the efficacy of sirolimus-coated balloons in AVFs is in progress, the benefit of sirolimus-coated balloons for arteriovenous fistulas is currently unknown. The purpose of this trial is to compare the efficacy of additional paclitaxel-coated or sirolimus-coated balloons on outcomes after a plain balloon fistuloplasty to preserve the patency of arteriovenous fistulae used for haemodialysis.</p><p><strong>Methods: </strong>The study design is a multicentre randomised controlled trial. Following a successful plain balloon fistuloplasty, participants will be randomised to further treatment with a paclitaxel-coated balloon, a sirolimus-coated balloon, or an uncoated control balloon. We will recruit 642 patients, each with one or two treatment segments, over a 3-year period. Patients will remain in the trial and be followed up for 1 year. The primary endpoint is time to loss of treatment segment primary patency. Cox-proportional hazards models will be used to estimate hazard ratios for the time to loss of treatment segment primary patency for each treatment group relative to the control group. Analysis of the primary endpoint will be based on treatment segments rather than participants and a shared frailty will be estimated to account for the clustering of treatment segments within patients. Secondary endpoints are time to loss of primary patency at any treatment segment; time to end of access circuit primary patency; time to AVF abandonment; number of radiological or surgical interventions; adverse events; intima-media thickness and degree of stenosis at 3 months on ultrasound; and patient quality of life assessed by EQ-5D-5L and VASQoL.</p><p><strong>Discussion: </strong>The three-armed design in this proposal will provide an answer on the efficacy of both paclitaxel- and sirolimus-coated balloons in the same trial. This trial is likely to provide a clear answer regarding the efficacy of drug-coated balloons for arteriovenous fistulas.</p><p><strong>Trial registration: </strong>ISRCTN ISRCTN40182296. Registered on 4 August 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11529252/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142558875","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}