Trials最新文献

{"title":"Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review.","authors":"Germán Andrés Alarcón Garavito, Katie Gilchrist, Coziana Ciurtin, Sanjay Khanna, Pinkie Chambers, Nick McNally, Edward Merivale, Edi Carr, Rosamund Yu, Cecilia Vindrola-Padros","doi":"10.1186/s13063-025-08769-y","DOIUrl":"10.1186/s13063-025-08769-y","url":null,"abstract":"<p><strong>Background: </strong>Clinical trials are essential to the development of healthcare innovations that advance life expectancy and improve quality of life. However, there exists a pronounced disparity in ethnic representation among trial participants. This imbalance, particularly in relation to minority ethnic groups, can lead to a limited understanding of how therapies affect diverse populations. The present systematic literature review (SLR) aims to identify the factors that both hinder and facilitate the participation of minority ethnic groups in clinical trials.</p><p><strong>Methods: </strong>This review involved a systematic search of keywords across four databases: Web of Science, PubMed, CINAHL Plus and The Cochrane Library. The review was not restricted by language or study site; however, the date of publication was limited between 1st January 2017 and 1st October 2022. Studies discussing or outlining the involvement of minority ethnic groups in clinical trials, and those outlining inclusive recruitment and participation procedures were targeted.</p><p><strong>Results: </strong>A total of 43 articles were included in the review. Of these, 36 articles were from the United States (US), 20 articles reported on oncology trials and 39 articles reported information from the patient's perspective. Reported barriers included a lack of researchers from minority ethnic groups implementing and conducting clinical research, inadequate funding for clinical trial efforts in geographical areas serving minority populations and a lack of awareness and education among research staff regarding which underrepresented groups to target for recruitment and the strategies to employ in reaching out to them. Several recommendations were suggested by the articles included in the review to address these barriers. Prominently, the use of patient navigators or community liaison roles was highly recommended as a way of supporting patients through the research recruitment process. The articles also highlighted the benefits of translating study materials and interventions into multiple languages and actively involving diverse communities in the development of health education materials. Lastly, leveraging technologies to address socioeconomic barriers, such as the use of virtual approaches to avoid lengthy travel, may also help to improve diversity in trials.</p><p><strong>Conclusions: </strong>Ensuring representation of minority ethnic groups in clinical trials is critical to developing therapies with generalisable efficacies. While progress has been made in enhancing outreach of wider racial groups and fortifying educational resources, there remains a pressing need to delve deeper into the obstacles impeding the recruitment of a diverse participant base, particularly in regions outside the US, where relevant studies are scarce.</p><p><strong>Registration: </strong>The review protocol was registered on PROSPERO (CRD42022368106) (1).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"65"},"PeriodicalIF":2.0,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11846389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143473125","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 efficacy of computerized cognitive training in patients with coronary heart disease and cognitive impairment, no dementia: study protocol for a randomized controlled trial.","authors":"Yi Ye, Qing Chen, Ruixuan Li, Xiaoyi Wang, Yueling Sun, Fangjiang Li, Xiaoping Liu, Le Wang, Xinhui Ning, Hongsen Tian, Wei Zhao, Changsheng Ma, Hongjia Zhang, Yong Zeng","doi":"10.1186/s13063-025-08745-6","DOIUrl":"10.1186/s13063-025-08745-6","url":null,"abstract":"<p><strong>Background: </strong>Cognitive training has been confirmed to significantly improve the overall cognitive function in patients. For patients with coronary heart disease, in addition to controlling common risk factors, there is a lack of effective evidence for the treatment of cognitive function in patients with coronary heart disease and its effectiveness. This randomized controlled study was designed to evaluate the effectiveness of computer-based cognitive training for improving cognitive function in such patients.</p><p><strong>Methods: </strong>COG-T CHD is a multicenter, double-blind, parallel-designed, randomized controlled trial. The patients will be divided 1:1 into two groups by a central randomized system, a cognitive digital therapy group or a positive control group. Patients assigned to the cognitive digital therapy group will undergo computer-based cognitive training for 30 min at least five times a week for 12 weeks. At the end of the 12 weeks, the subjects were randomly divided into two groups. One group continued the 12 weeks of cognitive digital therapy training and the other group stopped the training. Patients assigned to the positive control group will undergo computer-based cognitive training with little or no difficulty changes for 30 min at least five times a week for 12 weeks. The study will last approximately 2 years, with enrollment completed in approximately 18 months, with the last enrolled patient followed for at least 24 weeks. The primary outcome is the proportion of improvement in overall cognitive function at 12 weeks, using the Basic Cognitive Ability Test (BCAT). Secondary outcomes are the proportion of improvement in the overall cognitive function from baseline at 24 weeks, the change in overall cognitive function scores at 12 and 24 weeks, and the proportion of improvement in each cognitive domain, General Self-Efficacy Scale score, EuroQol five-dimension three-level questionnaire score, and Generalized Anxiety Disorder-7 score at 12 and 24 weeks from baseline. The investigational outcome is the change in head MRI structure and function from baseline at weeks 12/24.</p><p><strong>Discussion: </strong>COG-T CHD is the first clinical trial to evaluate the efficacy of computer-based cognitive training in patients with coronary heart disease, filling an important gap in the treatment evidence for cognitive digital therapy.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05735041. Registered on Jan. 18, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"64"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844177/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143473126","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 perioperative remote ischemic conditioning on myocardial injury in patients with unstable angina undergoing percutaneous coronary intervention: protocol of a multicenter, randomized, double-blind clinical trial.","authors":"Lingfeng Xia, Qingyan Yang, Lingjun Jiang, Yu Zheng, Leilei Chen, Song Lin, Jan D Reinhardt, Xiao Lu","doi":"10.1186/s13063-025-08744-7","DOIUrl":"10.1186/s13063-025-08744-7","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular disease is a leading cause of death, with ischemic heart disease being a significant contributor. While percutaneous coronary intervention (PCI) effectively reduces mortality in myocardial infarction patients, its efficacy for unstable angina (UA) patients is controversial. Complications associated with PCI further limit application in UA. RIC is hypothesized to be an effective co-intervention that reduces PCI-related complications and may potentially enhance the efficacy of the PCI procedure itself.</p><p><strong>Methods: </strong>This is a pragmatic, prospective, dual-center, double-blind, randomized controlled clinical trial assessing the effect of remote ischemic conditioning (RIC) during percutaneous coronary intervention (PCI) on injury in unstable angina patients aged ≥ 18 years undergoing coronary angiography. Participants will be randomized to receive either RIC or Sham RIC, in addition to standard pharmacotherapy. Primary outcome includes periprocedural myocardial injury measured by hs-cTnT levels, while secondary outcomes encompass major adverse cardiovascular events, coronary artery lesions Gensini Score, arrhythmia, angina incidence, SAQ scores, ECG changes, and cardiac function assessed by two-dimensional echocardiography. The trial aims to recruit 574 participants and is scheduled to be initiated on 15 January 2024. We will conduct the primary statistical analysis using the intention-to-treat principle. Results from the trial will be presented as comparative summary statistics following the Consolidated Standards of Reporting Trials (CONSORT) guidelines.</p><p><strong>Trial registration: </strong>ChiCTR2400079855, 15 January 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"63"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143473124","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":"Opportunities and challenges to delivering a trial for depressive symptoms in primary care during the COVID-19 pandemic: insights from the Alpha-Stim-D randomised controlled trial.","authors":"Shireen Patel, Priya Patel, Clement Boutry, Boliang Guo, Deborah Butler, Fred Higton, Rebecca McNaughton, Paul M Briley, Christopher Griffiths, Neil Nixon, Vibhore Prasad, Kapil Sayal, David Smart, Azhar Zafar, Joe Kai, Richard Morriss","doi":"10.1186/s13063-025-08772-3","DOIUrl":"10.1186/s13063-025-08772-3","url":null,"abstract":"<p><strong>Background: </strong>Randomised controlled trials (RCTs) are widely regarded as the most powerful research design for evidence-based practice. However, recruiting to RCTs can be challenging resulting in heightened costs and delays in research completion and implementation. Enabling successful recruitment is crucial in mental health research. Despite the increase in the use of remote recruitment strategies and digital health interventions, there is limited evidence on methods to improve recruitment to remotely delivered mental health trials. The paper outlines practical examples and recommendations on how to successfully recruit participants to remotely delivered mental health trials.</p><p><strong>Methods: </strong>The Alpha Stim-D Trial was a multi-centre double-blind randomised controlled trial, for people aged 16 years upwards, addressing depressive symptoms in primary care. Despite a 6-month delay in beginning recruitment due to the COVID-19 pandemic, the trial met the recruitment target within the timeframe and achieved high retention rates. Several strategies were implemented to improve recruitment; some of these were adapted in response to the COVID-19 pandemic. This included adapting the original in-person recruitment strategies. Subsequently, systematic recruitment using postal invitations from criteria-specific search of the sites' electronic health records was added to opportunistic recruitment to increase referrals in response to sub-target recruitment whilst also reducing the burden on referring sites. Throughout the recruitment process, the research team collaborated with key stakeholders, such as primary care clinicians and the project's Patient and Public Involvement and Engagement (PPI/E) representatives, who gave advice on recruitment strategies. Furthermore, the study researchers played a key role in communicating with participants and building rapport from study introduction to data collection.</p><p><strong>Conclusions: </strong>Our findings suggest that trial processes can influence recruitment; therefore, consideration and a regular review of the recruitment figures and strategies is important. Recruitment of participants can be maximised by utilising remote approaches, which reduce the burden and amount of time required by referring sites and allow the research team to reach more participants whilst providing participants and researchers with more flexibility. Effectively communicating and working collaboratively with key stakeholders throughout the trial process, as well as building rapport with participants, may also improve recruitment rates.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"62"},"PeriodicalIF":2.0,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11843808/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468940","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 effects of a nutritional intervention on the sports nutrition knowledge and nutritional status of track and field athletes: protocol for a randomized controlled trial.","authors":"Ranil Jayawardena, Kalani Weerasinghe, Indu Nanayakkara, Terrence Madhujith, Andrew P Hills, Nishan Sudheera Kalupahana","doi":"10.1186/s13063-024-08683-9","DOIUrl":"10.1186/s13063-024-08683-9","url":null,"abstract":"<p><strong>Background: </strong>Sports nutrition plays a crucial role in providing the fuel to meet the energy demands of athletes' training programmes, enhancing adaptations associated with training, and ensuring rapid recovery between workouts. However, evidence suggests that the dietary habits of many athletes are unsatisfactory when compared to sport-specific nutrition recommendations. This discrepancy is mainly due to a lack of up-to-date, evidence-based nutritional knowledge. Hence, this parallel-group, randomized controlled clinical trial aims to evaluate the effectiveness of a 16-week evidence-based, culturally appropriate, personalized sports nutrition intervention on the sports nutrition knowledge and nutritional status of track and field athletes in Sri Lanka, in comparison to a control group that does not receive this intervention.</p><p><strong>Methods: </strong>Elite and highly trained track and field athletes, competing at the national level and/or representing Sri Lanka in international competitions, will be randomly allocated to either the intervention group (IG) (n = 15) or the control group (CG) (n = 15). Participants in the IG will receive an evidence-based, culturally acceptable, personalized sports nutrition intervention from the principal investigator through one-to-one consultations at three-time points (zeroth, fourth, and eighth weeks), while participants in the CG will be followed up throughout the period without receiving the intervention. The primary outcome measure is the number of participants who achieve at least a 10% increase in mean sports nutrition knowledge (SNK) score at the end of the 16^th week, compared to the CG. Secondary outcomes include nutrition status and sports performance-related measures at the beginning and end of the intervention.</p><p><strong>Discussion: </strong>While the primary objective is to enhance SNK, it is anticipated that improvements in nutritional status and overall health may significantly impact sports performance and career longevity of the athletes.</p><p><strong>Trial registration: </strong>Sri Lanka Clinical Trials Registry, SLCTR/2024/013. Registered on 10^th April 2024. Universal Trial Number (UTN), U1111-1304-8890.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"61"},"PeriodicalIF":2.0,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844149/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468949","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":"Time to return of bowel function following perioperative probiotics in colorectal cancer surgery (PICCS-1): study protocol for a randomized controlled trial.","authors":"Dedrick Kok Hong Chan, Bei En Siew, Jerrald Lau, Jasmin Koh, Megan Xin-Hui Lee, Chermaine Ang, Ning Qi Pang, Ker-Kan Tan","doi":"10.1186/s13063-025-08773-2","DOIUrl":"10.1186/s13063-025-08773-2","url":null,"abstract":"<p><strong>Background: </strong>Postoperative ileus occurs in up to 30% of patients following major oncologic surgery for colorectal cancer, leading to significant morbidity, patient distress, as well as increased utilization of healthcare resources. Various modalities to reduce postoperative ileus rates have been explored. One such modality is the perioperative administration of probiotics which have hitherto achieved inconsistent success. Here, we design a trial to determine whether the perioperative administration with probiotics given together with nutritional supplementation can help to reduce postoperative ileus rates.</p><p><strong>Methods: </strong>We propose a parallel three-arm randomized controlled trial. In Arm 1, no nutritional supplementation is provided to the patient. In Arm 2, Nestle Isocal is provided to the participant. Nestle Isocal provides nutritional supplementation but without any probiotic. In Arm 3, Nestle Boost Optimum is provided to the patient. Nestle Boost Optimum contains a similar nutritional profile to Isocal, but with the addition of Lactobacillus paracasei. The primary outcome is the time to first bowel movement in days from the day of surgery. Secondary outcomes are time to first flatus, infective complications, and adverse events related to the administration of nutritional supplementation. Statistical analysis will be conducted in an intention-to-treat approach. ANOVA with the Tukey test will be used to compare continuous variables, while the χ² test will be used for categorical variables.</p><p><strong>Discussion: </strong>Nutritional supplementation with probiotics is a convenient, non-pill alternative for patients. Furthermore, the interventions are commonly found in the formulary of many hospitals worldwide. If successful, probiotics in nutritional supplementation could be a cost-effective and simple way to reduce postoperative ileus.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06456229. This trial was registered on 11 June 2024. Thai Clinical Trials Registry TCTR20240706003. This trial was registered on 6 July 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"60"},"PeriodicalIF":2.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11837682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143459671","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 multistage double-blind placebo-controlled study to assess the safety and efficacy of transdermal vitamin D phosphate supplementation (TransVitD).","authors":"Thomas Hibbard, Paolo Andriollo, Chui Hua Lim, Qing Guo, Karl P Lawrence, Bolaji Coker, Rayka Malek, Abdel Douiri, Mohamed A Alhnan, Stuart A Jones","doi":"10.1186/s13063-024-08711-8","DOIUrl":"10.1186/s13063-024-08711-8","url":null,"abstract":"<p><strong>Background: </strong>Lifestyle changes have meant that it is problematic for many people across the globe to maintain adequate vitamin D concentrations. As UV-catalysed production in the skin, which uses vitamin D-binding protein to facilitate systemic absorption, is the primary source of vitamin D, it is questionable if oral supplementation of this vitamin is the optimal means to replace it. However, supplementing an oil-soluble vitamin via the skin is problematic as it gets stuck in the stratum corneum after topical application. This clinical study will test if a new vitamin D ester, vitamin D phosphate, which is more water-soluble compared to vitamin D, administered via a transdermal patch, can be used to improve vitamin D status.</p><p><strong>Method: </strong>This is a two-part study comprising a dose-escalation with the vitamin D phosphate transdermal patch followed by a randomised, double-blind, placebo-controlled, multiarmed, multistage clinical trial. It is a single-centred, 12-week study that will enrol a maximum of 100 participants. The dose escalation study will monitor safety and tolerability using serum calcium and 25(OH)D₃ levels. The blinded, randomised trial will test different dose frequencies for 4 weeks compared to a placebo. Then, after an interim analysis, the best dosing frequency will be assessed against a placebo. The primary outcome for the multistage clinical study will be the percentage change in 25(OH)D₃ concentration in the serum (ng/mL) at weeks 4 and 8 compared to baseline. The secondary outcome measures include percentage change in serum vitamin D-binding protein levels, skin interstitial fluid biomarker concentrations, and nail appearance after 4 and 8 weeks compared to baseline.</p><p><strong>Discussion: </strong>This study will determine if a vitamin D phosphate transdermal patch can improve vitamin D status. In addition, it could provide a better understanding of how vitamin D is absorbed directly into the skin after application by measuring the serum vitamin D-binding protein and skin biomarker responses to transdermal supplementation.</p><p><strong>Trial registration: </strong>Clinical Trials.gov NCT06098846, registered on 23rd October 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"59"},"PeriodicalIF":2.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11837352/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143459647","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":"Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): statistical analysis plan for a randomised controlled trial.","authors":"Norin Ahmed, Hakim-Moulay Dehbi, Nick Freemantle, Jonathan Best, Philip S Nash, James K Ruffle, David Doig, David J Werring","doi":"10.1186/s13063-025-08761-6","DOIUrl":"10.1186/s13063-025-08761-6","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation causes one-fifth of ischaemic strokes, with a high risk of early recurrence. Although long-term anticoagulation is highly effective for stroke prevention in atrial fibrillation, initiation after stroke can be delayed by concerns over intracranial haemorrhage risk. Direct oral anticoagulants offer a significantly lower risk of intracranial haemorrhage than other anticoagulants, potentially allowing earlier anticoagulation and prevention of ischaemic stroke recurrence, but the safety and efficacy of this approach has not been established. This article describes the statistical analysis plan for the OPTIMAS trial as an update to the published protocol. It was written prior to the end of patient follow-up, before database lock and thus while the outcome of the trial is still unknown.</p><p><strong>Aim: </strong>The optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS) trial will investigate whether early treatment with a direct oral anticoagulant within 4 days of stroke onset is as effective as, or better than, delayed initiation at 7 to 14 days from onset.</p><p><strong>Methods and design: </strong>OPTIMAS is a multicentre randomised controlled trial with blinded outcome adjudication. Participants with acute ischaemic stroke and atrial fibrillation eligible for anticoagulation with a direct oral anticoagulant are randomised 1:1 to early or delayed initiation. Here, we describe in detail the statistical aspects of OPTIMAS, including outcome measures, sample size calculation, general analysis principles, descriptive statistics, statistical models, and planned subgroup analyses.</p><p><strong>Study outcomes: </strong>The primary outcome is a composite of recurrent stroke (ischaemic stroke or symptomatic intracranial haemorrhage) and systemic arterial embolism within 90 days. Secondary outcomes include each individual component of the composite outcome, major bleeding, functional status assessed by the modified Rankin Scale, ongoing anticoagulation, quality of life, health and social care resource use, and length of hospital stay.</p><p><strong>Discussion: </strong>OPTIMAS aims to provide high-quality evidence on the safety and efficacy of early direct oral anticoagulant initiation after atrial fibrillation-associated acute ischaemic stroke.</p><p><strong>Trial registrations: </strong>ISRCTN: 17,896,007; ClinicalTrials.gov: NCT03759938. Registered on November 30 2018.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"58"},"PeriodicalIF":2.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11837694/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449162","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":"6-mm vs 10-mm diameter fully covered self-expandable metal stents in patients with unresectable malignant distal bile duct stricture (COSMIC UNISON): study protocol for a multicenter, randomized controlled trial.","authors":"Reiko Yamada, Takamitsu Tanaka, Yasuaki Shimada, Hirono Owa, Kenji Nose, Yoshifumi Nakamura, Tetsuro Miwata, Junya Tsuboi, Kazuo Hara, Shunpei Hashigo, Akira Hashimoto, Susumu Hijioka, Kohei Okamoto, Yoshiki Hirooka, Hajime Imai, Tadahisa Inoue, Keisuke Iwata, Hideki Kamada, Shinya Kawaguchi, Hiroki Kawashima, Yosuke Kobayashi, Akinori Maruta, Tsuyoshi Mukai, Toji Murabayashi, Shigehito Nakashima, Hiroaki Naota, Fumihiro Okumura, Yumi Oya, Junya Sato, Ken Sugimoto, Yasushi Hamaya, Shunsuke Tano, Motohiro Yoshinari, Yasuhito Imai, Toru Ogura, Satoshi Tamaru, Hayato Nakagawa","doi":"10.1186/s13063-025-08771-4","DOIUrl":"10.1186/s13063-025-08771-4","url":null,"abstract":"<p><strong>Background: </strong>Unresectable malignant bile duct stricture (often caused by unresectable pancreatic cancer and cholangiocarcinoma) can be drained via insertion of self-expandable metal stents (SEMS) during endoscopic retrograde cholangiopancreatography (ERCP). Because recurrent biliary obstruction (RBO) and complications following stent insertion can delay chemotherapy and other treatments, a longer time to RBO (TRBO) is desirable. Although a longer TRBO has been reported among patients who undergo insertion with larger diameter SEMS, patients who undergo insertion with smaller diameter fully covered SEMS (FCSEMS) may have a lower incidence of complications than those with larger diameter FCSEMS. The aim of this study is to determine the TRBO and incidence of complications with 6-mm FCSEMS vs 10-mm FCSEMS in patients with unresectable malignant distal bile duct stricture.</p><p><strong>Methods: </strong>In this multicenter, open-label, randomized controlled, non-inferiority trial (COSMIC UNISON), a target of 250 patients over 23 locations in Japan will receive either the 6-mm FCSEM or the standard 10-mm FCSEM during ERCP, with 125 patients in each group. The observation period will be 24 months, and patients will be enrolled from 15 March 2024 and assessed until the date of RBO or the study end (31 March 2029). The primary endpoint is TRBO, with RBO defined as the coexistence of abnormal liver enzyme values and dilation of the common bile duct and intrahepatic bile duct upstream of the stent. The secondary endpoints are the incidence and rates (at 3, 6, and 12 months) of non-RBO events, overall survival, cause of RBO, and symptomatic stent deviation. Adverse events from endoscopic procedures will be classified by the Lexicon Classification from the American Society of Endoscopy, and all other adverse events will be classified per the Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0.</p><p><strong>Discussion: </strong>The COSMIC UNISON study is anticipated to provide evidence regarding the efficacy and safety of 6-mm vs 10-mm FCSEMS to inform the use of 6-mm FCSEMS for the treatment of unresectable malignant distal bile duct stricture.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials identifier: jRCT1042230170. Prospectively registered on 15 March 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"56"},"PeriodicalIF":2.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834171/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143450496","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 collaborative oral health care planning between older adults and personnel from public dental care and municipal care organizations: a study protocol for a cluster-randomized controlled study in Sweden.","authors":"Jessica Persson Kylén, Sara Björns, Catharina Hägglin, Lisa Bellander, Annsofi Brattbäck Atzori, Sven Persson Kylén, Ann-Christine Baar, Helle Wijk","doi":"10.1186/s13063-025-08753-6","DOIUrl":"10.1186/s13063-025-08753-6","url":null,"abstract":"<p><strong>Background: </strong>Patient participation is key in person-centred care, emphasizing individual choices in treatment. Oral health, integral to overall well-being, is sometimes a neglected part of health. This intervention introduces a novel approach to strengthen person-centred care in homecare settings, employing collaborative, interprofessional teamwork and shared documentation across care organizations. This protocol outlines the design of a cluster-randomized controlled trial (RCT) in Sweden, comparing traditional oral assessments with an interorganizational, team-based oral health care planning model facilitated by a shared digital platform for documentation. The overall aim is to evaluate a person-centred interprofessional and interorganizational model for oral health care planning supported by a digital platform to enable healthy ageing.</p><p><strong>Methods/design: </strong>The intervention, co-designed with older adults, academic institutions, healthcare providers in public dental care, and municipal organizations, will undergo ethical approval. The RCT will randomize older adults, dental hygienists (DHs) and nursing assistants (NAs) into two groups. The intervention group will attend a two-day workshop on a person-centred, three-step team-based model, while the control group will continue using standard procedures. Thereafter, the three-step collaborative model will be compared to standard procedures. Primary outcomes will be measured using the Revised Oral Assessment Guide (ROAG) and the General Oral Health Assessment Index (GOHAI). Secondary outcomes include health economic evaluations, participation rates and quality of care assessments. Qualitative studies from theoretical perspectives of change and learning based on interviews with key stakeholders will be conducted in both the test and control groups.</p><p><strong>Discussion: </strong>Taking a co-produced approach where theory and practice shape the research iteratively, a person-centred health care planning model supported by a shared digital platform for home settings is evaluated. Anticipated outcomes include improved oral assessments and a deeper understanding of effective person-centred care practices. The co-produced approach of the intervention is also expected to further develop knowledge regarding co-production within domains of healthy ageing from an oral health perspective. As such, the intervention shapes and fosters co-produced person-centred care and healthy ageing.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06310798. Registered on 13 March 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"57"},"PeriodicalIF":2.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11837625/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143450497","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}