Trials最新文献

{"title":"Prioritizing attributes of approaches to analyzing patient-centered outcomes that are truncated due to death in critical care clinical trials: a Delphi study.","authors":"Melanie Bahti, Brennan C Kahan, Fan Li, Michael O Harhay, Catherine L Auriemma","doi":"10.1186/s13063-024-08673-x","DOIUrl":"10.1186/s13063-024-08673-x","url":null,"abstract":"<p><strong>Background: </strong>A key challenge for many critical care clinical trials is that some patients will die before their outcome is fully measured. This is referred to as \"truncation due to death\" and must be accounted for in both the treatment effect definition (i.e. the estimand), as well as the statistical analysis approach. It is unknown which analytic approaches to this challenge are most relevant to stakeholders.</p><p><strong>Methods: </strong>Using a modified Delphi process, we sought to identify critical attributes of analytic methods used to account for truncation due to death in critical care clinical trials. The Delphi panel included stakeholders with diverse professional or personal experience in critical care-focused clinical trials. The research team generated an initial list of attributes and associated definitions. The attribute list and definitions were refined through two Delphi rounds. Panelists ranked and scored attributes and provided open-ended rationales for responses. A consensus threshold was set as ≥ 70% of respondents rating an attribute as \"Critical\" (i.e., score ≥ 7 on a 9-point Likert scale) and ≤ 15% of respondents rating the measure as \"Not Important\" (i.e., a score of ≤ 3).</p><p><strong>Results: </strong>Thirty-one (91%) of 34 invited individuals participated in one or both rounds. The response rate was 82% in Round 1 and 85% in Round 2. Participants included eight (26%) personal experience experts and 26 (84%) professional experience experts. After two Delphi rounds, four attributes met the criteria for consensus: accuracy (the approach will identify effects if they exist, but will not if they do not), interpretability (the approach enables a straightforward interpretation of the intervention's effect), clinical relevance (the approach can directly inform patient care), and patient-centeredness (the approach is relevant to patients and/or their families). Attributes that did not meet the consensus threshold included sensitivity, comparability, familiarity, mechanistic plausibility, and statistical simplicity.</p><p><strong>Conclusions: </strong>We found that methods used to account for truncation due to death in the treatment effect definition and statistical approach in critical care trials should meet at least four defined criteria: accuracy, interpretability, clinical relevance, and patient-centeredness. Future work is needed to derive objective criteria to quantify how well existing estimands and analytic approaches encompass these attributes.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"15"},"PeriodicalIF":2.0,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11721323/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142966791","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 recruitment manoeuvres on postoperative pulmonary complications in laparoscopic bariatric surgery patients: study protocol for a randomised clinical trial.","authors":"Yu-Qi Liao, Jin-Dong Yang, Yi He, Xin Tong, Jing Wen, Yan-Jun Liu, Qiang Fu","doi":"10.1186/s13063-024-08702-9","DOIUrl":"10.1186/s13063-024-08702-9","url":null,"abstract":"<p><strong>Background: </strong>Lung ultrasound-guided alveolar recruitment manoeuvres (RMs) may reduce the lung ultrasound score. However, whether the use of this strategy can reduce the incidence of postoperative pulmonary complications (PPCs) in the adult obese population has not yet been tested.</p><p><strong>Methods/design: </strong>This is a single-centre, two-arm, prospective, randomised controlled trial. A total number of 476 obese patients scheduled for bariatric surgeries will be enrolled. They will be randomly assigned to receive either lung ultrasound-guided RMs (intervention group) or conventional RMs (control group) intraoperatively. The occurrence of PPCs will be recorded as the primary outcome.</p><p><strong>Discussion: </strong>To the best of our knowledge, this is the first trial to test the effect of lung ultrasound-guided RMs on PPCs. The results of this trial will support the anaesthesiologists in choosing a potentially more efficient method to perform RMs for bariatric surgery patients.</p><p><strong>Trial registration: </strong>www.chictr.org.cn ChiCTR2400080203. Registered on 23 January 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"13"},"PeriodicalIF":2.0,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11716455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955644","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":"Implementation of a program to strengthen oral hygiene in patient with cleft deformities: a prospective randomized controlled clinical trial.","authors":"Camille Boeffard, Justine Loin, Roselyne Clouet, Alexis Gaudin, Pierre Corre, Tony Prud'Homme","doi":"10.1186/s13063-024-08507-w","DOIUrl":"10.1186/s13063-024-08507-w","url":null,"abstract":"<p><strong>Background: </strong>Cleft lip and/or palate is the most common congenital orofacial deformity, affecting 1/800 births. A thorough review of the literature has shown that children with cleft have poorer oral hygiene and dental health than other children, with higher levels of caries in both temporary and permanent teeth and poorer periodontal health. Cleft patients are treated by a multidisciplinary team that aims to provide comprehensive care from pre- or post-natal diagnosis to early adulthood and the end of growth. We aim to assess, through a single-center, prospective, randomized and controlled clinical trial conducted at the Nantes Cleft Centre, the impact of an enhanced dental program on oral hygiene and dental health in cleft patients.</p><p><strong>Methods: </strong>Patients aged 3 to 15 years with unilateral or bilateral cleft lip and/or palate will be offered to participate in this study. After acceptance, patients will be randomly assigned to 2 groups: test group or control group. For the control group, there will be no change in the patient's care, and they will continue to see their surgeon on an annual basis. For the test group, a 30-45-min consultation will be added to the annual check-up. During this visit, patients and their parents will receive oral and written oral hygiene instructions to improve oral hygiene knowledge and brushing technique. If necessary, dental treatment will be provided at the same appointment or at a later date. In addition, patients will be contacted via telemedicine every 2 months to increase motivation, and an additional dental appointment will be scheduled at 6 months.</p><p><strong>Discussion: </strong>This is a single-center study which, if conclusive, could lead to a paradigm shift in the dental care pathway for cleft patients.</p><p><strong>Trial registration: </strong>NCT05867862 submitted 2023-07-05 https://clinicaltrials.gov/study/NCT05867862?locStr=Nantes,%20France&country=France&state=Pays%20de%20la%20Loire&city=Nantes&distance=50&cond=CLEFT%20LIP&rank=1- -Trial Sponsor Nantes University Hospital.</p><p><strong>Trial status: </strong>8th Version date 2023 May 05; recruitment began in June 2023 and will be completed in June 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"14"},"PeriodicalIF":2.0,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11720328/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955654","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":"Twenty-four weeks of combined training in different environments, aquatic and land, in the type 2 diabetes management (Aquatic and Land Exercise for Diabetes -ALED): protocol of a randomized clinical trial.","authors":"Larissa Dos Santos Leonel, Ingrid Alessandra Victoria Wolin, Angélica Danielevicz, Mabel Diesel, Marina Isolde Constantini, João Batista de Oliveira Junior, Allana Andrade Souza, Thaís Reichert, João Gabriel Silveira-Rodrigues, Danusa Dias Soares, Marcelo Fernando Ronsoni, Simone Van De Sande Lee, Alex Rafacho, Guilherme Fleury Fina Speretta, Karla Siqueira Lottermann, Josefina Bertoli, Alexandre Pastoris Muller, Aline Mendes Gerage, Cíntia de La Rocha Freitas, Rodrigo Sudatti Delevatti","doi":"10.1186/s13063-024-08660-2","DOIUrl":"10.1186/s13063-024-08660-2","url":null,"abstract":"<p><strong>Background: </strong>Physical exercise is crucial in type 2 diabetes management (T2D), and training in the aquatic environment seems to be a promising alternative due to its physical properties and metabolic, functional, cardiovascular, and neuromuscular benefits. Research on combined training in aquatic and dry-land training environments is scarce, especially in long-term interventions. Thus, this study aims to investigate the effects of combined training in both environments on health outcomes related to the management of T2D patients.</p><p><strong>Methods: </strong>This is a randomized, unicentric, single-blinded, comparator clinical trial with two parallel arms. Participants with T2D, of both sexes, aged at 45 to 80 years old, will be randomized into two groups (aquatic combined training (AQUA) and dry-land combined training (LAND)), both performing combined aerobic and resistance training three times a week on alternate days for 24 weeks. Aerobic training will be performed using continuous and pyramidal methods, with linear exercise intensity and duration progression. Intensity will be prescribed by rated effort perception (Borg scale 6 to 20). Resistance training will be performed using exercise for the trunk, upper and lower limbs maximum speed, and target repetition zone in aquatic and dry-land environments, respectively, using multiple sets in a linear dosage progression. Before, at 12 weeks, and after the 24 weeks of training, biochemical analyses, functional capacity, maximum muscle strength, body composition assessments, cardiovascular measures, and the administration of questionnaires to assess mental, cognitive, sleep quality, and quality of life will be conducted. Throughout the 24 weeks, the training load date and acute capillary glucose and blood pressure measurements will also be conducted. The data will be analyzed using the SPSS (29.0) statistical package, using a significance level of 0.05. For intra- and inter-group comparisons, generalized estimating equations will be applied and analyzed by intention-to-treat and per-protocol adopting the Bonferroni post hoc test.</p><p><strong>Discussion: </strong>The obtained results may provide insights to enhance understanding of the benefits of the aquatic and dry-land environment on various health outcomes, as well as acute aspects and safety considerations of the training. Moreover, this could support the development of intervention strategies to optimize the T2D management.</p><p><strong>Trial registration: </strong>Brazilian Clinical Trial Registry (ReBEC) RBR-10fwqmfy. Registered on April 16, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"12"},"PeriodicalIF":2.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11716115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955569","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 single-centre randomised controlled trial comparing the standard method and target-controlled infusion as a method of administering cefoxitin, which is used to prevent surgical site infections in colorectal surgical patients: study protocol.","authors":"Ha-Jung Kim, Kyung Mi Kim, Jong Lyul Lee, In Ja Park, Byung-Moon Choi","doi":"10.1186/s13063-025-08716-x","DOIUrl":"10.1186/s13063-025-08716-x","url":null,"abstract":"<p><strong>Background: </strong>Prophylactic parenteral administration of antibiotics is strongly recommended to prevent surgical site infection (SSI). Cefoxitin is mainly administered intravenously in colorectal surgery. The current standard method for administering prophylactic antibiotics in adults is to administer a fixed dose quickly before skin incision. The percentage of time that the unbound concentration is maintained above the minimum inhibitory concentration (fT > MIC) during surgery is used as a surrogate measure for the effectiveness of prophylactic antibiotics. Target-controlled infusion (TCI) is a method of administration that changes the infusion rate to maintain a constant target concentration set by the user in consideration of the patient's physical characteristics. When cefoxitin is administered using the TCI method, it is possible that fT > MIC can be well maintained while reflecting the patient's physical characteristics compared to the standard method.</p><p><strong>Methods: </strong>This prospective, single-centre, parallel-arm, single-blinded, randomised controlled trial with a 1:1 allocation was designed to compare the effectiveness of the TCI method with that of the standard cefoxitin administration method. We shall enrol 2494 patients scheduled to undergo colon or rectal surgery. Prior to the procedure, we shall randomise each patient to the control group (standard administration method) or study group (TCI method). In the control group, 2 g of cefoxitin was dissolved in 100 ml of normal saline and administered for approximately 10 min. Redosing was performed every 2 h from the start of the first dose of cefoxitin. In the study group, 2 g of cefoxitin was dissolved in 50 ml of normal saline and administered using a commercialised TCI syringe pump until the end of surgery. It was administered at a target concentration of 80 μg/ml using the total concentration pharmacokinetic model of cefoxitin. In all groups, 2 g of cefoxitin was administered using the standard administration method 12 h after the end of surgery. The primary outcome will be the incidence of SSI. The secondary outcome will be the administered dose of cefoxitin. Preoperative, intraoperative, and postoperative data were collected.</p><p><strong>Discussion: </strong>This study will provide evidence for the effectiveness of administering cefoxitin using the TCI method compared to the standard method.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05253339 , Registered on February 23, 2022 {2a, 2b}.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"11"},"PeriodicalIF":2.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11708072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955632","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 PCSK9 inhibitor on early neurological deterioration in acute ischemic stroke patients with a history of coronary heart disease: a study protocol for a randomized controlled trial in Dalian, China.","authors":"Xing Gong, Xinting Yu, Lanlan Pu, Yang Jiao, Lin Liu, Hua Cao, Xiaofei Ji","doi":"10.1186/s13063-024-08709-2","DOIUrl":"https://doi.org/10.1186/s13063-024-08709-2","url":null,"abstract":"<p><strong>Background: </strong>Early neurological deterioration (END) is a critical determinant influencing the short-term prognosis of acute ischemic stroke (AIS) patients and is associated with increased mortality rates among hospitalized individuals. AIS frequently coexists with coronary heart disease (CHD), complicating treatment and leading to more severe symptoms and worse outcomes. Shared risk factors between CHD and AIS, especially elevated low-density lipoprotein cholesterol (LDL-C), contribute to atherosclerosis and inflammation, which worsen brain tissue damage. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors offer a promising treatment option. They effectively lower LDL-C levels and may help reduce END in AIS patients with CHD. This study aims to evaluate how effective PCSK9 inhibitors are in reducing END among this high-risk group and to provide new insights for treatment strategies.</p><p><strong>Methods: </strong>This is a prospective, randomized, parallel-group, blinded-endpoint, single-center clinical study. A total of 156 AIS patients with a history of CHD and within 24 h from symptom onset will be recruited and randomized in a 1:1 allocation to either the PCSK9 inhibitor combined with statin treatment group (PI group) or the statin monotherapy group (AT group). The PI group will receive a combination therapy consisting of evolocumab and rosuvastatin calcium tablets, while the AT group will receive only oral rosuvastatin calcium tablets. The trial duration will last for 90 days and comprise three phases: screening, treatment intervention, and follow-up assessments. Participants will undergo comprehensive examinations and assessments on days 1, 7, 30, and 90 after enrollment.</p><p><strong>Discussion: </strong>This study aims to investigate the potential preventive effects of PCSK9 inhibitors on END in AIS patients with a history of CHD. A positive outcome from this trial could provide novel clinical strategies for reducing the incidence of END and improving the short-term prognosis among these stroke patients.</p><p><strong>Trial registration: </strong>China Clinical Trial Registry, ChiCTR2300078198. Registered on 30 November 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"7"},"PeriodicalIF":2.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11702183/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143056074","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":"Open-label randomised clinical trial investigating whether robot-assisted kidney transplantation can reduce surgical complications compared to open kidney transplantation (ORAKTx): study protocol for a randomised clinical trial.","authors":"Milla Ortved, Julia Dagnæs-Hansen, Hein V Stroomberg, Thomas Kistorp, Malene Rohrsted, Søren Schwartz Sørensen, Andreas Røder","doi":"10.1186/s13063-024-08706-5","DOIUrl":"https://doi.org/10.1186/s13063-024-08706-5","url":null,"abstract":"<p><strong>Background: </strong>Kidney transplantation is the ultimate treatment for end-stage kidney disease. Function of the kidney graft is not only dependent on medical factors but also on a complication-free surgical procedure. In the event of major surgical complications, the kidney graft is potentially lost and the patient will return to the waiting list which may be long. To optimise peri-operative care and reduce complications, robot-assisted kidney transplantation (RAKT) has been introduced as an alternative to open kidney transplantation (OKT), but to our knowledge, no randomised clinical trials (RCT) have compared RAKT to OKT. In this study, we will explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation.</p><p><strong>Methods: </strong>This is a single-site, open-label, randomised clinical trial comparing RAKT to OKT. Participants are adult recipients of kidney transplantation recruited from Copenhagen University Hospital - Rigshospitalet, Denmark. The study plans to include 106 participants who will be randomised in a 1:1 manner between OKT and RAKT. Primary outcomes are vascular- and major surgical complications at 30 days post-operatively. Participants will be followed for 2 years to evaluate secondary outcomes including recovery, late complications and kidney graft function. This is designed as a superiority trial and planned analyses will follow intention-to-treat principles.</p><p><strong>Discussion: </strong>Studies indicate RAKT can reduce several surgical complications, but the lack of RCTs limits the extrapolation of these results to justify replacing an open approach with a robot-assisted one. Ultimately, the introduction of new surgical techniques should be as vigorously tested as any other new treatments. However, reducing surgical complications that compromise graft viability could lead to improved patient care and survival.</p><p><strong>Trial registration: </strong>The trial was prospectively registered with ClinicalTrials.gov on February 15th, 2023, with the identifier NCT05730257.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"8"},"PeriodicalIF":2.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11702044/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955656","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":"Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA): study protocol for a randomised controlled trial.","authors":"David J Berlowitz, Dominic Rowe, Mark E Howard, Amanda Piper, Marnie Graco, Sabine Braat, Bhajan Singh, Tanara Viera Souza, Natasha Lannin, Alistair McLean, Abbey Sawyer, Kate A Carey, Yasmin Ahamed","doi":"10.1186/s13063-024-08464-4","DOIUrl":"https://doi.org/10.1186/s13063-024-08464-4","url":null,"abstract":"<p><strong>Background: </strong>Non-invasive ventilation (NIV) uses positive pressure to assist people with respiratory muscle weakness or severe respiratory compromise to breathe. Most people use this treatment during sleep when breathing is most susceptible to instability. The benefits of using NIV in motor neurone disease (MND) are well-established. However, uptake and usage are low (~ 19%) and there is no consensus on how to best implement NIV in MND in Australia. Consequently, clinical practice models are highly variable. Our team has recently provided evidence that specific and individualised NIV titration using a sleep study (polysomnography; PSG) leads to better outcomes in people with MND. However, for this clinical practice model to result in sustained benefits, evidence of effectiveness across multiple sites, as well as culture and practice change, must occur.</p><p><strong>Methods: </strong>A two-arm, assessor-blinded, individual participant randomised controlled trial in MND care centres across Australia will be undertaken. Two-hundred and forty-four participants will be randomised (1:1) to either the intervention group (PSG-assisted commencement of NIV settings; PSG) or a control group (sham PSG). Participants will be asked to use their NIV device for 7 weeks and will then return for follow-up assessments. Respiratory, sleep and patient-reported outcome measures will be collected at baseline and follow-up. The primary aim is to determine if the proportion of participants using NIV for > 4 h/day during the intervention period is higher in the PSG than the control group. A process evaluation, health economic evaluation and 12-month cohort follow-up will be undertaken and reported separately.</p><p><strong>Discussion: </strong>The results of this trial will demonstrate the effects of PSG-assisted titration of NIV on usage of NIV in people with MND. We hypothesise that the PSG intervention will improve synchrony between the user and the machine, which will lead to greater NIV usage compared to the control group.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05136222. Registered on November 25, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"10"},"PeriodicalIF":2.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11705826/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955658","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":"Sexual Health Advocacy for Guys (SHAG): a randomized trial of the impact of a text-messaging program on HIV incidence and STI testing among a national sample of sexual minority cisgender adolescent and young adult men.","authors":"M L Ybarra, D J Feaster, R Garofalo, S Bull","doi":"10.1186/s13063-024-08540-9","DOIUrl":"https://doi.org/10.1186/s13063-024-08540-9","url":null,"abstract":"<p><strong>Background: </strong>Disparities in sexually transmitted infections (STI) including human immunodeficiency virus (HIV) among sexual minority boys and young men are substantial. Effective HIV and STI prevention programs that include access to pre-exposure prophylaxis (PrEP) medication do not consistently include younger sexual minority men. Text-messaging programs for HIV prevention have been associated with increases in HIV testing among sexual minority adolescent boys, but these programs have not incorporated a focus on PrEP or STIs beyond HIV.</p><p><strong>Methods: </strong>We will conduct a two-arm randomized trial with 1:1 allocation comparing the superiority of text messaging-based intervention focused on HIV and STI prevention to a generic HIV education program with content focused on promoting a \"healthy lifestyle\" (e.g., self-esteem). Outcomes include testing for HIV and other STIs, increasing PrEP and PEP use, and HIV incidence. Generalized linear models will be used to estimate treatment effects on primary study outcomes, with longitudinal models (estimated based on Generalized Estimating Equations) specified to examine effects over time. Mediation will be assessed based on a product of coefficients approach with bootstrapped standard errors.</p><p><strong>Discussion: </strong>This is the first randomized controlled trial (RCT) with a national sample of cisgender sexual minority adolescent boys and young men 13-22 years of age exploring the efficacy of a text messaging-based intervention in increasing HIV and STI testing, and PReP and PEP use. Findings will inform the scalability of text messaging programs for sexual health promotion and at-home STI testing, and will demonstrate impacts of a behavioral health intervention on HIV incidence.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06230367 . Date of registration: 1/29/2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"9"},"PeriodicalIF":2.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11702260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955568","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":"Core Outcome Set development for LEPtospirosis trials (COS-LEP): a study protocol to develop a core outcome set for the evaluation of clinical therapeutic interventions for human leptospirosis.","authors":"Nathaniel Lee, Chris Smith, Robin Bailey, Koya Ariyoshi, Sarah Smith, Nick Black, Tansy Edwards","doi":"10.1186/s13063-024-08713-6","DOIUrl":"https://doi.org/10.1186/s13063-024-08713-6","url":null,"abstract":"<p><strong>Background: </strong>Leptospirosis is a zoonotic bacterial infection occurring worldwide. It is of particular public health concern due to its global distribution, epidemic potential and high mortality without appropriate treatment. The method for the management of leptospirosis, particularly in severe disease, is clouded by methodological inconsistency and a lack of standardized outcome measures. The study this protocol details aims to develop a core outcome set (COS) for leptospirosis research. A COS is a set of outcomes with international consensus as a minimum for reporting in future studies focusing on leptospirosis. Establishing a COS will contribute to harmonizing Leptospirosis treatment research and will be instrumental in constructing a high-quality evidence base to feed into a planned future rigorous international clinical trial on leptospirosis.</p><p><strong>Methods: </strong>The COS-LEP study will employ a COS development methodology standardized by the COMET initiative framework. This includes (1) a systematic review of available quantitative and qualitative literature reporting therapeutic response and safety outcomes and measures; (2) focused interviews with healthcare professional and people treated for leptospirosis exploring outcomes of interests using qualitative methodology; (3) narrowing the choice of outcomes by international consensus using a Delphi survey process; and (4) undertaking a hybrid consensus meeting with key stakeholders to build the final COS.</p><p><strong>Discussion: </strong>This protocol describes the method to develop the first core outcome set for use in human leptospirosis studies. This will not only be a key feature in the design of a future definitive randomized controlled trial, but also provide a structure for clinicians and researchers collecting treatment cohort data in the various settings where leptospirosis is a public health issue.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"6"},"PeriodicalIF":2.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11702042/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955652","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}