Trials最新文献

{"title":"Staged Turnbull-Cutait pull-through anastomosis comparing with direct anastomosis plus prophylactic ileostomy in the treatment of low rectal cancer after internal sphincter resection (STAR-TAR): study protocol for a randomized controlled trial.","authors":"Wenhao Chen, Jianhua Ding, Jianbin Xiang, Yanlei Wang, Jiagang Han, Hui Ye, Donghua Wang, Binghu Lin, Junping Lei, Xiangbai Wu, Maojun Di, Yan Fu, Guiyi Yang, Chuanhui Qin, Aijun Chen, Jun Xu, Wenming Liu, Congqing Jiang","doi":"10.1186/s13063-025-08845-3","DOIUrl":"10.1186/s13063-025-08845-3","url":null,"abstract":"<p><strong>Background: </strong>Recent advancements in the understanding of lower rectum anatomy, rectal cancer biology, and surgical techniques have emphasized the importance of radical surgery for low rectal cancer that balances oncological safety and anal function preservation. After total mesorectal excision (TME) and coloanal anastomosis, participants face high risks of anastomotic leakage and infection, often requiring a protective ileostomy. However, ileostomies themselves lead to significant complications, such as dehydration and chronic renal failure, and many participants cannot have their stomas reversed as planned. The Turnbull-Cutait procedure, involving delayed transanal pull-through rectal resection, has emerged as a safer alternative, reducing leakage complications and avoiding the need for a protective stoma. Recent studies support its use in challenging rectal cases, showing comparable or better outcomes than standard techniques. Despite these promising results, limited data exists on its application to intersphincteric resection (ISR) or intersphincteric dissection (ISD), which itself has higher complication rates. Therefore, further research is needed to evaluate this Turnbull-Cutait anastomosis procedure (delayed transanal pull-through) in ISR, comparing its complications, oncological outcomes, and functional results to those of traditional methods (direct anastomosis). This study is a prospective, multicenter, 1:1, non-inferiority, randomized controlled trial with 110 participants, divided into two groups: the staged Turnbull-Cutait pull-through anastomosis group (n = 55) and the direct anastomosis group (n = 55). The control group will undergo ISR with traditional anastomosis plus protective ileostomy, while the experimental group will receive the transanal pull-through and delayed anastomosis without ileostomy. The primary outcome is the 30-day overall postoperative complication rate, including anastomotic leakage, infection, and other complications. Secondary outcomes include long-term complications, total surgery time, anorectal function (measured by LARS and Wexner scores), urinary and sexual function, quality of life (EORTC QLQ-CR29 and FIQL), and 3-year disease-free survival (DFS) and overall survival (OS).</p><p><strong>Discussion: </strong>Currently, there is a lack of systematic studies exploring the use of delayed pull-through anastomosis in intersphincteric resection (ISR) procedures. Existing research on this technique in low rectal cancer is limited to small, single-center, retrospective studies with low levels of evidence. Therefore, a multicenter, prospective, randomized controlled trial is needed to determine whether delayed pull-through anastomosis can serve as a viable alternative to ISR-coloanal anastomosis, offering comparable or lower rates of postoperative complications, as well as similar oncological outcomes and defecatory function. This study aims to provide higher-quality evidence through a larger,","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"168"},"PeriodicalIF":2.0,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12096633/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144128939","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 novel noninvasive assessment of portal pressure from computational biofluid mechanics in patients with portal hypertension.","authors":"Lei Zheng, Guangbo Wu, Jiayun Lin, Hongjie Li, Chihao Zhang, Zhifeng Zhao, Min Chen, Zhenghao Wu, Guqing Luo, Qiang Fan, Xiaoliang Qi, Haizhong Huo, Longci Sun, Meng Luo","doi":"10.1186/s13063-025-08818-6","DOIUrl":"10.1186/s13063-025-08818-6","url":null,"abstract":"<p><strong>Background and aims: </strong>To introduce and assess a novel method for portal pressure measurement based on biofluid mechanics in portal hypertensive patients undergoing surgery.</p><p><strong>Methods: </strong>The research was a multi-center, retrospective study, conducted on patients who underwent surgery and measurement of free portal pressure (FPP). There were 118 patients included and 21 patients excluded due to the failure or poor results of Doppler ultrasound, and 97 patients were screened. We used patients' CT images, Doppler ultrasound results of the portal system, blood density and viscosity to reconstruct their portal system and simulate its internal blood flow. According to the patient's physical property, geometry, and boundary conditions, the Navier-Stokes equations were solved by FLUENT software, and virtual free portal pressure (vFPP) was calculated. Finally, the Bland-Altman Limits of Agreement, intraclass correlation coefficient (ICC), and the Lin's concordance correlation coefficient were performed to evaluate the numerical correlation between the vFPP and FPP.</p><p><strong>Results: </strong>All patients enrolled in this study underwent the surgery, and the FPP of patients was measured during the surgery, with a mean FPP of 22.8 ± 3.3 mmHg (range: 13-33 mmHg). Meanwhile, according to computational biofluid mechanics, all patients' vFPP was calculated. Then, we further explored whether there was a close relationship between vFPP and FPP in the whole population. For the analysis of Bland-Altman Limits of Agreement, the mean value of difference was - 0.1569 (95% CI: - 0.4305 to 0.1167); lower limit of agreement: - 2.8176 (95% CI: - 3.2868 to - 2.3484); upper limit of agreement: 2.5038 (95% CI: 2.0346 to 2.9730). The ICC was 0.9215 (95% CI: 0.8848 to 0.9468). Furthermore, the Lin's concordance correlation coefficient showed a numerical correlation between the vFPP and FPP, which was 0.9205 (95% CI: 0.8840 to 0.9459). All these results confirmed that our vFPP model could provide an accurate prediction of FPP in patients.</p><p><strong>Conclusions: </strong>The vFPP of patients calculated by computational biofluid mechanics was significantly correlated with the FPP of portal hypertensive patients, which would be a novel, non-invasive, and accurate method for the assessment of portal pressure in surgical patients.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"167"},"PeriodicalIF":2.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12093596/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144120956","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":"Remote and In-person Supervised Exercise in Patients with Knee Osteoarthritis (RISE-KOA): study protocol for a non-inferiority randomized controlled trial.","authors":"Maurício Tatsch Ximenes Carvalho, Cristine Lima Alberton","doi":"10.1186/s13063-025-08884-w","DOIUrl":"10.1186/s13063-025-08884-w","url":null,"abstract":"<p><strong>Background: </strong>Knee osteoarthritis (OA) is a prevalent joint condition resulting in years lived with disability. A first-line treatment recommended by clinical guidelines is the therapeutic exercise to control pain and improve physical function. One possible approach for exercise supervision is telehealth using video calls, as it can be an effective alternative to in-person physical therapy for treating musculoskeletal conditions, expanding community access to physical rehabilitation. In this scenario, this study aims to investigate whether a muscle-strengthening exercise program for the lower limbs supervised remotely via video calls is as effective as the same exercise applied in person for improving pain, physical function, condition-specific patient-reported outcomes (PROMs), psychological well-being, sleep quality, functional performance, and quadriceps muscle architecture.</p><p><strong>Methods: </strong>A Remote and In-person Supervised Exercise in Patients with Knee Osteoarthritis (RISE-KOA) study is a parallel, two-armed, single-blinded protocol for a non-inferiority randomized controlled trial. Forty-eight participants aged 45 years or more, with a symptomatic and radiographic diagnosis of unilateral or bilateral knee OA (grade II or III according to Kellgren and Lawerence) will be randomly assigned to a remote exercise group supervised by video calls or in-person exercise group supervised at a physiotherapy clinic. Both groups will receive the same muscle-strengthening exercises for the lower extremities for 12 weeks. Follow-ups will be conducted during treatment (6 weeks), after treatment (12 weeks), and 18 weeks after randomization. The primary outcomes will be pain intensity and physical function during (6 weeks) and after treatment (12 weeks). Secondary outcomes will be condition-specific PROMs, psychological well-being, sleep quality, functional performance, and quadriceps muscle architecture.</p><p><strong>Discussion: </strong>We hypothesize that muscle strengthening exercise supervised remotely via video calls will not be inferior to in-person exercise at a physiotherapy clinic in terms of primary and secondary outcomes in patients with knee OA.</p><p><strong>Trial registration: </strong>The study was prospectively registered at ClinicalTrials.gov (NCT06101797). Registered on Oct 26, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"165"},"PeriodicalIF":2.0,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12090611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112222","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":"mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): statistical analysis plan.","authors":"Tomas Vetrovsky, Norbert Kral, Marketa Pfeiferova, Bohumil Seifert, Vaclav Capek, Katerina Jurkova, Michal Steffl, Richard Cimler, Jitka Kuhnova, Tess Harris, Michael Ussher, Charlotte Wahlich, Katerina Malisova, Jana Pelclova, Jan Dygryn, Steriani Elavsky, Iris Maes, Delfien Van Dyck, Alex Rowlands, Tom Yates","doi":"10.1186/s13063-025-08865-z","DOIUrl":"10.1186/s13063-025-08865-z","url":null,"abstract":"<p><strong>Background: </strong>Type 2 diabetes and prediabetes represent significant global health challenges, with physical activity (PA) being essential for disease management and prevention. Despite the well-documented benefits, many individuals with (pre)diabetes remain insufficiently active. General practitioners (GP) provide an accessible platform for delivering interventions; however, integrating PA interventions into routine care is hindered by resource constraints.</p><p><strong>Objectives: </strong>The ENERGISED trial aims to address these barriers through an innovative GP-initiated mHealth intervention combining wearable technology and just-in-time adaptive interventions.</p><p><strong>Methods: </strong>The ENERGISED trial is a pragmatic, 12-month, multicentre, randomised controlled trial, assessing a GP-initiated mHealth intervention to increase PA and reduce sedentary behaviour in patients with type 2 diabetes and prediabetes. The primary outcome is daily step count, assessed via wrist-worn accelerometry. The primary analysis follows the intention-to-treat principle, using mixed models for repeated measures. Missing data will be handled under the missing-at-random assumption, with sensitivity analyses exploring robustness through reference-based multiple imputation. The trial incorporates the estimand framework to provide transparent and structured treatment effect estimation.</p><p><strong>Discussion: </strong>This statistical analysis plan outlines a robust approach to addressing participant non-adherence, protocol violations, and missing data. By adopting the estimand framework and pre-specified sensitivity analyses, the plan ensures methodological rigour while enhancing the interpretability and applicability of results.</p><p><strong>Conclusions: </strong>The ENERGISED trial leverages innovative mHealth strategies within primary care to promote PA in individuals with (pre)diabetes. The pre-specified statistical framework provides a comprehensive guide for analysing trial data and contributes to advancing best practices in behavioural intervention trials for public health.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05351359 . Registered on April 28, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"166"},"PeriodicalIF":2.0,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12093599/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112221","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":"Health extension workers led home-based multicomponent intervention improves linkage to hypertension care in northwest Ethiopia: cluster-randomized controlled trial.","authors":"Destaw Fetene Teshome, Shitaye Alemu Balcha, Tadesse Awoke Ayele, Asmamaw Atnafu, Getnet Mitike, Kassahun Alemu Gelaye","doi":"10.1186/s13063-025-08862-2","DOIUrl":"10.1186/s13063-025-08862-2","url":null,"abstract":"<p><strong>Background: </strong>Uncontrolled hypertension is the leading cause of cardiovascular and cerebrovascular diseases in Ethiopia. Early detection and referral of hypertensive patients for clinical care is critical for initiating lifestyle changes and antihypertensive medications. This study aimed to evaluate the effects of health extension workers led home-based multicomponent intervention on linkage to hypertension care in patients with hypertension in rural districts of northwest Ethiopia.</p><p><strong>Methods: </strong>A parallel group, cluster randomized controlled trial was conducted in 20 rural communities. A total of 456 (228 in the intervention and 228 in the control clusters) participants were enrolled and followed for nine months. Participants in the intervention clusters received the interventions (home health education, behavioral and medication adherence counseling, and referral to nearby health facility) four times every other month for 40-60 min. The primary outcome was clinical linkage for hypertension care and the secondary outcome was initiation of antihypertensive treatment. Generalized estimating equation was used to evaluate the intervention's effect using an intention-to-treat approach. Effect sizes of relative benefit increases, absolute benefit increases, and attributable benefit were used. All statistical analyses were two-sided with a p-value of < 0.05.</p><p><strong>Results: </strong>The overall average systolic and diastolic blood pressure at baseline were 145.81 (± 13.89) mmHg and 87.11 (± 7.42) mmHg, respectively. The proportion of linkage to hypertension care increased from 11.0% at baseline to 66.2% at 9 months in the intervention group and from 12.3 to 39.7% in the control group, with an absolute benefit increase of 27.5% (95% CI: 19.6%, 35.4%; P-value < 0.001). The attributable benefit associated with the intervention was 40.1% (95% CI 20.7%, 59.5%) which means that more than a third of linkage to hypertension care was due to the HEWs led home-based multicomponent intervention. However, it is noteworthy that only 10.3% of patients initiated antihypertensive medication.</p><p><strong>Conclusions: </strong>In this study, health extension workers led home-based multicomponent interventions that provided home health education, behavioral counseling, and referral to a nearby health facility to improve linkage to hypertension care. A multicomponent intervention implemented on a large scale is likely to improve linkage to hypertension care and reduce hypertension-related morbidity and mortality in the country.</p><p><strong>Trial registration: </strong>PACTR202102729454417.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"163"},"PeriodicalIF":2.0,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12090684/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144102815","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 effectiveness of dual-task exercises in individuals with chronic obstructive pulmonary disease: a study protocol for a randomized controlled trial.","authors":"Begüm Ünlü, Aysel Yıldız Özer, İpek Özmen, Mine Gülden Polat","doi":"10.1186/s13063-025-08854-2","DOIUrl":"10.1186/s13063-025-08854-2","url":null,"abstract":"<p><strong>Background: </strong>Central nervous system dysfunction is an extrapulmonary complication of chronic obstructive pulmonary disease (COPD), and brain function, particularly frontal lobe function, has been shown to deteriorate. It has also been reported that the time taken to complete a functional test involving a cognitive task is prolonged in patients with COPD. The aim of this study is to evaluate the effect of dual-task performance on motor and cognitive function in COPD and to determine the effect of dual-task exercises delivered in a pulmonary rehabilitation program on cardiopulmonary and musculoskeletal parameters.</p><p><strong>Methods: </strong>COPD patients who are admitted to pulmonary rehabilitation, meet the inclusion criteria, and volunteer to participate will be randomly divided into the pulmonary rehabilitation group (control group) and dual-task exercise group. The Dual Task Exercise Group will continue the established rehabilitation programs. During the walking and balance exercises in the program, they will also do cognitive exercises, which are different from those in the pulmonary rehabilitation control group. The COPD Assessment Questionnaire will be applied, and dyspnea assessment will be done with the Modified Medical Research Council Dyspnea Scale. Mini-Mental State Examination and Frontal Assessment Battery will be used to assess cognitive status. Mini-BESTest: Balance Evaluation Systems Test will be used to assess balance. Functional balance and mobility assessment will be performed with the Timed Up and Go Test and the 10-m Walk Test. The tests will be applied twice, as a single task (normal walking) and a dual task (walking and cognitive task). The 6-min walk test will be used to assess functional capacity. Quality of life will be assessed using the St. George Respiratory Questionnaire. Results of pulmonary function tests performed at routine check-ups will be obtained. Assessments will be repeated at the end of the 8-week exercise program.</p><p><strong>Discussion: </strong>Extrapulmonary clinical problems may affect the treatment process in COPD. Studies examining the effect of cognitive dysfunction evaluated dual-task performance in COPD and compared it with healthy controls. Despite the differences in the results, it emphasized that the effects of adding dual-task training to pulmonary rehabilitation should be investigated. Our study may contribute to the literature at this point.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT05930158 (Date: 14.06.2023).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"164"},"PeriodicalIF":2.0,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12090634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144102024","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":"Statistical analysis plan for the Prenatal Iodine Supplementation and Early Childhood Neurodevelopment (PoppiE) randomised controlled trial.","authors":"Thomas R Sullivan, Tim J Green, Jacqueline F Gould, Maria M Makrides, Karen P Best","doi":"10.1186/s13063-025-08863-1","DOIUrl":"10.1186/s13063-025-08863-1","url":null,"abstract":"<p><strong>Background: </strong>Observational evidence suggests both low and high iodine intakes in pregnancy are associated with poorer neurodevelopment in children. This raises concern that blanket recommendations for iodine supplementation in pregnancy may negatively impact child neurodevelopment in women with sufficient iodine intake from food alone.</p><p><strong>Methods: </strong>PoppiE (Prenatal Iodine Supplementation and Early Childhood Neurodevelopment) is a multi-centre, parallel, two-arm, clinician, researcher and participant blinded randomised controlled trial. Seven hundred fifty-four consenting pregnant women ≤ 13 weeks of gestation with an iodine intake of > 165 μg/day from food will be randomised to receive a multivitamin and mineral supplement containing 20 µg/day (intervention) or 200 µg/day (control) of iodine from enrolment until delivery. The primary outcome is the developmental quotient of infants at 24 months of age as assessed with the Cognitive Scale Score of the Bayley Scales of Infant Development, 4th Edition, to be analysed using linear regression with generalised estimating equations to account for multiple births. In this article, we comprehensively detail the planned statistical analyses of the PoppiE trial, including approaches to intercurrent events, methods for handling missing data and planned sensitivity analyses.</p><p><strong>Conclusions: </strong>PoppiE is the first trial to examine the effect of prenatal iodine supplementation on early childhood development in women with sufficient iodine intake from food. At the time of writing (February 2025), recruitment into the trial is complete and data collection is due to conclude in July 2026. The statistical analysis plan was finalised before the database lock, which will ensure study conclusions are not subject to bias due to data-driven analyses.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04586348. Registered on October 14, 2020.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"162"},"PeriodicalIF":2.0,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087031/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144102816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of levothyroxine monotherapy in lowering the risk of cardiovascular disease in older adults with subclinical hypothyroidism: research protocols of a multicenter, open-label, randomized controlled trial.","authors":"Chong Xu, Hui Zhou, Xiaofan Lu, Shuhang Xu, Yu Sun","doi":"10.1186/s13063-025-08857-z","DOIUrl":"10.1186/s13063-025-08857-z","url":null,"abstract":"<p><strong>Objective: </strong>This multicenter, open-label, randomized controlled trial (RCT) aims to assess the efficacy and safety of levothyroxine monotherapy in lowering the risk of cardiovascular disease (CVD) in untreated older adults with subclinical hypothyroidism (SCH) who are diagnosed according to population-specific TSH reference values.</p><p><strong>Methods: </strong>A total of 254 patients with SCH who meet the diagnostic criteria will be recruited, and the baseline clinical data of the patients will be collected. Then, a total of 127 patients will be randomly divided into each of the treatment and control groups, and the treatment group will receive daily levothyroxine doses (Merck Euthyrox® levothyroxine 50 mcg tablet). Specifically, 50 µg of levothyroxine per day will be administered to patients in the treatment group (or 25 µg to patients with a body weight < 50 kg) for at least 48 weeks to maintain thyroid-stimulating hormone (TSH) levels within the normal range. The participants in the control group will be subjected only to thyroid status evaluation, and the results will be recorded. The participants will complete five visits before and after the start of the trial, and differences in the change in carotid intima-media thickness (CIMT), maximum mean change in plaque burden, and changes in lipid profiles, bone mineral densities, and incidences of fatal and nonfatal cardiovascular events between the initial visit and the last follow-up visit will be evaluated via vascular ultrasound.</p><p><strong>Discussion: </strong>We will explicitly address whether levothyroxine replacement therapy provides cardiovascular benefits for older adults with subclinical hypothyroidism.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov, No. ChiCTR2400092634. Registered on 30 November 2024. Recruitment for this study began on December 1, 2024, and continues until at least until November 30, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"161"},"PeriodicalIF":2.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083150/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080635","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 is the effect of the Informed Health Choices secondary school intervention on the ability of students in Rwanda to think critically about health choices after one-year follow-up? A cluster-randomized trial.","authors":"Michael Mugisha, Laetitia Nyirazinyoye, Dieudonne Kayiranga, Clarisse Marie Claudine Simbi, Faith Chesire, Ronald Senyonga, Matt Oxman, Allen Nsangi, Christopher James Rose, Jenny Moberg, Astrid Dahlgren, Margaret Kaseje, Simon Lewin, Nelson K Sewankambo, Sarah Rosenbaum, Andrew D Oxman","doi":"10.1186/s13063-025-08779-w","DOIUrl":"10.1186/s13063-025-08779-w","url":null,"abstract":"<p><strong>Aim: </strong>The aim of this study was to evaluate the effects of the Informed Health Choices secondary school intervention on the ability of students in Rwanda to think critically and make informed health choices after 1 year.</p><p><strong>Methods: </strong>This was a two-arm cluster-randomized trial conducted in 84 lower secondary schools from 10 districts representing five provinces of Rwanda. We used stratified randomization to allocate schools 1:1 to the intervention or control arm. One class in each intervention school had ten 40-min lessons taught by a trained teacher in addition to the usual curriculum. Control schools followed the usual curriculum. The primary outcome was a passing score (≥ 9 out of 18 questions answered correctly) for students on the Critical Thinking about Health Test completed 1 year after the intervention. We conducted an intention to treat analysis using generalized linear mixed models, accounting for the cluster design using random intercepts.</p><p><strong>Results: </strong>After 1 year, 35 of 42 teachers (83.3%) and 1181 of 1556 students (75.9%) in the control arm completed the test. In the intervention arm, 35 of 42 teachers (83.3%) and 1238 of 1572 students (78.8%) completed the test. The proportion of students who had a passing score in the intervention arm was 625/1238 (50.5%) compared to 230/1181 (19.5%) in the control arm (adjusted odds ratio 7.6 [95% CI: 4.6-12.6], p < 0.0001). The adjusted difference in the proportion of students with a passing score was 32.2% (95% CI 24.5-39.8%).</p><p><strong>Conclusions: </strong>The IHC secondary school intervention was effective after 1 year. However, the size of the effect was smaller than immediately after the intervention (adjusted difference 32.2% vs 37.2%) due to decay in the proportion of students in intervention schools with a passing score (50.5% vs 58.2%).</p><p><strong>Trial registration: </strong>Pan African Clinical Trial Registry (PCTR), trial identifier: PACTR202203880375077. Registered on February 15, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"160"},"PeriodicalIF":2.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12082997/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080672","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":"Clinical trial budgeting approaches in Switzerland-a meta-research study.","authors":"Alexandra Griessbach, Malena Chiaborelli, Klaus Ehrlich, Regina Grossmann, María De Medina Redondo, Aurélie Fayet, Reinhard Maier, Sven Trelle, Angèle Gayet-Ageron, Alessandro Ceschi, Benjamin Speich, Matthias Briel","doi":"10.1186/s13063-025-08855-1","DOIUrl":"https://doi.org/10.1186/s13063-025-08855-1","url":null,"abstract":"<p><strong>Background: </strong>Conducting clinical trials is resource demanding. Mirroring challenges experienced elsewhere, clinical trials conducted in Switzerland often face overoptimistic budget estimations and insufficient funding, leading to trial discontinuation and research waste. As a first step to address this problem, we investigated the current approaches to estimate clinical trial budgets in Switzerland.</p><p><strong>Methods: </strong>We collected and examined the budgeting tools and approaches for clinical trials provided by the seven Swiss clinical trial units (CTUs) and the Swiss National Science Foundation (SNSF). We compared available approaches to the publicly accessible budgeting tool of the Belgian Health Care Knowledge Centre (KCE). For each approach, we collected data about user-testing, the availability of prespecified cost items, and estimates on cost ranges.</p><p><strong>Results: </strong>We found substantial heterogeneity in budget calculation approaches used by Swiss CTUs. None of the currently used tools and approaches provided by the seven CTUs or the SNSF was user-tested and neither supplied cost ranges for investigators to rely on. Five CTU tools included a detailed list of cost items. The SNSF provided a costing template with broad categories and is available for open grant applications only. One CTU tool was publicly available. The publicly available Belgian KCE tool was developed with user feedback and provided a detailed list of cost items, some cost ranges, and an instruction manual.</p><p><strong>Conclusion: </strong>Stakeholders should consider improving budgeting practices in Switzerland by standardizing cost items and user-testing approaches. The continuously improved Belgian KCE tool could provide orientation.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"158"},"PeriodicalIF":2.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080633","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}