Trials最新文献

{"title":"Process evaluation of the randomized trial-\"Care management for older people with cognitive impairment during and after hospitalisation in Germany (intersec-CM)\".","authors":"N Chikhradze, A Hannich, I C Otte, T S Busse, A Suslow, A Nikelski, F Schumacher-Schoenert, S H Kreisel, M Boekholt, J R Thyrian, W Hoffmann, H C Vollmar","doi":"10.1186/s13063-026-09965-0","DOIUrl":"10.1186/s13063-026-09965-0","url":null,"abstract":"<p><strong>Background: </strong>Effective care of people with cognitive impairment and their families depends, among other things, on the cooperation of the professionals involved in their care. An effective dementia care management support model for people with dementia and their families for the outpatient sector has been further developed for ambulatory and hospital settings. The intersec-CM randomized controlled trial (RCT) implemented this intersectoral care management (iCM) model into routine care in three hospitals in Bielefeld and Greifswald (Germany). Care managers (CMs) trained in advance for the study used a computer-based information management system (IMS) to assess patients' health and care needs and to develop individualized care plans. The iCM aimed to improve hospital-to-primary-care transitions and ensure cross-sectoral care. This was accompanied by a process evaluation to complement the data collected in the RCT. The aim was to understand how the complex intervention works in the selected real-world setting. This paper presents the results of this process evaluation.</p><p><strong>Methods: </strong>For the process evaluation, a mixed-method design was chosen and applied. The evaluation was based on the guidelines of the British Medical Research Council for the implementation and process evaluation of complex interventions (MRC framework). A method triangulation was conducted consisting of several successive phases (t1: qualitative, t2: quantitative, t3: qualitative).</p><p><strong>Results: </strong>The sample (t1: individual interviews n = 30, t2: survey n = 177, t3: individual interviews n = 33) consisted of patients and their relatives, clinical physicians, social workers, carers, general practitioners, care managers (CMs), and project management. The process evaluation showed that intersectoral iCM could be implemented in the hospitals. The CMs were partially successful in assessing needs, developing individual treatment plans, and coordinating and monitoring the needs of people with cognitive impairment and their families. They found it difficult to work with the different actors in the healthcare system because of the rigid daily routines and lack of time in the clinics. Overall, the results show that (1) people with cognitive impairment and their families can benefit from the intervention and (2) iCM can help with the flow of information between health professionals.</p><p><strong>Conclusions: </strong>The present process evaluation underlines the necessity and meaningfulness of process evaluations to understand the functionality and procedural feasibility of an RCT. Through the study, significant insights into the \"black box\" of the implementation of the iCM intervention could be gained.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03359408. The trial was registered on December 2, 2017.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13525668/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148857850","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 norepinephrine infusion combined with goal-directed fluid therapy on delayed graft function in patients undergoing kidney transplantations: study protocol for a multicenter randomized controlled trial.","authors":"Muyan Shi, Yuhan Zhang, Xibing Ding, Xiangyang Cheng, Jie Zhou, Diansan Su","doi":"10.1186/s13063-026-09972-1","DOIUrl":"10.1186/s13063-026-09972-1","url":null,"abstract":"<p><strong>Background: </strong>Chronic kidney disease presents a formidable challenge to global healthcare systems. With ongoing advancements in surgical techniques, kidney transplantation has emerged as a principal therapeutic modality for individuals afflicted with end-stage renal disease, markedly enhancing their long-term prognosis and overall quality of life postoperatively. Nevertheless, the occurrence of delayed graft function represents a prevalent early complication following kidney transplantations, mainly stemming from the ischemia-reperfusion injury incurred by the transplanted kidneys and the utilization of extended criteria donor organs. The manifestation of delayed graft function can precipitate primary allograft nonfunction, acute rejection episodes, and potentially fatal outcomes. Vigilant attention to perioperative fluid management emerges as a cornerstone in mitigating the risk of delayed graft function. Recent strides in Goal-directed fluid therapy have garnered substantial attention within critical care contexts, with empirical evidence underscoring its favorable impact on postoperative outcomes in critically ill cohorts. However, the efficacy of Goal-directed fluid therapy specifically in the context of kidney transplantation remains a subject of ongoing debate and scrutiny. Hence, the imperative arises to investigate potential strategies aimed at attenuating the incidence of delayed graft function in this patient demographic.</p><p><strong>Methods: </strong>A multicenter, randomized, single-blind, two-arm parallel-group, controlled trial will be undertaken to assess the efficacy of norepinephrine in conjunction with Goal-directed fluid therapy on graft function recovery among individuals slated for kidney transplantations. Patients will be allocated randomly to either a control or intervention arm, wherein conventional fluid management or the administration of norepinephrine infusion combined with Goal-directed fluid therapy will be administered, respectively.</p><p><strong>Discussion: </strong>The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy in mitigating the occurrence of delayed graft function among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06367205. Registered on April 16, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13536601/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148881957","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 SP16 in preventing acute kidney injury in at-risk subjects with chronic kidney disease undergoing elective cardiac surgery using the heart-lung-machine (EASE-AKI): study protocol for a prospective, randomised, double-blind, placebo-controlled clinical trial.","authors":"Tilman Jobst-Schwan, Karl Bihlmaier, Dana Austin, Cohava Gelber, Ann-Sophie Kaemmerer-Suleiman, Mathieu Suleiman, Robert Cesnjevar, Frank Harig, Mario Schiffer","doi":"10.1186/s13063-026-09966-z","DOIUrl":"10.1186/s13063-026-09966-z","url":null,"abstract":"<p><strong>Background: </strong>Cardiac surgery using cardiopulmonary bypass uses controlled hypoperfusion which leads to relative organ damage. Acute kidney injury is the most frequent and most important organ failure, in particular in patients with chronic kidney disease. To date, there are no approved drug treatments that could effectively prevent acute kidney injury. SP16, an agonist of the low-density lipoprotein receptor-related protein 1, has been shown to exert both kidney- and cardioprotective effects in preclinical trials. Early clinical use of SP16 in phase I trials was safe. Administration of SP16 had beneficial trends on inflammatory response and infarct size in patients with ST-segment elevation myocardial infarction. The primary objective of this phase IIa trial is to demonstrate that injection of SP16 is safe and superior to placebo in preventing cardiac surgery-associated acute kidney injury within 7 days after surgery.</p><p><strong>Methods: </strong>This randomised, double-blinded, placebo-controlled, single-centre study evaluates the efficacy and safety of SP16 in 120 high-risk chronic kidney disease patients with disease stage G2-G3b undergoing cardiac surgery who are randomised into one of two treatment groups in a 1:1 ratio: SP16 (12 mg) or placebo. The study medication is administered via two subcutaneous injections, with the first dose given before surgery, followed by an additional dose after 9 h. Primary endpoints are the incidence of acute kidney injury during 7 days post-surgery and the frequency of adverse events within 72 h after index surgery. Important secondary endpoints include the incidence of major adverse kidney events at day 90 and impact on cardiac function. Safety assessments encompass adverse events, vital signs, electrocardiograms and routine safety laboratory tests. Additional evaluations include pharmacokinetics and immunological biomarkers.</p><p><strong>Discussion: </strong>This single-centre phase IIa trial will assess the incidence of cardiac surgery-associated acute kidney injury, describing the kidney-protective potential of SP16 and its safety profile in patients undergoing cardiac surgery.</p><p><strong>Trial registration: </strong>EUCT, EUCT number 2025-522491-89-00. Registered on February 2, 2026, https://euclinicaltrials.eu/ctis-public/view/2025-522491-89-00 . Patient recruitment is planned to start on August 1, 2026.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13523505/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148851281","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":"Metacognitive Training for Negative Symptoms (MCT-Minus) in schizophrenia: study protocol for a pragmatic randomized controlled trial.","authors":"Linda Swanson, Benjamin Rask, Jonas Persson, Pascaline Graner, Johan Bengtsson, Robert Bodén, Martin Cernvall, Ulrika Sällström, Mårten J Tyrberg, Steffen Moritz, Simon Cervenka","doi":"10.1186/s13063-026-09879-x","DOIUrl":"10.1186/s13063-026-09879-x","url":null,"abstract":"<p><strong>Background: </strong>Negative symptoms are experienced by up to 60% of the individuals with schizophrenia and represent a stronger indicator of current and future functioning than positive symptoms. These symptoms respond poorly to pharmacological and existing psychosocial interventions, highlighting the need for targeted treatments. Previous research suggests that defeatist performance beliefs, combined with metacognitive deficits, may contribute to negative symptoms. A recent pilot study, adapting the cognitive intervention metacognitive training (MCT) to address negative symptoms, found symptom reduction, primarily due to improved reflective functioning and reduced perceived stigma. The current study aims to further assess the efficacy of this intervention and to explore potential mechanisms of change in negative symptoms.</p><p><strong>Methods: </strong>Ninety participants aged 18 and older with a psychotic disorder will be recruited from psychiatric care settings in Sweden. Participants will be randomly assigned to either the intervention group (MCT-Minus) or a control group receiving supportive counselling (SC). Data will be collected at baseline, post-intervention, and at 12-week and 12-month follow-ups. Magnetic resonance imaging (MRI) will be performed at baseline and post-intervention. Exit interviews will be held after completing the intervention. The primary outcome is change in negative symptom, measured by the Clinical Assessment Interview for Negative Symptoms (CAINS), across all time points. Repeated measures ANCOVA will be used to evaluate primary outcomes. Additional analyses will address changes in positive symptoms and potential mechanisms of change, including metacognition and internalized stigma. Qualitative data from exit interviews will be analyzed using reflexive thematic analysis.</p><p><strong>Discussion: </strong>This study is designed to evaluate the efficacy of MCT-Minus compared to supportive counselling. Given the limited treatment options for negative symptoms in schizophrenia, the findings may have important clinical implications.</p><p><strong>Trial registration: </strong>This study was registered on the 6th of November 2023 on Clinical Trials with the trial registration number NCT06127004. Statistical analyses will be preregistered on the Open Science Framework.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13523483/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148851318","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":"Interim analysis in clinical trials: caution against premature conclusions-the SWOG multiple myeloma S0777 case study.","authors":"Emily Goren, Rachael Sexton, Robert Z Orlowski, Antje Hoering","doi":"10.1186/s13063-026-09969-w","DOIUrl":"10.1186/s13063-026-09969-w","url":null,"abstract":"<p><strong>Background: </strong>Interim monitoring for efficacy and futility provides critical decision-making boundaries on early termination of randomized clinical trials. Such analyses can accelerate access to effective therapies and limit exposure to ineffective ones, but this must be weighed against premature closure that can risk obscuring a true treatment benefit. We discuss these considerations and present a case study highlighting the importance of following a well-designed interim analysis plan.</p><p><strong>Methods and findings: </strong>SWOG Cancer Research Network (SWOG) S0777 was a randomized phase III study of bortezomib, lenalidomide, and dexamethasone (VRd) versus Rd in newly diagnosed multiple myeloma that incorporated two pre-planned interim analyses. At both interim analyses, while the futility stopping boundaries were not crossed, the accumulating data suggested a limited or diminishing benefit in progression-free survival (PFS). In contrast, at final analysis, VRd demonstrated significant improvement in both PFS (hazard ratio (HR) = 0.71, p = 0.0018) and overall survival (HR = 0.71, p = 0.025) compared to Rd, helping establish VRd as standard of care. Retrospective analysis shows that use of common alternative futility stopping rules would have also not been crossed, despite the lack of positive results at the interim analysis.</p><p><strong>Conclusions: </strong>S0777's success underscores the importance of pre-specified interim monitoring plans and cautions against premature trial termination.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13520253/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148841269","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":"Cast Or ePineural Suture for digital nerve injuries (COPS): study protocol for a randomized controlled trial.","authors":"Carin Carlsson, Johanna von Kieseritzky, Marianne Arner, Cecilia Mellstrand Navarro","doi":"10.1186/s13063-026-09956-1","DOIUrl":"10.1186/s13063-026-09956-1","url":null,"abstract":"<p><strong>Background: </strong>Injuries to digital nerves in the hand are very common and result in sensory disturbances, which can have a major negative impact on hand function. The gold standard of treatment is end-to-end nerve repair with sutures, at the latest within 2 weeks from injury. Despite operative treatment of digital nerve injuries, the clinical results are often poor. Recent literature questions the evidence supporting surgical repair of digital nerve injuries in adults.</p><p><strong>Methods: </strong>In this randomized controlled trial, we will allocate patients with injury to a single digital nerve to either surgical nerve repair and cast, or immobilization only. The primary outcome is the return of sensation, measured as static two-point discrimination, at 12 months after injury. Secondary outcomes include complications, the Semmes-Weinstein monofilament test, the Mini Sollerman hand function test, and patient-reported outcome measures.</p><p><strong>Discussion: </strong>The lack of high-quality studies comparing surgical repair of digital nerve injuries to simple immobilization of the finger motivates the conduct of this randomized study.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov. TRN: NCT05536609. Registered on 08/23/2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13508327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating sedation efficacy and perioperative safety of fospropofol disodium versus propofol in elderly patients undergoing elective TURP: study protocol for a randomized controlled trial.","authors":"Hongyuan Sui, Tong Wu, Lijuan Gao, Qingying He, Jiaming Fan, Qi Li","doi":"10.1186/s13063-026-09957-0","DOIUrl":"10.1186/s13063-026-09957-0","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Fospropofol disodium is the first novel water-soluble propofol prodrug in China. After administration, it is mainly converted to propofol by alkaline phosphatase on the surface of endothelial cells to exert its pharmacological effects. Compared with propofol, fospropofol disodium has the characteristics of longer duration of action, lower incidence of injection pain and adverse events related to the respiratory and circulatory systems, and no adverse reactions related to lipid metabolism. At present, there are few reports on the safety and efficacy of fospropofol disodium in the induction and maintenance of general anesthesia. Therefore, this study aims to evaluate the safety and efficacy of fospropofol disodium in routine anesthesia for elective surgery in the elderly, so as to provide new medication guidance for its application in the induction and maintenance stages of general anesthesia in the elderly population.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Seventy elderly patients aged 65-85 years with American Society of Anesthesiologists (ASA) physical status II or III, scheduled for elective transurethral resection of the prostate under general anesthesia, will be enrolled. Patients will be randomly divided into the propofol group (group E) and the fospropofol disodium group (group F) using a random number table, with 35 cases in each group. Anesthesia induction: sufentanil 0.2-0.4 µg/kg and cisatracurium besilate 0.15 mg/kg will be administered intravenously. Group E will receive an intravenous bolus of propofol 1-1.5 mg/kg, while group F will receive an intravenous bolus of fospropofol disodium 10-15 mg/kg, both infused within 60 s. Tracheal intubation will be performed when the patient's Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score decreases to 1 with BIS &lt; 60 sustained for ≥3 min, followed by routine mechanical ventilation. For anesthesia maintenance, group E will receive continuous intravenous infusion of propofol 4-12 mg/(kg·h) and remifentanil 0.2-0.4 µg/(kg·min) via a syringe pump; group F will receive continuous intravenous infusion of fospropofol disodium 10-20 mg/(kg·h) and remifentanil 0.2-0.4 µg/(kg·min) via a syringe pump. During the operation, the infusion rates of maintenance anesthetics will be adjusted according to hemodynamic status to maintain blood pressure and heart rate fluctuations within 20% of the baseline values, and the Bispectral Index (BIS) value will be maintained between 40 and 60. After the operation, patients will be transferred to the post-anesthesia care unit (PACU). Primary outcomes of this study: success rate of sedation and time to onset of sedation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Secondary outcomes: &lt;/strong&gt;(1) perioperative indicators, (2) hemodynamic indices at each time point, (3) adverse reactions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;Elderly patients undergoing transurethral resection of the prostate (TURP) are often complicated with multiple comorbidities, leading to a ","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13660162/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149184675","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":"IBP-DISTAL protocol: distal vs radial access for invasive BP in critical care.","authors":"Hongmei Liu, Yuanyuan Zhao, Meiqun Yu, Yuan Zhang, Feifei Zhang, Yang Zhang, Ya Liu, Qian Song, Ran Zhang, Yuan Du, Minghao Liu, Jinwei Zhai, Yang Yang, Xiuchun Yang, Aihua Lian, Pingzhen Li, Yang Tang, Lei Wang, Qiang Zhang, Zhu Zhu, Xiaoyan Feng, Kai Zou, Shuilian Wang, Juan Xu, Jing Zhao, Jidong Guo, Yihui Han, Jingtao Li, Caixia Zhang, Yueyue Yuan, Wenjuan Wu, Jiangwen Liu, Xiongwei He, Lijian Gao","doi":"10.1186/s13063-026-09962-3","DOIUrl":"10.1186/s13063-026-09962-3","url":null,"abstract":"<p><strong>Aims: </strong>To determine whether distal radial artery (dTRA) cannulation is non-inferior to conventional radial artery (TRA) cannulation for first-pass success and subsequent safety and accuracy of invasive blood pressure monitoring in awake, critically ill adults.</p><p><strong>Design: </strong>Prospective, multicenter, randomized, open-label, parallel-group, non-inferiority trial.</p><p><strong>Methods: </strong>The study will be conducted in three tertiary hospitals in northwestern China. Eligible patients (≥ 18 years old) requiring invasive arterial pressure monitoring, with palpable distal and proximal radial pulses and a negative modified Allen test, will be centrally randomized (1:1; stratified by previous ipsilateral intervention) to dTRA or TRA. Both groups will undergo blind puncture with a uniform 20 G catheter-over-needle system; ultrasound is reserved for rescue. Pre-procedure ultrasound maps vessel diameter, intima-media thickness and flow velocity.</p><p><strong>Primary endpoint: </strong>one-time success rate of catheterization. Secondary endpoints: total cannulation time, crossover rate, 24 h and 30-day radial artery occlusion (RAO) by Doppler, local complications (EASY hematoma grade), BARC major bleeding (types 2, 3, 5), accidental dislodgment, pain (VAS 0-10), functional score (Barthel Index), and major adverse cardiovascular/cerebrovascular events during ICU stay. Target enrollment 204 (102 per arm) gives 85% power to demonstrate non-inferiority at one-sided α = 0.025, allowing 20% failure rate. All ultrasound assessments are performed by technicians blinded to allocation.</p><p><strong>Discussion: </strong>This nurse-led protocol reflects real-world Chinese practice (blind puncture, no ultrasound routine) while standardizing compression (≥ 5 min) and post-procedural care across centers. Results will clarify whether dTRA offers shorter hemostasis time, lower RAO and better comfort without compromising hemodynamic monitoring fidelity.</p><p><strong>Impact: </strong>If non-inferiority is confirmed, dTRA could become the preferred default access for invasive blood pressure monitoring in critical care, preserving future radial conduit and improving patient experience.</p><p><strong>Trial registration: </strong>This study has been registered on Chinese Clinical Trial Registry (ChiCTR.org.cn) under the identifier ChiCTR2500101331 (Apr 23, 2025).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13625380/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149082302","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 process evaluation of a randomized clinical trial of selective decontamination of the digestive tract in ventilated adults admitted to intensive care: the SuDDICU PE study.","authors":"K N Dainty, M B Seaton, K Amog, S Murthy, R Pinto, B H Cuthbertson, L Rose","doi":"10.1186/s13063-026-09935-6","DOIUrl":"10.1186/s13063-026-09935-6","url":null,"abstract":"<p><strong>Background: </strong>The SuDDICU trial evaluated the effectiveness of selective digestive decontamination (SDD), a prophylactic antibiotic regimen comprising oral, gastric and intravenous (IV) components in ventilated adults admitted to intensive care. The trial recruited 9289 participants in 26 clusters across Australia and Canada. There was no difference in the primary outcome of in-hospital mortality, but a reduction in new positive blood cultures and antibiotic organisms. We conducted a concomitant process evaluation in Canadian sites. Our objectives were to quantify participant reach, intervention fidelity and understand drivers of implementation.</p><p><strong>Methods: </strong>Multiple methods process evaluation comprising quantitative data on participant reach and intervention fidelity, and qualitative data using key informant interviews and non-participant observation. Analyses were informed by the Consolidated Framework for Implementation Research (CFIR).</p><p><strong>Results: </strong>Of 6317 patients screened in Canadian clusters, 577/3020 (19.1%) screened during the intervention phase were eligible but not included; 47/3297 (1.4%) in the control phase. There were 274/1432 (19.1%) participants without oral or gastric SDD components commenced within 6 h of enrolment; 54/1432 (3.8%) for the IV component. Excluding enrolment and extubation days, the median (IQR) number of ventilator days was 5 (2, 11), with 7438/12,299 (60.5%) ventilator days with 100% SDD oral dose fidelity and 7076/12,299 (57.5%) ventilator days with 100% SDD gastric dose fidelity. Considering all 4 days of IV antibiotic administration, there were 4663/5160 (90.4%) days with 100% fidelity. We interviewed 30 clinical/research team members and conducted 40 h of non-participant observation. Considering CFIR domains, individual, intervention, implementation and contextual influences on fidelity included (1) variable understanding of trial importance/objectives; (2) trial complexity, specifically drug preparation and administration resulting in additional and unanticipated workload, exacerbated at some sites due to physical ICU layout and usual drug preparation/administration practices; (3) concerns about the SDD oral aspect and overall antibiotic side effects; (4) lack of sustained implementation education; (5) lack of research staff availability out-of-hours; and (6) the broader context of running a complex trial during the COVID-19 pandemic.</p><p><strong>Conclusions: </strong>We identified moderate fidelity within the Canadian sites participating in the SuDDICU trial, with important fidelity drivers identified across all CFIR domains.</p><p><strong>Trial registration: </strong>SuDDICU Trial-ClinicalTrials.gov NCT02389036 (registered 03/17/2015); https://clinicaltrials.gov/ct2/show/NCT02389036 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13508299/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819806","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":"Correction: A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty.","authors":"Babar Kayani, Sujith Konan, Jenni Tahmassebi, Sam Oussedik, Peter D Moriarty, Fares S Haddad","doi":"10.1186/s13063-026-09948-1","DOIUrl":"https://doi.org/10.1186/s13063-026-09948-1","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13471611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148762328","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}