Trials最新文献

{"title":"Crystalloid vs colloid for Hemodynamics during Anesthesia INduction in TAVR patients (CHAIN-T): study protocol for a randomized controlled trial.","authors":"Xiaoshuang Tuo, Fahan Wang, Youjun Chen, Min Chen, Zhihong Lu","doi":"10.1186/s13063-026-09906-x","DOIUrl":"10.1186/s13063-026-09906-x","url":null,"abstract":"<p><strong>Objective: </strong>To assess whether preload with colloids could reduce hypotension during induction in patients undergoing transcatheter aortic valve replacement (TAVR) compared to crystalloids.</p><p><strong>Methods: </strong>This study is a single-center, prospective, randomized, double-blind, parallel-controlled trial conducted at Xijing Hospital. A total of 116 patients scheduled for elective TAVR under general anesthesia will be randomly assigned in a 1:1 ratio to either the colloid group or the crystalloid group, receiving either 5 ml/kg of colloid or crystalloid solution before anesthesia induction infused over 15 min. The primary outcome is the area under curve (AUC) of the change in mean arterial pressure (MAP) from baseline during the induction period (until 15 min after induction). Secondary outcomes include the incidence of intraoperative hemodynamic instability, the use of intraoperative vasoactive drugs, the Sequential Organ Failure Assessment (SOFA) score on the first postoperative day, postoperative hospital length of stay, the rate of intensive care unit (ICU) admission postoperatively, all-cause mortality during hospitalization and by 30 days after surgery, and the incidence of renal replacement therapy by 30 days after surgery.</p><p><strong>Discussion: </strong>The results of this study will provide evidence on optimizing fluid preload to prevent hypotension during induction, reduce postoperative complications, and enhance recovery for patients undergoing TAVR. The findings are expected to promote anesthesia protocols in this patient population.</p><p><strong>Trial registration: </strong>The study protocol and statistical analysis plan were approved by the institutional Ethics Committee of Xijing Hospital, Fourth Military Medical University (XJLL-KY-20252560). The study was registered in ClinicalTrials.gov (NCT07329660) on December 29, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13685197/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149228754","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":"Accelerated intermittent theta burst stimulation (iTBS) for the upper limb recovery after subacute stroke (ATLAS): study protocol for a multicenter randomized controlled trial.","authors":"Hong Yang, Tian Shu, Chunyu Duan, Lin Chen, Xin Zhang, Xinyue Xu, Yiyu Chen, Han Chen, Jingming Hou","doi":"10.1186/s13063-026-09857-3","DOIUrl":"10.1186/s13063-026-09857-3","url":null,"abstract":"<p><strong>Background: </strong>Stroke is the second leading cause of death globally, with residual upper limb dysfunction being a major contributor to its high disability rate. Currently, there remains a lack of effective rehabilitation approaches to substantially improve upper limb dysfunction. While transcranial magnetic stimulation (TMS) has shown potential in promoting functional reorganization in stroke patients, more effective treatment protocols are still under exploration. In recent years, numerous clinical evidence has indicated that intermittent theta burst stimulation (iTBS) may offer a more efficient pathway for the upper limb recovery after stroke. A few studies have employed accelerated iTBS protocols, preliminarily confirming its safety and efficacy, yet large-sample comparative studies against the standard protocol are lacking. This ATLAS trial aims to compare the effects of accelerated iTBS versus a standard TMS protocol on upper limb recovery and overall functional outcomes in patients with subacute stroke.</p><p><strong>Methods: </strong>This is a prospective, single-blind, multicenter, randomized controlled clinical trial. A total of 240 patients in the subacute phase of stroke will be recruited from 13 hospitals across 11 cities. Participants will be randomly allocated to either an iTBS group or a low-frequency repetitive TMS (LF-rTMS) group. Both groups will receive treatment 5 days per week for three consecutive weeks. In addition, all participants will receive standard conventional rehabilitation therapies, including physical agent modalities, therapeutic exercise, occupational therapy, and other commonly used clinical rehabilitation approaches. The primary outcome is the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) evaluated after 3 weeks of treatment. Secondary outcomes include measures of upper limb function, activities of daily living, clinical disease severity, and neurophysiological indicators assessed by rTMS, evaluated at both post-intervention and after a 3-week follow-up period.</p><p><strong>Discussion: </strong>ATLAS trial is the first multicenter randomized controlled trial to apply an accelerated iTBS protocol to a large cohort of patients with subacute stroke and compare it directly with a standard stimulation protocol. The findings are expected to address the current gap in high-quality evidence regarding the efficacy of accelerated iTBS on upper limb recovery after stroke, thereby promoting the broader clinical adoption of more efficient iTBS-based therapeutic strategies.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry (ChiCTR2500110766). Registered on Oct 20, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13685232/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149239597","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 World Health Organization Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns (ACTION-III) trial-rationale for the selected lower steroid dose.","authors":"","doi":"10.1186/s13063-026-09903-0","DOIUrl":"10.1186/s13063-026-09903-0","url":null,"abstract":"<p><p>Antenatal corticosteroids (ACS), most commonly administered as betamethasone or dexamethasone, remain a cornerstone of care for women at risk of preterm birth. However, the standard 24-mg regimen introduced more than five decades ago has not undergone formal dose-finding evaluation. Emerging concerns regarding possible dose-related adverse effects, particularly among late preterm infants subsequently born at term, have renewed interest in optimizing corticosteroid exposure. Experimental data across species, supported by human pharmacokinetic analyses, indicate that fetal lung maturation is driven by sustained low corticosteroid concentrations rather than high peak levels. This commentary summarizes key experimental, pharmacokinetic, and modelling evidence that informed the selection of the lower-dose betamethasone phosphate regimen evaluated in the WHO ACTION-III trial and explains the scientific rationale for this dosing strategy. Pharmacokinetic modeling indicates that 2 mg betamethasone phosphate administered intramuscularly every 12 h for four doses achieves fetal concentrations within the 1 to 4 ng/mL range identified in experimental studies, while avoiding the supratherapeutic peaks observed with conventional regimens. The ACTION-III trial will evaluate whether this lower dose ACS regimen, chosen on the basis of carefully developed models and clinical studies, maintains clinical efficacy while potentially reducing unnecessary systemic corticosteroid exposure in women at risk of late preterm birth.Trial registration: ISRCTN11434567, registered on 7 June 2021.  https://www.isrctn.com/ISRCTN11434567?q=ACTION-III&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13401291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148585336","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":"Intracluster correlation coefficients for neonatal trials: an analysis of national population level clinical data.","authors":"S Jawad, A T Prevost, C Gale","doi":"10.1186/s13063-026-09893-z","DOIUrl":"10.1186/s13063-026-09893-z","url":null,"abstract":"<p><strong>Background: </strong>Clustering of outcomes occurs naturally in neonatal data due to multiple births clustered by mother and infants clustered within the neonatal unit administering their care. Estimating these cluster effects is important for neonatal study design and impacts upon sample sizes for neonatal trials.</p><p><strong>Methods: </strong>We analysed retrospective data from all neonatal admissions in England and Wales between January 2016 and January 2020 held in the National Neonatal Research Database. Intracluster correlation coefficients (ICCs) and their 95% confidence intervals were calculated for core neonatal outcomes and those commonly used in trials, at the level of both the neonatal unit and mother. Results were stratified by gestational age and neonatal unit level of birth. To illustrate the impact of clustering, the design effect was estimated for a theoretical cluster trial.</p><p><strong>Results: </strong>Intracluster correlation coefficients varied between outcomes and gestational age groups. Neonatal unit level intracluster correlation coefficients were low for mortality (0.0054, 95% CI 0.0039, 0.0068) and other core outcomes (severe necrotising enterocolitis 0.0042, 95% CI 0.0020, 0.0063) and were higher for outcomes related to care delivery (duration of intensive care 0.0237, 95% CI 0.0177, 0.0298; duration receiving parenteral nutrition 0.0265, 95% CI 0.0197, 0.0332). Gestation at birth was inversely correlated with neonatal unit ICC estimates. At the level of the mother, ICC estimates were generally larger, especially for preterm infants.</p><p><strong>Conclusions: </strong>We have estimated ICCs for key neonatal outcomes at the level of both neonatal unit and mother with high precision using national, population-level routinely recorded data. These ICC estimates can be used to inform future neonatal studies and sample size calculations for neonatal trials.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13679098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149220804","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":"Considering the timing and appropriateness of trial consent during childbirth: a secondary analysis from the qualitative process evaluation of the ROTATE trial.","authors":"Eleanor Molloy, Jacqueline Nicholls, Dawn Parris, Rachel Plachinkski, Dimitrios Siassakos, Laura Jones","doi":"10.1186/s13063-026-09881-3","DOIUrl":"10.1186/s13063-026-09881-3","url":null,"abstract":"<p><strong>Background: </strong>The ROTATE trial is a multi-centre randomised controlled trial of manual versus instrumental rotation of the fetal head in malposition at birth, to evaluate if manual compared with instrumental rotation reduces the risk of severe maternal perineal trauma, without increasing caesarean birth rates. ROTATE internal pilot phase ran from June 2022 to June 2023 with an embedded qualitative process evaluation (QPE). The QPE aimed to explore the feasibility, acceptability, and appropriateness of the trial for parents and healthcare professionals (HCPs). ROTATE had a two-stage consent process where verbal assent was sought prior to randomisation, and written consent was gained and recorded after the birth. This paper reports a secondary analysis of ROTATE QPE data focusing on gaining informed consent to trial entry in time-pressured maternity settings.</p><p><strong>Methods: </strong>Secondary analysis of data from semi-structured interviews with women (n = 9), their birth partners (n = 3), and HCPs (n = 11). Data were analysed using codebook thematic analysis.</p><p><strong>Results: </strong>Parents and HCP reported that offering a clinical trial at late-stage labour added additional complexities and challenges at a time-pressured period of their labour and birth. Using a layered approach to trial offering, where the trial information was shared prior to full eligibility, and discussed with multiple trusted HCPs, meant clinical trial approaches in late-stage labour can be anticipated. HCPs were concerned whether parents would recall conversations and decision-making about trial entry when they had been under physical and psychological stress in the second stage of labour. The two-stage consent process for ROTATE, using pre-randomisation verbal assent, with post-randomisation and post-birth written consent was considered acceptable to parents and pragmatic for HCPs delivering the trial. Gaining subsequent written consent, combined with appropriate birth partner support at the time of trial approach, was considered supportive of autonomous decision-making for women/birthing parents.</p><p><strong>Conclusions: </strong>Clinical trial approaches in time-pressured maternity settings may be ethically challenging and add additional complexities at an already stressful time. A two-stage consent process, and early, layered information about the potential for participation in intrapartum clinical trials, supported informed consent and autonomous decision-making for women/birthing parents.</p><p><strong>Trial registration: </strong>ISRCTN10193017. Registered on 24 November 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13673691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149196628","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":"Gut Regulated Associations of Neuronal Signalling in High Blood Pressure (GRAINS-BP): a double-blinded randomised crossover placebo-controlled trial.","authors":"Malindi Welathanthree, Matthew Snelson, Donggyu Rim, Brendan McCarthy, Gianni Sesa-Ashton, David G S Farmer, Chaoran Yang, Jianan Lu, Phoebe T T Cheong, Matthew P Pase, Tracy McCaffrey, Francis J Ha, Sushil Dhital, Esther Davis, Elisabeth Lambert, Vaughan G Macefield, Francine Z Marques, Rikeish R Muralitharan","doi":"10.1186/s13063-026-09911-0","DOIUrl":"10.1186/s13063-026-09911-0","url":null,"abstract":"<p><strong>Background: </strong>Hypertension affects 1 in 3 Australian adults and is a major contributor to stroke and myocardial infarction. Despite the availability of various medications, over 50% of patients struggle to control their blood pressure (BP) due to nonadherence, difficulty finding the right treatment, or avoidance of medication. Diet plays a key role in cardiovascular health, with high-fiber intake shown to lower BP through the production of short-chain fatty acids (SCFAs), metabolites formed during fiber fermentation. A previous clinical trial found that incorporating a specific type of resistant starch - high amylose maize starch enriched with acetate and butyrate (HAMSA/B) - significantly reduced blood pressure in hypertensive patients. While the exact mechanism remains unclear, SCFAs may influence BP via the gut-brain axis by reducing muscle sympathetic nerve activity (MSNA), which has vasoconstrictor function and is elevated in hypertensive individuals.</p><p><strong>Methods: </strong>The GRAINS-BP clinical trial will recruit 29 adults with untreated hypertension (≥ 140/90 mmHg) for a double-blind, cross-over study using HAMSA/B administered as a shake delivered twice daily. The assessment period will span 48 days and include four visits at the Alfred Hospital, Melbourne, Australia. At visit 1, baseline measurement will be taken, including muscle sympathetic nerve activity (MSNA) and electrocardiogram (ECG). Participants will be randomised to the order in which they receive the placebo and HAMSA/B shake. Each intervention period will last 14 days, separated by a 20-day washout before participants cross over to the alternate treatment. At each visit, faecal, urine, and blood samples will be collected to investigate microbiome, cardiometabolic, renal, and immune profiles, respectively. Univariate and multivariate statistical analyses will be conducted to examine treatment effects and to identify correlations among microbiome, cardiometabolic, renal, and immune outcomes.</p><p><strong>Discussion: </strong>This project's primary outcome is change in autonomic nervous system activity. Secondary outcomes include 24-h BP, gut microbiome composition, SCFA levels, immune cell profiles gastrointestinal transit time, quality of life, anxiety and depression symptoms, cognitive function, gut barrier integrity, and circulating micro- and nanoplastics. Findings from this study will reveal whether SCFAs reduce blood pressure by their influence on the autonomic nervous system.</p><p><strong>Trial registration: </strong>This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12625000557437).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13679180/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149220810","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 time-restricted eating in comparison with energy-restricted diet on expression of BMAL-1 and miRNA-let-7f-1-3p genes, circadian rhythm status, sleep quality, metabolic and anthropometric markers in obese women: a study protocol for a randomized controlled clinical trial.","authors":"Atefeh Tavakoli, Neda Kermani, Parastou Zamani, Bahram Pourghassem Gargari, Parvin Dehghan, Khadijeh Mirzaei","doi":"10.1186/s13063-026-09905-y","DOIUrl":"10.1186/s13063-026-09905-y","url":null,"abstract":"<p><strong>Introduction: </strong>One of the most common chronic diseases is obesity. Disturbances in circadian rhythm and sleep quality are common in these people. Genes related to circadian rhythm control are also disrupted. One of the methods of controlling and reducing obesity is to intervene in the individual's diet, and one of the alternative methods to the conventional low-calorie diet is the use of fasting diets, including time-restricted eating (TRE), which can have effects on the expression of a circadian rhythm genes, the circadian rhythm status, and the quality of sleep. This randomized controlled trial (RCT) will be aimed to examine the effect of the TRE diet in comparison with an energy-restricted diet (ERD) on the expression of basic helix-loop-helix ARNT-Like-1 (BMAL-1) and micro ribonucleic acid (miRNA)-let-7f-1-3p genes, circadian rhythm status, and sleep quality in women with obesity.</p><p><strong>Methods and analysis: </strong>This study will be conducted on 42 obese women. Participants will be randomly assigned to receive either 16:8 TRE (fasting from 8 to 12 PM the next day) or an ERD (55% carbohydrate, 30% fat, 15% protein) diet for 12 weeks. Gene expression, circadian rhythm status, sleep quality, anthropometric measurements, and metabolic evaluations will be assessed before and after the intervention. Dietary evaluations will be performed at baseline, middle, and end of the study.</p><p><strong>Discussion: </strong>Since circadian rhythm-related gene expression has a role in circadian rhythm and ultimately obesity regulation, it seems that TRE, as a dietary approach, can affect these gene expressions.</p><p><strong>Trial registration: </strong>Iranian Registry of Clinical Trials (IRCT20100123003140N25), which was registered and approved on 28 July 2025 ( https://irct.behdasht.gov.ir/user/trial/84484/view ).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13660246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148498091","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 statistical methods are more appropriate for predicting recruitment at the design stage of a randomised controlled trial?","authors":"Freya J Marks, Stephen J Walters, Laura Sutton, Richard M Jacques","doi":"10.1186/s13063-026-09900-3","DOIUrl":"10.1186/s13063-026-09900-3","url":null,"abstract":"<p><strong>Background: </strong>Effective prediction and monitoring of recruitment in randomised controlled trials (RCTs) is critical to ensuring the target sample size is met, with 37% of trials failing to do so. This research aimed to identify various statistical methods for predicting recruitment during the design stage of an RCT and implement them using case-study trials, with a view to determining which method is more appropriate.</p><p><strong>Methods: </strong>Various deterministic, Poisson and Bayesian methods were identified and applied to data from six previously conducted RCTs, with varying numbers of participants recruited, sites opened, durations and recruitment outcomes.</p><p><strong>Results: </strong>Poisson methods were found to be more appropriate for obtaining predictions at the design stage of a trial. They produced confidence intervals to model uncertainty, unlike deterministic methods, and exhibited narrower intervals than Bayesian methods using informative priors. For single-centre trials, a homogeneous Poisson process was recommended, whilst a Non-homogeneous Poisson Process could be more suitable for multicentre trials. However, the non-homogeneous approach yielded more conservative estimates and required site-specific start dates, which may be less readily available at the design stage. Limitations included a lack of usable software for method implementation, difficulties with parameter elicitation, and a lack of additional data required to implement more complex methods, all of which may hinder the application of statistical methods for predicting recruitment which occurs in only 10% of RCTs.</p><p><strong>Conclusions: </strong>To enhance transparency and reproducibility, it is recommended that RCTs publish the methods and parameters used in recruitment predictions. This may improve their accuracy, thereby reducing the cost and minimising the research waste associated with insufficient recruitment. Further research across a wider range of trials and methods may also be required due to the complexity of factors which influence recruitment and the variability in the accuracy of statistical methods across trials.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13670443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148473127","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 measurement and reporting of healing-related outcomes in randomised controlled trials of compression for venous leg ulcers: a systematic review.","authors":"Klaudia Kornalska, Chunhu Shi, Nicky Cullum, Jo Dumville","doi":"10.1186/s13063-026-09882-2","DOIUrl":"10.1186/s13063-026-09882-2","url":null,"abstract":"<p><strong>Aim: </strong>Venous leg ulcers (VLUs) are the most prevalent type of leg ulcer and can be slow to heal. Compression therapy is a widespread, evidence-based treatment for people with VLUs, with many associated randomised controlled trials (RCTs). Healing-related outcomes are important in the field but there is currently limited insight on how these outcomes are captured and reported in RCTs. This review analyses the measurement and reporting of healing-related outcomes in RCTs of compression therapy in people with VLUs.</p><p><strong>Methods: </strong>This systematic review followed the Cochrane guidelines and is reported in line with the PRISMA statement. RCTs of compression for people with VLUs were included. Five medical literature databases were searched (September 2024), and data were extracted on the type of healing outcomes assessed, the follow-up time, the used definitions of healing-related outcomes, the wound measurement techniques, and the use and techniques of assessor masking.</p><p><strong>Results: </strong>This review included 68 RCTs, reporting 158 healing-related outcomes. These outcomes commonly evaluated change in wound size (34%) or complete wound closure (59%). Only 44% of complete wound closure outcomes were accompanied by a clear definition, and those definitions varied. Change in wound size was measured by four techniques, with planimetry used most often (51%). Notably, 56% of healing-related outcomes were evaluated by healthcare professionals and none by patients. The use of assessor masking was limited: in 38% of cases outcomes were judged by unmasked assessors, and in 42% the masking status was unclear. Follow-up duration was most commonly between 90 days and 6 months.</p><p><strong>Conclusion: </strong>This is the first systematic review to investigate the measurement and reporting of healing-related outcomes in RCTs of compression therapy for people with VLUs. Although healing-related outcomes including complete wound closure were frequently used in the included RCTs, limitations in measuring and reporting were identified. These limitations included frequent collection of surrogate outcomes, limited follow-up periods, inconsistent use of outcome definitions, variation in wound measurement techniques, and lack of assessor masking. Development of a set of guidelines on the measurement and reporting of healing-related outcomes could help to address these limitations.</p><p><strong>Registration: </strong>The protocol for this systematic review has been registered on the Open Science Framework platform and can be viewed  HERE .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13656612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148473098","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":"Building Emotional Awareness and Mental Health in Parenting (BEAM): protocol for a parallel-group randomized controlled non-inferiority trial for an app based intervention to improve postpartum mental health and support children's brain development in Western Canada.","authors":"Lianne M Tomfohr-Madsen, Leslie E Roos, Ariana M Martinez, Hayal Muslu, Harleen Gill, Emily E Cameron, Makayla Freeman, Kyle Dewsnap, Gerald F Giesbrecht, Tim F Oberlander, Lara Leijser, Frank MacMaster, Bryce Geeraert, Deborah McNeil, Catherine Lebel","doi":"10.1186/s13063-026-09849-3","DOIUrl":"10.1186/s13063-026-09849-3","url":null,"abstract":"<p><strong>Background: </strong>Symptoms of depression, anxiety and anger are common amongst parents and are associated with increased risk of offspring mental health problems and differences in child brain development. Many parents do not access treatment, in part due to expense, wait times, and stigma. Increasing access to treatment may improve quality of life for parents and their children. eHealth and peer-supported interventions may offer accessible and effective treatment avenues for parents of young children. The primary aim of this non-inferiority trial is to estimate the effect of the Building Emotional Awareness and Mental Health (BEAM) intervention, a digital and peer-supported mental health and parenting program, administered by trained peer paraprofessionals, on parental depression, anxiety and anger symptoms relative to a treatment-as-usual (TAU) waitlist control group. The secondary aims are to compare child internalizing and externalizing behaviours between BEAM and TAU groups to estimate the effect of the BEAM program on child behavioural outcomes. The final aim is to estimate differences in child structural and functional brain connectivity 6 months post intervention between the BEAM and TAU control groups.</p><p><strong>Methods: </strong>A two-arm, single-blinded, parallel groups randomized controlled trial (RCT) with a 1:1 allocation ratio and repeated measures will be conducted in Western Canada. Parents and primary caregivers (aged 18 +) who self-report moderate to severe symptoms of anger, anxiety, or depression at time of enrolment and reside in the provinces of British Columbia or Alberta, Canada, will be eligible to participate from the larger Pregnancy During the Pandemic (PdP) cohort and invited to enrol. PdP research coordinator will distribute invitations to individuals who previously consented to be contacted for future studies and meet eligibility criteria. Parents will also be recruited from the community through social media advertisements to reach a total sample of 240 participants. Assessments will be conducted at baseline (T1), post-intervention (T2), and 6 months post treatment (T3) and will include self-report questionnaires, and neuroimaging.</p><p><strong>Discussion: </strong>Findings from this study will provide data on the potential efficacy of the BEAM program in supporting parental mental health, child well-being, and neurodevelopment. Results may inform future large-scale trials and may guide the development of accessible, community-based interventions aimed at improving family mental health and child developmental outcomes.</p><p><strong>Trial registration: </strong>This trial was registered on ClinicalTrials.gov on September 20, 2023. The first planned enrolment date was April 24, 2024. The registration number is NCT06046989. https://clinicaltrials.gov/study/NCT06046989 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13660072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148473053","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}