Trials最新文献

{"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}

{"title":"Robot-assisted versus open pancreatoduodenectomy for cancer in the pancreatic head (DIPLOMA-2x2): study protocol for an international multicentre patient- and assessor-blinded randomized controlled non-inferiority trial.","authors":"Nine de Graaf, Caro L Bruna, Julia E Menso, Anouk M L H Emmen, Bergthor Björnsson, Hakon Blomstrand, Ugo Boggi, Bert Bonsing, Olivier R Busch, Daniela Campani, Valentina Caputo, Tiane Chen, Annalisa Comandatore, A Stijn L P Crobach, Freek Daams, Wouter Derksen, Michail Doukas, Ann Driessen, Alessandro Esposito, Giovanni Ferrari, Sebastiaan Festen, Raffaele Gaeta, Michael Ginesini, Martina Guerra, Bas Groot Koerkamp, Thilo Hackert, Vera Hartman, Jin He, Ignace de Hingh, Jony van Hilst, Casper Jansen, Tobias Keck, Pui Y Lee, Mike S L Liem, Daan J Lips, Thomas Longerich, Martin Loos, Claudio Luchini, Misha D P Luyer, Michele Mazzola, Christoph W Michalski, J Sven D Mieog, Katharina Möller, Luca Morelli, I Quintus Molenaar, Felix Nickel, Mihaela Raicu, Geert Roeyen, Christian Watermann, Ulrich Wellner, Roeland F de Wilde, Roberto Salvia, Per Sandström, Johanna W Wilmink, Arantza Fariña Sarasqueta, Mahsoem Ali, Johannes Berkhof, Patrick Maisonneuve, Mohammad Abu Hilal, Marc G Besselink","doi":"10.1186/s13063-026-09692-6","DOIUrl":"10.1186/s13063-026-09692-6","url":null,"abstract":"<p><strong>Background: </strong>Robot-assisted pancreatoduodenectomy (RPD) is increasingly performed for cancer in the pancreatic head. Randomised evidence confirming its oncological safety and efficacy is lacking. The DIPLOMA-2x2 trial aims to compare the oncological safety of RPD versus OPD in terms of radicality (microscopically radical resection [R0] resection). We hypothesise that RPD is non-inferior to OPD in terms of radicality and superior regarding time to functional recovery.</p><p><strong>Methods: </strong>The DIPLOMA-2x2 trial is an investigator-initiated, international, multicentre, patient- and assessor-blinded randomised non-inferiority trial. The trial was conducted as a roll-over of the DIPLOMA-2 trial and includes 20 high-volume tertiary referral hospitals in 7 countries. Minimum surgeon's experience is 60 RPD and 60 OPD, with a minimum annual centre volume of 30 RPD prior to trial initiation. Eligible patients are adults (≥18 years) with suspected or proven upfront resectable pancreatic ductal adenocarcinoma (PDAC) and distal cholangiocarcinoma (DCC) without any vascular involvement. Participants are randomised in a 2:1 ratio to RPD or OPD, respectively, stratified by tumour indication (proven PDAC versus other) and preoperative pancreatic fistula risk (high versus low). In total, 413 patients will be included, of which 137 previously randomised in DIPLOMA-2 and 276 newly recruited in DIPLOMA-2x2. Patients are blinded up to postoperative day 5. Primary outcome is pathological R0-resection rate (pR0; >1 mm tumour clearance at surgical resection margins and anatomical surfaces, 0 mm clearance at anterior surface), tested for non-inferiority with a -7% margin. Pathological assessment is blinded, and a randomly selected 10% of specimen will undergo central review. The key secondary outcome, tested for superiority, is time to functional recovery. Other secondary outcomes include lymph node retrieval, initiation/completion of adjuvant therapy, time to start of adjuvant therapy, disease-free and overall survival, quality of life, and cost-effectiveness. Safety outcomes include major complications (Clavien-Dindo grade ≥ III), serious adverse events, and 90-day mortality. Primary analyses will be based on the modified intention-to-treat principle, including all patients who underwent resection. Postoperative follow-up is up to 90 days for short-term outcomes and up to 60 months for survival.</p><p><strong>Discussion: </strong>The DIPLOMA-2x2 trial evaluates whether RPD is oncologically safe compared to OPD in patients with upfront resectable PDAC and DCC in experienced high-volume centres.</p><p><strong>Trial registration: </strong>ISRCTN27483786. Registered: January 11, 2021 (updated: February 6, 2025). First enrolment: January 3, 2021. Expected completion of enrolment: May 2026.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13656715/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148473071","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":"Tracking outcome changes in benign prostatic hyperplasia trials: a version history review of ClinicalTrials.gov records.","authors":"Tanner Livsey, Malek Itani, Ahmed Elghzali, Rachel Hazlitt, Kellen Keefer, Ryan Sherry, Daniel Archer, Alicia Ito Ford, Matt Vassar","doi":"10.1186/s13063-026-09892-0","DOIUrl":"10.1186/s13063-026-09892-0","url":null,"abstract":"<p><strong>Background: </strong>Benign prostatic hyperplasia (BPH) is a common condition with trials that frequently rely on subjective outcomes. While federal regulations require prospective outcome registration in ClinicalTrials.gov, modifications to these outcomes are permitted and often unjustified, potentially compromising transparency and interpretability. This study examined the frequency, timing, type, and transparency of prespecified outcome modifications in BPH trials.</p><p><strong>Methods: </strong>We conducted a registry-based cross-sectional analysis of interventional BPH trials registered on ClinicalTrials.gov between January 18, 2017, and December 31, 2024. Eligible trials enrolled adult males, reported posted results, contained prespecified outcomes in both original and most recent registry versions, and were linked to peer-reviewed publications. Modifications were categorized by type (e.g., additions, removals, rewordings), timing, and severity. Key variables included the Outcome Load Index (OLI) and a Severity-Weighted Change Score. Statistical analyses included Cochran's Q tests, Kaplan-Meier time-to-event analysis, and correlation tests.</p><p><strong>Results: </strong>Of 1383 records screened, 36 trials met inclusion criteria. All trials (100%) exhibited at least one outcome modification, none of which were justified. Modifications occurred exclusively after primary completion; half occurred before publication and half after. Minor rewording and broad-to-specific definitional shifts were most common. Changes were significantly more frequent in secondary outcomes (p < 0.01). Severity scores varied widely but were not consistently associated with funder or intervention type. OLI showed weak correlation with modification frequency (r = 0.17).</p><p><strong>Conclusions: </strong>In this registry-based analysis of BPH clinical trials, outcome modifications were universal, occurred exclusively after primary completion, and were never justified in either the registry or corresponding publications. These findings highlight a persistent gap in transparency that could affect the interpretability of trial results. Greater oversight of registry version histories and stronger disclosure standards are needed to ensure the credibility of outcome reporting in BPH research and beyond.</p><p><strong>Trial registration: </strong>Registered on the Open Science Framework. The study was additionally submitted to PROSPERO; the OSF registration is the protocol of record. Registered on July 17, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13651306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148456059","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 blinding in trials of endometrial scratching: a randomised nested survey within two randomised controlled trials.","authors":"Sarah Lensen, Afsana Afroz, Lynn Sadler, Cindy Farquhar, Jack Wilkinson","doi":"10.1186/s13063-026-09763-8","DOIUrl":"10.1186/s13063-026-09763-8","url":null,"abstract":"<p><strong>Background: </strong>Blinding of participants in randomised controlled trials is considered a robust method to protect against biases associated with departures from the intended intervention and measurement of the outcome. Even when implemented, the success of blinding is not guaranteed, and participants may be able to discern their allocation through the experience of medication side effects or procedural discomfort. To assess the effectiveness of blinding, formal evaluation tools such as the James and Bang blinding indices have been developed.</p><p><strong>Aim: </strong>To explore whether participants can be effectively blinded in randomised controlled trials involving physical procedures, using endometrial scratching as a case study. Secondary aims were to measure whether symptoms from the procedures (pain, bleeding, and pregnancy outcome) are associated with unblinding, and whether behaviours of trial participants (intercourse patterns and protocol violations) may manifest as a result of unblinding.</p><p><strong>Methods: </strong>A randomised survey was conducted during two existing trials of endometrial scratching compared to a placebo procedure, in couples attempting to conceive from intercourse. Participants were asked to guess their trial allocation and to provide a reason for their guess. Participants were randomised to guess their allocation either early (within 1 week of study intervention) or late (after their window to conceive had closed). Blinding was assessed using both Bang's and James' blinding indexes, and the association of participant guesses and the measured symptoms and behaviours was evaluated by chi-squared test and the independent Student's t-test.</p><p><strong>Results: </strong>Of 278 participants, 56% correctly guessed their allocation, 32% guessed incorrectly, and 21% selected 'don't know'. Pain and bleeding were significantly higher in the endometrial scratching arm and were associated with correct guessing. Blinding indices suggested a lack of blinding, particularly in the intervention group (James' blinding index 0.42 (0.36-0.48)). No differences were observed in intercourse timing or protocol violations between groups.</p><p><strong>Conclusion: </strong>The sham procedure used in these studies does not appear to have achieved complete blinding; however, there was no evidence that lack of blinding led to impacts on important trial behaviour, such as frequency of intercourse.</p><p><strong>Trial registration: </strong>ACTRN12614000657628, ACTRN12614000656639. Registered on June 24 2014.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13656522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148456923","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":"Practical applicability and effectiveness of passive, back-support exoskeletons in logistics and care: a randomized controlled trial protocol (ELSA LogiCare).","authors":"Wendi Sieber, Johannes Voß, Roberto Falz, Max Schuhte, Claudia Wendel, Olaf Ueberschär","doi":"10.1186/s13063-026-09890-2","DOIUrl":"10.1186/s13063-026-09890-2","url":null,"abstract":"<p><strong>Background: </strong>Musculoskeletal disorders (MSDs) are the leading work-related health issue in Europe. While passive back-support exoskeletons have shown promise in reducing physical strain in laboratory settings, their medium-term effects under real-world working conditions remain largely unexplored. This study will assess the applicability and the medium-term effects of passive back-support exoskeletons on MSDs in the logistics and healthcare sectors.</p><p><strong>Methods: </strong>ELSA LogiCare is a multicenter, parallel-designed, randomized controlled trial. Participants will be randomly assigned in a 2:1 ratio to either an intervention group or a control group. The intervention group will be randomly assigned (1:1) to use one of two passive back-support exoskeleton models for 3 months, while the control group works unassisted as usual. We aim to recruit a total sample size of 120 participants, resulting in approximately 80 participants in the intervention group and 40 participants in the control group. Primary outcomes focus on feasibility and use of the exoskeleton, including daily wearing time. Effectiveness-related outcomes include musculoskeletal complaints after 3 months, assessed using the Cornell Musculoskeletal Discomfort Questionnaire. Secondary outcomes include physical and mental workload (NASA-Raw Task Load Index), job satisfaction (Copenhagen Psychosocial Questionnaire), cognitive performance (Wiener Testsystem), fatigue (Fatigue Scale), acceptance of exoskeletons (Technology Commitment), user satisfaction (Quest 2.0), user experience and implementation barriers (short interviews), absences due to illness, blood pressure, physical activity (Fitbit/Garmin) and dropouts. Outcomes will be assessed at baseline, every 4 weeks during, and immediately after the intervention. The study is open-label, with blinding applied to outcome assessors and data analysts only. Primary analyses will follow the intention-to-treat principle and will be conducted using mixed-effects models with repeated measures to estimate feasibility- and effectiveness-related outcomes over time.</p><p><strong>Discussion: </strong>When effectively integrated into workplace environments, passive back-support exoskeletons have the potential to significantly alleviate physical strain and enhance efforts to reduce the risks associated with MSDs. Our process evaluation can also help to understand how passive back-support exoskeletons can be successfully integrated into the logistics and care sectors.</p><p><strong>Trial registration: </strong>German Clinical Trials Register (DRKS) under the DRKS-ID: DRKS00036072.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13366805/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148437467","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 study of self-management interventions for neurogenic bladder patients based on symptom management theory.","authors":"Xiaomei Li, Xixi Li, Chun Li, Wei Lin","doi":"10.1186/s13063-026-09894-y","DOIUrl":"10.1186/s13063-026-09894-y","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the clinical efficacy of a self‑management intervention programme based on symptom management theory for patients with neurogenic bladder (NB).</p><p><strong>Methods: </strong>One hundred NB patients treated at a rehabilitation centre between May 2023 and May 2025 who met the inclusion criteria were randomly assigned to two groups (n = 50 each). The control group received routine nursing care, while the observation group received the theory‑based self‑management intervention. Outcomes included self‑management capability, quality of life, voiding parameters (bladder capacity, residual urine volume, daily voiding frequency), NB symptoms, anxiety/depression, and neurogenic bowel function.</p><p><strong>Results: </strong>After 4 weeks, the observation group showed higher self‑management scores and bladder capacity than the control group [57 (49,66) vs. 35 (28,42) points; (376.18 ± 59.65) vs. (224.38 ± 38.13) mL], and lower quality‑of‑life scores, residual urine volume, and daily voiding frequency [(15.10 ± 5.12) vs. (22.02 ± 5.64) points; (103.56 ± 24.25) vs. (155.18 ± 57.43) mL; (9.72 ± 2.33) vs. (17.52 ± 2.87) times; all P < 0.05]. Symptom scores (NBSS, NBDS, SAS, SDS) were also lower in the observation group (P < 0.05).</p><p><strong>Conclusion: </strong>The programme enhances self‑management, improves bladder function, alleviates symptoms, and increases quality of life in NB patients.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13640200/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148431002","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}