Trials最新文献

{"title":"Efficacy of transcranial direct current stimulation for post-stroke urinary incontinence: study protocol for a randomized controlled trial.","authors":"Gen Ran, Yuling Chen, Yali Feng, Botao Tan, Yi Zhou, Wei Jiang, Lanjie Xiao","doi":"10.1186/s13063-026-09866-2","DOIUrl":"10.1186/s13063-026-09866-2","url":null,"abstract":"<p><strong>Background: </strong>Post-stroke urinary incontinence is a prevalent and debilitating complication that severely impacts patient recovery and quality of life. Although pelvic floor muscle training is a recognized standard rehabilitative intervention, its clinical efficacy in stroke survivors is often suboptimal, largely because it addresses peripheral muscle function without mitigating the underlying central neurological deficits that disrupt micturition control. Emerging evidence suggests that neuromodulation via transcranial direct current stimulation can enhance neuroplasticity in cortical motor areas. This trial aims to address the current therapeutic gap by evaluating whether the synergistic combination of central neuromodulation and peripheral muscle training provides superior therapeutic benefits for post-stroke urinary incontinence recovery compared to pelvic floor muscle training alone.</p><p><strong>Methods: </strong>This randomized controlled trial will randomly assign an aggregate of 50 eligible patients into two groups. Participants allocated to the intervention group (n = 25) will undergo PFMT coupled with active, low-frequency tDCS over M1, whereas those in the control group will receive identical PFMT alongside sham tDCS. The 20 treatment sessions will be administered on a schedule of five sessions per week across four consecutive weeks for every participant. The primary outcome is leakage episodes. The secondary outcomes are defined as simplified cystometry, the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), Overactive Bladder Symptom Score (OABSS), Incontinence Quality of Life Questionnaire Score (I-QOL), surface electromyography (sEMG), Neurogenic Bowel Dysfunction Score and the number of urinations.</p><p><strong>Discussion: </strong>This randomized controlled trial protocol evaluates a novel intervention combining tDCS targeting the contralesional M1 with PFMT for post-stroke urinary incontinence. To address a critical gap in stroke rehabilitation, the study designs a rigorous double-blind, sham-controlled design to explore the combined effects of central neuromodulation and peripheral muscle training. A comprehensive assessment will be used to generate robust evidence of this innovative intervention. The findings are expected to contribute to an effective neurorehabilitation strategy, potentially transforming clinical approaches to this common yet under-addressed complication and significantly enhancing the quality of life for stroke survivors.</p><p><strong>Trial registration: </strong>URL: https://www.chictr.org.cn ; Unique identifier: ChiCTR2500099178. Registered on 2025-03-19.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13573409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148377151","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":"Compression therapies for the treatment of venous leg ulcers: a mixed method process evaluation in a randomised controlled trial, VenUS6.","authors":"Maartje Kletter, Jane Griffiths, Catherine Arundel, Jo Dumville","doi":"10.1186/s13063-026-09854-6","DOIUrl":"10.1186/s13063-026-09854-6","url":null,"abstract":"<p><strong>Background: </strong>Strong compression treatment is an evidence-based first-line treatment that helps reduce the healing time of venous leg ulcers. VenUS 6 is a three-arm RCT conducted in the UK that aimed to compare 4-layer bandages and 2-layer hosiery with compression wraps and 2-layer bandages. The study found that compression wraps are unlikely to reduce time to venous leg ulcer healing compared to the other treatments evaluate, although there was some uncertainty with this estimate. We nested a mixed-methods process evaluation within VenUS 6 to gain a more in-depth understanding of trial participant and nursing staff views on and experiences of various compression therapies, and to consider how these insights may explain VenUS 6 outcomes.</p><p><strong>Methods: </strong>We conducted individual, in-depth interviews with 11 trial participants and focus group discussions with 19 relevant health professionals based at seven participating primary, secondary and community care NHS Trust sites. We also used data collected during the trial from patients about their experience of compression use. We conducted a separate UK-wide survey with nurses to learn more about availability of the trial compression treatment options in clinics and their views on the ease of use of the compression treatments in scope. Qualitative data were analysed using framework analysis and quantitative data were analysed descriptively. Data were integrated with the help of the Pillar Integration Process.</p><p><strong>Results: </strong>There was high satisfaction with compression wraps and limited discomfort among trial participants, who appreciated the wraps could be adjusted and taken off to allow them to take showers. Staff mentioned, however, that trial participants were prone to loosen the wraps. Whilst 2-layer hosiery allowed for self-application and could be taken off, trial participants said the hosiery was very tight and difficult to apply. Bandages, on the other hand, whilst bulky and sometimes uncomfortable, would often not be removed by trial participants, leading to greater exposure to effective compression.</p><p><strong>Conclusion: </strong>We have identified that people with venous ulcers wearing compression wraps are more likely to report loosening them and removal at night, than people wearing other types of compression treatment which was confirmed by staff. These reported behaviours could explain longer healing times for compression wraps, compared to other treatments delivered in our RCT. Despite longer times to healing, compression wraps may still be an appropriate compression treatment option for some people, and it is important for nursing staff to have conversations with service users and share decisions about suitable treatment options.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13595631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148369950","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":"Methodological guidance for incorporating lived experience in the early stages of core outcome set development: a scoping review.","authors":"Marci Kay Livingston, Elaine Toomey, Katie Robinson","doi":"10.1186/s13063-026-09848-4","DOIUrl":"10.1186/s13063-026-09848-4","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Core Outcome Sets (COS) provide a systematic approach to ensuring that outcomes measured in health research matter to the individuals most affected by the research. While methodological guidance generally exists for COS development, specific guidance on incorporating the perspectives of people with lived experience (PWLE) during the long-list stage remains fragmented and unclear. This stage is crucial for including outcomes that matter to those directly impacted. Therefore, this scoping review aims to systematically identify and chart the available methodological literature on incorporating the perspectives of PWLE into the long-list generation stage of COS development.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This review followed JBI guidance for scoping reviews and adhered to PRISMA-ScR reporting standards. A comprehensive search was conducted across multiple databases (MEDLINE, Embase, Scopus, CINAHL, ProQuest Theses & Dissertations, and the COMET Database) on 31 October 2024. In addition, a citation search of all included articles and further expert consultation were included to ensure that all relevant articles were identified. Articles were eligible for inclusion if they provided methodological guidance, recommendations and/or insight into how best to include the perspectives of PWLE into the long-list stage of COS development. Screening and data extraction were completed by two independent reviewers. The analysis was guided by a combined deductive-inductive qualitative content analysis process. Categories were developed from the data and synthesised into practical recommendations for COS developers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 45 articles were included. The analysis yielded four major categories of guidance: (1) PWLE Identification, Recruitment, and Engagement; (2) Data Collection Considerations; (3) Analysis and Reporting; and (4) Contextual Considerations. The results highlight an evolving methodological landscape surrounding PWLE perspective integration into COS development. The results emphasise the importance of purposeful and reflexive methodological choices and underscore the importance of utilising existing qualitative research, participatory action research (PAR), reporting standards, and existing equity, diversity, and inclusion principles throughout the long-list process.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This review identified a growing but uncoordinated body of methodological guidance for including the perspectives of PWLE into the long-list stage of COS development. The findings will support future COS developers in making methodologically rigorous decisions. Future research should aim to validate these findings and recommendations through empirical work with COS developers and PWLE, informing the co-production of best practice guidelines.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;This review is registered in the COMET Database: https://www.comet-initiative.org/Studies/Details/3590 . T","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13584413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148362386","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: The BrEasT cancer afTER-CARE (BETTER-CARE) programme to improve breast cancer follow-up: design and feasibility study results of a cluster-randomised complex intervention trial.","authors":"Anna Schäfer, Julia Wendel, Isabella Franke, Armin Bauer, Harald Baumeister, Eileen Bendig, Sara Y Brucker, Thomas M Deutsch, Patricia Garatva, Kirsten Haas, Lorenz Heil, Klemens Hügen, Helena Manger, Rüdiger Pryss, Viktoria Rücker, Jessica Salmen, Andrea Szczesny, Carsten Vogel, Markus Wallwiener, Achim Wöckel, Peter U Heuschmann","doi":"10.1186/s13063-026-09858-2","DOIUrl":"10.1186/s13063-026-09858-2","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13317311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148362513","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":"IMPACT-Introduction of Mycotic Prophylaxis At Cystectomy Trial: perioperative mycotic prophylaxis with fluconazole to reduce postoperative complications following cystectomy-study protocol for a national multi-center, double-blinded, placebo-controlled, randomized clinical trial.","authors":"Mie Skjøttgaard Ynddal, Hein Vincent Stroomberg, Maja Vejlgaard, Jørgen Bjerggaard Jensen, Claus Moser, Ulla Nordström Joensen, Andreas Røder","doi":"10.1186/s13063-026-09862-6","DOIUrl":"10.1186/s13063-026-09862-6","url":null,"abstract":"<p><strong>Introduction and objectives: </strong>Cystectomy with urinary diversion is one of the most complex surgeries in the urological specialty involving surgery on multiple organ systems. The postoperative risk of mortality and complications is considerable, and the first months after surgery are often the most critical. When creating the urinary diversion, the abdominal cavity is exposed to bacteria and fungus from the small intestine, and after the surgery, micro-leakage from the intestinal anastomosis may also contribute to a local infectious response. This contamination is suspected to increase the risk of bowel paralysis that, even with modern ERAS protocols, significantly impacts the postoperative recovery. Emerging data show that approximately 50% of the patients undergoing cystectomy have Candida albicans in samples from the terminal ileum. Current guidelines support the use of perioperative antibiotics, but there are currently no guidelines on antimycotic prophylaxis. We present a randomized clinical trial that tests whether incorporating antimycotics into the perioperative antimicrobial prophylactic regimen can reduce major complications after cystectomy.</p><p><strong>Materials and methods: </strong>This is a multi-center, double-blinded, randomized clinical trial including participants from all five centers in Denmark performing cystectomy. The study includes adult patients planned for cystectomy with an ileal conduit with no contraindications to fluconazole and no active treatment for mycotic infections. The 420 participants are randomized 1:1 to receive a single dose of perioperative fluconazole or placebo. Primary outcome is major postoperative complications, defined as Clavien-Dindo classification III-V, within 90 days following cystectomy. Secondary outcomes are days alive and out of hospital, gastrointestinal function, nasogastric tube placement, length of stay, readmissions, quality of life, and microbiological test results. We aim to reduce the absolute rate of Clavien-Dindo III-V complications from 30 to 18%. The study is a superiority study and analysis will be performed as intention-to-treat.</p><p><strong>Discussion: </strong>Patients undergoing cystectomy face a high risk of surgical complications, many of which can be attributed to infections. There is a growing concern about the consequences of fungal infections after abdominal surgery. This trial aims to explore whether prophylactic antifungal treatment at the time of cystectomy can prevent major postoperative complications.</p><p><strong>Trial registration: </strong>CTIS EU trial number: 2023-506226-36-00. Registered on February 16, 2024.</p><p><strong>Clinicaltrials: </strong>gov: NCT06770530. Registered on March 31, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13584429/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148362391","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":"Adjunctive optical and magnetic stimulation for venous and mixed etiology leg ulcers: protocol for the NAZARÉ multicenter randomized controlled trial.","authors":"Sebastian Probst, Camille Saini, Alessio Stefanelli, André Frei, Ewa Klara Stuermer, Joachim Dissemond, Lars-Peter Kamolz, Benedikt Weber, Jean-Paul Lembelembe, Jürg Traber, Dieter Mayer, Thomas Zehnder, Dave Baer, Claudio Ruzza, Jürg Hafner","doi":"10.1186/s13063-026-09859-1","DOIUrl":"10.1186/s13063-026-09859-1","url":null,"abstract":"<p><strong>Background: </strong>Venous leg ulcers (VLUs) and VLUs associated with peripheral arterial disease (PAD) are common, recurrent, and costly to manage. Adjunctive biophysical therapies may improve healing outcomes when combined with standard of care (SOC). Concurrent optical and magnetic stimulation (COMS) has shown promising mechanistic and preliminary clinical results but there is a lack of robust randomized controlled trials (RCTs).</p><p><strong>Method: </strong>This novel adjunct using concurrent optical and magnetic stimulation in a multicenter RCT in Europe (NAZARÉ) is a phase IV, post-market, multicenter, parallel-group, superiority randomized controlled trial conducted in Switzerland, France, Germany, and Austria. A total of 122 adults with VLU or mixed leg ulcers (ankle-brachial index > 0.5 and < 1.30 or ankle artery pressure > 60 mmHg), ulcer area 2-50 cm², and ulcer duration > 30 days and < 2 years will be enrolled. Following a 2-week run-in to confirm < 30% area reduction under SOC, participants will be randomized 1:1 to SOC + COMS or SOC alone. The primary outcome is percentage wound area reduction (PWAR) at week 12, assessed by blinded evaluators using standardized digital planimetry. Secondary outcomes include complete closure, time-to-healing, pain, health-related quality of life, recurrence, and healthcare resource use. Missing outcome data will primarily be analyzed as observed and may be addressed using multiple imputation under the assumption of data being missing at random.</p><p><strong>Discussion: </strong>This trial will rigorously assess the effectiveness of COMS as an adjunct to standard care for venous and mixed leg ulcers. By targeting chronic wounds and using a pragmatic, multicenter design, it aims to generate robust, generalizable evidence. If effective, COMS could offer a non-invasive, accessible option to enhance healing outcomes and reduce the burden of chronic leg ulcers.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov NCT06528873. Registred on 26 July 2024, https://register.</p><p><strong>Clinicaltrials: </strong>gov/prs/app/action/SelectProtocol?selectaction=Edit&sid=S000ERKB&uid=U0003LG4 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13576315/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148346397","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 cluster randomized trial to evaluate the effects of a quality cluster-based intervention on the use of prostate-specific antigen test in general practice-a study protocol.","authors":"Pernille Hølmkjær, Christian Leick, Thomas Drivsholm, Volkert Siersma, Flemming Bro, Marius Brostrøm Kousgaard","doi":"10.1186/s13063-026-09867-1","DOIUrl":"10.1186/s13063-026-09867-1","url":null,"abstract":"<p><strong>Background: </strong>Continuous quality improvement is an important endeavor for keeping clinical practice up to date with research evidence and professional guidelines for the sake of patients and the rational use of system resources. Quality clusters are a framework for quality improvement in general practice, but the effects of working in quality clusters have not been evaluated in randomized trials. The use of prostate-specific antigen (PSA) tests in general practice represents a clinically relevant area for quality improvement due to recent guideline revisions, practice variation, and concerns about overuse. The objective of this study is to evaluate the effectiveness of a quality cluster-based intervention on the use of PSA tests in general practice.</p><p><strong>Methods: </strong>The study is a cluster randomized controlled trial with an intervention group and a control group-receiving the intervention delayed-based in quality clusters in Denmark. We aim to include 50 quality clusters, each quality cluster having on average 13 general practice clinics. The intervention period is six months, and the total study period is 12 months. Randomization is 1:1 to intervention and control by a computer algorithm stratified by the five Danish health regions and cluster size. The intervention includes a cluster package about prostate-specific antigen used at a quality cluster meeting with data on use of prostate-specific antigen-tests, information on clinical guidelines, videos with clinicians, reflection questions, and hand-out materials to support implementation of changes to clinical practice. The control group proceeds with cluster work as usual and will receive the intervention delayed. Data for the primary and secondary outcomes will be obtained through registries and will be assessed at the end of the trial.</p><p><strong>Discussion: </strong>We anticipate that the intervention will encourage general practitioners to reflect on their use of PSA testing and adjust their practice in accordance with the clinical guidelines if needed, and that this will result in an overall reduction in the use of the test.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov NCT06748456. Registered on 16.10.2024. https://clinicaltrials.gov/study/NCT06748456?id=NCT06748456&rank=1 . Retrospectively registered.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13584573/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148353870","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":"Recruitment strategies for a randomized controlled trial in a rural American Indian community: the Cooking for Health Study.","authors":"Sarah A Green, Rae O'Leary, Corrine M Huber, Anne N Thorndike, Lyle G Best, Meagan C Brown, Marcia O'Leary, Jason Umans, Arlette Hager, Rebecca Whitebull, Shirley Beresford, Amanda M Fretts","doi":"10.1186/s13063-026-09874-2","DOIUrl":"10.1186/s13063-026-09874-2","url":null,"abstract":"<p><strong>Background: </strong>Conducting diet-focused interventions in rural, American Indian (AI), and/or under-resourced communities is critical to improve health. However, interventions that may work in urban or suburban settings may not work in rural or under-resourced communities due to differences in types of locally available food, food preferences, food insecurity, and/or limited access to grocery stores or supermarkets. This paper describes the acceptability of recruitment strategies used in the Cooking for Health (CFH) study, a culturally targeted healthy food budgeting, purchasing, and cooking skills intervention for AIs with type 2 diabetes who live on or around a large reservation in the North-Central United States.</p><p><strong>Methods: </strong>CFH was a two-armed parallel group randomized controlled trial (RCT) designed to evaluate the effectiveness of a 12-month intervention on diet, healthy food self-efficacy, food budgeting and cooking skills, and healthy food purchases. The intervention consisted of monthly lessons and videos related to cooking healthy foods, food budgeting skills, and optimal nutrition for diabetes management. AI men and women 18 + years old with diagnosed type 2 diabetes were eligible to participate. Recruitment strategies included passive, active, and word-of-mouth (refer-a-friend) methodologies. Additionally, research staff worked closely with a community partner, the Tribal Diabetes Program, to facilitate enrollment.</p><p><strong>Results: </strong>Of the 276 individuals screened for eligibility for the study, 226 individuals were deemed eligible to participate. Of these, 176 enrolled, 25 individuals scheduled a baseline study visit but did not show up, and 25 individuals declined participation. Reasons for declining participation included: no longer interested; too busy/employed full-time; already managing diabetes with own healthcare provider; or moved out of the area.</p><p><strong>Conclusions: </strong>These results support a multi-strategic recruitment approach of passive, active and word-of-mouth strategies for successful recruitment and enrollment of AIs in diet-focused RCTs. It is likely that the recruitment successes were largely due to community involvement and ownership in the study. The importance of trusting mutually beneficial and shared decision-making is also critical to project success.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, TRN: NCT03699709. Registered on 5 October 2018, https://clinicaltrials.gov/study/NCT03699709 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13573405/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148340288","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":"Research exploring monetary incentives for recruiting and retaining participants in randomised controlled trials: a scoping review.","authors":"Gloria Mongelli, Joy Adamson, Antonina Yakimova, Camila Piccolo-Lawrance, Adwoa Parker","doi":"10.1186/s13063-026-09872-4","DOIUrl":"10.1186/s13063-026-09872-4","url":null,"abstract":"<p><strong>Background: </strong>Poor participant recruitment and retention in randomised controlled trials (RCTs) is a widespread challenge. Offering trial participants monetary incentives (e.g. cash or vouchers) may boost recruitment and retention; however, no reviews have systematically mapped the existing quantitative, qualitative, and mixed-method evidence on this topic. We therefore conducted a scoping review aiming to map the extent and type of available research examining monetary incentives for recruiting and retaining trial participants to identify critical areas where evidence remains sparse.</p><p><strong>Methods: </strong>We included empirical studies examining the use of monetary incentives for recruiting or retaining participants in RCTs (excluding phase I trials). Case studies, protocols, and reviews without a systematic search strategy were excluded. Searches were run in the ORRCA database until the end of 2019 when it was last updated, and CINAHL, MEDLINE, Embase, and EconLit from 2020 onwards.</p><p><strong>Results: </strong>Out of 5421 identified records, 145 studies from 141 sources met our inclusion criteria. Monetary incentives were primarily studied in the context of trial retention (39%; 56/145) or trial participation more broadly (33%; 48/145), with many studies not specifying the format (61%; 88/145) or value (40%; 58/145) of monetary incentives in question. Additionally, the vast majority of studies were conducted in the USA (48%; 69/145) or UK (34%; 49/145), with very little research activity in low- and middle-income countries (LMICs) (9%; 13/145). Monetary incentives for recruiting or retaining trial participants were most often explored in the context of cross-sectional surveys (21%; 30/145), of which most involved members of the public being asked about hypothetical trial scenarios (53%; 16/30), rather than individuals actively invited to or involved in a trial.</p><p><strong>Conclusions: </strong>This scoping review consolidates available research on monetary incentives for recruiting and retaining trial participants. Less research is needed involving members of the public being asked about monetary incentives for a hypothetical trial. Rather, we need more qualitative studies exploring the perspectives of trial staff responsible for their implementation, as well as randomised studies within a trial (SWATs) assessing cost-effectiveness alongside effectiveness. Furthermore, more research is needed exploring the use of monetary incentives in LMICs.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13573473/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148340196","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 randomized controlled study on the effects of the T-REX Twente (Thoracic Surgical Rehabilitation Experts Twente) sternal precautions on quality of life and physical activity levels in cardiac surgery patients, compared to standard care in patients following a median sternotomy: the study protocol.","authors":"N Wielens, K Roerdink, W Lynch, L Esau, J van der Palen, F R Halfwerk","doi":"10.1186/s13063-026-09877-z","DOIUrl":"10.1186/s13063-026-09877-z","url":null,"abstract":"<p><strong>Background: </strong>In 2023, a majority (86%) of open-heart surgeries was performed at Thorax Centrum Twente (TCT) via a full median sternotomy. Currently, there is no consensus on postoperative sternal precautions following full median sternotomy. Research from the USA and Canada suggests that existing restrictive sternal precautions may not be necessary. More lenient sternal precautions, such as the \"Keep Your Move in the Tube\" principle, have shown positive outcomes, with no significant complications. Patients following this approach experienced fewer mobility issues and reported improved quality of life and reduced anxiety. This study explores the potential benefits of fewer restrictions, which could reduce patient anxiety and lead to fewer follow-up visits. This study aims to determine whether the Thoracic Surgical Rehabilitation Experts Twente (T-REX Twente) sternal precautions have a small positive effect on the Modified MacNew Quality of Life after Myocardial Infarction questionnaire (QLMI-2), physical activity, and reduction of movement-related anxiety in patients after full median sternotomy, compared to standard restrictive sternal precautions. It also assesses whether the T-REX sternal precautions result in no negative effects on pain, wound healing, or postoperative complications.</p><p><strong>Methods: </strong>This prospective, randomized, controlled, single-blind study will include adult patients undergoing full median sternotomy at TCT between June 2024 and June 2026, all participating in outpatient cardiac rehabilitation. Exclusion criteria include intensive care unit stays over 72 h, delirium, dementia, severe cognitive impairments, language barriers, or treatment by an external referring cardiologist. The control group will adhere to current restrictive sternal precautions, whereas those in the intervention group will follow the T-REX sternal precautions, which allow lifting, pushing, or pulling as long as arm movement remains within a defined \"tube.\" The primary endpoint is the change in QLMI-2 from baseline (T₀) to start of phase II cardiac rehabilitation (T₄).</p><p><strong>Discussion: </strong>The T-REX Twente sternal precautions may improve quality of life, physical activity, and reduce movement-related anxiety, supporting the idea that less restrictive postoperative sternal precautions can enhance patient outcomes.</p><p><strong>Trial registration: </strong>CCMO Trial Register NL78107.100.23, registered on 29 February 2024.</p><p><strong>Clinicaltrials: </strong>gov: NCT06115759.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13573408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148340157","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}