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Treatment of genitourinary syndrome of menopause with fractional CO₂ laser versus fractional microablative radiofrequency: study protocol for a double-blind, randomised, non-inferiority trial.
Garcia Dalbem Teles CC, Mesquita Garcia Dalbem CM, de Souza MR … +1 more , Parizotto NA
Trials · 2026 Jul · PMID 42400086 · Full text
BACKGROUND: Genitourinary syndrome of menopause (GSM) affects a significant proportion of postmenopausal women, leading to symptoms such as vaginal dryness, irritation, dyspareunia, and urinary symptoms. Hormonal therapi...
BACKGROUND: Genitourinary syndrome of menopause (GSM) affects a significant proportion of postmenopausal women, leading to symptoms such as vaginal dryness, irritation, dyspareunia, and urinary symptoms. Hormonal therapies are not suitable for all patients, particularly those with contraindications to hormone use. This study aims to compare the efficacy and safety of two non-hormonal therapies-fractional CO₂ laser (CO₂ laser) and fractional microablative radiofrequency (MAFRF)-for the treatment of GSM. METHODS: This protocol describes a randomised, double-blind, non-inferiority clinical trial that will enrol 40 postmenopausal women diagnosed with GSM. Participants will be randomised to receive either fractional CO₂ laser or fractional microablative radiofrequency in three monthly sessions. The primary outcome will be the Vaginal Health Index Score (VHIS), assessed 30 days after the last treatment session (day 90). Secondary outcomes include sexual function, GSM symptom severity, and urinary symptoms. Follow-up assessments will be conducted at 120 and 300 days after the last session (days 180 and 365, respectively). Histological analysis of vaginal biopsies will be performed in a predefined subsample of participants as an exploratory analysis. DISCUSSION: This study is expected to contribute to the comparative understanding of the efficacy and safety of CO₂ laser and MAFRF as non-hormonal therapeutic options for the treatment of GSM, potentially supporting clinical decision-making for women who are not candidates for hormonal therapy. TRIAL REGISTRATION: Brazilian Clinical Trials Registry (ReBEC): RBR-2hgwvgy. The trial was registered retrospectively due to administrative delays in the registration process. However, no outcome data were accessed, analysed, or used to inform any decisions prior to registration, and no interim analyses were performed. Additionally, no modifications were made to the study design, outcomes, or planned analyses after the initiation of data collection. Registered on July 2, 2023.
TaILOR: a randomised trial to compare the clinical and cost-effectiveness of a patient-initiated follow-up (PIFU) strategy compared to standard care pathways in people with inflammatory arthritis: a study protocol.
Brewer G, Harris V, Mwema C … +18 more , Abhishek A, Bosworth A, Bundy C, Clark C, Conroy E, Dakin H, Dures E, Eddison J, Francis A, Galloway J, Jennings A, Lall H, MacPhie E, Norton S, Perry M, Raleigh J, Turfrey MB, Coates L
Trials · 2026 Jul · PMID 42400057 · Full text
BACKGROUND: Inflammatory arthritis comprises lifelong conditions, such as rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis that require long-term treatment and regular monitoring. People with inflamm...
BACKGROUND: Inflammatory arthritis comprises lifelong conditions, such as rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis that require long-term treatment and regular monitoring. People with inflammatory arthritis usually require long-term treatment with immune-suppressing medications and are typically reviewed in outpatient clinics every 6-12 months, accounting for 1.3 million appointments/year in the UK. The National Health Service (NHS) is implementing a move to patient-initiated follow-up (PIFU) where patients request appointments as required. To date, there are small studies of PIFU in rheumatoid arthritis and none in other arthritis. Research is required to configure services to optimise outcomes, inform patients and clinicians of the effectiveness and safety of PIFU and ensure that suitable patients are selected for this pathway. METHODS: TaILOR is a two-arm, pragmatic, parallel group, superiority, randomised controlled clinical study, with an embedded qualitative study conducted across 32 secondary care NHS sites in the UK. Eligible participants must be 18 years or older, with stable inflammatory arthritis, and diagnosed for at least 2 years. In addition, they need to be suitable for PIFU based on NHS England guidance and in the opinion of their usual care team; 438 participants will be randomised in a 1:1 ratio to either PIFU, with a fixed 24-month safety net appointment, or standard care, with 6-12 monthly follow-up visits. The trial includes an internal recruitment feasibility pilot, as well as health economics and qualitative analyses. The primary outcome will assess the effectiveness of PIFU compared to standard care on musculoskeletal quality of life at 24 months. Secondary outcomes include quality of life, incremental costs, cost-effectiveness, treatment escalation, disease activity, flares, patient confidence in interactions with their clinical team (patient perceived efficacy in patient-physician interactions), depression and acceptability of PIFU (via qualitative interviews). DISCUSSION: As a national multi-centre study, this will provide the definitive evaluation of PIFU for inflammatory arthritis. Qualitative analysis will generate insights into individual and contextual factors affecting the acceptability of PIFU, identify variation across sites or between patients and provide information on how this can be addressed. TRIAL REGISTRATION: ISRCTN ISRCN10480648. Registered on 17 January 2025. Protocol version {2}: Version 3.0 date 04 Dec 2025.
Scaling up community-based non-communicable disease research into practice in Pokhara Metropolitan City of Nepal (SCALE-NCD) trial: study protocol for a cluster-randomized controlled trial.
Inagaki Y, Koirala S, Khan MH … +17 more , Ghimire K, Soti PB, Bhattarai N, Bhandari P, Pathiravasan CH, Bhandari B, Thapa R, Khadka KB, Yao Z, Shrestha A, Garcia-Larsen V, Finkelstein EA, Moore JB, Closser S, Appel LJ, Kallestrup P, Neupane D
Trials · 2026 Jul · PMID 42400007 · Full text
BACKGROUND: Rapid globalization and urbanization continue to escalate the burden of non-communicable diseases (NCDs) across the world, disproportionally affecting low- and middle-income countries (LMICs). To date, trials...
BACKGROUND: Rapid globalization and urbanization continue to escalate the burden of non-communicable diseases (NCDs) across the world, disproportionally affecting low- and middle-income countries (LMICs). To date, trials have documented that task-sharing with community health workers (CHWs) can reduce systolic blood pressure (SBP), reduce fasting blood glucose, and achieve smoking cessation. However, most studies have been conducted in rural settings or focused on managing a single condition, such as hypertension only. METHODS: We propose an open-label, two-armed, community-based cluster-randomized controlled trial in Pokhara Metropolitan City of Nepal, the second largest city in Nepal. A total of 30 clusters will be randomized into intervention or control arm in a 1:1 ratio. An individual is eligible if living in Pokhara Metropolitan City and having one or more of the following conditions: hypertension, type 2 diabetes, and tobacco smoking. The participants will be recruited through study team home visits. The intervention group will receive an intervention package "SCALE-NCD" which includes (1) home-based monitoring, referral, and counseling for self-management of hypertension, diabetes, and tobacco smoking by Female Community Health Volunteers (FCHVs), and (2) weekly mobile phone messages to promote healthy lifestyle. FCHVs are CHWs in Nepal whose usual tasks are limited to maternal and child health care services. The control group will receive usual care, where there is neither of aforementioned two components. Primary outcomes are change in SBP, change in fasting plasma glucose, and change in smoking cessation, the required sample size for which is 405, 105, and 525 per arm, respectively. DISCUSSION: This study will inform us of the effectiveness of FCHV-led home-based management of the top three NCD risk factors coupled with weekly mobile phone messages in urban Nepal. Building on the previous studies that measured the efficacy of FCHV-led home-based management of a single NCD risk factor in a small geographical area, this scaled-up study will provide us with the realistic impact that FCHVs may have if they are trained to provide primary care services for management of major NCD risk factors. TRIAL REGISTRATION: ClinicalTrials.gov NCT06740708. Registered on 2024-12-13.
EECP intervention and coronary flow reserve in chronic coronary syndrome: a protocol of a multicentre, randomised controlled study in China (ECP-Core Trial).
Leng Y, Li Y, Jia X … +11 more , Tian S, Jiang Y, Lin L, Wang Y, Pan W, Liang J, Wu F, Zhou W, Liao Z, Zhang X, Wu G
Trials · 2026 Jul · PMID 42400000 · Full text
BACKGROUND: Few non-invasive approaches are available for improving coronary function in intermediate-risk chronic coronary syndrome (CCS) patients. Over the past 30 years, enhanced external counterpulsation (EECP) has b...
BACKGROUND: Few non-invasive approaches are available for improving coronary function in intermediate-risk chronic coronary syndrome (CCS) patients. Over the past 30 years, enhanced external counterpulsation (EECP) has been widely accepted and recommended for treating CCS in clinical guidelines. However, the effect of EECP on coronary function remains to be quantitatively validated in intermediate-risk CCS patients. Fractional flow reserve (FFR) is a gold standard (quantitative index) of coronary artery function, and FFR < 0.80 is regarded as an indicator for percutaneous coronary intervention (PCI) in clinical decision-making. However, FFR is invasive and cannot be performed repeatedly within a short time interval; therefore, FFR is not suitable for large-scale verification of the effect before and after EECP treatment. Conversely, with advancements in numerical theory and computation hardware, FFR derived from coronary computed tomography angiography (FFR) performs similarly to FFR used in coronary artery function measurement. Additionally, FFR is non-invasive and highly acceptable to patients. Therefore, in this study, we aim to explore whether EECP therapy can improve FFR in patients with intermediate-risk CCS and further enhance the long-term prognosis of CCS. METHODS: This prospective, multicentre, randomised controlled trial is blinded to the examination executors and analysts. One hundred four participants will be recruited, and they will be divided into the EECP and control groups. The primary outcome of this study is the between-group difference in FFR changes from baseline to follow-up. The secondary outcomes refer to between-group differences in ΔFFR, wall shear stress, axial plaque stress, total exercise time, time to 1 mm ST-segment depression, Seattle Angina Questionnaire score, and cardiovascular-related composite endpoint events. DISCUSSION: This is the first study to use the non-invasive coronary artery function index, FFR, to evaluate the efficacy of EECP in patients with CCS. It comprehensively evaluates the treatment efficacy from multiple dimensions, including exercise capacity, symptom changes, and prognosis. Therefore, this will potentially provide reliable evidence to inform treatment strategies for CCS. TRIAL REGISTRATION: Trial registration number: ChiCTR2400079915. Registered on January 16, 2024 (retrospectively registered), https://www.chictr.org.cn/about.html.
Impact of early tracheostomy in infratentorial lesions trial: rationale and design.
Han S, Li MY, Cheng YC … +1 more , Yan CX
Trials · 2026 Jul · PMID 42399948 · Full text
BACKGROUND: Tracheostomy is a common procedure in patients who undergo surgical resection of infratentorial lesions. However, the optimal timing and high-risk factors for tracheostomy remain unknown. METHODS: Value of Ea...
BACKGROUND: Tracheostomy is a common procedure in patients who undergo surgical resection of infratentorial lesions. However, the optimal timing and high-risk factors for tracheostomy remain unknown. METHODS: Value of Early versus Standard Tracheostomy in patients with Infratentorial Lesions (VENTIL) is a prospective, randomized, controlled, open-blinded endpoint (PROBE design) trial. Patients who have undergone resection of infratentorial lesions will be recruited within 48 h postoperatively based on a prediction score. This study will include 152 patients. Patients will be randomized 1:1 to either the early tracheostomy (< 2 days after surgery) or the control group (≥ 2 days after surgery). The primary endpoint is the occurrence of pneumonia by day 14 after resection of infratentorial lesions. The secondary endpoints include the modified Rankin scale score at 6 months, mortality, length of intensive care unit and hospital stays, time to successful extubation, and adverse events. CONCLUSION: High-risk factors and optimal timing for tracheostomy in patients undergoing resection of infratentorial lesions need to be identified. Therefore, VENTIL should clarify the clinical benefits of early tracheostomy in these patients. TRIAL REGISTRATION: This trial is registered on February 5, 2024, at chictr.org.cn (ChiCTR2400080714).
Efficacy of transcranial direct current stimulation for post-stroke urinary incontinence: study protocol for a randomized controlled trial.
Ran G, Chen Y, Feng Y … +3 more , Tan B, Zhou Y, Jiang W
Trials · 2026 Jul · PMID 42393784 · Full text
BACKGROUND: 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 rehabil...
BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: URL: https://www.chictr.org.cn; Unique identifier: ChiCTR2500099178. Registered on 2025-03-19.
Compression therapies for the treatment of venous leg ulcers: a mixed method process evaluation in a randomised controlled trial, VenUS6.
Kletter M, Griffiths J, Arundel C … +2 more , Dumville J, VenUS6 Collaborators
Trials · 2026 Jul · PMID 42387625 · Full text
BACKGROUND: 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 ban...
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Cheek acupuncture for enhancing postoperative recovery after endoscopic sinus surgery: study protocol for a pilot randomized controlled trial.
Wang M, Lei G, Yan J … +1 more , Wang G
Trials · 2026 Jul · PMID 42387589 · Full text
BACKGROUND: Postoperative pain and sleep disturbance are common after endoscopic sinus surgery (ESS) and may delay postoperative recovery. Acupuncture has demonstrated analgesic and sleep-enhancing effects in perioperati...
BACKGROUND: Postoperative pain and sleep disturbance are common after endoscopic sinus surgery (ESS) and may delay postoperative recovery. Acupuncture has demonstrated analgesic and sleep-enhancing effects in perioperative care; however, the impact of cheek acupuncture-a minimally invasive facial microsystem technique-on postoperative recovery after ESS has not been evaluated in randomized controlled trials. METHODS: This single-center, prospective, randomized controlled pilot trial will enroll 90 adults undergoing ESS. Participants will be randomized 1:1 to receive cheek acupuncture or sham cheek acupuncture within 30 min before anesthesia induction. The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 h postoperatively. Secondary outcomes include the Insomnia Severity Index (ISI), Numerical Rating Scale (NRS) for pain, intraoperative hemodynamics, postoperative care unit (PACU) stay duration, postoperative nausea and vomiting (PONV), and inflammatory biomarkers (serum interleukin-6 [IL-6] and C-reactive protein [CRP]). DISCUSSION: This trial will assess the feasibility, safety, and preliminary efficacy of cheek acupuncture in improving postoperative recovery after ESS. Results will inform the design of a future multicenter randomized trial. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2500110625). Registered on 16 October 2025.
Methodological guidance for incorporating lived experience in the early stages of core outcome set development: a scoping review.
Livingston MK, Toomey E, Robinson K
Trials · 2026 Jun · PMID 42381079 · Full text
BACKGROUND: 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 exi...
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: This review is registered in the COMET Database: https://www.comet-initiative.org/Studies/Details/3590. The protocol for this review is available at https://doi.org/10.1186/s13063-025-09149-2.
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.
Ynddal MS, Stroomberg HV, Vejlgaard M … +4 more , Jensen JB, Moser C, Joensen UN, Røder A
Trials · 2026 Jun · PMID 42380957 · Full text
INTRODUCTION AND OBJECTIVES: 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 complic...
INTRODUCTION AND OBJECTIVES: 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. MATERIALS AND METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: CTIS EU trial number: 2023-506226-36-00. Registered on February 16, 2024. CLINICALTRIALS: gov: NCT06770530. Registered on March 31, 2024.
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.
Schäfer A, Wendel J, Franke I … +19 more , Bauer A, Baumeister H, Bendig E, Brucker SY, Deutsch TM, Garatva P, Haas K, Heil L, Hügen K, Manger H, Pryss R, Rücker V, Salmen J, Szczesny A, Vogel C, Wallwiener M, Wöckel A, Heuschmann PU, BETTER-CARE Study Group
Trials · 2026 Jun · PMID 42380897 · Full text
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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.
Hølmkjær P, Leick C, Drivsholm T … +3 more , Siersma V, Bro F, Kousgaard MB
Trials · 2026 Jun · PMID 42374596 · Full text
BACKGROUND: 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 reso...
BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov NCT06748456. Registered on 16.10.2024. https://clinicaltrials.gov/study/NCT06748456?id=NCT06748456&rank=1. Retrospectively registered.
Adjunctive optical and magnetic stimulation for venous and mixed etiology leg ulcers: protocol for the NAZARÉ multicenter randomized controlled trial.
Probst S, Saini C, Stefanelli A … +12 more , Frei A, Stuermer EK, Dissemond J, Kamolz LP, Weber B, Lembelembe JP, Traber J, Mayer D, Zehnder T, Baer D, Ruzza C, Hafner J
Trials · 2026 Jun · PMID 42366370 · Full text
BACKGROUND: 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 wit...
BACKGROUND: 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). METHOD: 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 cm, 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. DISCUSSION: 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. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06528873. Registred on 26 July 2024, https://register. CLINICALTRIALS: gov/prs/app/action/SelectProtocol?selectaction=Edit&sid=S000ERKB&uid=U0003LG4.
Recruitment strategies for a randomized controlled trial in a rural American Indian community: the Cooking for Health Study.
Green SA, O'Leary R, Huber CM … +9 more , Thorndike AN, Best LG, Brown MC, O'Leary M, Umans J, Hager A, Whitebull R, Beresford S, Fretts AM
Trials · 2026 Jun · PMID 42365364 · Full text
BACKGROUND: 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 n...
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov, TRN: NCT03699709. Registered on 5 October 2018, https://clinicaltrials.gov/study/NCT03699709.
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.
Wielens N, Roerdink K, Lynch W … +3 more , Esau L, van der Palen J, Halfwerk FR
Trials · 2026 Jun · PMID 42365330 · Full text
BACKGROUND: 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 ful...
BACKGROUND: 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. METHODS: 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 (T) to start of phase II cardiac rehabilitation (T). DISCUSSION: 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. TRIAL REGISTRATION: CCMO Trial Register NL78107.100.23, registered on 29 February 2024. CLINICALTRIALS: gov: NCT06115759.
Investigating the effect of intermittent fasting (time-restricted eating) with and without calorie restriction compared to calorie restriction on anthropometric parameters, depression score, and metabolic factors in patients with major depression disorder and obesity: a study protocol for a randomized controlled trial.
Bagherzadeh-Karimi A, Mesri Alamdari N, Hosseini L … +1 more , Maghsoumi-Norouzabad L
Trials · 2026 Jun · PMID 42363285 · Full text
BACKGROUND: It is suggested that intermittent fasting, specifically time-restricted eating (TRE), may have potential impact on depression in obese patients with major depression disorder (MDD). This study will aim to eva...
BACKGROUND: It is suggested that intermittent fasting, specifically time-restricted eating (TRE), may have potential impact on depression in obese patients with major depression disorder (MDD). This study will aim to evaluate the effects of TRE with and without calorie restriction, compared to the traditional calorie restriction in patients suffering from MDD and obesity. METHODS/DESIGN: This single-center, single-blinded, prospective, randomized trial will be conducted on 90 obese patients with major depression over 24 weeks. Participants were randomly divided into three groups in a 1:1:1 ratio. Group 1: recipients of TRE with 8-h food intake restriction (fixed 8-h time period), 2: recipients of TRE (fixed 8-h time period) and calorie restriction (75% of required calories), and 3: group receiving calorie restriction (75% of required calories). MAIN OUTCOMES MEASURE(S): The primary objective is assessment of changes in depression severity scores, alongside secondary outcomes including changes in parameters such as body weight, body mass index (BMI), waist circumference, fat mass, fat-free mass, circadian rhythm score, quality of life, physical activity, and key metabolic factors such as fasting glucose levels, serum insulin, hemoglobin A1C, insulin resistance and sensitivity, lipid profile, and blood pressure. DISCUSSION: While calorie restriction can promote weight loss, its long-term adherence and mental health effects remain inconsistent. Emerging approaches like TRE have shown promise in improving body weight and metabolic parameters, but their impact on mental health is less understood. This study aims to fill this gap by comparing time-restricted eating with a fixed 8-h eating window plus and minus calorie restriction, against standard calorie restriction, in obese patients with major depressive disorder. The findings could have significant clinical implications for integrated management of obesity and depression. TRIAL REGISTRATION: Iran Clinical Trials Registry, IRCTID: ( https://irct.behdasht.gov.ir/IRCT20241029063543N1 ). Registered on 26-11-2024.
Imaging-based versus threshold assessment-based deep brain stimulation programming in Parkinson's disease: study protocol for a randomized controlled trial {1a}.
van der Weide A, Wiggerts Y, Beudel M … +4 more , Hoogland J, Bot M, Schuurman R, de Bie R
Trials · 2026 Jun · PMID 42363278 · Full text
BACKGROUND: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) effectively treats motor fluctuations in Parkinson's disease. The clinical outcome depends on optimal programming, which involves selecting active...
BACKGROUND: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) effectively treats motor fluctuations in Parkinson's disease. The clinical outcome depends on optimal programming, which involves selecting active contacts and adjusting stimulation parameters to maximize clinical benefit while minimizing adverse effects. The conventional clinically guided approach, the monopolar review (MPR), is complex and time-consuming due to numerous parameter combinations, interindividual anatomical variability, and differences in DBS lead placement. Recent advances in neuroimaging offer the potential to guide contact selection based on patient-specific anatomy. METHODS: A single-centre, prospective, randomized, open-label trial with blinded endpoint assessment (PROBE design) is being conducted in patients with Parkinson's disease undergoing STN-DBS to determine whether imaging-based contact selection is non-inferior to the current standard MPR for contact selection in treating motor symptoms. A total of 132 patients are randomized to either imaging-based programming (Imaging group) or threshold-assessment-based programming (i.e., MPR, Threshold group). In the Imaging group, contacts are selected using patient-specific 3D anatomical models derived from preoperative 7 T MRI and postoperative CT, visualizing the STN and simulating volumes of tissue activated (VTA) aligned with the motor subdivision. The primary outcome is the mean change from baseline to 6 months in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score during the off-drug phase. Secondary outcomes include motor symptoms in the on-medication phase, duration of off-medication time, dyskinesia severity and duration, non-motor symptoms, motor aspects of daily living, physical disability, disease-specific quality of life, (severe) adverse effects, treatment satisfaction and burden, crossover to the alternate programming arm, use of care, programming duration, final DBS settings, and concordance between 6-months stimulation contacts and initial selections. Follow-up is 6 months after initial programming. DISCUSSION: The trial evaluates whether imaging-based DBS programming can achieve motor improvements comparable to clinical threshold-assessment-based programming, while potentially offering greater efficiency, speed, and stability of stimulation settings. Although the study is designed as a non-inferiority trial, we hypothesize that imaging-based contact selection may ultimately provide a superior approach by enabling faster optimization with fewer parameter adjustments. TRIAL REGISTRATION: The DBS-ITAP trial was registered at clinicaltrials.gov (NCT06223399) on January 23, 2024, https://clinicaltrials.gov/study/NCT06223399.
Research exploring monetary incentives for recruiting and retaining participants in randomised controlled trials: a scoping review.
Mongelli G, Adamson J, Yakimova A … +2 more , Piccolo-Lawrance C, Parker A
Trials · 2026 Jun · PMID 42363211 · Full text
BACKGROUND: 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 r...
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Navigating Advanced Illness Goals And Treatment with Digital Engagement (NAVIGATE): a protocol for a randomised controlled trial of a website for caregivers of patients with serious illness.
Huynh VA, Koh GCH, Lim MJR … +6 more , Liew TM, Nga VDW, Yeo TT, Chan N, Tan JN, Sym FP
Trials · 2026 Jun · PMID 42351230 · Full text
BACKGROUND: Surrogate decision-makers (SDMs) of patients with serious illnesses (PSI) face significant challenges in making end-of-life decisions, including feeling unprepared and uncertain due to lack of clarity on what...
BACKGROUND: Surrogate decision-makers (SDMs) of patients with serious illnesses (PSI) face significant challenges in making end-of-life decisions, including feeling unprepared and uncertain due to lack of clarity on what patients and they themselves value. We developed a digital SDM-focused intervention (Careverse) that provides educational materials and tools for SDMs to initiate and discuss values conversation with patients and clinicians. The aims of this study are (i) to test the impact of Careverse on SDMs self-reported engagement in care planning behaviours and (ii) to evaluate whether Careverse increases caregivers' and patients' self-reported satisfaction with care and improves patient outcomes. METHODS: This is a two-armed, parallel-design, single-blinded, participant-level randomised controlled trial of 100 identified decision-makers for patients with serious illness, along with their patients in a public university hospital in Singapore. Participants are English-speaking adult SDMs (21 years and older) of PSIs, including brain tumours, spontaneous intracerebral haemorrhage, and late-stage chronic kidney disease. Physicians in charge must assess that the patient is an appropriate candidate for advance care planning (ACP). Eligible caregivers of these patients with serious illness are then assigned to the intervention or control group using randomisation stratified by patients' conditions. We will assess SDM outcomes (engagement in care planning behaviours as a surrogate decision maker within 6 weeks-primary outcome; satisfaction with care; goals of care congruence, wellbeing) and patient outcomes (healthcare utilisation at end-of-life). DISCUSSION: This trial will provide much-needed empirical evidence about a SDM-focused digital care planning intervention to empower caregivers to engage more effectively in care planning behaviours and be better prepared for their SDM role. This trial will also test the effect of Careverse on improving both SDM's- and patient-centred outcomes, and inform clinicians, payers and health systems seeking to adopt and scale effective and efficient digital strategies for supporting SDMs in real-world serious illness care settings. TRIAL REGISTRATION: ClinicalTrial.gov NCT07134881. Registered on 21 August 2025, https://clinicaltrials.gov/study/NCT07134881.
Coracoclavicular ligament reconstruction versus hook plate treatment in patients with Rockwood III-VI acute acromioclavicular dislocation: a multicentre randomized controlled trial.
Fang Q, Zhu Q, Lu S … +6 more , Shao L, Zhang W, Sun Q, Song W, Gao Y, Liu P
Trials · 2026 Jun · PMID 42343422 · Full text
BACKGROUND: In 9-12% of shoulder girdle injuries in athletes, acromioclavicular (AC) joint dislocations disproportionately affect young adults who are engaged in contact sports. Surgical reconstruction has emerged as the...
BACKGROUND: In 9-12% of shoulder girdle injuries in athletes, acromioclavicular (AC) joint dislocations disproportionately affect young adults who are engaged in contact sports. Surgical reconstruction has emerged as the gold standard for Rockwood III-VI lesions, particularly in professional athletes, where conservative management is correlated with high recurrence rates according to recent meta-analyses. However, the optimal surgical management for acute Rockwood type III-VI AC dislocations remains controversial, with no consensus on the most effective technique. This study aims to evaluate the efficacy of two prevalent surgical techniques: hook plate fixation and coracoclavicular ligament reconstruction using a ligament augmentation and reconstruction system (LARS). METHODS: This study is designed as a multicentre, single-blinded, two-arm, parallel-group randomized controlled superiority trial with a 1:1 allocation ratio. Hook plate (arm 1) and LARS ligament (arm 2) will be compared. The primary outcome will be the Disability Arm Shoulder and Hand (DASH) score. The secondary outcomes will include imaging evaluations of re-dislocation, the quality of life 12-item survey questionnaire (SF-12), the visual analog scale (VAS), the Constant-Murley-Shoulder joint score, and complications. Since treatment allocation involves surgery and X-ray access for patients and surgeons, only researchers who analyze the outcome data after 1 year of follow-up will be blinded to the allocation. A total of 72 participants will be included, and the estimated time to complete this trial will be approximately 2 years. All the work will be conducted at the National Orthopedic Medical Center and its partner trauma healthcare network. DISCUSSION: As the optimal surgical method for severe AC joint dislocation remains uncertain, this study highlights the differences in short-term and middle-term outcomes between hook plate and LARS ligament surgical treatments, which may hopefully reveal the most effective surgical interventions. TRIAL REGISTRATION: This study is registered at the Chinese Clinical Trial Registry (ChiCTR2400082168) and was granted permission by the institutional ethics committee of Shanghai Sixth People's Hospital on 02-29-2024. https://www.chictr.org.cn/showproj.html?proj=222307.
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