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Luker S, Doveton A, Manuel K, Adey-Wakeling Z, Jaggard D, Crotty M, Cameron ID, Karnon J, McNaughton H, Ullah S, Laver K. Take charge after long COVID: a mixed methods randomised controlled pilot study protocol. Ann Med 2025; 57:2516694. [PMID: 40492405 DOI: 10.1080/07853890.2025.2516694] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/23/2024] [Revised: 04/28/2025] [Accepted: 05/13/2025] [Indexed: 06/12/2025] Open
Abstract
INTRODUCTION Post COVID-19 condition is a debilitating illness with over 200 symptoms across 10 organ systems and is presently impacting millions worldwide. The National Institute for Health and Care Excellence recommends a multidisciplinary treatment approach including person-centred self-management strategies, however evidence for specific programs is lacking. The Take Charge intervention is a person-centred, self-management rehabilitation approach that has been effective in recovery after stroke, but not yet tested in post COVID-19 condition. METHODS & ANALYSIS A prospective, single-centre, parallel, 2 group, mixed methods, randomized controlled trial with embedded process evaluation of the Take Charge intervention in individuals living with post COVID-19 condition. Participants will be at least 18 years of age, have a confirmed diagnosis of post COVID-19 condition with ongoing symptoms, and be known to a hospital clinic for assessment and treatment of patients with post-acute sequelae of COVID-19. The primary outcomes are the Modified COVID-19 Yorkshire Rehabilitation Scale and the COVID-19 Core Outcome Measure for Recovery. The secondary outcomes include physical and self-report measures, and feasibility measures. Qualitative interviews will also be conducted to understand the clinicians' and participants' experiences. Statistical analysis will be performed on an intention-to-treat basis using a multivariate mixed-effect linear regression model. ETHICS & DISSEMINATION This study adheres to the Declaration of Helsinki. This study was approved by the Southern Adelaide Clinical Human Research Ethics Committee (approval number: 2022/SSA00695/OFR: 219.22, protocol version 3.3 19 February 2024). The results will be disseminated in peer-reviewed journals, conference presentations, and media.
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Affiliation(s)
- Subbuh Luker
- Division of Rehabilitation, Aged and Palliative Care, Southern Adelaide Local Health Network, Bedford Park, Australia
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
| | - Amelia Doveton
- Division of Rehabilitation, Aged and Palliative Care, Southern Adelaide Local Health Network, Bedford Park, Australia
| | - Kisani Manuel
- Division of Rehabilitation, Aged and Palliative Care, Southern Adelaide Local Health Network, Bedford Park, Australia
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
| | - Zoe Adey-Wakeling
- Division of Rehabilitation, Aged and Palliative Care, Southern Adelaide Local Health Network, Bedford Park, Australia
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
| | - Debrah Jaggard
- College of Education, Psychology & Social Work, Flinders University, Adelaide, Australia
| | - Maria Crotty
- Division of Rehabilitation, Aged and Palliative Care, Southern Adelaide Local Health Network, Bedford Park, Australia
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
| | - Ian D Cameron
- John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, St Leonards, Australia
- Faculty of Medicine and Health, University of Sydney, Sydney, Australia
| | - Jonathan Karnon
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
| | - Harry McNaughton
- Medical Research Institute of New Zealand, Wellington, New Zealand
| | - Shahid Ullah
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
| | - Kate Laver
- Division of Rehabilitation, Aged and Palliative Care, Southern Adelaide Local Health Network, Bedford Park, Australia
- College of Nursing and Health Sciences, Flinders University, Adelaide, Australia
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2
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Albrecht M, Hunfeld M, Arkesteijn-Muit A, Dulfer K, de Hoog M, de Jong G, de Jonge R, Lamoré A, Nadkarni V, Buysse C. A Dutch nationwide pediatric cardiac arrest registry with long-term follow-up - towards an international prognostication guideline. Resusc Plus 2025; 24:100976. [PMID: 40491775 PMCID: PMC12148594 DOI: 10.1016/j.resplu.2025.100976] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Collaborators] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2025] [Revised: 04/14/2025] [Accepted: 04/30/2025] [Indexed: 06/11/2025] Open
Abstract
Aims Pediatric cardiac arrest is associated with high mortality and significant morbidity among survivors. International guidelines for prognostication remain limited due to small heterogeneous patient populations, variable post-return of circulation diagnostics, and insufficient long-term follow-up. Pediatric Resuscitation Prognostication and Outcomes Registry (PROGNOSE) is a Dutch nationwide, multicenter registry aiming to standardize data collection, establish uniform neuromonitoring reporting, and implement structured follow-up protocols. Methods The Pediatric Resuscitation Prognostication and Outcomes Registry (ClinicalTrials.gov ID: NCT06938009) collects data on pediatric cardiac arrest across Dutch pediatric intensive care units, extending the pediRES-Q collaborative. It includes patients <18 years with out-of-hospital cardiac arrest requiring emergency services and in-hospital cardiac arrest patients admitted to academic hospitals. Return of circulation is defined as sustained spontaneous circulation or via extracorporeal support. Exclusions include pre-existing Do Not Resuscitate orders or neonates < 24 h. The registry captures pre-hospital factors, resuscitation characteristics, post-return of circulation care, neuroprognostication markers (biomarkers, electroencephalography, imaging), and long-term outcomes. Structured follow-up occurs at 3-6 months, 12 months, and evaluations through age 17 for neurodevelopmental, psychosocial, and functional outcomes. Conclusion The Pediatric Resuscitation Prognostication and Outcomes Registry (PROGNOSE) represents the first nationwide initiative to standardize data collection on pediatric cardiac arrest, post-return of circulation care and implement structured follow-up protocols in the Netherlands. This registry aims to address critical knowledge gaps, providing foundation for evidence-based prognostication, clinical decision-making, and long-term care policy recommendations. Future expansion efforts will focus on integrating pre-hospital data, extending follow-up into young adulthood, and strengthening international collaboration through the pediRES-Q network.
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Affiliation(s)
- Marijn Albrecht
- Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
| | - Maayke Hunfeld
- Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
- Department of Pediatric Neurology, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
| | - Annemieke Arkesteijn-Muit
- Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
| | - Karolijn Dulfer
- Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
- Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
| | - Matthijs de Hoog
- Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
| | - Gabry de Jong
- Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
| | - Rogier de Jonge
- Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
| | - Aldert Lamoré
- Department of Information Technology, Erasmus MC, Rotterdam, the Netherlands
| | - Vinay Nadkarni
- Department of Anesthesiology and Critical Care Medicine, The Children’s Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States
| | - Corinne Buysse
- Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands
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Collaborators
Nikki Schoenmaker, Annelies van Zwol, Geanne Krabben-de Vlaam, Nicole de la Haye, Jennifer Walker,
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3
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Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials. JAMA 2025; 333:1998-2005. [PMID: 40228499 DOI: 10.1001/jama.2025.4347] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/16/2025]
Abstract
Importance Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of health care interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomized trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Herein, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. Observations We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (harms, outcomes, nonpharmacological treatment), other related reporting guidelines (Template for Intervention Description and Replication [TIDieR]), and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, 3-round Delphi survey involving 317 participants and discussed at a 2-day online expert consensus meeting of 30 invited international experts. We have made substantive changes to the CONSORT checklist. We added 7 new checklist items, revised 3 items, deleted 1 item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomized trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. Conclusions and Relevance Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent.
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Affiliation(s)
- Sally Hopewell
- Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
| | - An-Wen Chan
- Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada
| | - Gary S Collins
- UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
| | - Asbjørn Hróbjartsson
- Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
- Open Patient Data Explorative Network, Odense University Hospital, Odense, Denmark
| | - David Moher
- Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Kenneth F Schulz
- Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill
| | - Ruth Tunn
- Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
| | - Rakesh Aggarwal
- Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Michael Berkwits
- Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Jesse A Berlin
- Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, New Jersey
- Statistical Editor, JAMA Network Open
| | - Nita Bhandari
- Centre for Health Research and Development, Society for Applied Studies, New Delhi, India
| | - Nancy J Butcher
- Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
- Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada
| | - Marion K Campbell
- Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, United Kingdom
| | - Runcie C W Chidebe
- Project PINK BLUE-Health and Psychological Trust Centre, Utako, Abuja, Nigeria
- Department of Sociology and Gerontology, Miami University, Oxford, Ohio
| | - Diana Elbourne
- Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
| | - Andrew Farmer
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom
| | | | - Robert M Golub
- Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois
| | - Steven N Goodman
- Department of Epidemiology and Population Health, Stanford University, Palo Alto, California
| | - Tammy C Hoffmann
- Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Robina, Queensland, Australia
| | - John P A Ioannidis
- Departments of Medicine, Epidemiology and Population Health, Biomedical Data Science, and Statistics and the Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California
| | - Brennan C Kahan
- MRC Clinical Trials Unit at University College London, London, United Kingdom
| | - Rachel L Knowles
- University College London, UCL Great Ormond Street Institute of Child Health, London, United Kingdom
| | - Sarah E Lamb
- NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, United Kingdom
| | - Steff Lewis
- Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, United Kingdom
| | - Elizabeth Loder
- The BMJ , London, United Kingdom
- Harvard Medical School, Boston, Massachusetts
| | - Martin Offringa
- Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
| | - Philippe Ravaud
- Université Paris Cité, Inserm, INRAE, Centre de Recherche Epidémiologie et Statistiques, Paris, France
| | - Dawn P Richards
- Clinical Trials Ontario, MaRS Centre, Toronto, Ontario, Canada
| | - Frank W Rockhold
- Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
| | - David L Schriger
- Department of Emergency Medicine, University of California, Los Angeles
- Associate Editor, JAMA
| | | | - Sophie Staniszewska
- Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Rod S Taylor
- MRC/CSO Social and Public Health Sciences Unit and Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom
| | - Lehana Thabane
- Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
- St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
| | - David Torgerson
- York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom
| | - Sunita Vohra
- Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada
| | - Ian R White
- MRC Clinical Trials Unit at University College London, London, United Kingdom
| | - Isabelle Boutron
- Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France
- Centre d'Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France
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Tersa-Miralles C, Bravo C, Bellon F, Masbernat-Almenara M, Rubí-Carnacea F, Arnaldo ER. A web-based workplace exercise intervention among office workers with spinal pain: Protocol of a mixed methods study. PLoS One 2025; 20:e0325376. [PMID: 40489458 DOI: 10.1371/journal.pone.0325376] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2024] [Accepted: 05/08/2025] [Indexed: 06/11/2025] Open
Abstract
INTRODUCTION Musculoskeletal disorders are a major cause of disability worldwide, significantly impacting office workers due to prolonged sitting and lack of movement. Implementing therapeutic exercise interventions in the workplace has been identified as a feasible and cost-effective strategy to address spinal pain. However, understanding workers' perspectives and workplace barriers is essential for designing effective interventions. This study aims to develop and evaluate a web-based workplace intervention with active breaks to reduce spinal pain among office workers. METHODS This study follows a sequential exploratory mixed-methods design. The qualitative phase will use semi-structured interviews with office workers to explore their experiences with spinal pain, active breaks, and perceived barriers to implementation. These findings will inform the development of a six-week web-based therapeutic exercise intervention, which will be evaluated through a two-arm cluster randomised controlled trial. The trial will compare an intervention group performing structured active breaks during work hours with a control group maintaining their usual routine. Primary outcomes include pain intensity (Visual Analogue Scale), spinal dysfunction (Spine Functional Index), and adherence to the program. Secondary outcomes include quality of life (EQ-5D-5L) and exercise motivation (Behavioural Regulation in Exercise Questionnaire-2). Statistical analyses will compare within- and between-group differences to assess the intervention's effectiveness. DISCUSSION Web-based interventions can enhance adherence to active breaks and provide an accessible, cost-effective solution for spinal pain management in sedentary workplaces. By adopting a mixed-methods approach, this study will generate valuable insights into implementing workplace exercise interventions, taking into account workers' expectations, workplace context, and adherence factors. Findings may inform future interventions aimed at managing musculoskeletal disorders in office workers. TRIAL REGISTRATION ClinicalTrials.gov NCT05571124.
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Affiliation(s)
- Carlos Tersa-Miralles
- Consolidated Research Group: Society, Health, Education and Culture(GESEC), Universitat de Lleida, Lleida, Spain
- Department of Nursing and Physiotherapy, Universitat de Lleida, Lleida, Spain
- Health Care Research Group Salut (GRECS), IRBLleida, Institut de Recerca Biomédica Fundació Dr. Pifarré, Lleida, Spain
| | - Cristina Bravo
- Consolidated Research Group: Society, Health, Education and Culture(GESEC), Universitat de Lleida, Lleida, Spain
- Department of Nursing and Physiotherapy, Universitat de Lleida, Lleida, Spain
- Health Care Research Group Salut (GRECS), IRBLleida, Institut de Recerca Biomédica Fundació Dr. Pifarré, Lleida, Spain
| | - Filip Bellon
- Consolidated Research Group: Society, Health, Education and Culture(GESEC), Universitat de Lleida, Lleida, Spain
- Department of Nursing and Physiotherapy, Universitat de Lleida, Lleida, Spain
- Health Care Research Group Salut (GRECS), IRBLleida, Institut de Recerca Biomédica Fundació Dr. Pifarré, Lleida, Spain
| | - Maria Masbernat-Almenara
- Consolidated Research Group: Society, Health, Education and Culture(GESEC), Universitat de Lleida, Lleida, Spain
- Department of Nursing and Physiotherapy, Universitat de Lleida, Lleida, Spain
- Health Care Research Group Salut (GRECS), IRBLleida, Institut de Recerca Biomédica Fundació Dr. Pifarré, Lleida, Spain
| | - Francesc Rubí-Carnacea
- Consolidated Research Group: Society, Health, Education and Culture(GESEC), Universitat de Lleida, Lleida, Spain
- Department of Nursing and Physiotherapy, Universitat de Lleida, Lleida, Spain
- Health Care Research Group Salut (GRECS), IRBLleida, Institut de Recerca Biomédica Fundació Dr. Pifarré, Lleida, Spain
| | - Esther Rubinat Arnaldo
- Consolidated Research Group: Society, Health, Education and Culture(GESEC), Universitat de Lleida, Lleida, Spain
- Department of Nursing and Physiotherapy, Universitat de Lleida, Lleida, Spain
- Health Care Research Group Salut (GRECS), IRBLleida, Institut de Recerca Biomédica Fundació Dr. Pifarré, Lleida, Spain
- Center for Biomedical Research on Diabetes and Associated Metabolic Diseases (CIBERDEM), Instituto de Salud Carlos III, Barcelona, Spain
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Wang YR, Liu CZ, Cong Y, Xi YW, Xu YY, Li B, Zhou Y, Tu JF, Fu YM, Chen W, Wang LQ, Shi GX. Acupuncture as an Adjunctive Therapy to Etoricoxib for Patients with Acute Gouty Arthritis: Protocol for a Multicenter Randomized Controlled Trial. J Pain Res 2025; 18:2889-2900. [PMID: 40520812 PMCID: PMC12165196 DOI: 10.2147/jpr.s523657] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/19/2025] [Accepted: 05/22/2025] [Indexed: 06/18/2025] Open
Abstract
Purpose Acute gouty arthritis (AGA) is often managed with non-steroidal anti-inflammatory drugs. However, patients still tolerate severe pain before the analgesic takes effect. Early adjuvant analgesia is necessary in the pharmacological management of AGA. Acupuncture has the advantage of quick analgesia; nevertheless, the evidence to support the use of early-acupuncture as an adjunctive therapy for AGA is limited. This study aims to assess the efficacy of acupuncture compared with sham acupuncture on pain relief among AGA patients who are concurrently receiving etoricoxib. Patients and methods In this multicenter, randomized, controlled trial, total 160 eligible patients with AGA will be randomly allocated into acupuncture group and sham acupuncture group in a 1:1 ratio. All patients will receive oral etoricoxib followed by 30-minute acupuncture or sham acupuncture for 1 session. The primary outcome is the change in pain intensity (Visual Analogue Scale) after the 30-minute acupuncture treatment from baseline. The secondary outcomes include tenderness of study joint, swelling of study joint, rescue medicine, credibility and expectation evaluation and blinding assessment. Adverse events will be recorded during the trial. All the patients who are randomized in this study will be included in the intention-to-treat analysis. Conclusion The results of this study will provide evidence for acupuncture used in the treatment of acute gouty arthritis and promote clinical decisions to physicians and patients. Trial Registration The protocol has been approved by the Medical Ethical Committee of Beijing University of Chinese Medicine (2023BZYLL0103) and registered at International Traditional Medicine Clinical Trial Registry (ITMCTR2024000218; http://itmctr.ccebtcm.org.cn/zh-CN/UserPlatform/ProjectView?pid=1749b951-b101-418f-8f82-77be3c72ea00).
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Affiliation(s)
- Yi-Ran Wang
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People’s Republic of China
| | - Cun-Zhi Liu
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People’s Republic of China
| | - Yan Cong
- Department of Rheumatology and Immunology, Lianyungang Affiliated Hospital of Nanjing University of Chinese Medicine, Lianyungang, People’s Republic of China
| | - Ya-Wei Xi
- Acupuncture-Moxibustion Department, Liangxiang Hospital of Beijing Fangshan District, Beijing, People’s Republic of China
| | - Ying-Ying Xu
- Endocrine Department, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, People’s Republic of China
| | - Bo Li
- Department of Traditional Chinese Medicine, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, People’s Republic of China
| | - Yi Zhou
- Endocrine Department, Xiamen Hospital of Traditional Chinese Medicine, Xiamen, People’s Republic of China
| | - Jian-Feng Tu
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People’s Republic of China
| | - Yi-Ming Fu
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People’s Republic of China
| | - Wen Chen
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People’s Republic of China
| | - Li-Qiong Wang
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People’s Republic of China
| | - Guang-Xia Shi
- International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People’s Republic of China
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Zilcha-Mano S, Bouknik Y, Malka M, Krasovsky T. An individual-specific understanding of how synchrony becomes curative: study protocol. BMC Psychiatry 2025; 25:587. [PMID: 40481468 PMCID: PMC12142965 DOI: 10.1186/s12888-025-06539-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/12/2024] [Accepted: 01/26/2025] [Indexed: 06/11/2025] Open
Abstract
BACKGROUND Interpersonal interactions are a fundamental part of daily life, shaping mental health in profound ways. Yet, the mechanisms by which these interactions influence mental health remain poorly understood. AIMS This research is the first to systematically and prospectively test the conceptual framework proposed by Zilcha-Mano (2024), which introduces the concept of an individual-specific synchrony signature-a trait-like characteristic that distinguishes individuals based on their unique patterns of synchronizing across interpersonal relationships and contexts. It builds on the framework's challenge to the prevailing assumption that higher levels of synchrony are universally beneficial, instead positing that synchrony becomes curative when tailored corrections are made to an individual's signature. Specifically, for synchrony to serve as a mechanism of therapeutic change, the direction and magnitude of the required synchrony adjustments must be tailored to align with the unique characteristics of the individual's synchrony signature. METHODS This research uses psychotherapy as a case demonstration of curative relationships, offering a contained environment that combines the authenticity of real interpersonal dynamics with the sterile precision of laboratory conditions for examining synchrony dynamics. Study 1 uses the innovative Synchrony Interaction Paradigm to investigate the existence and characteristics of individual-specific synchrony signatures in a sample of 68 participants, including individuals with major depressive disorder (MDD; N = 34). Study 2 examines how tailored adjustments to these signatures facilitate therapeutic change, using a randomized controlled trial with 78 individuals diagnosed with MDD assigned to therapy targeting interpersonal mechanisms or to a waiting list. Both studies employ multimodal markers (e.g., motion, acoustic, physiological, hormones, and facial expressions) to disentangle the stable trait-like components of synchrony from state-like deviations occurring in real-time interactions with humans and virtual humans. IMPLICATIONS This research redefines synchrony as an individual-specific mechanism of change, offering insights into its multi-modal nature and advancing a personalized framework for understanding its effect on mental health. The findings bridge critical gaps in synchrony research and contribute to more targeted and effective therapeutic interventions. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT06749392 submitted on December 12 st 2024. TRIAL STATUS Recruitment has not started yet.
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Affiliation(s)
- Sigal Zilcha-Mano
- Department of Psychology, University of Haifa, Mount Carmel, Haifa, 31905, Israel.
| | - Yael Bouknik
- Department of Psychology, University of Haifa, Mount Carmel, Haifa, 31905, Israel
| | - Michal Malka
- Department of Psychology, University of Haifa, Mount Carmel, Haifa, 31905, Israel
| | - Tal Krasovsky
- Department of Psychology, University of Haifa, Mount Carmel, Haifa, 31905, Israel
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Kunas B, Jung O, Schranz C, Schmoigl-Tonis M, Ploessnig M, Laireiter AR. Personalizing mHealth Interventions for Occupational Stress: Protocol for a Randomized Pilot Study. JMIR Res Protoc 2025; 14:e68012. [PMID: 40460419 DOI: 10.2196/68012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2024] [Revised: 03/25/2025] [Accepted: 03/26/2025] [Indexed: 06/11/2025] Open
Abstract
BACKGROUND Occupational stress is associated with detrimental consequences that are addressed by mobile health (mHealth) solutions. Previous developments of apps for occupational stress have not yet fully exploited the potential of multilevel diagnostics through the integration of wearable sensors for interventions. Personalizing mHealth approaches in terms of intervention time and content, which requires the use of artificial intelligence, is the next logical developmental step. The "Relax" approach developed a corresponding prototype of an app-wearable system, which will be evaluated for effectiveness in terms of stress reduction and usability. OBJECTIVE This study protocol describes an evaluation study used to test the effectiveness and usability of the Relax approach. METHODS The evaluation study was designed as a 2-arm randomized trial with 2 phases, each with a 3-week intervention period. In both phases, employees were required to use the app to record daily stress and to wear a wearable sensor to measure heart rate variability. The app offered interventions based on algorithms, which altered the probability of their selection after learning from the data, thereby personalizing the user experience. In the second phase of the study, the sample was divided into 2 groups, varying the degree of personalization of the app. To analyze effectiveness, a 2-factorial mixed within-between design will be applied to compare the outcomes between both groups as well as in a pre-post comparison. In addition, exploratory analyses of the usability of the approach are planned. RESULTS The study was conducted during the spring and summer of 2024, with a total of 46 participants enrolled, and is ready for data analysis. CONCLUSIONS The Relax approach, including a number of factors related to personalization that have not yet been incorporated into mHealth in current research, will provide new insights into the next steps of advanced mHealth solutions. Limitations of the study design, such as the lack of a control group and the sample representativity, have to be addressed. TRIAL REGISTRATION Open Science Foundation 10.17605/OSF.IO/MYRD9; https://osf.io/myrd9. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/68012.
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Affiliation(s)
- Beatrix Kunas
- Department of Psychology, Paris-Lodron University Salzburg, Salzburg, Austria
| | - Oliver Jung
- Salzburg Research Forschungsgesellschaft mbH, Salzburg, Austria
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8
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Sposato LA, Ayan D, Ahmed M, Fridman S, Mandzia JL, Elrayes M, Lodol F, Khaw AV, Mai LM, Bogiatzi C, Casserly C, Fraser JA, Chan R, Florendo Cumbermack A, Markovic N, Yu Y, Debicki D, Fleming L, Beauchamp B, Lambourn L, Mayich M, Milroy L, Sharma M, Pandey S, Bagur R. Extended CT angiography versus standard CT angiography for the detection of cardioaortic thrombus in patients with ischaemic stroke and transient ischaemic attack (DAYLIGHT): a prospective, randomised, open-label, blinded end-point trial. Lancet Neurol 2025; 24:489-499. [PMID: 40409313 DOI: 10.1016/s1474-4422(25)00111-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/16/2025] [Revised: 03/17/2025] [Accepted: 03/21/2025] [Indexed: 05/25/2025]
Abstract
BACKGROUND Cardioembolic sources often remain undetected after standard diagnostic stroke workup, contributing to high rates of recurrence. We aimed to assess whether a head-to-neck CT angiography extended at least 6 cm below the carina (extended CT angiography) can increase the detection of cardioaortic thrombi compared with standard-of-care CT angiography (standard CT angiography) in patients with ischaemic stroke or transient ischaemic attack. METHODS This single-centre, prospective, randomised, open-label, blinded end-point trial was done at London Health Sciences Centre, Western University, Canada. Eligible patients were adults aged 18 years or older with ischaemic stroke or transient ischaemic attack assessed during acute code strokes. Exclusion criteria were known allergy or concerns about the safety of iodinated contrast agents (eg, severe renal failure) and no intravenous access. Participants were randomly assigned in a 1:1 ratio to receive standard CT angiography or extended CT angiography. Patients, neurologists adjudicating qualifying events, cardiothoracic radiologists, and cardiologists adjudicating study outcomes were masked to randomisation. Adjudicators were considered masked to randomisation as they did not know which patients were crossovers, which patients in the standard of care arm had partial imaging of the left atrial appendage due to normal variations in size and shape, and which patients in the extended CT angiography group also had partial imaging of the left atrial appendage instead of full imaging. The primary efficacy outcome was the detection of a cardioaortic thrombus (modified intention-to-treat population). The primary safety outcome was time to CT angiography completion (as-treated population). The trial was registered at ClinicalTrials.gov, NCT05522244, and is closed. FINDINGS Between July 17, 2023, and May 6, 2024, 963 patients were assessed for inclusion. 133 were excluded because they already had a CT angiography at their local hospital, intracranial haemorrhage was identified on the initial non-contrast CT, a diagnosis of stroke was considered highly unlikely by the treating stroke neurologist, or randomisation was not possible. 830 patients were enrolled and randomly assigned to extended CT angiography (n=415) or standard CT angiography (n=415). One patient withdrew consent and was excluded from the analyses. 364 participants who were later adjudicated as having experienced stroke mimics were excluded. 465 patients with ischaemic stroke or transient ischaemic attack were included in the modified intention-to-treat population (226 in the extended CT angiography group and 239 in the standard CT angiography group). 239 (51%) of 465 patients were female and 226 (49%) were male. Median age of the analysis group at enrolment was 78·0 years (IQR 69·0-84·0). The primary outcome (cardioaortic thrombus) was detected in 20 (8·8%) of 226 patients in the extended CT angiography group and four (1·7%) of 239 in the standard CT angiography group (odds ratio 5·70, 95% CI 1·92-16·96; p=0·002). There were no statistically significant differences in the median time from code stroke activation to CT angiography completion between the extended CT angiography group (21·0 min; IQR 15·8-27·0 min) and the standard CT angiography group (20·0 min, 17·0-26·0 min). The median difference between extended CT angiography and standard CT angiography groups was 1·0 min (-1·0 to 2·5), p=0·67). INTERPRETATION Performing extended CT angiography during acute code strokes is feasible and results in increased cardioaortic thrombi detection without causing delays in CT angiography completion. Future studies should assess whether extended CT angiography can reduce recurrent stroke risk by prompting early anticoagulation after thrombus detection. FUNDING Western University, and the Kathleen and Dr Henry Barnett Chair in Stroke Research.
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Affiliation(s)
- Luciano A Sposato
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada; Brain & Heart Lab, Schulich School of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology & Biostatistics, Schulich School of Medicine, Western University, London, Ontario, Canada; Department of Anatomy & Cell Biology, Schulich School of Medicine, Western University, London, Ontario, Canada; Robarts Research Institute, Schulich School of Medicine, Western University, London, Ontario, Canada; Stroke Research Unit, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada.
| | - Diana Ayan
- Brain & Heart Lab, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Mobeen Ahmed
- Department of Medical Imaging, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Sebastian Fridman
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology & Biostatistics, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Jennifer L Mandzia
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Maged Elrayes
- Division of Cardiology, Department of Medicine, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Facundo Lodol
- Brain & Heart Lab, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Alexander V Khaw
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada; Stroke Research Unit, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Lauren M Mai
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada; Stroke Research Unit, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Chrysi Bogiatzi
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada; Stroke Research Unit, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Courtney Casserly
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - J Alexander Fraser
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada; Department of Ophthalmology, St Joseph's Health Care, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Richard Chan
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Anita Florendo Cumbermack
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Nevena Markovic
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Yeyao Yu
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Derek Debicki
- Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Lorraine Fleming
- Brain & Heart Lab, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Beth Beauchamp
- Stroke Research Unit, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Lindsay Lambourn
- Stroke Research Unit, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Michael Mayich
- Department of Medical Imaging, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Lindsay Milroy
- Department of Medical Imaging, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Manas Sharma
- Department of Medical Imaging, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Sachin Pandey
- Department of Medical Imaging, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
| | - Rodrigo Bagur
- Brain & Heart Lab, Schulich School of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology & Biostatistics, Schulich School of Medicine, Western University, London, Ontario, Canada; Division of Cardiology, Department of Medicine, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada
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9
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Kearney N, Connolly D, Bahramian K, Sheill G, Coghlan-Lynch K, O'Sullivan J, Coleman N, O'Hanlon Brown C, Gallagher D, O'Gorman C, O'Brien C, Tierney A, Rankin K, O'Neill L, Guinan E. A Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE): Protocol for a randomised controlled feasibility trial. Contemp Clin Trials 2025; 153:107923. [PMID: 40268238 DOI: 10.1016/j.cct.2025.107923] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/11/2024] [Revised: 04/04/2025] [Accepted: 04/19/2025] [Indexed: 04/25/2025]
Abstract
BACKGROUND Exercise is an important tool which has been shown to help patients manage many of the side effects of their cancer treatment, reduce toxicities, and improve prognosis. The benefits of exercise have been well documented, however, performing regular exercise during treatment remains a challenge for most patients. The Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE) is an exercise programme that has been co-designed by healthcare professionals and people with a personal lived experience of chemotherapy. The primary aim of this study is to examine the feasibility of delivering the FIERCE programme for cancer patients during chemotherapy. METHODS The FIERCE study is a randomised controlled feasibility trial which will include 50 participants who are scheduled to receive chemotherapy for the treatment of breast, colorectal, or ovarian cancer. Participants will be randomly allocated to Group 1: FIERCE programme, or Group 2: Self-managed pedometer programme in a 2:1 ratio. Participants will be enrolled in the study for the duration of their chemotherapy treatment. The primary outcome of feasibility will be measured using a mixed-methods approach. Secondary outcomes of cardiorespiratory fitness, muscular strength, skeletal muscle mass, physical function, fatigue, and quality of life will be measured at baseline (T0) and post-intervention (T1). DISCUSSION The FIERCE feasibility study aims to explore if a flexible, individualised exercise programme will support individuals to be active during chemotherapy treatment. If proven to be feasible, a large-scale randomised controlled trial will be undertaken focusing on the efficacy of the FIERCE programme on different health outcomes. TRIAL REGISTRATION The study is registered with ClinicalTrials.gov, registration number: NCT06280885.
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Affiliation(s)
- Neil Kearney
- Department of Surgery, School of Medicine, Trinity College Dublin, Dublin, Ireland; Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland.
| | - Deirdre Connolly
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; Discipline of Occupational Therapy, School of Medicine, Trinity College Dublin, Dublin, Ireland
| | | | - Grainne Sheill
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; Discipline of Physiotherapy, School of Medicine, Trinity College Dublin, Dublin, Ireland
| | | | - Jacintha O'Sullivan
- Department of Surgery, School of Medicine, Trinity College Dublin, Dublin, Ireland; Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland
| | - Niamh Coleman
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; The Haematology, Oncology and Palliative Care (HOPe) directorate, St James's Hospital, Dublin, Ireland
| | - Ciara O'Hanlon Brown
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; The Haematology, Oncology and Palliative Care (HOPe) directorate, St James's Hospital, Dublin, Ireland
| | - David Gallagher
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; The Haematology, Oncology and Palliative Care (HOPe) directorate, St James's Hospital, Dublin, Ireland
| | - Catherine O'Gorman
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; The Haematology, Oncology and Palliative Care (HOPe) directorate, St James's Hospital, Dublin, Ireland
| | - Catherine O'Brien
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; The Haematology, Oncology and Palliative Care (HOPe) directorate, St James's Hospital, Dublin, Ireland
| | - Antonia Tierney
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; The Haematology, Oncology and Palliative Care (HOPe) directorate, St James's Hospital, Dublin, Ireland
| | - Kate Rankin
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; The Haematology, Oncology and Palliative Care (HOPe) directorate, St James's Hospital, Dublin, Ireland
| | - Linda O'Neill
- Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland
| | - Emer Guinan
- Trinity St James's Cancer Institute, St James's Hospital, Dublin, Ireland; Discipline of Physiotherapy, School of Medicine, Trinity College Dublin, Dublin, Ireland; Wellcome - HRB Clinical Research Facility at St. James's Hospital, Dublin, Ireland
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10
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Hammersley ML, Dekker GA, Gurrin LC, Hoon EA, Schurer S, Lynch JW, Aldred M, Dalton J, Fletcher CJ, Smithers LG. The use of financial incentives for smoking cessation in pregnant women: A parallel-group randomised controlled trial protocol. Addiction 2025; 120:1260-1270. [PMID: 39916446 PMCID: PMC12046475 DOI: 10.1111/add.70004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/24/2024] [Accepted: 01/08/2025] [Indexed: 05/03/2025]
Abstract
BACKGROUND AND AIMS Smoking cessation during pregnancy results in short- and long-term health benefits for the mother and infant. Despite public health policies and initiatives to reduce smoking, smoking in pregnancy remains unacceptably high in Australia, particularly among populations of high disadvantage. Internationally, the use of financial incentives has shown some promise in assisting pregnant women to quit smoking, but more research is needed in different contexts. This study aims to determine the efficacy, cost-effectiveness and acceptability of the use of financial incentives in Australia. DESIGN 2-arm parallel-group randomised controlled trial. SETTING Australian antenatal care setting. PARTICIPANTS Pregnant women who smoke. INTERVENTION Women randomised to the intervention group will receive financial incentives of increasing value at three time points throughout their pregnancy (4 and 12 weeks from the first antenatal visit and 37 weeks gestation) upon confirmation of smoking abstinence. MEASUREMENTS The primary comparison outcome is a composite binary measure of abstinence at three time points during pregnancy (4, 12 and 37 weeks). Smoking abstinence will be determined by a carbon monoxide breath analysis reading of ≤3 ppm. The primary statistical analysis is estimation of the absolute difference in the prevalence of abstinence at all three time points based on the intention-to-treat groups. A cost-effectiveness analysis will be undertaken to quantify the social returns of the intervention. A qualitative process evaluation will also be conducted to determine fidelity, contextual factors and the acceptability of the intervention to pregnant women and healthcare workers. COMMENTS This study will be the first Australian trial of financial incentives in reducing smoking in pregnancy. The findings will provide evidence on the acceptability, effectiveness and cost-effectiveness of financial incentives to reduce smoking in pregnancy in Australia.
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Affiliation(s)
- Megan L. Hammersley
- School of Social Sciences, Faculty of the Arts, Social Sciences and HumanitiesUniversity of WollongongWollongongNew South WalesAustralia
| | - Gustaaf A. Dekker
- Northern Adelaide Local Health NetworkAdelaideSouth AustraliaAustralia
- Adelaide Medical SchoolUniversity of AdelaideAdelaideSouth AustraliaAustralia
| | - Lyle C. Gurrin
- Melbourne School of Population and Global HealthUniversity of MelbourneCarlton, MelbourneVictoriaAustralia
| | - Elizabeth A. Hoon
- Adelaide Medical SchoolUniversity of AdelaideAdelaideSouth AustraliaAustralia
- School of Public HealthUniversity of AdelaideAdelaideSouth AustraliaAustralia
| | - Stefanie Schurer
- School of EconomicsUniversity of SydneyCamperdown, SydneyNew South WalesAustralia
- IZABonnGermany
| | - John W. Lynch
- School of Public HealthUniversity of AdelaideAdelaideSouth AustraliaAustralia
| | - Marnie Aldred
- Northern Adelaide Local Health NetworkAdelaideSouth AustraliaAustralia
| | - Julia Dalton
- Northern Adelaide Local Health NetworkAdelaideSouth AustraliaAustralia
| | - Cherise J. Fletcher
- School of Public HealthUniversity of AdelaideAdelaideSouth AustraliaAustralia
| | - Lisa G. Smithers
- School of Social Sciences, Faculty of the Arts, Social Sciences and HumanitiesUniversity of WollongongWollongongNew South WalesAustralia
- School of Public HealthUniversity of AdelaideAdelaideSouth AustraliaAustralia
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11
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Sadigh G, Duan F, Gareen IF, Hancock J, Sicks JD, Hawley S, Shankaran V, Torres M, Wagner LI, Carlos RC. Effectiveness of out-of-pocket cost COMmunication and financial navigation (CostCOM) in cancer patients: Study protocol for ECOG-ACRIN EAQ222CD. Contemp Clin Trials 2025; 153:107889. [PMID: 40147544 DOI: 10.1016/j.cct.2025.107889] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2024] [Revised: 02/14/2025] [Accepted: 03/23/2025] [Indexed: 03/29/2025]
Abstract
BACKGROUND High out-of-pocket costs (OOPC) of cancer treatment and lost income result in financial hardship. There is compelling evidence that OOPC communication complemented by financial navigation and counseling will decrease financial hardship by enabling cancer patients to anticipate and accommodate treatment costs and proactively seek financial assistance. METHODS This is a two-arm randomized controlled trial enrolling 720 patients with newly diagnosed solid tumors (stratified by non-metastatic vs. metastatic) who plan to receive anticancer systemic therapy at one of the participating NCI Community Oncology Research Practices (NCORP). Participants are randomized to receive four up to 1-h remote counseling sessions which include systemic therapy OOP cost communication, financial navigation and counseling (CostCOM intervention) vs. enhanced usual care with provision of an informational brochure for Patient Advocate Foundation (PAF), a national non-profit financial navigation organization (EUC). Patients will complete surveys at baseline, 3, 6, and 12 months after enrollment. Our goals are to compare the effectiveness of CostCOM vs. EUC at 12 months on (1) patient-reported cost-related cancer care nonadherence, defined as any self-reported incident of delay, forgo, stop or change in cancer care due to cost concerns and (2) patient-reported material financial hardship, financial worry, and quality of life; and to (3) conduct a process evaluation to examine practice providers' and CostCOM arm patients' satisfaction with the intervention and their perceptions of barriers and facilitators to CostCOM. A successful CostCOM is a scalable and financially sustainable program that can improve cancer care delivery, patients' experience, and health outcomes. TRIAL REGISTRATION NCT06295367.
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Affiliation(s)
- Gelareh Sadigh
- Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA, USA.
| | - Fenghai Duan
- Brown University - ECOG-ACRIN Biostatistics Center, Providence, RI, USA
| | - Ilana F Gareen
- Brown University - ECOG-ACRIN Biostatistics Center, Providence, RI, USA
| | - Judy Hancock
- Cancer Research for the Ozarks NCORP, Springfield, MO, USA
| | - JoRean D Sicks
- Brown University - ECOG-ACRIN Biostatistics Center, Providence, RI, USA
| | - Sarah Hawley
- University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA
| | | | - Mylin Torres
- Winship Cancer Institute, Emory University, Atlanta, GA, USA
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Harada T, Shirasaka T, Baba T, Mizusawa A, Villaroman A, Noguera-Caoile R, Mercado MA, Peralta J, Hatto K, Kanamori S. Residential cognitive-behavioral therapy versus therapeutic community for patients with methamphetamine use disorders in the Philippines: A randomized controlled trial. Addict Behav Rep 2025; 21:100605. [PMID: 40290633 PMCID: PMC12032182 DOI: 10.1016/j.abrep.2025.100605] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/01/2024] [Revised: 03/17/2025] [Accepted: 04/10/2025] [Indexed: 04/30/2025] Open
Abstract
Introduction In the Philippines, an estimated 1.8 million people use methamphetamine. Despite the government's anti-drug campaign, repressive methods have been ineffective. Thus, treatment and human services are needed. We developed a cognitive-behavioral therapy (CBT) program for residential and rehabilitation center-based treatment and examined its effectiveness. Methods In this block-randomized single-blinded trial, control group participants received therapeutic community-type treatment only, while the intervention group additionally participated in our CBT program for 6 months. Primary outcomes were methamphetamine re-use, measured by urine tests and self-report at 3-months post-discharge, and self-reported well-being at pre-discharge and 3-months post-discharge. Findings Participants (n = 326) were randomized into intervention (n = 162) and control (n = 164) groups. At follow-up, 3/27 (11.11 %) and 1/27 (3.70 %) participants in the respective groups had positive urine tests for drug re-use (χ2(1) = 1.08, n.s., r = 0.037, 95 %CI [-0.064, 0.212]). The self-reported drug re-use rate was significantly higher in the intervention group (χ2(1) = 9.18, p < 0.01, r = 0.14 (95 %CI [0.050, 0.231]). However, pre-discharge self-rated health (F(1, 311) = 6.32, p < 0.025, η2 = 0.02, 95 %CI [0.001, 0.06]) and problem-focused coping (F(1, 311) = 6.50, p < 0.025, η2 = 0.021, 95 %CI [0.001, 0.06]) were significantly better among intervention group participants than among control participants. Conclusions Although without significant effect on drug re-use, the intervention had a small positive effect on patients' well-being, coping skills, and other psychological variables. Additional research is required to develop effective treatments for methamphetamine use in this region.
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Affiliation(s)
- Takayuki Harada
- College of Psychology, School of Human Sciences, University of Tsukuba, Tsukuba, Japan
| | - Tomohiro Shirasaka
- Department of Psychiatry, Teine Keijinkai Medical Center, Sapporo, Japan
| | - Toshiaki Baba
- National Center for Global Health and Medicine, Tokyo, Japan
| | - Aya Mizusawa
- Project for Introducing Evidence-based Relapse Prevention Programs to Drug Dependence Treatment and Rehabilitation Centers, Manila, Philippines
| | - Alfonso Villaroman
- Drug Abuse Treatment and Rehabilitation Center Bicutan, Taguig, Philippines
| | | | | | - Jasmin Peralta
- Drug Abuse Treatment and Rehabilitation Center, Cebu City, Mandaue, Philippines
| | - Keigo Hatto
- College of Psychology, School of Human Sciences, University of Tsukuba, Tsukuba, Japan
| | - Shogo Kanamori
- Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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13
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Pirie K, Traer E, Winter N, Brown W, Riedel B, Myles PS. Analgesia using intrathecal morphine to improve quality of recovery after minimally invasive major abdominal surgery (AIM Trial): study protocol for a multicentre randomised controlled trial. BJA OPEN 2025; 14:100386. [PMID: 40201333 PMCID: PMC11978349 DOI: 10.1016/j.bjao.2025.100386] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/06/2024] [Accepted: 02/07/2025] [Indexed: 04/10/2025]
Abstract
Background Evidence to support the effectiveness of intrathecal morphine in patients undergoing minimally invasive abdominal surgery is largely based on small, single-centre studies. We therefore designed a large, multi-centre clinical trial to investigate the effect of intrathecal morphine with local anaesthetic on patient postoperative quality of recovery. The primary objective is to compare quality of recovery on postoperative Day 1. The secondary objectives are to compare opioid consumption, pain scores, and opioid-related adverse events. Methods This multi-centre, prospective, randomised controlled trial will recruit 280 adult patients undergoing minimally invasive major abdominal surgery. The intervention group will receive 200 mcg of intrathecal morphine with local anaesthetic, as part of a multimodal analgesic strategy. Following safety analysis after the first 100 patients the dose of ITM will increase to 300 mcg. The control group will receive non-neuraxial multimodal analgesia. Conclusions This trial is expected to provide evidence on the effectiveness and the safety of two different ITM doses with local anaesthetic in major minimally invasive abdominal surgery. Clinical trial registration ACTRN12623001347651 (ANZCTR Registry Number). Protocol version number and date 1.0, May 2, 2024.
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Affiliation(s)
- Katrina Pirie
- Department of Anaesthesiology and Perioperative Medicine, The Alfred Hospital, Melbourne, VIC, Australia
- Department of Anaesthesiology and Perioperative Medicine, School of Translational Medicine, Monash University, Melbourne, VIC, Australia
| | - Emily Traer
- Department of Anaesthesia, Perioperative Medicine, and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
| | - Noam Winter
- Department of Anaesthesiology and Perioperative Medicine, The Alfred Hospital, Melbourne, VIC, Australia
- Department of Anaesthesiology and Perioperative Medicine, School of Translational Medicine, Monash University, Melbourne, VIC, Australia
| | - Wendy Brown
- Department of Anaesthesiology and Perioperative Medicine, The Alfred Hospital, Melbourne, VIC, Australia
- Department of Anaesthesiology and Perioperative Medicine, School of Translational Medicine, Monash University, Melbourne, VIC, Australia
| | - Bernhard Riedel
- Department of Anaesthesia, Perioperative Medicine, and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
- Department of Critical Care Medicine, and The Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia
| | - Paul S. Myles
- Department of Anaesthesiology and Perioperative Medicine, The Alfred Hospital, Melbourne, VIC, Australia
- Department of Anaesthesiology and Perioperative Medicine, School of Translational Medicine, Monash University, Melbourne, VIC, Australia
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Spampinato S, Tanderup K, Barcellini A, Burchardt E, Eminowicz G, Šegedin B, Stankiewicz M, Valgma M, Kirchheiner K. Impact of the Common Terminology Criteria for Adverse Events (CTCAE) evolution on toxicity scoring in gynaecological radiotherapy. Radiother Oncol 2025; 207:110881. [PMID: 40220903 DOI: 10.1016/j.radonc.2025.110881] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2024] [Revised: 03/31/2025] [Accepted: 04/01/2025] [Indexed: 04/14/2025]
Abstract
PURPOSE The Common Terminology Criteria for Adverse Events (CTCAE) is the established toxicity scoring system that assigns severity grades (G1 = mild to G5 = death) to Adverse Events (AEs). Compared to CTCAE v3.0 (2006), updated versions introduced changes in severity grade definitions. This study evaluated changes between v3.0 and v5.0 (2017) for AEs in gynaecological radiotherapy. MATERIAL AND METHODS After selecting AEs relevant for gynaecological radiotherapy in v3.0, changes in severity grades were identified using CTCAE v3.0-to-v5.0 mapping tables. Six radiation oncologists (ROs) evaluated severity grade definitions for changes in: clinical interpretation, subjective (patient-reported symptoms) and objective (details on medication/intervention) information, and expected severe (≥G3) events. Agreement was based on at least five (≥5)ROs. RESULTS Gastrointestinal, urinary, reproductive, general and injury/musculoskeletal AEs were selected (n = 118). G4 definitions in v5.0 were removed in 22 % of AEs. ≥5ROs agreed on changes affecting clinical interpretation especially for G2 (31 %) and G3 (30 %). For subjective information, 18 % of G2 and 15 % of G3 were judged relying more on patient-reported symptoms. Less objective information was found in 51 % of G3 definitions. Variability in agreement was observed especially for subjective information in G3 and expected ≥G3 events. CONCLUSION This analysis revealed that severity grade definitions in v3.0 and v5.0 for AEs in gynaecological radiotherapy present changes with potential impact on scoring in clinical studies. Notably, 22 % of AEs in v5.0 no longer have G4 defined, and G3 definitions often include fewer details on medication/intervention. Variability in ROs' interpretations is frequently observed, highlighting the need for education to standardise toxicity scoring.
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Affiliation(s)
- Sofia Spampinato
- Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.
| | - Kari Tanderup
- Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Amelia Barcellini
- Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; Radiation Oncology Unit, Clinical Department, National Center for Oncological Hadrontherapy (CNAO), Pavia, Italy
| | - Ewa Burchardt
- Department of Radiotherapy, Greater Poland Cancer Center in Poznan, Poland; University of Medical Sciences, Poznan, Poland
| | - Gemma Eminowicz
- Department of Oncology, University College London Hospital, London, United Kingdom
| | - Barbara Šegedin
- Department of Radiotherapy, Institute of Oncology, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Magdalena Stankiewicz
- Brachytherapy Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
| | - Margit Valgma
- Radiotherapy Centre, North Estonia Medical Centre Foundation, Tallinn, Estonia
| | - Kathrin Kirchheiner
- Department of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
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15
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Agostinho PAG, Bedoya ÉAP, Cota AR, Chaves SFN, Oliveira CEP, Carneiro-Júnior MA, Moreira OC. Flywheel resistance training: Functionality and strength in older women - A randomized controlled trial. J Bodyw Mov Ther 2025; 42:573-582. [PMID: 40325725 DOI: 10.1016/j.jbmt.2025.01.023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2024] [Revised: 12/23/2024] [Accepted: 01/17/2025] [Indexed: 05/07/2025]
Abstract
BACKGROUND Resistance training enhances functionality and strength in older populations, but the comparative effectiveness of traditional versus inertial flywheel modalities is under-researched. This study evaluates the effect of these modalities on functionality and strength in older women. METHODS In a parallel two-group randomized controlled trial, 36 sedentary older women (≥60 years) without psychiatric disorders or uncontrolled chronic diseases were randomly assigned to either the inertial flywheel group (n = 18) using a multi-leg isoinertial device, or the traditional resistance training group (n = 18) using gym machines and free weights. Conducted from May to December 2023 at the Federal University of Viçosa, both groups performed six generic exercises over eight weeks (two sessions per week). Functionality and muscle strength were assessed using the Short Physical Performance Battery and Timed Up and Go tests. Blinding was maintained using opaque envelopes managed by an external researcher. RESULTS One participant from the traditional group withdrew, requiring data imputation. Both groups showed significant improvements in functionality (Short Physical Performance Battery scores, p = 0.008; Timed Up and Go times, p = 0.025) and strength (isometric, dynamic, and explosive). No significant differences between groups were observed (p > 0.05), with small to moderate effect sizes (ηp2 = 0.01 to 0.06) and low statistical power (1-β < 0.80). Adverse events were minor (grade 1). CONCLUSIONS Both traditional and inertial flywheel resistance training significantly improved functionality and strength in older women over 16 sessions. Either training approach can enhance physical performance in this population.
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Affiliation(s)
- Pablo A G Agostinho
- Department of Physical Education, Federal University of Viçosa, Viçosa, Minas Gerais, Brazil.
| | - Édison A P Bedoya
- Department of Physical Education, Federal University of Viçosa, Viçosa, Minas Gerais, Brazil
| | - Amanda R Cota
- Department of Physical Education, Federal University of Viçosa, Viçosa, Minas Gerais, Brazil
| | - Suene F N Chaves
- Department of Physical Education, Federal University of Viçosa, Viçosa, Minas Gerais, Brazil
| | - Claudia E P Oliveira
- Department of Physical Education, Federal University of Viçosa, Viçosa, Minas Gerais, Brazil
| | | | - Osvaldo C Moreira
- Institute of Biological and Health Sciences, Federal University of Viçosa, Florestal Campus, Florestal, Minas Gerais, Brazil
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16
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Tang VFY, Jiang D, Kahlon M, Chow EOW, Yeung DYL, Aubrey R, Chou KL. A three-arm randomized controlled trial protocol: Effects of telephone-based, layperson-delivered wisdom-enhancement narrative therapy and empathy-focused interventions on loneliness, social, and mental health in older adults. Contemp Clin Trials Commun 2025; 45:101479. [PMID: 40235625 PMCID: PMC11999345 DOI: 10.1016/j.conctc.2025.101479] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2024] [Revised: 03/03/2025] [Accepted: 03/28/2025] [Indexed: 04/17/2025] Open
Abstract
Background Loneliness is an increasingly widespread issue among older adults globally, with significant implications on physical, social, and mental health. While various interventions exist to address this challenge, their long-term effects remain unclear. Using a 3-arm randomized controlled trial, this study aims to evaluate the efficacy of a telephone-based and layperson-delivered wisdom-enhancement narrative therapy (Tele-NT) and empathy-focused program (Tele-EP) against an active control group (ACG) in reducing loneliness. Methods 282 community-dwelling lonely older adults will be recruited and randomly allocated into 1 of the 3 interventions. Older adults will receive two 30-min intervention per week, over the course of 4 weeks, delivered over the phone by a layperson. Assessments will be conducted in-person at baseline (T0), 1-month (T1), 6-month (T2), and 12-month (T3) post-intervention. The primary outcome will be assessed using the Chinese validated 6-item De Jong Gierveld Loneliness Scale and the Revised UCLA Loneliness Scale. The secondary outcomes will include sleep quality, perceived social support, and depressive symptoms. Potential mediators and moderators will also be explored. The data will be analysed using linear mixed models on an intention-to-treat basis. Discussion This RCT is effective, Tele-NT and/or Tele-EP could serve as a model for broader implementation in the community, offering practical solutions to mitigate loneliness and its associated health burdens in the aging populations. Trial registration This trial is registered with the Chinese Clinical Trial Registry; ChiCTR2300070179 on April 4, 2024.
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Affiliation(s)
| | - Da Jiang
- The Education University of Hong Kong, Hong Kong
| | | | | | | | | | - Kee-Lee Chou
- The Education University of Hong Kong, Hong Kong
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17
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Wayne PM, Vining R, Long CR, Burton WM, Litrownik D, Guzman J, Kilgore K, Hagan TJ, Rist PM, Kowalski MH. Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial. Contemp Clin Trials Commun 2025; 45:101482. [PMID: 40321971 PMCID: PMC12049832 DOI: 10.1016/j.conctc.2025.101482] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2024] [Revised: 02/13/2025] [Accepted: 04/04/2025] [Indexed: 05/08/2025] Open
Abstract
Background Neck pain presents a personal and socioeconomic burden globally. Despite increasing prevalence, research on chronic neck pain (CNP) is limited and management relies on generalized approaches. There is growing interest in non-pharmacological interventions, however their efficacy remains uncertain due to the multifactorial etiology of CNP. Two interventions, multimodal chiropractic care (MCC) and Tai Chi, have shown promise individually in managing CNP, and when combined may offer synergistic benefits. This pilot study aims to assess the feasibility of combining these interventions for CNP.Methods/design: Forty-eight adults, aged 18-65y, with CNP defined as occurring ≥5 days a week for ≥3 consecutive months, severity of ≥3 on the numeric rating scale, and a score of ≥5 on the Neck Disability Index will be recruited. Participants will be randomized 1:1:1 to one of the three treatment groups (MCC plus Tai Chi and Enhanced Usual Care (EUC), MCC plus EUC, or EUC alone). The MCC was validated using a modified Delphi approach. Primary outcomes relate to feasibility (recruitment, retention, and adherence) and secondary outcomes include clinical measures of neck pain severity and disability, health-related quality-of-life, psychosocial well-being, and physical function. Outcomes will be assessed at baseline, 16-weeks (post-intervention), and 24-weeks. Qualitative interviews will be conducted. Discussion Results of this study will provide preliminary evidence regarding the feasibility and clinical evaluation of pragmatically delivered MCC, alone or in combination with Tai Chi, for individuals with CNP. These data will be used to inform the design of a fully powered, factorial trial evaluating two promising non-pharmacological therapies for CNP. Trial registration This study is registered in ClinicalTrials.gov (NCT05726331).
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Affiliation(s)
- Peter M. Wayne
- Osher Center for Integrative Health, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
- Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Robert Vining
- Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA
| | - Cynthia R. Long
- Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA, USA
| | - Wren M. Burton
- Osher Center for Integrative Health, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
- Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Daniel Litrownik
- Osher Center for Integrative Health, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
- Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Jacqueline Guzman
- Osher Center for Integrative Health, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
- Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Karen Kilgore
- Osher Center for Integrative Health, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
| | | | - Pamela M. Rist
- Osher Center for Integrative Health, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
- Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Matthew H. Kowalski
- Osher Center for Integrative Health, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
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18
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Aghajani R, Dehghani E, Khonji MS, Naghdi S, Nakhostin Ansari N, Dommerholt J, Nakhostin-Ansari A. Effect of dry needling on quadriceps muscles fatigue in taekwondo players: A protocol for a triple-blinded randomized controlled trial. Contemp Clin Trials Commun 2025; 45:101476. [PMID: 40235623 PMCID: PMC11997412 DOI: 10.1016/j.conctc.2025.101476] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/02/2024] [Revised: 03/22/2025] [Accepted: 03/28/2025] [Indexed: 04/17/2025] Open
Abstract
Background A common issue among athletes is muscle fatigue, a brief and transient reduction in the potential of skeletal muscle strength after engaging in muscular activity. A high-quality clinical investigation to evaluate the impact of dry needling (DN) on athletes' muscle fatigue is lacking. Therefore, this study aims to examine the effect of DN on quadriceps muscle fatigue in taekwondo players. Methods A triple-blind, randomized, controlled trial will be conducted to measure changes in quadriceps muscle fatigue after DN. Eighty-eight taekwondo players who meet the eligibility criteria will be selected to receive either DN or sham needling to the quadriceps muscle after exercise. Three assessments will be performed before the exercise, after exercise fatigue, and after intervention. The outcomes measured will be isometric peak torque, single-leg hop test, and vertical jump test. Conclusions The results of this study will provide preliminary evidence regarding the effectiveness of DN in improving quadriceps muscle fatigue in taekwondo players. Trial registration IRCT20210811052141N1.
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Affiliation(s)
- Reyhaneh Aghajani
- Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
| | - Elaheh Dehghani
- Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
| | - Mohammad Saeid Khonji
- Sports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
| | - Soofia Naghdi
- Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran
- Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran
| | | | - Jan Dommerholt
- Bethesda Physiocare, Bethesda, MD, USA
- Myopain Seminars, Bethesda, MD, USA
- University of Maryland, School of Medicine, Department of Physical Therapy and Rehabilitation Science, USA
| | - Amin Nakhostin-Ansari
- Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran
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19
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Losina E, Collins JE, Kumara M, Ehrlich-Jones L, Opare-Addo M, Safran-Norton C, Segal NA, Mitchell LM, Kopp PT, Selzer F, Mass H, Paskewicz M, Chang RW, Dunlop D, Chen AF, Lerner S, Chin S, Pellegrini C, Katz JN. KArAT (Knee Arthroplasty Activity Trial): Rationale and design features of a multicenter randomized controlled trial. OSTEOARTHRITIS AND CARTILAGE OPEN 2025; 7:100512. [PMID: 40276263 PMCID: PMC12019487 DOI: 10.1016/j.ocarto.2024.100512] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/28/2024] [Accepted: 08/12/2024] [Indexed: 04/26/2025] Open
Abstract
Background Total knee arthroplasty (TKA) is commonly performed to relieve pain in persons with severe knee osteoarthritis. Despite substantial pain reduction and functional improvements, physical activity (PA) does not necessarily increase post TKA. The premise for this randomized trial is that a behavioral intervention invoking internal and external motivators could lead to improvement in PA uptake post TKA. Methods KArAT (the Knee Arthroplasty Activity Trial) is a three-arm multi-center randomized controlled trial designed to establish the efficacy and sustainability of a personalized behavioral intervention in improving PA among TKA recipients with a primary diagnosis of knee osteoarthritis. The three arms include: 1) usual care, 2) attention control with Fitbit activity trackers, and 3) health coaching and financial incentives for reaching personalized PA goals. The primary outcome is defined as the proportion of participants engaged in at least 150 min of moderate-to-vigorous physical activity over a given week after the 6-month intervention. We also plan to conduct a cost-effectiveness analysis to establish the value and affordability of the KArAT interventions. Discussion This paper aims to outline the rationale, study design, and implementation of KArAT. Trial Registration Clinicaltrials.gov NCT04107649.
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Affiliation(s)
- Elena Losina
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
- Harvard Medical School, Boston, MA, USA
- Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA
| | - Jamie E. Collins
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
- Harvard Medical School, Boston, MA, USA
| | - Mahima Kumara
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
| | - Linda Ehrlich-Jones
- Shirley Ryan AbilityLab, Chicago, IL, USA
- Departments of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Maame Opare-Addo
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
| | - Clare Safran-Norton
- Department of Rehabilitation Services, Physical Therapy, Brigham and Women's Hospital, Boston, MA, USA
| | - Neil A. Segal
- Department of Physical Medicine and Rehabilitation, University of Kansas Medical Center, USA
| | - Lauren M. Mitchell
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
| | - Paul T. Kopp
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
| | - Faith Selzer
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
- Harvard Medical School, Boston, MA, USA
| | - Hanna Mass
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
| | - Michael Paskewicz
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
| | - Rowland W. Chang
- Departments of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Dorothy Dunlop
- Departments of Preventive Medicine, Medicine, and Physical Medicine & Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
| | - Antonia F. Chen
- Harvard Medical School, Boston, MA, USA
- Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
| | - Samuel Lerner
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
| | - Samantha Chin
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
| | - Christine Pellegrini
- Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA
| | - Jeffrey N. Katz
- Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA
- Harvard Medical School, Boston, MA, USA
- Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, USA
- Departments of Epidemiology and Environmental Health, Harvard T. H. Chan School of Public Health, Boston, MA, USA
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20
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Liang F, Young J, Koutsidis G, Lara Gallegos J. The effects of extra virgin olive oil or butter on cardiovascular biomarkers in European and Chinese males in the UK: A pilot randomised crossover trial. Nutr Health 2025; 31:485-498. [PMID: 37461824 DOI: 10.1177/02601060231187516] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/18/2025]
Abstract
Purpose: No dietary interventional studies have reported the impact of olive oil on cardiovascular risk markers in groups of different ethnic origins. We report a pilot randomised controlled trial of an intervention supplementing extra virgin olive oil (EVOO) on markers of cardiovascular risk among East Asian Chinese, and European Caucasian individuals. Methods: A cross-over, randomised controlled dietary intervention for 2 weeks was undertaken. Thirty-two adults, healthy, individuals of Chinese and European origin took part in this study. 24-h ambulatory systolic and diastolic blood pressure (SBP, DBP), and blood lipids, were assessed. Results: Positive benefits of EVOO consumption were observed in all participants. Lower 24-h ambulatory SBP (-4.3 mmHg; p = 0.020), and day-time SBP (5.528 mmHg; p = 0.008), night-time DBP (-3.784 mmHg; p = 0.008) and night-time MAP (-3.747 mmHg; p = 0.007) were seen in all participants independently of covariates. In addition, total cholesterol (7.9 mg/dL; p = 0.017) and LDL-cholesterol (6.5 mg/dL; p = 0.028) were increased with butter but not with olive oil. No significant difference in other cardiovascular risk factors were observed. However, differences were observed between Caucasians and East Asian individuals in the absence of significant differences in lifestyle. Conclusion: This pilot study suggests that consumption of EVOO should be advocated as a healthier dietary fat and recommended to replace butter as a dietary strategy to improve cardiovascular health in both Caucasians and East Asian individuals.
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Affiliation(s)
- Fan Liang
- Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK
| | - Julie Young
- Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK
| | - Georgios Koutsidis
- Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK
| | - Jose Lara Gallegos
- Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK
- NUTRAN, Northumbria University, Newcastle upon Tyne, UK
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21
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Ponting C, Baer RJ, Blackman K, Blebu B, Felder JN, Oltman S, Tabb KM, Jelliffe Pawlowski L. Transforming Health and Reducing Perinatal Anxiety Through Virtual Engagement: Protocol for a Randomized Controlled Trial. JMIR Res Protoc 2025; 14:e70627. [PMID: 40446294 PMCID: PMC12166326 DOI: 10.2196/70627] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/27/2024] [Revised: 05/02/2025] [Accepted: 05/05/2025] [Indexed: 06/18/2025] Open
Abstract
BACKGROUND Prenatal anxiety affects between 20% and 30% of pregnant people and is associated with adverse prenatal health conditions, birth outcomes, and postpartum mental health challenges. Individuals from racial and ethnic minority groups, sexual and gender minority groups, and those with low income are all at heightened risk for prenatal anxiety due to disproportionate exposure to adverse social determinants of health. Digital cognitive behavioral therapy (dCBT) has been shown to reliably reduce anxiety in mostly White and middle- to higher-income samples, but its efficacy in low-income and marginalized pregnant people is understudied. OBJECTIVE We propose a randomized controlled trial of a dCBT (Daylight app, Big Health, Ltd) in a sample of low-income pregnant people oversampled for racial, ethnic, sexual, and gender minority identity. METHODS Participants (N=132) will be randomized to the intervention or waitlist control group using a 1:1 allocation ratio. The intervention will be a self-guided application that uses an online therapist to teach and encourage the practice of 4 key cognitive behavioral therapy skills (eg, identifying catastrophic thinking and increasing physical relaxation) that can reduce anxiety. The primary outcome will be generalized anxiety symptoms; secondary outcomes will include depressive symptoms, stress, pregnancy-specific anxiety, and insomnia symptoms. Focus groups with a subset of participants will provide qualitative data about the acceptability of dCBT. RESULTS Recruitment began in June 2024. Data will be analyzed using linear mixed models, which will be fit with treatment condition (dCBT and waitlist control group) as the between-group factor, time (baseline, 3, 6, and 10 weeks post randomization) as a within-group factor, and a group-by-time interaction. Linear mixed models produce unbiased parameter estimates in situations where there are different numbers of observations per record and will accommodate intent-to-treat and sensitivity analyses. CONCLUSIONS This clinical trial will evaluate the efficacy and acceptability of a self-guided dCBT for prenatal anxiety among low-income and marginalized pregnant people, a group that continues to experience substantial barriers to accessing in-person evidence-based psychotherapy. TRIAL REGISTRATION ClinicalTrials.gov NCT06404450; https://clinicaltrials.gov/study/NCT06404450. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/70627.
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Affiliation(s)
- Carolyn Ponting
- Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, United States
| | - Rebecca J Baer
- Department of Obstetrics, Gynecology, and Reproductive Health Sciences, University of California San Francisco, San Francisco, CA, United States
- Department of Pediatrics, University of California San Diego, San Diego, CA, United States
- California Preterm Birth Initiative, University of California San Francisco, San Francisco, CA, United States
| | - Kacie Blackman
- Department of Health Sciences, College of Health and Human Development, California State University, Northridge, Northridge, CA, United States
| | - Bridgette Blebu
- Lundquist Institute for Biomedical Innovation, Harbor-UCLA Medical Center, Torrance, CA, United States
| | - Jennifer N Felder
- Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, United States
- Osher Center for Integrative Health, University of California San Francisco, San Francisco, CA, United States
| | - Scott Oltman
- California Preterm Birth Initiative, University of California San Francisco, San Francisco, CA, United States
- Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, United States
- Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, United States
| | - Karen M Tabb
- School of Social Work, University of Illinois Urbana-Champaign, Urbana, IL, United States
| | - Laura Jelliffe Pawlowski
- Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, United States
- Rory Meyers College of Nursing, New York University, New York, NY, United States
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22
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Linde DS, Le HM, Vu DTK, Dang NAT, Nguyen AT, Vu TP, Nguyen XB, Nguyen CD, Meyrowitsch DW, Søndergaard J, Vinter CA, Bygbjerg IC, Rasch V, Nguyen TD, Gammeltoft TM, Nguyen DK. A co-created self-care and informal support intervention targeting women with gestational diabetes mellitus in northern Vietnam (VALID-II): a protocol for a two-arm non-randomised feasibility study. Pilot Feasibility Stud 2025; 11:73. [PMID: 40442746 PMCID: PMC12121233 DOI: 10.1186/s40814-025-01657-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2023] [Accepted: 05/09/2025] [Indexed: 06/02/2025] Open
Abstract
BACKGROUND Gestational diabetes mellitus (GDM) is a transitory form of diabetes that presents during pregnancy with frequent adverse maternal and neonatal health consequences if left untreated. The prevalence of GDM is rapidly increasing in low- and middle-income countries such as Vietnam, and early sustainable interventions are important. The overall aim of this study-henceforth referred to as VALID-II-is to assess the feasibility of a co-created self-care and informal support intervention targeted at pregnant women with GDM. Further, the aim is to assess the potential efficacy of the intervention in reducing maternal and neonatal health complications compared with standard care. METHODS VALID-II is a two-site, two-arm, non-randomised feasibility intervention study in Thai Binh Province in northern Vietnam with a delayed start for the intervention group. The intervention study is nested in a larger cohort. In total, 2000 pregnant women will be screened for GDM, with an estimated 400 women screening positive according to the World Health Organisation-International Association of Diabetes and Pregnancy Study Group diagnostic criteria. First, 200 women who screen positive for GDM will be assigned to a control group that will receive standard care. Among the 200 women, 20 will take part in an in-depth ethnographic study along with their family members, and the intervention will be co-created with them. Second, once the intervention has been created, 200 women will be assigned to the intervention group, which will receive the intervention plus standard care. Twenty women and their families from the intervention group will also take part in an ethnographic study. The primary outcome is to evaluate how feasible the self-care intervention is (composite outcome: recruitment, retention, and acceptability). Other secondary outcomes include the number of new-borns born large for gestational age, prevalence and risk factors for GDM, self-care agency, self-care, and breastfeeding practices. DISCUSSION This study provides knowledge of the feasibility of informal/self-care and social support interventions and their preliminary impact on maternal and child health outcomes among women with GDM in northern Vietnam. Furthermore, it will inform parameters such as effect size and variance, which are essential for calculating the sample size needed to achieve the desired power in a future full-scale trial. This may guide decision makers in how to optimise the management of GDM in low- and middle-income contexts. TRIAL REGISTRATION NCT05744856. TRIAL STATUS Recruiting.
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Affiliation(s)
- Ditte S Linde
- Research unit for Gynaecology & Obstetrics, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
- Department of Gynaecology and Obstetrics, Odense University Hospital, Odense, Denmark.
- Centre for Global Health, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
| | - Hieu M Le
- Department of Internal Medicine, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam
| | - Dung T K Vu
- Faculty of Public Health, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam
| | - Ngoc-Anh T Dang
- Faculty of Public Health, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam
| | - Ai T Nguyen
- Faculty of Public Health, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam
| | - Tuc P Vu
- Faculty of Public Health, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam
| | - Xuan-Bai Nguyen
- Department of Histology, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam
| | - Cuong D Nguyen
- Department of Anaesthesia and Resuscitation, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam
| | - Dan W Meyrowitsch
- Department of Public Health, Global Health Section, University of Copenhagen, Copenhagen, Denmark
| | - Jens Søndergaard
- Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark
| | - Christina A Vinter
- Research unit for Gynaecology & Obstetrics, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
- Department of Gynaecology and Obstetrics, Odense University Hospital, Odense, Denmark
- Steno Diabetes Centre Odense, Odense University Hospital, Odense, Denmark
| | - Ib C Bygbjerg
- Department of Public Health, Global Health Section, University of Copenhagen, Copenhagen, Denmark
| | - Vibeke Rasch
- Research unit for Gynaecology & Obstetrics, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
- Department of Gynaecology and Obstetrics, Odense University Hospital, Odense, Denmark
- Centre for Global Health, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
| | - Thanh D Nguyen
- Faculty of Public Health, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam
| | - Tine M Gammeltoft
- Department of Anthropology, University of Copenhagen, Copenhagen, Denmark
| | - Dang K Nguyen
- Department of Gynaecology & Obstetrics, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam
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Kroese T, Andratschke N, Belka C, Corradini S, Marschner S, Liermann J, Hörner-Rieber J, Fink C, Debus J, Silvia F, Tanadini-Lang S, Pouymayou B, Mencarelli A, Fesslmeier D, Schiess A, Guckenberger M, Mayinger M. Online adaptive stereotactic body radiotherapy for localized prostate cancer in patients with lower urinary tract symptoms and/or prostate hyperplasia (X-SMILE). Radiat Oncol 2025; 20:90. [PMID: 40437508 PMCID: PMC12117833 DOI: 10.1186/s13014-025-02653-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/04/2024] [Accepted: 04/29/2025] [Indexed: 06/01/2025] Open
Abstract
BACKGROUND Stereotactic body radiotherapy (SBRT) for localized prostate cancer offers non-inferior oncological outcomes and toxicity profiles compared to conventionally or moderately hypofractioned radiotherapy regimens, with shorter treatment durations. However, SBRT may not be suitable for all patients, particularly those with lower urogenital tract symptoms and/or prostatic hyperplasia. METHODS This study aims to evaluate the safety and efficacy of weekly computed tomography (CT) or magnetic resonance image (MRI)-guided online adaptive SBRT in patients with intermediate to high-risk localized prostate cancer (i.e. ≤ cT3a and Gleason score ≤ 9 and PSA ≤ 20 ng/ml) who present with lower urinary tract symptoms (International Prostate Symptom Score [IPSS] > 12) and/or have prostate hyperplasia (prostate volume > 60 mL). The primary outcome measure is urogenital toxicity grade ≥ 3 within 3 months after completion of SBRT (according to CTCAE V5.0) or treatment-related discontinuation. Our aim is to show an event rate of 3% below a clinically acceptable threshold which is set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30. DISCUSSION In cases of moderate to high IPSS or significant obstructive urodynamics, a pre-emptive transurethral resection of prostate (TURP) may be beneficial. Notably, 10-20% of prostate cancer patients receiving radiotherapy patients have a history of TURP. While TURP can improve obstructive symptoms, its impact on late toxicity, particularly in SBRT, requires further investigation. To mitigate the risk of urogenital toxicity, especially in the case of patients with lower urogenital tract symptoms and/or prostatic hyperplasia, emerging approaches like MR-guided adaptive SBRT and weekly SBRT have shown promise. TRIAL REGISTRATION ClinicalTrials.gov/NCT06834152. PROTOCOL VERSION Version 6.0.
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Affiliation(s)
- Tiuri Kroese
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland.
| | - Nicolaus Andratschke
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland
| | - Claus Belka
- Department of Radiation Oncology, LMU University Hospital, LMU Munich, Munich, Germany
| | - Stefanie Corradini
- Department of Radiation Oncology, LMU University Hospital, LMU Munich, Munich, Germany
| | - Sebastian Marschner
- Department of Radiation Oncology, LMU University Hospital, LMU Munich, Munich, Germany
| | - Jakob Liermann
- Department of Radiation Oncology, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany
| | - Juliane Hörner-Rieber
- Department of Radiation Oncology, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany
| | - Christoph Fink
- Department of Radiation Oncology, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany
| | - Jürgen Debus
- Department of Radiation Oncology, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany
| | - Fabiano Silvia
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland
| | - Stephanie Tanadini-Lang
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland
| | - Bertrand Pouymayou
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland
| | - Alessandro Mencarelli
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland
| | - Debra Fesslmeier
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland
| | - Antonia Schiess
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland
| | - Matthias Guckenberger
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland
| | - Michael Mayinger
- Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Rämistrasse 100, Zürich, 8091, Switzerland
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24
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Hackett SS, Foscarini-Craggs P, Aafjes-van Doorn K, Franklin M, Riaz M, Zubala A, Condie J, McKinnon I, Iranpour A, Leigh Harrison T, Rose S, Randell E, McNamara R. Secure care (forensic) hospital evaluation of manualised interpersonal art-psychotherapy (SCHEMA): A randomised controlled trial protocol. NIHR OPEN RESEARCH 2025; 5:21. [PMID: 40242277 PMCID: PMC12000804 DOI: 10.3310/nihropenres.13801.1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Accepted: 05/13/2025] [Indexed: 04/18/2025]
Abstract
Background Within the criminal Justice System in the UK one-third of prisoners self-identified as having a learning difficulty and/or disability. This is broadly consistent with formal assessment of the needs of offenders, with 29% of the offender population having a learning disability. In the UK, NHS and private/independent sector secure care (Forensic) provides assessment and treatment for men and women who have come into contact within the Criminal Justice System and have mental health needs, a personality disorder, and/or learning disability. Patients in these services are often detained under the Mental Health Act (1983) and/or have licence conditions that have been set by the Ministry of Justice.Interpersonal art psychotherapy was developed within secure care as an accessible psychological intervention for adults with mild intellectual disabilities or borderline intellectual functioning. A feasibility randomised controlled trial of interpersonal art psychotherapy showed that assessment of key feasibility objectives were met and the trial procedures were acceptable, indicating progression to a definitive trial. Methods This is a two-arm single blind randomised controlled trial of effectiveness comparing manualised interpersonal art psychotherapy and Usual Care (UC) to UC. The Randomised Controlled Trial (RCT) will be conducted in a minimum of 10 secure care hospitals (NHS & Independent) with secure care (Forensic) facilities and will recruit 150 participants. The trial design includes an integrated assessment of cost-effectiveness. Results Individuals with intellectual disabilities and borderline intellectual functioning were involved in the design and set up of the trial. The trial is currently open to recruitment for participants from eight NHS and private/independent secure care sites in the UK. Conclusions A full report of study results will be published on completion of the trial. The trial has been registered ISRCTN57406593 ( ISRCTN registry, 2024). This published protocol corresponds with version 6, dated 12.08.2024.
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Affiliation(s)
- Simon S. Hackett
- Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, England, NE2 4AX, UK
- Tyne and Wear NHS Foundation Trust, Jubilee Rd, Cumbria Northumberland, Newcastle upon Tyne, England, NE3 3X, UK
| | - Paula Foscarini-Craggs
- Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK
| | - Katie Aafjes-van Doorn
- West Yangsi Rd, New York University Shanghai, Pudong Xin Qu 567, Shanghai, 200124, China
| | - Matthew Franklin
- Sheffield Centre for Health and Related Research (SCHARR), School of Medicine and Population Health, Regent Court, 30 Regent Street, The University of Sheffield, Sheffield, England, S1 4DA, UK
| | - Muhammad Riaz
- Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK
| | - Ania Zubala
- Centre for Brain Sciences, Kennedy Tower. Royal Edinburgh Hospital, Morningside Place, The University of Edinburgh, Edinburgh, EH10 5HF, UK
| | - Jennifer Condie
- Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK
| | - Iain McKinnon
- Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, England, NE2 4AX, UK
- Tyne and Wear NHS Foundation Trust, Jubilee Rd, Cumbria Northumberland, Newcastle upon Tyne, England, NE3 3X, UK
| | - Arman Iranpour
- Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, England, NE2 4AX, UK
- Tyne and Wear NHS Foundation Trust, Jubilee Rd, Cumbria Northumberland, Newcastle upon Tyne, England, NE3 3X, UK
| | - Toni Leigh Harrison
- Faculty of Medical Sciences, Baddiley-Clark Building, Richardson Road, Newcastle University Population Health Sciences Institute, Newcastle upon Tyne, England, NE2 4AX, UK
- Tyne and Wear NHS Foundation Trust, Jubilee Rd, Cumbria Northumberland, Newcastle upon Tyne, England, NE3 3X, UK
| | - Sophie Rose
- Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK
| | - Elizabeth Randell
- Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK
| | - Rachel McNamara
- Centre for Trials Research, Neuadd Meirionnydd, Heath Park, Cardiff University, Cardiff, Wales, CF14 4YS, UK
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25
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Taylor RS, Burrell E, O'Hare C, Thomson EA, Placzek A, Bollen JC, Cleland JGF, Cowie A, Dalal HM, Deaton C, Doherty PJ, Dudman K, Fraser H, Frost J, Greaves C, Hartshorne-Evans N, Hillsdon M, Ibbotson T, Jarallah M, Jolly K, McConnachie A, McIntosh E, Smith V, Squire I, Taylor L, van Beurden S, Lang CC, REACH-HFpEF Investigators. Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial - REACH-HFpEF trial. BMJ Open 2025; 15:e094254. [PMID: 40436450 PMCID: PMC12121609 DOI: 10.1136/bmjopen-2024-094254] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/26/2024] [Accepted: 03/13/2025] [Indexed: 06/01/2025] Open
Abstract
INTRODUCTION Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers. METHODS AND ANALYSIS REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients' disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators' experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked. ETHICS AND DISSEMINATION The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers. TRIAL REGISTRATION NUMBER ISRCTN47894539.
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Affiliation(s)
- Rod S Taylor
- School of Health & Wellbeing, University of Glasgow, Glasgow, UK
| | - Emma Burrell
- School of Health & Wellbeing, University of Glasgow, Glasgow, UK
| | - Claire O'Hare
- School of Health & Wellbeing, University of Glasgow, Glasgow, UK
| | | | - Anna Placzek
- School of Health & Wellbeing, University of Glasgow, Glasgow, UK
| | | | - John G F Cleland
- School of Health & Wellbeing, University of Glasgow, Glasgow, UK
- School of Cardiovascular & Metabolic Health, University of Glasgow, Glasgow, UK
| | - Aynsley Cowie
- Cardiac Rehabilitation, NHS Ayrshire and Arran, Kilmarnock, UK
| | - Hasnain M Dalal
- Research, Development and Innovation, Royal Cornwall Hospitals NHS Trust, Truro, Cornwall, UK
- Primary Care, University of Exeter Medical School, Truro, UK
| | - Christi Deaton
- Cambridge Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK
| | | | - Katie Dudman
- School of Health & Wellbeing, University of Glasgow, Glasgow, UK
| | - Heather Fraser
- Health Economics and Health Technology Assessment (HEHTA), University of Glasgow, Glasgow, UK
| | - Julia Frost
- Medical School, University of Exeter, Exeter, UK
| | - Colin Greaves
- School of Sport, Exercise and Rehabilitation Science, University of Birmingham, Birmingham, UK
| | | | | | - Tracy Ibbotson
- Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
| | - Mohammad Jarallah
- University of Birmingham, Birmingham, UK
- Department of Physical Therapy and Health Rehabilitation, Majmaah University, Al Majma'ah, Saudi Arabia
| | - Kate Jolly
- Institute of Applied Health Research, University of Birmingham, Birmingham, UK
| | - Alex McConnachie
- Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK
| | - Emma McIntosh
- Health Economics and Health Technology Assessment (HEHTA), University of Glasgow, Glasgow, UK
| | - Valerie Smith
- University College Dublin School of Nursing Midwifery and Health Systems, Dublin, Ireland
| | | | - Louise Taylor
- Heart Manual Department, Lothian Health Board, Edinburgh, UK
| | | | - Chim C Lang
- Division of Cardiovascular Research, University of Dundee, Dundee, UK
- University Kebangsaan Malaysia, Bangi, Selangor, Malaysia
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26
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Moors JJE, Xu Z, Xie K, Rashad A, Vladu O, Egger J, Röhrig R, Hölzle F, Puladi B. Full-thickness skin graft versus split-thickness skin graft for fasciocutaneous radial forearm free flap donor site closure: a systematic review and meta-analysis. Syst Rev 2025; 14:118. [PMID: 40426263 PMCID: PMC12108030 DOI: 10.1186/s13643-025-02863-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/21/2024] [Accepted: 05/11/2025] [Indexed: 05/29/2025] Open
Abstract
BACKGROUND The radial forearm free flap (RFFF) is widely used in microvascular reconstructions. However, donor site morbidity remains a concern, with complications such as wound healing issues, functional impairments, and aesthetic concerns. While both full-thickness skin grafts (FTSG) and split-thickness skin grafts (STSG) are commonly used for donor site closure, there is insufficient evidence to determine which technique leads to fewer complications. This study aims to systematically compare FTSG and STSG in RFFF donor site closure. METHODS We searched six databases and four clinical trial registries up to 1 March 2025. We focused on studies comparing FTSG and STSG. Primary outcome was the incidence of wound complications. Secondary outcomes included functional and aesthetic impairment. Risk of bias was assessed using the Risk Of Bias In Non-Randomized Studies-of Interventions (ROBINS-I) and quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS Fifteen studies were analyzed, involving 933 donor site closures. No RCTs met our inclusion criteria. Meta-analysis comparing FTSG versus STSG revealed no significant differences in major wound complications (RR 0.43; 95% CI 0.11 to 1.70; p = 0.23) and minor wound healing complications (RR 0.83; 95% CI 0.60 to 1.13; p = 0.23), with the evidence graded as low to very low certainty. CONCLUSION Current evidence does not conclusively favor either FTSG or STSG for radial forearm free flap donor site closure regarding wound, functional, or aesthetic outcomes. Future well-designed RCTs are needed to provide higher-quality evidence to guide clinical decision-making. Until more robust evidence becomes available, the optimal skin graft choice should be guided by patient-specific factors, surgical considerations, and donor site characteristics. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42023351903.
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Affiliation(s)
- Jasper J E Moors
- Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Aachen, 52074, Germany
- Institute of Medical Informatics, University Hospital RWTH Aachen, 52074, Aachen, Germany
| | - Zhibin Xu
- Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Aachen, 52074, Germany
| | - Kunpeng Xie
- Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Aachen, 52074, Germany
- Institute of Medical Informatics, University Hospital RWTH Aachen, 52074, Aachen, Germany
| | - Ashkan Rashad
- Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Aachen, 52074, Germany
| | - Oliver Vladu
- Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Aachen, 52074, Germany
| | - Jan Egger
- Cancer Research Center Cologne Essen (CCCE), West German Cancer Center Essen (WTZ), 45122, Essen, Germany
- Institute of Artificial Intelligence in Medicine, Essen University Hospital, 45131, Essen, Germany
| | - Rainer Röhrig
- Institute of Medical Informatics, University Hospital RWTH Aachen, 52074, Aachen, Germany
| | - Frank Hölzle
- Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Aachen, 52074, Germany
| | - Behrus Puladi
- Department of Oral and Maxillofacial Surgery, University Hospital RWTH Aachen, Aachen, 52074, Germany.
- Institute of Medical Informatics, University Hospital RWTH Aachen, 52074, Aachen, Germany.
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27
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Gray L, Coppack RJ, Barker-Davies R, Cassidy RP, Bennett AN, Caplan N, Atkinson G, Bradshaw L, Chauhan J, Lunt KM, Hughes L, Ladlow P. Efficacy and acceptability of different blood flow restriction training interventions during the rehabilitation of military personnel with lower limb musculoskeletal injuries: protocol for a two-phase randomised controlled trial. BMJ Open 2025; 15:e096643. [PMID: 40425246 PMCID: PMC12107567 DOI: 10.1136/bmjopen-2024-096643] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/15/2024] [Accepted: 05/09/2025] [Indexed: 05/29/2025] Open
Abstract
BACKGROUND Musculoskeletal injury (MSKI) is the leading cause of medical downgrading and discharge within the UK military, with lower limb MSKI having the greatest incidence, negatively impacting operational readiness. Pain is a primary limiting factor to rehabilitation progress following MSKI. Heavy-load resistance training (RT; ie, loads >70% 1-repetition maximum) is traditionally used but may be contraindicated due to pain, potentially prolonging recovery and leading to failure of essential physical employment standards for UK military personnel. Low-load RT with blood flow restriction (BFR) can promote favourable morphological and physiological adaption, as well as elicit hypoalgesia in healthy and clinical populations (eg, post-operative), and has proven a viable option in military rehabilitation settings. The acceptability and tolerance of higher relative BFR pressures in persistent pain populations are unknown due to the complexity of presentation and the perception of discomfort experienced during BFR exercise. Greater relative pressures (ie, 80% limb occlusion pressure (LOP)) elicit a greater hypoalgesic response in pain-free individuals, but greater perceived discomfort which may not be tolerated in persistent pain populations. However, lower relative pressure (ie, 40% LOP) has elicited hypoalgesia in pain-free individuals, which therefore may be more clinically acceptable and tolerated in persistent pain populations. The primary aim of both randomised controlled trials (RCT) is to investigate the efficacy and acceptability of using high-frequency, low-load BFR-RT in UK military personnel with lower limb MSKI where persistent pain is the primary limiting factor for progression. METHODOLOGY The presented protocol is a two-phase RCT based within a military rehabilitation setting. Phase One is a 1-week RCT to determine the most efficacious and acceptable BFR-RT protocol (7× BFR-RT sessions over 5 days at 40% or 80% LOP; n=28). Phase Two is a 3-week RCT comparing the most clinically acceptable BFR pressure, determined by Phase One (21× BFR-RT sessions over 15 days; n=26) to usual care within UK Defence Rehabilitation residential rehabilitation practices. Outcomes will be recorded at baseline, daily and following completion of the intervention. The primary outcome will be the brief pain inventory. Secondary outcomes include blood biomarkers for inflammation and pain (Phase Two only), injury-specific outcome measures, lower extremity function scale, objective measures of muscle strength and neuromuscular performance, and pressure pain threshold testing. ETHICS AND DISSEMINATION The study is approved by the Ministry of Defence Research Ethics Committee (2318/MODREC/24) and Northumbria University. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences. TRIAL REGISTRATION NUMBER Registered with Clinical Trials. The registration numbers are as follows: NCT06621914 (Phase One) and NCT06621953 (Phase Two).
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Affiliation(s)
- Luke Gray
- Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, Tyne and Wear, UK
- Academic Department of Military Rehabilitation, Defence Medical Rehabilitation Centre, Loughborough, UK
| | - Russ J Coppack
- Academic Department of Military Rehabilitation, Defence Medical Rehabilitation Centre, Loughborough, UK
- Department for Health, University of Bath, Bath, UK
| | - Robert Barker-Davies
- Academic Department of Military Rehabilitation, Defence Medical Rehabilitation Centre, Loughborough, UK
- School of Sport, Exercise, and Health Sciences, Loughborough University, Loughborough, UK
| | - Robyn P Cassidy
- Academic Department of Military Rehabilitation, Defence Medical Rehabilitation Centre, Loughborough, UK
- Department for Health, University of Bath, Bath, UK
| | - Alexander N Bennett
- Academic Department of Military Rehabilitation, Defence Medical Rehabilitation Centre, Loughborough, UK
- Department of Bioengineering, Imperial College London, London, UK
| | - Nick Caplan
- Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, Tyne and Wear, UK
| | | | | | | | - Kieran M Lunt
- Academic Department of Military Rehabilitation, Defence Medical Rehabilitation Centre, Loughborough, UK
- Department for Health, University of Bath, Bath, UK
| | - Luke Hughes
- Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, Tyne and Wear, UK
| | - Peter Ladlow
- Department for Health, University of Bath, Bath, UK
- Defence Medical Rehabilitation Centre, Loughborough, UK
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Diaz KM, Murdock ME, Clark AW, Kumar S, Jerez V, Serafini MA, Xu C, Boudreaux BD, Romero EK, Aguirre J, Seid H, Nandakumar R, Ginsberg H, Shimbo D, Cheung YK. Breaking up prolonged sedentary behavior to improve cardiometabolic health (BREAK2): protocol for a dose-finding adaptive randomization trial. BMC Public Health 2025; 25:1929. [PMID: 40414835 DOI: 10.1186/s12889-025-22250-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/30/2024] [Accepted: 03/07/2025] [Indexed: 05/27/2025] Open
Abstract
BACKGROUND Excessive sedentary behavior is highly prevalent in developed nations and is a risk factor for cardiovascular disease (CVD) morbidity and mortality. As such, health agencies have provided general recommendations to "sit less, move more" by interspersing brief periods of activity. However, a lack of empirical evidence describing how often (e.g. every 30 min, every 60 min) and for how long (e.g., 1 min activity bouts, 5 min activity bouts) sedentary time should be interrupted (a "sedentary break") to yield health benefit has precluded more quantitative, actionable guidelines. To date, rigorous and methodical dose escalation experiments have not been conducted to elucidate effective and tolerated sedentary break doses. The objective of the proposed study is to determine the minimally effective dose (e.g., the lowest dose) for two elements of a sedentary break (frequency and duration) that yields improvements in established CVD risk factors. The maximally tolerated dose (e.g. the highest dose that does not cause undue physical/psychological distress) for both frequency and duration of sedentary breaks will also be determined. METHODS This study is a randomized crossover trial conducted under laboratory conditions among 324 adults without chronic medical conditions. Participants complete two trial conditions (8 h each), a sedentary break (intervention) condition and an uninterrupted sitting (control) condition, in a randomized order. The sedentary break condition consists of 1 of 25 possible frequency/duration combinations (e.g. walk every 30 min for 5 min), selected according to a Bayesian adaptive randomization method. Primary outcomes used to inform the adaptive randomization are glucose and blood pressure serially assessed over each trial condition. Constructs of dose toxicity (tolerability, safety, physical exhaustion/fatigue, and affect) are also serially assessed. DISCUSSION This study will elucidate the minimally effective and maximally tolerated frequency and duration of a sedentary break that yields improvements in established CVD risk factors, information important for the development of quantitative sedentary behavior guidelines. TRIAL REGISTRATION This trial has been registered with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health on April 29, 2022. The registration ID is NCT05353322.
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Affiliation(s)
- Keith M Diaz
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA.
| | - Margaret E Murdock
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Adriana Wu Clark
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Sitara Kumar
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Victor Jerez
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Maria A Serafini
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Chang Xu
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Benjamin D Boudreaux
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Emily K Romero
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Jennifer Aguirre
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Heather Seid
- Bionutrition Research Core, Irving Institute for Clinical and Translational Research, Columbia University Irving Medical Center, New York, NY, 10032, USA
| | - Renu Nandakumar
- Biomarkers Core Laboratory, Irving Institute for Clinical and Translational Research, Columbia University Irving Medical Center, New York, NY, 10032, USA
| | - Henry Ginsberg
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Daichi Shimbo
- Department of Medicine, Columbia University Irving Medical Center, 622 West 168th Street PH9-301, New York, NY, 10032, USA
| | - Ying Kuen Cheung
- Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, 10032, USA
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Vellingiri K, Acharya AM, Bhat AK. A protocol for randomized controlled trial on early active flexion versus passive flexion mobilization therapy for Spaghetti wrist injuries. J Orthop Surg Res 2025; 20:506. [PMID: 40410794 PMCID: PMC12102783 DOI: 10.1186/s13018-025-05884-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/10/2025] [Accepted: 05/02/2025] [Indexed: 05/25/2025] Open
Abstract
BACKGROUND Spaghetti-wrist injuries representing Zone-5 flexor tendon lacerations remain a major challenge for hand surgeons despite the use of careful and meticulous surgical techniques and appropriate rehabilitation programs. Injuries in these regions can lead to adhesion formation, stiffness, and loss of hand function in view of its delicate and complex anatomy. One of the methods to prevent adhesion is the use of active flexion rehabilitation protocols. Its benefits have been shown in numerous reports on zone-2 injuries. However, there is a paucity of reports for this regime in Zone-5 and Spaghetti-wrist injuries. METHODS This study proposes a double-blind, single-center, randomized controlled trial (RCT) to compare the functional results of two rehabilitation methods following the repair of Spaghetti-wrist injuries. This includes the passive or active flexion therapy regime performed over six weeks. After fulfilling the inclusion criteria, adults aged 18-60 who have presented with spaghetti-wrist injuries will be selected. Patients will receive a comprehensive document outlining the study's purpose, methodology, and follow-up schedule, which will be a part of the informed consent. 44 patients will be immobilized in a plaster slab and assigned equally to the passive or active flexion group. They will be assessed for primary and secondary outcomes, which include Tang's criteria, independent digital function, sensory assessment, pinch and grip strength, and Michigan Hand Outcome Questionnaire (MCHQ), each at six and 12 weeks, six and 12 months. The study will follow the SPIRIT guidelines. DISCUSSION The proposed RCT compares early active and passive flexion regimes' functional results in zone-5 flexor tendon injuries. This trial is unique as an active flexion regime was not described earlier in a major comparison study. It will answer the role and possible benefits of a more aggressive early active flexion program. Additionally, the study will give information on patient-reported outcomes and address the incidence of complications in a much longer follow-up of one year. TRIAL REGISTRATION DETAILS The institute ethics committee approval was confirmed for the study (approval No. IEC - 383/2022), and registration for the Clinical Trial Registry of India was completed (CTRI/2023/03/050721).
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Affiliation(s)
- Kishore Vellingiri
- Department of Hand Surgery, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, 576104, India
| | - Ashwath M Acharya
- Department of Hand Surgery, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, 576104, India.
| | - Anil K Bhat
- Department of Hand Surgery, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, 576104, India
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Aebi PS, Adam L, Haller M, Bardoczi JB, Gencer B, Bonnet F, Beer JH, Carballo S, Christ-Crain M, Feller M, Gabutti L, Haynes AG, Moutzouri E, Chocano-Bedoya PO, Bassetti S, Escher R, Egger M, Poortvliet RKE, Schuetz P, Trelle S, Wertli MM, Zekry D, Méan M, Aujesky D, Bauer D, Blum MR, Rodondi N. Rationale and design of 'discontinuing statins in multimorbid older adults without cardiovascular disease (STREAM)': study protocol of a randomised non-inferiority clinical trial. BMJ Open 2025; 15:e093833. [PMID: 40409969 PMCID: PMC12104904 DOI: 10.1136/bmjopen-2024-093833] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2024] [Accepted: 05/09/2025] [Indexed: 05/25/2025] Open
Abstract
INTRODUCTION Statins are among the most widely used drugs. While they are effective for primary and secondary prevention of cardiovascular (CV) disease in middle-aged subjects, their benefits for prevention in older adults (aged ≥70 years) without CV disease are uncertain, particularly for those with multimorbidity. Statin side effects and drug interactions are common in older patients and may negatively impact quality of life. To date, the only randomised controlled trial (RCT) investigating statin discontinuation in older adults has demonstrated no difference in survival but did note a small improvement in quality of life for those who discontinued statins. However, this trial exclusively enrolled patients with a life expectancy <1 year. Therefore, the present RCT aims to assess the safety and potential benefits of statin discontinuation in primary prevention for the ever-growing population of multimorbid older adults. METHODS AND ANALYSIS This study is a multicentre, randomised, non-inferiority trial conducted in both inpatient and outpatient settings in Switzerland, France and the Netherlands, targeting patients using statins for primary prevention. 1800 participants are randomly assigned 1:1 to either discontinue (intervention arm) or continue (control arm) statin therapy. The primary objective is to compare the primary composite endpoint of major CV events (non-fatal myocardial infarction or non-fatal ischaemic stroke) and all-cause death between the control and intervention groups over a follow-up duration of up to 48 months. We hypothesise that discontinuing statins does not result in shorter event-free survival, with a non-inferiority margin set at 5.2 weeks over a 2-year observation period. Secondary objectives are to compare patient-centred outcomes (health-related quality of life, muscle pain symptoms, falls and sarcopenia) and all-cause death, non-CV death, major CV events and coronary and peripheral artery revascularisation. The study is open-labelled, with blinded outcome adjudication of the primary endpoints. ETHICS AND DISSEMINATION The trial protocol has received approval from the local ethics committees in Switzerland, France and the Netherlands. Results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER Clinicaltrials.gov: NCT05178420; BASEC (Swiss Ethics Commission): 2021-01513; FOPH (Swiss national portal): SNCTP000005172; Netherlands Trial Register: NL83907.058.23; France Trial Register: 22.04747.000158- IDRCB 2022-A02481-42.
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Affiliation(s)
- Philipp Stefan Aebi
- Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
| | - Luise Adam
- Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
- Department of Internal Medicine, Angiology, Kantonsspital Schaffhausen, Schaffhausen, Switzerland
| | - Moa Haller
- Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
| | - Julia Bianca Bardoczi
- Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
| | - Baris Gencer
- Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
- Department of Cardiology, University of Lausanne, Lausanne, Switzerland
| | - Fabrice Bonnet
- Service de Médecine Interne et Maladies Infectieuses, Hôpital Saint-André, CHU de Bordeaux, and INSERM U1219, Bordeaux Population Health, Université de Bordeaux, Bordeaux, France
| | - Jürg-Hans Beer
- Department of Internal Medicine, Cantonal Hospital of Baden, Baden, Switzerland
- University of Zürich, Zürich, Switzerland
| | - Sebastian Carballo
- Division of General Internal Medicine, Hôpitaux Universitaires Genève, Geneva, Switzerland
| | - Mirjam Christ-Crain
- Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland
| | - Martin Feller
- Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
| | - Luca Gabutti
- Department of Internal Medicine, Repubblica e Cantone Ticino Ente Ospedaliero Cantonale, Bellinzona, Switzerland
| | - Alan G Haynes
- CTU Bern, Department of Clinical Research, University of Bern, Bern, Switzerland
| | - Elisavet Moutzouri
- Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
| | | | - Stefano Bassetti
- Division of Internal Medicine, University Hospital Basel, Basel, Switzerland
| | - Robert Escher
- Department of Internal Medicine, Spital Emmental, Burgdorf, Switzerland
| | - Martin Egger
- Clinic of Internal Medicine, Spital Emmental, Langnau, Switzerland
| | - Rosalinde K E Poortvliet
- Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands
- LUMC Center for Medicine for Older people, Leiden University Medical Center, Leiden, The Netherlands
| | - Philipp Schuetz
- Division of Internal Medicine, Kantonsspital Aarau, Aarau, Switzerland
| | - Sven Trelle
- CTU Bern, Department of Clinical Research, University of Bern, Bern, Switzerland
| | - Maria M Wertli
- Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- Department of Internal Medicine, Cantonal Hospital of Baden, Baden, Switzerland
| | - Dina Zekry
- Division of Internal Medicine for the Aged, Hôpitaux Universitaires Genève, University of Geneva, Geneva, Switzerland
| | - Marie Méan
- Division of Internal Medicine, Department of Medicine, Lausanne University Hospital, Lausanne, Switzerland
| | - Drahomir Aujesky
- Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Douglas Bauer
- Department of Medicine, University of California, San Francisco, San Francisco, California, USA
| | - Manuel R Blum
- Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
| | - Nicolas Rodondi
- Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
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Zhou X, Li X, Chen N, Chen Z, Yu H, Liang J, Fan Q, Zhu X, Zhang T, Zhou X, Du Q. Efficacy of sensorimotor training combined with core strength training for low back pain in adult idiopathic scoliosis: a study protocol for a randomized controlled trial. BMJ Open 2025; 15:e091476. [PMID: 40409968 PMCID: PMC12104929 DOI: 10.1136/bmjopen-2024-091476] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/22/2024] [Accepted: 04/29/2025] [Indexed: 05/25/2025] Open
Abstract
INTRODUCTION Sensorimotor training (SoMT) is a gradual balance training technique employed to treat various chronic musculoskeletal pain. Core strength training (CST) is one of the most commonly used interventions for managing low back pain (LBP). This randomied controlled trial protocol aims to determine whether the combination of SoMT and CST can significantly reduce LBP, and improve scoliosis-related outcomes and overall functional status in adult idiopathic scoliosis (AdIS) patients. METHODS AND ANALYSIS A total of 300 AdIS patients will be recruited from the outpatient clinic and randomly assigned to one of three groups: CST group, SoMT group or the combined therapy group, using stratified block randomization based on the severity of scoliosis curve. All groups will receive the intervention three times a week for 12 weeks. Sessions will be conducted in the hospital, and no home programme will be provided. Adherence and attendance will be monitored and recorded. The CST group will receive CST therapy, while the SoMT group will receive SoMT therapy, which consists of three progressive phases: static, dynamic and functional. Participants will progress to the next phase on achieving pelvic stability in the current phase. The combined therapy group will receive both CST and SoMT. Assessors and statisticians will remain blinded to participant allocation throughout the study. Assessments will be performed at baseline and at the endpoint, 12 weeks after the initiation of the intervention. The primary outcome will be the self-reported pain level, measured using the visual analogue scale. Secondary outcomes will include pain-related disability (by the Oswestry Disability Index and the Roland-Morris Disability Questionnaire), spinal morphology indicators (including Cobb angle, the angle of trunk rotation and the Sagittal Index), postural control ability (by the Tetrax IBSTM), proprioceptive sensitivity (by the repositioning error test) and health-related quality of life (by the 36-Item Short Form Health Survey). Statistical analysis will adhere to the intention-to-treat principle and will be complemented by per-protocol analysis. To compare the effects of SoMT versus CST and combined therapy versus SoMT on both primary and secondary outcomes, a linear mixed-effects model or generalised linear mixed model will be applied. ETHICS AND DISSEMINATION The current study received ethical approval from the Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2024-080-3). Written informed consent will be obtained from all participants. Any interim analysis and full results will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2400085370).
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Affiliation(s)
- Xiangyue Zhou
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- Children's Rehabilitation Innovation and Transformation Research Center of Yuanshen Rehabilitation Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Xin Li
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- Children's Rehabilitation Innovation and Transformation Research Center of Yuanshen Rehabilitation Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Shanghai University of Sport School of Exercise and Health, Shanghai, China
| | - Nan Chen
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Zhengquan Chen
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Hong Yu
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Juping Liang
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Qimeng Fan
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Xiaoqing Zhu
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Tongtong Zhang
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Xuan Zhou
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- Children's Rehabilitation Innovation and Transformation Research Center of Yuanshen Rehabilitation Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Qing Du
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- Children's Rehabilitation Innovation and Transformation Research Center of Yuanshen Rehabilitation Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China
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Langa JC, Sidat M, Sacarlal J, Moon TD. Re-introduction of India ink testing as a low-cost laboratory diagnostic for cryptococcosis among HIV infected patients in Southern Mozambique: An implementation research protocol. PLoS One 2025; 20:e0324792. [PMID: 40408629 PMCID: PMC12101839 DOI: 10.1371/journal.pone.0324792] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2025] [Accepted: 04/28/2025] [Indexed: 05/25/2025] Open
Abstract
Laboratory diagnosis for cryptococcal disease among HIV-infected patients remains a challenge in most low- and middle-income countries (LMIC). Difficulties with sustained access to cryptococcal rapid tests is cited as a major barrier to the routine screening for cryptococcus in many LMIC. Thus, clinicians in these countries often resort to empirical treatment based solely on clinical suspicion of cryptococcosis. To address this challenge, we aim to evaluate the re-introduction of India ink testing for diagnosis of cryptococcosis among HIV-infected patients in southern Mozambique. India ink testing was historically a common first choice, low-cost, laboratory diagnostic tool for cryptococcal infection. This study uses implementation science methods framed by the Dynamic Adaption Process (DAP) and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) conceptual frameworks to develop a multi-phase, stepped-wedged trial using mixed-methods approaches. The study will be conducted in six hospitals from southern Mozambique over a period of 15 months and will include the following phases: pre-implementation (baseline assessment), Adaptation-implementation (gradual introduction of the intervention), and post-implementation (post-intervention assessment). This study aims to promote the use of India Ink staining as a cheap and readily available tool for cryptococcosis diagnosis in southern Mozambique. Lessons learned in this study may be important to inform approaches to overcome the existing challenges in diagnosis of cryptococcosis in many LMICs due unavailability of readily diagnostic tools. Trial registration: ISRCTN11882960, Registered 06 August 2024.
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Affiliation(s)
- José C. Langa
- Department of Microbiology, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique
| | - Mohsin Sidat
- Department of Community Health, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique
| | - Jahit Sacarlal
- Department of Microbiology, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique
| | - Troy D. Moon
- Department of Tropical Medicine and Infectious Diseases, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, United States of America
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Nielsen CP, Samsøe E, Offersen BV, Lorenzen EL, Persson G, Mortensen HR, Nissen HD, Vogelius IR, Kallehauge JF, Muren LP, Brincker M, Felter MVO, Dahlrot RH, Hokland SB, Schytte T, Havelund BM, Weber B, Møller DS, Serup-Hansen E, Jensen K, Jakobsen KL, Josipovic M, Krogh SL, Lukacova S, Hoffmann L, Hansen CR. Recommendations for radiotherapy quality assurance in clinical trials. Radiother Oncol 2025:110950. [PMID: 40412533 DOI: 10.1016/j.radonc.2025.110950] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2024] [Revised: 04/30/2025] [Accepted: 05/19/2025] [Indexed: 05/27/2025]
Abstract
Robust quality assurance (QA) of clinical trials in radiotherapy (RT) is paramount for minimising uncertainties in treatment delivery, thereby strengthening the statistical power of the study and increasing the likelihood of accurately answering the research question. As RT techniques evolve and become more complex, establishing an appropriate QA program for a specific clinical trial becomes increasingly challenging, highlighting the importance of clear and standardised recommendations. This study provide such recommendations for Principal Investigators (PIs) to consider when planning and conducting RT Quality Assurance (RTQA) for clinical trials. They arise from experiences with RTQA in the clinical trials conducted in the Danish Multidisciplinary Cancer Groups (DMCGs). The recommendations include a checklist to guide PIs in developing an effective RTQA program.
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Affiliation(s)
- Camilla Panduro Nielsen
- Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark
| | - Eva Samsøe
- Department of Oncology and Palliative Care, Zealand University Hospital, Denmark
| | - Birgitte Vrou Offersen
- Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark; Department of Oncology, Aarhus University Hospital, Denmark; Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Ebbe Laugaard Lorenzen
- Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark
| | - Gitte Persson
- Department of Oncology, Copenhagen University Hospital- Herlev and Gentofte, Herlev, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark
| | - Hanna Rahbek Mortensen
- Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Henrik Dahl Nissen
- Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Denmark
| | - Ivan Richter Vogelius
- Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Oncology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Denmark
| | - Jesper Folsted Kallehauge
- Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Ludvig Paul Muren
- Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Mads Brincker
- Department of Medical Physics, Oncology, Aalborg University Hospital, Aalborg, Denmark
| | | | - Rikke Hedegaard Dahlrot
- Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark; Department of Oncology, Odense University Hospital, Denmark
| | - Steffen Bjerre Hokland
- Department of Oncology, Aarhus University Hospital, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Tine Schytte
- Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Oncology, Odense University Hospital, Denmark
| | | | - Britta Weber
- Department of Oncology, Aarhus University Hospital, Denmark; Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark
| | - Ditte Sloth Møller
- Department of Oncology, Aarhus University Hospital, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Eva Serup-Hansen
- Department of Oncology, Copenhagen University Hospital- Herlev and Gentofte, Herlev, Denmark
| | - Kenneth Jensen
- Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark
| | | | - Mirjana Josipovic
- Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Oncology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital - Rigshospitalet, Denmark
| | - Simon Long Krogh
- Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark
| | - Slávka Lukacova
- Department of Oncology, Aarhus University Hospital, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Lone Hoffmann
- Department of Oncology, Aarhus University Hospital, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Christian Rønn Hansen
- Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark.
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Baharudin MH, Mokhtar SA, Azman AZF, Mohd Nazan AIN. Utilizing Theory of Planned Behaviour to increase intention to participate in hepatitis C treatment therapy among Methadone maintenance therapy clients (MMT) in Malaysia: A cluster randomised control trial. PLoS One 2025; 20:e0324718. [PMID: 40403097 PMCID: PMC12097622 DOI: 10.1371/journal.pone.0324718] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2024] [Accepted: 04/29/2025] [Indexed: 05/24/2025] Open
Abstract
INTRODUCTION The World Health Organization (WHO) has targeted eliminating viral hepatitis as a public health problem by 2030. Thus, high-risk groups such as Methadone Maintenance Therapy (MMT) clients should be targeted for hepatitis C health intervention to increase intention for hepatitis C infection treatment. This study aims to evaluate the effectiveness of theory-based hepatitis C health education and learning module (HEAL) in increasing intention to participate in hepatitis C treatment among MMT clients in Malacca. METHODS A single-blinded cluster randomised control trial was conducted among selected MMT clients from government health clinics in Malacca from July 2023 to February 2024. The clinics involved was randomly allocated into intervention and control groups. The intervention group received HEAL module developed based on the Theory of Planned Behavioural while the control group attended clinic session as usual. Generalized Estimating Equation (GEE) analysis was used for statistical analysis. RESULTS GEE shows that there is significant interaction between time and group for both intention for hepatitis C treatment and knowledge on hepatitis C. Intervention group at immediately post intervention follow up had higher intention for hepatitis C treatment as compared to control group (β = 0.56, 95% CI = 0.12, 1.01, p-value < 0.01). However, there were no significant different in intention for hepatitis C treatment between the two group at 3-month post intervention follow up. Furthermore, intervention group had significant higher knowledge at immediately post intervention (β = 8.85, 95% CI = 7.35, 10.36, p-value < 0.001) and at 3-month post intervention (β = 5.25, 95% CI = 3.76, 6.75, p-value < 0.001) as compared to the control group. However, the knowledge level among the intervention group reduces at 3-month post intervention follow up as compared to knowledge level at immediately post intervention follow up. CONCLUSION HEAL module which utilizes motion video and group discussion was effective in increasing MMT client's intention for hepatitis C treatment and knowledge about hepatitis C. However, future research should focus on finding effective strategies to ensure retention of the outcomes of HEAL module intervention over time.
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Affiliation(s)
- Mohd Hafiidz Baharudin
- Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia
- Ministry of Health, Kuala Muda District Health Office, Kedah, Malaysia
| | - Siti Aisah Mokhtar
- Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia
| | - Ahmad Zaid Fattah Azman
- Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia
| | - Ahmad Iqmer Nashriq Mohd Nazan
- Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia
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Nagai M, Noma H, Sakata M, Oi H, Shigematsu J, Matsumura K, Furukawa TA, Nakajima S. Reasonable access to brief behavioural insomnia treatment among medical and psychiatric outpatients (RABBIT): a multicentre randomised controlled trial protocol. BMJ Open 2025; 15:e094602. [PMID: 40404326 PMCID: PMC12096993 DOI: 10.1136/bmjopen-2024-094602] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/04/2024] [Accepted: 04/27/2025] [Indexed: 05/24/2025] Open
Abstract
INTRODUCTION Insomnia is a significant global health issue associated with substantial economic costs. International guidelines recommend cognitive behavioural therapy for insomnia (CBT-I) as the first-line treatment for chronic insomnia; however, pharmacotherapy remains more common in clinical practice. Maintaining the effectiveness while reducing the time and frequency of CBT-I is essential for its implementation. We conducted a randomised controlled trial (RCT) to evaluate the effectiveness of a brief behavioural treatment for insomnia (BBTI) that focuses on sleep restriction and stimulus control (SC)-both established as effective standalone interventions. This article presents the study protocol to examine whether adding BBTI to treatment as usual improves outcomes in patients with chronic insomnia. METHODS AND ANALYSIS We will conduct a multicentre RCT. We will randomly assign patients with chronic insomnia to two groups (BBTI vs sleep hygiene) in a 1:1 ratio. The BBTI consists of three 15 min sessions over 4 weeks delivered by healthcare professionals following a detailed manual. The primary outcome is the Insomnia Severity Index at 8 weeks. Secondary outcomes include sleep latency, wake after sleep onset, total sleep time, sleep efficiency, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9 and EuroQol-5D-5L. We will conduct the assessment at weeks 0 (baseline), 4 (end of intervention), 8 (post-intervention, primary endpoint) and 12 (follow-up). We will assess each sleep variable from the sleep diary at weeks 0 and 8. The analysis will be performed on an intention-to-treat basis. ETHICS AND DISSEMINATION This study has been approved by the Ethics Committee for Clinical and Epidemiological Research of Toyama University (approval no. R2023152). TRIAL REGISTRATION NUMBER UMIN000052911; pre-results.
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Affiliation(s)
- Makie Nagai
- Faculty of Pharmacy and Pharmaceutical Sciences, Josai University, Saitama, Japan
- International Institute for Integrative Sleep Medicine (WPI-IIIS), Tsukuba Daigaku, Tsukuba, Japan
| | | | - Masatsugu Sakata
- Neurodevelopmental Disorders, Nagoya City University, Nagoya, Japan
| | - Hitomi Oi
- Department of Psychological Sciences, University of Human Environments, Matsuyama, Japan
| | - Jun Shigematsu
- Faculty of Humanities, University of Toyama, Toyama, Japan
| | - Kenta Matsumura
- Graduate School of Health Sciences, Aomori University of Health and Welfare, Aomori, Japan
| | - Toshi A Furukawa
- Office of Institutional Advancement and Communications, Kyoto University, Kyoto, Japan
| | - Shun Nakajima
- International Institute for Integrative Sleep Medicine (WPI-IIIS), Tsukuba Daigaku, Tsukuba, Japan
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Elazaly H, Dimitriou IM, Maleitzke T, Dahne M, Jaecker V, Maerdian S, Tafelski S, Diekhoff T, Lindner T, Akgün D, Mielke AM, Paksoy A, Amini DA, Planatscher EM, Leopold V, González-Khatib S, Köhli PC, Niemann M, Hildebrandt A, Oehme S, Palmowski Y, Paraskevaidis M, Schönnagel L, Braun SB, Pumberger M, Hardt S, Stricker S, Akyüz L, Grütz G, Schaller S, Lauterbach L, Volcksdorff M, Mödl L, Textor M, Ort M, Reinke S, Stöckle U, Perka C, Duda GN, Schmidt-Bleek K, Geissler S, Winkler T. ILOBONE: A phase I/IIa randomized controlled trial to assess the safety and feasibility of local iloprost therapy for enhancing proximal humerus fracture healing- a pilot study design. J Orthop Surg Res 2025; 20:498. [PMID: 40405317 PMCID: PMC12096472 DOI: 10.1186/s13018-025-05865-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2025] [Accepted: 04/27/2025] [Indexed: 05/24/2025] Open
Abstract
BACKGROUND Proximal humerus fractures (PHFs) are the third most common fractures in elderly patients. Over 70% of PHFs in patients aged over 60 are displaced fractures, often necessitating surgical treatment. However, osteosynthesis is associated with a high rate of complications, highlighting the urgent need for additional therapeutic approaches to enhance bone healing and prevent osteonecrosis. This study evaluates the safety, feasibility and potential efficacy of local prostacyclin (iloprost) to improve bone healing in patients with PHFs. METHODS Thirty eligible patients will be randomized into one of three groups at a 1:1:1 ratio. All patients will receive angular stable locking plate fixation. Two treatment groups will receive an additional single dose of local iloprost through a 24-hour infusion postoperatively (group 1: low dose; group 2: high dose), while the control group will only receive the osteosynthesis. Patients will be monitored for 52 weeks. The primary endpoint is safety, with secondary endpoints including the preservation of the screw tip apex distance as an indicator of fracture healing, head shaft angle, necrosis rate, and patient-related outcome measures. DISCUSSION The Ilobone study aims to provide data on the potential for biological augmentation of osteosynthesis procedures in PHFs, prone to healing challenges and complications. TRIAL REGISTRATION The trial is registered with ClinicalTrial.gov (NCT04543682), registered 02 Sep. 2020, https://clinicaltrials.gov/show/NCT04543682 and the German Clinical Trials Registry (DRKS00027081), registered 10 Nov. 2021 https://drks.de/search/de/trial/DRKS00027081 .
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Affiliation(s)
- Hisham Elazaly
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
| | - Ioanna Maria Dimitriou
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
- Department of Biology, Chemistry and Pharmacy, Institute of Chemistry and Biochemistry, Freie Universität Berlin, Berlin, Germany
| | - Tazio Maleitzke
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Biomedical Innovation Academy, BIH Charité Clinician Scientist Program, Berlin, Germany
- Department of Orthopedic Surgery, Copenhagen University Hospital- Amager and Hvidovre, Hvidovre, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Michael Dahne
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Vera Jaecker
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Sven Maerdian
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Sascha Tafelski
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Torsten Diekhoff
- Department of Radiology, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Tobias Lindner
- Emergency Department, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Doruk Akgün
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Anna-Maria Mielke
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Alp Paksoy
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Dominik Adl Amini
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Elisa Marie Planatscher
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Vincent Leopold
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Susana González-Khatib
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Paul Christoph Köhli
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Biomedical Innovation Academy, BIH Charité Junior Clinician Scientist Program, Berlin, Germany
| | - Marcel Niemann
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Department of Biology, Chemistry and Pharmacy, Institute of Chemistry and Biochemistry, Freie Universität Berlin, Berlin, Germany
| | - Alexander Hildebrandt
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Stephan Oehme
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Yannick Palmowski
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Melissa Paraskevaidis
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Lukas Schönnagel
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Sebastian Benedict Braun
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Matthias Pumberger
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Sebastian Hardt
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Sigmar Stricker
- Department of Biology, Chemistry and Pharmacy, Institute of Chemistry and Biochemistry, Freie Universität Berlin, Berlin, Germany
| | - Levent Akyüz
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
| | - Gerald Grütz
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
| | - Stefan Schaller
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Luis Lauterbach
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
| | - Maximilian Volcksdorff
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
| | - Lukas Mödl
- Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Martin Textor
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
| | - Melanie Ort
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
- Department of Biology, Chemistry and Pharmacy, Institute of Chemistry and Biochemistry, Freie Universität Berlin, Berlin, Germany
| | - Simon Reinke
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
| | - Ulrich Stöckle
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Carsten Perka
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Georg N Duda
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
- Department of Biology, Chemistry and Pharmacy, Institute of Chemistry and Biochemistry, Freie Universität Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Biomedical Innovation Academy, BIH Charité Clinician Scientist Program, Berlin, Germany
| | - Katharina Schmidt-Bleek
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
- Department of Biology, Chemistry and Pharmacy, Institute of Chemistry and Biochemistry, Freie Universität Berlin, Berlin, Germany
| | - Sven Geissler
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany
- Department of Biology, Chemistry and Pharmacy, Institute of Chemistry and Biochemistry, Freie Universität Berlin, Berlin, Germany
- Berlin Center for Advanced Therapies (BECAT), Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Tobias Winkler
- Center for Musculoskeletal Surgery, Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, Julius Wolff Institute (JWI), Berlin, Germany.
- Berlin Institute of Health (BIH) at Charité- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany.
- Department of Biology, Chemistry and Pharmacy, Institute of Chemistry and Biochemistry, Freie Universität Berlin, Berlin, Germany.
- Berlin Center for Advanced Therapies (BECAT), Charité- Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
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Paraj D, Bhat AK, Acharya A, Kunder MA. Comparison of the clinical and functional outcomes of two immobilisation protocols after arthroscopic peripheral triangular fibrocartilage complex (TFCC) repair in adults: a single-centre, double-blinded randomised controlled trial protocol. BMJ Open 2025; 15:e095855. [PMID: 40398936 PMCID: PMC12096963 DOI: 10.1136/bmjopen-2024-095855] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/30/2024] [Accepted: 05/09/2025] [Indexed: 05/23/2025] Open
Abstract
INTRODUCTION Injury to triangular fibrocartilage complex (TFCC) is a common cause of ulnar-sided wrist pain, of which peripheral TFCC tears are amenable to repair. The surgical approaches to treat TFCC tears are well-established, with arthroscopic or arthroscopic-assisted repair as the preferred method. However, the postoperative rehabilitation protocols significantly vary across different studies, ranging from 2 to 9 weeks, often without sufficient justification. METHODS AND ANALYSIS This research is designed to conduct a randomised controlled trial at a single centre with double-blinding to compare the clinical and functional results of two immobilisation protocols of 3 weeks and 6 weeks, following arthroscopic repair of peripheral TFCC tears (ie, Palmar 1B, 1C and 1D) in adults, considering the phase of ligament healing. The hypothesis that there will be no significant difference in outcomes between the two groups is considered. Adults aged 18-60 years of both genders who present with ulnar-sided wrist pain and satisfy the inclusion criteria are included in the study. Following the arthroscopic TFCC repair using the Polydioxanone Suture (PDS) inside-out suture technique, the patients will be immobilised in an above-elbow cast according to their assigned immobilisation groups, which will be determined by a computer-generated 1:1 block randomisation. In this study, each group will have at least 16 participants. The primary outcomes will be evaluated by the weight-bearing press test and the ballottement test. Secondary outcomes, including the Visual Analogue Scale (VAS) score, grip strength, pinch strength, foveal sign, Modified Mayo Wrist Score (MMWS), patient-rated wrist/hand evaluation (PRWHE) score and the range of movements in the wrist and forearm, will be assessed and compared across the groups at each point of assessment, with the results subsequently reported in a detailed manner. The study will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines. ETHICS AND DISSEMINATION The Ethics Committee of Kasturba Medical College, Manipal, approved the trial (approval No. IEC1 - 386). The data from this trial will be presented at academic conferences and published in peer-reviewed international journals. TRIAL REGISTRATION NUMBER This trial has been registered at the Clinical Trial Registry of India (registration number: CTRI/2023/03/050692).
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Affiliation(s)
- Deepthi Paraj
- Department of Hand Surgery, Kasturba Medical College,Manipal, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India
| | - Anil K Bhat
- Department of Hand Surgery, Kasturba Medical College,Manipal, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India
| | - Ashwath Acharya
- Department of Hand Surgery, Kasturba Medical College,Manipal, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India
| | - Manjula Anil Kunder
- Department of Community Medicine, Kasturba Medical College,Manipal, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India
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Ruiz MT, da Conceição Rodrigues E, Christoffel MM, de Resende CV, Cavalcanti MC, Ferreira MG, da Silva JA, da Silva KEPO, Wernet M, Gomes ALM, Raponi MBG, de Oliveira JF, Contim D, Linares AM. Effectiveness of individualized breastfeeding counseling during the dyad's stay in rooming-in: a randomized, multicenter, open and parallel study. Int Breastfeed J 2025; 20:41. [PMID: 40400003 PMCID: PMC12093738 DOI: 10.1186/s13006-025-00710-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/15/2024] [Accepted: 03/11/2025] [Indexed: 05/23/2025] Open
Abstract
BACKGROUND Breastfeeding counseling is a proven strategy to protect and promote breastfeeding, as evidenced by numerous studies. However, there is limited research on its application during the dyad's stay in rooming-in and its impact on the duration of exclusive breastfeeding. This study aims to evaluate the effectiveness of individualized counseling during the dyad's rooming-in period and its role in maintaining exclusive breastfeeding until the sixth month of life, compared to standard care. METHODS This randomized, multicenter, parallel, and open clinical trial was conducted at two Brazilian university hospitals. A total of 102 primiparous women, who had conditions and intentions favorable to breastfeeding, were enrolled between December 2023 and April 2024. Following hospital discharge, participants were followed up via telephone until the child reached six months of age, with the study concluding in October 2024. Participants were randomly assigned to one of two groups. The intervention group received two to four breastfeeding counseling sessions during their hospital stay, while the control group received standard institutional care. Both groups were provided with educational materials on the benefits of breastfeeding and information on where to seek help if complications arose. During the telephone follow-ups, outcomes were measured without any additional interventions. The primary outcome measured was the exclusive breastfeeding rate since birth to the sixth month. RESULTS A total of 97 breastfeeding women completed the follow-up, forming the sample for analysis. Compared to the control group, women who received counseling were more likely to maintain exclusive breastfeeding at the fourth month (27/48 (56.2%) vs. 15/50 (30.0%), Prevalence Ratio = 1.88 (Confidence Interval 95% 1.15, 3.07) and the sixth month of the child's life (27/47 (57.4%) vs. 12/50 (24.0%), Prevalence Ratio = 2.40 (Confidence Interval 95% 1.38, 4.16). CONCLUSION Breastfeeding counseling during the dyad's stay in rooming-in was effective in maintaining exclusive breastfeeding until the child's sixth month of life. TRIAL REGISTRATION UTN: U1111-1284-3559 / RBR-4w9v5rq (2023-03-20).
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Affiliation(s)
- Mariana Torreglosa Ruiz
- Stricto sensu Graduate Program in Health Care, Federal University of Triangle Mineiro, Av. Getúlio Guaritá, 107, Uberaba, Minas Gerais, 38025-440, Brazil.
- Didactic-Scientific Department of Nursing in Hospital Care, Institute of Health Sciences, Federal University of Triangle Mineiro, Av. Getúlio Guaritá, 107, Uberaba, Minas Gerais, CEP: 38025- 440, Brazil.
| | - Elisa da Conceição Rodrigues
- Posgraduate Program in Nursing, Anna Nery School of Nursing, Rua Afonso Cavalcanti, 275, Cidade Nova, Rio de Janeiro, Rio de Janeiro, 20211110, Brazil
| | - Marialda Moreira Christoffel
- Posgraduate Program in Nursing, Anna Nery School of Nursing, Rua Afonso Cavalcanti, 275, Cidade Nova, Rio de Janeiro, Rio de Janeiro, 20211110, Brazil
| | - Cynthya Viana de Resende
- Stricto sensu Graduate Program in Health Care, Federal University of Triangle Mineiro, Av. Getúlio Guaritá, 107, Uberaba, Minas Gerais, 38025-440, Brazil
| | - Michele Curcino Cavalcanti
- Posgraduate Program in Nursing, Anna Nery School of Nursing, Rua Afonso Cavalcanti, 275, Cidade Nova, Rio de Janeiro, Rio de Janeiro, 20211110, Brazil
| | - Marianne Guterres Ferreira
- Posgraduate Program in Nursing, Anna Nery School of Nursing, Rua Afonso Cavalcanti, 275, Cidade Nova, Rio de Janeiro, Rio de Janeiro, 20211110, Brazil
| | - Jéssica Aparecida da Silva
- Stricto sensu Graduate Program in Health Care, Federal University of Triangle Mineiro, Av. Getúlio Guaritá, 107, Uberaba, Minas Gerais, 38025-440, Brazil
| | | | - Monika Wernet
- Pos graduate Program in Nursing Federal, University of Sāo Carlos, Rodovia Washington Luis, km 235, Sāo Carlos, São Paulo, 13565905, Brazil
| | - Ana Letícia Monteiro Gomes
- Posgraduate Program in Nursing, Anna Nery School of Nursing, Rua Afonso Cavalcanti, 275, Cidade Nova, Rio de Janeiro, Rio de Janeiro, 20211110, Brazil
| | - Maria Beatriz Guimarães Raponi
- School of Medicine, Nursing Course, Federal University of Uberlândia, Avenida Pará, Bloco 2U, 1720, Umuarama, Uberlândia, Minas Gerais, 38400-902, Brazil
| | - Jacqueline Faria de Oliveira
- Clinic Hospital of Federal University of Triangle Mineiro, Av. Getúlio Guaritá, 130, Uberaba, Minas Gerais, CEP: 38025-440, Brazil
| | - Divanice Contim
- Stricto sensu Graduate Program in Health Care, Federal University of Triangle Mineiro, Av. Getúlio Guaritá, 107, Uberaba, Minas Gerais, 38025-440, Brazil
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Tomaskovic A, Weber V, Ochmann DT, Neuberger EW, Lachtermann E, Brahmer A, Haller N, Hillen B, Enders K, Eggert V, Zeier P, Lieb K, Simon P. Multimodal Web-Based Telerehabilitation for Patients With Post-COVID-19 Condition: Protocol for a Randomized Controlled Trial. JMIR Res Protoc 2025; 14:e65044. [PMID: 40397936 DOI: 10.2196/65044] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/02/2024] [Revised: 03/22/2025] [Accepted: 03/26/2025] [Indexed: 05/23/2025] Open
Abstract
BACKGROUND Patients with post-COVID-19 condition (PCC) experience persistent, long-term health consequences following SARS-CoV-2 infection, including fatigue, hyperventilation, cognitive impairment, and limitations in daily activities. There is emerging evidence suggesting that exercise and respiratory therapy-based telerehabilitation is safe and could potentially improve physical capacity while reducing health care costs. OBJECTIVE This study aims to evaluate the superiority of a multimodal, symptom-titrated telerehabilitation program over standard care in patients with PCC who are severely affected, using the highest oxygen uptake rate (VO2peak [mL/min/kg]) achieved during the cardiopulmonary exercise test (CPET) and minute ventilation/carbon dioxide production slope (VE/VCO2 [full slope]) as primary outcomes. In addition, this study seeks to provide novel insights into the clinical and physiological adaptations associated with PCC, informing future rehabilitation strategies. METHODS This prospective, randomized, waitlist-controlled trial was approved by the Rhineland-Palatinate Medical Association ethics committee. All procedures comply with the Declaration of Helsinki. This study comprises 3 examination time points, which include patient-reported outcomes, clinical assessments, and a CPET. It is structured into an 8-week intervention phase followed by an 8-week follow-up phase. Following baseline assessment, patients will be randomly assigned to either the intervention group (IG) or the control group (CG). During the intervention phase, IG participants will receive a web-based, multimodal, symptom-titrated telerehabilitation program consisting of sports medicine consultations, weekly teleconsultations, a structured pacing approach, and exercise and respiratory therapy. In contrast, CG participants will receive treatment as usual, which includes a single sports medicine consultation on healthy habits and a self-directed pacing approach for managing symptoms and daily activities. During the follow-up phase, IG participants will continue training independently without teleconsultations, whereas CG participants will undergo the same telerehabilitation intervention as the IG. A follow-up assessment will be conducted for both groups to evaluate long-term effects. This study adheres to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines and follows the Consensus on Exercise Reporting Template. RESULTS Recruitment began in August 2023 and was extended until March 2025. As of March 2025, 80 participants have been recruited, and data analysis is ongoing. Final results are expected by December 2025, with a cross-sectional analysis of baseline data anticipated by July 2025. CONCLUSIONS This study is the first randomized controlled trial investigating the effectiveness of multimodal and symptom-titrated telerehabilitation in patients with PCC who are severely affected. The integration of various objective diagnostic systems will provide valuable insights into emerging postviral fatigue syndromes, supporting the development of CPET-based diagnostics, personalized rehabilitation strategies, and future research on long-term telerehabilitation effectiveness. The findings will be disseminated through peer-reviewed publications, professional networks, and patient advocacy groups to ensure scientific, clinical, and public impact. TRIAL REGISTRATION German Clinical Trials Register (DRKS) DRKS00032394; https://drks.de/search/de/trial/DRKS00032394. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/65044.
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Affiliation(s)
- Aleksandar Tomaskovic
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
| | - Vincent Weber
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
| | - David T Ochmann
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
| | - Elmo Wanja Neuberger
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
| | - Ella Lachtermann
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
| | - Alexandra Brahmer
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
| | - Nils Haller
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
- Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria
- Division of Exercise and Movement Science, Institute for Sport Science, University of Göttingen, Göttingen, Germany
| | - Barlo Hillen
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
| | - Kira Enders
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
| | - Viktoria Eggert
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
| | - Peter Zeier
- Department of Clinical Psychology and Neuropsychology, Institute of Psychology, Johannes Gutenberg University Mainz, Mainz, Germany
| | - Klaus Lieb
- Department of Psychiatry and Psychotherapy, Leibniz Institute for Resilience Research, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
| | - Perikles Simon
- Department of Sports Medicine, Prevention and Rehabilitation, Institute of Sport Science, Johannes Gutenberg University Mainz, Mainz, Germany
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Lavoie A, Dubé V. Web-Based Nursing Intervention to Promote Physical Activity Among Older Adults After Coronary Revascularization: Protocol for Mixed Method Pilot Study. JMIR Res Protoc 2025; 14:e67678. [PMID: 40397502 DOI: 10.2196/67678] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2024] [Revised: 02/24/2025] [Accepted: 03/21/2025] [Indexed: 05/22/2025] Open
Abstract
BACKGROUND Given the high prevalence of coronary heart disease among older adults and aging populations, there is a need for secondary prevention interventions to help older adults become more physically active. Web-based interventions could be considered for this purpose, knowing that internet use is growing rapidly among older adults. In addition, since older adults would appreciate developing a trusting relationship with a nurse, web-based interventions should include this support, which is not widely observed in the literature. OBJECTIVE This study aims to evaluate a web-based nursing intervention aimed at promoting physical activity in people 65 years and older with coronary heart disease. METHODS A web-based nursing intervention was developed according to the Intervention Mapping framework in collaboration with a team of health care professionals (n=5) and based on the needs of older adults (n=10). The 7-week intervention (1 session per week) aims to support older adults living with coronary artery disease in resuming, maintaining, or increasing their level of physical activity after coronary bypass surgery or percutaneous coronary intervention. The intervention offers educational content on coronary heart disease and physical activity, suggestions for physical activity, reflective activities, case histories of older adults who have experienced different journeys, an electronic physical activity diary to track progress, and support from a nurse through feedback to increase knowledge, motivation, and sense of self-efficacy. The preliminary effects and impacts of the intervention will be assessed through a mixed method pilot study with a sequential explanatory design. First, a single-group pre-post test will be used to assess the intervention's preliminary effects on physical activity (electronic journal), quality of life (36-Item Short Form Health Survey version 2), knowledge (quiz), motivation, and self-efficacy (visual analog scale) of 30 older adults living with coronary heart disease, as well as the feasibility of the intervention. Second, a descriptive qualitative design will use semistructured interviews to assess the intervention's impacts as perceived by 8-12 older adults and its acceptability. Quantitative data on the effects of the intervention will be integrated with the collection and analysis of qualitative data to assess the impact perceived by older adults, using matrices. Nonparametric statistics and a thematic analysis will be produced. A joint display will be used to integrate mixed data. RESULTS The results of this study will provide insight into the preliminary evaluation of a web-based nursing intervention to support older adults living with coronary heart disease as they increase their physical activity levels. The recruitment commenced in June 2024, and data collection should be completed by June 2025. CONCLUSIONS With the potential to promote older adults' health, this study could guide the development of new interventions to meet the needs of an aging population. TRIAL REGISTRATION ClinicalTrials.gov NCT06197347; https://clinicaltrials.gov/study/NCT06197347. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/67678.
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Affiliation(s)
- Audrey Lavoie
- Faculty of Nursing, Université de Montréal, Montreal, QC, Canada
- Marguerite-d'Youville Research Chair on Humanistic Nursing Interventions, Université de Montréal, Montreal, QC, Canada
- Research center, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada
| | - Véronique Dubé
- Faculty of Nursing, Université de Montréal, Montreal, QC, Canada
- Marguerite-d'Youville Research Chair on Humanistic Nursing Interventions, Université de Montréal, Montreal, QC, Canada
- Research center, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada
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Rocke M, Knochenhauer E, Thams F, Antonenko D, Fromm AE, Jansen N, Aziziaram S, Grittner U, Schmidt S, Vogelgesang A, Brakemeier EL, Flöel A. Neuromodulation through brain stimulation-assisted cognitive training in patients with post-chemotherapy subjective cognitive impairment (Neuromod-PCSCI) after breast cancer: study protocol for a double-blinded randomised controlled trial. BMJ Open 2025; 15:e096162. [PMID: 40398955 PMCID: PMC12096976 DOI: 10.1136/bmjopen-2024-096162] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/05/2024] [Accepted: 04/24/2025] [Indexed: 05/23/2025] Open
Abstract
INTRODUCTION Breast cancer is the most common form of cancer in women. A considerable number of women with breast cancer who have been treated with chemotherapy subsequently develop neurological symptoms such as concentration and memory difficulties (also known as 'chemobrain'). Currently, there are no validated therapeutic approaches available to treat these symptoms. Cognitive training holds the potential to counteract cognitive impairment. Combining cognitive training with concurrent transcranial direct current stimulation (tDCS) could enhance and maintain the effects of this training, potentially providing a new approach to treat post-chemotherapy subjective cognitive impairment (PCSCI). With this study, we aim to investigate the effects of multi-session tDCS over the left dorsolateral prefrontal cortex in combination with cognitive training on cognition and quality of life in women with PCSCI. METHODS AND ANALYSIS The Neuromod-PCSCI trial is a monocentric, randomised, double-blind, placebo-controlled study. Fifty-two women with PCSCI after breast cancer therapy will receive a 3-week tDCS-assisted cognitive training with anodal tDCS over the left dorsolateral prefrontal cortex (target intervention), compared with cognitive training plus sham tDCS (control intervention). Cognitive training will consist of a letter updating task. Primary outcome will be the performance in an untrained task (n-back task) after training. In addition, feasibility, safety and tolerability, as well as quality of life and performance in additional untrained tasks will be investigated. A follow-up visit will be performed 1 month after intervention to assess possible long-term effects. In an exploratory approach, structural and functional MRI will be acquired before the intervention and at post-intervention to identify possible neural predictors for successful intervention. ETHICS AND DISSEMINATION Ethical approval was granted by the ethics committee of the University Medicine Greifswald (BB236/20). Results will be available through publications in peer-reviewed journals and presentations at national and international conferences. TRIAL REGISTRATION NUMBER ClinicalTrials.gov; NCT04817566, registered on 26 March 2021.
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Affiliation(s)
- Merle Rocke
- Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany
| | - Elena Knochenhauer
- Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany
| | - Friederike Thams
- Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany
| | - Daria Antonenko
- Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany
| | | | - Nora Jansen
- Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany
| | - Samaneh Aziziaram
- Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany
| | - Ulrike Grittner
- Berlin Institute of Health at Charite, Berlin, Germany
- Charite - Universitätsmedizin Berlin Institut fur Biometrie und Klinische Epidemiologie, Berlin, Germany
| | - Sein Schmidt
- Charite - Universitätsmedizin Berlin Klinik fur Neurologie mit Experimenteller Neurologie, Berlin, Germany
| | - Antje Vogelgesang
- Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany
| | - Eva-Lotta Brakemeier
- Department of Psychology and Psychotherapy, Universität Greifswald, Greifswald, Germany
| | - Agnes Flöel
- Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany
- German Centre for Neurodegenerative Diseases, Bonn, Germany
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Baumel A, Aderka IM. The Impact of Mechanisms of Action on Adherence and Outcomes in Self-Guided Digital Mental Health Interventions: Protocol for a Randomized Controlled Trial With Mediation Analysis. JMIR Res Protoc 2025; 14:e71238. [PMID: 40397492 DOI: 10.2196/71238] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2025] [Revised: 03/12/2025] [Accepted: 04/21/2025] [Indexed: 05/22/2025] Open
Abstract
BACKGROUND One of the main recognizable challenges in the digital mental health interventions field is that users adhere to these interventions in their unguided forms poorly. Studies have shown that a persuasive system design focused on encouraging users to make positive behavior changes in their lives can increase user engagement and a program's efficacy. This design approach can be referred to as therapeutic persuasiveness (TP) and includes a call to action, monitoring, ongoing feedback, and program adaptation based on user state. The goal of this study is to examine the causal impact of TP on program completion and outcomes in unguided digital mental interventions. We aim to examine these questions in digital parent training programs (DPTs) aimed at treating children's behavior problems. OBJECTIVE This study aims to (1) examine the impact of TP quality on usage, reduction in child behavior problems, and improvement in parenting variables; (2) examine the maintenance of treatment gains over a follow-up period; and (3) examine mediational pathways, including whether adherence to the program (measured by module completion rates) mediates reported changes. METHODS A randomized controlled trial will be conducted to compare 2 interventions that use the same evidence-based components of established DPTs, but that differ in terms of the quality of TP (standard: DPT-STD; enhanced TP: DPT-TP). We will recruit parents from 160 families with children aged 3-7 years with behavior problems who will be randomized into one of the 2 intervention arms. We will measure child behavior problems and related parenting variables at 5 time points: before (T1), during (T2 and T3), and after the intervention (T4 and T5). Program usage will be passively collected. RESULTS The study was funded in October 2023, and enrollment began in September 2024. As of the end of December 2024, 100 participants were enrolled in the study. Analyses are expected to be completed by September 2027. CONCLUSIONS Identifying conceptual scientific theories that draw a link between active ingredients embedded within a digital intervention function and their outcomes is crucial in advancing our understanding of what influences usage and outcomes. TRIAL REGISTRATION ClinicalTrials.gov NCT06514326; https://clinicaltrials.gov/study/NCT06514326. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/71238.
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Affiliation(s)
- Amit Baumel
- Department of Community Mental Health, University of Haifa, Haifa, Israel
| | - Idan M Aderka
- Department of Psychology, University of Haifa, Haifa, Israel
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Ombasa L, Miller J, Ware L, Abbotts-Holmes H, Tang J, Gasser O, Fraser K, Bayer S, Kemp R, Costello R, Highton A, Evans J, Merry T, Schultz M, Frampton C, Gearry R, McNabb W, Roy N. Impact of Mānuka Honey on Symptoms and Quality of Life in Individuals With Functional Dyspepsia: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc 2025; 14:e66417. [PMID: 40397937 DOI: 10.2196/66417] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2024] [Revised: 03/28/2025] [Accepted: 04/04/2025] [Indexed: 05/23/2025] Open
Abstract
BACKGROUND Functional dyspepsia is a common gastrointestinal condition that reduces the quality of life and increases health care costs. The lack of well-defined causes limits effective treatments. Consumers report using mānuka honey to treat gastrointestinal symptoms, although clinical evidence supporting such use is limited. Preclinical studies suggest its unique bioactive compounds may reduce gastrointestinal inflammation. Recently, 3,6,7-trimethyllumazine (Lepteridine), a natural pteridine in mānuka honey, was shown to inhibit enzymes involved in gastrointestinal inflammation in in vitro studies. Therefore, Lepteridine-standardized mānuka honey may deliver digestive health benefits. OBJECTIVE The aim of this feasibility study is to gather the data required to estimate sample size and support study logistics to design future trials. The primary objective will be preliminary assessments of the impact of Lepteridine-standardized mānuka honey on symptom severity and the quality of life in participants with mild-to-moderate functional dyspepsia. Other feasibility objectives include assessing the biological responses to mānuka honey standardized to medium and high levels of Lepteridine and measuring mānuka honey-derived metabolites in blood and urine. METHODS This is a 3-arm, parallel, controlled, double-blind, randomized feasibility study. A total of 75 healthy adults with symptoms of functional dyspepsia (Rome IV criteria) and mild-to-moderate dyspepsia severity (Short Form Leeds Dyspepsia Questionnaire) were recruited between October 2022 and September 2023. Participants were randomized into one of three groups: (1) mānuka honey standardized to contain 10 mg/kg Lepteridine, (2) mānuka honey standardized to contain 40 mg/kg Lepteridine, or (3) honey maple flavored syrup control. After a 2-week lead-in period, participants consumed 10 g of allocated intervention twice daily for 6 weeks. Throughout the study, participants completed daily bowel movement diaries and validated weekly questionnaires about their gastrointestinal symptoms and quality of life. Stool samples and 3-day diet records were collected at baseline and the end of the intervention. Blood samples were collected at baseline, weeks 2 and 4, and at the end of the intervention. In addition, 6 healthy participants without symptoms of functional dyspepsia were recruited to undergo an acute 5-hour assessment for the appearance of Lepteridine and related metabolites in plasma and urine following consumption of Lepteridine-standardized mānuka honey. The study was approved by the Northern B Health and Disability Ethics Committee. RESULTS Initial analysis includes 68 participants, with laboratory and data analyses being undertaken as of March 2024. The results of the primary and secondary outcomes will be published in peer-reviewed journals. CONCLUSIONS This study will provide essential information on the potential efficacy and suitability of Lepteridine-standardized mānuka honey for designing future clinical trials investigating its effect in treating symptoms of functional dyspepsia. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622001140741p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384094. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/66417.
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Affiliation(s)
- Laura Ombasa
- Department of Human Nutrition, University of Otago, Dunedin, New Zealand
- Riddet Institute, Massey University, Palmerston North, New Zealand
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
| | - Jody Miller
- Department of Human Nutrition, University of Otago, Dunedin, New Zealand
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
| | - Lara Ware
- Department of Human Nutrition, University of Otago, Dunedin, New Zealand
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
| | - Holly Abbotts-Holmes
- Department of Human Nutrition, University of Otago, Dunedin, New Zealand
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
| | - Jeffry Tang
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
- Malaghan Institute of Medical Research, Wellington, New Zealand
| | - Olivier Gasser
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
- Malaghan Institute of Medical Research, Wellington, New Zealand
| | | | - Simone Bayer
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
- Department of Medicine, University of Otago, Christchurch, New Zealand
| | - Roslyn Kemp
- Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand
| | - Rory Costello
- Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand
| | - Andrew Highton
- Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand
| | | | - Troy Merry
- Comvita NZ Limited, Paengaroa, New Zealand
| | - Michael Schultz
- Department of Medicine, University of Otago, Dunedin, New Zealand
| | | | - Richard Gearry
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
- Department of Medicine, University of Otago, Christchurch, New Zealand
| | - Warren McNabb
- Riddet Institute, Massey University, Palmerston North, New Zealand
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
| | - Nicole Roy
- Department of Human Nutrition, University of Otago, Dunedin, New Zealand
- Riddet Institute, Massey University, Palmerston North, New Zealand
- High-Value Nutrition National Science Challenge, Auckland, New Zealand
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Peralta-Gámez MS, Gómez de Quero Córdoba M, Reverté-Villarroya S, Cuesta-Martínez R. Comparison of Traditional and Ultrasound-Guided Techniques for Vascular Access in Patients with Difficult Venous Access in Emergency Departments: Randomized Clinical Trial Protocol. NURSING REPORTS 2025; 15:177. [PMID: 40423208 DOI: 10.3390/nursrep15050177] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2025] [Revised: 05/11/2025] [Accepted: 05/16/2025] [Indexed: 05/28/2025] Open
Abstract
Background: Vascular access in emergency departments (ED) is challenging for patients with difficult venous access (DIVA), causing delays and discomfort. Ultrasound-guided techniques may offer improved outcomes, making it crucial to assess their benefits, risks, and the effectiveness of validated identification systems. Objectives: To contribute new evidence regarding the effectiveness of validated tools for identifying DIVA and to assess the clinical benefits of ultrasound-guided vascular access in emergency care, and to assess their utility in arterial puncture for arterial blood gas sampling, from now on ABG, within the ED. Methods: This study follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for protocol development and the Consolidated Standards of Reporting Trials (CONSORT) guidelines for the conduct and reporting of the randomized clinical trial (RCT). The trial will be conducted in Spain throughout 2025. The study population will consist of 114 subjects with difficult intravenous access (DIVA), identified using the DIVA scale for individuals under 14 years of age and the A-DICAVE scale for adults, along with 80 subjects from the general surgical area (GSA). Participants will be randomly assigned, in a 1:1 ratio, to either the Control Group (CG) (traditional technique) or the Experimental Group (EG) (ultrasound-guided technique). Data collected will include sociodemographic characteristics, procedure-related variables (e.g., time required, human resources, and materials used), as well as pain levels, assessed using validated scales (EVA, FLACC, PAINAD), and overall satisfaction from both patients and healthcare professionals. Ethical approval has been obtained, and the trial will be registered as an RCT through an official clinical trial registry before recruitment begins. Results: Expected results suggest ultrasound guidance will significantly improve first-attempt success rates, reduce procedural time, enhance patient comfort, and optimize resource utilization compared to traditional techniques. Conclusions: The integration of ultrasound-guided vascular access into routine emergency protocols could enhance patient safety, satisfaction, and procedural efficiency in emergency care settings.
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Affiliation(s)
- Mercedes S Peralta-Gámez
- Emergency Department, Ávila Care Complex, Nuestra Señora de Sonsoles Hospital, Avenida Juan Carlos I, s/n, 05004 Ávila, Spain
| | - Marina Gómez de Quero Córdoba
- Nursing Department, Seu Vilafranca, Universitat Rovira i Virgili, Carrera Amalia Soler, 29, 08720 Vilafranca del Penedés, Spain
- Research Group on Advanced Nursing (CARING)-161, Universitat Rovira I Virgili, 43002 Tarragona, Spain
| | - Silvia Reverté-Villarroya
- Research Group on Advanced Nursing (CARING)-161, Universitat Rovira I Virgili, 43002 Tarragona, Spain
- Nursing Department, Campus Terres de l'Ebre, Universitat Rovira i Virgili, Avenue Remolins, 13-15, 43500 Tortosa, Spain
| | - Roser Cuesta-Martínez
- Research Group on Advanced Nursing (CARING)-161, Universitat Rovira I Virgili, 43002 Tarragona, Spain
- Nursing Department, Campus Catalunya, Universitat Rovira i Virgili, Avinguda Catalunya, 35, 43002 Tarragona, Spain
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Mueller M, Visini M, Mueller SA, Stadler T, Rajan GP, Morand GB, Hool SL, Schanne DH, Balermpas P, Limacher A, Chan S, Trelle S, Elicin O, Giger R. DeintensiF: Standard versus individualized deintensified follow-up after curative treatment in head and neck cancer: protocol of a randomized pilot study. Pilot Feasibility Stud 2025; 11:69. [PMID: 40380278 DOI: 10.1186/s40814-025-01651-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2024] [Accepted: 04/28/2025] [Indexed: 05/19/2025] Open
Abstract
BACKGROUND Around 70% of head and neck cancer (HNC) cases are diagnosed in an advanced stage. Improvements in treatment have led to a cure rate of up to 80-90% for early-stage and 40-50% for advanced-stage disease. However, routine follow-up involves social and financial burdens, including frequent imaging associated with radiation exposure and costs. Currently, there is no consensus on the follow-up strategy after HNC treatment, and no conclusive evidence shows a survival advantage for routine follow-up over symptom-driven self-referrals. The DeintensiF study aims to provide robust evidence, comparing standard follow-up with a tailored deintensified approach. Additionally, it seeks to explore whether early detection of recurrence/second primary malignancy in asymptomatic patients impacts survival and quality of life. The pilot phase aims to assess feasibility of patients' recruitment and adherence to the assigned follow-up strategy and patient-reported outcomes (PROs) questionnaire in the first 2 years. METHODS This randomized-controlled, multicenter, open-label, pilot study has the goal to randomize a minimum of 16 patients across three Swiss sites into two arms within 1 year. The Experimental Arm A: scheduled clinical exams every 6 months and monthly PRO with evaluation and possibility to alert for open urgent appointments; and the Control Arm B: regular visits every 3 months for the first 2 years and less frequent thereafter plus multiple scheduled imaging appointments for head and neck magnet resonance imaging (MRI) and computed tomography (CT) with contrast and chest CT scans. Patients' motivation for participation or not will be explored by additional questionnaire before randomization. The primary objective during the pilot phase is to evaluate the feasibility of recruiting and randomizing patients with complete remission 6 months after treatment of head and neck squamous cell carcinoma to a deintensified and to a conventional follow-up. The secondary objective is to assess adherence to the two different follow-up strategies. DISCUSSION If feasible, the DeintensiF pilot study will expand from the recruited patients (detailed in the "Methods" section) to a larger cohort of advanced HNC cases in the main trial, integrating electronic PRO tailored follow-up care. This approach aims to reshape follow-up practices, enhancing patient-centered strategies and outcomes in head and neck oncology. TRIAL-REGISTRATION ClinicalTrials.gov (NCT05388136); Swiss National Clinical Trial Portal (SNCTP000005198).
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Affiliation(s)
- M Mueller
- Department of Otorhinolaryngology, Head and Neck Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
- Private University in the Principality of Liechtenstein (UFL), Triesen, Liechtenstein
| | - M Visini
- Department of Otorhinolaryngology, Head and Neck Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
| | - S A Mueller
- Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich and University of Zurich, Zurich, Switzerland
| | - T Stadler
- Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich and University of Zurich, Zurich, Switzerland
| | - G P Rajan
- Department of Otorhinolaryngology, Head and Neck Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland
| | - G B Morand
- Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich and University of Zurich, Zurich, Switzerland
- Department of Otorhinolaryngology, Head and Neck Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland
| | - S-L Hool
- Department of Otorhinolaryngology, Head and Neck Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
| | - D H Schanne
- Department of Radiation-Oncology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
| | - P Balermpas
- Department of Radiation-Oncology, University Hospital Zurich and University of Zurich, Zurich, Switzerland
| | - A Limacher
- Department of Clinical Research, University of Bern, Bern, Switzerland
| | - S Chan
- Department of Clinical Research, University of Bern, Bern, Switzerland
| | - S Trelle
- Department of Clinical Research, University of Bern, Bern, Switzerland
| | - O Elicin
- Department of Radiation-Oncology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
| | - R Giger
- Department of Otorhinolaryngology, Head and Neck Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
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46
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Everhart KC, Wirth MD, Iskersky VN, Dail RB. Evaluating a blood warming device for packed red blood cell transfusions to decrease hypothermia in very preterm infants: A randomised control trial protocol. Transfus Med 2025. [PMID: 40371767 DOI: 10.1111/tme.13143] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2024] [Revised: 04/16/2025] [Accepted: 04/29/2025] [Indexed: 05/16/2025]
Abstract
BACKGROUND This protocol describes a study to test a commercial blood warming device in warming blood transfusions to prevent hypothermia associated with packed red blood cell (PRBC) transfusions in very preterm infants. OBJECTIVES Very preterm infants receiving blood transfusions warmed by a commercial blood warmer will have less central body hypothermia post transfusion (abdominal temperatures <36.5°C) and/or a higher mean abdominal temperature for the hour after the transfusion is complete compared to those receiving blood transfusions by standard of care. This trial has been registered with Clinicaltrials.gov (trial number NCT05170633). METHODS In this trial, which is funded by The Gerber Foundation and adhered to the SPIRIT2013 checklist, 140 very preterm infants with an order to receive PRBCs will be randomised into a standard of care group to receive one PRBC transfusion over 3 h with blood in a syringe at room temperature or into the intervention group to receive one PRBC transfusion over 3 h using a Hotline® Blood and Fluid Warmer. Abdominal skin temperatures will be measured every minute through a blood transfusion using a skin thermistor and datalogger. DATA ANALYSIS Descriptive statistics will be computed for each group to compare demographics and all infant pre-, during, and post-transfusion body temperatures. A student t-test will be used to compare the groups on mean post-transfusion temperatures as a primary outcome variable. To examine thermal change over time between the two groups, linear mixed models with a random intercept will be utilised. RESULTS This trial began in January 2022, in a South Carolina neonatal intensive care unit and is ongoing. DISCUSSION This RCT will determine if warming PRBC transfusions will prevent hypothermia in preterm infants during and after blood transfusions. Results from this trial will be used to design national standards for blood transfusions in preterm infants to decrease morbidity and mortality.
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Affiliation(s)
- Kayla C Everhart
- College of Nursing, University of South Carolina, Columbia, South Carolina, USA
| | - Michael D Wirth
- College of Nursing, University of South Carolina, Columbia, South Carolina, USA
| | - Victor N Iskersky
- Department of Neonatology, PEDIATRIX/PRISMA Health Richland, Columbia, South Carolina, USA
| | - Robin B Dail
- Health Sciences Endowed Professor, University of South Carolina College of Nursing, Columbia, South Carolina, USA
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47
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Wzorek-Łyczko K, Piwowarczyk A, Woźniak W, Kuchar E, Szymański H. A randomised trial of pleuran in paediatric acute gastroenteritis. Sci Rep 2025; 15:16912. [PMID: 40374943 PMCID: PMC12081596 DOI: 10.1038/s41598-025-94893-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/25/2024] [Accepted: 03/17/2025] [Indexed: 05/18/2025] Open
Abstract
Pleuran, as a potent immunomodulator targeting intestinal immunity with a strong safety profile, could be a potential treatment for acute gastroenteritis. This study evaluates the effect of pleuran on the duration and severity of acute infectious diarrhoea in children. This is a multi-centre, randomised, double-blind, placebo-controlled, CONSORT statement superiority trial. Children aged 2-10 years presenting to hospital with acute gastroenteritis were included. The primary outcome measure was the duration of diarrhoea. Twenty-seven children were enrolled. There were no significant differences between the experimental and control groups regarding duration of diarrhoea, hospitalisation, intravenous rehydration and symptom severity. The administration of Pleuran was well tolerated. In this study, Pleuran was ineffective in the treatment of acute gastroenteritis in children. Further studies are needed to investigate its potential as a nutraceutical in children.Clinical registration: ClinicalTrials.gov ID: NCT03988257 (the date of registration: 17/06/2019). The Medical University of Warsaw Bioethical Committee Approval: KB/45/2018. Nutricia Foundation Grant: RG-3/2018.
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Affiliation(s)
- Katarzyna Wzorek-Łyczko
- The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, 63A Żwirki & Wigury Street, Warsaw, 02-091, Poland.
| | - Anna Piwowarczyk
- The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, 63A Żwirki & Wigury Street, Warsaw, 02-091, Poland
| | - Weronika Woźniak
- The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, 63A Żwirki & Wigury Street, Warsaw, 02-091, Poland
| | - Ernest Kuchar
- The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, 63A Żwirki & Wigury Street, Warsaw, 02-091, Poland
| | - Henryk Szymański
- The Department of Pediatrics, St Hedwig of Silesia Hospital, Trzebnica, Poland
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48
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Yuan Y, Wang YJ, Guo A, Wang WG, Wang W, Liu PL, Shen ZX, Xie JR, Liu KL, Zhao M, Zuo JL, Liu K, Shi ZY, Liu ZL, Weng XS, Liu JP. Tibetan medicine pain relieving plaster for treatment of knee osteoarthritis: protocol for a multi-center, randomized, and positive drug controlled trial. Front Med (Lausanne) 2025; 12:1597183. [PMID: 40443514 PMCID: PMC12119513 DOI: 10.3389/fmed.2025.1597183] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2025] [Accepted: 05/01/2025] [Indexed: 06/02/2025] Open
Abstract
Objective This trial aims to evaluate the effectiveness and safety of a Tibetan medicine pain relieving plaster (PRP) in knee osteoarthritis (KOA) management, generating evidence-based support for clinical application. Method This multi-center, randomized, positive drug-controlled, non-inferiority trial will evaluate the effectiveness and safety of the PRP in symptomatic participants with KOA. The trial will enroll 440 participants, allocated in a 1:1 ratio to the PRP group and flurbiprofen cataplasms group. All participants will undergo a 7-day treatment period followed by 14-day post-treatment monitoring. We will assess pain severity by the pain dimension score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale, and evaluate knee joint function using the stiffness and joint function dimension scores of the WOMAC scale and knee joint range of motion. We will assess joint swelling by measuring knee circumference. The quality of life will be evaluated using EQ-5D-5L scale, with utility scores calculated based on utility values and changes in the frequency of each level across dimensions. For safety assessment, we will perform blood laboratory tests, detailed recording of adverse events, and assessment of the severity of local skin reactions to the plaster based on a four-point Likert scale. In addition, we will record information related to plaster use, compliance, and the use of rescue therapy. Discussion This methodologically robust randomized controlled trial will comprehensively characterize PRP's therapeutic potential in KOA management, specifically examining its impacts on core clinical manifestations (pain, mobility restriction, joint swelling) and patient-reported outcomes. The findings will inform evidence-based utilization of this approved Tibetan medicinal formulation in real-world clinical practice.
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Affiliation(s)
- Yi Yuan
- Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
| | - Ying-jie Wang
- Department of Orthopedic Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China
| | - Ai Guo
- Beijing Friendship Hospital, Capital Medical University, Beijing, China
| | | | - Wei Wang
- Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China
| | - Pei-lai Liu
- Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Zhi-xiu Shen
- Tibet Cheezheng Tibetan Medicine Co., Ltd., Tibet, China
| | - Jian-rong Xie
- Tibet Cheezheng Tibetan Medicine Co., Ltd., Tibet, China
| | - Kai-lie Liu
- Tibet Cheezheng Tibetan Medicine Co., Ltd., Tibet, China
| | - Min Zhao
- Tibet Cheezheng Tibetan Medicine Co., Ltd., Tibet, China
| | - Jing-ling Zuo
- Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
| | - Kai Liu
- Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
| | - Ze-yang Shi
- Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
| | - Zhao-lan Liu
- Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
| | - Xi-sheng Weng
- Department of Orthopedic Surgery, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China
| | - Jian-ping Liu
- Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
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49
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Smyth E, Politi L, Guinan E, Mockler D, O'Neill L. Dissemination planning in exercise oncology trials-a systematic review of trial protocols. Support Care Cancer 2025; 33:473. [PMID: 40369320 PMCID: PMC12078369 DOI: 10.1007/s00520-025-09532-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2024] [Accepted: 05/07/2025] [Indexed: 05/16/2025]
Abstract
PURPOSE The paucity of exercise rehabilitation services for cancer survivors indicates a research-to-practice gap. Dissemination and Implementation research addresses this gap by focusing on the adoption, implementation, and sustainability of evidence-based interventions. Dissemination, the active process of sharing research findings, is critical to the implementation of evidence-based practice. This systematic review examined adherence of exercise oncology trial protocols to the SPIRIT 2013 checklist items pertaining to dissemination planning, items 31a, 31b, and 31c, which address how dissemination is planned, authorship eligibility is considered, and what plans are in place to share data and the protocol. METHODS A systematic review was conducted following the PRISMA guidelines. EMBASE, MEDLINE, CINAHL, Web of Science-Core Collection, Google Scholar, and the Central Trial Registry via Cochrane were searched (16/05/2024). Title and abstract screening, full-text review, and data extraction were completed in duplicate. RESULTS Eighty-six trial protocols were included, thirty-one (36.1%) did not report dissemination plans. Item 31 was reported as follows (n = number of trials, frequency (%)); 31a plans to communicate trial results to: participants (n = 19, 22.1%), healthcare professionals (n = 43, 50%), the public (n = 25, 29.2%), and other relevant groups (n = 22, 25.6%), 31b: author eligibility (n = 3, 3.5%) and plans regarding use of professional writers (n = 4, 4.7%), and 31c plans for granting access to participant level dataset (n = 28, 32.6%), full protocol (n = 1, 1.2%) and statistical code (n = 1, 1.2%). Peer-reviewed journal (n = 41, 47.67%) and conferences/professional meetings (n = 38, 44.2%) were the most frequently reported planned dissemination strategies. CONCLUSION Reporting of the SPIRIT 2013 checklist Item 31 is generally low in exercise oncology trial protocols. Greater consideration of dissemination planning is required to support the implementation of exercise oncology research into practice. REGISTRATION https://doi.org/10.17605/OSF.IO/M8HFP.
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Affiliation(s)
- Emily Smyth
- Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland
- Trinity St James's Cancer Institute, Dublin, Ireland
| | - Lydia Politi
- School of Biochemistry and Immunology, Trinity College Dublin, The University of Dublin, Dublin, Ireland
| | - Emer Guinan
- Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland
- Trinity St James's Cancer Institute, Dublin, Ireland
| | - David Mockler
- John Stearne Library, Trinity Centre for Health Sciences, St. James's Hospital, Dublin, Ireland
| | - Linda O'Neill
- Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland.
- Trinity St James's Cancer Institute, Dublin, Ireland.
- Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland.
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50
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Hinten AE, Schluter PJ, van Deurs J, van Noorden L, McLay L. Outcomes of participating in the Let's Play programme on 0-5-year-old autistic children's engagement and caregivers' stress: study protocol for a parallel randomised controlled trial. BMJ Open 2025; 15:e081030. [PMID: 40379306 PMCID: PMC12083321 DOI: 10.1136/bmjopen-2023-081030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/16/2023] [Accepted: 04/11/2025] [Indexed: 05/19/2025] Open
Abstract
INTRODUCTION Vast empirical evidence highlights the importance of early identification, diagnosis and support for autistic children. Caregivers of autistic children often experience high levels of psychological distress; hence there is a need for parallel child and caregiver support. Autism New Zealand's Let's Play programme is a caregiver-mediated, community-based programme based on the principles of developmental and relational interventions (henceforth, developmental). Developmental interventions are evidence-based supports designed to enhance children's learning within the context of developmentally appropriate, naturalistic settings (eg, everyday routines, play). We aim to evaluate the effects of the Let's Play programme on autistic children's engagement and caregiver stress. METHODS AND ANALYSIS This study will be a single-blind (rater) randomised controlled trial with two parallel arms: immediate programme access (intervention) versus a waitlist control. Participants will be 64 caregivers of children aged 0-5 years with diagnosed or suspected autism, allowing for 20% attrition, based on power calculations. The Let's Play programme will be delivered over 9 weeks using a combination of small group workshops and in-home coaching. Primary outcome variables include child engagement and caregiver stress. Caregivers will complete measures at three time points (baseline, immediately post-programme and at the 6-month follow-up), and effectiveness will be analysed using generalised estimating equation models and intention-to-treat and per protocol analyses. ETHICS AND DISSEMINATION This trial was approved by Aotearoa New Zealand Ministry of Health's Health and Disability Ethics Committee (2022 FULL 13041). Findings will be communicated nationally and internationally via conferences, journal publications and stakeholder groups (eg, service providers for autistic children). Results will be shared regardless of magnitude or direction of effect. TRIAL REGISTRATION NUMBER ACTRN12622001139763.
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Affiliation(s)
- Ashley E Hinten
- Te Kaupeka Oranga | Faculty of Health, Te Whare Wānanga o Waitaha | University of Canterbury, Christchurch, New Zealand
| | - Philip J Schluter
- Te Kaupeka Oranga | Faculty of Health, Te Whare Wānanga o Waitaha | University of Canterbury, Christchurch, New Zealand
- School of Clinical Medicine, Primary Care Clinical Unit, The University of Queensland, Brisbane, Queensland, Australia
| | - Jenna van Deurs
- Te Kaupeka Oranga | Faculty of Health, Te Whare Wānanga o Waitaha | University of Canterbury, Christchurch, New Zealand
| | - Lauren van Noorden
- Te Kaupeka Oranga | Faculty of Health, Te Whare Wānanga o Waitaha | University of Canterbury, Christchurch, New Zealand
| | - Laurie McLay
- Te Kaupeka Oranga | Faculty of Health, Te Whare Wānanga o Waitaha | University of Canterbury, Christchurch, New Zealand
- Child Well-being Research Institute, Te Whare Wānanga o Waitaha | University of Canterbury, Christchurch, New Zealand
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