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Zheng W, Chotipanvithayakul R, Ingviya T, Guo F. Effects of home-based integrated sensory stimulation program to preterm infants on parents' depression and anxiety: a randomized controlled trial. Glob Health Action 2025; 18:2491848. [PMID: 40314668 PMCID: PMC12051557 DOI: 10.1080/16549716.2025.2491848] [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: 12/14/2024] [Accepted: 04/07/2025] [Indexed: 05/03/2025] Open
Abstract
BACKGROUND Preterm parents face higher risks of postpartum depression and anxiety, affecting bonding and infant development. Sensory stimulation shows promise, but its long-term impact on parental mental health needs further study. OBJECTIVES This study aimed to evaluate whether a home-based integrated sensory stimulation program, administered to preterm infants by their parents, could alleviate parental mental health issues and enhance maternal bonding and parenting competence. METHODS The program, including tactile, auditory, visual, gustatory, and olfactory stimuli, was assessed in a block-randomized controlled trial from November 2018 to January 2020. A total of 200 parents of preterm infants were recruited, and the intervention continued at home until the infants reached six months corrected age. Parents' depression and anxiety were assessed using validated scales at baseline, and at first, third, and sixth month follow-ups. RESULTS The intervention group included 98 parents, and the control group comprised 102 parents. At the six-month follow-up, the intervention group demonstrated significant improvements in maternal depression, state anxiety, and trait anxiety compared to the control group. In the mixed linear model, the intervention was associated with reductions in maternal trait anxiety (d =-2.18; 95% CI: -4.30, -0.06), paternal trait anxiety (d =-3.37; 95% CI: -5.62, -1.11) and state anxiety (d =-4.63; 95% CI: -7.00, -2.26). CONCLUSION The home-based integrated sensory stimulation program, when provided by parents to preterm infants, was effective in improving parents' mental health and can serve as an alternative treatment for postpartum depression and anxiety in parents of preterm infants at home.
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Affiliation(s)
- Wenjing Zheng
- Department of Pediatrics, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
| | - Rassamee Chotipanvithayakul
- Department of Epidemiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand
- Research Center for Kids and Youth Development, Prince of Songkla University, Hat Yai, Songkhla, Thailand
| | - Thammasin Ingviya
- Department of Family and Preventive Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand
- Department of Clinical Research and Medical Data Science, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand
| | - Fang Guo
- Department of Neonatology, Affiliated Hospital of Kunming University of Science and Technology Clinical College, Kunming, Yunnan, China
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Grepl P, Botek M, Krejčí J, McKune A. Molecular hydrogen inhalation modulates resting metabolism in healthy females: findings from a randomized, double-blind, placebo-controlled crossover study. Med Gas Res 2025; 15:367-373. [PMID: 39923133 PMCID: PMC12054672 DOI: 10.4103/mgr.medgasres-d-24-00085] [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: 09/13/2024] [Revised: 10/31/2024] [Accepted: 11/19/2024] [Indexed: 02/10/2025] Open
Abstract
Initially, molecular hydrogen was considered a physiologically inert and non-functional gas. However, experimental and clinical studies have shown that molecular hydrogen has anti-inflammatory, anti-apoptotic, and strong selective antioxidant effects. This study aimed to evaluate the effects of 60 minutes of molecular hydrogen inhalation on respiratory gas analysis parameters using a randomized, double-blind, placebo-controlled, crossover design. The study was conducted at Faculty of Physical Culture, Palacký University Olomouc from September 2022 to March 2023. Twenty, physically active female participants aged 22.1 ± 1.6 years who inhaled either molecular hydrogen or ambient air through a nasal cannula (300 mL/min) for 60 minutes while resting were included in this study. Metabolic response was measured using indirect calorimetry. Breath-by-breath data were averaged over four 15-minute intervals. Compared with placebo (ambient air), molecular hydrogen inhalation significantly decreased respiratory exchange ratio and ventilation across all intervals. Furthermore, the change in respiratory exchange ratio was negatively correlated with body fat percentage from 30 minutes onwards. In conclusion, 60 minutes of resting molecular hydrogen inhalation significantly increased resting fat oxidation, as evidenced by decreased respiratory exchange ratio, particularly in individuals with higher body fat percentages.
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Affiliation(s)
- Pavel Grepl
- Department of Natural Sciences in Kinanthropology, Faculty of Physical Culture, Palacký University Olomouc, Olomouc, Czech Republic
| | - Michal Botek
- Department of Natural Sciences in Kinanthropology, Faculty of Physical Culture, Palacký University Olomouc, Olomouc, Czech Republic
| | - Jakub Krejčí
- Department of Natural Sciences in Kinanthropology, Faculty of Physical Culture, Palacký University Olomouc, Olomouc, Czech Republic
| | - Andrew McKune
- Faculty of Health, UC-Research Institute for Sport and Exercise, University of Canberra, Canberra, ACT, Australia
- Discipline of Biokinetics, Exercise and Leisure Sciences, School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa
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Wu RY, Li XH, Li YC, Ren ZH, Yang BX, Liu ZT, Zhong BL, Liu CL. The effect of social robot interventions on anxiety in children in clinical settings: a systematic review and meta-analysis. J Affect Disord 2025; 382:304-315. [PMID: 40274113 DOI: 10.1016/j.jad.2025.04.102] [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: 01/06/2025] [Revised: 03/31/2025] [Accepted: 04/19/2025] [Indexed: 04/26/2025]
Abstract
AIMS Children in clinical settings are prone to anxiety due to developmental limitations, which hinders treatment progress. This systematic review and meta-analysis aimed to evaluate the efficacy of social robot interventions compared to routine care or alternative non-pharmacological strategies in reducing anxiety among children aged 4-12 years undergoing medical procedures in clinical settings, based on evidence from randomized controlled trials. METHODS The review protocol was prospectively registered in PROSPERO. Five electronic databases PubMed, Web of Science, Embase, Cochrane Library and PsycINFO were searched for randomized controlled trials (RCTs) examining the effects of SRs on children's anxiety. The search ends on 1 December 2024. A total of 10 RCTs meeting the inclusion criteria were identified, involving 877 children aged 4-12 years. RESULTS The meta-analysis reveals a significant reduction in anxiety levels among children who interacted with social robots in clinical settings. Subgroup analyses showed that 1) Both inpatient and outpatient children exhibited reduced anxiety levels. 2) School-age children experienced a decrease in anxiety following interventions with social robots. 3) The social robots were effective in alleviating children's anxiety using distraction techniques and psycho-educational interventions. CONCLUSIONS This meta-analysis is the first to summarize the effects of social robots on anxiety in children and finds an overall positive trend. It's more effective than traditional psychotherapy and has no adverse effects due to drug use. In the context of care shortages, social robots represent a significant tool for reducing anxiety among children in clinical settings and demonstrate promising potential.
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Affiliation(s)
- Ruo-Yan Wu
- Institute of Education, Research Center for Psychological and Health Science, China University of Geosciences, Wuhan 430070, China
| | - Xin-Heng Li
- School of Automation, China University of Geosciences, Wuhan 430070, China
| | - Yi-Chen Li
- Wuhan Mental Health Center, Hubei Province 430022, China
| | - Zhi-Hong Ren
- School of Psychology, Central China Normal University, Wuhan 430079, China
| | | | - Zhen-Tao Liu
- School of Automation, China University of Geosciences, Wuhan 430070, China.
| | | | - Chen-Ling Liu
- Institute of Education, Research Center for Psychological and Health Science, China University of Geosciences, Wuhan 430070, China.
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Boerhout CKM, Namba HF, Liu T, Beijk MAM, Damman P, Meuwissen M, Ong P, Sechtem U, Appelman Y, Berry C, Escaned J, Lerman A, Henry TD, van der Harst P, Delewi R, Piek JJ, van de Hoef TP. Rationale and design of the ILIAS ANOCA clinical trial: A blinded-arm controlled trial for routine ad-hoc coronary function testing. Am Heart J 2025; 286:1-13. [PMID: 40068714 DOI: 10.1016/j.ahj.2025.03.004] [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] [Received: 11/26/2024] [Revised: 02/19/2025] [Accepted: 03/05/2025] [Indexed: 04/04/2025]
Abstract
BACKGROUND Angina with nonobstructive coronary arteries (ANOCA) is a major cause of chronic coronary syndromes, affecting nearly half of patients with anginal symptoms who undergo invasive coronary angiography. ANOCA may lead to substantial symptom burden, increased risk of adverse cardiac events, increased healthcare utilization due to ongoing symptoms, repeat hospitalizations, and invasive testing. The pathophysiology of ANOCA often involves a variety of coronary disorders, such as coronary microvascular dysfunction, epicardial or microvascular vasospasm and endothelial dysfunction. While coronary function testing (CFT) can identify each of these specific endotypes, in current practice it is used as a second- or third-line diagnostic tool, delaying diagnosis which contributes to persistent symptoms and diminished quality of life. The ILIAS ANOCA clinical trial aims to enhance understanding and management of ANOCA through early routine CFT-guided management. METHODS After exclusion of obstructive coronary artery disease, eligible patients undergo comprehensive CFT, and will be randomized to blinding of the CFT results (control group) or disclosure of the CFT results combined with a tailored medical therapy escalation plan (intervention group). The control group will be unblinded after 1 year. The primary outcome is the mean difference in the within-subject change in Seattle Angina Questionnaire (SAQ) summary score between the groups at 6 months from baseline. Secondary outcomes include differences in SAQ-summary score and additional health-status and quality of life questionnaires at 12 and 24 months from baseline. CLINICAL TRIAL REGISTRATION International Clinical Trials Registry Platform identifier NL-OMON20739.
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Affiliation(s)
- Coen K M Boerhout
- Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands
| | - Hanae F Namba
- Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands
| | - Tommy Liu
- Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands; HartKliniek Rijswijk, Rijswijk, The Netherlands
| | - Marcel A M Beijk
- Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands
| | - Peter Damman
- Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands
| | | | - Peter Ong
- Department of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany
| | - Udo Sechtem
- Department of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany
| | - Yolande Appelman
- Department of Cardiology, Amsterdam University Medical Center, Location VUmc, Amsterdam, The Netherlands
| | - Colin Berry
- British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland; The West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, Scotland
| | - Javier Escaned
- Cardiology Department, Hospital Clínico San Carlos, IDISSC Universidad Complutense de Madrid Spain
| | - Amir Lerman
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN
| | - Timothy D Henry
- The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, OH
| | - Pim van der Harst
- Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands
| | - Ronak Delewi
- Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands
| | - Jan J Piek
- Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands
| | - Tim P van de Hoef
- Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
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5
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Niemelä VH, Reinikainen M, Nielsen N, Bass F, Young P, Lilja G, Dankiewicz J, Hammond N, Hästbacka J, Levin H, Moseby‐Knappe M, Saxena M, Tiainen M, Ceric A, Holgersson J, Kamp CB, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Düring J, Lybeck A, Johnsson J, Unden J, Lundin A, Kåhlin J, Grip J, Lotman E, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwé P, Ameloot K, Wise MP, McGuigan PJ, White J, Govier M, Maccaroni M, Ostermann M, Hopkins P, Proudfoot A, Handslip R, Pogson D, Jackson P, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Arnott C, Ramanan M, Panwar R, Delaney A, Reade M, Venkatesh B, Navarra L, Crichton B, Knight D, Williams A, Friberg H, Cronberg T, Jakobsen JC, Skrifvars MB. Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand 2025; 69:e70040. [PMID: 40392139 PMCID: PMC12090973 DOI: 10.1111/aas.70040] [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: 02/20/2025] [Accepted: 03/04/2025] [Indexed: 05/22/2025]
Abstract
BACKGROUND In patients resuscitated after cardiac arrest, a higher mean arterial pressure (MAP) may increase cerebral perfusion and attenuate hypoxic brain injury. Here we present the protocol of the mean arterial pressure after cardiac arrest and resuscitation (MAP-CARE) trial aiming to investigate the influence of MAP targets on patient outcomes. METHODS MAP-CARE is one component of the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) 2 x 2 x 2 factorial randomized trial. The MAP-CARE trial is an international, multicenter, parallel-group, investigator-initiated, superiority trial designed to test the hypothesis that targeting a higher (>85 mmHg) (intervention) versus a lower (>65 mmHg) (comparator) MAP after resuscitation from cardiac arrest reduces 6-month mortality (primary outcome). Trial participants are adults with sustained return of spontaneous circulation who are comatose following resuscitation from out-of-hospital cardiac arrest. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to allocation group. The sample size of 3500 participants provides 90% power with an alpha of 0.05 to detect a 5.6 absolute risk reduction in 6-month mortality, assuming a mortality of 60% in the control group. Secondary outcomes will be poor functional outcome 6 months after randomization, patient-reported overall health 6 months after randomization, and the proportion of participants with predefined severe adverse events. CONCLUSION The MAP-CARE trial will investigate if targeting a higher MAP compared to a lower MAP during intensive care of adults who are comatose following resuscitation from out-of-hospital cardiac arrest reduces 6-month mortality.
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Affiliation(s)
- V. H. Niemelä
- Department of Anaesthesia and Intensive CareHelsinki University Hospital and University of HelsinkiHelsinkiFinland
| | - M. Reinikainen
- Institute of Clinical MedicineUniversity of Eastern FinlandKuopioFinland
- Department of Anaesthesiology and Intensive CareKuopio University HospitalKuopioFinland
| | - N. Nielsen
- Department of Clinical Sciences Lund, Anesthesia and Intensive CareLund UniversityLundSweden
- Department of Anesthesia and Intensive CareHelsingborg HospitalHelsingborgSweden
| | - F. Bass
- The George Institute for Global HealthSydneyAustralia
- Royal North Shore HospitalSydneyAustralia
| | - P. Young
- Intensive Care UnitWellington HospitalWellingtonNew Zealand
- Medical Research Institute of New ZealandWellingtonNew Zealand
- Australian and New Zealand Intensive Care Research CentreMonash UniversityMelbourneVictoriaAustralia
- Department of Critical CareUniversity of MelbourneMelbourneVictoriaAustralia
| | - G. Lilja
- Neurology, Department of Clinical Sciences LundLund UniversityLundSweden
- Department of NeurologySkåne University HospitalLundSweden
| | - J. Dankiewicz
- Department of Clinical Sciences Lund, Section of CardiologySkåne University HospitalLundSweden
| | - N. Hammond
- Critical Care Program, The George Institute for Global HealthUNSWSydneyAustralia
- Malcolm Fisher Department of Intensive CareRoyal North Shore HospitalSydneyNew South WalesAustralia
| | - J. Hästbacka
- Wellbeing Services County of Pirkanmaa and Tampere University, Faculty of Medicine and Health TechnologyTampere University HospitalTampereFinland
| | - H. Levin
- Department of Clinical Sciences LundLund UniversityLundSweden
- Department of Research, Development, Education and InnovationSkåne University HospitalLundSweden
| | - M. Moseby‐Knappe
- Department of Clinical Sciences LundLund UniversityLundSweden
- Department of Neurology and RehabilitationSkåne University HospitalLundSweden
| | - M. Saxena
- Critical Care Division, Department of Intensive Care MedicineThe George Institute for Global HealthSydneyAustralia
- St George Hospital Clinical SchoolUniversity of New South WalesSydneyNew South WalesAustralia
| | - M. Tiainen
- Department of NeurologyHelsinki University Hospital and University of HelsinkiHelsinkiFinland
| | - A. Ceric
- Anesthesia and Intensive Care, Department of Clinical SciencesLund University, Skane University HospitalMalmöSweden
| | - J. Holgersson
- Department of Clinical Sciences Lund, Anesthesia and Intensive CareLund UniversityLundSweden
- Department of Anesthesia and Intensive CareHelsingborg HospitalHelsingborgSweden
| | - C. B. Kamp
- Copenhagen Trial Unit, Centre for Clinical Intervention ResearchCopenhagen University Hospital—RigshospitaletCopenhagenDenmark
- Department of Regional Health Research, Faculty of Health SciencesUniversity of Southern DenmarkCopenhagenDenmark
| | - J. Tirkkonen
- Intensive Care UnitTampere University HospitalTampereFinland
| | - T. Oksanen
- Department of Anaesthesia and Intensive Care, Jorvi HospitalUniversity Hospital of Helsinki and University of HelsinkiHelsinkiFinland
| | - T. Kaakinen
- Research Unit of Translational Medicine, Research Group of Anaesthesiology, Medical Research Center OuluOulu University Hospital and University of OuluOuluFinland
- OYS Heart, Oulu University HospitalMRC Oulu and University of OuluOuluFinland
| | - S. Bendel
- Institute of Clinical MedicineUniversity of Eastern FinlandKuopioFinland
- Department of Anaesthesiology and Intensive CareKuopio University HospitalKuopioFinland
| | - J. Düring
- Department of Clinical Sciences, Anesthesia and Intensive CareLund University, Skåne University HospitalMalmöSweden
| | - A. Lybeck
- Anesthesia and Intensive Care, Department of Clinical Sciences LundLund University, Skane University HospitalLundSweden
| | - J. Johnsson
- Department of Anesthesia and Intensive CareHelsingborg HospitalHelsingborgSweden
| | - J. Unden
- Department of Operation and Intensive CareHallands Hospital HalmstadHalmstadSweden
- Department of Intensive and Perioperative Care, Skåne University HospitalLund UniversityLundSweden
| | - A. Lundin
- Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska AcademyUniversity of GothenburgGothenburgSweden
| | - J. Kåhlin
- Perioperative Medicine and Intensive Care (PMI)Karolinska University HospitalStockholmSweden
- Department of Physiology and PharmacologyKarolinska InstitutetStockholmSweden
| | - J. Grip
- Perioperative Medicine and Intensive CareKarolinska University HospitalStockholmSweden
- Department of Clinical Science, Intervention and TechnologyKarolinska InstituteStockholmSweden
| | - E. Lotman
- North Estonia Medical CentreTallinnEstonia
| | - L. Romundstad
- Department of Anesthesia and Intensive Care Medicine, Division of Emergencies and Critical careOslo University HospitalOsloNorway
- Lovisenberg Diaconal University CollegeOsloNorway
| | - P. Seidel
- Department of Intensive Care MedicineStavanger University HospitalStavangerNorway
| | - P. Stammet
- Department of Anaesthesia and Intensive Care Medicine CentreHospitalier de LuxembourgLuxembourgLuxembourg
- Department of Life Sciences and Medicine, Faculty of Science, Technology and MedicineUniversity of LuxembourgEsch‐sur‐AlzetteLuxembourg
| | - T. Graf
- University Hospital Schleswig‐HolsteinUniversity Heart Center LübeckLübeckGermany
- German Center for Cardiovascular Research (DZHK), partner site Hamburg/Lübeck/KielGermany
| | - A. Mengel
- Department of Neurology and StrokeUniversity Hospital TuebingenTuebingenGermany
- Hertie Institute of Clinical Brain ResearchTuebingenGermany
| | - C. Leithner
- Department of NeurologyFreie Universität and Humboldt‐Universität zu Berlin, Charité—Universitätsmedizin BerlinBerlinGermany
| | - J. Nee
- Department of Nephrology and Medical Intensive CareCharité—Universitaetsmedizin BerlinBerlinGermany
| | - P. Druwé
- Department of Intensive Care MedicineGhent University HospitalGhentBelgium
| | - K. Ameloot
- Department of CardiologyZiekenhuis Oost‐LimburgGenkBelgium
| | - M. P. Wise
- Adult Critical CareUniversity Hospital of WalesCardiffUK
| | - P. J. McGuigan
- Wellcome‐Wolfson Institute for Experimental MedicineQueen's University BelfastBelfastUK
- Regional Intensive Care UnitRoyal Victoria HospitalBelfastUK
| | - J. White
- CEDAR (Centre for Healthcare Evaluation, Device Assessment and Research)Cardiff and Vale University Health Board CardiffCardiffUK
| | - M. Govier
- Bristol Royal InfirmaryUniversity Hospitals Bristol and WestonBristolUK
| | - M. Maccaroni
- Essex Cardiothoracic CentreEssexUK
- Anglia Ruskin School of MedicineARUEssexUK
| | | | - P. Hopkins
- Intensive Care Medicine Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life SciencesMedicine King's CollegeLondonUK
- Intensive Care Medicine, King's Critical CareKing's College Hospital, NHS Foundation TrustLondonUK
| | - A. Proudfoot
- Department of Perioperative Medicine, Barts Heart CentreSt Bartholomew's HospitalLondonUK
| | - R. Handslip
- St George's University Hospital NHS Foundation TrustLondonUK
| | - D. Pogson
- Department of Critical CarePortsmouth University Hospitals Trust CoshamPortsmouthUK
| | - P. Jackson
- Leeds Teaching Hospitals NHS TrustLeedsUK
| | - A. Nichol
- Australian and New Zealand Intensive Care Research CentreMonash UniversityMelbourneVictoriaAustralia
- University College Dublin Clinical Research Centre at St Vincent's University HospitalUniversity College DublinDublinIreland
- The Alfred HospitalMelbourneAustralia
| | - M. Haenggi
- Institute of Intensive Care MedicineUniversity Hospital ZurichZurichSwitzerland
| | - M. P. Hilty
- Institute of Intensive Care MedicineUniversity Hospital ZurichZurichSwitzerland
| | - M. Iten
- Department of Intensive Care MedicineInselspital University Hospital BernBernSwitzerland
| | - C. Schrag
- Klinik für IntensivmedizinKantonsspital St. GallenSt. GallenSwitzerland
| | - M. Nafi
- Istituto Cardiocentro TicinoLuganoSwitzerland
| | - M. Joannidis
- Division of Intensive Care and Emergency Medicine, Department of Internal MedicineMedical University InsbruckInnsbruckAustria
| | - C. Robba
- IRCCS Policlinico San MartinoGenoaItaly
- Dipartimento di Scienze Chirurgiche Diagnostiche IntegrateUniversity of GenovaGenovaItaly
| | - T. Pellis
- Anaesthesia and Intensive CarePordenone Hospital Azienda Sanitaria Friuli OccidentalePordenoneItaly
| | - J. Belohlavek
- 2nd Department of Internal Medicine, Cardiovascular MedicineGeneral University Hospital, 1st Faculty of Medicine, Charles University in PraguePragueCzech Republic
- Institute for Heart DiseasesWroclaw Medical UniversityWrocławPoland
| | - D. Rob
- 2nd Department of Medicine, Department of Cardiovascular Medicine, First Faculty of MedicineCharles University in Prague, General University Hospital in PraguePragueCzech Republic
| | - Y. Arabi
- King Saud bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research CenterRiyadhSaudi Arabia
| | - S. Buabbas
- Department of Anesthesia, Critical Care and Pain MedicineJaber Alahmad Alsabah HospitalKuwait
| | - C. Yew Woon
- Tan Tock Seng HospitalSingaporeSingapore
- Yong Loo Lin School of MedicineNational University of SingaporeSingaporeSingapore
- Lee Kong Chian School of MedicineNanyang Technological UniversitySingaporeSingapore
| | - A. Aneman
- Intensive Care UnitLiverpool Hospital, South Western Sydney Local Health DistrictSydneyNew South WalesAustralia
- South Western Clinical SchoolUniversity of New South WalesSydneyNew South WalesAustralia
- The Ingham Institute for Applied Medical ResearchSydneyNew South WalesAustralia
| | - A. Stewart
- Liverpool HospitalSydneyNew South WalesAustralia
| | - C. Arnott
- The George Institute for Global HealthSydneyAustralia
| | - M. Ramanan
- Department of CardiologyRoyal Prince Alfred HospitalSydneyNew South WalesAustralia
- Caboolture and Royal Brisbane and Women's HospitalsMetro North Hospital and Health ServiceBrisbaneQueenslandAustralia
- School of Clinical MedicineQueensland University of TechnologyBrisbaneQueenslandAustralia
| | - R. Panwar
- Critical Care Division, The George Institute for Global HealthUniversity of New South WalesSydneyNew South WalesAustralia
- School of Medicine and Public HealthUniversity of NewcastleNewcastleNew South WalesAustralia
| | - A. Delaney
- Critical Care Program, The George Institute for Global HealthUNSWSydneyAustralia
- Malcolm Fisher Department of Intensive CareRoyal North Shore HospitalSydneyNew South WalesAustralia
- Intensive Care UnitJohn Hunter HospitalNewcastleNew South WalesAustralia
| | - M. Reade
- Northern Clinical School, Sydney Medical SchoolUniversity of SydneySydneyNew South WalesAustralia
| | - B. Venkatesh
- The George Institute for Global HealthSydneyAustralia
| | - L. Navarra
- Medical Research Institute of New ZealandWellingtonNew Zealand
| | - B. Crichton
- Medical Research Institute of New ZealandWellingtonNew Zealand
| | - D. Knight
- Department of Intensive CareChristchurch HospitalChristchurchNew Zealand
| | | | - H. Friberg
- Anesthesia and Intensive Care, Department of Clinical Sciences LundLund UniversityLundSweden
- Intensive and Perioperative CareSkåne University HospitalMalmöSweden
| | - T. Cronberg
- Neurology, Department of Clinical Sciences LundLund UniversityLundSweden
- Department of NeurologySkåne University HospitalLundSweden
| | - J. C. Jakobsen
- Copenhagen Trial Unit, Centre for Clinical Intervention ResearchCopenhagen University Hospital—RigshospitaletCopenhagenDenmark
- Department of Regional Health Research, Faculty of Health SciencesUniversity of Southern DenmarkCopenhagenDenmark
| | - M. B. Skrifvars
- Department of Anaesthesia and Intensive CareHelsinki University Hospital and University of HelsinkiHelsinkiFinland
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6
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Adan MM, Mao X, Ding L, Abdullahi KM, Li G. Efficacy and safety of BCG and immune checkpoint inhibitors in non-muscle invasive bladder cancer: A meta-analysis with exploratory chemotherapy comparisons. Oncol Lett 2025; 30:348. [PMID: 40438876 PMCID: PMC12117413 DOI: 10.3892/ol.2025.15094] [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: 08/17/2024] [Accepted: 01/15/2025] [Indexed: 06/01/2025] Open
Abstract
Bladder cancer (BC) is a significant global health concern and includes non-muscle-invasive BC (NMIBC), which poses challenges due to recurrence and progression. Immunotherapy, such as immune checkpoint inhibitors (ICIs) and Bacillus Calmette-Guérin (BCG), shows promise particularly in cases of BCG failure or BCG-unresponsive NMIBC, with ICIs emerging as a potential treatment option for these challenging cases. To the best of our knowledge, the present study is the first to systematically compare the efficacy and safety of BCG with ICIs in NMIBC. The present meta-analysis identifies response predictors and treatment outcomes, which can help in recognizing potential biomarkers such as tumor characteristics, hemoglobin levels and baseline performance status, associated with therapy response. These insights may guide future research in developing personalized treatment strategies for BCG non-responsive NMIBC cases. Following the Preferred Reporting Standards for Systematic Reviews and Meta-Analyses guidelines, a systematic literature search identified relevant studies published between January 2015 and April 2024. Randomized controlled trials and clinical trials involving patients with BCG-refractory NMIBC were included in the primary analysis. Data extraction and analysis were conducted using Review Manager version 5.4, employing a random effects model. The risk of bias assessment followed the Cochrane guidelines. The present study included 2,154 participants across 10 studies evaluating treatments for NMIBC. Primary comparisons focused on BCG vs. ICIs: Pembrolizumab significantly improved tumor control (OR, 4.67; 95% CI, 1.43-15.25; P=0.01), progression-free survival (PFS; OR, 4.85; CI, 1.58-14.85; P=0.006), and overall survival (OS; OR, 3.61; CI, 1.28-10.19; P=0.02). Atezolizumab similarly outperformed BCG in metastatic disease (OR, 0.19; CI, 0.06-0.59; P=0.004) and lymph node involvement (OR, 0.43; CI, 0.20-0.93; P=0.03). ICIs exhibited a favorable safety profile vs. BCG, with fewer incidents of anemia (OR, 2.87; P=0.001) and diarrhea (OR, 1.79; P=0.03), despite higher rates of asthenia (OR, 7.33; P<0.00001) and pyrexia (OR, 3.26; P<0.00001). Exploratory comparisons with chemotherapy revealed pembrolizumab's advantages in terms of PFS (OR, 1.36; P=0.02) and OS (OR, 1.31; P=0.005), while atezolizumab improved metastatic control (OR, 0.54; P=0.0008). Heterogeneity was low for BCG comparisons (I2=0%) but high for chemotherapy (I2=81-95%). In conclusion, ICIs, particularly pembrolizumab and atezolizumab, demonstrate superior efficacy and safety over BCG in BCG-refractory NMIBC, supporting their use as first-line alternatives. These findings advocate for a paradigm shift in managing BCG-unresponsive disease, emphasizing personalized immunotherapy.
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Affiliation(s)
- Mohamed Mohamoud Adan
- Department of Urology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, P.R. China
| | - Xudong Mao
- Department of Urology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, P.R. China
| | - Lifeng Ding
- Department of Urology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, P.R. China
| | - Khalid Mohamoud Abdullahi
- Zhejiang Clinical Research Center of Minimally Invasive Diagnosis and Treatment of Abdominal Diseases, The Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310058, P.R. China
| | - Gonghui Li
- Department of Urology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, P.R. China
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7
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Sørensen JK, Jensen MSH, Grevstad U, Nikolajsen L, Runge C. Optimal Analgesic Volume for Popliteal Plexus Block After Total Knee Arthroplasty: A Blinded RCT Protocol. Acta Anaesthesiol Scand 2025; 69:e70057. [PMID: 40346895 PMCID: PMC12065016 DOI: 10.1111/aas.70057] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/11/2025] [Accepted: 04/26/2025] [Indexed: 05/12/2025]
Abstract
BACKGROUND Adjunct treatment with a popliteal plexus block (PPB) provides moderate enhancement to multimodal analgesic regimens following total knee arthroplasty while maintaining motor function. However, the optimal anesthetic volume of local anesthetic for PPB remains unknown. AIM To compare the analgesic effects of PPB with 10 versus 20 mL of local anesthetics as an adjunct to a femoral triangle block after total knee arthroplasty. METHODS This blinded, controlled, randomized clinical trial will include 120 patients, randomly assigned to receive PPB with either 10 or 20 mL of bupivacaine 5 mg/mL. All patients undergo primary total knee arthroplasty under spinal anesthesia and receive a multimodal analgesia regimen, including paracetamol, ibuprofen, opioids, dexamethasone, and a femoral triangle block. OUTCOMES Primary outcome is 24-h postoperative opioid consumption. Secondary outcomes include the frequency of patients with opioid-free analgesia in the first 24 h after surgery, postoperative pain intensity at rest and during mobilization, postoperative muscle function of the leg, ability to mobilize with crutches 6 h after surgery, and Quality of Recovery-15 survey at 24 h after surgery. CONCLUSION This trial hopes to optimize postoperative pain management after total knee arthroplasty by providing valuable insights into the optimal analgesic volume for PPB. TRIAL REGISTRATION Danish Data Protection Agency: 693807, clinicaltrials.gov: NCT06908837, CTIS: 2024-520204-26-00.
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Affiliation(s)
- Johan Kløvgaard Sørensen
- Department of AnaesthesiologyElective Surgery Centre, Silkeborg Regional HospitalSilkeborgDenmark
- Department of Clinical MedicineAarhus UniversityAarhusDenmark
| | | | - Ulrik Grevstad
- Department of AnaesthesiaGentofte HospitalGentofteDenmark
| | - Lone Nikolajsen
- Department of Clinical MedicineAarhus UniversityAarhusDenmark
- Department of AnaesthesiologyAarhus University HospitalAarhusDenmark
| | - Charlotte Runge
- Department of AnaesthesiologyElective Surgery Centre, Silkeborg Regional HospitalSilkeborgDenmark
- Department of Clinical MedicineAarhus UniversityAarhusDenmark
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8
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Khan E, Lambrakis K, Briffa T, Cullen LA, Karnon J, Papendick C, Quinn S, Tideman P, Hengel AVD, Verjans J, Chew DP. Re-engineering the clinical approach to suspected cardiac chest pain assessment in the emergency department by expediting research evidence to practice using artificial intelligence. (RAPIDx AI)-a cluster randomized study design. Am Heart J 2025; 285:106-118. [PMID: 39993551 DOI: 10.1016/j.ahj.2025.02.016] [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] [Received: 07/04/2024] [Revised: 01/19/2025] [Accepted: 02/18/2025] [Indexed: 02/26/2025]
Abstract
BACKGROUND Clinical work-up for suspected cardiac chest pain is resource intensive. Despite expectations, high-sensitivity cardiac troponin assays have not made decision making easier. The impact of recently validated rapid triage protocols including the 0-hour/1-hour hs-cTn protocols on care and outcomes may be limited by the heterogeneity in interpretation of troponin profiles by clinicians. We have developed machine learning (ML) models which digitally phenotype myocardial injury and infarction with a high predictive performance and provide accurate risk assessment among patients presenting to EDs with suspected cardiac symptoms. The use of these models may support clinical decision-making and allow the synthesis of an evidence base particularly in non-T1MI patients however prospective validation is required. OBJECTIVE We propose that integrating validated real-time artificial intelligence (AI) methods into clinical care may better support clinical decision-making and establish the foundation for a self-learning health system. DESIGN This prospective, multicenter, open-label, cluster-randomized clinical trial within blinded endpoint adjudication across 12 hospitals (n = 20,000) will randomize sites to the clinical decision-support tool or continue current standard of care. The clinical decision support tool will utilize ML models to provide objective patient-specific diagnostic probabilities (ie, likelihood for Type 1 myocardial infarction [MI] versus Type 2 MI/Acute Myocardial Injury versus Chronic Myocardial Injury etc.) and prognostic assessments. The primary outcome is the composite of cardiovascular mortality, new or recurrent MI and unplanned hospital re-admission at 12 months post index presentation. SUMMARY Supporting clinicians with a decision support tool that utilizes AI has the potential to provide better diagnostic and prognostic assessment thereby improving clinical efficiency and establish a self-learning health system continually improving risk assessment, quality and safety. TRIAL REGISTRATION ANZCTR, Registration Number: ACTRN12620001319965, https://www.anzctr.org.au/.
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Affiliation(s)
- Ehsan Khan
- College of Medicine and Public Health, Flinders University of South Australia, Adelaide, Australia; Department of Health, SA Health, South Australian, Adelaide, Australia
| | - Kristina Lambrakis
- College of Medicine and Public Health, Flinders University of South Australia, Adelaide, Australia; Department of Health, SA Health, South Australian, Adelaide, Australia
| | - Tom Briffa
- School of Population and Global Health, University of Western Australia, Perth, Australia
| | - Louise A Cullen
- Emergency and Trauma Centre, Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Public Health, Queensland University of Technology, Brisbane, Australia; School of Medicine, University of Queensland, Brisbane, Australia
| | - Jonathon Karnon
- College of Medicine and Public Health, Flinders University of South Australia, Adelaide, Australia
| | - Cynthia Papendick
- Department of Health, SA Health, South Australian, Adelaide, Australia
| | - Stephen Quinn
- Department of Statistics, Department of Health Science and Biostatistics, Swinburne University of Technology, Melbourne, Australia
| | - Phil Tideman
- College of Medicine and Public Health, Flinders University of South Australia, Adelaide, Australia; Department of Health, SA Health, South Australian, Adelaide, Australia
| | - Anton Van Den Hengel
- Australian Institute for Machine Learning (AIML), The University of Adelaide, Adelaide, SA, Australia
| | - Johan Verjans
- South Australian Health and Medical Research Institute, Adelaide, Australia; Department of Health, SA Health, South Australian, Adelaide, Australia
| | - Derek P Chew
- College of Medicine and Public Health, Flinders University of South Australia, Adelaide, Australia; South Australian Health and Medical Research Institute, Adelaide, Australia; Department of Health, SA Health, South Australian, Adelaide, Australia.
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Springborg AH, Varnum C, Nielsen NI, Rasmussen LE, Kjærsgaard-Andersen P, Pleckaitiene L, Gromov K, Troelsen A, Kehlet H, Foss NB. Repeat-dose dexamethasone to prevent pain relapse after total knee arthroplasty in high-pain-response patients: A randomised, double-blind, placebo-controlled superiority trial. Eur J Anaesthesiol 2025; 42:599-608. [PMID: 40364780 DOI: 10.1097/eja.0000000000002189] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/15/2025]
Abstract
BACKGROUND Peri-operative glucocorticoids reduce pain after total knee arthroplasty, with evidence suggesting potential benefits of increased dosing in specific patient groups. However, the impact of repeat-dose glucocorticoids has not been studied in high-pain-response patients receiving pre-operative high-dose glucocorticoids. OBJECTIVE To investigate the effect on pain of an oral dose of dexamethasone after total knee arthroplasty in selected high-pain-response patients who had received a pre-operative high dose of intravenous dexamethasone (1 mg kg -1 ). DESIGN Randomised, double-blind, placebo-controlled superiority study. SETTING A multicentre study conducted at two major arthroplasty centres in Denmark from November 2021 to March 2024. PATIENTS One hundred and ten patients undergoing total knee arthroplasty who had received multimodal analgesia including pre-operative intravenous dexamethasone 1 mg kg -1 . Selection criteria included a Pain Catastrophising Scale score greater than 20 and moderate-to-severe pain (VAS >30) during walking 24 h postoperatively. INTERVENTION Patients were randomised to either oral dexamethasone 24 mg or placebo on postoperative day 1. MAIN OUTCOME MEASURES The primary outcome was the proportion of patients experiencing moderate-to-severe pain during walking at 48 h postoperatively. Secondary outcomes included pain scores at various time points within 1 week postoperatively, rescue analgesics, quality of sleep, length of hospital stay and morbidity with follow-up at 30 days. RESULTS At 48 h postoperatively, 65% of patients in the dexamethasone group and 79% in the placebo group reported moderate-to-severe pain during walking: odds ratio 0.48 [95% confidence interval (CI), 0.20 to 1.16]; P = 0.100. The mean ± SD Visual Analogue Scale (VAS) at 48 h during walking was 43 ± 21 in the dexamethasone group and 51 ± 22 in the placebo group ( P = 0.051). There were no differences between the groups regarding secondary pain outcomes or the use of rescue analgesics. CONCLUSION The administration of a high oral dose of dexamethasone following an initial pre-operative dose of 1 mg kg -1 intravenously in selected high-pain-response patients had no effect on postoperative pain following total knee arthroplasty. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT05563155.
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Affiliation(s)
- Anders H Springborg
- From the Department of Anaesthesiology, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre (AHS, NIN, NBF), Department of Orthopaedic Surgery, Lillebaelt Hospital - Vejle, Vejle (CV, LER, PKA, LP), Department of Orthopaedic Surgery, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre (KG, AT), Department of Clinical Medicine, University of Copenhagen (KG, AT, HK, NBF) and Section of Surgical Pathophysiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark (HK)
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10
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Brilli D, Giansanti M, Cassetta M. Does the operator's generational cohort influence the accuracy of orthodontic miniscrews insertion in the palatine vault in dynamic computer-guided surgery? A randomized prospective study. Oral Maxillofac Surg 2025; 29:120. [PMID: 40493264 DOI: 10.1007/s10006-025-01414-7] [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: 03/24/2025] [Accepted: 06/01/2025] [Indexed: 06/12/2025]
Abstract
PURPOSE This study aimed to evaluate intergenerational differences in miniscrew placement accuracy in the palatine vault using dynamic computer-assisted surgery (d-CAS), and to assess the correlation between the number of surgeries, and both accuracy variables and procedure duration. MATERIALS AND METHODS 72 subjects were enrolled and for each two miniscrews were inserted in the paramedian region via d-CAS (144 overall). Subjects were randomly allocated into three groups according to the operator's generation: Group A (Generation X), Group B (Generation Y), and Group C (Generation Z). CBCT scans were superimposed to evaluate five variables: Entry-3D, Entry-2D, Apex-3D, Apex-Vertical, and angular deviation. Procedure duration was calculated. Statistical analyses included descriptive statistics, Shapiro-Wilk, ANOVA, Kruskal-Wallis, Tukey and Dunn's tests and Pearson Correlation. P-value was set at ≤ 0.05. RESULTS ANOVA test demonstrated significant differences between the three groups in Entry-3D (P < 0.001), Entry-2D (P < 0.001), and Apex-3D (P = < 0.001) parameters, while Kruskal-Wallis test found a significant difference in angular deviation (P = 0.003). Post-hoc comparison revealed significant differences between groups A and C, and groups B and C. Pearson correlation indicated a negative correlation between intervention time and number of surgeries. CONCLUSIONS Miniscrew insertion using d-CAS is operator-dependent, and the generational cohort of the operator is a factor that influences certain accuracy parameters. There is a correlation between the progression of surgeries and a reduction in the time employed. Understanding the impact of generational differences can encourage the use of digital technologies for novices in clinical practice. CLINICAL TRIAL NUMBER NCT06661551 (clinicaltrials.gov; 10/25/2024).
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Affiliation(s)
- Davide Brilli
- Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Via Caserta, 6, 00161, Roma, RM, Italy.
| | - Matteo Giansanti
- Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Via Caserta, 6, 00161, Roma, RM, Italy
| | - Michele Cassetta
- Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Via Caserta, 6, 00161, Roma, RM, Italy
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11
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Preuss M, Röhrig R, Hübel C, Vos C, Unterkofler J, Brokmann JC, Willmes K, Plata C. Using an audiovisual feedback device improves cardiopulmonary resuscitation performance during day and night - a randomized controlled simulation study. BMC Emerg Med 2025; 25:95. [PMID: 40483391 PMCID: PMC12145583 DOI: 10.1186/s12873-025-01249-1] [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: 03/10/2025] [Accepted: 05/23/2025] [Indexed: 06/11/2025] Open
Abstract
BACKGROUND Survival of in-hospital-cardiac-arrests is lower when they occur at night and at weekends than when they occur during the day. Despite numerous studies, there is little evidence regarding the cardiopulmonary resuscitation quality at night and the influence of a feedback device depending on time of day. The present study investigates the differences between chest compressions at night and during the day, with and without the use of a feedback device. METHODS The study was approved by the local Ethics Committee and registered in the German Clinical Trials Register on 22nd of February 2022 (DRKS00027309) prior to inclusion of the first participant. 158 medical professionals were randomized into one of two groups: "no feedback" and "feedback"-group. In both groups, participants carried out three two-minute intervals of cardiopulmonary resuscitation on a manikin at day and at night. Members of the "feedback"-group received guidance by a feedback device. Primary endpoint was the mean compression depth at two time-intervals at the beginning (t1 = 30-60 s) and the end (t2 = 480-540 s) of the experience at night. Secondary endpoints included mean compression depth, adequate compression depth (%), compression rate and effective compressions (%). RESULTS At night, mean compression depth was significantly higher in the "feedback"-group at t1 (47.7 ± 7.9 mm, 95% CI [45.6-49.8] vs 42.9 ± 11.0 mm, 95% CI [40.8-45.0]) and t2 (46.2 ± 7.9 mm, 95% CI [44.0-48.4] vs 39.6 ± 11.6 mm, 95% CI [37.3-41.8]). There was no significant difference in mean compression depth between day and night in the "no feedback"-group (41.4 ± 10.8 mm, 95% CI [39.3-43.5] vs 42.2 ± 10.8 mm, 95% CI [40.1-44.3]) nor in the "feedback-group" (47.4 ± 7.6 mm, 95% CI [45.3-49.4] vs 47.4 ± 7.5 mm; 95% CI [45.4-49.5]). CONCLUSION The use of a real-time audiovisual feedback significantly improved compression depth during the day and night in a manikin-based simulation study with medical professionals.
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Affiliation(s)
- Melanie Preuss
- Center for Acute and Emergency Medicine, University Hospital, RWTH Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany
| | - Rainer Röhrig
- Institute for Medical Informatics, University Hospital, RWTH Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany
| | - Christian Hübel
- Center for Acute and Emergency Medicine, University Hospital, RWTH Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany
| | - Clara Vos
- Center for Acute and Emergency Medicine, University Hospital, RWTH Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany
| | - Jenny Unterkofler
- Center for Acute and Emergency Medicine, University Hospital, RWTH Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany
| | - Jörg Christian Brokmann
- Center for Acute and Emergency Medicine, University Hospital, RWTH Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany
| | - Klaus Willmes
- Department of Neurology, University Hospital, RWTH Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany
| | - Christopher Plata
- Center for Acute and Emergency Medicine, University Hospital, RWTH Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany.
- Institute for Medical Informatics, University Hospital, RWTH Aachen University, Pauwelsstrasse 30, 52074, Aachen, Germany.
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12
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Narayanan A, Khashram M, Fisher JP. Randomized cross-over trial comparing stress responses amongst undergraduates and surgeons with and without background music during simulated surgery. Sci Rep 2025; 15:19461. [PMID: 40461582 PMCID: PMC12134096 DOI: 10.1038/s41598-025-02202-9] [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: 04/06/2024] [Accepted: 05/12/2025] [Indexed: 06/11/2025] Open
Abstract
High stress may diminish a surgeon's performance in the operating room. Music is perceived to reduce stress in this setting, however the psycho-physiological effects of music on intra-operative stress in inexperienced and experienced operators is incompletely understood. The effect of music on the psychological (Six-Item State-Trait Anxiety Inventory [STAI-6] and Surgical Taskload Index [SURG-TLX]) and physiological responses (e.g., heart rate variability) was determined to a simulated surgical task (carotid patch-angioplasty) in 15 medical students and 12 vascular surgeons under stressing conditions in a randomised crossover design. Music did not affect the speed or accuracy of the simulated surgical stress task performance. While the surgical task increased SURG-TLX scores from baseline to control (Δ32 [22-42]; mean difference [95% confidence interval]) and to music (Δ30 [20-40]), and increased STAI-6 scores in both conditions, there was no difference between music and control. The surgical task also increased heart rate (peak Δ5.1 bpm [3.0-7.1] vs. baseline p < 0.0001) and an index of cardiac sympathetic nervous system activity, and reduced an index of parasympathetic nervous system activity, with the latter two exacerbated by music (SNS index: 0.14 [0.004-0.27], p = 0.042; PNS index: - 0.11 [- 0.22 to - 0.008], p = 0.032). The more experienced group performed faster and more accurately than the inexperienced group, but there were no psychological or physiological differences in their responses to music. Despite previous research identifying generally positive surgeon perceptions of music on the intra-operative experience of stress, herein, background music failed to improve surgical task performance or attenuate subjective ratings of task load and anxiety, and physiological arousal.
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Affiliation(s)
- Anantha Narayanan
- Department of Surgery, Faculty of Medicine and Health Sciences, University of Auckland, Auckland, New Zealand.
- Department of Vascular Surgery and Endovascular Surgery Waikato Hospital, Waikato, New Zealand.
- Department of Physiology, Faculty of Medicine and Health Sciences, University of Auckland, Auckland, New Zealand.
| | - Manar Khashram
- Department of Surgery, Faculty of Medicine and Health Sciences, University of Auckland, Auckland, New Zealand
- Department of Vascular Surgery and Endovascular Surgery Waikato Hospital, Waikato, New Zealand
| | - James P Fisher
- Department of Physiology, Faculty of Medicine and Health Sciences, University of Auckland, Auckland, New Zealand
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13
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Abbott K, Seton N, Kaur G, Zhao J, Jones M, Singh K. Long-term (12 months) vs. short-term (<12 months) dual antiplatelet therapy post-percutaneous coronary intervention with drug-eluting stents: a critical appraisal and systematic review. Coron Artery Dis 2025; 36:312-325. [PMID: 40326591 DOI: 10.1097/mca.0000000000001483] [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] [Indexed: 05/07/2025]
Abstract
BACKGROUND A growing body of evidence supports short-term DAPT as safe and efficacious following PCI with DES. However, methodological criticism of RCTs has led to caution when translating results into clinical practice. This study aimed to critically appraise the methodological rigour of included studies and consolidate the evidence on the safety and efficacy of short-term DAPT. METHODS Medline, Cochrane Library and Embase were searched from inception until August 2022. The primary outcome was the methodological quality of published primary studies. Risk of bias was assessed using RoB 2.0 and the CASP tool. Evidence was rated for quality using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) score approach. Other endpoints were all-cause mortality and major bleeding. RESULTS Eighteen RCTs were included. Based on GRADE score, there was a moderate level of certainty that the reported results for both outcomes are probably close to the true effect. A total of 78% (14/18) of RCTs had a low risk of bias when assessing all-cause mortality and 61% (11/18) when assessing major bleeding. The CASP tool confirmed methodological rigour; however, only 33% (6/18) of studies were applicable beyond the studied populations. Compared with 12 months of DAPT, short-term DAPT was associated with a reduced risk of major bleeding [relative risk (RR): 0.69, 95% CI: 0.54-0.88, P = 0.003, I2 = 45%] and trended towards a reduced risk in all-cause mortality (RR: 0.90, 95% CI: 0.79-1.01, P = 0.08, I2 = 0%). CONCLUSION With moderate certainty evidence, short-term DAPT appears safe and efficacious post-PCI with DES in the studied populations.
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Affiliation(s)
- Kolten Abbott
- Department of Medicine, Cairns and Hinterland Hospital and Health, Cairns North
- Department of Medicine, Griffith University School of Medicine
| | - Nicholas Seton
- Department of Medicine, Griffith University School of Medicine
- Department of Cardiology, Gold Coast Health Service, Southport
| | - Gurjeevan Kaur
- Department of Cardiology, Gold Coast Health Service, Southport
| | - Jilai Zhao
- Department of Medicine, Griffith University School of Medicine
| | - Mark Jones
- Department of Cardiology, Gold Coast Health Service, Southport
- Bond University Faculty of Health Sciences and Medicine, Gold Coast, Robina, Queensland
| | - Kuljit Singh
- Department of Medicine, Griffith University School of Medicine
- Department of Cardiology, Gold Coast Health Service, Southport
- Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia
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Guo X, Zai F, Tang X, Deng Y, Cheng J. Effectiveness and safety of acupoint embedding therapy for treating intractable facial paralysis: A systematic review and meta-analysis. Complement Ther Med 2025; 90:103162. [PMID: 40081507 DOI: 10.1016/j.ctim.2025.103162] [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: 04/13/2024] [Revised: 03/06/2025] [Accepted: 03/07/2025] [Indexed: 03/16/2025] Open
Abstract
OBJECTIVE Limited systematic reviews have explored the impact of acupoint embedding (AE) therapy on intractable facial paralysis (IFP). This review presents the current evidence on the efficacy and safety of AE therapy in the treatment of IFP. METHODS PubMed, Embase, Cochrane Library, Web of Science, Chinese Biomedical Literature Database, VIP Database for Chinese Technical Periodicals, China National Knowledge Infrastructure, and Wanfang databases were systematically searched from inception to February 2024 to identify randomized controlled trials (RCTs) without language restrictions. Data extraction and analysis were independently conducted by two reviewers. The Risk of Bias was assessed using the Risk of Bias tool (version 2.0), and a meta-analysis was performed using the RevMan software (V5.4). SETTING Eighteen RCTs involving 1881 patients were included in the analysis. RESULTS AE therapy demonstrated a higher total effective rate (relative risk [RR]: 1.28; 95 % confidence interval [CI]: 1.13-1.44; P < 0.0001), cure rate (RR: 1.81; 95 % CI: 1.05-3.12; P = 0.03), and facial nerve function score (standardized mean differences [SMD]: 1.57; 95 % CI: 1.16-1.99; P < 0.00001) compared to that of manual acupuncture. Additionally, AE therapy showed a higher total effective rate (RR: 1.16; 95 % CI: 1.10-1.22; P < 0.00001) and cure rate (RR: 1.70; 95 % CI: 1.46-1.98; P < 0.00001) in comparison to that of electroacupuncture. However, there were no significant differences in facial nerve function scores(SMD:2.04; 95 % CI: -1.25-5.32; P = 0.22) or adverse reactions(RR: 1.16; 95 % CI: 0.35-3.78; P = 0.81) between AE therapy and electroacupuncture therapy. Evidence supporting the efficacy and safety of AE treatment is also insufficient. CONCLUSION Most of the included studies indicated that AE therapy was more effective than MA/EA therapy for IFP. However, the quality of evidence for the majority of these studies was low, and all were conducted in China, where limited information has been reported regarding the safety of AE therapy.
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Affiliation(s)
- Xiaotong Guo
- Department of Acupuncture-Moxibustion and Physiotherapy, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China
| | - Fenglei Zai
- Department of Acupuncture-Moxibustion and Physiotherapy, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China.
| | - Xianliang Tang
- General Surgery, Zhuzhou People's Hospital, Zhuzhou, Hunan, China
| | - Yongkang Deng
- Department of Rehabilitation, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China
| | - Jianghui Cheng
- Department of Acupuncture-Moxibustion and Physiotherapy, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China
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15
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Sumphaongern T, Chantarangsu S. Effect of Dexmedetomidine on Blood Loss and Patient Outcomes in Orthognathic Surgery: A Randomised Clinical Trial. Int Dent J 2025; 75:1961-1969. [PMID: 39880716 DOI: 10.1016/j.identj.2025.01.009] [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: 10/03/2024] [Revised: 12/15/2024] [Accepted: 01/06/2025] [Indexed: 01/31/2025] Open
Abstract
INTRODUCTION AND AIMS Blood loss is a common side-effect in orthognathic surgery. Deliberated hypotensive anaesthesia can reduce blood loss. The purpose was to evaluate the effect of add-on dexmedetomidine compared with the usual hypotensive drug bolus on blood loss and patient outcomes in orthognathic surgery. METHODS This double-blinded randomised controlled trial study was conducted on patients with American Society of Anaesthesiology class I or II, and 18 to 45 years-old, scheduled for bimaxillary orthognathic surgery. Patients were randomly divided into 2 groups: study (add-on dexmedetomidine; D group) and control (usual bolus of the hypotensive drug; C group) by block randomisation. The primary outcome variables were blood loss, postoperative haemoglobin, and incidence of intraoperative blood transfusion. The secondary outcome variables were the stability of the vital signs, overall pain score and opioid requirement, anaesthetic time, quality of the operative visual field, surgeons' satisfaction, hospital stay length and side effects. Statistical significance was defined as P-value <.05. RESULTS The sample was composed of 60 patients with a mean age of 25.93 (4.66) years and 26 (43.30%) were male. The blood loss for D and C groups was 401.67 (131.62) and 898.33 (548.58) mL, respectively (P < .001). The D group demonstrated a significantly lower overall pain score 2.43 (1.36) versus 4.10 (1.19) for C group. The quality of the surgical field using Fromme's scale was significantly higher in D group 0.93 (0.83) versus 2.53 (0.94). Nausea/vomiting was also significantly lower in D group. CONCLUSIONS Adding-on dexmedetomidine in orthognathic surgery decreases blood loss and improves patient outcomes, especially in overall pain score, quality of the surgical field, and incidence of nausea/vomiting. CLINICAL RELEVANCE Dexmedetomidine can be considered a safe and effective medication for performing DHA in orthognathic surgery. Adding-on dexmedetomidine significantly reduced estimated blood loss by over 50% and improves patient outcomes.
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Affiliation(s)
- Thunshuda Sumphaongern
- Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.
| | - Soranun Chantarangsu
- Department of Dental Pathology, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand
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16
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Barbosa JC, da Luz BV, da Silva BFP, Marques AP, Saragiotto BT, Comachio J, Magalhaes MO. Effectiveness of Telerehabilitation Exercise Programme on Disability and Pain in Patients With Chronic Non-Specific Neck Pain: Randomised Controlled Trial Assessor-Blinded. Musculoskeletal Care 2025; 23:e70119. [PMID: 40374317 DOI: 10.1002/msc.70119] [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: 04/18/2025] [Revised: 04/19/2025] [Accepted: 05/08/2025] [Indexed: 05/17/2025]
Abstract
INTRODUCTION Chronic neck pain is an important public health problem. Telerehabilitation has emerged as an important tool for individuals with musculoskeletal conditions. OBJECTIVES The study aims to identify the effectiveness of a telerehabilitation exercise programme compared with a digital self-care booklet on non-specific neck pain. METHODS A randomised controlled trial assessor-blinded, 3 months follow-up. 70 patients were randomised into two groups of 35. The telerehabilitation group received 6 weeks of individualised training through vídeo calls and an online booklet. The control group received an online booklet. The primary outcome was functional disability. Secondary outcomes included pain intensity, global perceived effect, self-efficacy, quality of life, and kinesiophobia. All outcomes were assessed at baseline, 6 weeks, and a 3-month follow-up. RESULTS There was a significant difference between groups for functional disability (Mean 10.3, CI 95% 4.8-15.7), pain intensity (Mean 2.8, CI 95% 1.4-4.1), global perceived effect (Mean -2.3, CI 95% -3.7 to -0.9), and self-efficacy (Mean -24.7, CI 95% -41.0 to -8.4) at the 6-week. At the 3-month follow-up, statistically significant differences were observed for perceived overall effect (Mean -2.0, CI 95% -3.4 to -0.6) and self-efficacy (Mean -26.3, CI 95% -42.8 to -9.8). CONCLUSIONS Telerehabilitation is effective in improving disability and pain intensity compared with self-care booklets only in individuals with non-specific chronic neck pain. TRIAL REGISTRATION This trial is registered at https://ensaiosclinicos.gov.br/rg/RBR-10h7khvk under the registration number RBR10h7khvk at 09/16/2022.
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Affiliation(s)
- Juliene Corrêa Barbosa
- Master's Program in Human Movement Sciences, Federal University of Pará, Belém-Pará, Brazil
- Faculty of Physiotherapy and Occupational Therapy, Federal University of Pará, Belém-Pará, Brazil
| | - Bruna Vale da Luz
- Faculty of Physiotherapy and Occupational Therapy, Federal University of Pará, Belém-Pará, Brazil
| | | | - Amelia Pasqual Marques
- Department of Physiotherapy, Rehabilitation Sciences Program, Speech-Language Pathology and Audiology and Occupational Therapy, Faculty of Medicine, University of São Paulo, São Paulo, Brazil
| | | | - Josielli Comachio
- Sydney Musculoskeletal Health, School of Health Sciences, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, Australia
| | - Mauricio Oliveira Magalhaes
- Master's Program in Human Movement Sciences, Federal University of Pará, Belém-Pará, Brazil
- Faculty of Physiotherapy and Occupational Therapy, Federal University of Pará, Belém-Pará, Brazil
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17
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Thornton J, Barton KI, Churchill L, Schulz JM, Bryant D, Ambrose A, Hart HF, Stephenson D, Zou G, Correa S, MacDonald SJ, Degen R, Zwarenstein M, Getgood A. Novel uses of healthcare technology for individuals with mild to moderate hip or knee osteoarthritis: The technology, exercise and activity prescription for enhanced mobility (TEAM) study randomized controlled trial protocol. OSTEOARTHRITIS AND CARTILAGE OPEN 2025; 7:100586. [PMID: 40115196 PMCID: PMC11925574 DOI: 10.1016/j.ocarto.2025.100586] [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: 10/28/2024] [Accepted: 02/16/2025] [Indexed: 03/23/2025] Open
Abstract
Objectives Patient education, physical activity, and exercise are recommended as first-line treatments for mild to moderate hip and knee osteoarthritis (OA). We developed two novel healthcare interventions: an electronic medical record-embedded physical activity prescription tool (PARx) for physicians, and a free, online educational platform (Joint Management (JM)) with exercise programming and optional telerehabilitation with a physiotherapist for patients. Objectives: 1) Determine the effectiveness of PARx ± JM on patient-reported outcomes, physical activity levels, and performance-based functional outcomes in individuals with mild to moderate hip or knee OA, versus usual care; 2) evaluate engagement and adherence to PARx + JM; and 3) explore the feasibility of PARx and PARx + JM. Registration NCT04544904. Methods Randomized controlled trial (type 1 hybrid implementation effectiveness). We will recruit 339 (113/group) participants ≥40 years old with mild to moderate hip or knee OA and randomize them into three groups: PARx, PARx + JM, or control (usual care). Follow-up appointments will be completed at 2-, 6-, and 12-months. Primary outcome: Knee Injury/Hip Disability and OA Outcome Score. Secondary outcomes: physical activity levels, anthropometric measurements, physical function, and other patient-reported outcomes. We will assess intervention feasibility and hold focus groups with patients and providers to explore perceptions of the interventions. Conclusion Two novel healthcare interventions will be used to provide physical activity and exercise programming for individuals with mild-moderate knee and hip OA. This study will allow us to determine the effectiveness of these interventions on patient-reported outcomes, physical activity levels, and performance-based functional outcomes.
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Affiliation(s)
- Jane Thornton
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
- Fowler Kennedy Sport Medicine Clinic, Western University, London, ON, Canada
- Bone and Joint Institute, Western University, London, ON, Canada
| | - Kristen I Barton
- Orthopaedic Surgery, London Health Sciences Centre, London, ON, Canada
- School of Physical Therapy, Faculty of Health Sciences, Western University, London, ON, Canada
| | - Laura Churchill
- School of Physical Therapy, Faculty of Health Sciences, Western University, London, ON, Canada
- University of Colorado School of Medicine, Department of Physical Medicine and Rehabililtation, Physical Therapy Program, Colorado University, Denver, CO, United States
| | - Jenna M Schulz
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
- Fowler Kennedy Sport Medicine Clinic, Western University, London, ON, Canada
- Bone and Joint Institute, Western University, London, ON, Canada
| | - Dianne Bryant
- School of Physical Therapy, Faculty of Health Sciences, Western University, London, ON, Canada
- Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
| | - Ashley Ambrose
- Fowler Kennedy Sport Medicine Clinic, Western University, London, ON, Canada
| | - Harvi F Hart
- Bone and Joint Institute, Western University, London, ON, Canada
- School of Physical Therapy, Faculty of Health Sciences, Western University, London, ON, Canada
- Department of Kinesiology, Michigan State University, East Lansing, MI, United States
| | - Daryl Stephenson
- Health and Rehabilitation Sciences Graduate Program, Faculty of Health Sciences, Western University, London, ON, Canada
| | - Guangyong Zou
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
| | - Susana Correa
- Fowler Kennedy Sport Medicine Clinic, Western University, London, ON, Canada
| | - Steven J MacDonald
- Health and Rehabilitation Sciences Graduate Program, Faculty of Health Sciences, Western University, London, ON, Canada
| | - Ryan Degen
- Fowler Kennedy Sport Medicine Clinic, Western University, London, ON, Canada
- Bone and Joint Institute, Western University, London, ON, Canada
- Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
| | - Merrick Zwarenstein
- Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
- Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
| | - Alan Getgood
- Fowler Kennedy Sport Medicine Clinic, Western University, London, ON, Canada
- Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada
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Li T, Han Y, Zhang X, Zhao J, Suo Y, Hu Y. Impact of a high inspired oxygen fraction on oxidative stress in pediatric patients: reassuring results based on a randomized trial. Med Gas Res 2025; 15:332-338. [PMID: 39829169 PMCID: PMC11918476 DOI: 10.4103/mgr.medgasres-d-24-00073] [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: 08/22/2024] [Revised: 09/12/2024] [Accepted: 10/17/2024] [Indexed: 01/22/2025] Open
Abstract
High-concentration oxygen inhalation is the primary intervention to prevent perioperative hypoxemia. However, there are concerns that this may induce an imbalance in oxidation‒reduction processes, particularly in pediatric patients with compromised antioxidant defenses. This study aimed to evaluate the impact of varying intraoperative concentrations of oxygen inhalation on oxidative stress in children by analyzing plasma biomarkers, oxygenation indices, and the duration of surgery and oxygen inhalation. Forty-five children scheduled for laparoscopic pyeloplasty under general anesthesia were randomly assigned to three groups, each receiving different fractions of inspired oxygen during surgery: 30%, 50%, or 80%. The primary outcome was the plasma concentration of oxidative stress markers, and the other measurements included the surgical duration and duration of oxygen exposure. Thirty-five children completed the study, with 11 in the low group, 12 in the medium group and 12 in the high group. The levels of superoxide dismutase at immediately post-tracheal intubation, hydrogen peroxide at 1 hour post-intubation, and 8-isoprostane at immediately post-surgical procedure were significantly higher in the high group than in the low group. The S100B levels at immediately post-surgical procedure were higher than those at immediately post-tracheal intubation and 1 hour post-intubation within the low group. Therefore, we conclude that inhaling a high concentration of oxygen during laparoscopic pyeloplasty under general anesthesia, for a duration of less than 3 hours, does not significantly increase oxidative stress in pediatric patients. This study was registered at the Chinese Clinical Trial Registry (registration No. ChiCTR2400083143).
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Affiliation(s)
- Ting Li
- Department of Anesthesiology, Shaoxing Maternity and Child Health Care Hospital, Maternity and Child Health Care Affiliated Hospital, Shaoxing University, Shaoxing, Zhejiang Province, China
- Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
| | - Ying Han
- Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
| | - Xiaodie Zhang
- Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
| | - Jialian Zhao
- Department of Anesthesiology, Children’s Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
| | - Yaojun Suo
- Department of Anesthesiology, Children’s Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
| | - Yaoqin Hu
- Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
- Department of Anesthesiology, Children’s Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
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Liu J, Luo X, Chen Y, Zhao L, Yao M, Yu J, Yang J, Li L, Sun X. IDEAL-Acu: A Methodological Framework for Evaluating the Effects of Acupuncture. J Evid Based Med 2025; 18:e70043. [PMID: 40490676 DOI: 10.1111/jebm.70043] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2024] [Revised: 03/17/2025] [Accepted: 03/17/2025] [Indexed: 06/11/2025]
Abstract
OBJECTIVES The demand for high-quality clinical evidence supporting acupuncture remains urgent, necessitating the establishment of a suitable methodological framework to promote its generation. METHODS Following internal deliberations and extensive online discussions with experts in the IDEAL Collaboration, we proposed the IDEAL-Acu framework specifically for acupuncture, based on the surgery-focused IDEAL model with necessary modifications to accommodate the characteristics of acupuncture. To ensure consensus on recommendations, a panel of external experts and internal research team members was convened, and any disagreements were iteratively resolved through expert review. RESULTS This article introduces an IDEAL-Acu framework with five stages for evaluating acupuncture outcome and improving practice to optimize treatment. The framework includes Idea (proposal of an acupuncture regime), Development (optimization or standardization of the acupuncture regime), Exploration (feasibility assessment for conducting a definitive RCT), Assessment (evaluation of effects through comparison with standard therapy or sham acupuncture), and Long-term monitoring (examination of long-term efficacy and safety) stages. We provide clear recommendations for each stage along with specific examples. CONCLUSION The framework highlights the importance of conducting studies at each stage in acupuncture evaluation process and can serve as a helpful guide for assessing its effects and promoting evidence-based practice in acupuncture.
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Affiliation(s)
- Jiali Liu
- Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-Based Medicine Center, Cochrane China Center and IDEAL China Center, West China Hospital, Sichuan University, Chengdu, China
- NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China
- Sichuan Center of Technology Innovation for Real World Data, Chengdu, China
| | - Xiaochao Luo
- Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-Based Medicine Center, Cochrane China Center and IDEAL China Center, West China Hospital, Sichuan University, Chengdu, China
- NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China
- Sichuan Center of Technology Innovation for Real World Data, Chengdu, China
| | - Yemeng Chen
- New York College of Traditional Chinese Medicine, Mineola, New York, NewYork
| | - Ling Zhao
- Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Minghong Yao
- Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-Based Medicine Center, Cochrane China Center and IDEAL China Center, West China Hospital, Sichuan University, Chengdu, China
- NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China
- Sichuan Center of Technology Innovation for Real World Data, Chengdu, China
| | - Jiajie Yu
- Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-Based Medicine Center, Cochrane China Center and IDEAL China Center, West China Hospital, Sichuan University, Chengdu, China
| | - Jiahui Yang
- Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-Based Medicine Center, Cochrane China Center and IDEAL China Center, West China Hospital, Sichuan University, Chengdu, China
- College of Acupuncture and Massage, Jiangxi University of Chinese Medicine, Nanchang, China
| | - Ling Li
- Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-Based Medicine Center, Cochrane China Center and IDEAL China Center, West China Hospital, Sichuan University, Chengdu, China
- NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China
- Sichuan Center of Technology Innovation for Real World Data, Chengdu, China
| | - Xin Sun
- Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-Based Medicine Center, Cochrane China Center and IDEAL China Center, West China Hospital, Sichuan University, Chengdu, China
- NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China
- Sichuan Center of Technology Innovation for Real World Data, Chengdu, China
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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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Visser ME, Chipojola R, Gordon S, Brand A, Mbeye N, Kunje G, Mpando T, Lakudzala S, Besnier E, Naude CE. Early versus delayed enteral nutrition in critically ill children under 12 years of age: A systematic review and meta-analysis of randomised controlled trials. CLINICAL NUTRITION OPEN SCIENCE 2025; 61:108-128. [PMID: 40352760 PMCID: PMC7617657 DOI: 10.1016/j.nutos.2025.03.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/14/2025] Open
Abstract
Background & aims Enteral nutrition (EN) is key to reducing malnutrition risk in critically ill children, with timing of EN initiation being an important consideration. This systematic review aimed to assess the effects of early enteral nutrition (EEN) compared to delayed enteral nutrition (DEN) in critically ill children as part of the Global Evidence, Local Adaptation (GELA) project. Methods We searched PubMed, Embase and two trial registries (January 2000-November 2023) and included randomised controlled trials (RCTs) comparing EEN (typically within 24-48 hours of admission) to DEN (typically >48 hours of admission) in children aged one month to 12 years, and excluding studies in children with severe acute malnutrition, or conditions requiring long-term EN. Guided by Cochrane methods, we conducted random-effects meta-analyses to obtain pooled effect estimates for outcomes selected by the guideline development group, assessed risk of bias using Cochrane's Risk-of-Bias-2 tool and assessed certainty of the evidence using Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Results Four RCTs randomising 899 children in critical care settings in India, Iran and USA were included. Overall risk of bias was assessed as 'high risk' or 'some concerns' for all outcomes. Low-certainty evidence suggests that EEN may reduce in-hospital mortality (absolute effect (AE) 53 fewer deaths per 1000, 95% CI -85 to -12, I2=0%, 3 RCTs, n=869) and length of hospital stay on average (mean difference (MD) -2.98 days, 95% CI -9.79 to 3.83, I2=0%, 2 RCTs, n=760) compared to DEN, and may result in little to no difference in nosocomial infections (wound and blood stream infections) (AE 5 fewer cases per 1000, 95% CI -52 to 52, I2=0%, 3 RCTs, n=869). Evidence is very uncertain about effects on length of paediatric intensive care unit stay, number of days on the ventilator, sepsis, ventilator-associated pneumonia, and time to wound healing. Conclusion EEN may reduce in-hospital mortality and length of hospital stay in critically ill children, but our confidence in the effect estimates is limited. More high-quality studies comparing EEN to DEN in relation to patient-relevant and clinically important outcomes in paediatric critical illness are needed. Prospective registration PROSPERO CRD42023487325.
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Affiliation(s)
- Marianne E. Visser
- Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa
| | - Roselyn Chipojola
- Evidence Informed Decision-making Centre, Department of Community and Environmental Health, School of Global and Public Health, Kamuzu University of Health Sciences, Malawi
| | - Sarah Gordon
- Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa
| | - Amanda Brand
- Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa
| | - Nyanyiwe Mbeye
- Evidence Informed Decision-making Centre, Department of Community and Environmental Health, School of Global and Public Health, Kamuzu University of Health Sciences, Malawi
| | - Gertrude Kunje
- Evidence Informed Decision-making Centre, Department of Community and Environmental Health, School of Global and Public Health, Kamuzu University of Health Sciences, Malawi
| | - Talitha Mpando
- Evidence Informed Decision-making Centre, Department of Community and Environmental Health, School of Global and Public Health, Kamuzu University of Health Sciences, Malawi
| | - Suzgika Lakudzala
- Evidence Informed Decision-making Centre, Department of Community and Environmental Health, School of Global and Public Health, Kamuzu University of Health Sciences, Malawi
| | - Elodie Besnier
- Department of Health Sciences in Ålesund, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Norway
| | - Celeste E. Naude
- Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa
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Conte da Silva A, Nazário AK, Aily JB, Mattiello SM. Treatment of upper trapezius myofascial trigger points does not influence pain in individuals with shoulder pain: A randomized trial. J Bodyw Mov Ther 2025; 42:71-77. [PMID: 40325744 DOI: 10.1016/j.jbmt.2024.11.023] [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: 03/29/2024] [Revised: 10/26/2024] [Accepted: 11/16/2024] [Indexed: 05/07/2025]
Abstract
OBJECTIVE Assess whether manual therapy combined with the ischemic compression (IC) technique on myofascial trigger points (MTrPs) in the upper trapezius has the potential to affect shoulder pain and the quantity of MTrPs in the middle and lower trapezius muscles in individuals experiencing shoulder pain. METHODS Sixty individuals with shoulder pain were randomly assigned to three groups: Mobilization Group (MG, n = 20), underwent joint mobilizations of the shoulder complex; Compression Group (CG, n = 20), received mobilizations combined with IC on the myofascial trigger points (MTrPs) in the upper trapezius; and Placebo Group (PG, n = 20), underwent mobilizations combined with placebo IC. The interventions were administered twice a week for a duration of six weeks. Assessments were conducted at three time points: pre-treatment (week-0), post-treatment (week-6), and after a 1-month follow-up (week-10). Pain levels were evaluated using the Visual Analogue Scale and the number of MTrPs was counted by manual palpation for each muscle portion. RESULTS Assessments in week 6 showed decreased pain for all groups (p < 0.05). Moreover, the number of MTrPs of the upper trapezius decreased in the CG and MG (p = 0.05); for the middle trapezius decreases were observed only in the MG and for the lower trapezius decreases only in the CG. At week 10, all groups maintained the post-intervention effects, without differences between groups. CONCLUSION The addition of the IC technique on the upper trapezius MTrPs was able to influence the number of MTrPs of the three portions of the trapezius muscle. The pain decreased in all individuals.
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Affiliation(s)
- Alyssa Conte da Silva
- Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.
| | - Ana Karoline Nazário
- Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil
| | - Jéssica Bianca Aily
- Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil
| | - Stela Marcia Mattiello
- Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil
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Ram A, Kovats A, Ser Foong Ho D, Cooke L, Ram GP, Gibbs MT, Booth J, Thom JM, Jones MD. The influence of education on pain during and following acute exercise in people with knee osteoarthritis: A randomised controlled trial. Musculoskelet Sci Pract 2025; 77:103314. [PMID: 40139141 DOI: 10.1016/j.msksp.2025.103314] [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: 12/09/2024] [Revised: 03/12/2025] [Accepted: 03/17/2025] [Indexed: 03/29/2025]
Abstract
BACKGROUND Explicit education about exercise-induced hypoalgesia (EIH) reduces experimental pain after a single exercise session in pain-free individuals. However, the effect in people with chronic pain is unclear. This study aimed to determine the effect of EIH education on pain during and following exercise in people with knee osteoarthritis (OA). METHODS All procedures were administered online. Participants were randomised to receive 15-min of explicit EIH education or 15-min of general education about knee OA. Participants then completed a questionnaire on their beliefs about exercise and pain, followed by a bout of home-based lower limb resistance exercise. Pain intensity (0-10) was assessed before, during and immediately after exercise. RESULTS 40 participants completed the study (67.3 ± 10.8 years old, 73 % female). Participants only somewhat agreed pain could be reduced following a single session of exercise and that the education changed what they thought about exercise and pain, but these beliefs were not significantly different between groups (p = 0.053 and p = 0.104, respectively). Pain was similar between groups (adjusted mean difference [95 % CI]) during exercise (0.51 [-0.72 to 1.74], p = 0.410) and following exercise (-0.75 [-1.62 to 1.11], p = 0.087. Compared to baseline, pain (mean difference [95 % CI]) was lower during exercise (-1.01 [-1.66 to -0.36], p = 0.003) and following exercise (-0.96 [-1.5 to -0.42], p < 0.001). CONCLUSION A single exercise session reduces pain in people with knee OA, but this was not influenced by pre-exercise education about EIH. Further research is needed to understand if and how EIH can be modulated in people with knee OA.
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Affiliation(s)
- Adrian Ram
- School of Health Sciences, Faculty of Medicine & Health, The University of New South Wales, Sydney, Australia
| | - Alexandre Kovats
- School of Health Sciences, Faculty of Medicine & Health, The University of New South Wales, Sydney, Australia; School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Australia
| | - Darryl Ser Foong Ho
- School of Clinical Medicine, Faculty of Medicine & Health, The University of New South Wales, Sydney, Australia
| | - Laura Cooke
- School of Clinical Medicine, Faculty of Medicine & Health, The University of New South Wales, Sydney, Australia
| | - G Pramod Ram
- School of Clinical Medicine, Faculty of Medicine & Health, The University of New South Wales, Sydney, Australia
| | - Mitchell T Gibbs
- School of Health Sciences, Faculty of Medicine & Health, The University of New South Wales, Sydney, Australia; Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
| | - John Booth
- School of Health Sciences, Faculty of Medicine & Health, The University of New South Wales, Sydney, Australia
| | - Jeanette M Thom
- School of Health Sciences, Faculty of Medicine & Health, The University of New South Wales, Sydney, Australia; School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Australia
| | - Matthew D Jones
- School of Health Sciences, Faculty of Medicine & Health, The University of New South Wales, Sydney, Australia; Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.
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Vilarrasa J, Pereira Couto C, Àlvarez G, Carrió N, Gil J, Blanc V, Nart J. Microbiological, Inflammatory and Clinical Outcome of Citric Acid Passivated Definitive Abutments: Interim 12-Month Results From a Randomised Controlled Clinical Trial. J Clin Periodontol 2025; 52:813-825. [PMID: 40070156 DOI: 10.1111/jcpe.14146] [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: 10/14/2024] [Revised: 02/16/2025] [Accepted: 02/18/2025] [Indexed: 05/17/2025]
Abstract
AIM To assess the efficacy of citric acid passivation on implant abutments by evaluating their impact on bacterial load, microbiome composition, inflammatory response, and clinical and radiographic outcomes compared with control abutments over a 12-month follow-up period. METHODS Implants were placed subcrestally in the posterior sextants and randomly assigned to receive a 2-mm high definitive abutment, either with citric acid passivation (CA group) or without (CTR group). Final restorations were delivered after 12 weeks. Samples of the peri-implant crevicular fluid were collected at 3, 6 and 12 months for microbiological and inflammatory analysis. Clinical and radiographic measurements were also performed at these intervals. The primary outcome was total bacterial quantification (log CFU/mL). RESULTS Data from 17 patients in the CA group and 16 in the CTR group were analysed. At 12 months, there were no significant differences in total bacterial load between groups (p = 0.689). The biofilm was predominantly composed of commensal bacterial genera in both groups throughout the study period. Although no significant differences were observed in the microbiome alpha- and beta-diversity (p > 0.05), the microbiome within study time points showed an increased beta-diversity in the CA group at 12 months (p = 0.019). CA abutments also showed a higher differential abundance of peri-implant pathogenic bacterial genera at 12 months. At the 6-month mark, the CA group exhibited a trend toward lower IL-1β levels compared with the CTR group (p = 0.072). No significant differences were noted in other clinical or radiographic parameters. CONCLUSIONS Citric acid passivation of definitive abutments does not enhance the microbiological or inflammatory profiles in the short term. Further studies are needed to explore the potential benefits of citric acid passivation on implant abutments. TRIAL REGISTRATION Initially registered on clinicatrials.gov (NCT05592327).
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Affiliation(s)
- Javi Vilarrasa
- Department of Periodontology, Universitat International de Catalunya, Barcelona, Spain
| | - Carlos Pereira Couto
- Department of Periodontology, Universitat International de Catalunya, Barcelona, Spain
| | - Gerard Àlvarez
- Department of Microbiology, Dentaid Research Center, Cerdanyola del Vallès, Spain
| | - Neus Carrió
- Department of Periodontology, Universitat International de Catalunya, Barcelona, Spain
| | - Javier Gil
- Bioengineering Institute of Technology, Universitat Internacional de Catalunya, Barcelona, Spain
| | - Vanessa Blanc
- Department of Microbiology, Dentaid Research Center, Cerdanyola del Vallès, Spain
| | - José Nart
- Department of Periodontology, Universitat International de Catalunya, Barcelona, Spain
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Barcelos de Souza JC, da Silveira J, de Bem Fretta T, Gil PR, de Azevedo Guimarães AC. What are the effects of free dance and dance therapy on self-esteem, anxiety, body image and depressive symptoms of women undergoing breast cancer surgery? A randomized clinical trial. J Bodyw Mov Ther 2025; 42:1159-1167. [PMID: 40325652 DOI: 10.1016/j.jbmt.2025.03.004] [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: 11/02/2024] [Revised: 02/05/2025] [Accepted: 03/02/2025] [Indexed: 05/07/2025]
Abstract
OBJECTIVE To analyze the effect of two 12-week interventions with free dance and dance therapy compared to the control group on self-esteem, body image anxiety and depressive symptoms in women undergoing breast cancer surgery. METHODS Randomized clinical trial, with two different interventions (free dance and dance therapy) carried out at different periods, consisting of 23 female breast cancer survivors (58.7 ± 9.9 years), divided into two groups, the intervention group (IG - n = 11) who received different interventions at different times and the control group (CG -n = 12) who maintained their routine activities. The interventions lasted 12 weeks, with 60-min sessions, held twice a week and with a washout period of 35 days between them. The outcomes assessed were self-esteem (Self-Esteem Scale), anxiety (Beck Anxiety Inventory), body image (Body Image after Breast Cancer), and depressive symptoms (Beck Depression Inventory). RESULTS There was an improvement within the free dance group in depressive symptoms (p = 0.013) and within the dance therapy group in anxiety (p ≤ 0.001). Difference between the free dance group in the variable depressive symptoms (p ≤ 0.001) and difference between the dance therapy group in anxiety (p ≤ 0.001). In body image, the limitations domain showed an intragroup difference (p = 0.039) due to a worsening post-intervention in the CG compared to the dance therapy group. CONCLUSION Women survivors of breast cancer showed improvement in anxiety and depressive symptoms after performing 12 weeks of free dance and dance therapy. REGISTRATION Clinical registry: Brazilian Clinical Trials Registry (ReBEC) (nº 0RBR-772ktp).
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Affiliation(s)
| | - Juliana da Silveira
- College of Health and Sport Science, Santa Catarina State University, Florianopolis, Brazil
| | - Tatiana de Bem Fretta
- College of Health and Sport Science, Santa Catarina State University, Florianopolis, Brazil
| | - Priscila Rodrigues Gil
- College of Health and Sport Science, Santa Catarina State University, Florianopolis, Brazil
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Zipp CR, Semlitsch T, Tögel G, Krenn C, Loder C, Jeitler K, Siebenhofer A. An overview of systematic reviews on the efficacy and safety of osteopathic techniques. J Bodyw Mov Ther 2025; 42:1186-1197. [PMID: 40325655 DOI: 10.1016/j.jbmt.2025.03.018] [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: 08/18/2023] [Revised: 01/20/2025] [Accepted: 03/02/2025] [Indexed: 05/07/2025]
Abstract
OBJECTIVE To investigate the efficacy and safety of manipulative osteopathic techniques in persons of all ages with various medical indications. DESIGN Overview of systematic reviews and meta-analyses. METHOD We conducted a systematic literature search for systematic reviews of randomized controlled trials in English or German that compared osteopathic interventions to no treatment, sham treatment or any other non-osteopathic treatment, in bibliographic databases and other sources. RESULTS We included 27 systematic reviews covering nine therapeutic indications. Based on moderate quality of evidence, osteopathic treatment was an effective means of reducing pain and partially improving physical function in adults with acute neck pain, chronic non-specific low back pain, low back pain in pregnancy, and chronic non-oncologic pain. It can also shorten the length of hospital stays in premature infants. Furthermore, osteopathic treatment may relieve symptoms in adults with chronic neck pain, postpartum low back pain, migraine, and irritable bowel syndrome, and it may help children with otitis media. It did not appear to provide relief to adults with acute non-specific low back pain, fibromyalgia, headaches of various causes, women with lower urinary tract symptoms, and children with cerebral palsy. Evidence for other indications like vertigo, chronic obstructive pulmonary disease, hypertension, gynecological or birth-related complaints, and a number of pediatric indications was insufficient to draw firm conclusions. CONCLUSION Manipulative osteopathic techniques appears to be particularly effective in musculoskeletal conditions. Overall, the evidence base for the outcomes of manual osteopathic treatment has improved, despite heterogeneous studies that are partly of poor methodological quality.
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Affiliation(s)
- Carolin R Zipp
- Medical University of Graz, Institute of General Practice and Evidence-Based Health Services Research, Neue Stiftingtalstraße 6, 8010, Graz, Austria.
| | - Thomas Semlitsch
- Medical University of Graz, Institute of General Practice and Evidence-Based Health Services Research, Neue Stiftingtalstraße 6, 8010, Graz, Austria
| | - Gregor Tögel
- Medical University of Graz, Institute of General Practice and Evidence-Based Health Services Research, Neue Stiftingtalstraße 6, 8010, Graz, Austria
| | - Cornelia Krenn
- Medical University of Graz, Institute of General Practice and Evidence-Based Health Services Research, Neue Stiftingtalstraße 6, 8010, Graz, Austria
| | - Christine Loder
- Medical University of Graz, Institute of General Practice and Evidence-Based Health Services Research, Neue Stiftingtalstraße 6, 8010, Graz, Austria
| | - Klaus Jeitler
- Medical University of Graz, Institute of General Practice and Evidence-Based Health Services Research, Neue Stiftingtalstraße 6, 8010, Graz, Austria; Medical University of Graz, Institute for Medical Informatics, Statistics and Documentation, Auenbruggerplatz 2/5, 8036, Graz, Austria
| | - Andrea Siebenhofer
- Medical University of Graz, Institute of General Practice and Evidence-Based Health Services Research, Neue Stiftingtalstraße 6, 8010, Graz, Austria; Goethe University Frankfurt, Institute of General Practice, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany
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27
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Liu Q, Zhong Q, Tang G, Yang P, Ye L. Ultrasound-guided Genicular Nerve Block in Patients Undergoing Knee Arthroscopy: A Randomized Controlled Trial. Sports Med Arthrosc Rev 2025; 33:47-53. [PMID: 39724016 DOI: 10.1097/jsa.0000000000000384] [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: 12/28/2024]
Abstract
This study was to investigate the efficacy of ultrasound-guided genicular nerve block for patients who underwent knee arthroscopy. Patients were randomized into 2 groups: (1) nerve block group: ultrasound-guided genicular nerve block (superomedial, superolateral, and inferomedial genicular nerve, 2 ml 0.5% ropivacaine each nerve.) before the general anesthesia, (2) control group: no intervention before the general anesthesia. The measurements were pain severity at 3,6, 12, 24, 48, and 72 hours after surgery at rest and at activity (Pain severity was primary outcome at 3 hours after surgery at rest); the time for first ambulation; straight leg raise; mechanical pain threshold of the block areas; time of the surgery, anesthesia and extubation; the use of analgesics in the perioperative period and 72 hours after the surgery; the number of patients awakening from pain on the first 2 nights after the surgery; the length of hospital stay; postoperative adverse effects. The pain severity was measured by visual analogue scale (VAS) (A 10-point VAS, 0 points painless, 10 points severe pain) and median (interquartile range). A total of 70 patients (median age: 53 y, 32 men; 35 per group) were included. Compared with the control group, the nerve block group had a lower pain VAS score at rest [2 (2-2) vs. 3 (2-4), P <0.01] at 3 hours, and lower pain VAS score at rest persisted for 24 hours and activity persisted for 12 hours after the surgery, also had a lower intraoperative dosage of sufentanil (20±4.8 vs. 28.5±5.1 mg; P <0.001), lower requirement for analgesics for pain and lower postoperative nausea and vomiting throughout the 72-hour observation period. There were no significant differences in the incidence of postoperative adverse effects and straight leg raise. In conclusion, ultrasound-guided genicular nerve block could reduce the pain severity after knee arthroscopy and decrease the use of intraoperative sufentanil without affecting motor function.
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Affiliation(s)
- Qian Liu
- Department of Pain Management, West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China
- Department of Anesthesiology, Zigong First People's Hospital, Sichuan, People's Republic of China
| | - Qing Zhong
- Department of Anesthesiology, People's Hospital, Jianyang, Sichuan, People's Republic of China
| | - Guoqiang Tang
- Department of Anesthesiology, Zigong First People's Hospital, Sichuan, People's Republic of China
| | - Pingliang Yang
- Department of Anesthesiology, The First Affiliated Hospital of Chengdu Medical College, Xindu, Sichuan, P. R. China
| | - Ling Ye
- Department of Pain Management, West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China
- West China Tianfu Hospital, Sichuan University, Chengdu, Sichuan, China
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28
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Abd El Azeim AS, Mohamed FS, Felaya ESE, Ragab MM, Elkhateeb YS. Influence of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in mechanical neck pain randomized controlled trials. J Bodyw Mov Ther 2025; 42:629-637. [PMID: 40325732 DOI: 10.1016/j.jbmt.2025.01.045] [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: 07/24/2024] [Revised: 12/27/2024] [Accepted: 01/22/2025] [Indexed: 05/07/2025]
Abstract
BACKGROUND The high-power pain threshold ultrasound (HPPTUS) technique is one of the ultrasound modifications used to treat trigger points and is strongly recommended for patients with mechanical neck pain because this method has excellent benefits but the clinical significance of this method is unclear. AIM To investigate the influence of adding High power pain threshold ultrasound technique to traditional therapy on axioappendicular muscles amplitude and fatigue of patients with mechanical neck pain. DESIGN Single-blind, Randomized clinical trial. SETTING Outpatient clinic. POPULATION Sixty patients (19-38 years old) with mechanical neck pain participated in this study and were recruited from the outpatient clinic at the faculty of physical therapy after a referral from an orthopedist. METHODS Patients were randomly assigned by the opaque sealed envelope to two treatment groups: Group A Received High power pain threshold ultrasound (HPPTUS), traditional therapy in form of (active range of motion, stretching exercises, and postural correction exercises (PCES), whereas Group B Received traditional therapy only; therapeutic sessions were performed Twice/week for 4 weeks. The visual analog scale, pressure pain threshold, neck disability index, upper trapezius and Levator scapulae median frequency, and root mean square were used to evaluate the patients' pre-treatment and post-treatment status. RESULTS Multiple pairwise comparisons within each group revealed statistically significant differences in all outcome variables in both groups with favor to the HPPTUS group as p = 0.0001. Between group analysis at post treatment revealed statistical significant difference between both groups in all outcome variables as p = 0.0001. CONCLUSION The High-power Pain Threshold Ultrasound technique combined with traditional therapy is an effective method more than traditional therapy alone for management the patients with MNP. CLINICAL REHABILITATION IMPACT The present study has implications, especially for clinical decision-making with regard to the therapy of choice in MNP to reduce pain, improve function and muscle activity through HPPTUS technique, and its impact on normal lifestyle and highlight the need for active intervention.
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Affiliation(s)
- Alshaymaa S Abd El Azeim
- Physical Therapy department of Basic Science, Physical Therapy College, Cairo University, Egypt.
| | - Fatma Sh Mohamed
- Physical Therapy department of neurology and nuerosurgery, Physical Therapy College, Suez university, Egypt
| | - El-Sayed E Felaya
- Internal medicine department, faculty of physical therapy, Cairo University, Egypt
| | - Mohamed M Ragab
- Physical Therapy department of Basic Science, Physical Therapy College, Cairo University, Egypt
| | - Yasmin S Elkhateeb
- Physical Therapy department of Basic Science, Physical Therapy College, Egyptian Chinese University, Egypt
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29
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Christian H, Nathan A, Adams E, Trost SG, Schipperijn J. Impact of the Play Active policy intervention on early childhood educator's sedentary behaviour-related practices, psychosocial influences and meeting policy recommendations: Results from a pragmatic cluster randomized trial. Pediatr Obes 2025; 20:e70005. [PMID: 40068962 PMCID: PMC12056534 DOI: 10.1111/ijpo.70005] [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: 03/08/2024] [Revised: 02/13/2025] [Accepted: 02/17/2025] [Indexed: 05/08/2025]
Abstract
BACKGROUND High levels of sedentary behaviour are associated with poor child health outcomes such as obesity. Early childhood education and care (ECEC) services are a key intervention setting. Most ECEC policy-based interventions focus on children's nutrition and physical activity with few aimed at children's sedentary behaviour. OBJECTIVE To evaluate the effect of the Play Active ECEC policy intervention on educator adherence to sedentary behaviour policy recommendations, educator's practices and educator psychosocial influences related to children's sedentary behaviour. METHODS Pragmatic cluster randomized trial in 81 ECEC services in Perth, Western Australia. Services implemented the Play Active policy over three months. Outcomes were educator-reported changes in adherence to sedentary behaviour policy recommendations, practices and psychosocial influences related to children's sedentary behaviour. Analysis involved descriptive statistics and generalized linear mixed-effects models. RESULTS Adherence to sedentary behaviour policy recommendations and educator's practices and psychosocial influences related to children's sedentary behaviour was high at baseline and did not significantly change in response to the Play Active policy intervention. CONCLUSIONS Educators appeared to adhere to best-practice guidelines for children's sedentary behaviour in ECEC. Clear evidence informed policy, standards and legislation to maintain children's low levels of sedentary behaviours in ECEC is warranted.
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Affiliation(s)
- Hayley Christian
- The Kids Research Institute AustraliaThe University of Western AustraliaPerthWestern AustraliaAustralia
- School of Population and Global HealthThe University of Western AustraliaPerthWestern AustraliaAustralia
| | - Andrea Nathan
- The Kids Research Institute AustraliaThe University of Western AustraliaPerthWestern AustraliaAustralia
| | - Emma Adams
- The Kids Research Institute AustraliaThe University of Western AustraliaPerthWestern AustraliaAustralia
- School of Population and Global HealthThe University of Western AustraliaPerthWestern AustraliaAustralia
| | - Stewart G. Trost
- School of Human Movement and Nutrition SciencesUniversity of QueenslandBrisbaneQueenslandAustralia
| | - Jasper Schipperijn
- Department of Sports Science and Clinical BiomechanicsUniversity of Southern DenmarkOdenseDenmark
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Cercueil E, Henriet A, Barbe C, Santos Machado G, Bouvet L. Diagnostic accuracy of qualitative gastric ultrasound assessment for detecting high gastric fluid volume in children: a prospective randomised study. Anaesthesia 2025; 80:636-644. [PMID: 39764617 DOI: 10.1111/anae.16539] [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] [Accepted: 12/17/2024] [Indexed: 05/13/2025]
Abstract
INTRODUCTION The diagnostic accuracy of gastric ultrasound in children has not been assessed thoroughly. We aimed to determine the sensitivity and specificity in children of a qualitative ultrasound examination of the gastric antrum in the supine 45° semi-recumbent position and a clinical algorithm for detecting a gastric fluid volume > 1.25 ml.kg-1, reported to represent an 'at-risk stomach' for pulmonary aspiration. METHODS We conducted a prospective, observer-blinded, randomised trial in healthy children fasted according to current pre-operative guidelines. An initial ultrasound assessment of gastric contents ensured that the stomach was empty. Children then drank a specific volume of water (0; 0.6; 1; 1.25; 1.5; or 2 ml.kg-1). Gastric ultrasound was performed after 3 min of fluid ingestion, in children lying supine and then in the right lateral decubitus position, with the head of the bed elevated to 45° (semi-recumbent). A clinical algorithm combining the qualitative assessment with calculation of gastric fluid volume was also completed. The sensitivity and specificity of the qualitative assessment in the supine semi-recumbent position and the clinical algorithm for the diagnosis of gastric fluid volume > 1.25 ml.kg-1 were estimated. RESULTS Ninety children, median (IQR [range]) age 7 (4.5-9 [1-10]) y, were studied. The sensitivity and specificity of the qualitative assessment for detecting gastric fluid volume > 1.25 ml.kg-1 were 75% (95%CI 58-88%) and 85% (95%CI 73-93%), respectively. The sensitivity and specificity of the clinical algorithm were 86% (95%CI 71-95%) and 78% (95%CI 64-88%), respectively. DISCUSSION In order to achieve high sensitivity of gastric ultrasound for the diagnosis of fluid volume > 1.25 ml.kg-1 in children, qualitative ultrasound assessment of gastric antrum contents should be combined with calculation of gastric fluid volume when fluid contents are seen in the gastric antrum.
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Affiliation(s)
- Eloïse Cercueil
- Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France
| | - Anaïs Henriet
- Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France
| | - Corwyn Barbe
- Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France
| | - Guinter Santos Machado
- Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France
| | - Lionel Bouvet
- Department of Anaesthesia and Intensive Care, Hospices Civils de Lyon, Femme Mère Enfant Hospital, Bron, France
- Research Unit APCSe VetAgro Sup UP 2021.A101-University of Lyon, Université Claude Bernard Lyon 1, Villeurbanne, France
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Karaarslan D, Ergin D, Bal A, Utar A. The effect of the vein imaging device used in peripheral intravenous catheterization on the initial vascular access of the procedure in patients admitted to the children's emergency department: A randomized controlled trial. Int Emerg Nurs 2025; 80:101613. [PMID: 40349486 DOI: 10.1016/j.ienj.2025.101613] [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: 04/16/2024] [Revised: 04/09/2025] [Accepted: 04/16/2025] [Indexed: 05/14/2025]
Abstract
INTRODUCTION The intravenous cannulation of children in emergency can be extremely challenging. This study was aimed at investigating the effect of the vein-imaging device used in peripheral intravenous catheterization on the success of the procedure in patients who presented to the children's emergency department. METHODS In this randomized controlled study, 70 6- to 12-year-old children who presented to the emergency department were enrolled in the study. Then, they were randomly assigned to the vein imaging group (experimental group, n = 35) and to the standard group (control group, n = 35). The primary outcome measure was the success of the first attempt. Secondary outcome measures were the number of intravenous attempts and time allocated to the peripheral intravenous catheter placement. RESULTS Seventy children completed the study. Of them, 35 were girls and 35 were boys. The total time for the attempts per patient were shorter in the vein imaging group than it was in the standard group (29.48 ± 10.21 vs 35.00 ± 24.65). There was a significant difference between the children in the vein imaging device and standard groups in terms of the mean difficult intravenous access scores during the procedure (p < 0.05). The children in the vein imaging device group obtained higher mean scores than did the children in the standard group. DISCUSSION The use of new AccuVein AV500 technology assisted with peripheral intravenous catheterization access in children improves the first time success rate. Improved visualization of veins also reduced the number of attempts and the time required for the placement.
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Affiliation(s)
- Duygu Karaarslan
- Manisa Celal Bayar University, Faculty of Health Sciences, Department of Pediatric Nursing, Turkey.
| | - Dilek Ergin
- Manisa Celal Bayar University, Faculty of Health Sciences, Department of Pediatric Nursing, Turkey
| | - Alkan Bal
- Manisa Celal Bayar University, Department of Pediatric Emergency, Turkey
| | - Abdulkadir Utar
- Manisa Celal Bayar University, Department of Pediatric Emergency, Hafsa Sultan Hospital, Turkey
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Hussain N, Speer J, D'Souza RS, Palettas M, Abdel-Rasoul M, Uribe A, Weaver TE, Kushelev M, Coffman J, Abdallah FW. Exploring the Additive or Synergistic Effects of the Systemic and Perineural Routes of Dexamethasone as Adjuncts to Supraclavicular Block: A Randomized Controlled Trial. Anesthesiology 2025; 142:1127-1137. [PMID: 40036049 DOI: 10.1097/aln.0000000000005433] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/06/2025]
Abstract
BACKGROUND Both perineural and intravenous dexamethasone have been proposed as effective adjuncts that prolong the duration of peripheral nerve blocks. The authors sought to explore whether combining systemic with perineural dexamethasone yields any additive or synergistic effect on the characteristics and analgesic effects of peripheral nerve blocks. METHODS Adult patients having distal radius open reduction and internal fixation and/or carpometacarpal arthroplasty under supraclavicular block were randomized to intravenous dexamethasone, a combination of perineural plus intravenous dexamethasone, or no dexamethasone (control). Sensory block duration was set as the primary outcome. Secondary outcomes included motor block duration; postoperative rebound pain scores as well as worst pain at 8, 16, 24, 32, 40, and 48 h; opioid consumption at 0 to 24 and 25 to 48 h; incidence of nausea/vomiting; and presence of burning sensation in the blocked limb at 24 and 48 h. The null hypothesis was lack of difference in sensory block duration between the three groups. RESULTS A total of 104 patients were included in the analysis (intravenous dexamethasone, 37; intravenous plus perineural dexamethasone, 34; control, 33). Compared to intravenous dexamethasone alone, adding perineural dexamethasone did not yield any incremental benefits in any of the outcomes examined. The mean ± SD of sensory block duration was 21.3 ± 7.3 h in the intravenous dexamethasone group, 20.6 ± 6.1 h in the perineural plus intravenous group, and 16.8 ± 6.8 h in the control group. The mean difference (95% CI) of sensory block duration was significantly prolonged by 4.5 h (95% CI, 1.3 to 7.7; P = 0.006) in the intravenous dexamethasone group and 3.8 h (95% CI, 0.8 to 6.8; P = 0.015) in the perineural plus intravenous dexamethasone group compared to control; however, no difference was observed when the two dexamethasone groups were compared to each other (0.7 h [95% CI, -2.5 to 3.9]; P = 0.670). Compared to control, both intravenous and intravenous plus perineural dexamethasone similarly reduced 24-h pain scores and opioid consumption and decreased incidence of rebound pain. CONCLUSIONS The authors' findings suggest that intravenous dexamethasone alone is sufficient to improve analgesic outcomes for patients receiving supraclavicular block for upper extremity surgery. Combining the intravenous and perineural dexamethasone routes does not yield an additive or synergistic effect on the characteristics and analgesic effects of supraclavicular block.
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Affiliation(s)
- Nasir Hussain
- Department of Anesthesiology, The Ohio State University, Wexner Medical Center, Columbus, Ohio
| | - Jarod Speer
- Department of Anesthesiology, The Ohio State University, Wexner Medical Center, Columbus, Ohio
| | - Ryan S D'Souza
- Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota
| | - Marilly Palettas
- Center for Biostatistics, Department of Biomedical Informatics, College of Medicine, The Ohio State University, Columbus, Ohio
| | - Mahmoud Abdel-Rasoul
- Center for Biostatistics, Department of Biomedical Informatics, College of Medicine, The Ohio State University, Columbus, Ohio
| | - Alberto Uribe
- Department of Anesthesiology, The Ohio State University, Wexner Medical Center, Columbus, Ohio
| | - Tristan E Weaver
- Department of Anesthesiology, The Ohio State University, Wexner Medical Center, Columbus, Ohio
| | - Michael Kushelev
- Department of Anesthesiology, The Ohio State University, Wexner Medical Center, Columbus, Ohio
| | - John Coffman
- Department of Anesthesiology, The Ohio State University, Wexner Medical Center, Columbus, Ohio
| | - Faraj W Abdallah
- Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Canada; Department of Anesthesia, and Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Canada
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Abohadida RM, Mansy HF, Badr EA, El-Ashry AM, Mohamed HI. Self-Instructional Module Regarding Ventilator-Associated Pneumonia Care Bundle Prevention on Pediatric Nursing Internship Students' Knowledge and Clinical Performance: A Randomized Control Trial. Nurs Health Sci 2025; 27:e70117. [PMID: 40275689 DOI: 10.1111/nhs.70117] [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: 01/05/2025] [Revised: 04/08/2025] [Accepted: 04/10/2025] [Indexed: 04/26/2025]
Abstract
To assess the impact of a self-instructional ventilator-associated pneumonia care bundle prevention module on pediatric nursing internship students' knowledge and clinical performance. A two-arm randomized control was carried out. One hundred nursing interns were assigned randomly into two equal groups: control and study. Nursing interns' knowledge test, ventilator-associated pneumonia observational checklist bundle, and self-instructional module feedback questionnaire were used. Before the intervention, both groups had 100% low knowledge. Post-intervention, the study group achieved 100% high knowledge, compared to 16% in the control group (p < 0.001). After 3 months, 92% of the study group maintained high knowledge vs. 6% in the control group. Performance followed a similar trend, with the study group showing 96% high performance initially and 88% after 3 months. Implementing a self-instructional module significantly enhanced nursing internship students' performance and knowledge of ventilator-associated pneumonia care bundle prevention. Nursing interns' application of the self-instruction module on bundle prevention guidelines enhances their professional growth, delivers safe, appropriate practice, and improves the quality of care to critically ill children.
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Affiliation(s)
- Rasha Mohamed Abohadida
- Paediatric Nursing Department, Faculty of Nursing, Alexandria University, Alexandria, Egypt
- Nursing Department, Faculty of Nursing, Irbid National University, Irbid, Jordan
| | - Heba Fakieh Mansy
- Nursing Education Department, Faculty of Nursing, Alexandria University, Alexandria, Egypt
| | - Eman Arafa Badr
- Paediatric Nursing Department, Faculty of Nursing, Alexandria University, Alexandria, Egypt
| | - Ayman Mohamed El-Ashry
- Psychiatric and Mental Health Nursing Department, Faculty of Nursing, Alexandria University, Alexandria, Egypt
| | - Heba Ibrahim Mohamed
- Paediatric Nursing Department, Faculty of Nursing, Kafr El-Sheikh University, Kafr El-Sheikh, Egypt
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Kasten MME, Gross O, Wettstein MS, Anderson CE, Birkhäuser V, Borer J, Koschorke M, Liechti MD, McCallin SE, Mehnert U, Röthlisberger R, Sadri H, Stächele L, Kessler TM, Leitner L. Similar artefact susceptibility for water- and air-filled urodynamic systems: a non-inferiority randomised controlled trial. BJU Int 2025; 135:1039-1048. [PMID: 40071572 DOI: 10.1111/bju.16706] [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] [Indexed: 05/07/2025]
Abstract
OBJECTIVES To determine whether air-filled systems (AFS) provide comparable urodynamic investigation (UDI) trace quality to water-filled systems (WFS), the recommended standard by the International Continence Society. PATIENTS AND METHODS A total of 490 patients undergoing UDI from April 2021 to January 2022 were included in this non-inferiority randomised controlled trial. Eligible patients were female and male adults with neurogenic lower urinary tract dysfunction (NLUTD). Patients were allocated by block randomisation in a 1:1 ratio to undergo UDI using a WFS (n = 244) or an AFS (n = 246). The primary endpoint was artefact susceptibility evaluated by a 'blinded' assessor using a modified 'Bristol UTraQ' quality scoring scale ranging from 0 to 18, with higher scores indicating a better quality. A clinically meaningful non-inferiority margin was pre-specified as -2 points on the quality scoring scale (AFS-WFS). RESULTS The median (interquartile range [IQR]) overall quality score was 14.5 (13.5-15.5) points for the WFS and 15.5 (14.5-16.5) points for the AFS. Inferiority of AFS could be rejected at the pre-specified non-inferiority margin (0.96, 95% confidence interval 0.68-1.25; P < 0.001). Artefacts were more frequent in WFS. Typical artefacts consisted of repeat rectal contractions, poor pressure transmission during cough test at empty bladder, and detrusor resting pressure outside of the physiological range at empty bladder. CONCLUSIONS Our results indicate that AFS are non-inferior to WFS regarding overall urodynamic trace quality in patients with NLUTD.
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Affiliation(s)
- Madlen M E Kasten
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Oliver Gross
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Marian S Wettstein
- Division of Urology, Department of Surgery, University of Toronto, Toronto, ON, Canada
| | - Collene E Anderson
- Swiss Paraplegic Research, Nottwil, Switzerland
- Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland
| | - Veronika Birkhäuser
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Joëlle Borer
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Miriam Koschorke
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Martina D Liechti
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Shawna E McCallin
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Ulrich Mehnert
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Raphael Röthlisberger
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Helen Sadri
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Lara Stächele
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Thomas M Kessler
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
| | - Lorenz Leitner
- Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
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Xin L, Wang L, Feng Y. Acute Pain Management with Ultrasound-Guided Erector Spinae Plane Block and Serratus Anterior Plane Block in Patients Undergoing Coronary Artery Bypass via Mini-thoracotomy: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth 2025; 39:1514-1521. [PMID: 40122708 DOI: 10.1053/j.jvca.2025.02.045] [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: 08/23/2024] [Revised: 11/28/2024] [Accepted: 02/26/2025] [Indexed: 03/25/2025]
Abstract
OBJECTIVE This study was designed to examine the analgesic efficacy of erector spinae plane (ESP) block or combined ESP and superficial serratus anterior plane (SAP) block in patients undergoing elective coronary artery bypass via mini-thoracotomy. DESIGN Randomized controlled study. SETTING Operating room, intensive care unit, and ward. PATIENTS Fifty-four patients undergoing elective coronary artery bypass via mini-thoracotomy. INTERVENTIONS Eligible patients were randomly allocated to single-ESP block (ESP group) or combined ESP and superficial SAP block (ESP+SAP group). MEASUREMENTS AND MAIN RESULTS The primary outcome was dynamic numerical rating scale (NRS) scores (on coughing) for the surgical incision site 6 hours after skin closure. Secondary outcomes included dynamic NRS scores for surgical incision at 12, 18, 24, and 48 hours postoperatively plus NRS scores for the chest tube, hydromorphone consumption, quality of recovery, and adverse events within 48 hours postoperatively. The ESP+SAP group had lower dynamic NRS scores for surgical incision at postoperative 6 hours (mean difference: -2.1, 95% CI -2.8 to -1.4, adjusted p < 0.001) and 12 hours (-1.3, 95% CI -2.0 to -0.7, adjusted p < 0.001) compared to the ESP group. The ESP+SAP group also showed lower dynamic NRS scores for the chest tube at 6 hours (-1.4, 95% CI -2.0 to -0.9, adjusted p < 0.001) and 12 hours (-1.2, 95% CI -1.7 to -0.6, adjusted p < 0.001) postoperatively. Linear mixed-model analysis showed that NRS scores for the surgical incision and chest tube were lower in the ESP+SAP group compared to the ESP group (both p < 0.05). CONCLUSION Compared with ESP block alone, ESP combined with superficial SAP block reduced pain scores in patients undergoing coronary artery bypass via mini-thoracotomy.
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Affiliation(s)
- Ling Xin
- Department of Anesthesiology, Peking University People's Hospital, Beijing, China
| | - Lu Wang
- Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China
| | - Yi Feng
- Department of Anesthesiology, Peking University People's Hospital, Beijing, China.
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Jin G, Li W, Sun L, Wang B, Liu L, Dong C, Jiao T, Wu Q, Liu Y, Zhang X, Wang S, Wang S, Zhou K, Cai Y, Zhou X, Zhang X, Liu K, Zhao Z. A randomized, double-blind, placebo-controlled trial of Wenshenyang decoction for the improvement of renal function and kidney-yang deficiency syndrome in patients with CKD. JOURNAL OF ETHNOPHARMACOLOGY 2025; 348:119575. [PMID: 40096899 DOI: 10.1016/j.jep.2025.119575] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/06/2024] [Revised: 02/02/2025] [Accepted: 03/01/2025] [Indexed: 03/19/2025]
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Chronic kidney disease (CKD) poses an increasing challenge to the middle-aged and elderly population. Wenshenyang decoction (WSY), an herbal formula from China, has been shown to have a considerable effect on the recovery of the renal function in a real-world study. However, no randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety yet. AIM OF THE STUDY This study aimed to investigate the efficacy, advantages, limitations, and safety, and provide insights into methods and strategies for utilizing WSY in CKD management. MATERIALS AND METHODS Participants were recruited from six tertiary hospitals in Beijing, China. Eligible participants were randomly assigned to receive either WSY and conventional Western medicine or placebo and conventional Western medicine in a 1:1 ratio. The treatment and follow-up cycles each lasted 90 days, with a total of six follow-up visits. The primary outcome measures were the change in 24-h urine protein excretion (24h UPRO) and serum creatinine (SCR) from baseline at Visit 3 (90 days after the treatment) and Visit 5 (90 days after the follow-up). The secondary outcome measures were the improvement in symptoms and other renal function indicators. Additionally, we explored the correlation between the effect of WSY treatment and CKD type and stage through subgroup analysis. Finally, the safety of this decoction was assessed. RESULTS In total, 257 participants were diagnosed with CKD characterized by kidney Yang deficiency. Of these patients, 240 underwent randomization, and 203 were included in the subsequent analysis. After 180 days of treatment and follow-up, there was a significant decrease in the primary outcome 24h UPRO (a 43.19°% improvement at Visit 3, 95°% CI: 27.68°%, 58.71°%; a 51.28°% improvement at Visit 5, 95°% CI: 31.40°%, 71.16°%), and SCR (a 16.34°% improvement at Visit 3, 95°% CI: 11.28°%, 21.40°%; a 20.52°% improvement at Visit 5, 95°% CI: 14.05°%, 26.99°%). Compared to the control group, the difference was statistically significant (p < 0.05). Additionally, the secondary outcome of symptom score showed that 79.21°% of the patients felt "completely improved" and "greatly improved"; which was much higher than placebo (p < 0.05). Subgroup analysis showed that WSY was more effective for diabetic kidney disease (DKD) and stage 3 of CKD. No severe adverse events occurred during the period. CONCLUSIONS These results indicate that WSY could improve the renal function and alleviate the kidney Yang deficiency symptoms in patients with CKD without adverse effects. This study provided evidence-based medicine in the treatment of CKD with compound prescriptions of traditional Chinese medicine (TCM) and contributed to promoting the use of phytomedicine.
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Affiliation(s)
- Ge Jin
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Wenge Li
- China-Japan Friendship Hospital, Beijing, 100029, China
| | - Luying Sun
- Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, 102401, China
| | - Baokui Wang
- Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, 100078, China
| | - Lanying Liu
- The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, 100029, China
| | - Chao Dong
- Beijing First Hospital of Integrated Traditional Chinese and Western Medicine, Beijing, 100026, China
| | - Tingting Jiao
- Beijing Daxing District People's Hospital, Daxing Teaching Hospital, Capital Medical University, Beijing, 102600, China
| | - Qi Wu
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Yunhua Liu
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Xinjiang Zhang
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Shuyue Wang
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Sitong Wang
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Kaidong Zhou
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Yanmo Cai
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Xin Zhou
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Xinxue Zhang
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China
| | - Kun Liu
- Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, 102401, China.
| | - Zongjiang Zhao
- School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100105, China.
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Zhang WJ, Chen G, Dai DF, Chen XP. Not all reoperative laparoscopic liver resection procedures are feasible for hepatolithiasis patients with a history of biliary surgery. World J Hepatol 2025; 17:105890. [DOI: 10.4254/wjh.v17.i5.105890] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2025] [Revised: 04/04/2025] [Accepted: 04/18/2025] [Indexed: 05/27/2025] Open
Abstract
BACKGROUND Laparoscopic hepatectomy (LH) has been applied in the treatment of hepatolithiasisa in patients with a history of biliary surgery and has already achieved good clinical outcomes. However, reoperative LH (rLH) includes multiple procedures, and the no studies have examined the clinical value of individual laparoscopic procedures.
AIM To evaluate the safety and feasibility of each rLH procedure for hepatolithiasisa in patients with a history of biliary surgery.
METHODS Patients with previous biliary surgery who underwent reoperative hepatectomy for hepatolithiasis were studied. Liver resection procedures were divided into three categories: (1) Laparoscopic/open left lateral sectionectomy [reoperative laparoscopic left lateral sectionectomy (rLLLS)/reoperative open left lateral sectionectomy (rOLLS)]; (2) Laparoscopic/open left hemihepatectomy [reoperative laparoscopic left hemihepatectomy (rLLH)/reoperative open left hemihepatectomy (rOLH)]; and (3) Laparoscopic/open complex hepatectomy [reoperative laparoscopic complex hepatectomy (rLCH)/reoperative open complex hepatectomy (rOCH)]. The clinical outcomes were compared between the rLLLS, rLLH, and rLCH groups, and subgroup analyses were performed for the rLLLS/rOLLS, rLLH/rOLH, and rLCH/rOCH subgroups.
RESULTS A total of 185 patients were studied, including 101 rLH patients (40 rLLLS, 50 rLLH, and 11 rLCH) and 84 reoperative open hepatectomy (40 rOLLS, 33 rOLH, and 11 rOCH). Among the three types of rLH procedure, rLLLS required the shortest operation time (240.0 minutes vs 325.0 minutes vs 350.0 minutes, P = 0.001) and the lowest blood transfusion rate (10.0% vs 22.0% vs 54.5%, P = 0.005), followed by rLLH. The rLCH had the highest conversion rate (P < 0.05) and postoperative intensive care unit stay rate (P = 0.001). Most clinical outcomes in rLLLS and rLLH were superior or similar to those in the corresponding open surgery, while there were no differences in all outcomes between the rLCH and rOCH subgroups.
CONCLUSION The rLH is safe for hepatolithiasis patients with a history of biliary surgery. The rLLLS and rLLH can be recommended for these patients, whereas rLCH should be applied with caution.
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Affiliation(s)
- Wen-Jun Zhang
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China
- Department of Hepatobiliary Surgery, The Fifth Clinical Medical College of Anhui Medical University, Wuhu 241000, Anhui Province, China
| | - Guang Chen
- Department of Pediatrics, The First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China
| | - Da-Fei Dai
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China
- Department of Hepatobiliary Surgery, The Fifth Clinical Medical College of Anhui Medical University, Wuhu 241000, Anhui Province, China
| | - Xiao-Peng Chen
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China
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Keuppens L, Marten F, Baeyens D, Boyer B, Roose A, Becker S, Danckaerts M, Van der Oord S. Effectiveness of a cognitive-behavioral sleep hygiene intervention for adolescents with ADHD: a randomized controlled trial. Eur Child Adolesc Psychiatry 2025:10.1007/s00787-025-02755-0. [PMID: 40423708 DOI: 10.1007/s00787-025-02755-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/30/2024] [Accepted: 05/14/2025] [Indexed: 05/28/2025]
Abstract
OBJECTIVE Sleep problems are frequent and impairing in adolescents with ADHD. This randomized controlled trial investigates the effectiveness of a newly developed CBT sleep hygiene intervention for adolescents with ADHD - SIESTA. METHOD Adolescents with ADHD and sleep problems (N = 92, Mage = 14.36, SD = 1.43, 47% males) were randomized to receive SIESTA next to treatment as usual targeting ADHD (SIESTA+TAU) or TAU only. Adolescent and parent ratings, actigraphy and sleep diaries, were collected at pre-, post-, and at 4 month follow-up test. A linear mixed effects model was used with an intent-to-treat approach. RESULTS Results indicated significant improvement in SIESTA+TAU compared to TAU from pre- to post-test on sleep hygiene (effect size =.21), chronic sleep reduction (effect size =.15), and sleep-wake problem behaviors (effect size =.05). Actigraphy and sleep diaries showed no significant differences, with both groups improving on sleep diaries. The improvements in sleep hygiene were maintained at follow-up (effect size =.09). Of secondary outcomes, depressive symptoms reduced significantly more from pre- to post-test in SIESTA+TAU than in TAU only (effect size =.09). CONCLUSIONS This study indicates that SIESTA is effective at improving sleep hygiene, perceived sleep problems, and depressive symptoms in adolescents with ADHD. However, to maintain long-term effects, booster sessions may be beneficial.
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Affiliation(s)
- Lena Keuppens
- KU Leuven, Leuven, Belgium.
- PraxisP, Academic Clinical Center of the Faculty of Psychology and Educational Sciences of KU Leuven, Leuven, Belgium.
| | | | - Dieter Baeyens
- KU Leuven, Leuven, Belgium
- PraxisP, Academic Clinical Center of the Faculty of Psychology and Educational Sciences of KU Leuven, Leuven, Belgium
| | | | | | - Stephen Becker
- Cincinnati Children's Hospital Medical Center, Cincinnati, United States
- University of Cincinnati Medical Center, Cincinnati, United States
| | | | - Saskia Van der Oord
- KU Leuven, Leuven, Belgium.
- PraxisP, Academic Clinical Center of the Faculty of Psychology and Educational Sciences of KU Leuven, Leuven, Belgium.
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Canlı K, Demirkıran G, Can F. The efficiency of tactile discrimination training and oculomotor exercises in people with chronic neck pain: a randomized controlled trial. BMC Musculoskelet Disord 2025; 26:519. [PMID: 40420069 DOI: 10.1186/s12891-025-08755-0] [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: 06/24/2024] [Accepted: 05/13/2025] [Indexed: 05/28/2025] Open
Abstract
BACKGROUND Tactile discrimination training (TDT) and oculomotor exercises (OEs) have been widely used somatosensory-based interventions for a wide range of chronic pain conditions. There is, however, little evidence for the effectiveness of these approaches in people with chronic neck pain. This study aimed to determine the superiority of one intervention over another on pain outcomes in people with chronic neck pain. METHODS Fifty seven participants were randomly divided into three groups: TDT, OEs, and a control group who received no intervention. TDT, OEs groups received either TDT or OEs, respectively, three times per week for four weeks. The control group received no intervention. Pain intensity, neck pain-related disability, pressure pain thresholds (PPTs), mechanical pain of temporal summation (mTSP), and conditioned pain modulation were assessed as pain outcomes. Depending on the normality, a repeated measures ANOVA or F1-LD-F1 design was used to analyse the data. RESULTS A significant group*time interaction and main effects for time were found for pain intensity (p: 0.001, p: 0.001, respectively) and pain-related disability (p < 0.019, p < 0.009; respectively). There was a significant main effect for time for mTSP at the painful side of the neck (p: 0.022). TDT and OEs resulted in a significantly higher improvement in pain intensity (p: 0.005, p < 0.001; respectively) and neck pain-related disability (p: 0.005, p: 0.007; respectively). There was a higher improvement in pain intensity in OEs group compared to TDT group (p: 0.010). A significantly higher improvement in PPT at the painful site after OEs was found (p: 0.038). The control group demonstrated a significantly higher improvement in mTSP in the painful area of the neck (p: 0.048). There were no other significant within- or between-group changes. CONCLUSION OEs and TDT are effective somatosensory-based interventions for improving pain intensity and pain-related disability. IMPACT This study demonstrated that sensory retraining interventions improves the subjective pain perception. TRIAL REGISTRATION Trial Registration Number: NCT05605132, Date of trial registration: 10/29/2022, Name of trial registry: Neck Pain.
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Affiliation(s)
- Kübra Canlı
- Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Karadeniz Technical University, Trabzon, Türkiye.
- Department of Orthopaedics and Traumatology, Faculty of Medicine, Hacettepe University, Ankara, Türkiye.
| | - Gökhan Demirkıran
- Department of Orthopaedics and Traumatology, Faculty of Medicine, Hacettepe University, Ankara, Türkiye
| | - Filiz Can
- Department of Musculoskeletal Physiotherapy and Rehabilitation, Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Türkiye
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Guo S, Sun B, Wang X, Zhou C, Li W, Sun J, Wang L, Fan C. Effect of intravenous lidocaine on postoperative fatigue syndrome in patients undergoing laparoscopic radical colorectal cancer surgery: a randomized clinical trial. Sci Rep 2025; 15:18146. [PMID: 40415064 DOI: 10.1038/s41598-025-01892-5] [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: 11/12/2024] [Accepted: 05/08/2025] [Indexed: 05/27/2025] Open
Abstract
To investigate the effect of intravenous lidocaine on postoperative fatigue syndrome (POFS) in laparoscopic radical colorectal cancer surgery patients, a randomized controlled trial enrolled 86 patients aged over 18 with preoperative Christensen score ≤ 4 at Xuzhou Central Hospital from September 2023 to June 2024. The lidocaine group (group L) received an intravenous infusion of 1.5 mg·kg-1 of lidocaine for 15 min, 30 min prior to anesthetic induction, followed by sustained infusion at 1.5 mg·kg- 1·h- 1 until surgical closure. The control group (group C) received an equal volume of normal saline in the same manner. Compared with the group C, the time-weighted average (TWA) of Christensen score in the group L decreased by 0.42 (95% CI, 0.12 ~ 0.73, P < 0.05). Compared with the group C, the VAS at 1,3 and 5 days after surgery in the group L were lower (P < 0.05), the levels of IL-6 and TNF-α immediately after surgery and 24 h after surgery were lower (P < 0.05), and the time to first flatus and defecation was shorter (P < 0.05). No significant differences between the two groups in extubation time, PACU stay duration, incidence of postoperative nausea and vomiting (PONV), or length of postoperative hospital stay (P > 0.05). Results indicate that intravenous lidocaine effectively improved POFS in patients undergoing laparoscopic radical resection of colorectal cancer, which might be achieved by inhibiting the postoperative inflammatory response and reducing postoperative pain.
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Affiliation(s)
- Songhai Guo
- College of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China
- Department of Anesthesiology, Xuzhou Central Hospital, Xuzhou, Jiangsu, China
- Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China
| | - Bin Sun
- Department of Anesthesiology, Xuzhou Central Hospital, Xuzhou, Jiangsu, China
- The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China
| | - Xinghe Wang
- College of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China
- Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China
| | - Chunyan Zhou
- College of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China
- Department of Anesthesiology, Xuzhou Central Hospital, Xuzhou, Jiangsu, China
- Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China
| | - Weihua Li
- College of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China
- Department of Anesthesiology, Xuzhou Central Hospital, Xuzhou, Jiangsu, China
- Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China
| | - Jia Sun
- Department of Anesthesiology, Xuzhou Central Hospital, Xuzhou, Jiangsu, China.
- The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China.
| | - Liwei Wang
- College of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.
- Department of Anesthesiology, Xuzhou Central Hospital, Xuzhou, Jiangsu, China.
- Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.
- The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, China.
| | - Conghai Fan
- College of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.
- Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.
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von Känel R, Neuner-Jehle S, Kressig RW, Guessous I, Krayenbühl PA, Zimmerli L, Angelilo-Scherer A, Keller T, Elzner C, Pauls K, Morin N, Battegay E. Effects of a novel differential diagnosis aid for managing patients with unexplained fatigue in primary care: a prospective randomized, controlled, open and multicenter study in primary care. BMC PRIMARY CARE 2025; 26:183. [PMID: 40413405 DOI: 10.1186/s12875-025-02873-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/17/2023] [Accepted: 05/02/2025] [Indexed: 05/27/2025]
Abstract
AIMS OF THE STUDY Unexplained fatigue is a common reason for encounters in primary care. However, currently no aid orients physicians in detecting its potential causes. The aim of this study was to evaluate whether the novel Fatigue Differential Diagnostic Aid (FDDA) supported clinicians in better managing unexplained fatigue. METHODS This was a prospective, cluster-randomized, controlled, open, and multicenter study comparing the use of the FDDA vs usual care in patients with unexplained fatigue as the main reason for encounter. The primary endpoint was difference in Patient Global Impression of Change (PGIC) between groups at 3 months. Among pre-defined secondary endpoints were: Difference in change of PGIC between groups at 6 months; percentage of patients with fatigue reduction; mean reduction in fatigue; clinician's confidence in diagnosis; patient satisfaction with quality of care (diagnostic process and treatment); number of clinician-reported visits; number of referrals to specialists; and time until final diagnosis. RESULTS 112 primary care practitioners (PCPs) recruited in Switzerland between 2017 to 2020 were randomly cluster-assigned to the FDDA = 57 or usual care = 55 arm. Of these, 15 (FDDA) and 22 (usual care) PCPs recruited 93 patients (FDDA: n = 40, usual care: n = 53). The achieved sample size was less than planned. There was no difference in PGIC at 3 months between groups (D = 0.06, 95%-CI: -0.41 - -0.53, p = 0.802). Among secondary endpoints, no significant differences occurred in PGIC at 6 months, nor in fatigue reduction. However, in the FDDA group, more patients reported less fatigue at 3 or 6 months (D = 18.9%, 95%-CI: -33.6 - -4.3%, p = 0.011), and increased satisfaction with treatment management at 1 month (FDDA 56.8% vs usual care 25.0%, p = 0.004) and 3 months (FDDA 64.9% vs usual care 31.0%, p = 0.003); the FDDA was also associated with higher total number of visits (median 4.0 vs 3.0, p < 0.001). CONCLUSIONS In this pilot study, the FDDA, a structured diagnostic aid for guiding PCPs in identifying the causes of unexplained fatigue in their patients, was not able to show a global improvement in patient outcomes despite improvements in fatigue and satisfaction with care. The evaluation of fatigue in larger-scale studies is warranted. TRIAL REGISTRATION This trial was retrospectively registered on ClinicalTrials.gov. TRIAL REGISTRATION NUMBER NCT05861492. Date of registration: 17th May 2023. The ethics committee of Ethikkommission Nordwest- und Zentralschweiz (EKNZ) had originally voiced the opinion that no registration was required because no drug or intervention was involved, i.e., the study was non-interventional and observational. However, the study authors felt that the study should be retrospectively registered because the FDDA could be interpreted to be an active intervention. At the time of registration, two protocol deviations occurred that are explicitly addressed in the Methods section of this manuscript. Because of the low sample size, we statistically compared "patients" instead of "comparing patients nested in doctors" (the latter was performed as an additional analysis). Thus, cluster randomization was performed, but the analysis to consider this was not feasible.
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Affiliation(s)
- Roland von Känel
- Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland
| | - Stefan Neuner-Jehle
- Institute of Primary Care, University of Zurich and University Hospital of Zurich, Zurich, Switzerland
| | - Reto W Kressig
- University Department of Geriatric Medicine Felix Platter &, University of Basel, Basel, Switzerland
| | - Idris Guessous
- Unit of Population Epidemiology, Department of Community Medicine, Primary Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland
| | | | - Lukas Zimmerli
- Department of Internal Medicine, Cantonal Hospital Olten, Solothurner Spitäler AG, Olten, Switzerland
| | - Anne Angelilo-Scherer
- Department of Haematology and Central Haematology Laboratory, University Insel Hospital, Bern, and Medical Faculty, Basel University, Basel, Switzerland
| | | | | | - Karl Pauls
- Berlin Center for Epidemiology and Health Research, ZEG, Berlin, Germany
| | - Neige Morin
- Medical Affairs Department, CSL Vifor, Zurich, Switzerland
| | - Edouard Battegay
- International Center for Multimorbidity and Complexity in Medicine (ICMC), UZH Longevity Center, University of Zurich, Merian Iselin Klinik, Basel, Switzerland.
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Maharaj N, Uppada DR, Eswaraiah A, Kakkattu R, Reddy P, Kalenik VA, Belada D, Ramos AO, Kim JS, Baranau YV. Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera ® in low-tumor-burden follicular lymphoma: the FLINTER study. Ther Adv Med Oncol 2025; 17:17588359251339925. [PMID: 40421128 PMCID: PMC12104602 DOI: 10.1177/17588359251339925] [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: 07/09/2024] [Accepted: 04/17/2025] [Indexed: 05/28/2025] Open
Abstract
Background and objectives This phase III study (RI-01-006; FLINTER) was conducted to demonstrate equivalent efficacy of DRL_RI to EU-approved rituximab (MabThera®) in patients with previously untreated Stage II-IV, CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL). This study also evaluated safety, immunogenicity, rituximab concentrations, and pharmacodynamics (PD) of DRL_RI compared with MabThera. Design and methods Previously untreated, stage II-IV, CD20-positive LTB-FL patients (N = 317) were randomized (1:1) to receive DRL_RI (n = 162) or MabThera (n = 155) as intravenous infusions of 375 mg/m² weekly for 4 weeks (induction period), and thereafter every 8 weeks from Week 12 to Week 36 (maintenance treatment), and followed up till Week 52. The primary end point was best overall response rate (BORR) up to Week 28 based on blinded independent central review. Efficacy equivalence was demonstrated if the two-sided 90% confidence interval (CI) for BORR difference was within the prespecified equivalence margin (±17%). Secondary end points included objective and complete responses, duration of response, progression-free survival, overall survival, safety, immunogenicity, mean serum concentrations, and PD. Results The BORR up to Week 28 was 80.2% versus 79.4% for DRL_RI versus MabThera group; with a difference of 0.89% (90% CI: -6.67 to 8.48; 95% CI: -8.05 to 9.93 within the prespecified margin). Both treatment groups were comparable for all secondary efficacy end points. Treatment-emergent adverse events were reported in 68.6% of patients; safety, immunogenicity, and mean serum concentrations were similar between groups. Peripheral B-cell counts declined below quantifiable limits in most patients, with a median time to B-cell depletion of 6.9 versus 7.0 days for DRL_RI versus MabThera. Conclusion The study demonstrated efficacy equivalence of DRL_RI to MabThera; with comparable safety, immunogenicity, serum concentrations, and PD between groups. Trial registration This trial was registered at ClinicalTrials.gov identifier: NCT03976102 and EudraCT (2018-004223-36).
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Affiliation(s)
- Narendra Maharaj
- Biologics Division, Dr. Reddy’s Laboratories Ltd, Bachupally, Hyderabad, Telangana 500090, India
| | | | | | | | - Pramod Reddy
- Dr. Reddy’s Laboratories Ltd, Hyderabad, Telangana, India
| | - Volha A. Kalenik
- N. N. Alexandrov National Cancer Center, Center of Belarus, Minsk Region, Republic of Belarus
| | - David Belada
- Fakultini Nemocnice, Hradec Kralove, IV. Interni Hematologicka Klinika, Hradec Kralove, Czech Republic
| | - Ana Oliveira Ramos
- Hematología Clínica, Unidad Funcional de Linfomas, ICO—Hospital Duran i Reynals, Hospitalet, Barcelona, Spain
| | - Jin Seok Kim
- Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seodaemun-gu, Seoul, Korea
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Pilakouta Depaskouale MA, Archonta SA, Moutafidou SΚ, Paidakakos NA, Dimakopoulou AN, Matsota PK. Effectiveness of hypotension prediction index software in reducing intraoperative hypotension in prolonged prone-position spine surgery: a single-center clinical trial. J Clin Monit Comput 2025:10.1007/s10877-025-01303-0. [PMID: 40410627 DOI: 10.1007/s10877-025-01303-0] [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: 12/11/2024] [Accepted: 04/29/2025] [Indexed: 05/25/2025]
Abstract
Intraoperative hypotension (IOH) is associated with morbidity and mortality. The Hypotension Prediction Index (HPI), a machine learning-based tool, offers the opportunity for a proactive approach by predicting hypotensive events. This single center, single blind randomized clinical trial aimed to evaluate the hypothesis that an HPI software-guided approach to IOH management during prone position spine surgery could reduce its incidence compared to our standard care practices. 85 adult patients undergoing spine fusion surgery in the prone position were enrolled. Patients were randomized with a 1:1 allocation ratio. Participants were blinded to their group allocation. In the intervention group, the HPI software was actively used to guide IOH management. In the control group, HPI software readings were blinded, and standard care was administered. The primary outcome was the comparison of time-weighted average (TWA) of IOH between the two groups. Secondary outcomes included a comparison of the incidence of postoperative in-hospital events related to IOH between groups. 77 patients were included in the final analysis (39 in the intervention group), as 8 patients were excluded due to technical issues. No statistically significant difference was found between the intervention and control groups in the TWA of IOH (0.10 mmHg [0.05, 0.23] vs. 0.15 mmHg [0.09, 0.37], p-value 0.088). However, the total duration of hypotensive events per patient was significantly lower in the intervention group (4 min [0.5, 12.2] vs. 11.2 min [2.6, 20.1]; p-value 0.019). Postoperative complication rates did not differ significantly between the two groups. HPI-guided management did not significantly reduce the TWA of IOH compared to standard care in patients undergoing prone-position spine surgery. Complication rates were similar between the two groups.Clinical Trial Registration: This trial was registered with ClinicalTrials.gov (registration number: NCT05341167).
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Affiliation(s)
- Myrto A Pilakouta Depaskouale
- 2nd Department of Anesthesiology, School of Medicine, National and Kapodistrian University of Athens, "Attikon" Hospital, Athens, Greece.
- Department of Anesthesiology, Athens General Hospital "Georgios Gennimatas", Athens, Greece.
| | - Stela A Archonta
- Department of Anesthesiology, Athens General Hospital "Georgios Gennimatas", Athens, Greece
| | - Sofia Κ Moutafidou
- Department of Anesthesiology, Athens General Hospital "Georgios Gennimatas", Athens, Greece
| | - Nikolaos A Paidakakos
- Department of Neurosurgery, Athens General Hospital "Georgios Gennimatas", Athens, Greece
| | - Antonia N Dimakopoulou
- Department of Anesthesiology, Athens General Hospital "Georgios Gennimatas", Athens, Greece
| | - Paraskevi K Matsota
- 2nd Department of Anesthesiology, School of Medicine, National and Kapodistrian University of Athens, "Attikon" Hospital, Athens, Greece
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Xu C, Wang X, Wang M, Wang D, Kong S, Zhou Q, Lu J, Wang A. Implication of Preoperative Intravenous Dexamethasone on Pain and Nausea in Late-Stage Elderly Total Knee Arthroplasty Patients: a randomized double-blind trial. J Arthroplasty 2025:S0883-5403(25)00583-2. [PMID: 40414368 DOI: 10.1016/j.arth.2025.05.065] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/22/2025] [Revised: 05/16/2025] [Accepted: 05/16/2025] [Indexed: 05/27/2025] Open
Abstract
BACKGROUND Total knee arthroplasty (TKA) is a standard procedure in elderly patients; however, postoperative pain and postoperative nausea and vomiting (PONV) remain challenging. This study aimed to evaluate the effects of a single preoperative intravenous dose of dexamethasone (10 mg) on postoperative pain and PONV in older patients (≥ 75 years) undergoing TKA. METHODS A single-center, double-blind, two-arm study compared preoperative dexamethasone (10 mg) versus saline on postoperative pain and PONV in planned TKA patients over 75 years old. Subjects received multimodal analgesia, including femoral nerve block, cyclooxygenase inhibitors, local anesthetic infiltration, and patient-controlled intravenous analgesia with opioids. The primary outcomes were resting numeric rating scale (NRS) score and incidence of PONV at 24 hours. Secondary outcomes included motion pain scores, opioid consumption, nausea severity, blood glucose, inflammatory factors, and side effects. RESULTS There were 160 patients randomized; 153 completed the allocated interventions (dexamethasone n = 77, control n = 76). At 24 hours postoperatively, the dexamethasone group had a lower median resting NRS score (4 [IQR (interquartile range) 3 to 4] versus 5 [IQR 4 to 6], P < 0.001) and a lower incidence of PONV (16.9 versus 40.8%, P = 0.002) compared with controls. Select secondary outcomes showed significantly lower motion pain scores (24 hours, 36 hours, and one week) and reduced serum IL-6 and C-reactive protein (CRP) levels in the dexamethasone group (all P < 0.05). No significant difference was noted in total opioid consumption, rescue analgesics, or incidence of infection and delayed wound healing between groups. CONCLUSIONS Preoperative administration of 10 mg intravenous dexamethasone to relatively healthy late-stage elderly patients (American Society of Anesthesiologists Physical Status I to II) undergoing TKA significantly reduced postoperative pain and PONV without increasing wound complications or infections. However, caution should be exercised when extrapolating these results to more comorbid populations, and further research is needed to assess long-term outcomes and broader applicability.
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Affiliation(s)
- Cheng Xu
- Department of Anaesthesiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600 Yishan Road, Shanghai, China
| | - Xintao Wang
- Department of Anaesthesiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600 Yishan Road, Shanghai, China
| | - Miao Wang
- Department of Anaesthesiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600 Yishan Road, Shanghai, China
| | - Di Wang
- Department of Anaesthesiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600 Yishan Road, Shanghai, China
| | - Sai Kong
- Department of Anaesthesiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600 Yishan Road, Shanghai, China
| | - Quanhong Zhou
- Department of Critical Care, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600 Yishan Road, Shanghai, China
| | - Jie Lu
- Department of Anaesthesiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600 Yishan Road, Shanghai, China
| | - Aizhong Wang
- Department of Anaesthesiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 600 Yishan Road, Shanghai, China.
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Ghochani G, Aghajani A, Rajabi MT, Zand A, Yaseri M, Rafizadeh SM. Comparison of Two Botulinum Neurotoxin Type A Preparations (Masport and Dysport) for Upper Face Rhytides: A Randomized Clinical Trial. Aesthetic Plast Surg 2025:10.1007/s00266-025-04929-2. [PMID: 40410321 DOI: 10.1007/s00266-025-04929-2] [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: 01/30/2025] [Accepted: 04/03/2025] [Indexed: 05/25/2025]
Abstract
BACKGROUND Botulinum neurotoxin type A has played a key role in the treatment of facial rhytides. We aimed to compare the safety and effectiveness of Masport and Dysport as botulinum toxin type A preparations in the treatment of upper face rhytides. METHODS A double-blind randomized, clinical trial was conducted on adults with at least mild severity (scale 1) for lateral canthal (crow's feet), glabellar, and frontal lines at maximum contraction positions (dynamic status), regardless of their static scales (rest position). Participants were randomly assigned to receive either Masport or Dysport. Rhytides in each area were scaled at baseline and at post-injection weeks 2, 8, 12, and 16. Self-satisfaction were assessed at follow-ups. RESULTS For both groups, a decrease in dynamic rhytides was observed at week 2 compared to baseline (all Ps < 0.05). Although dynamic rhytides increased again in subsequent follow-ups, they remained significantly lower than baseline levels until week 12 (all Ps < 0.05). By week 16, no differences were observed compared to baseline (all Ps > 0.05). While at week 2, both dynamic and static scales were higher in the Masport group (all Ps < 0.05), this difference did not persist for most of them at weeks 12 and 16. Satisfaction scores were similar between the groups throughout all follow-ups (all Ps > 0.05). CONCLUSION The onset and duration of action for Masport and Dysport are similar in the treatment of upper face rhytides at equal doses. While Dysport may initially show a stronger effect than Masport in treating upper face rhytides, this advantage does not persist in the long term. LEVEL OF EVIDENCE I This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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Affiliation(s)
- Ghazal Ghochani
- Department of Oculofacial Plastic and Reconstructive Surgery, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
| | - Amirhossein Aghajani
- Department of Oculofacial Plastic and Reconstructive Surgery, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
| | - Mohammad Taher Rajabi
- Department of Oculofacial Plastic and Reconstructive Surgery, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
| | - Amin Zand
- Department of Oculofacial Plastic and Reconstructive Surgery, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
| | - Mehdi Yaseri
- Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
| | - Seyed Mohsen Rafizadeh
- Department of Oculofacial Plastic and Reconstructive Surgery, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
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Ulutas ME, Yilmaz AH. Comparison of open and laparoscopic inguinal hernia repair in the elderly patients: a randomized controlled trial. Hernia 2025; 29:179. [PMID: 40407912 PMCID: PMC12101994 DOI: 10.1007/s10029-025-03368-x] [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: 03/20/2025] [Accepted: 05/04/2025] [Indexed: 05/26/2025]
Abstract
PURPOSE It is well known that inguinal hernia repair in geriatric patients carries a higher risk of postoperative complications compared to younger patients. One of the key factors influencing these complications is the surgical technique employed. However, there is limited knowledge regarding the impact of laparoscopy on elderly patients. This prospective randomized study aims to compare the outcomes of laparoscopic and open hernia repair techniques in this patient population. METHODS Between April 2023 and April 2024, 120 consecutive patients aged 65 years and older with inguinal hernia were randomly assigned to one of two groups: the laparoscopic TEP group (n = 60) and the open (Lichtenstein) procedure group (n = 60). The study was registered at ClinicalTrials.gov (NCT06417346). The primary outcome of this study was the comparison of postoperative complication rates. Secondary outcomes included comparisons of hernia types, operative times, postoperative pain levels, and recurrence rates. RESULTS A total of 120 patients were followed up for 12 months. The mean age was 71.7 ± 6.5 years in the open group and 69.6 ± 3.9 years in the TEP group (p = 0.18). The mean operative time was 35.8 ± 7.8 min in the open group and 36.3 ± 8.7 min in the TEP group (p = 0.92). The mean time to return to normal daily activities was 10.6 ± 4.3 days in the open group and 7.5 ± 2.4 days in the TEP group (p < 0.001). On postoperative day 1, the VAS score was 3.7 ± 1.3 in the open group and 2.9 ± 1.1 in the TEP group (p < 0.001). At the end of the first month, the VAS score was 2.6 ± 1.0 in the open group and 1.7 ± 0.9 in the TEP group (p < 0.001). Chronic pain was observed in 6 patients (10%) in the open group and 1 patient (1.7%) in the TEP group (p = 0.05). No complications occurred in 51 patients (85%) in the open group and 52 patients (86.7%) in the TEP group (p = 0.84). Recurrent inguinal hernia was detected in 4 patients (6.7%) in the open group and 1 patient (1.7%) in the TEP group (p = 0.17). CONCLUSION Based on the data obtained from our study, laparoscopic inguinal hernia repair in elderly patients was found to offer advantages such as faster recovery, reduced postoperative and chronic pain, without an increase in complications. Given these benefits, laparoscopic hernia repair can be considered a safe and preferable approach for elderly patients. TRIAL REGISTRATION Clinical trials number: NCT06417346.
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Affiliation(s)
- Mehmet Esref Ulutas
- Department of Surgery, University of Health Science, Gaziantep City Hospital, Şahinbey/Gaziantep, Turkey.
| | - Abdullah Hilmi Yilmaz
- Department of Surgery, University of Health Science, Van Training and Research Hospital, Van, Turkey
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Löfgren M, Nordeman L, Ariai N, Björkelund C, Rembeck G, Svenningsson I, Törnbom K, Hange D. Effect on work ability and health-related quality of life following an interactive patient education aiming to increase sense of coherence and health literacy - the LEARN-to-COPE cluster randomized trial. Scand J Prim Health Care 2025:1-16. [PMID: 40405458 DOI: 10.1080/02813432.2025.2507859] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/11/2024] [Accepted: 05/10/2025] [Indexed: 05/24/2025] Open
Abstract
OBJECTIVE To evaluate the effect of the LEARN-to-COPE intervention on sick leave, symptoms, and coping. DESIGN AND SETTING Cluster-randomized controlled trial including 40 primary care centers (PCCs) in Region Västra Götaland, Sweden. Randomization at the PCC level. Effect of the intervention was compared to Care-as-Usual (CAU). Follow-up was conducted using registry sick leave data, validated questionnaires, and patient-reported data. SUBJECTS Primary healthcare patients with recurrent or long-term sick leave or health-related unemployment from included PCCs (n = 243). INTERVENTION Patient education was conducted via interactive study groups, which convened for half a day every week over eight consecutive weeks. Implementation was centralized in close collaboration with educational associations. The purpose of the intervention was to strengthen participants' sense of coherence and health literacy, with the aim of enhancing their work ability and health. MAIN OUTCOME MEASURES The primary outcome measure was change in scheduled activity, derived from data on sick leave (obtained from the Swedish Social Insurance Agency) and participation in work-oriented rehabilitation (self-reported occupational status). Secondary outcomes (symptoms and coping) were measured with validated questionnaires at baseline and follow-ups after 3, 6, and 12 months. RESULTS Included participants suffered from anxiety, depression, exhaustion, and pain and had poor health-related quality of life. After 12 months, there was no significant change in scheduled activity, sense of coherence, symptoms, or health-related quality of life, but a statistically significant positive change in health literacy and self-efficacy was found in the intervention group. CONCLUSION Considering participants' pronounced burden of symptoms, the focus should be on improving the sick leave process as a whole, rather than seeking quick remedies for patients' complex health issues. Centralized implementation of the intervention was a promising concept that deserves further evaluation. TRIAL REGISTRATION NUMBER Clinicaltrials.gov NCT04254367.
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Affiliation(s)
- Märit Löfgren
- Primary Health Care/School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Research, Education, Development & Innovation Primary Health Care, Research, Education, Development & Innovation Center Södra Älvsborg, Region Västra Götaland, Sweden
| | - Lena Nordeman
- Research, Education, Development & Innovation Primary Health Care, Research, Education, Development & Innovation Center Södra Älvsborg, Region Västra Götaland, Sweden
- Sahlgrenska Academy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Nashmil Ariai
- Primary Health Care/School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Cecilia Björkelund
- Primary Health Care/School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Research, Education, Development & Innovation Primary Health Care, Region Västra Götaland, Sweden
| | - Gun Rembeck
- Primary Health Care/School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Research, Education, Development & Innovation Primary Health Care, Research, Education, Development & Innovation Center Södra Älvsborg, Region Västra Götaland, Sweden
| | - Irene Svenningsson
- Primary Health Care/School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Research, Education, Development & Innovation Primary Health Care, Research, Education, Development & Innovation Center Fyrbodal, Region Västra Götaland, Sweden
| | - Karin Törnbom
- Department of Social Work, University of Gothenburg, Gothenburg, Sweden
| | - Dominique Hange
- Primary Health Care/School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Research, Education, Development & Innovation Primary Health Care, Region Västra Götaland, Sweden
- Research, Education, Development & Innovation Primary Health Care, Research, Education, Development & Innovation Center Skaraborg, Region Västra Götaland, Sweden
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Hüttner FJ, Klotz R, Giese NA, Kong B, Ahmed A, Merz D, Pöchmann A, Burghaus I, Hackert T, Strobel O, Mihaljevic AL, Michalski CW, Büchler MW, Diener MK. Pancreatic resection with perioperative drug repurposing of propranolol and etodolac - the phase II randomized controlled PROSPER trial. Langenbecks Arch Surg 2025; 410:168. [PMID: 40402347 PMCID: PMC12098435 DOI: 10.1007/s00423-025-03735-3] [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] [Subscribe] [Scholar Register] [Received: 04/20/2025] [Accepted: 05/07/2025] [Indexed: 05/23/2025]
Abstract
PURPOSE The perioperative period is characterized by psychological stress and inflammatory reactions that can contribute to disease recurrence or metastatic spread. These reactions are mediated particularly by catecholamines and prostaglandins. The PROSPER trial aimed to evaluate whether a perioperative drug repurposing with a non-selective betablocker (propranolol) and a COX-2 inhibitor (etodolac) is feasible and safe in the setting of pancreatic cancer surgery. METHODS Patients undergoing partial pancreatoduodenectomy for pancreatic cancer were randomized to perioperative treatment with propranolol and etodolac or placebo. Main safety endpoint was the rate of serious adverse events (SAE) and the main feasibility endpoint was adherence. Overall and disease-free survival (DFS) as well as recurrences were assessed as efficacy parameters and the trial was accompanied by a translational study. RESULTS The trial was prematurely closed due to slow recruitment. 26 patients were randomized, but 6 never started trial medication. Finally, 9 patients received the trial medication and 11 patients placebo. There were 6 SAE in the treatment vs. 14 in the placebo group. Adherence was lower in the treatment group, but without statistically significance. Median DFS was 16.36 months (95%-CI 1.18 - not reached) in verum vs. 11.25 (95%-CI 2.2 - 17.25) in placebo group. The rate of distant recurrences was 11.1% in verum vs. 54.5% in placebo group. CONCLUSION There were no safety concerns, but the trial intervention was not feasible given slow recruitment and limited adherence. However, the translational study and preliminary efficacy data revealed some promising findings, warranting further investigation. REGISTRATION DRKS00014054.
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Affiliation(s)
- Felix J Hüttner
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
- Department of General, Visceral and Thoracic Surgery, Klinikum Nürnberg, Prof.-Ernst-Nathan-Str. 1, 90419, Nuremberg, Germany
| | - Rosa Klotz
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
- Study Center of the German Surgical Society (SDGC), Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany
| | - Nathalia A Giese
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
| | - Bo Kong
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
| | - Azaz Ahmed
- Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany
- Department of Cancer Immunology and Cancer Immunotherapy, German Cancer Research Center, Heidelberg, Germany
| | - Daniela Merz
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
| | - Alexandra Pöchmann
- Department of Cancer Immunology and Cancer Immunotherapy, German Cancer Research Center, Heidelberg, Germany
- Helmholtz Institute for Translational Oncology (HI-TRON), Mainz, Germany
| | - Ina Burghaus
- Coordination Centre for Clinical Trials (KKS), Medical Faculty & Heidelberg University Hospital, Heidelberg, Germany
| | - Thilo Hackert
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
- Department of General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf, Hamburg, Germany
| | - Oliver Strobel
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
- Division of Visceral Surgery, Department of General Surgery, Medical University of Vienna, Vienna, Austria
| | - André L Mihaljevic
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
- Department of General, Visceral and Transplantation Surgery, University Hospital Tübingen, Tübingen, Germany
| | - Christoph W Michalski
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
| | - Markus W Büchler
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany
- Botton-Champalimaud Pancreatic Cancer, Champalimaud Foundation, Lisbon, Portugal
| | - Markus K Diener
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany.
- Department of General, Visceral and Thoracic Surgery, Klinikum Nürnberg, Prof.-Ernst-Nathan-Str. 1, 90419, Nuremberg, 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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50
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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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