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Irvine S, Whiteing N, Andrew S. Assessment of undergraduate nursing students' medication administration competency: A systematic review. NURSE EDUCATION TODAY 2025; 151:106744. [PMID: 40273614 DOI: 10.1016/j.nedt.2025.106744] [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: 01/21/2025] [Revised: 04/04/2025] [Accepted: 04/08/2025] [Indexed: 04/26/2025]
Abstract
BACKGROUND Nursing students must be well-prepared and competent in medication administration (MA) and be able to apply pharmacology knowledge as registered nurses. MA is integral to ensuring patient safety, but nursing students find it challenging to acquire competency in MA. Little is known about assessing medication administration competency in various clinical practice settings. AIM To conduct a systematic review of how undergraduate nursing students' medication administration competency is assessed in clinical practice settings. METHOD Original research studies were identified using PubMed, Web of Science, CINAHL, PsycINFO, Scopus, ScienceDirect, and ERIC. This systematic literature review included primary research studies using objective competency measures of MA assessment of undergraduate nursing students in a clinical practice setting, published in English between 1990 and 2023. Data was extracted and synthesised using the Preferred Reporting Items for Systematic Reviews. RESULTS 32 original research papers were included in the review. Studies came from 12 countries. A quasi-experimental design was used by 75 % of studies to examine MA competency assessment. Medication assessments were conducted primarily in simulation labs. Simulation was found to have positive outcomes on MA competency on clinical placement. Studies were grouped into three categories: 'Using technology', 'Educational Strategies', and 'Focus on Safety skills'. Studies reported error rates associated with patient identification and hand hygiene, including those of senior nursing students. Quality appraisal was conducted using the Medical Education Research Study Quality Instrument (MERSQI). The MERSQI Mean score was 12.92/18. Several studies failed to report the sample size calculation and the validity of instruments. CONCLUSION A whole-curriculum approach with MA content and skills mapped and scaffolded across the undergraduate nursing program is required to enable students to achieve MA competency. Attention to the design of studies is required to ensure the reliability of results. Further research is required to understand the cognitive and affective behaviours contributing to the ongoing errors, focusing on assessing competency in clinical placement.
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Affiliation(s)
- Susan Irvine
- First Year College, Victoria University PO Box 14428, Melbourne, Victoria 8001, Australia; School of Nursing and Midwifery La Trobe University, Plenty Rd, Bundoora, Victoria 3086, Australia.
| | - Nicola Whiteing
- Faculty of Health, Southern Cross University, Military Road, East Lismore 2480, NSW, Australia.
| | - Sharon Andrew
- Institute Health & Sport, Victoria University, PO Box 14428, Melbourne, Victoria 8001, Australia.
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Quan Y, Lo CY, Wolff L, Wang J, Olsen KN, Thompson WF. Cognitive benefits of music in aerobic exercise: Evidence from a Bayesian network meta-analysis in adults with mild cognitive impairment. Arch Gerontol Geriatr 2025; 134:105848. [PMID: 40287987 DOI: 10.1016/j.archger.2025.105848] [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: 01/29/2025] [Revised: 03/28/2025] [Accepted: 03/29/2025] [Indexed: 04/29/2025]
Abstract
Aerobic exercise improves cognitive functions in older adults with mild cognitive impairment (MCI), while dance, combining music and synchronized movement, offers additional cognitive benefits. Despite music's potential role in enhancing cognitive outcomes, most research on aerobic exercise has not considered the impact of accompanying music. This review compared the effectiveness of aerobic exercise with music, aerobic exercise without music, and dance on cognitive function in adults with MCI. A total of 38 papers from 25 randomized controlled trials (N = 2048) were synthesized. The multilevel meta-analyses showed that compared to the control group, global cognition was improved by aerobic exercise with music (g = 1.2 [0.47, 1.94]), aerobic exercise without music (g = 0.48 [0.18, 0.79]), and dance (g = 0.55 [0.13, 0.96]). Dance also enhanced short-term memory (g = 0.41 [0.24, 0.59]), learning efficiency (g = 0.39 [0.14, 0.65]), and retrieval fluency (g = 0.7 [0.19, 1.22]). Bayesian network meta-analyses indicated that aerobic exercise with music had the highest probability of being the most effective for improving global cognition, executive function, and processing speed. Dance was likely to be the most beneficial for enhancing short-term memory, learning efficiency, and retrieval fluency. This study supports that incorporating music in exercise amplifies the cognitive benefits beyond exercise alone for individuals with MCI. The "Music Exercise Synergy Model" is proposed to explain the cognitive benefits of combining music with exercise. Dance strategically uses music for coordination, offering psychological, social, cognitive, and neurobiological benefits and contributing to the observed enhancements in memory functions.
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Affiliation(s)
- Yixue Quan
- School of Psychological Sciences, Macquarie University, Sydney, NSW, Australia.
| | - Chi Yhun Lo
- Department of Linguistics, Macquarie University, Sydney, NSW, Australia; Department of Psychology, Toronto Metropolitan University, Toronto, ON, Canada; Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, Australia
| | - Lee Wolff
- Faculty of Society and Design, Bond University, Gold Coast, QLD, Australia
| | - Jinyu Wang
- Department of Music, Northeastern University, Boston, MA, United States
| | - Kirk N Olsen
- School of Psychological Sciences, Macquarie University, Sydney, NSW, Australia; Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, Australia
| | - William Forde Thompson
- School of Psychological Sciences, Macquarie University, Sydney, NSW, Australia; Faculty of Society and Design, Bond University, Gold Coast, QLD, Australia
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Su H, Chau H, Li Q, Xiao F, Sun Y, Chen J, He Y, Ning J, Hu Q, Xiao Y, Li C, Huang B, Zhao J, Li Y, Li H. Bridging the gap: clinical translation of adipose-derived stem cells - a scoping review of clinical trials. Stem Cell Res Ther 2025; 16:288. [PMID: 40483503 PMCID: PMC12145640 DOI: 10.1186/s13287-025-04405-3] [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: 03/23/2025] [Accepted: 05/19/2025] [Indexed: 06/11/2025] Open
Abstract
BACKGROUND Adipose-derived stem cells (ADSCs) have emerged as a promising therapeutic tool in regenerative medicine due to their multipotency, immunomodulatory properties, and ease of procurement. Despite extensive preclinical research, the clinical translation of ADSCs remains fragmented, with challenges in standardization, reproducibility, and evidence synthesis. OBJECTIVE This scoping review, complemented by bibliometric analysis, aims to map the landscape of randomized controlled trials (RCTs) evaluating ADSC therapies, identify gaps between basic research and clinical translation, and highlight emerging trends in the field. METHODS A systematic search of Web of Science, PubMed, Embase, ClinicalTrials.gov, EudraCT, and ChiCTR database (2009-2025) identified 82 RCTs. Bibliometric analysis of preclinical studies was conducted using VoSviewer to visualize keyword clusters and temporal trends. Data on trial characteristics, endpoints, and translational challenges were extracted and synthesized. RESULTS The 82 included RCTs spanned 17 medical specialties, with orthopedics (26.8%), dermatology (14.6%), and neurology (9.7%) being the most studied. Spain (21.95%) and China (18.29%) and the USA (15.85%) led trial numbers, but 97% were single-country studies with a median sample size of 40. Primary endpoints trends from safety to efficacy. Bibliometric analysis revealed three clusters: stem cell sources and basic biology, orthopedic applications, and tissue regeneration mechanisms. Key gaps included protocol heterogeneity (e.g., isolation methods, cryopreservation variability), regulatory fragmentation, limited long-term follow-up, and inconsistent clinical outcomes, particularly in neurology. Emerging trends highlighted the therapeutic potential of stromal vascular fraction (SVF) and ADSC-derived exosomes. CONCLUSIONS While ADSCs demonstrate significant therapeutic potential, clinical translation is hindered by standardization deficits and mechanistic knowledge gaps. Future research should prioritize international collaboration, large-scale trials, and mechanistic studies to optimize ADSC therapies. Innovations in SVF and exosome-based treatments represent promising avenues for advancing regenerative medicine. TRIAL REGISTRY This scoping review was preregistered at OSF platform: https://doi.org/10.17605/OSF.IO/YKHW3 .
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Affiliation(s)
- Hankun Su
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
- Xiangya School of Medicine, Central South University, Changsha, Hunan, China
| | - Hoksan Chau
- Xiangya School of Medicine, Central South University, Changsha, Hunan, China
| | - Qilin Li
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
- Xiangya School of Medicine, Central South University, Changsha, Hunan, China
| | - Fen Xiao
- Department of Metabolism and Endocrinology, The Second Xiangya, Hospital of Central South University, Changsha, Hunan, China
| | - Yuanyuan Sun
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
| | - Jingjing Chen
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
| | - Yayi He
- Xiangya School of Medicine, Central South University, Changsha, Hunan, China
| | - Jinyao Ning
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
| | - Qin Hu
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
| | - Yujie Xiao
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
| | - Caiwen Li
- Department of Fetal Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
| | - Bixia Huang
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
| | - Jing Zhao
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
| | - Yanping Li
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China
| | - Hui Li
- Department of Reproductive Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.
- Clinical Research Center for Women's Reproductive Health in Hunan Province, Changsha, Hunan Province, China.
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Ramsden R. A systematic review of attachment interventions for people with intellectual disability and their caregivers. JOURNAL OF INTELLECTUAL DISABILITIES : JOID 2025; 29:469-499. [PMID: 39366922 PMCID: PMC12084664 DOI: 10.1177/17446295241289734] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Accepted: 09/20/2024] [Indexed: 10/06/2024]
Abstract
ObjectiveThe current mixed-methods systematic review evaluated available literature to find out which attachment-based interventions have been implemented for people with intellectual disability and whether they are efficacious and acceptable.MethodsFive databases were searched (in July 2023 and April 2024), using terms related to intellectual disability and attachment-based interventions. The search yielded 793 papers; 15 papers (13 studies) met inclusion criteria. Relevant data was extracted from each study. Paper quality was appraised using the Mixed Methods Appraisal Tool. Findings were synthesised in an integrative review.ResultsOf the included studies, 7 had people with intellectual disability as participants and 6 had their caregivers. Interventions included education, psychotherapy, technology assisted therapy, video interaction guidance/feedback and circle of security. Research methods varied.ConclusionsEvidence for efficacy and acceptability of interventions was mixed but promising. Most studies had limited generalisability. Therefore, further research is required. Pre-registration with PROSPERO [351287].
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Affiliation(s)
- Ruby Ramsden
- Oxford Institute for Clinical Psychology Research and Training, University of Oxford, UK
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Zhou F, Parrish R, Afzal M, Saha A, Haynes RB, Iorio A, Lokker C. Benchmarking domain-specific pretrained language models to identify the best model for methodological rigor in clinical studies. J Biomed Inform 2025; 166:104825. [PMID: 40246186 DOI: 10.1016/j.jbi.2025.104825] [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: 12/01/2024] [Revised: 03/02/2025] [Accepted: 04/03/2025] [Indexed: 04/19/2025]
Abstract
OBJECTIVE Encoder-only transformer-based language models have shown promise in automating critical appraisal of clinical literature. However, a comprehensive evaluation of the models for classifying the methodological rigor of randomized controlled trials is necessary to identify the more robust ones. This study benchmarks several state-of-the-art transformer-based language models using a diverse set of performance metrics. METHODS Seven transformer-based language models were fine-tuned on the title and abstract of 42,575 articles from 2003 to 2023 in McMaster University's Premium LiteratUre Service database under different configurations. The studies reported in the articles addressed questions related to treatment, prevention, or quality improvement for which randomized controlled trials are the gold standard with defined criteria for rigorous methods. Models were evaluated on the validation set using 12 schemes and metrics, including optimization for cross-entropy loss, Brier score, AUROC, average precision, sensitivity, specificity, and accuracy, among others. Threshold tuning was performed to optimize threshold-dependent metrics. Models that achieved the best performance in one or more schemes on the validation set were further tested in hold-out and external datasets. RESULTS A total of 210 models were fine-tuned. Six models achieved top performance in one or more evaluation schemes. Three BioLinkBERT models outperformed others on 8 of the 12 schemes. BioBERT, BiomedBERT, and SciBERT were best on 1, 1 and 2 schemes, respectively. While model performance remained robust on the hold-out test set, it declined in external datasets. Class weight adjustments improved performance in most instances. CONCLUSION BioLinkBERT generally outperformed the other models. Using comprehensive evaluation metrics and threshold tuning optimizes model selection for real-world applications. Future work should assess generalizability to other datasets, explore alternate imbalance strategies, and examine training on full-text articles.
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Affiliation(s)
- Fangwen Zhou
- Health Information Research Unit, Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
| | - Rick Parrish
- Health Information Research Unit, Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
| | - Muhammad Afzal
- Department of Computing, Faculty of Computing, Engineering and the Built Environment, Birmingham City University, Birmingham, United Kingdom
| | - Ashirbani Saha
- Department of Oncology, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
| | - R Brian Haynes
- Health Information Research Unit, Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
| | - Alfonso Iorio
- Health Information Research Unit, Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
| | - Cynthia Lokker
- Health Information Research Unit, Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
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Columbo JA, Krafcik BM, Baughan E, Sickels AD, Beck AW, Neal D, Scali ST, Stone DH. Textbook outcomes as a novel patient-centric metric to inform carotid revascularization. J Vasc Surg 2025; 81:1370-1379.e2. [PMID: 39922241 PMCID: PMC12103996 DOI: 10.1016/j.jvs.2025.01.220] [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: 11/18/2024] [Revised: 01/13/2025] [Accepted: 01/16/2025] [Indexed: 02/10/2025]
Abstract
OBJECTIVE The recent National Coverage Determination surrounding carotid stenting and shared decision-making has ushered in an era of patient-centric carotid care. However, historical carotid intervention endpoints have lacked patient-centered nuances to inform clinical decisions. Accordingly, we aimed to create a comprehensive novel, patient-centric textbook outcome (TO) to inform treatment paradigms. METHODS We developed a novel composite TO for patients who underwent carotid revascularization reflecting a combination of patient-centric outcomes derived from previous patient interviews and the published literature. We defined a TO to include freedom from postprocedural neurologic events, myocardial infarction, cranial nerve injury, return to the operating room, reperfusion syndrome, or access site complications. The endpoint also included discharge on postprocedural day 1, home discharge, and 30-day survival. We measured the risk of a TO vs non-TO among asymptomatic patients undergoing carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), or transfemoral carotid artery stenting (TF-CAS) in the Vascular Quality Initiative (VQI) from 2016 to 2023. RESULTS We studied 72,778 patients who underwent carotid revascularization, 70.3% CEA, 21.0% TCAR, and 8.7% TF-CAS. The mean age across all patients was 71.6 ± 8.4 years, 39.9% were female, and 91.7% were White. A TO was achieved in 76.9% of patients, and was 76.7% after CEA, 76.5% after TCAR, and 79.1% after TF-CAS (P < .001). Postprocedural length of stay was 2 days or more in 21.0% of patients, and was 21.1% after CEA, 21.6% after TCAR, and 18.4% after TF-CAS (P < .001). Postprocedural neurologic events occurred in 1.0% of patients after CEA, 1.3% after TCAR, and 1.4% after TF-CAS (P = .037). A sensitivity analysis of the TO that did not include postprocedural length of stay demonstrated a non-TO in 5.9% of patients after CEA, 5.5% after TCAR, and 6.3% after TF-CAS (P = .070). Patients who did not achieve a TO had inferior 5-year survival compared with patients who did have a TO across all three cohorts (log-rank P < .001). CONCLUSIONS This novel patient-centric endpoint demonstrated that a substantial percentage of patients fail to achieve a TO in current practice, and that failure to achieve a TO was associated with inferior 5-year survival. These findings are particularly important in light of the recent Medicare mandate for a shared decision-making approach to carotid care delivery and may help to best align patient preferences with procedure type.
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Affiliation(s)
- Jesse A Columbo
- Geisel School of Medicine at Dartmouth, Hanover, NH; Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH.
| | - Brianna M Krafcik
- Geisel School of Medicine at Dartmouth, Hanover, NH; Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH
| | | | - Angela D Sickels
- Division of Vascular and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, AL
| | - Adam W Beck
- Division of Vascular and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, AL
| | - Dan Neal
- Division of Vascular and Endovascular Therapy, University of Florida Medical Center, Gainesville, FL
| | - Salvatore T Scali
- Division of Vascular and Endovascular Therapy, University of Florida Medical Center, Gainesville, FL; University of Florida School of Medicine, Gainesville, FL
| | - David H Stone
- Geisel School of Medicine at Dartmouth, Hanover, NH; Section of Vascular Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH
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Dias AC, Moreira VP, Comba JLD. RoBIn: A Transformer-based model for risk of bias inference with machine reading comprehension. J Biomed Inform 2025; 166:104819. [PMID: 40250743 DOI: 10.1016/j.jbi.2025.104819] [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: 11/01/2024] [Revised: 03/12/2025] [Accepted: 03/25/2025] [Indexed: 04/20/2025]
Abstract
OBJECTIVE Scientific publications are essential for uncovering insights, testing new drugs, and informing healthcare policies. Evaluating the quality of these publications often involves assessing their Risk of Bias (RoB), a task traditionally performed by human reviewers. The goal of this work is to create a dataset and develop models that allow automated RoB assessment in clinical trials. METHODS We use data from the Cochrane Database of Systematic Reviews (CDSR) as ground truth to label open-access clinical trial publications from PubMed. This process enabled us to develop training and test datasets specifically for machine reading comprehension and RoB inference. Additionally, we created extractive (RoBInExt) and generative (RoBInGen) Transformer-based approaches to extract relevant evidence and classify the RoB effectively. RESULTS RoBIn was evaluated across various settings and benchmarked against state-of-the-art methods, including large language models (LLMs). In most cases, the best-performing RoBIn variant surpasses traditional machine learning and LLM-based approaches, achieving a AUROC of 0.83. CONCLUSION This work addresses RoB assessment in clinical trials by introducing RoBIn, two Transformer-based models for RoB inference and evidence retrieval, which outperform traditional models and LLMs, demonstrating its potential to improve efficiency and scalability in clinical research evaluation. We also introduce a public dataset that is automatically annotated and can be used to enable future research to enhance automated RoB assessment.
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Affiliation(s)
- Abel Corrêa Dias
- Instituto de Informatica, Av. Bento Goncalves 9500 - Caixa Postal 15064, Porto Alegre, 91501-970, Rio Grande do Sul, Brazil
| | - Viviane Pereira Moreira
- Instituto de Informatica, Av. Bento Goncalves 9500 - Caixa Postal 15064, Porto Alegre, 91501-970, Rio Grande do Sul, Brazil
| | - João Luiz Dihl Comba
- Instituto de Informatica, Av. Bento Goncalves 9500 - Caixa Postal 15064, Porto Alegre, 91501-970, Rio Grande do Sul, Brazil.
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Brookhart MA, Mayne TJ, Coombs C, Breskin A, Ness E, Bessonova L, Chu YJ, Li J, Fried MW, Hansen BE, Kowdley KV, Jones D, Mells G, Trivedi PJ, Hiu S, Kareithi DN, Wason J, Smith R, Seeger JD, Hirschfield GM. Hepatic real-world outcomes with obeticholic acid in primary biliary cholangitis (HEROES): A trial emulation study design. Hepatology 2025; 81:1647-1659. [PMID: 39630028 PMCID: PMC12077331 DOI: 10.1097/hep.0000000000001174] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/14/2023] [Accepted: 09/28/2024] [Indexed: 01/29/2025]
Abstract
BACKGROUND AND AIMS Primary biliary cholangitis is a rare, progressive liver disease. Obeticholic acid (OCA) received accelerated approval for treating patients with primary biliary cholangitis in whom ursodeoxycholic acid failed, based on a surrogate endpoint of reduction in ALP. Analysis of the long-term safety extension with 2 external control groups demonstrated a significant increase in event-free survival in OCA-treated patients. This fully real-world evidence study assessed the effect of OCA treatment on clinical outcomes. APPROACH AND RESULTS This trial emulation used data from the Komodo Healthcare Map claims database linked to US national laboratory, transplant, and death databases. Patients with compensated primary biliary cholangitis and intolerance/inadequate response to ursodeoxycholic acid who initiated OCA therapy were compared with patients who were OCA-eligible but not OCA-treated. The primary endpoint was time to the first occurrence of death, liver transplant, or hospitalization for hepatic decompensation, analyzed using a propensity-score weighted Cox proportional hazards model. Baseline prognostic factors were balanced using standardized morbidity ratio weighting. For the primary analysis, 4174 patients contributed 11,246 control index dates, and 403 patients contributed OCA indexes. Weighted groups were well balanced. Median (95% CI) follow-up in the OCA and non-OCA arms was 9.3 (8.4-10.6) months and 17.5 (16.2-18.6) months (weighted population; censored at discontinuation). Eight events occurred in the OCA arm and 32 in the weighted control (HR = 0.37; 95% CI = 0.14-0.75; p < 0.001). Effects were consistent for each component of the composite endpoint. CONCLUSIONS We identified a 63% reduced risk of hospitalization for hepatic decompensation, liver transplant, or death in OCA-treated versus non-OCA-treated individuals. TRIAL REGISTRATION HEROES; ClinicalTrials.gov NCT05292872.
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Affiliation(s)
- M. Alan Brookhart
- Department of Population Health Sciences, Duke University, Durham, North Carolina, USA
- Target RWE, Durham, North Carolina, USA
| | | | | | | | - Erik Ness
- Intercept Pharmaceuticals, Morristown, New Jersey, USA
| | | | | | - Jing Li
- Intercept Pharmaceuticals, Morristown, New Jersey, USA
| | | | - Bettina E. Hansen
- Department of Epidemiology and Biostatistics, Erasmus MC, Rotterdam, The Netherlands
- Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
- Toronto Centre for Liver Disease and TGHRI, University Health Network, Toronto, Ontario, Canada
| | - Kris V. Kowdley
- Liver Institute Northwest and Elson S. Floyd College of Medicine, Washington State University, Seattle, Washington, USA
| | - David Jones
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - George Mells
- Department of Hepatology, Cambridge Liver Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
- Academic Department of Medical Genetics, University of Cambridge, Cambridge, UK
| | - Palak J. Trivedi
- Department of Immunology and Immunotherapy, National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK
| | - Shaun Hiu
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - Dorcas N. Kareithi
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - James Wason
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - Rachel Smith
- Department of Hepatology, Cambridge Liver Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
| | | | - Gideon M. Hirschfield
- Toronto Centre for Liver Disease and TGHRI, University Health Network, Toronto, Ontario, Canada
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Koch E, Smart S, Einarsson G, Kämpe A, Jonsson L, Alver M, Iveson M, Göteson A, Pardiñas AF, Sønderby IE, O'Connell KS, Li Q, Lu Y, Stefánsson H, Stefánsson K, Whalley H, Landén M, O'Donovan MC, Smerud K, Dawson GR, Werge T, Buil A, Reif A, Milani L, Molden E, Fabbri C, Serretti A, Walters J, Lewis CM, Andreassen OA. Recommendations for defining treatment outcomes in major psychiatric disorders using real-world data. Lancet Psychiatry 2025; 12:457-468. [PMID: 40222385 DOI: 10.1016/s2215-0366(25)00061-6] [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: 11/29/2024] [Revised: 02/10/2025] [Accepted: 02/18/2025] [Indexed: 04/15/2025]
Abstract
Although information from real-world data can be used to identify factors that aid treatment choice, there are no guidelines for the use of such data. The aim of this Review is to summarise and evaluate definitions of treatment outcomes for antidepressants, antipsychotics, and mood stabilisers when using real-world data, and to suggest standards for the field. Given that no standards for the use of these data in estimating treatment outcomes exist, variability is high for treatment outcome definitions. We make recommendations for different scenarios of available data and highlight the importance of using other sources of information to validate proxy measures such as continued treatment, switching between medications, or polypharmacy of psychotropic medications. Well defined and validated treatment outcome measures that incorporate real-world data could facilitate the development of precision psychiatry approaches and support regulatory decision making regarding psychopharmacological agents.
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Affiliation(s)
- Elise Koch
- Center for Precision Psychiatry, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway
| | - Sophie Smart
- Centre for Neuropsychiatric Genetics and Genomics, Division of Psychological Medicine and Clinical Neurosciences, Cardiff University, Cardiff, UK
| | | | - Anders Kämpe
- Institute for Molecular Medicine Finland (FIMM), Helsinki, Finland; Department of Molecular Medicine and Surgery (MMK), Karolinska Institutet, Stockholm, Sweden
| | - Lina Jonsson
- Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Maris Alver
- Estonian Genome Centre, Institute of Genomics, University of Tartu, Tartu, Estonia
| | - Matthew Iveson
- Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK
| | - Andreas Göteson
- Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Antonio F Pardiñas
- Centre for Neuropsychiatric Genetics and Genomics, Division of Psychological Medicine and Clinical Neurosciences, Cardiff University, Cardiff, UK
| | - Ida E Sønderby
- Center for Precision Psychiatry, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Medical Genetics, Oslo University Hospital, Oslo, Norway; KG Jebsen Centre for Neurodevelopmental Disorders, University of Oslo, Oslo, Norway; Oslo University Hospital, Oslo, Norway
| | - Kevin S O'Connell
- Center for Precision Psychiatry, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway
| | - Qingqin Li
- Janssen Research and Development, Neuroscience, Titusville, NJ, USA
| | - Yi Lu
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
| | | | - Kári Stefánsson
- deCODE Genetics, Reykjavik, Iceland; Faculty of Medicine, University of Iceland, Reykjavik, Iceland
| | - Heather Whalley
- Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; Generation Scotland, Centre for Medical Informatics, University of Edinburgh, Edinburgh, UK
| | - Mikael Landén
- Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
| | - Michael C O'Donovan
- Centre for Neuropsychiatric Genetics and Genomics, Division of Psychological Medicine and Clinical Neurosciences, Cardiff University, Cardiff, UK
| | - Knut Smerud
- Smerud Medical Research International AS, Oslo, Norway
| | | | - Thomas Werge
- Institute of Biological Psychiatry, Mental Health Services, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark
| | - Alfonso Buil
- Institute of Biological Psychiatry, Mental Health Services, Copenhagen University Hospital, Copenhagen, Denmark
| | - Andreas Reif
- Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Medical Centre Frankfurt, Frankfurt, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany
| | - Lili Milani
- Estonian Genome Centre, Institute of Genomics, University of Tartu, Tartu, Estonia
| | - Espen Molden
- Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway; Department of Pharmacy, University of Oslo, Oslo, Norway
| | - Chiara Fabbri
- Department of Biomedical and NeuroMotor Sciences, University of Bologna, Bologna, Italy
| | - Alessandro Serretti
- Department of Medicine and Surgery, Kore University of Enna, Enna, Italy; Oasi Research Institute-IRCCS, Troina, Troina, Italy
| | - James Walters
- Centre for Neuropsychiatric Genetics and Genomics, Division of Psychological Medicine and Clinical Neurosciences, Cardiff University, Cardiff, UK
| | - Cathryn M Lewis
- Social, Genetic and Developmental Psychiatry Centre, King's College London, London, UK; NIHR Maudsley Biomedical Research Centre, South London and Maudsley NHS Trust, London, UK
| | - Ole A Andreassen
- Center for Precision Psychiatry, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway; KG Jebsen Centre for Neurodevelopmental Disorders, University of Oslo, Oslo, Norway; Oslo University Hospital, Oslo, Norway.
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10
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Chen H, Li X, He X, Chen A, McGill J, Webber EC, Xu H, Liu M, Bian J. Enhancing Patient-Trial Matching With Large Language Models: A Scoping Review of Emerging Applications and Approaches. JCO Clin Cancer Inform 2025; 9:e2500071. [PMID: 40489722 DOI: 10.1200/cci-25-00071] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2025] [Revised: 04/24/2025] [Accepted: 04/28/2025] [Indexed: 06/11/2025] Open
Abstract
PURPOSE Patient recruitment remains a major bottleneck in clinical trial execution, with inefficient patient-trial matching often causing delays and failures. Recent advancements in large language models (LLMs) offer a promising avenue for automating and improving this process. This scoping review aims to provide a comprehensive synthesis of the emerging applications of LLMs in patient-trial matching. METHODS A comprehensive search was conducted in PubMed, Web of Science, and OpenAlex for literature published between December 1, 2022, and December 31, 2024. Studies were included if they explicitly integrated LLMs into patient-trial matching systems. Data extraction focused on system architectures, patient data processing, eligibility criteria processing, matching techniques, evaluation metrics, and performance. RESULTS Of the 2,357 studies initially identified, 24 met the inclusion criteria. The majority (21/24) were published in 2024, highlighting the rapid adoption of LLMs in this domain. Most systems used patient-centric matching (17/24), with OpenAI's generative pretrained transformer models being the most commonly used LLM. Core components of these systems included eligibility criteria processing, patient data processing, and matching, with some incorporating retrieval algorithms to enhance computational efficiency. LLM-integrated approaches demonstrated improved accuracy and scalability in patient-trial matching, although challenges such as performance variability, interpretability, and reliance on synthetic data sets remain significant. CONCLUSION LLM-based patient-trial matching systems present a transformative opportunity to enhance the efficiency and accuracy of clinical trial recruitment. Despite current limitations related to model generalizability, explainability, and data constraints, future advancements in hybrid modeling strategies, domain-specific fine-tuning, and real-world data set integration could further optimize LLM-based trial matching. Addressing these challenges will be crucial to realizing the full potential of LLMs in streamlining patient recruitment and accelerating clinical trial execution.
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Affiliation(s)
- Hongyu Chen
- Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
| | - Xiaohan Li
- Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
| | - Xing He
- Department of Biostatistics and Health Data Science, School of Medicine, Indiana University, Indianapolis, IN
- Regenstrief Institute, Indianapolis, IN
| | - Aokun Chen
- Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
| | | | - Emily C Webber
- Riley Hospital for Children at Indiana University Health, Indianapolis, IN
- Division of Pediatric Hospital Medicine, School of Medicine, Indiana University, Indianapolis, IN
| | - Hua Xu
- Section of Biomedical Informatics and Data Science, School of Medicine, Yale University, Yale, NH
| | - Mei Liu
- Department of Health Outcomes & Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL
| | - Jiang Bian
- Department of Biostatistics and Health Data Science, School of Medicine, Indiana University, Indianapolis, IN
- Regenstrief Institute, Indianapolis, IN
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11
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Cheng F, Niu X, Wang Y, Yang F, Yang K, Li W. Decoding the impact of glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist on cardiometabolic health: inflammatory mediators at the focus. Diabetol Metab Syndr 2025; 17:175. [PMID: 40426228 PMCID: PMC12117674 DOI: 10.1186/s13098-025-01744-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/31/2024] [Accepted: 05/15/2025] [Indexed: 05/29/2025] Open
Abstract
BACKGROUND The Glucagon-like peptide-1 receptor (GLP-1R) and the glucose-dependent insulinotropic polypeptide receptor (GIPR) are well-established drug targets for the treatment of diabetes and obesity. Studies have linked GLP-1R agonist to cardiometabolic diseases (CMDs), while the therapeutic potential of the GIPR agonist remains a topic of debate. METHODS Using genetic variants as instrumental variables, we performed a two-sample Mendelian randomization (MR) analysis to investigate causal relationships between genetically proxied GIPR agonist and 23 CMD outcomes, and a two-step mediation analysis to identify mediating inflammatory biomarkers. The inverse variance weighted (IVW) method served as the primary analytical approach, supplemented by sensitivity analyses to validate robustness. RESULTS The genetic mimicry of GIPR enhancement showed significant protective associations with 14 CMDs. Mediation analysis revealed that Fms-related tyrosine kinase 3 ligand (Flt3L) partially mediated the effects of GIPR agonist on angina (OR 0.997 [0.995-0.999], P = 0.0048) and myocardial infarction(MI) (OR 0.998 [0.996-0.999], P = 0.0077), accounting for 15.49% and 16.71% of the total risk reduction, respectively. CONCLUSION Our study revealed that GIPR agonist lowers the risk of 14 CMDs. Flt3L is pinpointed as a key mediating factor in reducing angina and MI risk, suggesting a new therapeutic avenue.
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Affiliation(s)
- Fang Cheng
- Department of Geriatrics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No 1277, Jiefang Avenue, Wuhan, 430000, Hubei, China
| | - Xinyu Niu
- Department of Geriatrics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No 1277, Jiefang Avenue, Wuhan, 430000, Hubei, China
| | - Yaoling Wang
- Center of Gerontology and Geriatrics, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, 610041, China
| | - Fan Yang
- Department of Geriatrics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No 1277, Jiefang Avenue, Wuhan, 430000, Hubei, China
| | - Kang Yang
- Department of Geriatrics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No 1277, Jiefang Avenue, Wuhan, 430000, Hubei, China
| | - Wei Li
- Department of Geriatrics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No 1277, Jiefang Avenue, Wuhan, 430000, Hubei, China.
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12
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Gunawan YA, Suen MW, Denny HM, Restya WP. Alleviating work stress with physical activity: A comprehensive review. Work 2025:10519815251337040. [PMID: 40420835 DOI: 10.1177/10519815251337040] [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: 05/28/2025] Open
Abstract
BACKGROUND Work stress presents significant challenges to employee well-being and productivity. Physical activity interventions in the workplace have been associated with occupational stress reduction; however, further investigation with meticulous planning and comprehensive descriptions of the interventions is necessary. OBJECTIVE This study aimed to synthesize the effects of physical activity interventions on work stress among employees based on studies published from 2019 to 2024. METHODS This comprehensive review examines the effects of physical activity interventions on work stress outcomes, synthesizing studies published between 2019 and 2024. The study followed the PRISMA guidelines and was registered in PROSPERO (CRD42024611620). Quality assessment was performed using Cochrane's Risk of Bias tools, and meta-analysis was conducted using Comprehensive Meta-Analysis software. RESULTS The review analyzed interventions such as aerobic training, resistance training, holistic movement practices, and sports activities. This study revealed a small negative correlation between physical activity and stress (d = -0.24, 95% CI [-0.83, 0.35]). Substantial heterogeneity (I² = 98%, p < 0.001) indicated variation across populations and intervention types. CONCLUSIONS Despite modest effects, results highlight the potential of tailored, sustainable physical activity programs to improve employee resilience and workplace well-being. This study emphasizes incorporating physical activity into wellness strategies and encourages future research to optimize intervention design and implementation for maximum impact.
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Affiliation(s)
| | - Mein-Woei Suen
- Health Administration Department, Asia University, Taichung, Taiwan
- Psychology Department, Asia University, Taichung, Taiwan
| | - Hanifa M Denny
- Faculty of Public Health, Diponegoro University, Semarang, Indonesia
| | - Winda Pd Restya
- Health Administration Department, Asia University, Taichung, Taiwan
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13
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Nazar W, Romantowski J, Nazar G, Niedoszytko M, Braun-Dullaeus R, Daniłowicz-Szymanowicz L. Serious adverse drug reactions associated with anti-SARS-CoV-2 vaccines and their reporting trends in the EudraVigilance database. Sci Rep 2025; 15:18582. [PMID: 40425703 PMCID: PMC12116907 DOI: 10.1038/s41598-025-03428-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2024] [Accepted: 05/20/2025] [Indexed: 05/29/2025] Open
Abstract
A serious adverse reaction (SADR) may follow a vaccination against SARS-CoV-2 infection. We aimed to explore symptoms and reporting trends of SADRs to anti-SARS-CoV-2 vaccines based on the EudraVigilance database. This retrospective observational study analysed 250,966 suspected SADRs (with 62.8% reported in females), following the administration of 733,837,251 vaccine doses against SARS-CoV-2. Pfizer BioNTech (Comirnaty-Tozinameran), Moderna (Spikevax-Elastomeran), Janssen (Jcovden) and AstraZeneca (Vaxzevria) vaccines were analysed. The assessment included 897 types of SADRs across 12 categories. The most common clinical manifestations of SADRs to anti-SARS-CoV-2 vaccines vaccines encompassed neuropsychiatric (n = 121,877), cardiovascular (n = 78,167), as well as musculoskeletal and connective tissue disorders (n = 63,994). After summarising all SADRs, vaccination with Comirnaty was associated with the lowest risk of experiencing SADRs (754/million administered doses), followed by Spikevax (785/million doses), Jcovden (1,248/million doses) and Vaxzevria (2,301/million doses; p < 0.001). Regarding the vaccine administration timelines, the reporting of SADRs tends to be delayed and occurs over a longer time (p < 0.001). SADRs associated with anti-SARS-CoV-2 vaccines seem to be relatively rare. Compared to adenovirus-based vector vaccines (Jcovden, Vaxzevria), mRNA vaccines appear to offer improved safety profiles (Comirnaty, Spikevax). The risk of SADR to any SARS-CoV-2 vaccine seems to be outweighed by the benefits of active immunization against the virus.
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Affiliation(s)
- Wojciech Nazar
- Faculty of Medicine, Medical University of Gdańsk, Marii Skłodowskiej-Curie 3a, 80-210, Gdańsk, Poland.
- Laboratory of Experimental and Translational Allergology, Department of Allergology, Faculty of Medicine, Medical University of Gdańsk, Smoluchowskiego 17, 80-214, Gdańsk, Poland.
| | - Jan Romantowski
- Department of Allergology, Faculty of Medicine, Medical University of Gdańsk, Smoluchowskiego 17, 80-214, Gdańsk, Poland
| | - Grzegorz Nazar
- Faculty of Medicine, Medical University of Gdańsk, Marii Skłodowskiej-Curie 3a, 80-210, Gdańsk, Poland
| | - Marek Niedoszytko
- Department of Allergology, Faculty of Medicine, Medical University of Gdańsk, Smoluchowskiego 17, 80-214, Gdańsk, Poland
| | - Rüdiger Braun-Dullaeus
- Department of Cardiology and Angiology, Otto Von Guericke University Magdeburg, Leipziger Street 44, 39120, Magdeburg, Germany
| | - Ludmiła Daniłowicz-Szymanowicz
- Department of Cardiology and Electrotherapy, Faculty of Medicine, Medical University of Gdańsk, Smoluchowskiego 17, 80-214, Gdańsk, Poland
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14
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Zane GK, Sutton A, Brumwell A, Hossain MR, Hawes SE, Giovannoni G, Mowry EM, Jacobson S, Cohen JI, Bebo B, Patel RC. The path to prevention of multiple sclerosis: Considerations for Epstein-Barr virus vaccine-based prevention studies. Mult Scler 2025:13524585251340812. [PMID: 40415641 DOI: 10.1177/13524585251340812] [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: 05/27/2025]
Abstract
Recent advancements in our understanding of the association between Epstein-Barr virus (EBV) and multiple sclerosis (MS), along with progress in EBV vaccine development, warrant serious considerations of future EBV vaccine-based MS-prevention studies. The clinical, financial, logistical, and technological considerations for designing and conducting retrospective and/or prospective prevention studies with the primary objective of evaluating the effectiveness of EBV vaccines in preventing MS and other EBV-associated sequelae are presented here. As implementation of these studies may require hundreds of thousands of participants, millions of dollars, and decades to observe if meaningful reductions in MS incidence occur, alternative approaches using pragmatic phase IV, post-licensure study designs focused on either the prevention of MS or infectious mononucleosis (IM), a common clinical manifestation of EBV infection that has been associated with increased risk of MS, are also explored. Current knowledge gaps in technology, funding, and research that must be addressed for a study protocol to be successfully designed and implemented are also discussed.
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Affiliation(s)
- Gregory K Zane
- Department of Epidemiology, University of Washington, Seattle, WA, USA
- Strategic Analysis, Research, and Training (START) Center, Seattle, WA, USA
| | - Anna Sutton
- Department of Epidemiology, University of Washington, Seattle, WA, USA
- Strategic Analysis, Research, and Training (START) Center, Seattle, WA, USA
| | - Amanda Brumwell
- Strategic Analysis, Research, and Training (START) Center, Seattle, WA, USA
- Department of Global Health, University of Washington, Seattle, WA, USA
| | - Md Rezaul Hossain
- Department of Epidemiology, University of Washington, Seattle, WA, USA
- Strategic Analysis, Research, and Training (START) Center, Seattle, WA, USA
| | - Stephen E Hawes
- Department of Epidemiology, University of Washington, Seattle, WA, USA
- Strategic Analysis, Research, and Training (START) Center, Seattle, WA, USA
| | - Gavin Giovannoni
- Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK
| | - Ellen M Mowry
- Department of Neurology, Johns Hopkins University, Baltimore, MD, USA
| | - Steven Jacobson
- Viral Immunology Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA
| | - Jeffrey I Cohen
- Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA
| | - Bruce Bebo
- Department of Advocacy, Services, and Research, National Multiple Sclerosis Society, New York, NY, USA
| | - Rena C Patel
- Department of Global Health, University of Washington, Seattle, WA, USA
- Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, WA, USA
- Division of Infectious Diseases, and Epidemiology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA
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15
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Sung SH, Jeong H, Park JH, Park M, Lee G. Clinical Evidence of Bee Venom Acupuncture for Ankle Pain: A Review of Clinical Research. Toxins (Basel) 2025; 17:257. [PMID: 40423339 DOI: 10.3390/toxins17050257] [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: 04/03/2025] [Revised: 05/13/2025] [Accepted: 05/19/2025] [Indexed: 05/28/2025] Open
Abstract
The prevalence of ankle pain in adults is 9-15%, with up to 45% of sports-related injuries attributed to ankle pain and injuries. If ankle pain is not controlled in a timely manner, it can lead to ankle instability, resulting in further damage, recurrence of pain, and secondary injuries. The present study aimed to assess the therapeutic potential and safety profile of bee venom acupuncture (BVA) in the management of ankle pain. Ten electronic databases were searched for articles published up to March 2025. We included clinical studies that utilized BVA for the treatment of ankle pain and studies that included pain- and function-related assessment tools. The safety of bee venom acupuncture (BVA) was assessed by extracting adverse events from the included studies and categorizing them according to the Common Terminology Criteria for Adverse Events (CTCAE). A total of 14 clinical studies were selected, of which 9 were case reports, 2 were case-controlled clinical trials (CCTs), and 3 were randomized controlled trials (RCTs). The conditions causing ankle pain were mostly traumatic (42.9%), followed by inflammatory (21.4%) and neuropathic disorders (14.3%). BVA was applied at concentrations ranging from 0.05 to 0.5 mg/mL, with a per-session volume ranging from 0.04 to 2.5 mL. In most studies, BVA was reported to improve both ankle pain and function simultaneously. Among the 14 studies, four participants reported adverse events following BVA treatment, all of which were classified as grade 1 or grade 2, indicating mild to moderate severity. This review suggests that BVA may be recommended for controlling ankle pain based on clinical evidence. However, the number of high-quality RCTs is limited, and half of the studies did not report side effects, indicating the need for further clinical research to verify its safety and efficacy.
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Affiliation(s)
- Soo-Hyun Sung
- Department of Policy Development, National Institute of Korean Medicine Development, Seoul 04554, Republic of Korea
| | - Hyein Jeong
- Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul 02447, Republic of Korea
| | - Jong-Hyun Park
- Department of Pathology, College of Korean Medicine, Daegu Haany University, 1 Haanydaero, Gyeongsan 38610, Republic of Korea
| | - Minjung Park
- Department of Preventive Medicine, College of Korean Medicine, Gachon University, Seungnam 13120, Republic of Korea
| | - Gihyun Lee
- College of Korean Medicine, Dongshin University, Naju 58245, Republic of Korea
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Chimoriya R, James S, Kritharides L, Sen S, Behdasht S, Suryawanshi A, Davie H, Thillainadesan J, Elias N, Aitken SJ. Recruitment Feasibility of Patients with Peripheral Artery Disease for a Multidisciplinary Intervention: Findings from the TEAM-PAD Trial. Ann Vasc Surg 2025:S0890-5096(25)00354-1. [PMID: 40409491 DOI: 10.1016/j.avsg.2025.05.011] [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: 12/19/2024] [Revised: 04/28/2025] [Accepted: 05/15/2025] [Indexed: 05/25/2025]
Abstract
INTRODUCTION Peripheral Arterial Disease (PAD) is a chronic progressive vascular condition with high morbidity and mortality, often necessitating comprehensive management to mitigate cardiovascular risk. AIMS This study assessed the feasibility of recruiting patients with PAD for a multidisciplinary team (MDT)-based care intervention, comparing its effectiveness to standard care within a clinical trial setting. METHODS Conducted as a cross-sectional analysis nested within the ongoing TEAM-PAD trial, this study targeted the recruitment of 30 patients within 12 weeks and evaluated recruitment, consent, and retention rates to assess feasibility. RESULTS A total of 30 participants were consented within 11 weeks, with an overall recruitment rate of 36.4% and retention rate of 90%. Baseline characteristics were balanced between groups. Participants had a mean age of 68.9 years and a high prevalence of comorbidities. The mean 10-year cardiovascular risk (SMART-REACH) was 42.8%. In the intervention group, implementing MDT recommendations is projected to reduce this risk by 12.1%. CONCLUSION Recruitment of patients with PAD into an MDT intervention was feasible and timely, with strong retention and well-balanced baseline characteristics. While modelled estimates suggest a potential benefit from MDT recommendations, these findings are preliminary and based on a small interim cohort. Evaluation of clinical effectiveness within the larger ongoing randomised controlled trial is needed to evaluate the medium and long-term impacts of integrated vascular care.
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Affiliation(s)
- Ritesh Chimoriya
- Institute of Academic Surgery, Vascular Department, Concord Repatriation General Hospital, Concord, Sydney, New South Wales, Australia; Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
| | - Sophie James
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Concord Hospital, The University of Sydney, 1 Hospital Road, Concord, NSW, 2139, Australia
| | - Leonard Kritharides
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Concord Hospital, The University of Sydney, 1 Hospital Road, Concord, NSW, 2139, Australia
| | - Shaundeep Sen
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia; Department of Renal Medicine, Concord Repatriation General Hospital, Concord, Australia
| | - Samim Behdasht
- Department of Pharmacy, Concord Repatriation General Hospital, Concord, Australia
| | - Avinash Suryawanshi
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia; Department of Endocrinology and Metabolism, Concord Repatriation General Hospital, Concord, New South Wales, 2139, Australia
| | - Huw Davie
- Concord Drug Health Services, Concord Repatriation General Hospital, Concord, New South Wales, 2139, Australia
| | - Janani Thillainadesan
- Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia; Centre for Education and Research on Ageing, Concord Hospital, Concord, Sydney, NSW, Australia; Department of Geriatric Medicine, Concord Hospital, Hospital Road, Building 12, Concossrd, Sydney, NSW, 2139, Australia
| | - Nadine Elias
- Department of Geriatric Medicine, Concord Hospital, Hospital Road, Building 12, Concossrd, Sydney, NSW, 2139, Australia
| | - Sarah Joy Aitken
- Institute of Academic Surgery, Vascular Department, Concord Repatriation General Hospital, Concord, Sydney, New South Wales, Australia; Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
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17
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van Hal AFRL, Roman Galdran S, Wijnen RMH, Leyh J, Lacher M, Vlot J, Madadi-Sanjani O. Collaborative Efforts in Pediatric Surgery: Lessons from European Randomized Controlled Trials. Eur J Pediatr Surg 2025. [PMID: 40398495 DOI: 10.1055/a-2596-3857] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/23/2025]
Abstract
Conducting multicenter randomized controlled trials (RCTs) in pediatric surgery for rare congenital anomalies presents unique challenges, including low patient recruitment, complex regulatory landscapes, and variability in care standards. This paper reflects on the experiences and lessons learned from the MUC-FIRE and STEPS-EA trials, supported by the European Reference Network for Rare Inherited and Congenital Anomalies (ERNICA), to provide guidance for future studies.A retrospective review was conducted on the design and execution of these trials, focusing on team composition, endpoint selection, patient recruitment strategies, regulatory compliance, and adaptive methodologies. Insights were derived from study protocols, monitoring reports, and the authors' experiences.Key factors contributing to trial success included multidisciplinary collaboration, leveraging existing research networks, and defining clear, measurable endpoints. Challenges such as recruitment delays, regulatory hurdles, and variations in care were mitigated through flexible protocols, proactive amendments, and stakeholder engagement. The COVID-19 pandemic amplified these difficulties, necessitating innovative strategies and extended timelines.The MUC-FIRE and STEPS-EA trials underscore the critical importance of international collaboration, adaptive strategies, and patient-centered approaches in overcoming the complexities of multicenter RCTs. Lessons from these experiences can inform the design and implementation of future trials, ultimately enhancing evidence generation and improving outcomes for children with rare congenital anomalies.
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Affiliation(s)
- Anne-Fleur R L van Hal
- Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, South Holland, The Netherlands
| | - Sara Roman Galdran
- Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, South Holland, The Netherlands
| | - Rene M H Wijnen
- Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, South Holland, The Netherlands
| | - Judith Leyh
- Department of Pediatric Surgery, Faculty of Medicine, University of Leipzig, Leipzig, Saxony, Germany
| | - Martin Lacher
- Department of Pediatric Surgery, Faculty of Medicine, University of Leipzig, Leipzig, Saxony, Germany
| | - John Vlot
- Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, South Holland, The Netherlands
| | - Omid Madadi-Sanjani
- Department of Pediatric Surgery, Hannover Medical School, Hanover, Lower Saxony, Germany
- Department of Pediatric Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany
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18
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Krasowski R, Kamińska K, Głodek K, Ostrowska J, Zajda K, Pawliczak R, Kleniewska P. The therapeutic potential of vitamin D supplementation in asthma. Pharmacol Rep 2025:10.1007/s43440-025-00734-5. [PMID: 40392518 DOI: 10.1007/s43440-025-00734-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2024] [Revised: 04/27/2025] [Accepted: 05/08/2025] [Indexed: 05/22/2025]
Abstract
Recent years have seen a search for more effective forms of asthma therapy, with one possible option being vitamin D supplementation. The main objective of this study was to present the current state of knowledge on the effect of vitamin D supplementation on the course of asthma in children and adults; it also reviews the existing literature on prenatal vitamin D supplementation and asthma status. The search comprised articles, mostly randomized controlled trials (RCTs), included in the PubMed database and published after 2018. Most RCTs conducted on children indicate that vitamin supplementation did not affect the course of the disease, its control, or exacerbations; however, several trials in adults confirm it to have beneficial effects, with an important role being played by vitamin D deficiency. Unfortunately, the studies demonstrated considerable heterogeneity concerning the age and number of participants, dose, duration, and use of guidelines for pharmaceutical drugs, making it difficult to draw clear conclusions. Further, properly designed, large-scale studies with long-term follow-ups are needed.
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Affiliation(s)
- Rafał Krasowski
- Department of Immunopathology, Faculty of Medicine, Medical University of Lodz, Żeligowskiego 7/9, bldg 2 Rm 177, Łódź, 90-752, Poland
| | - Katarzyna Kamińska
- Department of Immunopathology, Faculty of Medicine, Medical University of Lodz, Żeligowskiego 7/9, bldg 2 Rm 177, Łódź, 90-752, Poland
| | - Katarzyna Głodek
- Department of Immunopathology, Faculty of Medicine, Medical University of Lodz, Żeligowskiego 7/9, bldg 2 Rm 177, Łódź, 90-752, Poland
| | - Joanna Ostrowska
- Department of Immunopathology, Faculty of Medicine, Medical University of Lodz, Żeligowskiego 7/9, bldg 2 Rm 177, Łódź, 90-752, Poland
| | - Klaudiusz Zajda
- Department of Immunopathology, Faculty of Medicine, Medical University of Lodz, Żeligowskiego 7/9, bldg 2 Rm 177, Łódź, 90-752, Poland
| | - Rafał Pawliczak
- Department of Immunopathology, Faculty of Medicine, Medical University of Lodz, Żeligowskiego 7/9, bldg 2 Rm 177, Łódź, 90-752, Poland
| | - Paulina Kleniewska
- Department of Immunopathology, Faculty of Medicine, Medical University of Lodz, Żeligowskiego 7/9, bldg 2 Rm 177, Łódź, 90-752, Poland.
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Ramirez S, Ríos N, Rojas-Barahona CA, Cárcamo M, Sepulveda-Pañaloza A, Araya R, Gaete J. Acceptability, feasibility, fidelity and quality implementation of the culturally adapted version of the Social Competence Promotion Program among Young Adolescents ("Mi Mejor Plan") to prevent substance use among adolescents in Chile: a pilot randomized control study. BMC Public Health 2025; 25:1860. [PMID: 40394545 DOI: 10.1186/s12889-025-23033-3] [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: 01/13/2025] [Accepted: 05/02/2025] [Indexed: 05/22/2025] Open
Abstract
INTRODUCTION Substance use among adolescents is a public health problem. We culturally adapted The Social Competence Promotion Program for Young Adolescents (SCPP-YA) program to the school context in Chile (henceforth "Mi Mejor Plan or MMP") and assessed the acceptability, feasibility, fidelity, and quality of the implementation among 6th graders. We also explored the efficacy of the program in improving individual protective factors and reducing risk factors and substance use. METHODS Cluster randomized controlled trial conducted in Chile. The schools were randomly assigned to one of two conditions in a 1:1 ratio: 1) the "MMP" intervention group, and 2) the Control group. The program consisted of a 16-h class-based curriculum promoting social problem-solving skills delivered by a trained facilitator. Primary outcomes were acceptability, feasibility, fidelity, and quality of the implementation using detailed reports of facilitators and from observers of the performance of the facilitators in vivo. Additionally, we explored the efficacy of the intervention on secondary outcomes: 30-day prevalence of tobacco, alcohol, and cannabis use and individual risk and protective factors promoted by MMP. We performed an intention-to-treat analysis using mixed models, taking into account the hierarchical nature of the data. RESULTS Seven hundred sixty-five 6th graders from 11 schools were enrolled (one school dropped out after the randomization); 608 were analyzed at baseline, and 538 were analyzed post-intervention. 52.5% were male, and the average age was 11.3 in both groups. All 16 sessions were implemented, and students' attendance at each session ranged from 83.8% to 92.4%. The program was generally well-received, with up to 91.3% of students rating acceptability positively. Facilitators and observers reported high adherence to the contents of the program in most sessions. Protective factors, such as negative beliefs about tobacco and alcohol, increased significantly in the IG. Still, there were no significant changes in substance use, risk factors, emotion regulation, or school membership. CONCLUSIONS The MMP program was well accepted, and we achieved high levels of implementation and fidelity. The program improved some individual protective factors, such as negative beliefs about tobacco and alcohol, with no changes in substance use among adolescents. TRIAL REGISTRATION ClinicalTrials.gov, number NCT04236947; registration date: 17/01/2020.
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Affiliation(s)
- Saray Ramirez
- Research Center for Student Mental Health (ISME), School of Education, Faculty of Social Sciences, Universidad de los Andes, Santiago, Chile
- ANID, Millennium Science Initiative Program, Millennium Nucleus to Improve the Mental Health of Adolescents and Youths, Imhay, Santiago, Chile
| | - Natalia Ríos
- Research Center for Student Mental Health (ISME), School of Education, Faculty of Social Sciences, Universidad de los Andes, Santiago, Chile
| | - Cristian A Rojas-Barahona
- Faculty of Psychology, Universidad de Talca, Talca, Chile
- ANID, Millenium Nucleus for the Sciences of Learning, Santiago, Chile
| | - Marcela Cárcamo
- ANID, Millennium Science Initiative Program, Millennium Nucleus to Improve the Mental Health of Adolescents and Youths, Imhay, Santiago, Chile
- Department of Epidemiology and Health Studies, Faculty of Medicine, Universidad de los Andes, Santiago, Chile
| | | | - Ricardo Araya
- Department of Health Service and Population Research, King's College London, London, UK
| | - Jorge Gaete
- Research Center for Student Mental Health (ISME), School of Education, Faculty of Social Sciences, Universidad de los Andes, Santiago, Chile.
- ANID, Millennium Science Initiative Program, Millennium Nucleus to Improve the Mental Health of Adolescents and Youths, Imhay, Santiago, Chile.
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20
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Paul JK, Azmal M, Talukder OF, Ghosh A. Statin use and Pancreatic Cancer: A Meta-analysis of its Association with Incidence in the General Population and Survival in Patients. J Gastrointest Cancer 2025; 56:121. [PMID: 40379858 DOI: 10.1007/s12029-025-01238-4] [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: 04/29/2025] [Indexed: 05/19/2025]
Abstract
PURPOSE Statins have been appearing as a potential anti-cancer agent in numerous studies. The study aimed to unravel the impact of statins in pancreatic cancer in terms of reducing the occurrence (morbidity) and improving survival (mortality). METHODS A comprehensive search of databases was carried out to collect the eligible studies up to July 2024. This meta-analysis evaluates two distinct questions: (1) whether statin use reduces the incidence of pancreatic ductal adenocarcinoma (PDAC) in the general population, and (2) whether statins improve survival among patients diagnosed with PDAC. In total, 39 studies were included in the meta-analysis, comprising 15 case-control studies, 20 cohort studies, three randomized controlled trials, and one non-randomized controlled trial. A generic inverse variance weighted random-effects model was applied to calculate the pooled risk ratio and 95% confidence intervals. Subgroup analyses were performed based on the availability of relevant information. RESULTS In the total meta-analysis, aggregated results demonstrated a substantial decrease in pancreatic cancer risk in all statin users (RR 0.94; 95% CIs, 0.90-0.97, and p-value = 0.0008). The pooled risk ratio estimate of lipophilic statins was 0.97 (95% CI, 0.87-1.07; P = 0.50; I2 = 0.0%). The estimated pooled risk ratios of long-term and short-term statin use were 0.80 (95% CI, 0.69-0.92; P = 0.002; I2 = 42%) and 0.86 (95% CI, 0.70-1.06; P = 0.15; I2 = 96%), respectively. For long-term and short-term follow-up, the risk ratios were 0.81 (95% CI, 0.70-0.94; P = 0.007; I2 = 55%) and 0.96 (95% CI, 0.90-1.02; P = 0.16; I2 = 26%), respectively. As for the studies collectively, heterogeneity was tested using the Cochrane chi square test (p-value = = 0.40, I2 = 4%). No publication bias was found. CONCLUSION The overall outcome of the study indicates that statins might lower the occurrence and increase the survival of PDAC patients.
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Affiliation(s)
- Jibon Kumar Paul
- Department of Biochemistry and Molecular Biology, Shahjalal University of Science and Technology, Sylhet, 3114, Bangladesh
| | - Mahir Azmal
- Department of Biochemistry and Molecular Biology, Shahjalal University of Science and Technology, Sylhet, 3114, Bangladesh
| | - Omar Faruk Talukder
- Department of Biochemistry and Molecular Biology, Shahjalal University of Science and Technology, Sylhet, 3114, Bangladesh
| | - Ajit Ghosh
- Department of Biochemistry and Molecular Biology, Shahjalal University of Science and Technology, Sylhet, 3114, Bangladesh.
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21
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Wang L, Zheng J, Yang J, Feng Q, Liu J, Lu Z, Zhang J, Zheng G. Reporting quality and evidence support in randomized controlled trials of herbal medicine formulas for vestibular migraine. PHYTOMEDICINE : INTERNATIONAL JOURNAL OF PHYTOTHERAPY AND PHYTOPHARMACOLOGY 2025; 143:156864. [PMID: 40449448 DOI: 10.1016/j.phymed.2025.156864] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/24/2025] [Revised: 05/06/2025] [Accepted: 05/14/2025] [Indexed: 06/03/2025]
Abstract
BACKGROUND Vestibular migraine (VM) is a prevalent condition characterized by recurrent episodes of dizziness, vertigo, and/or headache, often posing diagnostic and therapeutic challenges. Numerous randomized controlled trials (RCTs) have highlighted potential benefits of herbal medicine formulas (HMFs) for treating VM. However, current evidence remains insufficient to recommend their routine clinical use. The validity of trial results relies heavily on the completeness of the reporting. Therefore, this study aimed to comprehensively evaluate the reporting quality and evidence support of RCTs investigating HMFs for VM. METHODS We performed a comprehensive search across eight databases from their inception to August 2024. The included studies were primarily RCTs assessing the effectiveness and safety of HMFs for treating VM. The quality of the RCTs was evaluated using the Consolidated Standards of Reporting Trials (CONSORT) guidelines, along with its extension for Chinese medicine formulas (CONSORT-CHM Formulas). A meta-analysis was conducted to assess the effectiveness and safety of HMFs for the treatment of VM following the Cochrane methodolog. High-frequency herbal medicines (HMs) for VM treatment were identified as those appearing with a cumulative frequency exceeding 50 % among the top-ranked HMs. RESULTS A total of 33 RCTs involving 2358 patients with VM were included. The mean score for CONSORT reporting items was 14.24, while the mean score for CONSORT-CHM reporting items was 13.64. Few trials adequately reported essential elements such as appropriate titles, sample size calculations, allocation concealment, randomization implementation, and descriptions of blinding within the CONSORT core items. For CONSORT-CHM, less than half of the studies specified the formula names, dosage forms, and targeted traditional Chinese medicine (TCM) patterns in their titles and abstracts. Most studies demonstrated a high risk of bias, particularly regarding randomization sequence generation, allocation concealment, and blinding. The meta-analysis indicates that HMFs are effective in treating VM with minimal adverse effects; however, the high heterogeneity in certain outcomes suggests a potential risk of bias. The five most frequently used herbs across all studies were, in descending order: Gastrodiae Rhizoma, Rhizoma Pinelliae, Rhizoma Chuanxiong, Poria, Atractylodis Macrocephalae Rhizoma. CONCLUSIONS The meta-analysis supports the effectiveness and safety of HMFs for treating VM, with a low incidence of adverse events. However, the CONSORT and CONSORT-CHM reporting items were underreported. Future RCTs should strictly adhere to these guidelines to enhance reporting quality, ensuring full transparency in study design and methodolog. This study contributes to a more rigorous evidence base for HMFs in VM treatment. It aims to improve the quality of future RCTs involving herbal formulas for VM, enabling clinicians to make better-informed decisions.
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Affiliation(s)
- Lixiang Wang
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China
| | - Jueyan Zheng
- Science and Technology Innovation Center, Guangzhou University of Chinese Medicine, Guangzhou, China
| | - Jiangli Yang
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China
| | - Qinghua Feng
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China
| | - Jingjing Liu
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China
| | - Zheyu Lu
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China
| | - Junming Zhang
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China
| | - Guoqing Zheng
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China.
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22
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Tok HH, Kesgin MT. Effect of drama-education for alcohol/substance user on attitudes toward violence against women: randomized controlled design. BMC Public Health 2025; 25:1781. [PMID: 40375196 PMCID: PMC12079858 DOI: 10.1186/s12889-025-23012-8] [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: 01/08/2025] [Accepted: 04/30/2025] [Indexed: 05/18/2025] Open
Abstract
BACKGROUND Alcohol is an important risk factor for substance abuse and violence against women. Educating alcohol users has become important in preventing violence against women. OBJECTIVES The aim of this study is investigate the impact of creative drama education on the attitudes of male patients with alcohol and substance dependence towards violence against women. METHODS This study has a pre-test post-test parallel group randomized controlled design. This study as carried out at a treatment center for individuals with alcohol and substance addiction. The study was conducted with 35 male patients (Experimental group n = 18, Control group: n = 17) diagnosed with alcohol and substance addiction in a state hospital. Participants filled in the measurement tools before and after the training. RESULTS Post-intervention, the experimental group showed statistically significant improvements in total ISKEBE scores (Z = - 3.421, p = 0.001, Cohen's d = 1.44), as well as in the subdimensions of attitudes toward the body (Z = - 3.332, p = 0.001, d = 1.30) and identity (Z = - 3.075, p = 0.002, d = 1.18). No significant changes were observed in the control group (p > 0.05). CONCLUSION The findings suggest that creative drama education may have a beneficial effect on improving attitudes toward VAW among men with alcohol and substance use disorders. Further studies with larger and more diverse samples are recommended to confirm the generalizability and long-term impact of this approach. CLINICAL TRIAL NUMBER NCT05595759-10/23/2022.
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Affiliation(s)
- Hümeyra Hançer Tok
- Susehri School of Health-Nursing Department, Sivas Cumhuriyet University, Sivas, Türkiye.
| | - Makbule Tokur Kesgin
- Faculty of Health Science, Department of Nursing, Bolu Abant Izzet Baysal University, Bolu, Türkiye
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23
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Rafiei M, Das S, Roos EM, Skou ST, Baumbach J, Baumbach L. Are Changes in Physical Activity, Pain, and Quality of Life in Patients with Knee Osteoarthritis After Exercise Therapy and Education Beyond Normal Fluctuations? A Comparative Study. J Clin Med 2025; 14:3406. [PMID: 40429401 PMCID: PMC12112693 DOI: 10.3390/jcm14103406] [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: 03/27/2025] [Revised: 04/30/2025] [Accepted: 05/07/2025] [Indexed: 05/29/2025] Open
Abstract
Objective: This study evaluates whether one-year changes in physical activity (PA), pain intensity, and quality of life (QOL) after exercise therapy and education are larger than normal fluctuations over time in individuals with knee osteoarthritis. Method: Patients with knee osteoarthritis participating in the Good Life with Osteoarthritis in Denmark (GLA:D®) exercise therapy and education program (n = 7603) and participants from the Osteoarthritis Initiative (OAI) who received no specific treatment (n = 1156) were included. PA was measured using the UCLA PA scale (1-10) in the GLA:D® group and the PASE (0-531) in the OAI group. PASE scores were mapped to the UCLA distribution. Pain intensity was measured using a standardized visual analog scale (VAS, 0-100), and QOL was assessed via the KOOS QOL scale (0-100). Changes were categorized as increased, maintained, and decreased. To ensure comparability between GLA:D® and OAI participants, we used entropy balancing, considering the covariables age, gender, BMI, depression, employment status, and our outcome variables at baseline. Results: At one year, 41% of GLA:D® participants showed increased PA compared to 38% in the balanced OAI group (p = 0.015). Pain intensity decreased by ≥20 mm on the VAS in 39% of GLA:D® and 27% of OAI participants (p < 0.001). QOL improved by ≥ 10 mm on the KOOS scale in 48% of GLA:D® and 40% of OAI participants (p < 0.001). Additionally, for PA, pain, and QOL, 6%, 13%, and 7% more patients in the control group experienced worsening in these outcomes, respectively. Conclusions: Twelve percent more participants experienced clinically relevant pain reductions in the GLA:D® group compared to OAI participants, and 3% and 8% more reported improvements in PA and QOL, respectively. Additionally, more patients in the control group experienced worsening in these outcomes. These differences indicate that clinically relevant pain improvements following exercise therapy and education may exceed normal fluctuations in patients with knee osteoarthritis.
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Affiliation(s)
- Mahdie Rafiei
- Institute for Computational Systems Biology, University of Hamburg, 22761 Hamburg, Germany
| | - Supratim Das
- Institute for Computational Systems Biology, University of Hamburg, 22761 Hamburg, Germany
- Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany;
| | - Ewa M. Roos
- Center for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, 5230 Odense, Denmark
| | - Søren T. Skou
- Center for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, 5230 Odense, Denmark
- The Research and Implementation Unit PROgrez, Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, 4200 Slagelse, Denmark
| | - Jan Baumbach
- Institute for Computational Systems Biology, University of Hamburg, 22761 Hamburg, Germany
- Computational Biomedicine Laboratory, Department of Mathematics and Computer Science, University of Southern Denmark, 5230 Odense, Denmark
| | - Linda Baumbach
- Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany;
- Chair of Genome Informatics, Center for Bioinformatics, University of Hamburg, 22761 Hamburg, Germany
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24
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Carlsson LM, Peltonen M, Jacobson P, Andersson-Assarsson JC, Svensson PA, Taube M, Karlsson C, Ahlin S, Kristensson FM, Perkins R, Arnetorp I, Carlsson A, Admeus L, Langegård E, Carlsson B, Sjöholm K. Possible selection bias in register-based obesity studies. Eur J Epidemiol 2025:10.1007/s10654-025-01237-6. [PMID: 40353980 DOI: 10.1007/s10654-025-01237-6] [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: 07/09/2024] [Accepted: 04/22/2025] [Indexed: 05/14/2025]
Abstract
Some studies of obesity treatments use control groups identified from real-world registers, which may differ from people with obesity in the general population. We evaluated whether such control groups affect the results. The SOS study examines long-term mortality post-bariatric surgery. Among volunteers with obesity, 2,007 individuals underwent surgery, while a control group of 2,040 individuals was matched using 18 variables. Age was 37-60 years and BMI was ≥ 34/≥38 kg/m2 for men and women, respectively. We subdivided the control group into those with an obesity diagnosis (n = 177) and those without an obesity diagnosis (n = 1,863) in the Swedish National Patient Register prior to study inclusion. Mortality was determined over a median follow-up period of 26 years. The controls with a prior obesity diagnosis had a higher mortality rate than the controls without a prior obesity diagnosis, with 19.7 (95% CI, 15.5-25.1) and 14.4 (95% CI, 13.3-15.7) deaths per 1000 person-years, respectively. This corresponds to a hazard ratio of 1.45 (95% CI, 1.12-1.89; p = 0.005) and a 3.4-year shorter life expectancy. These results were confirmed in another cohort (n = 2,759, HR = 1.82 [95% CI, 1.47-2.25; p<0.001] and a 6.1-year shorter life expectancy). Controls with obesity identified from real-world datasets may be in poorer health than those who voluntarily participate in clinical studies. Consequently, selection bias could lead to an overestimation of the survival benefits of obesity treatments in research using controls identified by prior obesity diagnosis.
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Affiliation(s)
- Lena Ms Carlsson
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | | | - Peter Jacobson
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | | | - Per-Arne Svensson
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Magdalena Taube
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Cecilia Karlsson
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Late-Stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
| | - Sofie Ahlin
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Clinical Physiology, Region Västra Götaland, NU hospital group, Trollhättan, Sweden
| | - Felipe M Kristensson
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Dept of Surgery, Region Västra Götaland, Sahlgrenska University Hospital/Östra, Gothenburg, Sweden
| | - Rosie Perkins
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Ida Arnetorp
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Alexander Carlsson
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Lucas Admeus
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Elin Langegård
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Björn Carlsson
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- BioPharmaceuticals R&D, AstraZeneca, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), Gothenburg, Sweden
| | - Kajsa Sjöholm
- Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
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25
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Soutar S, Macdougall A, Wallis J, O'Reilly JE, Carpenter L. Flexible quantitative bias analysis for unmeasured confounding in subject-level indirect treatment comparisons with proportional hazards violation. BMC Med Res Methodol 2025; 25:131. [PMID: 40348970 PMCID: PMC12066054 DOI: 10.1186/s12874-025-02551-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2024] [Accepted: 04/07/2025] [Indexed: 05/14/2025] Open
Abstract
BACKGROUND Indirect treatment comparisons can provide evidence of relative efficacy for novel therapies when implementation of a randomised controlled trial is infeasible. However, such comparisons are vulnerable to unmeasured confounding bias due to incomplete data collection and non-random treatment assignment. Quantitative bias analysis (QBA) is a framework used to assess the sensitivity of a study's conclusions to unmeasured confounding. As indirect comparisons between therapies with differing treatment modalities may result in violation of the proportional hazards (PH) assumption, QBA methods that are applicable in this context are required. However, few QBA methods are valid under PH violation. METHODS We proposed a simulation-based QBA framework which quantifies the sensitivity of the difference in restricted mean survival time (dRMST) to unmeasured confounding, and is therefore valid under violation of the PH assumption. The proposed framework utilises Bayesian data augmentation for the multiple imputation of an unmeasured confounder with user-specified characteristics. Adjustment of dRMST is then implemented in a weighted analysis using the imputed values. The accuracy and precision of our proposed imputation-based adjustment method was assessed through a simulation study. Confounded data was simulated using a common non-PH data generating process, and imputation-based effect estimates were compared against estimates obtained following adjustment for all confounders. Implementation of the proposed QBA framework was also illustrated using a data from an external control arm study demonstrating clear PH violation. RESULTS Imputation-based adjustment using Bayesian data augmentation was observed to estimate the true adjusted dRMST with minimal bias. Moreover, the bias was comparable to that observed under adjustment when all confounders were measured. Application of the proposed QBA framework to an indirect treatment comparison study enabled identification of the characteristics of an unmeasured confounder that would be required to nullify the study's conclusions. CONCLUSIONS Imputation-based adjustment can accurately recover the true adjusted dRMST in the presence of unmeasured confounding with known exposure and outcome associations. Therefore, the proposed QBA framework can correctly determine the characteristics required by an unmeasured confounder to invalidate a study's conclusions. Consequently, this framework enables the construction of sensitivity analyses to investigate the robustness of relative efficacy evidence derived from indirect treatment comparisons which exhibit PH violation.
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Affiliation(s)
- Steven Soutar
- Arcturis Data, Building One, Oxford Technology Park, Technology Drive, Oxford, OX5 1GN, UK.
| | - Amy Macdougall
- Arcturis Data, Building One, Oxford Technology Park, Technology Drive, Oxford, OX5 1GN, UK
| | - Jamie Wallis
- Arcturis Data, Building One, Oxford Technology Park, Technology Drive, Oxford, OX5 1GN, UK
| | - Joseph E O'Reilly
- Arcturis Data, Building One, Oxford Technology Park, Technology Drive, Oxford, OX5 1GN, UK
| | - Lewis Carpenter
- Arcturis Data, Building One, Oxford Technology Park, Technology Drive, Oxford, OX5 1GN, UK
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De Luca Canto G, Pauletto P, Stefani CM, Gonçalves TMSV, Junior NC, Flores-Mir C, Pinto ACPN, Trevisani VFM. Spin Bias in randomized controlled trials of botulinum toxin for bruxism management: a meta-epidemiologic study. BMC Med Res Methodol 2025; 25:125. [PMID: 40340732 PMCID: PMC12060433 DOI: 10.1186/s12874-025-02547-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2024] [Accepted: 04/01/2025] [Indexed: 05/10/2025] Open
Abstract
OBJECTIVE To perform a quantitative and qualitative analysis of spin bias in randomized clinical trials (RCTs) focusing on botulinum toxin (BTX-A) for managing bruxism. STUDY DESIGN AND PROTOCOL This is a meta-epidemiologic study. The protocol was registered on the Open Science Framework. STUDY SELECTION We included RCTs that evaluated the effectiveness of BTX-A for managing bruxism, associated or not with signs and symptoms of temporomandibular disorders. The outcomes were changes in pain and bruxism events. Spin bias was investigated in abstract and main text. The frequency of spin bias was assessed, and a qualitative analysis was conducted. The study was classified as effective if the outcome analyzed was statistically significant (p-value 0.05) and reached the minimum important difference of 20% and ineffective if the reported outcome was statistically nonsignificant or the study did not report the p-value or the results did not reach the minimum important difference of 20%. RESULTS An overall frequency of 59.4% spin bias was identified in eight included RCTs. The conclusion in the main text (87.5%) was the section with the highest frequency of spin bias. In the qualitative analysis, the most common strategies identified were inadequate extrapolation to a large population (30.61%), inadequate implication for clinical practice (20.41%), and misleading reporting (12.25%). CONCLUSION There is a high frequency of spin bias in RCTs that evaluated BTX-A for bruxism management. Close to 90% of the selected RCTs presented spin bias in the main text's conclusion. The most common spin was the inadequate extrapolation of the results. CLINICAL SIGNIFICANCE Applying BTX into the temporalis did not reduce muscle activity and the results for masseter injections remain controversial. It seems that BTX-A injections can reduce pain from two weeks to one year. It is not possible to have certainty about the efficacy and safety of using BTX-A to reduce pain and bruxism events.
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Affiliation(s)
- Graziela De Luca Canto
- Brazilian Centre for Evidence-Based Research, Federal University of Santa Catarina, Florianopolis, Brazil
- Department of Dentistry, Federal University of Santa Catarina, Florianopolis, Brazil
- Postgraduate Program in Evidence Based Medicine, Federal University of São Paulo, São Paulo, Brazil
- Emergency Medicine and Evidence-Based Medicine, Federal University of São Paulo, São Paulo, Brazil
| | | | - Cristine Miron Stefani
- Brazilian Centre for Evidence-Based Research, Federal University of Santa Catarina, Florianopolis, Brazil
- Department of Dentistry, University of Brasilia, Brasilia, Brazil
| | | | - Nelson Carvas Junior
- Postgraduate Program in Evidence Based Medicine, Federal University of São Paulo, São Paulo, Brazil
| | - Carlos Flores-Mir
- Mike Petryk School of Dentistry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada
| | - Ana Carolina Pereira Nunes Pinto
- Postgraduate Program in Evidence Based Medicine, Federal University of São Paulo, São Paulo, Brazil
- Emergency Medicine and Evidence-Based Medicine, Federal University of São Paulo, São Paulo, Brazil
- Iberoamerican Cochrane Centre - Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain
- Biological and Health Sciences Department, Federal University of Amapa, Macapá, Brazil
| | - Virginia Fernandes Moça Trevisani
- Postgraduate Program in Evidence Based Medicine, Federal University of São Paulo, São Paulo, Brazil
- Emergency Medicine and Evidence-Based Medicine, Federal University of São Paulo, São Paulo, Brazil
- Medicine, Santo Amaro University, São Paulo, Brazil
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Chen S. Two-sample bi-directional causality between two traits with some invalid IVs in both directions using GWAS summary statistics. HGG ADVANCES 2025; 6:100449. [PMID: 40336198 PMCID: PMC12145707 DOI: 10.1016/j.xhgg.2025.100449] [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: 10/30/2024] [Revised: 05/01/2025] [Accepted: 05/01/2025] [Indexed: 05/09/2025] Open
Abstract
Mendelian randomization (MR) is a widely used method for assessing causal relationships between risk factors and outcomes using genetic variants as instrumental variables (IVs). While traditional MR assumes uni-directional causality, bi-directional MR aims to identify the true causal direction. In uni-directional MR, invalid IVs due to pleiotropy can violate assumptions and introduce biases. In bi-directional MR, traditional MR can be performed separately for each direction, but the presence of invalid IVs poses even greater challenges. We introduce a new bi-directional MR method incorporating stepwise selection (Bidir-SW) designed to address these challenges. Our approach leverages public genome-wide association study (GWAS) datasets for two traits and uses model selection criteria to identify invalid IVs iteratively by stepwise selection. This method accounts for potential bi-directional causality in the presence of common invalid IVs for both directions, even if only GWAS summary statistics are provided. Through simulation studies, we demonstrate that our method outperforms traditional MR techniques, such as MR-Egger and inverse-variance weighted (IVW), with uncorrelated SNPs. We also provide simulations to compare our approach with existing transcriptome-wide association study (TWAS) to show its effectiveness. Finally, we apply the proposed method to genetic traits such as CRP levels and BMI to explore possible bi-directional relationships among these traits. We also used the proposed method to discover causal protein biomarkers. Our findings suggest that the Bidir-SW approach is a powerful tool for bi-directional MR or TWAS, which can provide a valuable framework for future genetic epidemiology studies.
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Affiliation(s)
- Siyi Chen
- School of Public Health, LSU Health Sciences Center New Orleans, New Orleans, LA 70112, USA.
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Chen Q, Shou W, Zhang L, Fang J, Guo Y. Exploring the causal relationship between iron status and subarachnoid hemorrhage based on two sample mendelian randomization. Sci Rep 2025; 15:15549. [PMID: 40319034 PMCID: PMC12049442 DOI: 10.1038/s41598-025-00203-2] [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: 09/20/2024] [Accepted: 04/25/2025] [Indexed: 05/07/2025] Open
Abstract
This study investigates the causal association between genetic prediction of iron status and subarachnoid hemorrhage (SAH). A two-sample MR analysis was conducted using genome-wide association study (GWAS) summary data for four iron biomarkers: serum iron, serum ferritin, total iron-binding capacity (TIBC), and transferrin saturation (TSAT). Genetic variants were selected as instrumental variables (IVs) to minimize confounding. Causal estimates were obtained using inverse variance weighting (IVW), MR-Egger, weighted median, and weighted mode methods. Sensitivity analyses, including Cochran's Q-test, MR-Egger regression, MR-PRESSO, and leave-one-out analysis, were performed to assess heterogeneity and pleiotropy. IVW analysis revealed a significant association between increased genetically predicted TIBC and higher SAH risk (OR = 1.71, 95% CI: 1.21-2.41, P = 0.002), while higher TSAT was associated with lower SAH risk (OR = 0.76, 95% CI: 0.62-0.93, P = 0.01). No causal association was found between serum iron, serum ferritin, and SAH. Sensitivity analyses confirmed the robustness of the results, with no evidence of horizontal pleiotropy. However, heterogeneity was detected in serum ferritin, suggesting potential variability in its effect. This MR study provides genetic evidence for the causal relationship between TIBC, TSAT, and SAH risk. These findings highlight the potential role of iron metabolism in SAH pathophysiology, warranting further investigation.
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Affiliation(s)
- Qian Chen
- Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China
| | - Weiling Shou
- Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China
| | - Li Zhang
- Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China
| | - Jiaying Fang
- Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China
| | - Ye Guo
- Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China.
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Wu Y, Xu Y, Bi Z, Chen J, Song X, Liao S, Jin L, Bi Z, Han Y, Liu J. Snoring as a Possible Protective Factor for Temporomandibular Joint Disorders. J Oral Rehabil 2025; 52:678-692. [PMID: 40296205 DOI: 10.1111/joor.13916] [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: 08/11/2023] [Revised: 11/27/2024] [Accepted: 12/01/2024] [Indexed: 04/30/2025]
Abstract
BACKGROUND Previous studies have linked sleep quality to temporomandibular joint disorders (TMD), suggesting a role for snoring in this association. However, the directionality of this relationship remains a subject of debate. This investigation aimed to elucidate the connections between snoring and TMD. METHODS This research employed a two-sample Mendelian randomization (MR) approach, leveraging publicly available large-scale genome-wide association study (GWAS) data on snoring and TMD. We utilised a suite of analytical methods, including the inverse variance weighted (IVW) method, maximum likelihood estimation, adjusted profile score, weighted median, MR-Egger regression, and a series of sensitivity analyses, to rigorously assess the existence of relationships. RESULTS Our findings indicate that a greater genetic predisposition to snoring is significantly associated with a reduced risk of TMD (IVW method; odds ratio [OR] = 0.156, 95% confidence interval [CI] = 0.028-0.843, p = 0.0309). Conversely, the analysis did not support a potential influence of TMD on snoring susceptibility (IVW method; 95% CI = 0.990 to 1.002, p = 0.1926). Additionally, our sensitivity analyses did not reveal any significant pleiotropy that could bias these findings. CONCLUSION This MR study provides limited but novel genetic evidence supporting a potential causal link between snoring and a decreased risk of developing TMD. On the other hand, it does not substantiate an effect of TMD on the likelihood of snoring.
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Affiliation(s)
- Yi Wu
- The First Hospital of Jilin University, Changchun, Jilin Province, China
| | - Yan Xu
- The First Hospital of Jilin University, Changchun, Jilin Province, China
- Department of Social Medicine and Health Management, School of Public Health, Jilin University, Changchun, Jilin, China
| | - Zhijun Bi
- Hunan University of Medicine, Huaihua, China
| | - Jintian Chen
- The First Hospital of Jilin University, Changchun, Jilin Province, China
| | - Xin Song
- The First Hospital of Jilin University, Changchun, Jilin Province, China
| | - Shiyu Liao
- Guangdong Provincial Hospital of Chinese Medicine-Zhuhai Hospital, Zhuhai, China
| | - Long Jin
- The First Hospital of Jilin University, Changchun, Jilin Province, China
| | - Zhiguo Bi
- The First Hospital of Jilin University, Changchun, Jilin Province, China
| | - Yu Han
- The First Hospital of Jilin University, Changchun, Jilin Province, China
| | - Jianguo Liu
- The First Hospital of Jilin University, Changchun, Jilin Province, China
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Wang A, Kim E, Kwon D, Coleman-Belin J, Oleru O, Seyidova N, Taub PJ. Statistical Fragility of Outcomes on Breast Reconstruction with Acellular Dermal Matrix: A Systematic Review of Randomized Controlled Trials. Plast Reconstr Surg 2025; 155:845e-853e. [PMID: 39356685 DOI: 10.1097/prs.0000000000011798] [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: 10/04/2024]
Abstract
BACKGROUND Acellular dermal matrix (ADM) is pivotal in breast surgery, yet the statistical robustness of surgical outcomes remains underexplored. This study uses the fragility index (FI), reverse FI, and fragility quotient (FQ) to investigate the statistical fragility of ADM breast reconstruction outcomes. METHODS Randomized controlled trials (2013 to present) with dichotomous outcomes were sourced from PubMed, Embase, SCOPUS, Medline, and Cochrane databases. FI and reverse FI (event reversals needed to alter outcome significance) and FQ (standardized fragility across trials) were computed and reported as median (interquartile range [IQR]). Subgroup analysis focused on intervention types. RESULTS Of 33 studies screened, 19 RCTs comprising 204 outcomes were included, with a median FI of 4 (IQR, 3 to 5) and FQ of 0.039 (IQR, 0.029 to 0.070). Twenty-six outcomes achieved statistical significance, with a median FI of 3.5 (IQR, 1 to 5) and FQ of 0.033 (IQR, 0.010 to 0.073). The remaining 178 outcomes were not significant, exhibiting a median FI of 4 (IQR, 3 to 5) and FQ of 0.040 (IQR, 0.030 to 0.070). Of the 204 outcomes, 18% had a number of patients lost to follow-up equal to or surpassing the FI. By intervention type, the median FIs were similar in value but remained low. CONCLUSIONS ADM-related breast reconstruction outcomes are statistically fragile; thus, reversal of a few outcomes or maintaining follow-up with patients may alter the significance of findings. Future researchers are thus recommended to report FI and FQ metrics with P values to accurately portray reconstructive surgery outcomes.
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Affiliation(s)
- Anya Wang
- From the Division of Plastic and Reconstructive Surgery, Icahn School of Medicine at Mount Sinai
| | - Esther Kim
- From the Division of Plastic and Reconstructive Surgery, Icahn School of Medicine at Mount Sinai
| | - Daniel Kwon
- From the Division of Plastic and Reconstructive Surgery, Icahn School of Medicine at Mount Sinai
| | - Janet Coleman-Belin
- From the Division of Plastic and Reconstructive Surgery, Icahn School of Medicine at Mount Sinai
| | - Olachi Oleru
- From the Division of Plastic and Reconstructive Surgery, Icahn School of Medicine at Mount Sinai
| | - Nargiz Seyidova
- From the Division of Plastic and Reconstructive Surgery, Icahn School of Medicine at Mount Sinai
| | - Peter J Taub
- From the Division of Plastic and Reconstructive Surgery, Icahn School of Medicine at Mount Sinai
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Mahar EA, Stephenson KR, Brotto LA. A randomized controlled trial of online mindfulness and cognitive-behavioral interventions for sexual interest/arousal disorder in women: eSense. Behav Res Ther 2025; 188:104732. [PMID: 40147247 DOI: 10.1016/j.brat.2025.104732] [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: 09/08/2024] [Revised: 12/03/2024] [Accepted: 03/17/2025] [Indexed: 03/29/2025]
Abstract
OBJECTIVE Sexual interest/arousal disorder (SIAD) is a common and distressing sexual dysfunction in women. Although efficacious psychological treatments for SIAD exist, they are generally underutilized and inaccessible. eSense is a feasible and useable online intervention containing Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Therapy (MBT) programs. Our goal was to test the efficacy of the CBT and MBT arms of eSense relative to a waitlist control condition. METHOD Women with SIAD were randomized to eSense-CBT (n = 43), eSense-MBT (n = 43), or a waitlist (n = 43). Both interventions consisted of 8 modules with a recommended completion time of 8-12 weeks. Participants also met remotely with non-expert "navigators" for up to 12 weeks. Participants completed validated self-report measures of primary outcomes (sexual desire/arousal and distress) and secondary outcomes (sexual satisfaction, dissatisfaction, and overall sexual function) at baseline, mid-treatment, posttreatment, and 6-month posttreatment. RESULTS AND CONCLUSIONS Compared to waitlist, both active treatment groups reported significant improvements in primary outcomes at post-treatment (desire/arousal d > .90; sexual distress d < -0.62) and these improvements were generally maintained at follow-up. The two active treatments did not differ in terms of primary outcomes. Effects on sexual satisfaction were also significant (d = 0.70-0.81) and MBT resulted in slightly greater improvements. There was no effect on sexual dissatisfaction. For overall sexual function, the effect was large (d = 1.20 to 1.23) with no between-arm differences. Future steps to improve engagement and increase access are discussed.
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Saeed A, Haider M, Yousuf S, Ahmad S, Fine M, Yazdani A, Hayat U, Noverati N, Khan MA, Gangwani MK, Aziz M, Farooq U, Kamal F. Role of Proton Pump Inhibitors in Prevention of Upper Gastrointestinal Bleeding in Patients on Dual Antiplatelet Therapy: Systematic Review and Meta-Analysis. Am J Ther 2025; 32:e256-e261. [PMID: 40338683 DOI: 10.1097/mjt.0000000000001834] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/10/2025]
Abstract
BACKGROUND Dual antiplatelet therapy (DAPT) with oral P2Y12 inhibitors and aspirin is crucial for patients with acute coronary syndrome (ACS) and postpercutaneous coronary interventions (PCI). Concomitant proton pump inhibitor (PPI) therapy with DAPT can potentially reduce the risk of upper gastrointestinal bleeding (UGIB). AIM We conducted a meta-analysis of randomized controlled trials to evaluate the prevention of UGIB with concomitant use of PPI with DAPT. METHODS We reviewed several databases to identify randomized controlled trials comparing the risk of UGIB in patients using DAPT + PPI vs . DAPT with no PPI or DAPT + Histamine 2 receptor antagonists. Our outcomes of interest were UGIB, major cardiovascular adverse events (MACE), myocardial infarction, and all-cause mortality. We calculated pooled risk ratio (RR) with 95% confidence intervals (CI) for all of the outcomes and analyzed data using random effect model. Heterogeneity was assessed using I 2 statistic. RESULTS Seven randomized controlled trials comprising 6708 patients were included. Rate of UGIB was significantly lower in the PPI + DAPT group, RR (95% CI): 0.39 (0.25-0.60). There was no significant difference in the rate of MACE between groups, RR (95% CI): 0.87 (0.69-1.10). Rate of MI was also not significantly different between groups, RR (95% CI): 0.93 (0.75-1.14). Rate of mortality was significantly lower in the PPI + DAPT group, RR (95% CI) 0.46 (0.27-0.80). CONCLUSIONS Our meta-analysis demonstrates that adding PPI therapy to DAPT significantly lowers the risk of UGIB and all-cause mortality, without adversely affecting major cardiovascular outcomes.
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Affiliation(s)
- Aamir Saeed
- Department of Medicine, Vanderbilt University Medical Center, Nashville, TN
| | - Marjan Haider
- Department of Gastroenterology, Trinity Health Ann Arbor, MI
| | - Saira Yousuf
- Department of Medicine, Vanderbilt University Medical Center, Nashville, TN
| | - Soban Ahmad
- Department of Cardiovascular Medicine, University of Nebraska Medical Center, Omaha, NE
| | - Michael Fine
- Department of Gastroenterology, Trinity Health Ann Arbor, MI
| | - Ali Yazdani
- Department of Gastroenterology, Trinity Health Ann Arbor, MI
| | - Umar Hayat
- Division of Gastroenterology, Geisinger Wyoming Valley Medical Centre, Wilkes-Barre, PA
| | - Nicholas Noverati
- Division of Gastroenterology, Thomas Jefferson University Hospital, Philadelphia, PA
| | - Muhammad Ali Khan
- Department of Gastroenterology, Hepatology and Nutrition, University of Texas MD Anderson Cancer Center, Houston, TX
| | | | - Muhammad Aziz
- Division of Gastroenterology, Bon Secours Mercy Health, Toledo, OH; and
| | - Umer Farooq
- Division of Gastroenterology, St Louis University School of Medicine, St Loius, MO
| | - Faisal Kamal
- Division of Gastroenterology, Thomas Jefferson University Hospital, Philadelphia, PA
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Lan Y, Wang L, Lin X, Wu Y, Huang Z. Evaluation of the implementation effectiveness of accelerated drug marketing registration procedures in China: lessons from the 2016-2024 regulatory review. Drug Discov Today 2025; 30:104353. [PMID: 40216292 DOI: 10.1016/j.drudis.2025.104353] [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: 03/28/2025] [Accepted: 04/04/2025] [Indexed: 04/20/2025]
Abstract
China has implemented accelerated drug marketing registration procedures (ADMRPs) since 2016, including priority review and approval (PRA), conditional approval (CA), and breakthrough therapy drugs (BTDs). This study analyzed the characteristics of drugs approved by ADMRPs from 2016 to 2024 and explored the implementation effectiveness of these procedures. Overall, 922 drugs were approved for marketing through five ADMRPs (or procedure combinations): PRA (759, 82.3%), CA (12, 1.3%), CA + PRA (108, 11.7%), BTD + PRA (23, 2.5%), and BTD + CA + PRA (20, 2.2%). Drugs approved through the different procedures differed widely in terms of drug attributes and clinical uses, clinical trial design, and drug registration and marketing. Implementing ADMRPs has demonstrated excellent results in accelerating the development and marketing of clinically value-driven drugs.
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Affiliation(s)
- Yipeng Lan
- School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China
| | - Li Wang
- School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China
| | - Xiaofeng Lin
- School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China
| | - Yiqing Wu
- School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China
| | - Zhe Huang
- School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China; Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang, China.
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Slade A, Reily NM, Fujimoto H, Seidler ZE, Christensen H, Shand F, Tang S. Men's mental health and suicide prevention service landscape in Australia: a scoping review. BMC Public Health 2025; 25:1593. [PMID: 40307779 PMCID: PMC12042427 DOI: 10.1186/s12889-025-22676-6] [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: 03/21/2024] [Accepted: 04/08/2025] [Indexed: 05/02/2025] Open
Abstract
BACKGROUND Men represent the majority of suicide deaths globally and men are more likely to die by suicide without contact with formal mental health services. In Australia, three-quarters of suicide deaths are men. If services were better able to meet their needs, men might be more likely to seek help. In this scoping review, we sought to describe the formal and informal service landscape for men at risk of suicide in Australia, and to determine the extent of research evidence for the effectiveness of these in lowering suicidality, and improving mental health or help-seeking behaviours. We limited our investigation to Australian services, in order to comprehensively identify all community and health system services. METHODS Relevant services and initiatives in Australia were identified through multiple methods: (1) a hand search of key websites and directories; (2) a systematic search of PsycINFO, Cochrane Central, EmBASE, and PubMed; and (3) suggestions by researchers, consumers and clinicians. Evaluations were also identified using multiple methods, including the initial systematic search, targeted website searches, and via multiple search engines. Findings are presented using narrative synthesis. RESULTS Included services and initiatives (N = 88) were diverse in their characteristics (e.g., cost to the user, mode of delivery, location), however, there was considerable overlap in the types of components offered. Awareness and education were the most commonly offered (84.1% of services and initiatives). Only 22.7% of services and initiatives had been formally evaluated and existing evaluations varied in quality. Pre-post intervention designs were most often used, and only three evaluations assessed outcomes in a randomised controlled trial. CONCLUSIONS The service landscape for Australian men is broad. However, there appears to be substantial overlap in the components offered by services and initiatives. The prevalence of awareness and education-based offerings is disproportionate to evidence about men's preferences for support. There is a lack of high-quality evaluations. We conclude that the cohesiveness of men's suicide prevention approaches must improve through service development and policy.
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Affiliation(s)
- Aimy Slade
- Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.
| | - Natalie M Reily
- Black Dog Institute, University of New South Wales, Sydney, NSW, Australia
| | - Hiroko Fujimoto
- Black Dog Institute, University of New South Wales, Sydney, NSW, Australia
| | - Zac E Seidler
- Orygen, Melbourne, Australia
- Centre for Youth Mental Health, The University of Melbourne, Melbourne, Australia
- Movember Institute of Men's Health, Melbourne, Australia
| | - Helen Christensen
- Black Dog Institute, University of New South Wales, Sydney, NSW, Australia
| | - Fiona Shand
- Black Dog Institute, University of New South Wales, Sydney, NSW, Australia
| | - Samantha Tang
- Black Dog Institute, University of New South Wales, Sydney, NSW, Australia
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Maeneja R, Rato J, Ferreira IS. How Is the Digital Age Shaping Young Minds? A Rapid Systematic Review of Executive Functions in Children and Adolescents with Exposure to ICT. CHILDREN (BASEL, SWITZERLAND) 2025; 12:555. [PMID: 40426734 PMCID: PMC12109849 DOI: 10.3390/children12050555] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 03/21/2025] [Revised: 04/18/2025] [Accepted: 04/22/2025] [Indexed: 05/29/2025]
Abstract
Objectives: This review assesses how daily exposure to Information and Communication Technologies (ICTs) affects executive functions in children and adolescents and explores the roles of parents in mitigating potential negative impacts on cognitive development and emotional regulation. Methods: Following PRISMA guidelines, a systematic search was conducted from 2022 to 2024 using PubMed, Scopus, and Cochrane Library. The study criteria included cohort studies, randomized controlled trials (RCTs), quasi-RCTs, and systematic reviews. Data extraction and risk-of-bias assessments were performed using ROBIS and ROBINS-E tools. Due to the heterogeneity of the results, a narrative synthesis was carried out. Results: Ten studies were included for analysis, comprising a total of 231,117 children from nine countries on three continents. Most studies indicated that excessive ICT exposure negatively affects executive functions, particularly working memory, inhibitory control, cognitive flexibility, and attention. Adverse effects were linked to increased screen time, poor sleep quality, and multitasking. However, two studies found no significant association, highlighting the influence of contextual factors like socioeconomic status, parental mediation, and screen content type. Shared ICT use with parents or siblings appeared to reduce negative effects. Conclusions: Excessive ICT exposure is associated with impaired executive function development in children and adolescents. Parental supervision and structured ICT use may mitigate risks. Future research should investigate moderating factors, such as socioeconomic status and ICT content, to develop guidelines for healthy digital engagement in youth.
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Affiliation(s)
- Reinaldo Maeneja
- Faculdade de Ciências de Saúde e Desporto, Universidade Save, Maxixe 1301, Mozambique;
| | - Joana Rato
- Center for Interdisciplinary Research in Health, Faculty of Health Science and Nursing, Universidade Católica Portuguesa, 1649-023 Lisbon, Portugal;
| | - Inês Saraiva Ferreira
- Health Sciences Faculty, Universidade Europeia, 1500-210 Lisbon, Portugal
- Center for Research in Neuropsychology and Cognitive and Behavioural Intervention (CINEICC), Psychological Assessment and Psychometrics Laboratory (PsyAssessmentLab), Universidade de Coimbra, 3000-115 Coimbra, Portugal
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Gemmerich R, Müller O, Schaller A. The application of fNIRS in studies on occupational workload: a systematic review. Front Public Health 2025; 13:1560605. [PMID: 40331113 PMCID: PMC12053328 DOI: 10.3389/fpubh.2025.1560605] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2025] [Accepted: 03/27/2025] [Indexed: 05/08/2025] Open
Abstract
Background Occupational workload can contribute to significant health problems such as chronic stress, fatigue and burnout. To investigate the underlying mechanisms, it is necessary to monitor brain activity in real work environments. Functional near-infrared spectroscopy (fNIRS) is a portable, non-invasive neuroimaging method that captures neural correlates of occupational workload under natural conditions. However, despite its increasing application, a comprehensive overview of fNIRS-based research in this field is lacking. Therefore, this systematic review examines how fNIRS can be utilized to investigate occupational workload. Methods Following PRISMA 2020 guidelines, we conducted our systematic review by searching Web of Science, PubMed, and Scopus between November 15, 2023 and March 20, 2025. We included all studies published in English or German at any date, as long as they examined healthy adult professionals performing occupational tasks with functional near-infrared spectroscopy (fNIRS). Extracted data included study characteristics, workload details, signal processing methods, main fNIRS findings, and study quality, assessed using the JBI Critical Appraisal Tool. Results We included 41 studies. Of these, 23 reported a significant increase in oxygenated hemoglobin (HbO) concentration and functional connectivity in the prefrontal cortex (PFC) under higher occupational workload conditions. Only five studies examined typical office tasks. Nine studies analyzed differences in cortical activation between experts and novices, with experts showing increased HbO concentration in the PFC than novices. Regarding methodology, 26 studies used standardized optode placements, while only 17 applied systemic and extracerebral artifact correction. Small sample sizes and the absence of randomized controlled trials limited the reliability and reproducibility of the findings. Conclusion Functional near-infrared spectroscopy effectively detects neural correlates of occupational workload and provides objective insights into cognitive demands in real-world work settings. Standardizing optode placement, harmonizing signal-processing methods, and increasing sample sizes would enhance the validity and comparability of future research. Expanding investigations to typical office environments is also crucial for understanding daily workload and for developing interventions that promote employee well-being and productivity. Overall, fNIRS represents a promising tool for establishing evidence-based workplace health promotion strategies across diverse occupational settings.
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Affiliation(s)
- Robin Gemmerich
- Department of Workplace Health Promotion and Prevention, University of the Bundeswehr Munich, Neubiberg, Germany
| | | | - Andrea Schaller
- Department of Workplace Health Promotion and Prevention, University of the Bundeswehr Munich, Neubiberg, Germany
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Tan X, Yang S, Ye W, Faries DE, Lipkovich I, Kadziola Z. Double machine learning methods for estimating average treatment effects: a comparative study. J Biopharm Stat 2025:1-20. [PMID: 40259671 DOI: 10.1080/10543406.2025.2489281] [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: 04/29/2024] [Accepted: 03/03/2025] [Indexed: 04/23/2025]
Abstract
Observational cohort studies are increasingly being used for comparative effectiveness research to assess the safety of therapeutics. Recently, various doubly robust methods have been proposed for average treatment effect estimation by combining the treatment model and the outcome model via different vehicles, such as matching, weighting, and regression. The key advantage of doubly robust estimators is that they require either the treatment model or the outcome model to be correctly specified to obtain a consistent estimator of average treatment effects, and therefore lead to a more accurate and often more precise inference. However, little work has been done to understand how doubly robust estimators differ due to their unique strategies of using the treatment and outcome models and how machine learning techniques can be combined to boost their performance, which we call double machine learning estimators. Here, we examine multiple popular doubly robust methods and compare their performance using different treatment and outcome modeling via extensive simulations and a real-world application. We found that incorporating machine learning with doubly robust estimators such as the targeted maximum likelihood estimator gives the best overall performance. Practical guidance on how to apply doubly robust estimators is provided.
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Affiliation(s)
- Xiaoqing Tan
- Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA
| | - Shu Yang
- Department of Statistics, North Carolina State University, Raleigh, NC, USA
| | - Wenyu Ye
- Real World Analytics, Eli Lilly and Company, Indianapolis, IN, USA
| | - Douglas E Faries
- Real World Analytics, Eli Lilly and Company, Indianapolis, IN, USA
| | - Ilya Lipkovich
- Real World Analytics, Eli Lilly and Company, Indianapolis, IN, USA
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38
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González Aroca J. [How to choose a research design?]. NUTR HOSP 2025; 42:394-395. [PMID: 39898445 DOI: 10.20960/nh.05626] [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: 02/04/2025] Open
Abstract
Introduction
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Affiliation(s)
- Joaquín González Aroca
- MSKD. Grupo de Investigación: Uniendo ciencia y práctica en trastornos musculoesqueléticos. Universidad de La Serena
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Liao WC, Angus F, Conley J, Chen LC. The Efficacy of Digital Interventions on Adherence to Oral Systemic Anticancer Therapy Among Patients With Cancer: Systematic Review and Meta-Analysis. JMIR Cancer 2025; 11:e64208. [PMID: 40239191 PMCID: PMC12017607 DOI: 10.2196/64208] [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: 07/11/2024] [Revised: 01/14/2025] [Accepted: 01/15/2025] [Indexed: 04/18/2025] Open
Abstract
Background Digital interventions have been increasingly applied in multidisciplinary care plans to improve medication adherence to oral systemic anticancer therapy (SACT), the crucial lifesaving treatments for many cancers. However, there is still a lack of consensus on the efficacy of those digital interventions. objectives This systematic review and meta-analysis aimed to investigate the efficacy of digital interventions in improving adherence to oral SACTs in patients with cancer. Methods This systematic review and meta-analysis followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement guidelines. The protocol has been registered at PROSPERO (no. CRD42024550203). Fully published, randomized controlled trials (RCTs) in English on adults with cancer assessing digital interventions for improving adherence to oral SACTs were retrieved from MEDLINE, Embase, APA PsycINFO, and CINAHL Plus up to May 31, 2024. Adherence measures compared between digital intervention users and nonusers were extracted. The proportions of poor adherence were synthesized using a random-effects model. The pooled results were reported as the odds ratio and 95% CI. The heterogeneity was assessed with the I2 test (%). The mean difference and 95% CI were calculated from the mean adherence score and SD. A risk of bias assessment was conducted using version 2 of the Cochrane Risk of Bias Assessment Tool (RoB 2) for RCTs, which ensured that a quality assessment of all included studies was conducted as recommended by the Cochrane Collaboration. Results This study included 13 RCTs on digital interventions for improving adherence to oral SACTs in patients with cancer. The 13 RCTs, published between 2016 and 2024, were conducted in the United States, South Korea, France, Egypt, Finland, Australia, Colombia, Singapore, and Turkey. The technologies used were mobile apps (n=4), reminder systems (n=4), telephone follow-ups (n=3), and interactive multimedia platforms (n=2). Adherence was measured by surveys (n=8), relative dose intensity (n=2), pill count (n=1), self-reported missed doses (n=1), a smart pill bottle (n=1), and urine aromatase inhibitor metabolite assays (n=1). Concerns regarding risk of bias primarily involved randomization, missing outcome data, and outcome measurement, including nonblinded randomization, subjective patient-reported data, and difficulties in distinguishing between missed appointments and actual medication nonadherence. Pooled results from 11 trials showed that digital technology users had significantly lower risk of poor adherence (odds ratio 0.60, 95% CI 0.47-0.77). Two studies reported positive mean differences in adherence scores comparing digital intervention users and nonusers. However, due to considerable heterogeneity (I²=73.1%), it is difficult to make a definitive conclusion from the pooled results about the effect of digital interventions upon adherence to oral anticancer therapy. Conclusions Digital intervention users exhibited significantly lower risk of poor oral SACTs adherence than nonusers. Acknowledging individual variation and tailoring digital technologies to prioritize patient needs is essential.
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Affiliation(s)
- Wan-Chuen Liao
- Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester, United Kingdom, 44 01613066000
- School of Dentistry, College of Medicine, National Taiwan University, Taipei, Taiwan
| | - Fiona Angus
- Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester, United Kingdom, 44 01613066000
- Department of Pharmacy, The Christie NHS Foundation Trust, Manchester, United Kingdom
| | - Jane Conley
- Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester, United Kingdom, 44 01613066000
| | - Li-Chia Chen
- Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester, United Kingdom, 44 01613066000
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Ramadan OME, Alshammari AM, Alruwaili AN, Elsharkawy NB, Alhaiti A, Baraka NIM. Transforming neonatal nursing: a randomized controlled trial comparing kangaroo care and standard protocols for survival in preterm infants with respiratory distress syndrome. BMC Nurs 2025; 24:430. [PMID: 40241073 PMCID: PMC12004858 DOI: 10.1186/s12912-025-03088-8] [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: 02/13/2025] [Accepted: 04/09/2025] [Indexed: 04/18/2025] Open
Abstract
BACKGROUND Respiratory Distress Syndrome (RDS) remains a leading cause of mortality among preterm infants weighing < 2000 g, particularly in resource-limited settings. While Kangaroo Mother Care (KMC) has shown promise in stable preterm infants, its effectiveness for those requiring respiratory support remains unclear. This study evaluated nurse-led implementation of KMC for preterm infants with RDS. METHODS A prospective, multicenter, randomized controlled trial was conducted across four neonatal intensive care units in Tanta, Egypt (January 2023-June 2024). Two hundred forty preterm infants (<2000 g) with RDS were randomly assigned to either nurse-implemented KMC (n = 120) or standard care (n = 120). The KMC protocol, implemented for a minimum of 6 h per day until hospital discharge, integrated continuous skin-to-skin contact, exclusive breastfeeding promotion, and structured parental education. Outcomes included 28-day survival, respiratory status (Silverman-Anderson Scores), nosocomial infections, maternal-infant bonding, growth trajectories, and clinical course metrics. RESULTS The KMC intervention significantly improved 28-day survival (adjusted HR = 0.42, 95% CI 0.28-0.63, p < 0.001) and reduced nosocomial infections by 55% (RR = 0.45, 95% CI 0.27-0.75, p < 0.001). KMC recipients demonstrated faster respiratory improvement, shorter CPAP duration (-2.2 days, p < 0.001), and higher rates of exclusive breastfeeding at discharge (74.2% vs. 48.3%, p < 0.001). Maternal competency scores showed progressive improvement with enhanced bonding and responsiveness. CONCLUSION Nurse-implemented KMC is a safe, effective intervention for preterm infants with RDS, yielding significant improvements in survival, clinical outcomes, and family-centered care metrics. IMPLICATIONS FOR PRACTICE These findings support the expansion of nursing roles in implementing KMC for high-risk infants in resource-limited settings. TRIAL REGISTRATION ClinicalTrials.gov (NCT06707376).
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Affiliation(s)
| | - Afrah Madyan Alshammari
- College of Nursing, Department of Maternity and Pediatric Health Nursing, Jouf University, Sakaka, 72388, Saudi Arabia.
| | - Abeer Nuwayfi Alruwaili
- College of Nursing, Nursing Administration and Education Department, Jouf University, Sakaka, 72388, Saudi Arabia
| | - Nadia Bassuoni Elsharkawy
- College of Nursing, Department of Maternity and Pediatric Health Nursing, Jouf University, Sakaka, 72388, Saudi Arabia
| | - Ali Alhaiti
- Department of Nursing, College of Applied Sciences, Almaarefa University, Diriyah, Riyadh, 13713, Saudi Arabia
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Xu HG, Zhao YC, Duff J, Marsh N. A scoping review of randomised controlled trials in vascular access devices in emergency departments. Australas Emerg Care 2025:S2588-994X(25)00019-3. [PMID: 40234114 DOI: 10.1016/j.auec.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] [Received: 01/10/2025] [Revised: 03/13/2025] [Accepted: 03/13/2025] [Indexed: 04/17/2025]
Abstract
AIMS To synthesise findings from randomised controlled trials (RCTs) on vascular access devices (VADs) in emergency departments (EDs). BACKGROUND VADs play a critical role in EDs, enabling rapid delivery of supportive therapies to address urgent medical needs. This scoping review will map current evidence and determine areas to focus future research priorities. METHODS Following Arksey and O'Malley's scoping review framework, a comprehensive search was conducted (2012-2024) across four databases. RCTs that focused on peripheral intravenous catheters, central venous catheters, arterial catheters, or intraosseous catheters in an ED setting were included. RESULTS 48 RCTs were included, a majority focused on peripheral intravenous catheters (n = 41, 85 %), followed by central venous catheters (n = 4, 8 %), arterial catheters (n = 2, 4 %), and intraosseous catheters (n = 1, 3 %). The findings were categorised by intervention type, including vessel visualisation technology, catheter design, dressing and securement design, distraction techniques, topical anaesthetics, inserter models, and other related techniques. The top three most frequently reported outcomes were insertion success (n = 21), time to successful insertion (n = 20), and catheter-related complications (n = 19). CONCLUSION This review provides ED clinicians with current evidence on VAD technologies and techniques, enabling them to select and implement the most effective options into daily practice reduce costs and improve patient satisfaction.
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Affiliation(s)
- Hui Grace Xu
- School of Nursing, Queensland University of Technology, Kelvin Grove, Brisbane, QLD, Australia; Nursing and Midwifery Research Centre, Royal Brisbane and Women's Hospital, Herston, Brisbane, QLD, Australia; Emergency Department, Queen Elizabeth II Jubilee Hospital, Queensland Health, Australia.
| | - Yang Camila Zhao
- Emergency Department, Queen Elizabeth II Jubilee Hospital, Queensland Health, Australia
| | - Jed Duff
- School of Nursing, Queensland University of Technology, Kelvin Grove, Brisbane, QLD, Australia; Nursing and Midwifery Research Centre, Royal Brisbane and Women's Hospital, Herston, Brisbane, QLD, Australia
| | - Nicole Marsh
- Nursing and Midwifery Research Centre, Royal Brisbane and Women's Hospital, Herston, Brisbane, QLD, Australia; School of Nursing, Midwifery and Social Work, University of Queensland, Brisbane, QLD, Australia
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Buchanan M, Holly LE. A Systematic Review of Parents' Mental Health Literacy Programs: Examining Program Effectiveness and Parent Satisfaction. Child Psychiatry Hum Dev 2025:10.1007/s10578-025-01836-0. [PMID: 40220087 DOI: 10.1007/s10578-025-01836-0] [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] [Accepted: 03/30/2025] [Indexed: 04/14/2025]
Abstract
Current estimates suggest that nearly one in five youth in the United States have a clinically significant mental health problem. Many of these youth do not receive services, and if they do, they are often not evidence-based treatments. Parents are critical to the utilization of psychological services for youth; they are typically considered the gatekeepers to mental health services and frequently initiate help-seeking on behalf of their youth. Research has demonstrated that parents do not have sufficient knowledge and skills needed to handle youth mental health problems (i.e., mental health literacy), which likely contributes to the youth treatment disparity. To address this, the current systematic review explored global mental health literacy programs for parents to examine program effectiveness and parent satisfaction with programs. Nine programs were identified and described in terms of structure, content, and delivery method. Several programs demonstrated improvement in at least one component of parents' mental health literacy. Additionally, when assessed, parent satisfaction was generally positive, though areas for improvement were noted (e.g., program content lacked specificity, need for more practical parenting skills). Overall, findings have meaningful implications for future research and program development.
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Affiliation(s)
| | - Lindsay E Holly
- Department of Psychology, Marquette University, Milwaukee, WI, USA
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43
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Jackson R, Johnson P, Berhane S, Kolamunnage-Dona R, Hughes D, Dodd S, Neoptolemos J, Palmer D, Cox T. Estimating treatment effects using parametric models as counter-factual evidence. BMC Med Res Methodol 2025; 25:91. [PMID: 40205360 PMCID: PMC11983918 DOI: 10.1186/s12874-025-02540-2] [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: 01/20/2025] [Accepted: 03/25/2025] [Indexed: 04/11/2025] Open
Abstract
Randomisation controlled trial are the gold standard for causal inference, however the rapidly increasing development of new treatments and the movement towards personalised medicine mean there is a need to measure efficacy outside of the costly and time-consuming RCT.Here we propose a method of estimating treatment effects using parametric models to act as control against which to compare data from an experimental arm. This allows for treatment effects to be estimated where data are only available from an experimental arm and can be a tool useful in the analysis of observational cohorts or for the design and analysis of RCTs.We develop this approach using Bayesian estimation procedures and compare this approach against other casual inference tools. We then demonstrate how this may be used to estimate the efficacy between two treatment in different RCTs for the analysis of Pancreatic Cancer.It is proposed that with reasonable assumptions, this approach can produce a reliable estimate of efficacy and can have applications in both evaluating currently available data and in the efficient design of future trials.
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Affiliation(s)
- Richard Jackson
- University of Liverpool, Brownlow Hill, Liverpool, L69 3GL, UK.
| | - Philip Johnson
- University of Liverpool, Brownlow Hill, Liverpool, L69 3GL, UK
| | - Sarah Berhane
- NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK
- Institute of Applied Health Research, University of Birmingham, Birmingham, UK
| | | | - David Hughes
- University of Liverpool, Brownlow Hill, Liverpool, L69 3GL, UK
| | - Susanna Dodd
- University of Liverpool, Brownlow Hill, Liverpool, L69 3GL, UK
| | - John Neoptolemos
- Department of General Surgery, University of Heidelberg, Im Neuenheimer Feld 420, 69120, Heidelberg, Baden-Württemberg, Germany
| | - Daniel Palmer
- University of Liverpool, Brownlow Hill, Liverpool, L69 3GL, UK
| | - Trevor Cox
- University of Liverpool, Brownlow Hill, Liverpool, L69 3GL, UK
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Smit MS, Mölenberg F, Mensink-Bout R, Nieboer D, Voortman T, Duijts L, Raat H, Jansen W. Long-term effects of a primary school-based overweight preventive intervention on physical fitness and physical activity: a propensity score-matched retrospective cohort study within the Generation R Study. BMJ Open 2025; 15:e088272. [PMID: 40204310 PMCID: PMC11979498 DOI: 10.1136/bmjopen-2024-088272] [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: 05/01/2024] [Accepted: 03/28/2025] [Indexed: 04/11/2025] Open
Abstract
OBJECTIVES In this study, we evaluate the long-term effects (±1.5 years postintervention) of 6-year exposure to the Lekker Fit! intervention on physical fitness and physical activity (PA). DESIGN The retrospective intervention evaluation is embedded within the Generation R Study in Rotterdam, the Netherlands, a population-based prospective birth cohort study. SETTING Measurements took place in the research centre of the Generation R cohort study. PARTICIPANTS 5489 adolescents from the Generation R Study were eligible for inclusion within this study. Successful linking to school career data was possible for 4129 adolescents who were then retrospectively subdivided into a Lekker Fit! group, mixed group and regular school group based on their primary school career. INTERVENTIONS The Lekker Fit! intervention is a multicomponent primary school-based intervention for the prevention of overweight. It focuses on a healthy diet and healthy lifestyle rather than focusing directly on the reduction of overweight. The intervention targets individual behaviour of children as well as their obesogenic environment and parental engagement in shaping their children's behaviour. PRIMARY AND SECONDARY OUTCOME MEASURES Aged 13/14 years old, physical fitness was measured with an incremental ergometer test. The actual highest achieved work rate was divided by the expected highest achieved work rate (age- and sex-related Dutch population-based reference data), and converted into z-scores. PA was determined by the number of days with at least 1 hour of PA, obtained by a self-reported questionnaire. Propensity score matching was performed to correct for non-random selection bias. Linear regression analyses were performed to estimate intervention effects. RESULTS Children from the Lekker Fit! group had significantly lower fitness z-scores (-0.18 (95% CI -0.29 to -0.06), n=1826) compared with children from the matched regular school group. No Lekker Fit! intervention effect was found on PA (-0.12 (95% CI -0.36 to 0.12), n=1258). CONCLUSIONS No evidence was found for long-term favourable effects of a school-based multicomponent intervention on physical fitness and PA. Recommendations for policy and future research are discussed.
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Affiliation(s)
| | | | | | - Daan Nieboer
- Public Health, Erasmus MC, Rotterdam, The Netherlands
| | | | - Liesbeth Duijts
- Pediatrics-Division of Respiratory Medicine, Erasmus MC, Rotterdam, The Netherlands
| | - Hein Raat
- Public Health, Erasmus MC, Rotterdam, The Netherlands
| | - Wilma Jansen
- Public Health, Erasmus MC, Rotterdam, The Netherlands
- Social Development, Municipality of Rotterdam, Rotterdam, The Netherlands
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Farsi DN, Mathur H, Beresford T, Cotter PD. Cottage cheese, a relatively underexplored cultured dairy product with potential health benefits? Crit Rev Food Sci Nutr 2025:1-11. [PMID: 40188423 DOI: 10.1080/10408398.2025.2487682] [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: 04/08/2025]
Abstract
Cottage cheese (CC) is a member of the "fresh cheese" family of cheeses and is widely consumed due to its culinary versatility and some perceived health benefits. However, the evidence of direct health effects of CC is not well established. This review describes the production and nutritional characteristics of CC, before exploring the evidence of health effects from human intervention, in vitro, and in vivo models. Despite widespread consumption and advocated health benefits, there is a dearth of evidence pertaining to the health effects of CC from high-quality human randomized controlled trials. To date, a limited number of human intervention models with CC have explored nutrient bioavailability, metabolic health, and appetite regulation, in small, niche study populations. Findings with in vitro and in vivo models suggest that CC may be an efficacious vehicle for bioactive compounds. In conclusion, CC is a cultured dairy product that could impose a myriad of benefits across health outcomes including cardiometabolic, gastrointestinal, body composition, appetite regulation, and nutrient status. However, there is a need for high-quality human randomized controlled trials to develop a substantiated evidence base relating to the full potential of CC in human health.
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Affiliation(s)
- Dominic N Farsi
- Department of Nutritional Sciences, King's College London, London, UK
- Université Clermont Auvergne, INRAE, UNH, Clermont-Ferrand, France
- Centre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK
| | - Harsh Mathur
- Food Biosciences, Teagasc Food Research Centre, Moorepark, Co. Cork, Ireland
| | - Tom Beresford
- Food Biosciences, Teagasc Food Research Centre, Moorepark, Co. Cork, Ireland
| | - Paul D Cotter
- Food Biosciences, Teagasc Food Research Centre, Moorepark, Co. Cork, Ireland
- APC Microbiome Ireland, University College Cork, Cork, Ireland
- VistaMilk, Co. Cork, Ireland
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O' Brien S, Sethi A, Blair J, Tully J, Martins D, Velthuis H, Petrinovic MM, Scott S, Blackwood N, Murphy DGM, Craig MC. Intranasal oxytocin modulates brain activity during emotional processing in children with treatment resistant conduct problems. Sci Rep 2025; 15:11422. [PMID: 40180973 PMCID: PMC11968994 DOI: 10.1038/s41598-025-92276-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2024] [Accepted: 02/26/2025] [Indexed: 04/05/2025] Open
Abstract
One of the most highly replicated neural correlates of Conduct Problems (CP) is amygdala hypoactivity to another person's fear. We recently reported that this correlate was only observed in boys with persistent CP (i.e. antisocial behaviour that persisted following a gold-standard psychological intervention), suggesting that amygdala hypoactivity to fear could be an important neural signature for treatment-resistant CP, and a putative target for future treatments. Potential treatment candidates include the oxytocin system, as this has been reported to modulate amygdala activity and social behaviour across species. Further, in adults with antisocial personality disorder, intranasal oxytocin improved facial emotion recognition for fearful and happy faces. However, to-date, no-one has studied whether intranasal oxytocin can normalise neural processing differences in children with CP. Twenty boys (mean age 9.85±1.26 years) with persistent CP underwent functional magnetic resonance imaging in a within-subject randomised control design to investigate whether, compared to placebo, a single-dose of intranasal oxytocin could 'shift' abnormal neural processing to fear. Oxytocin failed to reduce amygdala hypoactivity to fearful faces, but increased activation in the posterior cingulate cortex / precuneus to happy faces. These findings tentatively suggest that intranasal oxytocin may promote a more neurotypical profile in treatment-resistant CP children, therefore, supporting the merit of investigating oxytocin in further larger clinical studies in this population.
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Affiliation(s)
- Suzanne O' Brien
- Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. suzanne.o'
| | - Arjun Sethi
- Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - James Blair
- Research Unit at Child and Adolescent Mental Health Center Copenhagen, Capital Region of Denmark, Copenhagen, Denmark
- Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - John Tully
- Academic Unit of Mental Health and Clinical Neurosciences, School of Medicine, Institute of Mental Health, University of Nottingham, Nottingham, UK
| | - Daniel Martins
- Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, College London & NIHR Maudsley Biomedical Research Centre, King's, South London and Maudsley NHS Trust, London, UK
| | - Hester Velthuis
- Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Marija M Petrinovic
- Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Stephen Scott
- Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Nigel Blackwood
- Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Declan G M Murphy
- Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
| | - Michael C Craig
- Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK
- National Female Hormone Clinic, Maudsley Hospital, London, UK
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Su X, Mo X, Kan J, Yang F, Zhang B, Huang Y. Decoding the genetic links between substance use disorder and cancer vulnerability. Psychopharmacology (Berl) 2025:10.1007/s00213-025-06781-3. [PMID: 40178608 DOI: 10.1007/s00213-025-06781-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/01/2024] [Accepted: 03/24/2025] [Indexed: 04/05/2025]
Abstract
OBJECTIVE Cancer remains a leading cause of mortality and morbidity worldwide, imposing a significant public health burden. While cannabis and opioids are widely used in cancer pain management, their potential for abuse and addiction has raised concerns regarding their long-term health effects, including possible associations with cancer risk. However, the relationship between substance use disorders (SUDs) and cancer susceptibility remains controversial. This Mendelian randomization (MR) study aimed to investigate the potential causal effects of cannabis use disorder (CUD) and opioids use disorder (OUD) on cancer vulnerability. METHODS We conducted a two-sample MR study using summary statistics from genome-wide association studies, including data from FinnGen and UK Biobank. The primary analytical approach was the inverse-variance weighted (IVW), complemented by a range of sensitivity analyses to assess the robustness of the findings. RESULTS IVW analysis identified a causal association between OUD and bladder cancer (OR = 1.040, 95% CI 1.004-1.078, P = 0.029, adj. P = 0.125), acute myeloid leukemia (OR = 0.931, 95% CI 0.885-0.978, P = 0.005, adj. P = 0.061) and ovarian cancer (OR = 0.937, 95% CI 0.891-0.984, P = 0.010, adj. P = 0.064). Sensitivity analysis yielded directionally consistent results. Reverse MR analysis provided no statistically significant evidence supporting a causal effect of these cancers on OUD (all P > 0.05). Additionally, no evidence of a significant causal relationship was observed between CUD and any cancer type (P > 0.05). CONCLUSIONS This study suggests a potential causal link between OUD and increased susceptibility to bladder cancer, acute myeloid leukemia, and ovarian cancer, warranting further investigation in larger, multi-ethnic population studies. These results contribute to the ongoing discourse on the long-term health impacts of substance use disorders and highlight the need for further research to elucidate their potential oncogenic effects.
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Affiliation(s)
- Xin Su
- State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, China
| | - Xiaoyan Mo
- State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, China
| | - Jun Kan
- State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, China
| | - Fan Yang
- Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China
| | - Bei Zhang
- State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, China.
| | - Yuanyuan Huang
- State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, China.
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Warne D, Baker T, Burson M, Kelliher A, Buffalo M, Baines J, Whalen J, Archambault M, Jinnett K, Mohan SV, Fineday RJ. Barriers and unmet needs related to healthcare for American Indian and Alaska Native communities: improving access to specialty care and clinical trials. FRONTIERS IN HEALTH SERVICES 2025; 5:1469501. [PMID: 40248761 PMCID: PMC12003380 DOI: 10.3389/frhs.2025.1469501] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/23/2024] [Accepted: 03/11/2025] [Indexed: 04/19/2025]
Abstract
Substantial healthcare barriers, especially to specialty and cancer care, exist for American Indian and Alaska Native (AI/AN) individuals and communities at all levels. The unique history of AI/AN Tribal Nations and resulting policies, treaties, and relationships with the US government and federal agencies have created specific barriers to healthcare and clinical trial access for AI/AN peoples. Commonly, AI/AN peoples harbor a long-standing mistrust of the healthcare system based on lived and historical experiences. The intersection of various barriers to care for AI/AN communities results in health inequities, lack of representation in clinical research, and other disparities faced by historically marginalized and underrepresented peoples. AI/AN patients face unique barriers in their healthcare journey due to a disproportionate burden of life-threatening and chronic diseases, including many cancers. Identifying barriers specific to AI/AN peoples and improving access to high-quality care, with a focus on building on the strengths and capacities in each AI/AN community are vital to improving health equity. In this review, we describe patient, provider, and institutional barriers to healthcare, particularly specialty care and clinical research, for AI/AN peoples, with a focus on the Northern Plains AI communities. Examples and best practices to improve AI/AN patient access to health services, including screening and specialty care, as well as to clinical research, are provided. We emphasize the importance of longitudinal community-based partnerships and strength- and trust-based approaches as essential components of promoting equitable access to high-quality specialty care and recruitment and participation of AI/AN individuals and communities in clinical research.
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Affiliation(s)
- Donald Warne
- Johns Hopkins Bloomberg School of Public Health, and School of Nursing, Baltimore, MD, United States
| | - Twyla Baker
- Nueta Hidatsa Sahnish College, New Town, ND, United States
| | - Michael Burson
- Sanford Roger Maris Cancer Center, Fargo, ND, United States
| | - Allison Kelliher
- Johns Hopkins Bloomberg School of Public Health, and School of Nursing, Baltimore, MD, United States
| | - Melissa Buffalo
- American Indian Cancer Foundation, Minneapolis, MN, United States
| | | | - Jeremy Whalen
- Genentech, Inc., South San Francisco, CA, United States
| | | | - Kimberly Jinnett
- Genentech, Inc., South San Francisco, CA, United States
- UCSF Institute for Health and Aging, San Francisco, CA, United States
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Daniel S, Bishop R, Killner E, Whight A, Lennard S, Howard S, Laugharne R, Shankar R. Serious Games for constipation management for people with intellectual disabilities: A scoping review and narrative synthesis. Int J Med Inform 2025; 196:105832. [PMID: 39933200 DOI: 10.1016/j.ijmedinf.2025.105832] [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: 12/22/2024] [Revised: 02/03/2025] [Accepted: 02/07/2025] [Indexed: 02/13/2025]
Abstract
INTRODUCTION People with intellectual disability (PwID) are 2% of the UK population. Constipation and bowel movement (BM) problems (diarrhoea/faecal incontinence etc.) affects over a third of PwID and is a serious cause of morbidity and mortality. Pw ID rely heavily on outside support (family/professional carers/healthcare professionals), many of whom are ignorant to bowel related harms. There is significant stigma to discuss BM particularly constipation. Serious Games (SG) are increasingly used for education of health needs. This review examines if game-based technology can assist improving knowledge and reducing stigma of BM problems particularly constipation. OBJECTIVE To identify and gain evidence of SGs aimed at improving knowledge of BM management particularly constipation. METHODS A systematic search of publications between 2010 and 2024 was conducted following the PRISMA ScR statement for scoping reviews. The search inclusion/exclusion criteria were designed and overseen by an information specialist. PUBMED, EMBASE and PsychINFO databases were searched. Extracted variables included SG title, co-production and expert involvement, target outcome, evaluation methodology, effectiveness, sustainability and game platform. Results were narratively synthesised. RESULTS Of 2966 papers retrieved, three were selected for inclusion, none RCTs. All three included SGs aimed to teach BM management or recognition to healthcare workers/ professionals. Two studies evaluated game efficacy. No SGs were assessed after initial trials, none were implemented in clinical practice. Only one game successfully improved participant knowledge. All game creators consulted experts during game design, but none consulted patients. None discussed reducing stigma amongst their audience. CONCLUSION Only one of three SGs identified improved BM knowledge in healthcare workers/professionals and was not specific to PwID. There is potential to co-produce with PwID and their carers a SG to support BM problems particularly constipation to reduce stigma, improve outcomes and be a templar for other similarly vulnerable groups like those with dementia.
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Affiliation(s)
| | - Ruth Bishop
- Cornwall Intellectual Disability Equitable Research (CIDER) Cornwall Partnership NHS Foundation Trust, Truro, UK
| | | | | | - Sarah Lennard
- Cornwall Intellectual Disability Equitable Research (CIDER) Cornwall Partnership NHS Foundation Trust, Truro, UK; CIDER Peninsula School of Medicine, University of Plymouth, Plymouth, UK
| | | | - Richard Laugharne
- Cornwall Intellectual Disability Equitable Research (CIDER) Cornwall Partnership NHS Foundation Trust, Truro, UK; CIDER Peninsula School of Medicine, University of Plymouth, Plymouth, UK
| | - Rohit Shankar
- Cornwall Intellectual Disability Equitable Research (CIDER) Cornwall Partnership NHS Foundation Trust, Truro, UK; CIDER Peninsula School of Medicine, University of Plymouth, Plymouth, UK.
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Mehrabi S, Flores-Sandoval C, Fleet JL, Cameron L, Teasell R. Comparing Interventions Used in Randomized Controlled Trials of Upper Extremity Motor Rehabilitation Post-stroke in High-Income Countries and Low-to-Middle-Income Countries. Arch Phys Med Rehabil 2025; 106:632-636. [PMID: 39537002 DOI: 10.1016/j.apmr.2024.11.001] [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: 07/30/2024] [Revised: 11/04/2024] [Accepted: 11/05/2024] [Indexed: 11/16/2024]
Abstract
OBJECTIVE To identify and compare interventions for upper extremity (UE) motor recovery poststroke in randomized controlled trials (RCTs) conducted in high-income countries (HICs) and low-to-middle-income countries (LMICs). DATA SOURCE Systematic searches were conducted for RCTs published in English in 5 databases (CINAHL, Embase, PubMed, Scopus, and Web of Science) up to April 2021, in line with PRISMA guidelines. STUDY SELECTION RCTs, including crossover design, were included if they were in English and evaluated an intervention for poststroke UE motor rehabilitation, in an adult population (≥18y) diagnosed with stroke. DATA EXTRACTION Data on country of origin and type of intervention in each RCT were extracted using a data extraction template in Covidence software. Study screenings and data extraction were performed by 2 independent reviewers. DATA SYNTHESIS A total of 1276 RCTs met the inclusion criteria, with 978 RCTs conducted in HICs and 298 in LMICs. A significantly larger proportion of RCTs evaluating robotics and task-specific training interventions were conducted in HICs, compared to LMICs (P<.009). In contrast, a higher proportion of RCTs conducted in LMICs examined acupuncture (P<.001) and repetitive transcranial magnetic stimulation (rTMS) (P=.001) when compared to HICs. CONCLUSIONS Poststroke rehabilitation in LMICs is conducted in a lower resource environment when compared to HICs. Some differences exist in the use of UE motor rehabilitation interventions between LMICs and HICs such as robotics, task-specific training, rTMS, and acupuncture; however, there was no significant difference between HICs and LMICs for most interventions.
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Affiliation(s)
| | | | - Jamie L Fleet
- Lawson Research Institute, London, ON, Canada; Department of Physical Medicine and Rehabilitation, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada; St. Joseph's Health Care London, London, ON, Canada
| | | | - Robert Teasell
- Lawson Research Institute, London, ON, Canada; Department of Physical Medicine and Rehabilitation, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada; St. Joseph's Health Care London, London, ON, Canada.
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