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Search Results (194)

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Keywords = clinical guidelines compliance

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12 pages, 676 KiB  
Article
Challenges Pertaining to the Optimization of Therapy and the Management of Asthma—Results from the 2023 EU-LAMA Survey
by Michał Panek, Robab Breyer-Kohansal, Paschalis Steiropoulos, Peter Kopač, Monika Knopczyk, Tomasz Dębowski, Christer Janson and Maciej Kupczyk
Biomedicines 2025, 13(8), 1877; https://doi.org/10.3390/biomedicines13081877 - 1 Aug 2025
Viewed by 144
Abstract
Background: Treatment compliant with the Global Initiative for Asthma (GINA) can promote more effective disease control. Single-inhaler triple therapy (SITT) is one method that is used to optimize therapy in this context, but TRIPLE therapy is still employed by physicians to a limited [...] Read more.
Background: Treatment compliant with the Global Initiative for Asthma (GINA) can promote more effective disease control. Single-inhaler triple therapy (SITT) is one method that is used to optimize therapy in this context, but TRIPLE therapy is still employed by physicians to a limited extent. Objective: This study aimed to describe the factors influencing challenges in optimizing asthma therapy. Methods: A 19-question survey, created via the CATI system, was distributed among pulmonologists, allergologists, general practitioners, and internal medicine specialists in Poland, Greece, Sweden, Slovenia, and Austria. Results: Statistically significant percentage differences in the use of TRIPLE therapy in the context of asthma management were observed among countries as well as between pulmonologists, allergists, and other specialists. Overuse of oral corticosteroids (OCSs) to treat nonsevere and severe asthma in the absence of an approach that focuses on optimizing inhalation therapy among asthma patients receiving TRIPLE therapy was observed in different countries as well as among physicians with different specialties. Twenty elements associated with the challenges involved in diagnosing and managing difficult-to-treat and severe asthma were identified. Six clinical categories for the optimization of asthma therapy via SITT were highlighted. The degree of therapeutic underestimation observed among severe asthma patients was assessed by comparing actual treatment with the recommendations of the GINA 2023 guidelines. Conclusions: Physicians of various specialties in Europe are subject to therapeutic inertia in terms of their compliance with the GINA 2023 guidelines. Full article
(This article belongs to the Special Issue New Insights in Respiratory Diseases)
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14 pages, 628 KiB  
Article
Variations in the Diagnosis and Management of Benign Paroxysmal Positional Vertigo Among Physician Specialties in Saudi Arabia: Influence of Clinical Experience and Case Exposure
by Sarah Alshehri, Abdullah Oudah Al Ahmree, Abdulaziz Qobty, Abdullah Musleh and Khalid A. Alahmari
Healthcare 2025, 13(15), 1887; https://doi.org/10.3390/healthcare13151887 - 1 Aug 2025
Viewed by 146
Abstract
Background/Objectives: Benign paroxysmal positional vertigo (BPPV) is the most prevalent vestibular disorder encountered in clinical settings and is highly responsive to evidence-based diagnostic and therapeutic interventions. However, variations in practice patterns among physician specialties can compromise timely diagnosis and effective treatment. Understanding [...] Read more.
Background/Objectives: Benign paroxysmal positional vertigo (BPPV) is the most prevalent vestibular disorder encountered in clinical settings and is highly responsive to evidence-based diagnostic and therapeutic interventions. However, variations in practice patterns among physician specialties can compromise timely diagnosis and effective treatment. Understanding these variations is essential for improving clinical outcomes and standardizing care. This study aimed to assess the diagnostic and treatment practices for BPPV among Ear, Nose, and Throat (ENT) specialists, neurologists, general practitioners, and family physicians in Saudi Arabia and to examine how these practices are influenced by clinical experience and patient case exposure. Methods: A cross-sectional, questionnaire-based study was conducted between April 2023 and March 2024 at King Khalid University, Abha, Saudi Arabia. A total of 413 physicians were recruited using purposive sampling. Data were analyzed using IBM SPSS version 24.0. Parametric tests, including one-way ANOVA and chi-square tests, were used to assess differences across groups. A p-value of <0.05 was considered statistically significant. Results: Overall, all physician groups exhibited limited adherence to guideline-recommended positional diagnostic and therapeutic maneuvers. However, ENT specialists and neurologists demonstrated relatively higher compliance, particularly in performing the Dix–Hallpike test, with 46.97% and 26.79% reporting “always” using the maneuver, respectively (p < 0.001, Cramér’s V = 0.22). Neurologists were the most consistent in conducting oculomotor examinations, with 73.68% reporting routine performance (p < 0.001, Cramér’s V = 0.35). Epley maneuver usage was highest among neurologists (86.36%) and ENT specialists (77.14%) compared to family physicians (50.60%) and GPs (67.50%) (p = 0.044). Physicians with 11–15 years of experience and >50 BPPV case exposures consistently showed a greater use of diagnostic maneuvers, repositioning techniques, and guideline-concordant medication use (betahistine 76.67%; p < 0.001). Continuing medical education (CME) participation and the avoidance of unnecessary imaging were also highest in this group (46.67% and 3.33%, respectively; p < 0.001). Conclusions: Significant inter-specialty differences exist in the management of BPPV in Saudi Arabia. Greater clinical experience and higher case exposure are associated with improved adherence to evidence-based practices. Targeted educational interventions are needed, particularly in primary care, to enhance guideline implementation. Full article
(This article belongs to the Special Issue Care and Treatment of Ear, Nose, and Throat)
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25 pages, 1829 KiB  
Article
Development and Validation of a New LC-MS/MS Method for Simultaneous Quantification of Ivacaftor, Tezacaftor and Elexacaftor Plasma Levels in Pediatric Cystic Fibrosis Patients
by Alessandro Mancini, Raffaele Simeoli, Luca Cristiani, Sara Cairoli, Fabiana Ciciriello, Alessandra Boni, Federico Alghisi, Chiara Rossi, Giacomo Antonetti, Carlo Dionisi Vici, Alessandro Giovanni Fiocchi, Renato Cutrera and Bianca Maria Goffredo
Pharmaceuticals 2025, 18(7), 1028; https://doi.org/10.3390/ph18071028 - 10 Jul 2025
Viewed by 426
Abstract
Background: “CFTR modulators” (also named “caftor”) have been developed and introduced into clinical practice to improve the functionality of defective CFTR protein. Therapeutic drug monitoring (TDM) is not currently used for CFTR modulators in routine clinical practice and there is still much [...] Read more.
Background: “CFTR modulators” (also named “caftor”) have been developed and introduced into clinical practice to improve the functionality of defective CFTR protein. Therapeutic drug monitoring (TDM) is not currently used for CFTR modulators in routine clinical practice and there is still much to learn about the pharmacokinetic/pharmacodynamic (PK/PD) and the safety profiles of these drugs in a real-world setting. Moreover, therapeutic ranges are not yet available for both pediatric and adult cystic fibrosis (CF) patients. Methods: A new and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method for contemporary quantification of ivacaftor (IVA), tezacaftor (TEZ) and elexacaftor (ELX) in plasma samples has been developed and validated. The clinical performance of our method has been tested on samples collected during the routine clinical practice from n = 25 pediatric patients (aged between 7 and 17 years) affected by cystic fibrosis. This LC-MS/MS method has been validated according to ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines for the validation of bioanalytical methods. Results: Our method fulfilled ICH guidelines in terms of accuracy, precision, selectivity, specificity and carry-over. Intra- and inter-day accuracy and precision were ≤15%. The 9-day autosampler stability was 90–100% for TEZ and ELX; meanwhile, it fell to 76% for IVA. An injection volume of 1 µL and a wider quantification range (0.1–20 µg/mL) represent a novelty of our method in terms of sensitivity and fields of application. Finally, the evaluation of PK exposure parameters for IVA revealed strong agreement with previously published reports and with results from the summary of product characteristics (SmPCs). Conclusions: This method could be adopted to contemporarily measure ELX/TEZ/IVA plasma levels for both PK studies and monitor therapy compliance, especially in case of poor or partial responses to treatment, or to evaluate drug–drug interactions when multiple concomitant medications are required. Considering also the high cost burden of these medications to the health system, a TDM-based approach could facilitate more cost-effective patient management. Full article
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14 pages, 706 KiB  
Article
First-Line Prescriptions and Effectiveness of Helicobacter pylori Eradication Treatment in Ireland over a 10-Year Period: Data from the European Registry on Helicobacter pylori Management (Hp-EuReg)
by Sinéad M. Smith, Olga P. Nyssen, Rebecca FitzGerald, Thomas J. Butler, Deirdre McNamara, Asghar Qasim, Conor Costigan, Anna Cano-Catalá, Pablo Parra, Leticia Moreira, Francis Megraud, Colm O’Morain and Javier P. Gisbert
Antibiotics 2025, 14(7), 680; https://doi.org/10.3390/antibiotics14070680 - 5 Jul 2025
Viewed by 698
Abstract
Background: Local audits of Helicobacter pylori (H. pylori) prescriptions and outcomes are necessary to assess guideline awareness among clinicians and treatment effectiveness. Aims: The aims were to investigate first-line prescriptions and effectiveness over a 10-year period in Ireland and evaluate the [...] Read more.
Background: Local audits of Helicobacter pylori (H. pylori) prescriptions and outcomes are necessary to assess guideline awareness among clinicians and treatment effectiveness. Aims: The aims were to investigate first-line prescriptions and effectiveness over a 10-year period in Ireland and evaluate the influence of the 2017 Irish consensus guidelines on these trends. Methods: Data were collected at e-CRF AEG-REDCap from the European Registry on H. pylori management (Hp-EuReg) and quality reviewed from 2013 to 2022. All treatment-naïve cases were assessed for effectiveness by modified intention-to-treat (mITT) analysis. Multivariate analysis was also performed. Results: Data from 1000 patients (mean age 50 ± 15 years; 54% female) were analyzed. Clarithromycin (C) and amoxicillin (A) triple therapy represented 88% of treatments, followed by sequential C, A, and metronidazole (M) therapy (4.3%) and triple C + M (2.7%). Bismuth quadruple therapy was prescribed in 1.7% of cases. Treatment durations of 14, 10, and 7 days accounted for 87%, 4.5%, and 8.5% of prescriptions, respectively. High-, standard-, and low-dose proton pump inhibitors (PPIs; 80 mg, 40 mg, and 20 mg omeprazole equivalent b.i.d.) were used in 86%, 0.9%, and 13% of cases, respectively. The overall eradication rate was 80%, while it was 81% for triple C + A. Good compliance and high-dose PPI were associated with higher overall mITT eradication rates (OR 4.5 and OR 1.9, respectively) and triple C + A eradication rates (OR 4.2 and OR 1.9, respectively). Overall eradication rates increased from 74% pre-2017 to 82% (p < 0.05) by the end of 2022. Similarly, the triple C + A eradication rates increased from 76% to 83% (p < 0.05). Conclusions: While first-line treatment effectiveness improved in clinical practice over time, cure rates remain below 90%. Alternative first-line strategies are required in Ireland. Full article
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31 pages, 922 KiB  
Review
Controversies and Perspectives in the Current Management of Patients with Locally Advanced Rectal Cancer—A Systematic Review
by Roxana Elena Stefan, Rodica Daniela Birla, Mircea Gheorghe, Daniela Elena Dinu, Petre Angel Hoara, Diana Ciuc, Valeriu-Gabi Dinca and Silviu Constantinoiu
Life 2025, 15(7), 1011; https://doi.org/10.3390/life15071011 - 25 Jun 2025
Viewed by 723
Abstract
Traditionally, the therapeutic approach to rectal cancer has involved neoadjuvant chemoradiotherapy followed by surgical resection, and, in some cases, adjuvant chemotherapy. This study aims to present current advances and ongoing controversies in the management of patients with locally advanced rectal cancer (LARC), with [...] Read more.
Traditionally, the therapeutic approach to rectal cancer has involved neoadjuvant chemoradiotherapy followed by surgical resection, and, in some cases, adjuvant chemotherapy. This study aims to present current advances and ongoing controversies in the management of patients with locally advanced rectal cancer (LARC), with a particular focus on clarifying the role of total neoadjuvant therapy (TNT) in contemporary treatment strategies. Methods: We conducted a systematic literature review in Medline/PubMed using various keyword combinations, including “rectal cancer/neoplasia” and“therapy” or “neoadjuvant therapy” or “TNT”, and included articles published between 2015 and 2025. Results: The association of neoadjuvant radiochemotherapy with preoperative systemic chemotherapy has led to the current concept of total neoadjuvant therapy. The advantages of preoperative chemotherapy include better patient compliance, a decrease in the rate of local recurrence and distant metastases via the early destruction of infra-clinical micrometastases, and higher rates of pathological complete response. All of these have led to the inclusion of this strategy in treatment guidelines for patients with locally advanced rectal cancer. Conclusions: However, the selection of patients with advanced rectal tumors for optimal therapy requires comprehensive imaging assessments, molecular and genetic testing, and a multidisciplinary team to determine the most appropriate total neoadjuvant therapy approach. Full article
(This article belongs to the Section Medical Research)
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16 pages, 735 KiB  
Systematic Review
Clinical Outcomes of Pharmacist Involvement in Cardiac Arrest and Trauma Resuscitations: A Scoping Review
by Harshita Patel, Myles Wee, Aaron M. Tejani and Anthony Lau
Pharmacy 2025, 13(4), 89; https://doi.org/10.3390/pharmacy13040089 - 24 Jun 2025
Viewed by 810
Abstract
Background: The role of clinical pharmacists in the emergency department continues to gain recognition, particularly during cardiac and trauma resuscitations. However, their contributions to patient outcomes remain unclear. The objective of this scoping review with narrative synthesis was to determine the impact of [...] Read more.
Background: The role of clinical pharmacists in the emergency department continues to gain recognition, particularly during cardiac and trauma resuscitations. However, their contributions to patient outcomes remain unclear. The objective of this scoping review with narrative synthesis was to determine the impact of pharmacists on medication and patient outcomes during cardiac and trauma resuscitations and to identify barriers to integration. Methods: A literature search of databases in September 2024 identified randomized and non-randomized control trials, evaluating the impact of pharmacists’ involvement in cardiac or trauma resuscitations. Excluded were studies on acute stroke, acute hemorrhage, and sepsis. Data were extracted and analyzed for primary (e.g., medication errors and Advanced Cardiovascular Life Support [ACLS] compliance) and secondary outcomes (e.g., pharmacists’ education and training). Results: Of the 560 records screened, 26 records were included in the final analysis. Due to heterogeneity, quantitative analysis was not feasible. Among primary outcomes, ACLS guideline compliance and medication errors were commonly reported; mortality and length of stay were less commonly reported. ACLS certification improved pharmacists’ confidence in their tasks. Pharmacists’ presence also correlated with reduced healthcare costs. Conclusions: Our analysis suggests that the involvement of pharmacists in the context of emergency cardiac or trauma resuscitations may benefit direct patient outcomes and indirect outcomes. Full article
(This article belongs to the Topic Optimization of Drug Utilization and Medication Adherence)
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13 pages, 532 KiB  
Article
The Impact of AI-Driven Chatbot Assistance on Protocol Development and Clinical Research Engagement: An Implementation Report
by Kusal Weerasinghe, David B. Olawade, Jennifer Teke, Maines Msiska and Stergios Boussios
J. Pers. Med. 2025, 15(7), 269; https://doi.org/10.3390/jpm15070269 - 24 Jun 2025
Cited by 1 | Viewed by 495
Abstract
Background: The integration of artificial intelligence (AI) into healthcare research has the potential to enhance research capacity, streamline protocol development, and reduce barriers to engagement. Medway NHS Foundation Trust identified a plateau in homegrown research participation, particularly among clinicians with limited research experience. [...] Read more.
Background: The integration of artificial intelligence (AI) into healthcare research has the potential to enhance research capacity, streamline protocol development, and reduce barriers to engagement. Medway NHS Foundation Trust identified a plateau in homegrown research participation, particularly among clinicians with limited research experience. A generative AI-driven chatbot was introduced to assist researchers in protocol development by providing step-by-step guidance, prompting ethical and scientific considerations, and offering immediate feedback. Methods: The chatbot was developed using OpenAI’s GPT-3.5 architecture, customised with domain-specific training based on Trust guidelines, Health Research Authority (HRA) requirements, and Integrated Research Application System (IRAS) submission protocols. It was deployed to guide researchers through protocol planning, ensuring compliance with ethical and scientific standards. A mixed-methods evaluation was conducted using a qualitative-dominant sequential explanatory design. Seven early adopters completed a 10-item questionnaire (5-point Likert scales), followed by eight free-flowing interviews to achieve thematic saturation. Results: Since its launch, the chatbot has received an overall performance rating of 8.86/10 from the seven survey respondents. Users reported increased confidence in protocol development, reduced waiting times for expert review, and improved inclusivity in research participation across professional groups. However, limitations in usage due to free-tier platform constraints were identified as a key challenge. Conclusions: AI-driven chatbot tools show promise in supporting research engagement in busy clinical environments. Future improvements should focus on expanding access, optimising integration, and fostering collaboration among NHS institutions to enhance research efficiency and inclusivity. Full article
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18 pages, 1780 KiB  
Article
Evaluating the Role of Artificial Intelligence in Making Clinical Decisions for Treating Acute Pancreatitis
by Mete Ucdal, Amir Bakhshandehpour, Muhammed Bahaddin Durak, Yasemin Balaban, Murat Kekilli and Cem Simsek
J. Clin. Med. 2025, 14(12), 4347; https://doi.org/10.3390/jcm14124347 - 18 Jun 2025
Viewed by 570
Abstract
Background/Objectives: Acute pancreatitis (AP) is an illness that requires prompt diagnosis and treatment since it has the potential to become life-threatening. The American College of Gastroenterology 2024 (ACG24) guidelines offer a framework for diagnosis, severity, and treatment criteria. To assess Google Gemini application [...] Read more.
Background/Objectives: Acute pancreatitis (AP) is an illness that requires prompt diagnosis and treatment since it has the potential to become life-threatening. The American College of Gastroenterology 2024 (ACG24) guidelines offer a framework for diagnosis, severity, and treatment criteria. To assess Google Gemini application of ACG24 guidelines to Medical Information Mart for Intensive Care-III AP cases for risk, nutrition, and complication management. Methods: This observational cross-sectional study was based on 512 patients with AP who were treated in the Medical Information Mart for Intensive Care-III database from 2001 to 2012. The study compared the efficiency of Gemini in relation to the ACG24 guidelines in the three main areas of risk stratification, enteral nutrition timing, and necrotizing pancreatitis management. Enteral nutrition, according to the ACG24 guidelines, should be started within 48 h for patients who are capable, and antibiotics should only be used for confirmed infected necrosis. Results: The study included 512 patients who were divided into two groups: 213 patients with mild pancreatitis (41.6%) and 299 patients with severe pancreatitis (58.4%). The model achieved 85% accuracy for mild cases and 82% accuracy for severe cases of pancreatitis. The Acute Physiology and Chronic Health Evaluation II and Ranson scores matched the predictions of Gemini for both mild cases (p = 0.28 and p = 0.33, respectively) and severe cases (p = 0.31 and p = 0.27, respectively). The recommendations for early enteral nutrition and delayed feeding in mild cases were correct for 78% of patients, but the system suggested oral intake prematurely in 8% of severe cases. The antibiotic guideline compliance reached 82% among 156 patients with necrotizing pancreatitis, and the procedure for draining infected necrosis was correct 85% of the time. Conclusions: The Gemini model achieved 78–85% accuracy in determining pancreatitis severity and adherence to treatment guidelines but showed lower accuracy in nutrition timing compared to other parameters. Core Tip: This study evaluated the Google Gemini model in applying the American College of Gastroenterology 2024 guidelines for acute pancreatitis across 512 Medical Information Mart for Intensive Care-III cases. Results demonstrated 85% accuracy in severity classification, precise prediction of Acute Physiology and Chronic Health Evaluation II and Ranson scores, and 78–85% compliance with nutritional and necrotizing pancreatitis management guidelines. These findings suggest that artificial intelligence-based clinical decision support systems can provide rapid, consistent, and guideline-concordant recommendations, which are particularly valuable in settings with limited specialist expertise. Full article
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33 pages, 984 KiB  
Article
Artificial Intelligence in Healthcare: How to Develop and Implement Safe, Ethical and Trustworthy AI Systems
by Sasa Jenko, Elsa Papadopoulou, Vikas Kumar, Steven S. Overman, Katarina Krepelkova, Joseph Wilson, Elizabeth L. Dunbar, Carolin Spice and Themis Exarchos
AI 2025, 6(6), 116; https://doi.org/10.3390/ai6060116 - 6 Jun 2025
Viewed by 2331
Abstract
Background/Objectives: Artificial intelligence (AI) is increasingly integrated into everyday life, including the complex and highly regulated healthcare sector. Given healthcare’s essential role in safeguarding human life and well-being, AI deployment requires careful oversight to ensure safety, effectiveness, and ethical compliance. This paper aims [...] Read more.
Background/Objectives: Artificial intelligence (AI) is increasingly integrated into everyday life, including the complex and highly regulated healthcare sector. Given healthcare’s essential role in safeguarding human life and well-being, AI deployment requires careful oversight to ensure safety, effectiveness, and ethical compliance. This paper aims to examine the current regulatory landscapes governing AI in healthcare, particularly in the European Union (EU) and the United States (USA), and to propose practical tools to support the responsible development and implementation of AI systems. Methods: The study reviews key regulatory frameworks, ethical guidelines, and expert recommendations from international bodies, professional associations, and governmental institutions in the EU and USA. Based on this analysis, the paper develops structured questionnaires tailored for AI developers and implementers to help operationalize regulatory and ethical expectations. Results: The proposed questionnaires address critical gaps in existing frameworks by providing actionable, lifecycle-oriented tools that span AI development, deployment, and clinical use. These instruments support compliance and ethical integrity while promoting transparency and accountability. Conclusions: The structured questionnaires can serve as practical tools for health technology assessments, public procurement, accreditation processes, and training initiatives. By aligning AI system design with regulatory and ethical standards, they contribute to building trustworthy, safe, and innovative AI applications in healthcare. Full article
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23 pages, 5685 KiB  
Systematic Review
Telemonitoring Tools for Glaucoma Patients: A Systematic Review of Current Trends and Applications
by Jeniffer Jesus, Catarina Aguiar, Dália Meira, Ignacio Rodriguez-Una and João M. Beirão
J. Clin. Med. 2025, 14(10), 3317; https://doi.org/10.3390/jcm14103317 - 9 May 2025
Viewed by 552
Abstract
Background/Objectives: In 2010, approximately 60.5 million people were affected by glaucoma, making it the leading cause of permanent vision impairment globally. With the rise of telehealth tools and technological advancements in glaucoma care, this review aims to provide an up-to-date analysis regarding [...] Read more.
Background/Objectives: In 2010, approximately 60.5 million people were affected by glaucoma, making it the leading cause of permanent vision impairment globally. With the rise of telehealth tools and technological advancements in glaucoma care, this review aims to provide an up-to-date analysis regarding remote monitoring systems in glaucoma management. Methods: A systematic literature search (in compliance with PRISMA guidelines) was conducted across six databases (CINAHL, MEDLINE, PsycINFO, Web of Science, Scopus, and Cochrane Library) and one grey literature source (Google Scholar), covering the period from 2000 to 2024. Relevant studies meeting predefined inclusion criteria were identified and analyzed. Results: The search identified 21 eligible studies focusing on various glaucoma telemonitoring tools. Several studies demonstrated the potential for continuous remote intraocular pressure (IOP) monitoring and highlighted the effectiveness of home-based visual field-testing technologies (e.g., Melbourne Rapid Fields, Eyecatcher, and VF-Home), which showed results closely matching in-clinic tests. All 21 studies underwent risk of bias assessment with appropriate tools based on study design, and none showed a high overall risk of bias, indicating robust methodology. Conclusions: Glaucoma telemonitoring tools are feasible and cost-effective, helping to reduce patient travel and waiting times and improving patient satisfaction. However, periodic in-person examinations remain necessary to optimally monitor disease progression and adjust treatments. Future directions should focus on interdisciplinary collaboration and the development of advanced algorithms (including artificial intelligence) to further enhance patient outcomes in teleglaucoma care. Full article
(This article belongs to the Special Issue Recent Advances in Glaucoma Management)
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15 pages, 740 KiB  
Article
A Similar Nonclinical Safety Evaluation of Prev(e)nar 13 in a Multi-Dose Formulation Containing the Preservative 2-Phenoxyethanol
by Yana Chervona, Wen Shen, Shambhunath Choudhary, Victoria Markiewicz, Peter C. Giardina and Cynthia M. Rohde
Vaccines 2025, 13(5), 486; https://doi.org/10.3390/vaccines13050486 - 30 Apr 2025
Viewed by 565
Abstract
Background: 2-Phenoxyethanol (2-PE) has been safely included as a preservative and/or stabilizer in more than thirty vaccine formulations at amounts ranging from 0.5 to 5 mg per dose; however, the nonclinical safety data publicly available for intramuscular (IM) or subcutaneous (SC) administration are [...] Read more.
Background: 2-Phenoxyethanol (2-PE) has been safely included as a preservative and/or stabilizer in more than thirty vaccine formulations at amounts ranging from 0.5 to 5 mg per dose; however, the nonclinical safety data publicly available for intramuscular (IM) or subcutaneous (SC) administration are relatively limited. Here, in addition to the available clinical and nonclinical data for 2-PE, we summarize the nonclinical safety data of experimental 13vPnC (Prev(e)nar 13) formulations with or without 2-PE. Methods: Two repeat-dose toxicity studies in rabbits, one for a 2-PE-free formulation of 13vPnC and the other for an MDV formulation of 13vPnC with 5 mg/dose 2-PE, were conducted as part of an overall nonclinical safety package for vaccine development. The studies were designed and conducted in compliance with the relevant guidelines and regulations. Results: In repeat-dose toxicity studies in rabbits, five IM administrations of a preservative-free 13vPnC single-dose syringe formulation or a 13vPnC multi-dose vial (MDV) formulation containing 5 mg 2-PE/0.5 mL dose were well tolerated with no systemic toxicity. Robust serotype-specific IgG antibody responses to each of the 13 pneumococcal serotypes were also confirmed for both formulations. The observations for the 13vPnC MDV including local inflammatory reaction, increases in fibrinogen, and increased splenic germinal centers were nonadverse, reversible, and consistent with findings previously observed for the IM administration of vaccines, including the 2-PE-free 13vPnC single-dose syringe formulation. Conclusions: Together with the other available nonclinical and clinical data of 2-PE and vaccine formulations containing 2-PE and following the 3Rs principle, our risk-assessment-based recommendation is that no additional nonclinical safety studies are needed when evaluating a 2-PE-containing presentation of a previously well-characterized vaccine product if the amount of 2-PE is ≤10 mg/dose. Full article
(This article belongs to the Section Vaccines and Public Health)
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14 pages, 235 KiB  
Article
Factors Affecting the Direct and Indirect Performance of Infection Control for Centrally Inserted Central Catheters Among ICU Nurses
by Yoonjeong Park and Seunghye Choi
Healthcare 2025, 13(9), 988; https://doi.org/10.3390/healthcare13090988 - 24 Apr 2025
Viewed by 418
Abstract
Background/Objectives: This descriptive study investigated the influence of intensive care unit (ICU) nurses’ knowledge and perception of the importance of patient safety management, nursing professionalism, and infection control organizational culture on the direct and indirect performance of centrally inserted central catheter (CICC) infection [...] Read more.
Background/Objectives: This descriptive study investigated the influence of intensive care unit (ICU) nurses’ knowledge and perception of the importance of patient safety management, nursing professionalism, and infection control organizational culture on the direct and indirect performance of centrally inserted central catheter (CICC) infection control. Direct performance encompasses immediate infection control interventions administered to patients, whereas indirect performance constitutes physician communication and documentation protocols. Methods: A structured questionnaire was used to survey 176 ICU nurses from a tertiary hospital in Korea. Results: There were no significant differences in CICC infection control performance according to participants’ general characteristics. The direct performance of CICC infection control showed a significant positive correlation with clinical experience (p = 0.006), ICU work experience (p = 0.020), the perception of the importance of patient safety management (p < 0.001), nursing professionalism (p < 0.001), and infection control organizational culture (p < 0.001). The indirect performance of CICC infection control did not show any significant correlation with participants’ general characteristics; however, it showed significant positive correlations with the perception of the importance of patient safety management (p < 0.001), nursing professionalism (p < 0.001), and infection control organizational culture (p < 0.001). The factors affecting the direct performance of CICC infection control were the perception of the importance of patient safety management and infection control organizational culture. The perception of the importance of patient safety management affected the indirect performance of CICC infection control. Conclusions: To enhance overall infection control performance among ICU nurses, it is crucial to raise the perception of the importance of patient safety management and implement systematic strategies targeting both the direct and indirect performance of CICC infection control. Healthcare institutions should establish more detailed guidelines distinguishing between direct and indirect performance of CICC infection control and continuously educate ICU nurses on the importance of compliance with both aspects. Full article
12 pages, 666 KiB  
Review
Compliance of Physiotherapeutic Scoliosis-Specific Exercise in Adolescent Idiopathic Scoliosis: A Scoping Review
by Azharuddin Fazalbhoy, Jeb McAviney and Rosemary Mirenzi
J. Clin. Med. 2025, 14(9), 2950; https://doi.org/10.3390/jcm14092950 - 24 Apr 2025
Viewed by 901
Abstract
Background: Non-surgical management of adolescent idiopathic scoliosis (AIS) includes physiotherapeutic scoliosis-specific exercise (PSSE). Determining the efficacy of PSSE in AIS has been challenging as the clinical effect is closely linked to exercise compliance (a dose–response relationship), with home exercise programs (HEPs) showing [...] Read more.
Background: Non-surgical management of adolescent idiopathic scoliosis (AIS) includes physiotherapeutic scoliosis-specific exercise (PSSE). Determining the efficacy of PSSE in AIS has been challenging as the clinical effect is closely linked to exercise compliance (a dose–response relationship), with home exercise programs (HEPs) showing a general trend for decreased participation over time. The existing literature reports contradictory definitions and parameters of appropriate PSSE compliance in AIS. As such, this scoping review is necessary for therapists to identify PSSE prescription consistency, enabling clear guidelines for improved PSSE compliance. Methods: A scoping review of the literature was conducted to synthesize original research from inception to November 2024 and reference lists were examined for studies reporting compliance, adherence, or motivational strategies for PSSE in AIS. Results: Fifteen articles with a focus on PSSE in AIS were included in this review. The results demonstrate that compliance (C) and adherence (A) are terms commonly used interchangeably, only half of the studies clearly define compliance and/or adherence, and some utilize motivational strategies; however, outcomes of compliance/adherence were often not reported in the Results section or reflected in the discussion of results. Conclusions: Compliance and/or adherence are inconsistently reported within studies and numerous variations exist in (1) the section of the paper it is mentioned, (2) whether the inclusion criteria hinged on patient compliance/adherence, and (3) whether motivational strategies were employed and outcomes reported. Notably, there was a lack of compliance or adherence reporting in Results and Discussion sections of papers. The definition of appropriate compliance and any effective motivational strategies to improve compliance to achieve the desired results for treatment of AIS remain undetermined. Full article
(This article belongs to the Section Orthopedics)
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16 pages, 793 KiB  
Article
Counseling and Prescription of Physical Exercise in Medical Consultations in Portugal: The Clinician’s Perspective
by Rita Quintas Oliveira, Edite Teixeira-Lemos, Jorge Oliveira, Joana Morais, Diogo Miguel, Luís Pedro Lemos and João Páscoa Pinheiro
Healthcare 2025, 13(9), 986; https://doi.org/10.3390/healthcare13090986 - 24 Apr 2025
Cited by 1 | Viewed by 418
Abstract
Background/Objectives: Physical exercise (PE) is essential in promoting health and quality of life and protecting against chronic diseases. Health professionals are identified as key figures in promoting and prescribing PE, yet various factors may impact this during consultations. This study aims to [...] Read more.
Background/Objectives: Physical exercise (PE) is essential in promoting health and quality of life and protecting against chronic diseases. Health professionals are identified as key figures in promoting and prescribing PE, yet various factors may impact this during consultations. This study aims to assess Portuguese specialist physicians’ understanding of the importance of PE prescriptions. It will also investigate the approaches they utilize in promoting and prescribing PE, their knowledge of incorporating this practice into their consultations, and the major facilitators or barriers to prescription. Methods: A cross-sectional observational study was conducted using a validated questionnaire distributed via email by the Centre Regional Section of the Portuguese Medical Association to physicians. The data were analyzed using descriptive and inferential statistics. Results: In total, 414 responses were collected, with participants representing different medical specialties. The participants were primarily women (62.8%) with a mean age of 49.9 ± 14.9 years. While 85.5% of physicians promoted and prescribed PE, recognizing its cardiovascular and metabolic health benefits, only 24.0% received specific training, and 73.7% were unaware of relevant guidelines. Older male physicians (over 60 years old) expressed more confidence in PE prescriptions, while younger ones were more familiar with electronic prescribing tools. Identified barriers included patient compliance (42.3%), a lack of accessible PE resources (18.4%), and limited consultation time (17.4%). Most physicians (64.4%) relied on oral counseling for prescriptions. Conclusions: Most Portuguese specialist doctors recognize the benefits of PE prescriptions. However, barriers like inadequate training and patient compliance hinder PE implementation. Enhanced training and resources are vital for effectively integrating PE into clinical practice. Full article
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17 pages, 831 KiB  
Review
Culture and Behaviour Management of Children in the Dental Clinic: A Scoping Review
by Adebola Oluyemisi Ehizele, Love Bukola Ayamolowo, Adeyinka Ishola and Moréniké Oluwátóyìn Foláyan
Dent. J. 2025, 13(5), 186; https://doi.org/10.3390/dj13050186 - 24 Apr 2025
Cited by 1 | Viewed by 1124
Abstract
Cultural norms, beliefs, and practices influence parental expectations, children’s responses, and the acceptance of behaviour management techniques (BMTs) in paediatric dentistry. Despite this, the existing guidelines often adopt a standardized approach, overlooking critical cultural differences. This scoping review maps the links between culture [...] Read more.
Cultural norms, beliefs, and practices influence parental expectations, children’s responses, and the acceptance of behaviour management techniques (BMTs) in paediatric dentistry. Despite this, the existing guidelines often adopt a standardized approach, overlooking critical cultural differences. This scoping review maps the links between culture and behaviour management strategies in paediatric dental settings. A scoping review following PRISMA guidelines was conducted across PubMed, Cochrane Library, Web of Science, Google Scholar, and hand-searched sources from the inception of the databases to 31 January 2025. A total of 671 studies were identified, with 15 meeting the inclusion criteria. Data on the key findings were inductively analyzed to assess cultural influences on parental acceptance, child behavior, and communication. The findings show that non-invasive BMTs such as TellShow–Do and positive reinforcement were the most accepted across cultures, while passive and active restraints were least accepted, especially in Western populations. Parental preferences varied; Jordanian parents were more accepting of passive restraint than German parents, while general anaesthesia was preferred in Bahrain. Cultural norms shaped communication styles—Latino families emphasized warm interpersonal interactions, whereas Pakistani families exhibited limited parental involvement due to language barriers. Black and Hispanic Medicaid-enrolled mothers in the U.S. reported lower satisfaction with pain management, highlighting disparities in culturally competent care. In conclusion, cultural factors significantly influence paediatric behaviour management in dental clinics. Integrating cultural competence into practice can enhance communication, improve patient compliance, and promote equitable care. Further research is needed, particularly in Africa and South America, to inform globally inclusive behaviour management guidelines. Full article
(This article belongs to the Special Issue Preventive Dental Care, Chairside and Beyond)
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