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Objectives: This study aimed to translate and test the psychometric properties of the Chase Nurse Manager Competency Instrument (CNMCI) among Italian nurse managers and to provide further support for the scale's validity testing. Methods: An instrument translation and cross-sectional validation study was conducted. The English version was translated into Italian using the translation method, which included pre-translation (establishing equivalence), initial translation, pretesting, review, and administration. From August 2022 to June 2023, 349 nurse managers were recruited through a web survey from 31 public and private healthcare organizations in North, Central, and Southern Italy. Validity assessments included content and structural validity. Reliability was evaluated using Cronbach's α coefficient and test-retest reliability. Results: The content validity confirmed all the items of the CNMCI in the Italian version, including the two measurement sections, "knowledge and understand" and "ability to implement and/or use." The instrument's item-content validity index (I-CVI) ranged from 0.83 to 1.00, while the scale-level content validity index (S-CVI) for both instrument sections was 0.97. The confirmatory factor analysis showed an acceptable fit. In the "knowledge and understand" section, Cronbach's α coefficient was 0.978, and in the "ability to implement and/or use" section, Cronbach's α coefficient was 0.976. The correlation coefficient between each dimension was 0.494-0.908. The test-retest reliability score was 0.82, suggesting good instrument consistency. Conclusions: Overall, the Italian CNMCI demonstrates good reliability and validity for measuring nurse managers' core competencies and supports the construct's multi-dimensionality. Also, our findings support the hierarchical nature of the factors, further supporting the validity of the instrument.
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AIM: This study aimed to describe the levels of self-care behaviors and self-care self-efficacy in patients with Marfan syndrome and to identify the individual-level determinants of self-care behaviors. BACKGROUND: The behaviors aimed at maintaining health stability (self-care maintenance), monitoring signs and symptoms (self-care monitoring), and taking action when signs and symptoms occur (self-care management) are key aspects of the care for addressing the complexity of care of patients with Marfan syndrome. However, the description of self-care behaviors and their determinants in patients with Marfan syndrome are highly under-described. METHODS: The adopted design was descriptive observational with a cross-sectional data collection on 111 patients with MFS in a single Italian specialized and reference center for this disease between 2020 and 2021. RESULTS: Performing healthy activities and managing illness, therapies, and follow-ups to maintain health over time (self-care maintenance) was almost adequate (mean score = 67.87 ± 13.17), as well as the ability to recognize signs and symptoms promptly (self-care monitoring, mean score = 67.95 ± 26.70). The ability to respond to symptoms when they occur (self-care management, mean score = 54.17 ± 19.94) was sub-optimal. The stronger positive predictor of each self-care behavior was self-care self-efficacy. CONCLUSIONS: This study suggested prioritizing educational activities focused on enhancing self-care management in patients with Marfan syndrome and strengthening their self-care self-efficacy. Researchers should develop and validate evidence-based educational approaches to enhance self-care in patients with Marfan syndrome, and clinical nurses should strengthen their focused educational activities to improve the self-care management of these patients.
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Síndrome de Marfan , Autocuidado , Humanos , Síndrome de Marfan/psicologia , Síndrome de Marfan/terapia , Estudos Transversais , Itália , Feminino , Masculino , Autocuidado/psicologia , Autocuidado/métodos , Adulto , Pessoa de Meia-Idade , Adulto Jovem , Autoeficácia , IdosoRESUMO
This study explores burnout among nursing students in Bangalore, India, focusing on Exhaustion and Disengagement scores. A cross-sectional design was applied using the Oldenburg Burnout Inventory modified for nursing students, collecting data using a survey that was conducted between October and December 2023. The sample consisted of 237 female nursing students from the Bachelor of Science in Nursing program at Bangalore College of Nursing, South India. The study integrated the t-distributed Stochastic Neighbor Embedding (t-SNE) procedure for data simplification into three t-SNE components, used in a hierarchical clustering analysis, which identified distinct student profiles: "High-Intensity Study Group" and "Altruistic Aspirants". While burnout scores were generally high, students with high study hours ("High-Intensity Study Group") reported greater Exhaustion, with a mean score of 26.78 (SD = 5.26), compared to those in the "Altruistic Aspirants" group, who reported a mean score of 25.00 (SD = 4.48), demonstrating significant differences (p-value = 0.005). Conversely, those motivated by altruism ("Altruistic Aspirants") showed higher Disengagement, with a mean score of 19.78 (SD = 5.08), in contrast to "High-Intensity Study Group", which reported a lower mean of 17.84 (SD = 4.74) (p-value = 0.002). This segmentation suggests that burnout manifests differently depending on the students' academic load and intrinsic motivations. This study underscores the need for targeted interventions that address specific factors characterizing the clusters and provide information for designing future research and interventions. This study was not registered.
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Digital and technological solutions (DTS) in cardiovascular nursing are profoundly transforming the landscape of patient care by integrating advanced data-driven approaches. DTS help to enhance patient outcomes and streamline clinical workflows, supporting the shift of the traditional roles of healthcare providers and patients towards more engaged and collaborative care processes. This article presents a perspective in this regard. The adoption of DTS, including mobile health applications and wearable devices, enables continuous monitoring and management of patient health, fostering significant improvements in cardiovascular health management. However, the rapid incorporation of such technologies presents various challenges, such as robust data standardization, the development of digital literacy among healthcare professionals, and addressing privacy and security concerns. Effective integration of DTS into nursing practice demands structured clinical curricula that equip nurses with essential technological skills and a deep understanding of ethical considerations. Theoretical frameworks should guide the systematic implementation and integration of digital tools, ensuring comprehensive consideration of the complexities involved in digital transformations in healthcare.
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[This corrects the article DOI: 10.2196/51084.].
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OBJECTIVES: This umbrella review aimed to consolidate the evidence base on the impact of high-fidelity simulation on knowledge and performance among undergraduate nursing students. DESIGN: Umbrella review with meta-analyses of pooled effect sizes, followed by an additional meta-analysis of primary studies from the included systematic reviews, excluding overlapping results. DATA SOURCES: Systematic searches were performed up to August 2023 in PubMed, Embase, and Cochrane Library. We included reviews that compared high-fidelity simulation against other learning strategies. REVIEW METHODS: The risk of bias was assessed for each included systematic review (ROBIS tool) and primary study (RoB 2 or ROBINS-I as appropriate). Random-effect meta-analyses of meta-analyses were performed to estimate the pooled effects of high-fidelity simulation on knowledge and performance. Further random-effect meta-analyses of primary studies were conducted, with overlapping studies excluded (12 %). Subgroup analyses were performed to provide a more comprehensive analysis of the findings. Trim-and-fill analyses were conducted to adjust for potential publication bias. RESULTS: Six systematic reviews were included and encompassed 133 primary studies (2767 and 3231 participants concerning performance and knowledge, respectively). The adjusted pooled effects for knowledge (SMD = 0.877, 95 % CI: 0.182 to 1.572) and performance (SMD = 0.738, 95 % CI: 0.466 to 1.010) closely aligned with those obtained from meta-analyzing the primary studies for knowledge (SMD = 0.980) and performance (SMD = 0.540), both showing high statistical heterogeneity. Traditional lectures represented the more common comparison. The subgroup analysis revealed significant differences in effect sizes across geographic locations, topics, types of control, and how interventions were reported. CONCLUSIONS: The results provide robust evidence supporting the integration of high-fidelity simulation into undergraduate nursing programs to enhance students' knowledge and performance. The high reported heterogeneity may be attributed to variations in study contexts or methodologies. Future research should explore the optimal use of high-fidelity simulation in different educational and cultural contexts.
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Competência Clínica , Bacharelado em Enfermagem , Estudantes de Enfermagem , Revisões Sistemáticas como Assunto , Humanos , Estudantes de Enfermagem/estatística & dados numéricos , Estudantes de Enfermagem/psicologia , Bacharelado em Enfermagem/métodos , Competência Clínica/normas , Competência Clínica/estatística & dados numéricos , Treinamento com Simulação de Alta Fidelidade/métodosRESUMO
INTRODUCTION: Given the significance of healthcare decisions in women with BRCA1 and BRCA2 mutations and their impact on patients' lives, this study aims to map the existing literature on decision regret in women with BRCA1 and BRCA2 mutations. METHODS: A scoping review was conducted in the following databases: PubMed, Embase, Scopus, CINAHL, Cochrane, and Google Scholar. Inclusion criteria focused on decision regret in the female population with BRCA1 and/or BRCA2 mutations, with no restrictions on the methodologies of the included studies, but only in the English language. The selection process led to the inclusion of 13 studies. RESULTS: The analysis revealed a significant trend toward decision regret among patients facing complex medical choices. The quality of healthcare communication, decision support, and genetic counselling emerged as key factors influencing patients' perceptions and experiences, with direct implications for their quality of life and psychological well-being. The results suggest that these decisions considerably impact patients, both in terms of clinical outcomes and emotional experiences. DISCUSSION: The investigation highlights the vital importance of a personalized care approach, emphasizing the critical role of managing patients' emotional and psychological complexity. Managing decision regret requires acute attention to individual needs and effective communication to mitigate emotional impact and improve patient outcomes. CONCLUSIONS: Insights from a nursing perspective in the analysis of results indicate the need for informed, empathetic, and integrated care that considers the emotional complexity of women with BRCA1 and/or BRCA2 mutations in their lives and health choices.
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Proteína BRCA1 , Proteína BRCA2 , Neoplasias da Mama , Tomada de Decisões , Emoções , Mutação , Qualidade de Vida , Humanos , Feminino , Proteína BRCA1/genética , Proteína BRCA2/genética , Neoplasias da Mama/genética , Neoplasias da Mama/psicologia , Aconselhamento Genético/psicologia , Aconselhamento Genético/métodos , Genes BRCA1 , Comunicação , Técnicas de Apoio para a Decisão , Genes BRCA2RESUMO
Objectives: To provide an in-depth analysis of noninvasive methods for the early diagnosis of oral premalignant lesions, focusing on novel biomarkers and optical technologies, and to discuss their potential in improving the prognosis of patients with oral oncological diseases. Methods: This state-of-the-art review examines various noninvasive diagnostic techniques, including the utilization of salivary microRNAs and optical technologies such as Raman spectroscopy, elastic scattering spectroscopy, diffuse reflectance spectroscopy, narrow-band imaging, autofluorescence imaging, toluidine blue staining, and microendoscopy. Results: Several noninvasive techniques have shown varying degrees of effectiveness in detecting oral cancer. Autofluorescence imaging exhibited sensitivities up to 100% but had variable specificity. toluidine blue staining reported sensitivity between 77% and 100% for high-risk lesions or cancer, with specificity around 45% to 67%. Spectroscopy techniques achieved 72% to 100% sensitivities and specificities of 75% to 98%. Microendoscopy presented a sensitivity of 84% to 95% and a specificity of 91% to 95%. Conclusion: The review highlights the strengths and limitations of each noninvasive diagnostic method and their recent advancements. Although promising results have been demonstrated, there is a need for further development of reliable strategies for early detection and intervention in oral oncology.
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Background & aims: This phase Ib/II trial evaluated the safety and efficacy of capmatinib in combination with spartalizumab or spartalizumab alone in patients with advanced hepatocellular carcinoma (HCC). Methods: Eligible patients who had progressed or were intolerant to sorafenib received escalating doses of capmatinib 200 mg, 300 mg, and 400 mg twice a day (bid) plus spartalizumab 300 mg every 3 weeks (q3w) in the phase Ib study. Once the recommended phase II dose (RP2D) was determined, the phase II study commenced with randomised 1:1 treatment with either capmatinib + spartalizumab (n = 32) or spartalizumab alone (n = 30). Primary endpoints were safety and tolerability (phase Ib) and investigator-assessed overall response rate per RECIST v1.1 for combination vs. single-agent arms using a Bayesian logistic regression model (phase II). Results: In phase Ib, the RP2D for capmatinib in combination with spartalizumab was determined to be 400 mg bid. Dose-limiting toxicity consisting of grade 3 diarrhoea was reported in one patient at the capmatinib 400 mg bid + spartalizumab 300 mg q3w dose level. The primary endpoint in the phase II study was not met. The observed overall response rate in the capmatinib + spartalizumab arm was 9.4% vs. 10% in the spartalizumab arm. The most common any-grade treatment-related adverse events (TRAEs, ≥20%) were nausea (37.5%), asthenia and vomiting (28.1% each), diarrhoea, pyrexia, and decreased appetite (25.0% each) in the combination arm; TRAEs ≥10% were pruritus (23.3%), and rash (10.0%) in the spartalizumab-alone arm. Conclusion: Capmatinib at 400 mg bid plus spartalizumab 300 mg q3w was established as the RP2D, with manageable toxicities and no significant safety signals, but the combination did not show superior clinical activity compared with spartalizumab single-agent treatment in patients with advanced HCC who had previously been treated with sorafenib. Impact and implications: Simultaneous targeting of MET and programmed cell death protein 1 may provide synergistic clinical benefit in patients with advanced HCC. This is the first trial to report a combination of capmatinib (MET inhibitor) and spartalizumab (programmed cell death protein 1 inhibitor) as second-line treatment after sorafenib for advanced HCC. The combination did not show superior clinical activity compared with spartalizumab single-agent treatment in patients with advanced HCC who had previously been treated with sorafenib. The results indicate that there is a clear need to identify a reliable predictive marker of response for HCC and to identify patients with HCC that would benefit from the combination of checkpoint inhibitor +/- targeted therapy. Clinical trial number: NCT02795429.
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BACKGROUND: The COVID-19 pandemic has sharpened the focus on health care safety and quality, underscoring the importance of using standardized metrics such as the International Classification of Diseases, Tenth Revision (ICD-10). In this regard, the ICD-10 cluster Y62-Y69 serves as a proxy assessment of safety and quality in health care systems, allowing researchers to evaluate medical misadventures. Thus far, extensive research and reports support the need for more attention to safety and quality in health care. The study aims to leverage the pandemic's unique challenges to explore health care safety and quality trends during prepandemic, intrapandemic, and postpandemic phases, using the ICD-10 cluster Y62-Y69 as a key tool for their evaluation. OBJECTIVE: This research aims to perform a comprehensive retrospective analysis of incidence rates associated with ICD-10 cluster Y62-Y69, capturing both linear and nonlinear trends across prepandemic, intrapandemic, and postpandemic phases over an 8-year span. Therefore, it seeks to understand how these trends inform health care safety and quality improvements, policy, and future research. METHODS: This study uses the extensive data available through the TriNetX platform, using an observational, retrospective design and applying curve-fitting analyses and quadratic models to comprehend the relationships between incidence rates over an 8-year span (from 2015 to 2023). These techniques will enable the identification of nuanced trends in the data, facilitating a deeper understanding of the impacts of the COVID-19 pandemic on medical misadventures. The anticipated results aim to outline complex patterns in health care safety and quality during the COVID-19 pandemic, using global real-world data for robust and generalizable conclusions. This study will explore significant shifts in health care practices and outcomes, with a special focus on geographical variations and key clinical conditions in cardiovascular and oncological care, ensuring a comprehensive analysis of the pandemic's impact across different regions and medical fields. RESULTS: This study is currently in the data collection phase, with funding secured in November 2023 through the Ricerca Corrente scheme of the Italian Ministry of Health. Data collection via the TriNetX platform is anticipated to be completed in May 2024, covering an 8-year period from January 2015 to December 2023. This dataset spans pre-pandemic, intra-pandemic, and early post-pandemic phases, enabling a comprehensive analysis of trends in medical misadventures using the ICD-10 cluster Y62-Y69. The final analytics are anticipated to be completed by June 2024. The study's findings aim to provide actionable insights for enhancing healthcare safety and quality, reflecting on the pandemic's transformative impact on global healthcare systems. CONCLUSIONS: This study is anticipated to contribute significantly to health care safety and quality literature. It will provide actionable insights for health care professionals, policy makers, and researchers. It will highlight critical areas for intervention and funding to enhance health care safety and quality globally by examining the incidence rates of medical misadventures before, during, and after the pandemic. In addition, the use of global real-world data enhances the study's strength by providing a practical view of health care safety and quality, paving the way for initiatives that are informed by data and tailored to specific contexts worldwide. This approach ensures the findings are applicable and actionable across different health care settings, contributing significantly to the global understanding and improvement of health care safety and quality. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54838.
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BACKGROUND: Family and community nurses (FCNs) play a crucial role in delivering primary care to patients within their homes and communities. A key aspect of their role involves various health interventions, which are influenced by their unique competencies, such as health promotion, advanced clinical knowledge, and strong interpersonal skills. However, it is essential to understand which specific health outcomes these interventions impact to better understand the relationship between FCNs' skills and the health results. OBJECTIVE: This study aims to outline the steps we will take to develop a set of core outcomes. These outcomes will be particularly sensitive to the health interventions carried out by FCNs, providing a clearer picture of their practice's impact. METHODS: A Delphi survey will be used for this research, conducted from January to December 2024. The process will involve 5 steps and input from 3 stakeholder categories. These stakeholders will help identify a preliminary list of outcomes that will form the basis of our core outcome set (COS). RESULTS: This guideline will be beneficial for a wide range of stakeholders involved in COS development, including COS developers, trialists, systematic reviewers, journal editors, policy makers, and patient groups. As of January 2024, we have successfully completed the first stage of the study, with the stakeholder group approving the reported outcomes and assigning participant lists for each stakeholder group. CONCLUSIONS: This study will provide a roadmap for identifying the key health outcomes influenced by the interventions of FCNs. The multistakeholder, multiphase approach will ensure a comprehensive and inclusive process. Ultimately, the findings will enhance our understanding of FCNs' impact on health outcomes, leading to more effective primary care strategies and policies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51084.
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OBJECTIVES: This study systematically investigates the evidence regarding the use of probiotics in managing cancer-related fatigue (CRF). STUDY DESIGN: We conducted a systematic review of randomized controlled trials. DATA SOURCES: The systematic search encompassed six databases: PubMed, CINHAL, Cochrane Database of Systematic Reviews, Web of Science, Scopus, and EMBASE, covering the period from inception to December 2023. The assessment of risk of bias employed the Cochrane risk of bias tool (RoB 2). A narrative synthesis and an exploratory meta-analysis were conducted to summarize the evidence. RESULTS: Among 460 records, three studies met the eligibility criteria and were included in the review. These studies involved a total of 284 participants with colorectal and breast cancer. One study demonstrated a marginal improvement in CRF postchemotherapy in colorectal cancer patients using probiotics. Another study, also using probiotics, reported a significant reduction in CRF among colorectal cancer patients undergoing chemotherapy. Additionally, a study employing synbiotics showed a substantial decrease in CRF severity in breast cancer patients receiving chemotherapy. CONCLUSION: The study presents initial but varied evidence suggesting the potential of probiotics and synbiotics as adjunctive therapies in managing CRF alongside anticancer treatments. IMPLICATIONS FOR NURSING PRACTICE: In nursing practice, large-scale clinical trials are urgently needed to evaluate the effectiveness of probiotics in treating cancer-related fatigue during cancer therapy. Insights from this review could guide nurses in selecting appropriate probiotic strains and integrating microbiome modifiers into comprehensive care plans, potentially enhancing the quality of life for cancer patients.
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Fadiga , Neoplasias , Probióticos , Humanos , Fadiga/terapia , Fadiga/etiologia , Probióticos/uso terapêutico , Neoplasias/complicações , Feminino , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias da Mama/complicações , Neoplasias Colorretais/complicações , MasculinoRESUMO
BACKGROUND & AIMS: The escalating prevalence of diabetes mellitus may benefit from add-on therapeutic approaches. Given the recognized need for an updated synthesis of the literature, this systematic review and meta-analysis aimed to synthesize and critically assess the available randomized controlled trials (RCTs) that investigate the efficacy of probiotics and synbiotics on glycemic control in patients with Type 1 (T1DM) and Type 2 (T2DM) diabetes mellitus. METHODS: Comprehensive searches were conducted on PubMed, Embase, CINAHL, Scopus, and Web of Science, focusing on adults with T1DM or T2DM. All comparators were deemed eligible. Primary outcomes included changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and insulin levels. Only RCTs were included, and the Cochrane RoB2 tool assessed the risk of bias. Random-effect models facilitated data analysis, supplemented by sensitivity, subgroup analyses, and meta-regressions. RESULTS: A total of 537 records were screened, resulting in 41 RCTs for analysis, which comprises 2991 (54% females) patients with diabetes. The meta-analysis revealed statistically significant improvements in HbA1c (standardized mean difference (SMD) = -0.282, 95% CI: [-0.37, -0.19], p < 0.001), FPG (SMD = -0.175, 95% CI: [-0.26, -0.09], p < 0.001), and insulin levels (SMD = -0.273, 95% CI: [-0.35, -0.20], p < 0.001). A medium degree of heterogeneity between studies was found in HbA1c (I2 = 62.5%), FPG (I2 = 71.5%), and insulin levels (I2 = 66.4%) analyses. Subgroup analyses indicated that the efficacy varied based on the type of strains used and the country. Multispecies strains were particularly effective in improving HbA1c levels. CONCLUSION: The study findings suggest that probiotics and synbiotics may be effective as complementary therapies for managing diabetes. Additionally, the study underscores the need for further tailored research that considers variables such as strain types and geographical factors to deepen the understanding of the role of these interventions in diabetes care. REVIEW REGISTRATION NUMBER: PROSPERO (CRD42023396348).
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Insulinas , Probióticos , Simbióticos , Feminino , Humanos , Masculino , Glicemia/análise , Hemoglobinas Glicadas , Controle Glicêmico , Probióticos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Symptom management remains challenging in cancer care. Emerging from nutritional science, nutritional metabolomics has seen exponential growth over recent years, aiming to discern the relationship between dietary habits and health consequences. This protocol aims to present the rationale and methodology for conducting a scoping review to summarize the extent of evidence on synbiotics utilization in cancer symptom management among adults. The scoping review will be undertaken in accordance with the Joanna Briggs Institute (JBI) principles and the research process guided by the PRISMA 2020 scoping reviews extension. The following electronic databases will be searched from the inception: PubMed, Cinahl, Web of Science and Scopus. The authors expect to map the literature regarding the clinical outcomes, including patient-report measures and patient-experience measures, on which the effects of probiotics were tested, and identify potential gaps. This protocol presents a rigorous methodological approach to map the literature on the clinical outcomes that the utilization of synbiotics might improve. This analysis will shape future researchers to examine the efficacy of probiotics on specific clinical outcomes in oncology care. Nurses are uniquely positioned to influence cancer symptom management through the selection and use of appropriate interventions in the field of nutritional supplements, along with nutritional counseling.
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INTRODUCTION: mHealth apps are the most commonly used applications by women for seeking information and support for breastfeeding. The primary goal of this study is to provide a quality assessment of Italian-language mHealth apps for breastfeeding using the Italian version of the Mobile App Rating Scale (I-MARS). METHODS: A systematic search was conducted on the Apple App Store, Google Play Store, and Windows Store. Inclusion criteria were: mHealth apps available in Italian, free of charge, and focused on the theme of breastfeeding. The quality assessment of the eligible mHealth apps was carried out on the latest available version using the I-MARS, by two authors independently. RESULTS: A total of 381 mHealth apps were identified, of which 38 mHealth apps were included and evaluated (n=9 on Google Play Store, n=29 on Apple App Store). The average total score of the objective dimension of I-MARS was found to be adequate, equal to 3,07±0,75, with a Cohen's Kappa score of 65,8%. The subjective dimension of the I-MARS, however, achieved a low average total score of 2,44±1,03, with a Cohen's Kappa score of 60,5%. In this regard, the subjective dimension of the I-MARS shows lower values compared to the subjective evaluation of the users (3,28±1,95). DISCUSSION: The informational quality dimension of mHealth apps was found to be lacking and/or inadequate in 80% of cases. 53% of the selected mHealth apps presented average quality scores that were adequate. The results of this study thus lay the groundwork for future recommendations for the development and proper use of mHealth apps for the protection, promotion, and support of breastfeeding.
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Aleitamento Materno , Aplicativos Móveis , Telemedicina , Humanos , Aleitamento Materno/métodos , Feminino , ItáliaRESUMO
BACKGROUND: Although the detrimental effects of conventional combustible cigarettes on oral health and dental esthetics are well known, there is limited information about the long-term impact of combustion-free nicotine alternatives (C-F NA) such as e-cigarettes or heated tobacco products. OBJECTIVE: This multicenter, prospective, 3-parallel-arm randomized controlled trial will investigate whether switching from combustible cigarettes to C-F NA will lead to measurable improvements in oral health parameters and dental esthetics over 18 months in adult smokers with limited gum disease. METHODS: Regular smokers not intending to quit and without clinical signs of periodontitis will be randomly assigned (1:4 ratio) to either standard of care with brief cessation advice (control group; arm A) or C-F NA use (intervention group; arm B). The study will also include a reference group of never smokers (reference group; arm C). The primary end point is the change in the Modified Gingival Index (MGI) score from baseline between the control arm (arm A) and the intervention arm (arm B) at the 18-month follow-up. In addition, the study will analyze the within- and between-group (arms A, B, and C) changes in MGI assessment, plaque imaging, dental shade quantitation, tooth stain scores, and oral health-related quality of life questionnaires measured at each study time point. All participants will attend a total of 7 clinic visits: screening, enrollment, and randomization (visit 0); baseline visit-day 14 (visit 1); day 90 (visit 2); day 180 (visit 3); day 360 (visit 4); and day 540 (visit 5). This multicenter study will be conducted in 4 dental clinics in 4 countries. The statistical analysis will involve descriptive statistics for continuous and categorical data. Primary end points will undergo tests for normality and, based on distribution, either a 2-sided t test or Mann-Whitney U test. Linear mixed model with random factors center and study arms by center will also be applied. Secondary end points, including MGI assessment and quality of life, will be subjected to similar tests and comparisons. Only if one value of the parameter MGI is missing after day 1, the last available observation will be carried forward. The analysis will be performed on the substituted data. Secondary parameters will not have missing value replacement. RESULTS: Participant recruitment began in October 2021, and enrollment was completed in June 2023. Results will be reported in 2025. CONCLUSIONS: This will be the first study to provide key insights into oral health benefits or risks associated with using C-F NA in smokers who are seeking alternatives to cigarette smoking. TRIAL REGISTRATION: ClinicalTrials.gov NCT04649645; https://clinicaltrials.gov/ct2/show/NCT04649645. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53222.
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AIM: The primary aim of this scoping review was to explore and categorise the medication-related self-care behaviours exhibited by patients with non-valvular atrial fibrillation (NVAF) who are on oral anticoagulant (OAC) therapy. METHODS AND RESULTS: A scoping review was performed, and the systematic search of the literature yielded an initial 887 records. After deduplication and screening, 61 studies were included in the analysis, ranging from 2003 to 2023. The studies represented a wide geographical distribution and diverse methodologies. The results identified 16 self-care behaviours: a higher focus of the included literature on self-care monitoring (60.65% of studies), followed by self-care management and self-care maintenance (each 16.39%). These behaviours ranged from regular blood testing to consulting healthcare providers and lifestyle changes. The results also highlighted the relationship between treatment satisfaction, self-efficacy, and adherence. Several studies emphasised the critical role of healthcare providers in influencing medication adherence. Furthermore, patient knowledge, quality of life, and psychological factors were identified as key elements affecting self-care behaviours. CONCLUSION: The review provides a comprehensive landscape of medication-related self-care behaviors among NVAF patients on OAC therapy. It underscores the predominance of self-care monitoring behaviours and the critical roles of healthcare providers, psychological factors, and patient knowledge in influencing these behaviours. The findings also highlight the necessity for an integrated, patient-centred approach to improving self-care and self-management in OAC treatment. Future research should focus on addressing the identified gaps, including the relative lack of studies on lifestyle modification, emotional well-being, and technology-assisted interventions. REGISTRATION: This review is part of a broader project and is documented at ClinicalTrials.gov (NCT05820854).
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AIMS: Congenital heart diseases (CHDs) often show a complex 3D anatomy that must be well understood to assess the pathophysiological consequences and to guide therapy. Three-dimensional imaging technologies have the potential to enhance the physician's comprehension of such spatially complex anatomies. Unfortunately, due to the new introduction in clinical practice, there is no evidence on the current applications. We conducted a survey to examine how 3D technologies are currently used among CHD European centres. METHODS: Data were collected using an online self-administered survey via SurveyMonkey. The questionnaire was sent via e-mail and the responses were collected between January and June 2022. RESULTS: Ninety-eight centres correctly completed the survey. Of these, 22 regularly perform 3D rotational angiography, 43 have the availability to print in-silico models, and 22 have the possibility to visualize holographic imaging/virtual reality. The costs were mostly covered by the hospital or the department of financial resources. CONCLUSION: From our survey, it emerges that these technologies are quite spread across Europe, despite not being part of a routine practice. In addition, there are still not enough data supporting the improvement of clinical management for CHD patients. For this reason, further studies are needed to develop clinical recommendations for the use of 3D imaging technologies in medical practice.
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Cardiopatias Congênitas , Humanos , Cardiopatias Congênitas/diagnóstico por imagem , Imageamento Tridimensional , Inquéritos e Questionários , Impressão Tridimensional , Modelos AnatômicosRESUMO
Background: Post-operative infections are a substantial cause of morbidity and mortality worldwide. Polyhexamethylene biguanide (PHMB) is an antimicrobial agent that has been used in various surgical settings to prevent infections. However, the literature on its efficacy in reducing post-operative infections remains unclear. Materials and Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy of PHMB in reducing post-operative infections. The risk of bias and methodologic quality of the included studies were also assessed. Results: The systematic review included nine RCTs, and eight were included in the meta-analysis that showed that the use of PHMB was associated with a reduction in the rate of post-operative infections. The overall effect size was statistically significant, with moderate heterogeneity across the included studies (log Peto's odds ratio [OR], -0.890; 95% confidence interval [CI], -1.411 to -0.369; I2 = 41.89%). However, the diversity in the application of PHMB and the potential influence of other factors, such as adherence to infection prevention protocols and organizational-level variables, underscore the need for further primary studies. Conclusions: Polyhexamethylene biguanide appears to be a promising intervention for reducing post-operative infections. However, more high-quality, well-designed RCTs are needed to confirm these findings and to explore the most effective ways to use PHMB within specific infection prevention bundles. Future research should also aim to control for potential confounding factors to provide a more comprehensive understanding of the efficacy of PHMB in reducing post-operative infections.