Shaping the future research agenda of Cancer Nursing in Italy: Insights and strategic directions.

This report analyzes the evolution of cancer nursing research in Italy, focusing on 207 publications from nursing journals indexed in MEDLINE. Using Latent Dirichlet Allocation, we identified four primary research topics from the included abstracts: Patient-Centered Care, Clinical Nursing Practice, Healthcare Institutions and Systems, and Research and Data Analysis. The temporal trends reveal a shift from foundational studies on healthcare systems in the late 1990s to more recent emphases on patient-centered care and clinical practice. This progression underscores the growing importance of personalized healthcare approaches. Our findings highlight the need for continued investment in innovative nursing interventions and advanced technologies, such as telehealth, to enhance patient outcomes. Research priorities need to investigate how to tailor nursing interventions to individual patient characteristics, such as their cultural background, lifestyle, and personal values, in the area of clinical nursing practice, which is less represented in the literature thus far. The limited publications regarding clinical nursing practice in the Italian context might reflect the need to strengthen cancer nursing as a specialization in Italy to trigger research and practice that address unmet patient needs. The current analysis provides a foundation for future comprehensive studies and strategic development of a research agenda for cancer nursing research in Italy, led by the Italian Association of Cancer Nursing.

Anatomical variations of origin of the internal carotid artery: Report of two cases and systematic review of the literature.

BACKGROUND: Anatomical variations of origin of the internal carotid artery (ICA) are very uncommon and may pose a diagnostic and therapeutic challenge. OBJECTIVE: We report a case of direct origin of the right ICA from the innominate artery (aplasia of common carotid artery) and a case of duplication of right ICA in healthy patients who performed duplex ultrasound (DUS) for primary cardiovascular prevention screening. METHODS: In both cases, the ultrasound scan was performed both in a transverse plane and on the longitudinal axis, and in one of the two cases, a computed tomography angiography was performed to confirm the diagnosis. A review of the current literature about anatomical variations of origin of carotid arteries was also performed. RESULTS: The most frequent congenital anomaly is represented by the aplasia of the CCA, followed by the agenesis and by the duplication of the ICA. In most cases, the anomaly is discovered occasionally and symptoms are aspecific. Diagnosis is usually confirmed through a multimodality imaging approach, including DUS of extracranial carotid arteries, magnetic resonance imaging (MRI), and computed tomographic angiography. In most cases, treatment was conservative, with pharmacological therapy aimed at the symptoms. CONCLUSION: The recognition of such variations is mandatory, particularly when the patient needs a surgical treatment that may involve the vessel with the anatomical variations.

Decision Regret and Vaccine Hesitancy among Nursing Students and Registered Nurses in Italy: Insights from Structural Equation Modeling.

This study focused on vaccine hesitancy and decision regret about the COVID-19 vaccine among nursing students (BScN and MScN) and Registered Nurses (RNs) in Italy. The primary aim was to describe decision regret and vaccine hesitancy among these groups and to understand what influences vaccine hesitancy. Data were collected through an e-survey conducted from March to June 2024. The Decision Regret Scale and the Adult Vaccine Hesitancy Scale were employed to assess regret and hesitancy levels, assessing trust, concerns, and compliance regarding vaccination. Among the participants, 8.64% were not vaccinated. The results indicated moderate to high levels of decision regret and diverse levels of trust, concerns, and compliance with COVID-19 vaccination. Structural equation modeling revealed that decision regret significantly predicted Trust (R2 = 31.3%) and Concerns (R2 = 26.9%), with lower regret associated with higher trust and lower concerns about vaccine safety. The number of COVID-19 vaccine boosters was a significant predictor of Trust and Concerns, with more boosters associated with higher trust and lower concerns. MScN students exhibited higher Compliance compared to RNs (R2 = 2.9%), highlighting the role of advanced education. These findings suggest that addressing decision regret and providing comprehensive vaccine information could enhance trust and compliance.

Reliability and validity of the Italian Version of the Chase Nurse Manager Competencies Scale.

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.

The Public's Perception of Florence Nightingale's Legacy in the Digital Media: A Critical Discourse Analysis.

This study critically examines the public's perception of Florence Nightingale's legacy through a critical discourse analysis (CDA) of digital media, specifically podcasts and YouTube. Nightingale, who is often remembered as "The Lady with the Lamp", holds a complex identity within modern narratives that is celebrated for her pioneering contributions to nursing and public health, even if there are some disagreements about her, given the colonialist setting that may have shaped some of her opinions and decisions. This research employed CDA to analyze 25 podcasts and 18 YouTube videos, which were systematically included according to a priori inclusion criteria. The study synthesized how these media products portray Nightingale and, by extension, shape public discourse about the nursing profession. The findings reveal five thematic representations of Nightingale: as a legendary figure, a modern feminist, a dedicated statistician, a pioneer in public health, and a pivotal STEM contributor. These portrayals challenge traditional nursing stereotypes by emphasizing Nightingale's role as a rigorous scientist and reformer, suggesting broader perceptions of nurses that encompass leadership, analytical skills, and strategic thinking. The study supports the hypothesis that digital narratives significantly influence the public's understanding and appreciation of nursing, advocating for a more nuanced professional identity that integrates traditional caregiving roles with critical and analytical capabilities.

Self-care behaviors and their individual-level determinants in Italian adults with Marfan syndrome: A single-center cross-sectional study.

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.

Exploring Burnout among Nursing Students in Bangalore: A t-Distributed Stochastic Neighbor Embedding Analysis and Hierarchical Clustering in Cross-Sectional Data.

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.

Correction: Development of a Core Outcome Set for Family and Community Nursing: Protocol for a Delphi Study.

[This corrects the article DOI: 10.2196/51084.].

Digital and technological solutions in cardiovascular nursing and perspectives for a smooth digital shift: A discussion paper.

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.

Past, Present, and Future Diagnostic Methods for the Early Noninvasive Detection of Oral Premalignant Lesions: A State of the Art and Systematic Review.

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.

[BRCA mutations and decision regret: a comprehensive analysis of existing research through a scoping review and reflections from a nursing perspective.] / Mutazioni BRCA e rimpianto decisionale: un'analisi approfondita della ricerca esistente tramite scoping review e riflessioni da una prospettiva infermieristica.

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.

The efficacy of high-fidelity simulation on knowledge and performance in undergraduate nursing students: An umbrella review of systematic reviews and meta-analysis.

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.

Global Trends of Medical Misadventures Using International Classification of Diseases, Tenth Revision Cluster Y62-Y69 Comparing Pre-, Intra-, and Post-COVID-19 Pandemic Phases: Protocol for a Retrospective Analysis Using the TriNetX Platform.

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.

A phase Ib/II trial of capmatinib plus spartalizumab vs. spartalizumab alone in patients with pretreated hepatocellular carcinoma.

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.

Synbiotics in Oncology: A Scoping Review Protocol on Their Impact and Outcomes in Cancer Care.

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.

Microbiome-Modifiers for Cancer-Related Fatigue Management: A Systematic Review.

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.

Development of a Core Outcome Set for Family and Community Nursing: Protocol for a Delphi Study.

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.

Probiotics and synbiotics for glycemic control in diabetes: A systematic review and meta-analysis of randomized controlled trials.

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).

Changes in Oral Health and Dental Esthetic in Smokers Switching to Combustion-Free Nicotine Alternatives: Protocol for a Multicenter and Prospective Randomized Controlled Trial.

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.