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.

Development and validation of the parents' healthcare needs scale for adolescents with congenital heart disease.

PURPOSE: The healthcare needs of parents of adolescents with congenital heart disease (CHD) have been under-investigated as no valid and reliable tools have been developed for assessing their needs. Therefore, this study aims to develop and validate the Parents' Healthcare Needs Scale for adolescents with CHD (PHNS-CHD). DESIGN AND METHODS: A multi-method approach and multi-phase design were employed. Phase one referred to generating scale items based on emerging themes in the literature, and phase two showed the validation process, divided into three steps. Step one tested the content and face validity of the first version of the PHNS-CHD. After that, step two described the initial psychometric validation process of scale using an exploratory factorial analysis (EFA). Then, step three confirmed the PHNS-CHD factorial structure and assessed its internal consistency. RESULTS: The PHNS-CHD showed evidence of face and content validity, adequate construct, and internal consistency and stability. Specifically, it had 22 items grouped into five domains, labeled as follows: Healthcare education to the child; to be supported as a parent, clinical support to the child, the continuum of care to the child; emotional support to the child. CONCLUSIONS: The PHNS-CHD is a psychometrically robust measure for assessing the healthcare needs of parents of adolescents with CHD. PRACTICE IMPLICATIONS: The PHNS-CHD might help clinicians, especially pediatric nurses, assess the healthcare needs of parents of adolescents with CHD and design adequate care plans for the whole family.

Repeatability of dental plaque quantitation by light induced fluorescence technology in current, former, and never smokers.

BACKGROUND: The effects of smoking on the accumulation of dental plaque have not been studied in depth. We compared dental plaque quantitation obtained with a novel light induced fluorescence technology among current, former, and never smokers and verified measurements' repeatability. METHODS: Dental plaque quantitation was objectively assessed by quantitative light induced fluorescence (QLF) technology on three separate study visits in current, former, and never smokers: baseline (day 0), day 7, day 30. Increase in the fluorescence intensity of at least 30% (ΔR30) and 120% (ΔR120) together with the simple oral hygiene (SOH) scoring were considered for analysis. RESULTS: The QLF parameters were highly repeatable in each study group (p < 0.0001, by regression analyses). All QLF parameters showed a significant difference between never smokers and current smokers (p = 0.041 for ΔR30; p = 0.027 for ΔR120; p = 0.04 for SOH). No significant differences were observed between never and former smokers and between current and former smokers except for ΔR120 (p = 0.033). CONCLUSION: Dental plaque measurements by QLF technology were highly reproducible and showed greater plaque formation among current smokers compared to non-smokers. Objective and reproducible quantitation of dental plaque can be a valuable clinical and regulatory science endpoint to investigate the effect of smoking cessation medications, combustion-free tobacco products, and consumer care products on oral health. CLINICAL RELEVANCE: There is a need to objectively evaluate the relationship between smoking and plaque build-up as well as maturation. Current smokers demonstrated greater and more mature plaque buildup when compared to never and former smokers. Differences in plaque build-up and maturation between current, former and non-smokers may be utilized as an effective tool for patient motivation, identifying therapeutic end-points, translational research as well as prognostication. TRIAL REGISTRATION: The study is a pilot study parts of a larger project with registration ID: NCT04649645. As preliminary study, the pilot study referred into this paper started before the larger study registered in ClinicalTrials.gov.

Repeatability of dental shade by digital spectrophotometry in current, former, and never smokers.

Cigarette smoking contributes to poor oral health and dental discoloration. Therefore, stopping smoking may translate into measurable amelioration of dental shade indices. We compared dental shade parameters by digital spectrophotometry among current, former, and never smokers and verified their repeatability at 7 and 30 days. Dental shade parameters (CIE L*a*b* and corresponding whiteness index for dentistry-WID) were measured in current, former, and never smokers with a digital spectrophotometer (Vita Easyshade V) on three separate study visits: at baseline (day 0), at day 7, and day 30. Dental shade parameters were analyzed in 18 current, 18 former, and 20 never smokers. The repeatability of shade parameters was consistent in current, former, and never smokers. L*, a*, b*, and WID show significant short and long-term repeatability (p < 0.0001, by regression analyses). The mean (± SD) WID score of 13.42 (± 4.9) in current smokers was significantly lower compared to the WID score of 20.38 (± 5.3) in never smokers (p = 0.001). No significant differences were observed between current and former smokers and between former smokers and former smokers. Dental shade measurements by digital spectrophotometry were highly reproducible and showed that teeth whiteness of current smokers is substantially inferior compared to never smokers. Objective discrimination of dental shade can be a valuable regulatory science endpoint for investigating oral hygiene and dental aesthetics of consumer care products, smoking cessation medications, and tar-free tobacco products (e-cigarettes, heated tobacco products, oral nicotine products) for cigarette substitution.Clinical trial registration: the study was not registered in ClinicalTrials.gov considering that it is a pilot study, parts of a larger project with ID: NCT04649645.

Mapping the literature on Digital and Technological Solutions in nursing: a scoping review protocol. / Mappatura della letteratura sulle soluzioni digitali e tecnologiche nell'assistenza infermieristica: un protocollo di scoping review.

INTRODUCTION: Digital and technological solutions (DTS) might have an impact on people's personal and professional lives. These types of solutions, according to studies, have the potential to revolutionize and improve the quality and long-term sustainability of healthcare activities, with nurses playing a significant role. Although DTS appears to be intimately linked to the future of nursing, technology must be utilized as an active rather than passive tool. Nonetheless, understanding DTS appears to be difficult, and a scoping study can provide a thorough overview of such a complicated topic. As a result, the scoping study on this topic will map all of the important aspects of DTS and synthesize studies on the nursing workforce, as well as analyze and clarify knowledge gaps and aid future research and development. This article presents the study protocol. METHODS: The Joanna Briggs Institute (JBI) scoping review methodology will be used for the proposed scoping review. It will include both quantitative and qualitative scientific research as well as grey literature on DTS in nursing. Only English-language works will be considered for inclusion. Two independent reviewers will take part in an iterative process of evaluating literature, choosing papers, and extracting data. Disagreements among reviewers will be resolved through debate until a consensus is reached or through consultation with the study team if necessary. Results will be presented using descriptive statistics, diagrammatic or tabular displayed information, and narrative summaries, as specified in the JBI guidelines. DISCUSSION: This scoping review protocol explained why it is important to describe the literature on embracing DTS in the nursing field, how to approach the research process, and what the study's key implications will be. The protocol itself may be helpful to increase transparency in the research process, attract interested researchers to work with the group that developed the protocol and offer a practical methodological benchmark for researchers interested in performing scoping reviews by serving as an example of a scoping review protocol.

Telomerase-based GX301 cancer vaccine in patients with metastatic castration-resistant prostate cancer: a randomized phase II trial.

Debate is around the optimal immunization regimen for cancer vaccines since too intense vaccination schedules may exhaust reactive lymphocytes. GX301 is a telomerase-based cancer vaccine whose safety and immunological effects were tested in a phase I trial applying an eight administrations schedule. Main objective of this study was to comparatively analyse safety and immunological response to three GX301 regimens in metastatic castration-resistant prostate cancer patients with response/disease stability after docetaxel chemotherapy. This was a multicentre, randomized, parallel-group, open-label trial registered with EudraCT (2014-000095-26) and ClinicalTrials.gov (NCT02293707, 2014). Ninety-eight patients were randomized to receive either eight (regimen 1), four (regimen 2) or two (regimen 3) vaccine administrations. Sixty-three patients were assessable for the primary immunological end-point. Vaccine-specific immune responses were evaluated by intracellular staining for IFN, elispot and cytotoxic assay at 90 and 180 days from baseline. No major side effects were recorded. A 54% overall immune responder rate was observed with 95% of patients showing at least one vaccine-specific immune response. Rate of immunological responders and number of immunizations were proportionally related, suggesting superiority of regimens 1 and 2 over regimen 3. Overall survival did not differ among regimens in both immunological responders and non-responders and was inversely associated (P = 0.002) with increase in the number of circulating CD8 + T regulatory cells at 180 days. These data indicate that GX301 cancer vaccine is safe and immunogenic in metastatic castration-resistant prostate cancer patients. Schedules with high number of administrations should be preferred in future studies due to their better immunological outcome.

Nursing self-efficacy for oral anticoagulant therapy management: Development and initial validation of a theory-grounded scale.

AIM: This study aimed to develop and validate a nursing self-efficacy scale for OAC management (SE-OAM). BACKGROUND: Oral anticoagulant therapy (OAC) requires specific nursing competencies. Given that self-efficacy acts as a proxy assessment of nursing competence, its measurement is pivotal for addressing educational programs to enhance nursing competence in managing OAC. Thus far, the measurement of self-efficacy in OAC is undermined by the unavailability of valid and reliable tools. METHODS: A multi-method and multi-phase design was adopted: Phase one was a methodological study encompassing developmental tasks for generating items. Phase two comprised the validation process for determining the content validity, construct and concurrent validity, and internal consistency through two cross-sectional data collections. RESULTS: In total, 190 nurses were enrolled for determining the psychometric structure of the SE-OAM through an exploratory approach, and 345 nurses were subsequently enrolled to corroborate its most plausible factor structure derived from the exploratory analysis. The SE-OAM showed evidence of face and content validity, adequate construct, concurrent validity, good internal consistency, and stability. The final version of the scale encompassed 21 items kept by five domains: clinical management, care management, education, clinical monitoring, and care monitoring. CONCLUSIONS: The SE-OAM showed evidence of initial validity and reliability, fulfilling a current gap in the availability of tools for measuring nursing self-efficacy in managing OAC. SE-OAM could be strategic for performing research to improve the quality of OAC management by enhancing nursing self-efficacy.

Renal Function Assessment Gap in Clinical Practice: An Awkward Truth.

INTRODUCTION: An accurate assessment of renal function is needed in the majority of clinical settings. Unfortunately, the most used estimated glomerular filtration rate (eGFR) formulas are affected by significant errors in comparison to gold standards methods of measured GFR (mGFR). OBJECTIVE: The objective of the study is to determine the extent of the error of eGFR formulas compared to the mGFR in different specific clinical settings. METHODS: A total retrospectively consecutive cohort of 1,320 patients (pts) enrolled in 2 different European Hospitals (Center 1: 470 pts; Center 2: 850 pts) was collected in order to compare the most common eGFR formulas used by physicians with the most widespread mGFR methods in daily clinical practice (Iohexol Plasma Clearance -Center 1 [mGFR-iox] and Renal Scintigraphy -Center 2 [mGFR-scnt]). The study cohort was composed by urological, oncological, and nephrological pts. The agreement between eGFR and mGFR was evaluated using bias (as median of difference), precision (as interquartile range of difference) accuracy (as P30), and total deviation index. RESULTS: The most accurate eGFR formula in the comparison with gold standard method (Iohexol plasma clearance) in Center 1 was represented by s-creatinine and cystatin C combined Chronic Kidney Disease-Epidemiology Collaboration-cr-cy, even though the P30 is reduced (84%) under the threshold of 60 mL/min/1.73 m2. Similar results were found in Center 2, with a wider discrepancy between mGFR-scnt and eGFR formulas due to the minor accuracy of the nuclear tool in respect to the mGFR-iox. CONCLUSIONS: The loss of accuracy observed for the formulas at lower values of GFR suggests the mandatory use of gold standards methods as Iohexol Plasma Clearance to assess the correct status of renal function for critical cases. The center 2 showed lower levels of agreement between mGFR and eGFR suggesting that the errors are partially accounted for the Renal Scintigraphy technique too. In particular, we suggest the use of mGFR-iox in oncological urological and nephrological pts with an eGFR lower than 60 mL/min/1.73 m2.

A multi-phase study for the development of a self-efficacy measuring scale for ostomy care nursing management.

AIM: To develop and psychometrically test a self-efficacy scale for ostomy care nursing management. DESIGN: This study adopted a multi-method and multi-phase design. METHOD: Phase 1 of the study was comprised of the developmental tasks, where items were generated based on the emergent themes from literature. The items were then discussed with a panel of experts. Phase 2 focused on the validation process of the scale, where its content validity, construct and concurrent validity, and its internal consistency were assessed. The validation process was conducted between January 2018 - January 2019. RESULTS: The final version of the self-efficacy scale in ostomy care nursing management encompasses 24 items in three domains, namely the clinical assessment domain, the education and relationship domain, and the teamwork domain. The scale showed the evidence of face and content validity, adequate construct and concurrent validity, and adequate internal consistency. CONCLUSION: The developed scale can be used in clinical and educational research. IMPACT: This study presents the development and validation of the first valid and reliable self-reporting measurement for nurses' self-efficacy in ostomy care nursing management. Self-efficacy ostomy care nursing management encompasses 24 items and three domains, which are clinical assessment, education and relationship, and teamwork. This research will have an impact on nursing education, as it addresses the need for a specific self-efficacy assessment of ostomy care nursing management. Self-efficacy ostomy care nursing management will have an impact on nurses and patients, as it can be used to improve nurses' self-efficacy and clinical outcomes for patients in ostomy care.

Root fillings with a matched-taper single cone and two calcium silicate-based sealers: an analysis of voids using micro-computed tomography.

OBJECTIVES: To compare the percentage of voids in matched-taper single-cone fillings with GuttaFlow Bioseal or BioRoot RCS root canal sealers, using micro-computed tomography. MATERIALS AND METHODS: Forty-eight single-rooted mandibular premolars were prepared using rotary files and randomly allocated into 2 groups (n = 24), wherein the canals were filled with a matched-taper single gutta-percha cone and one of the two sealers: Group 1, GuttaFlow Bioseal and Group 2, BioRoot RCS. The specimens were scanned with micro-CT before and after root canal filling. A specialized software was used to calculate the voids volume percentage (V%) in the filling for the whole root canal, root canal thirds, and the last millimeter from the apex. Data were statistically analyzed by ANOVA and Tukey tests (p < 0.05). RESULTS: Root canals filled with GuttaFlow Bioseal had significantly less V% than those filled with BioRoot RCS in all the root-thirds (p < 0.05) except at the apical 1 mm (p > 0.05). Comparing the root-thirds, GuttaFlow Bioseal showed similar V% in all regions (p > 0.05), while BioRoot RCS group had significantly greater V% in the coronal third compared with the other thirds (p < 0.05). CONCLUSIONS: Root canals filled with a matched-taper single cone and GuttaFlow Bioseal had significant less voids than those with BioRoot RCS, except at the apical 1 mm. CLINICAL RELEVANCE: Voids in root fillings have been reported to have a negative impact on root canal treatment. This study highlights the percentage of voids in root fillings composed of a single cone of gutta-percha with two types of calcium silicate-based bioceramic sealers.

The Byzantine Role of Big Data Application in Nursing Science: A Systematic Review.

Big data have the potential to determine enhanced decision-making process and to personalize the approach of delivering care when applied in nursing science. So far, the literature on this topic is still not synthesized for the period between 2014 and 2018. Thus, this systematic review aimed to identify and synthesize the most recent evidence on big data application in nursing research. The systematic search was undertaken for the evidence published from January 2014 to May 2018, and the outputs were formatted using the PRISMA Flow Diagram, whereas the quality appraisal was addressed by recommendations consistent with the Critical Appraisal Skills Program. Twelve studies on big data in nursing were included and divided into two themes: the majority of the studies aimed to determine prediction assessment, while only four studies were related to the impact of big data applications to support clinical practice. This review tracks the recent state of knowledge on big data applications in nursing science, revealing the potential for nursing engagement in big data science, even if currently limited to some fields. Big data applications in nursing might have a tremendous potential impact, but are currently underused in research and clinical practice.

Development and validation of the pressure ulcer management self-efficacy scale for nurses.

BACKGROUND: Pressure ulcers (PUs) represent a current issue for healthcare delivery. Nurse self-efficacy in managing PUs could predict patients' outcome, being a proxy assessment of their overall competency to managing PUs. However, a valid and reliable scale of this task-specific self-efficacy has not yet been developed. OBJECTIVES: To develop a valid and reliable scale to assess nurses' self-efficacy in managing PUs, that is, the pressure ulcer management self-efficacy scale for nurses (PUM-SES). METHODS: This study had a multi-method and multi-phase design, where study reporting was supported by the STROBE checklist (File S1). Phase 1 referred to the scale development, consisting in the items' generation, mainly based on themes emerged from the literature and discussed within a panel of experts. Phase 2 focused on a three-step validation process: the first step aimed to assess face and content validity of the pool of items previously generated (initial version of the PUM-SES); the second aimed to assess psychometrics properties through exploratory factorial analysis; the third step assessed construct validity through confirmative factorial analysis, while concurrent validity was evaluated describing the relationships between PUM-SES and an established general self-efficacy measurement. Reliability was assessed through the evaluation of stability and internal consistency. RESULTS: PUM-SES showed evidence of face and content validity, adequate construct and concurrent validity, internal consistency and stability. Specifically, PUM-SES had four domains, labelled as follows: assessment, planning, supervision and decision-making. These domains were predicted by the same second-order factor, labelled as PU management self-efficacy. CONCLUSION: PUM-SES is a 10-item scale to measure nurses' self-efficacy in PU management. A standardised 0-100 scoring is suggested for computing each domain and the overall scale. PUM-SES might be used in clinical and educational research. RELEVANCE TO CLINICAL PRACTICE: Optimising nurses' self-efficacy in PU management might enhance clinical assessment, determining better outcomes in patients with PUs.

'Nosce te ipsum': An Italian national survey to explore choice's differences in End of Life (EoL) care between healthcare professionals and general public.

BACKGROUND: The current debate regarding decision-making at the End-of-Life (EoL) is increasing remarkably and has spread all over the world. However, literature has paid little attention to describe choice's differences in EoL care between healthcare professionals and general public. OBJECTIVES: The aim of this study was to explore the difference between choices in EoL care made by healthcare professionals and those of the general public within the Italian context. SETTING AND PARTICIPANTS: In 2017, an Italian widespread survey was conducted using a snowball sampling. A total of 2038 participants completed the survey, 55.64% of which were the general public. RESULTS: The main differences related to specific EoL choices made by healthcare professionals and the general public. In particular, healthcare professionals were more likely to avoid cardiopulmonary resuscitation and mechanical forms of breathing in terminal-stage conditions, and they were also more likely to be favorable towards the use of opioids to avoid suffering. Overall, healthcare professionals were also more likely to make a choice rather than express a 'not sure' answer. CONCLUSION: The higher percentage of participants in the general public group that chose 'not sure' highlighted the importance of addressing and enhancing people's self-awareness. More cross-national investigation should help to frame the understanding of the choice's differences in EoL care between healthcare professionals and general public.

Individual-level determinants of interprofessional team collaboration in healthcare.

Interprofessional team collaboration (ITC) is pivotal for the safety and the quality of healthcare settings, being associated with higher staff and patient satisfaction. However, individual-level determinants (i.e. socio-demographic and working satisfaction) remain currently largely unexplored. This study aimed to describe the overall ITC (i.e. partnership, cooperation, coordination), identifying the individual-level determinants of each ITC domain. This study had a multicentre approach, using cross-sectional data collection. ITC was assessed using the Interprofessional Team Collaboration Scale II, Italian version (I-AITCS II). The determinants of ITC were investigated through multivariable linear regression models. The study results showed significant associations between the same ITC domains, as well as the important role of work satisfaction in determining cooperation and coordination. Physicians reported more inadequate partnership levels than other healthcare professionals. This study provides insights for future research and gives a useful description of the determinants of ITC for multi-stakeholder healthcare organizations.

Ostomy Adjustment Inventory-23 (OAI-23): Development and Testing of the Italian Version.

PURPOSE: The purpose of this study was to evaluate the validity and reliability of the Italian version of the Ostomy Adjustment Inventory-23 (OAI-23). DESIGN: This is a methodological study evaluated psychometric properties of the OAI-23. SUBJECTS AND SETTING: A sample of 230 patients with an ostomy was enrolled in an Italian university hospital from May to September 2017. METHODS: This study comprised two phases; during phase 1, the cultural-linguistic translation of the OAI-23 into Italian was completed. In addition, content and face validity were tested. In phase 2, psychometric testing of the OAI-23 was conducted in a cross-section sample of 258 Italian patients with a fecal ostomy. RESULTS: The Italian version of the OAI-23 presents 23 items giving a 3-dimensional structure: acceptance, negative feelings, and social engagement. Accordingly, this 3-dimensional structure arise from an exploratory factorial analysis with the maximum likelihood robust estimator (RMSEA = 0.089 [95% CI = 0.063-0.113; P = .05], and CFI = 0.901, explaining 44% of the total variance). The internal consistency of the OAI-23 was good (Cronbach α for acceptance = 0.91; for negative feelings = 0.87; for social engagement = 0.93; for overall scale = 0.91). CONCLUSIONS: The OAI-23 provides a valid and reliable assessment of patients' psychosocial adjustment to an ostomy. It provides important resource for clinical decision-making; for example, it may be used to design or tailor educational strategies to enhance psychosocial adjustment following creation of an ostomy.

Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma: an Italian multicenter study (MOVIE-GOIRC 01-2014).

BACKGROUND: Vinflunine is the only chemotherapeutic agent shown to improve survival in platinum-refractory patients with metastatic transitional cell carcinoma of the urothelium (TCCU) in a phase III clinical trial, which led to product registration for this indication in Europe. The aim of this study was to assess the efficacy of vinflunine and to evaluate the prognostic significance of risk factors in a large, unselected cohort of patients with metastatic TCCU treated according to routine clinical practice. METHODS: This was a retrospective multicenter study. Italian cancer centers were selected if, according to the Registry of the Italian Medicines Agency (AIFA), at least four patients had been treated with vinflunine between February 2011 and June 2014, after first- or second-line platinum-based chemotherapy. The primary objective was to test whether the efficacy measured by overall survival (OS) in the registration study could be confirmed in routine clinical practice. Multivariate analysis was carried out using Cox proportional hazard model. RESULTS: A total of 217 patients were treated in 28 Italian centers. Median age was 69 years (IQR 62-76) and 84% were male; Eastern Cooperative Oncology Group performance status (ECOG PS) was ≥ 1 in 53% of patients. The median number of cycles was 4 (IQR 2-6); 29%, 35%, and 36% received an initial dose of 320 mg/m2, 280 mg/m2 or a lower dose, respectively. Median progression-free survival (PFS) and OS for the entire population was 3.2 months (2.6-3.7) and 8.1 months (6.3-8.9). A complete response was observed in six patients, partial response in 21, stable disease in 60, progressive disease in 108, with a disease control rate of 40%. Multivariate analysis showed that ECOG PS, number of metastatic sites and liver involvement were unfavorable prognostic factors for OS. Toxicity was mild, and grade 3-4 adverse effects were mainly: neutropenia (9%), anemia (6%), asthenia/fatigue (7%) and constipation (5%). CONCLUSIONS: In routine clinical practice the results obtained with VFL seem to be better than the results of the registration trial and reinforce evidence supporting its use after failure of a platinum-based chemotherapy.

Phase I clinical and pharmacokinetic study of ombrabulin (AVE8062) combined with cisplatin/docetaxel or carboplatin/paclitaxel in patients with advanced solid tumors.

PURPOSE: Preclinical evidence supports synergy between the vascular disrupting agent ombrabulin and various chemotherapy agents. Ombrabulin was combined with two standard taxane/platinum doublets in a phase I study to determine the recommended combination doses. METHODS: Ombrabulin (30-min infusion, day 1 every 3 weeks) was escalated from 15.5 to 35 mg/m(2) with two chemotherapy doublets; OCD, 75 mg/m(2) cisplatin (C), day 1 (cohort 1) or day 2 (cohort 2) with 60/75 mg/m(2) docetaxel (D), day 2; and OCP, AUC5/6 carboplatin (C) and paclitaxel (P) 175 mg/m(2) (cohort 3) or 200 mg/m(2) (cohort 4), day 2. Safety, pharmacokinetics, and tumor response were evaluated. RESULTS: Sixty-nine patients were treated (32 OCD, 37 OCP). Four had DLTs in cycle 1, two in cohort 1 (grade 4 febrile neutropenia, grade 4 pulmonary embolism) and one each in cohorts 2 (grade 3 ALT elevation) and 4 (grade 3 peripheral ischemia). Ombrabulin escalation in cohorts 2, 3 and 4 was halted at the highest planned dose (35 mg/m(2)). Asthenia, nausea, paresthesia, alopecia, vomiting, and stomatitis were common, as was grade 3-4 neutropenia. Ombrabulin clearance was high with a short terminal half-life and a medium volume of distribution. Pharmacokinetic analysis showed no clinically relevant drug interactions between the taxane-platinum doublet and ombrabulin or its active metabolite RPR258063, however docetaxel and carboplatin pharmacokinetics were slightly altered. One complete and 15 partial responses (10 OCD, 5 OCP; median duration 5.5 and 4.4 months, respectively) were reported. CONCLUSIONS: The addition of ombrabulin to standard doses of cisplatin/docetaxel or carboplatin/paclitaxel proved feasible with manageable overlapping toxicities but appears to have limited impact on the efficacy of these doublets. Recommended combination doses are 35 mg/m(2) ombrabulin with 75 mg/m(2) cisplatin/75 mg/m(2) docetaxel or 200 mg/m(2) paclitaxel/AUC6 carboplatin, every 3 weeks.

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.

Description of self-care behaviours in patients with non-valvular atrial fibrillation on oral anticoagulant therapy: A scoping review.

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).

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.