Prospective study on nanoparticle albumin-bound paclitaxel in advanced breast cancer. Clinical results and biological observations in taxane-pretreated patients

Background: There is a deep need to improve the care of metastatic breast cancer (MBC) patients, since even today it remains an incurable disease. Taxanes are considered the most effective cytotoxic drugs for the treatment of MBC, both in monotherapy and in combined schedules, but the need for synthetic solvents contributes to the severe toxicities and may have a negative impact on the efficacy. Nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a colloidal suspension of paclitaxel and human serum albumin initially developed to avoid the toxicities associated with conventional taxanes. Patients and methods: The aim of this prospective, single-center open-label, noncomparative study was to evaluate the efficacy and safety of nab-paclitaxel in MBC patients pretreated with taxanes. The patients were treated with nab-paclitaxel as a single agent, 260 mg/m2 on day 1 of each 3-week cycle or 125 mg/m2 weekly. The primary endpoint was the overall response rate (ORR). Secondary objectives were duration of response, clinical benefit rate, progression-free survival (PFS), overall survival, and safety. Results: A total of 42 patients (median age 48 years, median Eastern Cooperative Oncology Group performance status 0, triple-negative MBC 19%, all pretreated with a taxane-based therapy, mainly in advanced disease) were enrolled in the study. The ORR was 23.8%, including one complete response (2.4%) and nine partial responses (21.4%); the disease control rate was 50%. The median duration of response was 7.2 months. After a median follow-up of 9 months, the median PFS was 4.6 months. ORR and PFS were similar irrespective of the previous chemotherapy lines, metastatic sites, and biomolecular expression. Nab-paclitaxel was well tolerated, and the most frequent treatment-related toxicities were mild to moderate (grades 1–2). Conclusion: This real-life study shows that nab-paclitaxel has a significant antitumor activity and a manageable safety profile in patients pretreated with taxanes and experiencing a treatment failure after at least one line of chemotherapy

Towards a New System for the Assessment of the Quality in Care Pathways: An Overview of Systematic Reviews

Clinical or care pathways are developed by a multidisciplinary team of healthcare practitioners, based on clinical evidence, and standardized processes. The evaluation of their framework/content quality is unclear. The aim of this study was to describe which tools and domains are able to critically evaluate the quality of clinical/care pathways. An overview of systematic reviews was conducted, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, using Medline, Embase, Science Citation Index, PsychInfo, CINAHL, and Cochrane Library, from 2015 to 2020, and with snowballing methods. The quality of the reviews was assessed with Assessment the Methodology of Systematic Review (AMSTAR-2) and categorized with The Leuven Clinical Pathway Compass for the definition of the five domains: processes, service, clinical, team, and financial. We found nine reviews. Three achieved a high level of quality with AMSTAR-2. The areas classified according to The Leuven Clinical Pathway Compass were: 9.7% team multidisciplinary involvement, 13.2% clinical (morbidity/mortality), 44.3% process (continuity-clinical integration, transitional), 5.6% financial (length of stay), and 27.0% service (patient-/family-centered care). Overall, none of the 300 instruments retrieved could be considered a gold standard mainly because they did not cover all the critical pathway domains outlined by Leuven and Health Technology Assessment. This overview shows important insights for the definition of a multiprinciple framework of core domains for assessing the quality of pathways. The core domains should consider general critical aspects common to all pathways, but it is necessary to define specific domains for specific diseases, fast pathways, and adapting the tool to the cultural and organizational characteristics of the health system of each country

Face Mask Use in the Community for Reducing the Spread of COVID-19: A Systematic Review.

Background: Evidence is needed on the effectiveness of wearing face masks in the community to prevent SARS-CoV-2 transmission. Methods: Systematic review and meta-analysis to investigate the efficacy and effectiveness of face mask use in a community setting and to predict the effectiveness of wearing a mask. We searched MEDLINE, EMBASE, SCISEARCH, The Cochrane Library, and pre-prints from inception to 22 April 2020 without restriction by language. We rated the certainty of evidence according to Cochrane and GRADE approach. Findings: Our search identified 35 studies, including three randomized controlled trials (RCTs) (4,017 patients), 10 comparative studies (18,984 patients), 13 predictive models, nine laboratory experimental studies. For reducing infection rates, the estimates of cluster-RCTs were in favor of wearing face masks vs. no mask, but not at statistically significant levels (adjusted OR 0.90, 95% CI 0.78–1.05). Similar findings were reported in observational studies. Mathematical models indicated an important decrease in mortality when the population mask coverage is near-universal, regardless of mask efficacy. In the best-case scenario, when the mask efficacy is at 95%, the R0 can fall to 0.99 from an initial value of 16.90. Levels of mask filtration efficiency were heterogeneous, depending on the materials used (surgical mask: 45–97%). One laboratory study suggested a viral load reduction of 0.25 (95% CI 0.09–0.67) in favor of mask vs. no mask. Interpretation: The findings of this systematic review and meta-analysis support the use of face masks in a community setting. Robust randomized trials on face mask effectiveness are needed to inform evidence-based policies. PROSPERO registration: CRD42020184963

Psychometric Properties of the Italian Version of the Leader Member Exchange Scale (LMX-7): A Validation Study

For decades, scholars have studied leader–member exchange (LMX) relationships to understand and explain the effects of leadership on follower attitudes and performance outcomes within work settings. One available instrument to measure these aspects is the LMX-7 scale. This measurement has been widely used in empirical studies, but its psychometric properties have been poorly explored. The aim of this study was to test the psychometric characteristics (content, structural and construct validity, and reliability) of the Italian version of the LMX-7 scale and to support its cultural adaptation. We used a cross-sectional multi-center design. The forward–backward translation process was used to develop the Italian version of the scale. The scale was administered through an online survey to 837 nurses and nurse managers working in different settings. The factorial structure was tested using both exploratory and confirmatory factor analyses (EFA and CFA), and reliability was evaluated using Cronbach’s alpha. For the construct validity, we used hypothesis testing and differentiation by known groups. The Italian version of the LMX-7 scale presented one dimension. All the psychometric tests performed confirmed its validity and suggested its usefulness for future research

Face Mask Use in the Community for Reducing the Spread of COVID-19: A Systematic Review

Background: Evidence is needed on the effectiveness of wearing face masks in the community to prevent SARS-CoV-2 transmission. / Methods: Systematic review and meta-analysis to investigate the efficacy and effectiveness of face mask use in a community setting and to predict the effectiveness of wearing a mask. We searched MEDLINE, EMBASE, SCISEARCH, The Cochrane Library, and pre-prints from inception to 22 April 2020 without restriction by language. We rated the certainty of evidence according to Cochrane and GRADE approach. / Findings: Our search identified 35 studies, including three randomized controlled trials (RCTs) (4,017 patients), 10 comparative studies (18,984 patients), 13 predictive models, nine laboratory experimental studies. For reducing infection rates, the estimates of cluster-RCTs were in favor of wearing face masks vs. no mask, but not at statistically significant levels (adjusted OR 0.90, 95% CI 0.78–1.05). Similar findings were reported in observational studies. Mathematical models indicated an important decrease in mortality when the population mask coverage is near-universal, regardless of mask efficacy. In the best-case scenario, when the mask efficacy is at 95%, the R0 can fall to 0.99 from an initial value of 16.90. Levels of mask filtration efficiency were heterogeneous, depending on the materials used (surgical mask: 45–97%). One laboratory study suggested a viral load reduction of 0.25 (95% CI 0.09–0.67) in favor of mask vs. no mask. / Interpretation: The findings of this systematic review and meta-analysis support the use of face masks in a community setting. Robust randomized trials on face mask effectiveness are needed to inform evidence-based policies. / PROSPERO registration: CRD42020184963

Workload, Job Satisfaction and Quality of Nursing Care in Italy: A Systematic Review of Native Language Articles

Nursing research is rapidly increasing, yet contributions from numerous countries that may interest the international nursing community are impeded because many research articles are published in authors’ native language and not in English. The objectives of this work were to systematically review papers published in Italian related to job satisfaction and the quality of nursing care, and to discuss their findings in light of the international literature. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) method was used. The Directory of Open Access Journals (DOAJ) and Indice della Letteretura Italiana di Scienze Infermieristiche (ILISI) databases were consulted for eligible studies published from January 2015 to November 2022. Two hundred sixteen papers were identified, 11 of which were selected for review: 8 on job satisfaction, two on workload issues, and 1 on quality of nursing care. The quality of included studies was assessed through the Effective Public Health Practice Project quality assessment tool (EPHPP). The results of our review were in line with those of international literature, and they can help to fill the knowledge gap on the quality of nursing performance in Italian care settings. In addition, the proposed method can provide further elements of discussion among literature providers and reviewers

Chronic non-cancer pain in primary care: an Italian cross-sectional study

Chronic non-cancer pain is a complex health condition that affects more than a quarter of the Italian population who mainly refers to general practitioners and primary care for their treatment. There are little information on the epidemiological and clinical characteristics and types of treatments for these patients who suffer from chronic pain. The aim of the study was to provide epidemiological and clinical information about patients with chronic non-cancer pain who refers to GPs for their treatment. An observational, multicentre, cross-sectional study was carried out using retrospectively reviewed clinical records from 29 GPs. Some pharmacoeconomic aspects were also investigated. A total of 1,007 patients who had chronic pain were selected for the study. Chronic pain was more common in women than in men (ratio 2.7 : 1) (P = 0.002). With regard to incomes, the women earned less than the men (P = 0.017). The chronic pain was musculoskeletal (73.4%), mixed (21.4%), neuropathic (4.9%) and visceral (0.3%). More women than men had pain in two or more sites, and 33.5% of the patients reported more than one diagnosis that related to chronic pain. The general practitioners had prescribed nonsteroidal anti-inflammatory drugs for 71.8% of the cases, opioids for 16.9%, adjuvants for 9.0% and acetaminophen for 2.4%, and about pharmacoeconomic aspects, the total cost for the sample was €111,331.42. Primary care is the essential frontline for patients who suffer from non-cancer pain. An interdisciplinary assessment and approach should start in primary care delivery to maximize the clinical outcomes

Resuscitative endovascular balloon occlusion of the aorta (REBOA) in patients with major trauma and uncontrolled haemorrhagic shock: a systematic review with meta-analysis

Background Multiple studies regarding the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in patients with non-compressible torso injuries and uncontrolled haemorrhagic shock were recently published. To date, the clinical evidence of the efficacy of REBOA is still debated. We aimed to conduct a systematic review assessing the clinical efficacy and safety of REBOA in patients with major trauma and uncontrolled haemorrhagic shock. Methods We systematically searched MEDLINE (PubMed), EMBASE and CENTRAL up to June 2020. All randomized controlled trials and observational studies that investigated the use of REBOA compared to resuscitative thoracotomy (RT) with/without REBOA or no-REBOA were eligible. We followed the PRISMA and MOOSE guidelines. Two authors independently extracted data and appraised the risk of bias of included studies. Effect sizes were pooled in a meta-analysis using random-effects models. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Primary outcomes were mortality, volume of infused blood components, health-related quality of life, time to haemorrhage control and any adverse effects. Secondary outcomes were improvement in haemodynamic status and failure/success of REBOA technique. Results We included 11 studies (5866 participants) ranging from fair to good quality. REBOA was associated with lower mortality when compared to RT (aOR 0.38; 95% CI 0.20–0.74), whereas no difference was observed when REBOA was compared to no-REBOA (aOR 1.40; 95% CI 0.79–2.46). No significant difference in health-related quality of life between REBOA and RT (p = 0.766). The most commonly reported complications were amputation, haematoma and pseudoaneurysm. Sparse data and heterogeneity of reporting for all other outcomes prevented any estimate. Conclusions Our findings on overall mortality suggest a positive effect of REBOA among non-compressible torso injuries when compared to RT but no differences compared to no-REBOA. Variability in indications and patient characteristics prevents any conclusion deserving further investigation. REBOA should be promoted in specific training programs in an experimental setting in order to test its effectiveness and a randomized trial should be planned

Evaluation of Different Recruitment Methods: Longitudinal, Web-Based, Pan-European Physical Activity Through Sustainable Transport Approaches (PASTA) Project

BACKGROUND: Sufficient sample size and minimal sample bias are core requirements for empirical data analyses. Combining opportunistic recruitment with a Web-based survey and data-collection platform yields new benefits over traditional recruitment approaches. OBJECTIVE: This paper aims to report the success of different recruitment methods and obtain data on participants' characteristics, participation behavior, recruitment rates, and representativeness of the sample. METHODS: A longitudinal, Web-based survey was implemented as part of the European PASTA (Physical Activity through Sustainable Transport Approaches) project, between November 2014 and December 2016. During this period, participants were recruited from 7 European cities on a rolling basis. A standardized guide on recruitment strategy was developed for all cities, to reach a sufficient number of adult participants. To make use of the strengths and minimize weakness, a combination of different opportunistic recruitment methods was applied. In addition, the random sampling approach was applied in the city of Örebro. To reduce the attrition rate and improve real-time monitoring, the Web-based platform featured a participant's and a researchers' user interface and dashboard. RESULTS: Overall, 10,691 participants were recruited; most people found out about the survey through their workplace or employer (2300/10691, 21.51%), outreach promotion (2219/10691, 20.76%), and social media (1859/10691, 17.39%). The average number of questionnaires filled in per participant varied significantly between the cities (P<.001), with the highest number in Zurich (11.0, SE 0.33) and the lowest in Örebro (4.8, SE 0.17). Collaboration with local organizations, the use of Facebook and mailing lists, and direct street recruitment were the most effective approaches in reaching a high share of participants (P<.001). Considering the invested working hours, Facebook was one of the most time-efficient methods. Compared with the cities' census data, the composition of study participants was broadly representative in terms of gender distribution; however, the study included younger and better-educated participants. CONCLUSIONS: We observed that offering a mixed recruitment approach was highly effective in achieving a high participation rate. The highest attrition rate and the lowest average number of questionnaires filled in per participant were observed in Örebro, which also recruited participants through random sampling. These findings suggest that people who are more interested in the topic are more willing to participate and stay in a survey than those who are selected randomly and may not have a strong connection to the research topic. Although direct face-to-face contacts were very effective with respect to the number of recruited participants, recruiting people through social media was not only effective but also very time efficient. The collected data are based on one of the largest recruited longitudinal samples with a common recruitment strategy in different European cities

Centrifuge modeling of earth-reinforced retaining walls

This paper is on the centrifuge modeling of reinforced soil retaining walls with modular blocks facing. The influence of design parameters, such as length and vertical spacing of reinforcement, on the behaviour of the structure was investigated. A total of 11 models were tested, each one with different length of reinforcement or spacing. Each model was constructed and then placed in the centrifuge in order to increase gravitational acceleration up to 35 g, reproducing the soil behaviour of a 5-m high wall. Vertical and horizontal displacements were recorded by means of a laser profiler which enabled tracking of deformations in the structure along its longitudinal cross section, essentially drawing its deformed shape. As expected, the results confirmed reinforcement parameters to be the governing factor in the behaviour of reinforced soil structures since increasing length and reducing spacing improved structural stability. However, the influence of the length was found to be the leading factor that reduced facial deformations up to five times, and the spacing playing an important role especially in unstable configurations. The failure surface was characterised by the same shape (circular) and depth, regardless of the reinforcement configuration. Furthermore, the results confirmed the over- conservatism of design codes, since models with reinforcement layers 0.3H long showed almost negligible deformations. The test results may be used to set up further numerical modeling in order to investigate on other issues, such as the influence of the reinforcement stiffness and varying backfill