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

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

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

From People to People - The Self-Benefit of Crowdsourced Cycling Data as Part of the European Cycling Challenge

The European Cycling Challenge (ECC) is a team competition among urban cyclists that takes place every year May, 1-31. Born in 2011 in Bologna as a small test within the CIVITAS Mimosa Project, the ECC is now an event joined every year by thousands of cyclists all around Europe. The ECC applies the gamification approach to daily commuting. In 2016, the fifth edition, 52 European cities joined the Challenge, from 17 different countries. 46.000 people cycled 4.000.000 km in a month, producing a huge amount of GPS data that are shown as live cities\u2019 heatmaps during the ECC and used by cities to assess user needs and for the cycling planning activities. ECC has been rewarded twice in 2013 and 2016 with the CIVITAS Award as the best communication initiative and for its novel use of online applications in order to assess user needs. Since the more cyclists join a team, the more chances a city has to win the Challenge (and the more GPS data are collected), each city implements its best local communication strategy to involve the highest number of people. ECC created a fun environment at local and international level, able to facilitate new partnerships between cities, new local groups (NGOs, advocacies, etc.), a countless number of linked events and to trigger behaviour changes among commuters. Crowdsourced GPS data have multiple effects in participating cities and most of the effects are eventually a direct benefit for the same people that produced those data. One important step to reach those effects is to build on research results. There have been different research approaches at local level: applied researches on pure data, GIS mapping and paths assessment, physical infrastructure safety checking and cross matching with GPS data, thesis on cyclists\u2019 behaviour, etc. This paper describes 3 use cases from Bologna and Rome in which cycling GPS data are exploited for the self-benefit of city users, in a virtuous circle, according to the fact that the analysis of cycling flows is made available by cyclists themselves

Role and skills of the oncology nurse. an observational study

The importance of nursing competence arises from its central role in influencing and determining care outcomes. The employment of adequately educated staff, able to base clinical decisions on the best scientific evidence, is one of the components required for delivering high quality nursing care in the oncological field. The aim of this study is to analyze - through the Nurse Competence Scale - the level of competence of nurses working in oncological settings

Nurse specialist and ostomy patient. Competence and skills in the care pathway. A scoping review

Aims and Objectives: To summarise the evidence published to date regarding nursing core competence in stoma care of any type of ostomy throughout the patient's ostomy surgery candidate care pathway from preoperative to follow-up. Background: Nurses should play a key role in all ostomy patient care pathways to help them to adapt to the new physics and psychological conditions from the preoperative phases to the prevention of tardive stomal complications. Design: Scoping review. Methods: This scoping review was conducted following the methodological framework proposed by Arskey and O'Malley, following the Preferred Reporting Item for Systematic Review and Meta-analysis for Scoping Review. PRISMA-ScR Checklist is included in the manuscript. The following databases were queried: PubMed, EMBASE and CINAHL, from August to October 2022. Results: The search strategy in the consulted databases identified 3144 studies. Different types of ostomies were found and investigated: tracheostomy, gastrostomy, jejunostomy, ileostomy, colostomy and urostomy. The results of the included studies helped address the objective that allowed the ostomatherapy skills to be broken down into the different periods of the care pathway. Conclusion: Caring for an ostomy patient requires advanced skills and a trusting relationship. The skills outlined in this research suggest how essential the stoma care nurse specialist is in these patients' care

Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire

Purpose. To develop an Italian tool that measures the therapy adherence of women with breast cancer undergoing treatment with oral endocrine therapy. Methods A two-phase study was conducted, which followed the guidelines of the European Statistical System for the development and validation of a questionnaire. In the first phase, the questionnaire was developed; in the second phase, a preliminary validation was carried out on patients with breast cancer undergoing treatment with oral hormonal therapies. Results In its final version, the questionnaire presents 6 main items which aim to investigate the level of adherence, the degree of awareness of the nature of the drug taken and the reasons that may influence nonadherence. 82 patients were recruited in the validation study, with an average age of 56.4 years, while for the re-test 40 were selected with an average age of 57.3 years. Content validity reported excellent results. Cronbach's alpha of each item showed a strong degree of correlation. Conclusions. The creation of a tool for measuring adherence to endocrine therapy in breast cancer patients can be a valuable support for healthcare professionals involved in their care. Future studies should be aimed at using A-BET (Adherence – Breast Endocrine Therapy) on larger cohorts of patients in order to verify its validity / reliability more accurately and to be able to generalize the results

Assessing the Policy Environment for Active Mobility in Cities—Development and Feasibility of the PASTA Cycling and Walking Policy Environment Score

The importance of setting a policy focus on promoting cycling and walking as sustainable and healthy modes of transport is increasingly recognized. However, to date a science-driven scoring system to assess the policy environment for cycling and walking is lacking. In this study, spreadsheet-based scoring systems for cycling and walking were developed, including six dimensions (cycling/walking culture, social acceptance, perception of traffic safety, advocacy, politics and urban planning). Feasibility was tested using qualitative data from pre-specified sections of semi-standardized interview and workshop reports from a European research project in seven cities, assessed independently by two experts. Disagreements were resolved by discussions of no more than 75 minutes per city. On the dimension “perception of traffic safety”, quantitative panel data were used. While the interrater agreement was fair, feasibility was confirmed in general. Validity testing against social norms towards active travel, modal split and network length was encouraging for the policy area of cycling. Rating the policy friendliness for cycling and walking separately was found to be appropriate, as different cities received the highest scores for each. Replicating this approach in a more standardized way would pave the way towards a transparent, evidence-based system for benchmarking policy approaches of cities towards cycling and walking

The efficacy of balneotherapy, mud therapy and spa therapy in patients with osteoarthritis: an overview of reviews

Osteoarthritis is a degenerative disease considered a leading cause of functional disability. Its treatment is based on a combination of pharmacological and non-pharmacological interventions, but the role of these latter is still debated. This overview of systematic reviews aimed at evaluating the short-term efficacy of different thermal modalities in patients with osteoarthritis. We searched PubMed, Scopus, CINHAL, Web of Science, ProQuest and the Cochrane Database of Systematic Reviews from inception until October 2020, with no language restrictions. We selected the following outcomes a priori: pain, stiffness and quality of life. Seventeen systematic reviews containing 27 unique relevant studies were included. The quality of the reviews ranged from low to critically low. Substantial variations in terms of interventions studied, comparison groups, population, outcomes and follow-up between the included SRs were found. From a re-analysis of primary data, emerged that balneotherapy was effective in reducing pain and improving stiffness and quality of life, mud therapy significantly reduced pain and stiffness, and spa therapy showed pain relief. However, the evidence supporting the efficacy of different thermal modalities could be seriously flawed due to methodological quality and sample size, to the presence of important treatment variations, and to the high level of heterogeneity and the absence of a double-blind design. There is some encouraging evidence that deserves clinicians' consideration, suggesting that thermal modalities are effective on a short-term basis for treating patients with AO

Pain Prevalence in two Italian Hospitals. An observational study

Introduction: Pain is the most common and distressing medical symptom in hospitalized patients in all wards. Pain prevalence among hospitalized patients is an indicator of the quality of health care. Objective: The aim of this study is to describe pain prevalence in two Italian hospitals. Material and method: This is an observational study. It involved hospitalized patients of both sexes, able and unable to self-report. Descriptive analysis and multivariate analysis were applied. Results: A sample of 754 inpatients were included. In Terni Ho-spital (n = 255), pain prevalence was 80.8%. The mean pain severity was 5.2 (sd \ub1 3.33). At Rome's San Camillo Hospital (n=499), pain prevalence was 46.9%. Acute pain is more prevalent in women (OR= 0.65; CI 95% 0.43-0.99) and increases with age (OR= 0.97; CI 95% 0.96-0.99). Chronic pain is more prevalent in men (OR= 2.34; CI 95% 1.41-3.97) and increases with age (OR= 1.04; CI 95% 1.03-1.06). Discussion and conclusion.: San Camillo Hospital presents data showing reduced pain prevalence, and describing pain even in patients unable to self-report. It is reasonable to believe that pain control by the staff at San Camillo is better, even though both hospitals are equally important regional institutions