Erythropoietin in amyotrophic lateral sclerosis: a multicentre, randomised, double blind, placebo controlled, phase III study

OBJECTIVE: To assess the efficacy of recombinant human erythropoietin (rhEPO) in amyotrophic lateral sclerosis (ALS). METHODS: Patients with probable laboratory-supported, probable or definite ALS were enrolled by 25 Italian centres and randomly assigned (1:1) to receive intravenous rhEPO 40,000 IU or placebo fortnightly as add-on treatment to riluzole 100 mg daily for 12 months. The primary composite outcome was survival, tracheotomy or >23 h non-invasive ventilation (NIV). Secondary outcomes were ALSFRS-R, slow vital capacity (sVC) and quality of life (ALSAQ-40) decline. Tolerability was evaluated analysing adverse events (AEs) causing withdrawal. The randomisation sequence was computer-generated by blocks, stratified by centre, disease severity (ALSFRS-R cut-off score of 33) and onset (spinal or bulbar). The main outcome analysis was performed in all randomised patients and by intention-to-treat for the entire population and patients stratified by severity and onset. The study is registered, EudraCT 2009-016066-91. RESULTS: We randomly assigned 208 patients, of whom 5 (1 rhEPO and 4 placebo) withdrew consent and 3 (placebo) became ineligible (retinal thrombosis, respiratory insufficiency, SOD1 mutation) before receiving treatment; 103 receiving rhEPO and 97 placebo were eligible for analysis. At 12 months, the annualised rate of death (rhEPO 0.11, 95% CI 0.06 to 0.20; placebo: 0.08, CI 0.04 to 0.17), tracheotomy or >23 h NIV (rhEPO 0.16, CI 0.10 to 0.27; placebo 0.18, CI 0.11 to 0.30) did not differ between groups, also after stratification by onset and ALSFRS-R at baseline. Withdrawal due to AE was 16.5% in rhEPO and 8.3% in placebo. No differences were found for secondary outcomes. CONCLUSIONS: RhEPO 40,000 IU fortnightly did not change the course of ALS

La sensibilití etica negli studenti di infermieristica: sviluppo di una scala

Aims: The objectives of this study were first to develop a valid and reliable instrument that measured the sensitivity of Italian nursing undergraduates, and, second, to conduct an observational study in second- and third-year Italian nursing students to provide new insight into the efficacy of nursing ethics education to develop ethical sensitivity. Methods: A quantitative, descriptive, observational pilot study was conducted in two Italian universities. To investigate the students' sensitivity, a brand new scale entitled "Ethical sensitivity scale undergraduates nursing students" (ESS-UNS) was produced. Twenty items that referenced the principles of the Italian Nursing Code of Ethics were identified (2009). Results: The measured exploratory factorial analysis outlined a two-factor solution (Table 1). Based on the semantics of the items, the first dimension was named "Ethical sensitivity as a positive attitude" and it was created to detect the perceptions and opinions of the students regarding good behaviours in nursing. The second dimension was named "Ethics sensitivity as a negative attitude" in virtue of the perceptions of the students regarding the behaviours considered ethically negative. Conclusion: The added value of our study is in the verification that academic ethical education significantly increases students' awareness regarding the possible ethical violations observed and lived in during clinical training. This can help students understand and identify the ethical conflicts in relationship with their moral maturity.Keywords: nursing students, academic ethical education, moral maturity.Scopo:Questo studio si pone l'obiettivo di sviluppare uno strumento valido ed affidabile utile a misurare la sensibilití  etica degli studenti di infermieristica italiani e condurre uno studio osservazionale per fornire nuove conoscenze sull'efficacia della formazione etica infermieristica nello sviluppo della sensibilití  etica. Metodo:E' stato condotto uno studio pilota descrittivo, osservazionale, con metodo quantitativo, in due importanti universití  italiane. In merito alla scala utilizzata per la raccolta dei dati, la stessa è stata sottoposta ad analisi di riduzione fattoriale attraverso l'analisi fattoriale esplorativa. Risultati:L'attendibilití  dello strumento, che è stata testata tramite la misura della coerenza interna della scala calcolando l'Alfa di Cronbach, ha riportato un'ottima attendibilití  dello strumento. Dal punto di vista descrittivo, i risultati ottenuti mostrano che la sensibilití  etica degli studenti, espressa nelle varie situazioni descritte dagli item, risulta soddisfacente in quanto i punteggi medi calcolati sono sempre vicino all'estremo positivo di rifermento. Inoltre, in linea con la letteratura, la maturití  e relativa formazione etica appresa, incide significativamente sulla sensibilití  etica degli studenti in misura crescente rispetto all'anno di corso frequentato. Conclusioni: La formazione etica accademica, aumenta in modo significativo la consapevolezza degli studenti delle possibili violazioni etiche osservate e vissute negli ambienti di tirocinio clinico, che li aiuta a discernere i conflitti che ne derivano in relazione alla sensibilití  etica maturata.Parole chiave: Studenti Infermieristica, formazione etica accademica, maturití  morale

Reliability, Validity, and Empirical Dimensionality of the Minnesota Nurses' Perceptions of Nursing Diagnoses Scale Among Italian Nursing Students

Perceptions toward nursing diagnosis (ND) may represent core drivers of its adoption within clinical practice. Few studies have investigated perceptions toward ND within nursing academic contexts. The study was conducted to validate the Italian version of the Minnesota Nurses' Perceptions of Nursing Diagnoses (MNPND) scale on a sample of Italian nursing students and explore the psychometric structure of perceptions in a sample drawn from this population

Psychometric properties of the Scale for Quality Evaluation of the Bachelor Degree in Nursing Version 2 (QBN 2)

To evaluate all the variables that affect nursing education is important for nursing educators to have valid and reliable instruments that can measure the perceived quality of the Bachelor Degree in Nursing. This study testing the Scale for Quality Evaluation of the Bachelor Degree in Nursing instrument and its psychometric properties with a descriptive design. Participant were first, second and third year students of the Bachelor Degree in Nursing Science from three Italian universities. The Scale for Quality Evaluation of Bachelor Degree in Nursing consists of 65 items that use a 4 point Likert scale ranging from “strongly disagree” to “strongly agree”. The instrument comes from a prior version with 41 items that were modified and integrated with 24 items to improve reliability. Six hundred and fifty questionnaires were completed and considered for the present study. The mean age of the students was 24.63 years, 65.5% were females. Reliability of the scale resulted in a very high Cronbach's alpha (0.96). The construct validity was tested with factor analysis that showed 7 factors. The Scale for Quality Evaluation of the Bachelor Degree in Nursing, although requiring further studies, represents a useful instrument to measure the quality of the Bachelor Nursing Degree