Psychometric Properties of the Italian Version of the Short-Form Supportive Care Needs Survey Questionnaire (SCNS-SF34-It): A Multicenter Validation Study.

This study aimed to evaluate psychometric properties of the Italian version of the Short-Form Supportive Care Needs Survey Questionnaire (SCNS-SF34) in a cancer population. A multicenter prospective observational study was carried out in outpatient and inpatient settings. The evaluated psychometric properties were as follows: the five-domain structure, the internal consistency, the convergent validity with the Edmond Symptom Assessment System (ESAS) questionnaire, the discriminant validity and test-retest reliability. A total of 714 patients with different types, stages and treatment settings of cancer were recruited. A total of 56% of participants were women, the median age 59 years (range 18-88). The prevalence of patients reporting at least one unmet need was 78.7%. The factor analysis explained 71.3% of the total variance, confirming the five-domain structure of the original model. Internal consistency was good, with Cronbach's alpha values ranging from 0.87 ("psychosocial need", "patient support and health system", "information") to 0.90 ("sexuality"). The convergent validity of the SCNS-SF34-It with the ESAS scale was low, suggesting that these questionnaires cover different concepts. The SCNS-SF34-It was able to discriminate differences between groups, and the test-retest reliability was good (ICC 0.72-0.84). The SCNS-SF34-It proved to be a reliable instrument for use in clinical practice for evaluating unmet needs in the Italian population of cancer patients. This study was not registered.

Fall predictors in hospitalized patients living with cancer: a case-control study.

PURPOSE: To identify fall predictors and develop an assessment tool to be used for screening hospitalized cancer patients at risk for fall. METHODS: A retrospective case-control study was conducted in 2018 at a cancer center in Northern Italy. The study participants were 448 adult cancer patients admitted to the oncology ward from 2009 to 2013. The case group consisted of 112 patients presenting at least one fall, while controls were randomly chosen by matching each case for age, sex, and admission period with three patients who did not fall. Data for the fall predictors were extracted from the electronic medical records. Conditional logistic regression was used to evaluate the association between patient's characteristics and fall risk. RESULTS: The overall prevalence of patients having at least one candidate fall predictor was high (98%). Seven of the studied variables showed an independent association with fall risk at multivariate analysis. These were tumor site, the presence of neurologic diseases, gait imbalance disorders, fatigue, and the assumption of certain medications such as diuretics, hypnotics, and opioids (odds ratios and 95% confidence intervals in brackets were 3.78 (1.78-8.13), 2.26 (1.08-4.77), 4.22 (1.87-9.52), 2.76 (1.45-5.26), 2.66 (1.52-4.66), 2.41 (1.20-4.85), and 3.03 (1.68-5.45), respectively). CONCLUSIONS: In this study, we identified falling risk factors in an Italian population of hospitalized cancer patients and developed a new risk assessment tool. An external validation is necessary before implementing our screening tool in clinical practice.

Identifying ethical values for guiding triage decisions during the COVID-19 pandemic: an Italian ethical committee perspective using Delphi methodology.

OBJECTIVES: This study aimed to identify the guiding ethical principles that should be considered for critical resource allocation during pandemic emergency situations, and especially for the COVID-19 outbreak. The secondary objective was to define the priority to be assigned to each principle. SETTING: The study was conducted from March to June 2020 within the context of an ethical committee (EC) in Northern Italy. PARTICIPANTS: Eleven EC members and five additional external healthcare and bioethical professionals, forming a multidisciplinary panel, took part in the study. PRIMARY AND SECONDARY OUTCOME MEASURES: The compilation of a list of ethical principles (maximum of 10 items) and their priority ranking and application within an emergency pandemic context was established as the expected outcome of this work. RESULTS: A consensus on 10 guiding ethical principles was reached by the multidisciplinary panel. Transparency ranked first on the priority list as the most frequently voted principle, followed by the number of lives saved, life-years saved, respect for individuals' autonomy and equity. Other principles including life cycle, 'sickest first', reciprocity, instrumental value and lottery were also considered appropriate as potential tiebreakers. These principles were discussed and made consistent with the current Italian pandemic context by producing an explanatory document. CONCLUSIONS: The identified principles could be used in preparedness plans to guide resource allocation during pandemic events. By combining their rank and relevance in relation to disease, health system organisations, social and economic settings, and critical resources at risk of scarcity, these principles could help to maximise the benefit of resource use for the community, thus reducing inequalities for individuals.

[Introducing clinical nurse specialists (CNS) in the ambulatory setting: the experience of a Research Cancer Center in Italy.] / L'inserimento degli infermieri specialisti nel contesto ambulatoriale di un centro di ricerca oncologico in Italia: un'esperienza di introduzione del ruolo.

. Introducing clinical nurse specialists (CNS) in the ambulatory setting: the experience of a Research Cancer Center in Italy. INTRODUCTION: In 2018 the role of clinical nurse specialist (CNS) was implemented in an ambulatory setting at our cancer institute. OBJECTIVES: To describe the CNS role implementation and the indicators to measure and the impact of the CNS after one year. METHODS: Indicators for the implementation: CNS interface mapping in disease pathways, participation in multidisciplinary team (MDT) meetings, and number of training hours per CNS on specific cancers. Indicators for the impact: patient satisfaction with CNS (survey), compliance with for waiting times for the first visit, number of documented CNS-patient communications and number of improvement projects in which CNSs were involved. RESULTS: One year after CNS introduction, pathway mapping was 100%; MDT meeting participation 95%; training hours 40.5/CNS vs. standard 30 hours; 83.2% of interviewed patients were very satisfied with CNSs. On average 27 face to face and 126 phone interviews per month were performed. The number of first visits increased of 13% componed to the previous year. CONCLUSIONS: CNSs were successfully introduced into disease pathways and played an active role in the MDTs. The positive impact observed suggests that this new role could represent a response to the need to design patient centered services for cancer diseases. Measuring the CNSs activities and their impact on the patient outcomes and on system efficiency is the key for defining nursing staffing standards in the disease pathways, tailored on patients and organization characteristics.

Psychometric assessment of the Italian version of the melanoma module (SCNS-M12-Ita) of the Supportive Care Needs Survey (SCNS-SF34).

INTRODUCTION: This study examines the validity and the reliability of the translated-into-Italian version of the SCNS-SF34 melanoma module (SCNS-M12-Ita) for a sample of patients with melanoma (n = 268). METHODS: Content validity was analyzed by examining the redundancy of items. Floor/ceiling effects were investigated via frequency tables. Factor structure was studied through principal component analysis. Internal consistency was evaluated with Cronbach α. Test-retest reliability was analyzed using intraclass correlation coefficients (ICCs). Convergent-discriminant validity was studied by calculating Pearson correlations. Construct validity was investigated by comparing subgroups of patients through multivariate analysis of variance. RESULTS: Content validity of the SCNS-M12-Ita was satisfactory. The floor effect ranged from 24.3% to 82.5%. The 2-factor solution explained 61.4% of the total variance. Internal consistency was excellent for component 1 (α = 0.92) and questionable (α = 0.58) for component 2. Test-retest reliability was excellent for component 1 (ICC = 0.92) and poor for component 2 (ICC = 0.58). Except for component 2, item-total correlations were greater than 0.60. Construct validity was confirmed, as the expected correlations (r < 0.40) were observed and 60% of the postulated hypotheses about between-group differences were confirmed. CONCLUSIONS: The study demonstrated that the SCNS-M12-Ita is a valid and reliable instrument for assessing the supportive care needs of patients with melanoma.

Prevalence and correlates of the supportive care needs of Italian early-stage melanoma patients in follow-up.

Purpose: To describe the supportive care needs of early-stage Italian melanoma patients and identify the predictors of unmet needs. Design: Bicenter cross-sectional. Sample: Two hundred eight (TIS-T3) melanoma patients in follow-up. Methods: In person self-assessment procedures; the Supportive Care Needs Survey short-form 34, the Distress Thermometer and the Hospital Anxiety and Depression Scale were used. Results: Of the patients surveyed, 56% experienced at least one or more moderate-to-high unmet needs. Lack of melanoma-specific information and psychological support aids were the most intense sources of need. Being aged 60-69 years, retired and distressed predicted unmet needs. Conclusions: This study's results demonstrate the need to implement supportive care needs screening among Italian early-stage melanoma patients during follow-up and to improve patient information and psychological support. Implications for psychosocial providers or policy: Providing patients with a point person within the hospital staff who centralizes the demand and refers to appropriate interventions may help the management of unmet needs.

A surveillance system model for central line-associated bloodstream infections (CLABSI) coordinated at the regional level: a pilot feasibility study.

We describe the methods used to define a surveillance model to incorporate into activities aimed at preventing central line-associated bloodstream infections (CLABSI) in non-critical care units (NCCUs) and designed to be implemented at the regional level. In 2015 we conducted a pilot feasibility study in three NCCUs based in hospitals of the Regional Health System of Emilia Romagna to evaluate the feasibility of the proposed model and to test its accuracy and cost-effectiveness in terms of resources needed to maintain the system. Our results indicate that the system is feasible at the regional level by using the available sources and instruments to collect data in clinical practice context. Observation of device utilization for at least three months in all NCCU wards is needed in order to prioritize the medical area on which to focus costs for surveillance prior to implementing it on a regular basis.

The Italian version of the FAMCARE scale: a validation study.

PURPOSE: Evaluation of the quality of care is a key element that healthcare providers now take into consideration to meet patients' needs, expectations, and values. The FAMCARE scale is one of the most important instruments available to assess the level of satisfaction about care received by patients and families. We describe the validation process used to develop an Italian version (IF) of the original FAMCARE scale for caregivers. METHODS: The IF was prepared according to standard guidelines for translation and transcultural adaptation of self-reported measures. The scale was self-administered to 132 informal caregivers of patients with cancer treated with curative and/or palliative care in a hospice, outpatient, or inpatient setting for at least 1 month. The participant group was composed of spouses (47.73 %), children (31.82 %), siblings (3.03 %), or other relatives (17.42 %). All participants simultaneously completed the EuroQol-5D (EQ-5D) questionnaire to test the construct validity. Twenty-two percent of randomly chosen participants re-completed the test after 1 month to evaluate IF test-retest stability. RESULTS: The IF showed a strong reliability with internal consistency [α = 0.93, confidence intervals (CI) = 0.91-0.95] and test-retest stability (Pearson r = 0.38; Kendall's tau-b = 0,25; Spearman's rho =0.34). Factor analysis identified four factors capable of explaining the 63 % total variance which did not change after the Varimax normalized rotation. Notwithstanding the lack of correlation with the VAS component of the EQ-5D questionnaire, our results highlighted robust psychometric properties of the IF. CONCLUSIONS: IF is a valid translation of the FAMCARE scale and can be used to assess caregiver satisfaction within the Italian context of cancer palliative care.

Evaluation of the impact of support for nursing research on scientific productivity in seven Italian hospitals: A multiple interrupted time series study.

BACKGROUND: Nursing research is not well-developed in Italy, and knowledge of the methodologies for conducting research is lacking. In several hospitals, including those in which this study was conducted, a research center has been established to support and educate nurses on how to conduct clinical research. AIMS AND OBJECTIVES: In this observational study, we sought to assess whether establishing a support center for nursing research has resulted in an increase in scientific production in terms of the numbers of protocols approved (primary outcome), articles published and nurse authors involved in the publications (secondary outcomes). DESIGN: Multiple interrupted time series. METHODS: Data from 2002 to 2012 were collected in seven hospitals. Research centers have been established at various times in only four of these hospitals. RESULTS: A statistically significant increase in the primary outcome (the number of protocols approved by the Research Ethics Committee in which the principal investigator was a nurse) was observed in two hospitals approximately 2years after establishing a research center. The number of nursing research articles published in scientific journals with an impact factor increased but was not statistically significant. Finally, the number of nurse authors increased significantly in two hospitals with support units. Definitive conclusions could not be reached for the other two experimental hospitals because notably few post-intervention data were available. In the control hospitals, the scientific production outcomes did not change. CONCLUSIONS: This study shows that establishing a support center for nursing research inside hospitals can facilitate the production of research.

Translation of Supportive Care Needs Survey Short Form 34 (SCNS-SF34) into Italian and cultural validation study.

BACKGROUND: The Supportive Care Needs Survey (SCNS) is one of the most comprehensive tools used in the clinical trials to measure the perceived unmet supportive care needs of cancer patients. The original 59-item instrument was developed and validated in English using rigorous methods. A short version containing 34 items was subsequently developed by the same authors (SCNS-SF34) and has since been translated into numerous other languages and validated, confirming its psychometrically robust properties. Cross-cultural validity is, in fact, important for international comparisons of self-reported measures. As an Italian form of the questionnaire does not exist at present, we decided to test the linguistic equivalence and cultural validity of a translated version of the SCNS-SF34 in a target population. METHODS: The adaptation process was performed in accordance with Beaton's guidelines by a dedicated research team in collaboration with patient representatives. RESULTS: The Italian questionnaire maintained the construct validity of the original version and was easy to understand and use. CONCLUSIONS: Preliminary results indicate that the SCNS-SF34 is feasible in an Italian population. Further research is ongoing at our institute to assess its psychometric properties in a larger case series and in different care settings.