ABSTRACT
Introduction: COVID-19 pandemic induced the emanation of extraordinary measures like quarantine, that can be considered a risk factor for both physical and mental health in the population. In particular, gym's closure and the need to stay home didn't allow people to perform physical activity easily, with a consequent worsening of cardiovascular risk factors. During quarantine some general recommendations have been disseminated, but little is known about specific guidelines for home-based exercise prescription in patients with cardiovascular disease. Therefore, the purpose of this study is to develop home-based physical exercise programs for cardiac patients referred to the Center for Exercise Science and Sports of University of Ferrara. Methods: On the basis of exercise capacity obtained from the last functional evaluation, performed in presence before the closure, three structured workouts were realized following the guidelines. They are composed as follows: warm-up, strenght and balance exercises alternate to indoor walking, cool-down. Patients received an explicative iconographic via e-mail or smartphone. Some domiciliary sessions were supervised by an operator through video connection. Results: All patients showed excellent compliance with the proposed program. Adherence has been verified through biweekly recalls. No adverse events occurred. Conclusions: Telemonitored exercise prescription in cardiac outpatients was effective and safe, helping to prevent negative consequences of the abrupt cessation of physical activity due to COVID-19 pandemic. These evidence could be useful even after the end of pandemic, for all those patients that are less likely to participate in traditional cardiovascular rehabilitation programs because of difficulties in reaching facilities or leaving home.
ABSTRACT
Background: The Integrated Palliative care Outcome Scale for Dementia (IPOS-Dem) is a version of the IPOS developed for professional caregivers working in NH, aimed to properly assess the palliative care needs of patients with dementia. The original tool was created in the UK and there is not an Italian version available. Aim: To translate the IPOS-Dem in Italian and adapt it to our cultural environment. Methods: Following the EORTC guidelines for translation and adaptation of questionnaires, a forward backward translation process was performed involving a professional translator whose first language was English, and the Italian researchers. A proof reading phase followed, involving the original IPOS -Dem authors. The final IPOS-Dem Italian version was tested in a qualitative assessment study aimed to adapt it to the Italian NH setting. This study included a focus group (FGM) with 5 professionals working in an Italian NH and 6 individual interviews with caregivers involved in the care of people with severe dementia. All the events happened during 2020 and, despite the limitation due to the COVID pandemic, could be performed with the physical attendance of the participants. Results: All participants involved in the FGM and in the interviews reported positive feedback about the tool. It was defined as useful, clear and applicable in Italian NH settings. It helps in the multidimensional assessment of cognitive impaired patients, in the individual care planning, allows to measure the explored items and follow them up overtime, providing a good insight on the outcomes of the interventions. Conclusions: IPOS-Dem is now available in Italian language, it confirmed its properties as an appropriate, acceptable and useful assessment tool in our cultural context. A full validation study remains needed in order to obtain a full validation.
ABSTRACT
Background: ConCure-SM is a mixed-methods research project for developing and testing an advance care planning (ACP) intervention for people with progressive multiple sclerosis (pwPMS) in Italy. It consists of a booklet to be used during the ACP conversation (the focus of this presentation) and a training program for neurologists and other MS healthcare professionals (HPs). Aims: To assess the acceptability and comprehensibility of the ConCure-SM booklet. Methods: An inter-disciplinary panel translated and adapted to the Italian legislation and to the MS context a booklet developed by the National ACP programme for New Zealand. The booklet was then probed via individual cognitive interviews with pwPMS and caregivers, and a focus group meeting (FGM) with MS HPs. Two weeks before the interview/ FGM, held on digital platform due to the COVID-19 pandemic, participants received the booklet and were invited to browse it. Results: Between September-January 2021 we conducted 13 interviews which lasted between 36 and 80 minutes. Participants were 10 pwPMS and 3 caregivers (2 spouse, one daughter);8 were men, median age was 54 years. Data saturation was achieved after 11 interviews were analyzed. Twelve HPs participated in the FGM (7 neurologists, 3 psychologists, one nurse and one physiotherapist), which lasted 1.45 min. Thematic analysis (performed by LDP, SV, and LG) identified 4 overarching themes: comprehensibility and clarity;content acceptability and emotional impact;images and layout;suggestions for improvement. Interviews revealed that the booklet was useful and informative, though pwPMS found it emotionally taxing. The FGM was well participated;few experiential data on ACP emerged, lack of training and time constraint emerging as major reasons. Conclusions: Cognitive debriefing was key to refine the ConCure-SM booklet. Interview and FGM results corroborated use of the booklet within the ACP conversation, and the challenge of appraisal as a standalone tool.
ABSTRACT
Genetic and Clinical Background: The clinical outcome of Core Binding Factor Leukemia (CBFL) seems influenced by the mutational status of KIT. In fact, several retrospective studies, in addition to our own, as well as a systematic review, indicate that KIT mutations have a negative prognostic impact in AML with t(8;21) or, to a lesser extent, with inv(16)/t(16;16). In addition, gene expression studies found KIT to be highly expressed in CBFL regardless of its mutational status. Furthermore, recent studies have identified novel recurrent somatic mutations co-occurring with KITmut. In-vitro studies revealed that Midostaurin (Mido) is effective in inhibiting both wild type (WT) and a range of KIT mutants. In addition, it is proven to be effective in KIT-positive malignancies such as Aggressive Systemic Mastocytosis (ASM), Mast Cell Leukemia (MCL), and SM with Associated Hematological Neoplasm (SM-AHN). With this background, we designed a Phase II trial to evaluate the safety and efficacy of Mido in association with Intensive Chemotherapy (IC), in CBFL regardless of KIT mutational status. Methods: The inclusion criteria were the following: age 18 to 60 years, diagnosis of de-novo CBFL, adequate organ function, signed informed consent. The exclusion criteria were: central nervous system involvement, uncontrolled infections, other active malignancies, a Qtc value greater than 470 ms (according to Bazett formula) at the electrocardiogram, significant uncontrolled or active cardiovascular diseases. Patients received standard induction therapy with an anthracycline containing regimen (“7+3”-like) + Mido, three cycles of post-remission consolidation chemotherapy with high-dose cytarabine + Mido, and 12 months of Mido as Maintenance. The Mido dosage was: 50 mg orally twice a day, on days 8-21, in association with IC, and 50 mg orally twice a day as single agent maintenance. In order to attain a reduction in 2 years Relapse Incidence (RI), from the historical value of 48% to 28% (Primary Objective of the Study), we plan to enrol 39 patients (power 82%, alpha error 4,6%). At diagnosis all patients were studied by a comprehensive NGS panel targeting 40 DNA genes and 29 RNA fusion driver genes. MRD status was assessed by qPCR and high-resolution multicolor flow cytometry at established check-points during consolidation and maintenance therapy. Results: 17 patients were enrolled between December 2018 to April 2020 (table1). Overall, the CR rate was 94.2%. At a median follow-up of 9 months (range 3-19 months), we recorded a RI of 12.5%, an OS of 93.7%, and a DFS of 81.2%. 16 patients continue on study and 14 patients are in 1st CR, MRD-negative by flow cytometry and qPCR. Six patients (35.2 %) experienced 12 Treatment Emergent Adverse Event (TEAE), 10 out of whom were infections, with grade 3-4 neutropenia (Table 2). We only recorded one death from SARS-Cov2 infection (Interstitial Pneumonia) in a patient in MRD-negative complete remission. There were no treatment-related deaths. Conclusion: In patients with CBFL, the regimen consisting of intensive chemotherapy and consolidation chemotherapy in association with Mido, followed by Mido maintenance, had an acceptable safety profile and excellent response rates with a significant proportion of patients in MRD-negative complete remission. Trial is continuing to accrue (EudraCT Number 2017-002094-18;ClinicalTrials ID: NCT 03686345). This work was supported by a grant from Fondazione Regionale per la Ricerca Biomedica (FRRB 2015). [Formula presented] Disclosures: Krampera: Janssen: Membership on an entity's Board of Directors or advisory committees;Novartis: Membership on an entity's Board of Directors or advisory committees. Todisco: Jannsen, Abbvie, Jazz: Membership on an entity's Board of Directors or advisory committees. Veronese: Novartis: Other: Travel Expenses;Bayer: Honoraria;AstraZeneca: Other: Travel Expenses;Janssen Cilag: Honoraria. OffLabel Disclosure: Midostaurin for treatment of Core Binding Factor Leukemia. The drug has been used as KIT inhibitor.