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During the COVID-19 2020 outbreak, a large body of data has been provided on general management and outcomes of hospitalized COVID-19 patients. Yet, relatively little is known on characteristics and outcome of patients managedin Internal Medicine Units (IMU). To address this gap, the Italian Society of Internal Medicine has conducted a nationwide cohort multicentre study on death outcome in adult COVID-19 patients admitted and managed in IMU. This study assessed 3044 COVID-19 patients at 41 referral hospitals across Italy from February 3rd to May 8th 2020. Demographics, comorbidities, organ dysfunction, treatment, and outcomes including death were assessed. During the study period, 697 patients (22.9%) were transferred to intensive care units, and 351 died in IMU (death rate 14.9%). At admission, factors independently associated with in-hospital mortality were age (OR 2.46, p = 0.000), productive cough (OR 2.04, p = 0.000), pre-existing chronic heart failure (OR 1.58, p = 0.017) and chronic obstructive pulmonary disease (OR 1.17, p = 0.048), the number of comorbidities (OR 1.34, p = 0.000) and polypharmacy (OR 1.20, p = 0.000). Of note, up to 40% of elderly patients did not report fever at admission. Decreasing PaO2/FiO2 ratio at admission was strongly inversely associated with survival. The use of conventional oxygen supplementation increased with the number of pre-existing comorbidities, but it did not associate with better survival in patients with PaO2/FiO2 ratio

congenital bleeding disorders

Vaccination against communicable diseases is crucial for disease prevention, but this practice poses challenges to healthcare professionals in patients with haemophilia. Poor knowledge of the vaccination requirements for these patients and safety concerns often result in vaccination delay or avoidance. In order to address this issue, a panel of 11 Italian haemophilia and immunization experts conducted a Delphi consensus process to identify the main concerns regarding the safe use of vaccines in patients with haemophilia. The consensus was based on a literature search of the available evidence, which was used by the experts to design 27 consensus statements. A group of clinicians then rated these statements using the 5‐point Likert‐type scale (1 = strongly disagree; 5 = strongly agree). The main issues identified by the expert panel included vaccination schedule for haemophilic patients; protocol and optimal route of vaccine administration; vaccination of haemophilic patients with antibodies inhibiting coagulation factor VIII (inhibitors); and vaccination and risk of inhibitor development. This manuscript discusses these controversial areas in detail supported by the available literature evidence and provides evidence‐ and consensus‐based recommendations. Overall, participants agreed on most statements, except those addressing the potential role of vaccination in inhibitor formation. Participants agreed that patients with haemophilia should receive vaccinations according to the institutional schedule for individuals without bleeding disorders; however, vaccination of patients with haemophilia requires comprehensive planning, taking into account disease severity, type and route of vaccination, and bleeding risk. Data also suggest vaccination timing does not need to take into consideration when the patient received factor VIII replacement.

SummaryData from large case series of children with cerebral thrombotic events are pivotal to improve prevention, early recognition and treatment of these conditions. The Italian Registry of Pediatric Thrombosis (R. I. T. I.) was established in 2007 by a multidisciplinary team, aiming for a better understanding of neonatal and paediatric thrombotic events in Italy and providing a preliminary source of data for the future development of specific clinical trials and diagnostic-therapeutic protocols. We analysed data relative to the paediatric cerebral thrombotic events of the R. I. T. I. which occurred between January 2007 and June 2012. In the study period, 79 arterial ischaemic stroke (AIS) events (49 in males) and 91 cerebral sinovenous thrombosis (CSVT) events (65 in males) were enrolled in the R. I. T. I. Mean age at onset was 4.5 years in AIS, and 7.1 years in CSVT. Most common modes of presentation were hemiparesis, seizures and speech disturbances in AIS, and headache, seizures and lethargy in CSVT. Most common etiologies were underlying chronic diseases, vasculopathy and cardiopathy in AIS, and underlying chronic diseases and infection in CSVT. Time to diagnosis exceeded 24 hours in 46 % AIS and 59 % CSVT. Overall data from the Italian Registry are in substantial agreement with those from the literature, despite small differences. Among these, a longer time to diagnosis compared to other registries and case series poses the accent to the need of an earlier recognition of paediatric cerebrovascular events in Italy, in order to enable prompt and effective treatment strategies.

We evaluated the outcome of 482 children with acute myeloid leukemia (AML) enrolled in the Associazione Italiana di Ematologia e Oncologia Pediatrica AML 2002/01 trial. Treatment was stratified according to risk group; hematopoietic stem cell transplantation (HSCT) was used in high-risk (HR) children. Patients with core binding factor leukemia achieving complete remission (CR) after the first induction course were considered standard risk (SR; 99 patients), whereas the others (n 5 383) were assigned to the HR group. Allogeneic (ALLO) or autologous (AUTO) HSCT was employed, respectively, in 141 and 102 HR patients after consolidation therapy. CR, early death, and induction failure rates were 87%, 3%, and 10%, respectively. Relapse occurred in 24%of patients achieving CR. The 8-year overall survival (OS), event-free survival (EFS), and disease-free survival (DFS) were 68%, 55%, and 63%, respectively. OS, EFS, and DFS for SR and HR patients were 83%, 63%, and 66% and 64%, 53%, and 62%. DFS was 63% and 73% for HR patients given AUTO-HSCT and ALLO-HSCT, respectively. In multivariate analysis, risk group, white blood cell >100 × 109/L at diagnosis, and monosomal karyotype predicted poorer EFS. Risk-oriented treatment and broad use of HSCT result in a long-term EFS comparing favorably with previously published studies on childhood AML. (Blood. 2013; 122(2):170-178) © 2013 by The American Society of Hematology.

Summary Despite great advances in haemophilia care in the last 20 years, a number of questions on haemophilia therapy remain unanswered. These debated issues primarily involve the choice of the product type (plasma-derived vs. recombinant) for patients with different characteristics: specifically, if they were infected by blood-borne virus infections, and if they bear high or low risk of inhibitor development. In addition, the most appropriate treatment regimen in non-inhibitor and inhibitor patients compel physicians operating at the haemophilia treatment centres (HTCs) to take important therapeutic decisions, which are often based on their personal clinical experience rather than on evidence-based recommendations from published literature data. To know the opinion on the most controversial aspects in haemophilia care of Italian expert physicians, who are responsible for common clinical practice and therapeutic decisions, we have conducted a survey among the Directors of HTCs affiliated to the Italian Association of Haemophilia Centres (AICE). A questionnaire, consisting of 19 questions covering the most important topics related to haemophilia treatment, was sent to the Directors of all 52 Italian HTCs. Forty Directors out of 52 (76.9%) responded, accounting for the large majority of HTCs affiliated to the AICE throughout Italy. The results of this survey provide for the first time a picture of the attitudes towards clotting factor concentrate use and product selection of clinicians working at Italian HTCs.

Data from the Italian Hemophilia Centres were collected to perform a retrospective survey of joint arthroplasty in patients with severe hemophilia. Twenty-nine of 49 hemophilia centers reported that 328 of the 347 operations were carried out in 253 patients with severe hemophilia A (HA) and 19 in 15 patients with severe hemophilia B (HB). When results were normalized to the whole Italian hemophilia population (1770 severe HA and 319 severe HB), patients with HA had a 3-fold higher risk of undergoing joint arthroplasty (odds ratio [OR], 3.38; 95% confidence interval [CI], 1.97-5.77; P < .001). These results were confirmed after adjustment for age, HIV, hepatitis C virus (HCV), and inhibitor in a Cox regression model (HR, 2.65; 95% CI, 1.62-4.33; P < .001). The survival analysis of time to joint arthroplasty in the subset of patients with severe HA was not affected by the severity of factor VIII (FVIII) gene mutations. A systematic review of literature articles reporting joint arthroplasties in HA and HB showed that the proportion of HA patients who had undergone arthroplasties was higher than that of HB patients, in agreement with the findings in our Italian cohort. These data suggest that the 2 inherited coagulation disorders have a different severity of clinical phenotype.

National haemophilia registries are powerful instruments to support health care and research. A national registry was established in Italy by the Ministry of Health until 1999. Since 2003 the Italian Association of Haemophilia Centres (AICE) started a new programme aiming at building up the Italian Registry of Haemophilia and Allied Disorders. The AICE identified an expert panel to steer the registry. A computer software to assist patient management was developed and all the AICE-affiliated haemophilia treatment centres (HTC) were prompted to adopt it. Twice a year a predefined set of anonymized data is centralized and merged into a national database. Duplicated entries are managed through a confidentiality sparing mechanism. The database covers sociodemographic, clinical, laboratory and treatment data. A subset of data are shared with the Ministry of Health (Istituto Superiore di Sanita,ISS).Overall, data were collected six times by 43 of 49 HTC; 41 centres updated their patients' records up to December 2006. The database contains 6632 unique records, 442 of them referring to dead patients. Database growth and missing data clearance showed a constantly positive trend over time. The database has collected records of the following alive patients - haemophilia A: 1364 severe, 398 moderate and 935 mild; haemophilia B: 231 severe, 138 moderate and 204 mild; von Willebrand's disease: 1208 type 1, 346 type 2 and 96 type 3. Inhibitor patients were 296 (of which 194 high responders and 65 low responders).The Italian registry run by AICE adds to the list of the available national haemophilia registries and is intended to establish treatment guidelines and foster research projects in Italy.

OBJETIVO: Investigar a influência de fatores socioeconômicos e gestacionais sobre a hospitalização por pneumonia no período pós-neonatal. MATERIAL E MÉTODO: Longitudinal. Crianças com idade entre 28 e 364 dias, nascidas na cidade de Pelotas, RS (Brasil), em 1993. A definição de caso foi a permanência em ambiente hospitalar por um período igual ou superior a 24 horas em conseqüência de pneumonia. Foi aplicado delineamento longitudinal. RESULTADOS: Dentre as 5.304 crianças da coorte, 152 (2,9%) foram hospitalizadas por pneumonia no período. O valor preditivo positivo do diagnóstico clínico comparado com o radiológico alcançou 76%. A análise através de regressão logística mostrou que a classe social e a escolaridade materna estiveram forte e inversamente associadas à admissão hospitalar. Filhos de mães adolescentes tiveram risco duplicado à internação; paridade igual ou superior a três representou risco 2,8 vezes maior em relação às mães primíparas; ganho de peso inferior a 10 kg durante a gestação implicou risco cerca de 40% maior à hospitalização. CONCLUSÕES: A classe social e a escolaridade materna foram os principais determinantes da hospitalização. Idade e paridade materna e o ganho de peso durante a gestação foram também fatores de risco importantes. OBJECTIVE: To investigate the influence of socioeconomic and gestational factors on admission due to pneumonia in the post-neonatal period. METHODOLOGY: Cohort. Children born in the city Pelotas, Brazil, in 1993. Cases were children admitted to hospital for 24 hours or more, between the ages of 28 and 364 days, with a diagnosis of pneumonia. RESULTS: Of the 5,304 children in the cohort, 152 (2.9%) were hospitalized with pneumonia. The positive preditive value of the clinical diagnosis compared to the radiological assessment was 76%. Analysis by conditional logistic regression showed that social class and maternal schooling were strongly inversely associated with pneumonia. Children of adolescent mothers were twice as likely to be admitted. The relative risk for children whose mothers were of parity three or greater was 2.8 relative to primiparae. Maternal weight gain during pregnancy of less than 10 kg was associated with a 40% increase in risk. CONCLUSION: Socioeconomic factors were important determinants of pneumonia admissions. Maternal age, parity and weight gain were also significant risk factors.

Purpose Between May 1995 and August 2000 the Associazione Italiana di Ematologia Oncologia Pediatrica conducted the ALL-95 study for risk-directed, Berlin-Frankfurt-Muenster (BFM) –oriented therapy of childhood acute lymphoblastic leukemia, aimed at exploring treatment reduction in standard-risk patients (SR) and intensification during continuation therapy in intermediate-risk patients (IR) as randomized questions and treatment intensification in high-risk patients (HR). The prognostic value of DNA index was explored in this setting. Patients and Methods A total of 1,744 patients were enrolled (115, SR; 1,385, IR; and 244, HR). SR patients (DNA index ≥ 1.16 and < 1.60; age, 1 to 5 years; and WBC < 20,000, non–T-immunophenotype, with no high-risk features) received a reduced induction therapy (no anthracyclines); IR patients were randomly assigned to receive or not receive vincristine and dexamethasone pulses during maintenance; HR therapy was based on a conventional BFM schedule intensified with three chemotherapy blocks followed by a double reinduction phase. Results The event-free survival and overall survival probabilities at 10 years for the entire group were 72.5% (SE, 1.3) and 83.6% (SE, 0.9); 85.0% (SE, 3.4) and 95.5% (SE, 2.0) in SR, 75.1% (SE, 1.5) and 87.5% (SE, 0.9) in IR, and 51.0% (SE, 3.2) and 57.2% (SE, 3.3) in HR patients, respectively. Patients with a favorable DNA index had superior EFS in both IR (83.8% [2.7%] v 73.9% [1.7%]) and in HR (67.8% [9.4%] and 49.6% [3.5%]). Of the six patients with DNA index less than 0.8, only one remained in remission. Conclusion Favorable DNA index was associated with a better prognosis in IR and HR patients defined by presenting clinical criteria and treatment with a BFM-oriented chemotherapy.

BACKGROUND: Increasingly, there is a trend toward the use of left ventricular assist devices (LVADs) for treating advanced heart failure, as both bridge-to-transplant therapy and destination therapy. Living with an LVAD profoundly influences patients' lives. Only a few study authors investigated the experience of people with abdominal LVADs, and nothing is known about the unique experience of those with retro-auricular LVADs. OBJECTIVE: The aim of this study was to explore and describe experiences and lifestyle adjustments in adults with retro-auricular LVADs implanted as destination therapy. METHODS: Interpretive description methodology was used to explore the experiences of a purposeful sample of 10 individuals with retro-auricular LVADs implanted as destination therapy. Data were collected using in-depth semistructured interviews. Data collection and analysis were simultaneous. Triangulation, journaling, and the "thoughtful clinician test" were used to increase trustworthiness of the findings. RESULTS: Three primary themes describing the experience of people with retro-auricular LVADs were developed: "a new life," "self-care," and "resilience"; in addition, a crosscutting theme was identified: "support system." This article focuses on the theme "a new life," described as a continuum of events. Individuals with advanced heart failure struggle with symptom burden and consider the implantation of the device as the final option to delay death; then, they wait for the surgery that represents a turning point, after which they begin to recover through a process of adjustment until they reach a new normality. CONCLUSIONS: Living with a retro-auricular LVAD impacts every aspect of people's lives. Knowing their experiences can help clinicians to develop targeted interventions and offer tailored support.

Purpose: To describe sex-related differences in self-care; to identify determinants of self-care according to sex, and to investigate how sex interacts with the effect of clinical and socio-demographic variables on self-care in adults with Type 2 Diabetes Mellitus (T2DM). Methods: Cross-sectional multicentre study with a consecutive sampling recruitment strategy, enrolling 540 adults with T2DM at six outpatient diabetes services. Clinical and socio-demographic variables were collected by medical records. Self-care maintenance, monitoring, management, and confidence were measured by the self-care of diabetes inventory. Results: Females reported higher disease prevention behaviors (P < 0.001), health-promoting behaviors (P < 0.001), body listening (P < 0.001), and symptom recognition (P = 0.010), but lower health-promoting exercise behaviors (P < 0.001). Determinants of self-care were different in male and female patients, where the role of task-specific self-care confidence predicted self-care monitoring (RR = 0.98; P < 0.001) and management (RR = 0.99; P < 0.001) among males, while persistence self-care confidence predicted self-care maintenance (RR = 0.97; P = 0.016) and management (RR = 0.99; P = 0.009) among females. Conclusions: Males and females differently perform self-care. Self-care confidence plays a different role predicting self-care behaviors in males and females. Future research should longitudinally describe self-care and its determinants in males and females with T2DM. Sex-specific self-care confidence interventions should be developed to improve self-care in male and female patients with T2DM.

Purpose This study explores the disease experience of adolescents and young adults with T1DM focusing on the barriers and facilitators that characterise their disease self-care. Self-care requires complex decision making and cooperation between patients, their families, the healthcare team, and the social support system. Personal and social factors affect self-care, and specific challenges impact adolescents and young adults, putting them at a higher risk of poor glycaemic control and more severe complications. Design and methods The study uses a qualitative description approach. Twenty-two people (15 women; 10–30 years old; 2–24 years from diagnosis) were purposefully recruited through snowballing techniques. Data were collected with semi-structured interviews and analysed inductively with semantic thematic analysis. Results Four themes and nine subthemes conceptualise the patients' experience as a life-long journey that has its difficult beginning at the time of diagnosis and continues through the resolution of the initial crisis by integrating disease at the identity level and acquiring expertise. Technology and social environment act both as self-care barriers and facilitators. Conclusions Findings highlight the importance of designing and improving technology related to diabetes accounting for patients' experiences. Second, it is imperative to work towards a de-stigmatisation of diabetes. Finally, health professionals should work with people with T1DM on the psychological aspects of the disease and identity integration. Practice implications Diabetes-related technology should promote usability and acceptability while addressing visibility and device burden issues. Clinicians should pay particular attention during the transition from the paediatric to the adult centres and offer global assessments and treatment.

Background The Self-care of Diabetes Inventory (SCODI) is a theory-based tool that measures self-care, a key strategy in the appropriate treatment of diabetes. However, despite the clinical differences between people with Type 1 Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus (T2DM), the psychometric properties of the SCODI were only tested in mixed samples. Purpose This study aims to test the psychometric performances of the SCODI in two separate groups of adults with T1DM and T2DM. Methods This is a secondary analysis from two previous multicentre cross-sectional observational studies involving patients with T1DM (n = 181) and T2DM (n = 540). We tested dimensionality with confirmatory factor analysis and reliability with a multidimensional model-based coefficient for every scale of the SCODI: self-care maintenance, self-care monitoring, self-care management, and self-care self-efficacy. Results We found that the SCODI showed the same dimensionality, with minimal variation in factor loadings for each factor and each scale among T1DM and T2DM groups. High reliability for each scale in both groups was also found (self-care maintenance: T1DM = 0.86, T2DM = 0.83; self-care monitoring: T1DM = 0.84, T2DM = 1.00; self-care management: T1DM = 0.87, T2DM = 0.86; self-care self-efficacy: T1DM = 0.88; T2DM = 0.86). Conclusion The SCODI can be used for measuring self-care in people with T1DM, T2DM, or mixed groups using identical scoring procedures. Considering the well-known differences between Type 1 and Type 2 diabetes diseases and patients’ characteristics, our results support the generalizability of the self-care theory on which the instrument is based.

The COVID-19 pandemic has had a severe impact on nursing care. This cross-sectional survey-based study compared aspects of nursing care and nurses’ satisfaction with care provided before and during the first wave of the COVID-19 pandemic. A total of 936 registered nurses (RNs) rated the frequency with which they performed fundamental care, nursing techniques, patient education, symptom management, and nurse–patient relationships before and during the pandemic. A recursive partitioning for ordered multivariate response in a conditional inference framework approach was applied. More frequent fundamental cares were associated with their frequency before the pandemic (p &lt, 0.001), caring for COVID-19 patients (p &lt, 0.001), and workplace reassignment (p = 0.004). Caring for COVID-19 patients (p &lt, 0.001), workplace reassignment (p = 0.030), and caring for ≤7.4 COVID-19 patients (p = 0.014) increased nursing techniques. RNs in high-intensity COVID-19 units (p = 0.002) who educated patients before the pandemic, stopped this task. RNs caring for COVID-19 patients reported increased symptom management (p &lt, 0.001), as did RNs caring for more non-COVID-19 patients (p = 0.037). Less frequent nurse–patient relationships before the pandemic and working in high-intensity COVID-19 units decreased nurse–patient relationships (p = 0.002). Despite enormous challenges, nurses continued to provide a high level of care. Ensuring the appropriate deployment and education of nurses is crucial to personalize care and to maintain nurses’ satisfaction with the care provided.

Aims: Explore the self-care experiences of patients with multiple chronic conditions (MCCs) and caregivers' contributions to patient self-care during COVID-19 pandemic. Design: A descriptive qualitative design was used. The COREQ checklist was used for study reporting. Methods: Individual semi-structured interviews were used to collect data from patients with MCCs and caregivers selected from the dataset of an ongoing longitudinal study. Data analysis was performed through deductive thematic analysis. The middle-range theory of self-care of chronic illness, which entails the three dimensions of self-care maintenance, monitoring and management, was used as a theoretical framework to guide data collection and analysis. Results: A total of 16 patients and 25 caregivers were interviewed from May to June 2020. The participants were mainly women, with a mean age for patients of 76.25years and caregivers of 45.76years; the caregivers were mainly the patients' children (72%). During the pandemic, some patients reported remaining unchanged in their self-care maintenance, monitoring and management behaviours, others intensified their behaviours, and others decreased them. Caregivers played an important role in protecting patients from the risk of contagion COVID-19 and in ensuring patients' self-care of chronic diseases through direct and indirect interventions. Conclusions: Critical events can modify the self-care experiences of chronically ill patients and caregivers' contributions, leading to maintenance, increase or decrease of self-care and contributions to self-care behaviours. Impact: Patients with MCCs and their caregivers can react in different ways in their performances of self-care and contribution to patients' self-care behaviours when ordinary daily life is disrupted; therefore, nurses should assess such performances during critical events to identify the individuals at risk of reduced self-care and promote the most suitable healthcare services (e.g. eHealth) to implement individualised interventions.

Objective of the Study:In this study we aimed to retrospectively evaluate how centers, belonging to the Associazione Italiana Ematologia e Oncologia Pediatrica (AIEOP), manage severe acquired hypofibrinogenemia in children with acute lymphoblastic leukemia, particularly evaluating the therapeutic role of human fibrinogen concentrate (HFC) and fresh frozen plasma (FFP).Methods:We conducted a survey among AIEOP centers; thereafter, we collected and analyzed data with regard to the treatment of episodes of severe acquired hypofibrinogenemia occurring during the induction and reinduction phases of the AIEOP-BFM ALL 2009 protocol.Results:In total, 15 of the 37 AIEOP centers invited to join the survey agreed to collect the data, with 10 and 5 centers declaring to react to severe acquired hypofibrinogenemia (

Rapid qualitative research (RQR) studies are increasingly employed to inform decision-making in public health emergencies. Despite this trend, there remains a lack of clarity around what these studies actually involve in terms of methodological processes and practical considerations or challenges. Our team conducted a global RQR study during the COVID-19 pandemic. In this article, we provide a detailed account of our methodological processes and decisions taken related to ethics, study design, and analysis. We describe how we navigated limitations on time and resources. We draw attention to several elements that operated as facilitators to the rapid launch and completion of this study. Rendering methodological considerations and rationales for specific RQR studies explicit and available for consideration by others can contribute to the validity of RQR, support further discussion and development of RQR methods, and make findings for particular studies more credible.

Background Collaboration in healthcare is essential but differences in personal values can be a potential source of disagreements between physicians and nurses. Objectives The purpose of this study was to verify if and to what extent there were divergences in the personal values profile between medical and nursing students at the beginning of their education and training. A second aim was to explore gender differences in personal values. Design This is an observational cross-sectional study. Settings This study was conducted at one University in northern Italy. Participants We compared the personal values of 393 first-year medical students with those of 403 first-year nursing students. Methods The Portrait Values Questionnaire-40 was administered and analyses of variance were performed to assess degree group and gender differences in terms of personal values. Results Medical students scored significantly higher than nursing ones on values related to dominance over others and personal success. Female students significantly outscored males on personal values that reflect other-oriented and social focus, whereas male students obtained higher scores than females on personal values related to personal and selfish orientation. Conclusions Schwartz's Theory of Basic Human Values may be a valuable theoretical framework for interprofessional education to promote a common reflection on personal values held by medical and nursing students since the early years of study.

Background The COVID-19 pandemic has spread widely among healthcare workers. Recently, new effective vaccines against COVID-19 have begun to be administered to healthcare workers in several countries, including Italy. Purpose Our aim was to evaluate the intentions to be vaccinated against COVID-19 in a population of nursing students, identifying factors associated with the intentions. Method We conducted an anonymous online survey among 728 nursing students. The questionnaire collected data on demographic and academic characteristics, health status, vaccine attitudes, and specific reasons regarding the intention to get or not get the COVID-19 vaccination. Results A total of 422 nursing students completed the survey. Almost 81% of participants wanted to take the vaccine against coronavirus. The intention to adhere to the vaccination program was associated with male gender, a previous flu vaccine uptake, and high school education. The main reason in favor of taking the vaccine was to protect family and friends. The main reason for opposition was the fear of adverse events. Conclusion It is fundamental to consider vaccine hesitancy in healthcare students and face it properly, since these are the healthcare workers of the future who will have to provide recommendations to patients and promote adherence to vaccination programs.

Objective: To explore the association between perceived sleep quality and participation in people with spinal cord injury (SCI). Design: Cross-sectional study. Setting: Spinal unit at the Città della Salute e della Scienza University Hospital of Turin, Italy. Participants: From May to July 2019, 55 consecutive outpatients were recruited. Outcome measures: A set of structured questionnaires was administered. It included sociodemographic data, the Pittsburgh Sleep Quality Index, the Utrecht Scale for Evaluation of Rehabilitation-Participation, the Spinal Cord Independence Measure Self-Report, the Short Form version 12.2, and the Hospital Anxiety and Depression Scale. T-tests were used to highlight differences between participation and participant characteristics. Bivariate analyses and linear regressions were performed to identify associations between sleep quality and participation. Results: Differences in participation occurred mainly in individuals with a higher level of injury, caregiver dependency, and lower functional level. Participants reporting better sleep quality had more frequent (r = –0.36, P < 0.01), less restricted (r = –0.32, P < 0.05), and more satisfactory participation (r = –0.33, P < 0.01). Linear regression analyses showed that poor sleep quality was significantly associated with reduced participation frequency (β = –0.30, P = 0.03) and less satisfaction with participation (β = –0.49, P < 0.001). Moreover, age, number of hours slept at night, and time since injury were associated with satisfaction with participation. Conclusions: An association was found between sleep quality and participation in people with SCI. Given the high prevalence of sleep problems and their association with all dimensions of participation, the promotion of sleep quality should be encouraged because it may positively affect participation.

Purpose: To evaluate how self-care maintenance, self-care monitoring, and self-care management affect glycated haemoglobin in type 2 diabetes mellitus patients and to set cut-off points of the Self-Care of Diabetes Inventory scales using glycated haemoglobin as outcome of interest. Methods: A secondary analysis of a previous multicentre observational cross-sectional study was conducted. Overall, 540 adults with type 2 diabetes mellitus confirmed diagnosis were involved. Socio-demographic and clinical data were collected. Self-care maintenance, self-care monitoring, and self-care management were measured by the Self-Care of Diabetes Inventory. Linear regression models were performed to assess the relationship between self-care maintenance, self-care monitoring, and self-care management and glycated haemoglobin. Receiver operating characteristics curves were carried out to identify the best cut-off score for each self-care scale considering glycated haemoglobin >7% as outcome of interest. Results: Self-care monitoring and self-care management were associated to glycated haemoglobin in both patients without (self-care monitoring p = 0.0008; self-care management p = 0.0178) and with insulin therapy (self-care monitoring p = 0.0007; self-care management p = 0.0224). Self-care maintenance was associated to glycated haemoglobin in patients without insulin therapy (p = 0.0118). Cut-off scores providing the best performance were 70 points for self-care maintenance and self-care monitoring, and 60 points for self-care management. Conclusions: Self-care maintenance, self-care monitoring, and self-care management differently affect glycated haemoglobin in patients with type 2 diabetes mellitus. Clinicians could implement tailored interventions to improve glycaemic control considering the lacking area of self-care.

The aims of this study were to describe self-care in US T2DM patients and to identify clinical and sociodemographic determinants of self-care maintenance, monitoring, and management in US T2DM patients. A secondary analysis was performed using data from a cross-sectional study done to test the psychometric performance of the Self-Care of Diabetes Inventory in US English speaking adults with diabetes. In our sample ( n = 207), self-care maintenance was adequately performed (median = 75), self-care monitoring was borderline (median = 67.6) and self-care management was poor (median = 55.6). Low income ( p = .0019) and low self-care confidence ( p < .0001) were associated with relatively lower self-care maintenance. Not taking insulin ( p = .0153) and low self-care confidence ( p < .0001) were associated with relatively low self-care monitoring. Low self-care confidence ( p < .0001) was associated with low self-care management. Self-care confidence is a strong determinant of self-care. Interventions designed to improve self-care confidence are urgently needed.

In type 2 diabetes mellitus (T2DM) patients, human values have been identified as having a possible impact on self-care. Despite this, basic human values have never been described in the T2DM population and the association between basic human values and self-care has not been assessed. The aims of this study were to describe basic human values and self-care, and investigate the associations between basic human values and self-care in adults with T2DM. The study was cross-sectional multicentre with T2DM patients ( n = 390). Sociodemographic and clinical data were collected from charts, and two questionnaires were administered. The Portrait Values Questionnaire (PVQ) measured basic human values and allowed us to group patients into four groups based on the value profile: (A) Openness to Change and Self-Transcendence, (B) Conservation and Self-Transcendence, (C) Conservation and Self-Enhancement, and (D) Openness to Change and Self-Enhancement. The Self-care of Diabetes Inventory measured self-care maintenance, self-care monitoring, self-care management, and self-care confidence, according to the Middle-Range Theory of Self-Care of Chronic Illness. Multiple regression models were used to assess associations between the basic human values and self-care. Group D (Openness to Change and Self-Enhancement) performed significantly lower self-care maintenance ( p = .024) and self-care monitoring ( p = .031) when compared with Group A, and lower self-care monitoring ( p = .008) and self-care management ( p = .018) when compared with Group B. Group D showed significantly lower self-care monitoring ( p = .027) when compared with Group C. People with T2DM who value more self-enhancement and openness to change might be more prone to perform worse self-care compared with those who value conservation and self-transcendence. Clinicians should consider this when designing interventions aimed at improving self-care behaviors in patients with T2DM.

Aims: To describe self-care as defined by the Middle Range Theory of Self-Care of Chronic Illness and to identify clinical and socio-demographic determinants in a T2DM population. Methods: A multicentre observational cross-sectional study was conducted involving 540 adults with a confirmed diagnosis of T2DM from six outpatient diabetes services in Italy. Socio-demographic and clinical data were collected from medical records. The Self-Care of Diabetes Inventory (SCODI) was used to measure self-care maintenance, monitoring, management, and confidence dimensions. For each separate scale, scores were standardized 0–100 with higher SCODI scores indicating better self-care; a score ≥ 70 is adequate. Multiple quantile regression models were performed to identify determinants of each self-care dimension. Results: Self-care maintenance (median = 81.3) and self-care confidence (median = 79.5) were adequate in most of the subjects. Self-care monitoring was adequate in only half of the sample (median = 70.6). Self-care management was poor (median = 59.4). Lower self-care maintenance was associated with lower self-care confidence (p < 0.001). Lower self-care monitoring was associated with being male (p < 0.001), having lower self-care confidence (p < 001), and having diabetes for < 10 years (p < 0.001). Lower self-care management was associated with being male (p = 0.002), being older (p = 0.005), having a low income (p = 0.030), being employed (p = 0.008), having missed diabetes education in the last year (p = 0.002), and lower self-care confidence (p < 0.0001). Lower self-care confidence was associated with having diabetes for < 10 years (p = 0.008), and having at least one comorbid condition (p = 0.006). Conclusions: Determinants of self-care maintenance, monitoring, management and confidence include both clinical and socio-demographic variables. Modifiable determinants such as self-care confidence and diabetes self-care management education could be used to tailor interventions to improve diabetes self-care

Background Sleep disturbance is one of the most common symptoms among heart failure patients. Sleep disturbance reduces quality of life and leads to higher rates of mortality. It may affect the ability of patients to perform adequate self-care. Although some research has evaluated the association between sleep quality and heart failure self-care, a synthesis of the most recent available evidence is lacking. Aims This systematic review aimed to assess the association between sleep quality and self-care in adults with heart failure. Methods The Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology was used. Medline, CINAHL, PsycINFO and SCOPUS were searched. Observational, case-control and cohort studies were considered. The quality of the studies was evaluated with the Joanna Briggs Institute’s Critical Appraisal Tools. Results Six articles were included. Association between sleep quality and self-care was reported by three studies. One of these did not find an association between sleep disturbance and heart failure self-care, while the other two studies did. An association between sleep quality and medication adherence was reported by three studies. All three of these studies found associations between these two variables. Studies have measured similar but different constructs. Two studies assessed sleep quality, while four other studies measured excessive daytime sleepiness. Half of the studies examined self-care, while the other half measured medication adherence. Conclusions Although the evidence should be strengthened, sleep quality seems to affect self-care in heart failure patients. The mechanism underlying the effect of sleep quality on heart failure self-care remains unclear. Future longitudinal interaction analyses could be useful to clarify this mechanism.

Background Self-care is essential for patients with diabetes mellitus. Both clinicians and researchers must be able to assess the quality of that self-care. Available tools have various limitations and none are theoretically based. The aims of this study were to develop and to test the psychometric properties of a new instrument based on the middle range-theory of self-care of chronic illness: the Self-Care of Diabetes Inventory (SCODI). Methods Forty SCODI items (5 point Likert type scale) were developed based on clinical recommendations and grouped into 4 dimensions: self-care maintenance, self-care monitoring, self-care management and self-care confidence based on the theory. Content validity was assessed by a multidisciplinary panel of experts. A multi-centre cross-sectional study was conducted in a consecutive sample of 200 type 1 and type 2 diabetes patients. Dimensionality was evaluated by exploratory factor analyses. Multidimensional model based reliability was estimated for each scale. Multiple regression models estimating associations between SCODI scores and glycated haemoglobin (HbA1c), body mass index, and diabetes complications, were used for construct validity. Results Content validity ratio was 100%. A multidimensional structure emerged for the 4 scales. Multidimensional model-based reliabilities were between 0.81 (maintenance) and 0.89 (confidence). Significant associations were found between self-care maintenance and HbA1c (p = 0.02) and between self-care monitoring and diabetes complications (p = 0.04). Self-care management was associated with BMI (p = 0.004) and diabetes complications (p = 0.03). Self-care confidence was a significant predictor of self-care maintenance, monitoring and management (all p

Paediatric patients with acute myeloid leukaemia (AML) who fail induction due to primary resistance to chemotherapy account for a significant proportion of cases and have a particularly dismal prognosis. We report the clinical and biological data, and final outcome of 48 paediatric patients with primary-resistant AML enrolled in the Associazione Italiana di Ematologia e Oncologia Pediatrica AML 2002/01 clinical trial. These patients had a significantly higher white blood cell count at diagnosis compared to other AML patients. Cytogenetic and molecular features did not differ between patients with primary induction failure and patients allocated to the high-risk group. For the whole patient population, the probability of overall survival, event-free survival (EFS) and disease-free survival (DFS) was 21·8% ± 6·2, 20·4% ± 5·9, and 49·5% ± 11·3, respectively. Twenty-eight (58%) patients received haematopoietic stem cell transplantation (HSCT); 3 were autologous and 25 were allogeneic. Patients who underwent HSCT had improved EFS (31·2% vs. 5%, P < 0·0001). Only one of the 20 patients who did not receive HSCT is alive and disease free. The 19 patients in complete remission at time of HSCT showed significantly better DFS than the 9 with active disease (46% vs. 0%, P = 0·02). This study represents one of the largest series with long-term follow up of paediatric AML patients with primary refractory disease. Children who underwent transplantation had an encouraging long-term outcome. Disease recurrence remains the major cause of treatment failure; a better understanding of the disease biology is desirable to develop more effective treatment strategies. © 2015 John Wiley

Approximately 10–15% of pediatric patients with acute lymphoblastic leukemia (ALL) have a T-cell phenotype. The prognosis of these patients has improved over the last years, owing to the use of more intensive treatment strategies. Characterization of molecular alterations with prognostic impact in T-ALL may be of great help for an early identification of patients at high risk (HR) of failure in whom more intensive treatments, including allogeneic hematopoietic stem cell transplantation, may be considered.

We analyzed 12 MLL/ENL positive ALL patients consecutively diagnosed between 1999 and 2009. The MLL/ENL fusion was identified in 4/150 (2.6%), 8/993 (0.8%), and 0/70 of pediatric, adult, and elderly patients, respectively. Eight patients had a WBC count >50 × 10(9) /L. Ten cases had an evaluable immunophenotyping. A B or T precursor ALL occurred in 7 and 3 patients, respectively. Eleven/12 patients (92%) achieved CR. At 48 months, overall survival and event-free survival rates were 73.3% and 67%, respectively. At CR, a parallel RT-PCR evaluation of the MLL/ENL expression was available in 5 cases. Of these latter, 2 tested MLL/ENL-negative and 3 positive. The minimal residual disease molecular monitoring showed that MLL/ENL status did not correlate with outcome. In fact, all the 2 PCR-negative and 1 of the 3 PCR-positive cases relapsed. Further, a MLL/ENL expression, not preceding a relapse, was detected several times during the follow-up of five long-survivors. In conclusion, also in adults, the MLL/ENL fusion identifies a rare leukemic entity with a favorable prognosis. The observed inconsistency between the clinical cure and the presence of detectable MLL/ENL transcript suggests the existence of a MLL/ENL-expressing "preleukemia" stem cells, similar to what demonstrated for the AML1/ETO-positive leukemia setting.

Introduction. Chronic myeloid leukemia (CML) patients (pts) treated with imatinib first line achieve complete cytogenetic response (CCyR) in > 70% of cases and major molecular response (MMR) in 18-58%. These pts have a life expectancy similar to the general population. However even undetectable BCR-ABL may not equate to eradication of the disease because of the sensitivity of Q-RT-PCR. A new diagnostic method, the digital-PCR (dPCR), able to detect 1 BCR-ABL+ cell out of 107 cells, has been recently developed (Goh HG et al., 2011). dPCR corresponds to a 100 fold increase in sensitivity as compared to Q-RT-PCR. Therefore, dPCR by assessing the presence of minimal residual disease with higher sensitivity, could potentially identify pts in whom CML has been eradicated. Aims. The Imatinib Suspension And Validation (ISAV) study is aimed at validating the capability of dPCR to predict relapses after imatinib discontinuation in CML pts with negative Q-RT-PCR results. Methods. This study involves 15 sites, 10 in Italy and 1 in each of the following countries: Germany, Spain, The Netherlands, Canada and Israel. CML pts (Chronic or Accelerated Phase) under imatinib therapy since more than 2 years and in complete molecular remission (CMR) were eligible for this study. Patients had to be in CMR for at least 18 months (mts), with a minimum of 3 Q-RT-PCR performed at their own sites. After signing the informed consent, blood samples are obtained for dPCR and the pts discontinue imatinib therapy. Standard Q-RT-PCR is performed monthly (mts 1-6) and then bimonthly for 36 mts to assess the maintenance of the molecular remission. The loss of molecular remission is defined as two consecutive positive Q-RT-PCR tests with at least one BCR-ABL/ABL value above 0.1%. Patients losing molecular remission resume imatinib treatment at the same dosage used before interruption. Patients’ quality of life during imatinib discontinuation/resumption is evaluated through the EORTC – C30 Quality of Life questionnaire. Results. The enrolment in ISAV began in November 2011 and ended in July 2013. The study enrolled 112 pts: Italy 69.6%, Germany 21.4%, Canada 5.3%, Spain 2.6% and Israel 0.9%. Among the 112 pts, 59.3% were male and 37.0% were aged 65 or older; median duration of imatinib treatment was 103.1 mts with median duration of CMR of 25.8 mts before imatinib discontinuation. To date, the median follow-up (FUP) time is 16.6 mts [95% CI: 14.9-18.2]. Forty-seven pts (43.5%, 95% CI: 34.0-53.4) of the 108 eligible pts relapsed and resumed imatinib; 38/47 (80.9%) of them relapsed in the first 9 mts and the last relapse occurred 19.6 mts after imatinib discontinuation. A loss of CCyR occurred in 11 pts (23.4%): 10/11 CCyR losses were recovered; 1 patient withdrew the consent shortly after obtaining a partial cytogenetic response. No case of CML progression was observed. After the resumption of imatinib the median time to either MMR or CMR was 1.9 [95% CI: 1.2-2.4] mts. Of the 61 not-relapsed pts, 43 (39.8% of the total) regained Q-RT-PCR positivity but never lost MMR. The median time to Q-RT-PCR positivity was 3.6 mts [95% CI: 3.0-4.8] and the range of duration of Q-RT-PCR positivity (below 0.1%) was between 5.7 and 29.2 mts. No significant correlation between relapse and previous duration of imatinib treatment, use of interferon, time to CCyR or duration of CMR was identified. An inverse relationship between pts age and risk of relapse is evident: 90% of pts < 45 years relapsed vs 37.5% in the class ≥ 45 - < 65 years and 27.5% of pts ≥ 65 years, p(χ2) Conclusions. After 32 mts from the beginning of the study, with a median FUP of 16.6 mts, 43.5% of pts relapsed; the majority of relapses developed in the first 9 months after imatinib discontinuation. Age < 45 years and dPCR positivity are significantly associated with relapses. Funded by Regione Lombardia. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures No relevant conflicts of interest to declare.