Clinical trials for elderly patients with multiple diseases (CHROMED) pilot study

The problem COPD (Chronic Obstructive Pulmonary Disease) is a significant socioeconomic burden which, particularly when associated with comorbidities such as Chronic Heart Failure (CHF), markedly affects patient outcomes. Care models based on telemedicine systems that enable early diagnosis and treatment of exacerbations are advocated to reduce the impact of chronic diseases on patient outcomes and health service costs. CHROMED (www.chromed.eu) is an international EU-funded project aimed at developing a multi-centre clinical trial to evaluate the impact of a new integrated home care approach to reduce care costs and improve quality of life in COPD. The approach We collaborated in a pilot study prior to the main trial which will include 300 patients from seven European countries (Italy, Spain, UK, Estonia, Slovenia, Sweden and Norway) with nine partners. The home monitoring system includes a novel forced oscillation technique (FOT) device for self-measurement of lung mechanics (RESMONPRO DIARY, Restech srl, Italy), a touch screen for collecting patients' symptoms and, where COPD is associated with CHF, by a device for measuring heart rate (HR), blood pressure (BP), pulse oximetry (SpO2) and body temperature (WRIST CLINIC, Medic4all, Israel). Findings The pilot included 16 patients (n=11 COPD, 5 COPD+CHF). The average monitoring period was 48.3±23.4 days resulting in a total of 504 patient days. The percentage of data correctly received within the period was: lung impedance and breathing pattern 90.0%; HR 91.7%, BP 91.7%; SpO2 74.0% and body temperature 71.4%. During the pilot, one patient was treated pharmacologically for an exacerbation of COPD. Offline processing demonstrated that the system identified warning of an exacerbation five days prior to admission. We also analysed qualitative data from patients and professionals about the acceptability of the telemedicine system and the interaction between patients, professionals and the monitoring system. Consequences The data suggest good acceptability and short-term compliance among patients with COPD. Lung function, HR and BP provided the most reliable data. The full RCT is currently under way and will be completed in August 2015

Lung function assessed by home forced oscillation and self reported symptoms during COPD exacerbations

CHROMED (clinical trials for elderly people with multiple diseases, www.chromed.eu) is an EU-funded project involving 9 partners from 7 European countries aimed at evaluating the impact of a new home care approach to reduce costs and improve quality of life in elderly patients with COPD and comorbidity. The trial involves 300 patients with a prior history of exacerbations randomly assigned to a monitoring or observational arm. Monitored patients performed daily self-assessment of lung mechanics with a FOT (Forced Oscillation Technique) device (RESMON PRO DIARY, Restech srl, Italy) and completed a symptom diary card on touchscreen device (HOME PATIENT MONITOR, EBM srl, Italy). Any detected worsening in lung mechanics generated an alert triggering a phone interview directed at verifying the patient's status and optimizing treatment. By the end of March 2015, 70 monitored patients had completed the trial resulting in 16198 measurements with an adherence of 90.1%. Based on lung mechanics, 311 worsening events were detected, resulting in 0.65±0.3 alerts/patient/month. At least one major symptom (dyspnea, sputum purulence and volume) was reported in 70% of events and 41% were associated with an exacerbation according to diary cards (Seemungal et al., Am J Respir Crit Care Med 1998). A total of 77 exacerbations were confirmed during the phone interview and treated, but 48% of them were not associated with an exacerbation defined by diary cards only. These results suggest that a significant percentage of exacerbations cannot be identified by diary cards only. Self-assessment of lung mechanics using FOT provides complementary information which can be useful to manage COPD patients at home

Multivariate Statistical Techniques to Manage Multiple Data in Psychology

Introduction:In big-data contexts, multivariate statistical techniques and machine learning methods play a crucial role for the assessment of the interrelations between and within sets of variables. In particular, in social and behavioural sciences, for which the exploration of patterns and mutual interrelation among subject features is needed, a proper use of this technique becomes paramount.Methods:A series of multivariate techniques –clustering, decision trees, principal component, multiple correspondence, partial least discriminate analysis –was applied to a sample of patients with diagnosis of borderline personality disorder (BPD)and bipolar disorder (BD), in order to outline specific socio-demographic and clinical profiles for both the diagnoses.Results:Although the BPD and BD patients are clinically blurred, some features appeared to well discriminate between the two diagnoses. BPD patients are more probably females who have shown self-harm behaviours and/or suicide attempts, while BD are more likely to be males who have never shown self-harm behaviours and have not attempted suicide. Moreover, the assessment variables with more discriminate power were BIS-11, SCL-90 and STAI-T. In particular, patients with SCL-90 total score <36 were more probably BD patients (probability p=87%); whereas patients with SCL-90 score 36 and a BIS-11 score 64 were more probably BPD patients (p=83%).Conclusions:The application of multivariate statistical analyses and machine learning techniques allows the definition of specific clinical and diagnostic profiles that can be crucial for taking adequately charge of the patients in a context of precision medicine andan ad-hoc diagnostic and care pattern

Multivariate Statistical Techniques to Manage Multiple Data in Psychology

Introduction: In big-data contexts, multivariate statistical techniques and machine learning methods play a crucial role for the assessment of the interrelations between and within sets of variables. In particular, in social and behavioural sciences, for which the exploration of patterns and mutual interrelation among subject features is needed, a proper use of this technique becomes paramount. Methods: A series of multivariate techniques –clustering, decision trees, principal component, multiple correspondence, partial least discriminate analysis –was applied to a sample of patients with diagnosis of borderline personality disorder (BPD)and bipolar disorder (BD), in order to outline specific socio-demographic and clinical profiles for both the diagnoses. Results: Although the BPD and BD patients are clinically blurred, some features appeared to well discriminate between the two diagnoses. BPD patients are more probably females who have shown self-harm behaviours and/or suicide attempts, while BD are more likely to be males who have never shown self-harm behaviours and have not attempted suicide. Moreover, the assessment variables with more discriminate power were BIS-11, SCL-90 and STAI-T. In particular, patients with SCL-90 total score = 36 and a BIS-11 score >=64 were more probably BPD patients (p=83%). Conclusions: The application of multivariate statistical analyses and machine learning techniques allows the definition of specific clinical and diagnostic profiles that can be crucial for taking adequately charge of the patients in a context of precision medicine and an ad-hoc diagnostic and care pattern

Emotional Regulation in Teens and Improvement of Constructive Skills (EmoTIConS):study protocol for a randomized controlled trial

BACKGROUND: Emotional dysregulation (ED) constitutes a relevant factor involved in the onset and maintenance of many mental disorders. Targeting ED during adolescence could be a determinant both to identify high-risk individuals and to promote preventive interventions. This study will aim to evaluate the impact of a brief Dialectical Behavioral Therapy (DBT)-based intervention for adolescent students by measuring changes in emotional regulation skills and impulsive behaviors. Moreover, alterations in biological features related to stress response and inflammation will be assessed as potential biological variables associated with ED. METHODS: This is a randomized trial. A total of 20 classes of adolescent students will be recruited among high schools in Brescia, a city in northern Italy. They will be randomized to the psychoeducational intervention (experimental group) or to a control condition (control group). The intervention will be based on DBT Skills Training for Emotional Problem Solving for Adolescents, and will consist of four monthly, 2-h sessions (for a total of 8 h) scheduled during regular school time. Participants will be assessed at baseline, post-intervention, and at 3 and 6 months of follow-up. The primary outcome measures will be represented by changes in the use of emotional regulation skills and by changes in the frequency of impulsive behaviors. Salivary samples will be collected at baseline and post-intervention to explore possible biological features underlying ED. DISCUSSION: Data from the present project will offer the opportunity to better understand the complex phenomenon of ED. Repeated assessment will cover several domains (emotional, behavioral, social, biological) as potential factors associated with ED. Moreover, it will be possible to establish the effect of the proposed intervention, thus helping to improve knowledge on the impact of school-based universal preventive programs. Finally, the current trial will propose an integrated screening and intervention-based model. Ultimately, this could reduce barriers to youths’ mental health care by fostering collaboration between schools and mental health services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04349709. Registered on April 16, 2020

Clinical trials for elderly patients with multiple diseases (CHROMED): a pilot study

Chronic Obstructive Pulmonary Disease (COPD) is a significant socio-economic burden. It is frequently associated with comorbidities, such as Congestive Heart failure (CHF), that affect patients' health outcomes. Telemedicine-based care models that enable early diagnosis and treatment are advocated to reduce the socioeconomic impact of chronic diseases. CHROMED (www.chromed.eu) is an EU-funded project involving 9 partners from 7 European countries (Italy, Spain, UK, Estonia, Slovenia, Sweden and Norway) aimed at evaluating the impact of a new integrated home care approach to reduce care costs and improve quality of life in COPD. CHROMED comprises a pilot study, followed by a multi-centric RCT with 300 patients. The CHROMED system includes a forced oscillation technique (FOT) device for self-measurement of lung mechanics (Resmon Pro Diary, Restech srl, Italy), a touch screen for collecting patient's symptoms and, for subjects with CHF comorbidity, a device for measuring heart rate (HR), blood pressure(BP), SpO2 and body temperature (WRIST CLINIC, Medic4all, Israel). The pilot study included 16 patients (11 COPD, 5 COPD+CHF). The average monitoring period was 48.3±23.4 days resulting in a total of 504 days. The percentage of data correctly received is reported in the table: Lung impedance and breathing pattern (90%); Heart rate (91.7%); Blood pressure (91.7%); SpO2 (74%); Body temperature (71.4%). During the pilot, one patient was treated pharmacologically for a COPD exacerbation. Offline processing demonstrated that the system identified this event 5 days in advance. A good acceptability of the system and short-term compliance among patients was found. Lung function, HR and BP provided the most reliable data

Aggressive behavior and metacognitive functions: A longitudinal study on patients with mental disorders

Background: Metacognitive functions play a key role in understanding which psychological variables underlying the personality might lead a person with a severe mental disorder to commit violent acts against others. The aims of this study were to: (a) investigate the differences between patients with poor metacognitive functioning (PM group) and patients with good metacognitive functioning (GM group) in relation to a history of violence; (b) investigate the differences between the two groups in relation to aggressive behavior during a 1-year follow-up; and (c) analyze the predictors of aggressive behavior. Methods: In a prospective cohort study, patients with severe mental disorders with and without a lifetime history of serious violence were assessed with a large set of standardized instruments and were evaluated bi-monthly with MOAS in order to monitor any aggressive behavior. The total sample included 180 patients: 56% outpatients and 44% inpatients, and the majority were male (75%) with a mean age of 44 (± 9.8) years, and half of them had a history of violence. The sample was split into two groups: poor metacognition (PM) group and good metacognition (GM) group, according to MAI evaluation scores. Results: The PM patients reported a history of violence more frequently than GM patients, during the 1-year follow-up, but no differences between groups in aggressive and violent behavior were found. The strongest predictors of aggressive behavior were: borderline and passive-aggressive personality traits and a history of violence, anger, and hostility. The metacognitive functions alone did not predict aggressive behavior, but metacognitive functions interacted with hostility and angry reactions in predicting aggressive behavior. Conclusions: This study led to some important conclusions: (a) some aspects closely related to violence are predictive of aggressive behavior only in patients with poor metacognition, thus good metacognition is a protective factor; (b) poor metacognition is associated with a history of violence, which in turn increases the risk of committing aggressive behavior