5,458 research outputs found
Creare una Sanità di valore attraverso la cultura della valutazione dell'outcome clinico
No full textLa valutazione delle prestazioni cliniche è di cruciale importanza per l’accountability dei servizi sanitari pubblici e per la definizione delle politiche sanitarie. L’analisi degli outcome è infatti fondamentale per indirizzare il miglioramento della qualità delle cure e dei servizi e, quindi, per la creazione di un sistema sanitario basato sul valore.
A questo proposito, il Programma Nazionale Esiti nel corso degli ultimi anni è diventato lo strumento più riconosciuto, tra quelli adottati dal Sistema Sanitario Nazionale italiano, per la misurazione, valutazione e confronto tra le attività ospedaliere e gli esiti clinici. In coerenza con tale quadro, la Provincia Autonoma di Trento ha sviluppato una serie di iniziative locali rivolte a fornire una valutazione completa e contestualizzata dei processi di cura, basata su dati provenienti da fonti cliniche ed amministrative.
Questo progetto di dottorato mira a disegnare e sperimentare un modello locale per la valutazione degli esiti di percorsi clinici e modelli organizzativi attraverso l’analisi di casi di studio di grande rilevanza clinica.
Per La valutazione di percorsi clinici sono stati presi in considerazione due casi d’uso. Il primo valuta diverse opzioni terapeutiche per i pazienti renali cronici curati dai servizi di dialisi della Provincia di Trento, mentre il secondo riguarda l’introduzione di un percorso clinico di ortogeriatria per la gestione di pazienti anziani dopo frattura del collo del femore nell'Ospedale Santa Chiara di Trento.
La valutazione dei modelli organizzativi è stata effettuata comparando gli outcome di una nuova configurazione basata su un approccio per intensità di cura rispetto a quelli di un modello standard, nel reparto di Medicina Interna dell'Ospedale Santa Chiara di Trento.
Lo studio di questi casi specifici, ha coinvolto l’analisi dei dati relativi a più di 3.500 pazienti, ha consentito l'acquisizione di metodi statistici e delle competenze tecniche, ora disponibili per una più ampia applicazione. Il lavoro ha aperto la strada ad un programma provinciale per la valutazione degli esiti clinici, ha contribuito al coinvolgimento di medici e alla diffusione di una cultura della valutazione dei risultati.Clinical performance assessment is crucial to accountability and policy making in health care. Outcomes data is indeed fundamental for directing quality improvement and creating a value-based healthcare system.
Among official tools adopted in the Italian National Health System with this purpose, the National Outcomes Program, over the last few years, became the most recognized tool for measuring, assessing and comparing hospital activities and clinical outcomes of care.
In coherence with that framework, local initiatives have been developed to provide a context-based and comprehensive assessment of care processes relying on data from multiple clinical and administrative sources.
This PhD project aimed at designing and piloting a local model for outcomes evaluation of clinical pathways and organizational models thorough analysis of case studies of major clinical relevance.
Evaluation of clinical pathways was implemented assessing different therapeutic options for chronic kidney patients cared by dialysis services of the Province of Trento and the setting up of an orthogeriatric hip fracture clinical pathway in the Santa Chiara Hospital of Trento.
Assessment of the organizational models was carried out by measuring selected outcomes of a new approach based on intensive medical care compared to standard medical care in the internal medicine ward of the Santa Chiara Hospital of Trento.
The training on specific cases, entailing the study of more than 3,500 inpatients, enabled the acquisition of statistical methods and technical skills now available for a wider application.
The work paved the road to a provincial program for clinical outcomes assessment and contributed to engagement of clinicians and spreading a culture of outcomes evaluation
Prevalence of perennial severe allergic asthma in Italy and effectiveness of omalizumab in its management: PROXIMA – an observational, 2 phase, patient reported outcomes study
No full textBackground: We designed the PROXIMA study (Patient-Reported Outcomes and Xolair® In the Management of Asthma) to determine the proportion of patients with severe asthma sensitive to perennial allergens, and to evaluate asthma control and treatment adherence up to 12 months in patients treated with omalizumab in Italian population. In addition, an ancillary study was designed to explore protein biomarkers and characterize them in relation to severe allergic asthma and treatment effects by proteomic approach. Methods: PROXIMA is an observational, multicenter, cross-sectional and prospective cohort study conducted at 25 centers in Italy, in outpatient settings. The study consists of two phases: 1) a cross-sectional phase plans to enroll 600 patients with severe allergic asthma, in step 4 therapy as per GINA guidelines, aged ≥18 years, needing a step up in therapy, and 2) a longitudinal phase on patients who will start omalizumab add-on therapy per clinician's judgment at baseline visit (approximately 180-240 patients). The primary variable of the cross-sectional phase is the proportion of patients with severe asthma presenting with perennial form of allergy (skin prick test or in vitro test). The primary variable of longitudinal phase is proportion of patients who achieve disease control (assessed by Asthma Control Questionnaire [ACQ]) with omalizumab at 6 months, and maintain it at 12 months. Secondary variables are patient compliance to omalizumab, patient-reported perception of cognitive and emotional impact of the illness, assessed by Brief Illness Perception Questionnaire (Brief IPQ) and the health related quality of life evaluated by the EuroQoL 5D-3 L (EQ-5D-3 L). Safety endpoints will be recorded during the course of the study. Patients participating in the longitudinal phase will be enrolled for ancillary study if they provide additional informed consent. Protein species in complex mixtures will be identified using innovative MudPIT (Multidimensional Protein Identification Technology) method. Conclusions: The results of this observational study will provide estimate of patient population allergic to perennial allergens in Italy and information on patient-reported outcomes with omalizumab therapy in a real-world setting. The exploratory proteomic analysis on asthma biomarkers could eventually provide new data to identify responder patients to anti IgE therapy
Heart failure patients unresponsive to implantable cardioverter‐defibrillator therapy: a neglected problem
No full textAppropriatezza delle linee guida per l’impianto di un defibrillatore cardiaco. Limiti di un approccio meta-analitico standard
No full textTomosintesi digitale e screening dei tumori mammari. Rapid Relative Effectiveness Assessment.
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Declining clinical benefit of ICD in heart failure patients: Temporal trend of mortality outcomes from randomized controlled trials
No full textThe risk of sudden cardiac death in patients with heart failure has declined over time thanks to the sequential introduction of new treatments. However, current guidelines recommendations for implantable cardioverter-defibrillator (ICD) are based on randomized controlled trials (RCTs) carried out in the past three decades and their meta-analyses. To highlight potential changes over time in ICD clinical benefit in primary prevention of sudden cardiac death, we analyzed the temporal trends of RCT risk of mortality outcomes in this time frame
Heart Rate Turbulence Is a Powerful Predictor of Cardiac Death and Ventricular Arrhythmias in Postmyocardial Infarction and Heart Failure Patients: A Systematic Review and Meta-Analysis
No full textBackground—Heart rate turbulence (HRT) has been proposed as a candidate marker of altered autonomic tone, and some
studies showed its prognostic value for both cardiac death (CD) and sudden death. Nevertheless, HRT is not currently
used in the clinical practice.
Methods and Results—We performed a systematic review and meta-analysis of the predictive value of HRT for the end
points of total mortality, CD, and fatal and nonfatal ventricular arrhythmias in postacute myocardial infarction and heart
failure patients. MEDLINE and The Cochrane Library databases were systematically searched to identify studies, which
analyzed the predictive value of abnormal HRT for the defined end points. Twenty studies (25 cohorts: 12 832 patients)
were identified by the systematic review, and 15 studies (20 cohorts: 11 499 patients) were included in the meta-analyses.
Abnormal HRT was a predictive marker for all the end points in heart failure patients and more markedly in postacute
myocardial infarction patients, where 9 out of the 10 cohorts had an ejection fraction >30%. In postacute myocardial
infarction patients, HRT had pooled risk ratios of 3.53 (95% confidence interval [CI], 2.54–4.90), 4.82 (95% CI, 3.12–
7.45), and 4.48 (95% CI, 3.04–6.60), and positive likelihood ratios of 3.5 (95% CI, 2.6–4.8), 4.1 (95% CI, 3.0–5.7), and
2.7 (95% CI, 2.2–3.3) for total mortality, CD, and arrhythmic events, respectively. The combination of abnormal HRT and
T-wave alternans (5 cohorts: 1516 patients) increased the predictive power for CD and arrhythmic events.
Conclusions—HRT is a powerful predictor of both CD and arrhythmic events, particularly in postacute myocardial
infarction patients with ejection fraction >30%. HRT power increases in combination with T-wave alternans analysis
Ventricular tachycardia-inducibility predicts arrhythmic events in post-myocardial infarction patients with low ejection fraction. A systematic review and meta-analysis
No full textBackground: Inducibility of ventricular arrhythmias at electrophysiological study (EPS) has long been suggested as predictive for subsequent arrhythmic events. Nevertheless, the usefulness of EPS in the clinical practice is still unclear. We performed a systematic review and meta-analysis to assess the predictive power of EPS in primary prevention of ventricular arrhythmias in post-myocardial infarction (MI) patients with left ventricular dysfunction. Methods: MEDLINE and the Cochrane Library databases were systematically searched to identify studies, which analyzed EPS predictive value in post-MI patients with mean EF < 40% for the composite arrhythmic endpoint defined by: sudden cardiac death (SCD), aborted SCD, ventricular tachycardia (VT), ventricular fibrillation (VF), appropriate implantable cardioverter-defibrillator (ICD) interventions. Results: Nine studies, evaluating 3959 patients with 647 arrhythmic events, were included in the meta-analyses. EPS showed a strong predictive power for the arrhythmic endpoint with a pooled odds ratio (OR) of 4.00 (95% confidence interval [CI]: 2.30–6.96) in the whole set of studies, albeit a high level of heterogeneity among studies. EPS predictive power was higher in studies where VT-inducibility was tested (OR 6.52; 95% CI: 2.30–18.44; sensitivity 0.65, specificity 0.78, and negative predictive value 0.94), versus those assessing VT/VF-inducibility (OR 2.09; 95% CI: 1.34–3.26). VT-inducibility was predictive even when assessed within one month after MI (OR 7.85; 95% CI: 3.67–16.80). Conclusions: Inducibility of ventricular arrhythmias at EPS is a strong predictor of the arrhythmic endpoint in post-MI patients with impaired EF, particularly when VT-inducibility is tested. EPS could help selecting the patients who can mostly benefit from ICD therapy. Keywords: Arrhythmia inducibility, Clinical electrophysiology, Implantable cardioverter-defibrillator, Left ventricular dysfunction, Myocardial infarction, Sudden cardiac deat
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