An Overview of Current Methods for Real-world Applications to Generalize or Transport Clinical Trial Findings to Target Populations of Interest.

It has been well established that randomized clinical trials have poor external validity, resulting in findings that may not apply to relevant-or target-populations. When the trial is sampled from the target population, generalizability methods have been proposed to address the applicability of trial findings to target populations. When the trial sample and target populations are distinct, transportability methods may be applied for this purpose.

An observational analysis of disease burden in patients with cold agglutinin disease: Results from a large US electronic health record database.

Cold agglutinin disease (CAD) is a rare autoimmune hemolytic anemia (AIHA). Information regarding the impact of CAD from the patient and health care system perspective is limited. To understand longitudinal trends in outcomes in patients with CAD, including anemia severity, hemolytic status, administration of CAD-related therapies, and health care resource utilization (HCRU).

Data Mining of Free-Text Responses: An Innovative Approach to Analyzing Patient Perspectives on Treatment for Chronic Rhinosinusitis with Nasal Polyps in a Phase IIa Proof-of-Concept Study for Dupilumab.

Purpose: Patient perspective is an important and increasingly sought-after complement to clinical assessment. The aim of this study was to transcribe individual patients' experience of treatment in a dupilumab clinical trial through free-text responses with analysis using natural language processing (NLP) to obtain the unique perspective of patients on disease impact and unmet needs with existing treatment to inform future trial design.

Patients And Methods: Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who were enrolled in a Phase IIa randomized controlled trial comparing dupilumab with placebo (NCT01920893) were invited to complete a self-assessment of treatment (SAT) tool at the end of treatment, asking, "What is your opinion on the treatment you had during the trial? What did you like or dislike about the treatment?" Free-text responses were analyzed for the overall cohort and according to treatment assignment using natural language processing including sentiment scoring.

Cardiac magnetic resonance features of left dominant arrhythmogenic cardiomyopathy: differential diagnosis with myocarditis.

Cardiac magnetic resonance (CMR) findings suggesting a suspected left-dominant arrhythmogenic cardiomyopathy (LDAC) may be difficult to distinguish from those related to previous myocarditis; however, especially in patients with ventricular arrhythmias (VA) with ECG morphology consistent with a left ventricle (LV) origin differential diagnosis is fundamental. Aim of the study was to identify potential imaging features at CMR specific for LDAC diagnosis. Between January 2011 and December 2019, we enrolled 15 consecutive stable patients with a recent diagnosis of significant VA and ECG morphology consistent with a LV origin, detection of potential LV arrhythmic substrate at CMR and undergoing a clinically-indicated LV endomyocardial biopsy showing tissue abnormalities consistent with the diagnosis of LDAC.

Indirect Treatment Comparison of the Efficacy and Safety of Sarilumab Monotherapy in Rheumatoid Arthritis Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs.

Introduction: To evaluate the comparative efficacy and safety of subcutaneous sarilumab 200 mg monotherapy administered every 2 weeks (q2w) versus other monotherapies of biologic, targeted and conventional synthetic disease-modifying antirheumatic drugs (bDMARDs, tsDMARDs, csDMARDs) at recommended doses for treatment of rheumatoid arthritis in patients who are intolerant of or inadequate responders to csDMARDs (csDMARD-IR).

Methods: A systematic literature review and network meta-analysis (NMA) were conducted on 24-week efficacy outcomes: Health Assessment Questionnaire Disability Index (HAQ-DI) score, American College of Rheumatology (ACR) 20/50/70 criteria, and European League Against Rheumatism Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28) < 2.6.

Impact of preclinical carotid atherosclerosis on global cardiovascular risk stratification and events in a 10-year follow-up: comparison between the algorithms of the Framingham Heart Study, the European SCORE and the Italian 'Progetto Cuore'.

Background: The aim of the study was to compare three widely used algorithms for stratification of the global cardiovascular risk (GCVR): the Framingham Heart Study (FHS) score, the European systemic coronary risk estimation (SCORE) and the Italian 'Progetto Cuore' (heart project) score. It was also investigated how preclinical carotid atherosclerosis (pre-ATS) might influence the incidence and improve the risk prediction of cerebrovascular and cardiovascular events.

Methods: Subjects (n = 358) without previous history of cardiovascular disease (CVD) were recruited and the GCVR was calculated for each patient.

Prognostic Value and Therapeutic Perspectives of Coronary CT Angiography: A Literature Review.

Coronary stenosis severity is both a powerful and a still debated predictor of prognosis in coronary artery disease. Coronary computed tomographic angiography (CCTA) has emerged as a noninvasive technique that enables anatomic visualization of coronary artery disease (CAD). CCTA with newer applications, plaque characterization and physiologic/functional evaluation, allows a comprehensive diagnostic and prognostic assessment of otherwise low-intermediate subjects for primary prevention.

QT-interval evaluation in primary percutaneous coronary intervention of ST-segment elevation myocardial infarction for prediction of myocardial salvage index.

Assessing the efficacy of revascularization therapy in patients with ST-segment elevation myocardial infarction (STEMI) is extremely important in order to guide subsequent management and assess prognosis. We aimed to determine the relationship between corrected QT-interval (QTc) changes on standard sequential ECG and myocardial salvage index in anterior STEMI patients after successful primary percutaneous coronary intervention. Fifty anterior STEMI patients treated by primary percutaneous coronary intervention underwent quantitative ECG analysis and cardiac magnetic resonance.

Prognostic Stratification of Patients With ST-Segment-Elevation Myocardial Infarction (PROSPECT): A Cardiac Magnetic Resonance Study.

Background: Cardiac magnetic resonance (CMR) is a robust tool to evaluate left ventricular ejection fraction (LVEF), myocardial salvage index, microvascular obstruction, and myocardial hemorrhage in patients with ST-segment-elevation myocardial infarction. We evaluated the additional prognostic benefit of a CMR score over standard prognostic stratification with global registry of acute coronary events (GRACE) score and transthoracic echocardiography LVEF measurement.

Methods And Results: Two hundred nine consecutive patients with ST-segment-elevation myocardial infarction (age, 61.

Role of Cardiac Magnetic Resonance Imaging in Myocardial Infarction.

Purpose Of Review: The purpose of the present paper is to analytically review the diagnostic and prognostic role of CMR in ST-segment elevation myocardial infarction (STEMI) survivors. Percutaneous coronary intervention (PCI) is the treatment of choice in patients STEMI. However, risk of future events remains substantial.

Glycaemic control and hypoglycaemia burden in patients with type 2 diabetes initiating basal insulin in Europe and the USA.

Aims: To evaluate short- and long-term glycaemic control and hypoglycaemia incidence in insulin-naïve patients ≥30 years of age with type 2 diabetes (T2DM) initiating basal insulin (BI) with or without oral anti-hyperglycaemic drugs (OADs).

Methods: This was an observational, retrospective longitudinal analysis of electronic medical records from 5 European countries and the USA. A multivariable logistic regression model assessed baseline and short-term (0-3 months post BI initiation) factors associated with long-term (3-24 months) glycaemic control and hypoglycaemia.

[Horizons and perspectives on the problem of non--responders to cardiac resynchronization therapy.].

Cardiac resynchronization therapy (CRT) has been shown as a successful strategy in the treatment of patients with heart failure and electrical dyssincrony. However, a significant proportion of implanted patients fails to respond sufficiently or in a predictable manner. Consequently, non response to CRT remains a valuable problem in clinical practice.

Fractional flow reserve: lessons from PLATFORM and future perspectives.

In the treatment of stable coronary artery disease (CAD) the identification of patients who may gain the highest benefit from further invasive treatments is of pivotal importance for the healthcare system. In this setting, it has been established that an ischemia-guided revascularization strategy yields improved clinical outcomes in a cost-effective fashion compared with anatomy-guided revascularization alone. Invasive fractional flow reserve (FFR) is considered the gold standard, especially in the intermediate-range atherosclerotic lesions, for assessing lesion specific ischemia at the time of invasive coronary angiography and has now become the standard of reference for studies assessing the diagnostic performance of the various non-invasive stress tests.

Non-responders to cardiac resynchronization therapy: Insights from multimodality imaging and electrocardiography. A brief review.

Background: Cardiac resynchronization therapy (CRT) is a successful strategy for heart failure (HF) patients. The pre-requisite for the response is the evidence of electrical dyssynchrony on the surface electrocardiogram usually as left bundle branch block (LBBB). Non-response to CRT is a significant problem in clinical practice.

Alzheimer's Disease Severity is Not Significantly Associated with Short Sleep: Survey by Actigraphy on 208 Mild and Moderate Alzheimer's Disease Patients.

Background: In epidemiological surveys, cognitive decline has been found to be associated with both short and long sleep duration.

Objective: Our goal was to objectively determine how total sleep time (TST) at night was associated or not with apathy or severity scores in patients with Alzheimer 's disease (AD).

Methods: During an observational first step of a clinical trial, sleep was assessed in institutionalized patients with mild or moderate AD using actigraphy (MW8, Camtech, Cambridge, UK) for 14 consecutive 24-hour periods.

Aortic stenosis: insights on pathogenesis and clinical implications.

Aortic stenosis (AS) is a common valvular heart disease in the Western populations, with an estimated overall prevalence of 3% in adults over 75 years. To understand its patho-biological processes represents a priority. In elderly patients, AS usually involves trileaflet valves and is referred to as degenerative calcific processes.

Magnitude of QRS duration reduction after biventricular pacing identifies responders to cardiac resynchronization therapy.

Background: Several studies have investigated the association between native QRS duration (QRSd) or QRS narrowing and response to biventricular pacing. However, their results have been conflicting. The aim of our study was to determine the association between the relative change in QRS narrowing index (QI) and clinical outcome and prognosis in patients who undergo cardiac resynchronization therapy (CRT) implantation.

Coronary artery fistulas as a cause of angina: How to manage these patients?

Coronary artery fistulas represent the most common hemodynamically significant congenital defect of the coronary arteries and the clinical presentation is mainly dependent on the severity of the left-to-right shunt. We describe a case of a 55-year-old man with history of chest pain and without history of previous significant chest wall trauma or any invasive cardiac procedures. A coronary multislice computed tomography showed two large coronary fistulas arising from the left anterior descending coronary artery and ending in an angiomatous plexus draining into the common pulmonary trunk.

Chronic Stress and Early Recurrence of Takotsubo Cardiomyopathy: A Clinical Case.

Takotsubo cardiomyopathy (TC) is characterized by transient systolic dysfunction of the apical and middle segments of the left ventricle, accompanied by electrocardiographic abnormalities and mild elevation of cardiac biomarker levels in the absence of obstructive coronary artery disease. The following case is of a woman suffering from chronic emotional stress with a very early recurrence. An acute trigger event was not detectable in both cases.

[Polycitemia vera and pulmonary embolism: case report].

Pulmonary embolism is a rare clinical onset of chronic myeloproliferative diseases. Early diagnosis is very important because medical therapy reduces both mortality and morbility. We describe a case of pulmonary embolism as clinical onset of an unknown myeloproliferative disorder.