Search results for "Observational study"
showing 10 items of 776 documents
Asthma control in elderly asthmatics. An Italian observational study
2014
SummaryBackgroundThe exponential increase of individuals aged >64 yrs is expected to impact the burden of asthma. We aimed to explore the level of asthma control in elderly subjects, and factors influencing it.MethodsA multicenter observational study was performed on consecutive patients >64 years old with a documented physician-diagnosis of asthma. Sixteen Italian centers were involved in this 6-month project.FindingsA total of 350 patients were enrolled in the study. More than one-third of elderly asthmatic patients, despite receiving GINA step 3–4 antiasthmatic therapy, had an Asthma Control Test score ≤19, with a quarter experiencing at least one severe asthma exacerbation in the previo…
Safety of sublingual-swallow immunotherapy in children aged 3 to 7 years
2005
Background The minimum age to start specific immunotherapy with inhalant allergens in children has not been clearly established, and position papers discourage its use in children younger than 5 years. Objective To assess the safety of high-dose sublingual-swallow immunotherapy (SLIT) in a group of children younger than 5 years. Methods Sixty-five children (51 boys and 14 girls; age range, 38-80 months; mean ± SD age, 60 ± 10 years; median age, 60 months) were included in this observational study. They were treated with SLIT with a build-up phase of 11 days, culminating in a top dose of 300 IR (index of reactivity) and a maintenance phase of 300 IR 3 times a week. The allergens used were ho…
The ‘real-life’ COPD patient in Germany: The DACCORD study
2016
Abstract Introduction DACCORD is an ongoing, longitudinal, non-interventional study within the German COPD National Prospective Registry. This manuscript describes the baseline characteristics of the first 5924 participants, recruited between November 2012 and November 2013. Methods The main inclusion criteria are a physician diagnosis of COPD, age ≥40 years, and initiating or changing COPD maintenance medication. Data collected included: Demographic and disease characteristics; prescribed medication; symptoms; COPD Assessment Test (CAT); modified Medical Research Council dyspnoea score (mMRC); exacerbations; comorbidities; and forced expiratory volume in 1 s (FEV 1 ). Results Approximately…
A two-year evaluation of the ‘real life’ impact of COPD on patients in Germany: The DACCORD observational study
2017
Abstract Introduction DACCORD is an observational, non-interventional study being conducted in German primary and secondary care centres. The study aims to describe the impact of disease (including exacerbations) and treatments over 2 years on ‘real-life' patients with chronic obstructive pulmonary disease (COPD). Materials and methods Patients had a clinical and spirometry diagnosis of COPD, were aged ≥40 years and, on recruitment, were initiating or changing COPD maintenance medication. The only exclusion criteria were asthma and randomised clinical trial participation. Exacerbations data were collected every 3 months. COPD medication, COPD Assessment Test (CAT) and forced expiratory volu…
GOLD 2017 treatment pathways in ‘real life’: An analysis of the DACCORD observational study
2017
Abstract Introduction The 2017 update to the Global Initiative for Obstructive Lung Disease (GOLD) strategy document includes recommendations for treatment intensification or step-down in chronic obstructive pulmonary disease (COPD), although recognises that limited supporting information is available. DACCORD is an ongoing observational, non-interventional study, recruiting patients following COPD maintenance treatment change or initiation, a subset of whom were receiving a long-acting β2-agonist (LABA) plus a long-acting muscarinic antagonist (LAMA) fixed-dose combination (FDC) on entry. Since there were no requirements in terms of prior medication (and no washout before commencing LABA/L…
Determinants of CAT (COPD Assessment Test) scores in a population of patients with COPD in central and Eastern Europe: The POPE study
2019
Abstract Background The COPD Assessment Test (CAT) has been proposed to help guide therapy in chronic obstructive pulmonary disease (COPD). It is important to understand the distribution of scores in different COPD populations and their determinants. Methods The POPE study is an international, observational cross-sectional study of COPD subjects in 11 Central and Eastern European countries aimed at characterizing COPD phenotypes. Here we report the analysis of CAT scores with the objective of identifying their determinants, evaluating symptom load and investigating the distribution of scores among the participating countries. Additionally, we investigated the discrepancies between the CAT a…
The COPD multi-dimensional phenotype: A new classification from the STORICO Italian observational study.
2019
BackgroundThis paper is aimed to (i) develop an innovative classification of COPD, multi-dimensional phenotype, based on a multidimensional assessment; (ii) describe the identified multi-dimensional phenotypes.MethodsAn exploratory factor analysis to identify the main classificatory variables and, then, a cluster analysis based on these variables were run to classify the COPD-diagnosed 514 patients enrolled in the STORICO (trial registration number: NCT03105999) study into multi-dimensional phenotypes.ResultsThe circadian rhythm of symptoms and health-related quality of life, but neither comorbidity nor respiratory function, qualified as primary classificatory variables. Five multidimension…
Effects of Vildagliptin/Metformin Therapy on Patient-Reported Outcomes: Work Productivity, Patient Satisfaction, and Resource Utilization
2013
Introduction: Type 2 diabetes mellitus (T2DM) is associated not only with high direct healthcare costs, but also with indirect costs, as diabetic complications and the disease itself result in loss of productivity. Vildagliptin is a novel dipeptidyl peptidase-4 inhibitor that is given either alone or in combination with oral hypoglycemic drugs, including metformin. The study was designed to assess the hypothesis that fixed-combination vildagliptin/metformin improves work productivity measured as Work Productivity and Activity Impairment (WPAI) scores. Secondary objectives were the assessment of patient satisfaction by means of the Diabetes Treatment Satisfaction Questionnaire (DTSQs), the c…
The safety attitudes questionnaire for out-of-hours service in primary healthcare—Psychometric properties of the Croatian version
2020
The aim of the study was to assess the reliability and construct validity of the Croatian trans- lation of the Safety Attitudes Questionnaire—Ambulatory version (SAQ-AV) in the out-of- hours (OOH) primary care setting. A cross-sectional observational study using anonymous web-survey was carried out targeting a convenience sample of 358 health professionals working in the Croatian OOH primary care service. The final sample consisted of 185 questionnaires (response rate 51.7%). Psychometric properties were assessed using exploratory hierarchical factor analysis with Schmid-Leiman rotation to bifactor solution, McDonald’s ω, and Cronbach’s α. Five group factors were identified: Organization cl…
Normal Reference Ranges for Echocardiography: Rationale, study design, and methodology (NORRE Study)
2013
International audience; BACKGROUND: Availability of normative reference values for cardiac chamber dimensions, volumes, mass, and function is a prerequisite for the accurate application of echocardiography for both clinical and research purposes. However, due to the lack of consistency in current echocardiographic 'reference values', their use for clinical decision-making remains questionable. AIMS: The aim of the 'Normal Reference Ranges for Echocardiography Study (NORRE Study)' is to obtain a set of 'normal values' for cardiac chamber geometry and function in a large cohort of healthy Caucasian individuals aged over a wide range of ages (25-75 years) using both conventional and advanced e…