A cluster-randomized study to evaluate the effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in South Tyrolean primary care for patients with COPD, asthma, type 2 diabetes, and heart failure: the ABCC South Tyrol study
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SUBMITTER: Wiedermann C
PROVIDER: S-EPMC10953192 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:IntroductionThe number of people that have one or multiple condition(s) with a chronic course is rising, which consequently challenges healthcare systems. Healthcare geared to long-term care should focus on patient-centredness, shared decision making and self-management. The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to integrate these elements in daily healthcare practice. The ABCC tool assesses and visualises burden of disease(s), helps to make shared decisions and stimulates self-management. The present paper documents a protocol for a quasi-experimental study investigating the effectiveness and cost-effectiveness of the ABCC tool for people with chronic obstructive pulmonary disease, asthma, type 2 diabetes mellitus and/or heart failure.Methods and analysisThe study has a pragmatic clustered quasi-experimental design and will be conducted in the Netherlands. The intervention will be allocated at the level of general practice. The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care. Outcomes include change in quality of care (Patient Assessment of Chronic Illness Care), quality of life (EuroQol-5D-5L), capability well-being (ICEpop CAPability measure for Adults), patients' activation (Patient Activation Measure) and costs. Follow-up time will be 18 months. Outcomes will be analysed using linear mixed models.Ethics and disseminationEthical approval was obtained from the Medical Ethics Committee Zuyderland-Zuyd Heerlen, the Netherlands (METCZ20180131). Results will be published in peer-reviewed journals and will be presented at national and international conferences.Trial registration numberClinicalTrials.gov Registry (NCT04127383).
| S-EPMC7674093 | biostudies-literature
Project description:ObjectiveAssessment of the prevalence of primary headache disorders, associated risk factors and use of acute/preventive medication in a representative large sample of adolescents.MethodsWithin the EVA-Tyrol project, a community-based non-randomized controlled cross-sectional study, data was collected from adolescents aged 14-19 years from 45 sites across North-, East- and South Tyrol. Headaches were classified according to the latest ICHD-3 and assessed by headache specialists in face-to-face interviews.FindingsOf 1923 participants 930 (48.4%) reported having headaches. Female to male ratio was 2:1. Migraine, tension-type headache and other headache were diagnosed in 10%, 30.2% and 8.2% respectively. Medication overuse was diagnosed in 3.4%, increasing up to 21.7% in participants with chronic headache. The use of preventative medication was not reported by any adolescent. Sleep disturbances (p < 0.05), alcohol consumption (p < 0.05), low physical activity (p < 0.01) and high screen time exposure (p < 0.01) were associated with an increased risk of headaches.ConclusionWe report high prevalence of primary headache disorders and medication overuse in a large community-based sample of teenagers. Acute and preventive non-drug and pharmacological treatments are not established due to lack of paediatric headache outpatient clinics. Promoting health education in teenagers and encouraging public awareness, including that of health care providers is pivotal.Trial registration: EVA-Tyrol has been retrospectively registered at clinicaltrials.gov under https://clinicaltrials.gov/ct2/show/NCT03929692 since April 29, 2019.
| S-EPMC9442274 | biostudies-literature
Project description:Previous studies have found suboptimal control of symptom burden to be widespread among patients with asthma and chronic obstructive pulmonary disease (COPD). The Phase IV SPRINT study was conducted in 10 countries in Europe to assess asthma disease control and COPD symptom burden in patients treated with a fixed-dose combination (FDC) of inhaled corticosteroids (ICS) and long-acting beta agonists (LABAs). SPRINT included 1101 patients with asthma and 560 with COPD; all were receiving treatment with an FDC of ICS/LABA, delivered via various inhalers. Data were obtained over a 3-month period, during a single routine physician's office visit. Asthma control was defined as Asthma Control Test (ACT) score >19. COPD symptom burden was assessed by COPD Assessment Test (CAT), with a CAT score <10 defining low COPD symptom burden. Among patients using any ICS/LABA FDC, 62% of patients with asthma had achieved disease control (ACT score >19) and 16% of patients with COPD had low symptom burden (CAT score <10).
| S-EPMC6946676 | biostudies-literature
Project description:The Cooperative Health Research in South Tyrol (CHRIS) study is a single-site population-based study aimed to investigate the genetic and molecular basis of common age-related chronic conditions and their interaction with lifestyle and environment. In recent work, we have been evaluating the impact of age, sex and diet, amongst others, on the human metabolome. Moreover, gene-metabolite associations, as well as genetic and metabolomic determinants of disease, have been investigated. Using Scanning SWATH acquisition on Triple TOF 6600 instruments (Sciex) we created a MS-based plasma proteomics data set with low technical variability for n = 3,632 CHRIS participants. We performed a general exploratory analysis of the data set to identify relevant factors affecting the plasma proteome, including commonly used drugs. We found hormonal contraceptives to be the main factor explaining the variation in this data set. Here we present the pooled study samples.
2024-07-08 | PXD052861 | Pride
Project description:The Salford Lung Study (SLS) of patients with asthma and chronic obstructive pulmonary disease (COPD) is a practical, community-based, randomized, open-label pragmatic study on the efficacy and safety of the once-daily dry powder inhaler that combines the inhaled corticosteroid fluticasone furoate (FF) with the long-acting beta2 agonist vilanterol (VI). The asthma component of the SLS is not yet reported but the COPD component, done over a 12-month period, found a statistically significant 8.4% reduction in COPD exacerbations when compared to usual care. No differences in adverse events, including serious adverse events and pneumonia, were noted. The importance of real-world findings, such as those found in the SLS COPD trial with inhaled FF/VI, is discussed in comparison to classical randomized controlled trials (RCTs) with inhaled FF/VI in COPD patients. The real-world, community-based pragmatic RCT like the SLS provides additional generalizable data with direct clinical applicability and potential usefulness in the development of practice guidelines. The results from the SLS, along with those of large and small RCTs, are supportive of the use of once-daily FF/VI in COPD maintenance therapy.
| S-EPMC5614786 | biostudies-other
Project description:BACKGROUND:According to the World Health Organization, cardiovascular diseases (CVDs) are the leading non-communicable cause of death. Awareness of the individual risk profile is crucial to implement a healthy lifestyle and prevent CVDs. Multiple studies demonstrated that atherosclerosis, the main cause of CVDs, begins early in life. Therefore, it may be necessary to start prevention programs already in childhood. METHODS:The EVA-Tyrol study is a population-based non-randomized controlled trial that will prospectively enroll 2000 participants from high schools and training companies in North- and East-Tyrol (Austria) and South-Tyrol (Italy). Participants will be assigned to either an intervention (n = 1500) or a control (n = 500) group. Intervention group participants will be enrolled at the 10th school grade (mean age 15-16 years), undergo two examinations within a two-year interval, with follow-up at the 12th grade (mean ages 17-18 years). Control group participants will be enrolled at the 12th grade (mean age 17-18 years). Medical examination will include anthropometric measurements, comprehensive lifestyle and dietary questionnaires, a fasting blood sample, high-resolution ultrasound of the carotid arteries, and measurement of carotid-femoral pulse wave velocity. Active intervention will consist of (1) enhancing knowledge about CVDs, (2) individual medical counseling based on the results of the baseline examination, (3) an online health promotion tool and (4) involvement of participants in planning and implementation of health promotion projects. Effectiveness of the intervention will be assessed by comparing the proportion subjects with ideal health metrics as defined by the American Heart Association between study groups. DISCUSSION:This study aims to improve cardiovascular health in Tyrolean adolescents by demonstrating the efficacy of a multi-layer health promotion program and may yield novel insights into the prevalence of vascular risk conditions and mechanisms of early vascular pathologies in adolescents. TRIAL REGISTRATION:EVA-Tyrol has been retrospectively registered at clinicaltrials.gov under NCT03929692 since April 29, 2019.
| S-EPMC7001281 | biostudies-literature
Project description:BackgroundREMIT is the first real-world study of mepolizumab effectiveness in patients with severe asthma (SA) in Taiwan.ObjectivesThe primary objective evaluated changes in clinically significant exacerbations (CSEs; defined as use of oral corticosteroids (OCS) or emergency department (ED) visits and/or hospitalizations) in the 12 months pre- and post-mepolizumab treatment. Secondary objectives assessed changes in the number of CSEs requiring ED visits/hospitalizations and daily maintenance OCS (mOCS) dosage 12 months pre- and post-mepolizumab treatment. Three- and four-component clinical remissions were analyzed based on OCS-free, exacerbation-free, and asthma control (± stability in lung function).DesignREMIT was a retrospective, observational, self-controlled study analyzing patients in Taiwan with SA who were newly prescribed subcutaneous mepolizumab 100 mg Q4W.MethodsData were extracted from records of 15 medical centers in Taiwan for patients indexed between November 1, 2018 and October 31, 2020.ResultsA total of 170 patients were included: mean age at index date, 58.7 years; 53.5% female; 100% Chinese; 7.1% with chronic rhinosinusitis with nasal polyps, 1.8% with eosinophilic granulomatosis with polyangiitis, 1.2% with hypereosinophilic syndrome; and 55.7% with blood eosinophil count >300/µL. Pre-treatment, 71.2% had ⩾2 exacerbations, and 28.7% were on mOCS; 75.3% had no prior biologic treatment, and 24.7% had switched from other biologics. Most patients (80.0%) completed ⩾10 mepolizumab doses. Following the first mepolizumab administration (index date), CSEs reduced by 46.0% (rate ratio (RR): 0.545, 95% confidence interval (CI): 0.418-0.710; p < 0.0001) in the 12 months post-index. Exacerbations requiring ED visits/hospitalization reduced by 46.9% (RR: 0.531, 95% CI: 0.349-0.808; p = 0.0031). Median mOCS dose reduced by 100% by end of study and 81.8% of patients discontinued mOCS post-treatment. After 1 year of mepolizumab treatment, 28% and 23% patients achieved three- and four-component clinical remission, respectively.ConclusionMepolizumab use in a patient population in Taiwan with SA significantly reduced CSEs and mOCS use in routine clinical practice.
| S-EPMC11744627 | biostudies-literature
Project description:BackgroundThere is increasing evidence of the important role that small, isolated populations could play in finding genes involved in the etiology of diseases. For historical and political reasons, South Tyrol, the northern most Italian region, includes several villages of small dimensions which remained isolated over the centuries.MethodsThe MICROS study is a population-based survey on three small, isolated villages, characterized by: old settlement; small number of founders; high endogamy rates; slow/null population expansion. During the stage-1 (2002/03) genealogical data, screening questionnaires, clinical measurements, blood and urine samples, and DNA were collected for 1175 adult volunteers. Stage-2, concerning trait diagnoses, linkage analysis and association studies, is ongoing. The selection of the traits is being driven by expert clinicians. Preliminary, descriptive statistics were obtained. Power simulations for finding linkage on a quantitative trait locus (QTL) were undertaken.ResultsStarting from participants, genealogies were reconstructed for 50,037 subjects, going back to the early 1600s. Within the last five generations, subjects were clustered in one pedigree of 7049 subjects plus 178 smaller pedigrees (3 to 85 subjects each). A significant probability of familial clustering was assessed for many traits, especially among the cardiovascular, neurological and respiratory traits. Simulations showed that the MICROS pedigree has a substantial power to detect a LOD score > or = 3 when the QTL specific heritability is > or = 20%.ConclusionThe MICROS study is an extensive, ongoing, two-stage survey aimed at characterizing the genetic epidemiology of Mendelian and complex diseases. Our approach, involving different scientific disciplines, is an advantageous strategy to define and to study population isolates. The isolation of the Alpine populations, together with the extensive data collected so far, make the MICROS study a powerful resource for the study of diseases in many fields of medicine. Recent successes and simulation studies give us confidence that our pedigrees can be valuable both in finding new candidates loci and to confirm existing candidate genes.
| S-EPMC1913911 | biostudies-literature
Project description:The Cooperative Health Research in South Tyrol (CHRIS) study is a single-site population-based study aimed to investigate the genetic and molecular basis of common age-related chronic conditions and their interaction with lifestyle and environment. In recent work, we have been evaluating the impact of age, sex and diet, amongst others, on the human metabolome. Moreover, gene-metabolite associations, as well as genetic and metabolomic determinants of disease, have been investigated. Using Scanning SWATH acquisition on Triple TOF 6600 instruments (Sciex) we created a MS-based plasma proteomics data set with low technical variability for n = 3,632 CHRIS participants. We performed a general exploratory analysis of the data set to identify relevant factors affecting the plasma proteome, including commonly used drugs. We found hormonal contraceptives to be the main factor explaining the variation in this data set. Here we present the commerical plasma samples used as quality controls.
2024-07-08 | PXD052892 | Pride
Project description:The role of eosinophilic inflammation in chronic obstructive pulmonary disease (COPD) pathogenesis is unknown and is probably different than in asthma. The molecular processes underlying the differences between eosinophils from asthma and COPD have not been studied. The study group included 5 patients with asthma and 4 patients with COPD. The RNA-Seq data analysis identified 26 differentially expressed genes between COPD and asthma (according to adjusted p-value). In total, 6 genes were up-regulated (CCL3L1, CCL4L2, SERPINB2, PRSS21, GPR82) and 20 were down-regulated (e.g. JUN, IFITM3, DUSP1, GNG7, ZNF107, BCL6) in peripheral eosinophils of COPD patients compared to asthma. Biological processes associated with down-regulated genes were cell differentiation, positive regulation of RNA metabolic process. The genes associated with signaling of IL-4 and IL-13 pathway were down-regulated in COPD eosinophils compared to asthma. Peripheral eosinophils from COPD and asthma patients present different transcriptomic profiles suggesting their different function in pathobiology of both obstructive airway diseases.
2024-01-01 | GSE237284 | GEO