Studies on the prevalence of asthma and allergies often lack representation of the pediatric population, and their impact has not been examined using children without these diseases as a reference ...group. This study aimed to determine the prevalence of asthma and allergies in children under 14 years old in Spain and their impact on health-related quality of life, activities, healthcare utilization, and environmental and household exposure risk factors.
Data came from a Spanish population-based representative survey of children aged <14 years (N=6297). A sample of controls (1:4) from the same survey was matched using propensity score matching. Logistic regression models and population-attributable fractions were calculated to determine the impact of asthma and allergy.
The population prevalence of asthma was 5.7% (95% CI: 5.0%, 6.4%), and of allergy was 11.4% (95% CI: 10.5%, 12.4. In children with lower percentiles of health-related quality of life (≤20th), 32.3% (95% CI, 13.6%, 47.0%) was attributed to asthma and 27.7% (95% CI: 13.0%, 40.0%) to allergy. Forty-four percent of restrictions in usual activity were attributed to asthma (OR: 2.0, p-value: <0.001), and 47.9% to allergy (OR: 2.1, p-value: <0.001). 62.3% of all hospital admissions were attributed to asthma (OR: 2.8, p-value: <0.001), and 36.8% (OR: 2.5, p-value: <0.001) of all specialist consults to allergy.
The high prevalence of atopic disease and its impact on daily life and healthcare utilization call for an integrated healthcare system focused on children and caregivers' needs with continuity of care across education and healthcare settings.
The main objective of this study is to measure the relationship between morbidity, direct health care costs and the degree of clinical effectiveness (resolution) of health centres and health ...professionals by the retrospective application of Adjusted Clinical Groups in a Spanish population setting. The secondary objectives are to determine the factors determining inadequate correlations and the opinion of health professionals on these instruments.
We will carry out a multi-centre, retrospective study using patient records from 15 primary health care centres and population data bases. The main measurements will be: general variables (age and sex, centre, service family medicine, paediatrics, and medical unit), dependent variables (mean number of visits, episodes and direct costs), co-morbidity (Johns Hopkins University Adjusted Clinical Groups Case-Mix System) and effectiveness.The totality of centres/patients will be considered as the standard for comparison. The efficiency index for visits, tests (laboratory, radiology, others), referrals, pharmaceutical prescriptions and total will be calculated as the ratio: observed variables/variables expected by indirect standardization.The model of cost/patient/year will differentiate fixed/semi-fixed (visits) costs of the variables for each patient attended/year (N = 350,000 inhabitants). The mean relative weights of the cost of care will be obtained. The effectiveness will be measured using a set of 50 indicators of process, efficiency and/or health results, and an adjusted synthetic index will be constructed (method: percentile 50).The correlation between the efficiency (relative-weights) and synthetic (by centre and physician) indices will be established using the coefficient of determination. The opinion/degree of acceptance of physicians (N = 1,000) will be measured using a structured questionnaire including various dimensions.
multiple regression analysis (procedure: enter), ANCOVA (method: Bonferroni's adjustment) and multilevel analysis will be carried out to correct models. The level of statistical significance will be p < 0.05.
Although inhaled glucocorticosteroids are recommended for persistent asthma, their long-term effect on recent onset, mild, persistent asthma has yet to be established.
We did a randomised, ...double-blind clinical trial in 7241 patients in 32 countries to assess the effects of budesonide in patients who had had mild persistent asthma for less than 2 years and who had not had previous regular treatment with glucocorticosteroids. Patients aged 5–66 years received either budesonide or placebo once daily for 3 years in addition to their usual asthma medications. The daily budesonide dose was 400 μg, or 200 μg for children younger than 11 years. The primary outcome was time to first severe asthma-related event, and analysis was by intention to treat.
198 of 3568 patients on placebo and 117 of 3597 on budesonide had at least one severe asthma exacerbation; hazard ratio 0·56 (95% CI 0·45–0·71, p<0·0001). Patients on budesonide had fewer courses of systemic corticosteroids and more symptom-free days than did those on placebo. Compared with placebo, budesonide increased postbronchodilator forced expiratory volume in 1 s (FEV
1) from baseline by 1·48% (p<0·0001) after 1 year and by 0·88% (p=0·0005) after 3 years (expressed as percent of the predicted value). The corresponding increase in prebronchodilator FEV
1 was 2·24% after 1 year and 1·71% after 3 years (p<0·0001 at both timepoints). The effect of treatment on all outcome variables was independent of the baseline lung function (prebronchodilator or postbronchodilator) or baseline medication. In children younger than 11 years, 3-year growth was reduced in the budesonide group by 1·34 cm. The reduction was greatest in the first year of treatment (0·58 cm) than years 2 and 3 (0·43 cm and 0·33 cm, respectively)
Long-term, once-daily treatment with low-dose budesonide decreases the risk of severe exacerbations and improves asthma control in patients with mild persistent asthma of recent onset.
Background The Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study enrolled 7241 patients aged 5 to 66 years with recent-onset, mild persistent asthma to assess early ...intervention with the inhaled corticosteroid budesonide on long-term asthma control. Objective The open-label phase of the START study was included to determine the effect on lung function and asthma control of adding budesonide to the reference group patients who had not initially received inhaled corticosteroids. Methods Patients were randomized to double-blind treatment with budesonide, 200 μg (those aged <11 years) or 400 μg once daily, or placebo plus the usual asthma therapy for 3 years, after which all patients received 2 years of open-label treatment with budesonide once daily. Results During the full 5-year study period, postbronchodilator FEV1 percent predicted decreased, irrespective of randomized treatment during the double-blind phase, by an average of 2.22% (SE, 0.15%). However, patients with inhaled budesonide in the double-blind phase had a significantly lower risk (odds ratio, 0.61; P < .001) of a severe asthma-related event during the full 5-year study period than those in the reference group. Moreover, patients in the reference group used more additional asthma medications during both the open-label and double-blind phases. Conclusions In mild persistent asthma early intervention with inhaled budesonide was associated with improved asthma control and less additional asthma medication use.
Introduction24-hour ambulatory blood pressure monitoring (ABPM) is the gold standard diagnostic method for hypertension, but has some shortcomings in clinical practice while clinical settings often ...lack sufficient devices to accommodate all patients with suspected hypertension. Home blood pressure monitoring (HBPM) and office blood pressure monitoring (OBPM) also have shortcomings, such as the white coat effect or a lack of accuracy. This study aims to study the validity of a new method of diagnosing hypertension consisting of monitoring blood pressure (BP) for 1 hour and comparing it with OBPM and HBPM and examining the sensitivity and specificity of this method compared with 24-hour ABPM. The patient experience will be examined in each method.Methods and analysisA minimum sample of 214 patients requiring a diagnostic test for hypertension from three urban primary healthcare centres will be included. Participants will undergo 24-hour ABPM, 1-hour BP measurement (1-BPM), OBPM for three consecutive weeks and HBPM. Patients will follow a random sequence to first receive 24-hour ABPM or 1-hour ABPM. Daytime 24-hour ABPM records will be compared with the other monitoring methods using the correlation coefficient and Bland Altman plots. The kappa concordance index and the sensitivity and specificity of the methods will be calculated. The patient’s experience will be studied, with selected indicators of efficiency and satisfaction calculated using parametric tests.Ethics and disseminationThe protocol has been authorised by the research ethics committee of the Hospital Clinic of Barcelona (Ref. HCB/2014/0615): protocol details and amendments will be recorded and reported to ClinicalTrials.com. The results will be disseminated in peer-reviewed literature, and to policy makers and healthcare partners.Trial registration NCT03147573; Pre-results.
Cardiac rehabilitation after acute myocardial infarction permits recovery of the heart function and enables secondary prevention programs in which changes in lifestyle habits are crucial. Cardiac ...rehabilitation often takes place in hospitals without coordination with primary healthcare and is not focused on individual patient preferences and goals, which is the core of the motivational interview. The objective of this study was to evaluate the efficacy of a cardiac rehabilitation program with a motivational interview in patients discharged from hospital after acute myocardial infarction.
A randomized, non-pharmacological clinical trial in six primary healthcare centers in Barcelona (Spain) will assess whether a tailored cardiac rehabilitation program consisting of four motivational interviews and visits with family physicians, primary healthcare nurses and a cardiologist, coordinated with the reference hospital, results in better cardiac rehabilitation than standard care. A minimum sample of 284 participants requiring cardiac rehabilitation after acute myocardial infarction will be randomized to a cardiac rehabilitation group with a motivational interview program or to standard primary healthcare. The main outcome will be physical function measured by the six-minute walk test, and the secondary outcome will be the effectiveness of secondary prevention: a composite outcome comprising control of blood pressure, cholesterol, diabetes mellitus, smoking and body weight. Results will be evaluated at 1,3 and 6 months.
This is the first clinical trial to study the impact of a new primary healthcare cardiac rehabilitation program with motivational interviews for patients discharged from hospital after myocardial infarction. Changes in lifestyles and habits after myocardial infarction are a core element of secondary prevention and require patient-centered care strategies such as motivational interviews. Therefore, this study could clarify the impact of this approach on health indicators, such as functional capacity.
ClinicalTriasl.gov NCT05285969 registered on March 18, 2022.
Asthmatic patients lose lung function faster than normal subjects. The effectiveness of early intervention with inhaled corticosteroids on this decline in lung function is not established in ...recent-onset disease.
The Inhaled Steroid Treatment as Regular Therapy in Early Asthma study was a randomized, double-blind study in 7,165 patients (5 to 66 years old), with persistent asthma for < 2 years to determine whether early intervention with low-dose inhaled budesonide prevents severe asthma-related events and the decline in lung function. Patients received budesonide (200 μg qd for children < 11 years old and 400 μg qd for others) or placebo for 3 years in addition to usual asthma medications.
Treatment with budesonide significantly improved prebronchodilator and postbronchodilator FEV1 percentage of predicted and reduced the mean declines from baseline for postbronchodilator FEV1 at 1 year and 3 years: – 0.62% and – 1.79% for budesonide and – 2.11% and – 2.68% for placebo, respectively (p < 0.001). The decline was more marked for male patients, active smokers, and patients > 18 years old, and the smallest treatment effects were in adolescents.
Long-term, once-daily treatment with low-dose budesonide improved both prebronchodilator and postbronchodilator FEV1 in patients with recent-onset, persistent asthma, and reduced the loss of lung function over time.
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