Chest
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Comparative Study
Two-year retrospective economic evaluation of three dual-controller therapies used in the treatment of asthma.
To compare asthma-related health-care utilization and expenditures for patients prescribed one of three dual-controller therapies: fluticasone plus salmeterol, inhaled corticosteroids (ICS) [excluding fluticasone] plus salmeterol, and ICS plus a leukotriene modifier (LTM). ⋯ Results from managed-care practice suggest that treatment with fluticasone plus salmeterol, and more broadly ICS plus salmeterol, yield important cost savings when compared to treatment with ICS plus LTM.
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Comparative Study
Response of lung volumes to inhaled salbutamol in a large population of patients with severe hyperinflation.
Current criteria use FEV(1) to assess bronchodilator responsiveness, despite its insensitivity and inability to predict improvement in symptoms or exercise tolerance. Response in lung volumes remains largely unexplored even though volume parameters, such as inspiratory capacity (IC), closely correlate with functional improvements. Therefore, we assessed the response of lung volumes (i.e., by IC, total lung capacity [TLC], functional residual capacity [FRC], residual volume [RV], and FVC) to salbutamol and the relationship of these changes to improvements in the spirometry in these patients. ⋯ Bronchodilators reduce hyperinflation. Measurements of lung volumes before and after bronchodilators add sensitivity when examining for bronchodilator responsiveness.
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Randomized Controlled Trial Comparative Study Clinical Trial
Power of outcome measurements to detect clinically significant changes in pulmonary rehabilitation of patients with COPD.
Several validated instruments are used to measure outcomes, such as exercise performance, dyspnea, and health-related quality of life after pulmonary rehabilitation (PR) in patients with COPD. However, no study has simultaneously compared the responsiveness of the most frequently used outcome measurements after PR. We designed this study to investigate the capacity of several of the most frequently used outcome measurements to detect changes after PR in a population of patients with severe COPD who qualified for lung volume reduction surgery. ⋯ We conclude that the VAS peak exercise, BDI/TDI, and CRQ adequately reflect the beneficial effects of PR. The 6MWD evaluates a unique domain not related to quality of life. Due to their simplicity and sensitivity, VAS at peak exercise, 6MWD, and CRQ may be the best practical tools to evaluate responsiveness to PR.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD.
To compare the efficacy, tolerability, and safety of therapy with formoterol and oral slow-release theophylline (THEO) in patients with COPD. ⋯ Long-term treatment with inhaled formoterol dry powder is more effective and better tolerated than treatment with therapeutically appropriate doses of oral slow-release THEO in symptomatic patients with COPD.
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Review Comparative Study
The design of randomized clinical trials in critically ill patients.
There are a number of difficulties in the conduct of randomized trials in the critically ill. These include difficulties in the definition of diseases and syndromes, a heterogenous population of patients undergoing a variety of therapeutic interventions, and outcomes that may not be able to discriminate between beneficial and risky therapies. Following a brief description of different randomized clinical trials (RCTs) and design philosophies, we outline the effects of different design choices in the complex critical care environment. ⋯ If an effectiveness design philosophy is chosen, then broad representation of study sites, liberal eligibility criteria, easily implemented intervention study protocols, and patient-centered outcomes should be chosen. The potential investigator wishing to establish efficacy will conduct the study in the centers of excellence and adopt stringent eligibility criteria, rigorous study protocols, and opt for outcomes that will be sensitive to change. In conclusion, we describe some of the major challenges and possible solutions to help a potential investigator through the myriad of difficulties in initiating an RCT in a complex environment.