COPD
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Simple walking tests are widely used for the assessment of functional status in patients with cardiorespiratory disorders. These tests require far less instrumentation than formal cardiopulmonary exercise tests, but they do require standardization of procedures to achieve reproducible results. The most widely used tests for patients with COPD are the 6-minute walking test (6MWT) and the incremental shuttle walking test (SWT). ⋯ The SWT results improve with pulmonary rehabilitation and bronchodilation, and are highly correlated with maximum oxygen consumption. There are no studies that address the issue of MCID for the SWT. In addition to the MCID, the design and interpretation of COPD clinical trials should take into account the severity of initial impairment, the asymmetry between positive and negative changes, the proportion of patients who show substantial improvement, and the costs and risks of the treatment.
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The Minimal Clinically Important Difference has become a key feature for both the validation of clinical tools and for the assessment of clinical studies. Several methods have been developed to establish what a Minimal Clinically Important Difference is. The primary purpose of the Minimal Clinically Important Difference, however, is to provide a measure of relevance for a statistically applied measure. ⋯ Conversely, parameters that are of great interest to selected individuals, that could be discerned by them with great subtly are likely to be poorly generalizable. Without doubt, defining a Minimal Clinically Important Difference will remain a key goal in the validation and application of tools for clinical investigations. The limits of the concept, particularly as it relates to issues of importance to patients, however, needs to be recognized.
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Limitation of physical activity occupies a central role in the symptom complex of patients with chronic obstructive pulmonary disease (COPD), and improvement in exercise capacity is a key outcome of response to COPD therapy. Maximum exercise capacity testing facilitates assessment of physiologic mechanisms of exercise and allows quantitation of the degree of limitation. This manuscript utilizes published data from the National Emphysema Treatment Trial to investigate the minimal clinically important difference (MCID) in maximum exercise capacity in patients with severe emphysema. ⋯ In subjects randomized to medical therapy, the mean (+/-SD) 24-month change in maximum exercise capacity following medical therapy was -9.2 +/- 1.2 Watts, whereas among those randomized to lung volume reduction surgery, mean 24-month change in maximum exercise capacity was 1.7 +/- 17.7 Watts, with a mean difference between the groups of 10.9 Watts. The observed difference in maximum exercise capacity after 24 months between subjects randomized to medical versus surgical therapy conforms to both opinion- and distribution-based estimates of MCID. Further investigation is needed to develop and validate estimates of MCID for maximum exercise capacity and other key clinical outcomes in COPD.
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Randomized Controlled Trial Comparative Study
Comparison of oral and depot intra-muscular steroids in assessing steroid-responsiveness in COPD.
Non-compliance or euphoria may limit the usefulness of prednisolone tablets in assessing steroid-responsiveness in chronic obstructive pulmonary disease (COPD). Depot intra-muscular methyl-prednisolone (imMP), producing a plateau steroid effect over two weeks, may be more reliable. Following two weeks of placebo, twenty-seven COPD patients (mean FEV 1 43% predicted) participated in a two-week randomised, double-blind, placebo-controlled, parallel-design trial taking either 120 mg imMP with placebo tablets or placebo injection with prednisolone 30 mg daily. ⋯ By contrast, there were small mean improvements in lung function on oral prednisolone (mean FEV 1, FVC and IC increased by 100, 320 and 150 ml, respectively). Only the improvement in FVC was significantly greater after prednisolone compared with imMP. Single depot intra-muscular injections of steroids have no advantage over oral daily prednisolone in testing steroid-responsiveness in COPD patients.