American journal of physical medicine & rehabilitation
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Am J Phys Med Rehabil · Oct 2003
ReviewOverview of clinical trials in medical rehabilitation: impetuses, challenges, and needed future directions.
The goal of clinical trials is to provide the strongest possible basis for inferring that the observed results of a health-oriented intervention are attributable to that intervention and not to other factors. Particularly strong causal inferences can be drawn from the randomized clinical trial in which participants are assigned on a random basis to either the intervention of interest or to a comparison condition. This article explains the reasons for that contention and explores its implications for medical rehabilitation research. Among the topics discussed are: the role of evidence-based practice in fostering interest in randomized clinical trials; a contextual view of randomized clinical trials that emphasizes strategies of investigation and the goals of particular studies; two key distinctions, efficacy-oriented vs. effectiveness-oriented clinical trials and pragmatic vs. explanatory clinical trials; the sequencing of different study designs, including randomized clinical trials; and needed advances in treatment theory, treatment fidelity, and adherence.
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Am J Phys Med Rehabil · Oct 2003
ReviewEmerging standards in statistical practice: implications for clinical trials in rehabilitation medicine.
This article discusses selected issues in statistical practice that occur during the conduct of clinical trials in medical rehabilitation: (1) supplementing null hypothesis statistical testing and P values, (2) determining sample size and statistical power, (3) handling missing data, and (4) dealing with multiplicity (i.e., multiple endpoints, multiple statistical comparisons, and repeated measurements). Suggested strategies to address these issues are offered in light of the International Conference on Harmonisation guideline "Statistical Principles for Clinical Trials."
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Am J Phys Med Rehabil · Oct 2003
ReviewOutcome measures for clinical rehabilitation trials: impairment, function, quality of life, or value?
Choosing outcome measures in rehabilitation research depends on the standard research skills of clear thinking, attention to detail, and minimizing the amount of data collected. In rehabilitation, outcome is more difficult to measure because (1) usually several outcomes are relevant, (2) relevant outcomes are affected by multiple factors in addition to treatment, and (3) even good measures rarely reflect the specific interest of any individual patient or member of the rehabilitation team, leading to some dissent. ⋯ Cost in terms of resources can be estimated, but there is no validated or even widely accepted method of relating this to benefit in a fair, open, and rational way. Outcome is best measured at the level of behavior (activities), with other measures being used to aid interpretation.
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Am J Phys Med Rehabil · Oct 2003
Comparative StudyMechanical insufflation-exsufflation vs. tracheal suctioning via tracheostomy tubes for patients with amyotrophic lateral sclerosis: a pilot study.
To compare the effects of mechanical insufflation-exsufflation vs. suctioning via tracheostomy tubes on respiratory variables for six amyotrophic lateral sclerosis patients. ⋯ For ventilator-dependent patients with amyotrophic lateral sclerosis, mechanical insufflation-exsufflation via a tracheostomy tube with an inflated cuff may be more effective in eliminating airway secretions than conventional tracheal suctioning.