Article

The growth of evidence-based medicine means that both researchers and clinicians
must grasp the complex issues involved in implementing clinical trials, which are
especially challenging for the behavioral (experience-based) treatments that
predominate in rehabilitation. In this article we discuss selected issues germane
to the design, implementation, and analysis of group-level clinical trials in
rehabilitation. We review strengths, weaknesses,
and best applications of
1-sample, between-subjects, and within-subjects study designs, including newer
models such as practical clinical trials and point-of-care trials.
We also
discuss the selection of appropriate control conditions against which to test
rehabilitation treatments, as well as issues related to trial blinding. In a
section on treatment definition, we discuss the challenges of specifying the
active ingredients in the complex interventions that are widely used in
rehabilitation, and present an illustration of 1 approach to defining treatments
via the learning mechanisms that underlie them. Issues related to treatment
implementation are also discussed, including therapist allocation and training,
and assessment of treatment fidelity. Finally we consider 2 statistical topics of
particular importance to many rehabilitation trials: the use of multiple or
composite outcomes, and factors that must be weighed in estimating sample size for clinical trials.
CI - Copyright (c) 2012 American Congress of Rehabilitation Medicine. Published by
Elsevier Inc. All rights reserved.

Langue : ANGLAIS