Document Detail

Review: efficient rehabilitation trial designs using disease progress modeling: a pediatric traumatic brain injury example.
MedLine Citation:
PMID:  19959829     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The identification of possible treatment effects against a background of spontaneous recovery is a major challenge to the successful completion of randomized clinical trials (RCTs) in rehabilitation research. Conventional trial outcomes such as the differences between group means of an outcome measure at a fixed time point are inefficient to an extent that is a major problem, particularly for exploratory studies seeking preliminary evidence of efficacy. OBJECTIVE: To quantitate gains in study power over conventional fixed-end-point designs by using parametric end points derived from the modeling of the time course of recovery after brain injury. METHODS: Nonlinear mixed effects (NLME) modeling of the recovery trajectories of 103 children rehabilitating after traumatic brain injury (TBI) as reflected in serial WeeFIM scores was performed. Pseudoreplicate data sets were generated replicating the statistical characteristics of the original data set, and these formed the basis of clinical trial simulations to derive robust estimates of study power. RESULTS: Parametric end points derived from modeling of recovery improve study power (and reduce necessary sample size) by up to 5 times in this example. CONCLUSIONS: Parametric end points derived from models of recovery trajectories offer an efficient alternative design for exploratory clinical studies of rehabilitation interventions.
Rob Forsyth; Thuy Vu; Cynthia Salorio; James Christensen; Nick Holford
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2009-12-03
Journal Detail:
Title:  Neurorehabilitation and neural repair     Volume:  24     ISSN:  1552-6844     ISO Abbreviation:  Neurorehabil Neural Repair     Publication Date:    2010 Mar-Apr
Date Detail:
Created Date:  2010-02-18     Completed Date:  2010-05-19     Revised Date:  2010-11-16    
Medline Journal Info:
Nlm Unique ID:  100892086     Medline TA:  Neurorehabil Neural Repair     Country:  United States    
Other Details:
Languages:  eng     Pagination:  225-34     Citation Subset:  IM    
Institute of Neuroscience, Newcastle University, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom.
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MeSH Terms
Brain Injuries / complications,  physiopathology,  rehabilitation*
Child, Preschool
Disability Evaluation*
Nonlinear Dynamics*
Outcome Assessment (Health Care) / statistics & numerical data
Randomized Controlled Trials as Topic
Recovery of Function
Research Design / statistics & numerical data*
Sample Size
Time Factors

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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