Abstract
Background Clinical trials require large monetary and time commitments and should provide information on both whether and how treatments work. Treatment mechanisms can be studied using mediation analysis, allowing refinement of treatments. Mediation studies often use only single contemporaneous measures of mediator and outcome limiting the conclusions that can be drawn. Longitudinally measured mediators and outcomes, such as those in the Pacing, Graded Activity, and Cognitive Behaviour Therapy: A Randomised Evaluation trial (PACE, ISRCTN 54285094) allow for more realistic estimates of mediated effects.
Highlights
Clinical trials require large monetary and time commitments and should provide information on both whether and how treatments work
Autoregressive models accounting for measurement error were used to study treatment effect mediation of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) in PACE
Fear avoidance and physical function were used as example mediator and outcome; these were measured at baseline and three times post-randomisation as part of the trial design
Summary
Longitudinal mediation in the PACE randomised clinical trial of rehabilitative treatments for chronic fatigue syndrome: modelling and design considerations. Kimberley Goldsmith1*, Trudie Chalder, Peter White, Michael Sharpe, Andrew Pickles. From 3rd International Clinical Trials Methodology Conference Glasgow, UK. From 3rd International Clinical Trials Methodology Conference Glasgow, UK. 16-17 November 2015
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