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Design and Analysis of Cross-Over Trials
Byron Jones,Michael G. Kenward +1 more
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In this article, the authors provide an overview of recent developments in the design and analysis of cross-over trials and present methods for testing for a treatment difference when the data are binary.Abstract:
This chapter provides an overview of recent developments in the design and analysis of cross-over trials. We first consider the analysis of the trial that compares two treatments, A and B, over two periods and where the subjects are randomized to the treatment sequences AB and BA. We make the distinction between fixed and random effects models and show how these models can easily be fitted using modern software. Issues with fitting and testing for a difference in carry-over effects are described and the use of baseline measurements is discussed. Simple methods for testing for a treatment difference when the data are binary are also described. Various designs with two or more treatments but with three or four periods are then described and compared. These include the balanced and partially balanced designs for three or more treatments and designs for factorial treatment combinations. Also described are nearly balanced and nearly strongly balanced designs. Random subject-effects models for the designs with two or more treatments are described and methods for analysing non-normal data are also given. The chapter concludes with a description of the use of cross-over designs in the testing of bioequivalence.read more
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Small Sample Inference for Fixed Effects from Restricted Maximum Likelihood
TL;DR: A scaled Wald statistic is presented, together with an F approximation to its sampling distribution, that is shown to perform well in a range of small sample settings and has the advantage that it reproduces both the statistics and F distributions in those settings where the latter is exact.
Journal ArticleDOI
Meta-analyses involving cross-over trials: methodological issues
Diana Elbourne,Douglas G. Altman,Julian P T Higgins,François Curtin,Helen V Worthington,Andy Vail +5 more
TL;DR: Methods do exist for including valuable information from two-period, two-treatment cross-over trials into quantitative reviews, however, poor reporting of cross- over trials will often impede attempts to perform a meta-analysis using the available methods.
Journal ArticleDOI
Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure and serum lipids: results of the OmniHeart randomized trial.
Lawrence J. Appel,Frank M. Sacks,Vincent J. Carey,Eva Obarzanek,Janis F. Swain,Edgar R. Miller,Paul R. Conlin,Thomas P. Erlinger,Bernard Rosner,Nancy Laranjo,Jeanne Charleston,Phyllis McCarron,Louise M. Bishop +12 more
TL;DR: In the setting of a healthful diet, partial substitution of carbohydrate with either protein or monounsaturated fat can further lower blood pressure, improve lipid levels, and reduce estimated cardiovascular risk.
Journal ArticleDOI
Morphine, Gabapentin, or Their Combination for Neuropathic Pain
TL;DR: Gabapentin and morphine combined achieved better analgesia at lower doses of each drug than either as a single agent, with constipation, sedation, and dry mouth as the most frequent adverse effects.
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Long-term donepezil treatment in 565 patients with Alzheimer's disease (AD2000): randomised double-blind trial.
C Courtney,D Farrell,Richard Gray,Robert Kerrin Hills,Lloyd Lynch,E Sellwood,S Edwards,Wendy Hardyman,James Raftery,Peter Crome,Corinne Lendon,H Shaw,Peter Bentham +12 more
TL;DR: Donepezil is not cost effective, with benefits below minimally relevant thresholds, and more effective treatments than cholinesterase inhibitors are needed for Alzheimer's disease.
References
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