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A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan

Research output: Contribution to journalArticle

Rebecca Walwyn, Laura Potts, Paul McCrone, Anthony L Johnson, Julia C Decesare, Hannah Baber, Kimberley Goldsmith, Michael Sharpe, Trudie Chalder, Peter D White

Original languageEnglish
Article number386
Number of pages23
JournalTrials
Volume14
DOIs
Published13 Nov 2013

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  • walwyn et al 2013

    walwyn_et_al_2013.pdf, 489 KB, application/pdf

    Uploaded date:24 Oct 2014

    Version:Final published version

King's Authors

Abstract

Background
The publication of protocols by medical journals is increasingly becoming an accepted means for promoting good quality research and maximising transparency. Recently, Finfer and Bellomo have suggested the publication of statistical analysis plans (SAPs).The aim of this paper is to make public and to report in detail the planned analyses that were approved by the Trial Steering Committee in May 2010 for the principal papers of the PACE (Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation) trial, a treatment trial for chronic fatigue syndrome. It illustrates planned analyses of a complex intervention trial that allows for the impact of clustering by care providers, where multiple care-providers are present for each patient in some but not all arms of the trial.

Results
The trial design, objectives and data collection are reported. Considerations relating to blinding, samples, adherence to the protocol, stratification, centre and other clustering effects, missing data, multiplicity and compliance are described. Descriptive, interim and final analyses of the primary and secondary outcomes are then outlined.

Conclusions
This SAP maximises transparency, providing a record of all planned analyses, and it may be a resource for those who are developing SAPs, acting as an illustrative example for teaching and methodological research. It is not the sum of the statistical analysis sections of the principal papers, being completed well before individual papers were drafted.

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