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Design and Reporting of Randomised Controlled Trials for Raynaud’s Phenomenon

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Raynaud’s Phenomenon

Abstract

Randomised controlled trials play a crucial role in the identification of safe, effective treatments provided that they are designed, conducted and reported with care. Additional considerations arise in trials of treatments for Raynaud’s phenomenon due to characteristics of the condition. In particular, strong placebo responses, heterogeneity in the patient population and the impact of seasonal effects on patient outcomes must be accounted for. I discuss the issues around the design, analysis and reporting of trials for Raynaud’s phenomenon using recent examples from the literature. The features of common trial designs are expounded and recommendations for best practice are presented. The appropriate use of pilot studies as preparatory exercises is discussed, and the role of systematic reviews in the investigation of treatments for Raynaud’s phenomenon is considered.

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Authors and Affiliations

  1. Research and Development, Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK

    Jack Wilkinson M.Sc., B.Sc.

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  1. Jack Wilkinson M.Sc., B.Sc.
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Correspondence to Jack Wilkinson M.Sc., B.Sc. .

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Editors and Affiliations

  1. School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA

    Fredrick M. Wigley

  2. Department of Rheumatology, The University of Manchester, Manchester, United Kingdom

    Ariane L. Herrick

  3. Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medic, Baltimore, Maryland, USA

    Nicholas A. Flavahan

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Wilkinson, J. (2015). Design and Reporting of Randomised Controlled Trials for Raynaud’s Phenomenon. In: Wigley, F., Herrick, A., Flavahan, N. (eds) Raynaud’s Phenomenon. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1526-2_18

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  • DOI: https://doi.org/10.1007/978-1-4939-1526-2_18

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  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-1-4939-1525-5

  • Online ISBN: 978-1-4939-1526-2

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