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Rheumatology
Protocol
Behaviour change interventions for the management of Raynaud's phenomenon: a systematic review protocol
  1. Jo Daniels1,
  2. John D Pauling2,3,
  3. Christopher Eccelston4
  1. 1 Department of Psychology, The University of Bath, Bath, UK
  2. 2 Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, UK
  3. 3 Department of Pharmacy and Pharmacology, The University of Bath, Bath, UK
  4. 4 Centre for Pain Research, Department for Health, The University of Bath, Bath, UK
  1. Correspondence to Dr Jo Daniels; j.daniels{at}bath.ac.uk

Abstract

Introduction Raynaud's phenomenon (RP) describes excessive peripheral vasospasm to cold exposure and/or emotional stress. RP episodes are associated with digital colour changes, pain and reduced quality of life. Pharmacological interventions are of low to moderate efficacy and often result in adverse effects such as facial flushing and headaches. Recommended lifestyle and behavioural interventions have not been evaluated. The objectives of the proposed systematic review are to assess the comparative safety and efficacy of behaviour change interventions for RP and identify what we can learn to inform future interventions.

Methods and analysis Studies eligible for inclusion include randomised controlled trials testing behaviour change interventions with a control comparator. A comprehensive search strategy will include peer review and grey literature up until 30 April 2017. Search databases will include Medline, Embase, PsychINFO and Cochrane. Initial sifting, eligibility, data extraction, risk of bias and quality assessment will be subject to review by two independent reviewers with a third reviewer resolving discrepancies. Risk of bias assessment will be performed using Cochrane risk of a bias assessment tool with quality of evidence assessed using Grading of Recommendations Assessment, Development and Evaluation(GRADE). A meta-analysis will be performed if there are sufficient data. Two subgroup analyses are planned: primary versus secondary RP outcomes; comparison of theoretically informed interventions with pragmatic interventions.

Ethics and dissemination This review does not require ethical approval as it will summarise published studies with non-identifiable data. This protocol complies with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Findings will be disseminated in peer-reviewed articles and reported according to PRISMA. This review will make a significant contribution to the management of RP where no review of behaviour-change interventions currently exist. The synopsis and protocol for the proposed systematic review is registered in the International Prospective Register of Systematic Reviews (registration number CRD42017049643).

  • Raynaud's Phenomenon
  • behaviour change
  • systematic review

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-017039

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    Footnotes

    • Contributors All authors, JD, JDP and CE were involved in developing the focus of the systematic review, arriving at the final conception of the proposed systematic review through an iterative process. JD produced the first draft of the protocol and supplementary information, coordinated and assimilated comments from JDP and CE on the protocol, approved the final version for publication and is the guarantor of the manuscript. JDP also critically revised successive drafts of the manuscript, provided expert advice and intellectual input regarding the subject area (Raynaud's phenomenon) and approved the final version for publication. CE critically revised successive drafts of the manuscript, provided expert advice on systematic review methodology and approved the final version for publication.

    • Funding This research received no specific grant or financial support from any funding agency in the public,commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.