What is the evidence for interventions used to manage sleep disturbances in people with fibromyalgia? A comprehensive evidence synthesis to inform clinical practice and future research

Research question: What is the evidence for interventions used to manage sleep disturbances in people with fibromyalgia? A comprehensive evidence synthesis to inform clinical practice and future research. Background: In people with fibromyalgia, sleep disturbance is one of the most common reported symptoms and an adverse prognostic factor. The James Lind Alliance Priority Setting Partnerships has identified the need to determine which interventions are more effective for the management of fibromyalgia-related sleep problems as one of their top priorities. Aims and objectives: Synthesis of quantitative and qualitative evidence and patient-reported outcome measures (PROMs) analysis to inform management of fibromyalgia-related sleep problems. Search strategy: Major electronic databases (MEDLINE, Embase, Science Citation Index, CINAHL, AMED, CDSR, CENTRAL, APA PsycInfo, DARE, the NIHR Journals Library) with no language or publication date restrictions and ongoing studies registries. Research strategy: Choice of primary and secondary outcomes will be agreed upon by the project Advisory Group. These may include measures of sleep, activities of daily living, adverse events and quality of life. Data selection and extraction will be performed independently by two reviewers. For the quantitative evidence synthesis, network meta-analysis (NMA) will be performed to compare interventions that have not been directly compared in clinical trials and analyse results of direct and indirect comparisons collectively. A Bayesian framework will be used, in accord with NICE Decision Support Unit guidance. Component NMAs will be used when appropriate. The GRADE approach for NMA will be used to rate the quality of direct and indirect effect estimates. A recently published systematic review of qualitative evidence assessing the experience of people with fibromyalgia-related sleep problems will be updated and the quality of its evidence assessed using GRADE-CERQual. Content analysis of PROMs of sleep quality in people with fibromyalgia will be performed. Using an interpretive approach, outputs from quantitative, qualitative and PROMs analyses will be synthesised to draw overall conclusions. Project timelines: Month 1-3: Protocol development and registration, consolidation of Advisory Group, literature searches; Month 4-11: Quantitative evidence synthesis, update of a recent qualitative systematic review, PROMs analysis, integration of findings/mixed-methods synthesis, writing up. Month 12: Final report, manuscripts preparation, dissemination activities. Anticipated impact and dissemination: Evidence to inform clinical practice and future research; enhanced quality of life for people with fibromyalgia-related sleep problems. Thorough dissemination strategies will be developed in discussion with the Advisory Group and our PPI co-applicant and targeted to different audiences. Outputs will include academic publications and presentations, methodological papers and appropriate summaries for patients, the public, policymakers and health professionals including infographics, podcasts, and tweets. Contacts with relevant PPI and social media groups will be established to facilitate access to our findings by people with fibromyalgia, carers and their families. Existing links with relevant charities, healthcare and professional organisations will be leveraged to cascade our findings to patients, healthcare professionals, policymakers and the public.