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Predictors of the effects of treatment for shoulder pain: protocol of an individual participant data meta-analysis

van der Windt, Danielle A.; Burke, Danielle L.; Babatunde, Opeyemi; Hattle, Miriam; McRobert, Cliona; Littlewood, Chris; Wynne-Jones, Gwenllian; Chesterton, Linda; van der Heijden, Geert J.M.G.; Winters, Jan C.; Rhon, Daniel I.; Bennell, Kim; Roddy, Edward; Heneghan, Carl; Beard, David; Rees, Jonathan L.; Riley, Richard D.

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Authors

Danielle L. Burke

Miriam Hattle

Cliona McRobert

Chris Littlewood

Linda Chesterton

Geert J.M.G. van der Heijden

Jan C. Winters

Daniel I. Rhon

Kim Bennell

Carl Heneghan

David Beard

Jonathan L. Rees

Richard D. Riley



Abstract

Background
Shoulder pain is one of the most common presentations of musculoskeletal pain with a 1-month population prevalence of between 7 and 26%. The overall prognosis of shoulder pain is highly variable with 40% of patients reporting persistent pain 1 year after consulting their primary care clinician. Despite evidence for prognostic value of a range of patient and disease characteristics, it is not clear whether these factors also predict (moderate) the effect of specific treatments (such as corticosteroid injection, exercise, or surgery).

Objectives
This study aims to identify predictors of treatment effect (i.e. treatment moderators or effect modifiers) by investigating the association between a number of pre-defined individual-level factors and the effects of commonly used treatments on shoulder pain and disability outcomes.

Methods
This will be a meta-analysis using individual participant data (IPD). Eligible trials investigating the effectiveness of advice and analgesics, corticosteroid injection, physiotherapy-led exercise, psychological interventions, and/or surgical treatment in patients with shoulder conditions will be identified from systematic reviews and an updated systematic search for trials, and risk of bias will be assessed. Authors of all eligible trials will be approached for data sharing. Outcomes measured will be shoulder pain and disability, and our previous work has identified candidate predictors. The main analysis will be conducted using hierarchical one-stage IPD meta-analysis models, examining the effect of treatment-predictor interaction on outcome for each of the candidate predictors and describing relevant subgroup effects where significant interaction effects are detected. Random effects will be used to account for clustering and heterogeneity. Sensitivity analyses will be based on (i) exclusion of trials at high risk of bias, (ii) use of restricted cubic splines to model potential non-linear associations for candidate predictors measured on a continuous scale, and (iii) the use of a two-stage IPD meta-analysis framework.

Discussion
Our study will collate, appraise, and synthesise IPD from multiple studies to examine potential predictors of treatment effect in order to assess the potential for better and more efficient targeting of specific treatments for individuals with shoulder pain.

Citation

van der Windt, D. A., Burke, D. L., Babatunde, O., Hattle, M., McRobert, C., Littlewood, C., …Riley, R. D. (2019). Predictors of the effects of treatment for shoulder pain: protocol of an individual participant data meta-analysis. Diagnostic and Prognostic Research, 15 -?. https://doi.org/10.1186/s41512-019-0061-x

Journal Article Type Article
Acceptance Date May 16, 2019
Online Publication Date Aug 8, 2019
Publication Date Aug 8, 2019
Journal Diagnostic and Prognostic Research
Print ISSN 2397-7523
Publisher BioMed Central
Pages 15 -?
DOI https://doi.org/10.1186/s41512-019-0061-x
Keywords Shoulder conditions, Pain, Disability, Individual participant data meta-analysis, Predictors of treatment effect
Publisher URL http://doi.org/10.1186/s41512-019-0061-x

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