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Epidemiology
Protocol
Assessing bias in osteoarthritis trials included in Cochrane reviews: protocol for a meta-epidemiological study
  1. Julie B Hansen1,2,
  2. Carsten B Juhl2,
  3. Isabelle Boutron3,4,
  4. Peter Tugwell5,
  5. Elizabeth A T Ghogomu6,
  6. Jordi Pardo Pardo6,
  7. Tamara Rader6,
  8. George A Wells7,
  9. Alain Mayhew4,8,
  10. Lara Maxwell6,
  11. Hans Lund2,
  12. Robin Christensen1,
  13. The Editorial Board of the Cochrane Musculoskeletal Group
  1. 1Musculoskeletal Statistics Unit, Department of Rheumatology, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Frederiksberg, Copenhagen, Denmark
  2. 2SEARCH Research Group, Research Unit of Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
  3. 3INSERM, University Paris Descartes, Paris, France
  4. 4Cochrane Bias Methods Group, Ottawa, Canada
  5. 5Ottawa Hospital Research Institute, Joint Coordinating Editor CMSG, Ottawa, Canada
  6. 6Cochrane Musculoskeletal Group, University of Ottawa, Ottawa, Canada
  7. 7Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
  8. 8Ottawa Hospital Research Institute, Centre for Practice-Changing Research, Ottawa, Canada
  1. Correspondence to Robin Christensen; Robin.Christensen{at}frh.regionh.dk

Abstract

Introduction The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta-analyses of interventions used for treating pain in osteoarthritis (OA). From the findings, we hope to consolidate guidance on interpreting OA trials in systematic reviews based on empirical evidence from Cochrane reviews.

Methods and analysis Only systematic reviews that compare experimental interventions with sham, placebo or no intervention control will be considered eligible. Bias will be assessed with the risk of bias tool, used according to the Cochrane Collaboration’s recommendations. Furthermore, center status, trial size and funding will be assessed. The primary outcome (pain) will be abstracted from the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment benefits, we will perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect. A relevant study-level covariate is defined as one that decreases the between-study variance (τ2, estimated as Tau-squared) as a consequence of inclusion in the mixed effects statistical model.

Ethics and dissemination Meta-analyses and randomised controlled trials provide the most reliable basis for treatment of patients with OA, but the actual impact of bias is unclear. This study will systematically examine the methodological quality in OA Cochrane reviews and explore the effect estimates behind possible bias. Since our study does not collect primary data, no formal ethical assessment and informed consent are required.

Trial registration number PROSPERO (CRD42013006924).

  • osteoarthritis
  • meta-analysis
  • meta-epidemiology
  • risk of bias

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2014-005491

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