title: Individual patient data meta-analysis of trials investigating the effectiveness of intra-articular glucocorticoid injections in patients with knee or hip osteoarthritis: an OA Trial Bank protocol for a systematic review.
abstract: BACKGROUND
  Based on small to moderate effect sizes for the wide range of symptomatic treatments in osteoarthritis (OA), and on the heterogeneity of OA patients, treatment guidelines for OA have stressed the need for research on clinical predictors of response to different treatments. A meta-analysis to quantify the effect modified by the predictors using individual patient data (IPD) is suggested. The initiative to collect and analyze IPD in OA research is commenced by the OA Trial Bank. The study aims are therefore: to evaluate the efficacy of intra-articular glucocorticoids for knee or hip OA in specific subgroups of patients with severe pain and (mild) inflammatory signs, over both short-term and long-term follow-up, using IPD from existing studies; to reach consensus on the rules for cooperation in a consortium; and to develop and explore the methodological issues of meta-analysis with individual OA patient data.
  
  
  METHODS
  For the current IPD analysis we will collect and synthesize IPD from randomized trials studying the effect of intra-articular glucocorticoid injections in patients with hip or knee OA. Subgroup analyses will be performed for the primary outcome of pain at both short-term and long-term follow-up, in the subgroups of patients with and without severe pain and with and without inflammatory signs.
  
  
  CONCLUSIONS
  This study protocol includes the first study of the OA Trial Bank, an international collaboration that initiates meta-analyses on predefined subgroups of OA patients from existing literature. This approach ensures a widely supported initiative and is therefore likely to be successful in data collection of existing trials. The collaboration developed (that is, the OA Trial Bank) may also lead to future IPD analyses on subgroups of patients with several intervention strategies applied in OA patients.
authors.affiliation: Department of General Practice, Erasmus MC Medical University, PO Box 2040, 3000, CA, Rotterdam, The Netherlands. m.vanmiddelkoop@erasmusmc.nl
authors.forename: Marienke
authors.initials: M
authors.lastname: van Middelkoop
authors.forename: Krysia S
authors.initials: KS
authors.lastname: Dziedzic
authors.forename: Michael
authors.initials: M
authors.lastname: Doherty
authors.forename: Weiya
authors.initials: W
authors.lastname: Zhang
authors.forename: Johannes W
authors.initials: JW
authors.lastname: Bijlsma
authors.forename: Timothy E
authors.initials: TE
authors.lastname: McAlindon
authors.forename: Stefan L
authors.initials: SL
authors.lastname: Lohmander
authors.forename: Sita M A
authors.initials: SM
authors.lastname: Bierma-Zeinstra
mesh_terms: D005938:Glucocorticoids / Q000627:therapeutic use*; D006615:Hip; D006621:Hip Joint; D006801:Humans; D007270:Injections, Intra-Articular; D007717:Knee; D007719:Knee Joint; D015201:Meta-Analysis as Topic; D059352:Musculoskeletal Pain / Q000209:etiology / Q000517:prevention & control*; D015207:Osteoarthritis, Hip / Q000150:complications / Q000188:drug therapy*; D020370:Osteoarthritis, Knee / Q000150:complications / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D012107:Research Design; D000078202:Systematic Reviews as Topic
chemical_list: D005938:Glucocorticoids