Lead Investigator: Shirley Yu, University of Sydney
Title of Proposal Research: Predictors of placebo response to local (intra-articular) therapy in osteoarthritis: an individual patient data meta-analysis
Vivli Data Request: 7660
Funding Source: Dr Shirley Yu holds a University of Sydney Postgraduate Research Scholarship (Part Time)
Potential Conflicts of Interest: Professor David Hunter provides consulting advice to Merck Serono, Pfizer, Lilly, TLCBio, Kolon Tissuegene. The potential conflicts of interest will be managed through disclosure of interests when the research is presented and published.
Summary of the Proposed Research:
Osteoarthritis (OA) is a highly prevalent and disabling condition with limited safe and effective treatment options available. Intra-articular therapies are increasingly being utilised, especially in patients with knee or hip osteoarthritis. However, whether the effect of these agents is due to active treatment or placebo remains largely unknown. The placebo effect is part of treatment effect and identifying the magnitude and potential predictors of this effect in intra-articular therapies will inform the design of future trials and clinical practice.
Method and analysis:
A systematic literature search will be conducted for randomised clinical trials comparing corticosteroid and viscosupplementation/hyaluronic acid intra-articular injection with placebo for knee and hip osteoarthritis. Literature searches will be conducted through Pubmed (Medline), EMBASE, Web of Science, Cochrane Central, and SCOPUS from inception to May 2018 . Individual patient data from each study will be requested and obtained from the corresponding authors of the trials. Risk of bias will be assessed using the Cochrane Collaboration’s tool.
The primary outcome will be change in pain from baseline. Secondary outcomes will be change in function and patient global assessment. Predictors of response to treatment that will be assessed include patient characteristics (age, gender, bilateral versus unilateral disease, other joints OA involvement, radiographic severity, pain severity and presence of inflammatory features based on imaging and physical examination) , intervention characteristics (aspirate volume, frequency of injection, volume of injection, and intra-articular injection approach), and trial characteristics (clinical setting , blinding, use of intention to treat analysis, funder/sponsor). We will report our results using the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA)-IPD guidelines.
A Multi-Centre, Parallel, Double-Blind, Blinded Evaluator, Randomised, Placebo-Controlled Evaluation of the Efficacy and Safety of a Single Dose of 6 mL of Synvisc in Patients With Symptomatic Osteoarthritis of the Knee
Data Contributor: Sanofi
Study ID: NCT00131352
Sponsor ID: SYNV00704