Selective reporting bias due to discrepancies between registered and published outcomes in osteoarthritis trials.

Abstract

Aim: Outcome reporting bias (ORB) occurs when outcomes planned in a study protocol are subsequently not reported or are partially reported. Our aim was to analyze ORB in randomized controlled trials (RCTs) about conservative interventions for osteoarthritis (OA) by comparing registered protocols and published manuscripts, as well as association between study funding type and intervention type, and ORB in those RCTs. Materials & methods: We analyzed RCTs that were published in a peer-review journal and analyzed any type of conservative intervention for treatment of OA in humans that reported in the manuscript registration in a public clinical trial registry and provided unique registration identifier. We extracted data indicating ORB by comparing outcomes in protocol and published article, and characteristics of trials. Results: In 190 (57%) of 334 included RCTs, it was indicated in the manuscript that a trial was registered. In 48% of trials we found discrepancies in number, type or time point of primary efficacy outcome between protocol and manuscript. Significantly less discrepancies in primary efficacy outcomes between protocols and published articles were found in trials funded by a commercial sponsor (p=0.0062) and trials of pharmacological interventions (p=0.0016). Conclusion: Trials about conservative therapies for OA have high prevalence of discrepancies between protocol and publication, and frequent ORB. This may mislead readers of published results because it has been shown that ORB can lead to both overestimation and underestimation of effects of interventions, depending on the intervention and outcome. Efforts to prevent nonregistration of protocols and selective reporting are needed.