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      Assessing baseline imbalance in randomised trials: implications for the Cochrane risk of bias tool.

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          Abstract

          A key component of the Cochrane Collaboration's risk of bias tool for critically evaluating randomised trials is the consideration of whether baseline characteristics of the treatment groups being compared are systematically different. Considered under the domain of 'selection bias', this is currently evaluated by looking at the methods of randomisation and specifically at the generation of the randomised allocation sequence and the concealment of this sequence during the process of randomisation. Assessment of the actual similarity of baseline variables across groups in demographic and clinical characteristics is seldom performed. Even when performed, the link with selection bias is sometimes not considered. Methods of randomisation and allocation concealment are often poorly reported in published trials, yet baseline data tables are presented in a large majority of trial reports. In this article, we propose that assessment of trial baseline data should form a key and prominent part of selection bias judgements when using the risk of bias tool. We outline the possible benefits from using this approach, including reduced uncertainty in systematic review conclusions, reduced risk of chance findings being ascribed to treatment effects and better use of available evidence by a more considered approach to evaluating studies using imperfect randomisation and allocation methods.

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          Author and article information

          Journal
          Res Synth Methods
          Research synthesis methods
          Wiley-Blackwell
          1759-2887
          1759-2879
          Mar 2014
          : 5
          : 1
          Affiliations
          [1 ] Centre for Reviews and Dissemination, University of York, York, YO10 5DD, UK.
          Article
          10.1002/jrsm.1090
          26054027
          e29ad40b-9e52-4c94-bc13-6767de1105dc
          History

          Cochrane Collaboration,baseline imbalance,randomised trials,risk of bias,systematic reviews

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