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RoB 2 provides a framework for assessing the risk of bias in a single estimate of an intervention effect reported from a randomised trial. The effect assessed is a comparison of two interventions, which we refer to as the experimental and comparator interventions, for a specific outcome or endpoint. The process of making a RoB 2 assessment is summarised in figure 1. Preliminary considerations (box 1) include specifying which result is being assessed, specifying how this result is being interpreted (see “The intervention effect of interest” below), and listing the sources of information used to inform the assessment. Review authors should contact trial authors in order to obtain information that is omitted from published and online sources, so far as this is feasible. Note that risk-of-bias assessments might be needed for results relating to multiple outcomes from the included trials.
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