STUDY GUIDE Revised Cochrane risk-of-bias tool for randomized trials (RoB 2) SHORT VERSION (CRIBSHEET)

Revised Cochrane risk-of-bias tool for randomized trials (RoB 2)
SHORT VERSION (CRIBSHEET)
Edited by Julian PT Higgins, Jelena Savović, Matthew J Page, Jonathan AC Sterne
on behalf of the RoB 2 Development Group
Version of 22 August 2019




The development of the RoB 2 tool was supported by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/2- N61), with the support of the
host MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures - MR/K025643/1), by MRC
research grant MR/M025209/1, and by a grant from The Cochrane Collaboration.




This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.




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,Preliminary considerations
Study design
 Individually-randomized parallel-group trial
 Cluster-randomized parallel-group trial
 Individually randomized cross-over (or other matched) trial

For the purposes of this assessment, the interventions being compared are defined as
Experimental: Comparator:


Specify which outcome is being assessed for risk of bias

Specify the numerical result being assessed. In case of multiple alternative
analyses being presented, specify the numeric result (e.g. RR = 1.52 (95% CI
0.83 to 2.77) and/or a reference (e.g. to a table, figure or paragraph) that
uniquely defines the result being assessed.

Is the review team’s aim for this result…?
 to assess the effect of assignment to intervention (the ‘intention-to-treat’ effect)
 to assess the effect of adhering to intervention (the ‘per-protocol’ effect)


If the aim is to assess the effect of adhering to intervention, select the deviations from intended intervention that should be addressed (at least one must be
checked):
 occurrence of non-protocol interventions
 failures in implementing the intervention that could have affected the outcome
 non-adherence to their assigned intervention by trial participants




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, Which of the following sources were obtained to help inform the risk-of-bias assessment? (tick as many as apply)
 Journal article(s)
 Trial protocol
 Statistical analysis plan (SAP)
 Non-commercial trial registry record (e.g. ClinicalTrials.gov record)
 Company-owned trial registry record (e.g. GSK Clinical Study Register record)
 “Grey literature” (e.g. unpublished thesis)
 Conference abstract(s) about the trial
 Regulatory document (e.g. Clinical Study Report, Drug Approval Package)
 Research ethics application
 Grant database summary (e.g. NIH RePORTER or Research Councils UK Gateway to Research)
 Personal communication with trialist
 Personal communication with the sponsor




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