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Table 3 SYRCLE risk of bias (RoB) tool

From: Efficacy and safety of regenerative cell therapy for pulmonary arterial hypertension in animal models: a preclinical systematic review protocol

Item Type of bias Domain Description of domain Review authors’ judgment
1 Selection bias Sequence generation Describe the methods used, if any, to generate the allocation sequence in sufficient detail to allow an assessment whether it should produce comparable groups. Was the allocation sequence adequately generated and applied?a
2 Selection bias Baseline characteristics Describe all the possible prognostic factors or animal characteristics, if any, that are compared in order to judge whether or not intervention and control groups were similar at the start of the experiment. Were the groups similar at baseline or were they adjusted for confounders in the analysis?
3 Selection bias Allocation concealment Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen before or during enrolment. Was the allocation adequately concealed?a
4 Performance bias Random housing Describe all measures used, if any, to house the animals randomly within the animal room. Were the animals randomly housed during the experiment?
5 Performance bias Blinding Describe all measures used, if any, to blind trial caregivers and researchers from knowing which intervention each animal received. Provide any information relating to whether the intended blinding was effective. Were the caregivers and/or investigators blinded from knowledge which intervention each animal received during the experiment?
6 Detection bias Random outcome assessment Describe whether or not animals were selected at random for outcome assessment, and which methods to select the animals, if any, were used. Were animals selected at random for outcome assessment?
7 Detection bias Blinding Describe all measures used, if any, to blind outcome assessors from knowing which intervention each animal received. Provide any information relating to whether the intended blinding was effective. Was the outcome assessor blinded?
8 Attrition bias Incomplete outcome data Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized animals), reasons for attrition or exclusions, and any re-inclusions in analyses for the review. Were incomplete outcome data adequately addressed?a
9 Reporting bias Selective outcome reporting State how selective outcome reporting was examined and what was found. Are reports of the study free of selective outcome reporting?a
10 Other Other sources of bias State any important concerns about bias not covered by other domains in the tool. Was the study apparently free of other problems that could result in high risk of bias?a
  1. aItems in agreement with the items in the Cochrane Risk of Bias tool. Hooijmans et al. BMC Medical Research Methodology 2014 14:43 doi:10.1186/1471-2288-14-43