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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