Risk of bias versus quality assessment of randomised controlled trials: cross sectional study.
OBJECTIVE
To evaluate the risk of bias tool, introduced by the Cochrane Collaboration for assessing the internal validity of randomised trials, for inter-rater agreement, concurrent validity compared with the Jadad scale and Schulz approach to allocation concealment, and the relation between risk of bias and effect estimates.


METHODS
Cross sectional study. Study sample 163 trials in children.


METHODS
Inter-rater agreement between reviewers assessing trials using the risk of bias tool (weighted kappa), time to apply the risk of bias tool compared with other approaches to quality assessment (paired t test), degree of correlation for overall risk compared with overall quality scores (Kendall's tau statistic), and magnitude of effect estimates for studies classified as being at high, unclear, or low risk of bias (metaregression).


RESULTS
Inter-rater agreement on individual domains of the risk of bias tool ranged from slight (kappa=0.13) to substantial (kappa=0.74). The mean time to complete the risk of bias tool was significantly longer than for the Jadad scale and Schulz approach, individually or combined (8.8 minutes (SD 2.2) per study v 2.0 (SD 0.8), P<0.001). There was low correlation between risk of bias overall compared with the Jadad scores (P=0.395) and Schulz approach (P=0.064). Effect sizes differed between studies assessed as being at high or unclear risk of bias (0.52) compared with those at low risk (0.23).


CONCLUSIONS
Inter-rater agreement varied across domains of the risk of bias tool. Generally, agreement was poorer for those items that required more judgment. There was low correlation between assessments of overall risk of bias and two common approaches to quality assessment: the Jadad scale and Schulz approach to allocation concealment. Overall risk of bias as assessed by the risk of bias tool differentiated effect estimates, with more conservative estimates for studies at low risk.
Hartling
Lisa
L
Alberta Research Centre for Health Evidence, Department of Pediatrics, University of Alberta, Aberhart Centre One, Edmonton, AB, Canada T6G 2J3. hartling@ualberta.ca
Ospina
Maria
M
Liang
Yuanyuan
Y
Dryden
Donna M
DM
Hooton
Nicola
N
Krebs Seida
Jennifer
J
Klassen
Terry P
TP
D015982:Bias; D003430:Cross-Sectional Studies; D015588:Observer Variation; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D013223:Statistics as Topic