Table 1. List of measures against risks of bias included in this study.
Measure | Definition | Bias |
---|---|---|
Allocation Concealment | Concealment of allocation sequence from those assigning subjects to treatment groups, until the moment of assignment. | Selection Bias |
Randomization | Allocation of study subjects randomly to treatment groups across the comparison, to ensure that group assignment cannot be predicted. | Selection Bias |
Blinding | Keeping the persons involved in an experiment (i.e. experimenter, data collector, outcome assessors) unaware of the treatment allocation. | Attrition Bias, Detection Bias, Performance Bias |
Sample Size Calculation | Appropriate a priori determination of number of study subjects for a given test setup that allows for a detection of a treatment effect given the power to find an effect of a defined size. | “Avoiding wastage of animals” |
Inclusion and Exclusion Criteria | A priori defined characteristics which describe on which basis subjects will be included in the study or how they need to be treated in case of attrition. | Attrition Bias, Selective Reporting |
Primary Outcome | A priori defined main variable of interest, on which the treatment effect is measured; with sample size calculation being based on it. | Selective Reporting |
Statistical Analysis Plan | A priori definition of statistical methods by which the primary outcome variable is analyzed at the end of the study. | Attrition Bias, Selective Reporting |
Definitions adapted from van der Worp et al. [5], CONSORT (www.consort-statement.org), the Cochrane Collaboration (methods.cochrane.org).