Bias Domains and Questions | Study designs | |||||
---|---|---|---|---|---|---|
Randomised controlled trials | Non‐randomised controlled trials | Randomised non‐controlled trials | Non‐randomised non‐controlled trials | Prospective observational studies | Retrospective studies | |
Appraisal of internal validity The ability of a study to provide an unbiased estimate of the true value of the parameter(s) that the study is intended to estimate. | ||||||
SELECTION BIAS | ||||||
1. Was administered dose or exposure level adequately randomised? | X | X | ||||
2. Was allocation to study groups adequately concealed? | X | X | ||||
3. Did selection of study participants result in appropriate comparison groups? | X | X | X | X | ||
CONFOUNDING BIAS | ||||||
4. Did the study design or analysis account for important confounding and modifying variables of the outcome? Were the confounding and modifying variables measured reliably and consistently? | X | X | X | X | X | X |
PERFORMANCE BIAS | ||||||
5. Were the research personnel and human subjects blinded to the study group during the study considering the health‐outcome ‘failure to thrive’? | X | X | X | X | ||
ATTRITION / EXCLUSION BIAS | ||||||
6. Were outcome data complete without attrition or exclusion from analysis? | X | X | X | X | X | |
DETECTION BIAS | ||||||
7. Can we be confident in the exposure characterisation? | X | X | X | X | X | X |
8. Can we be confident in the outcome assessment considering the outcome? | X | X | X | X | X | X |
SELECTIVE REPORTING BIAS | ||||||
9. Were all measured outcomes reported when considering the outcome? | X | X | X | X | X | X |
OTHER SOURCES OF BIAS | ||||||
10. Are there no other potential threats to internal validity (e.g. statistical methods were appropriate and researchers adhered to the study protocol)? | X | X | X | X | X | X |
Adapted from OHAT/NTP risk of bias tool (https://ntp.niehs.nih.gov/ntp/ohat/pubs/riskofbiastool_508.pdf).