2. Risk of bias criteria for single‐arm observational studies of interventions.
Internal validity | External validity | |
Study group | Selection bias (representative: yes/no) if the described study group consisted of more than 90% of eligible individuals |
Reporting bias (well defined: yes/no) if the intervention and number of participants was defined |
Follow‐up | Attrition bias (adequate: yes/no) if the outcome was assessed for more than 90% of the study group of interest (++) or if the outcome was assessed for 60% to 90% of the study group of interest (+) |
Reporting bias (well defined: yes/no) if the length of follow‐up was mentioned |
Outcome | Detection bias (blind: yes/no) if the outcome assessors were blinded to the investigated determinant |
Reporting bias (well‐defined: yes/no) if the outcome definition was objective and precise |
Risk estimation | Confounding (adjustment for other factors: yes/no) if important prognostic factors (i.e. age, gender) or follow‐up were taken adequately into account |
Analyses (well‐defined: yes/no) If the method of analysis was described and the effect of the intervention was quantified |