A1. Review of shortcomings – any systematic errors (bias) | Yes | No | Indefinite | Not applicable |
---|---|---|---|---|
A1. Selection bias | ||||
a) Was an appropriate method for randomizing used? | – | – | – | – |
b) If the study used any form of limitation within the process of randomizing (for example block, strata, minimizing), are the reasons for this adequate? | – | – | – | – |
c) Was the composition of the groups adequately analogous? | – | – | – | – |
d) If there was any correction for imbalances in the baseline variables, was it performed in an adequate way? | – | – | – | – |
Comments: | ||||
Concluding assessment: | Low: | Medium: | High: | |
A2. Treatment bias | ||||
a) Were the study participants blinded? | – | – | – | – |
b) Were the researchers blinded? | – | – | – | – |
Comments: | ||||
Concluding assessment: | Low: | Medium: | High: | |
A3. Assessment bias | ||||
a) Were the observers evaluating the results blinded to the type of intervention? | – | – | – | – |
b) Were the observers reviewing the outcome impartial? | – | – | – | – |
c) Was the outcome adequately defined? | – | – | – | – |
d) Was the outcome identified/diagnosed with a validated method of measurement? | – | – | – | – |
e) Were adequate statistical methods applied to reporting the outcome? | – | – | – | – |
Comments: | ||||
Concluding assessment: | Low: | Medium | High: | |
A4. Failure bias | ||||
a) Was the statistical handling of attrition adequate? | – | – | – | – |
b) Were the reasons for attrition analysed? | – | – | – | – |
Comments: | ||||
Concluding assessment: | Low: | Medium: | High: | |
A5. Reporting bias | ||||
a) Were side effects/complications measured in a systematic manner? | – | – | – | – |
Comments: | ||||
Concluding assessment: | Low: | Medium: | High: | |
A6. Conflicts of interest | ||||
a) Was there a risk of conflicts of interest or of influence from a financier? | – | – | – | – |
Comments: | ||||
Concluding assessment: | Low: | Medium: | High: | |
A7. Study population | ||||
a) Was the population from which the participants were sampled described and relevant? | – | – | – | – |
b) Was the recruitment of participants acceptable? | – | – | – | – |
c) Was the study population adequate? | – | – | – | – |
d) Was the analysed population (ITT or PP) appropriate to the question to be addressed by the study? | – | – | – | – |
Comments: | ||||
Concluding assessment: | Low: | Medium: | High: | |
Appraisal | ||||
A1. Selection bias | – | – | – | – |
A2. Treatment bias | – | – | – | – |
A3. Assessment bias | – | – | – | – |
A4. Failure bias | – | – | – | – |
A5. Reporting bias | – | – | – | – |
A6. Conflicts of interest bias | – | – | – | – |
A7. Study population | – | – | – | – |
Comments: | ||||
Concluding assessment of quality: | Low: | Medium: | High: |