Theoretical background |
Used for selection bias |
1. Is there a theoretical background for the hypothesis? |
Study participation |
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2. Is the study population clearly described in terms of age, gender, and important patients’ characteristics? |
Used for selection bias |
3. Is the percentage of eligible subjects who participated in the study (response rate) adequate? (More than 30 % is considered inappropriate) |
Used for selection bias |
Sampling |
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4. Are patients who participated in the study similar to eligible non-participants (the population), in terms of age, gender, and important disease characteristics? |
Used for selection bias |
Study attrition |
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5. Is the percentage of subjects available for analysis adequate? (<30 % not too many missing values or loss to follow-up)? |
Used for selection bias |
6. Were reasons for loss to follow-up presented and assessed during the study for possible systematic attrition? (Subjects that did not finish the study) |
Used for selection bias |
Outcome measurement |
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Definition of outcome variable(s) |
Used for information bias |
7. Are clear definitions of each outcome variable provided? |
8. Is clear operationalization of each outcome variable provided? How is it measured? |
Used for information bias |
Measurement of outcome variable(s) |
Used for information bias |
9. Are the measurement instruments used for the measurement of the outcome variable(s) reliable and valid? |
Method and setting of the outcome variable(s) |
Used for information bias |
10. Were the measurement approach, time and place of measurement of the outcome variable(s) standardized or conducted in a way that limits systematically different measurement? |
Study confounding |
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Definition of potential confounders |
Used for information bias |
11. Are clear definitions of each confounder provided? |
12. Is clear operationalization of each confounder provided? |
Used for information bias |
Measurement of potential confounders |
Used for information bias |
13.Are the measurement instruments used for the measurement of the confounder(s) reliable and valid? |
Method and setting of the confounder(s) |
Used for information bias |
14. Were the measurement approach, time and place of measurement of the confounder(s) standardized or conducted in a way that limits systematically different measurement? |
Statistical analyses |
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15. Is the percentage of missing values adequate? Less < 30 % |
Used for statistical analysis bias |
16. Were multivariable analyses performed? Yes is rated as “0” if yes |
Used for statistical analysis bias |
17. Was it clearly described which variables were included in the (multivariable) model(s)? |
Used for statistical analysis bias |