Appraising harm evidence
Assess patient similarities, study methods, follow-up period, and precision and magnitude of effect
1. Were there clearly defined groups of patients, similar in all important ways other than exposure to the treatment or other cause?
2. Were the treatments or exposures and clinical outcomes measured in the same ways in both groups and blinded?
3. Was the follow-up of the study patients sufficiently long and complete?
4. Is it clear that the exposure preceded the onset of the outcome?
5. Is there a dose-response gradient?
6. Is there any positive evidence from a dechallenge-challenge study?
7. Is the association consistent from study to study?
8. Does the association make biological sense?
9. What is the magnitude of the association between the exposure and outcome?
10. What is the precision of the estimate of the association between the exposure and the outcome?
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