| Reporting |
1 - Is the Hypothesis/aim/objective clearly described?
2 - Are the main outcomes to be measured clearly described in the Introduction or Methods section?
3 - Are the characteristics of the participants included in the study clearly described?
4 - Are the interventions of interest clearly described?
6 - Are the main findings of the study clearly described?
10 - Have actual probability values been reported (e.g. 0,035 rather than <0,05) for the main outcomes except where the probability value is less than 0.001?
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| External Validity |
11 - Were the subjects asked to participate in the study representative of the entire population from which they were recruited?
12 - Were those subjects who were prepared to participate representative of the entire population from which they were recruited?
13 - Were the staff, place, and facilities where the patients were treated, representative of the treatment the majority of patients receive?
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| Internal Validity - Bias |
18 - Were the statistical tests used to assess the main outcomes appropriate?
19 - Was the compliance with the interventions reliable?
20 - Were the main outcome measures used accurate (valid and reliable)?
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| Internal Validity - Confounding (selection bias) |
21 - Were the patients in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited from the same population?
22 - Were the study subjects in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited over the same period of time?
23 - Were study subjects randomized to intervention groups?
24 - Was the randomized intervention assignment concealed from both patient and health care staff until was complete and irrevocable?
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