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. 2019 Oct 10;15(4):e1056. doi: 10.1002/cl2.1056
YES NO Unclear
Reporting
1. Is the hypothesis/aim/objective of the study clearly described?
2. Are the main outcomes to be measured clearly described in the Introduction or Methods section?
3. Are the methods of inquiry are appropriate for the study's aims?
4. The authors discussed why they chose to use those methods?
5. Are the characteristics of the patients included in the study clearly described?
6. Are the interventions of interest clearly described?
7. Are the distributions of principal confounders in each group of subjects to be compared clearly described?
8. Are the main findings of the study clearly described?
9. Does the study provide estimates of the random variability in the data for the main outcomes?
10. Have all important adverse effects that may be a consequence of the intervention been reported?
11. Have the characteristics of patients lost to follow‐up been described?
12. Have actual probability values been reported for the main outcomes, except where the probability value is less than 0.001?
External Validity
13. Were the subjects asked to participate in the study representative of the entire population from which they were recruited?
14. Were those subjects who were prepared to participate, representative of the entire population from which they were recruited?
15. Were the staff, places, and facilities where the patients were treated, representative of the treatment the majority of patients received?
Internal Validity – bias
16. Was an attempt made to blind study subjects to the intervention they have received?
17. Was an attempt made to blind those measuring the main outcomes of the intervention?
18. If any of the results of the study were based on “data dredging,” was this made?
19. In trials and cohort studies, do the analyses adjust for different lengths of follow‐up of patients, or in case control studies, is the time period between the intervention and outcome the same for cases and controls?
20. Were the statistical tests used to assess the main outcomes appropriate?
21. Was compliance with the intervention/s reliable?
22. Were the main outcome measures used accurate (valid and reliable)?
Internal Validity – confounding (selection bias)
23. 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?
24. 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?
25. Were study subjects randomised to intervention groups?
26. Was the randomised intervention assignment concealed from both patients and health care staff until recruitment was complete and irrevocable?
27. Was there adequate adjustment for confounding in the analyses from which the main findings were drawn?
28. Were the losses of patients to follow‐up taken into consideration?
Power
29. Did the study have sufficient power to detect a clinically important effect where the probability value for a difference being due to chance is 5%?
Research Value
30. Do the study findings contribute to the current knowledge base
31. Can the findings reasonably be expected to inform current practices or polices?
32. Are these contributions discussed by the authors?
33. Have the authors identified new research areas?
34. Have the authors discussed how the research findings could be used and for what populations?