Study question: |
1. Was relevant background work cited to establish a foundation for the research questions? |
Study design: |
2. Was a comparison group used? |
3. Was patient status at more than one time point considered? |
4. Was data collection performed prospectively? |
5. Were patients randomized to groups? |
6. Were patients blinded to the extent possible? |
7. Were treatment providers randomized to the extent possible? |
8. Was an independent evaluator used to administer the outcome measures? |
Subjects: |
9. Did sampling procedures minimize sample/selection biases? |
10. Were inclusion/exclusion criteria defined? |
11. Was an appropriate enrollment obtained? |
12. Was appropriate retention/follow-up obtained? |
Intervention: |
13. Was the intervention applied according to established principles? |
14. Were biases due to the treatment provider minimized? |
15. Was the intervention compared to the appropriate comparator? |
Outcomes: |
16. Was an appropriate primary outcome defined? |
17. Was an appropriate secondary outcomes considered? |
18. Was an appropriate follow-up period incorporated? |
Analysis: |
19. Was an appropriate statistical test(s) performed to indicate differences related to the intervention? |
20. Was it established that the study had significant power to identify treatment effects? |
21. Was the size and significance of the effects reported? |
22. Were missing data accounted for and considered in interpreting results? |
23. Were clinical and practical significance considered in interpreting results? |
Recommendations: |
24. Were the conclusions/clinical recommendations supported by the study objectives, analysis, and results? |
Scoring methodology: |
0—criterion was not met |
1—criterion was partially met |
2—criterion was fully met |
Total quality score: |
Low (0 to 16) |
Moderate (17 to 32) |
High (33 to 48 points) |