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Criteria used for the assessment of the methodological quality of human clinical trials |
|
| Item |
Criterion |
|
|
|
| Study population |
|
| 1. |
Patients with radiographically confirmed osteoarthritis or selected according to American College of Rheumatology guidelines |
| 2. |
Age, gender, and body mass index reported and not statistically different between groups |
| 3. |
Efficacy assessed on a single anatomical joint (for example, knee) |
| Trial design |
|
| 4. |
Randomisation |
| 5. |
Placebo-controlled study |
| 6. |
Double-blind study |
| 7. |
Duration of at least 3 months |
| 8. |
Selection of a single primary endpoint before beginning of trial |
| 9. |
Sample size based on power calculation |
| Analysis and data presentation |
|
| 10. |
Data analysed according to the intention-to-treat principle |
| 11. |
Reported dropout rate not more than 25% |
| 12. |
Report of adverse effects |
Ameye and Chee Arthritis Research & Therapy 2006 8:R127 doi:10.1186/ar2016 |
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