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. 2006 Jul 19;8(4):R127. doi: 10.1186/ar2016

Table 2.

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