Table 1.
Category | Description | Grading |
---|---|---|
A | Sample size calculation, estimating the minimum number of participants required to detect a significant difference among compared groups | 0 = did not exist/not mentioned/not clear 1 = was reported but not confirmed 2 = reported and confirmed |
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B | Randomization and allocation concealment methods | 0 = clearly inadequate 1 = possibly adequate 2 = clearly adequate |
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C | Clear definition of inclusion and exclusion criteria | 0 = no 1 = yes |
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D | Completeness of follow-up (specified reasons for withdrawal and drop-outs for each group) | 0 = no/not mentioned/not clear 1 = yes/no withdrawals or drop-outs occurred |
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E | Experimental and control groups comparable at study baseline for important prognostic factors | 0 = no 1 = unclear/possibly not comparable for one or more important prognostic factors 2 = clearly adequate |
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F | Presence of masking | 0 = no 1 = unclear/not complete 2 = yes |
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G | Appropriate statistical analysis | 0 = no 1 = unclear/possibly not the best method applied 2 = yes |