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Method of treatment assignment
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Correct, blinded randomization method described OR randomized, double-blind method stated AND group similarity documented |
Blinding and randomization stated but method not described OR suspect technique (e.g. allocation by drawing from an envelope) |
Randomization claimed but not described and investigator not blinded |
Randomization not mentioned |
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Control of selection bias after treatment assignment
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Intention to treat analysis AND full follow-up |
Intention to treat analysis AND: 15% loss to follow-up |
Analysis by treatment received only OR no mention of withdrawals |
Analysis by treatment received AND no mention of withdrawals OR more than 15% withdrawals/loss-to-follow-up/post-randomization exclusions |
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Blinding
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Blinding of outcome assessor AND patient and care giver |
Blinding of outcome assessor OR (patient AND care-giver) |
Blinding not done |
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Outcome assessment (if blinding was not possible)
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All patients had standardized assessment |
No standardized assessment OR not mentioned |
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