Was the method of randomization adequate? |
1. Treatment allocation(a) Was a method of randomization performed?(b) Was the treatment allocation concealed? |
Was the study described as randomized (this includes words such as randomly, random, and randomization)? |
Was the treatment allocation concealed? |
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Was the method used to generate the sequence of randomization described and appropriate (table of random numbers, computer generated, etc.)? |
Were the groups similar at baseline regarding the most important prognostic indicators? |
2. Were the groups similar at baseline regarding the most important prognostic indicators? |
Was the study described as double blind? |
Was the patient blinded to the intervention? |
3. Were the eligibility criteria specified? |
Was the method of double blinding described and appropriate (identical placebo, active placebo, dummy, etc)? |
Was the care provider blinded to the intervention? |
4. Was the outcome assessor blinded? |
Was there a description of withdrawals and dropouts? |
Was the outcome assessor blinded to the intervention? |
5. Was the care provider blinded? |
Deduct one point if the method used to generate the sequence of randomization was described and it was inappropriate (patients were allocated alternately, or according to date of birth, hospital number, etc). |
Were co-interventions avoided or similar? |
6. Was the patient blinded? |
Deduct one point if the study was described as double blind but the method of blinding was inappropriate (e.g., comparison of tablet vs injection with no double dummy). |
Was the compliance acceptable in all groups? |
7. Were point estimates and measures of variability presented for the primary outcome measures? |
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Was the drop-out rate described and acceptable? |
8. Did the analysis include an intention-to-treat analysis? |
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Was the timing of the outcome assessment in all groups similar? |
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