• Was there definite allocation concealment:

(from CDAG Guidelines to Assess Study Quality)

Mark best category:

__ Adequate measures taken, such as central randomization, computerized systems, other strategies

__ Unclear concealment measures, either not reported by authors or reported and not included in above

__ Inadequate concealment measures, such as alternation, sequential assignment, dates of birth, day of week or any other such approach

(from CDAG Guidelines to Assess Study Quality)

What is overall loss to followup?

Choose the category below that best describes the study:

__ The trial presents an intention-to-treat analysis and very few losses to followup

__ There is intention-to-treat analysis AND are followup losses equal to or less than 20% or there is replacement of missing values

__ There is no reporting of dropouts, more than 20-25% loss to followup, or wide differences in losses to followup between groups
(Circle all that apply)

3. Were the patients and outcomes blinded?

(from CDAG Guidelines to Assess Study Quality)

Choose the category below that best describes the study:

__ Adequate blinding measures for participants (placebo) and in assessment of outcomes

__ Unclear blinding for participants or in outcome assessment

__ Inadequate blinding especially in outcome assessment

4. Were there clear a priori outcomes, similar baseline characteristics between intervention group & control group, groups treated equally except for intended intervention?

Choose the category below that best describes the study:

__ All criteria met (or at least the latter 2)

__ Groups differ in some way but differences are handled in analysis/non-critical

__ Groups differ and raise concerns about validity

5. Was the intervention clearly delivered? (How sure are we that the intervention patients received the intended protocol?)

__ YES

__ NO

__ UNSURE

6. Overall Quality Impression

__ GOOD-all criteria met and no significant concerns with 4 or 5

__ FAIR-criteria 1-3 at least partly met and no significant concerns with 4 or 5

__ POOR-at least one of first 3 criteria clearly not met

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