Study Authors: _______________________________________________________
Project Name: _______________________________________________________
Study Year: ___________ Journal: ________________________________________
Reviewer: ____________________________________ Date: __________________
1. Type of Randomization
(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 |
2. Attrition Bias
(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 |
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 Comments: |