Journal/title/abstract

Journal/title/abstract
• Is the journal reputable? Is it peer reviewed?
• Is the study title unbiased? Why is this important?
• Is there a structured abstract? What is the advantage of a structured abstract?
• Does the abstract accurately present information from the study?

Background/introduction
• Does the background information discuss previous pertinent studies?

Methods
• Is the primary objective easy to find and clearly stated? Is there only one?
• What are the secondary objectives? Are they appropriate?
• If the study is randomized, is patient assignment truly random?
• If the study is blinded, is there a potential for compromising blinding of patients and/or observers?
• Is the study multi centered? What is the advantage to the current design?
• Are there appropriate controls? If so, do they pose any ethical concerns?
• Does the study use a double-dummy design? What is a double-dummy study?
• Are the inclusion and exclusion criteria clear and reasonable?
• How do the inclusion and exclusion criteria compare with your served patient population?
• Is the study design clear? Is there a more appropriate study design to answer the primary objective?
• Is this study ethical? Why or why not?
• What ethical safeguards are used to protect subjects?
• What was the dose used? Are these doses appropriate?
• Are the measured outcomes surrogate markers or true endpoints of interest? If surrogate markers, have they been shown to correlate with the desired endpoint?
• Are reasonable efforts made to avoid patients being lost to follow-up?
• How long were the subjects followed? Was this appropriate given the condition and interventions?
• Were all subjects accounted for?
• How was compliance assessed?
• Was intention-to-treat or per protocol analysis specified?
• Were the outcomes reported with intention to-treat? (if applicable)

Tables/figures/graphs
• What does Table 1 demonstrate?
• What does Table 2 demonstrate?
• What does Figure/Graph 1 demonstrate?
• Is there a Kaplan-Meier analysis? What does this show?

Statistics
• Were the statistical methods used appropriate for the given outcomes? Can this be determined?
• Was a sample size calculation done? Was it done prospectively or after the study was completed?
• Were the changes between groups, power, and alpha specified? Are they reasonable clinically?
• Were there differences in baseline data between groups that may account for a difference in response to the intervention?
• Were standard deviations, confidence intervals, and/or p-values reported?
Results
• Did the authors “fish” for results not listed as outcomes in the Methods section?
• Did the study perform subgroup analyses? If so, what do they reveal?
• Did the authors offer explanations or theorize on the implications of the results (in the Results section)?
• Were data reported for the outcomes described in the Methods section?
• Were adverse events reported in the study?

Discussion/conclusion
• Does the author make conclusions that are not supported by the results?
• Does the author make conclusions that are not directly related to the primary or secondary objective?
• Does the author mention substantive study limitations?
• Does the author suggest future research that may be generated by this study?
• Does the author present new or additional information in the Discussion section?
• What is the overall clinical impact of this study?

References
• Are the references current?
• Are the references from reputable journals?
• Are the references routinely authored by the author of this article?

Potential sources of bias
• Is it clear where the funding came from for the research?
• Does the sponsor have a vested interest in the outcome of the study?

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