Objectives/Introduction
• Are the objective(s) clearly stated? What questions are to be answered?
• Is there a brief review of previous work and background on why the study was done?
Methodology
• Is the study prospective or retrospective? Blinded? Placebo-controlled? Randomized?
• Were the inclusion/exclusion criteria clearly stated? Will these affect the results?
• Were doses, schedules, and duration of drug treatment adequate and comparable?
• Were washouts used? Were they of sufficient length?
• Was concurrent therapy allowed? Was it controlled and detailed in the article?
• Were the outcome measures subjective or objective? Were they appropriate for the desired endpoint(s)?
• How long were the subjects followed? Was it long enough?
• Was the number of subjects adequate? Are the groups comparable?
Statistics
• What is considered statistically significant?
• What is the power of the study?
• Are the methods appropriate for the source and nature of the data?
Results
• Were the results clearly, accurately, and adequately presented?
• Were all of the findings presented?
• Were the dropouts accounted for?
• Were the results relevant to the study objective?
• What do the tables/figures show?
Discussions/Conclusions
• Does a statistically significant difference imply clinical significance?
• Were valid conclusions drawn based upon the results presented? You should critique the authors’ conclusions, not just list them (ie. do you think they were appropriate and supported by the results of the study).
• Do the authors place the results into perspective with previous trials, comparing and contrasting results?
• Does the discussion outline the shortcomings of the study? You should identify any additional shortcomings AND critique the validity of the authors’ discussion of their studies limitations (is their discussion unbiased and rigorous?).
• What is the place of the findings in current therapy? What population (if any) do they apply?
You should both critique the author’s conclusion (do you agree or disagree with it) and provide your own conclusion (i.e., an overview of the impact of the article on pharmacy practice and if there are any fatal flaws in the study (A fatal flaw is one that causes you not to accept the outcome of the study (i.e., a serious problem with methodology, clear bias, etc.)
