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  • Was the article published in a reputable, peer-reviewed journal?

  • Are the investigator’s training/education/practice sites adequate for the study objective?

  • Can the funding source bias the study?


  • Was the title unbiased?

  • Did the abstract contain information not found within the study?

  • Did the abstract provide a clear over view of the purpose, methods, results, and conclusions of the study?


  • Did the authors provide sufficient background information to demonstrate the rationale for the study?

  • Were the study objectives clearly identified?

  • What were the major null hypothesis and alternate hypothesis?


  • Was an appropriate study design used to answer the question?

  • Were reasonable inclusion/exclusion criteria presented to represent an appropriate patient population?

  • Was a selection bias present?

  • Was subject recruitment described? If so, how were subjects recruited? Was the method appropriate?

  • Was IRB approval obtained?

  • Was subject informed consent obtained?

  • Were the intervention and control regimens appropriate?

  • What type of blinding was used? Was this type appropriate?

  • Was randomization included? If so, what type was used? Was this appropriate?

  • Who generated the allocation sequence, enrolled participants, and assigned participants to groups? Was this appropriate?

  • Which ancillary treatments were permitted? Would they have affected the outcome?

  • Was a run-in period included? How does this affect the results?

  • Did the investigators measure compliance? How was compliance measured? Was compliance adequate?

  • Was the primary endpoint appropriate for the study objective?

  • Were secondary endpoints measured? If so, were they adequate for what was being studied?

  • Were planned subgroup analyses planned? If so, were they appropriate?

  • Was the method used to measure the primary endpoint appropriate?

  • What type of data best describes the primary endpoint?

  • Were data collected appropriately?

  • What number of patients was needed for the primary endpoint to detect a difference between groups (power analysis)? Was the necessary sample size calculated? Were there enough patients enrolled to reach this endpoint?

  • What were the alpha (α) and beta (β) values? Were these appropriate?

  • Were the statistical tests used appropriate?


  • Were the numbers of patients screened, enrolled, administered treatment, completing, and withdrawing from the study reported? Were reasons for subject discontinuations reported? Were withdrawals handled appropriately?

  • Was the trial adequately powered?

  • Were the subject demographics between groups similar at baseline? If not, were the differ- ences likely to have an affect on the outcome data?

  • Were data presented clearly?

  • Were the results adjusted to take into account confounding variables?

  • Was intention-to-treat analysis used? Was this appropriate?

  • Were estimated effect size, p-values, and confidence intervals reported?

  • Were the results statistically significant? Clinically different?

  • Was the null hypothesis accepted or rejected?

  • Can the trial results be extrapolated to the population?

  • Based on the results, could a Type I or Type II error have occurred?

  • Are subgroup analysis presented? Are these appropriate?

  • Was ancillary therapy included? ...

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