answers questions from the article provided
Journal Club Template
• Use the template below to prepare the journal article submission.
Background and Previous Literature with Critique Background & Rationale Provide pertinent background including treatment & disease state information.
Provide epidemiologic data to support importance of study.
Discuss current guidelines/treatment recommendations on the topic.
Discuss other relevant studies on topic that support or negate therapy (Use PICO format).
Objective What is the objective of the study?
Is the purpose of the study clinically relevant?
Is the trial relevant to clinical practice?
Design with Critique Study design What is the study design?
Is the study retrospective or prospective?
Was the design chosen appropriate for the objective?
Will the design provide the best evidence?
Was the design rigorous?
Were diagnoses made according to standard criteria?
Describe the internal validity of the study based on the design.
What biases were present (selection, funding)? Did bias (if present) affect the internal validity of the study? What was the risk of bias? How did the authors attempt to overcome/minimize bias?
What are the strengths and limitations of the design.
Population with Critique Inclusion criteria Who was included in the trial? Are the criteria appropriate? Why or why not?
Exclusion criteria Who was excluded from the trial? Are the criteria appropriate? Why or why not?
Describe the external validity of the study based on the inclusion and exclusion criteria.
Intervention & Comparator with Critique Intervention What interventions were used?
Describe therapy, dose, titration, dosing schedule, and timing of initiation.
Comparator Is the comparator the standard of care? Well-supported by other well-designed studies or evidence-based guidelines?
Describe therapy, dose, titration, dosing schedule, and timing of initiation
How was adherence assessed?
Compare and contrast the cost of the intervention and comparator. Is the treatment cost-effective?
Outcomes & Statistical Analysis with Critique Outcomes What is/are the primary outcome(s)? Was a composite endpoint used? If so, what were the individual components?
What is/are the secondary outcome(s)?
What is/are the safety outcome(s)?
Are the outcomes chosen clinically relevant? Were surrogate or hard outcomes used?
Were the measures objective, or were subjective measures made as objective as possible to prevent bias and for study to be replicable?
Was appropriate follow-up used?
Provide an additional statement to describe the design in patient friendly terms.
Statistical Analysis What types of data are used and were appropriate statistical tests used?
What are the power, alpha, and sample size needed and if adequate? Was the alpha level set in the study appropriate?
Is this a superiority or non-inferiority study and how does that affect interpretation of results?
Is this an intention-to-treat and/ or per-protocol analysis and how does that affect interpretation of results?
Population Results with Critique Baseline Characteristics Did the study meet power? Was the sample size met? How many patients were enrolled and what was the dropout rate in each group? How does that affect the results of the study?
Who did the patient population consist of?
Were the groups comparable at baseline? What differences were present between the groups? How could those differences affect the results?
What biases were present (attrition, confounding)? Did bias (if present) affect the internal validity of the study?
Outcomes Results with Critique Results Discuss primary, secondary, and safety outcomes (including p-values, CI).
Calculate NNT/NNH (when appropriate).
Was the study duration appropriate?
Were the results statistically significant?
Is the magnitude of results important clinically?
What are the strengths and limitations of the results?
Describe the internal and external validity of the results.
Conclusions with Critique Author’s Conclusions What did the authors conclude? Did the evidence support their conclusions?
Did they adequately and appropriately address all important limitations to the study?
Critique: Application to Practice How can this study be applied to clinical practice? How will it affect patient care? What role in therapy will this treatment option play?
Describe optimal candidates for treatment based on this study.
Describe who should not be eligible for this treatment based on this study.
My Conclusions Do you agree with the authors? Why/why not?
Who can the results of the study be applied to? To what patient groups can the findings be extrapolated?
Provide an additional statement to describe the results or conclusion in patient friendly terms.