Clinical Practice Guidelines

Citation Include the citation of your article using the AMA Manual of Style.
Funding List the funding source(s).
Trial Design State what type of trial design was used. For example, randomized, double-blind, placebo-controlled trial.
Study Background Describe the background behind the study objective and summarize information from relevant clinical practice guidelines and previously published, relevant articles.
Objective In your own words, list the study objective.
Inclusion Criteria List key inclusion criteria.
Exclusion Criteria List key exclusion criteria.
Study Procedures
Describe the procedures in a way that will make sense to the readers. This may be included as a graphic or flow chart or listed in bulleted key points. Include how patients were enrolled and assigned to treatment; what the treatment groups were including doses used; if blinding was used; length of the study; and how the data was handled.
Outcome Measures List the primary and secondary outcomes.
Statistical Analysis State if a power calculation was performed. If a power calculation was performed, list the sample size needed to meet power and the percent power. State if the study used intention-to-treat or per protocol to analyze the results. List the statistical test(s) used to analyze the results.
Population Characteristics List how many people were enrolled in the trial including the total and how many were enrolled in each group. List how many patients dropped out of the study. This information may be listed using a flowchart or table. List pertinent baseline characteristics and discuss if there were any pertinent differences in the baseline characteristic between the groups.
Endpoints Report pertinent results. If possible, include the results in a table or other visual. Data represented as a graphic can be directly copied from the article; however, any data represented in a table format should be recreated in your own formatting. Include results from the primary outcome and any other pertinent secondary or safety outcomes. Pertinent results related to safety may include things like pertinent adverse effects. For any statistically significant results, calculate the NNT or NNH as appropriate.
In your own words, state the authors’ conclusions here.
Discuss if the authors appropriately concluded the study based on the results.

List multiple strengths and weakness of the trial here. Things to consider when listing strengths and weaknesses may include:
• Funding source and potential conflicts of interest
• Appropriateness of study design based on the study objective
• Appropriateness of inclusion and exclusion criteria
• Appropriateness of how patients were enrolled in the trial
• Appropriateness of blinding used
• Appropriateness of “control” group
• Appropriateness of doses used for both the study medication and the “control”
• Appropriateness of the length of trial
• Appropriateness of primary and secondary outcomes
• Appropriateness of measurement of primary and secondary outcomes
• Appropriateness of statistical tests used
• Matching of baseline characteristics between treatment groups of enrolled patients
• External validity of the trial
• Internal validity of the trial

Conclusion: Using your clinical judgement, summarize the findings of the study, and also discuss how these findings will alter your practice. Discuss if the results of the trial were statistically significant or not and if the results of the trial were clinically significant or not.

List additional references used following the AMA Manual of Style.

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