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Clinical Question

Craft the clinical question being asked by the study in PICO (population, intervention, comparison, outcome) format.

Bottom Line

One or two sentences summarizing the purpose of the study and its outcomes.

Major Points

A few paragraphs summarizing the clinical question, the study itself, and how to apply it to practice. A simple approach is to use the first paragraph to discuss the background, use the second paragraph to discuss the study design and outcomes, and the third paragraph for interpretation which should incorporate criticisms, meta-analyses, and review-type content.


The relevant guidelines relating to this study, or {{no guidelines}} if no guidelines are available.


Bulleted list incorporating the following:

  • Trial type (randomized, multicenter, etc.)
  • N=number of patients randomized (often different from number of patients enrolled)
    • Experimental arm (n=number of patients in this arm)
    • Standard (n=number of patients in this arm)
  • Setting: where the study took place (e.g., 25 centers in the US)
  • Enrollment: years in which patients were enrolled (e.g., 2002-2008)
  • Mean follow-up: years, months, etc. (e.g., 3.5 years)
  • Analysis: main analysis type (e.g., intention-to-treat, per-protocol)
  • Primary outcome: name the primary outcome (e.g., 3-year progression-free survival) Please do not list secondary or other outcomes.


Inclusion Criteria

Bulleted list of the study's inclusion criteria.

Exclusion Criteria

Bulleted list of the study's exclusion criteria.

Baseline Characteristics

Bulleted list of baseline characteristics of the study population. Point out between-group differences that are clinically relevant. Pick only one of the groups to summarize. For RCTs, please omit P-values if presented by the journal.


Description of the interventions employed in the trial, with enough supportive information to allow a non-expert MD to understand how patients were treated.


Primary Outcome

Description of the study's primary outcome, with statistical analysis including HR, RR, OR (when appropriate), 95% confidence intervals, and P values.

Secondary Outcomes

Same as above, for secondary outcomes.

Subgroup Analysis

Description of clinically relevant subgroup analyses. Since these are usually post hoc and therefore only hypothesis-generating, link to prospective trials of particular subgroups when possible.

Adverse Events

Description of adverse events encountered in the study. Ensure that the most clinically relevant ones are here (e.g., bleeding in anticoagulant trials).


Bulleted list of internal and external criticisms, with references for the external criticisms. Each criticism should be in a complete sentence to provide clarity.


One or two sentences about how the trial was funded.

Further Reading

This should usually just contain a single <references /> piece of markup which will list all citations references in the main text of the article entry.