Comparative Effectiveness of Glucose-Lowering Drugs for Type 2 Diabetes
Clinical Question Comparing the benefits and harms of glucose lowering drugs in adults with type 2 diabetes.
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.
Guidelines The relevant guidelines relating to this study, or No guidelines have been published that reflect the results of this trial. if no guidelines are available.
Design 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. Population 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.
Interventions Description of the interventions employed in the trial, with enough supportive information to allow a non-expert MD to understand how patients were treated. Outcomes 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 for the primary outcome. Since these are usually underpowered (and occasionally post-hoc), they are thought of as only hypothesis-generating. If there wasn't any difference in any subgroup, no need to list out all of the statistics, can just write a sentence describing how the primary outcome was similar by prespecified subgroups, and list out the subgroups that were compared. If there were also post-hoc subgroup analyses (i.e., not prespecified), please indicate which subgroup analyses were post-hoc.
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).
Criticisms Bulleted list of internal (listed by the authors at the end of the discussion) and external criticisms (e.g., letters to the editor or editorial), with references for the external criticisms. Each criticism should be in a complete sentence to provide clarity. If the study did not meet its target enrollment, please include as a criticism.
Funding One or two sentences about how the trial was funded.
Further Reading This should usually just contain a single piece of markup which will list all citations references in the main text of the article entry.