The process for establishing "prior learning" expertise in Medical Literature Evaluation will require the adequate documentation of several skills including the ability to adequately critique articles from the primary literature. Below is the preferred format for submission of submit a write-up of an randomized controlled trial and a pharmacoepidemiology study.

INTRODUCTION

Title: Use the study or article's title, verbatim.

Authors:

• Name of lead author (can also include name of any other author who is important)
• Total number of authors
• Qualifications of authors
  • Degrees (e.g. 2 pediatricians and 1 PhD, probably statistician)
  • Previous work done in the same field
  • Institutional affiliations of authors: be general (e.g., McGill University, UW, Harvard).

Funding. Drug company versus government agency versus foundation, etc. No need to list exact name of funding grant. Speculate if you are not sure (although state that funding source wasn't obvious).

Study Objective. A single sentence description of the study purpose. Use your own words rather than those of the authors whenever possible.

Background. You will need to explain:

• Why the study is important. Outline why the results of the study would be clinically important or useful to patients or society.
• Why the study is unique. Detail why previous work failed to answer the study question.

METHODS

Design. This should be a short descriptive phrase describing study design.

Setting. Where did the study geographically take place? (e.g., Netherlands, Northeast USA, 37 countries around the world).

Sample population. Describe the entire group of patients available to the investigators from which the sample was drawn. Do not describe the sample.

Inclusion criteria. Paraphrase where possible, particularly if these are extensive.

Exclusion criteria. Omit if information basically covered in inclusion criteria.

Intervention. Include information about:

• How sample members were allocated to treatment.
• What that treatment was (include drug, dose, route, frequency information, if available).
• How and how often outcome data were gathered, i.e., describe the follow-up process.

Major study endpoints. (primary and secondary outcome measures). Endpoints may be event rates, percent change, or relationships between events and risk factors (risk, odds, hazards). You should be able to define each endpoint with 2-5 words. Please only list the major endpoints. Don't detail every single outcome the investigators examined.

Statistical analysis.

• State what tests were used for comparison of baseline data and study endpoints.
• State whether or not the use of each test made sense to you and explain why it did or did not.
• Tell either here or in the results what variables were controlled for in the statistical analysis.

RESULTS

Patients.

• How many patients were evaluated in each group? (You can also note how many people were lost to follow-up if you feel those numbers are important in your study evaluation.)
• How did their baseline characteristics compare? Note any baseline characteristics that were dissimilar.

Endpoints.

• Primary endpoints: raw numbers* + statistical significance**
• Secondary endpoints: raw numbers* + statistical significance**
• note any other outcomes that you felt were particularly interesting

*These can be fractions, rates, risk, percent change; if risk, report absolute risk differences as well as relative risk reduction
**p-values and/or confidence intervals

DISCUSSION

• In one sentence, summarize the authors' conclusion.
• Briefly: discussion information presented by authors

EVALUATION

Study strengths.

• List and justify at least three. Number each.
• Explain your critical thinking completely. Explain the "why" behind the "what" To force yourself to justify your point, try using the word "because" in each strength statement. Another tool to help you be complete is to never try to explain your point in just one sentence. Use several sentences to explain your point.
• One way to effectively explain why a strength is a strength is to outline how the study might have been biased, introduced confounding, or been less clinically significant if the authors had not done what they did.

Study weaknesses.

• List and justify at least three. Number each.
• Explain your critical thinking completely. Explain the "why" behind the "what" To force yourself to justify your point, try using the word "because" in each strength statement. Another tool to help you be complete is to never try to explain your point in just one sentence. Use several sentences to explain your point.

Usefulness. Here you present your overall opinion of the study. State how the study could fit into your practice or describe how you think the information could be used (or is useless).

Comments: expharmd@u.washington.edu
Revised: January 6, 2006