FOM: Literature Evaluation 8/14/2024

TOPIC: Literature Evaluation

FACULTY: Heather McEwen, MLIS, MS

LEARNING OBJECTIVES:

AT THE END OF THE LECTURE, STUDENTS WILL BE ABLE TO:

• Explain the criteria for evaluating journals including impact factors and peer-review

• Explain how the quality of evidence is illustrated by the EBM pyramid and where filtered resources are located on the pyramid

• Explain how the JBI checklists and FRISBEE can be used to determine the validity of a research article.

• Distinguish between surrogate outcomes (DOEs), composite outcomes, and clinical outcome (POEMs). 

• Explain what are levels of evidence, non-inferiority, superiority trials, and clinical significance.

• Summarize the drug clinical trial process and be able to distinguish between the different phases

• Distinguish between intention-to-treat analysis, per protocol, and modified per protocol and the implications of each for evaluating studies.

BRING TO CLASS: Your laptop

SUPPLEMENTAL READING:

• A Simple Method for Evaluating the Clinical Literature article by Robert J. Flaherty, MD PP-ICONS article: Flaherty R. A simple method for evaluating the clinical literature. Fam Pract Manag. 2004;11(5):47-52.

SUPPLEMENTAL CLASS RESOURCES:

• Example of a drug going through the clinical trial process:
  • See chapters 6-8. In: Lopes RD, Harrington RA. eds. Understanding Clinical Research. New York, NY: McGraw-Hill; 2013. (In AccessMedicine)
• Svensson S, Menkes DB, Lexchin J. Surrogate outcomes in clinical trials: a cautionary tale. JAMA Intern Med. 2013;173(8):611-2.
• Compound Interest's Understanding the Drug Discovery Process
• Heneghan C, Goldacre B, Mahtani KR. Why clinical trial outcomes fail to translate into benefits for patients. Trials. 2017;18(1):122.
• FDAAA TrialsTracker
• The Economist: Some Science Journals That Claim to Peer Review Papers Do Not Do So article
• Understanding the Drug Discovery Process -  Compound Interest
• A Rough Guide to Spotting Bad Science -  Compound Interest

• Mayor S. Insulin has never become a cheap generic drug in the US because of companies' small changes to "evergreen" the patent. BMJ. 2015;350:h1535.

• Twitter (mentioned in class):

  • RelativelyRisky @justsaysrisks

  • Health Nerd @gidmk

• EBM song videos by James McCormack, Pharm.D.

  • Some Studies That I Like to Quote

  • Viva la Evidence

• Greenhalgh’s How to Read Paper, Chapters 4-6, 9

• Ben Goldacre: Battling Bad Science - Ted Talk

• Ben Goldacre: What doctors don't know about the drugs they prescribe - Ted Talk

• CDC: The Journey of Your Child's Vaccine

• Composite Outcomes - Teachers of Evidence-Based Health Care

• "How researchers dupe the public with a sneaky practice called "outcome switching""