Teaching the Art of Literature Analysis Evan Williams, PharmD, BCPS Assistant Professor of Pharmacy Practice Husson University School of Pharmacy

Overview Why literature evaluation is important and why people hate it How to make literature less terrible for students and preceptors What parts of the study are important and what is beyond essential

Pre Test Questions Students should focus on the statistical methods used as it relates to internal validity of the findings more so than the external validity of the study when discussing journal articles.   True or False

Pre Test Questions Journal Article Presentations should Focus on an area of practice relevant to the practice site Tie into some other project or problem at the practice site Be flexible enough to fit into the amount of time a practice site or preceptor can devote to the assignment All of the above

Pre Test Questions The following study for gorillastatin produced the following results after 5 years of follow up. Based on the results in the table, about how many patients do I need to treat with gorillastatin for 5 years to prevent one CAD event? a) 5 b) 8 c) 12 d) 16

Objectives Discuss reasons literature evaluation is an essential skill for all pharmacists Identify components of a quality “journal club” format Describe ways to make student literature review useful to your practice Briefly distinguish between useful and confounding statistical methods and demonstrate ability to calculate NNT and NNH

Are your students this last guy?

Literature Evaluation is Important! Essential skill for any clinician Everyone wants to follow “evidence-based medicine” How do you know if recommended treatment is evidence based? Needed to keep up with emerging therapies New drugs New guidelines If you don’t do this, the next generation of pharmacists will be followers instead of leaders regarding drug therapy

Why People Hate Literature Dry, boring reading 50 Shades of Primary Literature? Time considerations Perceived lack of utility This is all summarized in Pharmacists’ Letter anyway Fear of statistics What the devil is the difference between a t-test, f- test, and a z-test, anyway?

Why Students Hate “Journal Club” There is nothing “clubby” about it We force them to present some random article and belittle them for not knowing stuff we never taught them It is detached from other learning outcomes “Pick a recent article that has something to do with your internal medicine rotation.” They pick terrible articles because of this They lack good examples of what we are expecting

How to Make This Better Decide what the desired learning outcome is Presentation skills? A refined, grammatically perfect handout? Identify all of the trial’s strengths and weaknesses? Distinguish important clinical implications of the trial presented? Once the outcome is identified, make sure this is communicated to the student

How to Make Lit Eval Better Selection of Articles Student vs. Preceptor Selection Ensure that the article relates to something happening on rotation! This will make it relevant and useful Type of Article Original Research Review Article Guideline Evaluation

How to Make Lit Eval Better Selection of Articles Good vs. Bad Articles Clinical vs. Surrogate Outcomes Sketchy statistics Primary outcomes vs. Secondary outcomes New vs. Old Older articles aren’t bad or irrelevant!! If the student doesn’t know it, it is a learning opportunity

How to Make Lit Eval Better Identify what you’d like the student to present Background Do you need this? Needs to be quick Methods Brief These are fairly standard Breeze through the stats

How to Make Lit Eval Better Identify what you’d like the student to present Results Best presented in a table format Identify primary vs secondary outcomes Distinguish between clinical and statistical significance Does power matter? Calculate NNT and NNH

How to Make Lit Eval Better Identify what you’d like the student to present Discussion should take the most time Is the outcome valid based on the test used? Confounders Are they looking at the right groups of patients? Influence of uncontrolled variables? Statistical vs. clinical significance? Does this change my practice? Conclusions Do you agree with the author’s conclusion?

How to Make Lit Eval Better Presentation Setting Big time presentation and roast? Conversational? Panel Discussion? CE style? Do what makes sense for your practice site! Make this useful to you

Other Points For Improvement Give students enough time Check in to make sure progress is being made Suggest addressing questions prior to the presentation to improve the quality of the presentation Read the article! Show the student a clear example of a good handout to follow Many are available, so pick one that you like Students tend to do better with bullet points Make them create their own tables

What You Need to Know In order to properly evaluate the student’s critique, you need to have identified the key points that should have pointed out What are the results? Are the results valid? How can I use the results in my practice?

What Are the Results? Any statistically significant differences? p-value vs confidence intervals Little p-values don’t make results more significant Confidence intervals can give an impression of how precise the results are Confidence intervals that cross unity are not significant Clinical significance?

What Are the Results? Number Needed to Treat Good way to quantify clinical significance 1/difference in the event rate between groups 25 of 500 people in the placebo group died - (5%) 10 of 550 people in the drug group died – (1.8%) The difference between the groups is 3.2%, or 0.032 1/0.032 = 31.25 ~ 31 If I treat 31 people with the drug, I will prevent one death Compare this to the Number Needed to Harm

What Are the Results? Number Needed to Harm Same calculation, but for adverse events 10 of 500 people had major bleeding in the placebo group – (2%) 22 of 550 people had major bleeding in the drug group – (4%) The difference between the groups is 2%, or 0.02 1/0.02 = 50 If I give 50 people the drug, I will cause 1 major bleed Does the risk vs benefit ratio seem reasonable?

Are the Results Valid? Was the primary endpoint clearly stated and reported? Was it relevant? Surrogate vs clinical endpoints Composite endpoints Was the designed to reveal the primary endpoint? Powered enough to detect a difference if one wasn’t found? Does the discussion focus on subgroup analyses?

Are the Results Valid? Where the right people included? Intent to Treat (ITT) or Per Protocol Analysis? Inclusion and exclusion criteria Do they control for confounders? Do they limit external validity? Was bias effectively dealt with? Blinding Valid control groups Placebo vs active control?

How Can I Apply the Results? NNT vs NNH Are the patients studied similar to my patients? How does this evidence jive with other studies regarding the same subject? Is this study important enough to shift clinical practice?

Make This Useful to You New Drugs New Guidelines What studies got this approved? Who was looked at? Side effect profiles? New Guidelines Check the references Things that have strong/low evidence Things you don’t know/always get questions about When is aspirin indicated? Evidence that vaccines don’t cause autism? Does LDL really correlate with MI? Why do we still use warfarin?

Summary Pharmacists need to be able to evaluate literature We should be showing students why this is important Make sure journal article presentations focus on preparing pharmacists that can critically evaluate literature Presentation style, format, handouts, length can all vary and should be adapted to the practice site Focus on the key issues within the studies presented Don’t get bogged down in statistics Consider the clinical impact Make the exercise beneficial for you and the student

Post Test Questions Students should focus on the statistical methods used as it relates to internal validity of the findings more so than the external validity of the study when discussing journal articles.   True or False

Post Test Questions Journal Article Presentations should Focus on an area of practice relevant to the practice site Tie into some other project or problem at the practice site Be flexible enough to fit into the amount of time a practice site or preceptor can devote to the assignment All of the above

Post Test Questions The following study for gorillastatin produced the following results after 5 years of follow up. Based on the results in the table, about how many patients do I need to treat with gorillastatin for 5 years to prevent one CAD event? a) 5 b) 8 c) 12 d) 16

Questions? Thank you!