Download Evidence Based Medicine(EBM) Module

Making the CA$E for Drug Company Independence
Marketing of Medicines (MoM)
Evidence Based Medicine (EBM) Module
Evaluation Questions
1. Evidence based medicine relies exclusively on the use of published data to treat
patients.
A. True
B. False
2. Trials funded by for-profit organizations were significantly more likely to
recommend the experimental drug as treatment of choice.
A. True
B. False
3. Clinical trials will often compare a new drug to a little used drug in order to
falsely inflate the efficacy of the new drug.
A. True
B. False
4. Number needed to treat (NNT) is calculated by 1/Absolute risk reduction.
A. True
B. False
5. The dose of medication in the study cited to support fexofenadine’s non-sedating
properties is 1/3 that of the tablet dose.
A. True
B. False
6. Interpret the following industry promotion for Ultracet:
A.
B.
C.
D.
Ultracet is stronger than Ultram.
Ultracet is stronger than Acetaminophen.
Ultracet is stronger than Ibuprofen.
Relative strength of these drugs cannot be determined without confidence
intervals.
7. Publication bias may withhold important information from prescribers.
A. True
B. False
8. In the strength of evidence pyramid, case control studies have an increased
ability to detect causality over cohort studies.
A. True
B. False
9. A 95% confidence interval:
A. Is significant if it crosses 0.
B. Estimates the range of the true effect.
C. Has no relationship to the number of patients studied.
D. Is stronger with a wider range.
10. What factors should you consider in determining whether a study’s results are
relevant to your patient?
A. The study was conducted with a similar population.
B. The study outcomes are relative to your patient.
C. Data suggests the benefits are likely to outweigh the risks.
D. All of the above.
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Evidence Based Medicine (EBM) Module
Evaluation Answers
1. Answer B: False. In fact David Sacket, one of the leaders of the evidence-based
medicine movement, defines EBM as "the integration of best research evidence with
clinical expertise and patient values." Note the three components: science, clinical
expertise and patient values.
2. Answer A: True, a study published in JAMA in 2003 found that, compared to those
funded by non-profit organizations, trials funded by for-profit organizations were
significantly more likely to recommend the experimental drug as the treatment of choice
(odds ratio was 5.3).
3. Answer A: True. This is one way in which even a randomized clinical trial may not
provide the best evidence for a new treatment. Comparison drugs should be gold
standards or standards of care.
4. Answer A: True. Number needed to harm (NNH) is another useful calculation when
considering clinical benefit and is represented by 1/absolute risk increase.
5. Answer A: True. The study cited in the advertisement text uses a dose of 60 mg for the
drug in question, but the tablets themselves are 180 mg, or 3 times that amount.
6. Answer D: The graph is designed to encourage the reader to believe answers A
through C, however without information regarding statistical significance or confidence
intervals we do not know if there is any real difference between the results reported.
7. Answer A: True. Some funders may choose not to release results because of
unfavorable or insignificant outcomes. Negative data can be helpful to prescribers, but
many companies may not want that information to be public. The example we used from
Lancet was a review of randomized controlled trials of antidepressants in adolescents
that showed many industry-funded trials that did not show efficacy were not published.
8. Answer B: False. Our hierarchy of evidence has systematic reviews, meta analysis
and randomized trials at the top. Under that, in descending order of quality of evidence
are cohort studies, case-control studies, cross-sectional studies, case reports, and expert
opinion.
9. Answer B: The confidence interval is an estimate of the range within which the true
effect lies. There are two pieces to evaluate with a confidence interval. The first is the
width of the confidence interval. This is determined by the number of patients studied
and the variability within the data. Narrower ranges are better.
The next point to consider is whether the interval includes the null value. The null
value is the measure that indicates no association between intervention and outcome.
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Any confidence interval that includes the null value allows "chance" as an explanation
for the results found.
10. Answer D: All of the answers help you to determine whether and how to apply study
results to your patient. Taking the answers one at a time, A) if a study population is very
different from your patient (in age, race, gender, co-morbidities, etc) your patient may
have a different outcome on the same medication; B) recall that the application of
evidence-based medicine requires that the provider integrate patient values into
treatment decisions; C) as we know, all medications carry some risk, balancing those to
determine whether the benefits outweigh the risks for your patient is an important step in
decision-making.
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