Researchers Are Interested in Further Investigating the Side Effects of a Relatively

question 596

Multiple Choice

Researchers are interested in further investigating the side effects of a relatively recent hypolipidemic drug.  A literature review showed several studies in which patients who took this drug reported severe acute myositis as an adverse event.  In many instances, affected patients experienced life-threatening complications from myositis, including rhabdomyolysis leading to acute renal failure and profound electrolyte abnormalities.  However, none of these studies documented a statistically significant difference in the occurrence of severe acute myositis between the treatment and placebo groups.  Which of the following is the best method to further investigate the association between use of this hypolipidemic drug and development of severe acute myositis?

• A)Conduct a new large-scale clinical trial.
• B)Perform stratified analysis on multiple risk factors.
• C)Pool the data from several trials.
• D)Review the medical charts to re-ascertain the events.
• E)There is no need to further study this statistically nonsignificant association.

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Definitions:

Type II Error

A statistical error that occurs when a false null hypothesis is not rejected, meaning a real effect or difference was failed to be detected.

Sample Size

The number of observations or data points collected in a sample from a population, used for statistical analysis.

Power of Test

Refers to the probability that the test correctly rejects the null hypothesis when the alternative hypothesis is true.

Type II Error

The error made when a statistical test fails to reject a false null hypothesis, also known as a false negative outcome.