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ILE 2 Final Exam Study Guide Questions and Answers 100% Solved
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ILE 2 Final Exam Study Guide Questionsand Answers 100% Solved
Sample size in NI - ✔✔cannot be too small because this will lead to low power. Low power may
result in failure to reject the null hypothesis so the drug would be concluded to be worse than
the control
Switching from NI to superiority - ✔✔Can be done if superiority is concluded-however if the
researcher stated that they are testing for NI, then that is what the tests should conclude
1. What is the research question in the Ytterberg, et al. tofacitinib study? - ✔✔a. Does a JAK
inhibitor, when given at the FDA approved dose of 5 mg twice a day, or double the approved
dose at 10 mg twice a day, increase the risk MACE more than a TNF inhibitor does?
1. What is the rationale for conducting the Ytterberg, et al. tofacitinib study? - ✔✔a. During drug
development, increases in serum lipid levels and the incidence of cancers, including lymphoma,
,were observed with tofacitinib which prompted the FDA to require a prospective, head-to-head
safety trial comparing tofacitinib with TNF inhibitors
1. What are the comparator groups in the Ytterberg, et al. tofacitinib study? - ✔✔a. Oral
tofacitinib at a dose of 5 mg or 10 mg twice daily or a subcutaneous TNF inhibitor (adalimumab
at a dose of 40 mg every 2 weeks or etanercept at a dose of 50 mg once weekly.
1. What is the null hypothesis (Ho) for the primary outcome in the Ytterberg et al. tofacitinib
study? - ✔✔a. The combined tofacitinib doses are worse (have more primary outcome events)
than the TNF inhibitor by more than the hazard ratio of 1.8.
1. What is the primary outcome in the Ytterberg, et al. tofacitinib study? - ✔✔a. Adjudicated
MACE (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) and
cancers
1. What regression analysis was conducted to determine non-inferiority of tofacitinib compared
to a TNF inhibitor - ✔✔a. Cox Proportional Hazards Regression
1. The Cox proportional hazards analysis resulted in an HR of 1.24 (0.81 to 1.91). This interval
exceeds the non-inferiority margin of 1.8 and therefore we cannot conclude non-inferiority. -
✔✔a. True
1. Regarding the blinding method: The Oral Rheumatoid Arthritis Trial (ORAL) Surveillance was a
randomized, single blinded, noninferiority, phase 3b-4 safety end-point trial. - ✔✔a. False i.
Open label blinding
1. The Ytterberg, et al tofacitinib study was conducted using a per protocol analysis, NOT an
intention to treat analysis. - ✔✔True
1. Which of the following types of data handling provides the most conservative estimate of
endpoints for non-inferiority trial designs? - ✔✔a. Per Protocol Analysis
1. The best way of describing the fundamental goal of non-inferiority trial designs when
comparing two treatments is: - ✔✔a. One treatment is not "acceptably worse" than another
, Tables for NI - ✔✔· Want the CI to cross the line of No difference and be within Delta to
conclude non-inferiority o Cross the line of no difference means that it is not
statistically significantly different
Dependent Variable - ✔✔Outcome Variable
Independent Variable - ✔✔The risk factors & Confounders; predictors or explanatory
Correlation Coefficient (r) - ✔✔A measure of the linear relationship between 2 numerical
measurements made on the same set of subjects (ranges from -1 to +1 with 0 indicating no
relationship) AKA Pearson product Moment
coefficient of determination (r^2) - ✔✔The square of the correlation coefficient. It is interpreted
as the amount of variance in one variable that is accounted for by knowing the second variable
Dummy Variable - ✔✔A set of indicators (dichotomous) variables used to differentiate among
2+ levels of a categorical or grouping variable (reference group = 1; other variables = 0 (dummy))
Logistic regression predicts a outcome - ✔✔Nominal; most widely used regression
method in medicine
The regression coefficient for each predictor in a logistic regression model can be exponential to
achieve the following measures? - ✔✔Odds Ratio
Multivariable methods include a number of specific procedures to simultaneously assess the
relationships between several exposure (i.e. risk factor variables) and a single outcome (True or
False) - ✔✔True
Multiple logistic regression analysis applies when there is a single dichotomous outcome and
one or more—t independent variable (true or False) - ✔✔True
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