Drug Lit II Midterm

when is a NI study design appropriate

new drug offers a clinical advantage over existing treatments other than efficacy

NI

make sure new treatment or drug is not unacceptably worse than existing treatment by amount M or greater

non inferiority margin

should reflect the largest clinically acceptable difference between intervention and control

what must active control show

expected effect

M can not be larger than effect of active control placebo should be no chance the intervention is worse than the placebo.

dont measure true effect of active control

well studied single drug placebo controlled trials

how do you determine M

active control vs placebo

determine amount of that effect that researchers are willing to lose for new treatment vs. active control

weaknesses of NI studies

may make it easier to show NI, power becomes important

NI studies alpha

0.025 okay to test for superiority after NI is proven successful

what should be consistent in the data

ITT and per protocol analysis should be used and results consistent

steps to interpret NI study

look at primary endpoint result that shows difference between the two groups

if it shows superiority you are all set

if it does not, does the 95% CI cross M if yes it is inferiority

if no the result is noninferiortiy

The study then continued to the next group sequential analysis, which was performed after 550 adjudicated primary endpoint events had occurred, to rule out a hazard ratio of more than 1.3. This analysis resulted in a hazard ratio of 0.96 and an upper boundary of the one-sided repeated confidence interval of 1.17...

a. inferior to placebo

b. superior to placebo

c. NI to placebo

c. NI to placebo

what is the primary endpoint result

apixaban group: (N=9120) pts with event 212

event rate %/year: 1.27

warfarin group: (N=9081) pts with event 265

event rate %/year: 1.60

hazard ratio 0.79 (0.66-0.95)

a. warfarin is superior

b.apixaban was NI to warfarin

c. apixaban was superior to warfarin

c.

systematic review

stuctured review of existing primary literature to answer a research question

meta analysis

conducted with SR, runs statistical analysis on data to determine overall treatment effect

PRISMA checklist

helps writers write good SR/MA and peer reviewers appraise them

reporting bias

failure to include all relevant studies

publication bias

non significant studies less likely to get published and included

citation bias

studies with more citations are more likely to get included

language bias

studies in less accessible languages dont get included

time lag bias

studies have rushed or delayed publication impacts which ones are included

reviewer bias

failure of an author to use systematic objective methods for study inclusion

what are the ways to test for reporting bias

funnel plot- skewed/asymmetrical shape shows reporting bias

eggers test- P< 0.05 shows significant reporting bias

how do you assess the quality of the included studies

cochrane risk of bias tool to appraise study characteristics and determine if they are high moderate or low risk of bias

heterogeneity of studies in MA

low heterogeneity is desired shows resultts were similar

cochranes Q test

P <0.05 shows significant heterogeneity

higgins test statistic

<25% good

>50% bad

subgroup analysis

important for MA results should be consistent with primary analysis to show robust conclusions

A meta-analysis was conducted in accordancewith the Preferred Reporting Items forSystematic Reviews and Meta analyses(PRISMA) reporting guideline.

A. This is a limitation of the MA

B. This is a strength of the MA

C. Unsure how to answer

B. This is a strength of the MA

Study quality (performed by M.G., U.M.,S.W.) was evaluated using the Cochrane Risk of Bias Tool.

A. This is a limitation of the MA

B. This is a strength of the MA

C. Unsure how to answer

B. This is a strength of the MA

Tests for heterogeneity in SGLT-2 inh MA:

(Q statistic, P = .02; I2 = 64.3%)What is the Q statistic showing?

A. Significant heterogeneity

B. No significant heterogeneity

C. Unsure how to answer

A. Significant heterogeneity

Tests for heterogeneity in SGLT-2 inh MA:

(Q statistic, P = .02; I2 = 64.3%)What is the I2 statistic showing?

A. Significant, high heterogeneity

B. Significant, moderate heterogeneity

C. No significant heterogeneity

D. Unsure how to answer

B. Significant, moderate heterogeneity

Which reference name is matched correctly with its purpose?

A. Yellow Book - therapeutic equivalence

B. Orange Book - principles of immunization

C. Green Book - drug pricing

D. Red Book - travelers' health information

E. Pink Sheet - regulatory and business developments

E. Pink Sheet - regulatory and business developments

Which of the following resource(s) can the pharmacist use to find information on IV drug compatibility? (Select ALL that apply.)

A. King's Guide

B. Koda-Kimble

C. Hansten and Horn's

D. Trissel's

E. Plumb's

A. King's Guide

D. Trissel's

A drug company recently learned that several lots of losartan were contaminated with a human carcinogen. It is unknown what effect consuming this carcinogen in small quantities may have on humans. The company recalls the drug and offers medical care for those exposed. The company plans to conduct a study to determine the effects of this exposure. They will follow people who used the contaminated losartan over time and compare the rates of cancer in people who used the drug to those who were not exposed to the contaminated lot. What study design does this trial represent?

A. Cohort study

B. Case-control study

C. Cross-sectional study

D. Case report

E. Case series

A. Cohort study

A case-control study was conducted to determine the odds of obesity among first grade children who were breast fed as infants.Current height and weight, as well as lifestyle factors and feeding habits during the first year of life, were gathered by interviewing parents of 6-year-old children in several sections of the country.Which one of the following biases may have occurred in this study based on the method of data collection?

A. Surveillance bias

B. Recall bias

C. Correlation bias

D. Selection bias

E. Significance bias

B. Recall bias

A case-control study found that odds ratio (OR) of stroke with vitamin E use was 1.28 (95% confidence interval, 1.12 to 1.95). Which one of the following statements is true regarding the results of this study?

A. Vitamin E increases the risk of stroke by 72%

B. The results are statistically significant because the95% CI does not include 1.0

C. Clinical significance cannot be determined without a p value

D. Vitamin E causes strokes

B. The results are statistically significant because the95% CI does not include 1.0

open label blinding

neither participant or investigator is blinded

single blinded

only participant is randomized

double blinded

participant and investigator are both blinded

triple blinded

the outcome assessor is blinded in addition to participant and investigator

simple randomization

1:1 ratio weakest

blocked randomization

randomizing groups of participants to make sure there are equal numbers in each group

stratified randomization

participants are grouped by a clinical characteristic that can influence the outcome of the trial strongest

allocation concealment

the system responsible for randomizing does not know when the next treatment allocation will be and conceals the results

prevents the knowledge of randomization sequence

allocation is not the same as

blinding

singular endpoint example

a.time til the first occurrence of nonfatal stroke, nonfatal MI, or death of any cause

b.lowered HbA1c

c. pain, nausea and photosensitivity 2 hours after intervention

d. cholesterol level to predict death from heart disease

lowered HbA1c

comprimary endpoint example

a.time til the first occurrence of nonfatal stroke, nonfatal MI, or death of any cause

b.lowered HbA1c

c. pain, nausea and photosensitivity 2 hours after intervention

d. cholesterol level to predict death from heart disease

pain, nausea and photosensitivity 2 hours after intervention

composite endpoint

a.time til the first occurrence of nonfatal stroke, nonfatal MI, or death of any cause

b.lowered HbA1c

c. pain, nausea and photosensitivity 2 hours after intervention

d. cholesterol level to predict death from heart disease

time til the first occurrence of nonfatal stroke, nonfatal MI, or death of any cause

surrogate endpoint example

a.time til the first occurrence of nonfatal stroke, nonfatal MI, or death of any cause

b.lowered HbA1c

c. pain, nausea and photosensitivity 2 hours after intervention

d. cholesterol level to predict death from heart disease

cholesterol level to predict death from heart disease

Which one of the following statistical tests is most appropriate for investigators to use to determine

any statistically significant difference between two groups in chronic hypertension at baseline?A. Unpaired student t-test

B. ANOVA

C. Chi-square

D. Kruskal-Wallis

E. One-sample t-test

C. Chi-square

selection bias

error in choosing the individuals or groups leading to one group being skewed

surveillance bias

one group is followed differently or more closely than the other group

correlation bias

authors state that there is a cause and effect relationship between exposure and the outcome

significance bias

confuse statistical with clinical significance

recall bias

participants do not remember previous events or experiences accurately or omit details

what do we learn from observational studies

association and causation

why do we use observational studies

identify risk factors for diseases

outcome of harmful unethical exposures

rare conditions

which one of the following resources would provide the best review of a drugs pharmacology

a. Remington

b. pink book

c. sanford guide

d. briggs

e. goodman and gilmans

e. goodman and gilmans

A new hospital pharmacist is being trained to evaluate and verify orders for the pediatric medicine units. Which drug information resource/s will be most useful to the pharmacist? (Select all that apply)

a. harriet lane

b. neofax and pediatrics

c. plumbs

d. american academy of pediatrics

a. harriet lane

b. neofax and pediatrics

d. american academy of pediatrics

a pharmacist needs to price a drug in her store which drug reference will list the AWP and the suggested retail price

a. red book

b. package insert

c. index nominum

d. goodman and gilman

e. merck index

a. red book

which of the following was an important lesson learned from the tuskegee syphillis study

a. unethical for clinical trials to withhold known cures or beneficial treatments from the patients

b. unethical for clinical trials to pay or otherwise compensate patients for their time spent in clinical trials

c. unethical to conduct clinical trials in patients with STIs

d. unethical to conduct clinical trials for longer than 10 years

a. unethical for clinical trials to withhold known cures or beneficial treatments from the patients

a pharmacist was too busy to counsel a patient on a new prescription consequently the patient experiences harm from taking the medication incorrectly and seeks legal action against the pharmacist for not counseling. which of the following principles would the pharmacist most likely be liable for violating

a. comparative negligence

b. duty to warn

c. statute of limitations

d. vicarious liability

b. duty to warn

which of the following is a proven way to limit a pharmacists risk of being held liable for negligence

a. being likeable

b. checking info in at least 2 sources

c. not ignoring contrary data

d. all of the answers are correct

d. all of the answers are correct

which of the following is true regarding legal negligence in relation to pharmacy select all that apply

a. negligence applies if a patient experiences harm because of the pharmacists failure to exercise the degree of care that a prudent and reasonable pharmacist would exercise under similar circumstances

b. negligence applies if a patient experiences harm because of the pharmacists consulted the correct source but was unable to locate the right answer

c. negligence applies if the action of the pharmacist could be proven to have theoretically lead to patient harm, even if the patient did not experience any harm

a. negligence applies if a patient experiences harm because of the pharmacists failure to exercise the degree of care that a prudent and reasonable pharmacist would exercise under similar circumstances

c. negligence applies if the action of the pharmacist could be proven to have theoretically lead to patient harm, even if the patient did not experience any harm

which one of the following best describes parameter negligence when providing drug information

a. failure to consult the correct source

b. consulting the correct source but failure to locate the correct answer

c. failure to counsel patients on their medications

d. failure to calculate an appropriate dose

a. failure to consult the correct source

an investigator designs a clinical trial that is intended to disprove that there is no difference between study groups what is the investigator trying to disprove

a. the null hypothesis

b. study power

c. alternate hypothesis

d. risk of type 1 error

e. risk of type 2 error

a. the null hypothesis

per protocol

only patient who followed most of the study procedures are included in the analysis

modified intention to treat

only patients who were randomized and met some other criteria are included in the analysis

intention to treat

all patients who are randomized are included in the analysis

randomized

patient has an equal chance of being assigned to each group

controlled

intervention group is compared to another group that received different treatment

cross over

each patient receives both the active treatment and the control treatment during the trial

parallel

each patient receives one treatment throughout the entire duration of the trial

students t test

continuous data normally distributed 2 groups

fishers exact test

categorial data 2 groups

kruskal wallis test

categorial data 3 groups

wilcoxon signed rank test

categorial data 1 group

anova

continuous data normally distributed 3 groups

which of the following best describes the null hypothesis of a non-inferiority trial

a. new treatment is equivalent to active control

b. new treatment is superior to the active control

c. new treatment is worse than the active control by an amount M or greater

d. new treatment is worse than the active control by an amount less than the non inferiority margin

c. new treatment is worse than the active control by an amount M or greater

true or false

Review articles are a summary of information on a selected topic without performing additional statistical analysis

true

true or false

Meta-analysis articles only use data from previously published clinical trials; they do not collect new data from patients

true

RRR =

1/RR

ARR=

% risk in control group - % risk in treatment group

NNT =(always round up)only calculated for significant dichotomous endpoints

100/ %ARR

NNH =(always round down)only calculated for significant dichotomous endpoints

If the study results in a negative outcome100 / % ARR