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Total questions: 115
Worksheet time: 1hrs 2mins
Which of the following is a common bias found within a retrospective cohort study?
Attrition Bias
Publication Bias
Recall Bias
none of the above
What does an I2 statistic of 50% mean regarding studies included in a meta-analysis?
There is no heterogeneity amongst the studies
There is low heterogeneity amongst the studies
There is moderate heterogeneity amongst the studies
There is high heterogeneity amongst the studies
Which of the following is the last step in the systematic review process?
Data synthesis
Define a focused research question
Review full-text articles
Define and conduct a literature search
Which of the following are general guidelines for selecting an article for journal club? [select all that apply]
Choose an article that is engaging and beneficial to the audience
Choose an article that is a review of the topic
Choose an article that aligns with the purpose of the journal club
Choose an article that is relevant to participants
The “R” in the MAARIE framework refers to:
Results
None of the above
Measurement
Resolutions
Returns
There is no standard method of grading evidence in clinical practice guidelines, however many experts utilize the “GRADE” criteria of evidence. Which of the following levels of evidence reflects support from well-conducted, generalizable randomized controlled trials that are adequately powered?
Level B evidence
Level A evidence
Level E evidence
Level C evidence
Which of the following study designs allows the reader to infer a casual relationship between an exposure and the development of an outcome of interest?
Randomized controlled trial
Case series
Retrospective case-control
Prospective cohort study
When comparing two medications used for Type II Diabetes Mellitus, the number needed to treat (NNT) to achieve goal hemoglobin A1c was calculated. The NNT for Tradjenta was 4. The NNT for Pioglitazone was 31. Which medication would be preferred to achieve goal hemoglobin A1c in a larger number of patients, based on NNT only (not side effect profile)?
Tradjenta
They will both achieve goal hemoglobin A1c in an equal number of patients.
Pioglitazone
This cannot be determined from the information provided.
If the null hypothesis is false and you fail to reject it, you are committing what type of error?
Type II Error
Random Error
Confounding
Type I Error
None of the above
Which of the following study designs is only hypothesis-generating, not hypothesis-proving (meaning you can NOT infer causality).
Retrospective cohort study
Systematic review and meta-analysis
Prospective, double-blind, randomized controlled trial
Phase III pivotal trial
Which of the following assesses the methodological quality of clinical trials included in systematic review and meta analysis?
Chi-squared test
ANOVA
Spearman Correlation
Jadad Score
Fixed effects model are/have: (SATA)
Due to random variation
Different underlying effect for each study
Narrower confidence intervals
Wider confidence intervals
The I2 statistic pertains to:
Heterogeneity amongst the studies
Presence of publication bias
Alpha error
Association between continuous variables
Used most commonly to convey RESULTS of data in a meta-analysis:
Forest plot
Funnel plot
PRISMA diagram
Evidence table
Inclusion of unpublished data minimizes this type of bias:
Investigator
Attrition
Selection
Publication
The “assessment” part of the journal club template includes all BUT:
Statistical analysis
Safety endpoints
Results
Primary endpoint
Which resource can be used to find grey literature?
Which resource can be used to find approval history of a medication?
A randomized controlled trial evaluating pregabalin versus gabapentin for neuropathic pain and found that pregabalin decreased neuropathic pain by 25%, while gabapentin decreased neuropathic pain by 15% (p = 0.001, 95% CI 1.76 to 2.32). Which of the following statements apply to these results?
Statistically significant, but not clinically significant.
Neither statistically nor clinically significant.
Not statistically significant, but clinically significant.
Statistically and clinically significant.
Balances subjects on baseline covariates & produces comparable groups regarding characteristics such as age, gender, race, disease, etc.:
Block randomization
Stratified randomization
Adaptive randomization
Simple randomization
Proper subject randomization strengthens:
Power
Heterogeneity
External validity
Internal validity
A combination of two endpoints (ex./ myocardial infarction or death to evaluate efficacy of Entresto vs valsartan alone)
Composite endpoint
Safety endpoint
Clinical endpoint
Surrogate endpoint
Odds ratio of negative outcome is 2.5 with Treatment A. Which is correct?
Calculated by dividing the statistic in the non-exposed group by the exposed group.
Odds ratio is used for prospective studies.
Treatment A protects patient from negative outcome 2.5x more than control treatment.
Treatment A predisposes patient to negative outcome 2.5x more than control treatment.
One researcher in a study uses a different reference range when reporting participant lab values. What type of bias does this describe?
Researcher bias
Information bias
Historical bias
Publication bias
A clinical trial designed to determine if ibuprofen is more effective at controlling muscle pain than acetaminophen is an example of a non-inferiority study.
False
True
Drug A has a number needed to harm (NNH) of 15, and Drug B has a NNH of 47. All other factors aside, which medication is preferred?
Drug B
Drug A
Both Drug A and Drug B
none of the above
Multivariate logistic regression analysis in case-control studies controls for:
Internal validity
Confounding variables
Alpha error rate
Selection bias
A relative risk of 1.52 means:
Risk of exposure is increased by 52%
Risk of disease is increased by 52%
Risk of disease is increased by 152%
Risk of exposure is increased by 152%
Study looking at exposure to an iced brown sugar oat milk shaken espresso and serotonin production provides a 95% confidence interval of 0.45 to 1.25. Would you expect the p value to be < 0.05 and the results to be statistically significant?
Yes
No
not enough information
it depends on the CI
The Consolidated Standards of Reporting Trials Statement includes:
Standardized reporting requirements
CONSORT
Provides standards for preparing reports of RCTs
Helps improve accuracy and clarity in medical literature
All of the above
The Jadad scale is a quality assessment scale to evaluate RCTs, what are the items that the Jadad scale includes to assess RCTs?
Sequence generations
Blinding methodology
Withdrawls and drop-outs
all of the above
Internal validity
The study is designed and conducted in an appropriate manner so as to arrive at accurate results
Randomization, measurement and assessment of variables, dropouts, overall methodology
The results of the study are able to be accurately generalized to the larger population
Recruitment and selection of participants, inclusion and exclusion criteria, sample size, setting
External validity
The study is designed and conducted in an appropriate manner so as to arrive at accurate results
Randomization, measurement and assessment of variables, dropouts, overall methodology
The results of the study are able to be accurately generalized to the larger population
Recruitment and selection of participants, inclusion and exclusion criteria, sample size, setting
Randomization in the clinical trial helps minimize many threats to internal validity
True
False
The following are factors which affect Internal Validity but randomization helps prevent them:
Statistical Regression
Selection bias
Maturation
all of the above
The intention of research is to disprove or reject the null hypothesis
True
False
If the study is said to deliver statistical significant results we should reject the null hypothesis
True
False
Which is of the following are example when you rejected the Null Hypothesis when the Null Hypothesis was true
False Positive
Type 1 error
Alpha error
Beta error
Type 2 error
Which is of the following are example when you failed to reject the Null Hypothesis when the Null Hypothesis was false
False Negative
Type 1 error
Alpha error
Beta error
Type 2 error
Stratification allows for balanced assignment to groups based on certain characteristics
True
False
Intention-to-treat analysis analyzes the patients according to the groups to which they were originally assigned. A process that reminds us to always analyze patients according to their original group assignment. This method of analysis preserves the prognostic balance afforded by randomization
True
False
Per-protocol analysis includes only patients that comply with treatment protocol and it has the risk of creating imbalance between groups
True
False
When evaluating a Relative Risk Reduction (RRR) it usually makes the risk/drug look better than when evaluating the same data with the Absolute Risk Reduction (ARR)
True
False
The drug approval process is standardized and reviewed by the FDA and it includes
all of the above
Phase I – IV testing
Investigational New Drug (IND) application
Preclinical testing
Which of the following are characteristics of the of preclinical testing
In vitro or in animals
FDA decides if it is safe to test in humans
Determine acute and subacute toxicity
Before filing an IND, must develop a pharmacologic profile of the drug
all of the above
IND application in the drug approval process includes which of the following
Clinical trials in humans may only be conducted after an IND has been approved by the FDA and investigational review board (IRB)
none of the above
Pretesting in humans after a signed consent
IRB approves clinical trial protocol on how the study will be conducted
A Phase 1 trial average 6 months – 1 year in duration and also involves
Purpose:
Determine safety and toxicity
Also test various dosage forms and develop pharmacokinetic data
Low doses are used in a small number of healthy subjects (20 – 80 patients)
First use in humans
all of the above
Phase II Trials Purpose is to Evaluate efficacy of the agent and which of the following
Average 2 years in duration
Help to develop preliminary evidence before larger trials
Continue to evaluate safety
all of the above
Small number of subjects with the disease or condition that the drug is proposed to treat (100 – 200 patients)
Phase III Trials Purpose is to Further define efficacy and safety of the agent, and which of the following:
Some Phase III trials are pivotal studies that serve as the basis for the New Drug Application (NDA) for marketing approval
Average 3 years in duration
Usually multicenter studies that treat 600 – 3,000 patients
New agent is compared to current therapy
all of the above
A New Drug Application (NDA) is submitted to the FDA after Phase III trial and Includes all data from animal and human testing, as well as pharmacokinetic and pharmacodynamic information and manufacturing processes
True
False
Which of the following are characteristics of the application review process
FDA has 60 days to file the NDA for review
Reviewers will approve application and issue a complete response letter
FDA evaluates the professional labeling and manufacturing facilities
If the FDA files the NDA, a review team (advisory committee) is assigned to evaluate the research
all of the above
The following are characteristics of Phase IV trials
May be requested by the FDA or initiated by the sponsor to gather more data on safety and efficacy
Rare adverse effects may develop
Long term safety and efficacy data
all of the above
During Phase IV Trials the FDA may initiate further restrictions on medication uses to ensure that benefits outweigh risks requiring before or after a drug is approved a Risk Evaluation Mitigation Strategies (REMS) developed by drug sponsors which may include:
Medication guide (patient package insert)
Communication plan for health care providers
Elements to assure safe use (ETASU) – training, limitations on use, monitoring, enrollment of patients in a registry
REMS must be assessed for adequacy at least by 18 months, 3 years, and 7 years after approval
True
False
Why is important to include unpublish date in studies?
Minimizes publication bias since Published studies are more often of a positive nature than unpublished studies
Includes more data from which to draw a conclusion, but has not been peer-reviewed
Overall result is published data overestimates efficacy and underestimates harm
About 50% of studies submitted to the FDA in support of drug approvals are not published after 5 years
all of the above
Scientific reviews of clinical trials are found in Drugs@FDA and done by FDA regulatory agencies which developed a narrative summary of the clinical trials that form the basis for approval of regulated drugs
True
False
An abstract of the article is an overview or synopsis of the study which addresses the objective, methods, results, and conclusions of the study
True
False
Which are the two purposes of the introduction of an article
Discussing the study rational
Study purpose - What are the outcomes of the study
Cite the appendixes of the study
Relate the subjects to the conclusions of the study
In the Methods section of a study we can find how the study was designed, type of subjects enrolled, comparative therapy, outcomes measure, statistics methods which at the end will reflect the internal validity of the study
True
False
Methods section of a study include:
Study design
Inclusion/Exclusion Criteria
Intervention/Control groups
Follow up
Endpoints
Power Analysis
Statistical Analysis
True
False
Study Results are usually summarized with a visual table including specific outcomes and p values, hazard ratios and confidence intervals
True
False
The Discussion section of a study include the following:
Evaluate and/or interpret the results
Begins with summary of key findings
Discuss internal and external validity
Comparison of study results to other trials
Discuss limitations of study
Clinical importance of results and how they can be used in practice
Conclusions should align with results of the trial
True
False
The acknowledgment of the studies include individuals contributing to the trial and financial support, and this section is a good place to asses publication bias
True
False
The steps order of a systematic approach to answer a drug information question is:
Obtain requestor demographic information (like name, credentials, phone number)
Categorize the question
develop an appropriate search strategy and conduct that search
Critically evaluate and synthesize the information
Formulate a response in the correct format, appropriately citing all references
Follow-up and document as needed
True
False
All of the following are consider advantages of tertiary resources, EXCEPT:
They are easy to use
They are convenient
They become out of date quickly
You may be able to stop your search after reviewing tertiary sources
Which of the following are secondary literature sources (SATA)
PubMed
Google scholar
Cochrane Library
Embase
CINAHL
Intention to treat analysis may be preferred to minimize attrition bias in RCT for which of the following reasons:
It preserves the original patient randomization scheme
It maximizes the external validity of the study
It underestimates the results of the active control or placebo group
It mimics the perfect world scenario to allow broader sensitivity analysis
Formal criteria for the assessment of RCT must include which of the following variables? (SATA)
Blinding
Sequence generation
Study sponsorship
Subject dropout or withdrawals
Cohort and Case control studies aim to evaluate the effects of exposure on disease risks, either retrospectively or prospectively, Which of the following is false regarding the characteristics of observational studies?
Observational studies allow researchers to observe exposures that would be unethical to purposely administer to patients to for the purpose of research
Observational studies can be conducted quickly and relatively unexpensive compared to prospective RCTs
Observational studies allow you to observe multiple outcomes or exposures in one trial
Observational studies are not prone to many sources of bias
A case-control study design is preferred for the study of which of the following measures?
Rare exposures
Common diseases
Rare outcomes
All of the above
In a clinical trial a drug's calculated NNH is found to be lower than the NNT. Therefore the drug should never be used in clinical practice
False
True
Why are incident cases preferred over prevalent cases in a case control study?
Incident cases are newly diagnosed and less prone to recall bias than prevalent cases
Incident cases are newly diagnosed and less prone to attrition bias than prevalent cases
Prevalent cases are preferred as they are less prone to selection bias than incident cases
Prevalent cases are preferred as they are less prone to history bias than incident cases
Which of the following study designs first identifies subjects who have the disease or outcome of interest, compares them to similar people who do not, then attempts to establish an association between an exposure and the outcome of interest
Crossover study
Retrospective cohort
RCT
Case control study
In a case study, the exposure occurs more frequently among the control group (subjects with disease) and less frequently among the cases (those with the disease). Which of the following OR values represents this scenario?
0.6
1.0
3.4
Cohort studies are consider the strongest observational study design due to which of the following factors?
Ability to tailor study outcomes to answer a specific study aim or question
Ability to conduct them either prospectively or retrospectively
ability to study rare exposure or side effects
ability to collect data relatively quickly and inexpensively
This type of randomization results in groups of equal size
Simple randomization
block randomization
stratified randomization
adaptive randomization
Why are prospective cohorts preferred over retrospective cohorts in clinical practice
Investigator can collect data quickly and relatively inexpensive
Investigator can determine what and how variables maybe be collected
investigator can make interventions with patients over time to tailor the study outcomes
All of the above are correct regarding prospective cohorts compare the retrospective cohorts
Which of the following study types best allows readers to infer real-world effectiveness of medications
RCT
Prospective cohort studies
Retrospective case controls studies
Retrospective cohort studies
The ideal NNT = 1
True
False
One kind of bias that can be observed in retrospective trials relates to errors in the measurement of collection of data, misclassification of data, or data which is missing from patient charts, leading to a bias in the intervention effects, What type of bias would this best represent?
Information bias
Selection bias
Researcher bias
History bias
Which of the following reasons are considered advantages of using secondary (pre-existing) databases for retrospective studies?
Researchers must contact the treatment team to obtain informed consent for patient records
Use of pre-existing data speeds up the data collection and publication process
Medical records data are 100% complete and accurate
Investigators are able to measure exposures before disease occurs, which enhances validity and reliability
Select the appropriate population for which a rate ratio should be calculated
Fixed cohort
case control
open cohort
All of the above are appropriate
What is the correct interpretation of a relative risk of 0.35
There is a 35% reduction in the risk of the outcome
There is a 65% reduction in the risk of the outcome
There is a 35% reduction in the risk of the exposure
There is a 65% reduction in the risk of the exposure
All the patients, the treatment team, and external study personnel are blinded to the study assignment and results. This best describes which type of blinding?
Open-label
Single-blind
Double-blind
Triple-blind
All the patients, the treatment team, and external study personnel are aware to the study assignment and results. This best describes which type of blinding?
Open-label
Single-blind
Double-blind
Triple-blind
What is the purpose of conducting multivariate logistic regression analysis in case-control studies?
To control for cofounding variables not accounted for by the case matching
To minimize testing bias
To allow inference of casualty in observational studies
It is required in order to calculate the odds ratio
This type of randomization allows study investigators to select for key patient characteristics and ensure equal numbers of these characteristics in both groups
Simple randomization
block randomization
stratified randomization
adaptive randomization
Which of the following statements most accurately describes the internal validity of RCT
The study is designed and conducted in an appropriate manner so as to arrive at accurate results
The results of the study are able to be accurately generalized to the larger population
Both statements describe the internal validity of a randomized control trial
This type of bias may occur if investigators are not able to objectively assess treatment differences. It can be minimized by having non-study personnel assess outcomes or by blinding
Attrition bias
Detection bias
Performance bias
Selection bias
The hawthorne effect most accurately describe which of the following principles?
Regression to the mean due to multiple testing over the course of a research study
Modification of behaviors because patients know they are being observed
Preferential treatment of study versus placebo group due to biased investigators
All of the above statement are true
What does a risk ratio > 1 represents
Exposure to a medication decreases the risk of developing the outcome studied
Risk are equivalent between exposed and unexposed
Exposure to a medication increases the risk of developing the outcome studied
Exposure to a medication is not related to the outcome studied
Which of the following treats to the internal validity of a study is not correctly matched with its definition?
Maturation = patient experiences progression of disease over time during the study period
History = Patient experiences an external event which may impact the study outcome
Selection = patient picks which group they would like to be in during the study period
Testing = patients know they are being tested so they modify behaviors during the study period
What is the major limitation of the RCT
Methodologically strong research design
Lacks generalizability to all practice settings
Can infer cause and effect relationship
There are no major limitations of RCTs
When evaluating outcome measures in case-control studies, what is critical to ensure appropriate exposures? (SATA)
Length of look-back period
Length of follow-up
How were cases and controls selected
Are the tools used to measure exposure and outcome accurate?
What is the correct interpretation of a non-inferiority study design?
Study drug is no worse than current treatment
Study drug is equivalent to current treatment
Study drug is not better than current treatment
Study drug is better then current treatment
A brand new anti-diabetic medication, Gawronglutide, is being marked to prevent progression of diabetic nephropathy and reduce the risk of diabetes related kidney transplant. Gawronglutide has been shown to reduce nephropathy and transplant by 15%, while metformin reduces the risk of nephropathy and transplant by 11%(95% CI 1.18-2.86) which of the following statements best represents the significance of these results
Clinically but not statistically significant
Statistically but clinical significant
Both statistically and clinically significant
Neither statistically nor clinically significant
Acase control study examined the effect of prescription antibiotic use during pregnacy and childhood cancer. Cases were randomly chosen from children with cancer from a cancer registry in the US and countries similar from the US population. Exposure to prescription antibiotics during pregnancy was determine from interviews with the child's mother. The study reported odds ratio of 2.1 and suggested that there was association of antibiotic use in pregnancy and childhood cancer. This study and its claims is subject to which type of bias(es) SATA
Recall bias
Selection bias
Participation bias
Matching bias
Which of the following is a common bias found within a systematic review and meta-analysis
Publication bias
Attrition bias
Recall bias
none of the above
What does an I2 statistic of 10% mean regarding studies included in a meta-analysis
There is a moderate heterogeneity amongst the studies
There is a low heterogeneity amongst the studies
There is a high heterogeneity amongst the studies
There is not heterogeneity amongst the studies
Which of the following is the first step in a systematic review
Data syhtnesis
Review full-text articles
Define a focused research question
Define and conduct a literature search
All of the following are general guidelines for selecting an article for journal club except
Choose an article that is a review of the topic
choose an article that is relevant to the participants
choose an article that aligns with the purpose of the journal club
choose an article that is engaging and beneficial to the audience
The presenter of the journal club should try to keep the audience involved by
asking questions
incorporating clinical questions into the presentation
referring to tables and figures
all of the above
The M in MAARIE framework refers to
none of the above
Measurement
Masking
Methods
Which of the following is found on a forest plot? (SATA)
Confidence intervals
I squared statistic
Pooled results
Baseline characteristics
Which of the following only reports the presence or absence of heterogeneity in a meta-analysis
I squared statistic
Cochrane's Q statistic
Higgings I statistic
None of the above
What should be included in a systematic review (SATA)
Grey literature
Unpublished data
Published data
All of the above
Which of the following is utilized to test for possible bias in a meta-analysis
Forest Plot
PRISMA diagram
Funnel Plot
Jadad score
Which of the following properly addresses the issues of how well a study was conducted?
Internal Validity
None of the above
Verification Validity
External Validity
A study compared a group of lifeguards that had developed cancer on their cheeks and noses to a group of lifeguards without this type of cancer and assessed their prior exposure to zinc oxide or absorbent sunscreen lotions. What type of study is this?
Prospective cohort
Prospective case-control
Retrospective cohort
Retrospective case-control
Which of the following descriptions accurately describes primary literature?
Summarized Review
Original Research
Searchable Database
1. Which of the following resources may be used to access the package insert for a medication? [select all that apply]
Which of the following is/are considered secondary resource(s)?
A Review Article (non-systematic)
Facts and Comparisons
PubMed
EMBASE
Which of the following is a strength of a case series study design?
Case series evaluate causality
Strict and detailed protocols are used to evaluate case series' outcomes
The findings of a case series can be directly related to routine clinical practice
Case series have high internal validity
A case report is efficient and cost-effective due to its simple study design.
False
True
A case series provides strong evidence similar to other observational study designs such as case-control or cohort studies.
True
False
The major bias seen in a case report are:
Reporting and Recall Bias
Selection and Measurement Bias
Sampling and Participation Bias
Design and Interviewer Bias
