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EBM > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

What are the 4 methods of EBM

A

best evidence
patient factors
clinical expertise
patient preferences

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2
Q

What are the 5’A of EBM

A

ask
acquire
appraise
apply
assess

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3
Q

What are the different applications of EBM

A

therapeutic guideline development
managed care organizations
answering questions regarding complex patients

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4
Q

What is the importance of EBM

A

medical knowledge is constantly changing and increases

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5
Q

What is primary literature

A

Clinical research studies​ (randomized controlled trial, cohort, case-control)W

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6
Q

What is secondary literature

A

Searchable database allowing for identification of primaryor tertiary resources​

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7
Q

What is tertiary literature

A

Provide information that has been summarized by anauthor or editor into a summary of the topic​

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8
Q

What is the anatomy of an article

A

title
abstract
introduction
methods
results
discussion
conclusion

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9
Q

Defn of peer review

A

Process where reviewers provide comments andinsight on a submitted article for publication inthe journal​

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10
Q

Format for authors rules

A

-All authors listed
-Rule to follow for this class and moving forward: If more than 6 authors, list first 3, then et al.
-When listing authors, list last name, first and second initial
-The end of the authors section needs a period

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11
Q

Format for article title rules

A

-Only capitalize the first word or any proper nouns
-The end of the title needs a period

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12
Q

Format for journal title rules

A

Must be presented as an abbreviation, if applicable

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13
Q

Format for date of publication

A

-year, month (3 letter abbreviation)
-date is followed by a semicolon

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14
Q

Format for volume number rule

A

Volume number (issue number) is followed by a colon

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15
Q

Format for page numbers rule

A

Recommended to be concise. Will not be counted for or against you if written correctly
Page numbers is followed by a period

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16
Q

What are RCTs

A

Premier study design to measure and quantify differences in effect of an intervention versus control

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17
Q

what is the only type of literature that can establish causality

A

RCTs

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18
Q

What administration gives approval for a new medication or new indication for RCTs

A

FDA
then can conduct clinical trials

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19
Q

what phase is this:
First study in humans
Healthy volunteers
Small number of subjects (20-100)
Short duration (less than 1 year)
Often have a pharmacokinetic component

A

phase 1

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20
Q

what phase is this:
Can be split into 2 groups
IIa: Evaluates short-term safety
IIb: Evaluates efficacy and determines correct dosing range
Study done in patient population of interest
May not have a comparator
Higher number of subjects than Phase I (100-200)
Longer duration than Phase I (1-2 years)

A

phase 2

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21
Q

what phase is this:
Evaluates efficacy and safety of the medication compared typically to standard of care
Study done in patient population of interest
Usually multicenter
Higher number of subjects than previous phases (hundreds to thousands of patients)
Duration is typically at least 3 years
This phase is the basis for FDA approval

A

phase 3

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22
Q

what phase is this:
Occurs after drug approval
Study done in patient population of interest
These studies may be requested by the FDA
Do not have to be initiated by a FDA request
Drug company may want additional information on safety and efficacy

A

phase 4

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23
Q

What are the two designs of RCTs

A

intervention group compared to a control group
all RCTs randomized

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24
Q

There are 3 types of RTCS: Superiority, Noninferiority, Bioequivalence; what do they mean

A

Superiority: Prove new treatment is better than the standard or placebo

Noninferiority: Prove new treatment is not worse than the standard

Bioequivalence: Prove new treatment is about the same as the standard

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25
Q

What are observational studies

A

-Alternative to RCTs
-Useful when a large population needs to be followed over extended periods of time
-Able to answer research questions that are difficult/not possible to evaluate with RCT

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26
Q

What are the 3 observational study types

A

cross-sectional
case-control
cohort

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27
Q

What is a cross-sectional study design

A

Evaluates a “snapshot” or “slice” in time
Data are only collected once on each included individual
Quick research study design to determine health status or disease control
Prevalence or incidence easily assessed with this study design
Surveys or questionnaires are typically used with this design

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28
Q

What is a case-control study design

A

-ALWAYS retrospective
-Identify potential risk factors for either disease or outcome
-Identify cases that have a characteristic or outcome and compared to controls who have not experienced the characteristic or outcome
-Good research design for care disease states

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29
Q

What is a cohort study design

A

Individuals identified by the exposure and then followed to determine if they have the outcome
Usually compares two groups: exposed vs unexposed
Can be prospective, retrospective or ambidirectional
Explore possible causes or risk factors but cannot confirm causality
Time consuming and not a good study design for rare outcomes

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30
Q

what is a case study

A

Descriptive research of a practitioner’s experiences or thoughts related to the care of one patient

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31
Q

what is a case report

A

Descriptive record of one patient where a possibility of an association between an observed effect and an intervention or exposure exists

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32
Q

what is a case series

A

Descriptive record of less than 3 patients that is a practitioner’s experiences and thoughts related to the care of multiple patients with similar scenarios

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33
Q

what is a meta analysis

A

Study that uses statistics to combine and weigh data from multiple pieces of primary literature to make a quantitative and objective assessment
Used to provide more information on a clinical decision than just one piece of primary literature

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34
Q

what are some cases in which a meta-analysis can be helpful

A

Helpful when previous data is:
Inconclusive
Conflicting
Small numbers of patients were included in a study
Rare outcomes
From lower quality studies
Can answer new questions not previous assessed in studies

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35
Q

What are the 5 steps of evidenced based medicine

A

develop a defined question from info
perform a literature search to find the most accurate evidence
evaluate the evidence
consider patient-specific factors when evaluating the evidence
follow-up and determine the effectiveness of the first 4 steps

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36
Q

Drug Information response step 1

A

-accepting responsibility for answering the question
-always assume your response will impact patient care
-questions may not always be specific to the patient, but your answer could be used in the future in a patient case

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37
Q

Drug Information response step 4

A

build a database and assess the critical factors
analysis an synthesis of info to form the response

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38
Q

Drug Information response step 5

A

determine the requestors preference for the response
response can be provided in multiple formats such as verbal, written, etc

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39
Q

What is the PICO method

A

P: patient or population
I: intervention
C: comparsion
O: outcome

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40
Q

PICO method: patient or population

A

consider the characteristics of this patient or demographics of this population, what is relevant and of interest

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41
Q

PICO method: intervention

A

what intervention/treatment is being considered

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42
Q

PICO method: comparsion

A

what other treatments or interventions should be compared to the intervention of interest? This could be standard of care

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43
Q

PICO method: outcome

A

the effect of the intervention of interest. This is the most important piece of information to the requestor

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44
Q

Purpose of results section

A

present study finding only

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45
Q

Discussion section purpose

A

describe the study finding, compares to previous studies and illustrates clinical importance

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46
Q

Purpose of study enrollment flowchart

A

to visually represent enrollment in the study
-can be in any study
-does not have to be present

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47
Q

Evaluation of the number of subjects should take place to determine if the investigators met _______

A

power

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48
Q

What are the key points of a study enrollment flowchart

A

number of subjects excluded
number of subjects in each group
is power met?

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49
Q

Baseline Characteristics in flowchart

A

table format
-characteristics for each patient group present
-stat tests
-reader should note significant differences between groups

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50
Q

Primary and Secondary Outcomes

A

presented in table/graph/figure/or in text

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51
Q

What is subgroup analysis

A

dividing the study population into subsets of participants based on a common characteristic
-not all studies have this
-evaulates certain patient population w/in entire study population

52
Q

What is post-hoc analysis

A

determined after the study is completed
-contrast to priori

53
Q

Discussion

A

no new study results
comparison to study findings in previous studies
impact on clinical practice presented

54
Q

Where can the location of strengths and limitation in a manuscript be found

A

typically, but not always, in final paragraph of discussion section

55
Q

What is study bias

A

systematic error introduced into the study by selecting or encouraging one outcome over another
-can occur at any part of study

56
Q

What is funding bias

A

funding source has influenced the design, analysis or publication of the study
-occurs in any study

57
Q

What is selection bias

A

Investigator is allowed to decide who is enrolled in the study and who is not enrolled
-imbalance of groups
-occur in any study

58
Q

What is admission rate bias

A

The hospital admission rate for cases and controls are different, leading to a higher odds of exposure in studies that are based in a hospital
-occurs in case-control studies

59
Q

What is non-response bias

A

If individuals do not respond or participate in follow-up, the rate of exposure or outcome is not well defined compared to respondents or active participation in study follow up
-occur in cohort, case-control, or cross-sectional

60
Q

What is prevalence-incidence bias

A

The timing that the investigators try to identify the exposure causes cases or outcomes to be missed (ex: flu)
-occur in cohort or case-control

61
Q

What is information bias

A

The same method of defining an outcome or exposure is not utilized for all enrolled subjects
-occur in cohort and cross-sectional
-case control is only retrospective so no surveys or interviews are used

62
Q

What is family history bias

A

More information is provided from family members with similar diseases or exposures from the study of interest
-occur in cohort or cross-sectional

63
Q

What is exposure suspicion bias

A

If a study investigator knows a subject’s disease status, this may influence the amount of time and energy taken to evaluate this subject
-occur in cohort and cross-sectional

64
Q

What is misclassification bias

A

A study subject is classified into the wrong group based on several possible factors
-occur in any study

65
Q

What is performance bias

A

Differences in a study site outcomes that influence the study results. This is an issue for multicenter studies with different providers at each site.
-occur in any study

66
Q

What is chronology bias

A

Occurs when historical data is used and treatment patterns may have changed since this time period
-occurs in retrospective

67
Q

What is transfer bias

A

Occurs when the loss to follow up in study groups is unequal
-occur in prospective

68
Q

What is channeling bias

A

Occurs when factors or characteristics about a subject influence the treatment a subject may receive
-occur in observational

69
Q

What is data analysis bias

A

When the data analysis methods of a study are not methodically sound, errors in analysis may occur
-occur in any study

70
Q

What is post hoc significance bias

A

When the level of significance (alpha) is chosen post-hoc, the conclusions of the study may not be correct
-occur in any study

71
Q

What is data degrading bias

A

When data analysis is done without specifying in advance in order to establish any type of association or causation (increase chance of false postitives)
-occur in any study

72
Q

What is significance bias

A

Investigators do not distinguish between clinical and statistical significance
-occur in any study

73
Q

What is correlation bias

A

Investigators conclude that causation exists, even though design/methods do not agree
-occur in any study (mainly observational study design)

74
Q

What is publication bias

A

Unfavorable study results are not published and favorable ones are frequently published
-occur in any study

75
Q

What is Ha (research hypothesis)

A

alternative hypothesis
-difference btw the study therapy (intervention) and the control

76
Q

What is H0 (null hypothesis)

A

no difference exists btw groups

77
Q

What is the inclusion criteria for RTC

A

subject demographics or characteristics that must be present in order to be enrolled in the study

78
Q

What is the exclusion criteria for RTC

A

-subject demographics or characteristics that cannot be present in order to be enrolled
-characteristics that prevent subject enrollment
-certain patient populations: pregnancy, conditions that alter pharmacokinetics

79
Q

External validity

A

ability to apply study results into general practice

80
Q

Internal validity

A

how well the study was done
-adherence to protocol, did the study answer the question

81
Q

What are the 4 main methods to recruit subjects for RTCs

A

-Financial or other incentive
-Investigators will include their own patients
-Investigators will seek referrals or review a disease registry
-Investigators or the sponsor of the study (drug company) will advertise the study

82
Q

What is the intervention group

A

cohort under investigation

83
Q

What is the control group

A

comparison group
-placebo
-active control (another recommended therapy)
-historical control (data collected prior to beginning of study)

84
Q

What is the run-in period

A

Period of time subjects are not on any therapy
“Washes out” any effect of previous therapies
Does not have to be performed

85
Q

When is a placebo not possible

A

Unethical to withhold therapy if an intervention has previously demonstrated to reduce morbidity and/or mortality

86
Q

IRB definition

A

Committee ensuring all study subjects are protected and not exposed to unnecessary harm and/or unethical medical procedures

87
Q

What does an RCTs informed consent form need to have

A

Study procedures
Rights and responsibilities for study participation
Risks/benefits of study participation
Compensation for study participation
Participation in the study is voluntary
Right to withdraw from the study

88
Q

Bias

A

Differences between the true value and the value that is actually obtained due to causes other than sampling variability

89
Q

What is open-label (no blinding)

A

investigators and study subjects are aware of assignment to intervention or control group

90
Q

What is single-blinding

A

investigators or study subjects are aware of assignment to intervention or control group

91
Q

What is double-blinding

A

investigators and study subjects are not aware of assignment to intervention or control group

92
Q

What is double-dummy

A

type of double-blind study that uses different dosing regimens or dosing forms but maintains blinding

93
Q

What is triple-blinding

A

investigators and study subjects are not aware. Study personnel involved with data analysis and interpretation of results are not aware of study assignment to intervention or control group

94
Q

Randomization definition

A

All included subjects have an equal chance to be in either an intervention or control group

95
Q

What is range from simple randomization

A

drawing names from a hat to stratification

96
Q

What is simple randomization

A

assign subjects to a group based on a simple criteria

97
Q

What is stratification randomizaiton

A

Assigns patients to groups based on certain factors
Helps ensure factors that may impact the results are present at a similar amount in each group

98
Q

What is blocked randomization

A

Provides a balanced number of subjects in each group
Useful when a study does an interim analysis (Determines the current study results at a certain point [ex. halfway] through the study)

99
Q

What is allocation ratio randomization

A

1:1 ratio of treatment to control: For every one patient allocated to treatment, one patient is allocated to control
2:1 ratio of treatment to control. For every two patients allocated to treatment, one patient is allocated to control
3:1 ratio of control to treatment. For every three patients allocated to control, one patient is allocated to treatment

100
Q

A rationale for why allocation ratios are being used should be provided in the what

A

methodology

101
Q

What is parallel group design

A

most common RCT
each subject assigned to only one treatment arm

102
Q

What is Confounders

A

A variable (or factor) that impact the study results if not accounted for

103
Q

What is group comparison parallel group design

A

Each subject is randomized to a therapy
Matched pairs design

104
Q

What is crossover design

A

Each participant is his or her own control
Each participant receives both treatments
A washout period is typically used

105
Q

What is the primary endpoint

A

One major effect caused by the intervention and control
The main objective of the study
Statistical tests will specifically assess this endpoint

106
Q

What is secondary endpoint

A

Important outcomes in the study but not the main purpose of the study

107
Q

What is composite endpoint

A

A group of endpoints that are considered clinically important
Can be used for primary and secondary endpoints
Can measure the overall effect of therapy
Can overstate the results of the study

108
Q

What is surrogate endpoint

A

Can be a primary or secondary endpoint
An endpoint that is associated with an outcome, but does not directly measure it

109
Q

What is subgroup analysis

A

Dividing the study population into subsets of participants based on a common characteristic

110
Q

Per Protocol (PP)

A

Subjects will be analyzed only if they complete all components of the study protocol
Strictest form of a RCT
Increases internal validity

111
Q

Intention to Treat (ITT)

A

“Once randomized, always analyzed”
Subjects will be analyzed, even if they withdraw or do not complete the study
Increases external validity

112
Q

Modified Intention to Treat (mITT)

A

More structured ITT analysis
Subjects have to adhere to some component of the study protocol to be included in the analysis

113
Q

Study Title and Citation components

A

Important to appropriately source information and materials
AMA format is standard

114
Q

Background components

A

Brief synopsis of background/introduction section of the article
-Incidence, epidemiology, drug info
MUST be supported by one additional source

115
Q

Objective/goal components

A

Clearly states the objective of the randomized control trial
Will be included towards the end of the background/introduction section
Must be reported verbatim

116
Q

Inclusion/Exclusion criteria components

A

Set of criteria by which patients were chosen to be evaluated or not evaluated to meet the objective/goal of the study and to achieve the primary/secondary endpoint(s)
(can shorten list and refer reader to article)

117
Q

Primary & Secondary endpoints components

A

The primary objective, or endpoint, is the principle reason the study has been conducted and will correlate to the objective or goal of the clinical trial

118
Q

Statistical analyses components

A

Reporting of the statistical tests utilized by the study authors to evaluate statistical significance
Should always provide context in this session

119
Q

Baseline characteristics components

A

Summarization of relevant baseline characteristics that will have an impact on the endpoints/outcomes of the study

120
Q

Results (endpoints) components

A

Reporting of results as presented in the research article
You must report on the primary endpoints (efficacy and safety endpoints)
Statistics supporting the results must be included

121
Q

Additional analyses components

A

Opportunity to report secondary outcomes
Not necessary to report every secondary outcome
Statistics supporting the results must be included

122
Q

Study strengths & Limitations components

A

Identify and discuss the strengths and limitations of the article
-Should relate to the primary and secondary endpoints
-Should include your interpretation of statistical analyses

123
Q

Authors’ conclusions components

A

Reporting of the authors’ disclosed strengths and limitations

124
Q

Reviewer conclusions components

A

Your opportunity to critique the article:
-Need to briefly revisit the strenghts and limitations
-you agree with the assessment of the primary and secondary endpoints?
-results support statistical vs. clinical significance?
-Issues related to the study methodology?

125
Q

Impact on practice components

A

Must unequivocally state how the results of this trial can be translated to clinical practice:
-“More research is needed” is not a complete answer to this prompt

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