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PHA6123 LAB Pharmacy Informatics > 3 |Drug Literature Evaluation > Flashcards

3 |Drug Literature Evaluation Flashcards

1
Q

Pharmacists need to ___________ locate, ____________ analyze, and ______________ communicate data from the primary literature in daily activities of patient care and medication use process.

A

efficiently locate, critically analyze, and effectively communicate

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2
Q

Premiere study design to measure and quantify differences in the effect of the intervention and control

A

Controlled Clinical Trial

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3
Q

Consists of an investigational (intervention) group being directly compared to a control group

A

Controlled Clinical Trial

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4
Q

Example of control groups include standard therapy, placebo

A

Controlled Clinical Trial

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5
Q

most robust method to measure and quantify differences in effects between a therapy under study and the control group

A

Controlled Clinical Trial

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6
Q
A
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7
Q

Subjected to experimental treatment

A

Experimental group

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8
Q

Subjected to standard treatment

A

Standard group

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9
Q

Reflective of the work, unbiased, specific, and concise but not too general or detailed

A

Title

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10
Q

Number of words for title to be considered concise

A

usually ≲ 10 words

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11
Q

T/F: Title pertains to a declarative sentences that tends to overemphasize conclusions are not preferred

A

True

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12
Q

should be identified in the title if performed

A

RCT (Randomized controlled trial)

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13
Q

T/F: Title should include key words that are both sensitive and specific

A

True

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14
Q

Characteristic of a title that eases the task of locating the appropriate articles

A

sensitive

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15
Q

Characteristic of a title that exclude those not being searched for

A

specific

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16
Q

What is wrong with this title?

Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma.

A

word “improved” assumes conclusion without readers having fully-read the entire work

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17
Q

A concise overview of the study or a synopsis of the significant principles of the article

A

Abstract

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18
Q

Abstract includes information addressing the article’s ____________, ___________, _____________, _________________.

A

objective, methods, results, conclusions

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19
Q

Abstract should be ____________, ________________, and ______________ in wording selection

A

thorough, complete, and unbiased

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20
Q

Usually composed of 1-2 sentences for the introduction about the topic, followed by the objectives, methods, results, and conclusions

A

Abstract

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21
Q

The introduction tackles 2 things

A
  1. study rationale
  2. study purpose/objective
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22
Q

the set of reasons a researcher uses to justify the need to conduct another research on the chosen topic

A

study rationale

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23
Q

statement that helps readers assess the importance of the
study relative to individual values

A

study purpose/objective

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24
Q

should include immediate and more extensive, eventual purpose

A

study purpose/objective

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25
Q

T/F: Research hypothesis and null hypothesis are formulated before the objectives

A

False (after the objectives)

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26
Q

states the difference in the therapy under investigation and control

A

Research hypothesis

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27
Q

states no difference between the two groups

A

Null hypothesis

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28
Q

may be missing in the introduction section and may be considered a deficiency but does not mean that the paper contains unreliable information

A

hypothesis

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29
Q

Design of the study is essential for the results to be valid

A

Methods

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30
Q

Includes types of subjects enrolled, the comparative therapy description,
outcome measures, and statistics

A

Methods

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31
Q

Two (2) types of validity of Clinical Trials

A
  1. Internal validity
  2. External validity
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32
Q

Quality of the study design

A

Internal validity

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33
Q

Ability to apply results to practice

A

External validity

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34
Q

Strong design should translate into reliable results

A

Application of Internal validity

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35
Q

Study results meaningful to practitioners and can be used for patient care

A

Application of External validity

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36
Q

Used to check whether a method can be applied to other practice

A

External Validity

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37
Q

Used to check whether a study can produce good results

A

Internal Validity

38
Q

T/F: Study questions does not dictate study design

A

False

39
Q

prospectively measures a difference in effect between two or more therapies

A

Controlled clinical trial

40
Q

In CCTs, groups are __________ and _______________________ with the except for the treatments under observation

A

similar and treated identically

41
Q

subjects in the study are assigned to one of the groups and monitored

A

Parallel design

42
Q

the most rigorous method of establishing a cause-and-effect relationship between treatment and outcome

A

Controlled clinical trial

43
Q

_________ the cause while _________ is the effect

A

treatment (cause); outcome (effect)

44
Q

compared to the among groups

A

treatment effect

45
Q

T/F: The magnitude of the difference in the outcome is not usually estimated.

A

False (outcome can be estimated)

46
Q

should be extrapolated to the patient type enrolled in the study

A

results of a controlled clinical trial

47
Q

Readers must be aware of the limitations of surrogate endpoints and subgroup analysis results

A

Patient Inclusion/Exclusion Criteria (Methods)

48
Q

a study measurement (lab value or physical assessment) that serves as a substitute marker for an actual clinical outcome (LDL levels for cardiovascular events)

A

Surrogate endpoint

49
Q

lists subject demographics that must be present for the subject to be enrolled in the trial

A

Inclusion criteria

50
Q

characteristics that prevent a subject from enrollment in the trial or necessitate withdrawal from the study

A

Exclusion criteria

51
Q

CONDOR (Celecoxib versus Omeprazole and Diclofenac in patients with Osteoarthritis and rheumatoid arthritis) trial is an example of what?

A

Patient Inclusion/Exclusion Criteria (Methods)

52
Q

Selection bias may be present

A

Patient Inclusion/Exclusion Criteria (Methods)

53
Q

T/F: Selection bias occurs after subjects meet the inclusion criteria but are disqualified from taking part in the study

A

True

54
Q

A common form in the run-in phase (Lead-in phase)

A

Selection bias

55
Q

Investigators prevent them from being enrolled because they may alter the results either positively or negatively

A

Selection bias

56
Q

Run-in phase is also known as

A

Lead-in phase

57
Q

2-4 weeks before being officially enrolled

A

Run-in phase (Lead-in phase)

58
Q

Can identify subjects who may or may not adhere to the therapy regimen, experience side effects from the therapy, or did not meet pre-specified criteria

A

Run-in phase (Lead-in phase)

59
Q

excluded from participating even if they met the original inclusion
criteria

A

Run-in phase (Lead-in phase)

60
Q

Produces a bias by selecting a group who do not entirely represent the
population

A

Run-in phase (Lead-in phase)

61
Q

consists of the therapy under investigation (medication or
procedure)

A

Intervention group

62
Q

Control group consists of either of the three (3) considerations

A
  1. no therapy (placebo)
  2. another therapy
    (active control)
  3. existing data (historical data)
63
Q

These two are supposed to be as similar as possible in all respects (average age, number of male/female, medication use, disease states) other than the treatment received

A

Intervention & control group

64
Q

committee charged with ensuring the participants are protected and not exposed to unnecessary harm or unethical medical procedures

A

Institutional Review Board (IRB)

65
Q

participant is presented with a document

A

Informed consent form

66
Q

Informed consent form is used to notify participants about ?

A
  1. study procedures
  2. the rights and responsibilities of the participant
  3. the risks, benefits, compensation, and voluntary participation
  4. right to withdraw without penalty
67
Q

ensures humane treatment for animal models used in the study

A

Institutional Animal Care and Use Committee (IACUC)

68
Q

These committees are sometimes used to substitute for IRB

A

Review Ethics Committee (REC) or Ethics Review Committee (ERC)

69
Q

A technique in which subjects, investigators, or both are
unaware of who is in the intervention or control group

A

Blinding (Methods)

70
Q

The purpose of blinding is to_________ the influence of bias on measuring a difference in effect between the intervention and control

A

reduce

71
Q

Four types of blinding

A
  1. No blinding (open-label)
  2. Single
  3. Double
  4. Triple
72
Q

Investigators and subjects are aware of the assignment to the intervention or control

A

No blinding (open-label)

73
Q

Either investigators or subjects, but not both, are aware of the assignment

A

Single

74
Q

Both investigators and subjects are unaware of the assignment

A

Double

75
Q

Like double blinding, both investigators and subjects unaware

A

Triple

76
Q

data interpretation personnel is unaware of subject assignment as well

A

Triple

77
Q

All persons in a clinical trial who have an equal chance to be in the intervention(treatment) or control group

A

Randomization (Methods)

78
Q

T/F: Using randomization method, the results are less dependable than nonrandomized trials

A

False (more dependable)

79
Q

one effect caused by the intervention and control

A

Primary endpoint

80
Q

Example includes BMI measurement as an endpoint for assessing obesity

A

Primary endpoint

81
Q

routine and useful measure; not considered to be the primary purpose of the study

A

Secondary endpoint

82
Q

Example includes

A

weight and height measurements for computing BMI

83
Q

T/F: The primary endpoint should be appropriate for the study purpose and measured using correct techniques and methods.

A

True

84
Q

a combination of endpoint measures into one primary endpoint

A

Composite endpoint

85
Q

Composite endpoint consists of clinical outcomes ___________________ to morbidity and mortality as opposed to a pharmacological action (reduction in any incidence of stroke/MI/CV-related death vs. lowering cholesterol levels

A

directly related

86
Q

aims to measure the overall effect of therapy

A

Composite endpoint

87
Q

include actual data collection period, follow-up, and monitoring of adherence

A

Data Gathering

88
Q

Two considerations for data gathering

A
  1. study should be conducted for an appropriate duration
  2. data need to be consistently collected throughout the entire trial
89
Q

Data gathering (Methods)

Monitoring of the trial results at predetermined intervals is _____________________ the trial.

A

essential throughout

90
Q

Four things that should be established before data gathering proceeds:

A
  1. protocol for discontinuing the clinical trial earlier than scheduled
  2. data collection methods
  3. competency of trial personnels
  4. availability of data collection materials
91
Q
A
92
Q
A

PHA6123 LAB Pharmacy Informatics (6 decks)

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