3 |Drug Literature Evaluation Flashcards by Jamaicah Cueto

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

efficiently locate, critically analyze, and effectively communicate

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

Controlled Clinical Trial

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

Controlled Clinical Trial

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Example of control groups include standard therapy, placebo

Controlled Clinical Trial

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

Controlled Clinical Trial

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Subjected to experimental treatment

Experimental group

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Subjected to standard treatment

Standard group

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

Title

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Number of words for title to be considered concise

usually ≲ 10 words

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

True

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should be identified in the title if performed

RCT (Randomized controlled trial)

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

True

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

sensitive

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Characteristic of a title that exclude those not being searched for

specific

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What is wrong with this title?

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

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

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

Abstract

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

objective, methods, results, conclusions

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

thorough, complete, and unbiased

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

Abstract

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The introduction tackles 2 things

study rationale
study purpose/objective

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

study rationale

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

study purpose/objective

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should include immediate and more extensive, eventual purpose

study purpose/objective

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

False (after the objectives)

states the difference in the therapy under investigation and control

Research hypothesis

states no difference between the two groups

Null hypothesis

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

hypothesis

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

Methods

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

Methods

Two (2) types of validity of Clinical Trials

1. Internal validity 2. External validity

Quality of the study design

Internal validity

Ability to apply results to practice

External validity

Strong design should translate into reliable results

Application of Internal validity

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

Application of External validity

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

External Validity

Used to check whether a study can produce good results

Internal Validity

T/F: Study questions does not dictate study design

False

prospectively measures a difference in effect between two or more therapies

Controlled clinical trial

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

similar and treated identically

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

Parallel design

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

Controlled clinical trial

_________ the cause while _________ is the effect

treatment (cause); outcome (effect)

compared to the among groups

treatment effect

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

False (outcome can be estimated)

should be extrapolated to the patient type enrolled in the study

results of a controlled clinical trial

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

Patient Inclusion/Exclusion Criteria (Methods)

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

Surrogate endpoint

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

Inclusion criteria

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

Exclusion criteria

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

Patient Inclusion/Exclusion Criteria (Methods)

Selection bias may be present

Patient Inclusion/Exclusion Criteria (Methods)

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

True

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

Selection bias

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

Selection bias

Run-in phase is also known as

Lead-in phase

2-4 weeks before being officially enrolled

Run-in phase (Lead-in phase)

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

Run-in phase (Lead-in phase)

excluded from participating even if they met the original inclusion criteria

Run-in phase (Lead-in phase)

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

Run-in phase (Lead-in phase)

consists of the therapy under investigation (medication or procedure)

Intervention group

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

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

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

Intervention & control group

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

Institutional Review Board (IRB)

participant is presented with a document

Informed consent form

Informed consent form is used to notify participants about ?

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

ensures humane treatment for animal models used in the study

Institutional Animal Care and Use Committee (IACUC)

These committees are sometimes used to substitute for IRB

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

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

Blinding (Methods)

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

reduce

Four types of blinding

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

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

No blinding (open-label)

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

Single

Both investigators and subjects are unaware of the assignment

Double

Like double blinding, both investigators and subjects unaware

Triple

data interpretation personnel is unaware of subject assignment as well

Triple

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

Randomization (Methods)

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

False (more dependable)

one effect caused by the intervention and control

Primary endpoint

Example includes BMI measurement as an endpoint for assessing obesity

Primary endpoint

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

Secondary endpoint

Example includes

weight and height measurements for computing BMI

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

True

a combination of endpoint measures into one primary endpoint

Composite endpoint

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

directly related

aims to measure the overall effect of therapy

Composite endpoint

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

Data Gathering

Two considerations for data gathering

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

Data gathering (Methods) Monitoring of the trial results at predetermined intervals is _____________________ the trial.

essential throughout

Four things that should be established before data gathering proceeds:

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