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Epi > Interventional Study > Flashcards

Interventional Study Flashcards

0
Q

Factorial interventional study

A
  • 2 or more groups, subdivided into 2 or more groups (more people)
  • Randomized more than once
  • improve efficacy/Increase complexity
  • Increases risk of dropout
  • may restrict generalizability off results
  • Test Multiple hypothesis
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1
Q

Simple Interventional Study

A
  • Divides groups exclusively into to or more groups
  • 1 Randomization process
  • Test ONE hypothesis at a time
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2
Q

Parallel Interventional Study

A
  • Groups simultaneously/exclusively Merged
  • No switching of groups after initial randomization
  • All simple & factorial studies are parallel
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3
Q

Cross-Over interventional study

A
  • Groups serve as their own control by crossing over from one intervention to another (still in the same study)
  • Smaller # of people
  • comparisons possible between & within groups
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4
Q

Disadvantages of an Interventional Study?

A
  • Cost * Ethical Considerations

* Complexity/time *Generalizability

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5
Q

Advantages of Interventional study?

A
  • The only study with “FDA Approval”

* Cause precedes effect; study has causation

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6
Q

Key Points of an Interventional study?

A
  • clinical: forced to take something experimental

* Randomization

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7
Q

In interventional studies there are 5 phases: describe the pre-clinical phase.

A

In-lab

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8
Q

In interventional studies there are 5 phases: describe phase 1.

A
  • new drug/device/procedure
  • healthy volunteers, first time use in humans
  • safety/toxicity
  • short duration (weeks)
  • usually less than 100 people
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9
Q

In interventional studies there are 5 phases: describe phase 2.

A
  • New drug/device/procedure: in people with the disease.
  • increase people: several hundred with a COMMON INTEREST
  • toxicity/efficacy
  • duration: weeks to months
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10
Q

In interventional studies there are 5 phases: describe phase 3.

A
  • New drug/device/prodecure
  • increase people: several thousand w/ disease
  • longer duration: Months to years
  • Primary Purpose: Efficacy
  • superiority vs. non-inferiority
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11
Q

In interventional studies there are 5 phases: describe phase 4.

A
  • post marketing
  • long term effects in people with disease
  • largest population size
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12
Q

When is a washout study done?

A

can be done in the middle of a cross over study or at the beginning of any study.

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13
Q

When does the lead-in/Run in take place and what is it used for?

A

Done at the beginning and allows the researcher to see if the study participants will cooperate with the study rules.

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14
Q

Outcomes/Endpoints of interventional studies

A

Primary=Most Important
secondary/tertiary/etc= less important but still valuable
Composite= combines multiple endpoints into single outcome
Direct endpoints= Most clinically relevant (ex. death, stroke, MI)
Surrogate Markers= Elements used in place of evaluating direct endpoints (ex. cholesterol, etc)

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15
Q

What does explanatory mean?

A

it explains the effectiveness of an intervention and only certain people get to play the game.

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16
Q

What does pragmatic mean?

A

Let everyone with the condition be in the study. More applicable to clinical use.

17
Q

Disadvantages of cross-over studies

A
  • only suitable for long term conditions
  • participation time is longer
  • washing-out prolongs study
  • complexity of data analysis
  • treatment-by-period interaction
18
Q

Explain sample selection and group allocation

A

Ex. pts attending morning clinic assigned to 1 group, pts attending afternoon clinic assigned to the other group.

NON-Random: subjects don’t have equal probability of being selected or assigned to each intervention

Random: Subjects do have equal probability of being assigned to each intervention group (most commonly utilized) EX random-number generator

19
Q

What is the purpose of RANDOMIZATION

A
  • make groups as equal as possible
  • attempts to reduce bias
  • shown in table 1
  • equality of groups NOT guaranteed
  • documentation of equality of groups represented as “P” values.
20
Q

What are the types of Randomization

A

Blocked: need groups to be equal in number
Stratified: need factor being tested to be equal
- ensures balance with known confounding variables.

21
Q

Masking: Single Blind

A

Subjects are not informed which intervention they are receiving.

22
Q

Masking: Double-Bling

A

Neither investigator nor subject are informed which intervention each subject receiving

23
Q

Masking: Open-Label

A

Everyone knows which intervention they are recieving

24
Q

Masking: Placebo (dummy therapy)

A

fake treatment made to look identical to real treatment

25
Q

Masking: Double-Dummy

A

more than 1 placebo

26
Q

Masking: Placebo-effect

A

improvement of condition by power of suggestion & due to care provided (can be as large as 30-50%)
* subjects want to please investigators

27
Q

Name the six principles of Bioethics

A
  • autonomy
  • beneficence
  • Justice
  • non-maleficence
  • Consent
  • Assent
28
Q

Define Autonomy:

A

Full/complete understanding of risk and benefits

29
Q

Define beneficence

A

to benefit or do good for patients

30
Q

NON-maleficence

A
  • Do harm
  • don’t withhold info
  • don’t provide false info
  • don’t exhibit professional incompetence
31
Q

Define consent

A

agreement to participate based on being fully & completely informed, given by mentally-capable individual of legal consenting age

32
Q

Define: Assent

A

agreement to participate based on being fully & completely informed, given by mentally-capable individuals NOT able to give legal consent (children)

33
Q

What does the Belmont Report provide?

A
  • Respect for persons
  • research should be voluntary, autonomous
  • Beneficence
  • research risk are justified by potential benefits
  • Justice
  • risk & benefits of the research are equally distributed.
34
Q

2 Levels or IRB Review

A

Full Review: ALL interventional trials w/ more than minimal/ no risk to patients. *ALL medication related studies

Exempt: No Patient identifiers, low/no risk, de-identified dataset analysis, environmental studies, use of de-identified existing data/specimens.

35
Q

What does the Data Safety & Monitoring Board )(DSMB) do?

A

Review study data as study progresses to asses for undue risk/benefit

36
Q

Post-Hoc Analysis

A

Trying o find a pattern you didn’t initially think about at start of study and find statistical test to prove the pattern.

37
Q

How do you manage drop outs/less-to-follow-ups? List the three types.

A
  1. Intent-to-treat
  2. As-Treated
  3. Ignore them
38
Q

Define intent-to-treat

A
  • will keep in study & use what i got
  • use most recent assessment for all subsequent assessments
  • preserves randomization
  • preserves baseline characteristics
  • maintains statistical power
39
Q

Define as-treated

A
  • Ignore group assignments

- allow subjects to switch groups & be evaluated in group they ended/stayed in the most

40
Q

Define ignore-them group

A

only tell about subjects who took full dosage.

41
Q

methods for improving adherence (compliance)

A
  • Frequent follow-up visits/communications
  • treatment alarms/notifications
  • medication blister packs or dosage containers.

Epi (3 decks)

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