L77 - Clinical Trials in Respiratory Disease: Critical Appraisal Flashcards

1
Q

What level of evidence is a systematic review of RCTS

A

Level 1

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2
Q

What level of evidence is a randomised controlled trial

A

Level 2

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3
Q

What level of evidence is a Pseudo-randomised controlled trial (i.e. alternate allocation)

A

3-1

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4
Q

What level of evidence is a comparative study trial with concurrent controle (i.e. non randomised clinical trial, cohort study, case control study

A

3-2

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5
Q

What level of evidence is a comparative study with historical controls (i.e.single arm clinical trial)

A

3-3

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6
Q

What level of evidence is a case series?

A

Level 4

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7
Q
What is the clinical Setting?
P
I
C
O
T
A
Population
Intervention
Comparator/Control
Outcome
Timng
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8
Q

What is Internal Validity

A

Extent to which the results of the study are valid (accurate, robust etc) for the sample of patients being studied?
Did the study answer the question it set out to answer?
Dependent on appropriate study design, data collection, and data analyses

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9
Q

What is blinding?

A

Non-awareness of intervention allocation

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10
Q

Single Blind

A

Subjects are unaware

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11
Q

Double blind

A

Subjects and investigators are unaware

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12
Q

Triple Blind

A

Subjects, investigators, and outcome assessors are unaware

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13
Q

How can you reduce selection bias?

A

Randomisation

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14
Q

How can you reduce information bias?

A

Blinding

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15
Q

What is information bias?

A

Prejudice about the intervention can influence the outcome or its ascertainment.

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16
Q

What is Objective Outcome Ascertainment?

A

Outcomes are determined according to strict, standardised, objective criteria

17
Q

What is the rationale of Objective Outcome Ascertainment?

A

Reduce information bias

18
Q

What is Intention-To-Treat-Analysis

A

Assume subjects remained in the group which they were randomly allocated, regardless of actual treatment received, drop-out, loss to follow up or cross over

19
Q

What is the rationale of Intention-To-Treat Analysis

A

Reduce Selection Bias

20
Q

What is the effect of the Intention to Treat Analysis?

A

Under estimates the treatment effect (i.e. provides a conservative estimate)

21
Q

Why does Intention-To-Treat Analysis under-estimate the treatment effect?

A

Less treatment in intervention group than assumed.

More treatment in control group than assumed?

22
Q

What do narrow and and wider confidence intervals indicate?

A

Wider CIs result from a smaller sample size and give a less precise result.

Narrower CIs result from a larr sample size and give a mroe precise result.

23
Q

What is a type 1 Error?

A

False Positive

You conclude there is a difference between your two groups when there isn’t.

A man who is not pregnant is told he is pregnant.

24
Q

What is a type 2 error?

A

False negative

You conclude there is no difference between the groups when there is

A woman who is pregnant is told she is not pregnant?

25
Q

What is an explanation for non-statistically significant results?

A

Lack of Power

26
Q

Number needed to Treat

A

NNT = 1/(absolute risk)

The number of people needed to undergo the treatment in order to prevent outcome.

27
Q

What affects the Number Needed to Treat (NNTT)

A
Relative effect (often a constant)
Underlying likelihood of the outcome.
28
Q

External validity

A

How applicable are the results of the general population?

Participants are often excluded for a number of reasons, i.e. kidney issues, likelihood of adherence etc