journal

()
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.

session

ESC

trialist

journal

appraise

Stuart Pocock () medical statistician

90

clinician

ESC guideline

IE

main

auditorium

session

guideline IE

main auditorium

90

( ...

90

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1.

Abstract


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2.

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3.

Internal

External validity

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4.

Critical Appraisal

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5. External validity

general population

-->

--> outcome

?
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6. Internal validity

?
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7.

Internal validity

study design


common bias

experimental study

--> allocation bias

confounding factor

bias

randomization

characteristics

trial

randomization

trial

study method

--> ascertainment bias

investigator
bias

baseline

Results

allocate

double-blinded

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8.

clinical trial

equivalence, superiority

non-inferiority?

--> equivalence trial

design

A is not too different from B

equivalency

null hypothesis

reject null hypothesis

reject

--> non-inferiority trial

therapeutic trial

A is not much worse than B

equivalency

much

non-inferior

upper limit

95% CI

margin

equivalence trial

superiority

margin

reject null hypothesis

non-inferior to B

A is not much worse

one-tailed test

non-inferiority margin

null hypothesis

unbounded

trial

--> superiority trial

A is better than B
null hypothesis

reject

equivalence trial

equally effective

reject null hypothesis

superiority

(abesence of proof is not proof of absence)

design

--

>http://img.medscape.com/article/726/896/726896-fig1.jpg
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9.

non-inferiority trial

reject null hypothesis

-->

--> poor compliance

drop out

intention-to-treat analysis

--> non-reflective outcome?

outcome

proven benefits

reflect

patients' benefit

--> missing data

--> too short follow-up time

--> set non-inferiority margin

margin

sample size

expected event rate

set margin

NI margin

non-inferiority trial

underpowered

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10.

treatment effect

lower limit

reject Ho

preserve at least 50% treatment effect

FDA

1.3

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11.

--> ITT

randomized

--> on treatment

Intention-to-treat

on treatment analysis

follow-up period

follow-up

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12. ITT

allocation bias

pragmatic

underestimate (true) treatment effect

non-inferiority

non-inferiority trial

on treatment analysis

falsely conclude non-inferiority

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13. On treatment

effect

Per protocol

superiority trial

explanatory

safety analysis

bias

formulate hypothesis

future trials

disrupt initial randomization

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14.

follow up

study design

analysis

compliance

drop out rate

internal validity

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15.

-->

event rate

rate

absolute risk (1/AR = NNT)

expected event

sample size

relative risk reduction (clinical

significance)
-->

95% CI

HR

p value

(statistical significance)
--> subgroup analysis

primary

secondary endpoints

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16. meta-analysis

clinical trials

systematic review

meta-analysis

-->

weight

HR

95% CI

sample size

total

95% CI

heterogeneity test

chi-square, p-value

heterogeneity test

HR

chi-square

p-value

total hazard ratio

null hypothesis

I^2

p-value

chi-square

sig

trials

sig

heterogeneity test

p value

0.10

I^2

reject Ho
herogeneity

heterogeneity

cut-off

heterogeneity test

0.05

quantitative test

heterogeneity

degree

heterogeneity

25% (low), 50%(intermediate), 75%(high)

total HR

fixed effect

fixed

random effect

true effect size

heterogeneity

total hazard ratio

random effect

heterogeneity

-->

sample size

Forest Plot

95% CI

HR