A graphical representation of the IRB methods for the PEM Module study

(PRELIM)

Todd Chang, MD

2012.02.14

TimelineMar 2012

Apr

May

June

July Jan 2013

SITE exam

Mar 2012

Apr

May

June

July Jan 2013

Method 1 (historical control)

pretest

posttestmods

mods

mods

mods

mods

mods

SITE exam

Etc.

ControlIntervention (modules)

Method 1 (historical control

PRO

• Institutional consistency

• No randomization required

CON

• Delayed module rollout

• Quasi-experimental, confounded by what part of academic year

Mar 2012

Apr

May

June

July Jan 2013

Method 2 (randomized control group)

modsmods

mods

mods

mods

mods

SITE exam

Control

Intervention (modules)

modsmods

mods

mods

mods

mods

Method 2 (randomized control group)

PRO

• Large span of institutions will insure similar traits between intervention & control

CON

• Randomization required

• Denial of modules to certain groups within institution– IRB issues?

– Difficulty with full denial particularly late in year

Mar 2012

Apr

May

June

July Jan 2013

Method 3 (geographic control)

modsmods

mods

mods

mods

mods

SITE exam

Control

Intervention (modules)

modsmods

mods

mods

mods

mods

Method 3 (geographic control)

PRO

• No randomization within institution– Institutional consistency

• Full academic year worth of ‘control data’

CON

• Cannot guarantee similarities between institutions