Clinical Trial Design

Question 1

Level 1

Answer 1

randomized controlled trial

Question 2

Level 2

Answer 2

prospective cohort study

Question 3

Level 3

Answer 3

retrospective cohort study / case-control study

Question 4

Level 4

Answer 4

case series

Question 5

Level 5

Answer 5

case report. expert opinion

Question 6

how does randomization help clinical trial design

Answer 6

minimizes selection bias

Question 7

intent to treat analysis vs. as-treated analysis

Answer 7

Intent to treat is a real RCT, if you do as-treated analysis it is no longer technically an RTC

Question 8

Describe how a prospective cohort works

Answer 8

You look at a group of patients that are followed after the initiation of the study, dividing them up into a group being exposed and a group not exposed to the topic of interest (a certain surgery), and determining what is the relative-risk that they develop an outcome/complication based on their surgery or no surgery.

Question 9

cohort study vs. case-control how do you express the results

Answer 9

relative risk for a cohort study (the risk of developing a certain outcome based on an exposure was so and so). Case control is odds-ratio (based on exposure, the odds someone had an outcome/complication was so and so).

Question 10

describe how a case-control works

Answer 10

you look at patients based on an outcome or disease and look to see for the prior exposure of interest. Expressed as an odds-ratio

Question 11

What is a meta-analysis

Answer 11

It is a systematic review that summarizes results of other studies.