Week 8

Question 1

What are the properties of outcome measures? (5)

Answer 1

• Must answer research question
• Clinically meaningful
• Important from the beginning of the study
• Inform the design of the study
• Must be defined before the study

Question 2

What is the difference between outcome and endpoint?

Answer 2

Outcome
Measured variable

Endpoint
Analysed parameter that reflect the effects of a drug

Question 3

What is a primary outcome? (3)

Answer 3

The main outcome that is measured and the main reason why the study is conducted
Clinically meaningful

Question 4

What is a secondary outcome?

Answer 4

Therapeutic effects of secondary importance and has some link to primary endpoint

Question 5

What is an exploratory outcome?

Answer 5

There may be another outcome that is measured, that can form a new research question

Question 6

What is the COMET initiative? (5)

Answer 6

Initiative to support investigators to develop a core outcome set that represents the minimum that should be measured and reported in all clinical trials for a specific condition
This is so that:
- Results/ outcomes of studies can be compared with other studies
- Results from different studies can be combined to answer research question

Question 7

What are surrogate outcomes and why are they used? (3)

Answer 7

A substitute for a direct outcome that is clinically meaningful
They are easier to obtain and could be less expensive

Question 8

What are patient reported outcomes?

Answer 8

Any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response

Question 9

What is a composite endpoint and when may they be used? (2)

Answer 9

A single endpoint that combines a combination of individual endpoints that are related
It is also used when individual endpoints are infrequent