Outcome Assessments

Question 1

What is an Outcome?

Answer 1

Quantification of a patient’s performance or health status based on standardized evaluation

Question 2

Why should we Standardize Outcome Measurement?

Answer 2

• International standards and universal measurement and reporting of outcomes promote international comparison of the quality of care

Question 3

Systems for Standardizing Patients Outcomes Measurements?

Answer 3

1. International Consortium for Health Outcomes Measurement
2. International Classification of Functioning, Disability, and health
3. Common Data Elements
4. Patient-Reported Outcomes Measurement Information System

Question 4

What is the International Consortium for Health Outcomes Measurement

Answer 4

• US Based organization to promote value-based health care
• Working groups outline minimum standard outcome sets and risk factors
• They endorse well-validated outcome measures for specific conditions (not development of new ones)
• Develop recommended outcome datasets to capture, compare, and improve care

Question 5

What does the International Classification of Functioning, Disability, and health do?

Answer 5

ICF identifies three levels of human functioning: functioning at the level of body or body parts, the whole person, and the whole person in their complete environment

Question 6

What is Common Data Elements?

Answer 6

Standardized of health data to support the capture and exchange of information between systems and harmonization of data
- Selected by experts in scientific community
- A CDE is defined as a data element, such as demographic information or patient- reported outcomes, that is mutual to specific populations across multiple data sets from different studies.
- Promotes data sharing for research

Question 7

Goals of Common Data Elements?

Answer 7

• Harmonization
• Collaboration
• Efficiency
• Data

Question 8

What is Patient-Reported Outcomes Measurement
Information System (PROMIS)

Answer 8

• GENERIC assessments for measures important across multiple chronic conditions
• Provides item banks that offer pros that are efficient, flexible, and precise
• Initial broad PROMIS core PRO domains: pain, fatigue, emotional distress, physical function and social function.
• Evaluates and monitors physical, mental, and social health in adults and children through person-centered measures

Question 9

Why do we need better PRO Measures in Clinical Trials?

Answer 9

• Responsiveness to differences should they exist across treatment groups
• Improves performance where floor and ceiling effects are expected
• Potential to reduce respondent burden
• Potential to reduce research cost

Question 10

How does PROMIS work?

Answer 10

1) Administers individually tailored questionnaires to measure health status outcome
2) Collects and analyzes data
3) Provides instant health status reports to users to enhance research, clinical decision making, and facilitate policy making

Question 11

What are PROs

Answer 11

Patient Report Outcomes
Domains: global health, pain, fatigue, sleep–wake function, physical function, emotional distress, and social health