®
PROMIS
Efficient, Standardized Tools to
Measure Self-Reported Health and
Quality of Life
David Cella
Northwestern University
Chicago, IL
October, 2013
®
PROMIS
Measures
Science
Software
Challenges
•
•
•
•
•
•
•
•
Many measures of same
health concept
Widely varying quality
Difficult to compare and
combine data
. . . across studies
. . . across conditions
Complex
Long
Not useful in clinical practice
PROMIS Cooperative Group
2004-2013 Highlights
•
•
More than 40 research protocols aligned with
evolving PROMIS standards
More than 50,000 people have contributed data
> 2,000 in qualitative research
> 45,000 in quantitative research
More than 10,000 children
More than 3,000 adults reporting for children
More than 40,000 adults on their own behalf
…including more than 4,000 Spanish-speaking adults and children
Cycle of Development and
Validation
Qualitative
Research
and Item
Writing
Testing
Item
Bank
Analysis
Interpretation
Refining
General Population
Clinical Samples
An item bank is a large
collection of items measuring a
single domain.
Any and all items can be used to
provide a score for that domain.
PROMIS is
Domain-specific;
not Disease-specific
A domain is the specific
feeling, function, or
perception you want to
measure.
Cuts across different diseases
PROMIS Domain Framework
Symptoms
Physical Health
Function
Affect
Self-Reported
Health
Mental Health
Behavior
Cognition
Social
Health
Relationships
Function
®
PROMIS
Adult Banks: v1.0
Items in
Bank
29
Items in
Short
Form
8
Emotional Distress – Anxiety
29
7
Emotional Distress – Depression
28
8
Fatigue
95
7
Pain – Behavior
39
7
Pain – interference
41
6
Physical Function
125
10
Satisfaction with Discretionary Social Activities
Satisfaction with Social Roles
12
14
7
7
Sleep Disturbance
27
8
Wake Disturbance (sleep related impairment)
16
8
Domains
Emotional Distress – Anger
Global Health
10
®
PROMIS
Pediatric Banks: v1.0
Domains
Emotional Distress – Anger
Emotional Distress – Anxiety
Emotional Distress – Depression
Fatigue
Click to edit Master title style
Pain – Interference
Physical Function-Mobility
Physical Function-Upper Extremity
Peer Relationships
Asthma
Items in
Bank
n/a
15
14
23
13
125
29
15
17
Items in
Short
Form
6
8
8
10
8
10
8
8
8
The PROMIS Metric
•
•
T Score
 Mean = 50
 SD = 10
Referenced to the US General
Population
IRT
Item Response Theory (IRT) models enable reliable
and precise measurement of PROs
Fewer items needed for equal precision
Making assessment briefer
More precision gained by adding items
Reducing error and sample size requirements
Error is understood at the individual level
Enabling practical individual assessment
IRT parameters
A person’s trait level and their
likelihood of responding to an
item can be described in terms
of several parameters.
Probability
 The point at which a participant
has 50% likelihood of responding
in the keyed direction
1.0
.8
.6
.4
 b, or difficulty
 Its ability to distinguish low trait
from high trait individuals
Item 6
.2
(b=0.3
 a, or discrimination
 The likelihood of low attribute
participants responding in the
keyed direction
 c, or guessing
Item 2
0.0
(b=0.4
-3
-2
-1
0
1
Fatigue
Score (θ)
2
Cognitive Decline Score (theta)
3
0
50
100
Physical Functioning Item Bank
Item
1
Item
2
Item
3
Item
4
Item
5
Item
6
Item
7
Item
8
Are you able to get in and out of bed?
Are you able to stand without losing your balance for 1 minute?
Are you able to walk from one room to another?
Are you able to walk a block on flat ground?
Are you able to run or jog for two miles?
Are you able to run five miles?
Item
9
Item
n
PROMIS Basic Tools
Derived from Item Banks
•
Computerized Adaptive Testing (CAT)
•
Fixed Length Forms
 Dynamic testing averaging 6 items per domain
 By individual domain (8-10 items)
 By health profile (-29, -43, -57)
Global Health Index
•
Global-10
Computerized Adaptive Tests
low
depression
2
2
1
1
0
2
1
-3
-2
-1
0
high
depression
3
2. Question 3. Question
Questionnaire
with a high
precision AND a
wide range
Value of PROMIS
1. Comparability
2. Reliability and Validity
3. Flexibility
Comparability
Fatigue Item Bank
Chemotherapy
trial
Osteoarthritis
trial
Parkinson’s
Disease trial
Items 1-10
CAT
Items 6-12
Diabetes trial
Items 2, 4, 9, 13
Epilepsy trial
Items 1-5
Same metric, same meaning
PROMIS Fatigue Across Five Clinical Conditions
Cancer
w/ benefit
(2 mos)
N = 310
N = 229
Cancer
Chemo
(B)
Back PainBack Pain Back Pain
(3 mos) (1 mo)
(B)
Depression Depression Depression
(1 mo)
(3 mos)
(B)
N = 114
N = 64
HF Post-transplant
HF Pre-transplant
Exacerbation to Stable
N = 125
COPD Stable (B)
35
40
45
50
55
Average for General Population
COPD Exacerbation (B
60
65
Reliability and
Validity
Reliability/Precision of PROMIS
Error
High
(Physical Function)
SF-36
HAQ
HAQ
(10 items)
items) CAT
(20(20
items)
(10 items)
Full Item Bank
(126 items)
Low
Rheumatoid
Arthritis Patients
Worse
Representative Sample
Physical Functioning
(T-Score; Mean=50, SD=10)
Better
Relative Precision of PROs
Error
High
(Physical Function)
Low
Rheumatoid
Arthritis Patients
Worse
Representative Sample
Physical Functioning
(T-Score; Mean=50, SD=10)
Better
60
60
Depression
50
40
0
10
20
30
CESD
30
20
10
0
0
100
250
-2
-1
0
1
2
3
4
2
3
4
Depression
0 80
CESD
40
50
r =0.84
-2
-1
0
1
PROMIS
Depression
Depression
Clinical Validity:
Outpatient Depressive Disorder
•
Sample Size
 127
• Population
 Adults who started treatment for Major
Depressive Disorder in the last 4 months at
Western Psychiatric Institute and Clinic
• Assessment Times
 Baseline, 1 month, 3 month
Responsiveness in Depressive Disorder:
PROMIS Anger
Responsiveness in Depressive Disorder:
PROMIS Anxiety
Responsiveness in Depressive Disorder:
PROMIS Depression
Flexibility
Assessment-Technology Center
• FREE online research management tool
• Enables study specific websites
– Secure data capture
• Clinical studies can be customized
Click to edit Master title style
• Includes PROMIS instruments
– short forms, CATs and Profiles
• Detailed statistical/development history
• Real-time scoring
• www.assessmentcenter.net
Assessment Center
www.nihpromis.org
PROMIS Instruments Available
on Assessment Center
•
•
•
All Item banks using CAT
All short forms
Profiles

29, 43, 57 item versions
CAT
Graph
Expanding PROMIS Flexibility
to HIT and Meaningful Use
• Multiple requests from providers to
•
•
integrate with HER or feed common data
warehouse
Interest from payers to provide a level
playing field for PROs as we move into
Accountable Care Act prime time
Interest from CMS, AHRQ, NQF, Gretzky
Group and Beacon Communities (HHS
Office of the National Coordinator)
Linking PROMIS and EHRs
Linking PROMIS and EHRs
SNOMED and LOINC codes
USPHS Grant No. RC4 CA157236-01
Raw Score to T-Score Conversion Table
SF-36/MH to PROMIS Anxiety
SF-36/MH Score
PROMIS
T-score
SE
25
24
23
22
21
20
19
18
17
16
15
14
13
12
11
10
9
8
7
6
5
33.2
38.9
43.1
46.8
49.4
51.7
53.7
55.6
57.3
59.0
60.6
62.1
63.7
65.2
66.8
68.5
70.3
72.2
74.3
76.8
80.1
6.3
5.6
5.0
4.7
4.5
4.3
4.1
4.0
3.9
3.8
3.8
3.7
3.7
3.7
3.7
3.7
3.8
3.8
3.9
4.0
4.2
Raw Score to T-Score Conversion Table
CES-D to PROMIS Depression
CES-D
Score
0
PROMIS
T-score
34.5
SE
6.0
CES-D
Score
21
PROMIS
T-score
59.1
SE
2.2
CES-D
Score
42
PROMIS
T-score
70.4
SE
2.3
1
38.6
5.1
22
59.7
2.2
43
71.0
2.4
2
41.1
4.7
23
60.2
2.2
44
71.7
2.4
3
42.9
4.6
24
60.8
2.2
45
72.3
2.5
4
44.7
4.1
25
61.3
2.2
46
73.0
2.5
5
46.2
3.8
26
61.8
2.2
47
73.7
2.6
6
47.5
3.6
27
62.3
2.1
48
74.4
2.7
7
48.7
3.4
28
62.9
2.1
49
75.2
2.7
8
49.8
3.2
29
63.4
2.1
50
76.0
2.8
9
50.8
3.0
30
63.9
2.1
51
76.8
2.9
10
51.7
2.9
31
64.4
2.1
52
77.7
3.0
11
52.6
2.8
32
64.9
2.1
53
78.7
3.1
12
53.4
2.7
33
65.4
2.1
54
79.7
3.2
13
54.1
2.6
34
66.0
2.2
55
80.8
3.2
14
54.8
2.5
35
66.5
2.2
56
82.0
3.2
15
55.5
2.4
36
67.0
2.2
57
83.1
3.2
16
56.2
2.4
37
67.6
2.2
58
84.3
3.1
17
56.8
2.3
38
68.1
2.2
59
85.4
2.8
18
57.4
2.3
40
69.2
2.3
60
86.4
2.5
19
58.0
2.3
41
69.8
2.3
20
58.6
2.3
The Value of PROMIS
1. Comparability
2. Reliability and Validity
3. Flexibility
www.nihpromis.org