Dagmar Amtmann, Ph.D. Karon Cook, Ph.D Department of Rehabilitation Medicine University of Washington Email:[email protected]Website: http://uwcorr.washington.edu Funded by the National Institutes of Health through the NIH Roadmapfor Medical Research, Grant 5U01AR052171-03 to University of Washington.
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Dagmar Amtmann, Ph Pain Definitions Pain is an unpleasant sensory or emotional experience associated with actual or potential tissue damage, or described in …
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Dagmar Amtmann, Ph.D.
Karon Cook, Ph.DDepartment of Rehabilitation Medicine
Funded by the National Institutes of Health through the NIH
Roadmap for Medical Research, Grant 5U01AR052171-03 to
University of Washington.
PAIN AND PHYSICAL FUNCTION
PROMIS ITEM BANKS� Pain and physical function are two of the most commonly
used domains in research assessing health related quality
of life (HRQL) in medical rehabilitation
� PROMIS Pain Interference and Pain Behaviors item banks
were developed and calibrated to the PROMIS metric
(Mean =50, SD =10)
� PROMIS physical function bank was modified to be
appropriate for users of mobility aids (wheelchairs,
walkers, reachers)
Overview� Pain interference and behaviors item banks:
� Definitions� Qualitative Research Results� Psychometric Properties and short forms
� Physical function item bank appropriate for users of assistive technology� Overview of the process� Psychometric Properties of the new PF bank
PROMIS Pain Domain Working Group Members:
� Dagmar Amtmann (Chair), University of Washington (UW)
� Karon Cook, UW
� Leigh Callahan, U of North Carolina
� Wen-Hung Chen, United Biosource
� Francis Keefe, Duke
� Dennis Revicki, United Biosource
� Arthur Stone, Stonybrook
� Mark Jensen, UW
� Dawn Ehde, UW
Pain Interference Item BankMany pain interference instruments are currently available. Why add another?
�Most available instruments were developed using Classical Test Theory �Only static instruments for measuring pain were available and item banking offers important advantages: CAT and targeted short forms�Availability of PROMIS pain interference item bank facilitates construction of patient profiles�Population norms
Example of PROMIS patient profiles
PROMIS t-scores for a sample of people with MS and SCI measured on PROMIS Short Forms (n=364 to 461 for MS and 213 to 239 for SCI)
PROMIS Pain DefinitionsPain is an unpleasant sensory or emotional experience associated with actual or potential tissue damage, or described in terms of such damage. Pain is what the patient says it is – that is, the “gold standard” of pain assessment is self-report. Pain is divided conceptually into components of quality (e.g. the nature, characteristics, intensity, frequency, and duration of pain), behaviors (e.g. verbal and nonverbal actions that communicate pain to others) and interference (e.g. impact of pain on physical, mental, and social activities).
The PROMIS Pain Interference item bank assesses the consequences of pain on relevant aspects of persons’ lives and may include the impact of pain on social, cognitive, emotional, physical, and recreational activities as well as sleep and enjoyment in life (Note that Pain Interference bank includes only one sleep item). The item bank uses a “past 7 days” reporting period. The PROMIS Pain Behavior item bank assesses external manifestations of experiencing pain. These actions or reactions can be verbal or nonverbal, involuntary or deliberate. Pain behaviors usually communicate to others that a person is experiencing pain. They include observable displays such as sighing or crying, and pain severity behaviors such as resting, guarding, facial expressions, and asking for help, as well as verbal reports of pain. The item bank uses a “past 7 days” reporting period.
Brief summary of Focus Groups� The PROMIS research site at the University of
Washington conducted 5 focus groups on pain, fatigue and physical function with individuals recruited from rehabilitation clinics. Main findings:� Pain interference is more meaningful to measure than
pain intensity (Please don’t ask me what my pain is on 0 to10!!);
� It is difficult for individuals with disabilities/chronic health conditions to separate the sources of interference (pain leads to fatigue and a lack of sleep, fatigue makes pain feel worse, etc.)
Cognitive interviews44 cognitive interviews were conducted to review items measuring pain. 168 items for measuring pain were included in three proposed pain item banks: pain interference, pain quality and pain behaviors. Issues identified in the interviews included that
� Time frame didn’t function as intended, � Pain quality items were not understood by the participants in a
way intended (pulling, shooting, freezing pain)� Participants reported that they intentionally inflated some
responses to communicate how much pain affects their functioning or endorsed types of pain or behaviors they did not have
� Participants expressed unease about the purpose of pain behavioritems (participants worried that if they do not endorse “screaming or crying” their pain may be dismissed by health care providers).
I don’t know what you mean. –
Problems with Item Clarity
� Some people interpreted “relationships” as strictly romantic and others considered not only romantic relationships, but also family and/or work relationships. When asked a question about “pain interfering with close personal relationships,” one participant responded “when you think about answering this, you go with two different categories...whether or not pain interferes with your sex life and then the other is… friendships and interactions with children and parents.”
When unsure endorse the
“safe” option (moderate pain)� Participants reported that, whenever they were
uncertain of what a pain item meant, they selected the response option that communicated “moderate pain” or endorsed an inflated level of pain as a “safe”response, that is, a response that is more likely to get a healthcare provider’s attention: “That’s what I do when I want to play it safe [mark moderate amount of pain]. And if I have to play it safe, that tells you right there what’s happening with the question.”
Attribution of causes� Participants reported being unable to tease apart the
contribution of other symptoms or life circumstances from their experience of pain.� For instance, one participant reported how he reinterpreted
the item “how much did pain interfere with your household chores?”“I reinterpreted the word pain… and I put down ‘a little bit’because of fatigue…fatigue is keeping me from doing it the way I used to do it.”
� Another participant, in response to the item “how anxious were you because of your pain?” reported “I’m anxious…but how much is because of my pain and how much is because I’m a law student? How much of that is just, like, my life?”
Frequency responses preferred � Most participants preferred frequency responses
(“never, rarely, sometimes, often, always”) to intensity response options (“not at all, a little bit, somewhat, quite a bit, very much”).
� The response option “strongly disagree, disagree, agree, strongly agree” was disliked by all but one participant. The respondent who preferred that option felt that it was “more scientific,” but was unable to rephrase her response when asked and had to change her response upon reflection
Issues with the time frameParticipants often reported disregarding the specified time frame (i.e., past 7 days). For 41 out of 56 items (75%) that measure the interference of pain, participants substituted a time frame theyjudged to be more relevant to them. Instead of considering the past seven days, some participants reported � thinking about their lives “in general” or over a longer time frame (i.e., since their disability began)�answering items with reference to a particular episode or salient event.
�“Did you think specifically about this week?” when responding to an item regarding pain interference with enjoyment of life replied, “I probably think more ‘in the last few months’ than I do this week.”�Another participant asked the same question with regard to an item about intensity of “burning pain” reported, “I only focused on the flaring episode during the migraine.”
Wave I testing for PROMIS banks� 21,133 individuals included both community and clinical
samples.
� The clinical samples included persons with heart disease (n = 1,156), cancer (n = 1,754), rheumatoid arthritis (n = 557), osteoarthritis (n = 918), psychiatric illness (n = 1,193), COPD (n = 1,214), spinal cord injury (n = 531), and other conditions (n = 560).
� A total of 14,848 persons met inclusion criteria and responded either to the full, 56-item PROMIS-PI bank (N=845) or to one of the eight, 7-item Pain Interference blocks (N=14,003).
Supplementary data collection� Purpose: To supplement PROMIS Wave I sample with
individuals who report greater levels of pain
� Data from 532 persons with cancer were collected from
two cancer clinics (NorthShore University HealthSystem
and John H. Stroger, Jr. Hospital of Cook County), and
from cancer support societies in the Chicago area and
across the country.
� Data from 523 individuals with chronic pain recruited
through the American Chronic Pain Association (ACPA)
Pain Interference
Full Bank Test Function (41 items)
Pain Interference
Short Form (6 items):In the past 7 days…
1. How much did pain interfere with your enjoyment of recreational activities?
2. How much did pain interfere with your ability to concentrate?
3. How much did pain interfere with doing your tasks away from home (e.g., getting groceries,
running errands)?
4. How much did pain interfere with your day to day activities?
5. How much did pain interfere with your enjoyment of life?
Response options: 1=Not at all; 2=A little bit; 3=Somewhat; 4=Quite a bit; 5=Very much
6. How often did pain keep you from socializing with others?
Pain Behaviors Short FormIn the past 7 days…1.When I was in pain I became irritable2.When I was in pain I called out for someone to help me3.When I was in pain I grimaced4.When I was in pain I isolated myself from others5.When I was in pain I moved extremely slowly6.When I was in pain I thrashed7.When I was in pain I moved stiffly
7-item Short Form 7-item CAT 39-item BankBank Precision:
reliability 0.80
Less Pain Behavior More Pain Behavior
reliability 0.90
More Precision
Less Precision
PHYSICAL FUNCITON AND PEOPLE
WITH DISABILITIES� Persons with disabilities are some of the most frequent
users of health care
� Meyers and Andresen1 describe administering the SF-36 to
a sample, the majority of whom were wheelchair users.
� Respondents rejected words such as “walk” and “climb” or
qualified their answers (“I can’t walk, but in my wheelchair, I
can go. . .”).
� Others answered angrily and some hung up on the
interviewers.
1Meyers, A. R. & Andresen, E. M. (2000). Enabling our instruments: accommodation,
universal design, and access to participation in research. Arch Phys Med Rehabil,
81,
Definition:
PROMIS Physical Function� The PROMIS Physical Function item bank assesses one's ability to carry out activities that require
physical actions, ranging from self-care (activities of daily living) to more complex activities that
require a combination of skills, often within a social context. “Physical Function” is inclusive of the
term “disability” and includes the full spectrum of physical functioning from severe impairment to
exceptional physical abilities.
� The PROMIS Physical Function items assess capability to perform a variety of physical activities, and
often begin with the stem “Are you able to . . .”. Items assessing performance of these activities
(the frequency with which physical activities were performed within a specified timeframe), may
have great utility for some purposes, but are not included in the physical function item bank.
Performance requires not only capability but also opportunity and motivation. The use of capability
stems in the PROMIS Physical Function item bank also excludes satisfaction items (e.g., "How
satisfied are you with your current level of functioning?"). Such questions address subjective
appraisals of oneself that incorporate concepts such as coping or adjustment. Additionally, because
many persons with a chronic disease will have more than one chronic condition and often are
unable to distinguish the proportion of physical limitation attributable to each condition, the
PROMIS physical function items assess physical capabilities and limitations without causal
attribution. Physical function is conceptually multidimensional, with four related subdomains:
mobility (lower extremity function), dexterity (upper extremity function), axial (neck and back
function), and ability to carry out instrumental activities of daily living. There is no reporting period
specified for these items; current status is inferred.
PROMIS Physical Function (PF)
Item Bank� James Fries, M.D. (PI)
�The bank includes Physical Function 125 items
�General short form includes 10 items
�Many items in the bank assume respondents can walk,
reach, or use their hands
�Supplemental funding was provided by NIH to ensure the
PROMIS-PF bank was appropriate and relevant to people
who use AT.
Expert Panel Recommendations� First develop physical function item bank capable of
measuring what one is able to do with the mobility aids (e.g., wheelchairs, walkers, reachers) available to them.
� Please note: This means that a person using a manual wheelchair who has considerable upper body function may have a similar physical function score as a person who operates a power wheelchair using a sip & puff system and is unable to use their arms or hands
� In the future, develop a way to measure improvement defined as being able to do the same level of function but with less support.
Items from sister item banking
projects were included:
– 5R01CA060068-12, Item Banking and CAT for Quality of Life
Outcomes (NeuroQOL). Purpose: to refine and broaden our
HRQOL item banking in neurologic populations. (Cella, PI)
– 5R01HD054569-03, Quality of Life for SCI Clinical Trials:
Development of the SCI-QOLR-01 (David Tulsky, PI).
Purpose: to do develop SCI-specific item banks that link to
PROMIS.
Procedures�PROMIS PF items reviewed by
experts and categorized regarding relevance and appropriateness for users of AT.
�New items added.
• To ensure aspects of PF most relevant to AT users were included.
• To create overlap with items of other item banking efforts.
�Candidate item bank consisted of
• Relevant and unchanged PROMIS PF items.
• Revised PROMIS PF items.
• New PF items.
Cognitive Interviewing� Conducted with 38 users of AT living with
� multiple sclerosis (MS) n=16,
� spinal cord injury (SCI) n=16
� arthritis (n=5) and lower limb amputation (n=1)
Each item was reviewed by both
� users of lower body AT devices, and
� users of upper body or trunk devices.
� 109 items evaluated
� 63 new; 46 linked (previously tested).
Candidate Item Bank (112 items)� Administered to 758 persons:
� SCI = 268
� MS = 274
� Arthritis = 216
� Participants had a choice of paper or on-line survey
� 483 individuals (64%) completed the survey on paper
� 275 completed it online (36%)
Mobility Aids Use in Sample• Asked about 36 different kinds of AT ranging from
– Mobility (e.g., cane, wheelchair)
– Braces
– Reachers, computer aids, shower seat
– Special equipment for personal care, gardening, etc.
• All but one person reported using at least one kind of AT (e.g., mobility, braces, reachers, special equipment for personal care, computer use, etc).
• Mobility
– No problems (8%)
– Walk with no problems but trouble with higher difficulty tasks (e.g. running, hiking) (30%)
– Walk some with AT, but regularly use mobility AT (15%)
– Mobile only with device or assistance (40%)
– Mobility severely limited even with assistance or AT (7%)
Preliminary Results: Comparison of Amount of Information in Original
PROMIS Anchor Items to Information Added with New Items In
form
ati
on
--- Enhanced Physical Function Item Bank- - Original PROMIS Items Included in Data Collection
Reliabili
ty ≈
0.90
Reliabili
ty ≈
0.95
Incr
eased
Info
rmatio
n for
Measu
ring P
eople
with
Very
Low
Physical F
unctio
n
Distribution of Physical
Function in Study Population
Reliability ≈ 0.90
Reliability ≈ 0.95Incr
eased In
form
ation fo
r Measu
ring
People w
ith V
ery L
ow P
hysical F
unctio
n
--- Enhanced Physical Function Item Bank- - Original PROMIS Items Included in Data Collection
Physical Function Scores
(US General Population
Mean = 50, SD = 10)
Coming soon� PROMIS PF Short forms for users of mobility aids