working paper no.7 22 november 2005 statistical commission andstatistical office of the un economic...
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Working Paper No.7
22 November 2005
STATISTICAL COMMISSION and STATISTICAL OFFICE OF THEUN ECONOMIC COMMISSION FOR EUROPEAN COMMUNITIESEUROPE (EUROSTAT)
CONFERENCE OF EUROPEAN WORLD HEALTHSTATISTICIANS ORGANIZATION (WHO)
Joint UNECE/WHO/Eurostat Meetingon the Measurement of Health Status (Budapest, Hungary, 14-16 November 2005)
Session 2 – Invited paper
Overview of PROMIS Network
University of Washington
This work was funded by the National Institutes of Health through the NIH Roadmap for Medical Research.
Principal Investigator
Deborah N. Ader, Ph.D.Director, Behavioral and Prevention Research Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Goals, Network, TasksPresented by:
Dagmar Amtmann, Ph.D.PI University of Washington Center for Outcomes in Rehabilitation
Research
PROMIS
The PROMIS Outcome…
To improve assessment of self-reported symptoms and other health-related quality of life measures across disabilities. Primary uses:
• Enhance research• Improve clinical decision-making• Facilitate policy-making by health plan and
systems and public programs
The PROMIS is on “the map” …
The PROMIS is one of the key projects under the “Re-engineering the Clinical Research Enterprises” branch of the trans-NIH Roadmap Initiative. All NIH institutes contribute funds to the initiative.
PROMIS will develop:
A publicly available, adaptable and sustainable Internet-based system that will:
1. Administer individually “tailored” questionnaires (using Computer Adaptive Testing (CAT) technology) to measure health status
2. Collect and analyze responses
The PROMIS Network
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University of Washington
Stanford University University of Pittsburgh
UNC –Chapel Hill
Evanston Northwestern Healthcare
NIH
Duke University
Stony Brook University
Goals of PROMIS
• Item banks for specific domains
• Relevant for a variety of chronic illnesses
• Relevant for a variety of literacy levels
• English, Spanish, and then other languages if funding can be acquired
• Ability to “cross-walk” between PROMIS score and selected Legacy Measures
ItemResponseTheory(IRT)
Item Bank(IRT-calibrated items reviewed forreliability, validity, and sensitivity)
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Short FormInstruments
CAT
Items fromInstrument
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Item Pool
Items fromInstrument
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NewItems
Questionnaireadministered to largerepresentative sample
SecondaryData Analysis
CognitiveTesting
FocusGroups
Content ExpertReview
PROMIS Data Repository
Laptop PhonePDAWeb
Assessment Module
Web Laptop PDA IVR
Report Module
Patient Reported Data
Patients
Users
Study Protocols
Central Database
Item Banks
Patients
Clinicians
Import Module
Paper and Pencil Study Coordinators
What is the PROMIS Time Line?
2005-06: Choose specific domains
Identify, review instruments and items
April 2006: Collect pilot response data
2007: Continue data collection
Create alpha version of CAT
2008: Conduct final calibration process,
Put CAT into final form
2009: Carry out feasibility testing
Build sustaining partnerships
PROMIS PRS’s
• Each PROMIS primary research sites (PRS) has its own Independent Project, in addition to contributing to the Network goal of developing an item bank and CAT module for measuring patient reported outcomes in adults.
PROMIS Independent Projects and PIs
• Duke University: Kevin Weinfurt, PhD
Challenges for Using IRT-Based Assessments in Multi-center Clinical Trials
• UNC, Chapel Hill: Harry A. Guess, MD, PhD
Pediatric Reported Outcomes Assessment Using CAT ("Kitty")
• University of Pittsburgh: Paul A. Pilkonis, PhD
Psychiatric Symptoms and Social Functioning: IRT and DIF
PROMIS Independent Projects and PIs Continued
• Stanford University: James F. Fries, MD
Improved Outcome Assessment in Arthritis and Aging
• Stony Brook University: Arthur A. Stone, PhD
Ecological Validity in Patient-Reported Chronic Disease Outcomes
• University of Washington: Dagmar Amtmann, PhD
Improving Measurement of Pain and Fatigue and Increasing the Scientific Understanding of Pain and Fatigue in Children and Adults with Disabilities
PROMIS Domain Framework
Mental Health
Physical Health Symptoms
Pain
Other
Social Health
Role Participation
Social Support
Fatigue
Positive Psychological Functioning
Cognitive Function
Anxiety
Anger/Aggression
Depression
Alcohol & Substance Use
Negative Impacts of illness
Emotional Distress
Subjective Well-Being (positive effect)
Positive Impacts of Illness
Meaning and Coherence (spirituality)
Mastery and Control (self-efficacy)
Performance
Satisfaction
General Health
HealthPRO
Satisfaction
Satisfaction
Satisfaction
Function/Disability
Upper Extremities (ADL): grip, buttons, etc
Central (ADL): neck & back (twisting, bending)
Activities: IADL (e.g. errands)
Lower Extremities (ADL): walking, arising, etc.
Domain Definition: Physical Function
Physical Function is defined as one's ability to carry out various activities, ranging from self-care (activities of daily living) to more challenging and vigorous activities that require increasing degrees of mobility, strength or endurance (Stewart & Kamberg, 1992; Haley, Coster & Binda-Sundberg, 1994; Haley, McHorney & Ware, 1994; Wilson & Cleary, 1995)*. Physical Function items, when considered as an outcome endpoint for clinical research in chronic illness, have a “capability” stem and a corresponding “capability” set of response items (e.g., “Are you able to…normally, with some difficulty, with moderate difficulty, with great difficulty, unable to do.”). This specifically excludes some items that may have great utility in other settings, as with “performance” items with the "Do you?" type of stem, which get at social or psychological issues, and “satisfaction” items (e.g., “How satisfied are you with your disability?”), which get at coping, stress, anxiety, etc. Also, since Physical Function/Disability is a much more fixed latent trait in chronic disease than Pain and some other domains, the response options will seldom be best expressed as "frequency" (“A little bit of the time”, etc.). Further, since many persons with a chronic disease will have more than one chronic disease and cannot distinguish the fraction of a problem attributable to each disease, Physical Function items attempt to quantitate the sum of these disease effects, leaving the teasing out of relative contributions to the analysis stage.
Domain Definition: Pain
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage (Sherbourne, 1992a; Merskey & Bogduk, 1994; Chang, 1999; Meuser, et al, 2001). Pain is what the patient says it is (that is, the "gold standard" of pain assessment is self-report).
Domain Definition: Fatigue
Fatigue is defined as an overwhelming, debilitating and sustained sense of exhaustion that decreases one’s ability to carry out daily activities, including the ability to work effectively and to function at one’s usual level in family or social roles (Stewart, Hays & Ware, 1992; North American Nursing Diagnosis Association, 1996; Glaus, 1998).
Domain Definition: Emotional Distress
Emotional distress refers commonly to unpleasant emotions or cognitions that may interfere with the ability to cope with a disease, its physical symptoms, and its treatment. It covers a wide range of feelings, including worry, powerlessness, sadness, fear, depression, anxiety and panic (Schag et al, 1994; Lawton, Parmellee, Katz & Nesselroade, 1996; van’t Spijker, et al, 1997; Bottomley, 1998a; 1998b; Stark, et al, 2002)*. Problems in mental health may also be manifested, however, in maladaptive behaviors less commonly associated with subjective distress. For example, research in psychiatric nosology (Krueger, 1999) suggests that the “structure of common mental disorders” (excluding psychosis) can be captured at a general (second-order) level by two dimensions of psychopathology: an internalizing dimension reflected in unipolar depression and anxiety disorders and an externalizing dimension reflected in alcohol and substance use and antisocial behavior.
The PROMIS Core Domain Definition: Social Role Participation
Social Role Participation: Role participation refers to involvement in, and satisfaction with, one’s usual social roles, including marital relationships, parental responsibilities, work abilities and social activities (Sherbourne, 1992b; McDowell & Newell, 1996; Dijkers, Whiteneck & El-Jaroudi, 2000)*. This has also been referred to as social adjustment (McDowell & Newell, 1996).
*References provided in the slide notes
Current State of PROMIS Items
• Items mostly from classical test theory
• Created for a specific scale
• Large variety of response options
• Large variety of recall periods
• Various methodologies in the development and validation of items
Qualitative Item Review Process
• Identification of extant items• “Binning and Winnowing”• Legacy scales• Expert item revision• Focus groups on domain coverage• Cognitive interviews for individual items• Integrate quantitative analysis from
archival data• Final revision
Expert Item Revision
• Put item in the PROMIS format
• 7 day recall period
• Preferred response options
• Stand alone on one screen
Revision Example
Original Due to your feet How much difficulty did you have climbing up or down curbs
101 point scale VAS (0 = No difficulty to 100 = unable)
Revised Over the last 7 days:
Could you climb up or down one step?
0 = Without difficulty1 = With some difficulty2 = With much difficulty3 = Unable to do
Final Revisions
• Revise based on focus group feedback, cognitive interview results
• Use Lexile framework to rate readability
• Send on to field testing (April 2006)
PROMIS Website http://www.nihPROMIS.org/
Contact Information:Shani Rolle, M.S.NIH Coordinator