Working Paper No.7 22 November 2005 STATISTICAL COMMISSION andSTATISTICAL OFFICE OF THE UN ECONOMIC COMMISSION FOREUROPEAN COMMUNITIES EUROPE (EUROSTAT) CONFERENCE OF EUROPEAN WORLD HEALTH STATISTICIANS ORGANIZATION (WHO) Joint UNECE/WHO/Eurostat Meeting
Working Paper No.7
22 November 2005
STATISTICAL COMMISSION andSTATISTICAL OFFICE OF THE
UN ECONOMIC COMMISSION FOREUROPEAN COMMUNITIES
CONFERENCE OF EUROPEAN WORLD HEALTH
STATISTICIANS ORGANIZATION (WHO)
Joint UNECE/WHO/Eurostat Meeting
on 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 InvestigatorDeborah N. Ader, Ph.D.Director, Behavioral and Prevention Research ProgramNational Institute of Arthritis and Musculoskeletal and Skin DiseasesGoals, Network, TasksPresented by:Dagmar Amtmann, Ph.D.PI University of Washington Center for Outcomes in Rehabilitation Research
Patient-Reported Outcomes Measurement Information System
To improve assessment of self-reported symptoms and other health-related quality of life measures across disabilities.
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.
A publicly available, adaptable and sustainable Internet-based system that will:
University of Washington
Stony Brook University
Evanston Northwestern Healthcare
University of Pittsburgh
UNC –Chapel Hill
administered to large
(IRT-calibrated items reviewed for
reliability, validity, and sensitivity)
Web Laptop PDA IVR
Patient Reported Data
Paper and Pencil
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
Challenges for Using IRT-Based Assessments in Multi-center Clinical Trials
Pediatric Reported Outcomes Assessment Using CAT ("Kitty")
Psychiatric Symptoms and Social Functioning: IRT and DIF
Improved Outcome Assessment in Arthritis and Aging
Ecological Validity in Patient-Reported Chronic Disease Outcomes
Improving Measurement of Pain and Fatigue and Increasing the Scientific Understanding of Pain and Fatigue in Children and Adults with Disabilities
Upper Extremities (ADL): grip, buttons, etc
Lower Extremities (ADL): walking, arising, etc.
Central (ADL): neck & back (twisting, bending)
Activities: IADL (e.g. errands)
Alcohol & Substance Use
Negative Impacts of illness
Subjective Well-Being (positive effect)
Meaning and Coherence (spirituality)
Positive Psychological Functioning
Mastery and Control (self-efficacy)
Positive Impacts of Illness
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.
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).
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).
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.
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
PROMIS Website http://www.nihPROMIS.org/
Shani Rolle, M.S.