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 THE UN ECONOMIC COMMISSION FOR EUROPEAN COMMUNITIES EUROPE (EUROSTAT) 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

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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

Patient-Reported Outcomes Measurement Information System

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 Structure of the PROMIS Network

SABPRS

SCC

PRS

PRS

SC

NIH Science Officers

The PROMIS Network

●●

●♦

●●

●●

●●

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

A

Item Pool

Items fromInstrument

B

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

[email protected]