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Working Paper No.7 22 November 2005 STATISTICAL COMMISSION andSTATISTICAL OFFICE OF THE UN ECONOMIC COMMISSION FOREUROPEAN COMMUNITIES PowerPoint PPT Presentation


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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

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Working Paper No.7 22 November 2005 STATISTICAL COMMISSION andSTATISTICAL OFFICE OF THE UN ECONOMIC COMMISSION FOREUROPEAN COMMUNITIES

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Slide 1

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

on the Measurement of Health Status

(Budapest, Hungary, 14-16 November 2005)

Session 2 – Invited paper

Overview of PROMIS Network

University of Washington


Slide 1

PROMIS

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


P atient r eported o utcomes m easurement i nformation s ystem

Patient-Reported Outcomes Measurement Information System

PROMIS


The promis outcome

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 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

PROMIS will develop:

A publicly available, adaptable and sustainable Internet-based system that will:

  • Administer individually “tailored” questionnaires (using Computer Adaptive Testing (CAT) technology) to measure health status

  • Collect and analyze responses


The structure of the promis network

PRS

PROMIS Network

PRS

S

C

C

SC

PRS

SAB

NIH

Science

Officers

The Structure of the PROMIS Network


The promis network

University of Washington

Stony Brook University

Evanston Northwestern Healthcare

NIH

University of Pittsburgh

Stanford University

UNC –Chapel Hill

Duke University

The PROMIS Network


Goals of promis

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


Slide 1

Items from

Instrument

A

Items from

Instrument

B

Items from

Instrument

C

New

Items

Item Pool

Content Expert

Review

Focus

Groups

Cognitive

Testing

Secondary

Data Analysis

Questionnaire

administered to large

representative sample

Item

Response

Theory

(IRT)

Item Bank

(IRT-calibrated items reviewed for

reliability, validity, and sensitivity)

CAT

Short Form

Instruments


Promis data repository

PROMIS Data Repository

Assessment Module

Central Database

Report Module

Item Banks

Study Protocols

Web Laptop PDA IVR

Patients

Users

Import Module

Patients

Clinicians

Patient Reported Data

Paper and Pencil

Study Coordinators


What is the promis time line

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

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

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

PROMIS Independent Projects and PIsContinued

  • 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

Upper Extremities (ADL): grip, buttons, etc

Lower Extremities (ADL): walking, arising, etc.

Function/Disability

Central (ADL): neck & back (twisting, bending)

Activities: IADL (e.g. errands)

Anxiety

Depression

Anger/Aggression

Alcohol & Substance Use

Negative Impacts of illness

PROMIS Domain Framework

General Health

Physical Health

Pain

Symptoms

Fatigue

Other

Satisfaction

HealthPRO

Emotional Distress

Mental Health

Cognitive Function

Subjective Well-Being (positive effect)

Satisfaction

Meaning and Coherence (spirituality)

Positive Psychological Functioning

Mastery and Control (self-efficacy)

Positive Impacts of Illness

Performance

Role Participation

Social Health

Satisfaction

Social Support

Satisfaction


Domain definition physical function

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

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

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

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

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

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

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

Expert Item Revision

  • Put item in the PROMIS format

  • 7 day recall period

  • Preferred response options

  • Stand alone on one screen


Revision example

Revision Example


Final revisions

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

PROMIS Website http://www.nihPROMIS.org/

Contact Information:

Shani Rolle, M.S.

NIH Coordinator

[email protected]


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