University of California at Los Angeles


Grant Number: 1U01AR057949-01
Project Title: Development and Initial Validation of PROMIS GI Distress Scale
PI Name, Title and Contact Information:
  1. Dinesh Khanna, MD, MS, Principal Investigator Assistant Professor of Medicine in the Division of Rheumatology, Department of Medicine, David Geffen School of Medicine at University of California at Los Angeles
  2. Brennan Spiegel, MD, MSHS, Associate Professor of Medicine, VA Greater Los Angeles Healthcare System, David Geffen School of Medicine at UCLA, UCLA School of Public Health, Department of Health Services
Other Key Personnel:  
Web Site:  

Abstract:

The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative aims to develop and disseminate core patient–reported items banks across a wide taxonomy of biopsychosocial illness experiences. Although the current PROMIS taxonomy is expansive, it does not yet include items pertaining to gastrointestinal (GI) Distress. Our objectives are to first develop a GI Distress domain using the rigorous standards established by the PROMIS network, and then to test the resulting items in three distinct patient populations with GI distress: (1) (2) (3)

  1. irritable bowel syndrome (IBS),
  2. inflammatory bowel disease (IBD), and
  3. systemic sclerosis (SSc) at four large Medical Centers.

Our U01 has two specific research aims:

AIM 1: To develop a GI Distress item pool by:

  • (a) developing an initial GI Distress item pool by identifying extant items in the literature, removing redundant and vague items, and revising chosen items to reach uniformity, and
  • (b) expanding the initial pool and establishing content validity by conducting focus groups and cognitive interviews of patients in three patient groups: IBS, IBD, and SSc.

AIM 2: To evaluate the psychometric properties of the GI Distress item pool by:

  • (a) evaluating the dimensionality of the GI distress item pool and assessing fit of item response theory models in 3 samples of 500 patients with IBS, IBD, and SSc (n=1500 overall),
  • (b) evaluating the associations of the GI Distress domains with health–related quality of life legacy instruments for GI illness and with symptom severity, and
  • (c) evaluating the responsiveness and estimating the minimally important differences for the GI Distress domains.

To achieve these aims, we have convened a team of clinicians with expertise in assessing PROs, experts in PRO item development and evaluation, and experts in item response theory.

Patient Populations:

  1. irritable bowel syndrome (IBS),
  2. inflammatory bowel disease (IBD), and
  3. systemic sclerosis (Scleroderma; SSc).

For questions concerning UCLA’s role in the PROMIS network, please contact Dinesh Khanna, MD, by e-mail at dkhanna@mednet.ucla.edu. For more information about the PROMIS network, go to http://www.nihpromis.org.