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 (Gl) Distress. Our objectives are to first develop a Gl Distress domain using the rigorous standards established by the PROMIS network, and then to test the resulting items in 3 distinct patient populations with Gl distress: (1) irritable bowel syndrome (IBS), (2) inflammatory bowel disease (IBD), and (3) systemic sclerosis (SSc) at 4 large Medical Centers. Our UOl has 2 specific research aims: 1) To develop a Gl Distress item pool by: (a) developing an initial Gl 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. 2) To evaluate the psychometric properties of the Gl Distress item pool by: (a) evaluating the dimensionality of the Gl 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 Gl Distress domains with health-related quality of life legacy instruments for Gl illness and with symptom severity, and (c) evaluating the responsiveness and estimating the minimally important differences for the Gl 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. The narrative describes our evolving conceptual framework for Gl Distress, reviews preliminary data from our group regarding PRO measurement in Gl disorders, emphasizes our past experience using PROMIS.

Public Health Relevance

Gl disorders engender an extraordinary burden of illness in the United States. This burden includes the high population prevalence, overwhelming costs of care, and the large impact of Gl disorders on health-related quality of life (HRQOL). Moreover, the Gl-specific rate of health care visits rose by 20 percent between 2000-2004. Given the significant burden of illness of Gl disorders, coupled with the over-representation of many Gl disorders in women, it is vital that the PROMIS taxonomy expand to include items pertaining to Gl Distress.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AR057936-01
Application #
7780848
Study Section
Special Emphasis Panel (ZRG1-RPHB-A (54))
Program Officer
Serrate-Sztein, Susana
Project Start
2009-09-30
Project End
2013-07-31
Budget Start
2009-09-30
Budget End
2010-07-31
Support Year
1
Fiscal Year
2009
Total Cost
$510,556
Indirect Cost
Name
University of California Los Angeles
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
092530369
City
Los Angeles
State
CA
Country
United States
Zip Code
90095
Reeve, Bryce B; Edwards, Lloyd J; Jaeger, Byron C et al. (2018) Assessing responsiveness over time of the PROMIS® pediatric symptom and function measures in cancer, nephrotic syndrome, and sickle cell disease. Qual Life Res 27:249-257
Ahmed, Shahzad; Almario, Christopher V; Chey, William D et al. (2018) Electronic patient agenda forms: comparing agreement between the reason for specialty consultation reported by referring providers and patients. Inform Health Soc Care :1-9
Kwakkenbos, Linda; Thombs, Brett D; Khanna, Dinesh et al. (2017) Performance of the Patient-Reported Outcomes Measurement Information System-29 in scleroderma: a Scleroderma Patient-centered Intervention Network Cohort Study. Rheumatology (Oxford) 56:1302-1311
Zhao, Yue (2017) Impact of IRT item misfit on score estimates and severity classifications: an examination of PROMIS depression and pain interference item banks. Qual Life Res 26:555-564
Morgan, Esi M; Mara, Constance A; Huang, Bin et al. (2017) Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMIS®) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers. Qual Life Res 26:565-586
Bevans, Katherine B; Riley, Anne W; Landgraf, Jeanne M et al. (2017) Children's family experiences: development of the PROMIS® pediatric family relationships measures. Qual Life Res 26:3011-3023
Lee, Augustine C; Driban, Jeffrey B; Price, Lori Lyn et al. (2017) Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis. J Pain 18:1096-1110
Moinpour, Carol M; Donaldson, Gary W; Davis, Kimberly M et al. (2017) The challenge of measuring intra-individual change in fatigue during cancer treatment. Qual Life Res 26:259-271
Cunningham, Natoshia R; Kashikar-Zuck, Susmita; Mara, Constance et al. (2017) Development and validation of the self-reported PROMIS pediatric pain behavior item bank and short form scale. Pain 158:1323-1331
Hedrick, Traci L; Harrigan, Amy M; Thiele, Robert H et al. (2017) A pilot study of patient-centered outcome assessment using PROMIS for patients undergoing colorectal surgery. Support Care Cancer 25:3103-3112

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