Our long-term research goal is to enhance the value of the Patient Reported Outcomes Measurement Information System (PROMIS) in clinical research in children. To bring the work of the first phase PROMIS pediatric item bank creation to fruition will entail demonstrating superior reliability, validity, and sensitivity to change of the PROMIS measures when compared to legacy items. Our objective is to demonstrate the content and construct validity of the PROMIS pediatric tool in important medical conditions of childhood that impair physical function and result in reduced health related quality of life (HRQOL): juvenile idiopathic arthritis (JIA), cerebral palsy (CP), and pediatric chronic pain syndromes. The PROMIS pediatric pain domain is recognized to need further development to add measurement of other facets of the pain experience to the current measure of pain impact. Given the centrality of pain to HRQOL, an important driver of this proposal is to enrich the PROMIS pediatric tool by developing and testing new pediatric pain item banks to address the large unmet need for adequate measurement of pain in children.
Our Specific Aims are thus: 1) to evaluate the validity and responsiveness of the PROMIS pediatric item banks with longitudinal assessments in children with JIA, CP, and chronic musculoskeletal pain. In each study population, we will assess content validity with key informant interviews, and analyze construct validity with co-administration of legacy scales and by test of responsiveness to change. A final product will be the determination of minimal important differences (MIDs) in PROMIS measures. And 2), to enhance PROMIS pediatric pain assessment with new item bank creation and testing. In recognition of the multiple facets of the pain experience, PROMIS pediatric pain items will be developed in the areas of pain intensity, pain quality, and pain behavior. Item creation will follow the established PROMIS process including qualitative item review and cognitive interviews with patients with chronic and recurrent painful conditions. Construct validity will be assessed by correlation with co-administered legacy scales. The expected outcome of the project is to foster use of PROMIS for improved PRO measurement in Pediatric Pain, Rheumatology and Rehabilitation Research.

Public Health Relevance

Medical interventions seek to improve the quality of life of patients, including their pain, physical functioning and emotional well-being. Patient reported outcomes measurement is critical to assessing the usefulness of any medical intervention. This proposal will test the validity and responsiveness to change of the PROMIS tool for assessment of health in children with Juvenile Idiopathic Arthritis, Cerebral Palsy, and Chronic Pain. The project also aims to improve assessment of pain in children by creating new PROMIS pain measures.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AR057940-02S1
Application #
8215438
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
2011-02-01
Budget End
2011-07-31
Support Year
2
Fiscal Year
2011
Total Cost
$110,461
Indirect Cost
Name
Cincinnati Children's Hospital Medical Center
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
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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
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
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Stephens, Helen E; Joyce, Nanette C; Oskarsson, Björn (2017) National Study of Muscle Cramps in ALS in the USA. Amyotroph Lateral Scler Frontotemporal Degener 18:32-36
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
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
Howell, Carrie R; Thompson, Lindsay A; Gross, Heather E et al. (2017) Association of consistently suboptimal quality of life with consistently poor asthma control in children with asthma. Ann Allergy Asthma Immunol 119:562-564.e1
Jones, Jordan T; Carle, Adam C; Wootton, Janet et al. (2017) Validation of Patient-Reported Outcomes Measurement Information System Short Forms for Use in Childhood-Onset Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken) 69:133-142

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