Expanding construct validity of established and new PROMIS Pediatric measures for children and adolescents receiving cancer treatment

• Type of Material: Article
• Authors: Bryce B. Reeve, Duke University; Molly McFatrich, Duke University; Jennifer W. Mack, Boston Childrens Hospital; Laura C. Pinheiro, Well Cornell Medicine; Shana S. Jacobs, Childrens National Health System; JN Baker, St Jude Childrens Res Hosp; Janice Withycombe, Emory University; Li Lin, Duke University; Courtney M. Mann, Duke University; Katie R. Villabroza, Childrens Hospital Los Angeles; Pamela S. Hinds, Childrens National Health System
• Language: English
• Date: 2020-01-06
• Publisher: Wiley
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2020 John Wiley & Sons, Inc. All rights reserved
• Final Published Version (URL): http://dx.doi.org/10.1002/pbc.28160
• Title of Journal or Parent Work: Pediatric Blood & Cancer
• Volume: 67
• Issue: 4
• Start Page: e28160
• End Page: e28160
• Grant/Funding Information: Research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases under award number U19AR069522 and the NIH including the NCI under award number R01CA175759.
• Keywords: Life Sciences & Biomedicine; Symptom assessment scale; Families; function; Pediatrics; Science & Technology; validity; Parents; Hematology; Sleep; pediatric; Standards; Validation; Patient-reported outcomes; symptoms; oncology; Oncology; Childhood; PROMIS; INSTRUMENT; Fatique
• Research Categories: Health Sciences, Oncology; Health Sciences, Human Development; Health Sciences, Rehabilitation and Therapy

Abstract

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric measures were designed to assess symptoms and functioning in children and adolescents. The study goal was to evaluate the validity and responsiveness of the PROMIS Pediatric measures in a diverse cohort of children with cancer. Methods: Children (7-18 years) from nine pediatric oncology hospitals completed surveys at 72 hours preceding treatment initiation (T1) and at follow-up (T2) approximately 7 to 17 days later for chemotherapy, and 4+ weeks later for radiation. Children completed PROMIS Pediatric measures (Mobility, Pain Interference, Fatigue, Depressive Symptoms, Anxiety, Psychological Stress), Memorial Symptom Assessment Scale (MSAS), and global impressions of change (GIC) questions on their symptoms and functioning at T2 reflecting on T1. Parents completed the Lansky Play-Performance Status (PPS) scale and medication list for their child. Results: The children (n = 482) were average age 12.9 years, 46% female, 60% Caucasian, and had diverse cancers and treatments. There were moderate to strong correlations between PROMIS Pediatric and MSAS, supporting convergent validity. In support for known-groups validity, the PROMIS Pediatric average scores were statistically different (P < 0.05) for most domains by PPS and if the child was on a medication (or not) for controlling a symptom. The PROMIS Pediatric measures were responsive over time in association with the GIC. Conclusions: In a large, diverse sample of children and adolescents with cancer, there was strong evidence for the construct validity and responsiveness of the PROMIS Pediatric measures. This evidence supports PROMIS Pediatric measure use in pediatric oncology trials.