Pamela S Hinds1,2, Jichuan Wang2,3, Yao I Cheng3, Emily Stern4, Mia Waldron1, Heather Gross5, Darren A DeWalt5, Shana S Jacobs2,4. 1. Department of Nursing Science, Professional Practice and Quality, Children's National Health System, Washington, District of Columbia. 2. Department of Pediatrics, The George Washington University, Washington, District of Columbia. 3. Department of Biostatistics and Study Methodology, Children's National Health System, Washington, District of Columbia. 4. Department of Hematology/Oncology, Children's National Health System, Washington, District of Columbia. 5. Division of General Medicine and Clinical Epidemiology, University of North Carolina at Chapel Hill, North Carolina.
Abstract
PURPOSE: This study assessed the responsiveness to change over time and theorized associations of Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measures in children and adolescents in treatment for cancer to determine measure readiness for use in cancer clinical trials. METHODS: We administered eight PROMIS (three symptom, two psychological, and three performance) pediatric short-form measures and the Symptom Distress Scale (SDS) to 96 pediatric oncology patients at three time points during a course of chemotherapy. We assessed responsiveness using paired t tests and generalized estimating equation (GEE) models, calculated standardized response mean (SRM) values for PROMIS measures, and examined scores over three data points (T1-T3). Guided by the theory of unpleasant symptoms (TOUS), we examined associations among the PROMIS measures, the SDS, and other variables using GEE. RESULTS: The paired t tests showed statistically significant changes in two psychological measures and one performance measure from T1 to T2; three symptom, two psychological and two performance measures from T2 to T3; and three symptom and two psychological measures from T1 to T3. Findings from GEE models indicate PROMIS pediatric measures had statistically significant short-term and long-term changes, controlling for demographic and clinical variables. One performance measure did not achieve significant change at any time point. We found positive support for theorized relationships in the TOUS. CONCLUSIONS: Most of the PROMIS pediatric measures demonstrated changes over time and had significant relationships as theorized, thus supporting concurrent and construct validity of these measures when administered to pediatric oncology patients during a course of chemotherapy. This evidence supports the measures' readiness for use in clinical trials.
PURPOSE: This study assessed the responsiveness to change over time and theorized associations of Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measures in children and adolescents in treatment for cancer to determine measure readiness for use in cancer clinical trials. METHODS: We administered eight PROMIS (three symptom, two psychological, and three performance) pediatric short-form measures and the Symptom Distress Scale (SDS) to 96 pediatric oncology patients at three time points during a course of chemotherapy. We assessed responsiveness using paired t tests and generalized estimating equation (GEE) models, calculated standardized response mean (SRM) values for PROMIS measures, and examined scores over three data points (T1-T3). Guided by the theory of unpleasant symptoms (TOUS), we examined associations among the PROMIS measures, the SDS, and other variables using GEE. RESULTS: The paired t tests showed statistically significant changes in two psychological measures and one performance measure from T1 to T2; three symptom, two psychological and two performance measures from T2 to T3; and three symptom and two psychological measures from T1 to T3. Findings from GEE models indicate PROMIS pediatric measures had statistically significant short-term and long-term changes, controlling for demographic and clinical variables. One performance measure did not achieve significant change at any time point. We found positive support for theorized relationships in the TOUS. CONCLUSIONS: Most of the PROMIS pediatric measures demonstrated changes over time and had significant relationships as theorized, thus supporting concurrent and construct validity of these measures when administered to pediatric oncology patients during a course of chemotherapy. This evidence supports the measures' readiness for use in clinical trials.
Authors: John M Salsman; Suzanne C Danhauer; Justin B Moore; Mollie R Canzona; David E Victorson; Bradley J Zebrack; Bryce B Reeve Journal: Cancer Date: 2020-09-10 Impact factor: 6.860
Authors: Bryce B Reeve; Molly McFatrich; Jennifer W Mack; Scott H Maurer; Shana S Jacobs; David R Freyer; Janice S Withycombe; Justin N Baker; Sharon M Castellino; Li Lin; Nicole R Lucas; Pamela S Hinds Journal: J Natl Cancer Inst Date: 2020-11-01 Impact factor: 13.506
Authors: Meaghann S Weaver; Jichuan Wang; Katie A Greenzang; Molly McFatrich; Pamela S Hinds Journal: Support Care Cancer Date: 2021-10-18 Impact factor: 3.603
Authors: Janice S Withycombe; Molly McFatrich; Pamela S Hinds; Antonia Bennett; Li Lin; Scott H Maurer; Nicole R Lucas; Courtney M Mann; Sharon M Castellino; Justin N Baker; Bryce B Reeve Journal: Cancer Nurs Date: 2022-02-05 Impact factor: 2.760
Authors: Bryce B Reeve; Molly McFatrich; Jennifer W Mack; Laura C Pinheiro; Shana S Jacobs; Justin N Baker; Janice S Withycombe; Li Lin; Courtney M Mann; Katie R Villabroza; Pamela S Hinds Journal: Pediatr Blood Cancer Date: 2020-01-06 Impact factor: 3.167
Authors: Scott H Maurer; Pamela S Hinds; Bryce B Reeve; Jennifer W Mack; Molly McFatrich; Li Lin; Janice S Withycombe; Shana S Jacobs; Justin N Baker; Sharon M Castellino; David R Freyer Journal: Cancer Date: 2021-07-01 Impact factor: 6.921
Authors: Pamela S Hinds; Meaghann S Weaver; Janice S Withycombe; Justin N Baker; Shana S Jacobs; Jennifer W Mack; Scott H Maurer; Molly McFatrich; Laura C Pinheiro; Bryce B Reeve; Jichuan Wang Journal: J Pain Symptom Manage Date: 2020-10-20 Impact factor: 5.576