@article{66adcb0a92a94dfb9789be174e6e4285,
title = "Responsiveness of 8 Patient-Reported Outcomes Measurement Information System (PROMIS) measures in a large, community-based cancer study cohort",
abstract = "BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) was a National Institutes of Health-funded initiative to develop measures of symptoms and function. Responsiveness is the degree to which a measure can detect underlying changes over time. The objective of the current study was to document the responsiveness of 8 PROMIS measures in a large, population-based cancer cohort. METHODS: The Measuring Your Health study recruited 2968 patients who were diagnosed with 1 of 7 cancers between 2010 and 2012 through 4 Surveillance, Epidemiology, and End Results registries. Participants completed a baseline survey (6-13 months after diagnosis) and a 6-month follow-up survey. Changes in 8 PROMIS scores were compared with global ratings of transition, changes in performance status, and clinical events. RESULTS: Measures were responsive to 6-month declines and improvements in performance status with small to large effect sizes (ES) (Cohen d = 0.34-0.71; P <.01). Mean changes and effect sizes were larger for participants who reported declines compared with those who reported improvements. Small-to-medium ES were observed in patients who reported being “a little” worse (d = 0.31-0.56), and medium-to-large ES were observed in those who reported being “a lot” worse (d = 0.53-0.72). Hospitalized participants reported significant score increases, resulting in worsening of pain (d = 0.51), fatigue (d = 0.35), and depression (d = 0.57; all P <.01). Cancer recurrence and progression were associated with smaller increases in pain, fatigue, and sleep disturbance (d = 0.22-0.27). CONCLUSIONS: The current results indicated that all 8 PROMIS measures were sensitive to patient-perceived worsening and improvement and to major clinical events. These findings will be able to inform the design and interpretation of future research studies and clinical initiatives administering PROMIS measures. Cancer 2017;123:327–335.",
keywords = "oncology, patient-reported outcomes, responsiveness, validation studies",
author = "Jensen, {Roxanne E.} and Moinpour, {Carol M.} and Potosky, {Arnold L.} and Tania Lobo and Hahn, {Elizabeth A.} and Hays, {Ron D.} and David Cella and Smith, {Ashley Wilder} and Wu, {Xiao Cheng} and Keegan, {Theresa H.M.} and Paddock, {Lisa E.} and Stroup, {Antoinette M.} and Eton, {David T.}",
note = "Funding Information: This work was supported by grants from the National Institutes of Health (NIH) (U01 AR057971 [to R.E.J., T.L., A.L.P, and C.M.M.] and P30 CA051008 [to R.E.J., T.L., and A.L.P.]); the National Center for Research Resources, the National Center for Advancing Translational Sciences, and the NIH through the Clinical and Translational Science Awards Program (KL2 TR000102 [to R.E.J.]) Patient-reported outcomes (PROs) are measures of functioning and well-being in physical, mental and social spheres of health. In 2004, the National Institutes of Health (NIH) launched the Patient-Reported Outcomes Measurement Information System (PROMIS) as part of an NIH Roadmap (and, later, an NIH Common Fund) initiative assessing all disease and health areas. PROMIS was designed using extensive qualitative and quantitative methods to develop a comprehensive set of item banks and short-form measures. Responsiveness is an important aspect of scale evaluation for determining the degree to which a PRO measure can detect underlying true changes. Anchors used as indicators of change include patient transition reports and documented clinical events over the study period. To date, only a few studies have been published examining the responsiveness of PROMIS measures. One study examined PROMIS responsiveness and minimally important differences in a clinic-based sample of patients with advanced-stage cancer (n = 101). Our current study builds on these findings, evaluating the responsiveness of 8 PROMIS short-form measures in the Measuring Your Health (MY-Health) Study. MY-Health was designed to conduct a large-scale psychometric evaluation of PROMIS measures across a diverse cancer sample using community-based sampling to represent the full range of known health disparities across age and race/ethnic groups. This study presents an ideal environment for evaluating responsiveness in a large sample of patients with 7 different cancers, providing 6-month prospective data and capturing both patient and clinical indicators. Demonstrating responsiveness in this heterogeneous cohort of patients with cancer will support using PROMIS measures in population-based studies, comparative effectiveness research, clinical trials, and other longitudinal studies. The Patient-Reported Outcomes Measurement Information System (PROMIS) was a National Institutes of Health-funded initiative to develop measures of symptoms and function. Responsiveness is the degree to which a measure can detect underlying changes over time. The objective of the current study was to document the responsiveness of 8 PROMIS measures in a large, population-based cancer cohort. Publisher Copyright: {\textcopyright} 2016 American Cancer Society",
year = "2017",
month = jan,
day = "1",
doi = "10.1002/cncr.30354",
language = "English (US)",
volume = "123",
pages = "327--335",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "2",
}