The challenge of measuring intra-individual change in fatigue during cancer treatment
To evaluate how well three different patient-reported outcomes (PROs) measure individual change.
Two hundred and fourteen patients (from two sites) initiating first or new chemotherapy for any stage of breast or gastrointestinal cancer participated. The 13-item FACIT Fatigue scale, a 7-item PROMIS® Fatigue Short Form (PROMIS 7a), and the PROMIS® Fatigue computer adaptive test (CAT) were administered monthly online for 6 months. Reliability of measured change was defined, under a population mixed effects model, as the ratio of estimated systematic variance in rate of change to the estimated total variance of measured individual differences in rate of change. Precision of individual measured change, the standard error of measurement of change, was given by the square root of the rate-of-change sampling variance. Linear and quadratic models were examined up to 3 and up to 6 months.
A linear model for measured change showed the following by 6 and 3 months, respectively: PROMIS CAT (0.363 and 0.342); PROMIS SF (0.408 and 0.533); FACIT (0.459 and 0.473). Quadratic models offered no noteworthy improvement over linear models. Both reliability and precision results demonstrate the need to improve the measurement of intra-individual change.
These results illustrate the challenge of reliably measuring individual change in fatigue with a level of confidence required for intervention. Optimizing clinically useful measurement of intra-individual differences over time continues to pose a challenge for PROs.
KeywordsMeasured change Intra-individual change Fatigue Patient-reported outcomes Cancer
Primary funding for the Clinical Study on Measuring Change in Fatigue was provided as part of a National Institutes of Health, Patient-Reported Outcomes Measurement Information System initiative for Grant # U01 AR057971 (Georgetown—4442-007-FHCRC): Arnold L. Potosky, PhD and Carol M. Moinpour, PhD, Co-Principal Investigators. The Patient-Reported Outcomes Measurement Information System® (PROMIS®) is an NIH Roadmap initiative to develop valid and reliable patient-reported outcome measures to be applicable across a wide range of chronic diseases and demographic characteristics. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. PROMIS II was funded by cooperative agreements with a Statistical Center (Northwestern University, PI: David Cella, PhD, 1U54AR057951), a Technology Center (Northwestern University, PI: Richard C. Gershon, PhD, 1U54AR057943), a Network Center (American Institutes for Research, PI: Susan (San) D. Keller, PhD, 1U54AR057926), and thirteen Primary Research Sites which may include more than one institution (State University of New York, Stony Brook, PIs: Joan E. Broderick, PhD and Arthur A. Stone, PhD, 1U01AR057948; University of Washington, Seattle, PIs: Heidi M. Crane, MD, MPH, Paul K. Crane, MD, MPH, and Donald L. Patrick, PhD, 1U01AR057954; University of Washington, Seattle, PIs: Dagmar Amtmann, PhD and Karon Cook, PhD, 1U01AR052171; University of North Carolina, Chapel Hill, PI: Darren A. DeWalt, MD, MPH, 2U01AR052181; Children’s Hospital of Philadelphia, PI: Christopher B. Forrest, MD, PhD, 1U01AR057956; Stanford University, PI: James F. Fries, MD, 2U01AR052158; Boston University, PIs: Stephen M. Haley, PhD and David Scott Tulsky, PhD (University of Michigan, Ann Arbor), 1U01AR057929; University of California, Los Angeles, PIs: Dinesh Khanna, MD and Brennan Spiegel, MD, MSHS, 1U01AR057936; University of Pittsburgh, PI: Paul A. Pilkonis, PhD, 2U01AR052155; Georgetown University, PIs: Arnold L. Potosky, PhD and Carol M. Moinpour, PhD (Fred Hutchinson Cancer Research Center, Seattle),U01AR057971; Children’s Hospital Medical Center, Cincinnati, PI: Esi M. Morgan DeWitt, MD, MSCE, 17 1U01AR057940; University of Maryland, Baltimore, PI: Lisa M. Shulman, MD, 1U01AR057967; and Duke University, PI: Kevin P. Weinfurt, PhD, 2U01AR052186). NIH Science Officers on this project have included Deborah Ader, PhD, Vanessa Ameen, MD, Susan Czajkowski, PhD, Basil Eldadah, MD, PhD, Lawrence Fine, MD, DrPH, Lawrence Fox, MD, PhD, Lynne Haverkos, MD, MPH, Thomas Hilton, PhD, Laura Lee Johnson, PhD, Michael Kozak, PhD, Peter Lyster, PhD, Donald Mattison, MD, Claudia Moy, PhD, Louis Quatrano, PhD, Bryce B. Reeve, PhD, William Riley, PhD, Ashley Wilder Smith, PhD, MPH, Susana Serrate-Sztein,MD, Ellen Werner, PhD and James Witter, MD, PhD. This manuscript was reviewed by PROMIS reviewers before submission for external peer review. The authors would like to thank the patients who participated in this study and who contributed data over the study period. We also appreciate the assistance of two individuals who helped set up the Clinical Study at FredHutch/SCCA: Denise L. Albano, MS and Christina G. Galer, MS. Chin H. Boo and Marjorie E. Alhadeff assisted with collection of SCCA clinical data. Kathleen Kealey and Nancy Williamson at the Fred Hutchinson Cancer Research Center provided key administrative assistance for the conduct of this study. We also appreciated assistance from Tania Lobo for statistical support at Georgetown University regarding form submission rates. In addition, we would like to thank Richard Gerson, PhD, Director of the PROMIS Technical Center that supports the PROMIS Assessment Center as well as Assessment Center staff Monica A. Prudencio and Linda Carrizosa.
This work was supported by National Institutes of Health (Georgetown University, PIs: Arnold L. Potosky, PhD and Carol M. Moinpour, PhD (Fred Hutchinson Cancer Research Center, Seattle), U01AR057971.
Compliance with ethical standards
Conflict of interest
The authors have no conflicts of interest to disclose.
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