Abstract
Objective
To assess minimally important differences (MIDs) for several pediatric self-report item banks from the National Institutes of Health Patient-Reported Outcomes Measurement Information System® (PROMIS®).
Methods
We presented vignettes comprising sets of two completed PROMIS questionnaires and asked judges to declare whether the individual completing those questionnaires had an important change or not. We enrolled judges (including adolescents, parents, and clinicians) who responded to 24 vignettes (six for each domain of depression, pain interference, fatigue, and mobility). We used item response theory to model responses to the vignettes across different judges and estimated MID as the point at which 50 % of the judges would declare an important change.
Results
We enrolled 246 judges (78 adolescents, 85 parents, and 83 clinicians). The MID estimated with clinician data was about 2 points on the PROMIS T-score scale, and the MID estimated with adolescent and parent data was about 3 points on that same scale.
Conclusions
The MIDs enhance the value of PROMIS pediatric measures in clinical research studies to identify meaningful changes in health status over time.
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Abbreviations
- PROMIS® :
-
Patient-Reported Outcomes Measurement Information System®
- NIH:
-
National Institutes of Health
- MID:
-
Minimally important difference
- PRO:
-
Patient-reported outcome
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Acknowledgments
PROMIS® was funded with cooperative agreements from the National Institutes of Health (NIH) Common Fund Initiative (Northwestern University, PI: David Cella, PhD, U54AR057951, U01AR052177; Northwestern University, PI: Richard C. Gershon, PhD, U54AR057943; American Institutes for Research, PI: Susan (San) D. Keller, PhD, U54AR057926; State University of New York, Stony Brook, PIs: Joan E. Broderick, PhD and Arthur A. Stone, PhD, U01AR057948, U01AR052170; University of Washington, Seattle, PIs: Heidi M. Crane, MD, MPH, Paul K. Crane, MD, MPH, and Donald L. Patrick, PhD, U01AR057954; University of Washington, Seattle, PI: Dagmar Amtmann, PhD, U01AR052171; University of North Carolina, Chapel Hill, PI: Harry A. Guess, MD, PhD (deceased), Darren A. DeWalt, MD, MPH, U01AR052181; Children’s Hospital of Philadelphia, PI: Christopher B. Forrest, MD, PhD, U01AR057956; Stanford University, PI: James F. Fries, MD, U01AR052158; Boston University, PIs: Alan Jette, PT, PhD, Stephen M. Haley, PhD (deceased), and David Scott Tulsky, PhD (University of Michigan, Ann Arbor), U01AR057929; University of California, Los Angeles, PIs: Dinesh Khanna, MD (University of Michigan, Ann Arbor) and Brennan Spiegel, MD, MSHS, U01AR057936; University of Pittsburgh, PI: Paul A. Pilkonis, PhD, U01AR052155; Georgetown University, PIs: Carol. M. Moinpour, PhD (Fred Hutchinson Cancer Research Center, Seattle) and Arnold L. Potosky, PhD, U01AR057971; Children’s Hospital Medical Center, Cincinnati, PI: Esi M. Morgan DeWitt, MD, MSCE, U01AR057940; University of Maryland, Baltimore, PI: Lisa M. Shulman, MD, U01AR057967; and Duke University, PI: Kevin P. Weinfurt, PhD, U01AR052186). NIH Science Officers on this project have included Deborah Ader, PhD, Vanessa Ameen, MD (deceased), 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 Reeve, PhD, William Riley, PhD, Peter Scheidt, MD, Ashley Wilder Smith, PhD, MPH, Susana Serrate-Sztein, MD, William Phillip Tonkins, DrPH, Ellen Werner, PhD, Tisha Wiley, PhD, and James Witter, MD, PhD. We thank Catriona Mowbray, PhD, RN at the Children’s National Health System site, as well as Susan Massengill at Levine Children’s Hospital and Rasheed Gbadegesin at Duke University for important contributions, and Karon Cook, PhD, and Ron Hays, PhD, for very helpful comments on an earlier draft. The contents of this article use data developed under PROMIS. These contents do not necessarily represent an endorsement by the US Federal Government or PROMIS. See www.nihpromis.org for additional information on the PROMIS® initiative. We would also like to acknowledge Susan Massengill at Levine Children’s Hospital and Rasheed Gbadegesin at Duke University, as they led the MID work for sampling the nephrotic syndrome population at these institutions.
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Darren DeWalt has copyright of the items in the PROMIS scales tested in this study. He has granted unrestricted license for use of the items to the PROMIS Health Organization and receives no payment or royalties for their use.
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Thissen, D., Liu, Y., Magnus, B. et al. Estimating minimally important difference (MID) in PROMIS pediatric measures using the scale-judgment method. Qual Life Res 25, 13–23 (2016). https://doi.org/10.1007/s11136-015-1058-8
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DOI: https://doi.org/10.1007/s11136-015-1058-8