TY - JOUR
T1 - Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples
AU - Schalet, Benjamin D.
AU - Pilkonis, Paul A.
AU - Yu, Lan
AU - Dodds, Nathan
AU - Johnston, Kelly L.
AU - Yount, Susan
AU - Riley, William
AU - Cella, David
N1 - Funding Information:
PROMIS was funded with cooperative agreements from the National Institutes of Health (NIH) Common Fund Initiative ( Northwestern University , PI: David Cella, PhD, U54AR057951 , U01AR052177 , R01CA60068 ; 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. The contents of this article uses 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.
Publisher Copyright:
© 2016 Elsevier Inc. All rights reserved.
PY - 2016/5/1
Y1 - 2016/5/1
N2 - Objectives The purpose of this study was to evaluate the responsiveness to change of the PROMIS negative affect measures (depression, anxiety, and anger) using longitudinal data collected in six chronic health conditions. Study Design and Setting Individuals with major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed PROMIS negative affect instruments as computerized adaptive test or as fixed-length short form at baseline and a clinically relevant follow-up interval. Participants also completed global ratings of health. Linear mixed effects models and standardized response means (SRM) were estimated at baseline and follow-up. Results A total of 903 individuals participated (back pain, n = 218; cancer, n = 304; CHF, n = 60; COPD, n = 125; MDD, n = 196). All three negative affect instruments improved significantly for treatments of depression and pain. Depression improved for CHF patients (anxiety and anger not administered), whereas anxiety improved significantly in COPD groups (stable and exacerbation). Response to treatment was not assessed in cancer. Subgroups of patients reporting better or worse health showed a corresponding positive or negative average SRM for negative affect across samples. Conclusion This study provides evidence that the PROMIS negative affect scores are sensitive to change in intervention studies in which negative affect is expected to change. These results inform the estimation of meaningful change and enable comparative effectiveness research.
AB - Objectives The purpose of this study was to evaluate the responsiveness to change of the PROMIS negative affect measures (depression, anxiety, and anger) using longitudinal data collected in six chronic health conditions. Study Design and Setting Individuals with major depressive disorder (MDD), back pain, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), and cancer completed PROMIS negative affect instruments as computerized adaptive test or as fixed-length short form at baseline and a clinically relevant follow-up interval. Participants also completed global ratings of health. Linear mixed effects models and standardized response means (SRM) were estimated at baseline and follow-up. Results A total of 903 individuals participated (back pain, n = 218; cancer, n = 304; CHF, n = 60; COPD, n = 125; MDD, n = 196). All three negative affect instruments improved significantly for treatments of depression and pain. Depression improved for CHF patients (anxiety and anger not administered), whereas anxiety improved significantly in COPD groups (stable and exacerbation). Response to treatment was not assessed in cancer. Subgroups of patients reporting better or worse health showed a corresponding positive or negative average SRM for negative affect across samples. Conclusion This study provides evidence that the PROMIS negative affect scores are sensitive to change in intervention studies in which negative affect is expected to change. These results inform the estimation of meaningful change and enable comparative effectiveness research.
KW - Anger
KW - Anxiety
KW - Chronic conditions
KW - Depression
KW - Item bank
KW - PROMIS
UR - http://www.scopus.com/inward/record.url?scp=84961817188&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84961817188&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2015.08.036
DO - 10.1016/j.jclinepi.2015.08.036
M3 - Article
C2 - 26931289
AN - SCOPUS:84961817188
SN - 0895-4356
VL - 73
SP - 119
EP - 127
JO - American journal of syphilis, gonorrhea, and venereal diseases
JF - American journal of syphilis, gonorrhea, and venereal diseases
ER -
