Kurt Kroenke1, Timothy E Stump2, Jacob Kean3, Tasneem L Talib4, David A Haggstrom5, Patrick O Monahan2. 1. Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA; Regenstrief Institute, Inc., Indianapolis, IN, USA. Electronic address: kkroenke@regenstrief.org. 2. Department of Biostatistics, Indiana University Fairbanks School of Public Health and School of Medicine, Indianapolis, IN, USA. 3. Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, Utah, USA. 4. Regenstrief Institute, Inc., Indianapolis, IN, USA. 5. Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA; Regenstrief Institute, Inc., Indianapolis, IN, USA; VA Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.
Abstract
OBJECTIVE: The 5 SPADE (sleep, pain, anxiety, depression, and low energy/fatigue) symptoms are among the most prevalent and disabling symptoms in clinical practice. This study evaluates the minimally important difference (MID) of Patient-Reported Outcomes Measurement Information System (PROMIS) measures and their correspondence with other brief measures to assess SPADE symptoms. STUDY DESIGN AND SETTING: Three hundred primary care patients completed a4-item PROMIS scale, a numeric rating scale (NRS), and a non-PROMIS legacy scale for each of the 5 SPADE symptoms. Optimal NRS cutpoints were examined, and cross-walk units for converting legacy measure scores to PROMIS scores were determined. PROMIS scores corresponding to standard deviation (SD) and standard error of measurement (SEM) changes in legacy scores were used to estimate MID. RESULTS: At an NRS ≥5, the mean PROMIS T-score exceeded 55 (the operational threshold for a clinically meaningful symptom) for each SPADE symptom. Correlations were high (0.70-0.86) between each PROMIS scale and its corresponding non-PROMIS legacy scale. Changes in non-PROMIS legacy scale scores of 0.35 SD and 1 SEM corresponded to mean PROMIS T-scores of 2.92 and 3.05 across the 5 SPADE symptoms, with changes in 0.2 and 0.5 SD corresponding to mean PROMIS T-scores of 1.67 and 4.16. CONCLUSION: A 2-step screening process for SPADE symptoms might use single-item NRS scores, proceeding to PROMIS scales for NRS scores ≥5. A PROMIS T-score change of three points represents a reasonable MID estimate, with two to four points approximating lower and upper bounds.
RCT Entities:
OBJECTIVE: The 5 SPADE (sleep, pain, anxiety, depression, and low energy/fatigue) symptoms are among the most prevalent and disabling symptoms in clinical practice. This study evaluates the minimally important difference (MID) of Patient-Reported Outcomes Measurement Information System (PROMIS) measures and their correspondence with other brief measures to assess SPADE symptoms. STUDY DESIGN AND SETTING: Three hundred primary care patients completed a 4-item PROMIS scale, a numeric rating scale (NRS), and a non-PROMIS legacy scale for each of the 5 SPADE symptoms. Optimal NRS cutpoints were examined, and cross-walk units for converting legacy measure scores to PROMIS scores were determined. PROMIS scores corresponding to standard deviation (SD) and standard error of measurement (SEM) changes in legacy scores were used to estimate MID. RESULTS: At an NRS ≥5, the mean PROMIS T-score exceeded 55 (the operational threshold for a clinically meaningful symptom) for each SPADE symptom. Correlations were high (0.70-0.86) between each PROMIS scale and its corresponding non-PROMIS legacy scale. Changes in non-PROMIS legacy scale scores of 0.35 SD and 1 SEM corresponded to mean PROMIS T-scores of 2.92 and 3.05 across the 5 SPADE symptoms, with changes in 0.2 and 0.5 SD corresponding to mean PROMIS T-scores of 1.67 and 4.16. CONCLUSION: A 2-step screening process for SPADE symptoms might use single-item NRS scores, proceeding to PROMIS scales for NRS scores ≥5. A PROMIS T-score change of three points represents a reasonable MID estimate, with two to four points approximating lower and upper bounds.
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Authors: Brett D Thombs; Linda Kwakkenbos; Brooke Levis; Angelica Bourgeault; Richard S Henry; Alexander W Levis; Sami Harb; Lydia Tao; Marie-Eve Carrier; Laura Bustamante; Delaney Duchek; Laura Dyas; Ghassan El-Baalbaki; Kelsey Ellis; Danielle B Rice; Amanda Wurz; Julia Nordlund; Maria Gagarine; Kimberly A Turner; Nora Østbø; Nicole Culos-Reed; Shannon Hebblethwaite; Scott Patten; Susan J Bartlett; John Varga; Luc Mouthon; Sarah Markham; Michael S Martin; Andrea Benedetti Journal: Lancet Rheumatol Date: 2021-04-16
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