Augustus John Rush1,2,3, Charles South4, Shailesh Jain1, Raafae Agha1, Mingxu Zhang1, Shristi Shrestha1, Zershana Khan1, Mudasar Hassan1, Madhukar H Trivedi5. 1. Department of Psychiatry, Texas Tech University Health Science Center, Midland, TX, USA. 2. Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA. 3. Professor Emeritus, Duke-National University of Singapore, Singapore. 4. Department of Statistical Science, Southern Methodist University, Dallas, TX, USA. 5. Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Abstract
OBJECTIVE: To develop clinically meaningful improvement thresholds in both the 17-item and the 6-item Hamilton Rating Scale for Depression (HRSD) total scores in depressed outpatients. METHODS: The post-hoc analysis included all adult outpatients with non-psychotic major depressive disorder in the STAR*D trial who entered and exited the first treatment step (up to 14 weeks of citalopram) with a complete set of study measures at baseline and exit and at least one post-baseline measure. Within-patient change and linear regression anchor-based analyses were conducted to define meaningful and substantial changes in the HRSD17 and HRSD6 using three patient-reported outcomes [Work and Social Adjustment Scale (WSAS), Quality of Life Enjoyment and Satisfaction-Short Form (Q-LES-Q-SF); Mini-Q-LES-Q] obtained at baseline and exit from the first treatment step in STAR*D. RESULTS: Linear regression analyses identified a meaningful change threshold for the HRSD17 as 3.9 [3.7-4.1] [lower, upper 95% CI] and a substantial change as 7.8 [7.4-8.3] with the WSAS. Analogous thresholds based on the Q-LES-Q-SF were 5.8 [5.5-6.1] and 11.6 [11.0-12.2], respectively, and 4.9 [4.7-5.2] and 9.9 [9.3-10.4] for the Mini-QLES-Q, respectively. For the HRSD6, linear regression analyses with the WSAS identified a meaningful change as 2.2 [2.1-2.4], while a substantial change was 4.5 [4.2-4.7]. Analogous figures based on the Q-LES-Q-SF were 3.2 [3.0-3.4] and 6.4 [6.1-6.8]. Similarly, based on the Mini-QLESQ, results were 2.8 [2.6-2.9] and 5.6 [5.3-5.9]. For both the HRSD17 and the HRSD6, within-patient analyses produced less precise estimates of the same change thresholds with substantial overlap between groups. Based on the WSAS, a clinically meaningful change in the HRSD17 total score was 9.6 (SD = 6.5), while a substantial change was 15.0 (SD = 6.7). Analogous change thresholds based on the Q-LESQ-SF were 12.9 (SD = 6.2) and 16.8 (SD = 6.4), respectively. For the Mini-Q-LES-Q, thresholds were 10.9 (SD = 6.5) and 16.1 (SD = 6.2). CONCLUSION: A 4-6 point change in the HRSD17 is clinically meaningful; a 7-12 point change is clinically substantial. For the HRSD6, analogous estimates were 2-3 and 4-7 point changes, respectively.
OBJECTIVE: To develop clinically meaningful improvement thresholds in both the 17-item and the 6-item Hamilton Rating Scale for Depression (HRSD) total scores in depressed outpatients. METHODS: The post-hoc analysis included all adult outpatients with non-psychotic major depressive disorder in the STAR*D trial who entered and exited the first treatment step (up to 14 weeks of citalopram) with a complete set of study measures at baseline and exit and at least one post-baseline measure. Within-patient change and linear regression anchor-based analyses were conducted to define meaningful and substantial changes in the HRSD17 and HRSD6 using three patient-reported outcomes [Work and Social Adjustment Scale (WSAS), Quality of Life Enjoyment and Satisfaction-Short Form (Q-LES-Q-SF); Mini-Q-LES-Q] obtained at baseline and exit from the first treatment step in STAR*D. RESULTS: Linear regression analyses identified a meaningful change threshold for the HRSD17 as 3.9 [3.7-4.1] [lower, upper 95% CI] and a substantial change as 7.8 [7.4-8.3] with the WSAS. Analogous thresholds based on the Q-LES-Q-SF were 5.8 [5.5-6.1] and 11.6 [11.0-12.2], respectively, and 4.9 [4.7-5.2] and 9.9 [9.3-10.4] for the Mini-QLES-Q, respectively. For the HRSD6, linear regression analyses with the WSAS identified a meaningful change as 2.2 [2.1-2.4], while a substantial change was 4.5 [4.2-4.7]. Analogous figures based on the Q-LES-Q-SF were 3.2 [3.0-3.4] and 6.4 [6.1-6.8]. Similarly, based on the Mini-QLESQ, results were 2.8 [2.6-2.9] and 5.6 [5.3-5.9]. For both the HRSD17 and the HRSD6, within-patient analyses produced less precise estimates of the same change thresholds with substantial overlap between groups. Based on the WSAS, a clinically meaningful change in the HRSD17 total score was 9.6 (SD = 6.5), while a substantial change was 15.0 (SD = 6.7). Analogous change thresholds based on the Q-LESQ-SF were 12.9 (SD = 6.2) and 16.8 (SD = 6.4), respectively. For the Mini-Q-LES-Q, thresholds were 10.9 (SD = 6.5) and 16.1 (SD = 6.2). CONCLUSION: A 4-6 point change in the HRSD17 is clinically meaningful; a 7-12 point change is clinically substantial. For the HRSD6, analogous estimates were 2-3 and 4-7 point changes, respectively.
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Authors: A John Rush; Madhukar H Trivedi; Hicham M Ibrahim; Thomas J Carmody; Bruce Arnow; Daniel N Klein; John C Markowitz; Philip T Ninan; Susan Kornstein; Rachel Manber; Michael E Thase; James H Kocsis; Martin B Keller Journal: Biol Psychiatry Date: 2003-09-01 Impact factor: 13.382
Authors: A John Rush; Madhukar H Trivedi; Stephen R Wisniewski; Jonathan W Stewart; Andrew A Nierenberg; Michael E Thase; Louise Ritz; Melanie M Biggs; Diane Warden; James F Luther; Kathy Shores-Wilson; George Niederehe; Maurizio Fava Journal: N Engl J Med Date: 2006-03-23 Impact factor: 91.245
Authors: Felipe A Jain; Sergey V Chernyak; Lisa D Nickerson; Stefana Morgan; Rhiana Schafer; David Mischoulon; Richard Bernard-Negron; Maren Nyer; Cristina Cusin; Liliana Ramirez Gomez; Albert Yeung Journal: Psychother Psychosom Date: 2022-03-14 Impact factor: 25.617