TARGET JNL: Neuropsychiatric Disease and Treatment Clinically Significant Changes in the 17- and 6-Item Hamilton Rating Scales for Depression: A STARD Report

• Published in: Neuropsychiatric disease and treatment Vol. 17; pp. 2333 - 2345
• Main Authors: Rush, Augustus John, South, Charles, Jain, Shailesh, Agha, Raafae, Zhang, Mingxu, Shrestha, Shristi, Khan, Zershana, Hassan, Mudasar, Trivedi, Madhukar H
• Format: Journal Article
• Language: English
• Published: Dove Medical Press 01.07.2021
• Subjects: depression ratings; meaningful change; patient-reported outcomes
• ISSN: 1178-2021; 1178-2021
• DOI: 10.2147/NDT.S305331

Augustus John Rush, 1- 3 Charles South, 4 Shailesh Jain, 1 Raafae Agha, 1 Mingxu Zhang, 1 Shristi Shrestha, 1 Zershana Khan, 1 Mudasar Hassan, 1 Madhukar H Trivedi 5 1Department of Psychiatry, Texas Tech University Health Science Center, Midland, TX, USA; 2Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA; 3Professor Emeritus, Duke-National University of Singapore, Singapore; 4Department of Statistical Science, Southern Methodist University, Dallas, TX, USA; 5Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USACorrespondence: Madhukar H TrivediDepartment of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390-9119, USATel +1 214-648-0188Fax +1 214-648-0167Email madhukar.trivedi@utsouthwestern.eduObjective: 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 HRSD 17 and HRSD 6 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 HRSD 17 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 HRSD 6, 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 HRSD 17 and the HRSD 6, 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 HRSD 17 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 HRSD 17 is clinically meaningful; a 7- 12 point change is clinically substantial. For the HRSD 6, analogous estimates were 2- 3 and 4- 7 point changes, respectively.Keywords: depression ratings, patient-reported outcomes, meaningful change