New HRSD thresholds reflect patient experience

In the 17-item Hamilton Rating Scale for Depression (HRSD), a change in score of 4–6 points can be considered as clinically meaningful, while a change of 7–12 points is clinically substantial, a recent Singapore study suggests. For the 6-item version of the HRSD, corresponding estimates were 2–3 and 4–7 points of score change, respectively.

“Both researchers and a growing number of clinicians who are using measurement-based care employ standardized symptom rating scales to determine whether treatments for depression and other conditions are working effectively,” the researchers said. “The degree of symptom improvement that is meaningful to patients remains unclear.”

“This report helps stakeholders (clinicians, researchers, administrators, regulators, and family members) understand the clinical relevance and meaning of various degrees of depressive symptom improvement on two widely used depression symptom rating scales,” they added.

The present post hoc study included data from the STAR*D trial, enrolling all adult outpatients with nonpsychotic major depressive disorder and who had finished the first-step treatment of ≤14 weeks of citalopram. Clinically meaningful and substantial thresholds for the 17-item and 6-item HRSD inventories were defined using three patient-reported scales: the Work and Social Adjustment Scale (WSAS), Quality of Life Enjoyment and Satisfaction-Short Form (Q-LES-Q-SF), and mini-Q-LES-Q.

For the 17-item version of HRSD, multiple linear regression showed that a 3.92-point change in score could be considered clinically meaningful when using the WSAS as an anchor, while a 7.83-point change was clinically substantial. [Neuropsychiatr Dis Treat 2021;17:2333-2345]

When using Q-LES-Q-SF as the anchor, the score change values of 5.81 and 11.62 were considered as clinically meaningful and substantial, respectively. Analogous estimates for mini-Q-LES-Q were 4.93 and 9.87.

For the 6-item HRSD, multiple linear regression indicated that score change estimates of 2.23 and 4.45 were clinically meaningful and substantial, respectively, when assessed according the WSAS.

When using Q-LES-Q-SF as the anchor, score changes of 3.21 and 6.43 were found to be meaningful and substantial, respectively. Relative to the mini-Q-LES-Q, corresponding estimates were 2.78 and 5.56.

Several study limitations are worth noting, chief of which is that the thresholds were chosen based on the nature of the scales the researchers’ experience in using them, “which raises questions as to their validity in representing the patient voice alone,” they said. The way meaningful and substantial were defined also had some degree of arbitrariness.

Moreover, the results have limited generalizability and may only be applicable to adult outpatients with major depressive disorder.

“The present results may not be precisely applicable to depressed patient participants who enter regulatory registration trials,” the researchers said.

“This report used a secondary data analysis of a large representative sample of depressed outpatients treated in primary care and psychiatric outpatient settings,” they said. “Based on a patient self-report of work and social adjustment and on two measures of quality of life, analyses estimated the degree of improvement in each of two commonly used Hamilton Rating Scales for Depression.”