TY - JOUR
T1 - Alternative metrics for characterizing longer-term clinical outcomes in difficult-to-treat depression
T2 - II. Sensitivity to treatment effects
AU - Aaronson, Scott T.
AU - Sackeim, Harold A.
AU - Jiang, Mei
AU - Badejo, Sarah
AU - Greco, Teresa
AU - Bunker, Mark T.
AU - Conway, Charles R.
AU - Demyttenaere, Koen
AU - Young, Allan H.
AU - McAllister-Williams, R. Hamish
AU - Rush, A. John
N1 - Publisher Copyright:
© The Author(s) 2023.
PY - 2024/3
Y1 - 2024/3
N2 - Objective: Characteristics of difficult-to-treat depression (DTD), including infrequent symptom remission and poor durability of benefit, compel reconsideration of the outcome metrics historically used to gauge the effectiveness of antidepressant interventions. Methods: Self-report and clinician assessments of depression symptom severity were obtained regularly over a 2-year period in a difficult-to-treat depression registry sample receiving treatment as usual (TAU), with or without vagus nerve stimulation (VNS). Alternative outcome metrics for characterizing symptom change were compared in effect size and discriminating power in distinguishing the vagus nerve stimulation + treatment as usual and treatment as usual treatment groups. We expected metrics based on remission status to produce weaker between-group separation than those based on the classifications of partial response or response and metrics that integrate information over time to produce greater separation than those based on single endpoint assessment. Results: Metrics based on remission status had smaller effect size and poorer discrimination in separating the treatment groups than metrics based on partial response or response classifications. Metrics that integrated information over the 2-year observation period had stronger performance characteristics than those based on symptom scores at single endpoint assessment. For both the clinician-rated and self-report depression ratings, the metrics with the strongest performance characteristics were the median percentage change in symptom scores over the observation period and the proportion of the observation period in partial response or better. Conclusion: In difficult-to-treat depression, integrative symptom severity-based and time-based measures are sensitive and informative outcomes for assessing between-group treatment effects, while metrics based on remission status are not.
AB - Objective: Characteristics of difficult-to-treat depression (DTD), including infrequent symptom remission and poor durability of benefit, compel reconsideration of the outcome metrics historically used to gauge the effectiveness of antidepressant interventions. Methods: Self-report and clinician assessments of depression symptom severity were obtained regularly over a 2-year period in a difficult-to-treat depression registry sample receiving treatment as usual (TAU), with or without vagus nerve stimulation (VNS). Alternative outcome metrics for characterizing symptom change were compared in effect size and discriminating power in distinguishing the vagus nerve stimulation + treatment as usual and treatment as usual treatment groups. We expected metrics based on remission status to produce weaker between-group separation than those based on the classifications of partial response or response and metrics that integrate information over time to produce greater separation than those based on single endpoint assessment. Results: Metrics based on remission status had smaller effect size and poorer discrimination in separating the treatment groups than metrics based on partial response or response classifications. Metrics that integrated information over the 2-year observation period had stronger performance characteristics than those based on symptom scores at single endpoint assessment. For both the clinician-rated and self-report depression ratings, the metrics with the strongest performance characteristics were the median percentage change in symptom scores over the observation period and the proportion of the observation period in partial response or better. Conclusion: In difficult-to-treat depression, integrative symptom severity-based and time-based measures are sensitive and informative outcomes for assessing between-group treatment effects, while metrics based on remission status are not.
KW - Difficult-to-treat depression
KW - outcome metrics
KW - registry
KW - vagus nerve stimulation
UR - http://www.scopus.com/inward/record.url?scp=85176143413&partnerID=8YFLogxK
U2 - 10.1177/00048674231209837
DO - 10.1177/00048674231209837
M3 - Article
C2 - 37927051
AN - SCOPUS:85176143413
SN - 0004-8674
VL - 58
SP - 250
EP - 259
JO - Australian and New Zealand Journal of Psychiatry
JF - Australian and New Zealand Journal of Psychiatry
IS - 3
ER -