Sources of site differences in the efficacy of a multisite clinical trial: the Treatment of SSRI-Resistant Depression in Adolescents.
Site differences in treatment outcomes are not often highlighted when the results of multisite randomized clinical trials (MRCTs) are reported. The primary analyses of a 6-site MRCT, the Treatment of SSRI-Resistant Depression in Adolescents (TORDIA) study, showed substantial variation by site in the performance of a medication-only condition and a combined medication plus cognitive-behavioral therapy (CBT) condition. Two potential primary causes of site differences in MRCT outcomes were examined in this article: sampling factors, particularly clinical characteristics of participants, and treatment protocol factors, particularly fidelity. The authors found that differences in the clinical characteristics of participants at baseline across site and within site/across conditions were the most salient explanations for site differences and differences within sites across conditions in outcome. Study findings are discussed with respect to the overall study outcomes in TORDIA as well as MRCTs in general.
Spirito
Anthony
A
Clinical Psychology Training Consortium, Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, USA. Anthony_Spirito@brown.edu
Abebe
Kaleab Z
KZ
Iyengar
Satish
S
Brent
David
D
Vitiello
Benedetto
B
Clarke
Gregory
G
Wagner
Karen Dineen
KD
Asarnow
Joan
J
Emslie
Graham
G
Keller
Martin
M
D000293:Adolescent; D015982:Bias; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003866:Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D004351:Drug Resistance; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data*; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States
D017367:Selective Serotonin Reuptake Inhibitors