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  • Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT).

Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT).

Health and quality of life outcomes (2013-04-17)
Quang A Le, Jason N Doctor, Lori A Zoellner, Norah C Feeny
ABSTRACT

To determine the minimal clinically important difference (MCID) for the health-utility measures EuroQol-5 dimensions (EQ-5D) and Quality of Well Being Self-Administered (QWB-SA) Scale in PTSD patients. Two hundred patients aged 18 to 65 years with PTSD enrolled in a doubly randomized preference trial (DRPT) examining the treatment and treatment-preference effects between cognitive behavioral therapy and pharmacotherapy with sertraline and completed the EQ-5D and QWB-SA at baseline and 10-week post-treatment. The anchor-based methods utilized a Clinical Global Impression-Improvement (CGI-I) and Clinical Global Impression-Severity. We regressed the changes in EQ-5D and QWB-SA scores on changes in the anchors using ordinary least squares regression. The slopes (beta coefficients) were the rates of change in the anchors as functions of change in EQ-5D and QWB, which represent our estimates of MCID. In addition, we performed receiver operating characteristic (ROC) curve analysis to examine the relationship between the changes in EQ-5D and QWB-SA scores and treatment-response status. The MCIDs were estimated from the ROC curve where they best discriminate between treatment responders and non-responders. The distribution-based methods used small to moderate effect size in terms of 0.2 and 0.5 of standard deviation of the pre-treatment EQ-5D and QWB-SA scores. The anchor-based methods estimated the MCID ranges of 0.05 to 0.08 for the EQ-5D and 0.03 to 0.05 for the QWB. The MCID ranges were higher with the distribution-based methods, ranging from 0.04 to 0.10 for the EQ-5D and 0.02 to 0.05 for the QWB-SA. The established MCID ranges of EQ-5D and QWB-SA can be a useful tool in assessing meaningful changes in patient's quality of life for researchers and clinicians, and assisting health-policy makers to make informing decision in mental health treatment. Clinicaltrials.gov; Identifier: NCT00127673.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Sertraline hydrochloride, ≥98% (HPLC)
Sertraline for peak identification, European Pharmacopoeia (EP) Reference Standard
Sertraline hydrochloride, European Pharmacopoeia (EP) Reference Standard
Sertraline for system suitability, European Pharmacopoeia (EP) Reference Standard
Supelco
Sertraline hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material, Cerilliant®