• Health Qual Life Out · Jan 2013

    Randomized Controlled Trial Comparative Study

    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).

    • Quang A Le, Jason N Doctor, Lori A Zoellner, and Norah C Feeny.
    • Department of Pharmacy Administration and Practice, Western University of Health Sciences, Pomona, CA 91766-1854, USA. qle@westernu.edu
    • Health Qual Life Out. 2013 Jan 1; 11: 59.

    ObjectiveTo 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.Research Design And MethodsTwo 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.ResultsThe 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.ConclusionsThe 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.Clinical Trial RegistrationClinicaltrials.gov; Identifier: NCT00127673.

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