Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from
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RESEARCH
Open Access
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 Le1*, Jason N Doctor2, Lori A Zoellner3 and Norah C Feeny4
Abstract Objective: 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. Research design and methods: 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. Results: 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. Conclusions: 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. Clinical trial registration: Clinicaltrials.gov; Identifier: NCT00127673. Keywords: EQ-5D, QWB-SA, Minimal clinically important difference, PTSD, Doubly randomized preference trial, Prolonged exposure therapy, Sertraline
* Correspondence: [email protected] 1 Department of Pharmacy Administration and Practice, Western University of Health Sciences, 309 E. Second Street, Pomona, CA 91766-1854, USA Full list of author information is available at the end of the article © 2013 Le et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Le et al. Health and Quality of Life Outcomes 2013, 11:59 http://www.hqlo.c
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