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 (Impact Factor: 2.12). 04/2013; 11(1):59. DOI: 10.1186/1477-7525-11-59
Source: PubMed


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.
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.
Clinical trial registration; Identifier: NCT00127673.

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Available from: Norah Feeny, Dec 17, 2013
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    • "Research may also take the patient perspective into account with use of shared decision-making methods. Both pilot studies36 and randomized clinical trials using such treatment models and patient preference designs37 have been performed in Europe with promising results.38 Clinical research also encompasses the introduction of methodology to assess patient stratification in order to account for and target specific subgroups based on etiology and/or treatment sensitivity, such as in the application of risk profiles. "
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    ABSTRACT: Background The size and increasing burden of disease due to mental disorders in Europe poses substantial challenges to its population and to the health policy of the European Union. This warrants a specific research agenda concerning clinical mental health research as one of the cornerstones of sustainable mental health research and health policy in Europe. The aim of this research was to identify the top priorities needed to address the main challenges in clinical research for mental disorders. Methods The research was conducted as an expert survey and expert panel discussion during a scientific workshop. Results Eighty-nine experts in clinical research and representing most European countries participated in this survey. Identified top priorities were the need for new intervention studies, understanding the diagnostic and therapeutic implications of mechanisms of disease, and research in the field of somatic-psychiatric comorbidity. The “subjectivity gap” between basic neuroscience research and clinical reality for patients with mental disorders is considered the main challenge in psychiatric research, suggesting that a shift in research paradigms is required. Conclusion Innovations in clinical mental health research should bridge the gap between mechanisms underlying novel therapeutic interventions and the patient experience of mental disorder and, if present, somatic comorbidity. Clinical mental health research is relatively underfunded and should receive specific attention in Horizon 2020 funding programs.
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    • "Le and colleagues found MCID estimates ranging between 0.05 and 0.08 when using anchor-based approaches and 0.04-0.10 using distribution-based approaches in a cohort of patients suffering from post-traumatic stress disorder [18]. Yet, another study conducted by Pickard and colleagues using a similar methodology to our own suggested MCID estimates for US-based EQ-5D scores ranged from 0.07-0.09 in patients with cancer, and between 0.04 and 0.07 across various types of cancer [19]. "
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