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01.12.2012 | Research | Ausgabe 1/2012 Open Access

Health and Quality of Life Outcomes 1/2012

Linking the Tinnitus Questionnaire and the subjective Clinical Global Impression: Which differences are clinically important?

Zeitschrift:
Health and Quality of Life Outcomes > Ausgabe 1/2012
Autoren:
Ilya Adamchic, Peter Alexander Tass, Berthold Langguth, Christian Hauptmann, Michael Koller, Martin Schecklmann, Florian Zeman, Michael Landgrebe
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1477-7525-10-79) contains supplementary material, which is available to authorized users.

Competing interests

C. Hauptmann and P. A. Tass have a contractual relationship with ANM Adaptive Neuromodulation GmbH. I. Adamchic, B. Langguth, M. Koller, M. Schecklmann, F. Zeman, M. Landgrebe declare that they have no competing interests.

Abstract

Background

Development of new tinnitus treatments requires prospective placebo-controlled randomized trials to prove their efficacy. The Tinnitus Questionnaire (TQ) is a validated and commonly used instrument for assessment of tinnitus severity and has been used in many clinical studies. Defining the Minimal Clinically Important Difference (MCID) for TQ changes is an important step to a better interpretation of the clinical relevance of changes observed in clinical trials. In this study we aimed to estimate the minimum change of the TQ score that could be considered clinically relevant.

Methods

757 patients with chronic tinnitus were pooled from the TRI database and the RESET study. An anchor-based approach using the Clinical Global Impression (CGI) scale and distributional approaches were used to estimate MCID. Receiver Operating Characteristic (ROC) curves were calculated to define optimal TQ change cutoffs discriminating between minimally changed and unchanged subjects.

Results

The relationship between TQ change scores and CGI ratings of change was good (r = 0.52, p < 0.05). Mean change scores associated with minimally better and minimally worse CGI categories were −6.65 and +2.72 respectively. According to the ROC method MCID for improvement was −5 points and for deterioration +1 points.

Conclusion

Distribution and anchor-based methods yielded comparable results in identifying MCIDs. ΔTQ scores of −5 and +1 points were identified as the minimal clinically relevant change for improvement and worsening respectively. The asymmetry of the MCIDs for improvement and worsening may be related to expectation effects.
Zusatzmaterial
Authors’ original file for figure 1
12955_2012_986_MOESM1_ESM.jpeg
Authors’ original file for figure 2
12955_2012_986_MOESM2_ESM.pdf
Authors’ original file for figure 3
12955_2012_986_MOESM3_ESM.pdf
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