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Comparative Study
. 2012 Jul 10:10:79.
doi: 10.1186/1477-7525-10-79.

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

Ilya Adamchic  1 , Peter Alexander Tass, Berthold Langguth, Christian Hauptmann, Michael Koller, Martin Schecklmann, Florian Zeman, Michael Landgrebe
Affiliations
Comparative Study

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

Ilya Adamchic et al. Health Qual Life Outcomes. .

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.

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Figures

Figure 1
Figure 1
Boxplots of Tinnitus Questionnaire score changes from baseline categorized by the Clinical Global Impression. Median value, 1st and 3d quartile and the non-outlier range are shown.
Figure 2
Figure 2
Receiver Operating Characteristic curve. Plot represents comparison of two operating characteristics, i.e., False-Positive Rate and True-Positive Rate as the criterion of TQ change.
Figure 3
Figure 3
Summary of distribution- and anchor-based estimates of MCID.
See this image and copyright information in PMC

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