Adamchic, Ilya and Tass, Peter Alexander and Langguth, Berthold and Hauptmann, Christian and Koller, Michael and Schecklmann, Martin and Zeman, Florian and Landgrebe, Michael (2012) Linking the Tinnitus Questionnaire and the subjective Clinical Global Impression: Which differences are clinically important? HEALTH AND QUALITY OF LIFE OUTCOMES, 10: 79. ISSN 1477-7525,
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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. Delta TQ 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | QUALITY-OF-LIFE; TRANSCRANIAL MAGNETIC STIMULATION; MINIMALLY IMPORTANT DIFFERENCES; PATIENT-REPORTED OUTCOMES; MEANINGFUL CHANGE; HEALTH-STATUS; PSYCHOMETRIC PROPERTIES; BACK-PAIN; THERAPY; RESPONSIVENESS; Tinnitus; Tinnitus questionnaire; Minimal clinically important difference; Clinical significance; Receiver operating characteristic |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 11 May 2020 05:56 |
| Last Modified: | 11 May 2020 05:56 |
| URI: | https://pred.uni-regensburg.de/id/eprint/18451 |
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