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Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant?
Otolaryngol Head Neck Surg. 2011 Aug; 145(2):282-7.OH

Abstract

OBJECTIVE

To determine the minimum change of the Tinnitus Handicap Inventory (THI) score that could be considered clinically relevant, the authors compared the absolute change of the THI with the Clinical Global Impression–Improvement (CGI-I) score.

STUDY DESIGN

International studies register with standardized data collection.

SETTING

Tinnitus Research Initiative (TRI).

SUBJECTS AND METHODS

Two hundred ten patients of the TRI database were eligible for this study. In the first analysis, the THI score change and CGI-I ratings were compared with equipercentile linking. In a second analysis, the authors categorized the CGI-I into the 4 groups much better or better, minimally better, no change, and worse and calculated the corresponding differences of the THI score and the effect sizes. An effect size separating the minimally better and the no-change groups was chosen, and the referring THI mean score difference was calculated.

RESULTS

According to the linking method, a CGI-I value of 3 (minimally better) corresponded to a THI score reduction of 6 to 16, whereas the CGI-I value of 4 (no change) corresponded to the range between improvement by 5 points and worsening by 4 points. For separating the no-change and minimally better groups, an effect size d = 0.5 was determined, resulting in a minimal clinically relevant difference of ΔTHI = 7.

CONCLUSION

Two different methods yielded comparable results in identifying a reduction in the THI score of 6 and 7 points, respectively, as the minimal clinically relevant change. This study provides a first orientation for sample size calculations and for planning the design of future studies.

Links

Publisher Full Text

Authors+Show Affiliations

Zeman F
Center for Clinical Studies, University Hospital Regensburg, Germany. florian.zeman@klinik.uni-regensburg.de
Koller M
No affiliation info available
Figueiredo R
No affiliation info available
Aazevedo A
No affiliation info available
Rates M
No affiliation info available
Coelho C
No affiliation info available
Kleinjung T
No affiliation info available
de Ridder D
No affiliation info available
Langguth B
No affiliation info available
Landgrebe M
No affiliation info available

MeSH

AdolescentAdultAgedAged, 80 and overDiagnostic Techniques, OtologicalDisability EvaluationDisease ProgressionFemaleHumansMaleMiddle AgedOtolaryngologyProspective StudiesQuality of LifeSeverity of Illness IndexSurveys and QuestionnairesTinnitusTreatment OutcomeYoung Adult

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21493265

Clinical Trial Links

Cochlear Promontory Stimulation for Treatment of Tinnitus

Citation

Zeman, Florian, et al. "Tinnitus Handicap Inventory for Evaluating Treatment Effects: Which Changes Are Clinically Relevant?" Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, vol. 145, no. 2, 2011, pp. 282-7.
Zeman F, Koller M, Figueiredo R, et al. Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? Otolaryngol Head Neck Surg. 2011;145(2):282-7.
Zeman, F., Koller, M., Figueiredo, R., Aazevedo, A., Rates, M., Coelho, C., Kleinjung, T., de Ridder, D., Langguth, B., & Landgrebe, M. (2011). Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, 145(2), 282-7. https://doi.org/10.1177/0194599811403882
Zeman F, et al. Tinnitus Handicap Inventory for Evaluating Treatment Effects: Which Changes Are Clinically Relevant. Otolaryngol Head Neck Surg. 2011;145(2):282-7. PubMed PMID: 21493265.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? AU - Zeman,Florian, AU - Koller,Michael, AU - Figueiredo,Ricardo, AU - Aazevedo,Andreia, AU - Rates,Marcello, AU - Coelho,Claudia, AU - Kleinjung,Tobias, AU - de Ridder,Dirk, AU - Langguth,Berthold, AU - Landgrebe,Michael, PY - 2011/4/16/entrez PY - 2011/4/16/pubmed PY - 2011/12/13/medline SP - 282 EP - 7 JF - Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery JO - Otolaryngol Head Neck Surg VL - 145 IS - 2 N2 - OBJECTIVE: To determine the minimum change of the Tinnitus Handicap Inventory (THI) score that could be considered clinically relevant, the authors compared the absolute change of the THI with the Clinical Global Impression–Improvement (CGI-I) score. STUDY DESIGN: International studies register with standardized data collection. SETTING: Tinnitus Research Initiative (TRI). SUBJECTS AND METHODS: Two hundred ten patients of the TRI database were eligible for this study. In the first analysis, the THI score change and CGI-I ratings were compared with equipercentile linking. In a second analysis, the authors categorized the CGI-I into the 4 groups much better or better, minimally better, no change, and worse and calculated the corresponding differences of the THI score and the effect sizes. An effect size separating the minimally better and the no-change groups was chosen, and the referring THI mean score difference was calculated. RESULTS: According to the linking method, a CGI-I value of 3 (minimally better) corresponded to a THI score reduction of 6 to 16, whereas the CGI-I value of 4 (no change) corresponded to the range between improvement by 5 points and worsening by 4 points. For separating the no-change and minimally better groups, an effect size d = 0.5 was determined, resulting in a minimal clinically relevant difference of ΔTHI = 7. CONCLUSION: Two different methods yielded comparable results in identifying a reduction in the THI score of 6 and 7 points, respectively, as the minimal clinically relevant change. This study provides a first orientation for sample size calculations and for planning the design of future studies. SN - 1097-6817 UR - https://www.unboundmedicine.com/medline/citation/21493265/Tinnitus_handicap_inventory_for_evaluating_treatment_effects:_which_changes_are_clinically_relevant L2 - https://journals.sagepub.com/doi/10.1177/0194599811403882?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -