Tinnitus Handicap Inventory for Evaluating Treatment Effects: Which Changes Are Clinically Relevant?
Open accessAbstract
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.
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The clinically important change in THI-score was determined at 7 points.
“The clinically important change in THI-score was determined at 7 points, Zeman et al. (2011).”
From Combining the unequal variance signal detection model with the health belief model to optimize shared decision making in tinnitus patients: part 2—patient profiling (2025) · cites this paper as Zeman et al., 2011
The planned sample size of 164 participants (82 per group) provides 80% power to detect a between-group THI difference of 15.79 with SDs 19.18 and 20.75 at a 5% type I error rate, after allowing for 20% dropout.
“To ensure an 80% statistical power with a type I error rate of 5%, we conducted a two-sample t-test for superiority.”
From SoundMind Trial: a study protocol for a randomised controlled trial for online acceptance and commitment therapy and sound therapy for tinnitus (2024) · cites this paper as [36]
The Abstract (p. 1) says the study offers an orientation for future sample-size calculations, and the Statistical Analysis section (p. 2) mentions Student t tests. Neither passage reports a planned sample of 164, the stated THI difference and standard deviations, or an 80% power calculation with a 20% dropout allowance. Searches for those figures and the power calculation found no supporting passage in our copy. (LLM, conf=0.77)
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Cites
Statistical Power Analysis for the Behavioral Sciences
Muller, K. E., & Cohen, J. (1989) · Technometrics · doi:10.2307/1270020 · Cited by 99,588 · see citing works
Statistical power analysis for the behavioral sciences
Cohen, J. (1990) · Computers Environment and Urban Systems · doi:10.1016/0198-9715(90)90050-4 · Cited by 65,406 · see citing works
Statistical Power Analysis for the Behavioral Sciences (2nd ed.).
Lachenbruch, P. A., & Cohen, J. (1989) · Journal of the American Statistical Association · doi:10.2307/2290095 · Cited by 37,385 · see citing works
(1976) · Medical Entomology and Zoology · Cited by 8,899 · see citing works
The proof and measurement of association between two things
Spearman, C. (1904) · The American Journal of Psychology · doi:10.2307/1412159 · Cited by 8,039 · see citing works
The proof and measurement of association between two things.
Spearman, C. (2015) · International Journal of Epidemiology · doi:10.1093/ije/dyq191 · Cited by 7,777 · see citing works
Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003) · Medical Care · doi:10.1097/01.mlr.0000062554.74615.4c · Cited by 4,700 · see citing works
Interpreting the significance of changes in health-related quality-of-life scores.
Osoba, D., Rodrigues, G., Myles, J., Zee, B. C.-Y., & Pater, J. L. (1998) · Journal of Clinical Oncology · doi:10.1200/jco.1998.16.1.139 · Cited by 2,971 · see citing works
Development of the Tinnitus Handicap Inventory.
Newman, C., Jacobson, G., & Spitzer, J. (1996) · Archives of Otolaryngology - Head and Neck Surgery · doi:10.1001/archotol.1996.01890140029007 · Cited by 2,140 · see citing works
Leucht, S., Kane, J., Kissling, W., Hamann, J., Etschel, E., & Engel, R. R. (2005) · Schizophrenia Research · doi:10.1016/j.schres.2005.04.008 · Cited by 1,230 · see citing works
Clinical Significance of Reported Changes in Pain Severity☆☆☆★
Todd, K. H., Funk, K. G., Funk, J. P., & Bonacci, R. P. (1996) · Annals of Emergency Medicine · doi:10.1016/s0196-0644(96)70238-x · Cited by 1,110 · see citing works
Clinical implications of Brief Psychiatric Rating Scale scores
Leucht, S., Kane, J. M., Kissling, W., Hamann, J., Etschel, E., & Engel, R. R. (2005) · The British Journal of Psychiatry · doi:10.1192/bjp.187.4.366 · Cited by 898 · see citing works
Test Equating, Scaling, and Linking: Methods and Practices
Kolen, M. J., & Brennan, R. L. (2004) · Springer eBooks · doi:10.1007/978-1-4757-4310-4 · Cited by 708 · see citing works
Psychometric adequacy of the Tinnitus Handicap Inventory (THI) for evaluating treatment outcome.
Newman, C. W., Sandridge, S. A., & Jacobson, G. P. (1998) · PubMed · Cited by 474 · see citing works
McCombe, A., Baguley, D., Coles, R. R. A., McKenna, L., Mckinney, C. D., & Windle‐Taylor, P. C. (2001) · Clinical Otolaryngology · doi:10.1046/j.1365-2273.2001.00490.x · Cited by 426 · see citing works
Tinnitus: Theory and Management
Arriaga, M. A. (2005) · Otology & Neurotology · doi:10.1097/00129492-200503000-00036 · Cited by 409 · see citing works
Langguth, B., Goodey, R., Azevedo, A., Björne, A., Cacace, A., Crocetti, A., del Bo, L., Ridder, D. D., Diges, I., Elbert, T., et al. (2007) · Progress in Brain Research · doi:10.1016/s0079-6123(07)66050-6 · Cited by 337 · see citing works
Self-citationLinking the PANSS, BPRS, and CGI: Clinical Implications
Leucht, S., Kane, J. M., Etschel, E., Kissling, W., Hamann, J., & Engel, R. R. (2006) · Neuropsychopharmacology · doi:10.1038/sj.npp.1301147 · Cited by 333 · see citing works
Factors influencing tinnitus loudness and annoyance
Hiller, W., & Goebel, G. (2006) · Archives of Otolaryngology–Head & Neck Surgery · doi:10.1001/archotol.132.12.1323 · Cited by 209 · see citing works
Health-related quality of life in childhood cancer: Discrepancy in parent-child reports
Levi, R. B., & Drotar, D. (1999) · International Journal of Cancer · doi:10.1002/(sici)1097-0215(1999)83:12+ · Cited by 200 · see citing works
Landgrebe, M., Zeman, F., Koller, M. T., Eberl, Y., Mohr, M., Reiter, J., Staudinger, S., Hajak, G., & Langguth, B. (2010) · BMC Medical Informatics and Decision Making · doi:10.1186/1472-6947-10-42 · Cited by 160 · see citing works
Self-citationAdjusting for baseline: Change or percentage change?
Kaiser, L. D. (1989) · Statistics in Medicine · doi:10.1002/sim.4780081002 · Cited by 126 · see citing works
Reliability and validity of a Danish adaptation of the Tinnitus Handicap Inventory
Zachariae, R. H., Mirz, F., Johansen, L. V., Andersen, S. E., Bjerring, P., & Pedersen, C. B. (2000) · Scandinavian Audiology · doi:10.1080/010503900424589 · Cited by 105 · see citing works
Monzani, D., Genovese, E., Marrara, A., Gherpelli, C., Pingani, L., Forghieri, M., Rigatelli, M., Guadagnin, T., & Arslan, E. (2008) · Europe PMC (PubMed Central) · Cited by 102 · see citing works
Adjusting for baseline: Chamge or percentage change
Matthews, J. N. S., Campbell, M. J., & Kaiser, L. D. (1992) · Statistics in Medicine · doi:10.1002/sim.4780111213 · Cited by 95 · see citing works
Clinically relevant effect sizes in depression
Montgomery, S. (1994) · European Neuropsychopharmacology · doi:10.1016/0924-977x(94)90093-0 · Cited by 67 · see citing works
Anders, M., Dvorakova, J., Rathova, L., Havránková, P., Pelcova, P., Vaněčková, M., Jech, R., Holcat, M., Seidl, Z., & Raboch, J. (2010) · PubMed · Cited by 63 · see citing works
Schmidt, L. P., Teixeira, V. N., Dall’Igna, C., et al. (2006) · Brazilian Journal of Otorhinolaryngology · doi:10.1016/s1808-8694(15)31048-x · Cited by 57 · see citing works
Schmidt, L. P., Teixeira, V. N., Dall’Igna, C., et al. (2006) · Revista Brasileira de Otorrinolaringologia · doi:10.1590/s0034-72992006000600012 · Cited by 41 · see citing works
Landgrebe, M., Binder, H., Koller, M. T., Eberl, Y., Kleinjung, T., Eichhammer, P., Graf, E., Hajak, G., & Langguth, B. (2008) · BMC Psychiatry · doi:10.1186/1471-244x-8-23 · Cited by 40 · see citing works
Self-citationEquating the Standard and Advanced Forms of the Raven Progressive Matrices
Jensen, A. R., Saccuzzo, D. P., & Larson, G. E. (1988) · Educational and Psychological Measurement · doi:10.1177/0013164488484026 · Cited by 32 · see citing works
Intranasal balloon catheters: How do they work?
McGarry, G. W., & AITKEN, D. (1991) · Clinical Otolaryngology · doi:10.1111/j.1365-2273.1991.tb00955.x · Cited by 22 · see citing works
Neri, G., Stefano, A. D., Baffa, C., et al. (2009) · PubMed · Cited by 21 · see citing works
Price, L. R., Lurie, A., & Wilkins, C. (2001) · Applied Psychological Measurement · doi:10.1177/01466210122032172 · Cited by 21 · see citing works
Effectiveness of a tinnitus management programme: a 2-year follow-up study
Gudex, C. M., Skellgaard, P. H., West, T., & Sørensen, J. R. (2009) · BMC Ear Nose and Throat Disorders · doi:10.1186/1472-6815-9-6 · Cited by 16 · see citing works
Flagged first, then by citations
Research works printed but not linked: 3
- [13]13. of life and psychological distress in tinnitus-sufferers. Acta Otorhinolaryngol Ital . 2008;28(3):126-134.
- [23]23. Price LR, Lurie A, Wilkins C. EQUIPERCENT: A SAS program for calculating equivalent scores using the equipercentile method. Appl Psychol Meas . 2001;25:332.
- [28]28. Osoba D. Interpreting the meaningfulness of changes in healthrelated quality of life scores: lessons form studies in adults. Int J Cancer Suppl . 1999;12:132-137.
Cited by
Sorted by citations
Cognitive behavioural therapy for tinnitus
Fuller, T., Cima, R., Langguth, B., Mazurek, B., Vlaeyen, J. W., & Hoare, D. J. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012614.pub2 · Cited by 212 · see citing works
Self-citationAdamchic, I., Tass, P., Langguth, B., Hauptmann, C., Koller, M., Schecklmann, M., Zeman, F., & Landgrebe, M. (2012) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-10-79 · Cited by 79 · see citing works
Self-citationRoland, L. T., Lenze, E. J., Hardin, F. M., Kallogjeri, D., Nicklaus, J., Wineland, A. M., Fendell, G., Peelle, J. E., & Piccirillo, J. F. (2015) · Otolaryngology–Head and Neck Surgery · doi:10.1177/0194599815571556 · Cited by 77 · see citing works
“At the 4-week follow-up assessment, 10 patients (77%) had achieved a clinically meaningful difference defined by 7 points or greater reduction in THI scores.(29) Friedman’s test revealed that there was an overall significant difference in the DTHI, x(2) (2 df) = 18.”
Aazh, H., Landgrebe, M., Danesh, A. A., & Moore, B. C. (2019) · Psychology Research and Behavior Management · doi:10.2147/prbm.s179138 · Cited by 75 · see citing works
Self-citationLangguth, B., & De Ridder, D. (2023) · Journal of Clinical Medicine · doi:10.3390/jcm12227117 · Cited by 44 · see citing works
“This recommended method has been used for the Tinnitus Handicap Inventory (THI) [28], the Tinnitus Questionnaire (TQ) [29,30], and the Tinnitus Functional index (TFI) [31,32,35], as well as for numeric scales of tinnitus loudness [6,36].”
InfluentialSelf-citationAbouzari, M., Goshtasbi, K., Sarna, B., Ghavami, Y., Parker, E. M., Khosravi, P., Mostaghni, N., Jamshidi, S., Saber, T., & Djalilian, H. R. (2021) · Annals of Otology, Rhinology & Laryngology · doi:10.1177/0003489420962818 · Cited by 22 · see citing works
Huang, X., Tang, D., Sun, S., & Li, H. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-080863 · Cited by 3 · see citing works
“36 Anticipating a mean difference of 15.79 between the treatment groups, and based on previous ACT studies on patients with tinnitus, 11 we established SD of 19.18 and 20.75 for the groups.”
InfluentialHoetink, A. E., Kaldenbach, S., Lieftink, A., Versnel, H., & Stokroos, R. J. (2024) · Frontiers in Neuroscience · doi:10.3389/fnins.2024.1451741 · Cited by 3 · see citing works
Lehóczky, Z. Z., Smit, A. L., Kaldenbach, S., Lieftink, A., Versnel, H., Stokroos, R. J., & Hoetink, A. E. (2025) · Frontiers in Neuroscience · doi:10.3389/fnins.2025.1466354
- Authors
- Zeman, F., Koller, M., Figueiredo, R., Aazevedo, A., Rates, M., Coelho, C., Kleinjung, T., de Ridder, D., Langguth, B., & Landgrebe, M.
- Affiliations
- University Hospital Regensburg (DE)
- Otosul, Otorrinolaringologia Sul‐Fluminense Volta Redonda Brazil
- Tinnitus Research Initiative Tinnitus Clinics Network
- Universidade de São Paulo (BR)
- University of Regensburg (DE)
- Corresponding author
- Zeman, Florian
- ORCID
- Venue
- Otolaryngology–Head and Neck Surgery
- Publisher
- Wiley
- Published
- 2011-04-04
- Volume
- 145
- Issue
- 2
- Pages
- 282-287
- ISSN
- 0161-6439 (ISSN-L)
- 0194-5998
- 1097-6817
- OpenAlex
- W2137905853
- Cited by
- 234
- References
- 35
- Citations by year
- 2026: 27 · 2025: 20 · 2024: 25 · 2023: 27 · 2022: 27 · 2021: 18 · 2020: 19 · 2019: 16 · 2018: 7 · 2017: 10 · 2016: 10 · 2015: 8 · 2014: 5 · 2013: 4 · 2012: 7
- FWCI
- 3.10
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- Otolaryngology (publishedVersion)
- PubMed (publishedVersion)
- University of Regensburg Publication Server (University of Regensburg) (acceptedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
- University of Regensburg Publication Server (University of Regensburg)
- Topics
- Life Sciences › Neuroscience › Sensory Systems › Hearing, Cochlea, Tinnitus, Genetics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Hearing Loss and Rehabilitation
- Health Sciences › Health Professions › Speech and Hearing › Noise Effects and Management
- Keywords
- Tinnitus Handicap Inventory, tinnitus, CGI-I, treatment effect evaluation, effect size, sample size determination, patient-reported outcomes
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Diagnostic Techniques, Otological, Disability Evaluation, Female, Humans, Male, Middle Aged, Otolaryngology, Prospective Studies, Quality of Life, Surveys and Questionnaires, Severity of Illness Index, Tinnitus, Treatment Outcome, Disease Progression, Young Adult
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