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New Tinnitus Questionnaire Is a Sensitive Tool for Clinical Trials

Tyler, Richard S. PhD; Deshpande, Aniruddha K. PhD

doi: 10.1097/01.HJ.0000461186.28616.3a
Journal Club

Dr. Tyler is a professor of otolaryngology–head and neck surgery and of communication sciences and disorders at the University of Iowa. Dr. Deshpande is a research audiologist and postdoctoral fellow in the Department of Otolaryngology–Head & Neck Surgery at the University of Iowa.

The psychological model of tinnitus proposed by Dauman and Tyler distinguished tinnitus from the reaction to it.1 Several counseling and sound therapy approaches to these reactions have evolved from the pioneering work of Hallam's habituation model2 and from the cognitive behavioral strategies suggested by Sweetow3 and by Henry and Wilson.4 (For a review of these strategies, see reference 55.)

Our own protocol, Tinnitus Activities Treatment, includes cognitive behavioral modification principles, acceptance, and attention-control exercises.6-7

Development and Validation of the Tinnitus Primary Function Questionnaire

Tyler R, Ji H, Perreau A, Witt S, Noble W, Coelho C

Am J Audiol

2014;23(3):260-272 http://aja.pubs.asha.org/article.aspx?articleid=1871415

We developed a questionnaire that focuses on how tinnitus affects a person's life. Our recent publication documents the validity, reliability, and sensitivity of the new Tinnitus Primary Function Questionnaire.

The questionnaire evolved from our clinical experience with the four primary areas affected by tinnitus: hearing, concentration, thoughts and emotions, and sleep. These primary functions can affect secondary factors such as work, recreation, friendships, and other general quality-of-life issues.

We analyzed data from 158 patients who had received an early version of the Tinnitus Activities Treatment. A factor analysis confirmed the validity of the four main functions affected by tinnitus.

The Tinnitus Handicap Questionnaire,8 which is employed worldwide to evaluate treatments, was used as a metric of validity in our study, as were the Beck Depression Inventory (BDI),9 the State-Trait Anxiety Questionnaire,10 and the Pittsburgh Sleep Quality Index (PSQI).11

All four questionnaires were correlated with the four subscales of the Tinnitus Primary Function Questionnaire. Cronbach's α, which measures inter-item correlation, indicated high internal consistency for the new questionnaire.

Scores on the Tinnitus Primary Function Questionnaire responded to treatment, as shown in the bar graph.

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FOCUS ON PRIMARY FUNCTIONS

Two advantages of the Tinnitus Primary Function Questionnaire are its zero-to-100 measurement scale and focus on primary functions, excluding secondary functions such as quality of life.

Since a questionnaire should respond to treatment changes, it is important to use a measurement scale with ample resolution. Many questionnaires over the years have used interval scales from zero to100, like the Tinnitus Primary Function Questionnaire does. When responding, patients typically choose a score of 0, 5, 10, 15, etc., resulting in 21 steps. This provides greater resolution than a zero-to-10 scale.

General quality-of-life questions can be influenced by family, social, and work issues. Therefore, their inclusion is likely to decrease a tinnitus questionnaire's responsiveness. A treatment might be effective, but, because of other life issues involving work or family, the questionnaire becomes a less sensitive tool.

Another unique attribute of the Tinnitus Primary Function Questionnaire is that the responsiveness to treatments can be even further improved by removing subscales for which a patient has no problems. For example, if a patient has no trouble sleeping, then all sleep questions will be insensitive to the treatment.

Before a trial begins, researchers can choose a within-subject design and plan to eliminate subscales with low handicap scores. Such a-priori screening to select the functions that are most likely to show changes can further improve the questionnaire's sensitivity.12

Many tinnitus questionnaires have been successfully used to document tinnitus distress and measure the effectiveness of treatments. Newman, Wharton, and Jacobson recommended the Tinnitus Handicap Questionnaire for clinical trials.8,13 Future work is needed to compare the validity, reliability, and responsiveness of the Tinnitus Primary Function Questionnaire with other questionnaires such as the Tinnitus Handicap Questionnaire.

The 12-item version of the Tinnitus Primary Function Questionnaire, which also has been shown to be valid and reliable, can be administered quickly in the clinic, thus helping save precious time.

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REFERENCES

1. Dauman R, Tyler RS. Some considerations on the classification of tinnitus. In: Aran J-M, Dauman R, eds. Tinnitus 91. Proceedings of the Fourth International Tinnitus Seminar. Amsterdam, the Netherlands: Kugler Publications; 1992.
2. Hallam R. Tinnitus: Living with the Ringing in Your Ears. Wellingborough, England: Thorsons Publishing Group; 1989.
3. Sweetow R. Cognitive behavior modification. In: Tyler RS, ed.Tinnitus Handbook. San Diego, CA: Singular Publishing Group; 2000.
4. Henry JL, Wilson PH. The Psychological Management of Chronic Tinnitus: A Cognitive-Behavioral Approach. Boston, MA: Allyn & Bacon Publishers; 2001.
5. Tyler RS. Neurophysiological models, psychological models, and treatments for tinnitus. In Tyler RS, ed. Tinnitus Treatment: Clinical Protocols. New York, NY: Thieme; 2006:1-22.
6. Tyler RS, Gehringer AK, Noble W, Dunn CC, Witt SA, Bardia A. Tinnitus Activities Treatment. In Tyler RS, ed. Tinnitus Treatment: Clinical Protocols. New York, NY: Thieme; 2006.
7. Tyler RS, Gogel SA, Gehringer AK. Tinnitus Activities Treatment. Prog Brain Res 2007;166:425-434. http://www.sciencedirect.com/science/article/pii/S0079612307660415
8. Kuk FK, Tyler RS, Russell D, Jordan H. The psychometric properties of a Tinnitus Handicap Questionnaire. Ear Hear 1990;11(6):434-442. http://journals.lww.com/ear-hearing/Abstract/1990/12000/The_Psychometric_Properties_of_a_Tinnitus_Handicap.5.aspx
9. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry 1961;4(6):561-571. http://archpsyc.jamanetwork.com/article.aspx?articleid=487993
10. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.
11. Buysse DJ, Reynolds CF III, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Res 1989;28(2):193-213. http://www.psy-journal.com/article/0165-1781(89)90047-4/abstract
12. Tyler RS, Noble W, Coelho C. Considerations for the design of clinical trials for tinnitus. Acta Otolaryngol 2006;126[suppl 556]:44-49. http://informahealthcare.com/doi/abs/10.1080/03655230600895424
13. Newman CW, Wharton JA, Jacobson GP. Retest stability of the Tinnitus Handicap Questionnaire. Ann Otol Rhinol Laryngol 1995;104(9):718-723. http://aor.sagepub.com/content/104/9/718.abstract
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