Assessment of tinnitus-related impairments and disabilities using the German THI-12: Sensitivity and stability of the scale over time

Abstract

Abstract

Objective: To evaluate the reliability, dimensionality, predictive validity, construct validity, and sensitivity to change of the THI-12 total and sub-scales as diagnostic aids to describe and quantify tinnitus-evoked reactions and evaluate treatment efficacy. Design: Explorative analysis of the German tinnitus handicap inventory (THI-12) to assess potential sensitivity to tinnitus therapy in placebo-controlled randomized studies. Correlation analysis, including Cronbach's coefficient α and explorative common factor analysis (EFA), was conducted within and between assessments to demonstrate the construct validity, dimensionality, and factorial structure of the THI-12. Study sample: N = 618 patients suffering from subjective tinnitus who were to be screened to participate in a randomized, placebo-controlled, 16-week, longitudinal study. Results: The THI-12 can reliably diagnose tinnitus-related impairments and disabilities and assess changes over time. The test–retest coefficient for neighboured visits was r > 0.69, the internal consistency of the THI-12 total score was α ≤ 0.79 and α ≤ 0.89 at subsequent visits. Predictability of THI-12 total score and overall variance increased with successive measurements. The three-factorial structure allowed for evaluation of factors that affect aspects of patients’ health-related quality of life. Conclusions: The THI-12, with its three-factorial structure, is a simple, reliable, and valid instrument for the diagnosis and assessment of tinnitus and associated impairment over time.

Sumario

Objetivo: Evaluar la confiabilidad, dimensionalidad, validez predictiva, validez de la estructura y sensibilidad de cambio del total del THI-12 y las subescalas, como ayuda diagnóstica para describir y cuantificar las reacciones con acúfeno evocado y para evaluar la eficacia del tratamiento. Diseño: Análisis exploratorio del Cuestionario Alemán de Desventaja por Acúfeno (THI-12) para evaluar la sensibilidad potencial de la terapia del acúfeno en estudios al azar, controlados con placebo. Se realizó un análisis de correlación incluyendo el coeficiente a de Cronbach’s y un análisis exploratorio de factor común de análisis (EFA), en y entre evaluaciones, para demostrar la validez de la estructura, la dimensionalidad y la estructura factorial del THI-12. Muestra: N = 618 pacientes con acúfeno subjetivo fueron tamizados para participar en un estudio al azar, controlado por placebo, de 16 semanas y longitudinal. Resultados: El THI-12 puede confiablemente diagnosticar los impedimentos y discapacidades relacionados con el acúfeno y evaluar los cambios en el tiempo. El coeficiente test-retest para visitas cercanas fue de r > 0.69 y la consistencia interna de la puntuación total del THI-12 fue de a ≤ 0.79 y de a ≤ 0.89, en visitas subsecuentes. La previsibilidad de la puntuación total del THI-12 y la variancia global se incrementó con mediciones sucesivas. La estructura factorial triple permitió la evaluación de factores que afectan aspectos que relacionados con la salud y calidad de vida de los pacientes. Conclusiones: El THI-12, con su estructura factorial triple es un instrumento simple, confiable y válido para el diagnóstico y la evaluación del acúfeno y de la discapacidad que con él se asocia, a lo largo del tiempo.

Key Words::

• Tinnitus
• THI-12
• impairments

Acknowledgements

This study was supported by Merz Pharmaceuticals. Editorial support for the preparation of this manuscript was provided by Ogilvy Healthworld Medical Education, and funded by Merz Pharmaceuticals.

Declaration of interest: Roman Görtelmeyer and Alexander Gebauer are employees of Merz Pharmaceuticals. Hagen Krüger is a former employee of Merz Pharmaceuticals. Pawel Jastreboff, Jürgen Schmidt, Markus Suckfüll, and Werner Wittmann have received honorarium as consultants for Merz Pharmaceuticals.