Objective: To identify all disease-specific health-related quality-of-life (HR-QoL) instruments used to assess tinnitus in clinical trials and detail their psychometric properties.
Data sources: A literature search was performed in the bibliographical databases of PubMed and Embase to identify all articles using specific HR-QoL instruments in tinnitus trials.
Review methods: The HR-QoL instruments used in these articles were investigated in more detail, focusing on characteristics and psychometric values by two independent reviewers.
Results: Seventeen studies were identified by the systematic search. The most used HR-QoL questionnaire was the Tinnitus Questionnaire, followed by the Tinnitus Handicap Inventory, the Tinnitus Reaction Questionnaire, and the Tinnitus Handicap Questionnaire. Internal consistency (Cronbach's alpha > 0.9) and reproducibility (> 0.8) were high for all questionnaires, and there was heterogeneity in responses between patients, endorsing the use of these questionnaires for discriminative purposes. However, the responsiveness, i.e., the usefulness of these questionnaires in evaluating treatment effects, is not known yet.
Conclusion: The HR-QoL instruments used in tinnitus trials appear not to be validated to measure effectiveness of interventions. Using tests or instruments that are valid and reliable is a crucial component of research quality, and both should therefore be studied before final conclusions can be drawn from the questionnaires in upcoming clinical trials.
Copyright (c) 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.