Kamalski Digna M, Hoekstra Carlijn E, van Zanten Bert G, Grolman Wilko, Rovers Maroeska M
Department of Otolaryngology, University Medical Center Utrecht, Utrecht, The Netherlands.
Otolaryngol Head Neck Surg. 2010 Aug;143(2):181-5. doi: 10.1016/j.otohns.2010.03.026.
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.
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.
The HR-QoL instruments used in these articles were investigated in more detail, focusing on characteristics and psychometric values by two independent reviewers.
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.
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.
识别在临床试验中用于评估耳鸣的所有特定疾病的健康相关生活质量(HR-QoL)工具,并详细说明其心理测量特性。
在PubMed和Embase的书目数据库中进行文献检索,以识别耳鸣试验中使用特定HR-QoL工具的所有文章。
由两名独立审阅者更详细地研究这些文章中使用的HR-QoL工具,重点关注其特征和心理测量值。
通过系统检索确定了17项研究。使用最多的HR-QoL问卷是耳鸣问卷,其次是耳鸣障碍量表、耳鸣反应问卷和耳鸣障碍问卷。所有问卷的内部一致性(Cronbach's alpha>0.9)和可重复性(>0.8)都很高,患者之间的回答存在异质性,支持将这些问卷用于鉴别目的。然而,这些问卷在评估治疗效果方面的反应性,即有用性,尚不清楚。
耳鸣试验中使用的HR-QoL工具似乎未经验证以测量干预措施的有效性。使用有效且可靠的测试或工具是研究质量的关键组成部分,因此在即将到来的临床试验中从问卷得出最终结论之前,两者都应进行研究。