Zotti P, Lugli D, Vaccher E, Vidotto G, Franchin G, Barzan L
Psychology Group, CRO-IRCSS, National Cancer Institute, Aviano (PN), Italy.
Qual Life Res. 2000;9(10):1147-53. doi: 10.1023/a:1016674507150.
The aim of this study was to test the validity and reliability of the European organization for research and treatment of cancer (EORTC) quality of life questionnaire (QLQ)-head and neck (H&N) 35 in Italian laryngeal cancer patients. The original questionnaire was developed by the EORTC quality of life (QoL) study group and tested in H&N cancer patients from Norway, Sweden, and the Netherlands. The Italian translation of the questionnaire used in this study was made by a team of the CRO, National Cancer Institute, using a double-back translation method between independent translators. The translated EORTC QLQ-H&N35 was given to 99 patients with H&N cancer who had undergone total laryngectomy 1-26 years before and had been then treated with radiotherapy and, in some cases, chemotherapy. The questionnaire was re-administrated to 33 patients after 1 month to test its stability over time. It was structurally made up of seven scales (pain, swallowing, sense, speech, social eating, social contact, and sexuality) and 11 single items that considered the most important clinical aspects characterizing the QoL in H&N cancer patients. The statistical analysis of the indexes of validity and reliability confirmed the results obtained with other linguistic versions of the questionnaire. Our Italian version of the EORTC QLQ-H&N35 proved to be a statistically valid instrument to assess QoL in laryngectomized patients.
本研究旨在测试欧洲癌症研究与治疗组织(EORTC)生活质量问卷(QLQ)-头颈癌(H&N)35在意大利喉癌患者中的有效性和可靠性。原始问卷由EORTC生活质量(QoL)研究小组编制,并在来自挪威、瑞典和荷兰的头颈癌患者中进行了测试。本研究中使用的问卷的意大利语翻译由国家癌症研究所CRO的一个团队采用独立翻译人员之间的双重回译方法完成。将翻译后的EORTC QLQ-H&N35发放给99名头颈癌患者,这些患者在1 - 26年前接受了全喉切除术,随后接受了放疗,部分患者还接受了化疗。1个月后,对33名患者再次发放问卷以测试其随时间的稳定性。该问卷在结构上由七个量表(疼痛、吞咽、感觉、言语、社交进食、社交接触和性功能)和11个单项组成,这些量表和单项考虑了头颈癌患者生活质量的最重要临床方面。有效性和可靠性指标的统计分析证实了该问卷其他语言版本所获得的结果。我们的意大利语版EORTC QLQ-H&N35被证明是评估喉切除患者生活质量的一个具有统计学有效性的工具。