Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen J F, Biörklund A, de Leeuw J R, Fayers P M, Jannert M, Westin T, Kaasa S
Department of Radiotherapy and Oncology, The Norwegian Radium Hospital, Oslo.
J Clin Oncol. 1999 Mar;17(3):1008-19. doi: 10.1200/JCO.1999.17.3.1008.
The aim of this study was to define the scales and test the validity, reliability, and sensitivity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N35, a questionnaire designed to assess the quality of life of head and neck (H&N) cancer patients in conjunction with the general cancer-specific EORTC QLQ-C30.
Questionnaires were given to 500 H&N cancer patients from Norway, Sweden, and the Netherlands as part of two prospective studies. The patients completed the questionnaires before, during (Norway and Sweden only), and after treatment, yielding a total of 2070 completed questionnaires.
The compliance rate was high, and the questionnaires were well accepted by the patients. Seven scales were constructed (pain, swallowing, senses, speech, social eating, social contact, sexuality). Scales and single items were sensitive to differences between patient subgroups with relation to site, stage, or performance status. Most scales and single items were sensitive to changes, with differences of various magnitudes according to the site in question. The internal consistency, as assessed by Cronbach's alpha coefficient, varied according to assessment point and within subsamples of patients. A low overall alpha value was found for the speech and the senses scales, but values were higher in assessments of patients with laryngeal cancer and in patients with nose, sinus, and salivary gland tumors. Scales and single items in the QLQ-H&N35 seem to be more sensitive to differences between groups and changes over time than do the scales and single items in the core questionnaire.
The QLQ-H&N35, in conjunction with the QLQ-C30, provides a valuable tool for the assessment of health-related quality of life in clinical studies of H&N cancer patients before, during, and after treatment with radiotherapy, surgery, or chemotherapy.
本研究旨在确定欧洲癌症研究与治疗组织生活质量问卷(EORTC QLQ)-H&N35的量表,并测试其有效性、可靠性和敏感性。该问卷旨在与通用的癌症特异性EORTC QLQ-C30一起评估头颈(H&N)癌患者的生活质量。
作为两项前瞻性研究的一部分,向来自挪威、瑞典和荷兰的500名头颈癌患者发放问卷。患者在治疗前、治疗期间(仅挪威和瑞典)和治疗后完成问卷,共获得2070份完整问卷。
依从率很高,问卷被患者广泛接受。构建了七个量表(疼痛、吞咽、感官、言语、社交进食、社交接触、性功能)。量表和单项对不同亚组患者在部位、分期或体能状态方面的差异敏感。大多数量表和单项对变化敏感,根据所涉部位不同,差异程度各异。通过克朗巴哈α系数评估的内部一致性根据评估时间点和患者亚样本而有所不同。言语和感官量表的总体α值较低,但在喉癌患者以及鼻、鼻窦和唾液腺肿瘤患者的评估中,该值较高。QLQ-H&N35中的量表和单项似乎比核心问卷中的量表和单项对组间差异和随时间变化更敏感。
QLQ-H&N35与QLQ-C30一起,为在放疗、手术或化疗治疗前、治疗期间和治疗后对头颈癌患者进行临床研究时评估与健康相关的生活质量提供了一个有价值的工具。