A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients
Introduction
Having head and neck (H&N) cancer may be a shattering experience. These patients not only have to face a life-threatening disease, but also have to deal with the impact of the disease and its treatment on appearance and on important functions like eating, swallowing, breathing and communication [1]. Treatment strategies are aimed not only at increasing the chances of cure but also at maintaining health-related quality of life (HQOL), for example, preservation of speech [2]. Measuring HQOL in these patients is therefore of great importance.
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed a strategy for measuring HQOL in clinical trials [3]. A tumour-specific module, e.g. a breast cancer [4] or a lung cancer module [5], is used in conjunction with a general cancer questionnaire — the QLQ-C30 [6]. These modules are developed according to the guidelines of the EORTC Quality of Life Group [7].
An EORTC H&N cancer-specific module was developed according to these guidelines [8]. The current 35-item version (QLQ-H&N35) (see the Appendix) has been translated into 10 languages following the EORTC Quality of Life Study Group translation guidelines [9].
A preliminary reliability and validity study of the module which started in 1993 included 500 patients with newly diagnosed disease in four centres in Norway, Sweden and The Netherlands [10]. Following this study, a structure consisting of seven symptom scales (pain, swallowing, senses, speech, social eating, social contact and sexuality), six symptom items (problems with teeth, problems with opening mouth, dry mouth, sticky saliva, coughing and feeling ill) and five additional dichotomous items (related to the use of painkillers, nutritional supplements and feeding tube, and to weight decrease or weight increase) was proposed (see the Appendix).
The final EORTC field study of the module was initiated in 1995. The primary aim of this study was to test the postulated scale structure of the QLQ-H&N35 with regard to its reliability and validity in a large international sample of patients, including patients with newly diagnosed disease, recurrent disease and disease-free patients. The secondary aim of the study was to test the reliability and validity of version 3.0 of the QLQ-C30 (with a changed response format of the physical functioning scale) in this patient group.
The results from the preliminary validation study indicated that some of the scales (senses and speech) performed better in some patient subgroups than in others. A few items (trouble eating and painful throat) could be included in more than one scale, and other items (problems with teeth and the last five items) were candidates for removal. This paper explores these issues, with a special emphasis on the clinical validity of scales and single items. This is the definitive report about the psychometric properties of the QLQ-H&N35, and a copy of the module is shown in the Appendix.
Section snippets
Patients
Patients were eligible for the study if they had newly diagnosed or recurrent squamous cell carcinoma of the larynx, oral cavity, oro-, naso- or hypopharynx undergoing active treatment (group I) or were disease-free 1–3 years after treatment (group II).
Group I was subdivided into five subgroups: newly diagnosed patients with laryngeal cancer receiving radiotherapy as first treatment (IA), or with cancer of the oral cavity or pharynx receiving radiotherapy (IB) or surgery (IC) as first
Patient characteristics
A total of 622 eligible and evaluable patients was included in the study: 204 patients with newly diagnosed disease (groups IA, IB and IC), 58 patients with recurrent disease (groups ID and IE) and 360 disease-free patients (group II) (Table 1). This patient group from 12 countries comprising nine languages represented the full range of sites, stages and treatments of H&N cancer.
Compliance
The percentage of missing items in both questionnaires was generally low (<3%), with the exception of some items of
Discussion
The EORTC QLQ-H&N35 has been tested in two large series of patients. The first analysis was performed in a sample of 500 patients with newly diagnosed H&N cancer from four institutions in Norway, Sweden and The Netherlands [10]. The scale structure proposed in that first study has now been tested and validated in this larger and more diverse sample (including patients with recurrent disease and disease-free patients) from 12 countries. This makes the EORTC QLQ-H&N35 one of the most widely
Acknowledgements
The following investigators also recruited patients into this study: C. Baughan (General Hospital, Southamptom, UK), A. Cull (Western General Hospital, Edinburgh, UK), L. Feenstra (Universiteitsziekenhuis Saint Rafael, Leuven, Belgium), K. Gamble and A. Bartlet (Royal Marsden Hospital, London, UK) and K. Pekkola-Heino (University Central Hospital, Turku, Finland). We are grateful for their contribution.
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