Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer

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Abstract

Quality of life (QOL) assessment requires clinically relevant questionnaires that yield accurate data. This study defined measurement properties and the clinical validity of the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess QOL in oesophageal cancer. The oesophageal module the QLQ-OES24 and core questionnaire, the Quality of Life-Core 30 questionnaire (QLQ-C30) was administered patients undergoing treatment with curative (n=267) or palliative intent (n=224) and second assessments performed 3 months or 3 weeks later respectively. Psychometric tests examined scales and measurement properties of the module. Questionnaires were well accepted, compliance rates were high and less than 2% of items had missing data. Multi-trait scaling analyses and face validity refined the module to four scales and six single items (QLQ-OES18). Selective scales distinguished between clinically distinct groups of patients and demonstrated treatment-induced changes over time. The EORTC QLQ-OES18 demonstrates good psychometric and clinical validity. It is recommended for use with the core questionnaire, the QLQ-C30, to assess QOL in patients with oesophageal cancer.

Introduction

Potentially curative resection of the oesophagus for oesophageal cancer is associated with significant morbidity and hospital mortality rates of approximately 5%. Long-term survival may be achieved after curative resection. However, most patients present with advanced disease and overall 5 year survival rates are poor 1, 2. Non-surgical treatment with radiation therapy plus chemotherapy is sometimes advocated for patients with squamous cell tumours, but this treatment may have significant complications and has not been widely evaluated in randomised studies [3]. The role of neoadjuvant treatment before surgery remains controversial 4, 5, 6, 7. Endoscopic palliation of malignant dysphagia or palliative chemotherapy may decrease symptoms, but survival benefits are small and sometimes at the expense of treatment-related toxicity 8, 9. The selection of specific treatments can be difficult and is dependent on disease stage, the general health of the patient and knowledge of treatment outcomes. Morbidity, mortality and survival data are widely available, but a growing body of opinion considers that a measure of the broader effects of ill health and treatment on the patient's quality of life (QOL) is necessary.

Although there is no strict definition of the elements that contribute to health-related QOL it is generally accepted that they include physical, social and psychological aspects 10, 11. These may be assessed with a valid QOL questionnaire such as the Short Form (SF)-36, Functional Assessment of Cancer Therapy Scale-General Measure (FACT-G), Gastro Intestinal Quality of Life Index (GIQLI) or the European Organisation for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) 12, 13, 14, 15. Some of these well known instruments have been specifically designed for patients with cancer and they may be supplemented by disease-specific modules to improve coverage, sensitivity and specificity of the core instrument 14, 15. For patients with oesophageal cancer, an additional module to assess important issues such as dysphagia and eating is essential because of their impact on QOL [16]. The EORTC Quality of Life Group has developed a disease-specific module for oesophageal cancer, the QLQ-OES24 based on interviews with patients, health-care professionals and the literature [17]. This questionnaire was designed for use in patients with oesophageal cancer undergoing surgery, chemotherapy, radiotherapy and/or endoscopic treatment. However, its clinical validation or psychometric properties have not been assessed. The aim of this study was therefore to test the reliability and validity of the EORTC oesophageal cancer module in patients undergoing treatment for oesophageal cancer.

Section snippets

Patients and methods

This study opened in March 1998 and closed in October 2001. It was co-ordinated at the Quality of Life Unit at the EORTC Data Centre in Brussels (Protocol 15961/40973). Patients were prospectively registered before treatment. Informed consent and local or national ethical committee approval were obtained.

Patient characteristics

591 patients, from six countries, entered the study and completed baseline questionnaires. One hundred patients were excluded from the psychometric and clinical analyses because the timing of the QOL assessments was outside the specified time windows of the study. There were 267 patients in Group A and 224 in Group B. Socio-demographic and clinical details are given in Table 1.

Patient compliance and questionnaire feasibility

All patients completed baseline questionnaires (n=491). At the follow-up assessment, 39 patients had died and 20

Discussion

This international validation study tested the EORTC QLQ-C30 and the EORTC QLQ-OES18 in a sample of 491 patients with oesophageal cancer. A combination of results from multi-trait scaling analyses, clinical changes over time and clinical judgement led to revision of the hypothesised scales and the removal of two single items. The final module scale structure (QLQ-OES18) was examined before and after oesophagectomy, radical chemoradiation therapy, endoscopic palliation of dysphagia and

Acknowledgements

We thank the following participating centres for entering patients into this study. Universitätsklinikum Charité Campus Mitte, Germany (V. Budach, H. Lochs, J.M. Müller, K. Possinger,), Charité Campus Virchow, Germany (R. Felix, B. Wiedenmann), Bristol Royal Infirmary, Bristol, UK (C.P. Barham, J. Vickers), University Hospital, Colmar, France (F. Husseini), University Hospital, Geneva, Switzerland (A. Roth), University Hospital Charles Nicolle, Rouen, France (B. Paillot), Universitatsklinikum,

References (28)

  • A Webb et al.

    Randomised trial comparing epirubicin, cisplatin and fluorouracil versus fluorouracil, doxorubicin and methrotrexate in advanced oesophagogastric cancer

    J. Clin. Oncol.

    (1997)
  • L Fallowfield

    The Quality of Life—The Missing Measurement in Health Care

    (1990)
  • H Troidl

    Quality of lifedefinition, conceptualization and implications—a surgeon's view

    Theor. Surg.

    (1991)
  • J.E Ware et al.

    The MOS 36-item short-form health profilesubjective health status and medical consultations

    Medical Care

    (1992)
  • Cited by (0)

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