Development of an EORTC disease-specific quality of life questionnaire for use in patients with liver metastases from colorectal cancer

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Abstract

Quality of life (QL) is an important outcome measure within clinical trials. This paper describes the development of a QL module for patients with liver metastases from colorectal cancer (CRC) to supplement the European Organization for Research and Treatment of Cancer (EORTC) core QL questionnaire, the EORTC QLQ-C30. Phases 1–3 of the EORTC QL Group guidelines for developing QL modules were followed. The literature search generated 71 QL issues. Semi-structured interviews with eight healthcare professionals and 47 patients from the United Kingdom, France, Germany and Austria reduced the list to 23 issues. Questionnaire items were formulated to be compatible with the EORTC QLQ-C30. The provisional module was further tested in 102 patients resulting in a 21-item module, the QLQ-LMC21 (Liver Metastases Colorectal). A combination of the core questionnaire and the QLQ-LMC21 will provide essential QL information regarding the use of treatments in both the curative and palliative settings.

Introduction

Colorectal cancer (CRC) is a worldwide health problem. In England and Wales, it was the third commonest cause of death due to cancer in the year 2000 being responsible for over 250 deaths per 1 000 000 of the population in that year [1]. Overall, 40–50% of patients with colorectal cancer develop metastatic disease and the liver is often the first site of metastatic disease and may be the only site of spread in 30–40% patients with advanced disease [2]. Treatment options vary depending on the extent of the metastatic disease. Hepatic resection of isolated colorectal cancer liver metastases may lead to 40–50% five-year survival rates [3]. Patients with liver metastases not suitable for resection may receive chemotherapeutic or local thermal treatments. The aim of treatment of advanced colorectal cancer is to control symptoms, maintain or improve quality of life (QL) and, ultimately, prolong survival. Survival and disease-free survival are the most frequently used outcome measures, although, patient-based measures of outcome (QL and satisfaction with care) are also being used both as primary and secondary endpoints, especially where the mainstay of treatment is palliation.

The most widely used instruments in assessing QL in cancer patients within the context of clinical trials are the European Organization for Research and Treatment of Cancer (EORTC) core QL questionnaire (QLQ-C30) and the Functional Assessment of Cancer Therapy-General (FACT-G) 4, 5. These both use a general core questionnaire and may be supplemented by disease-specific modules [6]. Modules for patients with CRC have been published by both groups 7, 8. Although designed for all patients with CRC, because they concentrate on gastrointestinal symptoms and the side-effects of treatment (stoma problems, bowel habits, sexual function), they may be insensitive and irrelevant to patients with CRC receiving treatment aimed at liver metastases. This was suggested at a consensus meeting in 1996 [9] and, in addition, a Cochrane review of palliative chemotherapy for advanced or metastatic CRC was unable to pool QL results because of the lack of use of valid instruments specific to patients with hepatic metastases from CRC [10]. The aim of this study, therefore, was to develop a disease-specific module specifically for patients with hepatic metastases from CRC according to the EORTC guidelines.

Section snippets

Study design

The development of the provisional module (phases 1–3) was according to the EORTC Quality of Life Group (QLG) published guidelines for questionnaire development (Table 1) 11, 12. The final part of module development (phase 4) consists of psychometric testing and is under preparation. It is not part of this report.

Subjects

Patients for the interviews carried out in phases 1 and 3 were recruited from six cancer hospitals in Europe. Eligible patients were required: (a) to have been diagnosed with hepatic

Literature search

Literature searches were performed in four databases: MEDLINE, PSYCHINFO, EMBASE and WEB OF SCIENCE. The search was limited to the English language and the time period of January 1991 to December 2000. Major subject headings were, colorectal cancer, liver metastases, advanced colorectal cancer and QL. These identified 158 articles. Fifty-three articles measured QL as an outcome using a QL questionnaire. There were no psychometrically tested disease-specific questionnaires used in any of these

Discussion

The EORTC QLQ-LMC21 has been methodically developed using standard guidelines. It is designed for use with the QLQ-C30 core instrument to assess all major dimensions of health-related QL in patients with hepatic metastases from colorectal cancer. The content of the questionnaire has been derived not only from the published literature, but also from health professionals dealing with these patients and, most importantly, from the patients themselves. It incorporates the experiences of clinicians

Acknowledgments

In Bristol, the authors are grateful to Professor D. Alderson and Mrs. M. Finch-Jones for allowing patients under their care to be studied. In Nancy, the authors are grateful to the assistance provided by Isabelle Léonard, and in Innsbruck, to Verena Meraner, for collecting data. This work was supported by grants: in the UK by NHS Executive South West Research and Development Directorate Project Grant EORTC Quality of Life Group Grant; in Berlin by a research grant from the Hector Stiftung,

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