Development of a questionnaire module to supplement the EORTC QLQ-C30 to assess quality of life in patients with hepatocellular carcinoma, the EORTC QLQ-HCC18
Introduction
Hepatocellular carcinoma (HCC) is one of the world’s most common malignancies, with a marked heterogeneous geographical distribution [1]. In high-risk areas, such as Asia and Africa, annual incidence rates are between 10 and 120 per 100,000 population, whereas in low-risk areas, Northern Europe, United States of America (USA) and India, annual incidence rates are below 3 per 100,000 population [1]. Over the past decade, advances in diagnostic techniques and multi-disciplinary management of HCC have led to small improvements in survival, although outcomes remains poor with overall one year survival being less than 20% [2], [3]. Trials evaluating systemic chemotherapy show very little benefit [4]. Local arterial infusion of cytotoxic agents or cytotoxic agents in combination with lipiodol may increase survival in well selected patients [5], [6]. Percutaneous approaches with ethanol, or radiofrequency ablation can be used for unresectable HCC and there is currently interest in the role of octreotide [7]. Potentially curative treatments, including resection, percutaneous ablation or liver transplantation can be offered to patients with small lesions confined to the liver and five year survival may reach 50% [5]. Treatment strategies are aimed at incorporating prognosis estimation with potential treatment advancements [8]. Although survival data and information about the side-effects of treatment are widely available, much less is known about how treatment for HCC impacts upon patients’ health-related quality of life (QoL). Self-reported QoL data includes measures of physical, social and emotional well-being and this is valuable for patients and clinicians in decision-making [9]. Self-reported health data may also predict survival in patients with cancer and in other populations [10].
The most widely used instruments in assessing QoL in cancer patients within the context of clinical trials are the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the Functional Assessment of Cancer Therapy (FACT) generic questionnaire [11], [12]. These both use a general core questionnaire and may be supplemented by disease-specific modules. A module for hepatobiliary cancers has been published by the FACT group [13]. This is designed for patients with cancer of the head of pancreas, colorectal liver metastases, primary liver cancer and cholangiocarcinoma. It has 18 items that may be aggregated to produce a FACT-Hep scale. The EORTC group has taken a more focused approach, by developing separate modules for pancreatic cancer, colorectal hepatic metastases and primary liver cancer [14], [15]. This approach was followed because these cancers have different aetiologies, epidemiology, clinical problems, treatments and disease progression. This paper describes the development of the EORTC questionnaire, module to accompany the EORTC QLQ-C30 to comprehensively assess QoL in patients with HCC.
Section snippets
Study design
The development of the provisional module was performed according to the EORTC Quality of Life Group (QLG) published guidelines for questionnaire development [16], [17], [18]. These guidelines are summarised in Table 1. The final part of module development (Phase 4) consists of psychometric testing and is not part of this paper.
Subjects
Patients for the interviews carried out in Phase 1 were recruited from the United Kingdom (UK), The Chinese University of Hong Kong and Egypt. In Phase 3 of the study,
Literature search
Literature searches were performed in three databases: MEDLINE (1966–June 2002), EMBASE (1980–June 2002), and CINAHL (1982–April 2002). The searches were limited to the English language. The major subject heading, HCC was combined with surgery, QoL, questionnaires, chemotherapy, alcohol ablation, chemoembolisation, physical distress, psychological distress, psychosocial distress and physical symptoms. This identified 2055 articles. Nine papers described QoL questionnaires used with patients
Discussion
The EORTC QLQ-HCC18 has been methodologically developed using standard guidelines. It is designed for use with the QLQ-C30 core instrument to assess all major dimensions of health-related QoL in patients with HCC. 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. Testing the QLQ-HCC18 in 158 patients from the UK, Taiwan and Hong Kong
Conflict of Interest Statement
None declared.
Acknowledgements
The authors acknowledge D. Alderson, M.D. Finch-Jones, R. Jones and F. Gordon (Bristol Royal Infirmary) for allowing us to study patients under their care. We are grateful to Mr. N. Dowidar (Egypt) for his contribution to the early Phase 1 part of the study. The authors are grateful to G. Velikova, T. Conroy, M. Sprangers, D. Osoba and E. Greimel, members of the EORTC Quality of Life Group who reviewed the development of this module. This work was sponsored by the EORTC Quality of Life Group,
References (24)
- et al.
Survival of patients with primary liver cancer, pancreatic cancer and biliary tract cancer in Europe
Eur. J Cancer
(1998) - et al.
Hepatocellular carcinoma
The Lancet
(2003) - et al.
Adjuvant intra-arterial lipiodol-iodine-131 for resectable hepatocellular carcinoma: a prospective randomised trial
The Lancet
(1999) - et al.
A randomized placebo-controlled study of long-acting octreotide for the treatment of advanced hepatocellular carcinoma
Hepatology
(2002) - et al.
Prognostic prediction and treatment strategy in hepatocellular carcinoma
Hepatology
(2002) - et al.
Development of a disease specific quality of life questionnaire module to supplement the EORTC core cancer quality of life questionnaire, the QLQ-C30 in patients with pancreatic cancer
Eur J Cancer
(1999) - et al.
Development of an EORTC disease-specific quality of life questionnaire for use in patients with liver metastases from colorectal cancer
Eur J Cancer
(2003) - et al.
The development and utilisation of the European Organisation for Research and Treatment of Cancer quality of life group item bank
Eur J Cancer
(2002) - et al.
Development of an EORTC disease specific quality of life module for use in patients with gastric cancer
Eur J Cancer
(2001) - et al.
Development of a EORTC questionnaire module to be used in quality of life assessment for patients with oesophageal cancer
Eur J Cancer
(1996)