An international validation study of the EORTC brain cancer module (EORTC QLQ-BN20) for assessing health-related quality of life and symptoms in brain cancer patients

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Abstract

Aims

The psychometric properties of the EORTC QLQ-BN20, a brain cancer-specific HRQOL questionnaire, have been previously determined in an English-speaking sample of patients. This study examined the validity and reliability of the questionnaire in a multi-national, multi-lingual study.

Methods

QLQ-BN20 data were selected from two completed phase III EORTC/NCIC clinical trials in brain cancer (N = 891), including 12 languages. Experimental treatments were surgery followed by radiotherapy (RT) and adjuvant PCV chemotherapy or surgery followed by concomitant RT plus temozolomide (TMZ) chemotherapy and adjuvant TMZ chemotherapy. Standard treatment consisted of surgery and postoperative RT alone. The psychometrics of the QLQ-BN20 were examined by means of multi-trait scaling analyses, reliability estimation, known groups validity testing, and responsiveness analysis.

Results

All QLQ-BN20 items correlated more strongly with their own scale (r > 0.70) than with other QLQ-BN20 scales. Internal consistency reliability coefficients were high (all α  0.70). Known-groups comparisons yielded positive results, with the QLQ-BN20 distinguishing between patients with differing levels of performance status and mental functioning. Responsiveness of the questionnaire to changes over time was acceptable.

Conclusion

The QLQ-BN20 demonstrates adequate psychometric properties and can be recommended for use in conjunction with the QLQ-C30 in assessing the HRQOL of brain cancer patients in international studies.

Introduction

The incidence of brain tumours is low compared to other common cancer sites such as breast and lung. Primary brain tumours account for only 2–3% of all cancers in adults.1 However, despite its low incidence, brain cancer is a disease characterised by severe symptoms and poor prognosis. Currently, efforts at developing new therapeutic strategies in brain cancer are focused on prolonging survival. However, these treatments may increase neurotoxicity2 and thereby negatively affect health-related quality of life (HRQOL). Special concerns exist with regard to cognitive dysfunction and personality changes.3 Consequently, clinical benefits of any new treatment should be weighed against treatment side-effects that adversely influence patients’ HRQOL.

In assessing the HRQOL of brain cancer patients it is important to use well-validated instruments. Today, the most widely used brain cancer-specific HRQOL questionnaires are the brain subscale of the Functional Assessment of Cancer Therapy (FACT-Br)4 and the EORTC brain cancer-specific Quality of Life Questionnaire (QLQ-BN20).5

The QLQ-BN20 has previously been tested in English-speaking samples, and has been demonstrated to have adequate psychometric properties.5 The purpose of the study reported here was to examine the validity and reliability of the QLQ-BN20 in an international setting, in multiple languages.

Section snippets

Patients

In this study we used data derived from two phase III EORTC/NCIC cancer clinical trials (EORTC Protocol 269516 and 268917). These studies were merged in order to create a large dataset (N = 941) in an international and cross-cultural setting.

Trial 26951 included 368 patients with newly diagnosed highly anaplastic oligodendroglioma (i.e. anaplastic oligodendroglioma or anaplastic oligo-astrocytoma), who were randomly assigned to either six cycles of adjuvant Procarbazine-CCNU-Vincristine (PCV)

Patient characteristics

Of the total sample of 941 brain cancer patients from the two clinical trials, 891 (94.7%) completed at least one HRQOL assessment and were included in the analysis. These patients were enroled by 119 institutions from 15 countries. Baseline socio-demographic and clinical characteristics for these 891 patients (see Table 1) were very similar to those of the total sample (data not shown).

Questionnaire completion rates

Based on the total patient sample (N = 941) the baseline questionnaire completion rate was 83%. HRQOL

Discussion

The objective of this study was to generate detailed data on the psychometric properties of the EORTC QLQ-BN20 HRQOL questionnaire module when used in a diverse sample of patients with primary brain tumours participating in large scale, international clinical trials. Such large scale, international field-testing of the questionnaire is important, given that it, along with the EORTC core HRQOL questionnaire (the QLQ-C30), is one of the most widely used measures for assessing HRQOL in brain

Conflict of interest statement

Dr. Stupp has served on advisory boards for Bristol-Myers Squibb, Merck KGaA, Roche and Schering-Plough.

Dr. Mirimanoff has received speaking engagements including travel and accommodation from Schering-Plough.

Dr. Van den Bent has been a consultant for Schering-Plough, has acted as a member for their speakersbureau and has received research grants from Schering-Plough.

Acknowledgements

This publication was supported by Grants no. 2U10 CA11488-37 from the National Cancer Institute (Bethesda, Maryland, USA) and by a donation from the KWF Kankerbestrijding from the Netherlands through the EORTC Charitable Trust. This analysis is funded by the EORTC Quality of Life Group. Its content is solely the responsibility of the authors and does not necessarily reflect the official views of the National Cancer Institute.

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