title: Evaluating health-related quality of life and symptom burden in brain tumour patients: instruments for use in experimental trials and clinical practice.
abstract: OBJECTIVE
  The evaluation of new treatments in brain cancer should address outcomes such as functional status, symptoms, cognition and health-related quality of life (HRQOL), yet these are infrequently evaluated. This review focuses on instruments for measuring HRQOL in brain tumour patients and the recent developments in the field.
  
  
  RESULTS
  HRQOL is now well accepted as a trial endpoint by the US Food and Drug Administration and the European Medicines Agency. Efforts to standardize HRQOL use in clinical trials are ongoing. Existing disease-specific instruments for brain tumour patients (e.g. EORTC BN-20, Functional Assessment of Cancer Therapy-Brain) appear to meet US Food and Drug Administration and European Medicines Agency requirements sufficiently. The EORTC BN-20 has recently completed the final validation process. The psychometric properties of single-item linear analogue scale assessments for patients with newly diagnosed high-grade gliomas were investigated. Nevertheless, only a few brain tumour trial results published over the last year reported on patients' HRQOL data or symptoms. The prognostic significance of HRQOL is debated as to whether it may have additional value over other well known prognostic factors.
  
  
  CONCLUSIONS
  With an increase in treatment options for brain tumours and also the risk of long-term neurotoxicity, more detailed reporting of patients' HRQOL and symptoms is essential. The use of HRQOL evaluations in brain tumour trials should be strongly encouraged by the clinical and academic community.
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, Quality of Life Department, Brussels, Belgium.
authors.forename: Murielle E
authors.initials: ME
authors.lastname: Mauer
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
authors.forename: Martin J B
authors.initials: MJ
authors.lastname: Taphoorn
mesh_terms: D001932:Brain Neoplasms / Q000150:complications / Q000523:psychology* / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003072:Cognition Disorders / Q000209:etiology / Q000523:psychology; D006304:Health Status; D006801:Humans; D011788:Quality of Life; D011795:Surveys and Questionnaires