Health related quality of life assessment methodology and reported outcomes in randomised controlled trials of primary brain cancer patients

Over the last 20 years, the assessment of quality of life (QOL) has become an important endpoint in cancer clinical trials, helping us to understand patient survival and QOL experiences and aiding clinicians in providing the best possible treatment and care, with the least toxicity and ill-effects. In primary brain cancer, these are critical issues. Survival is often limited and treatment difficult to tolerate. In recent years, some authors have questioned the methodological quality of the investigations and the reporting of QOL assessments from randomised controlled trials (RCTs), of cancer patients yet this assessment has never specifically focused on brain cancer. This paper therefore reports a systematic review of the research methodology and QOL assessment reporting in brain cancer patients in RCTs. The search was mainly performed on the following databases: Medline, Cancerlit and the Cochrane Controlled Trials Register. We identified only five RCTs, enrolling a total of 1026 patients. In many of these studies, we had identified methodological limitations which would hinder the interpretation of the results. These included a lack of detailed reporting regarding missing data, use of poorly validated tools, and general limitations regarding the presentation and interpretation of the results. Based on the results of our review, we make recommendations for future investigations to avoid these shortcomings. (C) 2002 Elsevier Science Ltd. All rights reserved.