Health-related quality of life and cancer clinical trials.

The measurement of patient-reported outcomes, including health-related quality of life, is a new initiative which has emerged and grown over the past four decades. Following the development of reliable and valid self-report questionnaires, health-related quality of life has been assessed in tens of thousands of patients and a wide variety of cancers. This review is based on a selection of data published in the last decade and is intended primarily for healthcare professionals. The assessments in clinical trials have been particularly useful for elucidating the effects of various cancers and their treatments on patients' lives and have provided additional information that enhances the usual clinical endpoints used for determining the benefits and toxicity of treatment. With growing experience the quality of the health-related quality of studies has improved and, in general, recent studies are more likely to be methodologically robust than those that were performed in earlier decades. Health-related quality of life has become a more accurate predictor of survival than some other clinical parameters, such as performance status. The overall outlook for the routine assessment of patient-reported outcomes in clinical trials is assured and, eventually, it is likely to become a standard part of clinical practice. However, there is still a need for a clear method for determining the clinical meaningfulness of changes in scores. The answer will probably come from the greater use of patient-reported outcomes and the consequent growth of experience that is necessary to make such judgements.