Clinical trials and quality of life assessment: the nurses' viewpoint.

The rationale for quality of life assessment has been largely developed in the literature. Quality of life is an important concept in the oncology environment because the physical, psychological and social wellbeing of patients are affected both by the disease and the related treatments. The relevance of quality of life assessment to nursing clinical practice has been discussed by several authors. There is a need to use more valid and reliable instruments to plan appropriate nursing care, to evaluate and document the effect of nursing interventions. In clinical trials, quality of life assessment is being used increasingly to predict patients' outcomes and to evaluate medical and nursing interventions. Nurses' viewpoints of potential benefits and pitfalls related to quality of life assessment are discussed. Among the benefits, it is usually considered that therapeutic interventions might be improved. These could be adjusted and individualised and the need for supportive care interventions might be evaluated more accurately. As for the pitfalls, the quality of life evaluation causes an extra burden if its implementation is not properly co-ordinated and if poor or incomplete guidelines are provided to patients and staff. Proposals for implementing effective quality of life assessment in clinical trials are discussed. Basic requirements, such as preliminary instructions, guidelines for administration of the questionnaire and proposals for reducing missing evaluations, are presented.