Summary
Assessments of quality of life (QL) in clinical trials need to include the palliation of symptoms and the adverse effects of treatment as well as data on physical, psychological, and functional domains. Methods of assessment fall into three broad groups: daily diary cards, linear analogue self-assessment scales, and categorical scales, and assessments may be made both by patients and by clinicians or other staff. Instruments need to be selected according to the research questions being addressed.
Data from randomised clinical trials have led to considerable improvements in palliative treatment regimens for patients with lung cancer, and have also identified important symptoms reported by patients that tend to be overlooked by clinicians.
There is increasing awareness amongst clinicians of the need to assess palliative endpoints in clinical trials, but this is not easily achieved reliably when the patient population is diminishing through death during the trial period. Further research is needed on defining palliative and other QL endpoints, on methods of measuring these endpoints and analysing QL data, on the relative importance to patients of different symptoms and adverse effects of treatment in relation to survival, and on the assessment of QL in routine practice.