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Palliative care aims at improving the patient's quality of life. Clinical trials, therefore, often include the patient's subjective evaluation of symptoms and psychosocial problems, so-called health-related quality of life (HRQL), as end-points. Unfortunately, there are frequently methodological weaknesses in the assessment of HRQL. This paper discusses four criteria which can be used in the evaluation of the quality of such studies: I. The authors should document that they have included the relevant HRQL issues in the questionnaire. If a trial misses important issues, its results may be misleading. II. The sample size should be sufficient to detect meaningful differences. Many trials are too small. III. The assessment of HRQL should have the appropriate timing, reflecting the research questions. The symptoms and the benefit resulting from treatments are not constant over time and often have cyclic patterns. The results may therefore be dependent on the timing of the administration of questionnaires to patients and on the time frames specified in the instructions. IV. The data must be reasonably complete. Incomplete data cannot be avoided in palliative care research, but missing data due to administrative failures or unrealistic schedules must be avoided. A pilot study may show whether a study is feasible. Missing data are likely to bias results. Many published palliative care studies are suboptimal with regard to one or more of these four criteria. This should be considered when reading published studies and when new trials are planned. [ABSTRACT FROM AUTHOR]

Fatigue describes reduced capacity to sustain force or power output, reduced capacity to perform multiple tasks over time and simply a subjective experience of feeling exhausted, tired, weak or having lack of energy. Pain and fatigue have several components in common, such as being subjective, prevalent in most patients with cancer and caused by multiple factors of both a physical and psychological nature. In order to explore the relationship between fatigue and pain, data from five studies were used: two random samples from the Norwegian population (n=2323 and n=1965), Hodgkin's disease survivors (n=459), palliative care patients (n=434) and patients with bone metastases (n=94). All patients had completed one or more of the following instruments: EORTC QLQ-C30, SF-36 and/or Fatigue Questionnaire. The level of fatigue was much higher in the two palliative care populations (54.4 and 63.2) as compared to the normal population samples (25.0). Patients with bone metastases had significantly more pain (72.0) than the patients in the palliative care trial (47.4) and norms (20.5). In the two palliative care and bone metastases populations fatigue was almost unchanged over time, while pain was reduced. In the palliative care population a high level of fatigue (80.3) and pain (57.8) was reported 0-1 month before death. The relationship between pain, fatigue and the health-related quality of life domains should be explored in more detail, especially in follow-up studies in order to assess possible changes over time. In addition, the validity of the existing instruments measuring fatigue should be investigated for use in patients with advanced disease and short life expectancy. [ABSTRACT FROM AUTHOR]