Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0015672 (fatigue)
 51,768 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Quality of life is an important focus of integrative oncology research. Choice of an appropriate way to measure quality of life is therefore a key concern. A common error of researchers has been to focus on whether a quality of life measure has been "validated". This may be a necessary condition for choice of endpoint, but it is certainly not sufficient. It is easily shown that interventions that undoubtedly improve quality of life, such as Epogen for chemotherapy anemia, will not have an important impact on items in some validated quality of life scales (e.g. "I trust my doctor") and therefore will not improve quality of life scores. Investigators are advised to move beyond "validation" as a criterion for choosing quality of life endpoints and focus instead on the specific content of different potential measures. A particularly important concern is whether a prior trial showing a statistically significant difference on a specific quality of life scale is published, as this would demonstrate that scores on the scale will improve if patients respond to treatment. In many cases, it is preferable to use specific symptoms, such as pain or fatigue, as opposed to more generic quality of life scales.
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PMID:How to measure quality of life in integrative oncology research. 1912 68

The health-related quality of life (HRQOL) claims in the current Epoetin alfa label are based on the reanalyses of the exercise and physical function data from the Canadian Erythropoietin Study Group trial. The reanalysis was done to comply with the Food and Drug Administration's requirement of using statistical methods that are currently standard in evaluating clinical trial data. Presented here are HRQOL results associated with anemia. The Canadian Erythropoietin Study Group trial was a multicenter, double blind, randomized, placebo-controlled trial evaluating the effects of Epoetin alfa on HRQOL in anemic hemodialysis patients. A total of 118 patients who were 18-75 years old, on hemodialysis for >3 months, who had a hemoglobin <9.0 g/dL, and did not have coronary artery disease or diabetes mellitus, were randomized to either receive placebo (n=40), or receive intravenous Epoetin alfa to achieve a target hemoglobin of 9.5-11.0 g/dL (n=40) or a target of 11.5-13.0 g/dL (n=38). Patients were followed for 6 months. The two Epoetin alfa-treatment groups were combined for all analyses performed. This post hoc analysis was conducted using an intent-to-treat repeated measures mixed model analysis of variance using Bonferroni's multiplicity correction. The Epoetin alfa-treated group showed a statistically significant improvement in the Kidney Disease Questionnaire symptom of fatigue in comparison with placebo. Additionally, the change in hemoglobin at 2 months was correlated with change in fatigue, energy, shortness of breath, and weakness, but had minimal effect on depression. These analyses confirm previously reported results, which indicate that treating hemodialysis patients with an erythropoiesis-stimulating agent improves HRQOL.
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PMID:Dialysis patients treated with Epoetin alfa show improved anemia symptoms: A new analysis of the Canadian Erythropoietin Study Group trial. 2034 90


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