Journal of pain and symptom management
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J Pain Symptom Manage · Jun 2010
Review Meta AnalysisA systematic review of topical treatments to control the odor of malignant fungating wounds.
Malignant fungating wounds (MFW) result from cutaneous infiltration by carcinogenic cells. Fetid odor, profuse exudate, pain, and infection are common symptoms that add to the physical and psychological suffering of patients with MFW. The topical treatment of MFW remains controversial. ⋯ Of the 59 studies of odor, 20 fulfilled all the criteria for inclusion. Few studies of high quality were found, and the principal methodological flaws were the design of the studies, the sample size, and the absence of scales to measure odor. Grade B evidence for the treatment of MFW was found with topical metronidazole, Mesalt dressing, activated carbon dressing, and curcumin ointment.
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J Pain Symptom Manage · Jun 2010
Review Meta AnalysisA systematic review of topical treatments to control the odor of malignant fungating wounds.
Malignant fungating wounds (MFW) result from cutaneous infiltration by carcinogenic cells. Fetid odor, profuse exudate, pain, and infection are common symptoms that add to the physical and psychological suffering of patients with MFW. The topical treatment of MFW remains controversial. ⋯ Of the 59 studies of odor, 20 fulfilled all the criteria for inclusion. Few studies of high quality were found, and the principal methodological flaws were the design of the studies, the sample size, and the absence of scales to measure odor. Grade B evidence for the treatment of MFW was found with topical metronidazole, Mesalt dressing, activated carbon dressing, and curcumin ointment.
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J Pain Symptom Manage · Jun 2010
Review GuidelineASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials.
Development of pharmacological and behavioral interventions for cancer-related fatigue (CRF) requires adequate measures of this symptom. A guidance document from the Food and Drug Administration offers criteria for the formulation and evaluation of patient-reported outcome measures used in clinical trials to support drug or device labeling claims. ⋯ There exist in the literature good measures of CRF for clinical trials, with strong evidence of clarity and comprehensibility to patients, content and construct validity, reliability, and sensitivity to change in conditions in which one would expect them to change (assay sensitivity), and sufficient evidence to establish guides for interpreting changes in scores. Direction for future research is discussed.
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J Pain Symptom Manage · Jun 2010
ReviewAssessing the Symptoms of Cancer Using Patient-Reported Outcomes (ASCPRO): searching for standards.
The U. S. Food and Drug Administration (FDA) 2006 draft guidance on "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" has engendered wide discussion about patient-reported outcome (PRO) domains that should be endpoints in clinical trials. ⋯ Accordingly, an interdisciplinary workgroup, Assessing the Symptoms of Cancer using Patient-Reported Outcomes (ASCPRO), has been formed to generate evidence-based recommendations for the assessment of patient-reported cancer-related symptoms and the use of that information to facilitate clinical research and decision making. ASCPRO is among the first working groups to focus primarily on nonpain symptoms, including fatigue, sleep disturbance, appetite loss, depression, cognitive impairment, and shortness of breath. ASCPRO members are stakeholders in optimal symptom assessment, including patient advocates, academics, clinicians, those who pay for symptom control and monitor quality of care, and those who produce products that palliate cancer-related symptoms but that may also engender treatment-related symptoms.