Articles: patients.
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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The U. S. Food and Drug Administration (FDA) 2006 draft guidance on "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" has engendered wide discussion about patient-reported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.
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To explore older people's and their relatives' views on and experiences of acute health care. ⋯ These findings highlight the perspectives of older people and their relatives on the delivery of personalized and dignified care in acute settings. They lend support to previous calls for relationship-centred approaches to care and provide a useful experience-based framework for practice for those involved in care for older people.
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The aim of the current review was to determine the predictive strength of low recovery expectations for activity limitation outcomes in people with non-chronic NSLBP. ⋯ Recovery expectations when measured using a specific, time-based measure within the first 3 weeks of NSLBP can identify people at risk of poor outcome.