Patient based method of assessing adverse events in clinical trials in rheumatology: the revised Stanford Toxicity Index
Contribuinte(s) |
Duncan A. Gordon Robert D. Inman Earl D. Silverman Peter Lee |
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Data(s) |
01/01/2001
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Resumo |
We describe the progress towards developing a patient rated toxicity index that meets all of the patient-important attributes defined by the OMERACT Drug Safety Working Party, These attributes are frequency, severity. importance to patient, importance to the clinician, impact on economics, impact on activities, and integration of adverse effects with benefits. The Stanford Toxicity Index (STI) has been revised to collect all attributes with the exception of impact on activities. However, since the STI is a part of the Health Assessment Questionnaire (HAQ). impact on activities is collected by the HAQ. In particular, a new question asks patients to rate overall satisfaction, taking into consideration both benefits and adverse effects. The nest step in the development of this tool is to ensure that the STI meets the OMERACT filter of truth, discrimination, and feasibility. Although truth and feasibility have been confirmed by comparisons within the ARAMIS database, discrimination needs to be assessed in clinical trials. |
Identificador | |
Idioma(s) |
eng |
Publicador |
Journal of Rheumatology Publishing Co |
Palavras-Chave | #Rheumatology #Clinical Importance #Toxicity #Patient Ratings #Questionnaire #Adverse Events #Juvenile Spondyloarthritides #Arthritis #Therapy #C1 #321028 Rheumatology and Arthritis #730114 Skeletal system and disorders (incl. arthritis) |
Tipo |
Journal Article |