Conceptual Framework for Patient-Reported Outcome Measures in Clinical Trials of Skeletal Muscle Cramping Experienced in Dialysis
| Autor: | Michelle M. Richardson, Amanda Grandinetti, Tandrea S. Hilliard-Boone, Kenneth R. Wilund, Rebecca Wingard, Wendy L. St. Peter, Dilani Logan, Francesca Tentori, San Keller, Melissa West, Eduardo Lacson |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Clinical Journal of the American Society of Nephrology. 17:1563-1574 |
| ISSN: | 1555-905X 1555-9041 |
| Popis: | Skeletal muscle cramping is a common and bothersome symptom for patients on maintenance dialysis therapy, regardless of modality, and it has not been prioritized for innovative assessments or treatments. Research to prevent or treat skeletal muscle cramping in patients receiving dialysis is hindered by poorly understood pathophysiology, lack of an accepted definition, and the absence of a standardized measurement method. The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a multidisciplinary workgroup to define a set of patient-reported outcome measures for use in clinical trials to test the effect of new dialysis devices, new KRTs, lifestyle/behavioral modifications, and medications on skeletal muscle cramping. Upon determining that foundational work was necessary, the workgroup undertook a multistep process to elicit concepts central to developing the basis for demonstrating content validity of candidate patient-reported outcome measures for skeletal muscle cramping in patients on dialysis. The workgroup sought to ( |
| Databáze: | OpenAIRE |
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