Patient Perspectives of Skeletal Muscle Cramping in Dialysis: A Focus Group Study.

Key Points: This first step demonstrated content validity for a patient-reported outcome measure for skeletal muscle cramping in dialysis. This work lays the foundation for developing a patient-reported outcome measure for regulatory use to assess skeletal muscle cramping in people receiving dialysis.

Background: Skeletal muscle cramping is a common, painful, and debilitating symptom experienced by people receiving dialysis.

Conceptual Framework for Patient-Reported Outcome Measures in Clinical Trials of Skeletal Muscle Cramping Experienced in Dialysis: A Kidney Health Initiative Workgroup Report.

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.