KHI Current Project

Patient Reported Outcomes for Muscle Cramping in Patients on Dialysis

Abstract

Muscle cramping is an especially bothersome symptom in patients receiving dialysis. New evidence suggests that hemodialysis patients feel that muscle cramping should be a priority area for development of new treatments. Currently, there is only a single question on the KDQOL survey addressing muscle cramping. However, before new treatments can be tested, the kidney community needs to develop measures that evaluate muscle cramping.

Deliverable

Conceptual Framework for Patient-Reported Outcome Measures in Clinical Trials of Skeletal Muscle Cramping Experienced in Dialysis

Key findings from the "Prioritizing Symptoms of ESRD Patients for Developing Therapeutic Interventions" showed that muscle cramping was one of three physical symptoms that in-center hemodialysis patients prioritized for development of therapies. A subsequent stakeholder meeting (patients and care partners, researchers, nephrologists, clinical pharmacists and health care delivery system representatives) determined that a critical actionable step for stimulating development of therapies for muscle cramping was to define a set of measures for this condition. Currently, there is only a single question on the KDQOL survey that addresses muscle cramping.

Stakeholders felt there was no sufficient measure for the diversity of muscle cramping symptoms experienced by patients (location, duration, frequency and timing related to dialysis). This project proposes to define a set of measures that could be used in future clinical trials to evaluate renal replacement therapy (RRT) devices as well as medications. This project would lessen the developmental risk burden of device and pharmaceutical manufacturers of establishing appropriate endpoints for muscle cramping. This project has important tie-ins with "Fostering Innovation in Fluid Management". These measures would allow for testing the impact of new dialysis devices, new RRT technologies and medications on alleviation of muscle cramping.

Phase 1 has the following objectives:

  1. Identify currently available methods of measuring muscle cramping
  2. Determine if there is the need to develop new measures for muscle cramping
  3. Develop a pilot set of measures that could be used in future clinical trials to evaluate RRT devices as well as medications for muscle cramping
Phase 2 has the following objectives:
  1. Obtain patient feedback on pilot measures and test measures for muscle cramping in a small diverse sample of dialysis patients.
  2. Develop a set of measures for muscle cramping that can be tested for reliability/validity
  3. Determine the need for development of an instrument for testing measures in diverse patient populations

Role Name Organization
MemberAmanda Grandinetti, MPHKHI Patient and Family Partnership Council
Co-ChairEduardo K. Lacson, Jr., MD, MPH Dialysis Clinic, Inc.
Board of Directors LiaisonWendy St. Peter, PharmD, FASNUniversity of Minnesota
Co-ChairMichelle M. Richardson, PharmD, BCPSTufts Medical Center
MemberFrancesca Tentori, MD, MSDaVita Kidney Care
MemberBijin Thajudeen, MD, FACP, FASNUniversity of Arizona
MemberKen Wilund, PhDUniversity of Illinois
MemberRebecca Wingard, MSN, RN, CNNFresenius Medical Care North America

References

Flythe JE, Hilliard T, Castillo G, Ikeler K, Orazi J, Abdel-Rahman E, Pai AB, Rivara MB, St. Peter WL, Weisbord SD, Wilkie C, Mehrotra R. Symptom prioritization among adults receiving incenter hemodialysis-a mixed methods study. CJASN 2018 Published online before print. March 2018, doi: 10.2215/CJN.10850917.

Final Report: Prioritizing symptoms of ESRD patients for developing therapeutic interventions: stakeholder convening. Submitted to Melissa West, Kidney Health Initiative, American Society of Nephrology, Washington DC. March 2018.