Kidney Health Initiative (KHI)

KHI Workgroup Opportunity

Develop Measures for Muscle Cramping in Dialysis Patients to Spur Development of Devices and Medicines for treating this Vexing Condition

Summary

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

Project

This project is divided into two phases, which will be completed sequentially.

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

In order to achieve these goals, we will first assemble a workgroup of key stakeholders drawing from the diverse membership of the Kidney Health Initiative:

  • Academic researchers
  • Dialysis providers
  • Patients
  • Device manufacturers
  • Government (FDA, CMS)

The deliverables will be:

  • Phase 1- Initial item bank of questions on muscle cramping
  • Phase 2: White Paper, instrument to measure muscle cramping that would be ready for device or pharmaceutical manufacturers to field test for validity/reliability

Workgroup Role and Responsibility

The charge for the workgroup includes:

  • Conduct literature review to identify current methods for measuring muscle cramping
  • Analyze data from literature review and other research to develop a needs assessment, gap analysis and design criteria for potential measures
  • Convene diverse stakeholder focus groups (patients, care partners, nephrologists, clinical pharmacists, FDA, researchers in muscle cramping physiology and therapies) to review summary of literature review and determine possible new measures (Concept elicitation)
  • Identify and evaluate potential domains and items for inclusion
  • Determine need for parallel development in multiple languages
  • Conduct cognitive interviews and testing with diverse set of patients for feedback on language, clarity of items, and content relevance
  • Finalize items to be included in set of muscle cramping measures

Estimated Time Commitment

Workgroup members will be asked to participate in regular conference calls or webinars (ideally no more than twice per month) and respond to emails in a timely manner. In-person planning or working meetings will be determined by the project plan. This is a volunteer position and compensation will not be offered for participation.

Goal for completion of the Phase 1 is 4-6 months with the project commencing in January, 2019. Phase 2 will begin immediately following completion of Phase 1 and be completed in 6-9 months.

Recommended Expertise

  • Direct experience and/or expertise with assessment and measurement of muscle cramping, both within and outside the nephrology community
  • Relevant expertise and ability to represent at least 1 of the following stakeholder groups on the project:
    • Dialysis providers
    • Academic researchers
    • Industry
    • Patients
    • Research groups
    • Additional groups and organizations that are essential to this area

Application and Deadline

Tuesday, November 27, 2018

All interested candidates should apply to serve on this workgroup. The application can be sent to khi@asn-online.org with a subject line of "Workgroup: Muscle Cramping". Please include the following information in your email:

  1. Name and contact information
  2. CV or resume
  3. Reason for wanting to participate in this workgroup (no more than 250 words)
  4. Explanation of how you will contribute to the project (no more than 250 words)
  5. Your interest in being the chair of the workgroup, a member or both.

All applicants need to have an updated a disclosure form on file https://www.asnonline.org/myasn/disclosure-form.aspx

Mailing List

If you are interested in the topic, but not in serving on the workgroup, please email khi@asn-online.org and KHI staff will send more information as available.

If you have any questions, please do not hesitate to contact KHI at khi@asn-online.org

Selected References

  1. 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 in center hemodialysis-a mixed methods study. CJASN 2018 Published online before print. March 2018, doi: 10.2215/CJN.10850917.
  2. 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.