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Approximately half of people on hemodialysis suffer from debilitating fatigue after their treatment, yet post-dialysis fatigue is under-recognized by clinicians; moreover, the scientific literature on post-dialysis fatigue is disproportionately sparse relative to the large burden it imposes on patients.
Purpose
The National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health calls people with kidney disease, clinicians, researchers, and the end-stage kidney disease community to action on May 22–May 23, 2023, for a workshop on post-dialysis fatigue. We seek your collective expertise on identifying the scientific gaps and the opportunities to move the field forward.
Your voices matter to invigorate scientific engagement for an overlooked complication of the hemodialysis treatment.
Registration Deadline
May 21, 2023
Agenda
Monday, May 22, 2023
Welcome
12:00 p.m. – 12:05 p.m.
Opening Remarks Kevin Chan, M.D., M.Sc., Program Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
How have other disciplines approached a syndrome that is debilitating to patients and without hard diagnostic markers?
12:05 p.m. – 12:15 p.m.
A Message from the Division Director Robert Star, M.D., Division Director, Kidney, Urologic, and Hematologic Diseases, NIDDK, NIH
Session I: A Call to Action
12:15 p.m. – 12:35 p.m.
Patient and Caregiver Panel Discussion
Moderator: Dawn Edwards, Co-Chair, National Forum of End-Stage Renal Disease Networks, Kidney Patient Advisory Council
Patient: Derek Forfang, Healthcare Advocate, Patient Thought Leader
Caregiver: Julie Ingelfinger, M.D., Deputy Editor, New England Journal of Medicine
Topics for Discussion:
Describe how post-dialysis fatigue (PDF) feels to you.
Describe the burden and impact on your life?
12:35 p.m. – 12:45 p.m.
Audience Questions and Discussion The audience can ask patients and caregivers how PDF feels and affects their lives; Patients and caregivers can provide frank answers.
Session II: The State of the Science and Practice
12:45 p.m. – 1:05 p.m.
Post-Dialysis Fatigue: What Is the Current State of the Science and Medicine?
Rajnish Mehrotra, M.D., Professor of Medicine, University of Washington
Topics for Discussion:
Epidemiology: Prevalence, severity, and demographics
Clinical: Presentation, diagnosis, differential diagnosis, and prognosis
PDF in home therapies: Data from the Frequent Hemodialysis Network Nocturnal Trial and Cohort Study from Lindsay et al.
Epidemiologic mechanisms: What dialysis and patient factors are associated with PDF Dialysis Outcomes and Practice Patterns (DOPPS) Study?
Therapies and best practices: What is the evidence?
Identify the scientific gaps
1:05 p.m. – 1:20 p.m.
Post-Dialysis Fatigue: What Is the Perspective from the Practicing Nephrologist?
Andrew Fenves, M.D., Associate Professor of Medicine, Harvard Medical School
Topics for Discussion:
Describe the current visibility, perception, and management of PDF in real-world practice. Is there a significant mismatch between how health care workers and patients perceive fatigue after hemodialysis?
What is the health care community’s perception of PDF in home-therapy patients? Are there any perceptions that fatigue after hemodialysis is an indication for a modality switch?
What patient, facility, and clinician practice issues do practitioners foresee as barriers to adoption of a new practice or therapy for PDF?
Identify the clinical gaps.
1:20 p.m. – 1:35 p.m.
Audience Questions and Discussion
1:35 p.m. – 1:45 p.m.
Break
Session III: Lessons Learned
1:45 p.m. – 2:05 p.m.
Lessons Learned from Chronic Fatigue Syndrome (CFS)
Dedra Buchwald, M.D., Director and Professor, Institute for Research and Education to Advance Community Health, Washington State University; Past President, American Association of Chronic Fatigue Syndrome (now International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis)
Topics for Discussion:
What is fatigue? What words do patients use? Are they referring to the same things?
What challenges and barriers did the CFS community face and what strategies were effective overcoming these issues to advance the field?
2:05 p.m. – 2:25 p.m.
The Last Battle of the Gulf War: How Did We Scientifically Conquer Gulf War Illness (GWI)?
Robert Haley, M.D., Professor of Medicine and Chief of Epidemiology, U.S. Armed Forces Veterans; Distinguished Chair for Medical Research, The University of Texas Southwestern Medical Center
Topics for Discussion:
Describe the process to uncover and validate an epidemiologic case definition and exposure agent for GWI? How can we apply this approach for PDF when we have no accepted case definition and are unclear of what causes PDF?
Briefly touch on how adjunctive neuroimaging pathology and the discovery of PON1 impacted the science and practice of GFI. How did this affect the patient?
2:25 p.m. – 2:40 p.m.
Audience Questions and Discussion
Breakout Session I
2:40 p.m. – 4:00 p.m.
Breakout Sessions Groups will be moderated by Planning Committee members.
4:00 p.m. – 4:30 p.m.
Summary of Breakout Group Findings Group findings will be presented by each moderator to the full audience.
4:30 p.m.
Adjournment of Day 1
Tuesday, May 23, 2023
Session IV: A Word from Patients
10:45 a.m. – 10:50 a.m.
Title TBD Paul Conway, AAKP Past-President, Chair of the Commonwealth of Virginia’s Renal Disease Council
10:50 a.m. – 11:00 a.m.
Audience Questions and Discussion
Session V: The Science of Quantifying Fatigue
11:00 a.m. – 11:20 a.m.
A Primer on Qualitative Tool Development for PDF
Vanessa Merker, Ph.D., Instructor in Neurology, Mongan Institute, Massachusetts General Hospital, Harvard University Medical School
Topics for Discussion:
Discuss the application of qualitative methods to develop clinical constructs from experiences in psychiatry and rare diseases.
Evaluate the strengths and gaps in existing PDF instruments.
Outline proper methods and outreach to define the population of interest.
Describe a roadmap to establish and validate a clinical construct for PDF.
11:20 a.m. – 11:40 a.m.
Regulatory Roadmap for New Treatments for PDF
David Reasner, Ph.D., Director, Division of Clinical Outcome Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)
Topics for Discussion:
What FDA regulatory issues should we consider in developing a valid instrument for measuring PDF?
What criteria does the FDA use to evaluate a Patient-Reported Outcome (PRO) for PDF for robustness and validity?
How do we establish what constitutes a meaningful change in fatigue from the patient and clinician perspective?
What is the FDA’s current and future position on the Patient-Reported Outcome Measurement Information System (PROMIS®) instrument for measuring fatigue? What are best practices for repurposing PROMIS for the PDF case?
Describe the FDA qualification process for new PRO development.
11:40 a.m. – 12:10 p.m.
At the Cutting Edge: The Forefront of Quantifying PDF
Arthur Stone, Ph.D., Director, Professor of Psychology, University of Southern California Dornsife College of Letters, Arts and Sciences
Topics for Discussion:
Demystify the “state of the art” for quantifying multidimensional fatigue over time and by context.
Describe the evolving science of Ecological Monitoring Assessment and just-in-time interventions.
12:10 p.m. – 12:30 p.m.
Audience Questions and Discussion
Session VI: Social Determinants, Discovery, and Adoption
12:30 p.m. – 12:40 p.m.
Social Factors That May Exacerbate or Reduce Post-Dialysis Fatigue
Sonya Brady, Ph.D., L.P., Associate Professor, Division of Epidemiology and Community Health, University of Minnesota
Topics for Discussion:
Highlight how conditions where people are born, live, learn, work, play, worship, and age could modify how people report fatigue.
12:40 p.m. – 1:00 p.m.
Capitalizing on -Omics to Uncover Mechanisms That Drive Fatigue after Chemotherapy in Outpatients
Kord Kober, Ph.D., Assistant Professor of Physiological Nursing, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco
Topics for Discussion:
Describe how -omics can identify mechanistic pathways for fatigue related to chemotherapy and uncover social factors that modify how fatigue is reported.
1:00 p.m. – 1:20 p.m.
Adoption of New Practices, Therapies, and Quality Metrics for Fatigue at the Centers for Medicare & Medicaid Services (CMS) Susan Miller, M.D., Medical Officer, CMS Stephanie Clark, M.D., M.P.H., Medical Officer, CMS
Topics for Discussion:
Provide a high-level roadmap on how CMS makes a national coverage decision on a new device or therapy for PDF. What data does CMS need to determine if a new treatment or practice is reasonable and necessary?
Provide a high-level roadmap on how CMS develops and adopts quality metric into practice? What data would be helpful to collect from a study to support quality metric development for payors?
1:20 p.m. – 1:30 p.m.
Audience Questions and Discussion
1:30 p.m. – 1:45 p.m.
Break
Breakout Session II
1:45 p.m. – 3:05 p.m.
Breakout Sessions Groups will be moderated by Planning Committee members.
3:05 p.m. – 3:35 p.m.
Summary of Breakout Group Findings Group findings will be presented by each moderator to the full audience.
Conclusion and Adjournment
3:35 p.m. – 4:05 p.m.
Full-room Discussion
4:05 p.m. – 4:20 p.m.
Closing Remarks Dawn Edwards, Co-Chair, National Forum of End-Stage Renal Disease Networks, Kidney Patient Advisory Council
Robert Star, M.D., Division Director, Kidney, Urologic, and Hematologic Diseases, NIDDK, NIH
4:20 p.m.
Adjournment of Day 2
Event Logistics
Registration
Registration Closed
Registration ended
Location
Webinar
The web link required to join the webinar will be distributed via email prior to the date of the event.
