A Scientific Workshop on Post-Dialysis Fatigue

Event Details

Background

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., Director, Division of 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.
• How does it differ from other fatigue you have experienced?
• Describe the burden and impact on your life?
• Describe what a “minimal meaningful improvement” in your fatigue would feel like for a new treatment of PDF.

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 and receive frank answers.

Session II: The State of the Science and Practice

12:45 p.m. – 1:05 p.m.

PDF: 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.

PDF: 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 challenges did the field face in medically advancing CFS, a disease without hard diagnostic markers?
• What strategies were most successful at overcoming these barriers? What challenges does the field continue to face?
• What strategies will move the field forward? Please share your lessons learned.

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 for uncovering and validating 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 affected 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. – 3:40 p.m.

Breakout Sessions
Groups will be moderated by Planning Committee members.

3:40 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: 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 for developing clinical constructs from experiences in psychiatry and rare diseases.
• Evaluate the strengths and gaps in existing PDF instruments.
• Outline proper methods and outreach for defining 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 be considered when 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 V: Social Determinants, Discovery, and Adoption

12:30 p.m. – 12:40 p.m.

Social Determinants of Fatigue (pending)
Sonya Brady, Ph.D., L.P., Associate Professor, Division of Epidemiology and Community Health, University of Minnesota

Topics for Discussion:

• Highlight how social determinants of health could affect how dialysis patients differentially experience PDF.
• Does PDF affect the patient’s social environment?

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 interact with social determinants of health.

1:00 p.m. – 1:15 p.m.

Adoption of New Practices and Therapies for Fatigue at the Centers for Medicare & Medicaid Services (CMS)
Shari Ling, M.D., Deputy Chief Medical Officer, CMS

Topics for Discussion:

• From the perspective of the payer, discuss what constitutes a robust yet pragmatic metric that quantifies uptake, adherence, and quality of care of an intervention for PDF adopted into real-world practice.

1:15 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. – 2:50 p.m.

Breakout Sessions
Groups will be moderated by Planning Committee members.

2:50 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
Robert Star, M.D., Director, Division of Kidney, Urologic, and Hematologic Diseases, NIDDK, NIH

4:20 p.m.

Adjournment of Day 2