KHI Current Project

Patient Reported Outcomes for Dialysis Vascular Access

Abstract

The overall goal of this project is to further the development of patient-reported tools that measure the impact that vascular access has on the functioning quality of life of patients on hemodialysis.

Deliverables

The working group will produce one or more "white papers" summarizing the findings to catalyze further uptake of access-specific Patient Reported Outcomes (PROs).

Timeline

Summer 2020

Vascular access is a determining factor of outcomes for the more than 700,000 people on dialysis with kidney failure in the US. Access-related clinical events, such as infection and thrombosis, are clear drivers of clinical outcomes and costs, and are well differentiated between access types. While the impact on patients of missing a dialysis session in order to have a clot removed and a catheter placed may be obvious, the full patient experience with the vascular access failure cycle is not well characterized. In addition to the time and resource burden of these events, patients also experience other physical symptoms, social impacts, changes in family relationships, and emotional effects all unique to vascular access which is separate from the general process of hemodialysis.[1-5] Importantly, these health-related quality of life (HRQOL) impacts across different access types are not well established. Reflecting the need for greater patient engagement in research, the SONG-HD group recently published a systematic review of clinical trials in maintenance hemodialysis and showed that PROs were used very infrequently in trials, with only 11% of 168 trials included patient-reported pain measures and only 3% included Quality Of Life (QOL) measures.[6] The SONG-HD group has also advocated for comprehensive measurement of patients' quality of life as a function of the "core measure" of access function.[7]

The project seeks to enhance uptake of access-related PROs by: 1) conducting an assessment of the domains of health-related quality of life, along with detailed impacts, that are affected by vascular access; 2) performing a critical review of available tools and questionnaires that attempt to measure access-related QOL; and 3) identifying any technical gaps between the needs identified in step 1 and existing measures in step 2. Next the working group will identify barriers to optimal use of access-related QOL measures, both historically and in the future. These barriers may involve technical, organizational, regulatory, and financial issues. Hypotheses regarding these barriers will be generated by the working group and these will be evaluated in qualitative interviews with external experts. Based on our literature-based gap assessment and qualitative research on potential barriers to optimal use of PROs, the Working Group will recommend solutions for overcoming barriers and outline study designs to improve the utility of access-related HRQOL measures to future observational studies and clinical trials in hemodialysis.

This project has the following three objectives:

  1. Review domains of HRQOL that are affected by vascular access, collect information on existing instruments, and identify gaps in existing measures.
  2. Assess the barriers to greater use of access-specific HRQOL measures; including funding, sponsorship, regulatory demand, and quality of measures.
  3. Define initiatives to overcome identified barriers and recommend study designs to improve the use of access-specific HRQOL tools in study settings.
Role Name Organization
Co-ChairRobert (Bob) J. Nordyke, PhD, MSBeta6 Consulting
Co-ChairKaren Woo, MD, MS, FACSUniversity of California Los Angeles
MemberRobert A. Fuld, MD, MBA, FACPMid-Atlantic Nephrology Associates
MemberAmanda Grandinetti, MPHKHI Patient and Family Partnership Council
MemberThomas HuberUniversity of Florida
MemberRobert E. Lee, MDU.S. Food and Drug Administration (CDRH)
MemberTerry LitchfieldAccess Solutions
MemberMark P. Ohan, PhDW.L. Gore and Associates, Inc.
MemberJohn Peipert, PhDNorthwestern University
MemberMatthew B. Rivara, MDUniversity of Washington Kidney Research Institute
MemberGlenda V. RobertsUniversity of Washington Kidney Research Institute
MemberMargo UnderwoodBD
Board of Directors LiaisonJeffrey Lawson, MD, PhDHumacyte, Inc.
Staff LiaisonJuanita RogersKidney Health Initiative

References

  1. Hays RD et al. Development of the kidney disease quality-of-life (KDQOL) instrument. Quality of Life Research 1994;3(5): 329-38.
  2. Quinn RR et al. The Vascular Access Questionnaire: assessing patient-reported views of vascular access. The Journal of Vascular Access 2008; 9: 122-128.
  3. Nordyke RJ et al. Vascular access-specific HRQOL impacts among hemodialysis patients: The HARQ project focus group results. Poster Presented at ISPOR 2018, May 19-23, 2018, Baltimore.
  4. Casey JR et al. Patients' perspectives on hemodialysis vascular access: A systematic review of qualitative studies. Am J Kidney Dis 2014;64(6):937-953.
  5. Taylor MJ et al. "You know your own fistula, it becomes a part of you" - Patient perspectives on vascular access: A semi-structured interview study. Hemodialysis International 2016; 20:5-14.
  6. Viecelli AK, et al. Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review. Am J Kidney Dis. 2018 Mar;71(3):382-391.
  7. Viecelli AK, et al. SONG-HD Vascular Access Workshop Investigators. Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop on Establishing a Core Outcome Measure