Vascular access complications are a leading cause of hospitalisations in patients on haemodialysis and are associated with increased mortality, morbidity, and cost. Vascular access complications can also be detrimental to the quality of life for patients on haemodialysis.
The aim of SONG-HD Vascular Access is to develop a core outcome measure for vascular access to be used in all trials involving patients on haemodialysis.
Carmel Hawley (Chair) | Princess Alexandra Hospital, Australia
Kevan Polkinghorne | Monash Medical Centre, Australia
Charmaine Lok | University of Toronto, Canada
Jan Tordoir | Maastricht University, The Netherlands
Pascal Kopperschmidt | Patient partner, Germany
Raymond Vanholder | Ghent University, Belgium
Rob Smith | Patient partner, Australia
Robert Quinn | University of Calgary, Canada
Theodore You | University of Pittsburgh Clinical and Translational Science Institute, United States
Timmy Lee | University of Alabama at Birmingham, United States
Tushar Vachharajani | Hefner VA Medical Center, United States
Lai-Seong Hooi | Hospital Sultanah Aminah, Malaysia
Li Zuo |Peking University People’s Hospital, China
Andrea Viecelli (Project coordinator) | Princess Alexandra Hospital, Australia
1. Review of outcome measures for vascular access outcomes in haemodialysis
A review of all contemporary clinical trials in haemodialysis has shown that vascular access outcomes are very heterogeneous with over 1400 different outcome measures used to report 23 different vascular access outcomes. Vascular access function was the most frequently reported outcome and assessed in nearly 500 different ways, followed by infection and maturation. Patient-reported outcomes including quality of life and pain were reported in a minority of trials. Standardised outcome definitions were rarely used emphasising the need for successful implementation of a standardised core outcome measure for vascular access in haemodialysis research that is considered most critically important by patients, caregivers and health professionals.
An international multi-language online survey to identify the most important vascular access outcomes for trials in haemodialysis was completed by 224 patients/caregivers and 649 health professionals from 58 countries. Vascular access function was rated the most important outcome.
3. SONG-HD Vascular Access Consensus workshop
On Friday 18th November 2016 in Chicago, 59 patients, caregivers and health professionals came together to discuss how to “best” measure vascular access function in trials in patients on haemodialysis. The attendees reviewed the initial results of the review and survey, and contributed their experiences and expertise, which has inform the selection of a core outcome measure which is currently being validated in an international multicentre study called VALID (Vascular Access outcome measure for function: a vaLidation study in haemodialysis).
Attendees* and contributors: Carmel Hawley (Chair)*, Charmaine Lok*, Eric Chemla, Kevan Polkinghorne*, Lai-Seong Hooi*, Li Zuo*, Raymond Vanholder*, Rob Quinn*, Timmy Lee*, Tushar Vachharajani*, Andrea Viecelli*, Jonathan Craig, Brenda Hemmelgarn, Braden Manns*, David Wheeler, John Gill, Peter Tugwell, Sally Crowe, Tess Harris*, Wim Van Biesen, Wolfgang Winkelmayer, Allison Tong*, Nicole Evangelidis, Angela Ju*, Camilla Hanson*, Emma O’lone*, Benedicte Sautenet*, Bharathi Reddy*, Stuart Sprague, Michelle Josephson*, Adeera Levin, Aliza Thompson, Angela Wang*, Anna Porter*, Brigitte Schiller, David Harris, David Johnson*, Dori Schatell*, Eduardo Lacson Jr*, Elena Bavlovlenkov, Fergus Caskey*, Giovanni Strippoli*, Harold Feldman*, Jan Tordoir, Jennifer Flythe, John Kusek*, Kevin Abbott*, Laura Dember*, Lilia Cervantes*, Louise Moist*, Lynn Poole*, Marcello Tonelli*, Maurizio Gallieni*, Meghan Elliot*, Michael Klusmeyer*, Michelle Robbin*, Miguel Riella, Peter Kerr*, Pietro Ravani, Prabir Roy-Chaudhury*, Ronke Apata*, Sharrilyn Evered, Stephan Segerer, Stephen Fadem*, Stephen McDonald*, Suetonia Palmer*, Tammy Poma*, Vanja Sikirica*, Vivek Jha*, Alison Mayers*, Barry Bell*, David Ennis*, David Mayers*, Donald Walker, Harvey Saver, Harvey Wells, Jane Carter*, Kimberly Hardy*, Mary Ennis*, Metarose Johnson*, Michael Thomas, Nieltjie Gedney, Noah Rouse Jr*, Quinetta Taylor, Sarita Wright*, Uthman Muhammad*, Vanessa McNortan*
Next steps: A draft workshop report will be sent to all attendees and contributors early 2017. The next step is to identify and validate a core outcome measure for vascular access in patients on haemodialysis to be used in all trials.