title: Results of human factors testing in a novel Hemodialysis system designed for ease of patient use.
abstract: Introduction Home hemodialysis has not been widely adopted despite superior outcomes relative to conventional in-center hemodialysis. Patients receiving home hemodialysis experience high rates of technique failure owing to machine complexity, training burden, and the inability to master treatments independently. Methods We conducted human factors testing on 15 health care professionals (HCPs) and 15 patients upon release of the defined training program on the Tablo™ Hemodialysis System. Each participant completed one training and one testing session conducted in a simulated clinical environment. Training sessions lasted <3 hours for HCPs and <4 hours for patients, with an hour break between sessions for knowledge decay. During the testing session, we recorded participant behavior and data according to standard performance and safety-based criteria. Findings Of 15 HCPs, 10 were registered nurses and five patient care technicians, with a broad range of dialysis work experience and no limitations other than visual correction. Of 15 patients (average age 48 years), 13 reported no limitations and two reported modest limitations-partial deafness and blindness in one eye, respectively. The average error rate was 4.4 per session for HCPs and 2.9 per session for patients out of a total possible 1,710 opportunities for errors. Despite having received minimal training, neither HCPs nor patients committed safety-related errors that required mitigation; rather, we noted only minor errors and operational difficulties. Discussion The Tablo™ Hemodialysis System is easy to use, and may help to enable self-care and home hemodialysis in settings heretofore associated with high rates of technique failure.
authors.affiliation: Design Science, Philadelphia, Pennsylvania, 19107, USA.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Wilcox
authors.affiliation: Outset Medical, Inc, San Jose, California, 95112, USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Carver
authors.affiliation: Outset Medical, Inc, San Jose, California, 95112, USA.
authors.forename: May
authors.initials: M
authors.lastname: Yau
authors.affiliation: Design Science, Philadelphia, Pennsylvania, 19107, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Sneeringer
authors.affiliation: Independent Consultant, North Palm Beach, Florida, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Prichard
authors.affiliation: Division of Nephrology, Department of Medicine, Palo Alto Medical Foundation, Palo Alto, California, USA.
authors.forename: Luis
authors.initials: L
authors.lastname: Alvarez
authors.affiliation: Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA. gchertow@stanford.edu.
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
mesh_terms: D005260:Female; D006437:Hemodialysis, Home / Q000379:methods*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis / Q000379:methods*; D012648:Self Care
keywords: Home hemodialysis; human factors testing; self-care hemodialysis