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Human factors testing of the Quanta SC+ hemodialysis system: An innovative system for home and clinic use

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Introduction: Uptake rates of home hemodialysis are the lowest among all modality types, despite providing patients with clinical and quality of life benefits at a lower cost to providers. Currently, there is a need to develop dialysis systems that are appealing to patients while also being suitable for use across the continuum of care. The SC+ hemodialysis system was developed by Quanta Dialysis Technologies Ltd. to provide patients with a dialysis system that is small, simple to use, and powerful enough to deliver acceptable dialysis adequacy. Methods: As part of the SC+ design validation, human factors testing was performed with 17 Healthcare Professionals (nephrology nurses and healthcare assistants) and 15 Home Users (patients and caregivers). To assess usability and safety, the human factors testing involved between 4.5 and 6 hours of training and, after a period of training decay, a subsequent test session in which participants independently performed tasks on SC+. Findings: Between the two user groups, there were only 29 errors observed out of 1216 opportunities for errors, despite minimal training. Errors that did occur were minor and attributed to an initial lack of familiarity with the device; none were safety related. Discussion: Among prevalent dialysis patients and healthcare professionals, the SC+ hemodialysis system was easy to use, even with minimal training and a learning decay period, and had a high level of use safety. By taking into account human factors to optimize the user experience, SC+ has the potential to address systemic and patient barriers, allowing for wider self‐care and home hemodialysis adoption.
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Hemodialysis International 2019
Original Article
Human factors testing of the Quanta
SC+ hemodialysis system: An innovative
system for home and clinic use
Oksana HARASEMIW,
1,2
Clara DAY,
3
John E. MILAD,
4
James GRAINGER,
4
Thomas FERGUSON,
1,2
Paul KOMENDA
1,2,4
1
Chronic Disease Innovation Centre, Seven Oaks General Hospital,
2
Department of Internal Medicine,
University of Manitoba, Winnipeg, Canada,
3
Department of Renal Medicine, Queen Elizabeth Hospital,
Birmingham and
4
Quanta Dialysis Technologies Ltd., Alcester, UK
Abstract
Introduction: Uptake rates of home hemodialysis are the lowest among all modality types, despite
providing patients with clinical and quality of life benets at a lower cost to providers. Currently,
there is a need to develop dialysis systems that are appealing to patients while also being suitable
for use across the continuum of care. The SC+ hemodialysis system was developed by Quanta Dialy-
sis Technologies Ltd. to provide patients with a dialysis system that is small, simple to use, and
powerful enough to deliver acceptable dialysis adequacy.
Methods: As part of the SC+ design validation, human factors testing was performed with 17
Healthcare Professionals (nephrology nurses and healthcare assistants) and 15 Home Users (patients
and caregivers). To assess usability and safety, the human factors testing involved between 4.5 and
6 hours of training and, after a period of training decay, a subsequent test session in which partici-
pants independently performed tasks on SC+.
Findings: Between the two user groups, there were only 29 errors observed out of 1216 opportu-
nities for errors, despite minimal training. Errors that did occur were minor and attributed to an ini-
tial lack of familiarity with the device; none were safety related.
Discussion: Among prevalent dialysis patients and healthcare professionals, the SC+ hemodialysis
system was easy to use, even with minimal training and a learning decay period, and had a high level of
use safety. By taking into account human factors to optimize the user experience, SC+ has the potential
to address systemic and patient barriers, allowing for wider self-care and home hemodialysis adoption.
Keywords: Home hemodialysis, human factors, usability, quality of life, end-stage renal disease
INTRODUCTION
In 2010, there were approximately 2.6 million individuals
on some form of renal replacement therapy worldwide.
Prevalence is expected to increase to 5.4 million by 2030,
driven by an aging population, increased survival of those
living with end stage renal disease (ESRD), and increasing
rates of diabetes and hypertension.
1
In most developed
countries, the majority of patients with ESRD are treated
with traditional facility-based hemodialysis, typically
administered in an outpatient dialysis facility for sessions of
Correspondence to: P. Komenda, MD, MHA, Chronic
Disease Innovation Centre, 2LB19-2300 McPhillips Street,
Winnipeg, Manitoba, Canada R2V 3M3.
E-mail: pkomenda@sogh.mb.ca
Conict of Interest: John E. Milad and James Grainger are
employees of Quanta Dialysis Technologies Ltd, Alcester,
UK. Paul Komenda and Clara Day are consultant
nephrologists with Quanta Dialysis Technologies Ltd.
Disclosure of grants or other funding: Funding for this study
was provided by Quanta Dialysis Technologies Ltd.
© 2019 The Authors. Hemodialysis International published by Wiley Periodicals, Inc. on behalf of International Society for Hemodialysis.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use,
distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
DOI:10.1111/hdi.12757 1
4 hours, three times a week. This type of treatment can be
burdensome for patients and their support networks, as
well as costly for healthcare payers and patients. In compar-
ison, dialysis offered in the home setting, such as home
hemodialysis (HHD), is a more cost-effective treatment
option in the long term.
2,3
Furthermore, HHD provides
patients with the ability to dialyze more frequently and/or
for longer periods of time on a exible schedule, which is
generally associated with improved outcomes over tradi-
tional thrice-weekly in-center dialysis regimens,
4
and may
also be associated with lower rates of dialysis-related com-
plications, hospitalizations, and mortality.
5,6
Moreover,
HHD also provides patients with greater autonomy and
exibility, allowing them to maintain a normal schedule
without frequent dialysis facility or hospital visits, while
also offering potential quality of life improvements.
7
Despite the benets that HHD offers, uptake rates are
the lowest among all dialysis modality types, with
reported utilization rates of 4.9% of dialysis patients in
Canada,
8
4.4% in the United Kingdom,
9
and 1.9% in the
United States.
10
Compared to facility-based hemodialysis,
HHD can present as a complex treatment method for
patients, and the fear associated with self-managing treat-
ments at home can be a signicant barrier when deciding
on modality type.
11
To improve HHD adoption rates and
procure the associated benets, it is imperative to
develop patient-centered, accessible dialysis systems that
will appeal to patients and encourage them to take con-
trol of their own treatments within the home setting,
while also reassuring nephrology care teams that a wide
scope of patients are capable of effectively and safely per-
forming patient-led care. Such systems should be suitable
for use across the continuum of carefrom dialysis facil-
ities to the hometo allow dialysis programs to balance
and optimize clinical resources and transition patients
from one treatment setting to the other without needing
to modify dialysis systems or treatment prescriptions for
different settings. To specically meet these priorities, the
SC+ was developed by Quanta Dialysis Technologies Ltd
(Quanta) for self-care dialysis treatments within the facil-
ity and home settings.
Human factors testing (HFT) is used during the devel-
opment of consumer products to evaluate how intended
users will interact with new technologies in a real-world
setting and is used in medical device development to
provide insights into systemic factors that may affect
usability and/or patient safety. This provides medical
device manufacturers the opportunity to eliminate or
mitigate potential safety and usability issues before bring-
ing products to market at scale.
12
The primary objective of this report is to present the
results from the HFT performed using the SC+, which
was conducted to critically evaluate whether this device
can be used safely and effectively by prevalent dialysis
patients, caregivers, dialysis nurses, and healthcare assis-
tants within a simulated at-home setting, supported only
by instruction for use (IFU) and minimal training.
MATERIALS AND METHODS
The Quanta SC+ hemodialysis system
The Quanta SC+ hemodialysis system was designed for
self-care use in the home and facility settings, with the
intent to simplify the interactions users have when using
HHD systems. For the HFT described in this report, all
activities occurred using the device pictured in Figure 1.
The device is compact (height: 480 mm x width: 370 mm
x depth: 450 mm) and weighs approximately 35 kg. The
SC+ provides conventional high-ux, bicarbonate
dialysate-based treatments, and like conventional dialysis
systems, it uses standard consumables, including concen-
trates and a dialyzer. The only proprietary elements are
the machine itself and a consumable set consisting of a
nonsterile dialysate cartridge and a sterile blood tube set.
The uidic system is based around a single-use disposable
cartridge to generate dialysate uid on demandachieved
by dosing and mixing water and concentrates on the
cartridgeand to accurately pump and deliver high
Figure 1 Quanta SC+ system, original design. [Color gure
can be viewed at wileyonlinelibrary.com]
Harasemiw et al.
2Hemodialysis International 2019
dialysate ow rates at 500 mL/min. This approach pro-
vides several benets: enabling a smaller, lighter form fac-
tor of the machine, simplifying set-up and tear-down of
consumables required for each treatment, negating the
need for disinfection of the machine between treatments,
and eliminating the need for regular descaling.
The SC+ is compatible with commonly used water
sources used for dialysis treatments, including central
water purication plants and ring-mains typically used in
clinics and stand-alone reverse osmosis water purication
devices used in home settings. This approach allows the
system to provide virtually unlimited volumes of dialy-
sate per treatment, avoiding the volume restrictions of
other HHD systems. The SC+ features a touchscreen
graphical interface that displays step-by-step instructions
to control the functionality of the device to aid the
patients progression through treatment and to provide
onscreen guidance for resolving alarms. The layout of the
interface, screen progression, and menu hierarchy were
designed to be uncluttered and intuitive, with a focus on
simplifying the information presented to streamline
workows. An accompanying IFU manual was developed
to be used both as training material as well as a reference
for troubleshooting.
Participants
Participants in this study consisted of two groups of
users: (1) Healthcare Professionals, including dialysis
nurses and healthcare assistants, who would typically
manage hemodialysis devices in a facility setting or pro-
vide HHD training to patients; and (2) Home Users,
including current dialysis patients and their caregivers.
All users had no previous training or experience using
the SC+ system. The participants were recruited from
across the United Kingdom, with study activities occur-
ring over July and August 2016 at Smethwick Dialysis
Centre in Birmingham, United Kingdom, and included
32 individuals17 in group 1 (the Healthcare Profes-
sionals), and 15 in Group 2 (the Home Users).
Human factors testing
The HFT process involved a training phase followed by a
training decay phase and an evaluation phase. One-to-
one training was provided to subjects by qualied
instructors who advised participants on how to use the
device using a predened training program. After a train-
ing decay period, a standardized testing session was con-
ducted to evaluate each subjects competency in
performing the tasks required to operate the device.
Testing environment and protocol
The study consisted of a series of three, 2-hour training
sessions for the Home Users and one 4.5-hour training
session for the Healthcare Professionals. After training and
prior to the evaluation session, there was a period of 3 to
9 days of training decay with the Home Users and 1 to
12 days with the Healthcare Professionals. The testing
method employed in this study was adapted from IEC
62366-1:2015
13
and ANSI/AAMI HE75:2009.
14
Each par-
ticipant provided informed consented to participate in the
study and was trained by personnel from Quanta. Given
that the HFT was used with an approved device, with low
risk observations, ethics board approval was not sought.
The test room was consistent for each test session and
was set up to adequately imitate a home environment,
with the SC+ device as the focal point (Figure 2). Each
participant received training on how to operate the SC+
system. The HFT assessed all tasks required to effectively
set up, operate, and shut down the system, including
handling and disposing of the consumable items and
responding to alarms. Altogether, 34 individual subtasks
related to administering dialysis treatment needed to be
completed, as well as an additional four subtasks related
to comprehension of the IFU. For analyses, the 38 subtasks
were subsequently grouped into 15 broad task categories.
A study protocol provided detailed information on the
testing methods, the testing equipment, the device and
the consumables, as well as the evaluation criteria
(Supporting Information Appendix S1). Table 1 lists the
risk assessment terms and denitions used to evaluate
the participants. Each participant was observed and then
scored according to the pre-specied criteria. Five
Figure 2 Test room set-up for Human Factors Testing of
the Quanta SC+ home hemodialysis system [Color gure
can be viewed at wileyonlinelibrary.com]
Human factors testing of the SC+
Hemodialysis International 2019 3
descriptive criteria were used to evaluate the degree to
which participants attempted and completed each of the
subtasks. If a participant successfully completed a
subtask as per instructions within 10 minutes of begin-
ning the attempt, the attempt was recorded as a Suc-
cess.If a participant managed to eventually complete a
subtask as intended, but either deviated from the instruc-
tions, or had difculties with completing the subtask
without any potential implications for safety, then this
was recorded as a Success with Difculty.For all sub-
tasks attempted but not successfully completed by a par-
ticipant, the evaluator classied the outcome into one of
three categories. If the participant encountered initial use
errors preventing task completion, but managed to nish
the subtask as intended by self-correcting (e.g., by refer-
ring to the IFU), this was classied as a Close Call.
When a participant deviated from the IFU and was
unable to complete a subtask as intended, or when the
subtask attempt itself was halted by the lead investigator,
this was categorized as a Use Error.Attempts recorded
as a Close Call or Use Error were initially treated as
potentially safety related; these were then subsequently
assessed using an impact analysis to make a nal safety
assessment. If it was not possible to complete a subtask
(e.g., due to a use error in a preceding step), then the
subtask was recorded as Unperformedand the users
comprehension of this task was assessed verbally.
RESULTS
Demographic characteristics
Table 2 presents the demographic characteristics of the
participants. Of the 17 Healthcare Professionals participat-
ing in the study, 13 were dialysis nurses, and 4 were
healthcare assistants. The group had a mean age of
42.5 years (with a range of 2552 years), 70.6% were
female, and had a mean of 9.6 years (with a range of
119 years) working in dialysis. In the Home Users group,
there were 15 individuals: 7 caregivers and 8 patients. This
group had a mean age of 43.7 years (range of
1976 years), 46.7% of the group was female, and the
group had a mean number of 4.65 years of dialysis experi-
ence (range of 2 months19 years). The mean testing ses-
sion length was 75.5 minutes (range of 5599 minutes)
for the Healthcare Professionals, and 99.5 minutes (range
of 78132 minutes) for the Home Users.
Results of the human factors testing
Tables 3 and 4 present the results of the HFT evaluation,
showing how well participants in the Healthcare Profes-
sionals group and Home Users group performed the vari-
ous subtasks within the 15 major task categories. Each of
Table 1 Risk assessment terms and their denitions
Term Denitions
Success The participant was able to complete
a task as requested without any
issues, completely as per the
instructions.
Success
with difculty
The participant managed to
eventually complete the task as
intended, but either deviated from
the instructions for small subtasks
or in sequencing, or had
difculties in completing the task,
without a potential implication for
safety.
Close call The participant encountered initial
use errors that did not result in an
outcome, but managed to
complete the task as intended by
self-correcting (using the
instructions).
Use error The participant deviated from the
instructions and was unable to
complete the task as intended, or
the task attempt itself was halted
by the lead investigator.
Unperformed
task
A task that was not completed either
because of a previous use error
(i.e., sequence error), or for
another reason.
Table 2 Participant demographic characteristics
Healthcare Professionals (n = 17)
Renal nurses n = 13
Healthcare assistants n = 4
Mean age
a
42.5 y old (2552 y)
Sex (% females) 70.6%
Mean number of years
of dialysis experience
a
9.6 y (119 y)
Mean testing session length
a
75.3 min (5599 min)
Home Users (n = 15)
Caregivers n = 7
Patients n = 8
Mean age
a
43.7 y old (1976 y)
Sex (% females) 46.7%
Mean number of years
of dialysis experience
a
4.65 y (2 mo-19 y)
Mean testing session length
a
99.5 min (78132 min)
a
Range presented in brackets.
Harasemiw et al.
4Hemodialysis International 2019
the 32 participants was required to complete 38 individual
subtasks, for a total of 1216 potential tasks to be com-
pleted: 646 by the Healthcare Professionals and 570 by the
Home Users. Between the two user groups, there were
28 use errors (2.3%) and 1 close call (0.1%), for a total of
29 errors observed (2.4%).
In the Healthcare Professionalsgroup, 11 subtasks
(1.7%) were unperformed, as were 5 subtasks (0.9%) in
the Home Usersgroup. These were largely due to
unrecoverable technical issues where the machine ended
the treatment as intended to protect the patient, resulting
in aspects of the session being skipped. In these situations,
performance for subsequent subtasks was evaluated by ask-
ing the participants to report the steps following the error,
and to provide an account of what they would do. None of
these technical issues were assessed as being safety related.
Table 3 Summary of recorded observations for the Healthcare Professionals group (n = 646 potential task attempts)
Task category Success
Success with
difculties Close call Use error Unperformed
Task 1: Turning on SC+ 17 0 0 0 0
Tasks 24: Selecting dialyses mode 48 3 0 0 0
Tasks 56: Assembling consumables 33 1 0 0 0
Tasks 79: Loading the blood line 37 14 0 0 0
Tasks 1017: Loading dialysate lines 120 11 0 1 4
Tasks 1820: Priming 37 14 0 0 0
Tasks 2123: Connecting the patient 43 7 0 1 0
Task 24: Starting treatment 16 1 0 0 0
Task 25: Responding to the low arterial pressure alarm 15 2 0 0 0
Task 26: Responding to the high venous pressure alarm 12 4 0 0 1
Task 27: Responding to the air in the blood alarm 7 7 0 2 1
Tasks 2831: Ending treatment 55 8 0 0 5
Task 32: Disposing of consumables 11 6 0 0 0
Task 33: Manual washback 13 2 0 2 0
Tasks 3438: Comprehension
of the instructions manual
80 5 0 0 0
Total 544 85 0 6 11
Table 4 Summary of recorded observations for the Home Users (patients and caregivers) group (n = 570 potential task
attempts)
Task category Success
Success with
difculties Close call Use error Unperformed
Task 1: Turning on SC+ 15 0 0 0 0
Tasks 24: Selecting dialyses mode 42 3 0 0 0
Tasks 56: Assembling consumables 26 4 0 0 0
Tasks 79: Loading the blood line 33 9 1 2 0
Tasks 1017: Loading dialysate lines 105 13 0 1 1
Tasks 1820: Priming 33 11 0 0 1
Tasks 2123: Connecting the patient 23 19 0 3 0
Task 24: Starting treatment 14 1 0 0 0
Task 25: Responding to the low arterial pressure alarm 14 1 0 0 0
Task 26: Responding to the high venous pressure alarm 7 7 0 1 0
Task 27: Responding to the air in the blood alarm 3 5 0 7 0
Tasks 2831: Ending treatment 44 12 0 3 1
Task 32: Disposing of consumables 10 3 0 0 2
Task 33: Manual washback 5 8 0 2 0
Tasks 3438: Comprehension
of the instructions manual
64 8 0 3 0
Total 438 104 1 22 5
Human factors testing of the SC+
Hemodialysis International 2019 5
Healthcare Professionals
Out of 646 potential tasks for the Healthcare Profes-
sionals group, six use errors were observed across four
task categories, producing an error rate of 0.9%. None of
these errors were assessed as being safety related. One
error occurred in the category Loading the dialysate
lines,as well as one in the category Connecting the
patient.Two use errors occurred in each of the follow-
ing categories: Responding to the air in the blood alarm
and Manual washback.
Home Users (patients and caregivers)
Out of 570 potential tasks for the patient and caregiver
group, 22 (3.9%) use errors were observed across eight
task categories. In addition, there was 1 close call (0.1%),
providing a total of 23 errors observed (4.0%).
Three errors occurred in the category Loading the
blood lines; one was a close call,and the other two
were use errors. In the Loading the dialysate linescate-
gory, one use error occurred, whereas three use errors
occurred in the Connecting the patientcategory. One
use error occurred during the task of Responding to a
high venous pressure alarm.The task category where
the highest number of use errors occurred was in the cat-
egory of Addressing the air in the blood alarm”—a total
of seven participants performed this subtask with a use
error. Three use errors were observed during the task
category Ending the treatment,while two use errors
occurred in the Manual washbackcategory. Lastly, dur-
ing the tasks evaluating the Comprehension of the
instructions for use,three use errors occurred. Subse-
quent risk analyses of all errors determined that none of
the observed errors were safety related.
DISCUSSION
Using a well-characterized HFT protocol and dened
evaluative criteria, SC+ has demonstrated excellent levels
of user safety and competency, despite minimal up-front
training and signicant training decay time. The SC+ sys-
tem achieved an overall task-specic success rate of
97.4% among Healthcare Professionals, and 95.1%
among Home Users. The vast majority of the errors made
were attributed to an initial lack of familiarity with the
device, rather than safety-related design aws.
Issues highlighted in this study have led to usability
improvements for SC+, resulting in an updated design of
the device (Figure 3). Specically, this includes a new
design for the graphic user interface, improved color cod-
ing of the consumables and clamps, repositioning of the
treatment drain to a higher location on the rear door and
optimizations to the air in bloodalarm. Furthermore, an
important component of the HFT included evaluating
participantscomprehension of the instructions for use,
and by extension, evaluating their health literacy as it
relates to risk management. For the majority of the use
errors that occurred in the two user groups, changes were
made to the IFU and/or the training documentation to
clarify proper procedures, such as how to properly con-
nect the two saline bags and how to resolve the air in the
blood alarms.
Despite being a cost-effective treatment option that may
improve patientshealth and psychosocial outcomes,
1517
HHD has relatively low uptake rates in many developed
countries.
18
When deciding on which modality type to
pursue, patients value autonomy, as well as quality and
quantity of life as the most pivotal factors.
19,20
However,
there are a number of barriers that have the potential to
prevent patients from choosing HHD, including being
wary of medicalizingtheir homes, wanting trained medi-
cal personnel to deliver treatments because of fears associ-
ated with making errors,
19
as well as not having the
physical space within their homes to store the dialysis sys-
tem and equipment.
21
Additionally, low HHD uptake rates
may also partially be a reection of the dialysis populations
high rates of multiple comorbidities and their social charac-
teristics that can impact their ability to self-manage dialysis
treatments at home. For example, 55% of the dialysis pop-
ulation has some form of diabetes,
8
which in turn is associ-
ated with peripheral neuropathy, carpal tunnel syndrome,
arthritis, and macular degeneration. Additionally, given that
the overall mean age at dialysis initiation is approximately
64 years old,
8
rates of cognitive impairment are estimated to
affect a signicant proportion of dialysis patients;
2224
cogni-
tive impairment affects a persons judgment and dexterity,
Figure 3 Quanta SC+ system, updated design. [Color gure
can be viewed at wileyonlinelibrary.com]
Harasemiw et al.
6Hemodialysis International 2019
hindering their ability to self-manage complicated HHD
systems. Moreover, although self-care can promote self-
empowerment, an individuals support network often
needstobeinvolvedinapatients care; and indeed this is
reected in several studies that suggest home dialysis
users tend to be younger and married or cohabitating,
with fewer comorbidities.
6,25,26
Given low uptake rates of HHD in developed countries,
it is imperative for the design of HHD systems to address
the needs of patients and caregivers of different ages and
abilities to help overcome some of these barriers and suc-
cessfully increase HHD uptake. SC+ was designed with
the intention of being a simple HHD system that delivers
adequate dialysis power when compared to traditional
hemodialysis systems, while having a compact size and an
approachable appearance, so that patients can integrate
the system within their homes with ease, without neces-
sarily overly medicalizingthe home environment. Fur-
thermore, to make facility-based self-care HD and HHD
more accessible to a wider range of patients, SC+ was
designed as a user-friendly, easy to learn, and easy to use
system. In this HFT study, SC+ demonstrated that a broad
spectrum of prevalent patients and caregivers can easily
learn how to use this new dialysis platform, even with
minimal training and after experiencing signicant training
decay. SC+ was also meant to be adaptable for use across
the continuum of carefrom in-center HD, to self-care
within a facility, to self-care at hometo allow for patients
to transition between care settings with ease.
Before arriving to market, new medical technologies
generally undergo rigorous testing during their develop-
ment stages to ensure that the technology is safe, easy to
use, and appealing to patients. HFT is one methodology
that allows manufacturers and researchers to observe
how real users naturally behave with technology, which
is especially pertinent during the design validation of
HHD systems to avoid training and technique failures
attributed to system design aws. Similar methodologies
have been employed for other HHD systems to assess the
clinical safety and performance of the systems within
controlled clinical environments prior to roll-out in
home settings. For example, HFT was conducted for the
recently developed Tablo hemodialysis system with
Healthcare Professionals and patients.
27
This HFT study does have certain limitations; although
the home is the principle target environment for use of SC
+, usability testing is difcult to execute in the home.
However, our simulated home environment was deemed
an adequate representation, particularly because it
included similar distractions that would be found in a
home, such as televisions, noise from patients and staff,
and variation in lighting conditions (i.e., bright sunlight
hitting the screen, as well as low ambient lighting condi-
tions). Furthermore, the average age of our patient sample
was younger than the average age of patients starting dial-
ysis, limiting generalizability. As well, our study popula-
tion only included prevalent patients and caregiversnot
naïve users. Additionally, although this HFT study was
cross-sectional, further longitudinal clinical testing is cur-
rently ongoing to evaluate the clinical usability and safety
of the SC+. This is in addition to formative usability stud-
ies that were performed prior to the HFT conducted in
this current study, which identied safety issues that led
to redesigning of various aspects of SC+, such as enhanced
labeling and revised instructions, to ensure that the nal
design of the device is optimized for human factors.
In conclusion, the HFT results presented in this report
demonstrate that, with minimal training, the SC+ hemo-
dialysis system is easy to use and has acceptable user
safety with intended users. We anticipate that the simple,
easy to use design of the SC+ might make HHD a more
appealing treatment option for a broader range of
patients, some of whom might otherwise choose facility-
based hemodialysis. Therefore, bringing the SC+ hemodi-
alysis system to market has the potential to support the
growing movement of shifting dialysis care from the clin-
ical setting into the home, in turn enhancing patients
quality of life, while mitigating the cost burden associated
with facility-based dialysis.
Manuscript received November 2018; revised February
2019; accepted March 2019.
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SUPPORTING INFORMATION
Additional supporting information may be found online
in the Supporting Information section at the end of the
article.
Appendix S1 Supporting Information.
Harasemiw et al.
8Hemodialysis International 2019
... Quanta Dialysis Technologies has developed SC+, a compact personal hemodialysis system designed and validated as easy to use by patients with a low user error rate after minimal training. 8 A key purported differentiator of the Quanta SC+ hemodialysis system is its ability to be used across a continuum of hemodialysis prescriptions, from conventional 3 times per week, as typically experienced by most patients globally, to the clinically preferred frequent and long prescriptions. The primary objective of this study was to demonstrate the safety and efficacy of the SC+ system in a clinical setting using conventional thriceweekly hemodialysis prescriptions. ...
... Previously published human factors testing work validates the design principles of the SC+ system in terms of patient usability with minimal training. 8 For this reason, the SC+ system is a well-suited hemodialysis device for patient use across a wide range of dialysis prescriptions in the home and in facilities. The device requires reverse-osmosis quality water and can be simply installed into the ring main of a dialysis clinic or with a single-station reverse-osmosis unit. ...
Article
Full-text available
Rationale & Objective Most patients with kidney failure receive hemodialysis 3 times per week in a facility. More frequent and longer duration dialysis prescriptions improve a number of key outcome measures. These prescriptions are best suited to self-care and home regimens. The Quanta SC+ hemodialysis system is a novel device with demonstrated ease of use for patients and health care practitioners through human factors testing. The primary objective of this study is to report the efficacy and safety of the SC+ system using conventional hemodialysis prescriptions. Study Design Nonrandomized observational study. Setting & Participants Prevalent hemodialysis patients in 4 sites in the United Kingdom were recruited to switch from their current device to the SC+ system with no other changes to their prescription. Interventions SC+ hemodialysis system. Outcomes Efficacy data were collected in terms of dialysis adequacy, urea reduction ratios, and net fluid removal accuracy. Results 60 patients were enrolled in the study, resulting in 1,333 evaluable treatments. The threshold single-pool Kt/V of 1.2 was exceeded in 96.6% of treatments in patients receiving 3-times-weekly regimens, whereas the threshold standard Kt/V of 2.1 was exceeded in 94% of treatments and 97.6% of treatments in patients without significant residual kidney function. Ultrafiltration accuracy was determined by measuring net fluid removal and validated to be within acceptable limits. The adverse event profile during treatment was typical of hemodialysis. There were no serious adverse events. Limitations Few patients on high-frequency treatment regimens were enrolled. Conclusions The SC+ system delivers safe and effective hemodialysis across a range of patients and dialysis prescriptions. It is one of the smallest systems available and has validated usability for patients to perform self-care safely with minimal training. This device may encourage patients to feel empowered to take on home hemodialysis, unlocking beneficial clinical and patient-reported outcomes associated with these modalities.
... Although some have been adapted for home use, more recently manufacturers have begun focusing on machines specifically developed for home therapy use and patient operation [11,12]. Such an approach has necessitated an improved understanding of industrial design, human factors and ergonomics to ensure that the burden of undertaking treatment in the home is reduced for the patient and their care partner [13,14]. ...
Article
Full-text available
Background and objective The SC+ haemodialysis system developed by Quanta Dialysis Technologies is a small, easy-to-use dialysis system designed to improve patient access to self-care and home haemodialysis. A prototype variant of the standard SC+ device with a modified fluidic management system generating a pulsatile push-pull dialysate flow through the dialyser during use has been developed for evaluation. It was hypothesized that, as a consequence of the pulsatile push-pull flow through the dialyser, the boundary layers at the membrane surface would be disrupted, thereby enhancing solute transport across the membrane, modifying protein fouling and maintaining the surface area available for mass and fluid transport throughout the whole treatment, leading to solute transport (clearance) enhancement compared to normal haemodialysis (HD) operation. Methods The pumping action of the SC+ system was modified by altering the sequence and timings of the valves and pumps associated with the flow balancing chambers that push and pull dialysis fluid to and from the dialyser. Using this unique prototype device, solute clearance performance was assessed across a range of molecular weights in two related series of laboratory bench studies. The first measured dialysis fluid moving across the dialyser membrane using ultrasonic flowmeters to establish the validity of the approach; solute clearance was subsequently measured using fluorescently tagged dextran molecules as surrogates for uraemic toxins. The second study used human blood doped with uraemic toxins collected from the spent dialysate of dialysis patients to quantify solute transport. In both, the performance of the SC+ prototype was assessed alongside reference devices operating in HD and pre-dilution haemodiafiltration (HDF) modes. Results Initial testing with fluorescein-tagged dextran molecules (0.3 kDa, 4 kDa, 10 kDa and 20 kDa) established the validity of the experimental pulsatile push-pull operation in the SC+ system to enhance clearance and demonstrated a 10 to 15% improvement above the current HD mode used in clinic today. The magnitude of the observed enhancement compared favourably with that achieved using pre-dilution HDF with a substitution fluid flow rate of 60 mL/min (equivalent to a substitution volume of 14.4 L in a 4-hour session) with the same dialyser and marker molecules. Additional testing using human blood indicated a comparable performance to pre-dilution HDF; however, in contrast with HDF, which demonstrated a gradual decrease in solute removal, the clearance values using the pulsatile push-pull method on the SC+ system were maintained over the entire duration of treatment. Overall albumin losses were not different. Conclusions Results obtained using an experimental pulsatile push-pull dialysis flow configuration with an aqueous blood analogue and human blood ex vivo demonstrate an enhancement of solute transport across the dialyser membrane. The level of enhancement makes this approach comparable with that achieved using pre-dilution HDF with a substitution fluid flow rate of 60 mL/min (equivalent to a substitution volume of 14.4 L in a 4-hour session). The observed enhancement of solute transport is attributed to the disruption of the boundary layers at the fluid-membrane interface which, when used with blood, minimizes protein fouling and maintains the surface area.
Article
Introduction New personal hemodialysis systems, such as the quanta SC+, are being developed; these systems are smaller and simpler to use while providing the clearances of conventional systems. Increasing the uptake of lower-intensity assistance and full self-care dialysis may provide economic benefits to the public health payer. In the United Kingdom, most hemodialysis patients currently receive facility-based dialysis costing more than £36,350 per year including patient transport. As such, we aimed to describe the annual costs of using the SC+ hemodialysis system in the United Kingdom for 3×-weekly and 3.5×-weekly dialysis regimens, for self-care hemodialysis provided both in-center and at home. Methods We applied a cost minimization approach. Costs for human resources, equipment, and consumables were sourced from the dialysis machine developer (Quanta Dialysis Technologies) based upon discussions with dialysis providers. Facility overhead expenses and transport costs were taken from a review of the literature. Findings Annual costs associated with the use of the SC+ hemodialysis system were estimated to be £26,642 for hemodialysis provided 3× weekly as home self-care; £30,235 for hemodialysis provided 3× weekly as self-care in-center; £29,866 for hemodialysis provided 3.5× weekly as home self-care; and £36,185 for hemodialysis provided 3.5× weekly as self-care in-center. Discussion We found that the SC+ hemodialysis system offers improved cost-effectiveness for both 3×-weekly and 3.5×-weekly self-care dialysis performed at home or as self-care in-center versus fully assisted dialysis provided 3× weekly with conventional machines in facilities.
Article
Home hemodialysis (HD) is growing in the United States, but the economics of the modality are largely unknown, especially considering the unique aspects of home HD in the United States . In this review, I focus on details of Medicare coverage, which directly applies to most patients on dialysis and influences the policies of private insurers. Key details in Medicare comprise the relationship between home dialysis training and initial Medicare eligibility, reimbursement for home HD training, coverage of additional HD treatments (ie., in excess of 3 treatments per week), and monthly capitated payments to nephrologists. The overarching narrative is that frequent home HD directly increases Medicare costs for outpatient dialysis, but these added costs can be mitigated by lower inpatient expenditures if increased HD treatment frequency lowers the risk of cardiovascular hospitalization and infection control is emphasized. I also review recent international literature; conventional home HD exhibits a superior cost profile, whereas frequent home HD is generally cost-effective over multiple treatment years (ie, if early technique failure is avoided). Out-of-pocket expenses for patients should be considered. The future economics of home HD in the United States will be determined by new equipment, new adaptations of the modality, and new payment models.
Article
Providing home hemodialysis (HHD) therapy is a complex process that not only requires the use of a complex technology but also involves a diverse group of stakeholders, and each stakeholder has their requirements and may not share a common interest. Bringing them together will require the alignment of their interests. A process management perspective can help to accomplish the alignment of their interests. To align their interests, it is crucial to identify interest groups and understand their interests. The main objective of this paper is to identify the stakeholders and represents their interests as a list of requirements in the HHD process. An extensive literature review has been carried out and PubMed was used for literature extraction. In total, 1848 articles were retrieved of which 80 have fulfilled the inclusion criteria. A large array of actors is identified and their interests/requirements at different stages of the HHD process are represented in the form of a list. They have both common and conflicting requirements in the HHD process. If these requirements are aligned and balanced, a stakeholder's driven treatment process will be developed and a real improvement will be achieved in the treatment process.
Chapter
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İntradiyalitik komplikasyonlar hemodiyaliz tedavisinin en önemli komplikasyonlarından birisidir ve kardiyovasküler morbidite ve mortalite ile ilişkilidir. İntradiyalitik komplikasyonlar arasında yer alan hipotansiyon, hipertansiyon, kas krampları, kaşıntı, bulantı ve kusma yaşam kalitesini önemli ölçüde etkiler ve temelinde kilo artışı, kuru ağırlıktaki yetersiz yönetim, diyaliz esnasında beslenmenin sürdürülmesi, diyaliz süresi, diyalizat içeriği, ultrafiltrasyon hızı, diyalizat ısısı ve ilaç uyumsuzluğu gibi faktörler yer alır. İntradiyalitik komplikasyonların önlenmesinde hasta izlemi, tanılama ve müdahale edebilme çok önemlidir. Hemşirenin intradiyalitik süreçte bilgi düzeyi ve müdahale yeteneği hemodiyalizde bakımın kalitesini artırır ve tedavinin başarı ile sürdürülme olanağını sağlar.
Article
Background Fluid management is integral to hemodialysis, both to correct abnormalities in a patient’s plasma composition and to maintain fluid balance. Consequently, accurate net fluid removal during treatment is a critical design element of hemodialysis machines. As dialyzers have evolved, with increased range of ultrafiltration coefficients available, it has become more challenging for dialysis machines to minimize errors in flow balance and net fluid removal. Research design and methods This paper describes the design, evaluation and experimental performance of the flow balance and ultrafiltration module of the SC+ system to deliver clinically specified fluid removal with both passive and active control measures, in laboratory conditions designed to simulate a wide range of therapies. Results The use of passive and active control allows the errors to be minimized across a wider dynamic range of conditions. For the SC+ system, the average flow balance error was 1 mL/hr with an SD of 19 mL/hr and with ultrafiltration it was 13 mL/hr and an SD of 20 ml/hr across all conditions. Conclusions This paper demonstrates that the SC+ hemodialysis system, a small, simple and versatile CE marked device, operates within the limits required by international standards across a wide range of experimental conditions.
Chapter
This chapter presents context for the need for better designed technologies within and outside of healthcare settings to support the increasing needs of ageing populations, and provides a model and exemplars through which technology development can have a greater impact.
Article
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There were 63,162 adult patients receiving renal replacement therapy (RRT) in the UK on 31 December 2016, an absolute increase of 3.1% from 2015. The actual number of patients increased by 0.9% for haemodialysis (HD), 5.1% for those with a functioning transplant and less than 0.1% for peritoneal dialysis (PD). The UK adult prevalence of RRT was 962 per million population (pmp). The reported prevalence in 2000 was 523 pmp. The number of patients receiving home HD increased slightly from 1,175 patients in 2015 to 1,256 patients in 2016. In 2016 the median age of prevalent patients was 59 years (HD 67 years, PD 64 years, transplant 54 years). In 2000 the median age was 55 years (HD 63 years, PD 58 years, transplant 48 years). The percentage of RRT patients aged greater than 75 years in 2016 was 16.0%. For all ages, RRT prevalence in men exceeded that in women, peaking in age group 80-84 years at 3,072 pmp in men and in the 70-74 years age group at 1,657 pmp in women. The most common identifiable renal diagnosis was glomerulonephritis (19%), followed by diabetes (17%), other (17%) and aetiology uncertain (15%). Transplantation continued as the most common treatment modality (54%), HD was used in 40% and PD in 6% of RRT patients.
Article
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Background/aim: Home hemodialysis (HHD) has been associated with improved clinical outcomes vs. in-center HD (ICHD). The prevalence of HHD in the United States is still very low at 1.8%. This critical review compares HHD and ICHD outcomes for survival, hospitalization, cardiovascular (CV), nutrition, and quality of life (QoL). Methods: Of 545 publications identified, 44 were not selected after applying exclusion criteria. A systematic review of the identified publications was conducted to compare HHD to ICHD outcomes for survival, hospitalization, CV outcomes, nutrition, and QoL. Results: Regarding mortality, 10 of 13 trials reported 13-52% reduction; three trials found no differences. According to 6 studies, blood pressure and left ventricular size measurements were generally lower in HHD patients compared to similar measurements in ICHD patients. Regarding nutritional status, conflicting results were reported (8 studies); some found improved muscle mass, total protein, and body mass index in HHD vs. ICHD patients, while others found no significant differences. There were no significant differences in the rate of hospitalization between HHD and ICHD in the 6 articles reviewed. Seven studies on QoL demonstrated positive trends in HHD vs. ICHD populations. Conclusions: Despite limitations in the current data, 66% of the publications reviewed (29/44) demonstrated improved clinical outcomes in patients who chose HHD. These include improved survival, CV, nutritional, and QoL parameters. Even though HHD may not be preferred in all patients, a review of the literature suggests that HHD should be provided as a modality choice for substantially more than the current 1.8% of HHD patients in the United States.
Article
Full-text available
Background: Survival and hospitalization are critically important outcomes considered when choosing between intensive hemodialysis (HD), conventional HD, and peritoneal dialysis (PD). However, the comparative effectiveness of these modalities is unclear. Objective: We had the following aims: (1) to compare the association of mortality and hospitalization in patients undergoing intensive HD, compared with conventional HD or PD and (2) to appraise the methodological quality of the supporting evidence. Data sources: MEDLINE, Embase, ISI Web of Science, CENTRAL, and nephrology conference abstracts. Study eligibility participants and interventions: We included cohort studies with comparator arm, and randomized controlled trials (RCTs) with >50% of adult patients (≥18 years) comparing any form of intensive HD (>4 sessions/wk or >5.5 h/session) with any form of chronic dialysis (PD, HD ≤4 sessions/wk or ≤5.5 h/session), that reported at least 1 predefined outcome (mortality or hospitalization). Methods: We used the GRADE approach to systematic reviews and quality appraisal. Two reviewers screened citations and full-text articles, and extracted study-level data independently, with discrepancies resolved by consensus. We pooled effect estimates of randomized and observational studies separately using generic inverse variance with random effects models, and used fixed-effects models when only 2 studies were available for pooling. Predefined subgroups for the intensive HD cohorts were classified by nocturnal versus short daily HD and home versus in-center HD. Results: Twenty-three studies with a total of 70 506 patients were included. Of the observational studies, compared with PD, intensive HD had a significantly lower mortality risk (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.53-0.84; I2 = 91%). Compared with conventional HD, home nocturnal (HR: 0.46; 95% CI: 0.38-0.55; I2 = 0%), in-center nocturnal (HR: 0.73; 95% CI: 0.60-0.90; I2 = 57%) and home short daily (HR: 0.54; 95% CI: 0.31-0.95; I2 = 82%) intensive regimens had lower mortality. Of the 2 RCTs assessing mortality, in-center short daily HD had lower mortality (HR: 0.54; 95% CI: 0.31-0.93), while home nocturnal HD had higher mortality (HR: 3.88; 95% CI: 1.27-11.79) in long-term observational follow-up. Hospitalization days per patient-year (mean difference: -1.98; 95% CI: -2.37 to -1.59; I2 = 6%) were lower in nocturnal compared with conventional HD. Quality of evidence was similarly low or very low in RCTs (due to imprecision) and observational studies (due to residual confounding and selection bias). Limitations: The overall quality of evidence was low or very low for critical outcomes. Outcomes such as quality of life, transplantation, and vascular access outcomes were not included in our review. Conclusions: Intensive HD regimens may be associated with reduced mortality and hospitalization compared with conventional HD or PD. As the quality of supporting evidence is low, patients who place a high value on survival must be adequately advised and counseled of risks and benefits when choosing intensive dialysis. Practice guidelines that promote shared decision-making are likely to be helpful.
Article
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Rachael C Walker,1,2 Kirsten Howard,1 Rachael L Morton3 1School of Public Health, Sydney Medical School, University of Sydney, Sydney, Australia; 2Hawke’s Bay District Health Board, Hastings, New Zealand; 3NHMRC Clinical Trials Centre, Sydney Medical School, University of Sydney, Sydney, Australia Abstract: Internationally, the number of patients requiring treatment for end-stage kidney disease (ESKD) continues to increase, placing substantial burden on health systems and patients. Home hemodialysis (HD) has fluctuated in its popularity, and the rates of home HD vary considerably between and within countries although there is evidence suggesting a number of clinical, survival, economic, and quality of life (QoL) advantages associated with this treatment. International guidelines encourage shared decision making between patients and clinicians for the type of dialysis, with an emphasis on a treatment that aligned to the patients’ lifestyle. This is a comprehensive literature review of patient-centered and economic impacts of home HD with the studies published between January 2000 and July 2016. Data from the primary studies representing both efficiency and equity of home HD were presented as a narrative synthesis under the following topics: advantages to patients, barriers to patients, economic factors influencing patients, cost-effectiveness of home HD, and inequities in home HD delivery. There were a number of advantages for patients on home HD including improved survival and QoL and flexibility and potential for employment, compared to hospital HD. Similarly, there were several barriers to patients preferring or maintaining home HD, and the strategies to overcome these barriers were frequently reported. Good evidence reported that indigenous, low-income, and other socially disadvantaged individuals had reduced access to home HD compared to other forms of dialysis and that this situation compounds already-poor health outcomes on renal replacement therapy. Government policies that minimize barriers to home HD include reimbursement for dialysis-related out-of-pocket costs and employment-retention interventions for home HD patients and their family members. This review argues that home HD is a cost-effective treatment, and increasing the proportion of patients on this form of dialysis compared to hospital HD will result in a more equitable distribution of good health outcomes for individuals with ESKD. Keywords: hemodialysis, home haemodialysis, economic considerations, end stage kidney disease, patients, quality of life
Article
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Objectives The purpose of this study is to assess the efficacy and safety of nocturnal hemodialysis on end-stage renal disease (ESRD) patients. Methods We searched Medline, EmBase, and the Cochrance Central Register of Controlled Trials for studies up to January 2016. Analysis was done to compare variant outcomes of different hemodialysis schedules, including mortality, cardiovascular-associated variables, uremia-associated variables, quality of life (QOL), side-effects, and drug usage. Results We collected and analyzed the results of 28 studies involving 22,508 patients in our meta-analysis. The mortality results in this meta-analysis indicated that the nocturnal hemodialysis (NHD) group was not significantly different from conventional hemodialysis (CHD) group (Mortality: OR: 0.75; 95% confidence intervals (CIs): 0.52 to 1.10; p = 0.145), but the CHD group had significantly fewer number of hospitalizations than the NHD group (OR: 1.54; 95%CI: 1.32 to 1.79; p<0.001). NHD was superior to CHD for cardiovascular-associated (left ventricular hypertrophy [LVH]: SMD: -0.39; 95%CI: -0.68 to -0.10; p = 0.009, left ventricular hypertrophy index [LVHI]: SMD: -0.64; 95%CI: -0.83 to -0.46; p<0.001) and uremia-associated intervention results (Serum albumin: SMD: 0.89; 95%CI: 0.41 to 1.36; p<0.001). For the assessment of quality of life, NHD treatment significantly improved the patients’ QOL only for SF36-Physical Components Summary (SMD: 0.43; 95%CI: 0.26 to 0.60; p<0.001). NHD intervention was relatively better than CHD for anti-hypertensive drug usage (SMD: -0.48; 95%CI: -0.91 to -0.05; p = 0.005), and there was no difference between groups in our side-effects assessment. Conclusion NHD and CHD performed similarly in terms of ESRD patients’ mortality and side-effects. NHD was superior to CHD for cardiovascular-associated and uremia-associated results, QOL, and drug usage; for number of hospitalizations, CHD was relatively better than NHD.
Article
Full-text available
Background: Chronic kidney disease (CKD) affects more than one third of older adults, and is a strong risk factor for vascular disease and cognitive impairment. Cognitive impairment can have detrimental effects on the quality of life through decreased treatment adherence and poor nutrition and results in increased costs of care and early mortality. Though widely studied in hemodialysis populations, little is known about cognitive impairment in patients with pre-dialysis CKD. Methods: Multicenter, cross-sectional, prospective cohort study including 385 patients with CKD stages G4-G5. Cognitive function was measured with a validated tool called the Montreal Cognitive Assessment (MoCA) as part of a comprehensive frailty assessment in the Canadian Frailty Observation and Interventions Trial. Cognitive impairment was defined as a MoCA score of ≤24. We determined the prevalence and risk factors for cognitive impairment in patients with CKD stages G4-G5, not on dialysis. Results: Two hundred and thirty seven participants (61%) with CKD stages G4-G5 had cognitive impairment at baseline assessment. When compared to a control group, this population scored lower in all domains of cognition, with the most pronounced deficits observed in recall, attention, and visual/executive function (p < 0.01 for all comparisons). Older age, recent history of falls and history of stroke were independently associated with cognitive impairment. Conclusions: Our study uncovered a high rate of unrecognized cognitive impairment in an advanced CKD population. This impairment is global, affecting all aspects of cognition and is likely vascular in nature. The longitudinal trajectory of cognitive function and its effect on dialysis decision-making and outcomes deserves further study.
Article
Full-text available
Background End-stage kidney disease is a leading cause of morbidity and mortality worldwide. Prevalence of the disease and worldwide use of renal replacement therapy (RRT) are expected to rise sharply in the next decade. We aimed to quantify estimates of this burden.
Article
Background and objectives: The prevalence of ESKD is increasing worldwide. Treating ESKD is disproportionately costly in comparison with its prevalence, mostly due to the direct cost of dialysis therapy. Here, we aim to provide a contemporary cost description of dialysis modalities, including facility-based hemodialysis, peritoneal dialysis, and home hemodialysis, provided with conventional dialysis machines and the NxStage System One. Design, setting, participants, & measurements: We constructed a cost-minimization model from the perspective of the Canadian single-payer health care system including all costs related to dialysis care. The labor component of costs consisted of a breakdown of activity-based per patient direct labor requirements. Other costs were taken from statements of operations for the kidney program at Seven Oaks General Hospital (Winnipeg, Canada). All costs are reported in Canadian dollars. Results: Annual maintenance expenses were estimated as $64,214 for in-center facility hemodialysis, $43,816 for home hemodialysis with the NxStage System One, $39,236 for home hemodialysis with conventional dialysis machines, and $38,658 for peritoneal dialysis. Training costs for in-center facility hemodialysis, home hemodialysis with the NxStage System One, home hemodialysis with conventional dialysis machines, and peritoneal dialysis are estimated as $0, $16,143, $24,379, and $7157, respectively. The threshold point to achieve cost neutrality was determined to be 9.7 months from in-center hemodialysis to home hemodialysis with the NxStage System One, 12.6 months from in-center hemodialysis to home hemodialysis with conventional dialysis machines, and 3.2 months from in-center hemodialysis to peritoneal dialysis. Conclusions: Home modalities have lower maintenance costs, and beyond a short time horizon, they are most cost efficient when considering their incremental training expenses. Podcast: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2018_07_18_CJASNPodcast_18_8_F.mp3.
Article
Background: Little is known about factors that are important to patients with advanced kidney disease and their perspectives at the time they choose a dialysis modality. EPOCH-RRT, a study supported in part by the Patient-Centered Outcomes Research Institute (PCORI), was designed to assist patients with this choice by identifying such factors and effectively provide relevant information. Study design: Cross-sectional study, designed and conducted in collaboration with a multistakeholder advisory panel that included patients, caregivers, and health care professionals. Setting & participants: 180 patients with advanced chronic kidney disease (CKD; estimated glomerular filtration rate < 25mL/min/1.73m(2)), either non-dialysis-dependent (NDD-CKD; n=65) or on dialysis therapy (hemodialysis [HD], n=77; or peritoneal dialysis, n=38), recruited across the United States through social media and in-person contacts. Methodology: Semistructured telephone interviews including open- and closed-ended questions. Analytical approach: Mixed methods, integrating quantitative and qualitative approaches; themes identified through content analysis of interview transcripts by 2 independent coders. Results: Themes most often reported as important were keeping as much independence as possible, quality and quantity of life, and flexibility in daily schedule. Other factors (eg, concern about the way they look) differed across patient subgroups based on age, sex, and NDD-CKD/dialysis modality. Among patients who had initiated dialysis therapy, almost half (47%) the HD patients believed that the decision to be treated by HD had largely not been their choice; this was only reported by 3% of peritoneal dialysis patients. Limitations: Recruitment through social media and willingness to participate in lengthy telephone interviews resulted in a select sample that may not be representative of the broader advanced CKD population; therefore, generalizability of findings cannot be determined. Conclusions: Incorporation of patient priorities in care improves health outcomes. Given the perceived limited role in the choice of dialysis treatment, our findings support the need for interventions to improve shared decision making on dialysis treatment options, targeting both patients and clinicians.
Article
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.