Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Harasemiw O

PROVIDER: S-EPMC6850132 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Harasemiw Oksana O Day Clara C Milad John E JE Grainger James J Ferguson Thomas T Komenda Paul P

Hemodialysis international. International Symposium on Home Hemodialysis 20190409 3

<h4>Introduction</h4>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, an ...[more]

PMID: 30968548

Similar Datasets

Project description: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.

Project description:Home hemodialysis (HHD) is associated with improved clinical and quality-of-life outcomes compared to in-center hemodialysis, but remains an underused modality in the United States. Discontinuation from HHD therapy may be an important contributor to the low use of this modality. This study aimed to describe the rate and timing of HHD therapy discontinuation, or technique failure, and identify contributing factors.Retrospective cohort study.Using data from a large dialysis provider, we identified a nationally representative cohort of patients who initiated HHD therapy from 2007 to 2009 (N=2,840).Demographics, end-stage renal disease duration, kidney transplant listing status, comorbid conditions, level of urbanization or rurality based on residence zip code, socioeconomic status based on residence zip code, and dialysis facility factors.Discontinuation from HHD therapy, defined as 60 or more days with no HHD treatments.Competing-risk models were used to produce cumulative incidence plots and identify sociodemographic and clinical variables associated with HHD therapy discontinuation. Transplantation and death were treated as competing risks for HHD therapy discontinuation.The 1-year incidence of discontinuation was 24.9%, and the 1-year mortality estimate was 7.6%. Median end-stage renal disease duration prior to initiating HHD therapy was 2.1 years. Diabetes and smoking/alcohol/drug use were associated with increased risk for HHD discontinuation (HRs of 1.34 [95% CI, 1.07-1.68] and 1.34 [95% CI, 1.01-1.78], respectively). Listing for kidney transplantation and rural residence (rural-urban commuting area ? 7) were associated with decreased risk for HHD therapy discontinuation (HRs of 0.73 [95% CI, 0.61-0.87] and 0.78 [95% CI, 0.59-1.02], respectively).Limited to variables available within the DaVita dialysis and US Renal Data System data sets.A substantial proportion of patients discontinue HHD therapy within the first 12 months of use of the modality. Patients with diabetes, substance use, nonlisting for kidney transplantation, and urban residence are at greater risk for discontinuation. Targeting high-risk patients for increased support from clinical teams is a potential strategy for reducing HHD therapy discontinuation and increasing technique survival.

Project description:BackgroundCardiovascular diseases (CVD) are the leading cause of morbidity and mortality worldwide. Early diagnosis is of pivotal importance for patients with cardiac arrhythmias and ischemia to minimize the consequences like strokes and myocardial infarctions. The chance of capturing signals of arrhythmias or ischemia is substantially high when a 12-lead electrocardiogram (ECG) can be recorded at the moment when a patient experiences the symptoms. However, until now, available diagnostic systems (Holter monitors and other wearable ECG sensors) have not enabled patients to record a reliable 12-lead ECG at home.ObjectiveThe objective of this project was to develop a user-friendly system that enables persons with cardiac complaints to record a reliable 12-lead ECG at home to improve the diagnostic process and, consequently, reduce the time between the onset of symptoms and adequate treatment.MethodsUsing an iterative design approach, ECGraph was developed. The system consists of an ECG measurement system and a mobile app, which were developed with the help of several concept tests. To evaluate the design, a prototype of the final design was built and a final technical performance test and usability test were executed.ResultsThe ECG measurement system consists of a belt and 4 limb straps. Ten wet Ag/AgCl electrodes are placed in the belt to optimize skin-electrode contact. The product is controlled via an app on the mobile phone of the user. Once a person experiences symptoms, he or she can put on the belt and record ECGs within a few minutes. Short instructions, supported by visualizations, offer guidance during use. ECGs are sent wirelessly to the caregiver, and the designated expert can quickly interpret the results. Usability tests with the final prototype (n=6) showed that the participants were able to put on the product within 8 minutes during first-time use. However, we expect that the placement of the product can be executed faster when the user becomes more familiar with the product. Areas of improvement focus mainly on confidence during product use. In the technical performance test, a 12-lead ECG was made and reproduced 6 times.ConclusionsWe developed a new 12-lead ECG system for home use. The product is expected to be more user-friendly than current hospital ECG systems and is designed to record more reliable data than current ECG systems for home use, which makes it suitable for expert interpretation. The system has great potential to be incorporated into an outpatient practice, so that arrhythmias and ischemia can be diagnosed and treated as early as possible.

Project description:INTRODUCTION:Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers. METHODS:A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/Vurea ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data. FINDINGS:Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/Vurea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8 seconds in-center and 5 seconds in-home. CONCLUSION:Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.

Project description:Background and objectivesThe last 15 years has seen growth in home hemodialysis (HD) utilization in Canada owing to reports of improved outcomes relative to patients on conventional in-center HD. What effect growth has had on home HD technique and patient survival during this period is not known.Design, settings, participants, & measurementsWe compared the risk of home HD technique failure, mortality, and the composite outcome among three incident cohorts of patients on home HD in Canada: 1996-2002, 2003-2007, and 2008-2012. A multivariable piece-wise exponential model was used to evaluate all outcomes using inverse probability of treatment and censoring weights.ResultsA total of 1869 incident patients on home HD were identified from the Canadian Organ Replacement Register. Relative to those treated between 2003 and 2007 (n=568), the risk of home HD technique failure was similar between patients treated between 1996 and 2002 (n=233; adjusted hazard ratio [AHR], 1.39; 95% confidence interval [95% CI], 0.78 to 2.46) but higher among incident patients on home HD treated between 2008 and 2012 (n=1068; AHR, 1.51; 95% CI, 1.06 to 2.15). Relative to patients treated between 2003 and 2007, adjusted mortality was similar among those treated between 2008 and 2012 (AHR, 0.83; 95% CI, 0.58 to 1.19) and those treated between 1996 and 2002 (AHR, 0.67; 95% CI, 0.38 to 1.21). The risk of the composite outcome of death and technique failure was similar across cohorts, as was the risk of receiving a kidney transplant. Increasing age, diabetes as a comorbidity, and smoking status were associated with an increased risk of death as well as the composite outcome. Medium-sized facilities had a lower risk of death, technique failure, and the composite outcome compared with larger facilities.ConclusionsA higher risk of technique failure was seen in the most contemporary era. Further characterization of the risk factors for, and causes of technique failure is needed to develop strategies to improve patient retention on home HD.

Project description:BackgroundThe success of HIV programs relies on widely accessible HIV testing and counseling (HTC) services at health facilities as well as in the community. Home-based HTC (HB-HTC) is a popular community-based approach to reach persons who do not test at health facilities. Data comparing HB-HTC to other community-based HTC approaches are very limited. This trial compares HB-HTC to mobile clinic HTC (MC-HTC).Methods and findingsThe trial was powered to test the hypothesis of higher HTC uptake in HB-HTC campaigns than in MC-HTC campaigns. Twelve clusters were randomly allocated to HB-HTC or MC-HTC. The six clusters in the HB-HTC group received 30 1-d multi-disease campaigns (five villages per cluster) that delivered services by going door-to-door, whereas the six clusters in MC-HTC group received campaigns involving community gatherings in the 30 villages with subsequent service provision in mobile clinics. Time allocation and human resources were standardized and equal in both groups. All individuals accessing the campaigns with unknown HIV status or whose last HIV test was >12 wk ago and was negative were eligible. All outcomes were assessed at the individual level. Statistical analysis used multivariable logistic regression. Odds ratios and p-values were adjusted for gender, age, and cluster effect. Out of 3,197 participants from the 12 clusters, 2,563 (80.2%) were eligible (HB-HTC: 1,171; MC-HTC: 1,392). The results for the primary outcomes were as follows. Overall HTC uptake was higher in the HB-HTC group than in the MC-HTC group (92.5% versus 86.7%; adjusted odds ratio [aOR]: 2.06; 95% CI: 1.18-3.60; p = 0. 011). Among adolescents and adults ? 12 y, HTC uptake did not differ significantly between the two groups; however, in children <12 y, HTC uptake was higher in the HB-HTC arm (87.5% versus 58.7%; aOR: 4.91; 95% CI: 2.41-10.0; p<0.001). Out of those who took up HTC, 114 (4.9%) tested HIV-positive, 39 (3.6%) in the HB-HTC arm and 75 (6.2%) in the MC-HTC arm (aOR: 0.64; 95% CI: 0.48-0.86; p = 0.002). Ten (25.6%) and 19 (25.3%) individuals in the HB-HTC and in the MC-HTC arms, respectively, linked to HIV care within 1 mo after testing positive. Findings for secondary outcomes were as follows: HB-HTC reached more first-time testers, particularly among adolescents and young adults, and had a higher proportion of men among participants. However, after adjusting for clustering, the difference in male participation was not significant anymore. Age distribution among participants and immunological and clinical stages among persons newly diagnosed HIV-positive did not differ significantly between the two groups. Major study limitations included the campaigns' restriction to weekdays and a relatively low HIV prevalence among participants, the latter indicating that both arms may have reached an underexposed population.ConclusionsThis study demonstrates that both HB-HTC and MC-HTC can achieve high uptake of HTC. The choice between these two community-based strategies will depend on the objective of the activity: HB-HTC was better in reaching children, individuals who had never tested before, and men, while MC-HTC detected more new HIV infections. The low rate of linkage to care after a positive HIV test warrants future consideration of combining community-based HTC approaches with strategies to improve linkage to care for persons who test HIV-positive.Trial registrationClinicalTrials.gov NCT01459120. Please see later in the article for the Editors' Summary.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure