President Trump wants to move 80% of US incident dialysis patients to home dialysis or transplantation by 2025! To enable this transformation, one of the most important factors to focus on will be usability.
By Jiang Cong
Globally, there are approximately 4 million people who suffer from kidney failure. Renal Replacement Therapies (“RRT”) are the standard of care for this type of patients. The ultimate form of RRT is kidney transplantation, which replaces the diseased organ with a compatible graft. However, in the light of the scarcity of supply of donor kidneys, dialysis is the most common viable alternative to sustain the patient’s life while waiting for a suitable donor. Among the patients on dialysis, approximately 11% are receiving Peritoneal Dialysis (“PD”). Compared with its predominant counterpart, Hemodialysis (“HD”), PD offers the benefits of better survival rate , higher autonomy, and better cost-effectiveness [1,2]. However, the current uptake of PD among kidney failure patients is still limited. This is owing to multiple factors, among which are patient/caregiver burnout, technique failure, and peritonitis .
To address these issues and provide the patients with more effective treatment, the PD device manufacturers need to conduct clinical trials to assess if the PD therapy is actually improving the quality of life of the patient. However, there is a lack of industry-recognized, patient-centered outcomes which can guide such clinical studies. To help the industry to remove this roadblock, the Standardized Outcomes in Nephrology (“SONG”) initiative was launched. The goals of this initiative are to define a set of outcomes that are meaningful and relevant to patients with kidney disease, their family, and their clinicians; and thus, support decisions about treatment . For PD, in particular, a set of 5 outcomes (listed below) are identified as Core Outcomes, which are of critical importance to all stakeholder groups (patients/caregivers and health professionals) :
- Cardiovascular Diseases
- PD Failure
- Life Participation
Among these core outcomes, the PD-Infection, PD Failure, and Life Participation share one thing in common: they are all closely related to the usability of the PD device. Usability is a measure of how well and how safe the product is during use. Ensuring high usability in the product design not only prevents risks related to device induced use errors, but also promotes effective use of the device and improve the overall user satisfaction with the device. It requires the application of a set of Usability Engineering (“UE”) principles and processes in product development. Below is an overview of key usability engineering tasks applicable to each stage of a medical device development cycle:
In the context of PD devices, if the usability is lacking, the entire process of dialyzing may be more time consuming and error-prone. This may result in more use errors which might negatively impact the PD Failure rate. Lack of usability may also lead to lower ratings in patient-reported outcomes like Mobility and Life Participation, which in turn may hinder the product commercialization. Making Usability Engineering an integral part of product development is thus essential for better clinical outcomes and commercial success of medical devices.
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2. Chui BK, Manns B, Pannu N, Dong J, Wiebe N, Jindal K, et al. Health care costs of peritoneal dialysis technique failure and dialysis modality switching. Am J Kidney Dis 2013; 61(1):104–11
3. Manera KE, Tong A, Craig JC, Brown EA, Brunier G, Dong J, Dunning T, Mehrotra R, Naicker S, Pecoits-Filho R, Perl J, Wang AY, Wilkie M, Howell M, Sautenet B, Evangelidis N, Shen JI, Johnson DW. Standardised Outcomes in Nephrology – Peritoneal Dialysis (SONG-PD): study protocol for establishing a core outcome set in peritoneal dialysis. Peritoneal Dialysis International 2017; 37:639-47
4. The SONG Handbook. Version 1.0 June 2017, Sydney, Australia Available at: songinitiative.org/reports-and-publications/
5. Standardized Outcomes in Nephrology (SONG) – SONG-PD Project. Available at: https://songinitiative.org/projects/song-pd/. Accessed 20 July 2019.
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