Evaluating Patient Safety And Ease Of Use Of A Novel Connection-Assist Device For Peritoneal Dialysis
Received 7 June 2019
Accepted for publication 3 October 2019
Published 29 October 2019 Volume 2019:13 Pages 1785—1790
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Nicola Ludin
Peer reviewer comments 2
Editor who approved publication: Dr Johnny Chen
Stephan Hess,1 Martin Dubach,2 Mirko Meboldt,1 Lukas Foggensteiner3
1Swiss Federal Institute of Technology in Zurich (ETH Zurich), Zurich, Switzerland; 2Peripal AG; 3University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
Correspondence: Stephan Hess
Swiss Federal Institute of Technology in Zurich (ETH Zurich), Leonhardstrasse 21, Zurich CH 8092, Switzerland
Tel +41 44 632 48 62
Introduction: It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but only approximately 11% of prevalent dialysis patients use this modality. Connection-assist devices can overcome the challenges posed by decreased manual dexterity and/or visual acuity, and can allow more patients to be treated with home-based therapies. As part of the CE marking authorization, a connection device has been evaluated for safety and ease of use in a usability study.
Methods: Fifteen patients and nine carers volunteered in this study, ranging from 23 to 86 years in age and from 0.3 to 24 years in experience in the PD therapy. The operating cycle consisted of eight tasks, each having several handling steps. The data analysis focused on the task effectiveness and the subjects’ subjective feedback from the NASA task load index (N-TLX) questionnaire and semi-structured interviews.
Results: Of 1248 handling steps performed in total, 38 use errors were observed and discussed with the subjects. This equates to 97% of all handling steps being performed safely and easily. In all six dimensions of the N-TLX, more than 50 percent of subjects rated the task load 50 points or less on the scale. Regarding the handling of the device, 13 of 15 of the patients and 8 of 9 of the carers gave positive feedback.
Discussion: Safety and ease of use was demonstrated by evaluating task effectiveness (97% SU), interviews and N-TLX. Additionally the study provided valuable individual user feedback, which will inform the final design of the system for PD. The majority of patients and carers gave positive feedback regarding use and handling of this connection device. Innovative connection devices in general promise to reduce the barriers to using this home-based dialysis treatment.
Keywords: patient safety, usability study, ease of use, connection-assist device, peritoneal dialysis, NASA Task Load Index
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