Evaluating Patient Safety And Ease Of Use Of A Novel Connection-Assist Device For Peritoneal Dialysis.
ABSTRACT: 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.
Project description:BACKGROUND:In order to give a wide range of people the opportunity to ensure and support home care, one approach is to develop medical devices that are as user-friendly as possible. This allows nonexperts to use medical devices that were originally too complicated to use. For a user-centric development of such medical devices, it is essential to understand which user interface design best supports patients, caregivers, and health care professionals. OBJECTIVE:Using the benefits of mobile eye tracking, this work aims to gain a deeper understanding of the challenges of user cognition. As a consequence, its goal is to identify the obstacles to the usability of the features of two different designs of a single medical device user interface. The medical device is a patient assistance device for home use in peritoneal dialysis therapy. METHODS:A total of 16 participants, with a subset of seniors (8/16, mean age 73.7 years) and young adults (8/16, mean age 25.0 years), were recruited and participated in this study. The handling cycle consisted of seven main tasks. Data analysis started with the analysis of task effectiveness for searching for error-related tasks. Subsequently, the in-depth gaze data analysis focused on these identified critical tasks. In order to understand the challenges of user cognition in critical tasks, gaze data were analyzed with respect to individual user interface features of the medical device system. Therefore, it focused on the two dimensions of dwell time and fixation duration of the gaze. RESULTS:In total, 97% of the handling steps for design 1 and 96% for design 2 were performed correctly, with the main challenges being task 1 insert, task 2 connect, and task 6 disconnect for both designs. In order to understand the two analyzed dimensions of the physiological measurements simultaneously, the authors propose a new graphical representation. It distinguishes four different patterns to compare the eye movements associated with the two designs. The patterns identified for the critical tasks are consistent with the results of the task performance. CONCLUSIONS:This study showed that mobile eye tracking provides insights into information processing in intensive handling tasks related to individual user interface features. The evaluation of each feature of the user interface promises an optimal design by combining the best found features. In this way, manufacturers are able to develop products that can be used by untrained people without prior knowledge. This would allow home care to be provided not only by highly qualified nurses and caregivers, but also by patients themselves, partners, children, or neighbors.
Project description:We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava®, an electromechanical device (e-Device) for self-injecting the anti-tumor necrosis factor certolizumab pegol (CZP).Healthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn's disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections. Formative participant questionnaire feedback was collected following e-Device prototype handling. Validation HFS (one EU study and one US study) assessed the safe and effective setup and use of the e-Device using 22 predefined critical tasks. Task outcomes were categorized as "failures" if participants did not succeed within three attempts.Two hundred eighty-three participants entered formative (163) and validation (120) HFS; 260 participants performed one or more simulated e-Device self-injections. Design changes following formative HFS included alterations to buttons and the graphical user interface screen. All validation HFS participants completed critical tasks necessary for CZP dose delivery, with minimal critical task failures (12 of 572 critical tasks, 2.1%, in the EU study, and 2 of 5310 critical tasks, less than 0.1%, in the US study).CZP e-Device development was guided by intended user feedback through HFS, ensuring the final design addressed patients' needs. In both validation studies, participants successfully performed all critical tasks, demonstrating safe and effective e-Device self-injections.UCB Pharma. Plain language summary available on the journal website.
Project description:Progression to end-stage renal disease (ESRD) is a major issue for heath care systems both clinically and financially. Given dialysis may not prolong life, and may indeed impair quality of life, alternative options for these patients such as conservative care are urgently needed. We appointed a dialysis charge nurse who had many years of experience of working with patients on dialysis to spearhead the newly set up Conservative Care Programme (CCP) in the Edinburgh Renal Unit. The rationale was to work as part of the renal multidisciplinary team to support patients and their families to make an informed shared decision whether to opt for dialysis or to follow the CCP. From the perspective of the patients, their families and carers we have received positive feedback since starting the CCP - thank you cards; phone calls both to the CCP Nurse Specialist and the renal unit affirming the positive experience patients had during the conservative management of their renal failure. Whilst continuing to provide the best quality of care to renal patients in NHS Lothian and Borders, the number of prevalent dialysis patients in our catchment area has fallen significantly over the last few years as demonstrated by Scottish Renal Registry data. These benefits are potentially applicable to other renal units across the UK.
Project description:INTRODUCTION:Kidney disease is common, affecting up to 1 in 10 of the adult population, and the numbers are expected to rise over the next decade. There are three main treatments that are available to patients with kidney disease: transplantation, dialysis and supportive care without dialysis. Dialysis can occur in a dialysis unit or in a person's home, but unit-based dialysis remains the most common initial treatment for patients in Wales. This is a cause for concern as most studies suggest that it is associated with the lowest quality of life and the highest mortality, and is a more expensive treatment option.This study aims to identify the factors that lead to patients choosing unit-based haemodialysis rather than home-based dialysis with a view to informing future changes in patient education and service commissioning in Wales. A secondary aim is to determine if the co-production of research leads to more sustainable services. METHODS AND ANALYSIS:This mixed-method study taking place between October 2018 and September 2020 will use a sequential explanatory design whereby the descriptive quantitative cross-sectional analysis of linked health and administrative data sets inform qualitative data collection from patients, carers and health and care professionals. Qualitative findings will be used to interpret or explain quantitative descriptive results. Additional strands to the study include a review of materials and education provided to patients and an economic review of treatment modalities. ETHICS AND DISSEMINATION:The study will be conducted in accordance with the principles expressed in the Declaration of Helsinki. It has full approval from Health and Care Research Wales Research Ethics Committee #5. As a co-productive study involving patients, clinicians, third sector partners and academics, findings from this study will be shared on a continual basis. Study results will be published in peer-reviewed journals and presented at national and international conferences.
Project description:OBJECTIVE:To develop a collaborative, person-centred model of clinical pharmacy support for community nurses and their medication management clients. DESIGN:Co-creation and participatory action research, based on reflection, data collection, interaction and feedback from participants and other stakeholders. SETTING:A large, non-profit home nursing service in Melbourne, Australia. PARTICIPANTS:Older people referred to the home nursing service for medication management, their carers, community nurses, general practitioners (GPs) and pharmacists, a multidisciplinary stakeholder reference group (including consumer representation) and the project team. DATA COLLECTION AND ANALYSIS:Feedback and reflections from minutes, notes and transcripts from: project team meetings, clinical pharmacists' reflective diaries and interviews, meetings with community nurses, reference group meetings and interviews and focus groups with 27 older people, 18 carers, 53 nurses, 15 GPs and seven community pharmacists. RESULTS:The model was based on best practice medication management standards and designed to address key medication management issues raised by stakeholders. Pharmacist roles included direct client care and indirect care. Direct care included home visits, medication reconciliation, medication review, medication regimen simplification, preparation of medication lists for clients and nurses, liaison and information sharing with prescribers and pharmacies and patient/carer education. Indirect care included providing medicines information and education for nurses and assisting with review and implementation of organisational medication policies and procedures. The model allowed nurses to refer directly to the pharmacist, enabling timely resolution of medication issues. Direct care was provided to 84 older people over a 15-month implementation period. Ongoing feedback and consultation, in line with participatory action research principles, informed the development and refinement of the model and identification of enablers and challenges. CONCLUSIONS:A collaborative, person-centred clinical pharmacy model that addressed the needs of clients, carers, nurses and other stakeholders was successfully developed. The model is likely to have applicability to home nursing services nationally and internationally.
Project description:BACKGROUND:In this study, we aimed to evaluate the impact of the COVID-19 epidemic on the workload and mental health of Iranian medical staff using the General Health Questionnaire (GHQ-12) and NASA -Task Load Index (NASA-TLX) Questionnaire between March and April 2020, respectively. METHODS:The present cross-sectional study was conducted from March 5th to April 5th, 2020. To evaluate the workload and mental health of participants NASA-TLX and GHQ-12 online questionnaires were distributed. Data were entered into software SPSS (Version 23) and T-test, ANOVA, Regression methods were used for data analysis. RESULTS:Health workers who encountered COVID- 19 patients, were subjected to more task load compared to those who had no contact with COVID- 19 patients at the workplace (p?<? 0.001). In terms of the subscale score of NASA-TLX, nurses had more scores in mental pressure, physical pressure, time pressure (temporal), and frustration compared to the other jobs (p?<? 0.05). Moreover, nurses had significantly more workload compared to the other jobs. CONCLUSIONS:Type of job, the shift of work, educational level, and facing COVID-19 affected the score of NASA-TLX. NASA-TLX scores were higher in nursing compared to the scores of other health staff groups. The results of this study indicate that the scores of NASA-TLX and GHQ-12 among staff who had contact with COVID-19 patients were significantly higher than those who did not face COVID-19 patients. We suggested that a comprehensive assistance should be provided to support the well-being of healthcare workers especially nurses and healthcare workers who treated COVID-19 patients.
Project description: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.
Project description:OBJECTIVE:Assistive technology (AT) can help carers (family, friends and neighbours) and people with dementia to stay well and safely at home. There are important gaps in what we know about experience of using AT from the perspective of carers of persons with dementia. This study investigates carers' experience of using AT in supporting and caring for persons with dementia who live at home. DESIGN:Qualitative phenomenological study with semi-structured interviews to achieve data saturation and thematic analysis to identify key themes. SETTING:Community-based within the UK. PARTICIPANTS:Twenty-three (14 women, 9 men) adult carers of persons with dementia who have used at least one AT device. RESULTS:All participants reported benefiting to varying degrees from using AT. There were 5 themes and 18 subthemes that highlighted reasons for using AT and use of AT over time. Providing care for a person with dementia, motivation for using AT, changes to roles and routines, carer knowledge and skills for using AT and social, environmental and ethical considerations were the main themes. This study showed that AT can provide reassurance and support for carers of persons with dementia but there are difficulties with acquiring and continued use of AT as dementia progresses. CONCLUSIONS:Carers consider AT as an adjunct to care they provided in caring for a person with dementia. Use of AT should be considered in the personal, social and environmental context of persons with dementia and their carers. Further research and policy interventions are needed to address best use of resources and guidance on data sharing and data protection while using AT.
Project description:Adult neurogenesis is maintained by self-renewable neural stem cells (NSCs). Their activity is regulated by multiple signaling pathways and key transcription factors. However, it has been unclear whether these factors interplay with each other at the molecular level. Here we show that SRY-box-containing gene 2 (Sox2) and nuclear receptor tailless (TLX) form a molecular network in adult NSCs. We observed that both Sox2 and TLX proteins bind to the upstream region of Tlx gene. Sox2 positively regulates Tlx expression, whereas the binding of TLX to its own promoter suppresses its transcriptional activity in luciferase reporter assays. Such TLX-mediated suppression can be antagonized by overexpressing wild-type Sox2 but not a mutant lacking the transcriptional activation domain. Furthermore, through regions involved in DNA-binding activity, Sox2 and TLX physically interact to form a complex on DNAs that contain a consensus binding site for TLX. Finally, depletion of Sox2 revealed the potential negative feedback loop of TLX expression that is antagonized by Sox2 in adult NSCs. These data suggest that Sox2 plays an important role in Tlx transcription in cultured adult NSCs.
Project description:Despite the many advantages it offers, the percentage of dialysis patients that receive home dialysis [peritoneal dialysis (PD) or home haemodialysis (HHD)] in the Netherlands has declined over the last decade. Pre-dialysis education could stimulate the use of home dialysis. This article presents the results of the pre-dialysis programme GUIDE, with regard to the following question: Does the implementation of a structured pre-dialysis programme with a home-focused approach increase the number of pre-dialysis patients that choose and receive home dialysis?The GUIDE process starts when a patient has an eGFR of 15 mL/min/1.73 m2. The process begins with a home visit from a case manager and the completion of questionnaires by the patient, the case manager and the nephrologist. A multidisciplinary meeting (MDM) is held to determine a specific patient profile (or treatment recommendation). This is followed by patient education, a second MDM and finally the selection of the treatment by the patient and the nephrologist. This retrospective observational study describes the selection process of all patients that received a treatment recommendation between 12 September 2013 and 18 December 2014 at Meander Medical Centre. Data were collected by file research and analysis of questionnaires.One hundred and two patients were included. They started the process at a mean eGFR of 12.3 mL/min/1.73 m2. Home dialysis was recommended for 62.8% of the patients who were advised to have dialysis treatment. Of the patients that opted for dialysis, 34.2% chose PD and 8.2% chose HHD; 22.9% started home dialysis as their first therapy, compared with 17.6% in the months before implementation of GUIDE. Finally, 32.1% of the patients that received dialysis therapy received home dialysis. In the months before GUIDE, an average of just 19.5% of the patients that received dialysis received home dialysis.In comparison to historical data, the pre-dialysis programme GUIDE increases the number of patients that choose and receive home dialysis.