Patient Engagement in Medical Device Design: Refining the Essential Attributes of a Wearable, Pre-Void, Ultrasound Alarm for Nocturnal Enuresis.

BACKGROUND: To date, no pre-void wearable alarm exists to treat nocturnal enuresis (NE)-night-time bedwetting, and children with NE and their families are disappointed in relation to the post-void moisture alarms and medicine currently available. Development of a safe, comfortable and non-invasive wearable pre-void alarm and associated technology, using advanced mechatronics, is underway (the MyPAD device). Each stage of development includes patient and public involvement (PPI), particularly with respect to human factors, in collaboration with physicians, radiologists, psychologists, nurses, engineers and designers.

OBJECTIVES: The aim of this study was to help us understand the families' experience of the condition of enuresis, and to provide opinion relating to existing NE alarms, designed to detect moisture, and most importantly, the initial design of the MyPAD wearable technology.

METHODS: A PPI workshop in the form of a focus group, made up of children with enuresis and their parents, was conducted during the early stage of the MyPAD product development. The key research questions (RQs) were: (RQ1) What were the families' experiences of using existing post-void enuresis alarms? (RQ2) What do families like about the MyPAD prototype? and (RQ3) What do families not like about the MyPAD prototype? A nurse specialised in terms of NE treatment, including post-void alarms, from the Lancashire Teaching Hospitals NHS Foundation Trust, and two MyPAD design engineers were also present, to explain the MyPAD design concept. Braun and Clarke's six-phase approach to thematic analysis was implemented, which included familiarisation with the data, initial descriptive coding, identifying themes, reviewing themes, defining and labelling themes and producing a report.

RESULTS: Four common themes were identified from the focus group discussions: the importance of sleep; children do not want to feel different; parents feel frustrated and concerned; resilience and perseverance. These themes applied across the research questions; for example, sleep disruption was highlighted as an issue with existing post-void alarms and as an important requirement for the design of MyPAD. The evaluation of the early version of the MyPAD device has prompted the consideration of changes to some existing facets of the device, including providing multiple alarm types, more options for the design of the garment that houses the device, and the need for clear, age-appropriate and informative instructions relating to how the device should be used, in order to maximise its performance/efficiency and acceptance.

CONCLUSIONS: The qualitative data derived from the focus group discussion was incredibly valuable as it enabled the research and design team to experience the perspectives of the families in terms of the challenges and conflicts of managing the condition and the limited utility of existing post-void alarms. This has improved our understanding of the social and environmental challenges that will need to be considered during the design process.