Translating patient needs into medical device development: co-design of a photoprotection visor for Xeroderma Pigmentosum using qualitative interviews.

INTRODUCTION: People with Xeroderma Pigmentosum (XP) have a heightened sensitivity to ultraviolet radiation (UVR) and are advised to wear photoprotective clothing including a visor covering the face and neck. Photoprotective visors are homemade and predominately worn by children with decreasing frequency as age increases. To improve upon the current design and efficacy we were tasked with developing a prototype visor to meet patients' needs. METHODS: Adopting a codesign methodology, patients' experiences of wearing a visor and patient and carer views of emerging prototypes were explored during interviews. A thematic analysis was conducted in parallel with data collection and themes were interpreted into design cues; desirable attributes of a visor that would counteract the negative user experiences and meet the requirements described by patients and carers. The design cues guided the iterative development of prototypes by academic engineers. RESULTS: Twenty-four interviews were conducted with patients and carers. Thematic analysis resulted in the following five themes: Being safe from UVR exposure; self-consciousness; temperature effects; acoustic difficulties; and material properties. The following design cues were developed from the themes respectively; materials and design with high UVR protection; ability to customise with own headwear; ventilation to reduce steaming up; acoustic functionality to enable hearing and speech; foldable, portable, and easy to put on and take off. CONCLUSIONS: It is important to understand people's experiences of using medical devices to improve their safety, efficiency and user satisfaction. The user experience themes and design cues, informed the iterative development of low fidelity visor prototypes as part of a codesign process. These design cues and responses to the prototypes are guiding commercial manufacturing and regulatory approval. The visor can then be prescribed to patients, providing an equitable service of care.

Participatory co-design of patient-reported outcome indicators and N-of-1 evaluation of a dressing glove for Epidermolysis bullosa.

OBJECTIVE: In autosomal recessive dystrophic Epidermolysis bullosa, repeat blistering results in finger webbing and severe contractures of the hands. The aim of this study was to codesign patient-reported outcome indicators for hand therapy with patients, carers and clinicians, and use these to proof-of-concept test a novel dressing glove for recessive dystrophic Epidermolysis bullosa, with cost analysis. METHOD: Qualitative interviews and focus groups with patients and carers generated content for the indicators. Validity and reliability were established through expert review, piloting and consensus between patients, carers and clinicians. The indicators were self-reported by patients before and while wearing the dressing glove in an N-of-1 study. Time for dressing changes and use of conventional products were also self-reported. RESULTS: A total of 11 indicators were initially generated from the thematic analysis. Expert review, piloting and consensus involved six patients, five carers and eight clinicians (total n=19). Participants agreed 14 indicators, covering hand skin condition (n=4), webbing between the digits (n=4), experiences of wearing and changing dressings (n=2), hand function (n=2), wrist function (n=1) and hand pain (n=1). In Phase 3, 12 patients scored indicators before wearing the gloves and four patients completed scoring while wearing the gloves. Statistically significant improvements between pre-glove and with-glove periods were found for most participants' experience scores. Skin appearance also improved for most participants. CONCLUSIONS: The indicators generated useful data, differentiation between scores and participants demonstrating proof-of-concept for patients with recessive dystrophic Epidermolysis bullosa who could wear the dressing gloves. The indicators are being used in routine practice, supporting clinical follow up, commercialisation and regulatory governance of the dressing glove.

Iterative codesign and testing of a novel dressing glove for epidermolysis bullosa.

OBJECTIVE: Recessive dystrophic epidermolysis bullosa (RDEB) is a rare genetic skin disorder which requires intensive hand therapy to delay fusion of the digits. Existing dressings do not conform to the complex structure of the hand and are applied in patches held with additional bandages, leading to an occlusive environment. The aim was to co-design with patients a dressing glove based on their user experiences and needs. METHOD: Qualitative interviews and focus groups with children and adults with RDEB, and their carers, were conducted. Iterative feedback of design cues, bench and surrogate testing of materials and prototype refinement were achieved through collaborative codesign with patients, carers, clinicians and manufacturers. RESULTS: Thematic analysis generated eight user needs and corresponding design cues, addressing issues of absorbency, adherence, comfort, adaptability, ease of application and removal, breathability, protection, and hand hygiene. A prototype was selected for proof of concept testing. CONCLUSION: This novel dressing glove design met the patient's requirements for a dressing, which conformed to the hand structure and sat in the web spaces to keep fingers separated. Proof of concept testing has since been undertaken with patients to determine performance, value for money and whether further developments are required.