Xeroderma Pigmentosum: Codesign and testing of a specialised visor
Research type
Research Study
Full title
Xeroderma Pigmentosum: Codesign and testing of a specialised visor for ultraviolet radiation protection
IRAS ID
244301
Contact name
Patricia Grocott
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Research Summary
Xeroderma Pigmentosum (XP) is a rare, inherited, incurable condition
affecting approximately one in 250,000 of the general population. People
with XP cannot tolerate ultraviolet radiation (UVR) from natural light, not
just sunshine. We cannot see or feel UVR, but it can cause normal cells to
become cancerous.
With XP, miniscule exposure can cause skin and eye cancers from around
the age of eight. Life expectancy is around 32 years; skin cancer is the
main cause of death. Preventing skin and eye cancers requires absolute
protection from UVR. Protective films are applied to car windows, homes,
schools, and offices. Outdoor activity requires full cover-up with clothing
and headwear, even on a cloudy day. Clothing is purchased. Headwear is
homemade. Patients and families say the headwear steams-up, interferes
with seeing, talking, and they receive unkind comments on their
appearance. Many avoid all of this by not covering up, with disastrous
consequences including eye damage/visual impairment, eye and skin
cancers.
We are working with XP charities and meeting patients with XP and their
families, to develop a protection visor.
Aim:
To co-design and test a UVR protection visor with children and adults with XP.
Expected Outputs:
A visor that does not steam-up, disturb breathing, vision, or communication and is acceptable to people with XP.
A fully tested visor.
Patient-recorded outcomes of the acceptability and functioning of the visor, and costs.
Manufacturing/commercialisation plans.
Benefits:
To patients: A wearable visor; reduced risk of eye/skin cancers and premature deaths.
To the NHS: A visor that meets the UVR protection required to avoid skin/eye cancers in XP; adoption of the visor, reduced numbers of eye/skin cancers, premature deaths and costs.
To the Public: A specialist visor that can benefit people without XP, who are vulnerable to eye/skin cancers.
To Industry: Business opportunities nationally and internationally.Summary of Results
Background:
Xeroderma Pigmentosum (XP) is a rare, incurable condition affecting approximately one in 250,000 of the general population. People with XP cannot tolerate ultraviolet radiation (UVR) from natural light. Miniscule exposure can cause skin and eye cancers; skin cancer is the main cause of death. Preventing skin and eye cancers requires absolute protection from UVR. Outdoor activity requires complete cover-up with clothing and headwear. Headwear is homemade. Patients and families say it steams-up, interferes with seeing, talking, and they receive public jibes. Many do not cover-up with disastrous consequences including eye damage, eye, and skin cancers
Objectives:
To co-design a novel photoprotection visor prototype based on user experiences and needs.
Methods:
These included participatory co-design, outcome indicator development and validation, economic modelling, and engineering. Collaborating with the National XP Service, XP Support Group and Teddington Trust, interviews with children and adults with XP and their carers were conducted, and extensive patient and public engagement. Design cues guided rapid 3D printing of visor prototypes. Engineered acoustics and ventilation were investigated. UVR absorbing materials were manipulated, then tested by medical physicists.
Key findings
Patients’ preferred two visor design concepts: ‘on the face’; ‘off the face’. The ‘on the face’ concept requires bespoke manufacturing, wearing glasses and lip protection. It is not being taken forward to commercialisation as costs and maintaining bespoke supplies are not feasible.
The COVID-19 pandemic prompted a Work Package risk analysis and mitigation. King’s College London Ethics approvals to maintain co-design activities via the national XP charities enabled prioritisation of commercially manufactured visor designs and validation of patient-recorded outcomes.
Outputs, impact and dissemination
Six user needs and design cues were identified: UVR protection, ventilation, acoustics, ability to customise headwear, portability and ability to drink. Nine prototype designs were iteratively developed to determine patient preferences. Acoustic and ventilation systems and UVR-absorbing materials were generated. TELER XP indicators of visor performance were co-designed from the design cues and validated with patients and families using the TELER-online Delphi system, under licence to TELER Limited. The XP digital platform for patients to record their experiences of visor performance was set up. A model to evaluate clinical effectiveness and costs consequences of health services supplying visors to patients as regulated medical devices was developed.
Conclusions
This was an intensive 30-month project. Surrogate and patient tests of early prototypes, and proof-of-concept tests of demonstrator visors were interrupted by the lack of delivery of a suitable 3D printer from the US, together with COVID-19 restrictions to university laboratories.
Future Plans
The intensive investigation into user preferences is being advanced into functional visors using commercial manufacturing methods, working collaboratively with The Manufacturing Technology Centre (MTC). Two Discovery/Ideation workshops were undertaken resulting in five commercial prototype designs; patients selected one.We were awarded an EPSRC Impact Accelerator Award to continue developing a commercially manufacturable photoprotection visor with The MTC.
Further funding is currently be applied for to support commercial manufacturing, device regulation and patient acceptance, visor effectiveness and costs. The patient-recorded outcome indicators, XP digital data platform and economic model will generate evidence that the functional prototypes afford UVR protection and are acceptable. UVR absorbency test evidence will support visor safety and medical device regulation for this high-risk group.
REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/1448
Date of REC Opinion
9 Oct 2018
REC opinion
Favourable Opinion