Impact case study database

Since 2001 King’s researchers have developed and evaluated novel medical devices using innovative design methodologies comprising:

1. Participatory co-design methodology, involves patients, parents, carers, clinicians, engineers and manufacturers collaborating to design and evaluate devices, and outcome measures (1)

2. Patients record their outcomes online using the TELER© Method (2, 3) to establish whether the devices perform to the standard they require

3. Case studies test device performance and capture individual experiences and costs, with routine clinical follow-up to off-set small study samples (4, 5, 6)

The methodologies have been applied to develop novel devices with people with wounds. Epidermolysis Bullosa (EB) is a rare inherited condition (5,000 people in the UK: 50,000 globally). People with severe types, including Recessive Dystrophic EB (RDEB), experience extremely painful skin and extensive wounds. This requires the use of pre-sized and shaped dressings over their wounds held in place with layers of flat and tubular bandages. Dressing changes take hours, and often require patching-up and replacement dressings. On the hands, post-healing scarring makes fingers conjoin and contract with loss of dexterity, function, and independence. Scarring is managed with dressings, bandages, reinforced gloves and fixed splints. However, patients do not tolerate current versions and often abandon them, resulting in contractures recurring.

To address the need for an alternative to bandages King’s researchers developed the Skinnies WEB™ dressing retention range (A-B). Participants reported greater comfort, healing of persistent wounds, and enhanced self-esteem using the new garments, Patients reported the Skinnies™ gloves, fit better than other gloves, leading to the GLOVE project (1-6). Working with patients, parents, carers and clinicians from Guy’s and St Thomas NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, academic engineers from Cardiff University, health economists from University of Surrey, Skinwear Limited (knitwear manufacturer) and TELER (IT company), King’s researchers co-designed and tested:

1. A disposable dressing glove to protect blistered skin (Skinnies™) (C)

2. A knitted glove with reinforced knitting at finger bases and around the thumb to keep fingers separated (Skinnies™ Reinforced web-spacer glove) (C)

3. A prototype adjustable splint glove with detachable robotics (to straighten bent fingers), wrist supports and digital sensors to measure range of movement with wireless data exchange between the splint glove and a digital data capture system called Hand Therapy-Online (HTO).

The methodologies have been applied for a common condition requiring hand splints. King’s researchers extended prototyping the adjustable splint glove to include people with Dupuytren’s Contracture in the GLOVED Project (1-6). Dupuytren’s is a common condition (20% men over 60; 20% women over 80; some earlier onset age >30) where lumps and string-like cords develop in the palm of the hand, pulling the fingers inwards so they are unable to straighten. Treatment includes surgery followed by splinting. People with Dupuytren’s report similar problems tolerating fixed splints as people with EB; current splints have not changed for decades. The Adjustable Splint Glove enables therapists to customise splinting to individual fingers and hands with digital measurements of finger curvature downloaded to an App with data transferred to the HTO system or NHS clinical electronic patient record systems. This enables clinicians and patients to react to deteriorating hand function, facilitating intervention to reverse this without being face-to-face, to maintain a functioning hand.

The methodologies have been applied to develop a device for people who cannot tolerate exposure to daylight. King’s researchers were invited by clinicians to codesign and test a specialised visor providing ultraviolet radiation (UVR) protection for people with Xeroderma Pigmentosum (XP). XP is inherited, rare and incurable, affecting around one in 250,000 of the global population. People with XP cannot repair damage from UVR in daylight and some artificial lights. Miniscule exposure causes lethal skin and eye cancers. Life expectancy is around 30 years unless individuals cover themselves in UVR-protective clothing and headwear. Of more than 100 patients registered with the UK National XP Service, 26% of children and 85% of adults do not cover their faces, with disastrous consequences. There is no provision of visors for people with XP; families make their own. During qualitative interviews with King’s researchers in the XP project, patients and families said homemade visors steam-up, interfering with sight and speech, and reported cruel jibes from the public. Eleven prototypes were developed with Cardiff University academic engineers and tested with patients of different ages to create acceptable designs for people with XP. King’s is now working in collaboration with The Manufacturing Technology Centre to advance commercially manufactured visors (D.1, D.2).

# Home-made Visor	# Home-made Visor	# Prototype 3 ‘On the Face’	# Prototype 4 ‘Off the Face’

Codesigning digital online systems to measure needs, therapeutic benefits, and outcomes. King’s researchers have developed The HTO system with software company TELER, for the routine recording and monitoring of treatment, patient recorded outcomes, and costs. Clinicians monitor outcomes remotely, detect deteriorations and adjust treatment online without needing to be face-to-face, thereby avoiding long journeys to specialist centres (E).

King’s application of the TELER methodology for patient-recorded outcomes involves co-creating observable outcomes in the form of valid indicators. For example, one participant in the GLOVE project requested surgery to regain lost hand function. When asked what function he had lost he replied: “My only measure is I can’t pick up a pint of beer... ” He had to pick up a pint with his left hand and then force it into his right hand, illustrating the importance of the primitive grasp reflex which, if impaired, affects independent living. King’s researchers, GLOVE clinicians and patients explored objective signs of progressive loss of grasp function and developed this simple code indicator for patients to measure and record their hand function onto the HTO system (Indicator title: Ability to grasp a can of drink; 330ml for adults; 150ml for children):

Code 5 - Able to grasp a can independently with one hand. Code 4 - Able to hold a can in one hand using the other hand to push it into the hand. Code 3 - Able to hold a can in one hand, using the other hand to push it into the hand and support it. Code 2 - Able to hold a can with two hands using fingers/thumb to support. Code 1- Able to hold a can using hands/arms or against the body, but not able to use fingers and thumbs. Code 0 - Unable to hold a can at all (Fig 2, p4; E).

An online Delphi validation process has been developed by the King’s researchers with TELER to facilitate remote development of the XP and Dupuytrens patient recorded outcomes (F). The HTO system has been evaluated in routine care at Guy’s and St Thomas NHS Foundation Trust in a Service Evaluation, funded by DEBRA (UK charity for those affected by EB), to advance adoption in UK EB specialist centres and international DEBRA organisations. The Senior Clinical Specialist Occupational Therapist for EB using HTO said: “…if people aren’t attending clinic for six months they can go on and score which means you can collect data, people can upload images onto the system, then you can view and that enables troubleshooting...” (G.1). HTO data compared with Electronic Patient Record data are objective, systematic, tracing responses to treatment over time.