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Advancing wound care in rare diseases: participatory co-design of patient-reported outcome indicators and an N-of 1 evaluation of a dressing glove for Epidermolysis Bullosa

Research output: Contribution to journalArticle

Tanya Graham, Sangeeta Sooriah, Rachel Box, Heather Gage, Peter Williams, Victoria Clemett, Patricia Grocott

Original languageEnglish
Accepted/In press8 Oct 2020

King's Authors


Aims: In Recessive Dystrophic Epidermolysis Bullosa (RDEB) repeat blistering results in finger webbing and severe contractures of the hands. The aim 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 RDEB 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 whilst wearing the dressing glove in an N-of-1 study. Time for dressing changes and use of conventional products were also self-reported.

Results: Eleven indicators were initially generated from the thematic analysis. Expert review, piloting and consensus involved six patients, five carers and eight clinicians. Fourteen indicators were agreed upon covering experiences of wearing and changing dressings (2), hand skin condition (4), webbing between the digits (4) wrist function (1) hand pain (1) and hand function (2). Twelve patients completed indicators before wearing the gloves and four completed whilst wearing the glove. Statistically significant improvements between pre-glove and with-glove periods were found for most participant’s experience scores. Skin appearance also improved for most participants.

Conclusion: The indicators generated useful data, differentiation between scores and participants demonstrating proof-of-concept for RDEB patients 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.

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