Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, UK.
Hand Therapy Department, Guy's and St Thomas's NHS Foundation Trust, UK.
J Wound Care. 2020 Dec 2;29(12):751-762. doi: 10.12968/jowc.2020.29.12.751.
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.
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.
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.
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.
在常染色体隐性营养不良性大疱性表皮松解症中，反复水疱导致手指并指和手部严重挛缩。本研究的目的是与患者、照顾者和临床医生共同设计手部治疗的患者报告结局指标，并使用这些指标对一种新型隐性营养不良性大疱性表皮松解症的新型敷料手套进行概念验证测试，同时进行成本分析。
对患者和照顾者进行定性访谈和焦点小组，为指标生成内容。通过专家审查、试点研究和患者、照顾者和临床医生之间的共识，确定了有效性和可靠性。患者在进行 N-of-1 研究时，在佩戴敷料手套前后自我报告这些指标。同时，还自我报告了更换敷料的时间和常规产品的使用情况。
共有 11 项指标最初是从主题分析中生成的。专家审查、试点研究和共识涉及 6 名患者、5 名照顾者和 8 名临床医生（总 n=19）。参与者一致同意了 14 项指标，涵盖手部皮肤状况（n=4）、手指之间的并指（n=4）、佩戴和更换敷料的体验（n=2）、手部功能（n=2）、腕部功能（n=1）和手部疼痛（n=1）。在第 3 阶段，12 名患者在佩戴手套前对指标进行评分，4 名患者在佩戴手套时完成评分。大多数参与者的体验评分在佩戴手套前和佩戴手套期间都有显著改善。大多数参与者的皮肤外观也有所改善。
所生成的指标提供了有用的数据，参与者的评分差异表明，对于能够佩戴敷料手套的隐性营养不良性大疱性表皮松解症患者，概念验证已经得到证明。这些指标正在常规实践中使用，为敷料手套的临床随访、商业化和监管治理提供支持。
