University of Salford, School of Health & Society, Brian Blatchford Building, Frederick Road Campus, Salford, M6 6PU, UK.
Department of Surgery, Sørlandet Hospital, Kristiansand, Norway.
J Foot Ankle Res. 2021 Dec 3;14(1):61. doi: 10.1186/s13047-021-00496-2.
Peripheral vascular diseases have a significant impact on functional quality of life. Previous research has demonstrated the complex, limiting and costly economic implications of these conditions such as lower limb ulceration chronicity and ischaemic amputation. These complex, limb and life threatening conditions demand the development of novel interventions with objective research as part of that development. Hence, a novel intermittent negative pressure medical device in the form of a wearable boot (FlowOx™) was developed. As part of the development process, this study aimed to explore patient and clinician opinions of the boot.
A qualitative approach was used to collect patient and clinician experiences in Norway. An advisory group informed the semi-structured questions used in seven patient interviews and one clinician focus group (n = 5). The data were recorded digitally and transcribed verbatim. Patient and clinician data were analysed as distinct groups using a thematic process.
Data analysis resulted in five themes from the patients which gave insight into; the impact of the disease process; practicalities of using the boot, positive experiences of use; perceived outcomes; reflecting on use. Six themes were created from the clinicians. These gave insight into; ideal outcomes and how to measure them; ways to potentially use the boot; using research in healthcare; positives of the device; observed effects and next steps; potential improvements to the device.
This study provides insight into the experiences and opinions of FlowOx™. Patients and clinicians were positive about the device due to its ease of use. Those patients with peripheral arterial disease experienced significantly more benefit, especially for ischaemic ulceration than those with a chronic venous condition. Clinicians placed value on the patient reported outcomes in the treatment decision-making process. This preliminary study into experiences of FlowOx™ use provides valuable feedback that will inform design modification and ongoing research into implementation points and prospective user groups. FlowOx™ demonstrates potential as a conservative therapy offering users a convenient, home use, self-care management solution for improving symptomatic peripheral arterial disease and quality of life.
外周血管疾病对外周血管疾病患者的功能生活质量有显著影响。既往研究已经证实，下肢溃疡的慢性化和缺血性截肢等这些病症存在复杂、受限和昂贵的经济影响。这些复杂的、威胁肢体和生命的病症需要开发新的干预措施，并将客观研究作为该开发过程的一部分。因此，一种新型的间歇负压医疗设备，即可穿戴靴（FlowOx™）被开发出来。作为开发过程的一部分，本研究旨在探索患者和临床医生对该靴的看法。
采用定性方法在挪威收集患者和临床医生的经验。一个顾问小组为七名患者访谈和一名临床医生焦点小组（n=5）中使用的半结构式问题提供了信息。数据以数字形式记录并逐字转录。患者和临床医生的数据分别作为独立的组进行分析，采用主题分析过程。
数据分析产生了五个来自患者的主题，深入了解了疾病过程的影响；使用靴子的实际情况；使用的积极体验；感知结果；使用的反思。从临床医生那里创建了六个主题。这些主题深入了解了理想结果及其衡量方法；潜在使用靴子的方法；在医疗保健中使用研究；设备的积极方面；观察到的效果和下一步措施；设备的潜在改进。
本研究深入了解了 FlowOx™的经验和意见。患者和临床医生对该设备的易用性持积极态度。那些患有外周动脉疾病的患者比患有慢性静脉疾病的患者受益更大，尤其是对于缺血性溃疡。临床医生在治疗决策过程中重视患者报告的结果。这项对 FlowOx™使用体验的初步研究提供了宝贵的反馈意见，这将为设计修改和正在进行的实施点和潜在用户群体研究提供信息。FlowOx™作为一种保守疗法具有潜力，为改善有症状的外周动脉疾病和生活质量，为患者提供了一种方便、家庭使用、自我护理的管理解决方案。
