Dormann Julia, Wendt Sebastian, Dreher Michael, Ansems Kelly, Rolland Carole, Spillner Jan, Szafran Agnieszka, Breuer Thomas, Pison Christophe, Verbelen Tom, Benstoem Carina
Department of Intensive Care Medicine and Intermediate Care, Medical Faculty, RWTH Aachen University, Aachen, Germany.
Department of Pneumology and Intensive Care Medicine, RWTH Aachen University, Aachen, Germany.
Med Devices (Auckl). 2023 Jul 28;16:201-210. doi: 10.2147/MDER.S415258. eCollection 2023.
Terminal lung diseases such as chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH) in progression cause a large reduction in quality of life and may lead to bilateral lung transplantation (bLTx). An artificial portable lung could provide a bridge to lung transplantation, allowing patients to remain at home and mobile for longer. To advance the development of such an artificial lung, patient feedback is essential. The aim of this study is to analyze patient acceptance about an extracorporeal artificial lung and to implement these findings into the development.
In collaboration with a medical device developer, we presented a portable dummy oxygenator to patients with advanced lung disease, as potential end users. Data collection in Germany and France was based on two different methods: an online questionnaire and face-to-face interviews (F2F).
A total of 604 participants answered the online questionnaire and 17 participants were included in the F2F interviews. The majority of participants (COPD n=140, PH n=17) were able to walk more than 1 km with a mean suffering pressure of 2.87 and 3, respectively. Six of the 17 F2F participants who could walk <1 km were interested in an assistive device. The statistical value of Fisher's exact test for suffering pressure and desire for a portable oxygenator was 0.45.
In patients with advanced lung disease, there is no statistically significant association between subjectively increased suffering pressure and desire for a portable oxygenator, so market introduction may be difficult. Potential end users should be implemented early in device development. Data collection via an online questionnaire combined with personal interviews has proven to be a successful approach here.
诸如慢性阻塞性肺疾病(COPD)和进行性肺动脉高压(PH)等终末期肺部疾病会导致生活质量大幅下降,并可能导致双侧肺移植(bLTx)。人工便携式肺可以为肺移植提供桥梁,使患者能够更长时间地居家并保持活动能力。为了推进这种人工肺的开发,患者反馈至关重要。本研究的目的是分析患者对体外人工肺的接受程度,并将这些结果应用于开发过程中。
我们与一家医疗设备开发商合作,向晚期肺病患者展示了一款便携式模拟氧合器,这些患者为潜在的最终用户。在德国和法国的数据收集基于两种不同的方法:在线问卷和面对面访谈(F2F)。
共有604名参与者回答了在线问卷,17名参与者纳入了面对面访谈。大多数参与者(COPD患者n = 140,PH患者n = 17)能够行走超过1公里,平均痛苦压力分别为2.87和3。17名面对面访谈参与者中有6名行走距离<1公里,他们对辅助设备感兴趣。痛苦压力与对便携式氧合器的需求之间的Fisher精确检验统计值为0.45。
在晚期肺病患者中,主观痛苦压力增加与对便携式氧合器的需求之间没有统计学上的显著关联,因此市场推广可能困难。潜在的最终用户应在设备开发早期参与。通过在线问卷结合个人访谈进行数据收集已被证明是一种成功的方法。