Usability Evaluation of a Noninvasive Neutropenia Screening Device (PointCheck) for Patients Undergoing Cancer Chemotherapy: Mixed Methods Observational Study.
Usability Evaluation of a Noninvasive Neutropenia Screening Device (PointCheck) for Patients Undergoing Cancer Chemotherapy: Mixed Methods Observational Study.
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DOI：
10.2196/37368
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发表时间：
2022-08-09
影响因子：
7.4
通讯作者：
Sloan, John Mark
中科院分区：
文献类型：
--
作者：
Lamaj, Ganimete;Pablo-Trinidad, Alberto;Butterworth, Ian;Bell, Nolan;Benasutti, Ryan;Bourquard, Aurelien;Sanchez-Ferro, Alvaro;Castro-Gonzalez, Carlos;Jimenez-Ubieto, Ana;Baumann, Tycho;Rodriguez-Izquierdo, Antonia;Pottier, Elizabeth;Shelton, Anthony;Martinez-Lopez, Joaquin;Sloan, John Mark
关键词：
接受细胞毒性化疗的癌症患者因其治疗而患严重感染的风险增加，因为治疗会降低他们的白细胞计数，更具体地说，降低他们的中性粒细胞绝对计数。这种情况被称为中性粒细胞减少症。中性粒细胞减少伴发烧被称为发热性中性粒细胞减少，这是化疗的常见副作用，死亡率很高。及时检测严重中性粒细胞减少症(中性粒细胞计数绝对值/μL)是发现和处理发热性中性粒细胞减少症的关键。目前的方法依赖于抽血，这将其限制在临床环境中，并且不允许频繁或便携式监测。在这项研究中，我们展示了PointCheck的可用性，这是一种用于中性粒细胞减少症筛查的非侵入性设备，在模拟的家庭环境中没有临床监督。PointCheck自动通过手指皮肤进行显微镜检查，以成像流经浅层微毛细血管的血液，并实现对中性粒细胞减少状态的远程监控，而无需静脉穿刺术。这项研究旨在评估PointCheck的可用性，这是一种用于筛查严重中性粒细胞减少症的非侵入性光学技术，目的是从未经培训的用户的角度确定潜在的用户界面、功能和设计问题。我们使用定量和定性的方法对154名未经培训的参与者进行了一项多中心研究，以评估PointCheck的可用性。我们使用混合方法通过用户测试观察、简短回答的定性问卷和标准化的量化系统可用性量表(SUS)调查来收集可用性数据，以评估感知的可用性和满意度。在154名参与者中，我们发现有108人(70.1%)在所有站点的SUS得分高于80.8，所有站点的SUS平均得分为86.1。此外，SUS的结果表明，在完成SUS调查的151名用户中，145名(96%)发现他们很快学会了如何使用PointCheck，141名(93.4%)在使用该设备时感到非常自信。我们已经证明，PointCheck，一种基于家庭的非侵入性中性粒细胞减少检测的新技术，可以安全有效地被首次使用的用户操作。在模拟的家庭环境中，这些用户发现它很容易使用，SUS的平均得分为86.1，这表明他们对可用性的感觉很好，并将该设备置于SUS评估的可用性系统的前10%。ClinicalTrials.gov NCT04448314；https://clinicaltrials.gov/ct2/show/NCT04448314(12月8日大学医院注册)和NCT04448301；https://clinicaltrials.gov/ct2/show/NCT04448301(波士顿医疗中心注册)
Patients with cancer undergoing cytotoxic chemotherapy face an elevated risk of developing serious infection as a consequence of their treatment, which lowers their white blood cell count and, more specifically, their absolute neutrophil count. This condition is known as neutropenia. Neutropenia accompanied by a fever is referred to as febrile neutropenia, a common side effect of chemotherapy with a high mortality rate. The timely detection of severe neutropenia (<500 absolute neutrophil count/μL) is critical in detecting and managing febrile neutropenia. Current methods rely on blood draws, which limit them to clinical settings and do not allow frequent or portable monitoring. In this study, we demonstrated the usability of PointCheck, a noninvasive device for neutropenia screening, in a simulated home environment without clinical supervision. PointCheck automatically performs microscopy through the skin of the finger to image the blood flowing through superficial microcapillaries and enables the remote monitoring of neutropenia status, without requiring venipuncture. This study aimed to evaluate the usability of PointCheck, a noninvasive optical technology for screening severe neutropenia, with the goal of identifying potential user interface, functionality, and design issues from the perspective of untrained users. We conducted a multicenter study using quantitative and qualitative approaches to evaluate the usability of PointCheck across 154 untrained participants. We used a mixed method approach to gather usability data through user testing observations, a short-answer qualitative questionnaire, and a standardized quantitative System Usability Scale (SUS) survey to assess perceived usability and satisfaction. Of the 154 participants, we found that 108 (70.1%) scored above 80.8 on the SUS across all sites, with a mean SUS score of 86.1 across all sites. Furthermore, the SUS results indicated that, out of the 151 users who completed the SUS survey, 145 (96%) found that they learned how to use PointCheck very quickly, and 141 (93.4%) felt very confident when using the device. We have shown that PointCheck, a novel technology for noninvasive, home-based neutropenia detection, can be safely and effectively operated by first-time users. In a simulated home environment, these users found it easy to use, with a mean SUS score of 86.1, indicating an excellent perception of usability and placing this device within the top tenth percentile of systems evaluated for usability by the SUS. ClinicalTrials.gov NCT04448314; https://clinicaltrials.gov/ct2/show/NCT04448314 (Hospital Universitario 12 de Octubre registration) and NCT04448301; https://clinicaltrials.gov/ct2/show/NCT04448301 (Boston Medical Center registration)
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