Home-based monitoring for the early detection of severe neutropenia in patients receiving chemotherapy to enable intervention and avoidance of adverse events.

该SBRI II期提案旨在从计划的临床研究和经济模型中建立必要的知识，以证明一种创新技术：使用白细胞（WBC）计数护理技术（POCT）的家庭远程监测可以帮助改善化疗癌症患者的护理途径和患者体验。大量接受化疗的癌症患者可能会出现不良事件，导致疗程延迟，影响癌症治疗的潜在成功。最严重的不良事件与化疗引起的白细胞计数低有关，称为中性粒细胞减少；中性粒细胞是参与人体免疫防御系统的主要一类白细胞。在最坏的情况下，这可能导致因危及生命的感染（发热性中性粒细胞减少症：FN）而紧急住院，并需要住院和多次静脉注射抗生素治疗。这些不良事件通常发生在患者在家中进行多个疗程化疗期间。管理这些患者的肿瘤团队可能没有意识到这些不良事件，直到：(a)患者提出下一个化疗疗程，并且他们的白细胞计数过低（中性粒细胞减少），无法进行下一轮化疗，因此浪费了患者的旅程和宝贵的临床治疗时间；或者(b)他们因感染危及生命而被紧急送往医院，随后住院治疗，如果早期干预，这种情况本可以避免。其目的是开发一种家用远程监测系统，用于测量手指穿刺血液中的白细胞计数以及患者的体温。这些是肿瘤团队用来监测化疗副作用的关键参数（以及观察到的体征和症状）。该监测系统将与患者家中的远程通信设备相连接，与临床管理的决策支持相连接，使肿瘤团队能够远程监测其癌症患者的白细胞计数和体温，并有可能通过适当的干预措施改善任何不良事件。白细胞计数低可能会触发下一次化疗门诊的重新安排（从而节省患者和临床医生的时间并优化门诊的利用），或者通过输血或使用生长因子来促进白细胞的产生。早期监测白细胞计数和体温有助于提示中性粒细胞减少症的发病，并伴有进展为FN的风险，可通过生长因子和抗生素进行主动管理。这种新型技术组合的好处对患者、医疗系统和临床医生来说都是巨大的，包括：增加了便利性，通过更优化的化疗和药物治疗改善了患者的预后，减少了患者不必要的旅程，更有效地利用了有限的医疗资源。

This SBRI Phase II proposal is to establish the necessary knowledge from the planned clinical studies and economic modelling to prove that an innovative technology: home tele-monitoring using white blood cell (WBC) count point of care technology (POCT) can help improve the care pathway and patient experience of people with cancer patients on chemotherapy.A large number of cancer patients on chemotherapy will potentially suffer from adverse events that can lead to delayed courses of therapy, affecting their potential success of cancer treatment. The most serious adverse event relates to a chemotherapy-induced low WBC count termed neutropenia; neutrophils being the major class of white blood cells involved in the human body’s immune defence system. At worst this can lead to emergency hospital admission due to life threatening infections (febrile neutropenia: FN) and require hospital admissions and multiple intravenous antibiotic treatments. These adverse events often occur whilst patients are at home between their multiple courses of chemotherapy. The oncology team managing these patients may be unaware of these adverse events until either: (a) the patient presents for their next course of chemotherapy and their WBC count is too low (neutropenia) for their next round of chemotherapy, so a wasted patient journey and a loss of valuable clinic treatment time; or (b) they are rushed into hospital with life threatening infections with subsequent hospitalisation, which might have been avoided with earlier intervention.The aim is to develop a home-use tele-monitoring system for measuring WBC count in a finger prick of blood, plus the patient’s temperature. These are the key parameters (alongside observations of signs and symptoms) used by the oncology team to monitor the side effects of chemotherapy. This monitoring system will be coupled to a tele-communications device in the patient’s home, linked with clinically-managed decision support, to enable the oncology team to remotely monitor their cancer patients’ WBC count and temperature, with the potential to ameliorate any adverse events with appropriate interventions. A low WBC count could trigger a re-schedule of the next chemotherapy clinic (so saving patient's and clinician's time and optimising out-patients clinic utilisation) or be managed by blood transfusions or administering growth factors to promote white cell production. Earlier monitoring of WBC count and temperature could help indicate the onset of neutropenia, with the risk of progression to FN, which could be managed proactively with growth factors and antibiotics.The benefits of this novel combination of technologies will be substantial to patients, the healthcare system and clinicians, including: increased convenience, improved patient outcomes through more optimised use of chemotherapy and drug treatments, reducing unnecessary journeys for the patient and more efficient utilisation of the limited healthcare resource.