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

这项SBRI第二阶段的建议是从计划中的临床研究和经济模型中建立必要的知识，以证明一项创新技术：使用白细胞(WBC)护理点技术(POCT)的家庭远程监控可以帮助改善癌症患者在化疗中的护理途径和患者体验。大量癌症患者在接受化疗时可能会发生不良事件，导致疗程延迟，影响他们潜在的癌症治疗成功。最严重的不良事件与化疗引起的白细胞减少有关，称为中性粒细胞减少症；中性粒细胞是人体免疫防御系统中的主要白细胞类别。在最糟糕的情况下，这可能会导致因危及生命的感染(发热性中性粒细胞减少症：FN)而紧急入院，并需要住院和多次静脉注射抗生素治疗。这些不良事件经常发生在患者在家中进行多个疗程化疗的时候。管理这些患者的肿瘤团队可能不知道这些不良事件，直到：(A)患者出现在下一疗程的化疗中，而他们的白细胞计数太低(中性粒细胞减少症)，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)他们因随后的住院治疗而被紧急送往医院，这本来可以通过早期干预避免的。目的是开发一种家用远程监测系统，用于测量手指点血中的白细胞计数和患者的体温。这些是肿瘤学团队用来监测化疗副作用的关键参数(以及对体征和症状的观察)。这一监测系统将与患者家中的远程通信设备相连，与临床管理的决策支持相连，使肿瘤学团队能够远程监测他们的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缓解任何不良事件。低白细胞计数可能会引发下一次化疗诊所的重新安排(从而节省患者和临床医生的时间，并优化门诊患者的诊所利用率)，或者通过输血或注射生长因子来促进白细胞的产生。及早监测WBC计数和体温可能有助于提示中性粒细胞减少症的发病，并有发展为FN的风险，这可以通过生长因子和抗生素主动控制。这种新型技术组合将对患者、医疗保健系统和临床医生产生重大好处，包括：增加便利性，通过更优化地使用化疗和药物治疗来改善患者结果，减少患者不必要的行程，以及更有效地利用有限的医疗资源。

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.