XM02 is superior to placebo and equivalent to Neupogen™ in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy

Abstract Background Recombinant granulocyte colony-stimulating factors (G-CSFs) such as Filgrastim are used to treat chemotherapy-induced neutropenia. We investigated a new G-CSF, XM02, and compared it to Neupogen™ after myelotoxic chemotherapy in breast cancer (BC) patients. Methods A total of 348 patients with BC receiving docetaxel/doxorubicin chemotherapy were randomised to treatment with daily injections (subcutaneous 5 μg/kg/day) for at least 5 days and a maximum of 14 days in each cycle of XM02 (n = 140), Neupogen™ (n = 136) or placebo (n = 72). The primary endpoint was the duration of severe neutropenia (DSN) in cycle 1. Results The mean DSN in cycle 1 was 1.1, 1.1, and 3.9 days in the XM02, Neupogen™, and placebo group, respectively. Superiority of XM02 over placebo and equivalence of XM02 with Neupogen™ could be demonstrated. Toxicities were similar between XM02 and Neupogen™. Conclusion XM02 was superior to placebo and equivalent to Neupogen™ in reducing DSN after myelotoxic chemotherapy. Trial Registration Current Controlled Trials ISRCTN02270769</p

Keeping track of railway safety and the mechanisms for risk

Crawford, EG ORCiD: 0000-0002-7140-9685A major technological shift is occurring in the railways giving rise to new safety concerns. The speed in which change is occurring along with technological trends is significant for an industry that can have major consequences when things go wrong. This surging technological shift has prompted re-examination of the literature related to the risks associated with system integration in high-risk (or safety-critical) industries. The aim of this paper is to raise awareness of potential health and safety risks emerging in the railway industry. Two mechanisms of risk that may have impact upon the success of an integrated railway are discussed, namely the human-automation design and progressive integration efforts. Past lessons learned are drawn from the literature that are considered relevant to current trends in the railways. The paper concludes with a presentation of six prevailing trends that raise concern for safety in the railways, namely: the shifting cognitive challenges for operators of centralised control systems, end-user adoption of systems that continuously rise in complexity, the growing prevalence of sedentary work particularly in control rooms, developing data security and privacy concerns, expanding demands for data analytics and an emerging paradigm shift in safety practice. For each trend, future research needs are presented. © 2018 Elsevier Lt

Keeping track of railway safety and the mechanisms for risk

Crawford, EG ORCiD: 0000-0002-7140-9685A major technological shift is occurring in the railways giving rise to new safety concerns. The speed in which change is occurring along with technological trends is significant for an industry that can have major consequences when things go wrong. This surging technological shift has prompted re-examination of the literature related to the risks associated with system integration in high-risk (or safety-critical) industries. The aim of this paper is to raise awareness of potential health and safety risks emerging in the railway industry. Two mechanisms of risk that may have impact upon the success of an integrated railway are discussed, namely the human-automation design and progressive integration efforts. Past lessons learned are drawn from the literature that are considered relevant to current trends in the railways. The paper concludes with a presentation of six prevailing trends that raise concern for safety in the railways, namely: the shifting cognitive challenges for operators of centralised control systems, end-user adoption of systems that continuously rise in complexity, the growing prevalence of sedentary work particularly in control rooms, developing data security and privacy concerns, expanding demands for data analytics and an emerging paradigm shift in safety practice. For each trend, future research needs are presented. © 2018 Elsevier Lt

Participatory design for optimizing the implementation of new transport technology

Crawford, EG ORCiD: 0000-0002-7140-9685; Dell, GP ORCiD: 0000-0002-6983-878X; Kift, R ORCiD: 0000-0001-8282-3868Abstract. The achievement of a seamless transportation system can potentially offer many efficiencies and passenger experience benefits. In support of this objective, many business units are moving towards a model similar to the air traffic control. However, lack of attention to the user experience at the control desk can negatively extend to the user experience of customers. Considering current advancements and risk potential, it is prudent to learn from the systems integration experiences of others. To achieve this aim, this study captured the unique experiences of end-users of new technology for safety-critical control systems. The results showed that a lack of end-user participation during the design process could put optimal system performance at risk. An ‘exemplary’ participatory process is shared, along with some of the benefits of following this method for end users. The paper closes with future research directions

Do end users really have a place in the design arena when safe design is critical?

There is a global trend towards more highly automated traffic man-agement systems. Problematic to increased automation are the higher levels of system integration and associated complexity and uncertainty this brings. This study explored whether end-user participation in new project design and imple-mentation can contribute to the smooth and effective introduction of these new systems for railway control rooms. Results showed that almost all participants agreed that end-user input is important to the success of new technology. Howev-er, experiences shared by interviewed controllers highlighted that end-user partic-ipation in major projects is underutilized and that certain types of involvement or action can actively hinder the implementation process. The authors anticipate that the experiences of controllers can enhance decision-making associated with end-user participation during the introduction of new traffic management systems. The authors also anticipate that end-user participation will advance improved human system integration