【罂粟摘要】止血交通灯，一种以用户为中心的用于急性出血的凝血管理工具：一项基于模拟的随机双中心试验
止血交通灯，一种以用户为中心的用于急性出血的凝血管理工具：一项基于模拟的随机双中心试验
止血交通灯是一种以用户为中心而设计的辅助诊断工具，可增强和简化围手术期出血的情况识别和决策。其设计结构有助于根据病理生理和出血的严重程度确定干预治疗的优先次序。这项由研究人员发起的，随机、前瞻性、国际性的双中心研究，旨在通过针对两家大学医院的常规凝血方案进行调整来验证止血交通灯的作用。
在2020年1月9日至5月12日期间，我们在瑞士的苏黎世大学医院和在阿根廷的意大利布宜诺斯艾利斯医院招募了84名受试者。每个中心的工作人员包括21位住院医师和21位麻醉医生。受试者被随机分配到基于文本的算法组或止血交通灯组。
所有受试者使用相同的算法处理了六个出血情况。在模拟出血情况下，止血红绿灯算法的设计可以更加正确地解决病例，即OR(95％CI)7.23(3.82-13.68),p <0.001，更快地采取治疗决策，HR(95％CI)1.97 (1.18-3.29，p = 0.010)。此外，该工具提高了治疗可信度，OR(95％CI)4.31(1.67-11.11，p=0.003)，感知工作负荷系数(95％CI)降低至6.1(10.98-1.22)，p=0.020)。
本研究为以用户为中心的设计在制定止血方案中的重要性提供了经验证据。
The Haemostasis Traffic Light is a cognitive aid with a user-centred design to enhance and simplify situation awareness and decision-making during peri-operative bleeding. Its structure helps to prioritise therapeutic interventions according to the pathophysiology and the severity of the bleeding. This investigator-initiated, randomised, prospective, international, dual-centre study aimed to validate the Haemostasis Traffic Light by adapting it to the local coagulation protocols of two university hospitals. Between 9 January and 12 May 2020, we recruited 84 participants at the University Hospital Zurich, Switzerland, and the Italian Hospital of Buenos Aires, Argentina. Each centre included 21 resident and 21 staff anaesthetists. Participants were randomly allocated to either the text-based algorithm or the Haemostasis Traffic Light. All participants managed six bleeding scenarios using the same algorithm. In simulated bleeding scenarios, the design of the Haemostasis Traffic Light algorithm enabled more correctly solved cases, OR (95%CI) 7.23 (3.82–13.68), p < 0.001, and faster therapeutic decisions, HR (95%CI) 1.97 (1.18–3.29, p = 0.010). In addition, the tool improved therapeutic confidence, OR (95%CI) 4.31 (1.67–11.11, p = 0.003), and reduced perceived work-load coefficient (95%CI) -6.1 (-10.98 to -1.22), p = 0.020). This study provides empirical evidence for the importance of user-centred design in the development of haemostatic management protocols.
E. D. Kataife, S. Said, J. Braun, et al. The Haemostasis Traffic Light, a user-centred coagulation management tool for acute bleeding situations: a simulation-based randomised dual-centre trial.[J].Anaesthesia, 2020, Nov 19, doi:10.1111/anae.15314.
