Jastremski M, Jastremski C, Shepherd M, Friedman V, Porembka D, Smith R, Gonzales E, Swedlow D, Belzberg H, Crass R
Hamilton Critical Care and Emergency Consultants, Syracuse, NY, USA.
Crit Care Med. 1995 Oct;23(10):1745-55. doi: 10.1097/00003246-199510000-00021.
To test a model for the assessment of critical care technology on closed loop infusion control, a technology that is in its early stages of development and testing on human subjects.
A computer-assisted search of the English language literature and reviews of the gathered data by experts in the field of closed loop infusion control systems.
Studies relating to closed loop infusion control that addressed one or more of the questions contained in our technology assessment template were analyzed. Study design was not a factor in article selection. However, the lack of well-designed clinical outcome studies was an important factor in determining our conclusions.
A focus person summarized the data from the selected studies that related to each of the assessment questions. The preliminary data summary developed by the focus person was further analyzed and refined by the task force. Experts in closed loop systems were then added to the group to review the summary provided by the task force. These experts' comments were considered by the task force and this final consensus report was developed.
Closed loop system control is a technological concept that may be applicable to several aspects of critical care practice. This is a technology in the early stages of evolution and much more research and data are needed before its introduction into usual clinical practice. Furthermore, each specific application and each device for each application (e.g., nitroprusside infusion, ventilator adjustment), although based on the same technological concept, are sufficiently different in terms of hardware and computer algorithms to require independent validation studies.
Closed loop infusion systems may have a role in critical care practice. However, for most applications, further development is required to move this technology from the innovation phase to the point where it can be evaluated so that its role in critical car practice can be defined. Each application of closed loop infusion systems must be independently validated by appropriately designed research studies. Users should be provided with the clinical parameters driving each closed loop system so that they can ensure that it agrees with their opinion of acceptable medical practice. Clinical researchers and leaders in industry should collaborate to perform the scientifically valid, outcome-based research that is necessary to evaluate the effect of this new technology. The original model we developed for technology assessment required the addition of several more questions to produce a complete analysis of an emerging technology. An emerging technology should be systematically assessed (using a model such as the model developed by the Society of Critical Care Medicine), before its introduction into clinical practice in order to provide a focus for human outcome validation trials and to minimize the possibility of widespread use of an unproven technology.
测试一种用于评估重症监护技术在闭环输注控制方面的模型，该技术尚处于对人体受试者进行开发和测试的早期阶段。
对英文文献进行计算机辅助检索，并由闭环输注控制系统领域的专家对收集到的数据进行综述。
分析了与闭环输注控制相关的、涉及我们技术评估模板中一个或多个问题的研究。研究设计不是文章选择的因素。然而，缺乏精心设计的临床结局研究是确定我们结论的一个重要因素。
一名核心人员总结了所选研究中与每个评估问题相关的数据。核心人员制定的初步数据总结由特别工作组进一步分析和完善。然后将闭环系统专家加入该小组，以审查特别工作组提供的总结。特别工作组考虑了这些专家的意见，并制定了这份最终共识报告。
闭环系统控制是一个技术概念，可能适用于重症监护实践的多个方面。这是一项处于发展早期阶段的技术，在引入常规临床实践之前，还需要更多的研究和数据。此外，每个具体应用以及每个应用的每种设备（例如硝普钠输注、呼吸机调节），尽管基于相同的技术概念，但在硬件和计算机算法方面差异很大，需要进行独立的验证研究。
闭环输注系统可能在重症监护实践中发挥作用。然而，对于大多数应用，需要进一步发展，以使这项技术从创新阶段发展到能够进行评估的阶段，从而确定其在重症监护实践中的作用。闭环输注系统的每个应用都必须通过适当设计的研究进行独立验证。应向用户提供驱动每个闭环系统的临床参数，以便他们能够确保该系统与他们认可的医疗实践观点一致。临床研究人员和行业领导者应合作开展科学有效的、基于结局的研究，以评估这项新技术的效果。我们最初开发的技术评估模型需要增加几个问题，才能对一项新兴技术进行全面分析。在将一项新兴技术引入临床实践之前，应系统地对其进行评估（使用诸如危重病医学会开发的模型），以便为人体结局验证试验提供重点，并尽量减少未经证实的技术广泛使用的可能性。
