Clinical trials data collection during patient care using a novel technology solu

描述(由申请人提供)：要约人提议开发和测试一种新型的硬件和软件组合解决方案，该解决方案由Livescribe Pulse智能笔和Mi-Forms数据收集软件组成，用于床边患者护理记录期间的临床数据收集。Livescribe Pulse智能笔是一款新的商用现成硬件产品，提供手写和语音捕获功能，而Mi-Forms数据采集软件是提供服务的小型企业的旗舰产品。医生仍然强烈倾向于通过笔和语音口述来记录患者信息和护理进度记录。到目前为止，还没有能够在单一集成平台中提供电子笔迹捕获、转换为文本和语音捕获的设备。今天Livescribe推出的Pulse SmartPEN就是这样一个平台，它比标准的圆珠笔大不了多少。目前提出的这项研究是为了测试Pulse Smart笔与Mi-Co用于处理笔和语音数据的独特软件在杜克大学癌症诊所部署的一种新颖架构中同时捕获语音和笔迹的能力。这一技术解决方案比目前的纸质转录和听写方法更快速、更高效，但仍符合当前医生的工作流程偏好，可以简化临床试验的患者数据收集，同时实现更多重要患者护理信息的自动共享，从而通过研究和护理改善患者的健康结果。这一创新的组合将使临床医生能够同时收集临床试验的患者数据，并通过笔和语音口述记录患者的进展记录。该系统将为忙碌的临床医生提供一个熟悉的、易于使用的系统，使患者数据能够自动从护理记录转录到病例报告表格中，并在以后转录口述的进度记录。该解决方案还将允许将CRF数据和进展说明自动传送到现有系统，以便更快地提供给临床试验赞助商和临床护理团队的其他成员，确保更有效的临床试验和改善患者护理的更好沟通和协调。 公共卫生相关性：要约人建议开发和测试由Livescribe Pulse Smartpen和Mi-Forms数据收集软件组成的新型硬件和软件组合解决方案，用于床边患者护理记录期间的临床数据收集。该系统将利用一种新的硬件设备，同时捕获手写和语音口述，并创建一个用户友好的临床试验数据输入系统，该系统到达患者床边，并自动填充用于临床研究和患者护理的后端系统。在收集临床试验数据方面提高效率并提高临床医生满意度的新系统，通过更简化的新药开发和测试，有利于公众健康。

DESCRIPTION (provided by applicant): The offeror propose to develop and test a novel hardware and software combination solution composed of the Livescribe Pulse Smartpen with Mi-Forms data collection software, for use in clinical data collection during patient care documentation at the bedside. The Livescribe Pulse Smartpen is a new commercial off the shelf hardware product providing both handwriting and speech capture, and Mi-Forms data collection software is the flagship product of the offering small business. Physicians continue to have a strong preference for recording patient information and care progress notes via pen and speech dictation. Until now, there have been no devices capable of providing electronic handwriting capture, conversion to text and speech capture in a single integrated platform. Today's Pulse Smartpen from Livescribe, not much larger than a standard ballpoint pen, is such a platform. This current proposed research is to test the simultaneous speech and pen-on-paper handwriting capture capability of the Pulse Smartpen, coupled with Mi-Co's unique software for processing pen and speech data, in a novel architecture deployed in the Duke University Cancer Clinics. More rapid and efficient than the current method of paper transcription plus dictation, but still conforming to current physician workflow preferences, this technology solution can serve to streamline the collection of patient data for clinical trials while enabling more automatic sharing of important patient care information, leading to improved patient health outcomes via both research and care. This innovative combination will allow clinicians to simultaneously collect patient data for clinical trial electronic Case Report Forms (eCRFs) and document patient progress notes via both pen and speech dictation. This system will provide busy clinicians with a familiar, easy to use system that will enable the automatic transcription of patient data from care records into case report forms and later transcription of dictated progress notes. The solution will also allow for the automated communication of CRF data and progress notes to existing systems for quicker availability to clinical trials sponsors and other members of the clinical care team, ensuring better communication and coordination for more efficient clinical trials and improved patient care. PUBLIC HEALTH RELEVANCE: The offerors propose to develop and test a novel hardware and software combination solution composed of the Livescribe Pulse Smartpen with Mi-Forms data collection software, for use in clinical data collection during patient care documentation at the bedside. This system will utilize a new hardware device that captures both handwriting and speech dictation, and create a user- friendly clinical trials data entry system that reaches the patient bedside and automatically populates back-end systems for clinical research and patient care. New systems that improve efficiency and also increase clinician satisfaction in collection of clinical trials data are beneficial to public health through more streamlined creation and testing of new medicines.