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

描述（由申请人提供）：要约人拟开发和测试一种新型硬件和软件组合解决方案，该解决方案由Livescribe Pulse Smartpen和Mi-Forms数据采集软件组成，用于在床边记录患者护理文件期间的临床数据采集。该Livescribe脉冲智能笔是一个新的商业现成的硬件产品，提供手写和语音捕捉，和Mi表格数据收集软件是旗舰产品的提供小企业。医生仍然强烈偏好通过笔和语音听写记录患者信息和护理进展记录。到目前为止，还没有能够在单个集成平台中提供电子手写捕获、到文本的转换和语音捕获的设备。今天的脉冲Smartpen从Livescribe，没有比标准圆珠笔大很多，就是这样一个平台。目前提出的这项研究是测试同时语音和笔在纸上的手写捕捉能力的脉冲智能笔，再加上Mi-Co的独特的软件处理笔和语音数据，在一个新的架构部署在杜克大学癌症诊所。这种技术解决方案比目前的纸质转录加口述的方法更快速、更有效，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，同时实现重要患者护理信息的更自动共享，从而通过研究和护理改善患者健康结果。这种创新的组合将允许临床医生同时收集临床试验电子病例报告表（eCRF）的患者数据，并通过笔和语音听写记录患者进展记录。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，该系统将能够将患者数据从护理记录自动转录到病例报告表中，并随后转录口述的进展记录。该解决方案还将允许将CRF数据和进度记录自动传送到现有系统，以便更快地提供给临床试验申办者和临床护理团队的其他成员，确保更好的沟通和协调，以提高临床试验的效率和改善患者护理。 公共卫生相关性：供应商建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 Smartpen和Mi-Forms数据采集软件组成，用于在床边记录患者护理期间的临床数据采集。该系统将利用一种新的硬件设备，可以捕获手写和语音听写，并创建一个用户友好的临床试验数据输入系统，该系统可以到达患者床边，并自动填充临床研究和患者护理的后端系统。新系统提高了效率，也提高了临床医生对临床试验数据收集的满意度，通过更精简的新药开发和测试，有利于公共卫生。

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.