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

描述（由申请人提供）：供方建议开发和测试一种新的硬件和软件组合解决方案，该解决方案由配备Mi-Forms数据收集软件的Livescribe脉搏智能笔组成，用于床边患者护理记录期间的临床数据收集。Livescribe脉搏智能笔是一种新的商业现成硬件产品，提供手写和语音捕获，而Mi-Forms数据收集软件是提供小型企业的旗舰产品。医生仍然强烈倾向于通过笔和语音听写记录患者信息和护理进度。到目前为止，还没有一种设备能够在一个集成平台上提供电子手写捕获、文本转换和语音捕获。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。目前提出的研究是在杜克大学癌症诊所部署的一种新型架构中，测试Pulse智能笔的同时语音和笔在纸上的手写捕捉能力，并结合Mi-Co独特的处理笔和语音数据的软件。该技术解决方案比目前的纸抄写加听写方法更快、更高效，但仍然符合当前医生的工作流程偏好，可以简化临床试验患者数据的收集，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的健康状况。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格（eCRFs）的患者数据，并通过笔和语音听写记录患者的进展情况。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，该系统将使患者数据从护理记录自动转录到病例报告表格中，然后转录口述的进度记录。该解决方案还将允许将CRF数据和进度记录自动传输到现有系统，以便临床试验发起人和临床护理团队的其他成员更快地获得数据，确保更好的沟通和协调，以实现更有效的临床试验和改善患者护理。

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.