PRO-Surveyor: Device for Capturing Patient Reported Outcome Data in Children

描述（由申请人提供）：摘要患者报告的预后（pro）是健康相关生活质量的一个组成部分，它衡量患者健康的各个方面，这些方面直接来自患者，通常通过使用有效和可靠的问卷调查。传统的管理方法是纸质表格或计算机化/互联网方法。这些当前的方法都有明显的缺陷。儿童的优点，包括有沟通障碍的儿童，一直没有得到充分的研究，这在很大程度上是由于方法问题。目前，数据收集方法不适合纳入特殊人群，如儿童、慢性病患者、不会说英语的人、文盲或生活在偏远地区的贫困人口。因此，开发特殊或弱势群体PRO数据收集的新方法是有益的。我们的目标是开发PRO- surveyor，一种专用的，低成本的手持设备，用于收集和电子传输儿科PRO问卷数据。PRO-Surveyor是创新的，因为它采用了一种新颖的方法，很容易适应任何问卷工具，各种响应模型，各种问卷管理模式（文本，音频，视频），并自动将数据传输给临床医生或远程调查员。第一阶段的具体目标是通过调查PRO测量的可重复性、使用效率和PRO- surveyor初步原型的可接受性来证明可行性，并与传统的纸质PRO测量进行比较。我们将使用一个初步的原型来收集正常发育儿童和有语言和声音障碍的儿童的PRO数据，年龄在8-12岁之间，每个孩子有一个父母。这个里程碑驱动的目标将分四个步骤完成：(1)设计和构建具有核心功能的PRO-Surveyor的工作原型；(2)对5名儿童和家长进行集中访谈；(3)对PRO-Surveyor进行修改，纳入重点访谈的结果，并在20名8-12岁的儿童中使用PedsQL 4.0进行PRO-Surveyor测试，这是一份有效、可靠、适合年龄的评估儿童一般健康质量感知的问卷；(4)完成数据分析和一期报告。制定收集儿童PRO数据的新策略对于获得治疗结果的包容性代表这一目标是必要的。虽然电脑和互联网的使用为电子数据采集带来了巨大的希望，但美国人口普查数据显示，许多家庭没有电脑或互联网接入，特别是有孩子的家庭和年收入低于2.5万美元的家庭。因此，迫切需要创新的方法来收集儿童PRO数据。PRO-Surveyor是一种创新的、低成本的、专用的手持式设备，用于收集和传输儿童的患者报告结果（pro）。鉴于美国食品和药物管理局（FDA）的新指导方针和美国国立卫生研究院（NIH PROMIS）的计划，收集这些数据的策略的发展是非常及时的，这些计划表明越来越重视获取和理解患者对他/她健康的看法。因此，制定改进和有效的数据收集方法，特别是在儿童等脆弱和通常被排斥的人群中收集数据的方法，对卫生保健和国家卫生研究院的使命非常重要和高度相关。

DESCRIPTION (provided by applicant): Abstract Patient-reported outcomes (PROs) are a component of health-related quality of life that measure aspects of a patient's health that come directly from the patient, typically via the use of valid and reliable questionnaires. Methods of administration are traditionally paper forms or computerized/internet methods. Each of these current methods has significant pitfalls. PROs of children, including children with communication impairments, have been understudied, due in large part to methodological issues. Presently, data collection methods are not amenable to inclusion of special populations, such as children, the chronically ill, those who do not speak English, the illiterate, or the impoverished living in remote areas. Therefore, it is beneficial to develop new methods for the collection of PRO data in special or vulnerable populations. Our goal is to develop PRO-Surveyor, a dedicated, low cost, handheld device for the collection and electronic transmission of pediatric PRO questionnaire data. PRO-Surveyor is innovative because it employs a novel approach easily adapted to any questionnaire instrument, various response models, various modes of questionnaire administration (text, audio, video), and automatic data transmission to the clinician or investigator from remote sites. The specific aim of Phase I is to demonstrate feasibility by investigating reproducibility of PRO measurements, efficiency of use, and acceptability of a preliminary PRO-Surveyor prototype, in comparison with traditional paper PRO measurements. We will use a preliminary prototype to collect PRO data from typically developing children and children with with speech and voice impairments, ages 8-12, and one parent per child. This milestone-driven aim will be accomplished in 4 steps: (1) design and build a working prototype of PRO-Surveyor with core functionality; (2) present the device to 5 children and parents in focused interviews; (3) modify PRO-Surveyor to incorporate results from focused interviews, and test PRO-Surveyor in 20 children, ages 8-12 using the PedsQL 4.0, a valid, reliable, and age-appropriate questionnaire that assesses perception of general health quality in children; and (4) complete data analysis and Phase I reporting. Development of new strategies for collecting PRO data in children is necessary toward the goal of obtaining an inclusive representation of treatment outcomes. While the use of computers and the internet has great promise for electronic data capture, US Census data revealed that many homes do not have computers or internet access, particularly homes with children and those with incomes less than $25,000 per year. Accordingly, there is a strong clinical need for innovative approaches to the collection of PRO data in children. 1 PUBLIC HEALTH RELEVANCE PRO-Surveyor is an innovative, low cost, dedicated, handheld device for collecting and transmitting patient reported outcomes (PROs) from children. Development of strategies for collecting these data is very timely given new Food and Drug Administration (FDA) guidance and NIH programs (NIH PROMIS) that signal an increased focus on obtaining and understanding the patient's perspective of his/her health. Accordingly, development of improved and efficient methods for data collection, especially in vulnerable and typically excluded populations, such as children, is important and highly relevant to healthcare and the mission of the NIH.