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

描述(由申请人提供)：抽象的患者报告结果(PRO)是与健康相关的生活质量的组成部分，通常通过使用有效和可靠的问卷来衡量患者直接来自患者的健康方面。管理方法传统上是纸质表格或计算机化/互联网方法。目前这些方法中的每一种都有明显的缺陷。在很大程度上由于方法问题，对儿童，包括有沟通障碍的儿童的利弊研究不足。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，开发新的方法在特殊或脆弱人群中收集PRO数据是有益的。我们的目标是开发PRO-Surveyor，一种专门的、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的方法，可以轻松适应任何问卷工具、各种回答模式、各种问卷管理模式(文本、音频、视频)，以及从远程站点向临床医生或研究人员自动传输数据。第一阶段的具体目标是通过调查PRO测量的重复性、使用效率以及与传统纸质PRO测量相比较的初步PRO原型的可接受性来证明可行性。我们将使用一个初步的原型来收集典型发育中的儿童和患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。这一里程碑式的目标将通过4个步骤实现：(1)设计和构建具有核心功能的PRO-Surveyor的工作原型；(2)在重点访谈中向5名儿童和家长展示该设备；(3)修改PRO-Surveyor以纳入重点访谈的结果，并使用PedsQL 4.0在20名8-12岁的儿童中测试PRO-Surveyor，PedsQL 4.0是一份有效、可靠且适合年龄的问卷，用于评估儿童对总体健康质量的看法；以及(4)完成数据分析和第一阶段报告。有必要制定收集儿童PRO数据的新战略，以实现获得治疗结果的包容性代表的目标。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，临床上对收集儿童PRO数据的创新方法有着强烈的需求。1与公共健康相关的PRO-Surveyor是一种创新的、低成本的专用手持设备，用于收集和传输儿童的患者报告结果(PRO)。考虑到新的食品和药物管理局(FDA)指南和NIH项目(NIH PROMIS)，制定收集这些数据的策略是非常及时的，这表明越来越重视获取和了解患者对其健康的看法。因此，开发改进和有效的数据收集方法，特别是在脆弱和通常被排除在外的人群中，如儿童，对于医疗保健和NIH的使命是重要的和高度相关的。

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.