The e-Itch Vital Signs: development of a new mobile outcomes measure for clinical trials in patients with chronic itch

项目总结 慢性症状性皮肤病是患者报告的常见情况的显著例子 都是至关重要的结果。这些疾病很少影响身体等传统的健康生命体征。 体温和血压，但经常影响症状和生活质量，我们称之为 “皮肤生命体征”，因为它们提供了患者皮肤相关健康的基本方面的快照。 最常见的皮肤症状是瘙痒，这是一种影响10%-20%的人的令人不安的经历，而且可能是 慢性的和致残的。瘙痒与糟糕的幸福感有关，包括情绪低落、焦虑和 睡眠质量下降。全面了解瘙痒患者的经历对于 监测临床试验中的治疗效果，并为护理决策提供信息。但尽管调查工具 已经开发出测量瘙痒的方法，但没有一种被接受为通用标准。经过验证的措施 患者的报告早就有了，但患者报告的衡量一直受到以下因素的阻碍 繁琐的纸质调查，快速沟通成绩的机制效率低下，以及不足 关于如何解释它们的信息。改善瘙痒和患者护理的临床试验面临的挑战 对于瘙痒，是缺乏一个标准化的、用户友好的工具来全面监测瘙痒及其影响，并且在 临床医生和研究人员可以轻松接受和解释的方式。 这项研究的长期目标是通过 实施严格的干预措施临床试验。我们开发了一个基于互联网的工具，名为 E-Skin生命体征-以实时和可解释的方式测量和交流患者的报告 他们的皮肤症状和对他们生活质量的影响。我们的目标是改进这个针对瘙痒的移动工具( 基于从患者和临床医生那里收集的经验数据，并建立 它的基本测量属性和可解释性，以便它可以立即用作 临床试验中的结果衡量标准。我们将开发和完善移动电子瘙痒生命体征，使用输入 来自患者和临床医生(目标1)，并将确定其可靠性、有效性和对变化的响应 随着时间的推移，慢性瘙痒患者(目标2)。在一项关于慢性瘙痒患者的前瞻性队列研究中 特应性皮炎，我们将确定e-瘙ch生命体征评分的最小重要差异，使用 以病人为中心(目标3)。 这项研究将提供一个准确的，用户友好的，可解释的衡量瘙痒及其影响的方法 立即用于临床试验。该项目将产生足够的数据，我们提交的e-瘙ch生命体征 FDA临床结果评估资格程序的工具-报告 在改善瘙痒的干预措施的临床试验中确定有效性的结果测量。

PROJECT SUMMARY Chronic symptomatic skin diseases are striking examples of common conditions for which patients' reports are crucial outcomes. These diseases only rarely affect conventional vital signs of health such as body temperature and blood pressure, but often affect symptoms and quality of life, features we have called the “Skin Vital Signs” because they provide a snapshot of fundamental aspects of the patient's skin-related health. The most common skin symptom is itch, a disturbing experience that affects 10-20% of persons, and can be chronic and disabling. Itch is associated with poor well-being, including depressed mood, anxiety, and diminished quality of sleep. A comprehensive understanding of the experience of patients with itch is crucial to monitor the effects of therapies in clinical trials and to inform care decisions. But although survey instruments have been developed to measure itch, none is accepted as the universal standard. Validated measures of patients' reports have long been available, but the measurement of patient's reports has been hampered by burdensome paper-based surveys, inefficient mechanisms for rapid communication of scores, and insufficient information about how to interpret them. A challenge for clinical trials to improve itch, and the care of patients with itch, is the lack of a standardized user-friendly tool to monitor itch and its effects comprehensively, and in ways that clinicians and researchers can easily receive and interpret. The long-term objective of this research is to improve treatment options for patients with itch through the performance of rigorous clinical trials of interventions. We have developed an internet-based tool—called the e-Skin Vital Signs—to measure and communicate in real-time and in interpretable ways patients' reports about their skin symptoms and effects on their quality of life. Our goals are to refine this mobile tool for itch (the “e-Itch Vital Signs”) based on empirically gathered data from patients and clinicians, and to establish its essential measurement properties and interpretability so that it will be ready for immediate use as an outcomes measure in clinical trials. We will develop and refine the mobile e-Itch Vital Signs, using input from patients and clinicians (Aim 1), and will determine its reliability, validity and responsiveness to changes over time in patients with chronic itch (Aim 2). In a prospective cohort study of patients with chronic itch from atopic dermatitis, we will determine the minimal important difference in e-Itch Vital Signs scores, using a patient-based anchor (Aim 3). This research will provide an accurate, user-friendly, and interpretable measure of itch and its effects for immediate use in clinical trials. This project will generate sufficient data for us to submit the e-Itch Vital Signs tool to the FDA's Clinical Outcome Assessment Qualification Program for qualification as a patient-reported outcome measure for effectiveness determination in clinical trials of interventions to improve itch.