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

项目摘要 慢性症状性皮肤病是常见疾病的突出例子， 是至关重要的结果。这些疾病很少影响传统的健康生命体征，如身体 温度和血压，但往往会影响症状和生活质量，我们称之为功能 “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，这是一种令人不安的经历，影响10-20%的人， 慢性和残疾。瘙痒与不良的健康状况有关，包括抑郁情绪，焦虑， 睡眠质量下降。全面了解瘙痒患者的经验是至关重要的 监测临床试验中治疗的效果，并为护理决策提供信息。但是，尽管测量仪器 已经被开发来测量瘙痒，没有一个被接受为通用标准。经验证的措施 病人的报告早就有了，但病人报告的衡量受到了阻碍， 繁琐的纸质调查，快速沟通分数的机制效率低下， 关于如何解释它们的信息。改善瘙痒的临床试验和患者护理面临的挑战 与瘙痒，是缺乏一个标准化的用户友好的工具，以监测瘙痒及其影响全面， 临床医生和研究人员可以很容易地接收和解释的方式。 这项研究的长期目标是通过以下方法改善瘙痒患者的治疗选择： 进行严格的干预临床试验。我们开发了一种基于互联网的工具， 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移动的工具， “e-Itch Vital Signs”），并建立 它的基本测量特性和可解释性，以便它将准备立即使用， 临床试验中的结果衡量标准。我们将开发和完善移动的电子瘙痒生命体征，使用输入 从患者和临床医生（目标1），并将确定其可靠性，有效性和反应的变化 随着时间的推移，慢性瘙痒患者（目标2）。在一项对慢性瘙痒患者的前瞻性队列研究中， 特应性皮炎，我们将确定最小的重要差异，在e-Itch生命体征评分，使用 基于患者的锚（目标3）。 这项研究将提供一个准确的，用户友好的，可解释的措施痒及其影响， 立即用于临床试验。该项目将产生足够的数据，供我们提交电子瘙痒生命体征 FDA临床结局评估资格认证程序的工具，用于患者报告的资格认证 用于确定改善瘙痒干预措施临床试验有效性的结果指标。

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.