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

e-Itch Vital Signs：开发一种新的移动结果测量方法，用于慢性瘙痒患者的临床试验

• 批准号: 9751211
• 负责人: Mary-Margaret Chren
• 金额: $ 21.13万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9751211
• 关键词: Affect; Anxiety; Atopic Dermatitis; Blood Pressure; Body Temperature; Car Phone; Caring; Chronic; Clinical; Clinical Trials; Communication; Complex; Computers; Data; Depressed mood; Development; Disease; Goals; Health; Human; International; Internet; Intervention Trial; Measurement; Measures; Methods; Monitor; Outcome; Outcome Assessment; Outcome Measure; Paper; Patient Care; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Performance; Personal Satisfaction; Persons; Property; Prospective cohort study; Pruritus; Quality of life; Reporting; Research; Research Personnel; Skin; Sleep disturbances; Standardization; Surveys; Symptoms; Time; base; chronic itch; clinical practice; cohort; effectiveness measure; experience; improved; programs; skin disorder; sleep quality; tool; user-friendly

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.

项目概要 慢性症状性皮肤病是患者报告的常见病症的突出例子 是至关重要的结果。这些疾病很少影响健康的常规生命体征，例如身体 温度和血压，但常常影响症状和生活质量，我们称之为“特征” “皮肤生命体征”，因为它们提供了患者皮肤相关健康基本方面的快照。 最常见的皮肤症状是瘙痒，这是一种影响 10-20% 人的令人不安的经历，并且可能是 慢性且致残。瘙痒与健康状况不佳有关，包括情绪低落、焦虑和 diminished quality of sleep.全面了解瘙痒患者的经历对于 监测临床试验中治疗的效果并为护理决策提供信息。 But although survey instruments 虽然已经制定了衡量瘙痒的标准，但没有一个标准被接受为通用标准。经验证的措施 患者的报告早已可得，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、快速沟通分数的低效机制以及不足 information about how to interpret them.改善瘙痒和患者护理的临床试验面临的挑战 与瘙痒相关的问题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 临床医生和研究人员可以轻松接收和解释的方式。 这项研究的长期目标是通过以下方式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——称为 电子皮肤生命体征——以可解释的方式实时测量和交流患者的报告 他们的皮肤症状及其对生活质量的影响。我们的目标是完善这个移动工具以解决问题（ “e-Itch Vital Signs”）基于从患者和临床医生收集的经验数据，并建立 其基本的测量特性和可解释性，以便可以立即使用 an outcomes measure in clinical trials.我们将使用输入来开发和完善移动 e-Itch Vital Signs 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能力 over time in patients with chronic itch (Aim 2).在一项针对慢性瘙痒患者的前瞻性队列研究中 特应性皮炎，我们将使用以下方法确定 e-Itch 生命体征评分的最小重要差异 patient-based anchor (Aim 3). 这项研究将为瘙痒及其影响提供准确、用户友好且可解释的测量方法 immediate use in clinical trials.该项目将为我们生成足够的数据来提交 e-Itch 生命体征 FDA 临床结果评估资格计划的工具，用于获得患者报告的资格 用于确定改善瘙痒干预措施临床试验有效性的结果测量。