Ecological validity in patient-reported chronic disease outcomes(RMI)

描述（由申请人提供）：有效、可靠和有效的慢性病症状自我报告评估是临床研究所必需的。虽然在患者报告结局（PRO）的心理测量学方面取得了许多进展，但缺乏关于其与患者日常生活中症状的日常经历相关的信息。确保PRO的生态有效性至关重要，因为大多数PRO依赖于相对较长的报告期（数周至数月）的回顾，认知科学研究表明，主观状态的回忆容易产生偏差。电子日记和收集患者数据的相关方法的出现使得在该领域评估PRO成为可能。本项目的目标是确定现有PRO项目和量表的生态有效性（与本RFA相关的网络中心合作选择的内容）。我们假设，根据规定的报告期，提供给患者的指示，项目的反应选项，项目内容修改项目可以提高生态效度。几项关于慢性风湿病和神经病患者疼痛和疲劳的研究将通过比较瞬时日记数据和回忆数据来验证这一假设。还将检查PRO项目对患者表现的更广泛的背景影响。对于网络项目，我们建议提供日志方法和专业知识，以评估合作中心的生态有效性，包括在临床试验背景下评估变化措施的全球印象。

DESCRIPTION (provided by applicant): Valid, reliable, and efficient self-report assessments of symptoms of chronic diseases are necessary for clinical research. Although there have been many advances in the psychometrics of patient-reported outcomes (PROs), there has been an absence of information about their association with patients' daily experiences of symptoms in their daily lives. Ensuring the ecological validity of PROs is paramount, because most PROs rely on retrospection over relatively long reporting periods (weeks to months) and cognitive science research has shown that recall of subjective states is prone to bias. The advent of electronic diaries and associated methods for collecting patient data has made it possible to assess PROs in the field. The goal of this project is to determine the ecological validity of existing PRO items and scales (content selected in collaboration with Network Centers associated with this RFA). We hypothesize that revising items according to the reporting period specified, the instructions provided to patients, the item response options, and item content can improve ecological validity. Several studies examining pain and fatigue in chronically-ill rheumatologic and neurological patients will test this hypothesis by comparing momentary diary data with recall data. Broader contextual influences on patient performance with PRO items will also be examined. For the Network Projects, we propose providing the diary methodology and expertise to assess ecological validity for the collaborating Centers, including the assessment of global impression of change measures in the context of clinical trial.