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

描述(由申请人提供)：对慢性病症状的有效、可靠和有效的自我报告评估是临床研究所必需的。虽然患者报告结果(PRO)的心理测量学已经取得了许多进展，但关于它们与患者在日常生活中的症状的日常经历之间的关联的信息一直很少。确保专业人士的生态有效性是最重要的，因为大多数专业人士依赖于相对较长的报告期(数周至数月)的回顾，而认知科学研究表明，对主观状态的回忆容易产生偏见。用于收集患者数据的电子日记和相关方法的出现使评估该领域的专业人员成为可能。该项目的目标是确定现有PRO项目和规模(与本RFA相关的网络中心合作选择的内容)的生态有效性。我们假设，根据指定的报告期、提供给患者的说明、项目响应选项和项目内容修改项目可以提高生态效度。几项检测慢性病、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。还将考察PRO项目对患者表现的更广泛的背景影响。对于网络项目，我们建议提供日记方法和专业知识来评估合作中心的生态有效性，包括在临床试验的背景下评估全球对变化措施的印象。

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.