Ecological validity of PROMIS instruments

描述（由申请人提供）：患者报告结果（pro）是医学研究和实践的必要组成部分。美国国立卫生研究院（NIH）资助的患者报告结果测量信息系统（PROMIS）已经为症状和功能的几个领域开发了题库和量表，这些评估已准备好验证。生态效度是一种新兴和创新的测量验证方法。它基于这样一个前提，即使用几天或更长时间的报告期的评估量表得分应与同一报告期每天或更频繁地对该经验进行的评级高度一致。良好的对应关系表明，记忆缺陷或其他记忆偏差不会严重影响回忆测量。本申请提出了三个主要目的：提供PROMIS量表的生态和已知群体有效性的证据；为量表随时间变化的响应性提供证据；以及，检验一个综合的7天回忆理论模型。研究参与者将完成几个领域的每周计算机辅助（CAT） PROMIS量表，并在为期4周的方案中每天监测症状（提供生态学有效信息）。选择了5个样本来提供PROMIS量表平均水平的可变性（例如，普通人群与骨关节炎），并提供28天内症状变化模式（例如，化疗或手术后的症状变化）。其次，PROMIS量表跟踪组内变化的预期模式的能力，这些变化与每日评级所捕获的变化相对应，将构成PROMIS量表对变化的反应性的有力测试。一个综合的理论模型的因素（认知启发），影响回忆评级也将进行测试。本研究将为PROMIS量表的验证提供一种独特而重要的形式。探究回忆等级的“意义”的能力也将对自我报告科学做出重要贡献，并为PROs的临床解释提供信息。公共卫生相关性：患者报告的症状和功能的结果（PROs）是医学研究事业和临床实践的核心。新开发的PROMIS仪器是改进pro测量的重要一步。本研究将提供有关PROMIS仪器有效性的信息。改进后的pro将提高我们评估一般人群健康状况和评估新药物和治疗方法的能力。

DESCRIPTION (provided by applicant): Patient Reported Outcomes (PROs) are a necessary component of medical research and practice. The NIH- sponsored Patient-Reported Outcome Measurement Information System (PROMIS) has developed item banks and scales for several domains of symptoms and functioning, and these assessments are ready for validation. Ecological validity is an emerging and innovative approach to measurement validation. It is based on the premise that assessment scale scores using reporting periods of several days or more should have a high level of correspondence with ratings of that experience that are made on a dally or more frequent basis for the same reporting period. Good cortespondence indicates that the recall measure is not seriously compromised by memory deficits or other recall biases. This application proposes three major aims: to provide evidence of ecological and known-group validity of the PROMIS scales; to provide evidence of the responsiveness of the scales to change across time; and, to test a comprehensive theoretical model of 7-day recall in PROs. Study participants will complete weekly computer-assisted (CAT) PROMIS scales of the several domains and will monitor symptoms daily (to provide ecologically valid information) across a 4-week protocol. Five samples have been selected to provide variability in mean levels of the PROMIS scales (e.g., general population vs. osteoarthritis) and to provide patterns of change in symptoms over the 28-days (e.g., symptom shifts following chemotherapy or surgery). Second, the ability of PROMIS scales to track expected patterns of within-group change that correspond to changes captured by daily ratings will comprise a strong test of PROMIS scales' responsiveness to change. A comprehensive theoretical model of factors (cognitive heuristics) that influence recall ratings will also be tested. This research will provide a unique and important form of validation of PROMIS scales. The ability to probe the "meaning" of recall ratings will also make important contributions to the science of self-report and inform clinical Interpretation of PROs. PUBLIC HEALTH RELEVANCE: Patient reported outcomes (PROs) of symptoms and functioning are central to the medical research enterprise and to clinical practice. The newly developed PROMIS instruments are a major step in improving measurement of PROs. This study will provide information about the validity of the PROMIS instruments. Improved PROs will enhance our ability to assess health in the general population and evaluate new medicines and treatments.