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。NIH赞助的患者报告结果测量信息系统(PROIS)已经为症状和功能的几个领域开发了题库和量表，这些评估已经准备好进行验证。生态效度是一种新兴的测量验证创新方法。它的前提是，使用几天或几天以上报告期的分摊比额表分数应与同一报告期内定期或更频繁地对这一经历进行的评级具有较高的一致性。良好的一致性表明，回忆测量没有受到记忆缺陷或其他回忆偏见的严重影响。这项申请提出了三个主要目标：提供PROMIS量表的生态和已知群体有效性的证据；提供量表随时间变化的反应能力的证据；以及检验PROIS中7天回忆的综合理论模型。研究参与者将每周完成几个领域的计算机辅助(CAT)PROMIS量表，并将在为期4周的方案中每天监测症状(以提供生态有效的信息)。选择了五个样本，以提供PROMIS量表平均水平的变异性(例如，普通人群与骨关节炎)，并提供28天内症状变化的模式(例如，化疗或手术后的症状变化)。其次，PROMIS量表能够跟踪与每日评级捕获的变化相对应的组内变化的预期模式，这将包括对PROMIS量表对变化的反应能力的强大测试。还将测试影响回忆评级的因素(认知启发式)的综合理论模型。这项研究将为PROMIS量表提供一种独特而重要的验证形式。探索回忆等级的“意义”的能力也将对自我报告的科学做出重要贡献，并为专业人士的临床解释提供信息。公共卫生相关性：症状和功能的患者报告结果(PRO)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PROS测量的重要一步。这项研究将提供有关PROMIS工具有效性的信息。改进的专业人员将增强我们评估普通人群健康和评估新药和治疗方法的能力。

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.