Innovative pain outcomes derived from patients real-time pain reports

 描述（由申请人提供）：疼痛强度的自我报告对于了解患者的健康状况和评估临床试验的核心结果是必不可少的。使用实时疼痛测量（生态瞬时评估）的最新方法学进展使得以高分辨率捕获患者的疼痛体验成为可能。这有可能通过考虑疼痛强度的时间方面和环境相关性来改善行为和医学研究的结果。然而，迄今为止，从瞬时数据创建的结果测量通常仅限于疼痛强度的平均水平。在拟议的研究中，我们将研究从患者的瞬时疼痛强度报告中得出的一组扩展的疼痛指数的实用性和有效性，并将确定哪些与利益相关者最相关。在拟议的研究计划中有两个主要阶段。首先，我们将捕捉利益相关者（患者，医疗保健提供者，监管机构，临床试验者）对他们最重要的瞬时疼痛模式的印象;这将成为创建其他疼痛指数的基础，这些疼痛指数可以提高对治疗效果的理解，并提供对临床结果的更深入的了解。其次，新指数的心理测量特性将在对来自学术研究和药物试验的许多现有瞬时疼痛数据集的广泛二级数据分析中进行彻底检查。这些分析将对指标的可靠性、有效性和敏感性进行综合评价， 以及它们与疼痛临床研究中其他关键结果的关系。将使用荟萃分析原则对研究结果进行综合，以评价其在测量和研究特征中的稳健性和普遍性。来自实时评估的疼痛状态的新指标将为试图了解疼痛决定因素和制定疼痛干预措施的研究人员完善疼痛测量。这些信息有可能（1）促进病因学知识，（2）促进诊断分类 （3）提供关于患者疼痛的新信息，可用于定制治疗，（4）增加对疼痛干预效果的理解。

 DESCRIPTION (provided by applicant): Self-reports of pain intensity are indispensable for understanding patients' health and for evaluating core outcomes in clinical trials. Recent methodological advances using real-time pain measurement (Ecological Momentary Assessment) have made it possible to capture patients' pain experiences with high resolution. This has the potential to improve outcomes for behavioral and medical research by considering temporal aspects and environmental correlates of pain intensity. However, to date, outcome measures created from momentary data have generally been limited to the average level of pain intensity. In the proposed research we will examine the utility and validity of an expanded set of pain indices derived from patients' momentary pain intensity reports and will determine which are most relevant to stakeholders. There are two broad stages in the proposed research plan. First, we will capture stakeholders' (patients, healthcare providers, regulators, clinical trialist) impressions of the momentary pain patterns that are most important to them; this will form the basis for creating additional pain indices that could improve understanding of treatment effects and provide richer insight into clinical outcomes. Second, the psychometric properties of the new indices will be thoroughly examined in extensive secondary data analyses of many existing momentary pain datasets from academic studies and pharmaceutical trials. These analyses will provide a comprehensive evaluation of the reliability, validity, and sensitivity of the indices, as well as their relationships with other key outcomes in pain clinical research. Results will be synthesized across studies using meta-analytic principles to evaluate their robustness and generalizability across measurement and study characteristics. Novel indices of pain status derived from real-time assessments will refine pain measurement for researchers trying to understand the determinants of pain and developing interventions for pain. Such information has the potential to (1) advance knowledge about etiology, (2) facilitate diagnostic classification of pain conditions, (3) provide new information about patients' pain that could be used to tailor treatments, and (4) augment understanding of the effects of pain interventions.