Validation of PROMIS in Diverse Cancer Populations

描述（由申请人提供）：患者报告的结局（PRO）作为合法的生物医学终点已获得越来越多的认可，2004年NIH启动了PROMIS计划，通过建立和验证项目库来改善结局测量。如果要实现使用患者报告的结果来监测和改善健康的“承诺”，就必须确保PROMIS工具适用于在专业医疗保健机构之外接受护理的不同人群，并且在心理测量上是等效的。鉴于种族/族裔、年龄和社会阶层群体之间的健康差距很大，这一点尤其重要。然而，建立不同群体之间措施等效性的研究有限。为了填补这一空白，我们提出了一个三管齐下的方法来评估PROMIS项目银行措施在人口为基础的样本白色，西班牙裔，黑人和亚洲成年癌症患者。我们专注于癌症，因为它是一种主要的慢性疾病，并且在整个疾病轨迹中存在重要的经验和结果差异。我们选择了5种癌症（女性乳腺癌、子宫癌和宫颈癌，以及男性和女性结肠直肠癌和非霍奇金淋巴瘤），以确保广泛的年龄范围和症状。我们使用基于IRT的方法和结构验证来评估疼痛，抑郁，疲劳，社会功能和身体功能领域的项目库措施的使用。在我们的第一阶段，我们经验丰富的多学科团队将进行定性研究，以评估PROMIS项目库的概念等效性，主要关注拉丁美洲和亚洲癌症患者，因为这些群体的研究很少;我们还将项目翻译成中文。在我们的下一阶段，我们将使用4个癌症登记处（来自加州（2）、新泽西、路易斯安那州）进行一项基于人群的研究，随机招募4,000名在过去6-9个月内确诊的患者。我们将采访来自每个种族/民族的1,000名患者，平均分为两个年龄组（21-64岁和65-84岁）。在最初招募时和6个月后，将使用混合模式（邮件和电话）对参与者进行调查。我们的第三个组成部分是一项探索性临床研究（n=200），以检查PROMIS疲劳指标是否在化疗的前6个月内产生足够精确的变化估计，以帮助指导护理管理。我们的研究将提供一套全面的经验数据，PROMIS测量性能的亚人群，指出可能的原因，任何观察到的差异。我们的方法通过制定可用于评估意图影响、告知实践和监测人口健康差异的措施，利用对PROMIS倡议的投资并扩大其范围。公共卫生相关性：我们的项目旨在评估由NIH资助的患者报告结果测量信息系统（PROMIS）开发的研究方法，以测量抑郁，疲劳，身体功能和社会功能。我们的研究重点是比较这些措施在4个主要种族/种族和2个年龄组的癌症患者中的表现。我们的研究将提供迄今为止收集的最多的证据，以确定不同人群中这些结果的测量是否存在差异。该研究将提供数据，以告知改进措施的变化，并最终使其在健康研究中得到更广泛的使用

DESCRIPTION (provided by applicant): Patient-reported outcomes (PROs) have gained increasing recognition as legitimate biomedical endpoints and in 2004 NIH launched the PROMIS Initiative to improve outcome measurement by building and validating item banks. If the "promise" of using patient-reported outcomes to monitor and improve health is to be realized, it is essential to ensure that PROMIS tools are appropriate and psychometrically equivalent for diverse populations cared for outside of specialized health care settings. This is especially important given the substantial health disparities across race/ethnic, age and social class groups. However, there has been limited research establishing equivalence of measures across diverse groups. To fill this gap, we propose a 3-pronged approach to evaluate PROMIS item bank measures in a population-based sample of White, Hispanic, Black and Asian adult cancer patients. We focus on cancer since it is a leading chronic disease and one where there are important disparities in experience and outcomes across the disease trajectory. We have selected 5 cancers (female breast, uterine and cervical cancer, and male and female colorectal cancer and non- Hodgkin's Lymphoma) to ensure a wide age range and symptoms. We use IRT-based methods and construct validation to assess the use of item bank measures for the domains of pain, depression, fatigue, social function, and physical function. In our first phase, our experienced, multidisciplinary team will conduct a qualitative study to assess conceptual equivalence of PROMIS item banks, focusing primarily on Latino and Asian cancer patients since there has been little research in these groups; we will also translate items into Chinese. In our next phase, we will conduct a population based study using 4 cancer registries (from California (2), New Jersey, Louisiana) to randomly recruit 4,000 patients diagnosed in the previous 6-9 months. We will interview 1,000 patients from each race/ethnic group divided evenly among two age groups (ages 21-64, and ages 65-84). Participants will be surveyed using a mixed mode approach (mail and phone) at initial recruitment and again 6 months later. Our third component is an exploratory clinical study (n=200) to examine whether the PROMIS fatigue measures generate sufficiently precise estimates of change over time during the first 6 months of chemotherapy to help guide care management. Our study will provide a comprehensive set of empirical data on PROMIS measurement performance across sub- populations, indicating likely causes of any observed differences. Our approach leverages investments in, and extends the scope of, the PROMIS Initiative by developing measures that can be used to evaluate the impact of intentions, inform practice, and monitor population health disparities. PUBLIC HEALTH RELEVANCE: Our project is designed to evaluate research methods being developed the by the NIH-funded Patient Reported Outcomes Measurement Information System (PROMIS) to measure depression, fatigue, physical function, and social function. Our research focuses on comparing how well these measures perform across 4 major race/ethnic and 2 age groups in large group of cancer patients. Our study will provide the most evidence assembled to date about whether there are differences in the measurements of these outcomes across different population groups. The research will provide data to inform changes to improve the measures and ultimately enable their wider use in health research