Validation of PROMIS in Diverse Cancer Populations

描述(由申请人提供)：患者报告的结果(PRO)作为合法的生物医学终点得到了越来越多的认可，2004年，美国国立卫生研究院发起了PROMIS倡议，通过建立和验证题库来改进结果衡量。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”，至关重要的是确保PROMIS工具是适当的，并且在心理测量学上等同于在专门医疗保健环境之外接受护理的不同人群。鉴于种族/族裔、年龄和社会阶层群体之间的巨大健康差距，这一点尤为重要。然而，在不同群体之间建立衡量标准等价性的研究有限。为了填补这一空白，我们提出了一种三管齐下的方法来评估基于人群的白人、西班牙裔、黑人和亚洲成年癌症患者的PROMIS题库措施。我们之所以关注癌症，是因为它是一种主要的慢性疾病，而且在整个疾病轨迹上，患者的经历和结果存在重大差异。我们选择了5种癌症(女性乳腺癌、子宫癌和宫颈癌，男性和女性结直肠癌和非霍奇金淋巴瘤)，以确保年龄和症状的广泛性。我们使用基于IRT的方法和构建验证来评估题库测量在疼痛、抑郁、疲劳、社会功能和身体功能领域的使用情况。在我们的第一阶段，我们经验丰富的多学科团队将进行一项定性研究，以评估PROMIS题库的概念等价性，主要集中在拉丁裔和亚洲癌症患者，因为这些群体的研究很少；我们还将把项目翻译成中文。在我们的下一阶段，我们将进行一项基于人群的研究，使用4个癌症登记处(来自加利福尼亚州(2)，新泽西州，路易斯安那州)随机招募在之前6-9个月内被诊断为癌症的4000名患者。我们将访问1,000名患者，他们来自两个年龄组(年龄21-和65-84岁)，每个种族/民族平均分配。参与者将在最初招聘时使用混合模式(邮件和电话)进行调查，并在6个月后再次进行调查。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疲劳测量是否能够产生足够准确的对化疗前6个月期间随时间变化的估计，以帮助指导护理管理。我们的研究将提供一套全面的关于PROMIS测量亚群绩效的经验数据，指出任何观察到的差异的可能原因。我们的方法利用对PROMIS倡议的投资，并通过制定可用于评估意图的影响、告知实践和监测人口健康差距的措施来扩大PROMIS倡议的范围。公共卫生相关性：我们的项目旨在评估由美国国立卫生研究院资助的患者报告结果测量信息系统(PROIS)开发的用于测量抑郁、疲劳、身体功能和社会功能的研究方法。我们的研究重点是比较这些措施在4个主要种族/民族和2个年龄组的大组癌症患者中的表现。我们的研究将提供迄今为止收集的最多证据，说明不同人群对这些结果的衡量是否存在差异。这项研究将提供数据，为改进措施的变化提供信息，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