Validation of PROMIS in Diverse Cancer Populations

PROMIS 在不同癌症人群中的验证

• 批准号: 7784164
• 负责人: CAROL M MOINPOUR
• 金额: $ 123.15万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7784164
• 关键词: 21 year old; Address; Adult; Age; Asians; California; Cancer Patient; Caring; Chinese People; Chronic Disease; Clinical; Clinical Research; Colorectal Cancer; Comorbidity; Data; Development; Diagnosis; Disease; Doctor of Philosophy; Ensure; Epidemiology; Ethnic Origin; Ethnic group; Fatigue; Female; Female Breast Carcinoma; Funding; General Population; Goals; Health; Health Services Research; Healthcare; Hispanics; Information Systems; Intervention; Interview; Investments; Language; Latino; Louisiana; Mails; Malignant Neoplasms; Measurement; Measures; Methods; Monitor; New Jersey; Non-Hodgkin' s Lymphoma; Outcome; Pain; Participant; Patient Outcomes Assessments; Patients; Performance; Phase; Physical Function; Population; Population Group; Population Heterogeneity; Principal Investigator; Property; Psychometrics; Race; Recruitment Activity; Research; Research Methodology; Sample Size; Sampling; Severities; Social Class; Social Functioning; Staging; Surveys; Symptoms; Telephone; Time; Translating; Translations; United States National Institutes of Health; Validation; Work; age group; base; cervical and uterine cancer; chemotherapy; depression; design; experience; health disparity; health related quality of life; improved; male; multidisciplinary; neoplasm registry; oncology; population based; population health; public health relevance; response; theories; tool

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

描述（由申请人提供）：患者报告结果 (PRO) 作为合法的生物医学终点已得到越来越多的认可，2004 年 NIH 启动了 PROMIS 计划，通过建立和验证项目库来改进结果测量。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 工具对于在专门医疗机构之外接受护理的不同人群来说是适当的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存在巨大的健康差异，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还很有限。为了填补这一空白，我们提出了一种三管齐下的方法，在白人、西班牙裔、黑人和亚洲成年癌症患者的人口样本中评估 PROMIS 项目库措施。我们关注癌症，因为它是一种主要的慢性疾病，并且在整个疾病轨迹上的经验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，以及男性和女性结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 的方法并构建验证来评估项目库测量在疼痛、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，主要关注拉丁裔和亚洲癌症患者，因为对这些群体的研究很少；我们还将把项目翻译成中文。在下一阶段，我们将使用 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）进行一项基于人群的研究，随机招募 4,000 名在过去 6-9 个月内诊断的患者。我们将采访来自每个种族/民族的 1,000 名患者，将其平均分为两个年龄组（21-64 岁和 65-84 岁）。参与者将在初次招募时和 6 个月后再次接受混合模式方法（邮件和电话）的调查。我们的第三个组成部分是一项探索性临床研究 (n=200)，旨在检查 PROMIS 疲劳测量是否能够对化疗前 6 个月内随时间的变化产生足够精确的估计，以帮助指导护理管理。我们的研究将提供一套关于跨亚群体的 PROMIS 测量性能的全面经验数据，表明任何观察到的差异的可能原因。我们的方法通过制定可用于评估意图影响、为实践提供信息和监测人口健康差异的措施，利用对 PROMIS 计划的投资并扩展其范围。公共健康相关性：我们的项目旨在评估 NIH 资助的患者报告结果测量信息系统 (PROMIS) 正在开发的研究方法，用于测量抑郁、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/民族和 2 个年龄组的大量癌症患者中的表现。我们的研究将提供迄今为止收集的最多证据，证明不同人群对这些结果的测量是否存在差异。该研究将提供数据来通知变革以改进措施，并最终使其在健康研究中得到更广泛的应用