Development and Initial Validation of PROMIS GI Distress Scale

PROMIS GI 应激量表的开发和初步验证

• 批准号: 7944064
• 负责人: DINESH KHANNA
• 金额: $ 50.37万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 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/7944064
• 关键词: Abdomen; Address; Autonomic nervous system; Brain; Caring; Characteristics; Chronic; Chronic Disease; Clinical Research; Cognitive; Communities; Coupled; Data; Development; Disease; Distress; Evaluation; Facilities and Administrative Costs; Feces; Focus Groups; Frequencies; Functional disorder; Health Care Visit; High Prevalence; Incidence; Inflammatory Bowel Diseases; Information Systems; Interview; Irritable Bowel Syndrome; Link; Literature; Measurement; Medical center; Modeling; Nervous system structure; Pain; Pathology; Patient Outcomes Assessments; Patients; Population; Prevalence; Productivity; Property; Psychometrics; Reporting; Research; Resources; Rosa; Sampling; Severities; Symptoms; Systemic Scleroderma; Taxonomy; Test Result; United States; Validation; Viscera; Woman; Work; biopsychosocial; burden of illness; cost; disability; experience; gastrointestinal; health related quality of life; instrument; patient population; public health relevance; response; theories

DESCRIPTION (provided by applicant): The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative aims to develop and disseminate core patient-reported items banks across a wide taxonomy of biopsychosocial illness experiences. Although the current PROMIS taxonomy is expansive, it does not yet include items pertaining to gastrointestinal (Gl) Distress. Our objectives are to first develop a Gl Distress domain using the rigorous standards established by the PROMIS network, and then to test the resulting items in 3 distinct patient populations with Gl distress: (1) irritable bowel syndrome (IBS), (2) inflammatory bowel disease (IBD), and (3) systemic sclerosis (SSc) at 4 large Medical Centers. Our UOl has 2 specific research aims: 1) To develop a Gl Distress item pool by: (a) developing an initial Gl Distress item pool by identifying extant items in the literature, removing redundant and vague items, and revising chosen items to reach uniformity, and (b) expanding the initial pool and establishing content validity by conducting focus groups and cognitive interviews of patients in three patient groups: IBS, IBD, and SSc. 2) To evaluate the psychometric properties of the Gl Distress item pool by: (a) evaluating the dimensionality of the Gl distress item pool and assessing fit of item response theory models in 3 samples of 500 patients with IBS, IBD, and SSc (n=1500 overall), (b) evaluating the associations of the Gl Distress domains with health-related quality of life legacy instruments for Gl illness and with symptom severity, and (c) evaluating the responsiveness and estimating the minimally important differences for the Gl Distress domains. To achieve these aims, we have convened a team of clinicians with expertise in assessing PROs, experts in PRO item development and evaluation, and experts in item response theory. The narrative describes our evolving conceptual framework for Gl Distress, reviews preliminary data from our group regarding PRO measurement in Gl disorders, emphasizes our past experience using PROMIS. PUBLIC HEALTH RELEVANCE: Gl disorders engender an extraordinary burden of illness in the United States. This burden includes the high population prevalence, overwhelming costs of care, and the large impact of Gl disorders on health-related quality of life (HRQOL). Moreover, the Gl-specific rate of health care visits rose by 20 percent between 2000-2004. Given the significant burden of illness of Gl disorders, coupled with the over-representation of many Gl disorders in women, it is vital that the PROMIS taxonomy expand to include items pertaining to Gl Distress.

描述（由申请人提供）：患者报告结果测量信息系统（PROMIS）计划旨在开发和传播生物心理社会疾病经历的广泛分类的核心患者报告项目库。尽管当前的 PROMIS 分类范围很广泛，但它尚未包括与胃肠道 (GI) 不适有关的项目。我们的目标是首先使用 PROMIS 网络建立的严格标准开发胃肠道不适领域，然后在 4 个大型医疗中心测试 3 个不同胃肠道不适患者群体的结果项目：(1) 肠易激综合征 (IBS)、(2) 炎症性肠病 (IBD) 和 (3) 系统性硬化症 (SSc)。我们的大学有 2 个具体研究目标：1) 通过以下方式开发胃肠道不适项目库：(a) 通过识别文献中现有的项目、删除冗余和模糊的项目并修改所选项目以达到统一性来开发初始胃肠道困扰项目库，以及 (b) 通过对三个患者组（IBS、IBD 和 SSc）的患者进行焦点小组和认知访谈来扩大初始库并建立内容有效性。 2) 通过以下方式评估 GI 困扰项目池的心理测量特性：(a) 评估 GI 困扰项目池的维数，并评估 500 名 IBS、IBD 和 SSc 患者的 3 个样本（总体 n=1500）中项目反应理论模型的拟合度，(b) 评估 GI 困扰领域与健康相关的 GI 疾病生活质量遗留工具和症状严重程度的关联，以及 (c) 评估 反应性并估计胃肠道应激域的最小重要差异。为了实现这些目标，我们召集了一支由具有评估 PRO 专业知识的临床医生、PRO 项目开发和评估专家以及项目反应理论专家组成的团队。该叙述描述了我们不断发展的胃肠道应激概念框架，回顾了我们小组关于胃肠道疾病 PRO 测量的初步数据，强调了我们过去使用 PROMIS 的经验。公共卫生相关性：胃肠道疾病在美国造成了巨大的疾病负担。这种负担包括高人口患病率、巨大的护理费用以及胃肠道疾病对健康相关生活质量 (HRQOL) 的巨大影响。此外，2000 年至 2004 年间，全球特定医疗保健就诊率上升了 20%。鉴于胃肠道疾病造成的巨大疾病负担，再加上许多胃肠道疾病在女性中的比例过高，因此将 PROMIS 分类法扩展到包括与胃肠道窘迫有关的项目至关重要。