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: 7780848
• 负责人: DINESH KHANNA
• 金额: $ 51.06万
• 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/7780848
• 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）：患者报告的结果测量信息系统（PROMIS）倡议旨在开发和传播核心患者报告的物品库，这些物品在广泛的生物心理社会疾病经验的分类法中进行。尽管目前的诺言分类法是广泛的，但尚未包括与胃肠道（GL）困扰有关的项目。我们的目标是首先使用Promis Network建立的严格标准来开发GL遇险领域，然后测试3个不同的患有GL困扰的不同患者人群中所得的项目：（1）肠易激综合征（IBS），（2）炎症性肠病（IBD）和（3）4个大型医疗中心的全身性硬化症（SSC）。 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）评估GL遇险项目库的心理测量特性：（a）评估GL遇险项目池的维度，并评估500名IBS，IBD和SSC患者的3个样本中的项目响应理论模型（n = 1500）（n = 1500），（b）评估与健康状况的质量及其质量的关联，并评估与健康的质量相关性，以及症状的关联。响应能力并估计GL遇险领域的最小重要差异。为了实现这些目标，我们召集了一个临床医生团队，该团队在评估专业人士，专家项目开发和评估专家以及项目响应理论方面具有专业知识。叙述描述了我们对GL遇险的不断发展的概念框架，回顾了我们小组中有关GL疾病的Pro测量的初步数据，强调了我们使用Promis的过去经验。公共卫生相关性：GL疾病在美国产生了特别的疾病负担。这项负担包括人口较高的患病率，压倒性的护理成本以及GL障碍对健康相关生活质量的巨大影响（HRQOL）。此外，在2000 - 2004年间，特定的GL特异性医疗访问率上升了20％。鉴于GL疾病疾病的重大负担，再加上许多GL疾病的过度表现，因此，Promis分类法至关重要的是要扩大与GL困扰有关的项目。