Development and Initial Validation of PROMIS GI Distress Scale

描述（由申请人提供）：患者报告结局测量信息系统（PROMIS）计划旨在开发和传播跨生物心理社会疾病经历广泛分类的核心患者报告项目库。虽然目前的PROMIS分类是广泛的，但它还不包括与胃肠道（GI）不适有关的项目。我们的目标是首先使用由PROMIS网络建立的严格标准开发GI困扰域，然后在4个大型医疗中心在患有GI困扰的3个不同患者群体中测试所得项目：（1）肠易激综合征（IBS），（2）炎性肠病（IBD），和（3）系统性硬化症（SSc）。我们的UOl具有2个具体的研究目标：1）通过以下方式开发GI困扰项目库：（a）通过识别文献中现存的项目、去除冗余和模糊的项目并修改所选项目以达到一致性来开发初始GI困扰项目库，以及（B）通过进行焦点小组和三个患者组中的患者的认知访谈来扩大初始库并建立内容效度：IBS、IBD和SSc。2)通过以下方式评价GI困扰项目池的心理测量学特性：（a）在患有IBS、IBD和SSc的500名患者的3个样本中评估GI困扰项目库的维度并评估项目反应理论模型的拟合（总体n=1500），（B）评估GI困扰域与健康的关联，用于GI疾病和症状严重性的相关生活质量遗留工具，以及（c）评估响应性并估计GI痛苦域的最小重要差异。为了实现这些目标，我们召集了一个由专业评估PRO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。叙述描述了我们不断发展的概念框架胃肠道不适，审查初步数据，从我们的小组有关PRO测量胃肠道疾病，强调我们过去的经验，使用PROMIS。

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.