Development and Initial Validation of PROMIS GI Distress Scale

描述（由申请人提供）：患者报告的结果测量信息系统（PROMIS）计划旨在开发和传播跨生物心理社会疾病经验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（Gl）窘迫有关的项目。我们的目标是首先使用PROMIS网络建立的严格标准开发Gl窘迫域，然后在4个大型医疗中心的3个不同的Gl窘迫患者群体中测试所得项目：(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UOl有两个具体的研究目标：1)通过以下方式建立一个Gl窘迫项目库：(a)通过识别文献中现存的项目，删除冗余和模糊的项目，并修改所选项目以达到一致性，建立一个初始的Gl窘迫项目库；(b)通过对IBS、IBD和SSc三个患者组的患者进行焦点小组和认知访谈，扩大初始池并建立内容效度。2)通过以下方式评估Gl窘迫项目库的心理测量特性：(a)在500名IBS、IBD和SSc患者的3个样本中评估Gl窘迫项目库的维度并评估项目反应理论模型的拟合性（n=1500）， (b)评估Gl窘迫领域与Gl疾病的健康相关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Gl窘迫领域的最小重要差异。为了实现这些目标，我们召集了一支临床医生团队，他们具有评估PRO的专业知识，PRO项目开发和评估专家，以及项目反应理论专家。叙述描述了我们不断发展的Gl窘迫概念框架，回顾了我们小组关于Gl障碍中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：Gl疾病在美国造成了巨大的疾病负担。这一负担包括高人群患病率、高昂的护理费用以及Gl疾病对健康相关生活质量（HRQOL）的巨大影响。此外，在2000年至2004年期间，针对gl的医疗访问率上升了20%。鉴于Gl疾病的重大负担，加上许多Gl疾病在女性中的过度代表，PROMIS分类法扩展到包括与Gl窘迫有关的项目是至关重要的。

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.