Development and Initial Validation of PROMIS GI Distress Scale

描述(由申请人提供)：患者报告结果测量信息系统(PROIS)倡议旨在开发和传播核心患者报告题库，涵盖生物、心理和社会疾病经验的广泛分类。虽然目前的PROMIS分类是广泛的，但它还不包括与胃肠道(Gl)痛苦有关的项目。我们的目标是首先使用PROMIS网络建立的严格标准开发一个Gl苦恼领域，然后在4个大型医学中心测试3个不同的Gl苦恼患者群体中产生的项目：(1)肠易激综合征(IBS)，(2)炎症性肠病(IBD)，(3)系统性硬化症(SSC)。我们的UOL有两个具体的研究目标：1)通过以下方式开发一个Gl苦恼项目库：(A)通过识别文献中现有的项目，去除多余和模糊的项目，并修改选定的项目以达到统一，建立一个初始的Gl苦恼项目库，以及(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，扩大初始库并建立内容效度。2)通过对500例IBS、IBD和SSC(总共1500例)患者的3个样本的Gl苦恼项目库的维度和项目反应理论模型的适合度进行评估，(B)评估Gl苦恼领域与用于Gl疾病的健康相关生活质量遗留工具以及与症状严重程度的关系，以及(C)评估Gl苦恼领域的反应性，并估计Gl苦恼领域的最小重要差异。为了实现这些目标，我们召集了一支具有评估专业知识的临床医生团队，专业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苦恼的概念框架，回顾了我们小组关于Gl障碍的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：在美国，GL障碍会产生一种非同寻常的疾病负担。这一负担包括高人口流行率、过高的护理费用以及Gl障碍对与健康相关的生活质量(HRQOL)的巨大影响。此外，在2000-2004年间，特定于Gl的医疗就诊率上升了20%。考虑到Gl障碍的重大疾病负担，加上许多Gl障碍在女性中的过度代表，至关重要的是PROMIS分类法扩大到包括与Gl痛苦有关的项目。

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.