Validating and Extending the PROMIS Sexual Function Measure for Clinical Research

描述（由申请人提供）：美国国立卫生研究院（NIH）建立了患者报告结果测量信息系统（PROMIS）网络，目的是开发一种全面、标准化和有效的方法来测量慢性疾病患者报告的结果。作为7个原始研究中心之一，杜克大学领导了癌症患者的两个测量领域的发展，包括性功能。性功能和性生活满意度是整体生活质量的重要决定因素，并受到许多慢性病及其治疗的影响。然而，使用一致的、高质量的测量方法来测量慢性病患者的性功能方面的工作还很少。PROMIS的第一阶段支持针对癌症人群的性功能领域的研究。早期测试表明，PROMIS方法在可理解性、全面性和对许多类型的人的适当性方面优于许多替代方法。在PROMIS的下一阶段，我们希望将该措施的适用性扩大到癌症以外的慢性疾病。本申请中提出的工作将确保NIH在PROMIS性功能领域的初始投资将产生跨治疗领域有用的测量，并符合所有的PROMIS标准。本研究将通过以下四个具体目标来推进性功能领域的发展：目的1：评估PROMIS性功能测量在接受前列腺或妇科癌症治疗的男性和女性中的有效性（包括反应性）。目的2：评估和确保PROMIS性功能测量在心力衰竭、糖尿病、情绪和焦虑障碍患者中的适用性。目的3：收集和分析美国人口中具有全国代表性的样本对PROMIS性功能测量的反应。目标4：制作一个西班牙语版本的PROMIS性功能测量。公共卫生相关性：许多慢性疾病会影响性功能，而性功能反过来又会影响整体生活质量。因此，性功能的测量对于了解慢性疾病的影响及其治疗至关重要。本研究将为临床研究人员和患者提供一种有效、全面、灵敏的性功能测量方法。

DESCRIPTION (provided by applicant): The National Institutes of Health (NIH) established the Patient-Reported Outcomes Measurement Information System (PROMIS) Network with the goal of developing a comprehensive, standardized, and efficient means of measuring patient-reported outcomes in persons with chronic diseases. As one of the 7 original research sites, Duke University led the development of 2 domains of measurement for patients with cancer, including sexual function. Sexual function and satisfaction are strong determinants of overall quality of life and are affected by many chronic diseases and their treatments. Yet little work has been done to measure sexual function across chronic diseases using consistent, high quality measurement approaches. The first phase of PROMIS supported research toward the development of the sexual function domain for cancer populations. Early testing suggests the PROMIS measure is superior to many alternatives in terms of understandability, comprehensiveness, and appropriateness for many types of people. In the next phase of PROMIS, we wish to broaden the applicability of the measure to chronic diseases beyond cancer. The work proposed in this application will ensure that the initial investment by NIH in the PROMIS sexual function domain will result in a measure that is useful across therapeutic areas and meets all of the PROMIS standards. The proposed work will advance the development of the sexual function domain by pursuing 4 Specific Aims: Aim 1: To assess the validity (including responsiveness) of the PROMIS sexual function measure in men and women undergoing treatment for prostate or gynecologic cancers. Aim 2: To evaluate and ensure the appropriateness of the PROMIS sexual function measure in patients with heart failure, diabetes mellitus, and mood and anxiety disorders. Aim 3: To collect and analyze responses to the PROMIS sexual function measure from a nationally representative sample of the US population. Aim 4: To produce a Spanish-language version of the PROMIS sexual function measure. PUBLIC HEALTH RELEVANCE: Many chronic diseases affect sexual functioning, which in turn has been shown to influence overall quality of life. The measurement of sexual function is thus critical to understanding the effects of chronic diseases and their treatments. The proposed research will provide investigators and patients with an efficient, comprehensive, and sensitive measure of sexual function for use in clinical research.