Development of a Computerized Adaptive Test for Patients with HIV Infection

描述(申请人提供)：随着艾滋病毒和艾滋病患者存活率的提高，最大限度地提高患者的功能状态和福祉越来越成为一个重要的治疗目标。现有的评估艾滋病毒患者自我报告的功能状态和幸福感的工具是固定形式的静态问卷。它们在范围和精确度方面都有局限性，这可能会限制它们在小团体研究和常规临床实践等情况下的实用性。我们项目的总体目标是开发结合计算机化自适应测试(CAT)技术和项目反应理论(IRT)的动态测量方法，为每个患者选择最相关的问题，并对HIV感染患者的患者报告结果(PRO)提供简短、全面和准确的评估。我们将开发一种针对艾滋病毒的计算机化适应性测试(HIV-CAT)及其组成题库，并测试这一新测量系统的性能。该项目第一阶段的目标是：(1)开发一个艾滋病毒-CAT原型，评估与艾滋病毒疾病相关的七个健康领域的PRO；(2)测试在临床环境中和通过互联网管理艾滋病毒-CAT原型的可行性和可接受性；(3)启动另外五个具体与艾滋病毒疾病相关的领域的题库建设。HIV-CAT的原型将使用现有的题库来研究身体功能、身体疼痛、一般健康感知、活力、社会功能和心理健康。将在第一阶段利用现有数据开发一个用于发挥作用的题库。与艾滋病毒特别相关的五个新题库将涵盖认知功能、身体形象、睡眠、胃肠道症状和性功能等领域。我们将评估HIV-CAT的原型，并使用约翰·霍普金斯·摩尔(HIV)诊所的100名艾滋病毒感染患者和另外100名通过互联网回答的样本来试验四个初步题库。使用原型艾滋病毒-CAT评估的可行性和可接受性将根据管理时间、数据完整性、患者报告的负担、相关性和评估的重要性以及基于IRT的反应一致性测试来评估。将使用定性和定量方法对五个初步题库进行评估。在该项目的第二阶段，将利用从艾滋病毒感染患者的大样本收集的数据，进一步开发和完善艾滋病毒-CAT原型及其组成题库，并将对艾滋病毒-CAT的测量特性(如精确度、有效性和响应性)进行严格评估。最后一个工具将在临床研究和实践中有用，并将帮助提供者更好地了解和监测艾滋病毒及其治疗的影响，从而提高对艾滋病毒/艾滋病患者的护理质量。问题7.问题7.问题7.项目说明这一SBIR第一阶段的成果将是一个试点艾滋病毒-CAT评估系统，包括与艾滋病毒疾病相关的12个健康领域：身体功能、身体疼痛、一般健康认知、活力、社会功能、角色功能、心理健康、认知功能、身体形象、睡眠、胃肠道症状和性功能。最后一个工具将在临床研究和实践中有用，并将帮助提供者更好地了解和监测艾滋病毒及其治疗的影响，从而提高对艾滋病毒/艾滋病患者的护理质量。

DESCRIPTION (provided by applicant): With improvements in the survival of patients with HIV and AIDS, maximizing patients' functional status and well-being is increasingly an important treatment goal. Existing instruments for assessing HIV patients' self- reported functional status and well-being are fixed-form static questionnaires. They have limitations in range and precision that can restrict their usefulness in situations such as small-group studies and routine clinical practice. The overall goal of our project is to develop dynamic measures that combine computerized adaptive testing (CAT) technology and item response theory (IRT) to select the most relevant questions for each patient and provide brief, yet comprehensive and precise, assessments of patient-reported outcomes (PRO) in patients with HIV infection. We will develop an HIV-specific computerized adaptive test (the HIV-CAT) and its constituent item banks and test the performance of this new measurement system. The aims in Phase I of this project are: (1) to develop a prototype HIV-CAT that assesses PRO in seven health domains of relevance in HIV disease; (2) to test the feasibility and acceptability of administering the prototype HIV-CAT in clinical settings and through the Internet; and (3) to initialize construction of item banks for five additional domains specifically relevant to HIV disease. The prototype HIV-CAT will use existing item banks for physical functioning, bodily pain, general health perception, vitality, social functioning and mental health. An item bank for role functioning will be developed in Phase I using existing data. The five new item banks with particular relevance for HIV will cover the domains of cognitive function, body image, sleep, gastrointestinal symptoms and sexual function. We will evaluate the prototype HIV-CAT and pilot the four preliminary item banks using a sample of 100 HIV-infected patients in the Johns Hopkins Moore (HIV) Clinic and another 100 answering via the Internet. The feasibility and acceptability of assessments using the prototype HIV-CAT will be evaluated according to administration time; data completeness; patient-reported burden, relevance, and importance of the assessment; as well as IRT-based tests of response consistency. The five preliminary item banks will be evaluated using both qualitative and quantitative methods. In Phase II of this project, the prototype HIV-CAT and its constituent item banks will be further developed and refined using data collected from large samples of HIV-infected patients and the measurement properties of the HIV-CAT (such as precision, validity, and responsiveness) will be critically evaluated. The final tool will be useful in clinical research and practice, and will help providers better understand and monitor the impact of HIV and its treatment, thus improving quality of care for people living with HIV/AIDS. Question 7. Project Narrative The outcome of phase I of this SBIR will be a pilot HIV-CAT assessment system encompassing 12 health domains of relevance in HIV disease: physical functioning, bodily pain, general health perception, vitality, social functioning, role functioning, mental health, cognitive function, body image, sleep, gastrointestinal symptoms and sexual function The final tool will be useful in clinical research and practice, and will help providers better understand and monitor the impact of HIV and its treatment, thus improving quality of care for people living with HIV/AIDS.