Functional Health CAT in Chronic Kidney Disease

描述（由申请人提供）：我们建议应用项目反应理论（IRT）和计算机化自适应测试（CAT），以实现慢性肾脏病（CKD）健康相关生活质量（HRQOL）指标标准化、数据收集和处理技术效率以及临床医生和患者报告有用性方面的重大进展。与静态仪器相比，静态仪器会向所有受访者询问相同的问题，而不管他们的答案如何，并且缺乏检测各种严重程度变化的精度，我们将使用动态健康评估（DYNHA）软件将问题与每个患者的评分和每个应用程序的要求相匹配，以实现更实用，更有用的评估。在我们对血液透析患者进行的I期试验中，原型CKD-CAT应用程序实现了与三个全长静态量表（肾脏疾病的影响、睡眠功能和身体疼痛）（包括肾脏疾病生活质量问卷（KDQOL）中的项目）相当的CAT评分和等同或更好的精度，并大幅降低了应答者负担。我们的方法的缺点也被确定：（a）需要额外的问卷项目开发，（B）仅对血液透析患者进行采样以代表广泛的CKD严重程度水平的局限性，以及（c）患者和数据收集技术之间的接口问题。为了解决这些问题，并满足对适用于更广泛疾病严重程度的评估工具和软件的需求，我们提出了第二阶段的努力，使样本和数据收集的强度/费用与以下目标的不同要求相匹配：（1）扩大项目库，并评估新项目对CKD特定应用的适当性;（2）通过收集和分析来自不同CKD阶段的成人大样本的响应，确定最有用和可行的领域并校准其项目（第3-5阶段）;（3）建立一个全面运作的CKD-CAT系统，并通过“真实的数据”模拟研究评估其性能，确定与完整表格相比的可靠性和临床有效性以及减少应答者负担的潜力;（4）确认管理的可行性、患者的接受度、评分的信度和效度，以及在临床和非临床环境中对患者（CKD 3-5期）进行实际CKD-CAT给药的临床医生和患者报告的有用性。通过大大缩短调查时间并降低管理成本，可以更准确地监测更多患者的CKD生活质量影响，并帮助临床医生和患者更好地了解和沟通治疗成功。

DESCRIPTION (provided by applicant): We propose to apply item response theory (IRT) and computerized adaptive testing (CAT) to achieve major advances in the standardization of Chronic Kidney Disease (CKD) health-related quality of life (HRQOL) metrics, in the efficiency of data collection and processing technologies, and in the usefulness of clinician and patient reports. In contrast to static instruments, which ask all respondents the same questions regardless of their answers and lack the precision to detect changes over a wide range of severity levels, we will use Dynamic Health Assessment (DYNHA¿) software to match questions to each patient's score and to the requirements of each application to achieve more practical and more useful assessments. In our Phase I test among hemodialysis patients, a prototype CKD-CAT application achieved comparable CAT scores and equivalent or better precision with substantial reductions in respondent burden compared to three full-length static scales (Effects of Kidney Disease, Sleep Functioning, and Bodily Pain) including items from the Kidney Disease Quality Of Life Questionnaire (KDQOL). Shortcomings of our approach were also identified: (a) the need for additional questionnaire item development, (b) limitations of sampling only hemodialysis patients to represent a wide range of CKD severity levels, and (c) problems with the interface between patients and data collection technologies. To address these concerns as well as meet the needs for assessment tools and software that are applicable across a wider range of disease severity levels, we propose a Phase II effort that matches samples and intensity/expense of data collection to the distinct requirements of each of the following aims: (1) Expand the item pool and evaluate the appropriateness of new items for CKD-specific applications; (2) Identify the most useful and feasible domains and calibrate their items by collecting and analyzing responses from large samples of adults varying across stages of CKD (Stages 3-5); (3) Create a fully operational CKD-CAT system and evaluate its performance through "real data" simulation studies, to determine reliability and clinical validity and the potential for reductions in respondent burden, in comparison with full-length forms; and (4) Confirm the administrative feasibility, patient acceptance, reliability and validity of scores, and the usefulness of clinician and patient reports from actual CKD-CAT administrations to patients (CKD Stages 3-5) sampled and assessed in clinical and in non-clinical settings. By greatly shortening surveys and lowering the costs of administering them, it will be possible to monitor the quality of life effects of CKD more accurately for more patients and help clinicians and patients better understand and communicate about treatment success.