Computer Adaptive Test for Patients with Heart Failure

描述（由申请人提供）：我们的目标是在用于评估心力衰竭（HF）患者报告结局的技术方面取得重大进展。目前，许多问卷调查被用来衡量HF患者的结果，但这些工具的分数不能直接比较。此外，没有一种固定长度的表格可以实现监测个体患者所需的呼吸和测量精度，并且仍然适用于临床使用。针对这些不足，第一阶段的目标是：（1）开发一个测量心力衰竭主要主观症状的计算机自适应测试（HF-CAT）原型（呼吸困难、疲劳和身体功能）;（2）发展一种交叉校准方法，以探索比较特定疾病静态问卷的可能性（慢性心力衰竭、明尼苏达心力衰竭患者和堪萨斯城心肌病问卷）;以及（3）评估HF-CAT的可行性。我们将通过互联网收集1，500名HF患者的数据，这些患者将回答上述仪器，两份呼吸困难问卷，以及SF- 36中的活力和身体功能量表。将应用项目反应理论方法估计项目参数，以扩展疲劳和身体功能的现有项目库，并建立新的呼吸困难项目库。这些项目库将作为HF-CAT的基础，并使我们能够探索比较调查表之间结果的可能性。我们将在两项模拟研究中评估测量精度和应答者负担，并在Montefiore医学中心对100名HF患者进行的研究中评估HF-CAT的可行性。第一阶段将产生HF-CAT的原型版本，初步证据表明其被患者接受，并更好地理解广泛使用的HF问卷的共同概念。我们期望HF-CAT将在不增加应答者负担的情况下在宽尺度范围内提供增强的测量精度。增强的测量精度是心理测量仪器的期望特征，以改进响应检测和风险预测。在第二阶段，我们将包括额外的项目，检查HF-CAT的反应性，并进行临床实地研究，以评估该工具预测HF恶化和医疗保健利用的能力。最终目标是提供一个全面的实用工具，以改善以患者为中心的护理和心力衰竭患者的预期寿命。公共卫生相关性：在这个项目中，我们将开发一种计算机自适应测试，它将更精确地测量心力衰竭的主观症状，并减少应答负担。这可能有助于高风险心力衰竭患者更早获得适当的治疗，以防止恶化和住院。

DESCRIPTION (provided by applicant): Our objective is to achieve a major advance in the technology used to assess patient reported outcomes in heart failure (HF). Numerous questionnaires currently are being used to measure outcomes of HF patients, but scores from these instruments can not be directly compared. In addition, no single fixed-length form can achieve the breath and precision of measurement needed to monitor individual patients, and yet still be practical for clinical use. To address these deficiencies, the Aims of Phase I are: (1) to develop a prototype Computer Adaptive Test (HF-CAT) to measure the cardinal subjective symptoms of heart failure (dyspnea, fatigue and physical function); (2) to develop a cross-calibration-approach to explore the possibility of comparing disease-specific static questionnaires (Chronic Heart Failure, Minnesota Living with Heart Failure, and Kansas City Cardiomyopathy Questionnaire); and (3) to evaluate the feasibility of a HF-CAT. We will collect data via the internet from 1,500 HF patients, who will answer the instruments mentioned above, two dyspnea questionnaires, and the vitality and physical functioning scale from the SF- 36. Item Response Theory methods will be applied to estimate item parameters to extend existing item banks for fatigue and physical functioning and to build a new item bank for dyspnea. These item banks will serve as a basis for the HF-CAT and will enable us to explore the possibility of comparing results between questionnaires. We will evaluate measurement precision and respondent burden in two simulation studies, and evaluate the feasibility of the HF-CAT in a study with 100 HF patients at the Montefiore Medical Center. Phase I will produce a prototype version of the HF-CAT with preliminary evidence of its acceptance by patients and a better understanding of the shared concepts of widely-used HF questionnaires. We expect the HF-CAT will provide enhanced measurement precision over a wide scale range without added respondent burden. Enhanced measurement precision is a desired feature for psychometric instruments, to improve response detection and risk prediction. In Phase II, we will include additional items, examine the responsiveness of the HF-CAT, and conduct clinical field studies to evaluate the tool's ability to predict deterioration of HF and health care utilization. The final goal will be to have a comprehensive practical tool available to improve patient centered care and life expectancy of patients with heart failure. Public Heath Relevance: Within this project we will develop a computer adaptive test which will measure the subjective symptoms of heart failure more precisely and with less respondent burden. This may help high risk heart failure patients get appropriate treatment earlier to prevent deterioration and hospitalization.