The Time Distribution Method for Measuring Clinically Valid Quality of Life State

描述（由申请人提供）：本申请的总体目标是通过开发一种新的评估方法并证明其在接受造血干细胞移植的患者中的可行性，来改善行为和健康科学中生活质量的测量。新方法要求患者使用高度直观的界面[视觉时间模拟（VITA）]将一天划分为相互排斥的，临床有效的生活质量状态。患者提供的分区产生有序的分类反应状态，具有非常理想的心理测量和统计特性，并且适用于个体临床监测以及试验终点。在PA-06-343到期后，本次R21第二次重新申请是对PA-06-351 （Exploratory Grants for Behavioral Research in Cancer Control [R21]）的回应。将进行焦点小组，以获得患者对VITA测量装置的易用性和意义的评估。此外，我们将从临床医生那里获得关于新设备获得的数据的临床意义的反馈。将对60名患者进行数据收集研究，这些患者将通过一个网站项目使用VITA格式对八个方面的健康状况进行评级。简短的每日评估和较长的每月评估将在患者家中进行三个月。我们假设，新的研究将导致更有效和敏感的测量患者的生活质量。我们相信所提出的评估方法会更直观地被患者所接受。临床医生将重视个体差异的改进描述，他们如何随时间变化，以及从这些更敏感的生活质量测量中预测重要临床事件的能力的提高。公共卫生相关性：生活质量（QOL）按周、日、小时变化；这些时刻对我们的影响决定了我们的生活质量。在医学研究中，我们使用标准化的问卷，通常试图总结这些长期变化的状态和感受。这个项目提供了一种新的方法来捕捉这种重要的变化，通过要求患者指出一天中（或其他时期）他们经历不同水平的健康的时间比例。

DESCRIPTION (provided by applicant): The broad objective of this application is to improve measurement of quality of life in the behavioral and health sciences by developing a novel assessment method and demonstrating its feasibility in patients who have had hematopoietic stem cell transplants. The new approach asks the patient to use a highly intuitive interface [VIsual Time Analog (VITA)] to partition the day into mutually exclusive, clinically valid, states of quality of life. The partitions provided by the patients generate ordered categorical response states that have very desirable psychometric and statistical properties, and which will be suitable for individual clinical monitoring as well as trial endpoints. This R21 second resubmission responds to PA-06-351 (Exploratory Grants for Behavioral Research in Cancer Control [R21]), following the expiration of PA-06-343. Focus groups will be conducted to obtain patient evaluations of the ease of use and the meaningfulness of the VITA measurement device. In addition, we will obtain feedback from clinicians regarding the clinical meaningfulness of data obtained with the new device. A data collection study will be conducted with 60 patients who will use the VITA format to rate eight areas of well-being through a website program. Both brief daily and longer monthly assessments will occur over a three-month period from the patient's home. We hypothesize that the new research will lead to more valid and sensitive measurement of patient QOL. We believe that the proposed assessment method will be more intuitively acceptable to patients. Clinicians will value the improved portrayal of how individuals differ, how they change over time, and the increased ability to predict important clinical events from these more sensitive QOL measures. PUBLIC HEALTH RELEVANCE: Quality of life (QOL) changes by the week, the day, and the hour; how these moments affect us becomes our QOL. In medical research, we use standardized questionnaires that usually try to summarize these changing states and feelings over a long period. This project offers a new method for capturing this important variation by asking patients to indicate the proportion of time during a day (or other period) they experience different levels of well-being.