Pills & Patient Behavior Smarter Experience Tracking

药丸

• 批准号: 6883348
• 负责人: Vesta Brue
• 金额: $ 19.89万
• 依托单位: LIFETECHNIQUES, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-02-01 至 2006-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6883348
• 关键词: behavior test; behavioral /social science research tag; bioengineering /biomedical engineering; biomedical automation; clinical biomedical equipment; clinical research; computer human interaction; computer program /software; data collection methodology /evaluation; data quality /integrity; drug /agent; health behavior; health economics; human old age (65+); human subject; human therapy evaluation; outcomes research; patient monitoring device; portable biomedical equipment; therapy compliance; time resolved data

DESCRIPTION (provided by applicant): Medication noncompliance is highly problematic in pharmaceutical studies. Without direct observation of pilltaking patterns, investigators - much like clinicians-are often misled by reported adherence, resulting in false interpretation of a protocol's true effects. Pill counts fail to reveal timing of intake, lost or hoarded medications, and "white coat" compliance in which patients compensate for missed pills by dosing heavily before appointments. Applied researchers have relied on retrospectively captured data that suffer from autobiographical and recall biases; low frequency of measurement, which may result in poor reliability; and inability to capture fine-grained, process data that may shift and change over time. Gerontological studies are particularly vulnerable to reporting errors due to large quantities of drugs taken by elders, high dosing frequencies, interactions between pills, cognitive impairment that is associated with elder years-all of which result in further confusion in self reports. For Pharmaceuticals, improved data quality can lead to rapid time to market for a new therapy, and with it, cost savings and alleviation of suffering. More reliable data collection methods can reduce the period a drug needs to be under evaluation, its digitalization time, and number of specialized personnel before it can be commercialized. Various electronic tools have emerged that provide various parts of a solution. Personal digital assistants (PDAs) help investigators pose questions and collect data that can be transferred to the host environment, but none are attached to the behavior being measured. Electronic medminding devices serve to measure pilltaking in its temporal context but none for multiple medications simultaneously in an affordable, patient-friendly portable device. This application calls for an integrated infrastructure that will support a 4-bin computerized pillbox that exists in prototype form. Together, the system will provide passively monitored, real-time data capture of pill consumption in naturalistic settings, and collect responses to study questions posed daily. When built and tested, the integrated research system will be an affordable, flexible, and end-to-end data collection infrastructure to assist in human subjects trials. It will be tested here in a crossover study among 40 elderly patients, each taking four drugs and responding daily to device-generating questions.

描述（由申请人提供）：药物不依从性在药物研究中是一个很大的问题。由于没有对服药模式的直接观察，调查人员--就像临床医生一样--经常被报告的依从性所误导，导致对方案真实效果的错误解释。药丸计数无法揭示摄入的时间，丢失或囤积的药物，以及“白色外套”的依从性，即患者在预约前大量服用药物来补偿错过的药丸。应用研究人员依赖于回顾性捕获的数据，这些数据存在自传和回忆偏差;测量频率低，可能导致可靠性差;无法捕获细粒度的过程数据，这些数据可能会随着时间的推移而变化。老年学研究特别容易出现报告错误，因为老年人服用大量药物，高剂量频率，药丸之间的相互作用，与老年相关的认知障碍，所有这些都会导致自我报告的进一步混乱。对于制药公司来说，提高数据质量可以缩短新疗法的上市时间，从而节省成本并减轻痛苦。更可靠的数据收集方法可以减少药物在商业化之前需要进行评估的时间，数字化时间和专业人员的数量。 已经出现了提供解决方案的各个部分的各种电子工具。个人数字助理（PDA）帮助调查人员提出问题并收集可以传输到主机环境的数据，但没有任何数据与被测量的行为相关。电子医疗设备用于在其时间背景下测量服药，但在负担得起的、对患者友好的便携式设备中不能同时测量多种药物。该应用程序需要一个集成的基础设施，将支持一个4仓计算机化的药盒，存在于原型形式。总之，该系统将在自然环境中提供被动监测的实时数据捕获，并收集对每天提出的研究问题的回答。在构建和测试后，集成研究系统将成为一个负担得起的，灵活的，端到端的数据收集基础设施，以协助人类受试者试验。它将在40名老年患者中进行交叉研究，每人服用四种药物，每天回答设备生成的问题。