Continuous Oxygen Monitor for Patients on Long-Term Oxygen Therapy (COMPLY)

描述(由申请人提供)：慢性阻塞性肺疾病(COPD)每年导致美国50多万人住院和100,000多人死亡。慢性阻塞性肺病目前是第四大死因；预计到2020年，它将成为美国的第三大死因，到2030年，将成为全球第三大死因。长期氧疗(LTOT)是通过连接氧源(如氧气浓缩器、压缩气体或液氧瓶)的鼻插管对患者进行的，已被证明是唯一能提高因心肺疾病引起的严重低氧血症患者存活率的治疗方法；当全天候开氧气时，死亡率的改善最大。长期氧疗还与住院和住院时间的显著减少以及生活质量的提高有关。坚持LTOT对COPD患者(在发病率和死亡率方面)和社会(在医疗成本节省方面)都有很大的好处。目前，临床医生和研究人员通过以下方法之一计算平均日使用量来评估在给定时期内对LTOT的依从性：(1)记录氧气浓缩器的小时计读数；(2)计算氧气瓶的使用量；或(3)称量液氧库。集中器的小时表读数在给定的时间段内只提供设备的通电时间。使用的钢瓶数量，或钢瓶液氧储罐重量的变化，只能揭示氧气的消耗量。所有这些患者依从性的衡量标准都无法识别患者是否真的戴着鼻管或吸入了氧气，而不仅仅是打开了氧气源。此外，目前的测量方法不能提供关于每个24小时间隔内的氧气使用模式的信息。目前，在临床实践或研究环境中还没有可靠的方法来评估LTOT的依从性。也没有可靠的手段来监测氧气依从性，以控制成本。基于评估LTOT依从性的现有方法的研究表明，许多患者没有遵循医生开出的治疗方案，导致治疗不足和浪费报销资金。对于医生来说，为了能够定期与患者沟通他们的LTOT治疗和坚持健康的重要性，准确和客观地衡量患者的坚持是至关重要的。拟议的第一阶段项目将为接受长期氧疗(COMPLE)的患者建立一个连续的氧气监测仪功能原型，该原型客观地确定每分钟坚持氧疗的持续时间和模式。随着第一阶段可以全天候测量患者依从性的可靠监测器的开发和演示，第二阶段的工作将专注于开发商业产品原型，该产品原型也支持医疗保健提供者的互联网链接监测，以及提供信息、意向、教育和激励反馈的互动患者界面，以鼓励和改善依从性，并相应地改善健康结果。 与公共卫生相关：接受LTOT治疗的患者群体约有80万人，仅氧疗一项的费用就约占耐用医疗设备医疗保险总支出的30%(13亿美元)。需要一种客观和准确的方法来衡量患者对LTOT的依从性，以增加临床选择性和长期的成本控制，并用于研究研究，以解决诸如LTOT对间歇性低氧血症患者的益处等争议。建议的系统将为在临床实践和研究环境中可靠地评估LTOT依从性提供一种可选的、实用的和可选择的方法。

DESCRIPTION (provided by applicant): Chronic obstructive pulmonary disease (COPD) is responsible for more than 500,000 hospitalizations and over 100,000 deaths in the United States annually. COPD is currently the fourth leading cause of death; it is projected to become the third leading cause of death in the U.S. by 2020 and worldwide by 2030. Long-term oxygen therapy (LTOT), which is administered to patients via a nasal cannula attached to an oxygen source, such as an oxygen concentrator or compressed-gas or liquid oxygen cylinder is the only treatment that has been shown to improve survival in severe hypoxemia due to cardiopulmonary diseases; the improvement in mortality is greatest when oxygen is prescribed 24/7. LTOT is also associated with significant reductions in hospitalizations and lengths of stay, and improved quality of life. The benefits of adherence to LTOT are substantial both to COPD patients (in terms of morbidity and mortality) and to society (in terms of healthcare cost savings). Clinicians and researchers currently assess adherence to LTOT over a given period by calculating the average daily use as determined via one of the following methods: (1) recording the hour-meter readings of oxygen con- centrators; (2) counting usage of oxygen cylinders; or (3) weighing liquid oxygen reservoirs. The concentrator's hour-meter reading provides only equipment \power-on" time over a given period. The number of cylinders used, or the change in weight of cylinder liquid oxygen reservoirs, reveals only the amount of oxygen expended. All of these measures of patient adherence fail to discern if the patient is actually wearing the nasal cannula or inhaling oxygen, as opposed to merely having the oxygen source turned on. Furthermore, current measures fail to provide information regarding the pattern of oxygen use within each 24-hour interval. There is currently no reliable means available in clinical practice or in research settings for assessing LTOT adherence. Nor is there a reliable means to monitor oxygen adherence for cost containment. Studies based on available methods for assessing adherence to LTOT indicate that many patients do not follow their physician's prescribed treatment regimen, resulting in inadequate therapy and wasted reimbursement dollars. For physicians to be able to communicate with their patients on a regular basis regarding their LTOT treatment and the importance of adherence to their health, it is essential to have accurate and objective measures of patients' adherence. The proposed Phase I project will establish a Continuous Oxygen Monitor for Patients on Long-term oxygen therapy (COMPLY) functional prototype that objectively determines the duration and pattern of adherence with oxygen therapy on a minute-by-minute basis. With the development and demonstration in Phase I of a reliable monitor that can measure patient adherence 24/7, the Phase II effort will focus on developing a commercial product prototype that also oers Internet-linked monitoring by healthcare providers and an interactive patient interface that provides informational, intentional, educational, and motivational feedback to encourage and improve adherence and, correspondingly, health outcomes. PUBLIC HEALTH RELEVANCE: The patient community receiving LTOT numbers approximately 800,000, and the cost of their oxygen therapy alone represents approximately 30% ($1.3 billion) of total Medicare expenditures for durable medical equipment. An objective and accurate method of measuring patient adherence to LTOT is required to augment clinical electiveness and cost containment for the long term, and for research studies to address such controversies as the benefits of LTOT in patients with intermittent hypoxemia. The proposed system will provide an elective, practical, and fordable method for reliably assessing LTOT adherence in clinical practice and research settings.