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）在美国每年导致超过500,000人住院和超过100,000人死亡。慢性阻塞性肺病目前是第四大死因；预计到2020年，它将成为美国第三大死因，到2030年将成为全球第三大死因。长期氧疗（LTOT）是唯一一种已被证明可改善心肺疾病所致严重低氧血症患者生存率的治疗方法。长期氧疗通过连接氧气源（如氧气浓缩器或压缩气体或液氧瓶）的鼻插管给予患者。当全天候供氧时，死亡率的降低是最大的。ltt还与住院时间和住院时间的显著减少以及生活质量的提高有关。对于COPD患者（发病率和死亡率方面）和社会（医疗成本节约方面），坚持ltt的益处都是巨大的。目前，临床医生和研究人员通过计算通过以下方法之一确定的平均每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表读数；(2)计算氧气瓶的使用情况；或(3)称重液氧储罐。集中器的小时表读数仅提供给定时间段内设备“开机”时间。所用钢瓶的数量，或钢瓶液氧储存罐重量的变化，只能显示耗氧量。所有这些对患者依从性的测量都无法辨别患者是否真的戴着鼻插管或吸入氧气，而不是仅仅打开氧气源。此外，目前的措施无法提供关于每24小时间隔内氧气使用模式的信息。目前在临床实践或研究环境中没有可靠的方法来评估lot的依从性。也没有一种可靠的方法来监测氧气依从性以控制成本。基于现有方法评估LTOT依从性的研究表明，许多患者不遵循医生规定的治疗方案，导致治疗不足和浪费报销费用。为了使医生能够定期与患者沟通他们的ltt治疗和坚持对他们健康的重要性，必须对患者的坚持进行准确和客观的衡量。拟议的I期项目将建立一个用于长期氧治疗患者的连续氧监测仪（COMPLY）功能原型，以每分钟为基础客观地确定氧治疗的持续时间和模式。随着第一阶段可靠监视器的开发和演示，该监视器可以全天候测量患者的依从性，第二阶段的工作将侧重于开发商业产品原型，该原型还可以通过医疗保健提供者与互联网连接的监测和交互式患者界面提供信息、有意、教育和激励反馈，以鼓励和改善依从性，并相应地改善健康结果。

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.