Epidemiology and Risk of Antipsychotic Use in Hospitalized Elderly with Delirium

项目总结/摘要 每年有200万老年人在医院接受抗精神病药物（APM），主要用于治疗谵妄。 虽然APM的危害有据可查，老年痴呆症患者的使用也有所减少， 住院老年人中标示外APM暴露的范围和风险在很大程度上仍然未知。的目标 本申请旨在确定住院患者中APM及其替代品的处方趋势和风险 老年人术后谵妄。研究小组将分析来自2个国家住院患者数据的数据- 来自5个NIH资助的队列的基础和详细的临床数据，以生成关于 APM及其替代品，可推广到现实世界的患者。中心假设是， 在住院的老年人中，与不使用APM相比，使用APM与不良事件风险增加相关 术后谵妄;特别是，新的“非典型”APM可能比传统的“典型”更有害， 短期使用的APM。申请方的初步数据显示，虽然非典型杀伤人员地雷可能是 在住院的老年外科病人中，使用非典型APM和某些精神活性药物是有害的， 近年来，毒品一直在上升。美国各地的APM处方率也相差30多倍 医院，这表明可能存在不适当的处方。缺乏住院患者使用APM的安全性数据 老年人以及几乎没有证据表明有更安全的替代品似乎助长了这些趋势。的理由 痴呆症患者的可用安全性数据可能无法推广到住院患者， 老年手术患者，以及APM和其他精神活性药物在 常规护理患者不能仅从临床试验中产生。这一为期三年的提案有三个具体目标： 1)确定住院死亡率、出院、住院时间延长和再入院的风险 与大手术后谵妄老年患者的不同APM相关; 2）确定 与不同APM相关的医院非致命性不良事件;以及3）确定可能 通过检查纵向处方趋势，将其作为APM的治疗替代品。The dream- 研究人员将采用创新的研究方法，利用现有的大型索赔数据集和队列数据 提高常规护理人群的可推广性，增加统计功效以解决患者安全性问题 亚组和个体药物，并减少偏倚。通过对病例识别算法进行验证， 研究人员将改进如何在住院药物安全性研究中测量住院不良事件。 这项研究的影响是重大的，因为高质量的证据对杀伤人员地雷的相对安全性 其替代方案可指导临床医生减少APM的过度使用，促进APM的合理安全使用 处方，从而提高老年外科患者的安全性和临床护理。

PROJECT SUMMARY/ABSTRACT Each year 2 million older adults receive antipsychotic medications (APMs) in the hospital, mainly for delirium. Although the harms of APMs are well documented and their use has declined in older adults with dementia, the scope and risk of off-label APM exposure in hospitalized older adults remain largely unknown. The objective of this application is to determine the prescribing trends and risks of APMs and their alternatives in hospitalized older adults with postoperative delirium. The research team will analyze data from 2 national inpatient data- bases and detailed clinical data from 5 NIH-funded cohorts to generate evidence on the comparative safety of APMs and their alternatives that is generalizable to real-world patients. The central hypothesis is that off-label APM use is associated with increased risk of adverse events compared with no use in hospitalized older adults with postoperative delirium; in particular, newer “atypical” APMs may be more harmful than conventional “typi- cal” APM for short-term use. The applicant's preliminary data showed that, although atypical APMs may be as harmful as typical APM in hospitalized older surgical patients, use of atypical APMs and certain psychoactive drugs has been rising in recent years. The APM prescribing rates also vary more than 30 folds across the US hospitals, which suggests potentially inappropriate prescribing. Lack of safety data on APMs for hospitalized older adults, as well as little evidence on safer alternatives seems to contribute to these trends. The rationale for this application is that the available safety data from dementia patients may not generalize to hospitalized older surgical patients and that evidence on the comparative safety of APMs and other psychoactive drugs in routine care patients cannot be generated from clinical trials alone. This 3-year proposal has 3 specific aims: 1) determine the risk of in-hospital mortality, institutional discharge, prolonged length of stay, and readmission associated with different APMs in older patients with delirium after major surgery; 2) determine the risk of in- hospital non-fatal adverse events associated with different APMs; and 3) identify psychoactive drugs that may be prescribed as therapeutic alternatives to APMs by examining longitudinal prescribing trends. The investiga- tors will apply innovative research methodologies of leveraging existing large claims datasets and cohort data to enhance generalizability to routine care populations, increase statistical power to address safety for patient subgroups and individual drugs, and reduce bias. By conducting validation of case-identification algorithms, the investigators will improve how in-hospital adverse events are measured in inpatient drug safety research. The impact of this research is significant, because high-quality evidence on the comparative safety of APMs and their alternatives can guide clinicians to reduce excessive APM use and promote rational and safe APM prescribing, thereby improving safety and clinical care of older surgical patients.