Use and safety of opioids in patients undergoing total joint replacement

7.项目总结/摘要 在美国，超过30%的65岁及以上的成年人患有骨关节炎（OA）。髋关节和膝关节OA是 最常见的OA类型，患病率不断增加。阿片类镇痛药常用于患者 中度至重度症状性OA当非药物和药物治疗不 有效，严重OA患者可接受全关节置换术（TJR）。利用TJR 在过去十年中急剧增加。阿片类药物，特别是长期使用，可能会导致严重的副作用， 影响包括胃肠道和心血管事件、呼吸抑制、跌倒、骨折和死亡。 因此，短期和长期使用阿片类药物的益处和危害不仅是老年患者的重要问题 OA，也是一个备受公共卫生关注的领域。此外，一些证据表明， 术前使用阿片类药物对临床结局的负面影响，包括疼痛、僵硬、患者满意度， 以及TJR后需要额外手术。本提案的主要目的是评估 TJR前后OA患者阿片类药物使用模式，并评估阿片类药物使用模式的影响 在一个基于美国人群的大型OA患者队列中进行TJR后的临床结局和安全性事件。 这项为期4年的提案的具体目标是：1）确定持续使用阿片类药物和阿片类药物的预测因素， 髋关节或膝关节OA TJR后患者的剂量递增; 2）评价阿片类药物使用模式对 TJR后的短期和长期临床结局和安全性。拟议的研究将使用来自 Medicare索赔数据库（2009-2013年）与临床数据和患者报告的功能结局相关联 全关节置换术（FORCE-TJR）的比较有效性和结局研究; FORCE-TJR TJR是一项由AHRQ资助的前瞻性TJR登记研究，纳入了来自美国所有地区的30，000多名患者， 包括索赔数据库中无法获得的详细纵向临床信息，例如 手术前后OA、体重指数、疼痛和功能状态。鉴于人们对大公司越来越感兴趣， 临床研究中的数据和数据链接，FORCE-TJR和Medicare索赔数据之间的链接 为开展高质量的药物流行病学研究提供了一个创新和重要的机会， 接受TJR的患者中的阿片类药物。 使用创新和严格的药物流行病学方法和两个数据源的链接， 我们将控制OA严重程度、合并症、药物和与以下因素相关的风险因素的混杂因素： 阿片类药物使用、临床结局和安全性事件。这项研究的结果将有助于提供证据- 基于TJR前后这些患者的手术风险分层和疼痛管理的指导。

7. Project Summary/Abstract Over 30% of adults aged 65 years and older in the US suffer from osteoarthritis (OA). Hip and knee OA are the most common types of OA with an increasing prevalence. Opioid analgesics are often used for patients with moderate to severe symptomatic OA. When non-pharmacologic and pharmacologic treatments are not effective, patients with severe OA may undergo total joint replacement (TJR). Utilization of TJR has dramatically increased over the past decade. Opioids, particularly long-term use, can result in significant side effects including gastrointestinal and cardiovascular events, respiratory depression, fall, fracture, and death. Benefits and harms of short- and long-term opioid use are thus not only an important issue for older patients with OA, but also an area of great public health concern. Furthermore, some evidence suggests potential negative effects of preoperative opioid use on clinical outcomes including pain, stiffness, patient satisfaction, and requirement of additional surgery following TJR. The primary objectives of this proposal are to evaluate patterns of opioid use among OA patients before and after TJR and to assess the effect of opioid use patterns on clinical outcomes and safety events after TJR in a large U.S. population-based cohort of OA patients. The specific aims of this 4-year proposal are: 1) to identify predictors of persistent opioid use and opioid dose escalation in patients after TJR for hip or knee OA and 2) to evaluate effects of opioid use patterns on short- and long-term clinical outcomes and safety following TJR. The proposed study will use data from the Medicare claims database (2009-2013) linked to clinical data and patient-reported outcomes from the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR); FORCE- TJR is an AHRQ-funded, prospective TJR registry of over 30,000 patients from all regions of the U.S. and includes detailed, longitudinal clinical information that are not available in claims databases such as severity of OA, body mass index, pain and functional status before and after surgery. Given the increasing interest in big data and data linkage in clinical research, the linkage between FORCE-TJR and Medicare claims data provides an innovative and important opportunity to conduct high-quality pharmacoepidemiologic study of opioids in patients undergoing TJR. Using innovative and rigorous pharmacoepidemiologic methods and the linkage of two data sources, we will control for confounding by OA severity, comorbidities, medications, and risk factors associated with opioid use, clinical outcomes, and safety events. The results of the proposed study will help provide evidence- based guidance on surgical risk stratification and pain management of these patients before and after TJR.