Use and safety of opioids in patients undergoing total joint replacement

7.项目摘要/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)。髋关节和膝盖骨关节炎 最常见的骨性关节炎类型，患病率越来越高。阿片类止痛药常用于患者 伴有中度到重度症状的骨性关节炎。当非药物和药物治疗不是 有效的，严重的骨关节炎患者可以接受全关节置换术(TJR)。TJR HAS的利用 在过去的十年里急剧增加。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一个重要问题 与骨质疏松症有关，但也是一个非常令人关注的公共卫生领域。此外，一些证据表明， 术前阿片类药物使用对临床结果的负面影响，包括疼痛、僵硬、患者满意度、 以及TJR后追加手术的要求。这项提案的主要目标是评估 骨性关节炎患者TJR前后阿片类药物的使用模式及阿片类药物使用模式的影响 对美国一大批以人群为基础的骨性关节炎患者进行TJR治疗后的临床结果和安全事件的研究。 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 髋关节或膝关节骨性关节炎患者TJR后的剂量递增2)评估阿片类药物使用模式对 TJR术后的短期和长期临床结果和安全性。拟议的研究将使用来自 与临床数据和患者报告的功能结果相关联的联邦医疗保险索赔数据库(2009-2013) 全关节置换术疗效比较结果研究(FORCE-TJR) TJR是由AHRQ资助的、预期的TJR登记，包括来自美国所有地区和 包括索赔数据库中没有的详细的纵向临床信息，如严重程度 手术前后的骨性关节炎、体重指数、疼痛及功能状态。鉴于对BIG的兴趣与日俱增 临床研究中的数据和数据链接，FORCE-TJR和医疗保险索赔数据之间的链接 提供了一个创新的重要机会，以进行高质量的药物流行病学研究 TJR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以及两个数据来源的联系， 我们将根据骨性关节炎的严重程度、合并症、药物和与以下因素相关的危险因素来控制混杂 阿片类药物的使用、临床结果和安全事件。拟议研究的结果将有助于提供证据- 基于对这些患者TJR前后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.