Use and safety of opioids in patients undergoing total joint replacement

阿片类药物在全关节置换术患者中的使用和安全性

• 批准号: 9355032
• 负责人: Seoyoung Catherine Kim
• 金额: $ 46.19万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-19 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9355032
• 关键词: Acetaminophen; Adult; Adverse effects; Affect; Age; Antidepressive Agents; Antiepileptic Agents; Antipsychotic Agents; Area; Back Pain; Benzodiazepines; Big Data; Body mass index; Calibration; Cardiovascular system; Cause of Death; Cessation of life; Characteristics; Client satisfaction; Clinical; Clinical Data; Clinical Research; Clinical effectiveness; Comorbidity; Data; Data Linkages; Data Set; Data Sources; Databases; Degenerative polyarthritis; Development; Dose; Dropout; Educational workshop; Ethics; Event; Exercise; Fracture; Funding; Guidelines; Healthcare; Hip Osteoarthritis; Injection of therapeutic agent; Inpatients; Intervention; Knee Osteoarthritis; Link; Longitudinal Studies; Medicare; Medicare claim; Methods; Morphine; Non-Steroidal Anti-Inflammatory Agents; Operative Surgical Procedures; Opioid; Opioid Analgesics; Outcome; Outcomes Research; Pain; Pain management; Patient Education; Patient Outcomes Assessments; Patients; Pattern; Pharmaceutical Preparations; Pharmacoepidemiology; Pharmacological Treatment; Physical therapy; Placebos; Population; Postoperative Period; Prevalence; Psyche structure; Public Health; Randomized Controlled Trials; Registries; Replacement Arthroplasty; Research Proposals; Risk; Risk Factors; Risk stratification; Role; Safety; Sampling; Scoring Method; Serious Adverse Event; Severities; Steroids; Structural Models; Surveys; Total Hip Replacement; United States Agency for Healthcare Research and Quality; United States National Institutes of Health; Ventilatory Depression; Work; aged; base; beneficiary; chronic pain; clinical practice; cohort; comparative; comparative effectiveness; demographics; evidence base; falls; functional status; gastrointestinal; hip replacement arthroplasty; hospital readmission; innovation; interest; knee replacement arthroplasty; older patient; opioid use; population based; prescription opioid; prospective; tool

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.

7. 项目总结/摘要 在美国，超过 30% 的 65 岁及以上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，且患病率不断增加。阿片类镇痛药常用于患者 患有中度至重度症状的 OA。当非药物治疗和药物治疗均无效时 如果有效，严重骨关节炎患者可以接受全关节置换术（TJR）。 TJR 的利用 过去十年急剧增加。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利弊不仅对老年患者来说是一个重要问题 OA，也是一个备受公共卫生关注的领域。此外，一些证据表明潜在的 术前使用阿片类药物对临床结果的负面影响，包括疼痛、僵硬、患者满意度、 TJR 后需要进行额外的手术。该提案的主要目标是评估 TJR 前后 OA 患者的阿片类药物使用模式并评估阿片类药物使用模式的效果 在美国大型 OA 患者队列中进行 TJR 治疗后的临床结果和安全事件。 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 髋部或膝部 OA 患者 TJR 后剂量递增，以及 2) 评估阿片类药物使用模式对 TJR 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 医疗保险索赔数据库（2009-2013）与该功能的临床数据和患者报告的结果相关联 全关节置换效果比较结果研究（FORCE-TJR）；力量- TJR 是一个由 AHRQ 资助的前瞻性 TJR 注册中心，拥有来自美国各地区的 30,000 多名患者 包括索赔数据库中未提供的详细纵向临床信息，例如疾病的严重程度 手术前后的骨关节炎、体重指数、疼痛和功能状态。鉴于人们对大型企业的兴趣日益浓厚 临床研究中的数据与数据联动，FORCE-TJR与医疗保险理赔数据之间的联动 为开展高质量的药物流行病学研究提供了一个创新且重要的机会 接受 TJR 治疗的患者使用阿片类药物。 使用创新和严格的药物流行病学方法以及两个数据源的链接， 我们将控制 OA 严重程度、合并症、药物和与 OA 相关的危险因素的混杂因素 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—— TJR 前后这些患者的手术风险分层和疼痛管理的基础指导。