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Protecting patients and ourselves: conversations with our leaders on advocacy. 保护患者和我们自己:就宣传问题与我们的领导人对话。
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-24 DOI: 10.1016/j.jse.2024.08.012
Daniel E Goltz, Adam Z Khan, Kevin J Cronin, Gerald R Williams, Anthony A Romeo, Theodore F Schlegel, Mark A Frankle, Joseph A Abboud
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引用次数: 0
European medical devices regulation: a plea for ensuring safety without slowing access to innovation. 欧洲医疗器械法规:呼吁在确保安全的同时不放慢创新步伐。
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-24 DOI: 10.1016/j.jse.2024.08.011
Salvador Peñarrubia-Ortiz, Emilio Calvo
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引用次数: 0
Reverse total shoulder arthroplasty policy in Germany - an analysis of the health care reality from 2010 to 2022. 德国的 RTSA 政策 - 2010-2022 年医疗现实分析。
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-24 DOI: 10.1016/j.jse.2024.09.005
Matthias Aurich, Milad Farkhondeh Fal, Sebastian Albers, Felix Krane, Jörn Kircher
<p><strong>Background: </strong>The last few years have been characterized by increasing numbers of reverse shoulder arthroplasties. In addition to the classic indication of cuff tear arthropathy, the use for complex proximal humeral fractures (PHFs) and rotator cuff tear (RCT) in very old patients have been established. The objective of this study is to clarify and substantiate the above statements specifically for Germany (based on official data from 2010 to 2022). Since substantial changes in the structure of the population are expected over time, all data must be adjusted for these changes. The hypotheses are (1) the German population is ageing with a shift to more elderly patients over time, and (2) the general use of shoulder arthroplasty (total anatomic - shoulder arthroplasty (aTSA) and reverse - rTSA) has increased during the time period, but the effect is beyond the shift of age stratification but attributable to a change of hospital admissions and surgical therapy for PHF and RCT.</p><p><strong>Methods: </strong>In this retrospective study, data were collected from the National Bureau of Statistics in Germany for the period of 2010 to 2022. Three different data sources were combined for the analysis: a database regarding the structure of the population in age groups for every year, a database reporting relevant operation codes, and the data on hospital admissions based on ICD-10 codes. The relevant data were extracted and combined using Excel spread sheets (Microsoft Corporation, version 2019). Absolute numbers are reported and adjusted for 100.000 inhabitants in each age group in order to calculate the incidence.</p><p><strong>Results: </strong>Only slight change in absolute numbers of the population (n = 81751602 to 84358845, +3%) was observed, but a substantial shift toward the group of elderly people: the peak age group has shifted from 40-50 to 55-65. The number of TSA has significantly increased (n = 15000 to n = 28117, +187%; incidence 18.35 to 28.53, +155%). The number of rTSA has largely increased (n = 5326 to n = 24067, +452%; incidence 6.51 to 28.53, +438%), whereas the number of aTSA steadily decreased (n = 9674 to n = 4050, -42%; incidence 11.83 to 4.80, -41%). The number of revision arthroplasties has increased 1.8-fold (n = 2179 to n = 3893; incidence 1.7-fold). The peak revision rate shifted from the age group 70-75 toward 90- 95; 76% of all revision cases were performed in patients 65 years and older in 2010 increasing to 87% in 2022. Hospital admissions for PHF have increased 7.8-fold (n = 110091 to n = 810907). The peak in the age groups has shifted by a decade from 70-74 to 80-84. The absolute number of surgical therapy for PHF has decreased (n = 12816 to n = 9562, 75%; incidence 72%). The number of hospital admissions for RCT increased by 2.6-fold (n = 47004 to n = 124096; incidence + 255%). The number of surgical interventions for RCT increased by 3.7% (n = 51350 to n = 53294; incidence 62.8 to 63.2). Combined num
背景:最近几年,反向肩关节置换术的数量不断增加。除了肩袖撕裂性关节病的传统适应症外,复杂性肱骨近端骨折(PHF)和肩袖撕裂(RCT)在高龄患者中的应用也已确立。本研究的目的是专门针对德国(基于 2010 年至 2022 年的官方数据)澄清并证实上述声明。由于随着时间的推移,人口结构会发生重大变化,因此所有数据都必须根据这些变化进行调整。假设是:(1) 随着时间的推移,德国人口老龄化,老年患者增多;(2) 在此期间,肩关节置换术(全解剖肩关节置换术(aTSA)和反向肩关节置换术(rTSA))的普遍使用有所增加,但其影响超出了年龄分层的变化,而是归因于PHF和RCT的入院人数和手术治疗的变化:在这项回顾性研究中,我们从德国国家统计局收集了 2010 年至 2022 年期间的数据。分析时综合了三种不同的数据来源:关于每年各年龄组人口结构的数据库、报告相关手术代码的数据库以及基于 ICD-10 代码的入院数据。相关数据通过 Excel 电子表格(微软公司,2019 年版)提取和合并。报告了绝对数字,并按每个年龄组的 10 万居民进行调整,以计算发病率:观察到人口绝对数(n = 81751602 到 84358845,+3%)仅有轻微变化,但向老年人群大幅转移:高峰年龄组从 40-50 岁转移到 55-65 岁。TSA 的数量明显增加(n = 15000 到 n = 28117,+187%;发病率从 18.35 到 28.53,+155%)。rTSA的数量大幅增加(n = 5326 到 n = 24067,+452%;发病率从 6.51 到 28.53,+438%),而aTSA的数量稳步下降(n = 9674 到 n = 4050,-42%;发病率从 11.83 到 4.80,-41%)。翻修关节置换数量增加了1.8倍(n = 2179 到 n = 3893;发生率为1.7倍)。翻修率峰值从 70-75 岁年龄组转向 90-95 岁年龄组;2010 年,所有翻修病例中有 76% 由 65 岁及以上的患者实施,到 2022 年,这一比例将增至 87%。因 PHF 住院的人数增加了 7.8 倍(n = 110091 到 n = 810907)。年龄组的峰值从 70-74 岁向 80-84 岁转移了十年。PHF 手术治疗的绝对数量有所下降(n = 12816 到 n = 9562,75%;发病率 72%)。因 RCT 而入院的人数增加了 2.6 倍(n = 47004 到 n = 124096;发生率 + 255%)。RCT 的手术治疗次数增加了 3.7%(n = 51350 到 n = 53294;发生率从 62.8 到 63.2)。PHF、RCT 和 rTSA 手术治疗的总人数增加了 124%(n = 69491 到 n = 86715),高峰期在 60-94 岁年龄组,其中 79% 的患者在 2022 年。rTSA发病率的增加与65岁及以上人口比例的增加密切相关:数据显示,在观察期内,德国肩关节置换术的使用率大幅上升,主要驱动因素是rTSA的增加,而aTSA的使用率则有所下降。对治疗PHF和RCT的入院人数和手术程序进行的综合分析表明,在这一年龄组中,治疗人数从老年人的开放复位内固定术和肩袖修复术转向了rTSA。观察到的年龄组分层的变化进一步解释了 rTSA 使用量的增加:具有 rTSA 典型适应症和替代适应症的年龄组患者人数大幅增加,高峰年龄组向老年人转移了 10 年。医疗保健官员应该意识到人口的这些根本性变化,这些变化对医疗保健系统提出了更高的要求。为应对预计将持续上升的住院治疗人数,需要提供充足的资源,如报销、手术和康复设施以及工作人员。
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引用次数: 0
Trends in payments for facility and surgeon professional fees for shoulder surgeries performed at ambulatory surgery centers. 在非住院手术中心进行肩部手术的机构和外科医生专业费用的支付趋势。
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-24 DOI: 10.1016/j.jse.2024.09.003
William Harkin, Vincent P Federico, Tyler Williams, Alexander J Acuna, Johnathon R McCormick, John P Scanaliato, Gregory P Nicholson, Nikhil N Verma, Grant E Garrigues

Background: It has previously been demonstrated that utilization of ambulatory surgery centers (ASCs) results in cost savings and improved outcomes. Despite these benefits, Medicare reimbursement for professional fees at ASCs are decreasing over time. In this study, we sought to analyze the discrepancy between facility fee and professional fee reimbursements for ASCs by Medicare for common shoulder procedures over time. We hypothesized that professional fees for shoulder procedures would decrease over the study period while facility fees kept pace with inflation.

Methods: Current Procedural Terminology codes were used to identify shoulder specific procedures approved for ASCs by Centers for Medicare and Medicaid Services. Procedures were grouped into arthroscopic and open categories. Publicly available data from Centers for Medicare and Medicaid Services was accessed via the Medicare Physician Fee Schedule Lookup Tool and used to determine professional fee payments from 2018 to 2024. Additionally, Medicare ASC Payment Rates files were accessed to determine facility fee reimbursements to ASCs from 2018 to 2024. Descriptive statistics were used to calculate means and percent change over time. Compound annual growth rates were calculated and discrepancies in inflation were corrected for using the Consumer Price Index. The Benjamini and Hochberg method was used to correct P values in the setting of multiple comparisons.

Results: A total of 33 common shoulder procedures were included for analysis (10 arthroscopic codes and 23 open codes). Reimbursements for facility fees have remained significantly higher than corresponding professional fees for both open and arthroscopic procedures (P < .01). On average, facility fee reimbursements for common shoulder surgeries have risen on an annual basis in a manner consistent with inflation (P = .838). However, professional fees for these procedures have experienced a nearly uniform decline over the study period both nominally and in inflation-adjusted dollars (P = .064 and P = .005, respectively).

Conclusion: Facility fee payments for outpatient approved shoulder surgeries have matched or outpaced inflation. Over the same time period, professional fee reimbursements for surgeons are consistently decreasing, both in absolute and inflation-adjusted dollars. Reform to the physician fee schedule is necessary to ensure that Medicare patients retain access to high-quality physician care.

背景:以前的研究表明,使用非住院手术中心(ASC)可以节约成本并改善治疗效果。尽管有这些好处,但随着时间的推移,医疗保险(Medicare)对门诊手术中心专业人员费用的报销却在减少。在这项研究中,我们试图分析随着时间的推移,医疗保险对非住院手术中心常见肩部手术的设施费和专业费报销之间的差异。我们的假设是,在研究期间,肩部手术的专业费用将下降,而设施费用将与通货膨胀保持同步:方法:使用现行医疗程序术语(CPT)代码确定医疗保险和医疗补助服务中心(CMS)批准的肩部ASC特定手术。手术分为关节镜手术和开放手术两类。通过 "医疗保险医师费用表查询工具 "访问了 CMS 的公开数据,并利用这些数据确定了 2018-2024 年的专业费用支付情况。此外,还访问了医疗保险 ASC 支付率文件,以确定 2018-2024 年 ASC 的设施费报销情况。描述性统计用于计算均值和随时间变化的百分比。计算了复合年增长率 (CAGR),并使用消费者物价指数校正了通货膨胀的差异。在多重比较的情况下,采用本杰明尼和霍赫伯格法校正 P 值:共有 33 种常见肩部手术纳入分析范围(10 种关节镜手术代码和 23 种开放式手术代码)。无论是开放手术还是关节镜手术,设备费的报销额度一直明显高于相应的专业费用(P结论:经批准的肩关节门诊手术的设施费支付与通胀率持平或高于通胀率。在同一时期,外科医生的专业费用补偿却在持续下降,无论是绝对值还是按通胀调整后的金额。有必要对医生收费标准进行改革,以确保医疗保险患者能够继续获得高质量的医生护理。
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引用次数: 0
Social and demographic health disparities in shoulder and elbow surgery. 肩肘手术中的社会和人口健康差异。
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-23 DOI: 10.1016/j.jse.2024.08.009
Edward J Testa, John D Milner, Ian R Penvose, Jeffrey Okewunmi, Phillip Schmitt, Brett D Owens, E Scott Paxton
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引用次数: 0
Does Use of GLP-1 Agonists Increase Postoperative Complications in Patients Undergoing Shoulder Arthroplasty? 使用 GLP-1 激动剂会增加肩关节置换术患者的术后并发症吗?
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-23 DOI: 10.1016/j.jse.2024.07.045
Zaid Elsabbagh, Mark Haft, Sudarsan Murali, Matthew Best, Edward George McFarland, Uma Srikumaran
<p><strong>Background: </strong>Amidst the rising prevalence of type 2 diabetes mellitus (T2DM) and obesity among individuals undergoing total shoulder arthroplasty (TSA), the impact of glucagon-like-peptide-1 (GLP-1) therapy on surgical outcomes merits thorough investigation. Though it is known that GLP-1 therapy poses an interesting challenge for anesthesia during the perioperative period, little is known regarding the effects of these medications on surgical outcomes. This study aimed to evaluate the influence of GLP-1 on postoperative outcomes and length of stay (LOS) in T2DM patients undergoing TSA.</p><p><strong>Methods: </strong>A retrospective cohort analysis was performed using a national database to identify primary TSA patients aged 18 and above with T2DM prescribed GLP-1 therapy at the time of surgery. Exclusion criteria included revision surgery, TSA for fracture, type 1 diabetes, steroid-induced diabetes, and contraindications for GLP-1 therapy. A control group of T2DM TSA patients not on GLP-1 therapy was used, and a 1:4 propensity-score match was performed. Incidence rates and odds ratios (OR) via multivariable logistic regression were calculated. The primary outcomes were 90-day major medical complications and LOS. Secondary outcomes included 2-year joint-related complications.</p><p><strong>Results: </strong>In the 90-day follow-up cohort, 64,567 patients met inclusion criteria, with 8,481 (13.1%) on GLP-1 therapy. No significant increase in 90-day major complications, including DVT, cardiac arrest, myocardial infarction, cerebrovascular accident, pneumonia, pulmonary embolism, urinary tract infection, surgical site infection, hypoglycemic event, sepsis, or readmission, was found between GLP-1 and non-GLP-1 cohorts after multivariable logistic regression. In the 2-year follow-up cohort, 47,814 patients were included, with 5,969 (12.5%) on GLP-1 therapy. Similarly, 2-year joint-related complications, including all-cause revision, prosthetic joint infection, periprosthetic fracture, and aseptic revision, showed no significant differences between the GLP-1 and non-GLP-1 cohorts. No significant difference was observed in LOS in the 90-day cohort.</p><p><strong>Conclusion: </strong>This study provides a comprehensive analysis of GLP-1 therapy's impact on TSA outcomes, revealing no significant change in postoperative complications or LOS. The lack of increased postoperative risk underscores the potential of GLP-1 therapy in managing T2DM without adverse effects on TSA recovery. These insights contribute to understanding postoperative management in orthopedic surgery, indicating that we did not note any increased risk with GLP-1 use perioperatively in TSA patients, unlike in other populations like the TKA patients. Future research should focus on prospective analyses to further elucidate the role of GLP-1 therapy in surgical outcomes, aiming to enhance patient care and optimize postoperative strategies for T2DM patients undergoing TSA.
背景:在接受全肩关节置换术(TSA)的患者中,2型糖尿病(T2DM)和肥胖症的发病率不断上升,胰高血糖素样肽-1(GLP-1)疗法对手术效果的影响值得深入研究。众所周知,GLP-1疗法对围手术期的麻醉是一个有趣的挑战,但这些药物对手术效果的影响却鲜为人知。本研究旨在评估 GLP-1 对接受 TSA 手术的 T2DM 患者的术后效果和住院时间(LOS)的影响:方法:利用国家数据库进行了一项回顾性队列分析,以确定手术时接受 GLP-1 治疗的 18 岁及以上 T2DM 初治 TSA 患者。排除标准包括翻修手术、骨折 TSA、1 型糖尿病、类固醇引起的糖尿病以及 GLP-1 治疗禁忌症。对照组为未接受 GLP-1 治疗的 T2DM TSA 患者,并进行了 1:4 的倾向分数匹配。通过多变量逻辑回归计算发病率和几率比(OR)。主要结果为 90 天主要医疗并发症和住院时间。次要结果包括2年关节相关并发症:在 90 天随访队列中,有 64,567 名患者符合纳入标准,其中 8,481 人(13.1%)接受了 GLP-1 治疗。经多变量逻辑回归后发现,GLP-1组群与非GLP-1组群之间的90天主要并发症(包括深静脉血栓、心脏骤停、心肌梗死、脑血管意外、肺炎、肺栓塞、尿路感染、手术部位感染、低血糖事件、脓毒症或再入院)无明显增加。在为期两年的随访队列中,共纳入了 47814 名患者,其中 5969 人(12.5%)接受了 GLP-1 治疗。同样,2 年的关节相关并发症,包括全因翻修、假体关节感染、假体周围骨折和无菌性翻修,在 GLP-1 和非 GLP-1 组群之间没有发现显著差异。90天队列中的LOS也无明显差异:本研究全面分析了 GLP-1 疗法对 TSA 结果的影响,结果显示术后并发症或 LOS 没有明显变化。术后风险没有增加凸显了 GLP-1 疗法在控制 T2DM 而不对 TSA 恢复产生不良影响方面的潜力。这些见解有助于了解骨科手术的术后管理,表明我们没有注意到 TSA 患者围手术期使用 GLP-1 会增加风险,这与 TKA 患者等其他人群不同。未来的研究应侧重于前瞻性分析,以进一步阐明 GLP-1 疗法在手术效果中的作用,从而加强对患者的护理,优化接受 TSA 手术的 T2DM 患者的术后策略。
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引用次数: 0
Advocacy: a reflection on my 30 years of orthopedic practice. 宣传:我三十年矫形外科实践的反思。
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-23 DOI: 10.1016/j.jse.2024.08.007
Gerald R Williams
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引用次数: 0
The future of Food and Drug Administration regulation on artificial intelligence-enabled medical devices: an orthopedic surgeon's guide. FDA 对人工智能医疗设备监管的未来:矫形外科医生指南》。
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-23 DOI: 10.1016/j.jse.2024.08.008
S Shamtej Singh Rana, Jacob S Ghahremani, Ronald A Navarro
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引用次数: 0
Access to shoulder arthroplasty in Australia: A balance of regulation, surveillance, and monitored efficacy to maximize patient outcome and optimum care. 澳大利亚肩关节置换术的可及性--兼顾监管、监督和疗效监测,最大限度地提高患者疗效和最佳护理。
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-21 DOI: 10.1016/j.jse.2024.07.042
Michael J Sandow, David R J Gill

Prosthetic arthroplasty has emerged as a major contributor to the management of shoulder disorders. This paper outlines the situation in Australia regarding the process by which shoulder replacement devices are made available. Although entry of joint replacement devices to the Australian market is relatively unrestricted, they must be first approved by the Therapeutic Goods Administration-based on safety and efficacy-to be legally used. In addition, to obtain a private insurance rebate (Prescribed List) and thus be commercially viable, the Federal Department of Health and Aged Care requires a more stringent benchmark of comparative clinical effectiveness and value for money. The AOANJRR (Australian Orthopaedic Associate National Joint Replacement Registry) records the implantation and possible revision of virtually all (>98%) major joint arthroplasties in Australia and plays an important role in informing surgeons about their implant selection, but also in identifying and highlighting devices with a higher than anticipated rate of revision. Although the increased cost of health care is placing pressure on health care systems around the world, in Australia, access to shoulder arthroplasty remains relatively unrestricted-but carefully controlled and monitored.

人工关节置换术已成为治疗肩关节疾病的主要手段。本文概述了澳大利亚肩关节置换器械的上市程序。虽然关节置换器械进入澳大利亚市场相对不受限制,但必须首先获得治疗用品管理局(TGA)基于安全性和有效性的批准,才能合法使用。此外,为了获得私人保险回扣(处方清单),从而实现商业上的可行性,联邦卫生与老年护理部对临床效果比较和性价比的基准要求更为严格。AOANJRR(澳大利亚骨科协会全国关节置换登记处)1 记录了澳大利亚几乎所有(>98%)主要关节置换术的植入情况和可能的翻修情况,在为外科医生提供植入物选择信息方面发挥着重要作用,同时也能识别和突出翻修率高于预期的器械。虽然医疗成本的增加给世界各地的医疗系统带来了压力,但在澳大利亚,肩关节置换术的使用仍相对不受限制,但会受到严格控制和监测。
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引用次数: 0
Are patients without insurance coverage less likely to undergo surgery for humeral shaft fractures? A national database analysis. 没有保险的患者是否不太可能接受肱骨轴骨折手术?全国数据库分析。
IF 2.9 2区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-21 DOI: 10.1016/j.jse.2024.07.048
Daniel B Calem, Tej Joshi, Francis G Alberta, Eitan M Kohan

Background: Historically, humeral shaft fractures have been managed nonoperatively in a functional brace. However, recent studies suggest an increase in rates of operative fixation. Disparities in surgical management based on insurance status have been demonstrated across many orthopedic conditions. This study aimed to identify if a correlation exists between insurance coverage and the probability of undergoing operative fixation for a humeral shaft fracture.

Methods: A retrospective examination of the National Readmissions Database from 2016 to 2021 was conducted. Patients diagnosed with isolated closed humeral shaft fractures were identified via International Classification of Disease, 10th Revision codes, and surgical interventions were identified using International Classification of Disease, 10th Revision procedural codes. Utilizing weighted data, a total of 56,468 patients with isolated closed humeral shaft fractures were identified, 25,075 (44.4%) of whom underwent operative fixation. A univariate analysis was conducted using Pearson's chi-square test to isolate variables for inclusion in a multivariable analysis. A binary logistic regression analysis was then employed to explore demographic and other pertinent factors. Findings were reported as odds ratios.

Results: After controlling for social and demographic variables, patients with Medicaid (OR, 0.54; 95% CI, 0.50-0.58; P < .001), Medicare (OR, 0.64; 95% CI, 0.60-0.68; P < .001), and self-pay patients (OR, 0.75; 95% CI, 0.67-0.84; P < .001) were less likely to undergo operative fixation of humeral shaft fracture than those with private insurance.

Conclusions: Patients without private insurance or those with no insurance coverage are less likely to undergo operative fixation for humeral shaft fractures compared to those with private insurance, even after adjusting for social and demographic variables. The observed variability underscores the necessity for more refined treatment guidelines for humeral shaft fractures. Surgeons should be aware of these potential biases affecting management decisions.

背景:一直以来,肱骨轴骨折都是在功能性支具中进行非手术治疗。然而,最近的研究表明,手术固定的比例有所增加。基于保险状况的手术管理差异已在许多骨科疾病中得到证实。本研究旨在确定保险范围与肱骨轴骨折接受手术固定的概率之间是否存在相关性:方法:对2016年至2021年的国家再入院数据库(NRD)进行了回顾性研究。通过国际疾病分类第十次修订版(ICD-10)代码确定被诊断为孤立闭合性肱骨轴骨折的患者,并通过ICD-10程序代码确定手术干预。利用加权数据,共确定了56468名孤立闭合性肱骨轴骨折患者,其中25075人(44.4%)接受了手术固定。使用皮尔逊卡方检验进行了单变量分析,以分离出纳入多变量分析的变量。然后采用二元逻辑回归分析来探讨人口统计学和其他相关因素。结果以几率比(ORs)的形式报告:结果:在对社会和人口统计学变量进行控制后,享受医疗补助的患者(OR,0.54;95% CI,0.50-0.58;p结论:没有私人保险或没有医疗保险的患者在接受治疗时,其患病率要比享受医疗补助的患者高:与有私人保险的患者相比,没有私人保险或没有保险的患者接受肱骨轴骨折手术固定的可能性较低,即使在调整了社会和人口变量后也是如此。观察到的差异突出表明,有必要制定更完善的肱骨轴骨折治疗指南。外科医生应该意识到这些影响管理决策的潜在偏差。
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引用次数: 0
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Journal of Shoulder and Elbow Surgery
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