Level of evidence

证据水平
  • 文章类型: Journal Article
    循证医学规定,临床决策应围绕科学证据。本研究的目的是评估最近发表在JAMA外科杂志上的外科研究的方法学质量,国际外科杂志,和英国外科杂志,影响因子最高的三种外科期刊。对PUBMED数据库进行了电子搜索,以检索JAMASurgery中发表的所有文章,国际外科杂志,和2022年的英国外科杂志。三位作者独立审查了所有检索到的文章,并使用牛津循证医学中心的证据水平(牛津证据水平量表)进行了分析和评估。最初的搜索确定了1236篇文章,其中809篇文章在标题和摘要筛选后被排除在外。其余427进行了全文/方法阅读,其中164人不符合纳入/排除标准。总共273项研究被纳入分析。在所有评估的研究中,平均证据水平为2.5±0.8。大多数研究设计由回顾性队列组成(n=119),前瞻性队列(n=47),非随机对照试验的系统评价(n=39),和RCT(n=37)。前三名期刊的平均证据水平没有显着差异(p=0.50)。影响因素最高的外科杂志上的大多数临床研究都是III级证据,与早期文献一致。然而,我们的分析表明,与文献中先前发表的相比,LOEI和II的百分比相对较高.
    Evidence-based medicine stipulates that clinical decision-making should revolve around scientific evidence. The goal of the present study is to evaluate the methodological quality of surgical research recently published in JAMA Surgery, International Journal of Surgery, and British Journal of Surgery, the three surgical journals with the highest impact factor. An electronic search of the PUBMED database was performed to retrieve all articles published in the JAMA Surgery, International Journal of Surgery, and British Journal of Surgery in the year 2022. Three authors independently reviewed all retrieved articles and methodological designs of the publications were analyzed and rated using a modification of the Oxford Centre for Evidence-Based Medicine Levels of Evidence (Oxford Levels of Evidence scale). The initial search identified 1236 articles of which 809 were excluded after title and abstract screening. The remaining 427 underwent full text/methods read, of which 164 did not meet the inclusion/exclusion criteria. A total of 273 studies were included in the analysis. The average level of evidence was 2.5 ± 0.8 across all studies assessed. The majority of study designs were comprised of retrospective cohorts (n = 119), prospective cohorts (n = 47), systematic reviews of non RCTs (n = 39), and RCTs (n = 37). There was no significant difference in the average level of evidence between the top three journals (p = 0.50). Most clinical studies in the highest impact factor surgical journals are of level III evidence, consistent with earlier literature. However, our analysis demonstrates a relatively higher percentage of LOE I and II compared to what was previously published in the literature.
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  • 文章类型: Journal Article
    目的:外伤性颅内血肿(TICH)是神经外科急症,死亡率和发病率高。手术减压时间是TICH患者的一个可修改但报告不一致的危险因素?
    结果:我们的目的是提供创伤系统中TICH疏散时间的当代数据和时间的长期趋势。
    方法:一项为期13年的回顾性队列研究于2021年结束,该研究在一个一级创伤中心的创伤系统中纳入了所有接受紧急开颅手术或开颅手术以撤离TICH的患者。人口统计,收集损伤严重程度和关键护理时间.分析的亚组是多发性外伤与孤立性颅脑损伤,直接入院与转学,幸存者与死者。对从损伤到手术室的时间进行线性回归。
    结果:确定了78例TICH患者(年龄:35(22-56);58(74%)男性;ISS:25(25-41);AIS头:5(4-5);死亡率:21(27%)患者)。初始GCS为8(3.25-14),到到达创伤中心时降至3(3-7)。有46名(59%)患者在到达之前插管。从受伤到手术的中位时间为4.88(3.63-6.80)小时。损伤对OR的线性回归显示,在研究期间,直接进入创伤中心的手术干预时间增加(p=0.04)。在同一时间内,死亡率或格拉斯哥结局评分没有相关变化。
    结论:这些当代数据显示,从受伤到撤离的时间接近5小时。在13年的研究期间,直接入院的手术干预时间显着增加。这项研究将指导我们的机构在未来对TICH演讲的回应。其他创伤系统应以相同的报告标准严格评估其结果。
    OBJECTIVE: Traumatic intracranial hematoma (TICH) is a neurosurgical emergency with high mortality and morbidity. The time to operative decompression is a modifiable but inconsistently reported risk factor for TICH patients?
    RESULTS: We aimed to provide contemporary time to evacuation data and long-term trends in timing of TICH evacuation in a trauma system.
    METHODS: A 13-year retrospective cohort study ending in 2021 at a trauma system with one level-1 trauma center included all patients undergoing urgent craniotomy or craniectomy for evacuation of TICH. Demographics, injury severity and key timeframes of care were collected. Subgroups analyzed were polytrauma versus isolated head injury, direct admissions versus transfers and those who survived versus those who died. Linear regression of times from injury to operating room was performed.
    RESULTS: Seventy-eight TICH patients (Age: 35 (22-56); 58 (74%) males; ISS: 25(25-41); AIS head: 5 (4-5); mortality: 21 (27%) patients) were identified. Initial GCS was 8 (3.25-14) which decreased to 3 (3-7) by arrival in the trauma center. There were 46 (59%) patients intubated prior to arrival. Median time from injury to operation was 4.88 (3.63-6.80) hours. Linear regression of injury to OR showed increasing times to operative intervention for direct admissions to the trauma center over the study period (p=0.04). There was no associated change in mortality or Glasgow outcome score over the same time.
    CONCLUSIONS: This contemporary data shows timing from injury to evacuation is approaching 5 hours. Over the 13-year study period the time to operative intervention significantly increased for direct admissions. This study will guide our institutions response to TICH presentations in the future. Other trauma systems should critically appraise their results with the same reporting standard.
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  • 文章类型: Journal Article
    这项研究的目的是检查三个主要的口腔修复学期刊中证据水平(LOE)特征和随时间变化的相关因素。
    发表在“修复牙科杂志”(JPD)上的文章,国际口腔修复学杂志(IJP),和口腔修复学杂志(JP)在2013年和2020年由8名独立审稿人进行了审查。在应用排除和纳入标准后,作者的数量,相应作者的教育程度,记录每篇临床研究文章中相应作者的来源。审稿人根据证据标准水平和拟议的证据相关因素水平对纳入的文章进行评级。描述性统计,单变量,和二元logistic回归分析用于调查因变量和潜在相关因素.所有影响显著的自变量均采用多变量检验进行分析。进入和退出α水平设置为αE=0.15。统计显著性设定为α=0.05。
    在所研究的年份中,来自3种选定期刊的439篇文章符合纳入标准。1、2、3、4、5级文章的百分比为2.7%,11.4%,9.6%,13.4%和62.9%,分别。单变量分析结果显示与作者数量显著相关(P=0.005),通讯作者的教育程度(P=0.022),和相应作者的地理来源(P=0.042)。多变量分析结果显示与作者数量显著相关(P=0.002),和相应作者的地理来源(P=0.014)。
    作者的数量,CA学位,CA起源与纳入口腔修复研究的LOE有显著关联。尽管从2013年到2020年出版物数量有所增加,但证据水平趋势多年来没有改善。
    UNASSIGNED: The purpose of this study was to examine the level of evidence (LOE) characteristics and associated factors that change over time in three leading prosthodontics journals.
    UNASSIGNED: Articles published in The Journal of Prosthetic Dentistry (JPD), International Journal of Prosthodontics (IJP), and Journal of Prosthodontics (JP) in 2013 and 2020 were reviewed by eight independent reviewers. After applying exclusion and inclusion criteria, the number of authors, the corresponding author\'s educational degree, corresponding author\'s origin in each clinical research article were recorded. The included articles were rated by reviewers according to the level of evidence criteria and proposed level of evidence-associated factors. Descriptive statistics, univariable, and binary logistic regression analysis were performed to investigate dependent variables and potentially associated factors. All independent variables with a significant effect were analyzed by using a multivariable test. The entry and exit alpha level were set at αE = 0.15. The statistical significance was set at α = 0.05.
    UNASSIGNED: A total of 439 articles from 3 selected journals for the years studied met the inclusion criteria. The percentages of level 1, 2, 3, 4, and 5 articles were 2.7 %, 11.4 %, 9.6 %, 13.4 % and 62.9 %, respectively. Univariable analysis results demonstrated significant associations related to the number of authors (P = 0.005), the corresponding author\'s educational degree (P = 0.022), and the corresponding author\'s geographic origin (P = 0.042). Multivariable analysis results demonstrated significant associations related to the number of authors (P = 0.002), and the corresponding author\'s geographic origin (P = 0.014).
    UNASSIGNED: The number of authors, CA degree, and CA origin had a significant association with the LOE of included prosthodontic studies. Although there was an increase in the number of publications from 2013 to 2020, the level of evidence trend shows no improvement over the years.
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  • 文章类型: Journal Article
    背景:自1999年成立以来,临床种植牙科及相关研究(CIDRR)杂志一直在口腔种植学领域内传播着重要的临床和转化研究。随着该杂志的里程碑25周年,这项研究努力系统地描绘出版趋势,证据水平,和表征CIDRR最初四分之一世纪学术活动的文献计量指数。值得注意的是,调查采用了现代方法,结合了Altmetric分析,从而通过评估已发表研究的更广泛的社会和在线影响来丰富评估。
    方法:在SCOPUS和PubMed中进行了全面搜索,以访问1999年至2024年在该杂志上发表的所有文章的书目数据。此外,Altmetric数据库用于获取社交媒体注意力得分(AAS)。通过影响因子和四分位数范围评估了期刊的整体表现。被引用的论文最多,也是最多产的作者,评估了机构和国家以及它们之间的合作网络。所有文章的证据水平是根据牛津证据水平量表确定的。所有文章都根据其在植入牙科领域的主要主题进行分类。
    结果:在其活动的前25年中,CIDRR发表了1912篇文章,年增长率为2.67%,并在“牙科(杂项)”和“口腔外科”期刊类别中始终排名第一四分位数。当考虑临床研究时,一级和二级证据占所有条款的22.82%和11.82%,分别。瑞典,美国,意大利和哥德堡大学,SahlgrenskaAkademin.马尔默Högskola分别是最多产的国家和机构。“植入系统/设计/特性,\"\"骨增强,“”和“植入假体”是研究最多的主题。
    结论:对该杂志最初25年的审查强调,CIDRR在发表更多高水平证据文章方面已经超过了类似的牙科研究期刊。它还展示了不同的国家和作者合作网络。然而,该杂志的社交媒体存在仍在发展。这篇文章,对期刊的科学计量学和书目活动进行全面概述,为研究人员提供了宝贵的参考,临床医生,和利益相关者,提供对传统和当代观点的见解。
    BACKGROUND: Since its establishment in 1999, the journal of Clinical Implant Dentistry and Related Research (CIDRR) has consistently disseminated notable clinical and translational research within the domain of oral implantology. As the journal approaches its milestone 25th anniversary, this study endeavors to systematically delineate the publication trends, level of evidence, and bibliometric indices characterizing the initial quarter-century of CIDRR\'s scholarly activity. Notably, the investigation adopts a contemporary methodology by incorporating Altmetric analysis, thereby enriching the evaluation with an assessment of the broader societal and online impact of the published research.
    METHODS: A comprehensive search was performed in SCOPUS and PubMed to access the bibliographic data of all articles published in the journal from 1999 to 2024. Additionally, Altmetric database was used to obtain social media attention scores (AAS). Journal\'s overall performance via impact factor and quartile range was assessed. Most cited papers were identified and the most prolific authors, institutions and countries and the collaboration networks among those were assessed. The level of evidence of all articles was determined based on Oxford level of evidence scale. All articles were categorized based on their major topic in the field of implant dentistry.
    RESULTS: Throughout its first 25 years of activity, CIDRR published 1912 articles with an annual growth rate of 2.67% and consistently being ranked at Q1 quartile in \"Dentistry (miscellaneous)\" and \"Oral Surgery\" journal categories. When clinical studies are considered, level I and II evidence constituted 22.82% and 11.82% of all articles, respectively. Sweden, the USA, and Italy as well as Göteborgs Universitet, Sahlgrenska Akademin. and Malmö Högskola were the most prolific countries and institutions respectively. \"Implant system/design/characteristics,\" \"Bone Augmentation,\" and \"Implant Prosthesis\" were the top most investigated topics.
    CONCLUSIONS: The examination of the journal\'s initial 25 years highlighted that CIDRR has surpassed similar dental research journals in publishing a greater number of high-level evidence articles. It also showcased diverse country- and author-collaboration networks. However, the journal\'s social media presence is still evolving. This article, presenting a comprehensive overview of the journal\'s scientometric and bibliographic activities, serves as a valuable reference for researchers, clinicians, and stakeholders, offering insights into both traditional and contemporary perspectives.
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  • 文章类型: Journal Article
    欧洲医学肿瘤学会(ESMO)指南是全球最全面和广泛使用的临床实践指南(CPG)之一。然而,支持ESMOCPG建议的科学证据水平尚未得到系统调查.本研究评估了ESMOCPG证据水平(LOE)和建议等级(GOR),以及它们在各种癌症环境中的趋势。
    我们从每个CPG中手动提取了美国传染病学会(IDSA)分类的每个建议。我们在所有可用的ESMOCPG指南中检查了LOE和GOR在不同主题和癌症类型中的分布。
    在当前CPG的1,823项建议中,30%被归类为LOEI,43%被归类为GORA。总体而言,与以前的版本相比,当前CPG中LOEI略有下降(-2%),GORA的比例增加(+1%).基于较高水平证据(如随机试验(LOEI-II))的GORA建议的比例有所下降(71%vs.63%,p=0.009),而基于较低水平证据的建议(LOEIII-V)显示增加(29%vs.37%,以前版本和当前版本之间的p=0.01)。在当前版本中,在与药物治疗相关的建议中发现LOEI的比例最高(42%),而GORA推荐比例最高的是病理学(50%)和诊断(50%)推荐.在不同的癌症类型中观察到LOEI和GORA建议的显着变异性及其随时间的变化。
    当前ESMOCPG建议的三分之一得到了最高级别的证据支持。需要更精心设计的随机临床试验来增加LOEI和GORA建议的比例,最终改善癌症患者的预后。
    UNASSIGNED: The European Society for Medical Oncology (ESMO) guidelines are among the most comprehensive and widely used clinical practice guidelines (CPGs) globally. However, the level of scientific evidence supporting ESMO CPG recommendations has not been systematically investigated. This study assessed ESMO CPG levels of evidence (LOE) and grades of recommendations (GOR), as well as their trends over time across various cancer settings.
    UNASSIGNED: We manually extracted every recommendation with the Infectious Diseases Society of America (IDSA) classification from each CPG. We examined the distribution of LOE and GOR in all available ESMO CPG guidelines across different topics and cancer types.
    UNASSIGNED: Among the 1,823 recommendations in the current CPG, 30% were classified as LOE I, and 43% were classified as GOR A. Overall, there was a slight decrease in LOE I (-2%) and an increase in the proportion of GOR A (+1%) in the current CPG compared to previous versions. The proportion of GOR A recommendations based on higher levels of evidence such as randomized trials (LOE I-II) shows a decrease (71% vs. 63%, p = 0.009) while recommendations based on lower levels of evidence (LOE III-V) show an increase (29% vs. 37%, p = 0.01) between previous and current version. In the current versions, the highest proportion of LOE I (42%) was found in recommendations related to pharmacotherapy, while the highest proportion of GOR A recommendations was found in the areas of pathology (50%) and diagnostic (50%) recommendations. Significant variability in LOE I and GOR A recommendations and their changes over time was observed across different cancer types.
    UNASSIGNED: One-third of the current ESMO CPG recommendations are supported by the highest level of evidence. More well-designed randomized clinical trials are needed to increase the proportion of LOE I and GOR A recommendations, ultimately leading to improved outcomes for cancer patients.
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  • 文章类型: Journal Article
    背景:外伤时COVID-19感染的影响仍未得到充分研究。先前的研究表明,创伤患者的COVID-19疫苗接种率仍然低于普通人群。本研究旨在了解伴随COVID-19感染对创伤患者预后的影响。
    方法:我们对2020年3月至2022年12月入住I级创伤中心的≥18岁患者进行了回顾性队列研究。包括使用快速抗原/PCR测试进行COVID-19感染测试的患者。我们使用2:1的年龄倾向匹配患者,性别,种族,合并症,疫苗接种状况,损伤严重程度评分(ISS),损伤的类型和机制,和GCS在抵达。主要结果是住院患者死亡率。次要结果包括住院时间(LOS),重症监护病房(ICU)LOS,重新接纳30天,和主要并发症。
    结果:在包括的4448例患者中,168(3.8%)为阳性(COV)。与COVID-19阴性(COV-)患者相比,COV+患者年龄相似,性别,BMI,ISS,损伤类型,区域AIS。在COV患者中,白人和非西班牙裔患者的比例较高。匹配后,确定了154例COV+和308例COV-患者。COVID-19阳性患者的死亡率更高(7.8%vs2.6%;P=.010),主要并发症(15.6%vs8.4%;P=0.020),和血栓性并发症(3.9%vs.6%;P=.012)。患者的住院LOS也更长(中位数,9天vs5天;P<.001)和ICULOS(中位数,5天vs3天;P=.025)。
    结论:合并COVID-19感染的创伤患者在匹配人群中具有更高的死亡率和发病率。应采取重点干预措施,以识别这一高危人群并预防其内部的COVID-19感染。
    BACKGROUND: The impact of COVID-19 infection at the time of traumatic injury remains understudied. Previous studies demonstrate that the rate of COVID-19 vaccination among trauma patients remains lower than in the general population. This study aims to understand the impact of concomitant COVID-19 infection on outcomes in trauma patients.
    METHODS: We conducted a retrospective cohort study of patients ≥18 years old admitted to a level I trauma center from March 2020 to December 2022. Patients tested for COVID-19 infection using a rapid antigen/PCR test were included. We matched patients using 2:1 propensity accounting for age, gender, race, comorbidities, vaccination status, injury severity score (ISS), type and mechanism of injury, and GCS at arrival. The primary outcome was inpatient mortality. Secondary outcomes included hospital length of stay (LOS), Intensive Care Unit (ICU) LOS, 30-day readmission, and major complications.
    RESULTS: Of the 4448 patients included, 168 (3.8%) were positive (COV+). Compared with COVID-19-negative (COV-) patients, COV+ patients were similar in age, sex, BMI, ISS, type of injury, and regional AIS. The proportion of White and non-Hispanic patients was higher in COV- patients. Following matching, 154 COV+ and 308 COV- patients were identified. COVID-19-positive patients had a higher rate of mortality (7.8% vs 2.6%; P = .010), major complications (15.6% vs 8.4%; P = .020), and thrombotic complications (3.9% vs .6%; P = .012). Patients also had a longer hospital LOS (median, 9 vs 5 days; P < .001) and ICU LOS (median, 5 vs 3 days; P = .025).
    CONCLUSIONS: Trauma patients with concomitant COVID-19 infection have higher mortality and morbidity in the matched population. Focused interventions aimed at recognizing this high-risk group and preventing COVID-19 infection within it should be undertaken.
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  • 文章类型: Journal Article
    外周血管外伤(PVT)在儿童中很少见,发病率估计低于1%。我们通过访问2019年国家创伤数据库(NTDB)研究了小儿PVT和严重截肢的危险因素。人口统计,损伤类型和位置,创伤中心能力,损伤严重程度评分(ISS),停留时间(LOS)和主要截肢率进行了评估。统计分析包括分类变量的卡方检验和连续变量的t检验。在130,554名儿科创伤患者中,1196(.9%)有1460例上肢(UE)和下肢(LE)PVT。患者主要为男性(n=933,78%),平均年龄为14岁。大多数患者遭受穿透性损伤(n=744,62.2%)。最常见的血管损伤是radial骨(n=198,13.6%)和股骨(n=196,13.4%)。2.6%的患者发生严重截肢(n=31)。遭受钝器损伤的患者(或,3.3;95%CI,1.5-7.5;P=.004)和下肢PVT(OR,11.1;95%CI,3.3-37.9,P=0.0001)截肢的几率更高。
    Peripheral vascular trauma (PVT) is rare in children, with an incidence estimated below 1%. We studied pediatric PVT and risk factors for major amputation by accessing the 2019 National Trauma Data Bank (NTDB). Demographics, injury type and location, trauma center capability, injury severity score (ISS), length of stay (LOS), and major amputation rates were evaluated. Statistical analysis included chi-square testing for categorical variables and t-tests for continuous variables. Of 130,554 pediatric trauma patients, 1196 (.9%) had 1460 upper extremity (UE) and lower extremity (LE) PVT. Patients were predominantly male (n = 933, 78%) with a mean age of 14 years. Most patients suffered penetrating injury (n = 744, 62.2%). The most common vessels injuries were radial (n = 198, 13.6%) and femoral (n = 196, 13.4%). Major amputation occurred in 2.6% of patients (n = 31). Patients who suffered blunt injury (OR, 3.3; 95% CI, 1.5-7.5; P = .004) and lower limb PVT (OR, 11.1; 95% CI, 3.3-37.9, P = .0001) had higher odds of amputation.
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  • 文章类型: Journal Article
    背景:损伤控制手术旨在控制手术室(OR)中的出血和污染,并延迟对损伤的明确处理,直到重症监护病房(ICU)恢复正常生理为止。有有限的研究评估损伤控制开胸手术(DCT)在创伤中的使用,暂时关闭的最佳方法尚不清楚。
    方法:对两个一级创伤中心接受开胸手术的创伤患者进行了回顾性回顾。24小时后接受开胸手术的受试者,年龄不到16岁,在创伤湾过期,或在ICU入院前的OR中被排除.单因素方差分析和Kruskal-Wallis检验用于比较DCT和确定性开胸手术(DT)患者之间的连续和分类变量。
    结果:207例创伤患者接受了开胸手术,76符合我们的纳入标准。30例患者(39%)进行了DCT,46例(61%)行DT手术。对胸部进行临时处理的技术与用缝线进行皮肤闭合不同(8),粘性敷料(5),毛巾夹(2),或负压装置(12)。与最终关闭相比,DCT在人力资源方面有更多的混乱,pH值,(110vs.95,p=0.04;7.05对7.24,p<0.001),和损伤严重程度评分(41vs25,p<0.001),并且需要更多的输血(40vs6,p<0.001)。11例(36.7%)DCT患者存活出院,而DT组为38例(95.0%)。DCT在心脏骤停和OR率的计划外恢复方面显示出显着更高的差异。呼吸机天数没有观察到差异,或ICU住院时间。
    结论:DCT是治疗胸外伤后极端患者的可行选择。DCT与较高的死亡率相关,可能是由于损伤和生理紊乱的差异。尽管如此,DCT与相似的并发症发生率相关,ICU停留,和呼吸机日。
    BACKGROUND: Damage control surgery aims to control hemorrhage and contamination in the operating room (OR) with definitive management of injuries delayed until normal physiology is restored in the intensive care unit (ICU). There are limited studies evaluating the use of damage control thoracotomy (DCT) in trauma, and the best method of temporary closure is unclear.
    METHODS: A retrospective review of trauma patients at two level I trauma centers who underwent a thoracotomy operation was performed. Subjects who underwent a thoracotomy after 24 h, age less than 16, expired in the trauma bay, or in the OR prior to ICU admission were excluded. One-way ANOVA and Kruskal-Wallis test were used to compare continuous and categorical variables between DCT and definitive thoracotomy (DT) patients.
    RESULTS: 207 trauma patients underwent thoracotomy, 76 met our inclusion criteria. DCT was performed in 30 patients (39%), 46 (61 %) underwent DT operation. Techniques for temporizing the chest varied from skin closure with suture (8), adhesive dressing (5), towel clamps (2), or negative pressure devices (12). Compared to definitive closure, DCT had more derangements in HR, pH, (110 vs. 95, p = 0.04; 7.05 vs 7.24, p < 0.001), and injury severity score (41 vs 25, p < 0.001), and required more blood transfusions (40 vs 6, p < 0.001). Eleven (36.7 %) DCT patients survived to discharge compared to 38 patients (95.0 %) in the DT group. DCT showed significantly higher differences in cardiac arrest and unplanned returns to the OR rates. No differences were observed in ventilator days, or ICU length of stay.
    CONCLUSIONS: DCT is a viable option for management of patients in extremis following thoracic trauma. DCT was associated with higher mortality rates, likely due to differences in injury and physiologic derangement. Despite this, DCT was associated with similar rates of complications, ICU stay, and ventilator days.
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  • 文章类型: Journal Article
    对医学文献的批判性分析以及基于证据的临床实践和医学决策方法在当代足病实践中至关重要。本文回顾了临床证据的水平及其在此范式中的应用。这包括确定哪种水平的证据最适合给定的方法,以及对每个级别证据的固有局限性的理解。文章最后讨论了统计学意义和临床意义之间的差异。
    Critical analysis of the medical literature and an evidence-based approach to clinical practice and medical decision-making is of vital importance in contemporary podiatric practice. This article reviews the levels of clinical evidence and their application within this paradigm. This includes determining which level of evidence is most appropriate for a given methodology, as well as an appreciation of inherent limitations within each level of evidence. The article concludes with a discussion on the difference between statistical significance and clinical significance.
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  • 文章类型: Journal Article
    背景:尽管在全髋关节置换术(THA)中越来越多地采用直接前路(DA)入路,与其他方法相比,超过一年的结果仍然存在不确定性。我们使用反向脆弱性指数(RFI)来评估文献中报道的结果的稳健性。
    方法:我们对比较DA和其他方法在THA中的植入物翻修率的随机对照试验(RCT)进行了系统评价,定义为所有与DA不同的人。我们的主要结果是RFI,衡量非重要结果变得重要所需的事件数量,DA和其他方法之间的修订率。我们还通过将RFI除以每个研究的样本量来计算反向脆弱性商(RFQ)。显示了中值和四分位间距(IQR)。
    结果:共纳入10个RCTs,共971例患者。RFI中位数为5(IQR,4至5),这表明,如果一个治疗组中的5名患者的结局逆转,研究结果将具有统计学意义。询价中位数为0.049(IQR,0.04至0.057),这表明4.9%患者的结局变化将使翻修率显着。失去随访的患者中位数为4(IQR,0至7)。在十个RCT中,6例失访患者多于各自的RFI值.
    结论:在将DA与其他THA方法进行比较的大多数研究中证明了显著的脆弱性。外科医生不应仅仅依靠P值来确定临床意义,而是使用多个指标。
    BACKGROUND: Despite increasing adoption of the direct anterior (DA) approach in total hip arthroplasty (THA), uncertainty persists regarding its outcomes beyond the 1-year mark in comparison to other approaches. We used the reverse fragility index (RFI) to evaluate the robustness of reported findings in the literature.
    METHODS: We conducted a systematic review of randomized controlled trials (RCTs) comparing implant revision rates between DA and other approaches in THA, defined as all those different from DA. Our primary outcome was the RFI, which gauges the number of events needed for a nonsignificant result to become significant, in the revision rate between DA and other approaches. We also calculated the reverse fragility quotient by dividing the RFI by each study\'s sample size. Median values and interquartile ranges (IQRs) were displayed.
    RESULTS: A total of 10 RCTs with a total of 971 patients were included. The median RFI was 5 (IQR, 4 to 5), indicating the study\'s results would be statistically significant if the outcomes of 5 patients in 1 treatment arm were reversed. The median reverse fragility quotient was 0.049 (IQR, 0.04 to 0.057), indicating that a change of outcome in 4.9% of patients would render the revision rate significant. The median number of patients lost to follow-up was 4 (IQR, 0 to 7). Of the 10 RCTs, 6 had more patients lost to follow-up than their respective RFI values.
    CONCLUSIONS: Notable fragility was evidenced in most studies comparing DA to other approaches for THA. Surgeons should not solely rely on the P value to determine clinical significance and instead use multiple metrics.
    METHODS: II.
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