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Medico-legal risk of infectious disease physicians in Canada: A retrospective review. 加拿大传染病医生的医疗法律风险:回顾性审查。
Q3 Medicine Pub Date : 2024-01-16 eCollection Date: 2024-01-01 DOI: 10.3138/jammi-2023-0022
Karen Pacheco, Jun Ji, Kate Barbosa, Karen Lemay, Jacqueline H Fortier, Gary E Garber

Objective: There is little known about the medico-legal risk for infectious disease specialists in Canada. The objective of this study was to identify the causes of these medico-legal risks with the goal of improving patient safety and outcomes.

Methods: A 10-year retrospective analysis of Canadian Medical Protective Association (CMPA) closed medico-legal cases from 2012 to 2021 was performed. Peer expert criticism was used to identify factors that contributed to the medico-legal cases at the provider, team, or system level, and were contrasted with the patient complaint.

Results: During the study period there were 571 infectious disease physician members of the CMPA. There were 96 patient medico-legal cases: 45 College complaints, 40 civil legal matters, and 11 hospital complaints. Ten cases were associated with severe patient harm or death. Patients were most likely to complain about perceived deficient assessments (54%), diagnostic errors (53%), inadequate monitoring or follow-up (20%), and unprofessional manner (20%). In contrast, peer experts were most critical of the areas of diagnostic assessment (20%), deficient assessment (10%), failure to perform test/intervention (8%), and failure to refer (6%).

Conclusion: While infectious disease physicians tend to have lower medico-legal risks compared to other health care providers, these risks still do exist. This descriptive study provides insights into the types of cases, presenting conditions, and patient allegations associated with their practice.

目的:人们对加拿大传染病专家的医疗法律风险知之甚少。本研究旨在找出这些医疗法律风险的原因,从而改善患者的安全和治疗效果:方法:对加拿大医疗保护协会(CMPA)2012年至2021年期间结案的医疗法律案件进行了为期10年的回顾性分析。同行专家的批评意见被用来确定在医疗服务提供者、团队或系统层面导致医疗法律案件的因素,并与患者投诉进行对比:结果:在研究期间,共有 571 名传染病医生加入了 CMPA。共有 96 起患者医疗法律案件:其中学院投诉 45 起,民事法律案件 40 起,医院投诉 11 起。其中 10 起与严重伤害患者或导致患者死亡有关。患者最有可能投诉的是评估不足(54%)、诊断错误(53%)、监测或随访不足(20%)以及态度不专业(20%)。相比之下,同行专家对诊断评估(20%)、评估缺陷(10%)、未进行测试/干预(8%)和未转诊(6%)方面的批评最多:虽然与其他医疗服务提供者相比,传染病医生的医疗法律风险较低,但这些风险仍然存在。这项描述性研究提供了与传染病医生执业相关的病例类型、病症和患者指控方面的见解。
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引用次数: 0
Prospective, clinical comparison of self-collected throat-bilateral nares swabs and saline gargle compared to health care provider collected nasopharyngeal swabs among symptomatic outpatients with potential SARS-CoV-2 infection. 在可能感染 SARS-CoV-2 的有症状门诊患者中,自取咽喉-双侧鼻腔拭子和生理盐水漱口与医护人员采集鼻咽拭子的前瞻性临床比较。
Q3 Medicine Pub Date : 2024-01-16 eCollection Date: 2024-01-01 DOI: 10.3138/jammi-2023-0002
Eric M Hempel, Aamir Bharmal, Guiyun Li, Aileen Minhas, Ramndip Manan, Kathy Doull, Lynsey Hamilton, Branco Cheung, Michael Chan, Kingsley Gunadasa, Ron Chow, Tracy Lee, Frankie Tsang, Mel Krajden, Karen Mooder, Trushna Kassan, Natalie Prystajecky, Agatha Jassem, Linda Mn Hoang

Background: In British Columbia (BC), self-collected saline gargle (SG) is the only alternative to health care provider (HCP)-collected nasopharyngeal (NP) swabs to detect SARS-CoV-2 in an outpatient setting by polymerase chain reaction (PCR). However, some individuals cannot perform a SG. Our study aimed to assess combined throat-bilateral nares (TN) swabbing as a swab-based alternative.

Methods: Symptomatic individuals greater than 12 years of age seeking a COVID-19 PCR test at one of two COVID-19 collection centres in Metro Vancouver were asked to participate in this study. Participants provided a HCP-collected NP sample and a self-collected SG and TN sample for PCR testing, which were either HCP observed or unobserved.

Results: Three-hundred and eleven individuals underwent all three collections. Compared against HCP-NP, SG was 99% sensitive and 98% specific (kappa 0.97) and TN was 99% sensitive and 99% specific (kappa 0.98). Using the final clinical test interpretation as the reference standard, NP was 98% sensitive and 100% specific (kappa 0.98), and both SG and TN were 99% sensitive and 100% specific (both kappa 0.99). Mean cycle threshold values for each viral target were higher in SG specimens compared to the other sample types; however, this did not significantly impact the clinical performance, because the positivity rates were similar. The clinical performance of all specimen types was comparable within the first 7 days of symptom onset, regardless of the observation method. SG self-collections were rated the most acceptable, followed by TN.

Conclusions: TN provides another less invasive self-collection modality for symptomatic outpatient SARS-CoV-2 PCR testing.

背景:在不列颠哥伦比亚省(BC),自取生理盐水漱口(SG)是在门诊环境中通过聚合酶链反应(PCR)检测 SARS-CoV-2 的唯一替代方法,而不是由医疗保健提供者(HCP)采集鼻咽(NP)拭子。然而,有些人无法进行 SG 检测。我们的研究旨在评估将咽喉-双侧鼻孔(TN)联合拭子法作为一种基于拭子的替代方法:方法:大温地区的两个 COVID-19 采集中心之一邀请 12 岁以上有症状的人参加本研究,寻求 COVID-19 PCR 检测。参与者提供一份由 HCP 采集的 NP 样本和一份自采的 SG 和 TN 样本进行 PCR 检测,这些样本可以是 HCP 观察到的,也可以是未观察到的:有 311 人进行了所有三种样本的采集。与 HCP-NP 相比,SG 的敏感性为 99%,特异性为 98%(kappa 0.97),TN 的敏感性为 99%,特异性为 99%(kappa 0.98)。以最终的临床检验解释作为参考标准,NP 的敏感性为 98%,特异性为 100%(kappa 0.98),SG 和 TN 的敏感性为 99%,特异性为 100%(kappa 均为 0.99)。与其他样本类型相比,SG 标本中每种病毒靶标的平均周期阈值较高;但是,由于阳性率相似,这并不会对临床性能产生显著影响。无论采用哪种观察方法,所有样本类型在症状出现后 7 天内的临床表现都相当。SG自取标本的可接受性最高,其次是 TN:结论:TN为有症状的门诊SARS-CoV-2 PCR检测提供了另一种侵入性较小的自采样方式。
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引用次数: 0
A longitudinal prospective cohort study of health-related quality of life assessment in outpatient adults with post-COVID-19 conditions. 对门诊患者中患有后 COVID-19 症状的成年人进行健康相关生活质量评估的纵向前瞻性队列研究。
Q3 Medicine Pub Date : 2024-01-16 eCollection Date: 2024-01-01 DOI: 10.3138/jammi-2023-0010
Kassandra Mercier, Jasmine Piché, Christine Rioux-Perreault, Samuel Lemaire-Paquette, Alain Piché

Background: Few studies have reported the long-term effects of post-COVID-19 condition (PCC) on health-related quality of life (HRQoL). We aim to assess HRQoL in outpatient adults with PCC over a 2-year period.

Methods: This prospective longitudinal cohort study compared 413 PCC participants (cases) to 520 COVID-19-positive participants who recovered (controls). HRQoL was assessed with the EuroQol 5-Dimension 5-Level preference-based questionnaire (EQ-5D-5L) and fitness and frailty with the Clinical Frailty Scale (CFS) at each visit for up to 24 months.

Results: Among a total of 933 participants, 413 (42.3%) met the definition of PCC (cases) and 520 (55.7%) did not (controls). Overall, there was a significant difference in EQ-5D-5L index score from 3 months post-infection up to 18 months between cases and controls (p < 0.001). This score continued to decline up to 18 months in the PCC group only. Most impaired EQ-5D-5L dimensions at 12 months in the PCC group included pain/discomfort, anxiety/depression, and usual activities.

Conclusions: This is one of the first studies to report 2-year alterations of HRQoL in outpatients with PCC. Our study highlights the need for continued monitoring for PCC long-term consequences. Given the high proportion of PCC participants experiencing anxiety/depression problems, further studies are needed to specifically address mental health in this population.

背景:很少有研究报道COVID-19后病情(PCC)对健康相关生活质量(HRQoL)的长期影响。我们旨在评估门诊成人 PCC 患者两年内的 HRQoL:这项前瞻性纵向队列研究比较了 413 名 PCC 患者(病例)和 520 名 COVID-19 阳性且已康复的患者(对照组)。在长达24个月的每次访问中,采用基于偏好的EQ-5D-5L(EuroQol 5-Dimension 5-Level preference-based questionnaire)调查问卷评估患者的HRQoL,并采用临床虚弱量表(CFS)评估患者的体质和虚弱程度:在总共 933 名参与者中,413 人(42.3%)符合 PCC 定义(病例),520 人(55.7%)不符合(对照组)。总体而言,感染后 3 个月至 18 个月期间,病例和对照组的 EQ-5D-5L 指数得分存在显著差异(p < 0.001)。只有 PCC 组的 EQ-5D-5L 指数得分在 18 个月内持续下降。PCC 组在 12 个月时受损最严重的 EQ-5D-5L 维度包括疼痛/不适、焦虑/抑郁和日常活动:这是首批报告 PCC 门诊患者 2 年 HRQoL 变化的研究之一。我们的研究强调了持续监测 PCC 长期后果的必要性。鉴于 PCC 患者中存在焦虑/抑郁问题的比例很高,因此需要进一步开展研究,专门探讨这一人群的心理健康问题。
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引用次数: 0
A Canadian children's hospital's experience with cystic echinococcosis over 30 years: A case series. 加拿大一家儿童医院 30 多年来治疗囊性棘球蚴病的经验:病例系列。
Q3 Medicine Pub Date : 2024-01-16 eCollection Date: 2024-01-01 DOI: 10.3138/jammi-2022-0041
Kescha Kazmi, Carsten Krueger, Waison Wong, Reto M Baertschiger, Charles Hui, Anita Nagy, Oscar M Navarro, Fathima Razik, Kevin L Schwartz, Andrea K Boggild, Shaun K Morris

Background: Cystic echinococcosis (CE) or hydatid disease caused by the cestode Echinococcus granulosus sensu lato is an uncommon infection in Canada especially among children. There are limited reports describing the clinical presentation and management in Canadian children.

Methods: The medical records of all children diagnosed with CE at a quaternary paediatric centre in Ontario between January 1988 and August 2021 were retrospectively reviewed. The clinical course, management, and outcomes of each case were summarized.

Results: We report two paediatric cases of cystic echinococcosis (CE) in detail and review four additional cases seen at our institution over 33.5 years. The first case was a previously healthy 12-year-old boy with pulmonary CE resulting in unilateral lung collapse and mediastinal shift, who was presumedly infected while living in the Middle East. The second case was a previously healthy 3-year-old girl with pulmonary CE acquired locally in southern Ontario. Four other cases of CE with hepatic involvement (median age 12.5 years) were identified during the study period. Five out of six patients received both surgical and medical therapy.

Conclusion: CE is a rare but serious disease seen in southern Canada that has historically been associated with travel or migration. Due to changes in urban wildlife landscapes and increased global migration, CE may become more prevalent in Canadian children. We describe the first locally acquired case in rural southern Ontario diagnosed at our centre. Prompt recognition of this infection in children by health care providers is important to prevent morbidity and mortality.

背景:囊性棘球蚴病(CE)或由普通棘球蚴引起的包虫病在加拿大并不常见,尤其是在儿童中。有关加拿大儿童的临床表现和治疗方法的报告很有限:方法:回顾性审查了 1988 年 1 月至 2021 年 8 月期间在安大略省一家四级儿科中心确诊为棘球蚴病的所有儿童的病历。结果:我们报告了两例儿童囊肿病例:我们详细报告了两例囊性棘球蚴病(CE)儿科病例,并回顾了 33.5 年来在我院就诊的另外四例病例。第一个病例是一名先前健康的 12 岁男孩,肺部棘球蚴病导致单侧肺塌陷和纵隔移位,推测他是在中东生活时感染的。第二个病例是一名原本健康的 3 岁女孩,在安大略省南部当地感染了肺动脉高压。研究期间还发现了另外四例肝脏受累的 CE 病例(中位年龄为 12.5 岁)。六名患者中有五名同时接受了手术和药物治疗:CE是加拿大南部一种罕见但严重的疾病,历来与旅行或迁徙有关。由于城市野生动物景观的变化和全球移民的增加,CE 可能会在加拿大儿童中更加流行。我们描述了本中心在安大略省南部农村地区诊断出的首例本地感染病例。医护人员及时发现儿童感染这种疾病对于预防发病和死亡非常重要。
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引用次数: 0
Public health implications of the evolving understanding of tuberculosis natural history. 不断发展的结核病自然史认识对公共卫生的影响。
Q3 Medicine Pub Date : 2024-01-16 eCollection Date: 2024-01-01 DOI: 10.3138/jammi-2023-02-24
Mariana Herrera, Erwin Taguiam, Kevin B Laupland, Zulma Vanessa Rueda, Yoav Keynan
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引用次数: 0
Alveolar Echinococcus in a 70-year-old man in Ontario. 安大略省一名 70 岁男子的肺泡棘球蚴病。
Q3 Medicine Pub Date : 2024-01-16 eCollection Date: 2024-01-01 DOI: 10.3138/jammi-2023-0012
Rahel T Zewude, Antoine Corbeil, Scott Fung, Carol-Anne Moulton, Isaac I Bogoch

Background: Alveolar echinococcus, caused by the tapeworm Echinococcus multilocularis, mimics hepatic malignancy, and carries a mortality rate exceeding 90% in untreated patients.

Methods: Diagnosis of E. multilocularis infection is established through clinical, radiographic, and microbiological assessments. Currently available laboratory diagnostics in Ontario are fresh tissue microscopy and histopathology. However, genus-specific Echinococcus enzyme-linked immunosorbent assay (ELISA) serology as well as confirmatory testing with species-specific serology and E. multilocularis polymerase chain reaction (PCR) can be obtained from external reference laboratories.

Results: The article presents the first case report of human alveolar echinococcus in Ontario. We outline the multidisciplinary approach of diagnosis as well as surgical and medical management of E. multilocularis infection in a 70-year-old man in Ontario. We describe prior literature of alveolar echinococcus in Canadian settings and highlight its emerging nature with recent human case clusters in the Prairies and reports of E. multilocularis in recent veterinary literature in Ontario.

Conclusion: E. multilocularis is an emerging parasitic infection in Canadian settings including Ontario. Clinicians should be aware of the emergence of this invasive infection, especially in those with close contact to canids.

背景:由多棘球蚴绦虫引起的肺泡棘球蚴病会诱发肝脏恶性肿瘤,未经治疗的患者死亡率超过 90%:方法:多棘球蚴感染的诊断需要通过临床、放射学和微生物学评估来确定。安大略省目前可用的实验室诊断方法是新鲜组织显微镜检查和组织病理学检查。不过,可从外部参考实验室获得棘球蚴属特异性酶联免疫吸附试验(ELISA)血清学以及物种特异性血清学和多棘球蚴聚合酶链反应(PCR)确证试验:本文是安大略省首例人类肺泡棘球蚴病病例报告。我们概述了安大略省一名 70 岁男子感染多孔棘球蚴的多学科诊断方法以及手术和药物治疗。我们介绍了加拿大有关肺泡棘球蚴病的文献,并强调了该病的新特性,即最近在草原地区出现的人类病例群以及安大略省最近兽医文献中有关多角体棘球蚴病的报道:结论:在加拿大(包括安大略省),多角孢子虫是一种新出现的寄生虫感染。临床医生应该意识到这种入侵性感染的出现,尤其是那些与犬科动物有密切接触的人。
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引用次数: 0
Testing the limits of multiplex respiratory virus assays for SARS-CoV-2 at high cycle threshold values: Comparative performance of cobas 6800/8800 SARS-CoV-2 & Influenza A/B, Xpert Xpress SARS-CoV-2/Flu/RSV, and cobas Liat SARS-CoV-2 & Influenza A/B. 测试高周期阈值下多重呼吸道病毒检测法检测 SARS-CoV-2 的极限值:cobas 6800/8800 SARS-CoV-2 & Influenza A/B、Xpert Xpress SARS-CoV-2/Flu/RSV 和 cobas Liat SARS-CoV-2 & Influenza A/B的性能比较。
Q3 Medicine Pub Date : 2024-01-16 eCollection Date: 2024-01-01 DOI: 10.3138/jammi-2022-0039
Nancy Matic, Tanya Lawson, Gordon Ritchie, Christopher F Lowe, Marc G Romney

Background: Multiplex real-time RT-PCR assays for respiratory pathogens are valuable tools to optimize laboratory workflow and turnaround time. At a time when resurgence of influenza and respiratory syncytial virus (RSV) cases have been widely observed along with continued transmission of SARS-CoV-2, timely identification of all circulating respiratory viruses is crucial. This study evaluates the detection of low viral loads of SARS-CoV-2 by four multiplex molecular assays: Roche cobas 6800/8800 SARS-CoV-2 & Influenza A/B Test, Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV, cobas Liat SARS-CoV-2 & Influenza A/B, and a laboratory-developed test (LDT).

Methods: Retrospective upper respiratory tract specimens positive for various respiratory viruses at a range of cycle threshold (Ct) values (18-40) were tested by four multiplex assays. Positive and negative percent agreement (PPA and NPA) with validated RT-PCR assays were calculated.

Results: A total of 82 samples were assessed, with discordant results observed in a portion of the samples (10/82, 12.2%) where Ct values were >33. The majority of the discordant results (6/10, 60%) were false negatives. Overall, PPA was 100% (58/58) for cobas 6800, 97.4% (38/39) for GeneXpert, 100% (17/17) for Liat, and 90.5% (57/63) for the LDT. PPA for the LDT increased to 92.1% after manual review of amplification curves.

Conclusions: Commercial multiplex respiratory virus assays have good performance for samples with medium to high viral loads (Ct values <33). Laboratories should consider appropriate test result review and confirmation protocols to optimize sensitivity, and may consider reporting samples with additional interpretive comments when low viral loads are detected.

背景:呼吸道病原体的多重实时 RT-PCR 检测是优化实验室工作流程和周转时间的重要工具。目前,流感和呼吸道合胞病毒(RSV)病例广泛出现,SARS-CoV-2 也在持续传播,因此及时识别所有流行的呼吸道病毒至关重要。本研究评估了四种多重分子检测方法对低病毒载量 SARS-CoV-2 的检测效果:罗氏 cobas 6800/8800 SARS-CoV-2 & Influenza A/B 检测试剂盒、Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV 检测试剂盒、cobas Liat SARS-CoV-2 & Influenza A/B 检测试剂盒和实验室开发的检测试剂盒(LDT):方法:采用四种多重检测方法对周期阈值(Ct)范围(18-40)内各种呼吸道病毒阳性的回顾性上呼吸道标本进行检测。计算与有效 RT-PCR 检测法的阳性和阴性一致率(PPA 和 NPA):共评估了 82 个样本,发现部分样本(10/82,12.2%)的 Ct 值大于 33,结果不一致。大部分不一致结果(6/10,60%)为假阴性。总体而言,cobas 6800 的 PPA 为 100% (58/58),GeneXpert 为 97.4% (38/39),Liat 为 100% (17/17),LDT 为 90.5% (57/63)。在人工审核扩增曲线后,LDT 的 PPA 上升到 92.1%:结论:商用多重呼吸道病毒检测对中高病毒载量样本(Ct 值
{"title":"Testing the limits of multiplex respiratory virus assays for SARS-CoV-2 at high cycle threshold values: Comparative performance of cobas 6800/8800 SARS-CoV-2 & Influenza A/B, Xpert Xpress SARS-CoV-2/Flu/RSV, and cobas Liat SARS-CoV-2 & Influenza A/B.","authors":"Nancy Matic, Tanya Lawson, Gordon Ritchie, Christopher F Lowe, Marc G Romney","doi":"10.3138/jammi-2022-0039","DOIUrl":"10.3138/jammi-2022-0039","url":null,"abstract":"<p><strong>Background: </strong>Multiplex real-time RT-PCR assays for respiratory pathogens are valuable tools to optimize laboratory workflow and turnaround time. At a time when resurgence of influenza and respiratory syncytial virus (RSV) cases have been widely observed along with continued transmission of SARS-CoV-2, timely identification of all circulating respiratory viruses is crucial. This study evaluates the detection of low viral loads of SARS-CoV-2 by four multiplex molecular assays: Roche cobas 6800/8800 SARS-CoV-2 & Influenza A/B Test, Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV, cobas Liat SARS-CoV-2 & Influenza A/B, and a laboratory-developed test (LDT).</p><p><strong>Methods: </strong>Retrospective upper respiratory tract specimens positive for various respiratory viruses at a range of cycle threshold (Ct) values (18-40) were tested by four multiplex assays. Positive and negative percent agreement (PPA and NPA) with validated RT-PCR assays were calculated.</p><p><strong>Results: </strong>A total of 82 samples were assessed, with discordant results observed in a portion of the samples (10/82, 12.2%) where Ct values were >33. The majority of the discordant results (6/10, 60%) were false negatives. Overall, PPA was 100% (58/58) for cobas 6800, 97.4% (38/39) for GeneXpert, 100% (17/17) for Liat, and 90.5% (57/63) for the LDT. PPA for the LDT increased to 92.1% after manual review of amplification curves.</p><p><strong>Conclusions: </strong>Commercial multiplex respiratory virus assays have good performance for samples with medium to high viral loads (Ct values <33). Laboratories should consider appropriate test result review and confirmation protocols to optimize sensitivity, and may consider reporting samples with additional interpretive comments when low viral loads are detected.</p>","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 4","pages":"328-335"},"PeriodicalIF":0.0,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10797767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139512981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Highly Pathogenic Avian Influenza in Canada. 加拿大的高致病性禽流感。
Q3 Medicine Pub Date : 2023-11-29 eCollection Date: 2023-11-01 DOI: 10.3138/jammi-05-08-info
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引用次数: 3
Infectious diseases as the human population enters a stationary phase. 传染病随着人口的增长进入一个平稳阶段。
Q3 Medicine Pub Date : 2023-11-29 eCollection Date: 2023-11-01 DOI: 10.3138/jammi-2023-06-01
Kevin B Laupland, Yoav Keynan
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引用次数: 0
Randomized trial of the safety and efficacy of anti-SARS-CoV-2 mAb in the treatment of patients with nosocomial COVID-19 (CATCO-NOS). 抗sars - cov -2单抗治疗院内感染COVID-19 (CATCO-NOS)患者的安全性和有效性的随机试验
Q3 Medicine Pub Date : 2023-11-29 eCollection Date: 2023-11-01 DOI: 10.3138/jammi-2023-0008
Alain Tremblay, Ranjani Somayaji, Holly Hoang, Conar O'Neil, Ashlesha Sonpar, John Conly, Srin Murthy, Robert Fowler, Wendy Sligl

Background: Patients with nosocomial acquisition of COVID-19 have poor outcomes but have not been included in therapeutic trials to date.

Methods: A pragmatic open-label randomized controlled trial of anti-SARS-CoV-2 monoclonal antibodies (mAb) was performed in hospitalized patients with nosocomial COVID-19 infection in acute care hospitals spanning a provincial health care network. Participants within 5 days of first positive test or symptom onset were randomized to standard of care (SOC) plus a single dose intravenous mAb treatment (bamlanivimab or casirivimab/imdevimab) or SOC alone on a 2:1 basis. The primary study endpoint was the need for invasive mechanical ventilation (IMV) or inpatient mortality by day 60 after randomization.

Results: Forty-six participants were enrolled from 13 hospitals between February 14 and October 8, 2021: 31 in the mAb and 15 in the SOC arm. IMV or inpatient mortality up to day 60 occurred in 4 (12.9%) participants in the mAb versus 3 in the SOC arm (20.0%), difference of -7.1% (95% CI -22.5 to 13.4, p = 0.67). The study was terminated early due to lack of equipoise as effectiveness of anti-viral therapies and mAb was published in similar high-risk patient populations.

Conclusions: The trial was underpowered to detect meaningful differences given its early termination. The study does highlight the feasibility of undertaking trials in this patient population using a pragmatic approach allowing for trial participation and treatment access across a large health care network and may serve as a template for future designs.

背景:院内获得性COVID-19患者预后较差,但迄今尚未纳入治疗性试验。方法:采用开放标签随机对照试验,对省级卫生保健网络急症医院院内感染的住院患者进行抗sars - cov -2单克隆抗体(mAb)检测。首次检测呈阳性或症状出现5天内的参与者按2:1的比例随机分为标准治疗组(SOC)加单剂量静脉单抗治疗组(bamlanivimab或casirivimab/imdevimab)或单独接受SOC治疗组。主要研究终点是随机分组后第60天的有创机械通气(IMV)需求或住院患者死亡率。结果:在2021年2月14日至10月8日期间,从13家医院招募了46名参与者:单抗组31名,SOC组15名。IMV或住院患者死亡至第60天,单抗组4例(12.9%),而SOC组3例(20.0%),差异为-7.1% (95% CI -22.5至13.4,p = 0.67)。由于在相似的高危患者群体中发表了抗病毒治疗和单克隆抗体的有效性,该研究由于缺乏均衡性而提前终止。结论:由于早期终止,该试验未能发现有意义的差异。该研究确实强调了在这一患者群体中进行试验的可行性,使用一种实用的方法,允许在大型医疗保健网络中参与试验和获得治疗,并可能作为未来设计的模板。
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引用次数: 0
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