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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。
JAMMI 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
{"title":"Medico-legal risk of infectious disease physicians in Canada: A retrospective review.","authors":"Karen Pacheco, Jun Ji, Kate Barbosa, Karen Lemay, Jacqueline H Fortier, Gary E Garber","doi":"10.3138/jammi-2023-0022","DOIUrl":"10.3138/jammi-2023-0022","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 4","pages":"319-327"},"PeriodicalIF":0.0,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10797760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139512702","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
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。
JAMMI 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
{"title":"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.","authors":"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","doi":"10.3138/jammi-2023-0002","DOIUrl":"10.3138/jammi-2023-0002","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>TN provides another less invasive self-collection modality for symptomatic outpatient SARS-CoV-2 PCR testing.</p>","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 4","pages":"283-298"},"PeriodicalIF":0.0,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10797771/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139512959","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
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。
JAMMI 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
{"title":"A longitudinal prospective cohort study of health-related quality of life assessment in outpatient adults with post-COVID-19 conditions.","authors":"Kassandra Mercier, Jasmine Piché, Christine Rioux-Perreault, Samuel Lemaire-Paquette, Alain Piché","doi":"10.3138/jammi-2023-0010","DOIUrl":"10.3138/jammi-2023-0010","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>p</i> < 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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 4","pages":"309-318"},"PeriodicalIF":0.0,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10797766/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139512618","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
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。
JAMMI 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
{"title":"A Canadian children's hospital's experience with cystic echinococcosis over 30 years: A case series.","authors":"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","doi":"10.3138/jammi-2022-0041","DOIUrl":"10.3138/jammi-2022-0041","url":null,"abstract":"<p><strong>Background: </strong>Cystic echinococcosis (CE) or hydatid disease caused by the cestode <i>Echinococcus granulosus sensu lato</i> is an uncommon infection in Canada especially among children. There are limited reports describing the clinical presentation and management in Canadian children.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 4","pages":"262-271"},"PeriodicalIF":0.0,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10797762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139511959","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
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。
JAMMI 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
{"title":"Public health implications of the evolving understanding of tuberculosis natural history.","authors":"Mariana Herrera, Erwin Taguiam, Kevin B Laupland, Zulma Vanessa Rueda, Yoav Keynan","doi":"10.3138/jammi-2023-02-24","DOIUrl":"10.3138/jammi-2023-02-24","url":null,"abstract":"","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 4","pages":"241-244"},"PeriodicalIF":0.0,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10797768/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139512974","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
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。
JAMMI 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
{"title":"Alveolar Echinococcus in a 70-year-old man in Ontario.","authors":"Rahel T Zewude, Antoine Corbeil, Scott Fung, Carol-Anne Moulton, Isaac I Bogoch","doi":"10.3138/jammi-2023-0012","DOIUrl":"10.3138/jammi-2023-0012","url":null,"abstract":"<p><strong>Background: </strong>Alveolar echinococcus, caused by the tapeworm <i>Echinococcus multilocularis</i>, mimics hepatic malignancy, and carries a mortality rate exceeding 90% in untreated patients.</p><p><strong>Methods: </strong>Diagnosis of <i>E. multilocularis</i> infection is established through clinical, radiographic, and microbiological assessments. Currently available laboratory diagnostics in Ontario are fresh tissue microscopy and histopathology. However, genus-specific <i>Echinococcus</i> enzyme-linked immunosorbent assay (ELISA) serology as well as confirmatory testing with species-specific serology and <i>E. multilocularis</i> polymerase chain reaction (PCR) can be obtained from external reference laboratories.</p><p><strong>Results: </strong>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 <i>E. multilocularis</i> 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 <i>E. multilocularis</i> in recent veterinary literature in Ontario.</p><p><strong>Conclusion: </strong><i>E. multilocularis</i> 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.</p>","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 4","pages":"336-342"},"PeriodicalIF":0.0,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10797761/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139512623","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
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。
JAMMI 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
{"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。
JAMMI Pub Date : 2023-11-29 eCollection Date: 2023-11-01 DOI: 10.3138/jammi-05-08-info
{"title":"Highly Pathogenic Avian Influenza in Canada.","authors":"","doi":"10.3138/jammi-05-08-info","DOIUrl":"https://doi.org/10.3138/jammi-05-08-info","url":null,"abstract":"","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 3","pages":"186"},"PeriodicalIF":0.0,"publicationDate":"2023-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10697105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138499702","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: 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。
JAMMI Pub Date : 2023-11-29 eCollection Date: 2023-11-01 DOI: 10.3138/jammi-2023-06-01
Kevin B Laupland, Yoav Keynan
{"title":"Infectious diseases as the human population enters a stationary phase.","authors":"Kevin B Laupland, Yoav Keynan","doi":"10.3138/jammi-2023-06-01","DOIUrl":"10.3138/jammi-2023-06-01","url":null,"abstract":"","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 3","pages":"172-175"},"PeriodicalIF":0.0,"publicationDate":"2023-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10697104/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138499704","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
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
JAMMI 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
{"title":"Randomized trial of the safety and efficacy of anti-SARS-CoV-2 mAb in the treatment of patients with nosocomial COVID-19 (CATCO-NOS).","authors":"Alain Tremblay, Ranjani Somayaji, Holly Hoang, Conar O'Neil, Ashlesha Sonpar, John Conly, Srin Murthy, Robert Fowler, Wendy Sligl","doi":"10.3138/jammi-2023-0008","DOIUrl":"10.3138/jammi-2023-0008","url":null,"abstract":"<p><strong>Background: </strong>Patients with nosocomial acquisition of COVID-19 have poor outcomes but have not been included in therapeutic trials to date.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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, <i>p</i> = 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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":36782,"journal":{"name":"JAMMI","volume":"8 3","pages":"214-223"},"PeriodicalIF":0.0,"publicationDate":"2023-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10697097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138499705","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
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