Publications by authors named "Valéry Lavergne"

93 Publications

The serum glycolate concentration: its prognostic value and its correlation to surrogate markers in ethylene glycol exposures.

Authors:
Darren M Roberts Robert S Hoffman Jeffrey Brent Valéry Lavergne Knut Erik Hovda William H Porter Kenneth E McMartin Marc Ghannoum

Clin Toxicol (Phila) 2022 07 24;60(7):798-807. Epub 2022 Mar 24.

Research Center, CIUSSS du Nord-de-l'île-de-Montréal, University of Montreal, Montreal, QC, Canada.

Context: Ethylene glycol poisoning manifests as metabolic acidemia, acute kidney injury and death. The diagnosis and treatment depend on history and biochemical tests. Glycolate is a key toxic metabolite that impacts prognosis, but assay results are not widely available in a clinically useful timeframe. We quantitated the impact of serum glycolate concentration for prognostication and evaluated whether more readily available biochemical tests are acceptable surrogates for the glycolate concentration.

Objectives: The objectives of this study are to 1) assess the prognostic value of the initial glycolate concentration on the occurrence of AKI or mortality in patients with ethylene glycol exposure (); 2) identify surrogate markers that correlate best with glycolate concentrations ).

Methods: A systematic review of the literature was performed using Medline/PubMed, EMBASE, Cochrane library, conference proceedings and reference lists. Human studies reporting measured glycolate concentrations were eligible. Glycolate concentrations were related to categorical clinical outcomes (acute kidney injury, mortality), and correlated with continuous surrogate biochemical measurements (anion gap, base excess, bicarbonate concentration and pH). Receiver operating characteristic curves were constructed to calculate the positive predictive values and the negative predictive values of the threshold glycolate concentrations that predict acute kidney injury and mortality. Further, glycolate concentrations corresponding to 100% negative predictive value for mortality and 95% negative predictive value for acute kidney injury were determined.

Results: Of 1,531 articles identified, 655 were potentially eligible and 32 were included, reflecting 137 cases from 133 patients for the prognostic study and 154 cases from 150 patients for the surrogate study. The median glycolate concentration was 11.2 mmol/L (85.1 mg/dL, range 0-38.0 mmol/L, 0-288.8 mg/dL), 93% of patients were treated with antidotes, 80% received extracorporeal treatments, 49% developed acute kidney injury and 13% died. The glycolate concentration best predicting acute kidney injury was 12.9 mmol/L (98.0 mg/dL, sensitivity 78.5%, specificity 88.1%, positive predictive value 86.4%, negative predictive value 80.9%). The glycolate concentration threshold for a 95% negative predictive value for acute kidney injury was 6.6 mmol/L (50.2 mg/dL, sensitivity 96.9%, specificity 62.7%). The glycolate concentration best predicting mortality was 19.6 mmol/L (149.0 mg/dL, sensitivity 61.1%, specificity 81.4%, positive predictive value 33.3%, negative predictive value 93.2%). The glycolate concentration threshold for a 100% negative predictive value for mortality was 8.3 mmol/L (63.1 mg/dL, sensitivity 100.0%, specificity 35.6%). The glycolate concentration correlated best with the anion gap ( = 0.73), followed by bicarbonate ( = 0.57), pH ( = 0.50) and then base excess ( = 0.25), while there was no correlation between the glycolate and ethylene glycol concentration ( = 0.00). These data can assist clinicians in planning treatments such as extracorporeal treatments and prognostication. Potentially, they may also provide some reassurance regarding when extracorporeal treatments can be delayed while awaiting the results of further testing in patients in whom ethylene glycol poisoning is suspected but not yet confirmed.

Conclusions: This systematic review demonstrates that the glycolate concentration predicts mortality (unlikely if <8 mmol/L [61 mg/dL]). The anion gap is a reasonable surrogate measurement for glycolate concentration in the context of ethylene glycol poisoning. The findings are mainly based on published retrospective data which have various limitations. Further prospective validation studies are of interest.
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http://dx.doi.org/10.1080/15563650.2022.2049811DOI Listing
July 2022

Treating ethylene glycol poisoning with alcohol dehydrogenase inhibition, but without extracorporeal treatments: a systematic review.

Authors:
Jessie Beaulieu Darren M Roberts Sophie Gosselin Robert S Hoffman Valery Lavergne Knut Erik Hovda Bruno Megarbane Derrick Lung Ruben Thanacoody Marc Ghannoum

Clin Toxicol (Phila) 2022 07 21;60(7):784-797. Epub 2022 Mar 21.

Research Center, CIUSSS du Nord-de-l'île-de-Montréal, University of Montreal, Montreal, QC, Canada.

Context: Ethylene glycol is metabolized to toxic metabolites that cause acute kidney injury, metabolic acidemia, and death. The treatment of patients with ethylene glycol poisoning includes competitively inhibiting alcohol dehydrogenase with ethanol or fomepizole to prevent the formation of toxic metabolites, and extracorporeal treatments such as hemodialysis to remove ethylene glycol and its metabolites. In the absence of significant metabolic acidemia or kidney injury, it is hypothesized that extracorporeal treatments may be obviated without adverse outcomes to the patient if alcohol dehydrogenase inhibitors are used.

Objectives: The objectives of this study are to: (1) identify indicators predicting ADH inhibitor failure in patients with ethylene glycol poisoning treated with either ethanol or fomepizole for whom extracorporeal treatment was not performed (aside from rescue therapy, see below) (), and (2) validate if the anion gap, shown in a previous study to be the best surrogate for the glycolate concentration, is associated with acute kidney injury and mortality ().

Methods: We conducted a systematic review to identify all reported patients with ethylene glycol poisoning treated without extracorporeal treatments but with either fomepizole () or ethanol (). Analyses were performed using both one case per patient and all cases (if multiple events were reported for a single patient). Data were compiled regarding poisoning, biochemistry, and outcomes. Treatment failure was defined as mortality, worsening of acid-base status, extracorporeal treatments used as rescue, or a worsening of kidney or neurological function after alcohol dehydrogenase inhibition was initiated. Also, we performed an analysis of previously described anion gap thresholds to determine if they were associated with outcomes such as acute kidney injury and mortality.

Results: Of 115 publications identified, 96 contained case-level data. A total of 180 cases were identified with ethanol monotherapy, and 231 with fomepizole monotherapy. Therapy failure was noted mostly when marked acidemia and/or acute kidney injury were present prior to therapy, although there were cases of failed ethanol monotherapy with minimal acidemia (suggesting that ethanol dosing and/or monitoring may not have been optimal). Ethylene glycol dose and ethylene glycol concentration were predictive of monotherapy failure for ethanol, but not for fomepizole. In the anion gap study (207 cases), death and progression of acute kidney injury were almost nonexistent when the anion gap was less than 24 mmol/L and mostly observed when the anion gap was greater than 28 mmol/L.

Conclusion: This review suggests that in patients with minimal metabolic acidemia (anion gap <28 mmol/L), fomepizole monotherapy without extracorporeal treatments is safe and effective regardless of the ethylene glycol concentration. Treatment failures were observed with ethanol monotherapy which may relate to transient subtherapeutic ethanol concentrations or very high ethylene glycol concentrations. The results are limited by the retrospective nature of the case reports and series reviewed in this study and require prospective validation.
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http://dx.doi.org/10.1080/15563650.2022.2049810DOI Listing
July 2022

Extracorporeal Treatment for Methotrexate Poisoning: Systematic Review and Recommendations from the EXTRIP Workgroup.

Authors:
Marc Ghannoum Darren M Roberts David S Goldfarb Jesper Heldrup Kurt Anseeuw Tais F Galvao Thomas D Nolin Robert S Hoffman Valery Lavergne Paul Meyers Sophie Gosselin Tudor Botnaru Karine Mardini David M Wood

Clin J Am Soc Nephrol 2022 04 2;17(4):602-622. Epub 2022 Mar 2.

Pharmacy Department, Verdun Hospital, CIUSSS du Sud-Ouest-de-l'ïle-de-Montréal, University of Montreal, Montreal, Quebec, Canada.

Methotrexate is used in the treatment of many malignancies, rheumatological diseases, and inflammatory bowel disease. Toxicity from use is associated with severe morbidity and mortality. Rescue treatments include intravenous hydration, folinic acid, and, in some centers, glucarpidase. We conducted systematic reviews of the literature following published EXtracorporeal TReatments In Poisoning (EXTRIP) methods to determine the utility of extracorporeal treatments in the management of methotrexate toxicity. The quality of the evidence and the strength of recommendations (either "strong" or "weak/conditional") were graded according to the GRADE approach. A formal voting process using a modified Delphi method assessed the level of agreement between panelists on the final recommendations. A total of 92 articles met inclusion criteria. Toxicokinetic data were available on 90 patients (89 with impaired kidney function). Methotrexate was considered to be moderately dialyzable by intermittent hemodialysis. Data were available for clinical analysis on 109 patients (high-dose methotrexate [>0.5 g/m]: 91 patients; low-dose [≤0.5 g/m]: 18). Overall mortality in these publications was 19.5% and 26.7% in those with high-dose and low-dose methotrexate-related toxicity, respectively. Although one observational study reported lower mortality in patients treated with glucarpidase compared with those treated with hemodialysis, there were important limitations in the study. For patients with severe methotrexate toxicity receiving standard care, the EXTRIP workgroup: () suggested against extracorporeal treatments when glucarpidase is not administered; () recommended against extracorporeal treatments when glucarpidase is administered; and () recommended against extracorporeal treatments instead of administering glucarpidase. The quality of evidence for these recommendations was very low. Rationales for these recommendations included: () extracorporeal treatments mainly remove drugs in the intravascular compartment, whereas methotrexate rapidly distributes into cells; () extracorporeal treatments remove folinic acid; () in rare cases where fast removal of methotrexate is required, glucarpidase will outperform any extracorporeal treatment; and () extracorporeal treatments do not appear to reduce the incidence and magnitude of methotrexate toxicity.
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http://dx.doi.org/10.2215/CJN.08030621DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8993465PMC
April 2022

Extracorporeal Treatment for Gabapentin and Pregabalin Poisoning: Systematic Review and Recommendations From the EXTRIP Workgroup.

Authors:
Josée Bouchard Christopher Yates Diane P Calello Sophie Gosselin Darren M Roberts Valéry Lavergne Robert S Hoffman Marlies Ostermann Ai Peng Marc Ghannoum

Am J Kidney Dis 2022 01 17;79(1):88-104. Epub 2021 Nov 17.

Research Center, CIUSSS du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Coeur de Montréal, University of Montreal, Montreal, Quebec, Canada. Electronic address:

Toxicity from gabapentin and pregabalin overdose is commonly encountered. Treatment is supportive, and the use of extracorporeal treatments (ECTRs) is controversial. The EXTRIP workgroup conducted systematic reviews of the literature and summarized findings following published methods. Thirty-three articles (30 patient reports and 3 pharmacokinetic studies) met the inclusion criteria. High gabapentinoid extracorporeal clearance (>150mL/min) and short elimination half-life (<5 hours) were reported with hemodialysis. The workgroup assessed gabapentin and pregabalin as "dialyzable" for patients with decreased kidney function (quality of the evidence grade as A and B, respectively). Limited clinical data were available (24 patients with gabapentin toxicity and 7 with pregabalin toxicity received ECTR). Severe toxicity, mortality, and sequelae were rare in cases receiving ECTR and in historical controls receiving standard care alone. No clear clinical benefit from ECTR could be identified although major knowledge gaps were acknowledged, as well as costs and harms of ECTR. The EXTRIP workgroup suggests against performing ECTR in addition to standard care rather than standard care alone (weak recommendation, very low quality of evidence) for gabapentinoid poisoning in patients with normal kidney function. If decreased kidney function and coma requiring mechanical ventilation are present, the workgroup suggests performing ECTR in addition to standard care (weak recommendation, very low quality of evidence).
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http://dx.doi.org/10.1053/j.ajkd.2021.06.027DOI Listing
January 2022

Majocchi's granuloma in a patient with GATA2 haploinsufficiency undergoing hematopoietic stem cell transplantation.

Authors:
Claudie Roy Sara Belga Valery Lavergne Thomas J Nevill

Transpl Infect Dis 2022 02 7;24(1):e13764. Epub 2021 Dec 7.

Leukemia/Bone Marrow Transplant Program of British Columbia, Vancouver General Hospital, University of British Columbia, Vancouver, Canada.

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http://dx.doi.org/10.1111/tid.13764DOI Listing
February 2022

Infectious Diseases Society of America Guidelines on Infection Prevention for Healthcare Personnel Caring for Patients with Suspected or Known COVID-19.

Authors:
John B Lynch Perica Davitkov Deverick J Anderson Adarsh Bhimraj Vincent Chi-Chung Cheng Judith Guzman-Cottrill Jasmine Dhindsa Abhijit Duggal Mamta K Jain Grace M Lee Stephen Y Liang Allison McGeer Jamie Varghese Valery Lavergne M Hassan Murad Reem A Mustafa Shahnaz Sultan Yngve Falck-Ytter Rebecca L Morgan

Clin Infect Dis 2021 Nov 15. Epub 2021 Nov 15.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario.

Background: Since its emergence in late 2019, SARS-CoV-2 continues to pose a risk to healthcare personnel (HCP) and patients in healthcare settings. Although all clinical interactions likely carry some risk of transmission, human actions like coughing and care activities like aerosol-generating procedures likely have a higher risk of transmission. The rapid emergence and global spread of SARS-CoV-2 continues to create significant challenges in healthcare facilities, particularly with shortages of personal protective equipment (PPE) used by HCP. Evidence-based recommendations for what PPE to use in conventional, contingency, and crisis standards of care continue to be needed. Where evidence is lacking, the development of specific research questions can help direct funders and investigators.

Objective: Develop evidence-based rapid guidelines intended to support HCP in their decisions about infection prevention when caring for patients with suspected or known COVID-19.

Methods: IDSA formed a multidisciplinary guideline panel including frontline clinicians, infectious disease specialists, experts in infection control, and guideline methodologists with representation from the disciplines of public health, medical microbiology, pediatrics, critical care medicine and gastroenterology. The process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and grey literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations.

Results: The IDSA guideline panel agreed on eight recommendations, including two updated recommendations and one new recommendation added since the first version of the guideline. Narrative summaries of other interventions undergoing evaluations are also included.

Conclusions: Using a combination of direct and indirect evidence, the panel was able to provide recommendations for eight specific questions on the use of PPE for HCP providing care for patients with suspected or known COVID-19. Where evidence was lacking, attempts were made to provide potential avenues for investigation. There remain significant gaps in the understanding of the transmission dynamics of SARS-CoV-2 and PPE recommendations may need to be modified in response to new evidence. These recommendations should serve as a minimum for PPE use in healthcare facilities and do not preclude decisions based on local risk assessments or requirements of local health jurisdictions or other regulatory bodies.
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http://dx.doi.org/10.1093/cid/ciab953DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8767890PMC
November 2021

Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords.

Authors:
Adarsh Bhimraj Rebecca L Morgan Amy Hirsch Shumaker Valery Lavergne Lindsey Baden Vincent Chi-Chung Cheng Kathryn M Edwards Rajesh T Gandhi Jason C Gallagher William J Muller John C O'Horo Shmuel Shoham Dana Swartzberg Wollins Yngve Falck-Ytter

Clin Infect Dis 2022 05;74(9):1686-1690

VA Northeast Ohio Healthcare System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

Given the urgent need for treatments during the coronavirus disease 2019 pandemic, the US Food and Drug Administration issued emergency use authorizations (EUAs) for multiple therapies. In several instances, however, these EUAs were issued before sufficient evidence of a given therapy's efficacy and safety were available, potentially promoting ineffective or even harmful therapies and undermining the generation of definitive evidence. We describe the strengths and weaknesses of the different therapeutic EUAs issued during this pandemic. We also contrast them to the vaccine EUAs and suggest a framework and criteria for an evidence-based, trustworthy, and publicly transparent therapeutic EUA process for future pandemics.
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http://dx.doi.org/10.1093/cid/ciab880DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8574541PMC
May 2022

Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults.

Authors:
Stuart Johnson Valéry Lavergne Andrew M Skinner Anne J Gonzales-Luna Kevin W Garey Ciaran P Kelly Mark H Wilcox

Clin Infect Dis 2021 09;73(5):755-757

Department of Microbiology, Leeds Teaching Hospitals NHS Trust, and Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.

This clinical practice guideline is a focused update on management of Clostridioides difficile infection (CDI) in adults specifically addressing the use of fidaxomicin and bezlotoxumab for the treatment of CDI. This guideline was developed by a multidisciplinary panel representing the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA). This guideline is intended for use by healthcare professionals who care for adults with CDI, including specialists in infectious diseases, gastroenterologists, hospitalists, pharmacists, and any clinicians and healthcare providers caring for these patients. The panel's recommendations for the management CDI are based upon evidence derived from topic-specific systematic literature reviews. Summarized below are the recommendations for the management of CDI in adults. The panel followed a systematic process which included a standardized methodology for rating the certainty of the evidence and strength of recommendation using the GRADE approach (Grading of Recommendations Assessment, Development, and Evaluation). A detailed description of background, methods, evidence summary and rationale that support each recommendation, and knowledge gaps can be found online in the full text.
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http://dx.doi.org/10.1093/cid/ciab718DOI Listing
September 2021

Recommendations from the EXTRIP workgroup on extracorporeal treatment for baclofen poisoning.

Authors:
Marc Ghannoum Ingrid Berling Valéry Lavergne Darren M Roberts Tais Galvao Robert S Hoffman Thomas D Nolin Andrew Lewington Kent Doi Sophie Gosselin

Kidney Int 2021 10 4;100(4):720-736. Epub 2021 Aug 4.

Emergency Medicine Department, Centre Intégré de Santé et de Services Sociaux (CISSS) de la Montérégie-Centre, Hôpital Charles-LeMoyne, Greenfield Park, Québec, Canada; Academic Emergency Medicine Department, Faculty of Medicine, McGill University, Montréal, Québec, Canada; Centre Antipoison du Québec, Québec, Québec, Canada. Electronic address:

Baclofen toxicity results from intentional self-poisoning (acute baclofen poisoning) or accumulation of therapeutic dose in the setting of impaired kidney function. Standard care includes baclofen discontinuation, respiratory support and seizure treatment. Use of extracorporeal treatments (ECTRs) is controversial. To clarify this, a comprehensive review of the literature on the effect of ECTRs in baclofen toxicity was performed and recommendations following EXTRIP methods were formulated based on 43 studies (1 comparative cohort, 1 aggregate results cohort, 1 pharmacokinetic modeling, and 40 patient reports or series). Toxicokinetic data were available for 20 patients. Baclofen's dialyzability is limited by a high endogenous clearance and a short half-life in patients with normal kidney function. The workgroup assessed baclofen as "Moderately dialyzable" by intermittent hemodialysis for patients with normal kidney function (quality of evidence C) and "Dialyzable" for patients with impaired kidney function (quality of evidence C). Clinical data were available for 25 patients with acute baclofen poisoning and 46 patients with toxicity from therapeutic baclofen in kidney impairment. No deaths or sequelae were reported. Mortality in historical controls was rare. No benefit of ECTR was identified in patients with acute baclofen poisoning. Indirect evidence suggests a benefit of ECTR in reducing the duration of toxic encephalopathy from therapeutic baclofen in kidney impairment. These potential benefits were balanced against added costs and harms related to the insertion of a catheter, the procedure itself, and the potential of baclofen withdrawal. Thus, the EXTRIP workgroup suggests against performing ECTR in addition to standard care for acute baclofen poisoning and suggests performing ECTR in toxicity from therapeutic baclofen in kidney impairment, especially in the presence of coma requiring mechanical ventilation.
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http://dx.doi.org/10.1016/j.kint.2021.07.014DOI Listing
October 2021

Clinical Practice Guideline by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America: 2021 Guideline on Diagnosis and Management of Acute Hematogenous Osteomyelitis in Pediatrics.

Authors:
Charles R Woods John S Bradley Archana Chatterjee Lawson A Copley Joan Robinson Matthew P Kronman Antonio Arrieta Sandra L Fowler Christopher Harrison Maria A Carrillo-Marquez Sandra R Arnold Stephen C Eppes Laura P Stadler Coburn H Allen Lynnette J Mazur C Buddy Creech Samir S Shah Theoklis Zaoutis David S Feldman Valéry Lavergne

J Pediatric Infect Dis Soc 2021 Sep;10(8):801-844

Department of Medical Microbiology and Infection Control, Vancouver General Hospital, Vancouver, British Columbia, Canada.

This clinical practice guideline for the diagnosis and treatment of acute hematogenous osteomyelitis (AHO) in children was developed by a multidisciplinary panel representing Pediatric Infectious Diseases Society (PIDS) and the Infectious Diseases Society of America (IDSA). This guideline is intended for use by healthcare professionals who care for children with AHO, including specialists in pediatric infectious diseases, orthopedics, emergency care physicians, hospitalists, and any clinicians and healthcare providers caring for these patients. The panel's recommendations for the diagnosis and treatment of AHO are based upon evidence derived from topic-specific systematic literature reviews. Summarized below are the recommendations for the diagnosis and treatment of AHO in children. The panel followed a systematic process used in the development of other IDSA and PIDS clinical practice guidelines, which included a standardized methodology for rating the certainty of the evidence and strength of recommendation using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. A detailed description of background, methods, evidence summary and rationale that support each recommendation, and knowledge gaps can be found online in the full text.
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http://dx.doi.org/10.1093/jpids/piab027DOI Listing
September 2021

Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults.

Authors:
Stuart Johnson Valéry Lavergne Andrew M Skinner Anne J Gonzales-Luna Kevin W Garey Ciaran P Kelly Mark H Wilcox

Clin Infect Dis 2021 09;73(5):e1029-e1044

Department of Microbiology, Leeds Teaching Hospitals NHS Trust, and Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom.

This clinical practice guideline is a focused update on management of Clostridioides difficile infection (CDI) in adults specifically addressing the use of fidaxomicin and bezlotoxumab for the treatment of CDI. This guideline was developed by a multidisciplinary panel representing the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA). This guideline is intended for use by healthcare professionals who care for adults with CDI, including specialists in infectious diseases, gastroenterologists, hospitalists, pharmacists, and any clinicians and healthcare providers caring for these patients. The panel's recommendations for the management CDI are based upon evidence derived from topic-specific systematic literature reviews. Summarized below are the recommendations for the management of CDI in adults. The panel followed a systematic process which included a standardized methodology for rating the certainty of the evidence and strength of recommendation using the GRADE approach (Grading of Recommendations Assessment, Development, and Evaluation). A detailed description of background, methods, evidence summary and rationale that support each recommendation, and knowledge gaps can be found online in the full text.
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http://dx.doi.org/10.1093/cid/ciab549DOI Listing
September 2021

The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing.

Authors:
Kimberly E Hanson Osama Altayar Angela M Caliendo Cesar A Arias Janet A Englund Mary K Hayden Mark J Lee Mark Loeb Robin Patel Abdallah El Alayli Shahnaz Sultan Yngve Falck-Ytter Valery Lavergne Razan Mansour Rebecca L Morgan M Hassan Murad Payal Patel Adarsh Bhimraj Reem A Mustafa

Clin Infect Dis 2021 Jun 23. Epub 2021 Jun 23.

Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.

Background: Immunoassays designed to detect SARS-CoV-2 protein antigens are now commercially available. The most widely used tests are rapid lateral flow assays that generate results in approximately 15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 antigen (Ag) assays have also been developed. The overall accuracy of SARS-CoV-2 Ag tests, however, is not well defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the literature and develop best practice guidance related to SARS-CoV-2 Ag testing. This guideline is the third in a series of rapid, frequently updated COVID-19 diagnostic guidelines developed by IDSA.

Objective: IDSA's goal was to develop evidence-based recommendations or suggestions that assist clinicians, clinical laboratories, patients, public health authorities, administrators and policymakers in decisions related to the optimal use of SARS-CoV-2 Ag tests in both medical and non-medical settings.

Methods: A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 Ag tests. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations.

Results: The panel agreed on five diagnostic recommendations. These recommendations address antigen testing in symptomatic and asymptomatic individuals as well as assess single versus repeat testing strategies.

Conclusions: Data on the clinical performance of U.S. Food and Drug Administration SARS-CoV-2 Ag tests with Emergency Use Authorization is mostly limited to single, one-time testing versus standard nucleic acid amplification testing (NAAT) as the reference standard. Rapid Ag tests have high specificity and low to modest sensitivity compared to reference NAAT methods. Antigen test sensitivity is heavily dependent on viral load, with differences observed between symptomatic compared to asymptomatic individuals and the time of testing post onset of symptoms. Based on these observations, rapid RT-PCR or laboratory-based NAAT remain the diagnostic methods of choice for diagnosing SARS-CoV-2 infection. However, when molecular testing is not readily available or is logistically infeasible, Ag testing can help identify some individuals with SARS-CoV-2 infection. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate.
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http://dx.doi.org/10.1093/cid/ciab557DOI Listing
June 2021

Extracorporeal treatment for poisoning to beta-adrenergic antagonists: systematic review and recommendations from the EXTRIP workgroup.

Authors:
Josée Bouchard Greene Shepherd Robert S Hoffman Sophie Gosselin Darren M Roberts Yi Li Thomas D Nolin Valéry Lavergne Marc Ghannoum

Crit Care 2021 06 10;25(1):201. Epub 2021 Jun 10.

Research Center, CIUSSS du Nord-de-L'île-de-Montréal, Hôpital du Sacré-Coeur de Montréal, University of Montreal, Montreal, QC, Canada.

Background: β-adrenergic antagonists (BAAs) are used to treat cardiovascular disease such as ischemic heart disease, congestive heart failure, dysrhythmias, and hypertension. Poisoning from BAAs can lead to severe morbidity and mortality. We aimed to determine the utility of extracorporeal treatments (ECTRs) in BAAs poisoning.

Methods: We conducted systematic reviews of the literature, screened studies, extracted data, and summarized findings following published EXTRIP methods.

Results: A total of 76 studies (4 in vitro and 2 animal experiments, 1 pharmacokinetic simulation study, 37 pharmacokinetic studies on patients with end-stage kidney disease, and 32 case reports or case series) met inclusion criteria. Toxicokinetic or pharmacokinetic data were available on 334 patients (including 73 for atenolol, 54 for propranolol, and 17 for sotalol). For intermittent hemodialysis, atenolol, nadolol, practolol, and sotalol were assessed as dialyzable; acebutolol, bisoprolol, and metipranolol were assessed as moderately dialyzable; metoprolol and talinolol were considered slightly dialyzable; and betaxolol, carvedilol, labetalol, mepindolol, propranolol, and timolol were considered not dialyzable. Data were available for clinical analysis on 37 BAA poisoned patients (including 9 patients for atenolol, 9 for propranolol, and 9 for sotalol), and no reliable comparison between the ECTR cohort and historical controls treated with standard care alone could be performed. The EXTRIP workgroup recommends against using ECTR for patients severely poisoned with propranolol (strong recommendation, very low quality evidence). The workgroup offered no recommendation for ECTR in patients severely poisoned with atenolol or sotalol because of apparent balance of risks and benefits, except for impaired kidney function in which ECTR is suggested (weak recommendation, very low quality of evidence). Indications for ECTR in patients with impaired kidney function include refractory bradycardia and hypotension for atenolol or sotalol poisoning, and recurrent torsade de pointes for sotalol. Although other BAAs were considered dialyzable, clinical data were too limited to develop recommendations.

Conclusions: BAAs have different properties affecting their removal by ECTR. The EXTRIP workgroup assessed propranolol as non-dialyzable. Atenolol and sotalol were assessed as dialyzable in patients with kidney impairment, and the workgroup suggests ECTR in patients severely poisoned with these drugs when aforementioned indications are present.
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http://dx.doi.org/10.1186/s13054-021-03585-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8194226PMC
June 2021

Extracorporeal treatments for isoniazid poisoning: Systematic review and recommendations from the EXTRIP workgroup.

Authors:
James B Mowry Greene Shepherd Robert S Hoffman Valery Lavergne Sophie Gosselin Thomas D Nolin Anitha Vijayan Jan T Kielstein Darren M Roberts Marc Ghannoum

Pharmacotherapy 2021 05 3;41(5):463-478. Epub 2021 Apr 3.

Research Center, CIUSSS du Nord-de-l'île-de-Montréal, University of Montreal, Montreal, Quebec, Canada.

Isoniazid toxicity from self-poisoning or dosing errors remains common in regions of the world where tuberculosis is prevalent. Although the treatment of isoniazid poisoning is centered on supportive care and pyridoxine administration, extracorporeal treatments (ECTRs), such as hemodialysis, have been advocated to enhance elimination of isoniazid. No systematic reviews or evidence-based recommendations currently exist on the benefit of ECTRs for isoniazid poisoning. The Extracorporeal Treatments in Poisoning (EXTRIP) workgroup systematically collected and rated the available evidence on the effect of and indications for ECTRs in cases of isoniazid poisoning. We conducted a systematic review of the literature, screened studies, extracted data on study characteristics, outcomes, and measurement characteristics, summarized findings, and formulated recommendations following published EXTRIP methods. Forty-three studies (two animal studies, 34 patient reports or patient series, and seven pharmacokinetic studies) met inclusion criteria. Toxicokinetic or pharmacokinetic analysis was available for 60 patients, most treated with hemodialysis (n = 38). The workgroup assessed isoniazid as "Moderately Dialyzable" by hemodialysis for patients with normal kidney function (quality of evidence = C) and "Dialyzable" by hemodialysis for patients with impaired kidney function (quality of evidence = A). Clinical data for ECTR in isoniazid poisoning were available for 40 patients. Mortality of the cohort was 12.5%. Historical controls who received modern standard care including appropriately dosed pyridoxine generally had excellent outcomes. No benefit could be extrapolated from ECTR, although there was evidence of added costs and harms related to the double lumen catheter insertion, the extracorporeal procedure itself, and the extracorporeal removal of pyridoxine. The EXTRIP workgroup suggests against performing ECTR in addition to standard care (weak recommendation, very low quality of evidence) in patients with isoniazid poisoning. If standard dose pyridoxine cannot be administered, we suggest performing ECTR only in patients with seizures refractory to GABA receptor agonists (weak recommendation, very low quality of evidence).
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http://dx.doi.org/10.1002/phar.2519DOI Listing
May 2021

Joint ESCMID, FEMS, IDSA, ISID and SSI position paper on the fair handling of career breaks among physicians and scientists when assessing eligibility for early-career awards.

Authors:
Angela Huttner Alice Bricheux Carianne J M Buurmeijer-van Dijk Matthew Harvey Alison Holmes Britta Lassmann Valéry Lavergne Alexandra Mailles Marc Mendelson Nicolas Muller Maurizio Sanguinetti Cynthia Sears Chrysanthi Skevaki Uzma Syed Salandra Thomas Talia H Swartz

Clin Microbiol Infect 2021 Feb 18. Epub 2021 Feb 18.

Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Background: Though women increasingly make up the majority of medical-school and other science graduates, they remain a minority in academic biomedical settings, where they are less likely to hold leadership positions or be awarded research funding. A major factor is the career breaks that women disproportionately take to see to familial duties. They experience a related, but overlooked, hurdle upon their return: they are often too old to be eligible for 'early-career researcher' grants and 'career-development' awards, which are stepping stones to leadership positions in many institutions and which determine the demographics of their hierarchies for decades to come. Though age limits are imposed to protect young applicants from more experienced seniors, they have an unintended side effect of excluding returning workers, still disproportionately women, from the running.

Methods: In this joint effort by the European Society of Clinical Microbiology and Infectious Diseases, the Federation of European Microbiological Societies, the Infectious Disease Society of America, the International Society for Infectious Diseases and the Swiss Society for Infectious Diseases, we invited all European Congress of Clinical Microbiology and Infectious Diseases-affiliated medical societies and funding bodies to participate in a survey on current 'early-career' application restrictions and measures taken to provide protections for career breaks.

Recommendations: The following simple consensus recommendations are geared to funding bodies, academic societies and other organizations for the fair handling of eligibility for early-career awards: 1. Apply a professional, not physiological, age limit to applicants. 2. State clearly in the award announcement that career breaks will be factored into applicants' evaluations such that: • Time absent is time extended: for every full-time equivalent of career break taken, the same full-time equivalent will be extended to the professional age limit. • Opportunity costs will also be taken into account: people who take career breaks risk additional opportunity costs, with work that they did before the career break often being forgotten or poorly documented, particularly in bibliometric accounting. Although there is no standardized metric to measure additional opportunity costs, organizations should (a) keep in mind their existence when judging applicants' submissions, and (b) note clearly in the award announcement that opportunity costs of career breaks are also taken into account. 3. State clearly that further considerations can be undertaken, using more individualized criteria that are specific to the applicant population and the award in question. The working group welcomes feedback so that these recommendations can be improved and updated as needed.
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http://dx.doi.org/10.1016/j.cmi.2021.01.029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9196972PMC
February 2021

Extracorporeal treatment for calcium channel blocker poisoning: systematic review and recommendations from the EXTRIP workgroup.

Authors:
Anselm Wong Robert S Hoffman Steven J Walsh Darren M Roberts Sophie Gosselin Timothy E Bunchman Sofia Kebede Valery Lavergne Marc Ghannoum

Clin Toxicol (Phila) 2021 May 8;59(5):361-375. Epub 2021 Feb 8.

Research Center, CIUSSS du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Coeur de Montréal, University of Montreal, Montreal, QC, Canada.

Background: Calcium channel blockers (CCBs) are commonly used to treat conditions such as arterial hypertension and supraventricular dysrhythmias. Poisoning from these drugs can lead to severe morbidity and mortality. We aimed to determine the utility of extracorporeal treatments (ECTRs) in the management of CCB poisoning.

Methods: We conducted systematic reviews of the literature, screened studies, extracted data, summarized findings, and formulated recommendations following published EXTRIP methods.

Results: A total of 83 publications (6 and 1 animal experiments, 55 case reports or case series, 19 pharmacokinetic studies, 1 cohort study and 1 systematic review) met inclusion criteria regarding the effect of ECTR. Toxicokinetic or pharmacokinetic data were available on 210 patients (including 32 for amlodipine, 20 for diltiazem, and 52 for verapamil). Regardless of the ECTR used, amlodipine, bepridil, diltiazem, felodipine, isradipine, mibefradil, nifedipine, nisoldipine, and verapamil were considered not dialyzable, with variable levels of evidence, while no dialyzability grading was possible for nicardipine and nitrendipine. Data were available for clinical analysis on 78 CCB poisoned patients (including 32 patients for amlodipine, 16 for diltiazem, and 23 for verapamil). Standard care (including high dose insulin euglycemic therapy) was not systematically administered. Clinical data did not suggest an improvement in outcomes with ECTR. Consequently, the EXTRIP workgroup recommends against using ECTR in addition to standard care for patients severely poisoned with either amlodipine, diltiazem or verapamil (strong recommendations, very low quality of the evidence (1D)). There were insufficient clinical data to draft recommendation for other CCBs, although the workgroup acknowledged the low dialyzability from, and lack of biological plausibility for, ECTR.

Conclusions: Both dialyzability and clinical data do not support a clinical benefit from ECTRs for CCB poisoning. The EXTRIP workgroup recommends against using extracorporeal methods to enhance the elimination of amlodipine, diltiazem, and verapamil in patients with severe poisoning.
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http://dx.doi.org/10.1080/15563650.2020.1870123DOI Listing
May 2021

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA): 2020 Guideline on Diagnosis and Management of Babesiosis.

Authors:
Peter J Krause Paul G Auwaerter Raveendhara R Bannuru John A Branda Yngve T Falck-Ytter Paul M Lantos Valéry Lavergne H Cody Meissner Mikala C Osani Jane Glazer Rips Sunil K Sood Edouard Vannier Elizaveta E Vaysbrot Gary P Wormser

Clin Infect Dis 2021 01;72(2):185-189

New York Medical College, Valhalla, New York, USA.

The purpose of this guideline is to provide evidence-based guidance for the most effective strategies for the diagnosis and management of babesiosis. The diagnosis and treatment of co-infection with babesiosis and Lyme disease will be addressed in a separate Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR) guideline [1]. Recommendations for the diagnosis and treatment of human granulocytic anaplasmosis can be found in the recent rickettsial disease guideline developed by the Centers for Disease Control and Prevention [2]. The target audience for the babesiosis guideline includes primary care physicians and specialists caring for this condition, such as infectious diseases specialists, emergency physicians, intensivists, internists, pediatricians, hematologists, and transfusion medicine specialists.
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http://dx.doi.org/10.1093/cid/ciab050DOI Listing
January 2021

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease.

Authors:
Paul M Lantos Jeffrey Rumbaugh Linda K Bockenstedt Yngve T Falck-Ytter Maria E Aguero-Rosenfeld Paul G Auwaerter Kelly Baldwin Raveendhara R Bannuru Kiran K Belani William R Bowie John A Branda David B Clifford Francis J DiMario John J Halperin Peter J Krause Valery Lavergne Matthew H Liang H Cody Meissner Lise E Nigrovic James Jay J Nocton Mikala C Osani Amy A Pruitt Jane Rips Lynda E Rosenfeld Margot L Savoy Sunil K Sood Allen C Steere Franc Strle Robert Sundel Jean Tsao

Clin Infect Dis 2021 01;72(1):1-8

Michigan State University, East Lansing, Michigan, USA.

This evidence-based clinical practice guideline for the prevention, diagnosis, and treatment of Lyme disease was developed by a multidisciplinary panel representing the Infectious Diseases Society of America (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR). The scope of this guideline includes prevention of Lyme disease, and the diagnosis and treatment of Lyme disease presenting as erythema migrans, Lyme disease complicated by neurologic, cardiac, and rheumatologic manifestations, Eurasian manifestations of Lyme disease, and Lyme disease complicated by coinfection with other tick-borne pathogens. This guideline does not include comprehensive recommendations for babesiosis and tick-borne rickettsial infections, which are published in separate guidelines. The target audience for this guideline includes primary care physicians and specialists caring for this condition such as infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists and dermatologists in North America.
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http://dx.doi.org/10.1093/cid/ciab049DOI Listing
January 2021

The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing.

Authors:
Kimberly E Hanson Angela M Caliendo Cesar A Arias Mary K Hayden Janet A Englund Mark J Lee Mark Loeb Robin Patel Abdallah El Alayli Osama Altayar Payal Patel Yngve Falck-Ytter Valery Lavergne Rebecca L Morgan M Hassan Murad Shahnaz Sultan Adarsh Bhimraj Reem A Mustafa

Clin Infect Dis 2021 Jan 22. Epub 2021 Jan 22.

Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.

Background: Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance.

Objective: The IDSA's goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings and highlight important unmet research needs in the COVID-19 diagnostic testing space.

Methods: IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations.

Results: The panel agreed on 17 diagnostic recommendations.

Conclusions: Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform solid organ or hematopoietic stem cell transplantation timing. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations.
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http://dx.doi.org/10.1093/cid/ciab048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929045PMC
January 2021

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease.

Authors:
Paul M Lantos Jeffrey Rumbaugh Linda K Bockenstedt Yngve T Falck-Ytter Maria E Aguero-Rosenfeld Paul G Auwaerter Kelly Baldwin Raveendhara R Bannuru Kiran K Belani William R Bowie John A Branda David B Clifford Francis J DiMario John J Halperin Peter J Krause Valery Lavergne Matthew H Liang H Cody Meissner Lise E Nigrovic James Jay J Nocton Mikala C Osani Amy A Pruitt Jane Rips Lynda E Rosenfeld Margot L Savoy Sunil K Sood Allen C Steere Franc Strle Robert Sundel Jean Tsao

Clin Infect Dis 2021 01;72(1):e1-e48

Michigan State University, East Lansing, Michigan, USA.

This evidence-based clinical practice guideline for the prevention, diagnosis, and treatment of Lyme disease was developed by a multidisciplinary panel representing the Infectious Diseases Society of America (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR). The scope of this guideline includes prevention of Lyme disease, and the diagnosis and treatment of Lyme disease presenting as erythema migrans, Lyme disease complicated by neurologic, cardiac, and rheumatologic manifestations, Eurasian manifestations of Lyme disease, and Lyme disease complicated by coinfection with other tick-borne pathogens. This guideline does not include comprehensive recommendations for babesiosis and tick-borne rickettsial infections, which are published in separate guidelines. The target audience for this guideline includes primary care physicians and specialists caring for this condition such as infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists and dermatologists in North America.
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http://dx.doi.org/10.1093/cid/ciaa1215DOI Listing
January 2021

Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.

Authors:
Andrea S Gershon Peter K Lindenauer Kevin C Wilson Louise Rose Allan J Walkey Mohsen Sadatsafavi Kevin J Anstrom David H Au Bruce G Bender M Alan Brookhart Raed A Dweik MeiLan K Han Min J Joo Valery Lavergne Anuj B Mehta Marc Miravitlles Richard A Mularski Nicolas Roche Eyal Oren Kristin A Riekert Noah C Schoenberg Therese A Stukel Curtis H Weiss Hannah Wunsch Joel J Africk Jerry A Krishnan

Am J Respir Crit Care Med 2021 01;203(1):14-23

Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy. The American Thoracic Society (ATS) created a multidisciplinary committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine. The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines. There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when ) no RCTs are identified or RCTs are appraised as being of low- or very low-quality (); ) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded (); or ) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; "). Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions.
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http://dx.doi.org/10.1164/rccm.202010-3943STDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7781125PMC
January 2021

Evaluation of the BioFire® COVID-19 test and Respiratory Panel 2.1 for rapid identification of SARS-CoV-2 in nasopharyngeal swab samples.

Authors:
Eric J Eckbo Kerstin Locher Melissa Caza Lisa Li Valery Lavergne Marthe Charles

Diagn Microbiol Infect Dis 2021 Mar 10;99(3):115260. Epub 2020 Nov 10.

Department of Pathology & Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada; Division of Medical Microbiology & Infection Control & Control, Vancouver Coastal Health, Vancouver, BC, Canada. Electronic address:

The BioFire® COVID-19 Test and Respiratory Panel 2.1 (RP2.1) are rapid, fully automated assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs. In the case of the RP2.1, an additional 21 viral and bacterial pathogens can be detected. Both tests have received emergency use authorization from the U.S. Food & Drug Administration and Interim Order authorization from Health Canada for use in clinical laboratories. We evaluated the performance characteristics of these tests in comparison to a laboratory-developed real-time PCR assay targeting the viral RNA-dependent RNA polymerase and E genes. A total of 78 tests were performed using the BioFire COVID-19 Test, including 30 clinical specimens and 48 tests in a limit of detection study; 57 tests were performed using the RP2.1 for evaluation of SARS-CoV-2 detection, including 30 clinical specimens and 27 tests for limit of detection. Results showed 100% concordance between the BioFire assays and the laboratory-developed test for all clinical samples tested, and acceptable performance of both BioFire assays at their stated limits of detection. Conclusively, the BioFire COVID-19 Test and RP2.1 are highly sensitive assays that can be effectively used in the clinical laboratory for rapid SARS-CoV-2 testing.
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http://dx.doi.org/10.1016/j.diagmicrobio.2020.115260DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7654322PMC
March 2021

Clinical Practice Guidelines by the Infectious Diseases Society of America, American Academy of Neurology, and American College of Rheumatology: 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease.

Authors:
Paul M Lantos Jeffrey Rumbaugh Linda K Bockenstedt Yngve T Falck-Ytter Maria E Aguero-Rosenfeld Paul G Auwaerter Kelly Baldwin Raveendhara R Bannuru Kiran K Belani William R Bowie John A Branda David B Clifford Francis J DiMario John J Halperin Peter J Krause Valery Lavergne Matthew H Liang H Cody Meissner Lise E Nigrovic James Jay J Nocton Mikala C Osani Amy A Pruitt Jane Rips Lynda E Rosenfeld Margot L Savoy Sunil K Sood Allen C Steere Franc Strle Robert Sundel Jean Tsao

Neurology 2021 02 30;96(6):262-273. Epub 2020 Nov 30.

From the Duke University School of Medicine (P.M.L.), Durham, NC; Pathway Neurology (J. Rumbaugh), Tampa, FL; Yale University (L.K.B., L.E.R.), New Haven, CT; Case Western Reserve University, VA Northeast Ohio Healthcare System (Y.T.F.-Y.), Cleveland; New York University School of Medicine (M.E.A.-R.), New York; Johns Hopkins University School of Medicine (P.G.A.), Baltimore, MD; Geisinger Medical Center (K.B.), Danville, PA; Tufts Medical Center (R.R.B., H.C.M., M.C.O., E.E.V.), Boston, MA; Childrens Hospital and Clinical of Minnesota (K.K.B.), Minneapolis; University of British Columbia (W.R.B.), Vancouver Canada; Massachusetts General Hospital (J.A.B., A.C.S.), Boston; Washington University School of Medicine (D.B.C.), St. Louis, Missouri; Connecticut Children's Medical Center (F.J.D.M., L.S.Z.), Hartford, CT; Atlantic Health System (J.J.H.), Summit, NJ; Yale School of Public Health (P.J.K.), New Haven, CT; University of Montreal (V.L.), Quebec, Canada; Brigham and Women's Hospital (M.H.L.), Boston, MA; Boston Children's Hospital (L.E.N., R.S.), Massachusetts; Medical College of Wisconsin (J.(J.)J.N.), Waowatosa; University of Pennsylvania (A.A.P.), Philadelphia; Consumer Representative (J. Rips), Omaha, NE; Temple University (M.L.S.), Philadelphia, PA; Northwell Health (S.K.S.), New York, NY; University Medical Centre Ljubljana (F.S.), Slovenia; Michigan State University (J.T.), East Lansing; and New York Medical College (G.P.W.), Valhalla.

This evidence-based clinical practice guideline for the prevention, diagnosis, and treatment of Lyme disease was developed by a multidisciplinary panel representing the Infectious Diseases Society of America (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR). The scope of this guideline includes prevention of Lyme disease, and the diagnosis and treatment of Lyme disease presenting as erythema migrans, Lyme disease complicated by neurologic, cardiac, and rheumatologic manifestations, Eurasian manifestations of Lyme disease, and Lyme disease complicated by coinfection with other tick-borne pathogens. This guideline does not include comprehensive recommendations for babesiosis and tick-borne rickettsial infections, which are published in separate guidelines. The target audience for this guideline includes primary care physicians and specialists caring for this condition such as infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists and dermatologists in North America.
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http://dx.doi.org/10.1212/WNL.0000000000011151DOI Listing
February 2021

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA): 2020 Guideline on Diagnosis and Management of Babesiosis.

Authors:
Peter J Krause Paul G Auwaerter Raveendhara R Bannuru John A Branda Yngve T Falck-Ytter Paul M Lantos Valéry Lavergne H Cody Meissner Mikala C Osani Jane Glazer Rips Sunil K Sood Edouard Vannier Elizaveta E Vaysbrot Gary P Wormser

Clin Infect Dis 2021 01;72(2):e49-e64

New York Medical College, Valhalla, New York, USA.

The purpose of this guideline is to provide evidence-based guidance for the most effective strategies for the diagnosis and management of babesiosis. The diagnosis and treatment of co-infection with babesiosis and Lyme disease will be addressed in a separate Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR) guideline [1]. Recommendations for the diagnosis and treatment of human granulocytic anaplasmosis can be found in the recent rickettsial disease guideline developed by the Centers for Disease Control and Prevention [2]. The target audience for the babesiosis guideline includes primary care physicians and specialists caring for this condition, such as infectious diseases specialists, emergency physicians, intensivists, internists, pediatricians, hematologists, and transfusion medicine specialists.
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http://dx.doi.org/10.1093/cid/ciaa1216DOI Listing
January 2021

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease.

Authors:
Paul M Lantos Jeffrey Rumbaugh Linda K Bockenstedt Yngve T Falck-Ytter Maria E Aguero-Rosenfeld Paul G Auwaerter Kelly Baldwin Raveendhara R Bannuru Kiran K Belani William R Bowie John A Branda David B Clifford Francis J DiMario John J Halperin Peter J Krause Valery Lavergne Matthew H Liang H Cody Meissner Lise E Nigrovic James Jay J Nocton Mikala C Osani Amy A Pruitt Jane Rips Lynda E Rosenfeld Margot L Savoy Sunil K Sood Allen C Steere Franc Strle Robert Sundel Jean Tsao

Arthritis Rheumatol 2021 01 29;73(1):12-20. Epub 2020 Nov 29.

Michigan State University, East Lansing.

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http://dx.doi.org/10.1002/art.41562DOI Listing
January 2021

Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease.

Authors:
Paul M Lantos Jeffrey Rumbaugh Linda K Bockenstedt Yngve T Falck-Ytter Maria E Aguero-Rosenfeld Paul G Auwaerter Kelly Baldwin Raveendhara R Bannuru Kiran K Belani William R Bowie John A Branda David B Clifford Francis J DiMario John J Halperin Peter J Krause Valery Lavergne Matthew H Liang H Cody Meissner Lise E Nigrovic James Jay J Nocton Mikala C Osani Amy A Pruitt Jane Rips Lynda E Rosenfeld Margot L Savoy Sunil K Sood Allen C Steere Franc Strle Robert Sundel Jean Tsao

Arthritis Care Res (Hoboken) 2021 01 29;73(1):1-9. Epub 2020 Nov 29.

Michigan State University, East Lansing.

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http://dx.doi.org/10.1002/acr.24495DOI Listing
January 2021

Extracorporeal Treatment for Chloroquine, Hydroxychloroquine, and Quinine Poisoning: Systematic Review and Recommendations from the EXTRIP Workgroup.

Authors:
Ingrid Berling Joshua D King Greene Shepherd Robert S Hoffman Badria Alhatali Valery Lavergne Darren M Roberts Sophie Gosselin Gabrielle Wilson Thomas D Nolin Marc Ghannoum

J Am Soc Nephrol 2020 10 22;31(10):2475-2489. Epub 2020 Sep 22.

Research Center, Centre Intégré Universitaire de Santé et de Services Sociaux du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Coeur de Montréal, University of Montreal, Montreal, Quebec, Canada

Background: Although chloroquine, hydroxychloroquine, and quinine are used for a range of medical conditions, recent research suggested a potential role in treating COVID-19. The resultant increase in prescribing was accompanied by an increase in adverse events, including severe toxicity and death. The Extracorporeal Treatments in Poisoning (EXTRIP) workgroup sought to determine the effect of and indications for extracorporeal treatments in cases of poisoning with these drugs.

Methods: We conducted systematic reviews of the literature, screened studies, extracted data, and summarized findings following published EXTRIP methods.

Results: A total of 44 studies (three studies, two animal studies, 28 patient reports or patient series, and 11 pharmacokinetic studies) met inclusion criteria regarding the effect of extracorporeal treatments. Toxicokinetic or pharmacokinetic analysis was available for 61 patients (13 chloroquine, three hydroxychloroquine, and 45 quinine). Clinical data were available for analysis from 38 patients, including 12 with chloroquine toxicity, one with hydroxychloroquine toxicity, and 25 with quinine toxicity. All three drugs were classified as non-dialyzable (not amenable to clinically significant removal by extracorporeal treatments). The available data do not support using extracorporeal treatments in addition to standard care for patients severely poisoned with either chloroquine or quinine (strong recommendation, very low quality of evidence). Although hydroxychloroquine was assessed as being non-dialyzable, the clinical evidence was not sufficient to support a formal recommendation regarding the use of extracorporeal treatments for this drug.

Conclusions: On the basis of our systematic review and analysis, the EXTRIP workgroup recommends against using extracorporeal methods to enhance elimination of these drugs in patients with severe chloroquine or quinine poisoning.
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http://dx.doi.org/10.1681/ASN.2020050564DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7609009PMC
October 2020

Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19:Serologic Testing.

Authors:
Kimberly E Hanson Angela M Caliendo Cesar A Arias Janet A Englund Mary K Hayden Mark J Lee Mark Loeb Robin Patel Osama Altayar Abdallah El Alayli Shahnaz Sultan Yngve Falck-Ytter Valéry Lavergne Rebecca L Morgan M Hassan Murad Adarsh Bhimraj Reem A Mustafa

Clin Infect Dis 2020 Sep 12. Epub 2020 Sep 12.

Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.

Background: The availability of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic testing has rapidly increased. Current assays use a variety of technologies, measure different classes of immunoglobulin or immunoglobulin combinations and detect antibodies directed against different portions of the virus. The overall accuracy of these tests, however, has not been well-defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the coronavirus disease 2019 (COVID-19) serology literature and construct best practice guidance related to SARS-CoV-2 serologic testing. This guideline is the fourth in a series of rapid, frequently updated COVID-19 guidelines developed by IDSA.

Objective: IDSA's goal was to develop evidence-based recommendations that assist clinicians, clinical laboratories, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 serologic tests in a variety of settings. We also highlight important unmet research needs pertaining to the use of anti-SARS-CoV-2 antibody tests for diagnosis, public health surveillance, vaccine development and the selection of convalescent plasma donors.

Methods: A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 serologic tests. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations.

Results: The panel agreed on eight diagnostic recommendations.

Conclusions: Information on the clinical performance and utility of SARS-CoV-2 serologic tests are rapidly emerging. Based on available evidence, detection of anti-SARS-CoV-2 antibodies may be useful for confirming the presence of current or past infection in selected situations. The panel identified three potential indications for serologic testing including: 1) evaluation of patients with a high clinical suspicion for COVID-19 when molecular diagnostic testing is negative and at least two weeks have passed since symptom onset; 2) assessment of multisystem inflammatory syndrome in children; and 3) for conducting serosurveillance studies. The certainty of available evidence supporting the use of serology for either diagnosis or epidemiology was, however, graded as very low to moderate.
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http://dx.doi.org/10.1093/cid/ciaa1343DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543294PMC
September 2020

Infectious Diseases Society of America Guidelines on Infection Prevention for Health Care Personnel Caring for Patients with Suspected or Known COVID-19.

Authors:
John B Lynch Perica Davitkov Deverick J Anderson Adarsh Bhimraj Vincent Chi-Chung Cheng Judith Guzman-Cottrill Jasmine Dhindsa Abhijit Duggal Mamta K Jain Grace M Lee Stephen Y Liang Allison McGeer Valery Lavergne M Hassan Murad Reem A Mustafa Rebecca L Morgan Yngve Falck-Ytter Shahnaz Sultan

Clin Infect Dis 2020 Jul 27. Epub 2020 Jul 27.

Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Minneapolis VA Health care System, Minneapolis, Minnesota.

Background: SARS-CoV-2 is a highly transmissible virus that can infect health care personnel and patients in health care settings. Specific care activities, in particular aerosol-generating procedures, may have a higher risk of transmission. The rapid emergence and global spread of SARS-CoV-2 has created significant challenges in health care facilities, particularly with severe shortages of personal protective equipment (PPE) used to protect health care personnel (HCP). Evidence-based recommendations for what PPE to use in conventional, contingency, and crisis standards of care are needed. Where evidence is lacking, the development of specific research questions can help direct funders and investigators.

Objective: Develop evidence-based rapid guidelines intended to support HCP in their decisions about infection prevention when caring for patients with suspected or known COVID-19.

Methods: IDSA formed a multidisciplinary guideline panel including front-line clinicians, infectious disease specialists, experts in infection control and guideline methodologists with representation from the disciplines of preventive care, public health, medical microbiology, pediatrics, critical care medicine and gastroenterology. The process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and grey literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations.

Results: The IDSA guideline panel agreed on eight recommendations and provided narrative summaries of other interventions undergoing evaluations.

Conclusions: Using a combination of direct and indirect evidence, the panel was able to provide recommendations for eight specific questions on the use of PPE for HCP providing care for patients with suspected or known COVID-19. Where evidence was lacking, attempts were made to provide potential avenues for investigation. There remain significant gaps in the understanding of the transmission dynamics of SARS-CoV-2 and PPE recommendations may need to be modified in response to new evidence.
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http://dx.doi.org/10.1093/cid/ciaa1063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454357PMC
July 2020

Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19.

Authors:
Kimberly E Hanson Angela M Caliendo Cesar A Arias Janet A Englund Mark J Lee Mark Loeb Robin Patel Abdallah El Alayli Mohamad A Kalot Yngve Falck-Ytter Valery Lavergne Rebecca L Morgan M Hassan Murad Shahnaz Sultan Adarsh Bhimraj Reem A Mustafa

Clin Infect Dis 2020 Jun 16. Epub 2020 Jun 16.

Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.

Background: Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance.

Objective: The IDSA's goal was to develop an evidence-based diagnostic guideline to assists clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings, and highlight important unmet research needs in the COVID-19 diagnostic testing space.

Methods: IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations.

Results: The panel agreed on 15 diagnostic recommendations.

Conclusions: Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered low to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform administration of immunosuppressive therapy. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations.
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http://dx.doi.org/10.1093/cid/ciaa760DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7337674PMC
June 2020
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