DOCSLIB.ORG

Indirect Comparison of Efficacy Between Different Antibiotic Prophylaxis Against the Intracranial Infection After Craniotomy

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Indirect Comparison of Efficacy Between Different Antibiotic Prophylaxis Against the Intracranial Infection After Craniotomy Cao et al. Antimicrobial Resistance and Infection Control (2020) 9:122 https://doi.org/10.1186/s13756-020-00784-9 RESEARCH Open Access Indirect comparison of efficacy between different antibiotic prophylaxis against the intracranial infection after craniotomy Yulong Cao1, Bin Wang2, Jiao Shan3, Zhizhong Gong4, Jiqiu Kuang1 and Yan Gao1* Abstract Background: Many studies had shown that prophylactic use of antibiotics could significantly reduce the intracranial infection (ICI) rate of craniotomy. However, there has been no comparison of these antibiotics. Methods: An electronic database search was performed, from inception to June 102,020. Randomized controlled trials (RCT) using different intravenous antibiotics (IVA) against the ICIs after craniotomy were considered. The primary outcome was the incidence rates of ICIs. An indirect treatment comparison (ITC) was conducted to compare the protective effect among the diverse antibiotic prophylaxis to prevent ICIs after craniotomy. Risk of potential bias was assessed. Results: A total of 3214 patients after craniotomy in 11 studies were included, 159 patients experienced postoperative ICI, including 33 patients in the antibacterial group and 126 in the control group. The calculate results of meta-analysis showed that except fusidic acid, preoperative intravenous injection of cephalosporin, clindamycin, vancomycin, and penicillin can significantly reduce the incidence of ICI after craniotomy, and ITC showed there was no statistically significance difference in the rates of post craniotomy ICI between the various antibiotics. Conclusion: The current evidence shows that low-grade antibacterial drugs can be selected to prevent ICI after craniotomy, but this may be due to the limited number of studies per antibiotic. It still needs more high-quality, large sample RCT to confirm. Systemic review registration: PROSPERO CRD42019133369. Keywords: Craniotomy, Intracranial infection, Antibiotic prophylaxis, Indirect treatment comparison Introduction accounted for cleaning incision surgical site infections Postoperative intracranial infections (ICIs) do not often [4]. ICIs can cause severe complications and poor out- occur but have potentially serious consequences [1]. comes, even death. In order to reduce the incidence of One of the greatest risks for these infections is undergo- ICIs, preoperative prophylactic use of antibiotics is still ing craniotomy. The rate of ICIs reached as high as 4.3 an important principle for reducing ICIs. ~ 7.4% in some developing countries, although the asep- Antibiotic prophylaxis is recommended in patients tic technique was developed in recent years [2, 3], more undergoing craniotomy. The conclusion of many surgi- cal research also supported that all kinds of antibiotics can be used to prevent ICIs after craniotomy [5], and yet * Correspondence: [email protected] 1Department of Hospital-Acquired Infection Control, Peking University there are no original studies of direct comparison People’s Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing between these antibiotics. 100044, P. R. China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Cao et al. Antimicrobial Resistance and Infection Control (2020) 9:122 Page 2 of 8 When no head-to-head clinical trials comparing alter- data, selective reporting bias, and other biases [8]. After native treatments are available it is, considered appropri- evaluating independently by two reviewers (CYL and ate to undertake an indirect treatment comparison WB), the assessment level of each papers were discussed (ITC). Therefore, randomized controlled trials of com- by two or three reviewer if necessary. Each potential monly used intravenous antibiotics (IVA) drugs for pre- item was graded as high, low, or unclear level of bias. venting ICIs were performed in an ITC to provide evidence for the prevention strategies of ICIs. Statistical analysis Two types of meta-analyses were performed. First, pair- Methods wise meta-analysis was used to assess the risk of ICIs This study was conducted following a protocol registered after craniotomy with different IVA. The risk ratio (RR) with PROSPERO (number CRD42019133369), and re- and 95% confidence interval (CI) were calculated and ported according to the Preferred Reporting Items for forest plots were created using RevMan 5.3.3. Publica- Systematic Reviews Incorporating Network Meta-analyses tion bias was examined by a comparison-adjusted funnel (PRISMA-NMA) guidelines [6]. A completed PRISMA- plot. Secondly, when no head-to-head RCT is available. NMA recommendation checklist is revealed as an add- The placebo then became a common comparator or a itional file (Additional file 1). bridge between these antibiotics. We used ITC applica- tion for this analysis using Bucher method [9]. Random- Search strategy and eligibility criteria effects modelling was selected a priori over fixed effects The initial search in the Cochrane Library, PubMed, models taking into account both within and between Embase, SinoMed, CNKI, VIP, and Wanfang database studies heterogeneity given differences in RCT design. from inception to 10 June, 2020 included clinical studies Therefore, the strength of randomization is partially that compared at least 2 interventions for the prevention maintained and any differences between treatments that of ICIs in patients after craniotomy. No language restric- are observed through an indirect comparison are less tion was applied. RCTs were considered for this indirect likely due to patient differences unrelated to the treat- comparison, irrespective of publication status. However, ment [10]. Indirect comparisons and statistical tests were the literature on the following conditions will be ex- presented using STATA version 14.2 (Stata Corp., cluded: 1) emergency brain injury, decompressive cra- College Station, TX, USA) software. niectomy, 2) preoperative prophylaxis is a combination of two or more antibiotics. Details of the search strategy Results are provided in Additional file 2. Literature identified Of 1258 potentially relevant articles identified in the Study selection and data extraction electronic database, 831 remained after the removal of The full texts of every retrieved potentially relevant stud- duplicate records in Endnote X9. Overall, 175 potentially ies were obtained and two of the reviewers (CYL and eligible articles were retrieved in full text. One hundred WB) scrutinized these reports independently to deter- and sixty-four articles were excluded, not reporting the mine which studies were required for further assess- outcomes of interest, not providing a complete outcome ment. Differences in eligibility assessments were resolved data, comparing interventions in the same category. by discussion and when necessary a final consensus was Finally, 11 trials studying 5 different antibiotics met the reached with the assistance of a third reviewer. Relevant criteria and were included in the ITC. Eligible studies of data from each article were abstracted by 2 reviewers comparison between intravenous antibiotics with ICIs using a standardized extraction form. The extracted data are shown in Fig. 1. included study characteristics, patient characteristics, in- terventions, outcomes, and relevant findings. Previous Evidence network and characteristics of the literature literature shows that few studies have met the criteria Six different interventions were included in this study: [7]. Therefore, there was no limitation on antibiotic clas- cephalosporin, clindamycin, penicillin, vancomycin, fusi- ses, dose, full name, manufacturers and companies in dic acid, and no prophylactic postoperative antibiotic/ this study. placebo. The network relationship among the six inter- vention measures is shown in Fig. 2. Of the 11 studies, Quality control all the control groups were no prophylactic antibiotic/ The risk of bias for each selected studies were evaluated placebo; In treatment group, three articles using ceph- by Cochrane risk of bias tool, which included the follow- alosporin, three using vancomycin, three using penicillin, ing items: random sequence generation, allocation con- one using clindamycin, and one using fusidic acid. cealment, blinding of participants and personnel, Details of the characteristics of the included studies are blinding of outcome assessment, incomplete outcome shown in Table 1. Cao et al. Antimicrobial Resistance and Infection Control (2020) 9:122 Page
Load more

Recommended publications
  • Urological Infections
    Guidelines on Urological Infections M. Grabe (chair), R. Bartoletti, T.E. Bjerklund-Johansen, H.M. Çek, R.S. Pickard, P. Tenke, F. Wagenlehner, B. Wullt © European Association of Urology 2014 TABLE OF CONTENTS PAGE 1. INTRODUCTION 8 1.1 Background 8 1.2 Bacterial resistance development 8 1.3 The aim of the guidelines 8 1.4 Pathogenesis of UTIs 8 1.5 Microbiological and other laboratory findings 9 1.6 Methodology 10 1.6.1 Level of evidence and grade of guideline recommendations 10 1.6.2 Publication history 10 1.7 References 11 2. CLASSIFICATION OF UTIs 12 2.1 Introduction 12 2.2 Anatomical level of infection 12 2.3 Grade of severity 13 2.4 Pathogens 14 2.5 Classification of UTI 14 2.6 Reference 15 3. UNCOMPLICATED UTIS IN ADULTS 15 3.1 Summary and recommendations 15 3.2 Definition 15 3.2.1 Aetiological spectrum 15 3.3 Acute uncomplicated sporadic cystitis in premenopausal, non-pregnant women 15 3.3.1 Diagnosis 15 3.3.1.1 Clinical diagnosis 15 3.3.1.2 Laboratory diagnosis 15 3.3.2 Therapy 15 3.3.3 Follow-up 16 3.4 Acute uncomplicated pyelonephritis in premenopausal, non-pregnant women 16 3.4.1 Diagnosis 16 3.4.1.1 Clinical diagnosis 16 3.4.1.2 Laboratory diagnosis 16 3.4.1.3 Imaging diagnosis 16 3.4.2 Therapy 17 3.4.2.1 Mild and moderate cases of acute uncomplicated pyelonephritis 17 3.4.2.2 Severe cases of acute uncomplicated pyelonephritis 17 3.4.3 Follow-up 19 3.5 Recurrent uncomplicated UTIs in premenopausal women 20 3.5.1 Diagnosis 20 3.5.2 Antimicrobial treatment and prevention 20 3.5.2.1 Antimicrobial prophylaxis 20 3.5.3 Non-antimicrobial
    [Show full text]
  • Consideration of Antibacterial Medicines As Part Of
    Consideration of antibacterial medicines as part of the revisions to 2019 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) Section 6.2 Antibacterials including Access, Watch and Reserve Lists of antibiotics This summary has been prepared by the Health Technologies and Pharmaceuticals (HTP) programme at the WHO Regional Office for Europe. It is intended to communicate changes to the 2019 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) to national counterparts involved in the evidence-based selection of medicines for inclusion in national essential medicines lists (NEMLs), lists of medicines for inclusion in reimbursement programs, and medicine formularies for use in primary, secondary and tertiary care. This document does not replace the full report of the WHO Expert Committee on Selection and Use of Essential Medicines (see The selection and use of essential medicines: report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2019 (including the 21st WHO Model List of Essential Medicines and the 7th WHO Model List of Essential Medicines for Children). Geneva: World Health Organization; 2019 (WHO Technical Report Series, No. 1021). Licence: CC BY-NC-SA 3.0 IGO: https://apps.who.int/iris/bitstream/handle/10665/330668/9789241210300-eng.pdf?ua=1) and Corrigenda (March 2020) – TRS1021 (https://www.who.int/medicines/publications/essentialmedicines/TRS1021_corrigenda_March2020. pdf?ua=1). Executive summary of the report: https://apps.who.int/iris/bitstream/handle/10665/325773/WHO- MVP-EMP-IAU-2019.05-eng.pdf?ua=1.
    [Show full text]
  • Computational Antibiotics Book
    Andrew V DeLong, Jared C Harris, Brittany S Larcart, Chandler B Massey, Chelsie D Northcutt, Somuayiro N Nwokike, Oscar A Otieno, Harsh M Patel, Mehulkumar P Patel, Pratik Pravin Patel, Eugene I Rowell, Brandon M Rush, Marc-Edwin G Saint-Louis, Amy M Vardeman, Felicia N Woods, Giso Abadi, Thomas J. Manning Computational Antibiotics Valdosta State University is located in South Georgia. Computational Antibiotics Index • Computational Details and Website Access (p. 8) • Acknowledgements (p. 9) • Dedications (p. 11) • Antibiotic Historical Introduction (p. 13) Introduction to Antibiotic groups • Penicillin’s (p. 21) • Carbapenems (p. 22) • Oxazolidines (p. 23) • Rifamycin (p. 24) • Lincosamides (p. 25) • Quinolones (p. 26) • Polypeptides antibiotics (p. 27) • Glycopeptide Antibiotics (p. 28) • Sulfonamides (p. 29) • Lipoglycopeptides (p. 30) • First Generation Cephalosporins (p. 31) • Cephalosporin Third Generation (p. 32) • Fourth-Generation Cephalosporins (p. 33) • Fifth Generation Cephalosporin’s (p. 34) • Tetracycline antibiotics (p. 35) Computational Antibiotics Antibiotics Covered (in alphabetical order) Amikacin (p. 36) Cefempidone (p. 98) Ceftizoxime (p. 159) Amoxicillin (p. 38) Cefepime (p. 100) Ceftobiprole (p. 161) Ampicillin (p. 40) Cefetamet (p. 102) Ceftoxide (p. 163) Arsphenamine (p. 42) Cefetrizole (p. 104) Ceftriaxone (p. 165) Azithromycin (p.44) Cefivitril (p. 106) Cefuracetime (p. 167) Aziocillin (p. 46) Cefixime (p. 108) Cefuroxime (p. 169) Aztreonam (p.48) Cefmatilen ( p. 110) Cefuzonam (p. 171) Bacampicillin (p. 50) Cefmetazole (p. 112) Cefalexin (p. 173) Bacitracin (p. 52) Cefodizime (p. 114) Chloramphenicol (p.175) Balofloxacin (p. 54) Cefonicid (p. 116) Cilastatin (p. 177) Carbenicillin (p. 56) Cefoperazone (p. 118) Ciprofloxacin (p. 179) Cefacetrile (p. 58) Cefoselis (p. 120) Clarithromycin (p. 181) Cefaclor (p.
    [Show full text]
  • Directed Molecular Evolution of Fourth-Generation Cephalosporin Resistance in Wellington Moore Iowa State University
    Iowa State University Capstones, Theses and Graduate Theses and Dissertations Dissertations 2011 Directed molecular evolution of fourth-generation cephalosporin resistance in Wellington Moore Iowa State University Follow this and additional works at: https://lib.dr.iastate.edu/etd Part of the Medical Sciences Commons Recommended Citation Moore, Wellington, "Directed molecular evolution of fourth-generation cephalosporin resistance in" (2011). Graduate Theses and Dissertations. 10107. https://lib.dr.iastate.edu/etd/10107 This Thesis is brought to you for free and open access by the Iowa State University Capstones, Theses and Dissertations at Iowa State University Digital Repository. It has been accepted for inclusion in Graduate Theses and Dissertations by an authorized administrator of Iowa State University Digital Repository. For more information, please contact [email protected]. Directed molecular evolution of fourth-generation cephalosporin resistance in Salmonella and Yersinia by Wellington Moore A thesis submitted to the graduate faculty in partial fulfillment of the requirements for the degree of MASTER OF SCIENCE Major: Biomedical Science (Pharmacology) Program of Study Committee: Steve Carlson, Major Professor Timothy Day Ronald Griffith Iowa State University Ames, Iowa 2011 ii TABLE OF CONTENTS LIST OF FIGURES………………………………………………………………………iii LIST OF TABLES………………………………………………………………………..iv ABSTRACT……………………………………………………………………………….v CHAPTER 1. INTRODUCTION…………………………………………………………1 Review of B-Lactam antimicrobials………………………………...………1
    [Show full text]
  • WHO Report on Surveillance of Antibiotic Consumption: 2016-2018 Early Implementation ISBN 978-92-4-151488-0 © World Health Organization 2018 Some Rights Reserved
    WHO Report on Surveillance of Antibiotic Consumption 2016-2018 Early implementation WHO Report on Surveillance of Antibiotic Consumption 2016 - 2018 Early implementation WHO report on surveillance of antibiotic consumption: 2016-2018 early implementation ISBN 978-92-4-151488-0 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution- NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons. org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non- commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. WHO report on surveillance of antibiotic consumption: 2016-2018 early implementation. Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • Antibiotic Classes
    Penicillins Aminoglycosides Generic Brand Name Generic Brand Name Amoxicillin Amoxil, Polymox, Trimox, Wymox Amikacin Amikin Ampicillin Omnipen, Polycillin, Polycillin-N, Gentamicin Garamycin, G-Mycin, Jenamicin Principen, Totacillin, Unasyn Kanamycin Kantrex Bacampicillin Spectrobid Neomycin Mycifradin, Myciguent Carbenicillin Geocillin, Geopen Netilmicin Netromycin Cloxacillin Cloxapen Paromomycin Dicloxacillin Dynapen, Dycill, Pathocil Streptomycin Flucloxacillin Flopen, Floxapen, Staphcillin Tobramycin Nebcin Mezlocillin Mezlin Nafcillin Nafcil, Nallpen, Unipen Quinolones Oxacillin Bactocill, Prostaphlin Generic Brand Name Penicillin G Bicillin L-A, First Generation Crysticillin 300 A.S., Pentids, Flumequine Flubactin Permapen, Pfizerpen, Pfizerpen- Nalidixic acid NegGam, Wintomylon AS, Wycillin Oxolinic acid Uroxin Penicillin V Beepen-VK, Betapen-VK, Piromidic acid Panacid Ledercillin VK, V-Cillin K Pipemidic acid Dolcol Piperacillin Pipracil, Zosyn Rosoxacin Eradacil Pivampicillin Second Generation Pivmecillinam Ciprofloxacin Cipro, Cipro XR, Ciprobay, Ciproxin Ticarcillin Ticar Enoxacin Enroxil, Penetrex Lomefloxacin Maxaquin Monobactams Nadifloxacin Acuatim, Nadoxin, Nadixa Generic Brand Name Norfloxacin Lexinor, Noroxin, Quinabic, Aztreonam Azactam, Cayston Janacin Ofloxacin Floxin, Oxaldin, Tarivid Carbapenems Pefloxacin Peflacine Generic Brand Name Rufloxacin Uroflox Imipenem, Primaxin Third Generation Imipenem/cilastatin Balofloxacin Baloxin Doripenem Doribax Gatifloxacin Tequin, Zymar Meropenem Merrem Grepafloxacin Raxar Ertapenem
    [Show full text]
  • Guidelines on Urological Infections
    Guidelines on Urological Infections M. Grabe (Chairman), T.E. Bjerklund-Johansen, H. Botto, M. Çek, K.G. Naber, P. Tenke, F. Wagenlehner © European Association of Urology 2010 TABLE OF CONTENTS PAGE 1. INTRODUCTION 7 1.1 Pathogenesis of urinary tract infections 7 1.2 Microbiological and other laboratory findings 7 1.3 Classification of urological infections 8 1.4 Aim of guidelines 8 1.5 Methods 9 1.6 Level of evidence and grade of guideline recommendations 9 1.7 References 9 2. UNCOMPLICATED URINARY TRACT INFECTIONS IN ADULTS 11 2.1 Definition 11 2.1.1 Aetiological spectrum 11 2.2 Acute uncomplicated cystitis in premenopausal, non-pregnant women 11 2.2.1 Diagnosis 11 2.2.1.1 Clinical diagnosis 11 2.2.1.2 Laboratory diagnosis 11 2.2.2 Therapy 11 2.2.3 Follow up 12 2.3 Acute uncomplicated pyelonephritis in premenopausal, non-pregnant women 12 2.3.1 Diagnosis 12 2.3.1.1 Clinical diagnosis 12 2.3.1.2 Laboratory diagnosis 12 2.3.1.3 Imaging diagnosis 13 2.3.2 Therapy 13 2.3.2.1 Mild and moderate cases of acute uncomplicated pyelonephritis 13 2.3.2.2 Severe cases of acute uncomplicated pyelonephritis 13 2.3.3 Follow-up 14 2.4 Recurrent (uncomplicated) UTIs in women 16 2.4.1 Diagnosis 16 2.4.2 Prevention 16 2.4.2.1 Antimicrobial prophylaxis 16 2.4.2.2 Immunoactive prophylaxis 16 2.4.2.3 Prophylaxis with probiotics 17 2.4.2.4 Prophylaxis with cranberry 17 2.5 Urinary tract infections in pregnancy 17 2.5.1 Definition of significant bacteriuria 17 2.5.2 Screening 17 2.5.3 Treatment of asymptomatic bacteriuria 17 2.5.4 Duration of therapy 18 2.5.5 Follow-up 18 2.5.6 Prophylaxis 18 2.5.7 Treatment of pyelonephritis 18 2.5.8 Complicated UTI 18 2.6 UTIs in postmenopausal women 18 2.6.1 Risk factors 18 2.6.2 Diagnosis 18 2.6.3 Treatment 18 2.7 Acute uncomplicated UTIs in young men 19 2.7.1 Men with acute uncomplicated UTI 19 2.7.2 Men with UTI and concomitant prostate infection 19 2.8 Asymptomatic bacteriuria 19 2.8.1 Diagnosis 19 2.8.2 Screening 19 2.9 References 26 3.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • Association of Cardiovascular Risk with Inhaled Long-Acting Bronchodilators in Patients with Chronic Obstructive Pulmonary Disease: a Nested Case-Control Study
    Supplementary Online Content Wang M-T, Liou J-T, Lin CW, et al. Association of cardiovascular risk with inhaled long-acting bronchodilators in patients with chronic obstructive pulmonary disease: a nested case-control study. JAMA Intern Med. Published online January 2, 2018. doi: 10.1001/jamainternmed.2017.7720 eMethods 1. Development of a disease risk score-matched nested case-control study eMethods 2. Modeling a nonlinear duration-response association using a restricted cubic splines function model. eMethods 3. A case-crossover study for assessing the association between the CVD risk and use of LABAs and LAMAs eTable 1. Diagnosis codes used to define the comorbidities and individual drugs of comedications eTable 2. Comparison of CVD risk between new LAMA use and new LABA use eTable 3. Risk of each primary cardiovascular outcome with new LABA and LAMA use eTable 4. Case-crossover analysis for the risk of CVDs with use of LABA and LAMA within 30 days eTable 5. Clinical characteristics of CVD patients during the case and control periods in an alternative case-crossover study eTable 6. Numbers needed to harm for patients who had an increased CVD risk from using LABAs and LAMAs in our primary and secondary analyses eFigure 1. Overview for the adopted nested case-control study design. CVD, cardiovascular disease; COPD, chronic obstructive pulmonary disease; ER, emergency room; NHI represents National Health Insurance eFigure 2. Specification of case and control periods in an alternative case-crossover study eFigure 3. The impact of unmeasured confounders assessed by the rule-out method eFigure 4. Study flow diagram outlining the selection of study cohort © 2018 American Medical Association.
    [Show full text]
  • Statistical Analysis Plan / Data Specifications the Risk of Acute Liver Injury Associated with the Use of Antibiotics. a Replica
    WP6 validation on methods involving an extended audience Statistical analysis plan / data specifications The risk of acute liver injury associated with the use of antibiotics. A replication study in the Utrecht Patient Oriented Database Version: July 11, 2013 Authors: Renate Udo, Marie L De Bruin Reviewers: Work package 6 members (David Irvine, Stephany Tcherny-Lessenot) 1 1. Context The study described in this protocol is performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium). The overall objective of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe. Work package 6 “validation on methods involving an extended audience” aims to test the transferability/feasibility of methods developed in other WPs (in particular WP2 and WP5) in a range of data sources owned or managed by Consortium Partners or members of the Extended Audience. The specific aims of this study within WP6 are: to evaluate the external validity of the study protocol on the risk of acute liver injury associated with the use of antibiotics by replicating the study protocol in another database, to study the impact of case validation on the effect estimate for the association between antibiotic exposure and acute liver injury. Of the selected drug-adverse event pairs selected in PROTECT, this study will concentrate on the association between antibiotic use and acute liver injury. On this topic, two sub-studies are performed: a descriptive/outcome validation study and an association study. The descriptive/outcome validation study has been conducted within the Utrecht Patient Oriented Database (UPOD).
    [Show full text]
  • Critically Important Antimicrobials for Human Medicine – 5Th Revision. Geneva
    WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) Critically Important Antimicrobials for Human Medicine 5th Revision 2016 Ranking of medically important antimicrobials for risk management of antimicrobial resistance due to non-human use Critically important antimicrobials for human medicine – 5th rev. ISBN 978-92-4-151222-0 © World Health Organization 2017, Updated in June 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/ igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Critically important antimicrobials for human medicine – 5th rev. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.
    [Show full text]
  • 6-Veterinary-Medicinal-Products-Criteria-Designation-Antimicrobials-Be-Reserved-Treatment
    31 October 2019 EMA/CVMP/158366/2019 Committee for Medicinal Products for Veterinary Use Advice on implementing measures under Article 37(4) of Regulation (EU) 2019/6 on veterinary medicinal products – Criteria for the designation of antimicrobials to be reserved for treatment of certain infections in humans Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Introduction On 6 February 2019, the European Commission sent a request to the European Medicines Agency (EMA) for a report on the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials. The Agency was requested to provide a report by 31 October 2019 containing recommendations to the Commission as to which criteria should be used to determine those antimicrobials to be reserved for treatment of certain infections in humans (this is also referred to as ‘criteria for designating antimicrobials for human use’, ‘restricting antimicrobials to human use’, or ‘reserved for human use only’). The Committee for Medicinal Products for Veterinary Use (CVMP) formed an expert group to prepare the scientific report. The group was composed of seven experts selected from the European network of experts, on the basis of recommendations from the national competent authorities, one expert nominated from European Food Safety Authority (EFSA), one expert nominated by European Centre for Disease Prevention and Control (ECDC), one expert with expertise on human infectious diseases, and two Agency staff members with expertise on development of antimicrobial resistance .
    [Show full text]