Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial
Philippe BéginJeannie CallumErin JamulaRichard J. CookNancy M. HeddleAlan TinmouthMichelle P. ZellerGuillaume Beaudoin-BussièresLuiz AmorimRenée BazinKent Cadogan LoftsgardRichard CarlMichaël ChasséMelissa M. CushingNick DanemanDana V. DevineJeannot DumaresqDean FergussonCaroline GabeMarshall J. GlesbyNa LiYang LiuAllison McGeerNancy RobitailleBruce S. SachaisDamon C. ScalesLisa SchwartzNadine ShehataAlexis F. TurgeonHeidi WoodRyan ZarychanskiAndrés FinziDanièle MarceauAndy HuangHolly CarrYulia LinRosemarie LallChristopher J GrahamChristine ArsenaultValérie SalesDavinder SidhuMakeda SemretCaroline HammEneko ArhanchiagueZiad SolhNadim SrourKarim SolimanColin YeeVinçent LarocheSusan NahirniakChristina GreenawayMenaka PaiAndréanne CôtéJennifer TsangChristine Cserti‐GazdewichDanielle TalbotSébastien PoulinRodrigo Régnier Chemim GuimarãesMoira Rushton-MarovacAlexandra LangloisShuoyan NingAndrew W. ShihMélissa BoileauHarjot SinghDonna LedinghamArjuna PonnampalamMatthew YanOksana Prokopchuk‐GaukAndré PoirierGabriel GirouardKaterina PavenskiOlivier DrouinDavid HarrisMadéleine DurandEmily RimmerDaniel OvakimFrançois MénardGlenna CuccaroloJulie CarruthersKayla J. LucierValérie ArsenaultMarie‐Christine AuclairMeda AvramMichael BrassardSabrina CerroVerónica González MartínezJulie MorinMarie Saint-JacquesMaxime VeilletteChantal ArmaliAmie KronDimpy ModiJoanne DuncanPauline JustumusMelanie St JohnGeneviève St‐OngeMilena Hadzi‐TosevPierre‐Marc DionLawrence McGillivaryAndre Valleteau de MoulliacSheila A. NymanStephanie PerilliPaulette Jean Van VlietShannon LaneKaterina PavenskiRebecca PereiraEmily SirotichJulie AbelsonSaara GreeneAditi KhandelwalSwarni ThakarSarah LongoSai Priya AnandMehdi BenlarbiCatherine BourassaMarianne BoutinJade Descôteaux-DinelleGabrielle Gendron‐LepageGuillaume GoyetteAnnemarie LaumaeaHalima MedjahedJérémie PrévostJonathan RichardDaniel E. KaufmannElsa Brunet‐RatnasinghamNicolas ChaumontMichael DrebotAlyssia RobinsonEmelissa J. MendozaKristina DimitrovaKathy ManguiatClark PhillipsonMichael ChanDavid T. EvansYi-Chan LinLucie BoyerMarc CloutierMathieu DrouinÉric DucasNathalie DussaultMarie‐Josée FournierPatricia LandyMarie-Ève NolinJosée PerreaultTony TremblayIshac NazyFeng XieDavid LiuMichelle WongGus SilverioKristin WalkusMikaela BartonKatherine HavemanDarlene MuellerAshley ScottMatthew MoherGordon WoodTracey RoartyF. C. AuldGayle CarneyVirginia ThomsonRodrigo OnellKeith R. WalleyKatie DonohoeCrystal BrunkGeraldine HernándezTina JacobucciLynda LazoskyPuneet MannGeeta RavalLigia Araujo ZampieriMypinder S. SekhonAlissa WrightNicola JamesGaby ChangRoy ChenKanwal DeolJorell GantioquiElyse LarsenNamita RamdinMargaret RocheKristin RosinskiLawrence ShamMichelle StormsMark R. GillrieEtienne MahéDeepa SuryanarayanAlejandra Ugarte-TorresTraci RobinsonMitchell GibbsJulia Hews‐GirardMarnie HolmesJoanna McCarthyMeagan OdyKaren DoucetteWendy SliglAshlesha SonparK RobertsonJeffrey NarayanLeka RavindranBreanne StewartLori ZapernickStephen LeeEric SyAlexander WongKarolina GryzbSarah CraddockDennaye FuchsDanielle MyrahSana SunnySheila Rutledge HardingSiddarth KogilwaimathNancy HodgsonDawn JohnsonSimona MeierKim ThomsonAmila HeendeniyaBrett L. HoustonYoav KenyanSylvain LotherKendiss OlafsonBarret RushTerence WuerzDayna SolvasonLisa AlbensiSoumya AliasNora ChoiLaura M. CurtisMaureen HutmacherHessam H. KashaniDebra LaneNicole MartenTracey Pronyk-WardLisa RigauxRhonda SilvaQuinn TaysRenuka NaiduJane MathewsMargaret MaiVictoria MiceliLiz MolsonR. GayathriLinda SchaeferMichel Ferreira Cardia HaddadShannon LandryRobert ChernishRebecca KruisselbrinkTheresa LiuJayna JerominAtif SiddiquiCarla GirolamettoKristin KrokoszynskiCheryl MainAlison Fox‐RobichaudBram RochwergErjona KrujaDana EllinghamDisha SampatNgan TangDaniela LetoMeera KarunakaranDaniel RicciutoKelly FuscoTaneera GhateHolly RobinsonIan BallSarah ShalhoubMarat SlessarevMichael G. SilvermanEni NanoTracey BentallEileen CampbellJeffery KinneySeema Nair ParvathyEvridiki FeraAnthony La DelfaJeya NadarajahH. SolowEdeliza MendozaKatrina EngelDiana MonacoLaura KononowSutharsan SuntharalingamMike FralickLaveena MunshiSamia SaeedOmar HajjajElaine HsuKarim AliErick DuanGeorge FarjouLorraine JensonMary SalibLisa PattersonSwati AnantJosephine DingJane JomyPavani DasAnna GeageaSarah IngberElliot OwenAlexandra LostunTashea AlbanoAntara ChatterjeeManuel GiraldoJennifer HickeyIda LeeNea OkadaNicholas PasqualeRomina PonzielliMary RahmatShelina SaburMaria SchlagLeonita AguiarAshmina DamaniSuhyoung HongMona KokabiCarolyn PerkinsJuthaporn CowanTony GiuliviDerek R. MacFaddenJoe CyrAmanda PecarskieRebecca PorteousPriscila Ogawa VedderIrene WatpoolPhil BerardiLaith BustaniAlison GraverAkshai IyengarMagdalena KisilewiczJake MajewskiMisha MarovacRuchi MurthyKaran SharmaMarina WalcerZain ChaglaJason Pui Yin CheungErick DuanFrance ClarkeKarlo MaticManuel GiraldoJennifer HickeyIda LeeNea OkadaNicholas PasqualeRomina PonzielliMary RahmatShelina SaburMaria SchlagTravis CarpenterKevin L. SchwartzParil SutharAziz JiwajeeDaniel LindsayAftab MalikBrandon TseLarissa MatukasJoel G. RayShirley K. BellElizabeth KrokRay GuoSusan JohnVishal D. JoshiJessica KeenChris LazongasJacqueline OstroKevin ShoreJianmin WangJinCheol ChoiPujitha NallapatiTina IrwinVictor WangPetra SheldrakeNeill K. J. AdhikariHannah WunschJacob BaileyHarley MeirovichConnie ColavecchiaEiad KahwashSachin SudMartin RomanoBryan CoburnLorenzo Del SorboJohn GrantonShahid HusainJacob PendergrastAbdu SharkawyLiz WilcoxSamia SaeedOmar HajjajMaria KulikovaSophia Z. MassinWendy KennetteIan MazzettiKrista NaccaratoGrace ParkAlex PennettiCorrin PrimeauCathy VilagYves LapointeAnne‐Sophie LemayEmmanuelle DuceppeBenjamin Rioux‐MasséCécile TremblayPascale ArlottoClaudia BouchardStephanie MatteMarc Messier-PeetCharles-Langis FrancoeurFrançois LauzierGuillaume LeblancDavid BellemareÈve CloutierOlivier CosterousseÉmilie Couillard ChénardRana DaherMarjorie DaigleStéphanie GrenierGabrielle GuilbeaultMarie-Pier RiouxMaude St‐OngeAntoine TremblayBrian BeaudoinL. LanthierPierre LarrivéePierre‐Aurèle MorinÉlaine CarbonneauRobert LacasseJulie AutmizguineIsabelle BoucoiranGeneviève Du Pont‐ThibodeauAnnie La HayeVincent LagueKarine LéveilléCaroline Quach-ThanhGuillaume ÉmériaudPhilippe JouvetÉlie HaddadCamille Turgeon-ProvostSusan M. FoxDiaraye BaldéLorraine MénardSuzanne MorissetteMiriam Schnorr-MelocheAndrée-Anne TurcotteCaroline ValléeStéphanie CastonguayTuyen NguyenNatalie RivestMarios RoussosEsther SimoneauAndreea BelecciuMarie-Hélène BouchardEric DaviauCynthia L. MartinNicole SabourinSolange TremblayÉmilie GagnéNancy-Lisa GagnéJulie LaroucheVanessa LaroucheVéronick TremblayVicky TremblayPierre BlanchetteDavid ClaveauMarianne LamarreDanielle TappsMartin AlbertAnatolie DucaJean‐Michel LeducJean-Samuel Boudreault-PedneaultAnnie BarsalouSuzanne Deschênes-DionStéphanie IbrahimStéphanie RidyardJulie RousseauStéphane P. AhernMarie‐Pier ArsenaultSimon-Frédéric DufresneLuigina MollicaHang Ting WangSoizic BeauDominique BeaupréMarjolaine DégarieIris DelormeMelissa FarkasMichel‐Olivier GrattonArnaud GuertinGuylaine JalbertMélanie MeilleurCharles Ratté LabrecqueElaine Vieira SantosJulie Trinh LuJulien AugerMarie-Claude LessardLouay MardiniYves PesantLaurie DelvesLisa DelvesSophie DenaultС. Ю. ГригороваMichelle LambertNathalie LangilleCorinne LangloisCaroline RockYannick Sardin-LaframboisePatrick ArchambaultJoannie Bélanger-PelletierEstel Duquet-DebloisVanessa Dupuis-PicardYannick HamelinSamuel LeducMélanie N. RichardMarc FortinPhilippe GervaisMarie‐Ève BoulayClaudine FerlandJakie GuertinJohane LepageAnnie RoySarit AssoulineStephen CaplanLing Yuan KongChristina CanticasCarley MayhewJohanne OuedraogoTévy-Suzy TepGerald BatistMatthew P. ChengMarina B. KleinNadine KronfliPatricia PelletierSalman QureshiDonald C. VinhRobert DziarmagaHansi PeirisKarène Proulx‐BoucherJonathan RogerMolly-Ann RothschildChung-Yan YuenSapha BarkatiJean‐Pierre RoutySondra Sinanan-PelletierRémi LeBlancÈve St‐HilairePatrick ThibeaultKarine MorinGilberte CaissieJackie Caissie ColletteL. DaigleMélissa DaigleBianca GendronNathalie GodinAngela LapointeG. MoreauLola Ouellette-BernierJoanne RockburnBrigitte Sonier-FergusonChristine M. WilsonRobert A. DeSimoneGrant EllsworthRebecca C. FryNoah GossRoy M. GulickCarlos VaamondeTimothy WilkinCeline ArarJonathan BerardiDennis ChenCristina Garcia-MillerArthur GoldbachLauren GrippDanielle HaydenKathleen KaneJiamin LiKinge-Ann MarcelinChristina MegillMeredith NelsonAilema PaguntalanGabriel RaabGianna RessoRoxanne RosarioNoah RossenShoran TamuraEthan ZhaoCheryl GossYoung KimEshan U. PatelSonal PaulTiffany RomeroNaima ElBadriLina FloresTricia SandovalShashi N. KapadiaLjiljana V. VasovićShanna-Kay GriffithsDaniel AlvaradoFiona GoudyMelissa LewisMarina LoizouRita LouieChantale PambrunSylvia TorranceSteven J. DrewsJanet McManusOriela CuevasWanda LafresnePatrizia RuosoChristine ShinTony SteedRachel N. WardIsabelle AllardMarc GermainSébastien GirardÉric ParentClaudia-Mireille PigeonMaria Esther LopesMargarida PêcegoNatalia Fonseca do RosárioCarlos Alexandre da Costa SilvaThais da Costa OliveiraMaria Cristina LopesSheila de Oliveira Garcia MateosLucette HallSarai ParadisoD StraussDonald M. Arnold
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Abstract The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset ( NCT04348656 ). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm—relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94–1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02–1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57–0.95 and OR = 0.66, 95% CI 0.50–0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14–2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care.Keywords:
Convalescent plasma
Globally, COVID-19 caused by SARS-CoV-2 has resulted in millions of infections and several thousand deaths. Amid the race for the development of vaccines and antiviral drugs, convalescent plasma therapy has emerged as an emergency treatment for SARS-CoV-2 infected patients. In this review, we provide an overview of the use of passive immunization-based therapy as an immediate measure during novel viral infections when no other treatments are available. We also discuss the benefits and challenges faced by the use of convalescent plasma therapy in the COVID-19 pandemic. Further, we attempted to stress the relevance of convalescent plasma-derived hyper-immunized immunoglobulins with high neutralizing activity as a potential therapeutic intervention for COVID-19.
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High expectations have been set around convalescent plasma (CP) for the treatment of COVID-19. However, none of the randomized controlled trials (RCTs) conducted so far have reached their primary endpoints. Herein we report that RCTs of CP disclose a high methodological variability in inclusion criteria, outcomes, appropriate selection of donors, dosage, concentration of neutralizing antibodies and times of transfusion. Therefore, at this time there is insufficient evidence to recommend for or against the use of CP as a treatment for COVID-19.
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In line with other medical journals, odds ratios are increasingly being reported in anaesthesia literature. the frequency of the use of odds ratio and how well it relates to the relative risk when it is interpreted as relative risk remains unknown. we investigated the use of odds ratio, and its relationship to relative risk and the incidence of outcome in this study. we identified 60 meta-analyses and 87 original articles that reported odds ratios. while relative risk could have been reported in 79% of the studies, only a small proportion (3%) of these studies have estimated and reported the relative risk in addition to the odds ratio. there is a significant bias if odds ratio is interpreted as relative risk, especially so when the incidence of outcome is high. while odds ratio is a valid measure of treatment effect in its own right, anaesthetists and investigators should be careful not to interpret odds ratio as equivalent to relative risk.
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The recent outbreak of COVID-19 in the world is currently a big threat to global health and economy. Convalescent plasma has been confirmed effective against the novel corona virus in preliminary studies. In this paper, we first described the therapeutic schedule, antibody detection method, indications, contraindications of the convalescent plasmas and reported the effectiveness of convalescent plasma therapy by a retrospective cohort study.
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We read with considerable interest the Comment from Long Chen and colleagues1Chen L Xiong J Bao L Shi Y Convalescent plasma as a potential therapy for COVID-19.Lancet Infect Dis. 2020; 20: 398-400Summary Full Text Full Text PDF PubMed Scopus (775) Google Scholar about the potential use of convalescent plasma for the treatment of COVID-19. Chen and colleagues mention the earlier pragmatic WHO recommendation for the use of convalescent plasma as therapy in Ebola virus disease.2WHOUse of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks.https://www.who.int/csr/resources/publications/ebola/convalescent-treatment/enDate: 2014Date accessed: June 3, 2020Google Scholar The absence of a clinically relevant therapeutic benefit in patients with Ebola virus infection described by Griensven and colleagues,3van Griensven J Edwards T de Lamballerie X et al.Evaluation of convalescent plasma for Ebola virus disease in Guinea.N Engl J Med. 2016; 374: 33-42Crossref PubMed Scopus (422) Google Scholar and more recently the finding of no therapeutic benefit in a small trial in patients with COVID-19 in Zhengzhou, China,4Zeng Q-L Yu Z-J Gou J-J et al.Effect of convalescent plasma therapy on viral shedding and survival in COVID-19 patients.J Infect Dis. 2020; (published online April 29.)DOI:10.1093/infdis/jiaa228Google Scholar will be used to question the usefulness of convalescent plasma in COVID-19. In the Guinea-Bissau Ebola study,3van Griensven J Edwards T de Lamballerie X et al.Evaluation of convalescent plasma for Ebola virus disease in Guinea.N Engl J Med. 2016; 374: 33-42Crossref PubMed Scopus (422) Google Scholar no attempt was made to select donors for the potency of their neutralising antibody. In the COVID-19 study,4Zeng Q-L Yu Z-J Gou J-J et al.Effect of convalescent plasma therapy on viral shedding and survival in COVID-19 patients.J Infect Dis. 2020; (published online April 29.)DOI:10.1093/infdis/jiaa228Google Scholar seropositive donors were recruited only after IgM antibody to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was no longer detected, and no attempt to quantify the antibody response was reported. We previously described the levels of detectable antibody and the inferred level of neutralising antibody in convalescent plasma donors for patients with Ebola virus disease in Sierra Leone,5Tedder RS Samuel D Dicks S et al.Detection, characterization, and enrolment of donors of Ebola convalescent plasma in Sierra Leone.Transfusion. 2018; 58: 1289-1298Crossref PubMed Scopus (21) Google Scholar showing 100-fold differences in the level of neutralising antibody. We described a strategy for selecting donors with the highest levels of neutralising antibody, which was not undertaken in donors in the Guinea-Bissau or Zhengzhou studies. For planned interventions in the treatment of patients with COVID-19 severe disease, we strongly recommend selection and qualification only of donors who carry the highest levels of detectable neutralising antibody to SARS-CoV-2. In this respect, we have data which indicate that quantification of specific antibody to the receptor-binding domain will indicate levels of neutralising antibody (unpublished). Commercial assays based on the receptor-binding domain alone, although not intended for the purpose of identifying suitable convalescent plasma donors, will probably be able to serve this need. MGS reports grants from DHSC National Institute for Health Research, Medical Research Council UK, and Health Protection Research Unit in Emerging and Zoonotic Infections at the University of Liverpool during the conduct of this work and being a minority owner of Integrum Scientific outside the submitted work. RST declares no competing interests. Convalescent plasma as a potential therapy for COVID-19The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. The pneumonia induced by the SARS-CoV-2 is named coronavirus disease 2019 (COVID-19). By Feb 22, 2020, this virus has affected more than 77 700 people worldwide and caused more than 2300 deaths. To date, no specific treatment has been proven to be effective for SARS-CoV-2 infection. Apart from supportive care, such as oxygen supply in mild cases and extracorporeal membrane oxygenation for the critically ill patients, specific drugs for this disease are still being researched. Full-Text PDF
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Guidelines for cervical screening await scientific evaluationEditor-In a news item about cervical screening in England 1 Wise refers to a report by the National Audit Office. 2 The office is particularly critical of serious failings in the interpretation of cervical smears in a small number of laboratories.The laboratory at the Hospital of St Cross in Rugby is included among these laboratories.In fact, a massive rescreening exercise at the hospital did not find any serious errors of interpretation, and the original reports were considered to be substantially correct and within the accepted operating limits of the smear test.The National Audit Office and the public assume that any deviation from the national guidelines for reporting rates represents mistakes by the laboratory.It is therefore interesting that, although the results at the hospital in Rugby were outside these guidelines, no serious errors were identified.This raises the question of whether the guidelines are an appropriate measure of laboratory performance.The guidelines themselves have come under considerable criticism in the pathology literature because of the lack of scientific evidence on which they are based. 3 One of their own authors has been particularly outspoken on the subject. 4 Though some of these arguments may seem of academic interest, cytology departments are being forced to close or merge as a result of the guidelines, which await scientific evaluation.Many staff feel threatened by the prescriptive way in which the guidelines have been introduced and applied and by the lack of understanding by the lay public and media of the limitations of the smear test.The incidence of and mortality from cervical cancer in the United Kingdom have shown accelerated falls since the introduction of organised screening (J Patnick, NHS cervical screening programme information sheet, 21 Nov 1996).Of course there is room for improvement, but it is ironic that the publication of various reports designed to improve the service could lead to its eventual collapse through staff leaving the profession.
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Both relative risk (RR) and odds ratio (OR) are common measures of treatment effect on randomized controlled trials, systematic reviews and meta-analyses. However few scientists interpret properly these measures, and many scientists mix-up their meanings and use either of them unsystematically, thus leading to misinterpretations. PURPOSE To systematize the proper usage of RR and OR on randomized controlled trials. METHODS We analyzed the complete relation between risk from 0 to 1 and odds from 0 to infinite with a precision of 0.01 for risk. Then, the relation between RR and OR was analyzed separately for both RR and OR values of either greater or less than one. When both of them were greater than one, the OR/RR ratio was analyzed at different control (5, 10, 15, 20, 30, 40, 50, 60 and 70%) and treatment (from 6 to 99%, with 1% of precision) event rates; in these cases the treatment event rate was always higher than the control event rate. When both RR and OR were less than one, we analyzed the RR/OR ratio at other control (10, 20, 30, 40, 50, 60, 70, 80, 90 and 95%) and treatment (from 1 to 94%, with 1% of precision) event rates; in these cases, the treatment event rate was always less than the control event rate. RESULTS Although odds was always higher than risk for all possible values, such risk overestimation by odds was low when risk was low. Actually, when the risk rose above 20% the gap between the odds and the risk widened. Since OR and RR are calculated by dividing these measures, the differences between RR and OR began from both control and treatment event rates higher than 20%. These differences (> 25%) were enough to misinterpret results. CONCLUSION OR is misleading when both treatment and control event rates are higher than 20%. In these instances, RR must be used instead of OR on randomized controlled trials.
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Abstract The COVID-19 is currently spreading around the world, which has posed significant threats to global health and economy. Convalescent plasma is confirmed effective against the novel corona virus in preliminary studies. In this paper, we first described the therapeutic schedule, antibody detection method, indications, contraindications of the convalescent plasmas, and reported the operability of the treatment by case study.
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2019-20 coronavirus outbreak
Corona (planetary geology)
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In line with other medical journals, odds ratios are increasingly being reported in anaesthesia literature. The frequency of the use of odds ratio and how well it relates to the relative risk when it is interpreted as relative risk remains unknown. We investigated the use of odds ratio, and its relationship to relative risk and the incidence of outcome in this study. We identified 60 meta-analyses and 87 original articles that reported odds ratios. While relative risk could have been reported in 79% of the studies, only a small proportion (3%) of these studies have estimated and reported the relative risk in addition to the odds ratio. There is a significant bias if odds ratio is interpreted as relative risk, especially so when the incidence of outcome is high. While odds ratio is a valid measure of treatment effect in its own right, anaesthetists and investigators should be careful not to interpret odds ratio as equivalent to relative risk.
Odds
Diagnostic odds ratio
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