www.bjorl.org
Brazilian
Journal
of
OTORHINOLARYNGOLOGY
ORIGINAL
ARTICLE
Validation
of
the
Modena
bleeding
score
in
endoscopic
sinus
surgery
夽,夽夽
Matteo
Alicandri-Ciufelli
a,
Luca
Pingani
b,c,
Francesco
Maccarrone
a,∗,
Lukas
Anschuetz
d,
Davide
Mariano
a,
Gian
Maria
Galeazzi
c,e,
Livio
Presutti
a,
Giulia
Molinari
aaUniversityHospitalofModena,Otolaryngology-HeadandNeckSurgeryDepartment,Modena,Italy bAziendaUSL-IRCCSdiReggioEmilia,HRDepartment,ReggioEmilia,Italy
cUniversityofModenaandReggioEmilia,DepartmentofBiomedical,MetabolicandNeuralSciences,Modena,Italy dInselspital,UniversityofBern,DepartmentofOtorhinolaryngology,HeadandNeckSurgery,Bern,Switzerland eAziendaUSLdiModena,DepartmentofMentalHealthandPathologicalAddiction,Modena,Italy
Received7May2020;accepted27August2020
KEYWORDS Bleeding; Endoscopicsurgery; Modenableeding score; Sinussurgery; Surgicalfieldrating
Abstract
Introduction:TheModenableedingscoreisacategoricalratingscalethatallowsthe assess-ment ofthesurgical fieldinrelationtobleedingduring endoscopicsurgery.Ithasrecently beenpresentedandvalidatedinthefieldofendoscopicearsurgeryby thepresentauthors. TheModenableedingscoreprovidesfivegradesforratingthesurgicalfieldduringendoscopic procedures(fromgrade1−nobleedingtograde5−bleedingthatpreventsevery surgical procedureexceptthosededicatedtobleedingcontrol).
Objective: TheaimofthisstudywastovalidatetheModenableedingscoreinthesettingof endoscopicsinussurgery.
Methods:Fifteenthree-minutevideosofendoscopicsinussurgeryprocedures(eachcontaining threebleedingsituations)wereevaluatedby15specialists,usingtheModenableedingscore. Intraandinter-raterreliabilitywereassessed,andtheclinicalvalidityoftheModenableeding scorewascalculatedusingareferentstandard.
Results:Thedataanalysisshowedanintra-raterreliabilityrangingfrom0.6336to0.861.The inter-raterreliabilityrangedfrom0.676to0.844.Theclinicalvaliditywas␣=0.70;confidence limits:0.64−0.75,correspondingtosubstantialagreement.
夽 Pleasecitethisarticleas:Alicandri-CiufelliM,PinganiL,MaccarroneF,AnschuetzL,MarianoD,GaleazziGM,etal.Validationofthe
modenableedingscoreinendoscopicsinussurgery.BrazJOtorhinolaryngol.2020.https://doi.org/10.1016/j.bjorl.2020.08.006
夽夽PeerReviewundertheresponsibilityofAssociac¸ãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial. ∗Correspondingauthor.
E-mail:fra.maccarrone@gmail.com(F.Maccarrone).
https://doi.org/10.1016/j.bjorl.2020.08.006
1808-8694/©2020Associac¸˜aoBrasileiradeOtorrinolaringologiaeCirurgiaC´ervico-Facial.PublishedbyElsevierEditoraLtda.Thisisanopen accessarticleundertheCCBYlicense(http://creativecommons.org/licenses/by/4.0/).
Conclusion:TheModenableedingscoreisaneffectivemethodtoscorebleedingduring endo-scopicsinussurgery.Itsapplicationinfuture researchcouldfacilitatetheperformanceand efficacy assessment ofsurgical techniques, materials ordevices aimed to bleedingcontrol duringendoscopicsinussurgery.
© 2020 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Published by Elsevier Editora Ltda. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/). PALAVRAS-CHAVE Sangramento; Cirurgiaendoscópica; Escorede sangramentode Modena; Cirurgiasinusal; Avaliac¸ãodocampo cirúrgico
Validac¸ãodoescoredesangramentodeModenaemcirurgiaendoscópicadoseionasal
Resumo
Introduc¸ão:OescoredesangramentodeModenaéumaescaladeclassificac¸ãodecategorias quepermite aavaliac¸ão docampo cirúrgicoem relac¸ãoao sangramento duranteacirurgia endoscópica.Recentemente,elefoiapresentadoevalidadonocampodacirurgiaendoscópica otológicapelospresentesautores.OescoredesangramentodeModenafornececincograus paraclassificac¸ãodocampocirúrgicoduranteprocedimentosendoscópicos(degrau1---Sem sangramentoatégrau5---Sangramentoqueimpedetodososprocedimentoscirúrgicos,exceto aquelesdedicadosaocontroledesangramento).
Objetivo:OobjetivodesteestudofoivalidaroescoredesangramentodeModenanocontexto dacirurgiaendoscópicanasossinusal.
Método: Quinzevídeosdetrêsminutosdeprocedimentosdecirurgiaendoscópica nasossinu-sais(cadaumcontendotrêssituac¸õesdesangramento)foramavaliadospor15especialistas, utilizandooescoredesangramentodeModena.A confiabilidadeintraeinterexaminadorfoi avaliada,eavalidadeclínicadoescoredesangramentofoicalculadautilizandoumpadrãode referência.
Resultados: Aanálisedosdadosmostrouconfiabilidadeintraexaminadorvariandode0,6336a 0,861.Aconfiabilidadeinterexaminadorvarioude0,676a0,844.Avalidadeclínicafoi␣=0,70; limitesdeconfianc¸a:0,64-0,75,correspondendoaconcordânciasubstancial.
Conclusão:OescoredesangramentodeModenaéummétodoeficazparaavaliarosangramento duranteacirurgiaendoscópicanasossinusal.Suaaplicac¸ãoempesquisasfuturaspodefacilitaro desempenhoeavaliac¸ãodaeficáciadetécnicascirúrgicas,materiaisoudispositivosdestinados aocontroledesangramentoduranteessascirurgias.
© 2020 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Publicado por Elsevier Editora Ltda. Este ´e um artigo Open Access sob uma licenc¸a CC BY (http:// creativecommons.org/licenses/by/4.0/).
Introduction
(ESS)isthecurrentstandardtreatmentforavarietyof con-ditionsaffectingthenasalcavityandtheparanasalsinuses, suchaschronicrhinosinusitis,benignandmalignanttumors orcerebrospinalfluidleaks.1
Being mostly a one-handed technique, ESS does not allowsimultaneoususeofoperativeinstrumentsandblood suction,thusendonasalbleedingcontrolrepresentsa chal-lengingissuefortheoperatingsurgeon.
Such narrow and highly vascularized cavities like the nasal fossae and paranasal spaces can be entirely filled withbloodwithinfewseconds,especiallyifthemucosais severelyinflamedasaconsequenceofrhinosinusitis.
Bleedingispossiblythemostrelevantfactor thatcould impairthe quality of the surgical fieldduring endoscopic procedures.Ithasbeenproventhatuncontrolled bleeding duringendoscopicsinussurgicalproceduresdeterminespoor visualizationoftheanatomicallandmarks,prolongssurgical timeandcarriesahigherrateofcomplications.2---4
Several techniques to control intraoperative bleeding andimprovesurgicalviewduringsinussurgery(e.g.topical vasoconstrictors, total intravenous anesthesia, controlled hypotension) have been described and analysed to deter-minetheirefficacy.5,6Thesetypesofstudies,however,are
complexandpronetobias,partiallybecausestandardized and validated methods of quantifying bleedingor grading thesurgicalfieldinendoscopicviewarelacking.
Among the most cited grading system is the Fromme-Boezaart grading scale, a six-point scale based on the frequencyofsuctioningrequiredtomaintaintheclarityof the surgicalfield.7 It wasvalidatedby Athanasiadis etal.
and, to present authors knowledge, it is the only bleed-ingscorecurrentlyvalidatedinsinussurgery.8Theratingin
theFromme-Boezaart grading scaledepends onfrequency of suctioning: this is actuallya major limitation,because suctioning during ESS is also used to help to dissect and remove irrigation fluid used for clarification of the field. Consequently,thefrequencyofsuctioningisnotalways pro-portional tothe actual entity ofbleeding. Anotherrating
Table1 Modenableedingscore.
Scoring
Nobleeding 1
Bleedingeasilycontrolledbysuctioning,washing orpackingwithoutanysignificantmodificationor slowingofsurgicalprocedure
2
Bleedingslowingsurgicalprocedure 3 Mostofthemaneuversdedicatedtobleeding control
4 Bleedingthatpreventseverysurgicalprocedure exceptthosededicatedtobleedingcontrol
5
scaledevelopedforESSistheWormaldsurgicalfield grad-ingscale,a11-gradescalebasedonnumberofoozingpoints inthesurgicalfieldandonthesecondsbloodtakestofillthe sphenoidsinus,whichmakesthisscalestrictlydependanton thisanatomicalsite.8
TheModenableedingscore(MBS)isacategoricalrating scalethatallowstheassessmentofthesurgicalfieldin rela-tiontobleedingduringendoscopicsurgery.Ithasrecently beenpresentedandvalidatedinthefieldofendoscopicear surgerybythepresentauthors.9Beingindependentfroma
specific anatomical district or dedicated instrumentation, itsapplication couldbe extended toother surgical fields, makingitapotentiallyuniversalbleedingscore.
TheaimofthepresentpaperwastovalidatetheMBSin thecontextofESS.Auniformandvalidatedbleedingscore like theMBS wouldbe a reliable toolin the performance andefficacy assessment of materials andtechniques used tocontrolintraoperativebleedinginESS.
Methods
TheModenableedingscore(MBS)
The MBSis acategoricalscale writtenin Englishthat pro-videsfivedifferentlevels(from‘‘Grade1−nobleeding’’to ‘‘Grade5−bleedingthatpreventseverysurgicalprocedure exceptthosededicatedtobleedingcontrol’’),asshownin
Table1.Beingalreadyassessed,9thefacevalidityoftheMBS
wasnotrepeatedforthisstudy.
Intra-raterandinter-raterreliability
Afterinformedconsent,fifteensurgeonscurrentlyworking at the Departmentof Otorhinolaryngology-Head andNeck SurgeryoftheUniversityHospitalofModenawereinvolved inthestudyasevaluatorsforintra-raterandinter-rater reli-abilityassessment.5outof15oftheratersperformmore than50nasalsurgeriesayear.5outof15performbetween 30---50proceduresayear,and5outof15performlessthan 30proceduresayear.
Fifteen videosofvariousendoscopicsinus surgical pro-cedureswererandomlyselectedbyoneoftheauthors(DM) fromthedepartmental archiveof operative video record-ings. Three bleeding situations (referred to ast0, t1 and t2) were selected haphazardly by the same author from eachvideo,andthentheseone-minuteclipswereeditedto
produceafinal three-minutevideo to beevaluated. Each participant had to evaluate the same randomly selected three-minutevideotwice,at15-daydistanceusingtheMBS, forthemeasurementof intra-raterreliability.Each evalu-atorwasalsoaskedtoassesstwoothereditedvideosfrom theselection,usingtheMBS.Theseevaluationswere sub-sequently compared to those of the other evaluators on thesameeditedvideos,tocalculatetheinter-rater relia-bility.
Intra-rater reliability was calculated using Spearman’s rank correlation coefficient ranging from -1 (perfect neg-ative correlation) to 1 (perfect positive correlation): the strength of the correlation was defined using the follow-ingcriteria: 0.00---0.19 ‘‘veryweak’’, 0.20---0.39‘‘weak’’, 0.40---0.59‘‘moderate’’,0.60---0.79‘‘strong’’and0.80---1.0 ‘‘verystrong’’.Intraclass correlation coefficient wasused forcalculatinginter-raterreliability(lessthan0.40:poor; between0.40and0.59:fair;between0.60and0.74:good; between0.75and1.00,excellent).10,11
Clinicalvalidity
TheclinicalvalidityoftheMBSwascalculatedusingagold standard. A group of four medical specialists in otorhi-nolaryngology (not involved in other areas of this study) collegiallyviewedandevaluatedallthe45bleeding situa-tions present in the 15 edited videos. After extensive discussion, the group defined a unanimous score through the MBS for each bleeding situations (to be referred to as referent standard). The referent standard evaluations were then compared with those obtained for inter-rater reliability. The agreement level was calculated through Krippendorff’s Alpha (<0 no agreement; 0---0.20 slight agreement;0.21---0.40fairagreement;0.41---0.60moderate agreement;0.61---0.80substantialagreement; 0.81---1 per-fectagreement).12,13
Considering that the agreement level wasassessed on a total number of 45 bleeding situations and defining 1-=0.700withastatisticalsignificance(p)of0.05,asample size of 15 videos to include in this study was considered appropriate.14
Duetothenatureofthisstudy,itwasgrantedan exemp-tion by the Institutional Review Board of the University HospitalofModena,Italy.
Results
Intra-raterandinter-raterreliability
AsillustratedinTable2,Spearman’srankcorrelation coef-ficientswereallabove0.600(rangingfrom0.6336to0.861) forintra-raterreliability,presentinganincreasingratefrom T0toT2,andwerestatisticallysignificant(p< 0.05)forall threeevaluations(t0,t1,t2).Theinter-raterreliabilitywas goodtoexcellentastheinterclasscorrelationcoefficients wereequalorhigherthan0.676forthethreeassessments (Table3).
Table2 Intra-raterreliability.
Firstvideoview
Secondvideoview t0 t1 t2
t0 =0,636 p=0,011 t1 =0,768 p=0,001 t2 =0,861 p<0,001
Table3 Inter-raterreliability.
Meanintraclasscorrelation 95%confidenceinterval
Lowerbound Upperbound
t0 Single mea-sures 0.844 0.671 0.941 t1 0.862 0.709 0.947 t2 0,676 0.316 0.876 Clinicalvalidity
TheclinicalvalidityoftheMBSwas␣=0.70;confidence lim-its:0.64---0.75,correspondingtosubstantialagreement.
Discussion
A clear visualization of the surgical field is a fundamen-tal requirement during ESS. A small amount of bleeding can impair the surgical field and the surgeon’s ability to visualizeanatomicallandmarks, representinganimportant cause of iatrogenic morbidity (including vessels or nerve damages and cerebrospinal fluid leakage).15 Data from a
preliminary extensive literature review performed by the present authors show that the methods used to quantify theamountofbleedingduringsurgicalprocedurescouldbe groupedintotwocategories.Firstly,objectivemethodsare based onthe entity of blood lost during surgery, such as measurementofthevolumeofsuctionedfluidsor compar-isonbetweenpreoperative hemoglobin(Hb) in apatient’s bloodandtheconcentrationofHbinthesuctionunitatthe endof surgery.16,17 Despite usingquantifiable parameters,
thesemethodsusuallyimplyspecifictoolsandlaboratories foranalysis,whichcouldbetime-consuming,expensiveand noteasilyaccessibleforimmediateuse.Furthermore, nei-thertheeffectofirrigationsolutiononbloodnortheblood ingestedbythepatientareconsideredintheseevaluations. Secondly, subjective methods for scoring bleeding dur-ing surgery typicallyrely ona specific visual rating scale usedbyarater,whoisasked,duringorimmediatelyafter thesurgical procedure,toassess thebleedingamount, or morecommonly,theeffectofbleedingonthesurgicalview. Theassessmentismadethroughadefinedscoringsystem. The mostrelevant advantages of thesemethods aretheir dynamicityandthedirectevaluationofhowbleedingcould impairsurgery, despite the actual quantity of blood loss. Among these, several are numerical, using either a 0---10
or 1---10 Visual Analog Scale (VAS) or defining a numeri-calstratification,throughdescriptivesentences.Numerical scores make the statistical management of data easier, compared to descriptive scores. However, a plain num-berlacksstraightforwardmeaning.Toovercomethis,some authorshavedefineddescriptivecategories,which encom-pass two or threenumerical scores. For example, in the studyof VanMontfoort etal.,givenaNRS(numerical rat-ingscale) of0---10,with0definingtheworst visualclarity and10thebestvisualclaritypossible,anNRSwas consid-ered ‘‘poor’’ when less than 4,‘‘fair’’ when 4<NRS < 7, and ‘‘good’’ when NRS>7. The cut-off value for the NRS was set at > 7 because,according to those authors, this was considered torepresent ‘‘good intraoperative visibil-ity’’.18
Another concern about bleeding scores in surgery is whetherthedifferencefromonegradetoanotherinagiven system corresponds to the so-called ‘‘minimum clinically significant difference’’ (MCSD) of bleeding assessment or surgicalfieldcondition.Asrecognizedbysomeauthors,the MCSDhasnotbeen establishedforall scoringsystemsand this might lower theeffectiveness of the score in assess-ingtherealsituation.19InESS,aswellasinendoscopicear
surgery,itispossiblethatevendifferentamountsof bleed-ing would similarly impact the endoscopic management, depending on the phase of the surgery and on the spe-cificanatomicalregion.Indeed,therealdifferencebetween bleeding conditions lies in how bleeding affects the sur-geon’swork,intermsofbeingirrelevantforthecontinuation ofsurgery,slowingthesurgicalprocedureorinterruptingthe surgicalstepsatall.
Inlightoftheabove-mentionedcriticalaspectson bleed-ingratingandthelackofvalidatedbleedingscoresemerged fromthe literature,the authorsdecidedto introducethe Modena Bleeding Score, that despite being a subjective method, it uniquely assesses the direct impact of bleed-ingonthesurgical steps.Itsindependencefromaspecific
instrumentoranatomicalstructuremakesitdifferentfrom otherscoringsystemsusedinESS.
From the present validation study, encouraging results for bothintra-raterandinter-rater reliabilitywerefound, similarly from the analysis performed in the context of endoscopic ear surgery. The intra-rater reliability ranged from0.6336to0.861,while theinter-raterreliabilitywas between0.676and0.844.Theevaluationsonthesamevideo byagivenratermaybemorepreciseastheraterbecomes moreconfident withtheuse of thescale in thefollowing evaluations.Thismaybethereasonfortheincreasingvalues ofintra-raterreliabilityfromt0tot2foundinthisstudy.
The comparisonbetween inter-raterreliabilityand the referent standard (referred to the group that collegially evaluatedallvideosduringclinicalvalidityphase)produced aKrippendorff’sAlphascoreof0.70,correspondingto sub-stantialagreement.
Surgicalfieldconditionsmaychangeseveraltimesduring asingleprocedure;sotheoretically,agoodscoringsystem shouldalsoconveytheconceptof time.Trying toachieve thisaim,Wuandcolleaguesassessedthevisualfield(during uppergastro-intestinalendoscopicevaluation ofbleeding) beforeandafterirrigationwithsalineandH2O2.Theimages
were scored as a worseningor improvement in the field, usinga‘‘visualclearance’’scoringsystem:-3,marked wors-eningof visual field;−2, moderate worsening; −1, slight worsening;0,nochange;+1,slightimprovement;+2, mod-erateimprovement;+3,markedimprovement.20
RegardingtheMBS,thesenseoftimeisnotincludedin the score system itself,though it has been developed to beaeasy-to-useandfasttool,ideallyapplicableanytime theraterhastheimpressionthatthebleedingconditionis changingduringsurgery.Consideringalltheratingsfroma single surgeryand the surgical time, a linearchart could graphically describe the variabilityof bleeding conditions duringthesurgicalprocedure.
AnotherpossiblewaytoapplytheMBS,similartoother bleedingscores, isto pre-operativelyset atimerangeby whichthesurgeonhastorepeatedlyratethesurgical con-ditions.Forexample,Littleetal.appliedtheWormaldand theBoeazaartgradingscalesat regular15minintervalsto assess the impact of total intravenous anesthesia versus inhaledanestheticduringendoscopicsinussurgeries.21This
standardizedmethodcouldfacilitatethecomparisonamong differentsurgeriesofsimilarduration.Overall,the simplic-ity of the MBSmakes it a dynamic instrumentwhose use couldbestandardizedaccordingtothesetting’srequests.
Conclusion
Intheopinionofthepresentauthors’,theMBSrepresentsa valuabletool,easilyapplicableduringthesurgical interven-tionasfrequentlyasthesurgeonfeelsthatthereisachange inhowtheintraoperativebleedingisinfluencinghisorher endoscopicwork.Consideringthehallmarks oftheMBSas comparedtoother bleedingscores andtheresults of this validationstudy,itrepresentsareliabletooltoassess the bleedingconditionsduringendoscopicsinussurgical proce-dures.TheMBSmaybecomethestandardmethodtoassess theperformanceandefficacyofhemostaticmaterials and techniquesusedtocontrolintraoperativebleedinginESS.
Conflicts
of
interest
Theauthorsdeclarenoconflictsofinterest.
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