www.bjorl.org
Brazilian
Journal
of
OTORHINOLARYNGOLOGY
ORIGINAL
ARTICLE
Use
of
the
long-term
quality
of
life
assessment
in
the
decision
to
indicate
surgery
in
patients
with
chronic
rhinosinusitis
夽
Pablo
Pinillos
Marambaia
a,
Manuela
Garcia
Lima
b,
Hélder
Macário
a,∗,
Amaury
de
Machado
Gomes
a,
Leonado
Marques
Gomes
b,
Melina
Pinillos
Marambaia
a,
Otávio
Marambaia
dos
Santos
aaInstitutodeOtorrinolaringologiaOtorrinosAssociados(INOOA),Salvador,BA,Brazil
bEscolaBahianadeMedicinaeSaúdePública,Salvador,BA,Brazil
Received24January2018;accepted19March2018 Availableonline22April2018
KEYWORDS
Rhinosinusitis; Qualityoflife; Surgery
Abstract
Introduction:Quality-of-life questionnaires have been used to support decision-making in patientswithchronicrhinosinusitis inthepastdecade.Thechoiceoftreatmentinpractice, however,alsoconsidersthepatient’sdecision.
Objective:Toassessthelong-termqualityoflifeofpatients withchronicrhinosinusitis who decidedtoavoidsurgery.
Methods:Thisisaprospectivelongitudinalstudywithagroupofpatientswithchronic rhinosi-nusitis,withandwithoutindicationforsurgery,withapplicationofthequestionnaireSNOT-22 intwoperiods:between2011and2012andbetweenJuneandAugust2016,viaemail.
Results:Datawerecollectedfrom42patients,ofwhich13presentedindicationsforsurgeryand 29werenotindicatedforsurgery.Theaveragequalityoflifescorewas42.1(±16.4)inthegroup withanindicationforsurgeryand40.6(±23.4)inthegroupwithoutthisindication,p=0.84. Allthepatientswereassessedbyasingledoctorwithblindinginrelationtotheinitialscore. Nodifferencesweredetectedbetweenthegroups.Theimpactofthechronicrhinosinusitiswas reducedevenamongthepatientswiththeindicationforsurgery.Bothgroupsscoredover40.
Conclusion:Thisstudycanhelppredicttheimpactofthechronicrhinosinusitisovertimeand betteradjustexpectationswithnon-surgicaltreatment.
© 2018 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/).
夽 Pleasecitethisarticleas:MarambaiaPP,LimaMG,MacárioH,GomesAM,GomesLM,MarambaiaMP,etal.Useofthelong-termquality
oflifeassessmentinthedecisiontoindicatesurgeryinpatientswithchronicrhinosinusitis.BrazJOtorhinolaryngol.2019;85:416---21.
∗Correspondingauthor.
E-mail:heldermacario@gmail.com(H.Macário).
PeerReviewundertheresponsibilityofAssociac¸ãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial. https://doi.org/10.1016/j.bjorl.2018.03.011
1808-8694/©2018Associac¸˜aoBrasileiradeOtorrinolaringologiaeCirurgiaC´ervico-Facial.PublishedbyElsevierEditoraLtda.Thisisanopen accessarticleundertheCCBYlicense(http://creativecommons.org/licenses/by/4.0/).
PALAVRAS-CHAVE
Rinossinusite; Qualidadedevida; Cirurgia
Usodaavaliac¸ãodaqualidadedevidaemlongoprazonadecisãodeindicac¸ão cirúrgicaempacientescomrinossinusitecrônica
Resumo
Introduc¸ão: Questionáriosdequalidadedevidatêmsidousadosnaúltimadécadaparaapoiar atomadadedecisãoempacientescomrinossinusitecrônica.Entretanto,naprática,aescolha dotratamentotambémconsideraadecisãodopaciente.
Objetivo: Avaliaraqualidadedevidaemlongoprazodepacientescomrinossinusitecrônica quedecidiramnãosesubmeteràcirurgia.
Método: Estudolongitudinalprospectivocomumgrupodepacientescomrinossinusitecrônica, comesemrecomendac¸ãodecirurgia,comaplicac¸ãodoquestionárioSino-NasalOutcomeTest
22(SNOT-22,testededesfechosinonasal)emdoisperíodos:entre2011e2012eentrejunhoe agostode2016,viae-mail.
Resultados: Foramcoletadosdadosde42pacientes,dosquais13tiveramrecomendac¸ãopara cirurgiae29nãotiveram.Oescoremédiodequalidadedevidafoide42,1(±16,4)nogrupo comindicac¸ãodecirurgia ede40,6(±23,4)nogrupo semessaindicac¸ão,p=0,84. Todos ospacientesforamavaliadosporumúnicomédico,cegadopara oescoreinicial.Nãoforam detectadasdiferenc¸asentreosgrupos.Oimpactodarinossinusitecrônicafoireduzidomesmo entreospacientescomindicac¸ãodecirurgia.Ambososgruposapresentaramumescoreacima de40.
Conclusão:Esteestudopodeajudarapreveroimpactodarinossinusitecrônicaao longodo tempoeajustardeformamaisadequadaasexpectativascomotratamentonãocirúrgico. © 2018 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
Classically,thetreatmentsofferedtopatientswithchronic rhinosinusitis(CRS) aremedicaland,when thistreatment fails,surgery.1Inpractice,thedecisionofwhichtreatment toindicateis notasCartesiananddoesnotfollowa well-definedcriterion. The decision isoften multifactorial and dependsonpatientfactors,suchasasenseofrisk, cultu-ral factors, the costof treatment, and the physician.2 In recentreports,someauthorsdemonstratedthat,according tothe patients,the most important factorsin the choice oftreatmentaretheimpactthatCRShasontheirphysical andmentalwell-being,thereductionintheirqualityoflife (QOL),thelossofproductivity,andthecostoftreatment.3 TheassessmentoftheQOLofpatientshasbeenused fre-quentlyinarangeofdifferentdiseasesanditisnodifferent inthefollow-upofpatientswithCRS.4Disease-specific ques-tionnaires,initiallyadministeredtoassessdiseaseovertime orassesstheimpactof interventionsinthesamegroupof patients, have always been used in the hope of support-ingthestandardisationofconductstopreventunnecessary proceduresandimprovecareforthispopulation.
The Sinonasal Outcome Test 22 (SNOT-22) is an easily applied questionnaire that has been validated for use in Portuguese.5 This instrument contains 22 questions about symptoms that are possibly related to chronic rhinosi-nusitis. Each symptom is given a score from 0 (zero) to 5 (five), where zero indicates the absence of a problem and fiveindicates the worstpossible problem. Therefore, the higherthe score,the worse the qualityof life of the subject.5,6 According to the European Position Paper on
RhinosinusitisandNasalPolyps(EPOS)2012,1theSNOT-22is agoodtoolforassessingQOLinpatientswithCRSbecause it can be used repeatedly and represented in graphs (SNOT gramas) containing the SNOT-22 scores in several momentsin time.These graphs clearly display the result of medicinaland surgical interventionsand complications overtime.
SeveralstudiesusingtheSNOT-22showthatpatientswith higherscores,thatis,thosewhohave beenmostaffected by the disease and have the worst QOL, clearly improve withsurgical treatment in comparisonwith sufferers who undergocontinueddrugtherapy.However,lowscoresdonot seemtodetermine thechoice oftreatment.7 Otherdata, however,shownodifferences betweensurgical treatment andcontinueddrugtherapyforcertaingroups.8Theuseof questionnairescouldhelpstratifypatients withthe great-est likelihood of surgery, for example, and, consequently facilitateorreinforceanindicationforreferraltotheENT. Questionnairescouldalsobeusedby non-specialist physi-ciansinprimarycare.
Themethodologyemployedinthevariousworks gener-allyrequiresseparategroupsforeveryQOLscore.Patients aretypicallydividedby choiceor randomisationin groups forthe maintenanceof drugtherapy or surgical interven-tion.The personal choice factor is not usually takeninto accountinclinical studies, butit hasa hugeinfluence on theeverydaypractice.Theaimofthispaperistocompare thequalityoflifeofpatientswithCRSwhodecidednotto undergosurgeryevenwhen surgery wasrecommendedby the ENT, and a group of patients who did notreceive an indicationforsurgery,after4years.
Methods
Thisisalongitudinal,prospective,andobservationalstudy, inwhich patients withCRS were monitoredfor at least 4 years,fromtheinitialconsultationin2011andfrom2012to 2016.
All the patients wereassessed in the first ENT consul-tation.AfterconfirmationofCRS(accordingtotheclinical criteriaof the EPOS-2012), they completeda registration formwithdemographicdataandtheSNOT-22questionnaire, andsignedaninformedconsentstatement.
The diagnosis of chronic rhinosinusitis wasdetermined usingtheclinicalcriteriaoftheEPOS-2012,wherebychronic rhinosinusitis is defined by the presence of two or more symptomsofnasalobstruction/congestion/blockage, ante-riororposterior rhinorrhea,hyposmia/anosmia,andfacial pain/pressurefor12weeksormore.Oneofthesesymptoms hadtobenasalobstruction/congestion/blockageoranterior orposteriorpurulentrhinorrhea.1
Theinclusioncriteriawereliteratepatientswithchronic rhinosinusitisandpatientsover18yearsofage.
Thecriteriaforexclusionwereilliteratepatients, smok-ers, patients with immune deficiency, cystic fibrosis or primaryciliarydyskinesia,patientswithbenignormalignant nasal tumours, patients with granulomatous diseases and vasculitis, patients whohadpreviously undergone surgery andsubjectswhorefusedtoparticipateinthestudy.
Duringtheanalysisperiod,thesubjectsweredividedinto 2groups: one group,called the surgical indicationgroup, hadreceived a medicalindication for surgical treatment, butchosenottoundergotheprocedure.Theothergroup, calledthecontrolgrouportheclinicaltreatmentgroup,did notreceivetheindicationofsurgery,thatis,theycontinued withtheclinicaltreatment.
Surgerywasindicatedwhenmaximumclinicaltreatment hadfailedforatleast6(six)weeks.Maximumclinical treat-mentreferstotheuseofsystemicortopicalcorticosteroids, antibiotics,andnasalsalinewash.
The failureofclinical treatmentwasdefinedwhenthe patientstatedthatthesymptomshadnotimproved.Inthe caseoflackofresponse,acomputedtomographyscanwas requestedtoevaluatethecondition,followedbythe possi-bleschedulingoffuturesurgery.
Surgery was also indicated when tomographic analysis ledto the diagnosis of a condition that required surgical treatment, namely significant anatomicalchangessuch as obstructiveseptum deviation,large or obstructivemiddle turbinatepneumatisationor extensivesinonasalpolyposis, andrhinosinusitisofdentalorfungalorigin.
Theindicationforsurgerywasbasedonthecriteria men-tionedaboveandontheconductofasingleENTprofessional whowasblindedregardingtheinitialSNOT-22scoreofthe patients.
Between June and August of 2016, the patients were contacted by telephone and, later, by email. During this contact, they were invited to participate in this study, complete theSNOT-22questionnaire, andreturn ittothe researcher.Inadditiontothequestionnaire,theparticipants signedanewinformedconsentstatement.
Thestudy inquestionwasapprovedbytheethics com-mitteeoftheEscolaBahianadeMedicinaandregisteredin PlatformBrasilundernumber54870816.1.0000.5544.
AsamplewascalculatedusingWinPepissoftwareversion 11.62,whereweusedthestandarddeviationoftheSNOT-22 scoreofSmithetal.7involvingthecomparisonofscoresfrom operated patients versus non-operated patients (SD=19.1 and 22.1, respectively), and detected a difference of 25 points.Inthiscase,22patientswereneeded,anddivided into twogroups of 11 subjects.Consequently, oursample exceedstherequirednumberofparticipants.
The resultswere tabulatedand analysed usingSPSS-17 software.
Thecategoricaldemographicdatalikegenderand pres-enceofcomorbiditiesandallergieswerepresentedusingthe validpercentile.The Chi-squaretest wasusedtocompare thecategoricalvariablesbetweenthegroups.
The score of the SNOT-22questionnaire was described usingtheaverageandstandarddeviationsincethesample distributionwasnormal.
Theaveragesbetweenthegroupswerecomparedusing theunpairedt-test.
Theunpairedt-testwasalsousedtocomparetheaverage scoreofeachitemoftheSNOT-22individually.
Thealphaerrorwasconsideredacceptablewhenp<0.05.
Results
A total of 42 patientrecords wereanalysed, of which 13 werepatientswithanindicationforsurgeryand29withan indicationfordrugtherapy.Table1showsthedemographic characteristicsofthesample.
WithregardtotheSNOT-22scoreafter4yearsof mon-itoring, we found that the group that evolvedto surgical treatment scored 42.1±16.4 and the clinical treatment groupaveraged40.6±23.4(Table2).
Fig.1showsthecomparisonoftheSNOT-22score aver-agesofthegroupsafter04years.
Thecomparisonofeachitem(symptom)intheSNOT-22 questionnaireandthesubdomainsoftheSNOT-22separately didnotdifferbetweenthegroups.
Fig.2showstheevolutionofthescoresofthetwogroups after04yearsofobservation.
Discussion
Drug therapy is the standard treatment of patients with uncomplicatedchronic rhinosinusitis.Mosthighlyqualified otolaryngologists would not recommend surgery, knowing that a large number of patients with uncomplicated CSR mayshowimprovementsorstabilisethediseasewithdrug therapy.9Surgeryisindicatedwhenclinicaltreatmentfails orinthecaseofcomplications.10 Endoscopicsinussurgery (ESS)is thesurgicalmodalityindicated inthesecasesand hasshowngoodresultssincethe1990s.10
Thechoice of treatment andthetiming of surgeryare notsimpleanddonotobeyaclearlydefinedrule.Thebias of patients, such as cultural factors, cost of treatment, aversion torisk, and the doctor-patient relationship, are unknown andunderexplored.2 Itis believedhowever, that QOL assessment instruments can significantly supportthis decision.11 Dataontheexactweightof theseinstruments inthechange ofconductstillallowsome roomfor discus-sion.Logically,datathatshowthebenefitsofsurgeryrather
Table 1 Sociodemographic characteristics ofthe sample ofpatients with chronic rhinosinusitis and a surgical indication (indicationgroup)andofpatientswithchronicrhinosinusitiswithanindicationforclinicaltreatment(clinicalgroup).
Variables Surgicalindication
group(n=13) Clinicaltreatment group(n=29) Significance (p) Gender(%) Male 06(46.2) 12(41.4) 0.517 Female 07(53.8) 17(58.6) Age(years) 43.5±3.1 38.4±2.5 0.438 Co-morbidities SAH 02 02 0.81 DM 0 02 0.307 Asthma 03 02 0.167 Others 0 02 0.307 Allergytomedication(%) Yes 04(30.8) 07(24.1) 0.736 No 09(69.2) 22(75.9) Respiratoryallergy(%) Yes 01(7.7) 02(6.9) 0.793 No 12(92.3) 27(93.1)
Surgicalindicationgroup,patientsreferredforsurgery;clinicaltreatmentgroup,patientsreferredforclinicaltreatment.
aSignificancelevelp<0.05.
Table2 QualityoflifescorewiththeSNOT-22ofthegroupsafter4years.
Variable Surgicalindicationgroup Clinicaltreatmentgroup Significance(p)
SNOT-22 42.1(±16.4) 40.6(±23.4) 0.84
SNOT-22,SinoNasalOutcomeTest.Unpairedt-test.Average(standarddeviation).
aSignificancelevelp<0.05. 100 80 60 40 20 42
Surgical indication group
Treatment modality A v er age SNO T -22 after 04 y e ars
Clinical treatment group 0
Figure1 Comparison ofthe SNOT-22scoreaveragesofthe groupsafter04years.
thandrugtherapycanhelpexplainandsupportpatientsin makingthebestdecision.
Inthisstudy,weassessedagroupofpatientswhodecided nottoundergosurgery,althoughsurgeryhadbeenindicated. The indication of surgery observes the rule of previous studies that reserve this option for patients who do not
70
Graph 2-Average SNOT-22 score of the groups during the 04 years of observation Clinical indication (n = 29) Surgical indication (n = 13) 60 50 40 30 20 10 0 2011/12 2013 2014 2015 2016
Figure2 Theevolutionofthescoresofthetwogroupsafter 04yearsofobservation.
show improvements with the so-called maximum clinical treatment. The QOL comparison between the group with indicationforsurgeryandthegroupwithoutindicationfor surgery showed no statistical difference after 4 years of follow-up(p=0.84).
The evaluation of the QOL after 4 years showed a reduction in the SNOT-22 score of all the patients; how-ever, there was no difference between the groups. The
pathophysiologicalrationale is thatpatients with an indi-cation for surgery should have worse scores or a gradual reductionofthescoresovertime.Thisresultcanstrengthen theindicationfor surgeryorhelp predictthe evolutionof a surgical patient. Our data says otherwise. Both groups evolved towards a reduction of the scores, and no dis-crepancy wasfound between the groups. These data can translate a simple statistical phenomenon of regression towardsthemeanafterthefirstmeasurement,thatis,they can show that the first measurement of a sequence may havebeenoverratedandthatthesubsequentmeasurements merelyportraytherealityofthedata.Serialsampleswould beneededtoruleoutthishypothesis. Anotherhypothesis refers to the measurement bias since the first measure-ment was made during a medical consultation, that is, thepatientprobablysoughttheservicebecauseheorshe was symptomatic and responded to the questionnaire in thisopportunity.Thesecond measurementwasperformed remotely, i.e. without face-to-face contact, which may haveportrayedpatientsoutsidethesymptomaticperiodor betweenepisodes.Thisoccurredinbothgroups,whichmay haveminimisedtheoccurrenceofbias.
This result leads us to conclude that the fact that a patientdoesnotundergosurgerydoesnotworsentheillness oritsimpactontheQOLofthepatient;onthecontrary,the diseasemayeven‘‘improve’’.However,whenwelookatthe averagefinalscoreoftheSNOT-22,weseethatbothgroups stillhadhighscores--- Surgicalindicationgroup:42.1(±16.4) versus the Clinical treatment group: 40.6 (±23.4). In the caseof surgery,thescoremayhavesignificantly dropped. Steeleetal.12maintainthatpatientswithalowscore (SNOT-22<30) report a stable QOL with drug therapy, and that when these patients undergo surgery, they experience a moresensitiveclinicalchange
The literature provides abundant data to support sur-gical treatment. Althoughthe authors didnot defendthe useofquestionnairesasastandalonedecision-makingtool, theybelievethesemechanismsprovideimportant support forcounsellingandriskstratification.Hopkinsetal.,3ina studywiththeEnglishpopulation,suggestthatpatientswith SNOT-22scores above 30 are more likely to show a clin-icalimprovement after surgery than patients with scores below 20, in which case surgery is not encouraged. Rud-mik et al.13 studied the American population and found similarresults. In thisrespect, it is important to remem-berthatevenpatientswithoutchronic rhinosinusitisscore around7 or 8 in the SNOT-22.14 This means that patients withlowscoresorfairlylowscoresdonothavemarginfor improvementandshould beanalysed carefullysincetheir scoresareverysimilartothoseofpeoplewithout the dis-ease.
Thecostoftreatmentshouldalsobetakenintoaccount. Inthisstudy,thecostofmedicationwasnotassessedover thestudiedperiod.Dependingontherealityofstudy loca-tion, this can be an important factor for deciding which treatment to indicate. Smith et al.7 found that the QOL improvedinthesurgicalandnon-surgicalgroups,although the latter group received more antibiotics, prescription nasalsprays,andsinusmedicationsintabletformthanthe formergroup.
Inthisstudy,thesubdomainsoftheSNOT-22were anal-ysed separately and showed no differences between the
two groups. The subdomains of nasal, extra-nasal, and aural/facial symptoms, sleep disorders and psychological symptoms are part of the instrument and help to assess variousaspectsofpatientsand,subsequently,evaluatethe impactofCSRontheirQOL.15Levyetal.16showinpatients witha lowSNOT-22score that,while thetotal scoremay notdiffer,when analysedseparately, thesubdomainsmay havediscrepanciesbetweenthevariousgroupsand conse-quently influence the choice of treatment. The scores of nasal,extra-nasal, and aural/facial symptomsseem tobe determiningfactors.Curiously,apreviousstudyshowedthat the domains of psychological symptoms and sleep distur-bances weremore closely associatedwiththe decisionto undergosurgery.11
Using the SNOT-22 to punctually assess patients does notseemtobethemostreliablemethodindecision mak-ing. Serial assessments can help trace the real evolution of each patient and detect periods in which the symp-tomsorthediseasegetworse.Snot-gramsaregraphsthat aremadewithdifferentmeasurementsinthe samegroup of individuals.1 The graph of this study has two distinct peaks thatareseparatedby aperiodof4 years.This gap between the peaksmay have been toolong, andit could haveprevented amoreprecisereview,sinceit lackedthe sensitivity to detect minor variations. The information it contains, however, cannot be overlooked. The fact that a single professional assessed the patients and indicated themethodoftreatmentstandardisesthisassessmentand reduces the bias of the examiner. By contrast, it reveals just how complex decisions regarding treatment can be. Patientswhorefusetoundergosurgerymaynothavesuch a marked improvement, but the long-term outcome does notdifferfromthatofpatientsfor whichsurgerywasnot indicated.
Futurestudies should include the presence of adverse effectsandthecomplicationsofdrugtherapyandsurgery. Inpractice,thisisaveryimportanttopictoaddressin con-versationswiththepatientsandindecisionmaking.Inthe literature,however,thistopicisscarcelydescribed.Ina sys-temicreviewandrecentmeta-analysis,Pateletal.9found thatthevastmajorityofstudies donotcontainthis infor-mation,andsuggesttheuseofexistingliteratureonadverse events and clinical judgement toweigh these risks when choosingmedicalorsurgicaltherapy.Inthisstudy,noneof theseaspectswasexplored.
Conclusion
TheSNOT-22scoresofpatientswithCRSwithanindication forsurgerywhodidnotwanttoundergotheproceduredid notdiffer fromthe scoresof theclinical treatment group after 4 years of follow-up. The average scoreshowed an improvement, butremained relativelyhigh. This informa-tion can help improve the management of patients with CRS.
Conflicts
of
interest
References
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