Rev. Bras. Reumatol. vol.57 número2

w w w . r e u m a t o l o g i a . c o m . b r

REVISTA

BRASILEIRA

DE

REUMATOLOGIA

Original

article

EpiFibro

(Brazilian

Fibromyalgia

Registry):

data

on

the

ACR

classification

and

diagnostic

preliminary

criteria

fulfillment

and

the

follow-up

evaluation

José

Eduardo

Martinez

,

Eduardo

S.

Paiva

,

Marcelo

C.

Rezende

,

Roberto

E.

Heymann

,

Milton

Helfenstein

Jr.

,

Aline

Ranzolin

,

Jose

Roberto

Provenza

,

Luiz

Severiano

Ribeiro

,

Eduardo

J.R.

Souza

,

Daniel

P.

Feldman

,

Marcos

Renato

de

Assis

b_{PontifíciaUniversidadeCatólicadeSãoPaulo,Sorocaba,SP,Brazil}

c_{UniversidadeFederaldoParaná,Curitiba,PR,Brazil}

d_{SantaCasadeCampoGrande,CampoGrande,MS,Brazil}

e_{UniversidadeFederaldoEstadodeSãoPaulo,SãoPaulo,SP,Brazil}

f_{HospitaldasClínicasdePernambuco,Recife,PE,Brazil}

g_{PontifíciaUniversidadeCatólicadeCampinas,Campinas,SP,Brazil}

h_{HospitaldoServidorPúblicodeMinasGerais,BeloHorizonte,MG,Brazil}

i_{SantaCasadeBeloHorizonte,BeloHorizonte,MG,Brazil}

j_{FaculdadedeMedicinadeMarília,Marília,SP,Brazil}

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Articlehistory:

Received17March2016 Accepted31July2016

Availableonline23November2016

Keywords: Fibromyalgia Classificationcriteria Diagnosticcriteria Follow-up

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Introduction:EpiFibro(BrazilianEpidemiologicalStudyofFibromyalgia)wascreatedtostudy Fibromyalgiapatients.Patientswereincludedsince2011accordingtothe1990American CollegeofRheumatologyClassificationCriteriaforFibromyalgia(ACR1990).

Objectives: TodeterminehowmanypatientsstillfulfilltheACR1990andtheACR2010criteria in2014;todeterminethecorrelationbetweentheimpactofFMandtodescribedataonthe follow-upevaluation.

Methods:Thisisacrosssectionalstudyinamulticentercohortofpatients.Thedatawas collectedbetween2013and2015.PhysicianincludedpatientsthatfulfilledtheACR1990 criteriaonthedateofentry.Thefollow-updatawereconsideredonlyforpatientswithat leasttwoevaluations.Aminimallysignificantchangewasconsideredtobea30%variation ofparametersscores.

Results:810patients’datawereanalyzed.Patientspresentedameanageof51.8±11.5years old.Therewere786female.Mostpatientsmetbothcriteria.Therewasagreater fulfill-ingoftheACR2010.TherewasamoderatecorrelationbetweenPolysymptomaticDistress

∗ _{Correspondingauthor.}

E-mail:jemartinez@terra.com.br(J.E.Martinez).

http://dx.doi.org/10.1016/j.rbre.2016.09.012

ScaleandFibromyalgiaImpactQuestionnaire.Threehundredfourteenpatientswithmore thanoneassessmentwerefound,but88patientswereexcluded.Thus,226patientswith onefollow-upmonitoringparameterwereconsidered(FibromyalgiaImpactQuestionnaire: 222;PolysymptomaticDistressScale:199;both:195).Themeanfollow-uptimewas9.1±7.5 months(1–44).Mostpatientsbecamestable.

Conclusion: InEpiFibro,mostpatientsfulfillsimultaneouslytheACR1990andACR2010.A largernumberofpatientsfulfilltheACR2010atthetimeoftheevaluation.Therewasa moderatecorrelationbetweenthePolysymptomaticDistressScaleandtheFibromyalgia ImpactQuestionnaire.Mostpatientsremainedstableovertime.

©2016ElsevierEditoraLtda.ThisisanopenaccessarticleundertheCCBY-NC-NDlicense (http://creativecommons.org/licenses/by-nc-nd/4.0/).

EpiFibro

(Registro

Brasileiro

de

Fibromialgia):

dados

sobre

a

classificac¸ão

do

ACR

e

preenchimento

dos

critérios

diagnósticos

preliminares

e

avaliac¸ão

de

seguimento

Palavras-chave: Fibromialgia

Critériosdeclassificac¸ão Critériosdiagnósticos Seguimento

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e

s

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o

Introduc¸ão: OEpiFibro(EstudoEpidemiológicoBrasileirodeFibromialgia)foi criadopara estudarpacientescomfibromialgia.Foramincluídospacientesdesde2011deacordocom oscritériosdeclassificac¸ãoparaafibromialgiadoAmericanCollegeofRheumatologyde1990 (ACR1990).

Objetivos:DeterminarquantospacientesaindaatendemaoscritériosACR1990eACR2010em 2014;determinaracorrelac¸ãoentreoimpactodaFMmedidopeloQuestionáriodeImpacto daFibromialgia(FIQ)epelaPolysymptomaticDistressScale(PDS)edescreverdadossobrea avaliac¸ãodeseguimento.

Métodos:Estudotransversalemumacoortemulticêntricadepacientes.Osdadosforam cole-tadosentre2013e2015.OmédicoincluiupacientesqueatenderamaoscritériosACR1990 nomomentodaentrada.Consideraram-seosdadosdeseguimentoapenasdospacientes compelomenosduasavaliac¸ões.Umavariac¸ãode30%nosescoresdosparâmetrosfoi consideradaumaalterac¸ãominimamentesignificativa.

Resultados: Analisaram-seosdadosde810pacientes.Ospacientesapresentarammédia de51,8±11,5anos.Havia786mulheres.Amaiorpartedospacientesatendeuaambosos critérios.HouveummaioratendimentoaoscritériosACR2010.Houveumacorrelac¸ão mod-eradaentreaPDSeoFIQ.Encontraram-se314pacientescommaisdeumaavaliac¸ão,mas 88pacientesforamexcluídos.Assim,foramconsiderados226pacientescomumparâmetro de monitoramentonoseguimento. (FIQ:222;PDS:199;ambos:195).Otempomédiode seguimentofoide9,1±7,5meses(1a44).Amaiorpartedospacientestornou-seestável. Conclusão: NoEpiFibro,amaiorpartedospacientesatendiasimultaneamenteaoACR1990 eaoACR2010.UmamaiorquantidadedepacientesatendiaaoACR2010nomomentoda avaliac¸ão.Houveumacorrelac¸ãomoderadaentreoPolysymptomaticDistressScaleeo QuestionáriodeImpactodaFibromialgia.Amaiorpartedospacientesmanteve-seestável aolongodotempo.

©2016ElsevierEditoraLtda.Este ´eumartigoOpenAccesssobumalicenc¸aCC BY-NC-ND(http://creativecommons.org/licenses/by-nc-nd/4.0/).

Significance

and

innovation

BrazilianRegistryonFibromyalgia.FulfillmentofACR classifi-cationanddiagnosticcriteria.Follow-updata

Introduction

TheFibromyalgiaSyndrome(FM)isaclinicalcondition char-acterized by chronic widespread pain usually associated to fatigue,sleep disturbancesand cognitive symptoms. Its

prevalenceishighandinBrazilitisestimatedat2.5%.1_The

influenceofsocial,psychologicalandculturalaspectsmakes itsclinicalexpressionhighlyvariable.Thereremainstheneed forepidemiologicalstudiesonFMinourcountry.

TheEpiFibro(BrazilianEpidemiologicalStudyof Fibromyal-gia) was created in order to analyze the epidemiology of FM and its comorbidities across the country. It shall offer betterconditions todiagnosis,treat and evaluatethe impact ofthis disorder inBrazilian society through online questionnaires.

Fibromyalgia (ACR1990).2 _{The clinical and epidemiological}

datawasalreadypublishedin2013.3

In2010,anACRcommitteepresentedthePreliminary Diag-nosticCriteriaforFibromyalgia(ACR2010),aftertwodecadesof criticsontheACR1990.Thenewcriteriaabolishedthetender pointscountingandemphasizedthe associationoffatigue; sleepdisorders, cognitivedisorders and somaticsymptoms to chronic widespread pain. It established 2 scores – an widespread pain index (WPI), composed by 19 potentially painfulareas tobeidentifiedbythe patients,and a symp-tomseverityindex(SSI)thatresultsfromthesumoffatigue, sleep disturbances, cognitive disorders and somatic symp-tomsscores(0–3each).Thetotalscorerangesfrom0to12.4_In

2011thesomaticsymptomsitemwasmodified,whichallowed creatingaself-reportversioninordertobeusedin epidemio-logicalstudies.5

The sum of these two indices, ranging from 0 to 31, namedPolysymptomaticDistressScale(PDS),canbeusedfor patients’clinicalmonitoring.6_{Thefollow-upmeasuresforthe}

FMpatientsusuallyareanalogicalsymptoms scales,asfor exampleforpain,andbyqualityoflifeorimpact question-nairessuchastheFibromyalgiaImpactQuestionnaire(FIQ) anditsrevisedform,whoseversionshavebeentranslatedand validatedtoBrazilianPortuguese.7,8

Objectives

Themainobjectivesofthepresentstudyaretodeterminehow manypatientsstillfulfilltheACR1990andtheACR2010criteria in2014,todeterminethecorrelationbetweentheimpactofFM measuredbytheFIQandbythePDSandtodescribedataonthe follow-upevaluationofthepatientsenrolledintheregistry.

Patients

and

methods

This is a cross sectional study in a multicenter cohort of patients with FM. The data was collected between 2013 and 2015, including demographic, clinical information and follow-upparameters.Analogicalsymptomscalesofpainand fatigue,FIQandthePDSwereconsideredclinicalparameters. Patients were included in EpiFibro by their physician, accordingtoatutorialbytheBrazilianRheumatology Soci-ety. It included patients that fulfilled the ACR1990 criteria on the date of the patient’s entry in the registry.Patients withincompleteformswereexcludedasthatpreventedthe dataanalysisfortheproposedobjectives.Thefollow-updata wereconsideredonlyforpatientswithatleasttwo evalua-tionformsseparatedbythreemonthsintervalasaminimum. A minimally significant clinical change was considered to bea30%upordownvariationofthefollow-upparameters scores.

Descriptivestatistics and the Pearson correlation coeffi-cientwereused.

Results

A total of 810 patients’ data were analyzed. Patients pre-sented a mean age of 51.8±11.5 years-old. There were

Table1–Fulfillmentofthe1990ClassificationCriteria forFibromyalgia(ACR1990)andthe2010Preliminary DiagnosticCriteriaforFibromyalgia(ACR2010).

ACR2010

Yes No Total

ACR1990

Yes 347 39 386

No 182 44 226

Total 529 83 612

Table2–ClinicalparametersoftheEpiFibrodatabase patients.

Parameter Values

PNS 8.4±1.4

FNS 7.9±2.3

PSD 22.19±5.8

FIQ 68.0±17.1

PNS, PainNumericalScale(0–10);FNS, FatigueNumericalScale (0–10); PSD, Polisymptomatic Distress Scale; FIQ, Fibromyalgia ImpactQuestionnaire. r-.576 100 80 FIQ 60 40 20 0

0 20 30

PDS 10

Fig.1–CorrelationbetweentheFIQandPDS.

786 female patients (97.0%) and only 24 men (3%). Most patients were attended in public health care(648 patients – 80%) and 162 patients (20%) were treated in private services.

MostpatientsmetbothACRcriteriaasshowninTable1. TherewasagreaterfulfillingoftheACR2010comparedtothe ACR1990,suggestingthatthenewcriteriaaremoresensitive andmaybelessspecificthantheolderone.

Table2showsclinicaldatainpatients’self-scoredreports. There was high intensityofpain and fatigueand a severe diseaseimpactmeasuredbyPDSandFIQ.

There wasamoderatecorrelation betweenPDS andFIQ (r=0.576),asshowninFig.1.

Table3–EvolutionparametersoftheEpiFibrodatabasefibromyalgiapatients.

Parameter Firstevaluation Lastevaluation Improved Worsened Unchanged

FIQ 66.10±19.59 67.06±19.13 37(16.61%) 21(9.45%) 164(73.87%) PDS 22.53±5.57 19.67±6.67 39(19.59%) 9(4.52%) 151(74.87%)

FIQ,FibromyalgiaImpactQuestionnaire;PDS,PolysymptomaticDistressScale.

Themeanfollow-uptimewas9.1±7.5months(1–44).FIQ andPDSmeasuresareshowninTable3.

Discussion

Inthisstudy,itwasobservedafemalepredominance,which iscompatible withtheliterature.9_{Althoughthereisalarge}

majority of patients seen in the Brazilian Public Health System, the private network is also represented in this study.

The intensity of pain and fatigue and the impact clin-ical parameters shows that the reported casesare severe. Higher severity can be justified by the main data collec-tion centers involved in this study are universities that composes the tertiary carehealthassistancelevel. So, this is a limitation of this research that prevents the data to be generalized to all Brazilian fibromyalgia patients. Any-way,itsuggestsaneedforepidemiologicalstudiesinvolving communitypatients. Thesame argument may beused for the high male predominance. It is important to empha-size that this is not a prevalence study, but a registry data.

The moderate correlation between the two follow-up parameters(FIQandPDS)suggeststhatbothcanbeusedin monitoring. The choice of the parameter should be based on the ease of use and the familiarity of the doctors or services. The FIQ has been used in clinical trials and in daily practice since 1993 with reliable results in our pop-ulation even before being validated formally. In 2006, it waspublishedits formaltranslationandvalidationfor Por-tugueseinBrazil.ThePDSwasrecentlycreatedandwestill havenot published datato assess its potential forclinical monitoring.7

Theobservedclinicalstability iscompatible with evolu-tionstudiespresentintheliterature.Kennedyetal.studied35 patientsandshowedthat100%continuedtohavesymptoms after10years.10_{Otherstudieshavereportedimprovementsin}

painovertime,butthetotalresolutionofsymptomsseems rare.11,12 _{In2011,Walittet al.publisheda 5year follow-up}

studywith1555fibromyalgiapatientsandfoundaclinically significantimprovementintheoverallseverityofsymptoms, despitethe painimprovementbeonlymoderate in25% of patients.13

Conclusion

Inthe EpiFibro Cohort,mostpatients fulfillsimultaneously theACR1990andACR2010criteriaforFM.Alargernumberof

patientsfulfilltheACR2010comparedtoACR1990atthetime oftheevaluation.Therewasamoderatecorrelationbetween theFIQandthePDSmonitoringandmostpatientsremained stableovertime.

Conflicts

of

interest

Theauthorsdeclarenoconflictsofinterest.

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