RPC 29(03) 353-372.pdf

8/14/2019 RPC 29(03) 353-372.pdf

1/20

Recebido para publicao: Maio de 2009 Aceite para publicao: Setembro de 2009

Received for publication: May 2009 Accepted for publication: September 2009

353

Propriedades psicomtricas da versoportuguesa doKansas City

Cardiomyopathy Questionnaire

na miocardiopatia dilatadacom insuficincia cardaca congestiva [26]

ELISABETE NAVE-LEAL (1, 2), JOS PAIS-RIBEIRO (2), MRIO MARTINS OLIVEIRA (3), NOGUEIRA DA SILVA (3), RUI SOARES (3),JOS FRAGATA (4), RUI FERREIRA (3)

1 Escola Superior de Tecnologia da Sade de Lisboa, Instituto Politcnico de Lisboa, Lisboa, Portugal2 Faculdade de Psicologia e Cincias da Educao, Universidade do Porto; Porto, Portugal

3 Centro Hospitalar de Lisboa Central, Hospital de Santa Marta, Servio de Cardiologia, Lisboa, Portugal4 Centro Hospitalar de Lisboa Central, Hospital de Santa Marta, Servio de Cirurgia Cardiotorcica, Lisboa, Portugal

Rev Port Cardiol 2010; 29 (03): 353-372

RESUMO

Vrios estudos demonstraram que os doentescom insuficincia cardaca congestiva (ICC) tm

um compromisso da qualidade de vida rela-cionada com a sade (QVRS), tendo esta, nos

ltimos anos, vindo a tornar-se umendpoint primrio quando se analisa o impacto

do tratamento de situaes crnicas como a ICC.Objectivos: Avaliar as propriedades psicomtri-

cas da verso portuguesa de um novo instru-mento especfico para medir a QVRS na ICC

em doentes hospitalizados: o Kansas CityCardiomyopathy Questionnaire (KCCQ).

Populao e Mtodos: O KCCQ foi aplicadoa uma amostra consecutiva de 193 doentesinternados por ICC. Destes, 105 repetiramesta avaliao 3 meses aps admisso hos-

pitalar, no havendo eventos ocorridosdurante este perodo de tempo. A idade era

64,4 12,4 anos (entre 21 e 88), com 72,5%a pertencer ao sexo masculino, sendo a ICC

de etiologia isqumica em 42%.Resultados: Esta verso do KCCQ foi sujeita

a validao estatstica semelhante ameri-cana com a avaliao da fidelidade e vali-

dade. A fidelidade foi avaliada pela con-

ABSTRACT

Psychometric properties of thePortuguese version of the Kansas CityCardiomyopathy Questionnaire in

dilated cardiomyopathy withcongestive heart failure

Several studies have shown that patientswith congestive heart failure (CHF) have acompromised health-related quality of life(HRQL), and this, in recent years, hasbecome a primary endpoint when consider-ing the impact of treatment of chronic con-ditions such as CHF.Objectives: To evaluate the psychometric

properties of the Portuguese version of a newspecific instrument to measure HRQL inpatients hospitalized for CHF: the KansasCity Cardiomyopathy Questionnaire (KCCQ).Methods: The KCCQ was applied to a sam-ple of 193 consecutive patients hospitalizedfor CHF. Of these, 105 repeated the assess-ment 3 months after admission, with noevents during this period. Mean age was64.412.4 years (21-88), and 72.5% were72.5% male. CHF was of ischemic etiology in

09-AO-49Maro

8/14/2019 RPC 29(03) 353-372.pdf

2/20

8/14/2019 RPC 29(03) 353-372.pdf

3/20

355

Elisabete Nave-Leal, et al.Rev Port Cardiol 2010; 29: 353-372

009-AO-49Maro

INTRODUO

Ainsuficincia cardaca (ICC) uma sn-drome progressiva com elevada incidn-cia e prevalncia e com prognstico adverso.Efectivamente, a mortalidade aos quatro anos

ronda os 50%(1). Com o envelhecimento da po-pulao, o aumento da sobrevivncia na sn-drome coronria agudo e a preveno da mortesbita arrtmica, muitos doentes desen-volvero miocardiopatia dilatada, que, dada asua sintomatologia, a conscincia do risco demortalidade e os efeitos da teraputica, comfrequentes hospitalizaes, tem repercussesevidentes na qualidade de vida relacionadacom a sade (QVRS).

O uso generalizado de instrumentos deQVRS em investigaes na rea da ICC re-flecte a crescente importncia que esta me-dida adquiriu em contexto clnico. De facto,diversos estudos confirmam o seu alto valorprognstico com poder preditivo quanto aoreinternamento e mortalidade, sendo vasto oseu uso como indicador de resultados na inter-veno em doentes com ICC (2-5).

A avaliao do estado de sade em contex-to clnico, ou seja, a QVRS, possui as carac-tersticas de multifactoriedade, auto-adminis-trao, variao temporal e subjectividade (6).Esta avaliao da QVRS na ICC compreendemedidas genricas e especficas. As medidasgenricas so aplicveis a patologias diversifi-cadas, cobrindo vrios domnios da QVRS,sendo exemplos de aplicao deste tipo deinstrumentos em estudos na ICC, o MedicalOutcomes Study 36-Item short Form Healthsurvey (SF-36), o Nottingham Health Profile

(NHP) e o Sickness Impact Profile (SIP). Asmedidas especficas permitem avaliar osdomnios clnicos significativos para ICC eidentificar mudanas nos sintomas. So exem-plos o Quality of Life in severe Heart FailureQuestionnaire (QLQ-SHF), o Chronic HeartFailure Questionnaire (CHQ), o Minnesota liv-ing with Heart Failure Questionnaire (MLHFQ),o Kansas City Cardiomyopathy Questionnaire(KCCQ). Num artigo de reviso recente so

feitos, alguns comentrios quanto falta de sen-sibilidade para a mudana dos sintomas relati-

INTRODUCTION

ACongestive heart failure (CHF) is a pro-gressive syndrome with a high incidenceand prevalence and poor prognosis: four-yearmortality is around 50% (1). With ageing popu-

lations, increased survival following acutecoronary syndrome and prevention of suddenarrhythmic death, many patients will developdilated cardiomyopathy, which, because of itssymptoms, patients awareness of their risk ofdying, and the effects of therapy, together withfrequent hospitalizations, has considerableimpact on patients health-related quality oflife (HRQL).

The widespread use of HRQL instruments

in research into CHF reflects the growingimportance of this measure in clinical prac-tice. Various studies have demonstrated itshigh prognostic value in predicting hospitalreadmission and mortality, and it is widelyused as a predictor of outcomes of interventionin CHF patients (2-5).

Assessment of patients state of health inclinical terms, or HRQL, is multifactorial,self-administered, subjective, and varies overtime (6). Both generic and specific measures areavailable to assess HRQL in CHF. Genericmeasures are applicable to different patholo-gies and cover various domains of HRQL;examples of such instruments applied in stud-ies of CHF are the Medical Outcomes Study36-Item Short Form Health Survey (SF-36),the Nottingham Health Profile (NHP) and theSickness Impact Profile (SIP). Specific instru-ments assess clinical domains that are signif-icant in CHF and identify changes in symp-

toms; they include the Quality of Life inSevere Heart Failure (QLQ-SHF)Questionnaire, the Chronic Heart FailureQuestionnaire (CHQ), the Minnesota Livingwith Heart Failure Questionnaire (MLHFQ),and the Kansas City CardiomyopathyQuestionnaire (KCCQ). A recent review arti-cle pointed out that the generic instruments(SF-36, NHP, SIP) lack sensitivity for changesin symptoms, and that certain specific instru-

ments are complex (CHQ, MLHFQ) or requirevalidation (QLQ-SHF) (7). The KCCQ showed

8/14/2019 RPC 29(03) 353-372.pdf

4/20

356

Rev Port CardiolVol. 29 Maro 10 / March 10

09-AO-49Maro

vamente aos instrumentos genricos (SF-36,NHP, SIP) e quanto complexidade (CHQ,MLHFQ) e necessidade de validao (QLQ-SHF) para os instrumentos especficos(7). OKCCQ mostrou maior sensibilidade mu-dana no tempo quando comparado com o SF-

36, o MLHFQ e a classificao da New YorkHeart Association (NYHA) (8-11), obtendo resul-tados semelhantes quando comparado com oEuroQol-5D e o SF-12 (12). Apresentou umaboa validade, fiabilidade e ndice de respostaem doentes com ICC aps enfarte agudo domiocrdio e em transplantados cardacos(13,14),sendo as suas propriedades psicomtricas si-milares em doentes com anemia e ICC (15).Estes factos justificam a crescente utilizao

deste instrumento em diversos estudos emvrios pases. Sendo um instrumento relativa-mente recente, apresenta at data outrasverses para alm da original (italiana,norueguesa, alem, sua e espanhola). A suaaplicao populao portuguesa torna-senecessria. Com a actual tendncia interna-cionalizao dos ensaios farmacolgicos e comparao entre pases dos resultados dasintervenes clnicas, criou-se uma necessi-dade de instrumentos traduzidos (16). Contudo,e dado que estes instrumentos avaliamdomnios que reflectem a cultura, contendoexpresses tpicas, a sua aplicao directa emdiferentes pases afectar os resultados e a suainterpretao, impondo-se uma validaotranscultural. O objectivo deste estudo avaliar as propriedades psicomtricas da ver-so portuguesa do KCCQ no mbito da mio-cardiopatia dilatada com ICC.

MTODOS

PopulaoAmostra consecutiva de 193 sujeitos com

diagnstico de ICC internados em cardiologiae cirurgia cardiotorcica (Quadro I). Demn-cia, incapacidade de se expressar e ausnciade vontade de participar neste estudo foramcritrios de excluso. A idade mdia era

64,4 12,4 anos (entre 21 e 88), com 72,5%do sexo masculino.

greater sensitivity to change over time thanthe SF-36, MLHFQ and the New York HeartAssociation (NYHA) classification(8-11), andobtained similar results to the EuroQol EQ-5Dand the 12-Item Short Form (SF-12) (12). It pre-sented good validity, reliability and respon-

siveness in patients with CHF after acutemyocardial infarction and in heart transplantrecipients (13, 14), and its psychometric proper-ties were similar in anemic heart failurepatients (15). These findings explain the growinguse of this instrument in various studies in dif-ferent countries. Although it was developedrelatively recently, translated versions arealready in use in other countries, includingItaly, Norway, Germany, Switzerland and

Spain, and there is obviously a need to intro-duce it into Portugal, given the current trendfor internationalization of drug trials and forcomparing results of clinical interventionsbetween countries (16). However, since there isa cultural dimension in the domains assessedin such instruments, which are often phrasedcolloquially, cross-cultural validation must beperformed. The aim of this study was to eval-uate the psychometric properties of thePortuguese version of the KCCQ in patientswith dilated cardiomyopathy and CHF.

METHODS

PopulationThe sample consisted of 193 consecutive

patients diagnosed with CHF and hospitalizedin cardiology and cardiothoracic surgerywards (Table I). Dementia, inability to express

themselves and unwillingness to participate inthe study were exclusion criteria. Mean agewas 64.412.4 years (21-88), and 72.5% weremale.

A subgroup of 105 from this sample, withsimilar characteristics to the overall sample,were assessed 3 months after hospitaldischarge. Mean age was 62.312.4 years(21-85), and 78.1% were male.

MaterialThe original version of the KCCQ is com-

8/14/2019 RPC 29(03) 353-372.pdf

5/20

357


09-AO-49Maro

Foi utilizado um subgrupo desta amostracom 105 doentes, com caractersticas idnti-cas da amostra global, que foram avaliadosao terceiro ms aps a alta hospitalar. A idademdia era 62,3 12,4 anos (entre 21 e 85),com 78,1% do sexo masculino.

MaterialA verso original do KCCQ constituda

posed of 23 items divided into 5 domains:physical limitation (question 1), symptoms(frequency questions 3, 5, 7 and 9; severity questions 4, 6 and 8; symptom stability question 2), quality of life (questions 12, 13,and 14), self-efficacy (questions 10 and 11),and social interference (question 15) (seeAnnex). The physical limitation domain meas-ures the extent to which CHF symptoms have

Caractersticas da Amostra Tipologia %Etiologia da ICC Isqumica 42

Hipertensiva 5Valvular 14Idioptica 32Outra 7

Tipo de Interveno Transplante Cardaco 4,1Cardioversor-desfibrilhador implantvel (CDI) 21,2Teraputica de Ressincronizao Cardaca (TRC) 24,9Cirurgia valvular 7,8Cirurgia de revascularizao do miocrdio (CRM) 2,6Cirurgia valvular com CRM 3,1Optimizao Teraputica Farmacolgica 25,4Outros 10,9

Classificao daNew York Heart Association Classe II 32,6Classe III 54,4Classe IV 13

Fraco de Ejeco do Ventrculo Esquerdo 50% 9,2

Quadro I Caractersticas gerais da amostra

Type %Etiology of CHF Ischemia 42

Hypertensive 5Valvular 14Idiopathic 32Other 7

Type of intervenion Heart transplantion 4.1

ICD 21.2CRT 24.9Valve surgery 7.8CABG 2.6Valve surgery with CABG 3.1Optimization of drug therapy 25.4Other 10.9

New York Heart Association classification Class II 32.6Classe III 54.4Classe IV 13

Left ventricular ejection fraction 50% 9.2

Table I General population characteristics

CABG: coronary artery bypass graft surgery; CRT: cardiac resynchronization therapy; ICD: implantable cardioverter-defibrillator

8/14/2019 RPC 29(03) 353-372.pdf

6/20

358


009-AO-49Maro

por 23 itens distribudos por 5 domnios: li-mitao fsica (questo 1), sintomas (frequncia questes 3, 5, 7 e 9; gravidade questes 4,6 e 8; estabilidade dos sintomas questo 2),qualidade de vida (questes 12, 13 e 14),auto-eficcia (questes 10 e 11) e limitao

social (questo 15) (Anexo). O domnio dalimitao fsica mede em que extenso os sin-tomas da ICC limitaram algumas das activi-dades dirias dos doentes num perodo deduas semanas. O domnio sintomas insere-seno nmero de vezes que os sintomas de ICC,como cansao, dispneia ou edema das extremi-dades ocorreram num perodo de duas semanase se houve alteraes destes sintomas noreferido perodo de tempo. O domnio auto-

eficcia mede a capacidade do doente paraperceber como pode evitar o agravamento dossintomas e o que fazer caso tal se verifique. Odomnio qualidade de vida avalia a percepodo doente acerca do seu gosto em viver ou odesnimo devido sua doena cardaca. Odomnio limitao social avalia como que aICC afecta o estilo de vida dos doentes. Parafacilitar a interpretao dos resultados, osautores constituram dois somatrios: oprimeiro denominado de estado funcional, quecompreende os domnios da limitao fsica esintomas, excluindo a questo 2 (referente estabilidade dos sintomas) e o segundo, de-nominado de sumrio clnico, que compre-ende o somatrio do estado funcional, dom-nios de qualidade de vida e limitao social.Os resultados das escalas so transformadosde 0-100 pela subtraco ao domnio do valormais baixo, seguido da diviso pelo valor maisalto subtrado do mais baixo e multiplicando

por 100, onde osscores mais elevados indicammelhor estado de sade. Aos sujeitos foi pedi-do que respondessem s 15 questes utilizan-do para o efeito escalas de Likert (17).

ProcedimentoNo presente estudo, foi testada a validade

transcultural do KCCQ com uma amostra por-tuguesa. Numa primeira fase, o instrumentopassou por processos de traduo e retro-

traduo, realizados por dois profissionais desade bilingues, independentes, de que resul-

limited some of the patients physical activi-ties over the previous two weeks. The symp-tom domain assesses the number of times thatCHF symptoms such as fatigue, dyspnea orlimb edema have occurred in the previous twoweeks and whether there have been changes

in symptoms during the same period. The self-efficacy domain measures the patients know-ledge of how to avoid worsening of symptomsand of what to do if this occurs. The quality oflife domain evaluates patients perception oftheir enjoyment of life and of their sense ofdiscouragement due to their heart failure,while the social interference domain assesseshow CHF affects the patients lifestyle. Tofacilitate interpretability, two summary scores

were developed: the first, the functional statusscore, combines the physical limitation andsymptom domains (excluding question 2 onsymptom stability), and the second, the clini-cal summary score, combines the functionalstatus score with the quality of life and sociallimitation domains. Scale scores are trans-formed to a 0 to 100 range by subtracting thelowest possible scale score, dividing by therange of the scale and multiplying by 100,higher scores indicating better health.Subjects are requested to answer the 15 ques-tions using Likert scales (17).

ProcedureIn the present study, the cross-cultural

validity of the KCCQ was tested with aPortuguese sample. First, the instrument wastranslated into Portuguese and then back-translated into English by two bilingual healthprofessionals working independently, in order

to develop a Portuguese version. This wasevaluated by the authors in terms of the clari-ty of the questions, and a Portuguese-languageform was then prepared to be given to anexpert panel. This panel, consisting of twocardiologists and two clinical psychologists,evaluated its suitability for patients with CHF.The results were analyzed and the number ofagreements and disagreements of the panelwas noted; the questionnaire was then refor-

mulated, incorporating relevant suggestions.This resulted in the pilot version, which was

8/14/2019 RPC 29(03) 353-372.pdf

7/20

tou uma verso portuguesa. Esta, foi avaliadapelos autores no sentido da clareza dos enun-ciados, aps o que foi elaborado um for-mulrio destinado ao corpo de juzes, queincluiu os itens na sua verso portuguesa. Ocorpo de juzes, constitudo por dois cardiolo-

gistas e dois psiclogos clnicos, verificaram asua adequao populao com ICC. Osresultados foram analisados, observando-se onmero de concordncias/discordncias docorpo de juzes, reformulando-se a verso comas sugestes de reformulao que se entender-am pertinentes. Surgiu assim a verso piloto,que foi aplicada a um grupo de 10 indivduos(de ambos os sexos e de vrios escalesetrios), com caractersticas semelhantes

populao-alvo, no sentido de verificar se oquestionrio era de fcil compreenso para apopulao em causa. Verificou-se no ser re-levante efectuar novos acertos na redaco dequalquer item, tendo, de um modo geral, oinstrumento sido considerado interessante eacessvel pelos sujeitos. Desta forma, a versofinal do instrumento pode ser consideradaclara e compreensvel. Ficou ento elaboradaa verso portuguesa do instrumento KCCQ(Anexo). O estudo foi autorizado peloConselho de Administrao do Hospital deSanta Marta, aps parecer da sua Comisso detica. Foram contactados doentes com o diag-nstico de ICC, internados neste hospital, nasenfermarias de cardiologia e cirurgia car-diotorcica, tendo acedido a participar numprimeiro momento um total de 193, que com-pletaram o questionrio. Destes, 105 man-tiveram-se sob teraputica mdica e vieram consulta de cardiologia ao terceiro ms aps

alta hospitalar, onde se repetiu a entrevista deaplicao do questionrio. Foram seguidos osprocedimentos ticos vigentes na instituiode sade.

Anlise EstatsticaOs dados recolhidos, foram reunidos e

tratados independentemente da enfermariaonde se encontravam, constituindo umaamostra nica. Na descrio da amostra e paraas medidas em escala nominal (sexo, etiologiae tipo de interveno e classificao do

applied to a group of ten individuals of bothsexes and of different ages with similar char-acteristics to the target population, in order toconfirm that the questionnaire was easy tounderstand. No changes were deemed neces-sary, and the instrument was generally found

to be useful and accessible; the final versionof the Portuguese-language version of theKCCQ can thus be considered clear and com-prehensible (see Annex).

The study was authorized by theAdministrative Board of Hospital de SantaMarta following approval by the hospitalsEthics Committee. Patients diagnosed withCHF and hospitalized in Hospital de SantaMarta in cardiology or cardiothoracic wards

were contacted, of whom 193 agreed to partic-ipate in the study and completed the question-naire. Of these, 105 remained under medicaltherapy and came for their 3-month follow-upappointment at the cardiology outpatient clin-ic, when they repeated the questionnaire. Allethical procedures in force at the hospitalwere followed.

Statistical analysisThe data collected were processed together

irrespective of the wards where the patientswere hospitalized to produce a single sample.In the description of the sample, nominalmeasures (gender, etiology, type of interven-tion and NYHA class) and ordinal measures(left ventricular ejection fraction) were ana-lyzed by descriptive statistics, using frequen-cies. Age, an ordinal scale, was analyzed bydescriptive statistics using measures of cen-tral tendency (mean), measures of dispersion

(standard deviation), maximum and minimum.In the evaluation of the questionnaires psy-chometric properties, Cronbach alpha wasused to measure reliability; to assess validity,the following tests were used: Pearsons coeffi-cient (correlation between the KCCQ andNYHA class, and between the differentdomains of the KCCQ), ANOVA (comparisonof symptoms and summary scores in differentNYHA classes), and the Students t test (com-

parison of initial and follow-up mean in thesame sample for the different KCCQ domains). 359


009-AO-49Maro

8/14/2019 RPC 29(03) 353-372.pdf

8/20

NYHA) e em escala ordinal (FEVE) recorreu--se a estatstica descritiva usando a frequn-cia. Para a idade (medida em escala ordinal)recorreu-se a estatstica descritiva usandomedidas de tendncia central (mdia), medi-das de disperso (desvio-padro), mximo e

mnimo. Na avaliao das propriedades psi-comtricas recorreu-se ao teste Alpha deCronbach para medir a fidelidade do ques-tionrio. Para aferir a validade recorreu-se aosseguintes testes estatsticos: correlao dePearson (correlao entre domnios do KCCQe NYHA e entre os vrios domnios do KCCQ),ANOVA (comparao da mdia dos sintomas edos somatrios nas diversas classes da NYHA)e t-student (comparao da mdia inicial e do

follow-up na mesma amostra para os vriosdomnios do KCCQ). A anlise estatsticarecorreu ao programa SPSS (verso 15).

RESULTADOS

A anlise das propriedades psicomtricasdo instrumento incidiu sobre a fidelidade,reprodutibilidade e validade.

FidelidadeEsta verso passou por uma validao

estatstica semelhante americana com aavaliao da consistncia interna dosdomnios e dos dois somatrios, apresentandovalores Alpha de Cronbach idnticos nosvrios domnios e somatrios (=0,50 a=0,94), com excepo do domnio auto-efic-cia onde obtivemos um valor mais baixo. Naverso original, este domnio j havia obtido

um valor mais baixo que os restantes domniosmas aceitvel, uma vez que o domnio commenor nmero de itens (apenas dois itens)(Quadro II).

ValidadeVerificou-se a validade convergente de

todos os domnios relacionados com funciona-lidade, pela correlao verificada entre estes euma medida de funcionalidade: a classificaoda NYHA. A estabilidade dos sintomas e aauto-eficcia tm melhor reflexo noutro tipo

The software used for the statistical analysiswas SPSS version 15.

RESULTS

Analysis of the psychometric properties ofthe KCCQ focused on reliability, reproducibil-ity and validity.

ReliabilityThis version was subjected to a similar sta-

tistical validation process to the original ver-sion, with assessment of internal consistencyof the domains and summary scores, whichshowed similar values of Cronbach alpha

(0.50-0.94), with the exception of the self-effi-cacy domain, for which a lower figure wasobtained. In the original version, this domainalso had a low Cronbach alpha but this wasdeemed acceptable as it had the smallestnumber of items (only two) (Table II).

ValidityThe convergent validity of all domains relat-

ed to functionality was assessed by analyzingthe correlation between them and a measure offunctionality, the NYHA classification. As inthe evaluation of the American version, symp-tom stability and self-efficacy are better reflect-ed in other types of measure (Table III). Thehighest values, and hence the greatest validity,was found for the physical limitation domainand the two summary scores that include it.

Sensitivity to differences was evaluated bytesting the correlation between the symptomdomain and the two summary scores and

NYHA class. A significant correlation wasfound, indicating that the KCCQ has a goodability to discriminate severity of clinical sta-tus (no events occurred during the periodunder study).

Figure 1A presents the mean scores of thesymptom domain (frequency and severity)among patients in different NYHA classes.Analysis of variance reveals statistically sig-nificant differences (F=23.47; =0.0001),

meaning that this domain discriminates sever-ity of clinical condition.360


009-AO-49

Maro

8/14/2019 RPC 29(03) 353-372.pdf

9/20

361


009-AO-49Maro

de medidas semelhana do que foi encontra-do no estudo original (Quadro III). Os valoresmais elevados encontram-se no domnio limi-tao fsica e nos doisscores que o englobam,expressando a sua validade.

Avaliou-se a sensibilidade s diferenas,testando a correlao entre o domnio sin-tomas e os dois somatrios com a classificaoda NYHA. Verifica-se uma correlao signi-ficativa entre o domnio e os somatrios com a

Figures 1B and 1C present the meanscores of the functional status and clinicalsummary scores among patients in differentNYHA classes. Analysis of variance revealsstatistically significant differences(F=36.44, F=37.36; p=0.0001), showing theability to discriminate severity of clinicalcondition.

A second evaluation was performed on 105patients after clinical intervention, no events

Domnios do KCCQ Alpha de Cronbach Alpha de Cronbach(Verso Portuguesa) (Verso Americana)

Limitao fsica 0,91 0,90Sintomas 0,87 0,88Qualidade de Vida 0,77 0,78Limitao Social 0,91 0,86Auto-eficcia 0,50 0,62

Estado Funcional 0,92 0,93Sumrio Clnico 0,94 0,95

Quadro II Consistncia Interna do KCCQ

Domain Cronbach alpha Cronbach alpha(Portuguese version) (American version)

Physical limitation 0.91 0.90Symptoms 0.87 0.88Quality of life 0.77 0.78Social interference 0.91 0.86Self-efficacy 0.50 0.62Functional status summary score 0.92 0.93

Clinical summary score 0.94 0.95

Table II Internal consistency of the KCCQ

Domnios do KCCQ Classificao NYHACorrelao de Pearson

Limitao fsica -0,54 *Sintomas -0,45 *Estabilidade dos sintomas -0,11Auto-eficcia 0,10Qualidade de Vida 0,42 *Limitao Social 0,38 *Estado Funcional 0,52 *Sumrio Clnico 0,52 *

Quadro III Coeficiente de Correlao entre os Domnios do KCCQ e a Classificao do NYHA

* p

8/14/2019 RPC 29(03) 353-372.pdf

10/20

362


009-AO-49

Maro

Figura 1A Mdia do domnio sintomas do KCCQ por classe da NYHA

Figure 1A. Mean KCCQ symptom domain scores by NYHA class

Figura 1B Mdia do somatrio estado funcional do KCCQ por classe da NYHA

Figure 1B. Mean KCCQ functional status summary scores by NYHA class

Figura 1C Mdia do somatrio sumrio clnico do KCCQ por classe da NYHA

Figure 1C. Mean KCCQ clinical summary scores by NYHA class

Symptomd

om

ainscores

Clinicalsummaryscores

Clinicalsummaryscore

s

8/14/2019 RPC 29(03) 353-372.pdf

11/20

classificao da NYHA, indicando que oKCCQ possui uma boa capacidade de des-criminao da gravidade da condio clnica(no se registaram ocorrncias durante o refe-rido perodo).

O grfico da Figura 1 A apresenta os resul-

tados mdios dos sintomas (frequncia e gravi-dade) entre pacientes em diferentes classes daNew York Heart Association. Uma anlise davarincia revela diferenas estatisticamente sig-nificativas (F=23,47; =0,0001), havendoneste domnio descriminao consoante agravidade da condio clnica.

Os grficos das Figuras 1B e 1C apresen-tam os resultados mdios do estado funcionale do sumrio clnico entre doentes em difer-

entes classes da New York Heart Association,respectivamente. Uma anlise da varinciarevela diferenas estatisticamente significati-vas (F=36,44, F=37,36; p=0,0001), descrimi-nando os doentes consoante a gravidade dasua condio.

Foi realizada uma segunda avaliao numgrupo de doentes sujeitos a interveno clni-ca, sem ocorrncias durante o perodo avalia-do, tendo-se observado alteraes significati-

vas nas mdias dos domnios avaliados entre ointernamento e a consulta no terceiro ms(diferenas de 14,9 a 30,6 numa escala de 0-100), indicando que os domnios avaliados sosensveis alterao da condio clnica notempo aps alta hospitalar (Quadro IV).

Correlao entre dimenses do KCCQA correlao inter dimenses da QVRS

que compem este instrumento moderada(entre 0,58 e 0,73), sugerindo dimenses

having occurred during the study period.Significant changes were observed in themeans of the domains assessed between hos-pital admission and the 3-month follow-upoutpatient clinic appointment (differencesfrom 14.9 to 30.6 on a scale of 0-100), indicat-

ing that the domains assessed are sensitive tochanges in clinical condition after hospitaldischarge (Table IV).

Correlation between dimensions of theKCCQ

The correlation between dimensions ofHRQL in the KCCQ is moderate (between0.58 and 0.73), suggesting that they are inde-pendent measures of the same concept, sup-

porting the multifactorial nature of HRQL andthe suitability of this measure for its evalua-tion (Table V).

DISCUSSION

The results of this validation study on thepsychometric properties of the KCCQ suggestthat the Portuguese version, like the original,

is valid and reliable for the assessment ofHRQL and the degree of limitation caused bydilated cardiomyopathy. It was shown to besimple to apply and had a high response rate.The domains measure independent dimen-sions of HRQL, which supports its suitabilityfor evaluation of this multifactorial concept.All the domains presented good internal con-sistency, confirming the instruments reliabili-ty. Validation studies in other countries haveobtained similar values to the original study

363


009-AO-49Maro

Domnios do Questionrio Mdia Mdia 3 Valor-t Valor-p Diferenade Estado de Sade de Cardiomiopatias inicial meses (T) (P) de mdias

(M) (M) (M)

Limitao fsica 59,2 81,9 7,8 0,0001 22,6Sintomas 60,2 80,1 7,0 0,0001 19,9Estabilidade dos Sintomas 50,5 65,3 4,1 0,0001 14,9Auto-eficcia 80,6 90,5 3,5 0,001 9,9Qualidade de Vida 41,2 71,8 9,1 0,0001 30,6Limitao Social 63,0 82,0 6,5 0,0001 18,9Estado Funcional 61,3 82,1 7,8 0,0001 20,8

Sumrio Clnico 58,4 80,6 8,7 0,0001 22,3

Quadro IV Avaliao ao 3 ms aps alta hospitalar (n=105)

8/14/2019 RPC 29(03) 353-372.pdf

12/20

for the domains and summary scores thatmake up the KCCQ (9, 11, 13-15).

With regard to validity, we found that thefunctionality domains (physical limitation,symptoms, quality of life, social interference,

364


009-AO-49Maro

independentes que medem o mesmo conceito,apoiando a estrutura multifactorial da QVRS ea adequao desta medida para a sua avali-ao (Quadro V).

Domain Inital 3-month t p Differencemean mean of means

Physical limitation 59.2 81.9 7.8 0.0001 22.6Symptoms 60.2 80.1 7.0 0.0001 19.9Stability of symptoms 50.5 65.3 4.1 0.0001 14.9Self-efficacy 80.6 90.5 3.5 0.001 9.9Quality of life 41,2 71.8 9.1 0.0001 30.6

Social interference 63.0 82.0 6.5 0.0001 18.9Functional status summary score 61.3 82.1 7.8 0.0001 20.8Clinical summary score 58.4 80.6 8.7 0.0001 22.3

Table IV Evaluation at 3 months after discharge (n=105)

Limitao Auto- Limitao QualidadeFsica Sntomas eficcia Social de Vida

Limitao fsicaSintomas 0.73(**)Auto-eficcia -0,52 00.1Limitao Social 0.64(**) 0.59(**) -0.92Qualidade de Vida 0.67(**) 0.61(**) -0.81 0.58(**)

Quadro V Correlao inter dimenses da Qualidade de Vida

** p

8/14/2019 RPC 29(03) 353-372.pdf

13/20

na, sendo uma medida fivel para medir aQVRS. As validaes noutros pases obtiver-am igualmente valores semelhantes aos doestudo original dos vrios domnios esomatrios que compem o KCCQ(9, 11, 13-15).

Relativamente sua validade, constatou-se

que nos domnios de ndole funcional (limi-tao fsica, sintomas, qualidade de vida, limi-tao social, estado funcional e sumrio clni-co), houve uma adequada correspondncia funcionalidade, por comparao com a medi-da mais usada internacionalmente para classi-ficar a gravidade da ICC: a classificao daNYHA. Verificou-se ainda que este instru-mento diferencia a gravidade da condioclnica, tendo-se obtido scores diferentes e

adequados s classes da NYHA em que osdoentes se encontravam. um instrumentoque apresenta uma excelente sensibilidade alterao da condio clnica ao longo dotempo, observada ao longo de trs meses numgrupo de doentes sujeitos a interveno clni-ca no mbito da ICC. Vrios estudos referemque, de facto, este questionrio o mais sen-svel mudana clnica e diferenciao dagravidade da condio clnica quando com-parado com o SF-36 e com o MLHFQ (as duasmedidas mais utilizadas na avaliao daQVRS em ICC) (8,9,11,13,14). Um estudo que inci-diu na responsividade (propriedade que umamedida de sade deve ter ao identificar a mu-dana ao longo do tempo), comparando o KCCQcom os questionrios genricos EuroQol-5D e oSF-12, identificou ser aquele o mais sensvel mudana clnica (12).

O presente questionrio, ao avaliar ummaior nmero de domnios que o MLHFQ, for-

nece informao mais detalhada sobre o esta-do dos doentes com ICC, sendo uma mais va-lia deste tipo de medidas especficas. Tambmo espao temporal a que se refere a avaliao,mais reduzido no KCCQ (duas semanas com-parativamente com um ms do MLHFQ) vaide encontro sguidelines para medir a QVRSem ensaios clnicos (9).

Num trabalho com uma populao comICC de etiologia isqumica, o KCCQ apresen-

tou semelhana do presente estudo, uma boavalidade, fiabilidade e ndice de resposta em

responsiveness, or sensitivity to clinicalchange over time, comparing the KCCQ andthe generic measures EQ-5D and SF-12,found the former to be the most responsive toclinical change (12).

By assessing more domains than the

MLHFQ, the KCCQ provides more detailedinformation on the status of CHF patients,which is an advantage of disease-specificmeasures. It also follows the guidelines formeasuring HRQL in clinical trials by assess-ing a shorter period (two weeks) than theMLHFQ (one month) (9).

As in the present study, an analysis of a pop-ulation with CHF of ischemic etiology showedthat the KCCQ presented good validity, reliabil-

ity and responsiveness in patients with previousmyocardial infarction(13). A recent study compar-ing the psychometric properties of the KCCQ inHF patients with and without anemia, a condi-tion that has similar symptoms to HF, providedevidence of its ability to evaluate HRQL regard-less of the presence of anemia (15). The same abil-ity was seen when applied in heart transplantrecipients (14).

Given the multiplicity of instruments, bothgeneric and specific, for measuring HRQL inCHF, there have been several studies aimingto clarify some of the questions raised con-cerning the suitability of different measures.A recent study comparing some of the morecommonly used HRQL instruments in CHF (7)

found that, although valid and reliable, gener-ic measures suffered from (a) low sensitivity tosmall changes in symptoms (NHP, SIP and SF-36), (b) the existence of domains that are notrelevant to CHF, such as pain in the NHP, and

(c) domains that are not relevant to the age-groups concerned, such as questions concern-ing work and vigorous activity in the SF-36,bearing in mind that many patients with CHFare aged over 75. With regard to disease-spe-cific measures, the authors observed that,although most were valid and reliable (exceptfor the CHQ, which requires further investiga-tion of its psychometric properties), there wereissues with (a) identification of CHF severity

in the QLQ-SHF and MLHFQ, (b) complexityof structure making it difficult to administer in 365


009-AO-49Maro

8/14/2019 RPC 29(03) 353-372.pdf

14/20

doentes com ICC aps enfarte agudo domiocrdio (13). Recentemente, foi realizado umestudo comparativo das propriedades psi-comtricas do KCCQ em doentes com ICC queapresentavam anemia (com manifestaoclnicas semelhantes ICC) e doentes com

ICC sem anemia, onde se verificou a capaci-dade deste questionrio para avaliar a QVRSna ICC apesar da presena desta comorbili-dade (15). As mesmas propriedades foramobservadas numa populao submetida atransplante cardaco (14).

Dado a multiplicidade de instrumentosgenricos e especficos utilizados na avaliaoda QVRS na ICC, algumas questes tm sidolevantadas quanto adequao destas medi-das. Vrios estudos tm dado o seu contributo

na sua clarificao. Um trabalho recente com-para algumas medidas de avaliao da QVRSfrequentemente utilizadas na ICC (7). No que serefere s medidas genricas, verificaram queembora vlidas e fiveis, apresentavam algunsproblemas referentes a: a) pouca sensibilidadea pequenas mudanas dos sintomas obser-vadas no NHP,SIP e SF-36; b) existncia deavaliao de domnios que no tm traduona ICC, como o caso da avaliao da dorpelo NHP; c) avaliao de domnios pouco

coerentes com a faixa etria observada, comoas questes referentes ao exerccio violento eao emprego em doentes com mais de 75 anosavaliado pelo SF-36 na ICC, atendendo incidncia e prevalncia elevada de idososnesta patologia. Relativamente s medidasespecficas, observaram que apesar da vali-dade e fiabilidade da maioria dos ques-tionrios especficos (com excepo para oCHQ por necessitar de mais investigao dassuas propriedades psicomtricas), apresen-tavam problemas ao nvel da: a) identificaoda gravidade da ICC observadas no QLQ-SHFe MLHFQ; b) complexidade da sua estruturatornando difcil a sua aplicao aos doentesverificada no CHQ; c) adequabilidade para aavaliao da QVRS para alm dos ensaiosclnicos no caso do MLHFQ. Como observado,o KCCQ apresenta alguns pontos favorveisrelativamente a estas fragilidades. Numareviso sistemtica de instrumentos especfi-

cos de QVRS na ICC por meta-anlise, con-cluiu-se que apesar do QLQ-SHF e do Left

the CHQ, and (c) the suitability of theMLHFQ in contexts other than the clinical tri-als for which it was designed. As has beenseen, the KCCQ has certain advantages inthese problematic areas. In a systematicreview with meta-analyses of disease-specific

health-related quality of life questionnaires forheart failure, the conclusion was that althoughthe QLQ-SHF and the Left VentricularDysfunction (LVD-36) Questionnaire met mini-mum psychometric criteria, current evidencewould support the use of the MLHFQ, KCCQand CHFQ (18). Concerning the form of admin-istration, for the KCCQ, application via theinternet is equivalent to pen-and-paper,unlike the MLHFQ and the Self-Care of Heart

Failure Index (SCHFI)(19)

.All of the above findings are evidence thatthe Portuguese version of the KCCQ, which hasundergone cross-cultural validation in thecourse of this study, is valid, reliable, simple toadminister and acceptable to patients as a CHF-specific measure of HRQL, and has a higherlevel of responsiveness than most generic andspecific instruments measuring the same con-cept. It thus enables the benefits perceived bypatients of clinical interventions to be quantified

directly, eliminating interobserver variability.

STUDY LIMITATIONS

Certain limitations of this study should bebeared in mind when interpreting the results.The absence of a stable follow-up group madeit impossible to assess reliability by the test-retest method, and the fact that we did not

administer another questionnaire to measurequality of life meant we could not test conver-gent/discriminant validity for domains otherthan functionality (for which we used NYHAclass).

To conclude, the results of the study showthat the KCCQ is practicable in the Portuguesecontext to evaluate HRQL in CHF, of which itis a valid and reliable measure.

366


009-AO-49Maro

8/14/2019 RPC 29(03) 353-372.pdf

15/20

Ventricular Dysfunction (LDV-36) atingirem oscritrios psicomtricos mnimos, a evidnciasuportava o uso do MLHFQ, KCCQ e CHFQ(18). Relativamente forma de administrao,observou-se que a aplicao do KCCQ porInternet equivalente do formato papel,

facto no constatado para o MLHFQ e o Self--Care Heart Failure Index (SCHFI)(19).Por todos estes factos, constata-se que a

presente medida, alvo de validao transcul-tural neste estudo, vlida, fivel, simples deaplicar e bem aceite pelos doentes, avaliandoespecificamente a QVRS na ICC e apresen-tando uma responsividade mais elevada que ageneralidade das medidas genricas e espec-ficas que medem o mesmo conceito. Constitui--se desta forma, como uma medida que per-

mite em contexto clnico quantificar de formadirecta os benefcios percebidos pelos doentesem relao s intervenes a que so sujeitos,eliminando a variabilidade interobservador.

LIMITAES DO ESTUDO

Algumas potenciais limitaes neste estudodevem ser consideradas ao interpretar os resul-

tados: a ausncia de um grupo que se mantenhaestvel no perodo de follow-up impossibilitoutestar a fidelidade por teste-reteste e a noaplicao de outro questionrio que avaliasseigualmente a QV no permitiu testar a validadeconvergente/discriminativa para os vriosdomnios avaliados pela QVRS para alm dafuncionalidade (em que usmos a classificaoda NYHA).

Conclui-se que, os resultados obtidosmostram a exequibilidade na utilizao do

KCCQ em contexto portugus, na avaliao daQVRS na ICC, assumindo-se como uma medi-da vlida e fivel.

AgradecimentosOs autores agradecem aos seguintes rgos eprofissionais do Hospital de Santa Marta;Conselho de Administrao; Comisso detica: Cardiologistas e Cardiopneumologistasda consulta de arritmologia; Cardiologistas da

consulta de insuficincia cardaca e psicolo-go.

ACKNOWLEDGEMENTSThe authors are grateful to the following

bodies and staff of Hospital de Santa Marta:the Administrative Board; the EthicsCommittee; cardiologists and cardiopneumol-ogists of the arrhythmology clinic; cardiolo-

gists of the heart failure clinic, and clinicalpsychologists.

Pedido de separatas:Address for reprints:

Elisabete Nave-LealEscola Superior de Tecnologia de Sadede Lisboa

Av. D. Joo II, Lote 4.69.1Parque das Naes1990-069 Lisboae-mail: [email protected]

367


009-AO-49Maro

8/14/2019 RPC 29(03) 353-372.pdf

16/20

1. The Task Force for the Diagnosis and Treatment of Acuteand Chronic Heart Failure 2008 of the European Society ofCardiology. ESC Guidelines for the diagnosis and treatment ofacute and chronic heart failure 2008. Eur Heart J 2008; 29:2388-2442.

2. Alla, F., Brianon, S., Guillemin, F., Juillire, I., Merts, P.,Villemont, J. et al. Self-rating of quality of life provides addi-tional prognostic information in heart failure. Insights into theEPICAL study. Eur J Heart Fail 2002; 4:337-43.

3. Rodriguez-Artlejo, F., Guallar-Castilln, P., Pascual, C.,Otero, C., Montes, A., Garcia, A. et al. Health-related qualityof life as a predictor of hospital readmission and death amongpatients with heart failure. Arch Intern Med 2005; 165:1274-9.

4. Cleland, J., Daubert, J., Erdmann E., Freemantle N., GrasD., Kappenberger, L. et al. The Effect of CardiacResynchronization on Morbidity and Mortality in HeartFailure. N Engl J Med 2005; 352:1539-49.

5. Grady, K., Naftel, D., White-Williams, C., Belg, A., Young,J., Pelegrin, D. et al. Predictors of quality of life at 5 to 6 yearsafter heart transplantation. J Heart Lung Transplant2005;24:1431-9.

6. Pais-Ribeiro, J. Introduo Psicologia da Sade. Coimbra:Quarteto, 2005.

7. Dunderdale, K., Thompson, D., Miles, J., Beer, S., Furze, G.Quality-of-life measurement in chronic heart failure: do wetake account of the patient perspective? Eur J Heart Fail 2005;7:572-82.

8. Green, C., Porter, C., Bresnahan, D. & Spertus, J.Development and evaluation of the Kansas CityCardiomyopathy Questionnaire: A new health status measurefor heart failure. J Am Coll Cardiol. 2000; 35(5):1245-55.

9. Miani, D., Rozbowsky, P., Gregory, D., Pilotto, L., Albanese,M., Fresco, C. et al. The Kansas City CardiomyopathyQuestionnaire: Italian translation and validation. Ital HeartJ.2003 Sep; 4(9):620-6.

10. Faller, H., Steinbuchel, T., Schowalter, M., Spertus, J.,Stork, S., & Angermann, C. (2005). The Kansas City

Cardiomyopathy Questionnaire (KCCQ) a new disease-spe-cific quality of life measure for patients with chronic heart fail-ure. Psychoter Psychosom Med Psychol 2005; 55(3-4): 200-8.

11. Patel, H., Ekman, I., Spertus, J., Wasserman, S., &

Persson, L. Psychometric properties of a Swedish version ofthe Kansas City Cardiomyopathy Questionnaire in a ChronicHeart Failure population. Eur J Cardiovasc Nurs. 2008 Sep;7(3): 214-21.

12. Eurich, D., Johnson, J., Reid, K., & Spertus, J. Assessingresponsiveness of generic and specific health related quality oflife measures in heart failure. Health Qual Life Outcomes.2006; 4 (89): 1-14.

13. Pettersen, K., Reikvam, A., Rollag, A., & Stavem, K.Reliability and validity of the Kansas City CardiomyopathyQuestionnaire in patients with previous myocardial infarction.Eur J Heart Fail.2005; 7(2): 235-42.

14. Ortega, T., Daz-Molina, B., Montoliu, M., Ortega, F.,Valds, C., Rebollo, P. et al. The utility of a specific measurefor heart transplant patients: reliability and validity of theKansas City Cardiomyopathy Questionnaire. Transplantation2008; 86(6): 804-10.

15. Spertus, J., Jones, P., Kim, J., & Globe, D. Validity, relia-bility, and responsiveness of the Kansas City CardiomyopathyQuestionnaire in anemic heart failure patients. Qual Life Res.2008; 17 (2):291-8.

16. Herdman, M., Fox-Rushby, J. & Badia, X. Equivalenceand the translation and adaptation of health-related quality oflife questionnaires. Qualit Life Res.1997; 6:237-47.

17. Pais-Ribeiro, J. Metodologia de Investigao em Psicologiae Sade. Porto: Legis/Livpsic, 2007.

18. Garin, O., Ferrer, M., Pont, A., Ru, M., Wiklund, I., VanGanse, E. et al. Disease-specific health-related quality of lifequestionnaires for heart failure: a systematic review with meta-analyses. Qual Life Res.2009; 18(1): 71-85.

19. Wu, R., Thorpe, K., Ross, H., Micevski, V., Marquez, C.,Straus, S. Comparing administration of questionnaires via theinternet to pen-and-paper in patients with heart failure: random-ized controlled trial. J Med Internet Res.2009 Feb 6; 11(1): e3.

368


09-AO-49Maro

BIBLIOGRAFIA / REFERENCES

8/14/2019 RPC 29(03) 353-372.pdf

17/20

369


009-AO-49Maro

8/14/2019 RPC 29(03) 353-372.pdf

18/20

370


09-AO-49Maro

8/14/2019 RPC 29(03) 353-372.pdf

19/20

371


009-AO-49Maro

English version

8/14/2019 RPC 29(03) 353-372.pdf

20/20

372


09-AO-49Maro

Documents

RPC 29(03) 353-372.pdf