validation of the minnesota living with heart failure.pdf

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Validation of the Minnesota Living With Heart FailureQuestionnaire in Primary CareJos C. Naveiro-Riloa, Dulcinea M. Diez-Jureza, Agustn Romero Blancoa,Francisco Rebollo-Gutirreza, Ana Rodrguez-Martneza and Miguel A. Rodrguez-Garcab

aGerencia de Atencin Primaria de Len, Len, SpainbServicio de Cardiologa, Hospital de Len, Len, Spain

ORIGINAL ARTICLE

Correspondence: Dr. J.C. Naveiro Rilo.Gerencia de Atencin Primaria de Len.

Abad Viayo, 1. 24008 Len. Spain.E-mail: [email protected]

Received November 23, 2009.Accepted for publication July 15, 2010.

Introduction and objectives. To evaluate theapplicability, internal consistency and validity of theMinnesota Living with Heart Failure Questionnaire(MLHFQ) when used in primary care, compared with theShort Form-36 (SF-36) health survey.

Methods. The two questionnaires were administered to589 patients with chronic heart failure who were registeredwith 97 primary care physicians. The applicability, internalconsistency and validity of the MLHFQ were evaluatedand comparisons were made with the SF-36.

Results. More than 90% of patients completed thequestionnaires. The percentage of uncompleted itemswas low. Cronbachs alpha ranged from 0.79 to 0.94for the various MLHFQ dimensions. Exploratory factorialanalysis identified two factors that explained 65.8% of thevariance. Moderate to good correlations were observedbetween similar dimensions of the MLHFQ and SF-36 (correlation coefficient 0.43 to 0.73). There weresignificant associations between scores on the MLHFQand clinical measures of disease severity.

Conclusions. When used in primary care, the MLHFQhad a high level of acceptability and good psychometricproperties compared with the SF-36. Consequently, itwould be useful for assessing health-related quality of lifein patients with chronic heart failure.

Key words: Chronic heart failure. Quality of life. Validation.Minnesota Living with Heart Failure Questionnaire.

Validacin del Minnesota Living with HeartFailure Questionnaire en atencin primaria

Introduccin y objetivos. Evaluar la aplicabilidad,la consistencia interna y la validez del Minnesota Living

with Heart Failure Questionnaire (MLHFQ) en atencinprimaria, comparndolo con el Short-Form Health Survey(SF-36).

Mtodos. Se aplicaron ambos cuestionarios a 589 pa-cientes con insuficiencia cardiaca crnica documentadaatendidos por mdicos de atencin primaria. Analiza-mos la factibilidad, la consistencia interna y la validez delMLHFQ comparado con el SF-36.

Resultados. Respondi los cuestionarios ms del 90%de la muestra. El porcentaje de tems no respondido esbajo. El coeficiente alfa de Cronbach oscila entre 0,79 y0,94 para las dimensiones del MLHFQ. Del anlisis fac-torial exploratorio, se extraen dos factores que explicanuna varianza total del 65,8%. Los coeficientes de corre-

lacin entre dimensiones similares del MLHFQ y el SF-36fueron de moderados a altos (0,43 a 0,73). Las pun-tuaciones del MLHFQ se asocian significativamente convariables clnicas de gravedad.

Conclusiones. En atencin primaria el MLHFQ, com-parado con el SF-36, muestra buena aceptabilidad ybuenas propiedades psicomtricas que lo hacen til paramedir la calidad de vida relacionada con la salud en pa-cientes con insuficiencia cardiaca crnica.

Palabras clave: Insuficiencia cardiaca crnica. Calidadde vida. Validacin. Minnesota Living with Heart FailureQuestionnaire.


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Naveiro-Rilo JC et al. Validation of the Minnesota Living With Heart Failure Questionnaire in Primary Care

records. Diagnosis could be based on a hospitaldischarge report from a medical specialist or amedical diagnosis made by a PC physician andshould be based on Framingham clinical criteria (2major criteria or 1 major and 2 minor) as well asadditional tests such as electrocardiogram, chest

x-ray, and echocardiography, with characteristicsigns of CHF. A further inclusion criterion was thatpatients should have been seen by a PC physicianin Len during at least the prior 6 months. Patientswhose heart failure was attributable to a reversiblecause were excluded.

Sampling Design

The sample was designed for a larger study (theLEONIC study) in the Leon Health Area, the mainobjective of which was to assess the epidemiological,clinical, and HRQL characteristics of patients with

CHF.All doctors in the areas PHC teams were invitedto participate. Each professional reviewed paper andcomputerized records and produced an anonymousregister of all patients on their lists with a documenteddiagnosis of CHF. Computerized records werelocated using search terms such as chronic heartfailure and congestive heart failure. From theregister produced, a proportional sample based onurban and rural strata was selected using systematicrandom sampling. The sampling interval was definedby the expression: N / n, where N = census populationwith CHF and n = predetermined sample size.

Sample Size

Sample size was calculated to meet the objectivesof the LEONIC study, ie, to estimate the prevalenceof clinical features in patients with CHF in both ruraland urban areas, with a 95% confidence interval and4% overall accuracy. It was estimated that a totalsample size of 630 patients would be required.

Fieldwork was conducted from January to April2009. Each patient completed the SF-36 and MLHFQbefore being examined by the clinician. A nurse was

present to assist if there were problems completingthe questionnaires. Clinical and treatment variables,hospital admissions, and any use of the emergencydepartment were also recorded. Functional capacitywas assessed using the New York Heart Association(NYHA) scale.

Instruments to Measure Quality of Life

The SF-36 is a validated, self-administeredquestionnaire for both the general population andpatients with a range of diseases. We used the Spanishversion 2 of the questionnaire, which includes 36

INTRODUCTION

Primary health care (PHC) is the appropriatesetting to follow up or patients with chronic heartfailure (CHF), as it is a highly prevalent conditionthat requires frequent monitoring. Few studies havebeen performed in PHC to investigate the health-related quality of life (HRQOL) of patients with

CHF.1-3 This may hinder the implementation ofclinical practice guidelines at that level of care.The quality of life (QOL) of patients with CHF

is more important than is generally recognized.4-6In a qualitative study, 49% of patients selected atherapy that would improve QOL, even if it meant areduction in survival.7

Primary care (PC) professionals need a simpleand reliable instrument to measure and identify theintervention, treatment, and QOL needs of patientswith CHF.

Both generic and specific instruments can beused to measure HRQOL in CHF. One of the most

frequently used generic measures is the Short Form-36 Health Survey (SF-36),8,9 the Spanish version ofwhich has demonstrated good reproducibility andvalidity.10 Disease-specific instruments measureaspects of health affected by the condition and areexpected to be more sensitive to changes in clinicalcondition. The most frequently used questionnairesare the Chronic Heart Failure Questionnaire, theKansas City Cardiomyopathy Questionnaire,and the Minnesota Living with Heart FailureQuestionnaire (MLHFQ).11 The latter is the mostwidely used in studies of the QOL of patients with

CHF in hospital settings,

1,2

and has been shown tohave good reliability and validity.12,13

The aim of the present study was to evaluate theapplicability, internal consistency, and validity ofthe MLHFQ when used to measure the QOL ofCHF patients in primary care, and compare it withthe SF-36 questionnaire.

METHODS

The study used a cross-sectional design. Tobe included, patients were required to have adocumented diagnosis of CHF in their PHC clinical

ABBREVIATIONS

CHF: chronic heart failureHRQOL: health-related quality of lifeNYHA: New York Heart AssociationPHC: primary health care


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The 3 aspects of the MLHFQs construct validitystudied were structural, convergent, and divergentvalidity. The Kaiser-Meyer-Oklin test (acceptable at

values over 0.5) and the Bartlett sphericity test wereused to test the statistical adequacy of the factoranalysis. Structure was evaluated using exploratoryfactor analysis with varimax rotation in which eachdimension (physical and emotional) was expected tobehave as a distinct factor, with item factor loadingsof 0.4 or more.22

The convergent and divergent validity of theMLHFQ were assessed using Pearsons multitrait-multimethod correlation matrices to determinewhether dimensions measuring similar aspects in theMLHFQ and SF-36 questionnaires correlated betterthan dimensions that were not conceptually related.

A priori hypotheses were that the highest correlationswould be observed between the MLHFQ physicalcomponent and the physical function, role-physical,and vitality dimensions of the SF-36 and betweenthe emotional component of the MLHFQ andthe role-emotional and mental health dimensionsof the SF-36. Strong correlations were definedas 0.6 and were assumed to indicate convergentconstruct validity. As regards divergent validity, wehypothesized that correlations would be low (0.4)between the SF-36 physical function, role-physical,and vitality dimensions and the MLHFQ emotional

dimension and between the physical dimension ofMLHFQ and the SF-36 role-emotional and mentalhealth dimensions.

The capacity of the MLHFQ to discriminatebetween relevant categories of patients was assessedby determining whether being female, having beenadmitted to hospital, having gone to the hospitalemergency room, being in a higher NYHA functionalclass, and having symptoms of dyspnea or fatiguein the past month led to higher mean scores on theMLHFQ dimensions and lower scores on the SF-36 summary components. We calculated confidenceintervals, and statistical testing was performed using

questions measuring 8 dimensions of health: physicalfunction, role-physical, bodily pain, general health,vitality, social function, role-emotional, and mental

health. Scores can be summarized in 2 summarycomponents assessing physical and mental health.Items in each dimension are coded, aggregated,summed, and transformed into a scale ranging from0 (worse health) to 100 (best health).14

The MLHFQ was developed in the United Statesby Rector15 as a specific tool to measure the QOLof patients with CHF. It has been validated foruse in different cultural settings and as a measureof response to medical treatment.16-20 It is selfadministered and uses Likert-type response scalesranging from 0 (no effect on QOL), to 5 (highestimpact on QOL) where higher scores reflect poorer

QOL. Table 1 shows the number of items in eachdimension and provides a brief description of themeaning of the scores.

The instrument asks about the extent to whichillness has prevented the respondent from livingas they would have liked over the last month. Thequestions cover signs and symptoms of the disease,social relations, physical activity, and sexual, workand emotions topics.

Statistical Analysis

Descriptive indices were calculated for bothquestionnaires. Acceptability was assessed bycalculating the percentage of patients with a missingresponse on any item in each dimension. Ceiling(the percentage of patients obtaining the highestpossible score) and floor (the percentage of patientsobtaining the lowest possible score) effects were alsocalculated for each component. Internal consistencywas assessed by determining the Cronbach alphacoefficient, which measures homogeneity amongitems in a given dimension. A value of 0.7 is usuallytaken to be acceptable for this coefficient forbetween, group comparisons.21

TABLE 1. Interpreting the Minnesota Living With Heart Failure Questionnaire

MLHFQ Meaning of Scores

Dimension Number of Items Worse Score Better Score

Physical dimension 8 40: Very limited in performing 0: Performs all physical activities, including the

all physical activities most vigorous, without any limitation due to health

Emotional dimension 5 25: Anxiety, depression, and a feeling 0: Feeling peaceful and calm at all timesof being a burden to their family

Overall 21 105: Very limited in performing all physical 0: Performs all physical activities, enjoys all

activities. Very depressed, tired, with a strong aspects of life

feeling of being a burden to others

MLHFQ, Minnesota Living with Heart Failure Questionnaire.


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on the role-physical and mental health dimensions,and 4 of its dimensions showed a ceiling effect (over20% of respondents with the highest possible score).

Internal consistency

All dimensions of both questionnaires showed highinternal consistency (>0.7), except for the generalhealth dimension (=0.68) of the SF-36 (Table 3).

Construct Validity

A value of 0.92 on the Kaiser-Meyer-Olkin testindicated adequate correlation matrices. The Bartlettsphericity test was significant atc2 = 4.213 (P


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increasing NYHA functional class, with mean scoreson the physical dimension of MLHFQ ranging from6.3 for patients in class I to 30.2 in class IV (P


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DISCUSSION

The results indicate that the MLHFQ has adequatemetric properties in terms of acceptability, internalconsistency, and convergent validity. The results ofexploratory factor analysis, as in the original model,extracted two factors that explained a significantproportion of the variance. The results indicate thevalue of the instrument as a measure of HRQOL inpatients with CHF who are usually monitored by a

primary care physician.Most of the studies which have measured the

QOL of CHF patients in Spain with the MLHFQor a generic questionnaire have been performed inpatients from a hospital setting.1,2,23-25

Questionnaire validation is a long and complexprocess and requires several studies in differentpopulations.26 The MLHFQ, which is the mostwidely used questionnaire in CHF patients,27has recently been validated in patients who wereselected while hospitalized and who were followedfor 2 months after discharge.13 The instrument

showed acceptable sensitivity to change and goodreliability and validity, but these results may not begeneralizable to CHF patients who are usually seenin PHC.

The proportion of patients who completed thequestionnaire was achieved with minimal supportfrom nurses and was similar to other studies.3,28,29The percentage who did not respond to any of theitems was small, indicating good acceptability.The low ceiling and floor effects on the MLHFQquestionnaire, compared with the SF-36, and theuse of the full range of scores may suggest thatthe content of this questionnaire better reflects the

poorer scores compared to those who were usuallysymptom-free. The mean scores of those admittedto hospital or attending an emergency departmentin the past year also reflected poorer QOL thanthose who were not admitted or had not gone to theemergency department.

TABLE 3. Distribution of Scores and Coefficients for Each Dimension of the SF-36 and MLHFQ Questionnaires

Missing Theoretical Observed Mean SD Median Floor Effect: Ceiling Effect:

Values, % Range Range Worst Best

Score, % Score, %

MLHFQ

Physical dimension 2.2 0-40 0-40 14.8 10.5 14 0.2 6 0.91

Emotional dimension 1.1 0-25 0-25 5.9 5.3 4 0.2 15.4 0.79Total 12.5 0-105 0-94 31 22.2 26 0 1.5 0.94

SF-36

Physical functioning 3 0-100 0-95 46.6 27.7 45 6.5 0 0.91

Role-physical 3.6 0-100 0-100 53.8 43.6 62.5 31.9 39.1 0.9

Bodily pain 0.3 0-100 0-100 64.1 27.3 67.5 1.5 20.9 0.79

General health 0.6 0-100 15-95 39.8 17.9 40 0 0 0.68

Vitality 1.8 0-100 0-100 51.6 25 50 1.2 2.5 0.81

Social functioning 1.1 0-100 0-100 73.9 28.4 87.5 1.5 39.9 0.78

Role-emotional 1.8 0-100 0-100 72.9 41.6 100 21.4 66.9 0.92

Mental health 3 0-100 0-100 65.6 22.1 70 0.3 6.1 0.82

PCS 4 0-100 3.2-92.8 50.4 26.7 49.7

MCS 3.1 0-100 4.8-92.5 68.2 26.3 78.1

Abbreviations: PCS, physical component summary; MCS, mental component summary; SD, standard deviation; MLHFQ, Minnesota Living with Heart Failure Questionnaire;

SF-36, Short Form-36 Health Survey.

TABLE 4. Factor Weights on the 2 Rotated

Components for Minnesota Living With Heart Failure

Questionnaire items

Item Factor 1 Factor 2

1a 0.48 0.19

2b 0.71 0.37

3b 0.83 0.39

4b 0.78 0.17

5b 0.81 0.25

6b

0.41 0.277b 0.51 0.25

8a 0.31 0.4

9a 0.37 0.25

10a 0.06 0.39

11a 0.37 0.27

12b 0.6 0.15

13b 0.7 0.25

14a 0.38 0.04

15a 0.21 0.32

16a 0.02 0.31

17c 0.25 0.68

18c 0.12 0.77

19c 0.27 0.72

20c

0.23 0.5121c 0.25 0.7

aItem not belonging to any factor.bItem belonging to physical factor.cItem belonging to emotional factor.


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version17 and to those obtained by Garin et al.13 Theyare also comparable to or higher than the equivalentcoefficients for the SF-36, and confirm the reliabilityof the Spanish version of the MLHFQ.

Evidence for convergent validity was providedby the strong correlations between dimensions ofMLHFQ and SF-36 measuring similar concepts,a finding which also provides additional supportfor the underlying constructs. However, divergent

specific QOL concerns of these patients, and maypoint to a greater ability to detect improvement ordeterioration.

Internal consistency was satisfactory in alldimensions, with Cronbach alpha coefficientsclose to or above 0.7, as recommended for groupcomparisons; these results provide further supportfor the factor structure emerging from the scale.21,30The coefficients are similar to those of the original

TABLE 5. Pearson Correlations Between Minnesota Living With Heart Failure Questionnaire and Short Form-36

Dimensions

SF-36 MLHFQ Physical Dimension MLHFQ Emotional Dimension MLHFQ Overall

I II IIIPCS 0.73 0.44

Physical function 0.68 0.5 0.65

Role-physical 0.58 0.47 0.59

Bodily pain 0.43 0.33 0.44

Vitality 0.67 0.51 0.65

IV V VI

MCS 0.44 0.6

Role-emotional 0.4 0.5 0.45

Mental health 0.45 0.55 0.52

Abbreviations: PCS, physical component summary; MCS, mental component summary; MLHFQ, Minnesota Living with Heart Failure Questionnaire; SF-36, Short Form-36.

Correlation significant at 0.01 (2-sided).

TABLE 6. Mean Scores on Minnesota Living With Heart Failure Questionnaire Dimensions and Short Form-36

Summary Scores According to Patient Characteristics

MLHFQ SF-36

Physical Dimension Emotional Dimension Overall PCS MCS

Sex

Women 16.5 (15.2-17.8) 6.4 (5.27-7) 33.9 (31.2-36.7) 45.3 (41.9-48.6) 58.9 (55.1-62.8)

Men 13.2 (11.9-14.5) 5.5 (4.8-6.1) 29.4 (26.6-32.2) 56 (52.6-59.3) 72.2 (68.9-75.5)

P


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bias to be unlikely and believe that the sample isprobably representative of patients diagnosed withCHF who are monitored by PC physicians. This isone of the studys main strengths, as the psychometriccharacteristics of the questionnaire being validatedare enhanced by the variety of patients included.

Another limitation of the study is that themeasurement properties of reproducibility andsensitivity to change were not investigated. Thiswas due to the study design, although it would beinteresting to evaluate these properties in differentpopulations and contexts to help extend use of thequestionnaire.

As regards the instruments interpretability (ie,the degree to which a clear meaning can be assignedto scores on an HRQOL instrument35), the supposedlack of interpretability of QOL scores such as thoseof the MLHFQ is a consequence of their noveltyor of a lack of widespread use. MLHFQ scores are

not standardized, although overall mean scoresof 27.7 and 42.7 correspond to NYHA functionalclasses II and III, respectively, in stable patients,36and a change of more than 5 points in total score isconsidered clinically significant.37

To improve interpretability, further studies areneeded with the MLHFQ in diverse groups withdifferent treatment needs and where it is possible topredict certain life events.

CONCLUSIONS

This study provides further information on the

psychometric properties of the Spanish version of theMLHFQ. It also provides evidence of its potential forfuture use in both research and in clinical practice inCHF patients seen in primary care, for which thereis a shortage of relevant data in the literature.

REFERENCES

1. Parajn T, Lupn J, Gonzlez B, Urrutia A, Altimir S, CollR, et al. Aplicacin en Espaa del cuestionario sobre calidadde vida Minnesota Living With Heart Failure para lainsuficiencia cardaca. Rev Esp Cardiol. 2004;57:155-60.

2. Morcillo C, Aguado O, Rosell F. Utilidad del MinnesotaLiving with Heart Failure Questionnaire en la evaluacin dela calidad de vida en enfermos con insuficiencia cardiaca. RevEsp Cardiol. 2007;60:1093-6.

3. Rao A, Asadi-Lari M, Walsh J, Wilcox R, Gray D. Quality oflife in patients with signs and symptoms of heart failure doessystolic function matter? J Cardiac Failure. 2006;12:677-83.

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validity was not completely confirmed, as thecorrelations between dimensions or componentsmeasuring different concepts were not as low asexpected.

The strategies used to assess construct validityshowed that the scores for each dimension measured

the appropriate concepts. Factor analysis extracted2 factors, indicating a similar structure to that of theoriginal,17 but our data showed a discrepancy, in thesense that factor loadings for item 1 (Has your heartfailure caused any swelling of the ankles, legs, etc?)suggest it could form part of the physical dimension.Construct validation is considered to be the firststep in evaluating a new instrument or when thereis limited experience with an instrument in a givenenvironment. A study on a small sample of patientswho had undergone heart valve surgery31 confirmedthat MLHFQ items fitted well to the physical andemotional dimensions, with factor loadings which

were higher than those obtained in our study. Thismay have been due to the greater similarity betweenpatients included in that study.

In relation to other variables that measure differentstages of disease severity, our results were consistentwith the a priori hypotheses. MLHFQ scores clearlydiscriminated between patients in different NYHAclasses as well as between those with symptomsof dyspnea and / or fatigue and those admitted tohospital or attending an emergency departmentin the previous year. In comparison to the SF-36, the MLHFQ appeared to discriminate betterbetween those admitted to hospital or who visited

an emergency department and those who did not.These results provide favorable data on criterionand predictive validity and mirror findings fromstudies performed in non-PC patients.31-33 Parajnet al1 found that increasing NYHA functional classand hospital admissions during the previous yearwere associated with higher scores on the MLHFQ,ie, with poorer QOL. Morcillo et al2 also reportedgood correlations between the MLHFQ, functionalclass, and the SF-36 in a small sample of patientswith advanced CHF.

One of the study limitations concerned the

inclusion criteria used to define the study population,as CHF diagnosed by clinical criteria alone can leadto false positives.34 This possible bias could affectexternal validity, in the sense that our populationmay not be representative of the overall populationof patients with the condition. However, in oursample, 75% of patients were diagnosed in hospitalsand, for those diagnosed in PHC, ultrasound valueswere available for a substantial proportion (29.2%).The average time from diagnosis was also over 3years, which would imply that the PC physicianshad considerable knowledge of the patients clinicalcondition. For those reasons, we consider selection


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6. Krumholz HM, Baker DW, Ashton CM, Dunbar SB,Friesinger GC, Havranek EP. Evaluating quality of care forpatients with Herat faillure. Circulation. 2000;101:122-40.

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