Summary
Background
Assessment of health-related quality of life is widely recommended by European health agencies in relevant research studies as well as in clinical care.
Aims
To validate the French version of the MacNew heart disease health-related quality of life questionnaire.
Methods
As part of the International HeartQoL Project, 323 French-speaking patients with ischaemic heart disease (angina, n = 76; myocardial infarction [MI], n = 155; heart failure, n = 91; mean age 58.6 ± 11.3 years) were recruited at seven cardiac rehabilitation centres. All patients completed the French versions of the MacNew questionnaire, the Short Form-36 Health Survey (SF-36) and the Hospital Anxiety and Depression Scale, to evaluate the psychometric properties of the French version of the MacNew instrument.
Results
The mean MacNew global scale scores were 4.6 ± 0.8, 5.0 ± 1.0 and 4.8 ± 0.9 in patients with angina, MI and heart failure, respectively ( P < 0.05, MI versus angina). We observed minimal missing items and ceiling effects and no floor effects. Factor analysis confirmed a three factorial structure explaining 55.9% of the observed variance. Internal consistency reliability (Cronbach’s α) ranged from 0.86 to 0.94 and test-retest reliability ranged from 0.68 to 0.73 Convergent validity was confirmed in the total group and each diagnosis, although the correlations between the MacNew physical subscale and the SF-36 mental component summary were higher than expected. Discriminative validity was partially confirmed with the SF-36 health transition item and fully confirmed with anxiety and depression as predictor variables.
Conclusion
The French version of MacNew questionnaire is recommended for assessing health-related quality of life in French-speaking patients with ischaemic heart disease.
Résumé
Contexte
L’utilisation d’un questionnaire de qualité de vie est largement recommandée par les agences de santé européennes tant en recherche que dans la pratique clinique.
Objectifs
Le but de cette étude était de valider la version française du questionnaire de MacNew en cardiologie.
Méthodes
Dans le cadre du projet international HeartQoL, 323 patients francophones coronariens (angor, n = 76 ; post-infarctus, n = 155 ; insuffisants cardiaques, n = 91) d’une moyenne d’âge de 58,6 ± 11,3 ans, ont été inclus dans 7 centres de réadaptation cardiaque. Tous ont complété les versions françaises du MacNew, du Short Form-36 (SF-36) et de l’échelle Hospital Anxiety Depression (HAD) dans le but d’évaluer les propriétés psychométriques du questionnaire MacNew français.
Résultats
Le score global du MacNew était de 4,6 ± 0,8, 5,0 ± 1,0 et 4,8 ± 0,9, respectivement dans l’angor, en post-infarctus et dans l’insuffisance cardiaque ( p < 0,05 entre infarctus et angor). Nous avons observé peu de données manquantes, d’effet plancher et l’absence d’effet plafond. L’analyse factorielle a abouti à une structure en trois composantes qui expliquent 55,9 % de la variance observée. Les coefficients de consistance interne (Cronbach’s alpha) étaient compris entre 0,86 et 0,94 et du test-retest entre 0,68 et 0,73. La validité de convergence était obtenue dans la population totale et dans chaque groupe clinique avec une corrélation plus élevée qu’attendue entre la composante physique du MacNew et le SF-36 mental component summary . La validité discriminante était confirmée, partiellement avec les items du SF3-6 transition, et totalement avec l’échelle HAD.
Conclusion
La version française du questionnaire MacNew peut être recommandée pour analyser la qualité de vie des patients coronariens.
Introduction
Traditionally, outcomes of existing and new therapies have been focused on mortality and morbidity. However, in addition to mortality and morbidity, agencies such as the European Medicines Agency and the US Food and Drug Administration recommend the use of patient-centred outcome measures, such as health-related quality of life (HRQL), in relevant research studies as well as in clinical care. This recommendation is supported by the National Heart, Lung and Blood Institute and the American Heart Association in patients with cardiovascular disease, and a recent report by the French Health Authority also supports the use of patient-centred outcome measures, especially in patients with myocardial infarction (MI) . The two basic formats for HRQL questionnaires – generic and disease-specific instruments – are designed for different purposes. Generic HRQL questionnaires are designed to assess a wide range of health states, while specific HRQL questionnaires, with a focus on disease-relevant issues, are appropriate outcome measures in both therapeutic intervention trials and routine clinical care . However, specific HRQL questionnaires should be used only in patients with the diagnosis for which the instrument is validated and not with an ‘off-label diagnosis’.
Marked health status deficits, including poor HRQL, are frequently seen in patients with ischaemic heart disease (IHD) . Treatments such as medications, interventions and rehabilitation in patients with angina, MI and heart failure have common therapeutic goals that include symptom management and improvement of HRQL. Across-diagnosis HRQL treatment outcome comparisons within a disease are not possible with a diagnosis-specific HRQL questionnaire and require the use of either a generic HRQL questionnaire or, alternatively, a core HRQL questionnaire validated in each diagnosis. Core HRQL questionnaires have been standard practice for 20 years or more in oncology , where across-diagnosis treatment comparisons are possible, allowing an understanding of the range of HRQL across diagnoses.
Comparisons across diagnoses such as angina, MI and heart failure should not be made with an IHD diagnosis-specific HRQL tool. For example, the Seattle Angina Questionnaire item stem refers specifically to ‘chest pain, chest tightness or angina’ , while the Minnesota Living with Heart Failure questionnaire item stem refers specifically to ‘your heart failure’, precluding across-diagnosis comparisons. On the other hand, the self-administered MacNew Heart Disease HRQL questionnaire uses an item stem that refers to ‘your heart problem’ , allowing across-diagnosis comparisons. The MacNew questionnaire, a modification of the interviewer-administered Quality of Life after Myocardial Infarction questionnaire , was originally developed and validated in 724 English-speaking patients with MI . There are now 38 language versions of the MacNew questionnaire, with validation studies in patients with MI ( n > 4000) in 13 languages, in patients with angina ( n > 1800) in 12 languages and in patients with heart failure ( n > 550) in 11 languages .
Reliability, validity, responsiveness and interpretability are important psychometric properties of patient-reported outcome measures . As the MacNew questionnaire has not been validated in French-speaking patients with angina, MI or heart failure, the primary objectives of this study are to report the reliability and validity of the French version of the MacNew questionnaire in patients with IHD (regardless of the specific diagnosis), with angina, with MI and with heart failure.
Methods
Patients
French-speaking patients with IHD and a diagnosis of angina, MI or heart failure were recruited at seven centres (Strasbourg, Bligny Essonne, Dijon, Machecoul, Saint-Denis, Saint-Orens and Les Moulineaux) as part of the international HeartQoL Project . The respective Institutional Review Boards approved the project and informed consent was obtained from all subjects.
A convenience sample of patients aged ≥ 18 years, without a documented psychiatric disorder or active substance abuse, who the referring physician considered able to complete the self-administered battery of HRQL instruments, were eligible if they were being treated for: angina (Canadian Cardiovascular Society class II, III or IV) with an objective measure of IHD (e.g. previous MI, exercise testing, echocardiogram, nuclear imaging or angiography); or MI diagnosed at least 4 weeks and < 6 months previously; or ischaemic heart failure (New York Heart Association [NYHA] class II, III or IV), with evidence of left ventricular dysfunction (ejection fraction ≤ 40% by invasive or non-invasive testing) and an objective measure of IHD (e.g. previous MI, exercise testing, echocardiogram, nuclear imaging or angiography).
Patient-centred outcome assessment
The referring physician provided routine clinical and diagnostic data and all patients completed a self-report sociodemographic and clinical questionnaire. The Short Form-36 Health Survey (SF-36), the Hospital Anxiety and Depression Scale (HADS) and the MacNew questionnaire were administered at baseline to all patients and 2 weeks later to approximately 20% of the patients for test-retest validation.
Short Form-36
The SF-36 is a validated generic health survey consisting of 36 items, with eight subscales summarized in a physical component summary (PCS) and a mental component summary (MCS), and has been used extensively internationally in clinical trials .
Hospital Anxiety and Depression Scale
The HADS is a validated psychological screening instrument designed to detect symptoms of anxiety and depression; it has been used extensively internationally in clinical trials, with scores ≥ 8 used to classify patients with symptoms of depression or anxiety .
MacNew questionnaire
The development of the MacNew instrument has been described previously ; it is designed to assess a patient’s feelings about how IHD affects daily functioning, and contains 27 items, with a global HRQL scale and physical limitation, emotional and social function subscales . The MacNew items and scales are scored from 1 (low HRQL) to 7 (high HRQL) and the minimal important difference (MID) on each MacNew scale is 0.50 points . Using forward-backward translation, the MacNew questionnaire was translated into French as part of the international HeartQoL Project . There is a licence fee for researchers and clinics who wish to use the French version of the MacNew questionnaire (it is free to students). Information about licence fees is available at http://www.macnew.org .
Statistical analysis
Clinical, sociodemographic and scale characteristics
Patient characteristics are described using frequencies and means ± standard deviations. Analysis of variance (continuous variables) and the Chi 2 test (categorical variables) were used to make comparisons between the three cardiac diagnostic groups. Floor and ceiling effects were determined at the lowest (1) and highest (7) scores.
Psychometric properties
The conceptual model, reliability and validity, as well as the interpretability and the respondent and administrative burden of the MacNew questionnaire, were assessed as recommended by the Scientific Advisory Committee of Medical Outcomes Trust . Face and content validities of the MacNew questionnaire have been established previously .
Factor analysis
An exploratory principal component factor analysis with varimax rotation using factor loadings of ≥ 0.40 was conducted to allocate items to a scale in the French version of the MacNew questionnaire and to determine the degree to which this factor structure replicated the original.
Reliability
The reliability of the MacNew questionnaire was evaluated by examining its internal consistency (Cronbach’s α); test-retest reliability (14-day) was assessed with intraclass correlation coefficient in a 20% target sample. A value of ≥ 0.70 was considered the criterion value for group comparisons and ≥ 0.90 for individual comparisons .
Validity
We hypothesized strong correlations between the SF-36 PCS and MCS and the similar MacNew scale constructs, and lower correlations between dissimilar constructs ( r < 0.20 = absent; 0.20–0.34 = weak; 0.35–0.49 = moderate; ≥ 0.50 = strong) as a test of construct validity . We tested discriminative validity of the MacNew questionnaire using the ‘known group’ method . We also examined the pattern of MacNew scores hypothesizing poorer HRQL in congestive heart failure patients who reported perceived health status on the health transition item of the SF-36 collapsed in three groups (deteriorated, no change, improved) and, using the HADS cut-off scores of < 8 and ≥ 8, in patients with and without anxiety or depression symptoms.
Results
Patient characteristics
Baseline sociodemographic and clinical data were collected on 323 patients with IHD (angina, n = 76; MI, n = 156; heart failure, n = 91) who were recruited at seven centres in France ( Table 1 ). The mean age in the group as a whole was 58.6 ± 11.3 years; patients with angina (mean age 64.2 ± 8.5 years) were older than patients with either MI or HF ( P < 0.001). Patients with angina were most likely to have high cholesterol ( P = 0.002); patients with MI were most likely to be current smokers ( P = 0.008) and to be physically inactive ( P < 0.03); patients with heart failure were most likely to be hypertensive ( P = 0.004). There were more patients with Canadian Cardiovascular Society angina class II (67.1%) than class III/IV (32.9%) and more patients with NYHA class II (57.1%) than class III/IV (42.9%).
| Patient characteristics | Total group ( n = 323) | Angina ( n = 76) | MI ( n = 156) | Heart failure ( n = 91) | P b |
|---|---|---|---|---|---|
| Age (years) | 58.6 ± 11.3 | 64.2 ± 8.5 | 55.9 ± 10.8 | 58.6 ± 12.4 | < 0.001 c |
| Sex | 0.55 | ||||
| Male | 82.7 | 86.8 | 81.4 | 81.3 | |
| Female | 17. | 13.2 | 18.6 | 18.7 | |
| Family status | 0.09 | ||||
| Single | 9.3 | 6.6 | 7.1 | 15.4 | |
| Married | 70.0 | 71.1 | 68.6 | 71.4 | |
| Other | 19.8 | 21.1 | 23.1 | 13.2 | |
| Employment | 0.26 | ||||
| White collar | 61.6 | 55.3 | 67.9 | 56.0 | |
| Blue collar | 24.1 | 27.6 | 21.2 | 26.4 | |
| Education | 0.43 | ||||
| < High school | 53.6 | 55.3 | 55.1 | 49.5 | |
| High school | 12.4 | 9.2 | 10.9 | 17.6 | |
| > High school | 23.2 | 19.7 | 25.6 | 22.0 | |
| HADS ≥ 8 | |||||
| Anxiety | 47.4 | 44.7 | 46.8 | 50.5 | 0.69 |
| Depression | 24.8 | 22.4 | 22.4 | 30.8 | 0.28 |
| Body mass index (kg/m 2 ) | 26.9 ± 4.4 | 26.8 ± 3.8 | 26.9 ± 4.3 | 27.1 ± 5.1 | 0.90 |
| Smoker | 18.6 | 10.5 | 25.0 | 14.3 | 0.008 d |
| Hypertension | 35.0 | 48.7 | 64.1 | 74.7 | 0.004 c |
| Diabetes | 14.9 | 18.4 | 11.5 | 17.6 | 0.27 |
| Hypercholesterolaemia | 51.4 | 67.1 | 49.4 | 41.8 | 0.002 c |
| Physically inactive (< 3 times/week) | 68.4 | 59.2 | 75.0 | 64.8 | < 0.03 e |
a Data missing when total < 100%.
b P value by diagnosis with ANOVA for age and Chi 2 for all other variables.
c Angina versus MI and heart failure.
Patient-centred outcome scores
MacNew questionnaire
Mean MacNew global scale scores were 4.9 ± 1.0 in the group as a whole and were higher in patients with MI than in patients with angina (5.0 ± 1.0 vs. 4.6 ± 0.8, respectively; P < 0.05) ( Table 2 ). Mean physical MacNew scores were 4.8 ± 1.0 in the group as a whole and were higher ( P < 0.001) in patients with MI (5.1 ± 1.0) than in patients with either angina (4.4 ± 0.09) or heart failure (4.7 ± 1.0). There were no differences in emotional or social MacNew scores by diagnosis.
| Total group | Angina | MI | Heart failure | P | |
|---|---|---|---|---|---|
| MacNew | |||||
| Global | 4.9 ± 1.0 | 4.6 ± 0.8 | 5.0 ± 1.0 | 4.8 ± 0.9 | < 0.05 a |
| Physical | 4.8 ± 1.0 | 4.4 ± 0.9 | 5.1 ± 1.0 | 4.7 ± 1.0 | < 0.001 a,b |
| Emotional | 5.0 ± 1.1 | 4.9 ± 1.0 | 5.0 ± 1.2 | 5.0 ± 1.1 | 0.67 |
| Social | 4.9 ± 1.0 | 4.7 ± 0.9 | 5.0 ± 1.1 | 4.8 ± 1.0 | 0.07 |
| SF-36 | |||||
| PCS | 41.1 ± 8.0 | 38.6 ± 6.6 | 43.4 ± 7.8 | 39.2 ± 8.2 | < 0.001 a,b |
| MCS | 41.1 ± 11.0 | 39.7 ± 10.5 | 40.4 ± 11.2 | 43.8 ± 10.8 | 0.03 |
| HADS | |||||
| Anxiety | 7.7 ± 4.4 | 7.5 ± 4.2 | 7.8 ± 4.6 | 7.6 ± 4.1 | 0.89 |
| Depression | 5.2 ± 3.6 | 4.9 ± 3.4 | 5.0 ± 3.7 | 5.9 ± 3.6 | 0.15 |
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