1477-7525-11-179 1477-7525 Research <p>A short questionnaire for the assessment of quality of life in patients with chronic obstructive pulmonary disease: psychometric properties of VQ11</p> NinotGregorygregory.ninot@univ-montp1.fr SoyezFranckfsoyez001@orange.fr PréfautChristianchristian.prefaut@orange.fr

Laboratory Epsylon, EA4556 Dynamics of Human Abilities & Health Behaviors, University MONTPELLIER 1, Montpellier F-34000, France

U1046 INSERM Physiologie et Physiopathologie du Coeur et du Muscle, University MONTPELLIER 1, CHRU Montpellier, Montpellier F-34295, France

Health and Quality of Life Outcomes 1477-7525 2013 11 1 179 http://www.hqlo.com/content/11/1/179 10.1186/1477-7525-11-179
2162013259201325102013 2013Ninot et al.; licensee BioMed Central Ltd.This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Chronic obstructive pulmonary disease Brief questionnaire Health-related quality of life Validity VQ11

Abstract

Background

There is a need for a validated short instrument that can be used in routine practice to quantify potential short-term change in Health-Related Quality of Life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD). Our aim is to determine the validity and reliability of the VQ11 questionnaire dedicated to the routine assessment of HRQoL.

Methods

181 COPD patients (40–85 yrs, I to IV GOLD stages) completed the VQ11, and several tests. One week later, 49 of these patients completed the VQ11 again.

Results

Confirmatory factor analysis supported the two-level hierarchical structure of the VQ11 with 11 items covering three components and HRQoL at a higher level. The VQ11 showed good internal consistency and good reproducibility (r = 0.88). Concurrent validity showed significant correlations between VQ11 total scores and St George’s Respiratory Questionnaire-C (r = 0.70), Short Form-36 (r = -0.66 for the physical component and -0.63 for the mental component). We obtained significant correlations with MRC Dyspnea Grades (r = 0.59), the Hospital Anxiety and Depression Scale total score (r = 0.62), and the BODE index (r = 0.53).

Conclusion

The VQ11 has good measurement properties and provides a valid and reliable measure of COPD-specific HRQoL. It is ready for use in routine practice.

Clinical registration

The study was approved by the University of Montpellier 1 Ethics Committee and the Regional Ethics Committee (authorization number: A00332-53).

Background

Self-administered questionnaires are required in order to estimate global outcomes of COPD 1 . Available disease-specific Health-Related Quality of Life (HRQoL) measures, mainly the St George’s Respiratory Questionnaire (SGRQ) 2 , and the Chronic Respiratory Disease Questionnaire (CRDQ) 3 , are reliable and valid, and widely used in clinical trials. There is increasing evidence that HRQoL questionnaires can also be useful in clinical settings 4 ; however, existing instruments are lengthy and have complex scoring algorithms, making them poorly suited for routine use in clinical practice and repeated assessment. Most patients require short questionnaires (reducing fatigue, eliminating redundancy of items, and facilitating spontaneous responses).

A standardized, patient-centered assessment instrument covering key aspects of COPD HRQoL facilitates information gathering and improves communication between patient and clinician, particularly for general practitioners. An ideal instrument would identify specific areas of greater severity that would serve as focal points for targeted management or the evaluation of management goals, thereby improving both the process and outcome of care. The instrument must be sensitive enough to measure mild-moderate COPD 5 , but also reliable 6 7 , valid for evaluative studies, and useful for determining rehabilitation routines. Previous studies have shown significant changes in quality of life score between three and six months in patients with COPD participating in a rehabilitation program 8 or, after discharge from a rehabilitation program 9 10 .

Recently, short self-administered questionnaires, the COPD Clinical Questionnaire (CCQ) 11 , the Short Form Chronic Respiratory Disease Questionnaire (SF-CRQ) 12 , the Visual Simplified Respiratory Questionnaire (VSRQ) 13 , the COPD Assessment Test (CAT) 14 , and the COPD specific HRQoL (VQ11) 15 , have been validated with similar psychometric properties (Table  1) and some limitations.

<p>Table 1</p>

CCQ 11

SF-CRDQ 12

VSRQ 13

CAT 14

VQ11 15

Dimension

Symptom

Dyspnea

Total

Total

Total (HRQoL)

Physical

Fatigue

(HRQoL)

(COPD impact)

Functional Psychological Social

Mental

Emotion

Total

Mastery

Items

10

8

8

8

11

Answer

Frequency

Frequency or intensity

Frequency or intensity

Frequency or intensity

Intensity

Likert 6

Likert 6

Likert 11

Likert 6

Likert 5

Range

0 - 6 (Total)

1 - 14 per dimension

0 - 80

0 - 40

11 - 55

Item reduction

From 77 to 10

From 20 to 8

From 18 to 8

From 21 to 8

From 24 to 11

Expert committee

Authors

Expert committee

Rasch

Confirmative factor analysis

Model

None

Principal component analysis

Principal component analysis

Rasch analysis

Structural equation modeling

α Chronbach

.91

.82

.84

.88

.83

Test-retest

.94

-

.77

.80

.72

r Total SGRQ

.71

-

-

.80

-

r FEV1

-.38

-.07 to -.28

-

-

-

Psychometric properties of short HRQoL questionnaires for COPD patients

In practice, the 8-item VSRQ and the 8-item CAT include no subscales. Conversely, the 8-item SF-CRDQ does not provide a total score. The SF-CRDQ, VSRQ and CAT mix answers for frequency and intensity, which could be difficult to distinguish in patients with COPD.

Conceptually, these instruments establish confusions to estimate the impact of COPD between health status and HRQoL. The concept of health status refers to the impact of health on the individual’s ability to perform daily life activities and to benefit from them 16 . HRQoL refers to the three broad dimensions of health: physical (e.g., autonomy, capacity, symptoms), psychological (e.g., pain, self-esteem, and symptoms), and social (e.g., social relationship, family relationship) 17 . Thus, an instrument dedicated to the measure of HRQoL needs to provide 3 dimensions (physical, psychological and social) and an overall total score.

Qualitatively, the SF-CRDQ and the CAT include information on daily symptoms, activity limitation and other physical manifestations of COPD (Table  2). These instruments are specific to the functional and psychological outcomes of COPD (symptoms, function and confidence in living at home), whereas the social effects produced by COPD can only be assessed by HRQoL measures 18 . The VSRQ and the CAT do not include any item on depression, which is prevalent in COPD patients and alters HRQoL 19 . The 10-item CCQ includes one social life question and relates directly to respiratory problems. The VQ11 is a short instrument that was designed to measure the functional, psychological and social aspects of COPD consequences and provide an overall score for specific HRQoL.

<p>Table 2</p>

Dimension

Aspect

CCQ

SF-CRDQ

VSRQ

CAT

VQ11

Shortness of breath

2

1

1

1

1

Fatigue

2

1

1

1

Functional

Activity limitations

3

1

1

1

1

Phlegm

1

1

Cough

1

1

Chest tightness

1

Low self-confidence

1

1

Psychological

Anxiety

1

2

1

1

Depression

1

1

1

Sleep

1

1

1

1

Sexual life trouble

1

1

Social

Life project limitation

1

1

Social support lack

1

Social life restriction

1

1

1

Item coverage of short HRQoL questionnaires for COPD patients

Psychometrically, for all the above instruments but the CAT and VQ11, the item reduction selection was made by a committee of experts and without the use of statistical analysis such as Confirmatory Factor Analysis. A previous study showed that the VQ11 has good content and internal properties 15 . This study was carried out to verify its construct’s validity and reliability in comparison to other short instruments (Table  1).

Methods

Participants

Participants were recruited from three pulmonary clinics and two medical offices between January 2008 and June 2009 using advertising flyers. To be included in the study, patients had to be aged between 40 and 85 years, and have an incompletely reversible limitation in airflow (forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) ratio ≤ 70%) and I to IV GOLD stage (FEV1 < 80% th.). Patients with severe or uncontrolled comorbidities (unstable and/or uncontrolled cardiac disease, terminal disease, dementia, or an uncontrolled psychiatric illness) were excluded. 181 (123 males and 58 females) participated in the study after providing informed written consent. Demographic and clinical characteristics are listed in Table  3. The subjects did not participate in any other research study during this period. This study was approved by the University of Montpellier 1 Ethics Committee and the Regional Ethics Committee (authorization number: A00332-53).

<p>Table 3</p>

Mean

SD

Min

Max

Sociodemographic and overall characteristics

Age (yrs)

61.4

9.8

37

85

BMI (kg/m2)

25.7

5.4

13.1

39.7

BODE score

3.5

2.4

0

10

Dyspnea MMRC

1.4

1.3

0

3

Smoking history

Pack-years (smokers)

33.5

32.3

0.1

135.0

Pack-years (ex-smokers)

45.5

28.9

0.8

157.5

Spirometry

Pre-BD FEV1 (ml)

1395

645

460

4090

FEV1 (% pred)

49.0

20.5

15

112

FEV1/FVC (%)

47.7

12.4

25

69

Exercise tolerance

Dyspnea 6MWD end

6.0

2.1

2

10

6MWT distance (m)

470.9

122.1

90

812

6MWT distance (% pred)

70.9

17.3

14

121

HRQoL Measures

SGRQ-C Symptoms score

54.3

18.9

6.8

97.3

SGRQ-C Activity score

55.3

22.7

7.3

100.0

SGRQ-C Impact score

34.2

18.7

4.2

89.1

SGRQ-C Total score

46.3

18.5

9.7

97.7

VQ11 Functional (3–15)

8.8

2.8

3

15

VQ11 Psychological (4–20)

10.2

3.2

4

18

VQ11 Social (4–20)

9.0

3.8

4

19

VQ11 Total score (11–55)

27.9

8.8

11

49

SF-36 Physical functioning

56.3

22.8

0

100

SF-36 Role physical

40.1

35.0

0

100

SF-36 Role emotional

55.7

40.2

0

100

SF-36 Energy/vitality

46.9

18.6

0

100

SF-36 Mental Health

64.0

15.3

20

100

SF-36 Social functioning

74.4

23.4

0

100

SF-36 Bodily pain

70.2

26.7

0

100

SF-36 General health perceptions

36.2

19.9

0

95

SF-36 Physical Component Scale

50.5

22.1

8.5

96.3

SF-36 Mental Component Scale

60.3

19.0

16.0

93.5

Other Measures

HADS Anxiety score (0–21)

8.2

3.8

0

19

HADS Depression score (0–21)

6.0

3.4

0

17

HADS Total score (0–42)

14.2

6.3

1

33

Physical self-worth (1–6)

2.8

1.1

1.0

5.6

Clinical characteristics and HRQoL measures for 181 patients (123 males and 58 females)

Study design

Upon recruitment, the following examinations were performed for each participant: a clinical assessment, the collection of cardio-respiratory family history and number of exacerbations for respiratory (or other) reasons, a respiratory function examination (spirometry, blood gas analysis), an electrocardiogram, and a six-minute walk test (6MWT). Participants were also required to complete the experimental questionnaire, the external validity questionnaires (Medical Outcome Survey Short - SF-36, SGRQ-C, Hospitalization Anxiety Depression Scale - HADS, Physical Self-Worth - PSW) and a datasheet on their socio-cultural situation. Appointments were made with participants who were able and willing to undergo a follow-up assessment one week later. Forty-nine participants completed the VQ11 again to test its reproducibility. To ensure uniform assessments in this multicentric study (Montpellier, Paris, Osséja), the medical and scientific committee of the healthcare network developed recommendations and one teaching session for a standard protocol for instrument use and patient assessment.

Completion of questionnaires

The participants completed the battery of self-administered questionnaires, presented in a randomized order, while resting between physical tests. Participants who took part in both sessions were examined by the same researcher on both occasions.

VQ11

The VQ11 is a brief, self-administered HRQoL questionnaire that was specifically designed to allow individual monitoring of COPD patients over a short-term period. The questionnaire’s preliminary versions were developed according to the standard stages of questionnaire validation 20 21 , including evaluation of content validity, item clarity and construct validity 15 . An initial version of the questionnaire was drawn up by a panel of experts consisting of 20 COPD professionals and 15 patients with different degrees of COPD and different psychosocial levels. The clarity of each item was then tested on 20 patients with different degrees of COPD and different psychosocial levels. After making adjustments to the initial questionnaire, the committee produced an experimental questionnaire with 24 items, covering three theoretical components (functional, psychological and relational) and 11 sub-components. Each sub-component consisted of two or three items. This experimental questionnaire was tested on 166 COPD patients. Confirmatory factor analysis showed that the best model was a two-level hierarchical model with an initial level comprising 11 items (one per sub-component) distributed across three components (functional = 3 items; psychological = 4 items; social = 4 items) and a top level (lower score indicates better HRQoL) combining these three components. Cronbach’s alphas were calculated to test the internal consistency scales. The resulting values were 0.83 for the functional component, 0.69 for the psychological component, 0.57 for the social component and 0.83 for the total scale. Table  4 shows the French version of the VQ11 and a cross-cultural translation produced by three native speakers of English.

<p>Table 4</p>

English

French

Information

The following sentences express feelings about the consequences of COPD. For each sentence, tick the intensity that best reflects your feeling at this moment (from “not at all” to “extremely”). There are no wrong answers. Each one is personal.

Les phrases suivantes expriment des sentiments sur les conséquences de la BPCO. Pour chacune, cochez l’intensité qui vous correspond le mieux maintenant (de « pas du tout » à « extrêmement »). Aucune réponse n’est juste. Elle est avant tout personnelle.

Dyspnea

I suffer from breathlessness

Je souffre de mon essoufflement

Anxiety

I am worried about my respiratory condition

Je me fais du souci pour mon état respiratoire

Closeness

I feel my entourage (family, friends, etc.) misunderstands me

Je me sens incompris(e) par mon entourage

Mobility

My respiratory condition prevents me from moving about as easily as I would like

Mon état respiratoire m’empêche de me déplacer comme je le voudrais

Sleep

I feel sleepy during the day

Je suis somnolent(e) dans la journée

Life project

I feel unable to achieve my objectives

Je me sens incapable de réaliser mes projets

Fatigue

I quickly get tired when doing day-to-day activities

Je me fatigue rapidement dans les activités de la vie quotidienne

Physical confidence

Physically, I am dissatisfied with what I can do

Physiquement. je suis insatisfait(e) de ce que je peux faire

Social life

My respiratory disease disrupts my social life

Ma maladie respiratoire perturbe ma vie sociale

Depression

I feel sad

Je me sens triste

Emotional life

My respiratory condition restricts my emotional life

Mon état respiratoire limite ma vie affective

Content and structure of the VQ11 questionnaire and its cross-cultural translation by three native speakers of English

Other questionnaires

The MOS-SF-36 22 23 , the SGRQ-C 24 , the HADS 25 , and the PSW of the French version 26 of the Physical Self-Perception Profile 27 were assessed.

MMRC scale

The degree of dyspnea was measured using the Modified Medical Research Council (MMRC) scale 28 , which correlates well with other scales and health status scores 29 .

Analyses of respiratory function

The pulmonary function tests (PFTs) included simple screening spirometry, formal lung volume measurement, diffusing capacity for carbon monoxide, and arterial blood gases. We measured the volume-time curve and the flow-volume loop, as well as FVC and FEV1 in order to calculate FEV1/FVC indices 30 .

Exercise tolerance

The 6MWT test was performed twice with more than 30 minutes between tests in order to allow heart rate and dyspnea to return to their initial rest values 31 . A dyspnea score was measured on a 10-cm visual analog scale (VAS) before and immediately after the test.

Statistical analyses

CFA was used to confirm the theoretical model found during the internal validation (Statistical Software Mplus 5.1). Fit assessment of the CFA models was based on multiple indicators 32 33 34 , including the Chi-square statistic (χ2), comparative fit index (CFI), Tucker-Lewis Index (TLI), root mean square error of approximation (RMSEA), and 90% confidence interval (CI) of the RMSEA. Values greater than 0.90 for CFI and TLI are considered to indicate adequate model fit, although values approaching 0.95 are preferable. Values smaller than 0.08 or 0.06 for the RMSEA indicate acceptable and good model fit, respectively 33 34 . For the RMSEA 90% CI, values less than 0.05 for the lower bound (left side) and less than 0.08 for the upper bound (right side) or of 0 for the lower bound and less than 0.05 for the upper bound (right side) indicate acceptable and good model fit, respectively 35 . Factor loadings, squared multiple correlations, standard errors and t values were inspected for appropriate sign and/or magnitude.

Concurrent validity was assessed by analyzing Pearson correlation coefficients between the dimensions of the study questionnaire and those of another questionnaire measuring similar concepts. Spearman correlation coefficients were calculated between the VQ11 (total and component scores) and other independent variables. In order to confirm good concurrent validity but no redundancy, the new questionnaire had to show moderate correlation (0.40 to 0.70) with a well-established mea surement tool.

Reliability is the degree to which an instrument is free from random error. It is evaluated by measuring internal consistency reliability and reproducibility. Internal consistency reliability refers to the homogeneity of the items of the scale and was assessed using Cronbach’s alpha. Reproducibility establishes the stability of an instrument over time in a stable population and was tested using a Pearson correlation.

Results

Patient demographics

One hundred eighty-one participants completed the study baseline questionnaires and 49 participants completed the follow-up questionnaires. The mean ± SD and range of the physiological and patient-reported outcomes for the study population are summarized in Table  3.

Factor validity

A CFA supported the validity of a two-level hierarchical model with a three-component initial level and a single top level (Figure  1). The weighted least squares mean- and variance-adjusted χ2 estimator analyzed all the items as categorical variables. Fit indices were acceptable (χ2 = 133.090; df = 24; CFI = 0.910, TLI = 0.955; RMSEA = 0.158). The fit for the one-factor model was as good as the fit for the three-factor model (χ2 = 135.573; df = 25; CFI = 0.909, TLI = 0.956; RMSEA = 0.156), but it was less acceptable with the difftest (difftest = 12.277; df: 3; p = 0.0065).

<p>Figure 1</p>

Hierarchical model and indices obtained for the VQ11 using confirmatory factor analysis (n = 181 COPD patients)

Hierarchical model and indices obtained for the VQ11 using confirmatory factor analysis (n = 181 COPD patients).

Reproducibility was assessed in terms of the correlations between the measures produced by the 49 COPD patients who were reassessed after a one-week period (42 patients under 10% of variation; 7 patients under 20% of variation). Correlation coefficients were 0.76 for the functional component (p < .01), 0.65 for the psychological component (p < .01), 0.73 for the social component (p < .01), and 0.88 for total VQ11 (p < .01).

Reliability

Cronbach’s alphas were 0.80 for the functional component, 0.68 for the psychological component, 0.77 for the social component and 0.89 for the whole scale. Alphas computed using the Spearman-Brown formula were 0.91, 0.81 and 0.87, respectively.

The low correlations between VQ11 and FEV1 (functional component, -0.26; total, -0.19) suggest that there are no significant differences between groups classified by grade of severity and VQ11 score.

Table  5 presents the clinical characteristics and HRQoL measures of the 181 COPD participants according to quartiles of VQ11 score. Associations between increasing VQ11 quartiles and clinical characteristics were found for FEV1, pre-BD FEV1, FEV1/FVC and 6MWT distance (negative association), as well as for BODE score and dyspnea from both MMRC classification and the 6MWT-end measure (positive association). There were no significant associations between VQ11 quartiles and either age or BMI. HRQoL measures from SGRQ were all positively and significantly associated with VQ11 quartiles including SGRQ symptoms, activity, impact and total scores (p < 0.0001).

<p>Table 5</p>

VQ11 quartiles

Q1(≤20)

Q2 (20–28)

Q3 (28–34.5)

Q4 (>34.5)

Scheffe **

F

(N = 45)

(N = 51)

(N = 37)

(N = 44)

P value $

*Mean ± SD.

**Significant at 0.05 level.

$Analysis of covariance for variables showing both normal distributions and homogeneous variance; Kruskal-Wallis test for variables showing normal distributions and/or homogeneous variance.

Clinical characteristics

Age (yrs)

62.1

±

9.1*

60.9

±

10.6

61.2

±

11.0

61.6

±

8.1

0.94

BMI (kg/m2)

25.3

±

5.0

25.9

±

4.7

25.0

±

5.4

26.6

±

6.3

0.55

MMRC Dyspnea

0.36

±

0.77

1.23

±

1.26

1.8

±

1.2

2.4

±

1.1

Q1 < Q3; Q1 < Q2 < Q4

<0.0001

Pre-BD FEV1 (ml)

1676

±

727

1413

±

586

1176

±

576

1267

±

590

Q1 < Q3,Q4

0.002

FEV1 (% pred)

55.8

±

18.7

51.4

±

21.6

43.5

±

19.2

44.2

±

20.5

NS

0.013

FEV1/FVC (%)

53.1

±

10.3

47.5

±

13.2

44.4

±

11.7

45.5

±

12.6

Q1 < Q3,Q4

0.006

Dyspnea 6MWD end

5.2

±

1.9

6.1

±

1.9

5.9

±

2.1

6.7

±

2.2

Q1 < Q4

0.026

6MWT distance (m)

521

±

85.0

504

±

119

449

±

111

403

±

132

Q1,Q2 < Q4

<0.0001

BODE

1.8

±

1.6

3.1

±

1.9

4.2

±

2.2

5.2

±

2.4

Q1,Q2 < Q4; Q1 < Q2,Q3

<0.0001

HRQoL Measures

SGRQ-C Symptoms

43.1

±

15.3

52.5

±

17.1

59.1

±

16.8

64.0

±

20.0

Q1 < Q3,Q4; Q2 < Q4

<0.0001

SGRQ-C Activity

38.9

±

17.2

51.8

±

19.4

60.7

±

18.9

71.5

±

21.9

Q1 < Q2 < Q4; Q1 < Q3

<0.0001

SGRQ-C Impact

16.3

±

9.2

31.6

±

13.7

42.3

±

16.8

48.9

±

16.5

Q1 < Q2 < Q3,Q4

<0.0001

SGRQ-C Total

28.9

±

10.6

43.3

±

13.5

53.4

±

14.6

61.4

±

17.0

Q1 < Q2 < Q3,Q4

<0.0001

Clinical characteristics and HRQoL measures by quartiles of VQ11 score

Construct validity

The construct validity results are shown in Tables  6 and 7. The VQ11 showed good correlation with SGRQ total scores (0.71), SF-36 component scores (-0.61 for MCS and -0.61 for PCF), HADS total scores (0.61), and physical self-worth (-0.59). SGRQ total scores correlated most strongly with the functional component of the VQ11 (0.66), whereas MCS and HADS scores correlated most strongly with the psychological and social components of the VQ11 (-0.61 and 0.63; -0.60 and 0.61 respectively). Furthermore, we found significant correlations between VQ11 total scores and 6MWT end dyspnea scores, 6MWT distances (in meters and in percentage of the predicted distance) and total BODE scores (0.26, -0.37, 0.51 respectively). These correlations were particularly satisfactory for the functional component of the VQ11 (0.28, -0.42, 0.56 respectively). Correlations with FEV1, FEV1 as a percentage of the predicted value, FEV1/FVC and pack-years for smokers were low.

<p>Table 6</p>

Functional

Psychological

Social

Total

In bold type, p < .05.

Age

0.10

-0.11

-0.08

-0.04

BMI

0.13

0.05

0.05

0.08

Pack-years (smokers)

0.01

0.10

0.06

0.06

Pack-years (ex-smokers)

0.29

0.19

0.20

0.25

Pre-BD FEV1

-0.28

-0.14

-0.16

-0.21

FEV1 % pred

-0.26

-0.14

-0.13

-0.19

FEV1/FVC

-0.26

-0.17

-0.16

-0.22

MMRC Dyspnea Grade

0.61

0.49

0.51

0.59

Dyspnea 6MWD start

0.17

0.04

0.10

0.11

Dyspnea 6MWD end

0.28

0.20

0.24

0.26

Dyspnea 6MWD difference

0.17

0.19

0.16

0.19

6MWT distance (m)

-0.42

-0.25

-0.34

-0.37

6MWT distance (% pred)

-0.41

-0.26

-0.35

-0.38

BODE Index

0.56

0.41

0.43

0.51

Correlation between VQ11 and other variables of interest

<p>Table 7</p>

Functional

Psychological

Social

Total

In bold type, p < .05.

SGRQ-C

  Symptoms

0.43

0.41

0.40

0.46

  Activity

0.57

0.48

0.54

0.59

  Impact

0.63

0.60

0.64

0.69

  Total

0.66

0.61

0.65

0.71

MOS SF-36

  Physical functioning

-0.64

-0.50

-0.53

-0.62

  Physical role

-0.45

-0.38

-0.36

-0.43

  Emotional role

-0.28

-0.42

-0.36

-0.39

  Energy/vitality

-0.44

-0.56

-0.54

-0.58

  Mental health

-0.21

-0.46

-0.41

-0.41

  Social functioning

-0.40

-0.53

-0.63

-0.59

  Bodily pain

-0.40

-0.38

-0.46

-0.46

  General health perceptions

-0.42

-0.54

-0.51

-0.55

  Physical Component Scale

-0.52

-0.57

-0.56

-0.61

  Mental Component Scale

-0.42

-0.61

-0.60

-0.61

HADS

  Anxiety

0.21

0.49

0.46

0.44

  Depression

0.47

0.59

0.58

0.62

  Total

0.39

0.63

0.61

0.61

Physical Self-Inventory

  Physical self-worth

-0.47

-0.62

-0.50

-0.59

Correlation between VQ11 and other questionnaire scores

Discussion

This study examined the validity and reliability of the VQ11, a short, self-administered questionnaire specifically designed for repeated assessment of patients with COPD and for use in routine care. The results show that the VQ11 provides a simple and reliable measure of overall COPD-related HRQoL and physical, psychological, and social components of HRQoL as expected by experts 17 .

The hierarchical structure of a preliminary version of the VQ11 had previously been tested on a sample of 166 COPD patients 15 . Therefore, the initial aim of the present study was to use CFA to verify this factorial structure with a new sample of COPD patients. Our findings demonstrated that the higher-order factor model provided a satisfactory fit to the data and a better fit than the alternative models. These results confirm those from a previous study 15 . The model contains physical, psychological, and social components, in line with guidelines for HRQoL questionnaires 17 22 34 . Our analysis showed that these components can be examined separately.

The concurrent validity of the VQ11 was confirmed by the correlation between VQ11 scores (for the individual components and for the total score) and the SF-36 or the SGRQ-C. VQ11 total scores strongly correlated with scores for the physical and mental components of the SF-36, and with scores on the eight scales that make up these components. As expected, the highest correlation was for the physical functioning scale 36 . Also as expected, the highest correlations were between corresponding components of the VQ11 and the SF-36 (VQ11-functional scale and the SF-36 physical component and physical functioning scales; VQ11-psychological scale and SF-36 emotional role, energy/vitality, mental health, general health perceptions and mental component scales; VQ11-social scale and SF-36 social functioning scale). By contrast, the correlation between the component and total scores on the VQ11 and the SF-36 bodily pain scale was not particularly strong. However, because the SF-36 was not designed to measure sleep disturbances and respiratory complaints, this relatively weak correlation does not affect the concurrent validity of the VQ11. As expected, VQ11 total scores correlated well with SGRQ-C scores and three specific domains.

As expected also 37 , VQ11 total scores correlated well with HADS depression and total scores. The results also supported the weak correlations between airway obstruction and HRQoL 7 38 39 .

The three components of the VQ11 are disease-specific domains of HRQoL for COPD patients. VQ11 functional scores correlated with dyspnea (MMRC grade and 6MWT distance), BODE index, exercise tolerance (6MWT distance), the activity and impact scores of the SGRQ-C, and the physical functioning and physical components of the SF-36. The items of the VQ11 reflect the main symptoms perceived by patients with COPD, dyspnea 28 , physical limitation 24 and fatigue 37 38 40 .

Significant correlations were found between the psychological component of the VQ11 and the HADS anxiety and depression scales, the SGRQ-C impact scale, the emotional role and mental components of the SF36, and physical self-worth (defined as physical self-esteem). This emphasizes that disease-associated anxiety and depression are important HRQoL factors for COPD patients. The degree of anxiety felt by COPD patients has been shown to be related to their degree of pulmonary dysfunction 41 .

The social component of VQ11 correlated with the social functioning and mental components of the SF36. Social relationships are affected by chronic respiratory disease, especially in patients with severe respiratory insufficiency who often depend on close social relationships to manage daily activities 42 . Patients with COPD experience losses in several areas of their lives, and they may feel useless, experience reduced sexual activity, depend on others for their personal care and lose interest in future projects.

The total, functional, psychological, and social components of the VQ11 showed good reliability over a period of one week for patients without clinical change. The correlation coefficient for the psychological component was the lowest. This result can be explained by intra-individual variability in the perception of disease and health status. A recent study noted higher day-to-day instability in self-esteem, which is a major correlate factor of HRQoL for COPD patients compared with healthy adults 41 . Consequently, it would be advisable for clinicians to ask patients to complete the VQ11 every three to six months, in order to assess the stability of patients’ perceptions of their illness, as this perception may be a sign of vulnerability and of the likelihood they will not fully adhere to their treatment.

There were limitations to the study. The sample was relatively homogenous, with all subjects having moderate to severe COPD, the majority being ex-smokers with a significant smoking history. The concept of quality of life and its implications on daily life are different for men and women 21 . We could not validate the new questionnaire separately for men and women due to the small sample size. The VQ11 also needs to be studied in other ethnic populations and cultures for cross-cultural validity. In addition, the responsiveness of the VQ11 to interventions and comparisons with other quality of life questionnaires is also required. Last, using a new patient-reported outcomes questionnaire requires the determination of the minimal clinically important difference 43 .

In practice, there are four general benefits to using the VQ11: (1) It helps clinicians quickly detect the worsening of HRQoL in COPD patients. This deterioration can then be explained by the acknowledgment of COPD, poor disease self-management (routine or acute situation), the presence of comorbidities (depression, sleep trouble, metabolic syndrome…) and/or weak support from family and friends. Possible consequences include an increase in the exacerbation risk and aggravation of COPD, the development of health-risk behavior or of a new disease, and/or the deterioration of communication with caregivers, family or friends. (2) The three components of the VQ11 allow caregivers to assess and correct a number of situations: based on a high score on the functional component, informed decisions can be made on therapy, modification of current treatment, new assessment, physiotherapy or comprehensive rehabilitation; with a high score on the psychological component, those decisions can be made regarding new assessment, psychological support, education, or comprehensive rehabilitation; finally, with a high score on the social component, decisions can be made concerning social support, psychological support, education, membership in a health network or patients association. (3) Based on the anticipated validation of a Minimal Clinically Important Difference, the VQ11 can also help monitor the efficacy of an individual’s therapeutic decision. (4) Lastly, the VQ11 provides clinicians with meaningful cues to examine a COPD life consequence more specifically when an answer to an item is more than three. Moreover, the back of the form includes an educational message with a space for drawing and commenting in which individual messages can be exchanged between patients and caregivers, family or friends.

Conclusions

This study showed the validity and reliability of the VQ11, a short, self-administered questionnaire specifically designed for repeated assessment of patients with COPD and for use in routine care. The VQ11 provides clinicians and patients with a simple and reliable measure of overall COPD-related HRQoL. The VQ11 facilitates discussions about the overall consequences of COPD arising from the illness’s physical symptoms and psychological perceptions, observance behaviors, health behaviors, life projects with COPD, and social support. Additional information is needed to provide responsiveness to change at the individual patient level, an essential feature for its use in clinical practice.

Abbreviations

BMI: Body mass index; COPD: Chronic obstructive pulmonary disease; CRDQ: Chronic respiratory disease questionnaire; CFI: Comparative fit index; CAT: COPD assessment test; CI: Confidence interval; CFA: Confirmatory factor analysis; CCQ: COPD clinical questionnaire; FEV1: Forced expiratory volume in 1 s; FVC: Forced vital capacity; HRQoL: Health-related quality of life; HADS: Hospitalization anxiety depression scale; MMRC: Modified medical research council; PSW: Physical self-worth; PFTs: Pulmonary function tests; RMSEA: Root mean square error of approximation; SF-CRQ: Short form chronic respiratory disease questionnaire; 6MWT: Six-minute walk test; SGRQ: St George’s respiratory questionnaire; TLI: Tucker-Lewis index; VAS: Visual analog scale; VSRQ: Visual simplified respiratory questionnaire.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

GN conceived the study, participated in its design, performed the statistical analysis, and coordinated the drafting of the manuscript. FS and CP participated in the design of the study and participated in drafting the manuscript. All authors read and approved the final manuscript.

Acknowledgements

The authors wish to thank A. Herkert, S. Stélianides, S. Jérome, K. Nassih, J. Desplan, M. Poulain, N. Oliver, M. Desplan, N. Fernandes, A. Morin, G. Garcia, L. Achouh, A. Guetta, C. Chouaid, G. Damien, G. Vallet, N. Heraud, M. Hayot, A. Couillard, G. Moullec, A. Pires, E. Chavignay, P. Bernard, F. Gouzi, M. Sabaté, S. Fiocco, M. Carayol, P. Jones and N. Roche for their contributions to the organization of the study and their many helpful comments.

Institutions at which the work was carried out

Service Central de Physiologie Clinique, Unité d’Exploration Respiratoire. CHRU Arnaud de Villeneuve, Montpellier

CHRU Béclère, Clamart

CHRU St-Antoine, Paris

Cabinet de pneumologie, Bagneux

Clinique du Souffle La Solane, Osséja

Clinique du Souffle La Vallonie, Lodève

Réseau AIR + R, Montpellier

Source of funding

This work was supported by Montpellier University Hospital (CHRU), GlaxoSmithKline France, Novartis, Société de Pneumologie de Langue Française, Association Nationale pour les Traitements à Domicile les Innovations et la Recherche, Fontalvie Group.

<p>Health-related quality of life and mortality in male patients with chronic obstructive pulmonary disease</p>Domingo-SalvanyALamarcaRFerrerMGarcia-AymerichJAlonsoJFelezMKhalafAMarradesRMMonsoESerra-BatllesJAntoJMAm J Respir Crit Care Med200216668068510.1164/rccm.211204312204865<p>The St George’s respiratory questionnaire</p>JonesPWQuirkFHBaveystockCMRespir Med199185 Suppl B2531discussion 33–271759018<p>A measure of quality of life for clinical trials in chronic lung disease</p>GuyattGHBermanLBTownsendMPugsleySOChambersLWThorax19874277377810.1136/thx.42.10.7734609503321537<p>Global strategy for diagnosis, management, and prevention of COPD</p>Global Initiative for Chronic Obstructive Lung DiseaseBook Global Initiative for Chronic Obstructive Lung Disease. Global strategy for diagnosis, management, and prevention of COPDEditor eds2009 http://www.goldcopd.org/ <p>Quality of life measurement for patients with diseases of the airways</p>JonesPWThorax19914667668210.1136/thx.46.9.6764633721835178<p>Methodological issues in evaluating measures of health as outcomes for COPD</p>JonesPWKaplanRMEur Respir J Suppl20034113s18s12795327<p>A self-complete measure of health status for chronic airflow limitation. The St. George’s respiratory questionnaire</p>JonesPWQuirkFHBaveystockCMLittlejohnsPAm Rev Respir Dis19921451321132710.1164/ajrccm/145.6.13211595997<p>Results at 1 year of outpatient multidisciplinary pulmonary rehabilitation included: a randomized controlled trial</p>GriffithsTLBurrMLCampbellIALewis-JenkinsVMullinsJShielsKTurner-LawlorPJPayneNNewcombeRGIonescuAAThomasJTunbridgeJLancet200035536236810.1016/S0140-6736(99)07042-710665556<p>Maintenance after pulmonary rehabilitation in chronic lung disease</p>RiesALKaplanRMMyersRPrewittLMAm J Respir Crit Care Med200316788088810.1164/rccm.200204-318OC12505859<p>The effect of post-rehabilitation programmes among individuals with chronic obstructive pulmonary disease</p>BrooksDKripBMangovski-AlzamoraSGoldsteinRSEur Respir J200220202910.1183/09031936.02.0185200112166571<p>Development, validity and responsiveness of the Clinical COPD Questionnaire</p>van der MolenTWillemseBWSchokkerSten HackenNHPostmaDSJuniperEFHealth Qual Life Outcomes200311310.1186/1477-7525-1-1315664012773199<p>The short-form chronic respiratory disease questionnaire was a valid, reliable, and responsive quality-of-life instrument in acute exacerbations of chronic obstructive pulmonary disease</p>TsaiC-LHodderRVPageJHCydulkaRKRoweBHCamargoCAJrJ Clin Epidemiol20086148949710.1016/j.jclinepi.2007.07.00318394543<p>Validity, reliability, and responsiveness of a new short Visual Simplified Respiratory Questionnaire (VSRQ) for health-related quality of life assessment in chronic obstructive pulmonary disease</p>PerezTArnouldBGrosboisJMBoschVGuilleminIBravoMLBrunMTonnelABGroupTSInt J Chron Obstruct Pulmon Dis20094918267278619436682<p>Development and first validation of the COPD assessment test</p>JonesPWHardingGBerryPWiklundIKline LeidyNEur Respir J20093464865410.1183/09031936.0010250919720809<p>[The VQ11, a short health-related quality of life questionnaire for routine practice in COPD patients]. Le VQ11, un questionnaire de qualite de vie specifique a la BPCO utilisable en clinique</p>NinotGSoyezFFioccoSNassihKMorinAJSPrefautCRev Mal Respir20102747248110.1016/j.rmr.2010.03.02020569880<p>Patient-assessed health outcomes in chronic lung disease: what are they, how do they help us, and where do we go from here?</p>CurtisJRMartinDPMartinTRAm J Respir Crit Care Med19971561032103910.1164/ajrccm.156.4.97-020119351600<p>How should health-related quality of life be assessed in patients with COPD?</p>MahlerDAChest200011754S57S10.1378/chest.117.2_suppl.54S10673476<p>50 years of psychological research on patients with COPD–road to ruin or highway to heaven?</p>KapteinAAScharlooMFischerMJSnoeiLHughesBMWeinmanJKaplanRMRabeKFRespir Med200910331110.1016/j.rmed.2008.08.01918930645<p>Anxiety and depression in COPD: current understanding, unanswered questions, and research needs</p>MaurerJRebbapragadaVBorsonSGoldsteinRKunikMEYohannesAMHananiaNAAnxietyAWPDepression inCKunikMChest200813443S56S10.1378/chest.08-0342284967618842932<p>A short version of the Self Description Questionnaire II: operationalizing criteria for short-form evaluation with new applications of confirmatory factor analyses</p>MarshHWEllisLAParadaRHRichardsGHeubeckBGPsychol Assess2005178110215769230StreinerDLNormanGRHealth Measurement Scales: a practical guide to their development and useOxford: Oxford University Press2008<p>The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection</p>WareJEJrSherbourneCDMed Care19923047348310.1097/00005650-199206000-000021593914<p>The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation</p>LeplegeAEcosseEVerdierAPernegerTVJ Clin Epidemiol1998511013102310.1016/S0895-4356(98)00093-69817119<p>Development and validation of an improved, COPD-specific version of the St. George respiratory questionnaire</p>MeguroMBarleyEASpencerSJonesPWChest200713245646310.1378/chest.06-070217646240<p>The hospital anxiety and depression scale</p>ZigmondASSnaithRPActa Psychiatr Scand19836736137010.1111/j.1600-0447.1983.tb09716.x6880820<p>L’évaluation de l’estime de soi dans le domaine corporel:35–48</p>NinotGDelignièresDFortesMRevue STAPS2000533548<p>The physical self-perception profile: development and preliminary validation</p>FoxKRCorbinCBJ Sport Exerc Psychol198911408430<p>Evaluation of clinical methods for rating dyspnea</p>MahlerDAWellsCKChest19889358058610.1378/chest.93.3.5803342669<p>Comparison of discriminative properties among disease-specific questionnaires for measuring health-related quality of life in patients with chronic obstructive pulmonary disease</p>HajiroTNishimuraKTsukinoMIkedaAKoyamaHIzumiTAm J Respir Crit Care Med199815778579010.1164/ajrccm.157.3.97030559517591<p>Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society</p>QuanjerPHTammelingGJCotesJEPedersenOFPeslinRYernaultJCEur Respir J Suppl1993165408499054<p>Six minute walking distance in healthy elderly subjects</p>TroostersTGosselinkRDecramerMEur Respir J19991427027410515400<p>Factor analytic models viewing the structure of an assessment instrument from three perspectives</p>ByrneBMJ Pers Assess200585173210.1207/s15327752jpa8501_0216083381<p>Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives</p>HuLTBentlerPMStruct Equ Modeling1999615510.1080/10705519909540118<p>A review and synthesis of the measurement invariance literature: suggestions, practices, and recommendations for organizational research</p>VandenbergRJLanceCEOrgan Res Meth2000347010.1177/109442810031002<p>Power analysis and determination of sample size for covariance structure modeling</p>MacCallumRCBrowneMWSugawaraHMPsychol Methods19961130149<p>Measurement of health-related quality of life in the national emphysema treatment trial</p>KaplanRMRiesALReillyJMohsenifarZGrp NETTRChest200412678178910.1378/chest.126.3.78115364757<p>Surprisingly high prevalence of anxiety and depression in chronic breathing disorders</p>KunikMERoundyKVeazeyCSouchekJRichardsonPWrayNPStanleyEAChest20051271205121110.1378/chest.127.4.120515821196<p>Health status measurement in chronic obstructive pulmonary disease</p>JonesPWThorax20015688088710.1136/thorax.56.11.880174595911641515<p>Quality of life: concept and definition</p>KaplanRMRiesALCopd2007426327110.1080/1541255070148035617729071<p>Perception of fatigue and quality of life in patients with COPD</p>BreslinEvan der SchansCBreukinkSMeekPMercerKVolzWLouieSChest199811495896410.1378/chest.114.4.9589792561<p>Anxiety and depression in end-stage COPD</p>HillKGeistRGoldsteinRSLacasseYEur Respir J20083166767710.1183/09031936.0012570718310400<p>Individual differences in stability of physical self: examining the role of chronic obstructive pulmonary disease</p>NinotGDelignièresDVarrayAEur Rev Appl Psychol201060354010.1016/j.erap.2009.07.001<p>Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research</p>BeatonDEBoersMWellsGACurr Opin Rheumatol20021410911410.1097/00002281-200203000-0000611845014