Validation of a Quality of Life Questionnaire for Bronchiectasis:psychometric analyses of the Spanish QOL-B-V3.0

Casilda Olveira • Gabriel Olveira • Francisco Espildora •

Rosa-Maria Giron • Gerard Munoz •

Alexandra L. Quittner • Miguel-Angel Martinez-Garcia

Accepted: 10 October 2013 / Published online: 19 October 2013

� Springer Science+Business Media Dordrecht 2013

Abstract

Purpose Bronchiectasis is a chronic disease, leading to

worsening of health-related quality of life. This study

evaluated the psychometric properties of a new patient-

reported outcome for non-cystic fibrosis bronchiectasis, the

Quality of Life Questionnaire Bronchiectasis, translated

into Spanish (QOL-B-Sp-V3.0).

Methods This prospective study recruited clinically stable

patients with non-cystic fibrosis bronchiectasis at 4 Spanish

centers. Health status was assessed with multiple indicators

(dyspnea, exacerbations, bronchorrhea, etc.), microbiological,

radiological, spirometric, and anthropometric parameters plus

St-George Respiratory Questionnaire (SGRQ). Psychometric

analyses included internal consistency, test–retest reliability,

convergent validity, predictive validity, and responsivity to

change.

Results The 207 stable patients (mean age 57.2 years) had a

Bhalla score of 11.53 ± 7.39 and FEV1% of 68.3 ± 22.2 %.

One hundred and sixty-one stable patients repeated the test

2 weeks later, and 80 patients who had an exacerbation within

6 months of the assessment also repeated it. Internal consis-

tency was high across all scales (Cronbach’s alpha [0.70).

Thirty-six of 37 items correlated more strongly with their

assigned scale than a competing scale. Test–retest coefficients

were strong (intraclass correlations r = 0.68–0.88). All scales,

except Treatment Burden, discriminated significantly between

patients with mild, moderate, and severe disease according to

FEV1% and other respiratory parameters. Strong convergence

was found between the QOL-B-Sp-V3.0 and SGRQ. Signifi-

cant correlations were found between QOL-B-Sp-V3.0 and

This study is included in the PII of Bronchiectasis of SEPAR (Spanish

Society of Pulmonology and Thoracic Surgery).

Montserrat Vendrell (Universitary Hospital Dr Josep Trueta, Gerona,

Spain) and Nuria Porras (Endocrinology and Nutrition Service, Carlos

Haya University Hospital, Malaga, Spain) also participated in this

study.

C. Olveira (&) � F. Espildora

Pneumology Service, Hospital Regional Universitario de

Malaga. IBIMA (Instituto de Investigacion Biomedica de

Malaga), Universidad de Malaga, Avenida Carlos Haya,

29010 Malaga, Spain

e-mail: casi1547@separ.es

F. Espildora

e-mail: espildorilla@hotmail.com

G. Olveira

Endocrinology and Nutrition Service, Hospital Regional

Universitario de Malaga. IBIMA (Instituto de Investigacion

Biomedica de Malaga), Universidad de Malaga, Malaga, Spain

e-mail: gabrielm.olveira.sspa@juntadeandalucia.es

G. Olveira

CIBERDEM, CIBER of Diabetes and Associated Metabolic

Diseases (Instituto de Salud Carlos III), Madrid, Spain

R.-M. Giron

Pneumology Service, La Princesa Hospital, Madrid, Spain

e-mail: rmgiron@gmail.com

G. Munoz

Pneumology Service, Idibgi, Hospital Universitari Dr Josep

Trueta, Gerona, Spain

e-mail: munoz.gerard@gmail.com

A. L. Quittner

Department of Psychology, University of Miami,

Coral Gables, FL, USA

e-mail: aquittner@miami.edu

M.-A. Martinez-Garcia

Pneumology Service, Polytechnic and University La Fe Hospital,

Valencia, Spain

e-mail: mianmartinezgarcia@gmail.com

123

Qual Life Res (2014) 23:1279–1292

DOI 10.1007/s11136-013-0560-0

various clinical, spirometric, radiological, and anthropometric

variables. Significant differences were found on all QOL-B-Sp-

V3.0 scales, except emotional functioning, between the base-

line responses and onset of an exacerbation; robust sensitivity

to change was observed on the Respiratory Symptoms scale.

Conclusions The QOL-B-Sp-V3.0 questionnaire demon-

strated strong reliability and validity. Scores were repro-

ducible after 2 weeks, and it discriminated between

patients who varied in severity and was responsive to

changes related to exacerbation.

Keywords Bronchiectasis � Health-related quality

of life � Patient-reported outcome � Forced spirometry

volume in the first second

Abbreviations

BQ Bronchiectasis

BMI Body mass index

CDRQ Chronic Respiratory Disease Questionnaire

CF Cystic fibrosis

CFQ-R Cystic Fibrosis Questionnaire Revised

FEV1 Forced spirometry volume in the first second

HI Haemophilus influenzae

HRCT High-resolution computed tomography

HRQOL Health-related quality of life

LCQ Leicester Cough Questionnaire

MID Minimal important difference score

MRC Medical Research Council

PA Pseudomonas aeruginosa

PRO Patient-reported outcome

QOL-B-Sp Quality of Life Questionnaire for patients

with Bronchiectasis. Spanish version

SEPAR Spanish Society of Pulmonology and Thoracic

Surgery

SGRQ St. George Respiratory Questionnaire

Introduction

Bronchiectasis (BQ) is a heterogeneous disease resulting

from different causes, but managed in similar ways. It is

chronic and leads to pulmonary exacerbations, loss of lung

function, and worsening of health-related quality of life

(HRQOL) [1, 2]. Care should be supervised by specialized

units, at least in cases of chronic infection, recurrent

exacerbations, or bronchiectasis with an etiology suscep-

tible to specific therapy [1, 2]. Although pulmonary and

nutritional outcomes are regularly monitored [1, 2], they

are not strongly predictive of how patients function or feel

in their daily lives [3–6]. The patient-reported outcome

(PRO) is a direct measure of how a patient functions, feels,

or survives in relation to his/her chronic illness [3, 5–10].

PROs are used to assess the patient’s perception of severity

[3, 5–10] and may be used as primary or secondary out-

come measures in drug registration trials [7, 11].

Several studies have found that patients with bronchiec-

tasis report worse HRQOL than the general population,

particularly patients with poor lung function, more frequent

exacerbations, bronchorrhea, chronic infection with Pseu-

domonas aeruginosa (PA) [3, 9, 10, 12–14], and symptoms

of depression and anxiety [4]. The St. George Respiratory

Questionnaire (SGRQ) is the most widely used PRO for

bronchiectasis, but is not specific for this disorder and has

certain limitations, such as its length and variable recall [8–

10, 15, 16]. In addition, other PROs used in bronchiectasis,

such as the Leicester Cough Questionnaire [17] (LCQ) and

the Chronic Respiratory Disease Questionnaire (CDRQ)

[18], are not designed specifically for this condition. Neither

the LCQ nor the CDRQ includes a comprehensive list of

respiratory symptoms, and the CRDQ requires an inter-

viewer for administration. Finally, none of these PROs fol-

lowed the instrument development guidelines published by

the Food and Drug Administration [7]. Thus, there is a clear

need for a disease-specific PRO for bronchiectasis.

The purpose of the current study was to evaluate the

psychometric properties of a new PRO for non-cystic fibrosis

(CF) bronchiectasis (QOL-B) that includes assessment of

respiratory symptoms and other domains of HRQOL. The

QOL-B was developed in accordance with the FDA guide-

lines [7], beginning with a physician consensus panel, open-

ended patient interviews, and cognitive testing, with several

revisions made in response to patient data and feedback [19–

21]. Strong evidence of internal consistency, test–retest reli-

ability, and convergent validity was found for the QOL-B in

the USA [20]. This version has been translated into Spanish

for use among Spanish speakers in the USA [2010, Quittner,

Cruz, Kimberg, Marciel, and Barker QOL-B, Version 3.0.

‘‘Appendix’’], and our group has adapted it, with slight

adaptations without changing the sense of the questions, to

make it more suitable for Spain (QOL-B-Spain-V3.0). The

transcultural validation of a HRQOL questionnaire that

already exists in one language has the advantage of obviating

the lengthy and tedious process of designing a new ques-

tionnaire. The aim of the present study was to validate this

questionnaire in Spanish patients with non-CF bronchiectasis.

Patients and methods

This prospective, multicenter sequential study included

patients aged 16 and older who met the diagnostic criteria

for bronchiectasis [1, 2] and attended a specific bronchi-

ectasis unit at one of the four Spanish university hospitals

for routine monitoring and treatment, over a recruitment

period of 8 months. In all cases, bronchiectasis was diag-

nosed by high-resolution computed tomography (HRCT) of

1280 Qual Life Res (2014) 23:1279–1292

123

the chest, with the use of a 1–1.5-mm window every

10 mm and acquisition times of 1 s during full inspiration,

following the criteria of Naidich et al. [22]. All patients had

undergone a full etiological study following the diagnostic

algorithm for bronchiectasis of the Spanish Society of

Pulmonology and Thoracic Surgery (SEPAR) [1]. A full

clinical history, from diagnosis to study participation, was

recorded following the SEPAR protocol [1]. At each visit

(every 2–3 months), demographic and clinical variables

were collected prospectively. Patients performed spirome-

try were weighed and measured, and a sputum sample was

collected and cultured for the usual bronchiectasis patho-

gens [1, 2]. The questionnaires were completed after a

clinical examination to confirm that the patients were in a

stable phase and before completing the clinical measures

(including spirometry) and the various elective medical

procedures in order not to bias responses. If at this time

they had a respiratory exacerbation or a recent hospital

admission, their participation was postponed for at least

60 days, until any acute illness was resolved. Patients were

excluded if they had CF [23], if they had difficulty

understanding the questionnaire, or if they refused to par-

ticipate or sign the consent form.

The study was approved by the Malaga Northeast Ethics

and Research Committee, and all the participants provided

written informed consent.

Clinical and demographic variables

Data were gathered on demographic (age, sex), anthropo-

metric (body mass index—BMI), clinical, and etiological

aspects of bronchiectasis. The degree of dyspnea was

recorded using the Medical Research Council (MRC) scale

[24] and the comorbidity, with the Charlson index [25].

Spirometry was also performed, with the forced expiratory

volume in 1 s (FEV1) expressed in absolute terms (mL) and

as a percentage, using a reference population [26]. Struc-

tural damage was assessed with HRCT using the Bhalla

scoring system (lower values indicate worse damage) at

baseline or during the previous 12 months [27]. Assess-

ment of the mean amount of sputum produced daily (in

milliliters) was evaluated by instructing the patients to

collect sputum during the 3 days prior to the visit in three-

graded sterile containers (one per day), marking the amount

reached each day on the container. Instructions were given

to ensure that sputum was collected correctly, with low

percentages of saliva recorded [12]. We analyzed chronic

colonization by microorganisms, considering their

appearance in sputum (at least 3 positive), regardless of

their persistence at the time of the study [1]. Pulmonary

exacerbations were assessed prospectively using the

SEPAR criteria [1]. A mild–moderate exacerbation was

defined as the acute development and persistence of

changes in sputum characteristics (increased volume,

thicker consistency, greater purulence, or hemoptysis), and/

or increased breathlessness unrelated to other causes, with

or without other symptoms, and if they could be treated

with oral antibiotics. An exacerbation was considered to be

severe if intravenous antibiotics were necessary and there

were tachypnea, acute respiratory failure, exacerbated

chronic respiratory failure, a significant decline in oxygen

saturation or respiratory function, hypercapnia, fever of

more than 38 �C, hemodynamic instability, and/or

impaired cognitive function [1]. The number of exacerba-

tions and hemoptysis (whatever amount) in the year prior

to the evaluation was also included in the analyses.

Questionnaires

QOL-B-Spain-V3.0

This is a disease-specific questionnaire for patients with

bronchiectasis. It is a self-report measure consisting of 37

questions and takes about 10 min to complete. The scores

are standardized across 8 scales, ranging from 0 to 100, with

higher scores indicating better health-related quality of life.

Strong evidence of internal consistency, test–retest reli-

ability, and convergent validity was found for the QOL-B in

the USA [19–21]. The Spanish version for Hispanic patients

in the USA [2010, Quittner, Cruz, Kimberg, Marciel, and

Barker QOL-B, Version 3.0. ‘‘Appendix’’] was adapted by

us for use in Spain. This adaptation was initially adminis-

tered to 20 patients to ensure complete understanding of all

the items, after which slight changes in the Spanish were

made without changing the sense of the questions.

The SGRQ is a self-report health status measure, yield-

ing three domain scores (symptoms, activity, and impact)

and a total score. Scores range from 0 to 100, with higher

scores representing worse health status [8]. The Spanish

version has been validated for use in patients with bron-

chiectasis and been shown to be a valid instrument for

analyzing health-related quality of life [9, 10].

Data analysis

Data were analyzed with SPSS version 12 (SPSS-Inc,

Chicago, IL). Quantitative variables were expressed as

means ± standard deviations, with 95 % confidence inter-

vals. Qualitative variables were compared using chi-square

tests, with Fisher’s exact test where necessary. The nor-

mality of distributions was verified using the Kolmogorov–

Smirnov test. For all variables, significance was set at

p \ 0.05 for two tails.

Qual Life Res (2014) 23:1279–1292 1281

123

Validation design

The following psychometric tests were conducted to evalu-

ate the reliability and validity of the Spanish QOL-B-Spain-

V3.0:

Reliability

Reliability measures were of two types: 1. Internal con-

sistency was evaluated using Cronbach’s alpha calculated

for each scale and 2. Test–retest reliability (reproducibil-

ity): the QOL-B-Spain-V3.0 was administered twice to a

subset of patients during stable visits, separated by a two-

week interval; intraclass correlation coefficients quantified

reproducibility of scores over 2 weeks.

Construct validity

Item-scale convergent and discriminant validity were

examined by comparing the item-scale correlation. Con-

vergent validity was supported if an item correlated

(r C 0.4) with the scale it was hypothesized to belong to.

Discriminant validity was supported whenever a correla-

tion between an item and its hypothesized scale was higher

than its correlation with the other components.

Criterion validity

Convergent validity: Spearman’s correlation coefficients were

calculated for each QOL-B scale with the SGRQ domains

and with demographic and health indicators, including age,

FEV1 % predicted, number of exacerbations in the previous

year, bronchiectasis severity as measured by the Bhalla score,

daily bronchorrhea, dyspnea, Charlson morbidity index, and

BMI. Discriminant (divergent) validity: to evaluate whether

the QOL-B-Spain-V3.0 discriminates between patients who

differ in disease severity based on lung function [26, 28]

(FEV1% predicted), presence of hemoptysis during the past

year, colonization by pathogens, and Bhalla scores (dichot-

omized based on the median of the sample- 13-). To compare

scores between these groups, a Mann–Whitney nonparamet-

ric test or Student’s t test was used, depending on the nor-

mality of scores. To compare scores across three or more

groups, we used an ANOVA or Kruskal–Wallis test.

Responsiveness (sensitivity to change)

In a subset of patients who experienced an exacerbation

within 6 months of the baseline visit, comparisons of their

scores prior to initiating treatment for the exacerbation

were evaluated using the Student’s t test for paired data or

Wilcoxon test, depending on normality. Effect sizes from

baseline to exacerbation were also calculated as the

difference between the two means of each scale (baseline

and exacerbation) divided by the pooled standard deviation

for those means. Effect size was interpreted as trivial

(\0.2), small (0.2–0.5), moderate (0.5–0.8), and large

([0.8) following the guidelines proposed by Cohen [29].

To determine the minimal important difference score

(MID) on the Respiratory Symptoms scale, which repre-

sents the smallest change a patient can detect, two distri-

bution-based methods were used: (1) � SD of the change on

the Respiratory Symptoms scale (exacerbation score minus

baseline score) and (2) one standard error of the mean

(SEM) for the Respiratory Symptoms scale, calculated as

SEM ¼ SDffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi

1� að Þp

[SD = SD of mean baseline QOL-B

Spain V3.0 respiratory score; a = scale reliability] [30].

Results

A total of 218 patients were approached for the study and

207 agreed to participate. Of the 11 patients who were

excluded, 3 had problems understanding the questionnaires

and 8 declined participation.

The mean age of the participants was 57.2 years (range

17–86) and 62.8 % were women. The mean Bhalla score was

11.53 (SD 7.39), and the mean FEV1% was 68.3 ± 22.2 %

(range 15–123 %). Table 1 summarizes the clinical, spiro-

metric, microbiological, radiological, and anthropometric

characteristics of the sample.

Two weeks after the baseline visit, the QOL-B-Spain-

V3.0 was administered a second time to 161 participants

who were stable. In addition, to estimate the MID, 80

patients who experienced an exacerbation (all mild or

moderate) within 6 months of the baseline visit also com-

pleted the QOL-B-Sp-V3.0, prior to starting treatment.

The QOL-B-Sp-V3.0 showed strong internal consistency,

as demonstrated by the strong Cronbach’s alpha coefficients

(C0.70) on each scale (Table 2). Item to total correlations

supported the content validity of the scales. Significant

associations (r [ 0.40) were found between all items and

their assigned versus competing scales (Table 3), except for

Respiratory item 33 (Have you had shortness of breath with

greater activity?), which correlated r = 0.66 on the Respi-

ratory Symptoms scale and r = 0.70 with Physical Func-

tioning. Floor effects were observed in \4 % and ceiling

effects in\15 % of respondents on four of the eight scales.

Test–retest reliability was also very strong, with a majority of

ICCs above 0.70 for the scales, except Treatment Burden

(0.68) (Table 2).

Few gender differences were found in scores on the QOL-

B-Sp-V3.0: Emotional Functioning (women: 67.6 ± 25.5;

men: 76.4 ± 24.5; p \ 0.05) and Treatment Burden (women:

63.6 ± 24.2; men: 72.3 ± 23.7; p \ 0.05).

1282 Qual Life Res (2014) 23:1279–1292

123

No significant differences were found in any scale between

the baseline and the re-test questionnaires (Table 4).

The QOL-B-Spain-V3.0 was also administered a second

time to those who experienced an exacerbation to determine

whether the instrument was responsive to these changes in

health status. Significant differences were found between

baseline scores and scores during a ‘‘sick’’ visit for an

exacerbation (Table 4). On the Respiratory Symptoms, the

mean difference was 17.6 ± 16.4 points (p \ 0.001), sug-

gesting a major increase in symptoms with an exacerbation.

Significant differences also existed in sputum volume

(21.4 ± 28.2 vs. 49.5 ± 35.4 cc p \ 0.0001: mean differ-

ence: 28.1 ± 18.7). Significant associations were found

between increased sputum volume and the reduction in the

Respiratory Symptoms score (r 0.34; p = 0.012). Effect

sizes were trivial for Emotional Functioning, small for

Physical Functioning, Social Functioning, and Treatment

Burden, moderate for Role Functioning, Vitality, and

Health Perceptions, and large for Respiratory Symptoms

(Table 4).

Using distribution-based methods to identify the MID,

�SD of the change in the Respiratory Symptoms score at

baseline versus exacerbation was 8.2 points. The majority

(70 %) of patients had a change in symptoms that was

above the MID. Using one SEM, the MID was 6.8 points,

indicating that most patients in exacerbation (71 %) were

above the MID.

Significant associations were found between all the

QOL-B-Sp-V3.0 and SGRQ scores (Table 5). Significant

positive associations existed between all QOL-B-Sp-V3.0

scores and FEV1%, except for Treatment Burden, and

significant negative correlations for all QOL-B-Sp-V3.0

scores and dyspnea. Sputum volume correlated significantly

and negatively with all QOL-B-Sp-V3.0 scales. Significant

negative associations were found between BMI and QOL-

B-Sp-V3.0 scores for Physical Functioning, Vitality, Health

Perceptions, and Respiratory Symptoms. Significant nega-

tive associations existed between age and each scale, except

Social Functioning and Treatment Burden (Table 6).

Figure 1 represents the mean QOL-B-Sp-V3.0 scores

categorized by disease severity according to FEV1% [26,

28]. All the scores showed significant differences (worse

HRQOL with greater severity) except for Treatment Burden.

Figures 2 and 3 represent the results according to the Bhalla

score, hemoptysis during the previous year, and colonization

by Haemophilus influenzae (HI) and P. aeruginosa (PA).

The Charlson index rose significantly according to

age group (B45:1.38 ± 1 vs. 45–65:2.26 ± 1.4 vs. [ 65:

2.94 ± 2; p \ 0.001).

Table 1 Demographic and clinical characteristics

Characteristics Mean SD n (%)

Age 57.2 18.1

\45 years 55 26.6

45–65 years 66 31.9

[65 years 86 41.5

Males 77 37.2

Body mass index (Kg/m2) 25.0 4.4

Undernourished (BMI \ 18.5 kg/m2) 12 5.8

Overweight (BMI: 25-30 kg/m2) 63 30.0

Obese (BMI [ 30 kg/m2) 30 14.5

Smoking history

Current smokers 9 4.3

Ex-smokers 56 27.1

Non-smokers 142 68.6

Etiology

Idiopathic 58 28.0

Post-infection 80 38.6

Immunodeficiency 12 5.8

Collagen disease 7 3.4

Ciliary dyskinesia 22 10.6

Other 28 13.5

Sputum production (ml/day) 21.8 25.6

FEV1% of predicted 68.3 22.2

Bhalla score 11.5 7.3

Chronic colonization

P. aeruginosa 68 32.9

H. influenzae 64 30.9

Exacerbations in the last year 1.7 1.6

Mild–moderate exacerbations 1.6 1.5

Severe exacerbations 0.1 0.4

Bhalla score: based on high-resolution computed tomography (a

lower score means more structural abnormalities)

BMI body mass index. FEV1 forced expiratory volume in the first

second

Table 2 General description, internal consistency, and test–retest

reliabilities of the QOL-B-Sp-V3.0

QOL-B-Sp-V3.0

scales

Items,

no.

Cronbach

aICC Floor

effect

Ceiling

effect

Physical functioning 5 0.91 0.88 1.9 13.5

Role functioning 5 0.84 0.86 1.4 18.4

Vitality 3 0.82 0.78 3.4 9.2

Emotional functioning 4 0.84 0.86 1.9 19.8

Social functioning 4 0.70 0.78 1.4 21.7

Treatment burden 3 0.72 0.68 1.7 16.6

Health perceptions 4 0.71 0.83 1.9 0.5

Respiratory symptoms 9 0.87 0.83 0.5 2.4

ICC intraclass correlation coefficient, QOL-B-Sp Quality of Life

Questionnaire for patients with Bronchiectasis. Spanish version

Qual Life Res (2014) 23:1279–1292 1283

123

Discussion

This study demonstrated that the QOL-B-Sp-V3.0 is a

reliable and valid PRO for patients with non-CF bronchi-

ectasis in Spanish patients, and is sensitive to the effects of

pulmonary exacerbations. These results are consistent with

those of the English version of the QOL-B [19–21] and

indicate that the Spanish version is conceptually equivalent

to the original. In this Spanish version, evidence of good

internal consistency was found across all scales, and it may

therefore be used to compare groups. Furthermore, the

scales Physical Functioning and Respiratory Symptoms

could even be contemplated for individual comparisons.

Similar strong internal consistency coefficients were also

reported for the English language version [20].

Excellent item to total correlations were found across

scales, supporting the underlying construct validity of these

scales. Item 33 on the Respiratory Symptoms cross-loaded

with the Physical Functioning scale. This reflects dyspnea

upon exertion, and it is therefore reasonable that it should

Table 3 Item-scale correlations on the QOL-B QOL-B-Sp-V3.0

Items Scales

Physical Role Vitality Emotion Social Treatment Health Respiratory

Physical 1 0.849** 0.635** 0.529** 0.468** 0.297** 0.250** 0.550** 0.510**

Physical 2 0.883** 0.692** 0.618** 0.590** 0.453** 0.264** 0.657** 0.639**

Physical 3 0.895** 0.666** 0.639** 0.555** 0.417** 0.292** 0.606** 0.587**

Physical 4 0.866** 0.601** 0.609** 0.524** 0.387** 0.264** 0.533** 0.617**

Health 5 0.566** 0.641** 0.654** 0.527** 0.343** 0.228** 0.741** 0.549**

Vitality 6 0.612** 0.623** 0.858** 0.573** 0.379** 0.197** 0.596** 0.564**

Emotional 7 0.427** 0.571** 0.470** 0.741** 0.384** 0.261** 0.511** 0.514**

Vitality 8 0.573** 0.505** 0.810** 0.475** 0.345** 0.327** 0.583** 0.497**

Vitality 9 0.631** 0.644** 0.867** 0.649** 0.461** 0.287** 0.624** 0.613**

Emotional 10 0.507** 0.598** 0.610** 0.869** 0.454** 0.282** 0.554** 0.478**

Emotional 11 0.522** 0.605** 0.550** 0.862** 0.445** 0.252** 0.581** 0.506**

Treatment 12 0.237** 0.301** 0.274** 0.287** 0.226** 0.866** 0.270** 0.305**

Treatment 13 0.293** 0.207* 0.187* 0.144 0.128 0.716** 0.163* 0.210**

Treatment 14 0.770 0.211** 0.171* 0.175* 0.291** 0.849** 0.231** 0.258**

Health 15 0.653** 0.664** 0.615** 0.606** 0.425** 0.305** 0.769** 0.632**

Physical 16 0.830** 0.664** 0.584** 0.547** 0.430** 0.234** 0.564** 0.553**

Role 17 0.660** 0.778** 0.558** 0.639** 0.461** 0.346** 0.611** 0.602**

Social 18 0.290** 0.372** 0.327** 0.395** 0.581** 0.207** 0.394** 0.371**

Social 19 0.408** 0.462** 0.402** 0.445** 0.634** 0.341** 0.350** 0.432**

Role 20 0.449** 0.745** 0.436** 0.461** 0.342** 0.208** 0.544** 0.504**

Health 21 0.308** 0.279** 0.245** 0.315** 0.425** 0.159* 0.631** 0.322**

Social 22 0.370** 0.425** 0.362** 0.411** 0.821** 0.166* 0.447** 0.498**

Emotional 23 0.543** 0.619** 0.486** 0.820** 0.569** 0.295** 0.523** 0.492**

Health 24 0.508** 0.624** 0.506** 0.536** 0.435** 0.248** 0.800** 0.518**

Role 25 0.541** 0.813** 0.462** 0.625** 0.457** 0.274** 0.562** 0.505**

Social 26 0.298** 0.370** 0.251** 0.358** 0.767** 0.165* 0.339** 0.342**

Role 27 0.695** 0.796** 0.600** 0.548** 0.402** 0.244** 0.601** 0.518**

Role 28 0.669** 0.803** 0.586** 0.561** 0.545** 0.250** 0.605** 0.597**

Respiratory 29 0.496** 0.519** 0.496** 0.441** 0.471** 0.351** 0.524** 0.784**

Respiratory 30 0.414** 0.440** 0.343** 0.365** 0.338** 0.209** 0.434** 0.731**

Respiratory 31 0.404** 0.481** 0.379** 0.430** 0.458** 0.282** 0.469** 0.763**

Respiratory 32 0.235** 0.250** 0.303** 0.208** 0.250** 0.224** 0.311** 0.509**

Respiratory 33 0.697** 0.650** 0.609** 0.578** 0.412** 0.231** 0.559** 0.657**

Respiratory 34 0.514** 0.456** 0.409** 0.395** 0.366** 0.171* 0.440** 0.753**

Respiratory 35 0.446** 0.482** 0.450** 0.470** 0.342** 0.275** 0.463** 0.612**

Respiratory 36 0.525** 0.462** 0.488** 0.447** 0.347** 0.148* 0.477** 0.559**

Respiratory 37 0.495** 0.516** 0.421** 0.444** 0.442** 0.221** 0.466** 0.773**

QOL-B-Sp Quality of Life Questionnaire for patients with Bronchiectasis. Spanish version

The correlation is significant * p \ 0.05 (bilateral) and ** p \ 0.01 (bilateral)

1284 Qual Life Res (2014) 23:1279–1292

123

correlate adequately with the Physical Functioning scale.

Additionally, across scales, minimal floor and ceiling

effects were observed, enabling patients to report both

improvement and worsening in their symptoms and daily

functioning.

Test–retest reliability over 2 weeks was strong, suggesting

that patients’ scores are stable and reproducible [6, 31–33].

These values were similar to those found for the English

language version [20].

We found good convergence between respiratory

parameters and almost all scales on the QOL-B-Sp-V3.0. In

all cases, higher scores correlated with better status, with

bronchorrhea and degree of dyspnea demonstrating the

highest associations. Martınez-Garcıa et al. [10, 12] and

Chan et al. [14] also found that the patients with more

severe dyspnea, bronchorrhea, and exacerbations had

worse HRQOL on the SGRQ. Wilson et al. [34] reported

similar results on the SGRQ in relation to exacerbations.

Patients with the greatest structural damage on the

HRCT had worse HRQOL on most scales. In the QOL-B

English version, Respiratory Symptoms scores were also

associated with HRCT scores [20, 21], and similar results

were reported for the SGRQ [10, 12].

Analyses of microorganisms also supported the validity

of the QOL-B-Spain-V3.0, for example, colonization by P.

aeruginosa (PA) was associated with worse scores across

most of the scales. Other authors also found a worse

HRQOL (SGRQ) in patients with chronic colonization by

P. aeruginosa [10, 12, 13].

Convergent validity was also demonstrated by the sig-

nificant correlations found between all dimensions of the

QOL-B-Sp-V3.0 and the SGRQ [8–10], reaching very high

values in scales measuring similar parameters, as occurred

with the QOL-B English version [20].

The instrument demonstrated good discrimination of

disease severity in relation to FEV1% for all scales except

Treatment Burden, the strongest associations being for

Respiratory Symptoms and Physical Functioning. A similar

pattern of results was found for the Cystic Fibrosis Ques-

tionnaire Revised [6] (CFQ-R) and its relationship to spi-

rometry but lack of association between disease severity

and Treatment Burden [5, 6]. The lack of a correlation with

this scale may be because it is of a conditional type and it

has a long heading, as it contains various types of therapy

Table 4 Mean scores on the scales of the QOL-B-Sp-V3.0

QOL-B-Sp-V3.0 scales Initial n = 207 Stable test–retest n = 161** Exacerbation n = 80 *** Effect size

Baseline 2 weeks p Baseline Exacerbation p

Mean ± SD Mean ± SD Mean ± SD Mean ± SD Mean ± SD

Physical functioning 57.5 ± 29.7 56.1 ± 29.3 56.6 ± 28.8 0.63 51.6 ± 29.1 38.4 ± 29.3 0.00* 0.45

Role functioning 70.4 ± 25.4 70.2 ± 25.6 68.5 ± 25.1 0.11 68.0 ± 25.8 51.1 ± 28.4 0.00* 0.62

Vitality 57.6 ± 24.8 56.9 ± 25.8 59.0 ± 25.3 0.12 54.4 ± 24.7 39.4 ± 29.6 0.00* 0.55

Emotional functioning 71.0 ± 25.4 71.1 ± 25.6 71.3 ± 24.1 0.88 69.3 ± 27.4 65.9 ± 26.0 0.14 0.13

Social functioning 72.4 ± 25.1 71.8 ± 25.1 71.1 ± 24.6 0.58 68.9 ± 28.2 60.4 ± 29.0 0.00* 0.32

Treatment burden 67.1 ± 24.4 67.9 ± 23.1 66.4 ± 22.5 0.38 67.6 ± 24.8 61.8 ± 24.0 0.04* 0.24

Health perceptions 46.5 ± 21.6 46.1 ± 21.9 48.1 ± 22.8 0.06 43.0 ± 19.5 32.2 ± 22.4 0.00* 0.52

Respiratory symptoms 70.7 ± 19.7 71.0 ± 19.9 71.4 ± 19.2 0.65 69.9 ± 18.9 52.2 ± 21.3 0.00* 0.88

Stable Test–retest n = 161**: scores on the QOL-B-Spain-V3.0 at baseline and 2 weeks after the baseline visit in 161 patients (in a stable

situation at both measurements)

Exacerbation n = 80***: mean scores on the QOL-B-Spain-V3.0 at baseline and prior to starting treatment in 80 patients who experienced an

exacerbation within 6 months of the baseline visit

QOL-B-Sp Quality of Life Questionnaire for patients with Bronchiectasis. Spanish version

* p \ 0.05 (Student’s t test for paired data or Wilcoxon test, depending on normality)

Table 5 Correlations between QOL-B-Sp-V3.0 scales and SGRQ

QOL-B-Sp-V3.0 scales SGRQ

Symptom Activity Impact Total

Physical functioning -0.56** -0.78** -0.71** -0.81**

Role functioning -0.48** -0.67** -0.77** -0.77**

Vitality -0.50** -0.59** -0.63** -0.67**

Emotional functioning -0.40** -0.54** -0.64** -0.64**

Social functioning -0.30** -0.41** -0.58** -0.53**

Treatment burden -0.24** -0.23** -0.37** -0.34**

Health perceptions -0.43** -0.58** -0.70** -0.68**

Respiratory symptoms -0.54** -0.57** -0.65** -0.69**

SGRQ St. George Respiratory Questionnaire (higher scores represent

worse quality of life), QOL-B-Sp Quality of Life Questionnaire for

patients with Bronchiectasis. Spanish version

The correlation is significant ** p \ 0.01 (bilateral)

Qual Life Res (2014) 23:1279–1292 1285

123

used for bronchiectasis, which could lead to poor under-

standing, particularly for older persons. Some authors

found a good capacity to differentiate the severity

according to the FEV1% with the SGRQ [10, 12, 14],

though others noted its poor associations with the func-

tional variables [34].

A stronger association was found between age and QOL-

B-Sp-V3.0 scores. Older patients reported worse HRQOL

across all scales except two. In contrast, the QOL-B English

version [20] found no differences by age, though the mean

age of this sample was 63 years versus a mean of 57.2 and a

wide age range (17-86 years) in the Spanish sample. Older

age also confers a higher probability of having other

comorbidities, which can affect HRQOL [9]. This was seen

in our study in which the Charlson index was significantly

higher in older patients and correlated negatively with

Health Perceptions, Physical, Role, and Emotional Func-

tioning scales.

Although our questionnaire does not specifically eval-

uate dimensions related to nutritional status, we found

Table 6 Correlations between QOL-B-Sp-V3.0 and health status variables

QOL-B-Sp-

V3.0 scales

Age FEV1%

predicted

Charlson

comorbidity

index

Bhalla

score

Mild

exacerbation

Severe

exacerbation

Sputum

production

(ml/day)

MRC

dyspnea

scale

BMI

Physical

functioning

-0.45** 0.41** -0.19** 0.33** -0.19** -0.21** -0.20** -0.60** -0.23**

Role

functioning

-0.34** 0.29** -0.18** 0.35** -0.19** -0.25** -0.26** -0.58** -0.13

Vitality -0.31** 0.29** -0.16* 0.30** -0.22** -0.19** -0.25** -0.45** -0.17*

Emotional

functioning

-0.27** 0.19** -0.17* 0.16 -0.11 -0.20** -0.20** -0.44** -0.10

Social

functioning

-0.11 0.14* -0.03 0.24 -0.07 -0.07 -0.30** -0.25** -0.00

Treatment

burden

-0.08 0.11 -0.04 0.23* -0.24** -0.16* -0.18* -0.19** 0.047

Health

perceptions

-0.26** 0.29** -0.18** 0.24* -0.23** -0.18** -0.27** -0.44** -0.18**

Respiratory

symptoms

-0.28** 0.34** -0.06 0.45** -0.18** -0.25** -0.48** -0.48** -0.15*

Bhalla score: based on high-resolution computed tomography (a lower score means more structural abnormalities)

QOL-B-Sp Quality of Life Questionnaire for patients with Bronchiectasis. Spanish version, FEV1 forced expiratory volume in the first second,

MRC Medical Research Council, BMI body mass index

The correlation is significant * p \ 0.05 (bilateral) and ** p \ 0.01 (bilateral)

Fig. 1 Scores on the QOL-B-

Sp-V3.0 questionnaire

according to forced expiratory

volume in one second, as a

percentage of the predicted

volume (FEV1 %). QOL-B-Sp

Quality of Life Questionnaire

for patients with Bronchiectasis.

Spanish version. **p \ 0.01;

*p \ 0.05

1286 Qual Life Res (2014) 23:1279–1292

123

significant negative correlations with the BMI (higher

BMI, worse HRQOL) in several domains. Obesity and

overweight condition a worse HRQOL in general and

obesity, particularly, can lead to worse mobility and

respiratory difficulty. Malnutrition is also associated with

a worse HRQOL [35]. The present study recruited very

few patients who were undernourished according to their

BMI (only 5.8 % had a BMI \18.5 kg/m2), though

44.5 % were either overweight or obese. In any case, it

would have been better to use a more precise measure of

body composition, for instance fat-free mass index, as this

is a better predictor of morbidity and mortality and is

associated with a worse lung function and its associated

inflammation in patients with bronchiectasis [35–37]. This

index is associated with a worse HRQOL in adult CF

patients (using the CFQ-R) in domains not directly related

to nutrition, as are Physical Functioning, Vitality, and

Respiratory Symptoms [5].

Finally, a PRO must demonstrate that it is responsive to

changes in health status that reflect the course of the disease

(e.g., exacerbations) or the use of new treatment. We found

significant differences between patients’ scores in a stable

vs. exacerbation state on each scale except Emotional

Functioning. This seems logical as this scale measures the

presence of symptoms of depression and/or anxiety, which is

usually related more with the number of exacerbations in the

last year [1, 2] than with the presence of exacerbations in the

short term. Most importantly, substantial changes were

documented on the Respiratory Symptoms scale, which

were greater than the MID, even though all the exacerba-

tions were mild or moderate and only needed oral antibi-

otics. Likewise, the effect size for this scale was also large.

Fig. 2 a Scores on the QOL-B-

Sp-V3.0 questionnaire

according to the Bhalla score

(scoring system based on

computerized tomography of

the chest). QOL-B-Sp Quality of

Life Questionnaire for patients

with Bronchiectasis. Spanish

version. **p \ 0.01; *p \ 0.05.

b Scores on the QOL-B-Sp-

V3.0 questionnaire according to

whether the patients had

hemoptysis during the previous

year. QOL-B-Sp Quality of Life

Questionnaire for patients with

Bronchiectasis. Spanish version.

**p \ 0.01; *p \ 0.05

Qual Life Res (2014) 23:1279–1292 1287

123

Further, one of the hallmark symptoms of an exacerbation in

this population is increased mucous production [1, 2], which

in fact increased markedly during the exacerbation period

and correlated with the reduction in the score on the

Respiratory Symptoms scale. Similar MID values based on

distribution methods have been found in Spain (8.2 using

�SD of the change and 6.8 using one SEM) and the USA

(8.08) [21]; both values triangulate well with the anchor-

based value derived from patient assessments of 9.0.

Accordingly, for the Respiratory Symptoms scale, we pro-

pose that 8 is a suitable cutoff for the MID.

The strengths of this study include its multicenter

design, large number of patients, analysis of several dif-

ferent variables, and detailed psychometric analyses. One

limitation was the application of only distribution-based

methods to determine the MID. A future study should re-

evaluate the MID using anchor-based methods, which more

closely reflect the patient’s perspective.

Conclusions

The QOL-B-Sp-V3.0 demonstrated its reliability, validity,

and responsivity in a large, diverse group of Spanish

patients with non-CF bronchiectasis.

Acknowledgments This study was supported by a grant from SE-

PAR (31/2011).

Fig. 3 a Scores on the QOL-B-

Sp-V3.0 questionnaire

according to whether the

patients had chronic bronchial

colonization by P. aeruginosa.

QOL-B-Sp Quality of Life

Questionnaire for patients with

Bronchiectasis. Spanish version.

**p \ 0.01; *p \ 0.05.

b Scores on the QOL-B-Sp-

V3.0 questionnaire according to

whether the patients had chronic

bronchial colonization by H.

influenzae. QOL-B-Sp Quality

of Life Questionnaire for

patients with Bronchiectasis.

Spanish version. **p \ 0.01;

*p \ 0.05

1288 Qual Life Res (2014) 23:1279–1292

123

CUESTIONARIO SOBRE CALIDAD DE VIDA – BRONQUIECTASIAS

Comprender los efectos de su enfermedad y su tratamiento en su vida diaria, puede ayudar a su médico a controlar su salud y ajustar sus tratamientos.

Por este motivo, hemos desarrollado un cuestionario sobre calidad de vida específico para las personas que tienen bronquiectasias. Gracias por acceder a rellenar este cuestionario.

Instrucciones: Las siguientes preguntas se refieren a como percibe usted su estado actual de salud.

Esta información nos permitirá comprender mejor cómo se siente en su vida diaria.

Le rogamos que responda a todas las preguntas. No hay respuestas correctas o incorrectas.

Si no está seguro de cómo responder, elija la respuesta que más se adecúe a su situación.

Durante los últimos 7 días, en qué medida ha tenido dificultad para:

Mucha dificultad

Dificultad moderada

Poca dificultad

Ninguna dificultad

1. Realizar actividades que requieren esfuerzo como, por ejemplo, trabajos de jardinería o ejercicio físico.

2. Caminar al mismo ritmo que otras personas (familiares, amigos, etc.).

3. Transportar objetos pesados como, por ejemplo, libros o bolsas de la compra.

4. Subir un tramo de escaleras.

Durante los últimos 7 días, indique con qué frecuencia:Siempre A menudo

Algunas veces Nunca

5. Se ha sentido bien.

6. Se ha sentido cansado/a.

7. Se ha sentido inquieto/a.

8. Se ha sentido con energía.

9. Se ha sentido agotado/a.

10. Se ha sentido triste.

11. Se ha sentido deprimido/a.

Apartado I. Calidad de vida Marque la casilla que corresponda a su respuesta.

¿Está actualmente bajo algún tratamiento para las bronquiectasias (por ejemplo, utiliza medicación oral o inhalada , nebulizadores como Pari® I-neb® o E-flow rapid®, fisioterapia respiratoria, dispositivos PEP o Flutter®, o bien el sistema The Vest®o ventilación mecánica no invasiva) ?

Sí No (vaya a la pregunta 15, al final de la página)

Marque con un círculo el número que corresponda a su respuesta. Elija sólo una respuesta para cada pregunta.

12. ¿En qué medida los tratamientos para las bronquiectasias hacen su vida diaria más difícil?1. Nada en absoluto2. Un poco3. Moderadamente4. Mucho

13. En la actualidad, ¿cuánto tiempo dedica diariamente a los tratamientos para las bronquiectasias?1. Mucho2. Una cantidad moderada 3. Un poco 4. Casi no le dedico tiempo

Appendix

Qual Life Res (2014) 23:1279–1292 1289

123

Marque la casilla que corresponda a su respuesta.

Teniendo en cuenta su estado de salud durante los últimos 7 días, indique en qué medida es cierta para usted cada afirmación. Totalmente

cierta

Cierta en su mayor

parteUn poco

ciertaNada cierta

16. Debo limitar las actividades que requieren esfuerzo como, por ejemplo, caminar o practicar ejercicio físico.

17. Debo quedarme en casa más de lo que me gustaría.

18. Me preocupa verme expuesto a otras personas que estén enfermas.

19. Me resulta difícil intimar con la pareja (besos, abrazos, etc.).

20. Llevo una vida normal.

21. Me preocupa que mi salud empeore.

22. Creo que mi tos molesta a los demás.

23. A menudo me siento solo/a.

24. Me siento sano/a.

25. Resulta difícil realizar planes para el futuro (vacaciones, asistir a acontecimientos familiares, etc.).

26. Me da vergüenza cuando toso.

Durante los últimos 7 días:

27. ¿En qué medida tuvo problemas para seguir el ritmo de su trabajo, tareas del hogar u otras actividades cotidianas?1. No tuvo problemas para seguir el ritmo.2. Se las arregló para seguir el ritmo pero con alguna dificultad.3. Realizó las actividades con retraso.4. No pudo realizar estas actividades.

Siempre A menudoAlgunas

veces Nunca

28. ¿Con qué frecuencia interfiere el hecho de tener bronquiectasias con realizar sus metas de trabajo, del hogar, de la familia o personales?

Marque con un círculo el número o bien marque la casilla que corresponda a su respuesta.

14. ¿Cuánto le cuesta conciliar los tratamientos para las bronquiectasias con su vida diaria?1. No me cuesta en absoluto2. Un poco3. Moderadamente4. Mucho

Marque con un círculo el número que corresponda a su respuesta. Elija sólo una respuesta.

15. ¿Cuál cree que es su estado de salud actual?1. Excelente2. Bueno3. Regular4. Malo

Indique cómo se ha sentido durante los últimos 7 días: Mucho

Una cantidad

moderada Un pocoNada en absoluto

29. ¿Ha notado congestión en el pecho?

30. ¿Ha tosido por el día?

31. ¿Ha expulsado mucosidad al toser?

Apartado II. Síntomas respiratorios Marque la casilla que corresponda a su respuesta.

1290 Qual Life Res (2014) 23:1279–1292

123

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