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1.  Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD 
Clinical manifestations of chronic obstructive pulmonary disease (COPD), including airflow limitation, dyspnea, and activity limitation, ultimately lead to impaired health-related quality of life (HRQoL). This 9-month, randomized, double-blind, multicenter study compared the effect of once-daily tiotropium 18 μg and placebo on HRQoL, spirometric parameters, and exacerbations in 554 patients with moderate-to-severe COPD. HRQoL was assessed using the St. George’s Respiratory Questionnaire (SGRQ) and the new 8-item Visual Simplified Respiratory Questionnaire (VSRQ), which is currently being validated. The primary efficacy endpoint was the proportion of patients achieving a reduction of at least 4 units in the SGRQ total score at study end (Month 9). Mean ± SD baseline SGRQ total score was 47.4 ± 18.1. Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score vs placebo at study end (59.1% vs 48.2%, respectively; p = 0.029). Tiotropium significantly improved spirometric parameters (forced expiratory volume in 1 second [FEV1]: 0.11 ± 0.02 L vs 0.01 ± 0.02 L; between-group difference: 0.10 ± 0.03 L, p = 0.0001) and reduced exacerbations vs placebo. Maintenance treatment with tiotropium provided significant and clinically relevant improvements in HRQoL, as measured by the SGRQ.
PMCID: PMC2629970  PMID: 18686739
chronic obstructive pulmonary disease; long-acting anticholinergic; health-related quality of life; tiotropium
2.  An empirical comparison of the St George's Respiratory Questionnaire (SGRQ) and the Chronic Respiratory Disease Questionnaire (CRQ) in a clinical trial setting 
Thorax  1999;54(11):995-1003.
BACKGROUND—The Chronic Respiratory Questionnaire (CRQ) and the St George's Respiratory Questionnaire (SGRQ) are the two most widely used quality of life questionnaires in chronic obstructive pulmonary disease (COPD). A study was undertaken to compare directly the self-administered version of the CRQ and the SGRQ with respect to feasibility, internal consistency, validity, and sensitivity to changes resulting from bronchodilator therapy.
METHODS—One hundred and forty four patients with moderate or severe COPD were randomly assigned to receive three months of treatment with either salmeterol, salmeterol + ipratropium bromide, or placebo. Quality of life was measured at baseline and after 12 weeks of treatment.
RESULTS—The proportions of missing values per patient were low for both questionnaires (0.54% for the CRQ and 2% for the SGRQ). The internal consistency was good for both questionnaires (Cronbach's α coefficients ⩾0.84 for the CRQ and ⩾0.76 for the SGRQ). Factor analysis confirmed the original domain structure of the CRQ but not of the SGRQ. Correlations with forced expiratory volume in one second (FEV1) % predicted and peak expiratory flow rate (PEFR) were low for both questionnaires but better for the SGRQ than for the CRQ. The ability to discriminate between subjects with different levels of FEV1 was somewhat better for the SGRQ. The correlations with symptom scores were comparable for both questionnaires. Cross sectionally, the scores of the two questionnaires were moderately to highly correlated (coefficients ranged from 0.35 to 0.72). Longitudinally, these correlations were lower (coefficients ranged from 0.17 to 0.54) but were still significant. The CRQ total and emotions score and the SGRQ symptoms score were the most responsive to change. The SGRQ symptoms domain was the only domain where the improvement in patients receiving combination treatment crossed the threshold for clinical relevance.
CONCLUSIONS—Since this analysis of reliability, validity, and responsiveness to change did not clearly favour one instrument above the other, the choice between the CRQ and the SGRQ can be based on other considerations such as the required sample size or the availability of reference values.

PMCID: PMC1745382  PMID: 10525558
3.  The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis 
The aim of this study is to validate the questionnaire ECOS-16 (Assessment of health related quality of life in osteoporosis) for the evaluation of health related quality of life (HRQoL) in post-menopausal women with osteoporosis.
An observational, prospective and multi-centre study was carried out among post-menopausal women with osteoporosis in primary care centres and hospital outpatient clinics. All patients attended 2 visits: at baseline and at 6 months. In addition, the subgroup of outpatients attended another visit a month after the baseline to assess the test-retest reliability. The psychometric properties of the questionnaire were evaluated in terms of feasibility, validity (content validity and construct validity) and internal consistency in baseline, and in terms of test-retest reliability and responsiveness to change in visit at month and visit at 6 months, respectively. In all visits, ECOS-16, EUROQoL-5D (EQ-5D) and four 7-point items about health status (general health status, back pain, limitation in daily activities and emotional status) were administered, whereas only outpatients were given MINI-OQLQ (Mini Osteoporosis Quality of Life Questionnaire), besides all clinical variables; and sociodemographic variables at baseline.
316 women were consecutively included, 212 from primary care centres and 104 from hospital outpatient clinics. Feasibility: 94.3% of patients answered all items of the questionnaire. The mean administration time was 12.3 minutes. Validity: factor analysis suggested that the questionnaire was unidimensional. In the multivariate analysis, patients with vertebral fractures, co-morbidity and a lower education level showed to have worse HRQoL. Moderate to high correlations were found between the ECOS-16 score and the other health status questionnaires (0.47–0.82). Reliability: internal consistency (Cronbach's α) was 0.92 and test-retest reliability (ICC) was 0.80. Responsiveness to change: ECOS-16 scores increased according to change perceived by the patient, as well as the effect size (ranges between 1.35 to 0.43), the greater the perception of change in patients' general health status, the greater the changes in patients' scores. The Minimal Clinically Important Difference (MCID) suggested a change of 0.5 points in the ECOS-16 score, representing the least improvement in general health status due to their osteoporosis: "slightly better".
ECOS-16 has been proven preliminarily to have good psychometric properties, so that it can be potentially a useful tool to evaluate HRQoL of post-menopausal women with osteoporosis in research and routine clinical practice.
PMCID: PMC514569  PMID: 15291959
4.  Evaluation of correlation of BODE index with health-related quality of life among patients with stable COPD attending a tertiary care hospital 
Chronic obstructive pulmonary disease (COPD) is characterized by progressive deterioration of respiratory function along with systemic effects which have a great impact on health-related quality of life (HRQoL). Classification of severity of airflow limitation in COPD does not represent the clinical consequences of COPD. Hence, combined COPD assessment should be preferred. BODE index (Body mass index, Airflow obstruction, Dyspnea and Exercise capacity) has recently been proposed to provide useful prognostic information.
To find out correlations between the BODE index and HRQoL, and between GOLD classification of COPD severity and HRQoL in stable COPD patients, and to compare between these two correlations.
Materials and Methods:
A longitudinal observational study was carried out with 114 stable COPD patients recruited over 10 months at the outpatient clinic of a tertiary care hospital in Kolkata, India. Patients were classified according to GOLD classification of severity of airflow limitation after performing spirometry. BODE index was calculated for each patient. Saint George's Respiratory Questionnaire (SGRQ) was used to assess the HRQoL.
BODE scores were categorized into four quartiles, quartile one to four with scores of 0-2, 3-4, 5-6 and 7-10, respectively. Higher BODE quartiles were associated with higher total SGRQ scores and SGRQ subscale scores (symptom, activity and impact). Very strong correlations were found between BODE quartiles and total SGRQ scores (P = 0.914; P < 0.01). In contrast, GOLD classes showed moderate correlation with total SGRQ scores (P = 0.590; P < 0.01).
BODE index was strongly correlated with the HRQoL in stable COPD patients and it was better than GOLD classes of COPD severity to reflect the health status in patients with stable COPD.
PMCID: PMC4298913  PMID: 25624592
BODE index; chronic obstructive pulmonary disease; health-related quality of life; Saint George's respiratory questionnaire
5.  The psychometric properties of the St George’s Respiratory Questionnaire (SGRQ) in patients with idiopathic pulmonary fibrosis: a literature review 
Assessment of health-related quality of life (HRQL) is particularly important in patients with progressive and incurable diseases such as idiopathic pulmonary fibrosis (IPF). The St George’s Respiratory Questionnaire (SGRQ) has frequently been used to measure HRQL in patients with IPF, but it was developed for patients with obstructive lung diseases. The aim of this review was to examine published data on the psychometric performance of the SGRQ in patients with IPF. A comprehensive search was conducted to identify studies reporting data on the internal consistency, construct validity, test-retest reliability, and interpretability of the SGRQ in patients with IPF, published up to August 2013. In total, data from 30 papers were reviewed. Internal consistency was moderate for the SGRQ symptoms score and excellent for the SGRQ activity, impact and total scores. Validity of the SGRQ symptoms, activity, impact and total scores was supported by moderate to strong correlations with other patient-reported outcome measures and with a measure of exercise capacity. Most correlations were moderately strong between SGRQ activity or total scores and forced or static vital capacity, the most commonly used marker of IPF severity. There was evidence that changes in SGRQ domain and total scores could detect within-subject improvement in health status, and differentiate groups of patients whose health status had improved, declined or remained unchanged. Although the SGRQ was not developed specifically for use with patients with IPF, on balance, its psychometric properties are adequate and suggest that it may be a useful measure of HRQL in this patient population. However, several questions remain unaddressed, and further research is needed to confirm the SGRQ’s utility in IPF.
Electronic supplementary material
The online version of this article (doi:10.1186/s12955-014-0124-1) contains supplementary material, which is available to authorized users.
PMCID: PMC4148554  PMID: 25138056
Idiopathic pulmonary fibrosis; Patient-reported outcomes; PROs; St George’s Respiratory Questionnaire; SGRQ; Health-related quality of life; HRQL; Psychometrics; Validity; Reliability
6.  Psychometric validation of the visual function questionnaire-25 in patients with diabetic macular edema 
Diabetic Macular Edema (DME) is a common cause of impaired vision and blindness amongst diabetics. If not detected and treated early, the resulting vision loss can lead to considerable health costs and decreased health-related quality of life (HRQoL). The aim of this study was to provide evidence of the psychometric properties of the National Eye Institute - Visual Functioning Questionnaire (VFQ-25) for use in a cohort of DME patients who participated in a clinical efficacy and safety trial of pegaptinib sodium (Macugen).
A phase 2/3 randomised, double masked trial evaluated pegaptanib injection versus sham injection in patients with DME. The analysis was conducted using baseline HRQoL data of the VFQ-25 and the EQ-5D, on a modified intent-to-treat sample of 235 patients. These measures were administered by a trained interviewer by telephone in all but one of the study countries, where face-to-face interviews were conducted in the clinic. The measures were completed in the week prior to baseline, and after 54 weeks of treatment. Distance visual acuity, measured according to the Early Treatment Diabetic Retinopathy Study (ETDRS), was assessed at all time points. Psychometric properties of the VFQ-25 assessed included domain structure, reliability, concurrent and construct validity, responsiveness.
The VFQ-25 was found to consist of 11 domains slightly different than those proposed. Nevertheless, none of the eight established multi-item scales met the criterion for further splitting and the VFQ-25 was scored as in the developers’ instructions. Internal consistency reliability was demonstrated for six out of the eight original multi-item scales, with Cronbach's alpha ranging from 0.58 (Distance Activities) to 0.85 (Vision Specific: Dependency). The VFQ-25 domains generally showed a low to moderate correlation with EQ-5D visual analogue scale (range 0.16-0.43) and with the visual acuity score (range 0.10-0.41). Construct validity was upheld with higher VFQ-25 scores for patients who saw more letters according to the ETDRS. Almost all scales were shown to be responsive with Guyatt's statistic ranging from 0.10 to 0.56 at 54 weeks.
The VFQ-25 has evidence to support its validity and reliability for measuring HRQoL in DME. However, some operating characteristics of the instrument need further consideration and discussion in the case of DME patients. Further research is therefore warranted in this indication.
PMCID: PMC3599421  PMID: 23347793
Diabetic macular edema; Visual functioning questionnaire; Psychometric analyses
7.  Predictors of Mortality in Patients with Stable COPD 
Journal of General Internal Medicine  2008;23(11):1829-1834.
To determine which easily available clinical factors are associated with mortality in patients with stable COPD and if health-related quality of life (HRQoL) provides additional information.
Five-year prospective cohort study.
Five outpatient clinics of a teaching hospital.
Six hundred stable COPD patients recruited consecutively.
The variables were age, FEV1%, dyspnea, previous hospital admissions and emergency department visits for COPD, pack-years of smoking, comorbidities, body mass index, and HRQoL measured by Saint George’s Respiratory Questionnaire (SGRQ), Chronic Respiratory Questionnaire (CRQ), and Short-Form 36 (SF-36). Logistic and Cox regression models were used to assess the influence of these variables on mortality and survival.
FEV1%(OR: 0.62, 95% CI 0.5 to 0.75), dyspnea (OR 1.92, 95% CI 1.2 to 3), age (OR 2.41, 95% CI 1.6 to 3.6), previous hospitalization due to COPD exacerbations (OR 1.53, 1.2 to 2) and lifetime pack-years (OR 1.15, 95% CI 1.1 to 1.2) were independently related to respiratory mortality. Similarly, these factors were independently related to all-cause mortality with dyspnea having the strongest association (OR 1.54, 95% CI 1.1 to 2.2). HRQoL was an independent predictor of respiratory and all-cause mortality only when dyspnea was excluded from the models, except scores on the SGRQ were associated with all-cause mortality with dyspnea in the model.
Among patients with stable COPD, FEV1% was the main predictor of respiratory mortality and dyspnea of all-cause mortality. In general, HRQoL was not related to mortality when dyspnea was taken into account, and CRQ and SGRQ behaved in similar ways regarding mortality.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-008-0783-x) contains supplementary material, which is available to authorized users.
PMCID: PMC2585660  PMID: 18795373
chronic obstructive pulmonary disease; mortality; health-related quality of life
8.  Cross-cultural adaptation and psychometric properties of the Brazilian-Portuguese version of the VSP-A (Vécu et Santé Perçue de l'Adolescent), a health-related quality of life (HRQoL) instrument for adolescents, in a healthy Brazilian population 
BMC Pediatrics  2011;11:8.
Health-related quality of life (HRQoL) assessment, encompassing the adolescents' perceptions of their mental, physical, and social health and well-being is increasingly considered an important outcome to be used to identify population health needs and to provide targeted medical care. Although validated instruments are essential for accurately assessing HRQoL outcomes, there are few cross-culturally adapted tools for use in Brazil, and none designed exclusively for use among adolescents. The Vécu et Santé Perçue de l'Adolescent (VSP-A) is a generic, multidimensional self-reported instrument originally developed and validated in France that evaluates HRQoL of ill and healthy adolescents.
To cross-culturally adapt and validate the Brazilian-Portuguese version of the VSP-A, a generic HRQoL measure for adolescents originally developed in France.
The VSP-A was translated following a well-validated forward-backward process leading to the Brazilian version. The psychometric evaluation was conducted in a sample of 446 adolescents (14-18 years) attending 2 public high schools of São Gonçalo City. The adolescents self-reported the Brazilian VSP-A, the validated Psychosomatic Symptom Checklist and socio-demographic information. A retest evaluation was carried out on a sub-sample (n = 195) at a two-week interval.
The internal construct validity was assessed through confirmatory factor analysis (CFA), multi-trait scaling analyses, Rasch analysis evaluating unidimensionality of each scale and Cronbach's alpha coefficients. The reproducibility was evaluated by intra-class correlation coefficients (ICC). Zumbo's ordinal logistic regression analysis was used to detect differential item functioning (DIF) between the Brazilian and the French items. External construct validity was investigated testing expected differences between groups using one-way analysis of variance (ANOVA), Mann-Whitney tests and the univariate general regression linear model.
CFA showed an acceptable fit (RMSEA=0.05; CFI=0.93); 94% of scaling success was found for item-internal consistency and 98% for item discriminant validity. The items showed good fit to the Rasch model except 3 items with an INFIT at the upper threshold. Cronbach's Alpha ranged from 0.60 to 0.85. Test-retest reliability was moderate to good (ICC=0.55-0.82). DIF was evidenced in 4 out of 36 items. Expected patterns of differences were confirmed with significantly lower physical, psychological well being and vitality reported by symptomatic adolescents.
Although DIF in few items and responsiveness must be further explored, the Brazilian version of VSP-A demonstrated an acceptable validity and reliability in adolescents attending school and might serve as a starting point for more specific clinical investigations.
PMCID: PMC3042386  PMID: 21272317
9.  A short questionnaire for the assessment of quality of life in patients with chronic obstructive pulmonary disease: psychometric properties of VQ11 
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.
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.
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).
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).
PMCID: PMC3842624  PMID: 24160852
Chronic obstructive pulmonary disease; Brief questionnaire; Health-related quality of life; Validity; VQ11
10.  Development and validity testing of an IPF-specific version of the St George's Respiratory Questionnaire 
Thorax  2010;65(10):921-926.
The St George's Respiratory Questionnaire (SGRQ) is often applied to assess health-related quality of life in patients with idiopathic pulmonary fibrosis (IPF). Some SGRQ items will inevitably have weaker measurement properties than others when applied to this population. This study was conducted to develop an IPF-specific version of the SGRQ.
Data from a recently completed trial that enrolled subjects with IPF (n=158) who completed the SGRQ and other measures were analysed at baseline and 6 months. There were four phases to the study: (1) removing items with missing responses and using Rasch analysis on retained items to identify fit and refine item response categories; (2) development of a new scoring scheme; (3) testing agreement between original and revised versions and testing construct validity of the revised SGRQ; and (4) rewording to finalise the IPF-specific version (SGRQ-I).
Items were removed due to missing responses (6 items) and misfit to the Rasch model (10 items); 34 items from the original 50 were retained. For certain items, disordered response thresholds were identified and corrected by collapsing response categories. A scoring algorithm was developed to place SGRQ-I scores on a scale with SGRQ scores. For any given outcome measure (eg, forced vital capacity (% predicted) and lung carbon monoxide transfer factor (% predicted), 6-min walk distance and patient-reported questionnaires), Pearson correlations were similar between pairs that included original SGRQ scores and corresponding pairs that included SGRQ-I scores. Internal reliability (Cronbach α) for each SGRQ-I component was comparable to the original SGRQ (Symptoms 0.62; Activities 0.80; Impacts 0.85).
The SGRQ-I contains items from the original SGRQ that are the most reliable for measuring health-related quality of life in patients with IPF.
PMCID: PMC3697105  PMID: 20861296
11.  Health-related quality of life assessment using St. George's respiratory questionnaire in asthmatics on inhaled corticosteroids 
Chronic diseases like asthma have significant effects on patients’ health-related quality of life (HRQoL). HRQoL measures additional indices as compared to objective measurements like spirometry.
To assess and compare disease-specific quality of life in asthma patients using St. George's Respiratory Questionnaire (SGRQ) receiving fluticasone, beclomethasone, and budesonide (BUD).
Settings and Design:
A prospective, open label, randomized, parallel group study conducted at a tertiary care teaching hospital in South India.
Materials and Methods:
A 6-month follow-up of 277 patients with mild, moderate, and severe persistent asthma was randomized to receive fluticasone propionate (FP), BUD, or beclomethasone dipropionate (BDP) in equipotent doses according to their global initiative on asthma (GINA) severity. Statistical analysis used: Data analyzed using SPSS version: 13.0. General linear-repeated measures using the post-hoc bonferroni method assessed significance between treatment groups.
Significant decrease (P < 0.05) in each SGRQ domains and total scores as well as improvement in FEV1 (P < 0.05) was observed in all study subjects. A significant early response (P < 0.05) was noted after 15 days treatment in patients receiving FP with respect to SGRQ (activity, impact and total) scores and dyspnea indices, but not FEV1. This improvement with FP was due to its greater effect in patients with moderate and severe persistent asthma. No difference was noted subsequently in all outcome measures studied until 6 months.
There was evidence for an early QoL improvement to FP as compared to BUD or BDP in moderate and severe persistent asthma. Subsequently, the three ICS showed similar improvements in lung functions and dyspnea indices throughout the study.
PMCID: PMC3276031  PMID: 22345912
Asthma; health-related quality of life; inhaled corticosteroids
12.  The pediatric rheumatology quality of life scale: validation of the English version in a US cohort of juvenile idiopathic arthritis 
This study aims to validate the English version of the Pediatric Rheumatology Quality of Life Scale (PRQL), a concise Health Related Quality of Life (HRQoL) measure, in a US cohort of children with juvenile idiopathic arthritis (JIA).
The PRQL is a 10-item HRQoL measure with two subscales: physical health and psychological health. The original version of this measure was validated using an Italian-speaking cohort of 472 JIA patients and 796 healthy controls and found to have acceptable psychometric properties. The English language version has not been validated in a US pediatric population. The English PRQL was administered to 161 JIA subjects from a US Rheumatology clinic. We assessed the reliability (internal consistency and test-retest) and validity (convergent, discriminative, and criterion) of the PRQL.
The English PRQL was feasible to administer and demonstrated good psychometric properties. Cronbach alpha (reliability) coefficients ranged from 0.72 to 0.81. Factor analysis yielded the existing subscales. The PRQL total and subscales were found to have moderate correlations with other HRQoL instruments, the Pediatric Quality of Life Inventory (PedsQL) generic core scale and the PedsQL rheumatology. The PRQL discriminated between subjects with active versus inactive disease and was responsive to an improvement or worsening in disease activity over time.
Our results suggest that the English version of the instrument is suitable for use in JIA patients in the US. This tool provides a relatively easy method to integrate at least one patient-reported outcome into routine clinical or research assessment.
PMCID: PMC3830514  PMID: 24206654
Quality of life; Patient-reported outcomes; Pediatric; Juvenile arthritis
13.  Feasibility and acceptance of electronic quality of life assessment in general practice: an implementation study 
Patients' health related quality of life (HRQoL) has rarely been systematically monitored in general practice. Electronic tools and practice training might facilitate the routine application of HRQoL questionnaires. Thorough piloting of innovative procedures is strongly recommended before the conduction of large-scale studies. Therefore, we aimed to assess i) the feasibility and acceptance of HRQoL assessment using tablet computers in general practice, ii) the perceived practical utility of HRQoL results and iii) to identify possible barriers hindering wider application of this approach.
Two HRQoL questionnaires (St. George's Respiratory Questionnaire SGRQ and EORTC QLQ-C30) were electronically presented on portable tablet computers. Wireless network (WLAN) integration into practice computer systems of 14 German general practices with varying infrastructure allowed automatic data exchange and the generation of a printout or a PDF file. General practitioners (GPs) and practice assistants were trained in a 1-hour course, after which they could invite patients with chronic diseases to fill in the electronic questionnaire during their waiting time. We surveyed patients, practice assistants and GPs regarding their acceptance of this tool in semi-structured telephone interviews. The number of assessments, HRQoL results and interview responses were analysed using quantitative and qualitative methods.
Over the course of 1 year, 523 patients filled in the electronic questionnaires (1–5 times; 664 total assessments). On average, results showed specific HRQoL impairments, e.g. with respect to fatigue, pain and sleep disturbances. The number of electronic assessments varied substantially between practices. A total of 280 patients, 27 practice assistants and 17 GPs participated in the telephone interviews. Almost all GPs (16/17 = 94%; 95% CI = 73–99%), most practice assistants (19/27 = 70%; 95% CI = 50–86%) and the majority of patients (240/280 = 86%; 95% CI = 82–91%) indicated that they would welcome the use of electronic HRQoL questionnaires in the future. GPs mentioned availability of local health services (e.g. supportive, physiotherapy) (mean: 9.4 ± 1.0 SD; scale: 1 – 10), sufficient extra time (8.9 ± 1.5) and easy interpretation of HRQoL results (8.6 ± 1.6) as the most important prerequisites for their use. They believed HRQoL assessment facilitated both communication and follow up of patients' conditions. Practice assistants emphasised that this process demonstrated an extra commitment to patient centred care; patients viewed it as a tool, which contributed to the physicians' understanding of their personal condition and circumstances.
This pilot study indicates that electronic HRQoL assessment is technically feasible in general practices. It can provide clinically significant information, which can either be used in the consultation for routine care, or for research purposes. While GPs, practice assistants and patients were generally positive about the electronic procedure, several barriers (e.g. practices' lack of time and routine in HRQoL assessment) need to be overcome to enable broader application of electronic questionnaires in every day medical practice.
PMCID: PMC2698929  PMID: 19493355
14.  Validity of Korean Versions of the Multiple Sclerosis Impact Scale and the Multiple Sclerosis International Quality of Life Questionnaire 
Background and Purpose
Assessment of the health-related quality of life (HRQoL) is important in clinical evaluations of multiple sclerosis (MS) patients for quantifying the impact of illness and treatment on their daily lives. Although MS-specific HRQoL instruments have been used internationally, there are no data regarding HRQoL instruments specifically designed for patients with MS in Korea. The objective of this study was to determine the reliability and validity of the Korean Multiple Sclerosis Impact Scale (MSIS-29) and the Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire.
Fifty-six patients with MS were recruited from June 2009 to February 2010 at the National Cancer Center in Korea. The original English versions of the MSIS-29 scale and the MusiQoL questionnaire were translated into Korean and evaluated for their acceptability, reliability, and validity.
The patients wereaged 36.5±8.6 years (mean±SD; range, 20-56 years). Their score on the Expanded Disability Status Scale was 2.0±1.9 (mean; range, 0-7.5), and their disease duration was 5.2±4.7 years (mean±SD; range, 1-24 years). The Korean versions of the MSIS-29 and MusiQoL questionnaires showed satisfactory psychometric properties, including construct validity (item-internal consistencies of 0.59-0.95 and 0.59-0.92, respectively; item-discriminant validities of 95-100% and 93.8-100%), internal consistency (Cronbach's alpha coefficients of 0.96-0.97 and 0.77-0.96), reliability (intraclass correlation coefficients of 0.78-0.90 and 0.50-0.93), unidimensionality (Loevinger scalability coefficients of 0.70-0.78 and 0.63-0.90), and acceptability. External validity testing indicated the presence of significant correlations between similar aspects of the two questionnaires.
The Korean translated versions of the MSIS-29 and MusiQoL questionnaires demonstrated reliability and validity for measuring HRQoL in Korean patients with MS.
PMCID: PMC4017018  PMID: 24829601
multiple sclerosis; health-related quality of life; MSIS-29; MusiQoL
15.  Use of the Airway Questionnaire 20 to detect changes in quality of life in asthmatic patients and its association with the St George’s Respiratory Questionnaire and clinical parameters 
The usefulness of the Airway Questionnaire 20 (AQ20) – a short version of the St George’s Respiratory Questionnaire (SGRQ) – to evaluate quality of life (QOL) in asthmatic patients following a hospital admission was assessed.
At baseline and at six months following the index admission, 135 asthmatic patients were asked to complete the AQ20 and the SGRQ. The patient’s peak flow, number of subsequent asthma exacerbations and number of repeat hospital admissions were also recorded.
The AQ20 scores ranged from 0 to 20, with a high score indicating poor QOL. The AQ20 had good coverage, with no obvious ceiling or floor effects. In multiple regression analysis, all three SGRQ components were important in predicting AQ20 scores (R2 values were 61.9% and 73.1% for baseline and six-month scores, respectively). The AQ20 was closely correlated with the SGRQ, but not redundant when used together. Bias was low when the retest reliability of the AQ20 was evaluated using the Bland-Altman method, but variation was high (−0.64). Patients with subsequent exacerbations (n=52) had higher AQ20 scores at six-month follow-up (P=0.002). In logistic regression, the AQ20 score was closely associated with the incidence of exacerbations (OR 1.15, 95% CI 1.05 to 1.25), with a similar magnitude of association between the AQ20 and the SGRQ. The AQ20 score did not correlate with peak flow at baseline (r=−0.05; P=0.573) or at six months (r=−0.31; P=0.006), and was not responsive to changes in peak flow (r=−0.06; P=0.583).
The AQ20 can be substituted for the more complicated SGRQ in the assessment of QOL in patients following a hospital admission for an asthma exacerbation.
PMCID: PMC2677936  PMID: 18437255
AQ20; Asthma; Peak flow; Quality of life; SGRQ
16.  Exacerbation-related impairment of quality of life and work productivity in severe and very severe chronic obstructive pulmonary disease 
Exacerbation-associated health-related quality of life (HRQoL) in patients with severe and very severe chronic obstructive pulmonary disease (COPD) is ill-defined. This study describes patterns, HRQoL, and the work productivity impact of COPD-related moderate and SEV exacerbations in patients with SEV/VSEV COPD, focusing on the chronic bronchitis subtype.
Patients and methods
A US sample of SEV and VSEV COPD patients with recent moderate or SEV exacerbation was recruited. Along with the demographic and clinical data collected from medical records, patients reported on exacerbation frequency, health-related quality of life (HRQoL) (using the St George’s Respiratory Questionnaire for COPD [SGRQ-C] and the European Quality of Life-5 Dimensions [EQ-5D]™ index), and work productivity and activity impairment (using the Work Productivity and Activity Impairment Questionnaire – Specific Health Problem [WPAI-SHP]). The HRQoL-related impacts of exacerbation frequency, time since exacerbation, and last exacerbation severity were evaluated via linear regressions.
A total of 314 patients (190 SEV/124 VSEV, mean age =68.0 years, 51% male, 28% current smokers) were included. In the previous 12 months, patients reported an average of 1.8 moderate exacerbations and 0.9 SEV exacerbations. Overall, 16% of patients were employed and reported a high percentage of overall work impairment (42.4% ± 31.1%). Activity impairment was positively associated with recent exacerbation severity (SEV 64.6% ± 26.8% versus moderate 55.6% ± 28.2%) (P=0.006). The HRQoL was significantly worse for SEV versus VSEV COPD (EQ-5D: 0.62 ± 0.23 versus 0.70 ± 0.17, respectively, and SGRQ-C: 70.1 ± 21.3 versus 61.1 ± 19.0, respectively) (P<0.001). Worse current HRQoL was reported by patients with a SEV versus moderate recent exacerbation (EQ-5D: 0.63 ± 0.21 versus 0.70 ± 0.20, respectively) (P=0.003); SGRQ-C: 70.3 ± 19.9 versus 61.7 ± 20.1, respectively (P<0.001). One additional exacerbation in the previous 12 months was associated with a 2.4-point SGRQ-C increase and a 0.02-point EQ-5D index decrease.
The severity and frequency of COPD-related moderate/SEV exacerbations in SEV and VSEV COPD patients were positively associated with poor HRQoL and work productivity and activity impairment.
PMCID: PMC3864879  PMID: 24376348
burden; HRQoL; chronic obstructive pulmonary disease; health-related quality of life; exacerbations; utilities
17.  Psychometric Evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): Reliability, Validity, Responsiveness, and Clinical Meaningfulness 
The Oncologist  2010;15(3):308-316.
This study evaluated the psychometric properties of the FCSI-9 administered to metastatic colorectal cancer patients in a phase III clinical trial. The results provide preliminary evidence to suggest that the FCSI-9, a brief, symptom-specific measure, is reliable, valid, and responsive in this population.
Patient-reported outcomes (PROs) are essential for evaluating treatment effects on health-related quality of life and symptoms from the patient's perspective. This study sought to evaluate the psychometric properties of the nine-item Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Colorectal Cancer Symptom Index (FCSI-9) in a metastatic colorectal cancer (mCRC) population.
The FCSI-9 and EQ-5D were administered every 2–4 weeks to mCRC subjects in a phase III clinical trial. Three hundred ninety-one mCRC subjects completed the questionnaires at baseline and at least one follow-up assessment. Internal consistency reliability, test–retest reliability, construct validity, known groups validity, responsiveness, and the minimum important difference (MID) of the FCSI-9 were evaluated.
The internal consistency and test–retest reliability of the FCSI-9 were acceptable (0.81 and 0.76, respectively). Construct validity was supported based on moderate correlations with the EQ-5D. Known groups validity was evaluated by examining the FCSI-9 scores of subjects categorized by their Eastern Cooperative Oncology Group performance status (PS) score. Subjects with better PS scores reported significantly higher FCSI-9 scores than those with lower PS scores at both baseline and week 8. Responsiveness, as measured by Guyatt's statistic, was 0.77 from baseline to week 8 and 0.60 from week 4 to week 12. Considering all data together, the MID of the FCSI-9 is estimated to be in the range of 1.5–3.0 points.
Results provide preliminary evidence of the reliability, validity, and responsiveness of the FCSI-9.
PMCID: PMC3227951  PMID: 20189976
Quality of life; Reliability and validity; Questionnaire; Patient outcomes; Colorectal cancer
18.  Comparison of the Adult Strabismus Quality of Life Questionnaire (AS-20) with the Amblyopia and Strabismus Questionnaire (ASQE) among adults with strabismus who seek medical care in China 
BMC Ophthalmology  2014;14(1):139.
The impact of strabismus on visual function, self-image, self-esteem, and social interactions might decrease health-related quality of life (HRQoL). This study aimed to evaluate the psychometric properties and clinical applications of two strabismus-specific HRQoL questionnaires in the cultural context of China.
The Chinese versions of the Adult Strabismus Quality of Life Questionnaire (AS-20) and the Amblyopia and Strabismus Questionnaire (ASQE) were self-administered to 304 adults with strabismus. The Cronbach’s α coefficient was calculated to assess the internal consistency reliability. The criterion-related validity was identified by exploring Spearman’s correlation with the most widely used vision-specific quality of life questionnaire NEI-VFQ-25. One-way ANOVA was employed to examine the differences in the quality of life of strabismus patients with visually normal adults and with other eye diseases patients.
Significantly positive correlations with NEI-VFQ-25 were shown in both scales (r = 0.21 - 0.44, p <0.05, p <0.01). Both scales could distinguish individuals with strabismus from visually normal adults (p <0.001) and adults with other eye diseases (p <0.001). The overall Cronbach’s α value were 0.91 for the AS-20 and 0.89 for the ASQE; and for the subscales, the α value ranged from 0.68 to 0.90.
This was the first cross-sectional study to compare the psychometric properties of two strabismus-targeted questionnaires, AS-20 and ASQE in the context of Chinese culture. Both AS-20 and ASQE showed satisfactory and comparable properties for measuring HRQoL in strabismus patients.
PMCID: PMC4258794  PMID: 25416453
Quality of life; Adult strabismus; Questionnaire; Chinese
19.  Factors affecting the relationship between psychological status and quality of life in COPD patients 
This study aims to (i) evaluate the association between anxiety and depressive symptoms and health-related quality of life (HRQoL); and (ii) identify the effect modifiers of this relationship in patients with chronic obstructive pulmonary disease (COPD).
A total of 337 clinically stable COPD patients answered the St. George's Respiratory Questionnaire (SGRQ) (assessing HRQoL) and the Hospital Anxiety and Depression Scale (HADS). Socio-demographic information, lung function, and other clinical data were collected.
Most patients (93%) were male; they had a mean (SD) age of 68 (9) years and mild to very severe COPD (post-bronchodilator FEV1 52 (16)% predicted). Multivariate analyses showed that anxiety, depression, or both conditions were associated with poor HRQoL (for all SGRQ domains). The association between anxiety and total HRQoL score was 6.7 points higher (indicating a worse HRQoL) in current workers than in retired individuals. Estimates for patients with "both anxiety and depression" were 5.8 points lower in stage I-II than in stage III-IV COPD, and 10.2 points higher in patients with other comorbidities than in those with only COPD.
This study shows a significant association between anxiety, depression, or both conditions and impaired HRQoL. Clinically relevant factors affecting the magnitude of this association include work status, COPD severity, and the presence of comorbidities.
PMCID: PMC2957389  PMID: 20875100
20.  The validity and precision of the leicester cough questionnaire in COPD patients with chronic cough 
A validated instrument to assess the effects of chronic cough on health status in patients with chronic obstructive pulmonary disease (COPD) is currently not available. The Leicester Cough Questionnaire (LCQ) is a cough-specific health status questionnaire which is originally validated for a population of general patients presenting with chronic cough. We examined the psychometric performance of the LCQ in patients with COPD and chronic productive cough.
Concurrent validity, internal consistency, reproducibility and responsiveness were determined. The St. George's Respiratory Questionnaire (SGRQ) and the Short Form-36 (SF-36) were used as external criteria. Questionnaires were completed at the start of the study. After 2 and 12 weeks the LCQ was repeated, together with a global rating of change.
In total 54 patients were included. Concurrent validity analysis showed significant correlations between corresponding domains of the LCQ and the SGRQ (rs -0.31 to -0.60). Corresponding domains of the LCQ and the SF-36 showed weaker correlations (rs 0.04 to 0.41). Internal consistency was adequate for two of the three domains (Cronbach's α 0.74 - 0.86). Test-retest reliability in stable patients was high (intraclass correlation coefficients 0.79 - 0.93). The mean difference after two weeks was 0.73 (± 1.75). Responsiveness analysis indicated that the LCQ was able to detect changes after 12 weeks.
The LCQ is a valid, reliable, responsive instrument to measure health status in COPD patients with chronic productive cough.
Trial Registration NCT01071161
PMCID: PMC3311606  PMID: 22230731
LCQ; COPD; validity; cough; health status
21.  Reliability and validity of PedsQL for Portuguese children aged 5–7 and 8–12 years 
Pediatric Quality of Life Inventory (PedsQL) is a measure to assess health-related quality of life (HRQoL) in children and adolescents. It is formed by 23 items adapted to children age and includes a parent proxy report version. With four multidimensional subscales and three summary scores, it measures health as defined by WHO. The concepts measured by this instrument are ‘physical functioning’ (8 items), ‘emotional functioning’ (5 items), ‘social functioning’ (5 items) and ‘school functioning’ (5 items). It also measures a ‘total scale score’ (23 items), a ‘physical health summary score’ (8 items) and a ‘psychosocial health summary score’ (15 items). The aim of this paper is to present the main results of the cultural adaptation and validation of the PedsQL into European Portuguese.
The Portuguese version was the result of a forward-backward translation process, with a cognitive debriefing analysis, guaranteeing face validity and semantic equivalence. Children aged 5–7 and 8–12 were randomly selected and were asked to fill a socio-demographic data survey and the Portuguese versions of PedsQL and KINDL, another HRQoL measure for children and adolescents. They were divided into three groups, healthy children, children with type I diabetes and children with spina bifida.
The reliability was tested for reproducibility (ICC) and internal consistency (Cronbach’s alpha). The construct validity (known-groups discriminant validity) was supported by differences between self-reports from healthy children and children with chronic conditions, and from children with chronic diseases and their parents. The criterion validity was tested after the correlations of the scores obtained by both children and adolescents HRQoL assessment instruments.
A total of 179 children and 97 parents were recruited. PedsQL demonstrated good levels of reproducibility (r > 0.95 in all versions) and acceptable levels of internal consistency with Cronbach’s alpha at 0.70 on most scales. Concordance values between children’s and parents’ perceptions ranged between 0.36 and 0.78 and the correlations with KINDL questionnaire were excellent, supporting concurrent validity.
The Portuguese version of the PedsQL demonstrated acceptable psychometric properties for future research and clinical practice for children aged 5–12.
PMCID: PMC4172820  PMID: 25208919
PedsQL; Children; Chronic illness; Health-related quality of life; Pediatrics
22.  Psychometric Properties of the Greek Haem-A-QoL for Measuring Quality of Life in Greek Haemophilia Patients 
BioMed Research International  2014;2014:968081.
Background and Objectives. Health Related Quality of Life (HRQoL) is an important health outcome measure in haemophilia. The aim of this study was to assess the psychometric properties of the Greek version of Haem-A-QoL, a disease-specific questionnaire for haemophiliacs. Methods. Haem-A-QoL and SF-36 were administered to 118 adult haemophilia patients. Hypothesized scale structure, internal consistency (Cronbach's α), and test-retest reliability, as well as various types of construct validity were evaluated. Results. Scale structure of Haem-A-QoL was confirmed, with good item convergence (87%) and discrimination (80.6%) rates. Cronbach's α was >0.70 for all but one dimension (dealing) and test-retest reliability was significantly high. The strength of Spearman's correlations between Haem-A-QoL and SF-36 scales ranged from 0.25 to 0.75 (P < 0.01). Multiple stepwise linear regression analysis revealed that all but one Haem-A-QoL dimensions were important predictors of SF-36 scales. Known-groups comparisons yielded consistent support of the instruments' construct validity and significant relationships were identified for age, educational level, haemophilia type, disease severity, and viral infections. Conclusion. Overall, the psychometric properties of the Greek version of Haem-A-QoL, resulting from this first time administration of the instrument to Greek adult haemophiliacs, confirmed it as a reliable and valid questionnaire for assessing haemophilia-specific HRQoL in Greece.
PMCID: PMC4026943  PMID: 24895637
23.  Validation of the new COPD assessment test translated into Thai in patients with chronic obstructive pulmonary disease 
BMC Pulmonary Medicine  2014;14(1):193.
The COPD Assessment Test (CAT™) is a new questionnaire that has been developed recently for measuring the COPD patient’s health status. It is known to have a good correlation with disease specific health status measured by St. George’s Respiratory Questionnaire (SGRQ). For the wider application in clinical practice, it has been validated in many countries. We evaluated the reliability and validity of the translated CAT questionnaire for Thai COPD patients.
The study was designed as a cross-sectional validation study enrolling stable Thai COPD patients from three academic centers in Thailand at a single visit. The original CAT questionnaire was translated to Thai through linguistic validation process. The official Thai CAT and SGRQ questionnaires were filled by Thai patients after orientation by the out-patient nurse. The reliability of all items was assessed by Cronbach’s formula for coefficient using pooled data from all patients. The validity of the questionnaire was tested using Pearson’s correlation with SGRQ.
A total of 98 Thai COPD patients completed the official Thai CAT questionnaire; 83% were male, mean age 71 years (SD 8.2), and % predicted of FEV1 56.6% (SD 20.9). The official Thai CAT questionnaire was shown to have a high internal consistency (Cronbach's α coefficient = 0.853). The assessment of validity of official Thai CAT questionnaire was moderately correlated with that of SGRQ (r = 0.652).
The official Thai CAT questionnaire has an acceptable reliability and validity. It can be expected to serve as a short and simple tool for assessment of the health status of Thai COPD patients.
PMCID: PMC4280747  PMID: 25471671
Chronic obstructive pulmonary disease; Health status assessment; Quality of life; Questionnaire; Validity
24.  Assessing health status in COPD. A head-to-head comparison between the COPD assessment test (CAT) and the clinical COPD questionnaire (CCQ) 
Health status provides valuable information, complementary to spirometry and improvement of health status has become an important treatment goal in COPD management. We compared the usefulness and validity of the COPD Assessment Test (CAT) and the Clinical COPD Questionnaire (CCQ), two simple questionnaires, in comparison with the St. George Respiratory Questionnaire (SGRQ).
We administered the CAT, CCQ and SGRQ in patients with COPD stage I-IV during three visits. Spirometry, 6 MWT, MRC scale, BODE index, and patients perspectives on questionnaires were recorded in all visits. Standard Error of Measurement (SEM) was used to calculate the Minimal Clinical Important Difference (MCID) of all questionnaires.
We enrolled 90 COPD patients. Cronbach's alpha for both CAT and CCQ was high (0.86 and 0.89, respectively). Patients with severe COPD reported worse health status compared to milder subgroups. CAT and CCQ correlated significantly (rho =0.64, p < 0.01) and both with the SGRQ (rho = 0.65; CAT and rho = 0.77; CCQ, p < 0.01). Both questionnaires exhibited a weak correlation with lung function (rho = −0.35;CAT and rho = −0.41; CCQ, p < 0.01). Their reproducibility was high; CAT: ICC = 0.94 (CI 0.92-0.96), total CCQ ICC = 0.95 (0.92-0.96) and SGRQ = 0.97 (CI 0.95-0.98). The MCID calculated using the SEM method showed results similar to previous studies of 3.76 for the CAT, 0.41 for the CCQ and 4.84 for SGRQ. Patients suggested both CAT and CCQ as easier tools than SGRQ in terms of complexity and time considerations. More than half of patients preferred CCQ instead of CAT.
The CAT and CCQ have similar psychometric properties with a slight advantage for CCQ based mainly on patients’ preference and are both valid and reliable questionnaires to assess health status in COPD patients.
PMCID: PMC3431277  PMID: 22607459
Health status; COPD Assessment Test (CAT); Clinical COPD Questionnaire (CCQ)
25.  Utility of brief questionnaires of health-related quality of life (Airways Questionnaire 20 and Clinical COPD Questionnaire) to predict exacerbations in patients with asthma and COPD 
There is some evidence that quality of life measured by long disease-specific questionnaires may predict exacerbations in asthma and COPD, however brief quality of life tools, such as the Airways Questionnaire 20 (AQ20) or the Clinical COPD Questionnaire (CCQ), have not yet been evaluated as predictors of hospital exacerbations.
To determine the ability of brief specific health-related quality of life (HRQoL) questionnaires (AQ20 and CCQ) to predict emergency department visits (ED) and hospitalizations in patients with asthma and COPD, and to compare them to longer disease-specific questionnaires, such as the St George´s Respiratory Questionnaire (SGRQ), the Chronic Respiratory Disease Questionnaire (CRQ) and the Asthma Quality of Life Questionnaire (AQLQ).
We conducted a two-year prospective cohort study of 208 adult patients (108 asthma, 100 COPD). Baseline sociodemographic, clinical, functional and psychological variables were assessed. All patients completed the AQ20 and the SGRQ. COPD patients also completed the CCQ and the CRQ, while asthmatic patients completed the AQLQ. We registered all exacerbations that required ED or hospitalizations in the follow-up period. Differences between groups (zero ED visits or hospitalizations versus ≥ 1 ED visits or hospitalizations) were tested with Pearson´s X2 or Fisher´s exact test for categorical variables, ANOVA for normally distributed continuous variables, and Mann–Whitney U test for non-normally distributed variables. Logistic regression analyses were performed to estimate the predictive ability of each HRQoL questionnaire.
In the first year of follow-up, the AQ20 scores predicted both ED visits (OR: 1.19; p = .004; AUC 0.723) and hospitalizations (OR: 1.21; p = .04; AUC 0.759) for asthma patients, and the CCQ emerged as independent predictor of ED visits in COPD patients (OR: 1.06; p = .036; AUC 0.651), after adjusting for sociodemographic, clinical, and psychological variables. Among the longer disease-specific questionnaires, only the AQLQ emerged as predictor of ED visits in asthma patients (OR: 0.9; p = .002; AUC 0.727). In the second year of follow-up, none of HRQoL questionnaires predicted exacerbations.
AQ20 predicts exacerbations in asthma and CCQ predicts ED visits in COPD in the first year of follow-up. Their predictive ability is similar to or even higher than that of longer disease-specific questionnaires.
PMCID: PMC3701555  PMID: 23706146
COPD; Asthma; Exacerbation; Risk factors; Emergency visits; Hospitalization; Health-related quality of life

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