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.
chronic obstructive pulmonary disease; long-acting anticholinergic; health-related quality of life; tiotropium
The St. George’s Respiratory Questionnaire (SGRQ) was a widely used tool to assess disease impact on patients with obstructive airways disease. Although traditional methods have generally supported construct validity and internal consistency reliability of SGRQ, such methods cannot facilitate the evaluation of whether items are equivalent to different individuals. The purpose of this study is to rigorously examine the psychometric properties of the SGRQ in patients with chronic obstructive pulmonary disease (COPD) using Rasch model analysis.
A methodological research was conducted on SGRQ in a sample of 240 male patients with COPD recruited from the outpatient services in Central Taiwan. The psychometric properties of the SGRQ were examined using Rasch model analysis with a mixed rating scale and partial credit mode by Winsteps software. The level of matching between the item’s difficulty and person’s ability was analyzed by item-person targeting as well as ceiling and floor effects. Item-person maps were also examined for checking the location of the item’s difficulty and person’s measures along the same scale. Finally, the differential item functioning (DIF) was examined to measure group equivalence associated with age and disease’s severity.
Each of the three domains (Symptom, Activity, Impact) of the SGRQ was found to be unidimensionality. The person separation index ranged from 1.21 (Symptom domain) to 2.50 (Activity domain). There was a good targeting for the SGRQ domains, except the Impact domain (1.36). The percentage of ceiling and floor effects were below 10 %, except the ceiling effect in the Impact domain (26.25 %). From item-person maps, gaps of location of item corresponded to patient’s ability were identified. The results have also showed that many items in SGRQ revealed age or severity related DIF.
Except the Symptom domain of SGRQ, the others have a reliabile internal consistency and a good hierarchical structure. The results of Rasch model analysis can highlight aspects for scale improvement, such as gap, duplicate items or scale responses. There was some age or severity related DIF indicating somewhat unstable across different characteristics of group.
IRB No.: DMR94-IRB-179.
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.
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.
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
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.
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.
Idiopathic pulmonary fibrosis; Patient-reported outcomes; PROs; St George’s Respiratory Questionnaire; SGRQ; Health-related quality of life; HRQL; Psychometrics; Validity; Reliability
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.
Diabetic macular edema; Visual functioning questionnaire; Psychometric analyses
The chronic obstructive pulmonary disease (COPD) assessment test (CAT) is a short questionnaire that has facilitated health status measurements in subjects with COPD. However, it remains controversial as to whether the CAT can be used as a suitable substitute for the St George’s Respiratory Questionnaire (SGRQ). This study investigated the reliability and score distributions of the CAT and SGRQ and evaluated which factors contributed to health status for each questionnaire.
A total of 109 consecutive subjects with stable COPD from a single center were enrolled in this study. Each subject completed pulmonary function tests, exercise tests, and the following self-administered questionnaires: the Baseline Dyspnea Index, the Hospital Anxiety and Depression Scale, the CAT, and SGRQ.
Internal consistencies of CAT and SGRQ total scores were both excellent (Cronbach’s α coefficients =0.890 and 0.933). Statistically significant correlations were observed between CAT and SGRQ total scores (R=0.668, P<0.001). Correlations of CAT scores with parameters related to pulmonary function, dyspnea, exercise performance, and psychological factors were inferior to correlations with those parameters with SGRQ total scores. Both multiple regression analyses and principal component analyses revealed that there were slight differences between SGRQ total scores and CAT scores.
The CAT is similar to SGRQ in terms of discriminating health status. However, we demonstrated that what is assessed by the CAT may differ slightly from what is measured by SGRQ.
chronic obstructive pulmonary disease; St George’s Respiratory Questionnaire; COPD assessment test; health status
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.
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.
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.
The study was approved by the University of Montpellier 1 Ethics Committee and the Regional Ethics Committee (authorization number: A00332-53).
Chronic obstructive pulmonary disease; Brief questionnaire; Health-related quality of life; Validity; VQ11
Objective. Dyspnoea is a common, multifactorial source of functional impairment among patients with dcSSc. Our objective was to assess the reliability, construct validity and responsiveness to change of the Saint George’s Respiratory Questionnaire (SGRQ) in patients with early dcSSc participating in a multicentre prospective study.
Methods. At enrolment and 1 year, patients completed the SGRQ (a multi-item instrument with four scales: symptoms, activity, impact and total), a visual analogue scale (VAS) for breathing and the HAQ Disability Index (HAQ-DI) and underwent 6 min walk distance and pulmonary function tests, physician and patient global health assessments and high-resolution CT (HRCT). We assessed internal consistency reliability using Cronbach’s α. For validity we examined the ability of the SGRQ to differentiate the presence vs absence of interstitial lung disease (ILD) on HRCT or restrictive lung disease and evaluated the 1 year responsiveness to change using pulmonary function tests and patient- and physician-reported anchors. Correlation coefficients of 0.24–0.36 were considered moderate and >0.37 was considered large.
Results. A total of 177 patients were evaluated. Reliability was satisfactory for all SGRQ scales (0.70–0.93). All scales showed large correlations with the VAS for breathing and diffusing capacity of the lung for carbon monoxide in the overall cohort and in the subgroup with ILD. Three of the four scales in the overall cohort and the total scale in the ILD subgroup showed moderate to large correlation with the HAQ-DI and the predicted forced vital capacity (r = 0.33–0.44). Each scale discriminated between the presence and absence of ILD and restrictive lung disease (P ≤ 0.0001–0.03). At follow-up, all scales were responsive to change using different anchors.
Conclusion. The SGRQ has acceptable reliability, construct validity and responsiveness to change for use in a dcSSc population and differentiates between patients with and without ILD.
scleroderma and related disorders; respiratory; quality of life; patient attitude to health; autoinflammatory conditions; systemic sclerosis; dyspnoea; patient-reported outcomes
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.
BODE index; chronic obstructive pulmonary disease; health-related quality of life; Saint George's respiratory questionnaire
Chronic obstructive pulmonary disease (COPD) is characterized by non-reversible airflow limitation. A common symptom of COPD is dyspnea or shortness of breath. Dyspnea may vary daily, with a large impact on patients’ lives. Previous clinical trials used patient-reported outcome (PRO) measures that quantified dyspnea at discrete intervals and hence did not reflect this variability. Recently the Shortness of Breath with Daily Activities (SOBDA) questionnaire was developed as a PRO measure of dyspnea utilizing a daily diary. This confirmatory post hoc meta-analysis of SOBDA data from a large clinical study program further supports the questionnaire and clarifies the minimum threshold of SOBDA response.
Data from four clinical trials (DB2113361, NCT01313637; DB2113373, NCT01313650; DB2113360, NCT01316900; DB2113374, NCT01316913) were analyzed. These 24-week trials were randomized, blinded studies investigating the efficacy and safety of several COPD treatments. These post hoc analyses focused on the SOBDA questionnaire properties. This electronic-diary consists of 13 items completed daily, in which patients rate their breathlessness level during common daily activities. Resultant SOBDA scores were compared with related, commonly used assessments: modified Medical Research Council Research Dyspnea Scale (mMRC), Baseline Dyspnea Index (BDI), Transition Dyspnea Index (TDI), St George’s Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and trough forced expiratory volume in 1 s (FEV1). The consistency, reliability, validity (convergent, known groups), and responsiveness of the SOBDA questionnaire was assessed.
In total, 4967 patients with COPD provided data for these analyses. The SOBDA questionnaire had high internal consistency (Cronbach’s alpha = 0.936), high test-retest reliability (Pearson’s correlation coefficient = 0.86) and convergent validity with related measures (SGRQ total score, Pearson’s correlation coefficient = 0.59; CAT, Spearman rank-order correlation coefficient = 0.50). SOBDA scores were statistically significantly lower in responders (as defined by TDI, SGRQ, CAT, and trough FEV1 levels) versus non-responders (p < 0.001 for all assessments and all time points). Using an anchor-based method, the threshold of a minimum response was calculated as a SOBDA score change of −0.2 (SOBDA score range = 1–4).
The reliability, validity, and responsiveness of the SOBDA questionnaire as a PRO measure to quantify dyspnea was supported in a large clinical trial population of patients with moderate–very severe COPD.
Electronic supplementary material
The online version of this article (doi:10.1186/s12955-015-0369-3) contains supplementary material, which is available to authorized users.
Chronic obstructive pulmonary disease; Dyspnea; Shortness of breath with daily activities questionnaire; SOBDA; COPD; Patient-reported outcome; PRO; Shortness of breath
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.
Asthma; health-related quality of life; inhaled corticosteroids
Chronic obstructive pulmonary disease (COPD) patients living in many countries are familiar with local dialects rather than the official language. We, therefore, compare the reliability and validity of the COPD Assessment Test (CAT) in Thai and northern Thai dialect versions, in stable COPD patients living in the northern part of Thailand.
A total of 160 COPD patients were randomly selected for the evaluation of each dialect version of CAT (n=80). The internal consistency of all eight items and test–retest reliability were investigated by using Cronbach’s alpha coefficient and intraclass correlation coefficient (ICCC), respectively. The validity was evaluated by the degree of correlation with St George’s Respiratory Questionnaire (SGRQ) using Pearson’s correlation. The correlations of CAT with clinical parameters such as forced expiratory volume in the first second (FEV1), modified Medical Research Council scale (mMRC) dyspnea score, and 6-minute walk distance (6-MWD) were also evaluated.
The two versions of CAT showed high internal consistency reliability (Cronbach’s alpha coefficient of 0.82 and 0.76) as well as a high test–retest reliability (ICCC of 0.82 and 0.84) for Thai and northern Thai dialect versions, respectively. The test results revealed that the northern Thai dialect version had good correlation with SGRQ whereas the Thai version correlated only moderately.
The two Thai versions of CAT were proven to be good clinical tools with high reliability and acceptable validity for assessing the quality of life of Thai COPD patients. However, the northern Thai dialect version is more suitable for evaluating COPD patients living in the northern part of Thailand.
chronic obstructive pulmonary disease; COPD assessment test; quality of life; validation; reliability
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.
chronic obstructive pulmonary disease; mortality; health-related quality of life
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.
Health-related quality of life (HRQoL) has been positioned as one of the major endpoints in oncology. Thus, there is a need to validate cancer-site specific survey instruments. This study aimed to perform a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire for HRQoL in prostate cancer patients and to validate the psychometric properties of the French-language version.
The EPIC questionnaire measures urinary, bowel, sexual and hormonal domains. The first step, corresponding to transcultural adaptation of the original English version of the EPIC was performed according to the back translation technique. The second step, comprising the validation of the psychometric properties of the EPIC questionnaire, was performed in patients under treatment for localized prostate cancer (treatment group) and in patients cured of prostate cancer (cured group). The EORTC QLQ-C30 and QLQ-PR25 prostate cancer module were also completed by patients to assess criterion validity. Two assessments were performed, i.e., before and at the end of treatment for the Treatment group, to assess sensitivity to change; and at 2 weeks’ interval in the Cured group to assess test-retest reliability. Psychometric properties were explored according to classical test theory.
The first step showed overall good acceptability and understanding of the questionnaire. In the second step, 215 patients were included from January 2012 to June 2014: 125 in the Treatment group, and 90 in the Cured group. All domains exhibited good internal consistency, except the bowel domain (Cronbach’s α = 0.61). No floor effect was observed. Test-retest reliability assessed in the cured group was acceptable, expect for bowel function (intraclass coefficient = 0.68). Criterion validity was good for each domain and subscale. Construct validity was not demonstrated for the hormonal and bowel domains. Sensitivity to change was exhibited for 5/8 subscales and 2/4 summary scores for patients who experienced toxicities during treatment.
The French EPIC questionnaire seems to have adequate psychometric properties, comparable to those exhibited by the original English-language version, except for the construct validity, which was not available in original version.
Health-related quality of life; Cross-cultural adaptation; Validation; Psychometric properties; EPIC questionnaire; Prostate cancer; Classical test theory
BACKGROUND AND OBJECTIVES:
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.
AQ20; Asthma; Peak flow; Quality of life; SGRQ
Health-Related Quality of Life (HRQoL) is a construct of increasing importance in modern healthcare, and has typically been assessed using retrospective instruments. While such measures have been shown to have predictive utility for clinical outcomes, several cognitive biases associated with human recall and current mood state may undermine their validity and reliability. Retrospective tools can be further criticized for their lack of ecology, as individuals are usually assessed in less natural settings such as hospitals and health centers, and may be obliged to spend time and money traveling to receive assessment. Ecological momentary assessment (EMA) is an alternative, as mobile assessment using mobile health (mHealth) technology has the potential to minimize biases and overcome many of these limitations. Employing an EMA methodology, we will use a smartphone application to collect data on real-time HRQoL, with an adapted version of the widely used WHOQOL-BREF questionnaire. We aim to recruit a total of 450 healthy participants. Participants will be prompted by the application to report their real-time HRQoL over 2 weeks together with information on mood and current activities. At the end of 2 weeks, they will complete a retrospective assessment of their HRQoL and they will provide information about their sleep quality and perceived stress. The psychometric properties of real-time HRQoL will be assessed, including analysis of the factorial structure, reliability and validity of the measure, and compared with retrospective HRQoL responses for the same 2-week testing period. Further, we aim to identify factors associated with real-time HRQoL (e.g., mood, activities), the feasibility of the application, and within- and between-person variability in real-time HRQoL. We expect real-time HRQoL to have adequate validity and reliability, and positive responses on the feasibility of using a smartphone application for routine HRQoL assessment. The direct comparison of real-time and retrospective measures in this study will provide important novel insight into the efficacy of mHealth applications for HRQoL assessment. If shown to be valid, reliable and feasible for the collection of HRQoL data, mHealth applications may have future potential for facilitating clinical assessment, patient-physician communication, and monitoring individual HRQoL over course of treatment.
mobile health; health-related quality of life; ecological momentary assessment; sleep quality; real-time assessment; smartphone application
Chronic obstructive pulmonary disease (COPD) patients experience a progressive deterioration and disability leading to worsening of their health-related quality of life (HRQoL) and functional exercise capacity. We performed this study to identify the correlation of HRQoL assessed by St George's Respiratory Questionnaire (SGRQ) and the functional exercise capacity assessed by the six-minute walk test (6MWT) with severity of COPD defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria among spirometry-confirmed COPD patients, admitted in a tertiary care rural hospital.
Materials and Methods:
The study included 129 spirometry-confirmed COPD patients defined by the GOLD criteria from a tertiary care hospital in central India. They underwent HRQoL measurement using the disease-specific (SGRQ). Functional exercise capacity was measured by 6MWT, as per the American Thoracic Society (ATS) guidelines.
We analyzed the various SGRQ scores and six-minute walk distance (6MWD) percentage predicted with various stages of COPD using the Student's t-test. The Pearson's correlation coefficient (r) was used to assess the relationships between various SGRQ scores and 6MWD with FEV1 % predicted.
We found that COPD patients with GOLD III and IV, but not GOLD II, had significantly poor HRQoL measured by SGRQ, as compared to patients with mild COPD (GOLD I). An inverse linear relation was found between 6MWD and the severity of COPD. Correlation of FEV1 % predicted with various SGRQ scores varied from - 0.40 to - 0.53, with a maximum correlation of FEV1 % predicted with an SGRQ symptom score (- 0.53) and SGRQ total score (- 0.50). A strong positive correlation was found between 6MWD and FEV1 % predicted (0.57).
Staging COPD according to the GOLD guidelines does correspond to important differences in the HRQoL of COPD patients having severe disease, but not for mild disease, whereas, the functional exercise capacity of COPD patients deteriorates in a linear fashion with the severity of disease assessed by the GOLD staging criteria.
Chronic obstructive pulmonary disease; health-related quality of life; six-minute walk test
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.
LCQ; COPD; validity; cough; health status
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.
PedsQL; Children; Chronic illness; Health-related quality of life; Pediatrics
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.
Quality of life; Patient-reported outcomes; Pediatric; Juvenile arthritis
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.
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.
multiple sclerosis; health-related quality of life; MSIS-29; MusiQoL