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
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.
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
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.
To compare the psychometric properties of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) instrument and the St. George’s Respiratory Questionnaire (SGRQ), and to examine the association between pulmonary function and domains and items of these questionnaires in patients with chronic obstructive pulmonary disease (COPD).
The WHOQOL-BREF and the SGRQ were administered to 211 patients. The reliability and validity of, and correlations among, the domain scores were examined. Multiple regression analyses were performed to identify which items were independently associated with subjects’ lung functions.
Both questionnaires showed good internal consistency (α > 0.8), except the SGRQ symptoms domain (α = 0.66), minimal ceiling and floor effects, and good item convergent and item discriminant validity. There were moderate correlations between physical domain of the WHOQOL-BREF and activity, impacts and total domains of the SGRQ, and between psychological domain of the WHOQOL-BREF and impacts and total domains of the SGRQ. Eighteen items were significantly associated with lung function, particularly those items relating to mobility/walking and activities of daily living (ADL).
Both the WHOQOL-BREF and the SGRQ showed comparable reliability and validity. Items related to mobility/walking and ADL may be useful in clinical screening for lung function impairment.
Chronic obstructive pulmonary disease; Health-related quality of life; SGRQ; WHOQOL-BREF
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.
Given that the assessment of health-related quality of life (HRQoL) is an essential outcome measure to optimize chronic obstructive pulmonary disease (COPD) patient management, there is a need for a short and fast, reliable and valid instrument for routine use in clinical practice. The objective of this study was to analyse the relationship between the disease-specific Airways questionnaire (AQ20) and the generic 15D health-related quality of life (HRQoL) instrument simultaneously in a large cohort of patients with COPD. We also compare the HRQoL of COPD patients with that of the general population.
The AQ20 and 15D were administered to 739 COPD patients representing an unselected hospital-based COPD population. The completion rates and validity of, and correlations among the questions and dimension scores were examined. A factor analysis with varimax rotation was performed in order to find subsets of highly correlating items of the questionnaires.
The summary scores of AQ20 and 15D were highly correlated (r = - 0.71, p < 0.01). In AQ20 over 50% of patients reported frequent cough, breathlessness during domestic work, and chest problem limiting their full enjoyment of life. 15D results showed a noteworthy decrease of HRQoL in breathing, mobility, sleeping, usual activities, discomfort and symptoms, vitality, and sexual activity (scores ≤ 0.75). Compared to the age- and gender-standardized Finnish general population, the COPD patients were statistically significantly worse off on 13 of 15 dimensions.
The AQ20 and 15D summary scores are comparable in terms of measuring HRQoL in COPD patients. The data support the validity of 15D to measure the quality of life in COPD. COPD compromises the HRQoL broadly, as reflected by the generic instrument. Both questionnaires are simple and short, and could easily be used in clinical practice with high completion rates.
To assess the effects of a self-management program on health-related quality of life (HRQoL) and morbidity commonly associated with chronic obstructive pulmonary disease (COPD).
A total of 57 outpatients with stable COPD received four weeks of self-management education, while 45 patients received usual care. Patients were evaluated at baseline, at three months and one year following the educational intervention. The primary outcome variable was HRQoL measured by the St George’s Respiratory Questionnaire (SGRQ). The secondary outcome variables were number of emergency room visits and hospitalizations for exacerbation.
The intervention group’s HRQoL improved significantly at three months (total score A=−5.0 [P=0.006]) and 12 months (total score A=−6.7 [P<0.001]), as evidenced by decreased scores on the SGRQ. In contrast, the SGRQ scores increased significantly in the control group at three months (total score A=+3.7 [P= 0.022]) and 12 months (total score A=+3.4 [P=0.032]). Global impact appeared to be responsible for the change in the intervention group. Moreover, in the intervention group, the number of hospitalizations dropped from 0.7/person/year to 0.3/person/year (P=0.017), and emergency room visits dropped from 1.1 person/year to 0.2/person/year (P=0.002), while subjects in the control group did not experience any significant decreases in these parameters.
A planned education program improved HRQoL while decreasing the number of emergency room visits and hospitalizations in patients with stable COPD; this improvement persisted at 12 months.
COPD; Quality of life; Self-management education
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
Although impaired health-related quality of life (HRQOL) has been reported in patients with sarcoidosis, there is currently no sarcoidosis-specific questionnaire in Japan. The 29-item Sarcoidosis Health Questionnaire (SHQ), originally developed in the United States, is the only sarcoidosis-specific HRQOL questionnaire currently available. The primary aim of this study was to develop and validate a Japanese version of the SHQ.
The SHQ was translated into Japanese following the forward-backward procedure. The reliability and validity of the Japanese version of the SHQ were examined. One hundred twenty-two Japanese patients with biopsy-proven sarcoidosis were evaluated by the SHQ, the Medical Outcomes Study 36-item short form (SF-36), the St. George's Respiratory Questionnaire (SGRQ), chest radiography, an electrocardiogram, laboratory blood tests, pulmonary function tests, an echocardiogram, and assessments of dyspnea and depressive symptoms. The SHQ was found to have acceptable levels of internal consistency (Cronbach's coefficient α values = 0.68 to 0.91). SHQ scores correlated significantly with scores on the SF-36 and SGRQ. The domain or total scores on the SHQ also significantly correlated with serum levels of the soluble interleukin-2 receptor, the percentage of the predicted forced vital capacity, pulmonary arterial systolic pressure, dyspnea, and depressive symptoms. Also, the SHQ scores of patients who had one or two organ systems affected by sarcoidosis were significantly different from those of patients who had three or more organ systems involvement.
The Japanese version of the SHQ can be used to assess the HRQOL of patients with sarcoidosis.
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
This study evaluates published clinical trials of Chinese herbal medicine (CHM) for chronic obstructive pulmonary disease (COPD) that employ a health-related quality of life (HRQoL) outcome measure.
Searches were conducted in April 2011 on MEDLINE®, Embase, the Cochrane Controlled Trials Register, CINAHL, Scopus, and Chinese databases (CNKI, CQVIP, WANFANG). Randomized controlled trials involving oral administration of CHM formulae or single herb, with or without blinding, compared to placebo, no treatment, routine pharmacotherapy control, or CHM plus routine pharmacotherapy versus routine pharmacotherapy, with a HRQoL questionnaire as an outcome measure were identified. The methodological quality was assessed using the Cochrane risk of bias assessment.
A total of 27 studies involving 1966 patients were identified. St. George Respiratory Questionnaire (SGRQ) or Cai's QoLQ were used in 13 and 14 studies, respectively. Assessment of the Cochrane risk of bias revealed adequate sequence of generation in 10 studies and adequate allocation concealment in 1 study; double blinding was not described adequately in any studies. Seventeen (17) studies addressed incomplete outcome data, and 17 studies were free of selective reporting. The main results of meta-analysis showed improvement of total HRQoL scores (SGRQ and Cai's QoLQ) when CHM was compared to no treatment (−6.07 [−9.21, −2.93] and −0.20 [−32, −0.07], respectively) and for CHM plus routine pharmacotherapy versus routine pharmacotherapy (−5.15 [−7.26, −3.05]) and (−0.25 [−0.37, −0.13]).
While the results of CHM on HRQoL for stable COPD sufferers were promising, they need to be interpreted with caution due to methodological problems, which should be addressed in future trials.
Improvement in quality of life (QOL) has become a focus for the management of incurable chronic diseases, including chronic obstructive pulmonary disease (COPD). This study investigates factors influencing the QOL of patients with COPD in India.
Seventy-three consecutive COPD patients visiting an outpatient pulmonary clinic underwent health-related QOL (HRQOL) assessment using the World Health Organization’s QOL abbreviated questionnaire and St George’s Respiratory Questionnaire (SGRQ). Symptom severity and grade of dyspnea were estimated by the Chronic Lung Disease Severity Index (CLD) and Medical Research Council assessments, and patient demographic data were collected. Spirometry and 6-minute walk tests were performed to assess lung function and functional status.
Patients with COPD showed significantly reduced HRQOL when measured by the World Health Organization’s QOL abbreviated questionnaire and the SGRQ. CLD estimate for severity of lung disease (P < 0.001), Medical Research Council assessment for dyspnea (P < 0.01), and duration of illness (P < 0.05) showed close correlation with HRQOL. Worsening forced expiratory volume in 1 second and 6-minute walk test results closely correlated with poorer HRQOL (P < 0.01). No association between QOL and age, quantum of smoking, education, comorbid illnesses, or occupational exposure was found.
This study showed that Indian patients with COPD had reduced HRQOL. Longer disease duration, patient perception of disease severity, and worsening dyspnea impacted negatively on HRQOL.
quality of life; COPD; disease severity; India; questionnaire
An important goal of rehabilitation and treatment after spinal cord injury (SCI) is to improve function and enhance health-related quality of life (HRQoL). However, previous assessments are limited by use of HRQoL instruments not specific to SCI. Although respiratory dysfunction is common in SCI, it has not been possible to assess the association of comorbid medical conditions, including respiratory symptoms and pulmonary function, to HRQoL. Therefore, we assessed whether these factors were associated with HRQoL in SCI using an SCI-specific HRQoL questionnaire.
In our cross-sectional study, 356 participants ≥ 1 yr post-SCI completed a 23-item SCI-specific HRQoL questionnaire and a detailed health questionnaire, and underwent pulmonary function testing and a neurological exam at VA Boston between 1998 and June 2003.
In a multivariate regression model, age, employment status, motor level and completeness of injury, and ambulatory mode (use of hand-propelled or motorized wheelchair, use of crutches or canes, or walking independently) were independently associated with HRQoL. After adjusting for these factors, chronic cough, chronic phlegm, persistent wheeze, dyspnea with activities of daily living, and lower forced expiratory volume in 1 sec and forced vital capacity were each associated with a lower HRQoL.
These results provide evidence for the clinical validity of our SCI-specific HRQoL instrument. We also identify potentially modifiable factors that, if addressed, may lead to HRQoL improvement in SCI.
Quality Of Life; Spinal Cord Injuries; Pulmonary Function Tests; Comorbidity
BACKGROUND--The Chronic Respiratory Questionnaire (CRQ) is frequently applied to assess quality of life in patients with chronic obstructive pulmonary disease (COPD). However, the reliability and validity of this questionnaire have not yet been determined. This study investigates the reliability and validity of the four separate dimensions of the CRQ. METHODS--The CRQ was administered on two consecutive days to 40 patients with COPD (mean FEV1 44% predicted, FEV1/IVC 37% predicted). Internal consistency reliability of each dimension was investigated by Cronbach's alpha reliability coefficient, test retest reliability by the Spearman-Brown reliability coefficient (p), and content validity by Pearson's correlation coefficient between the CRQ and the symptom checklist (SCL-90). RESULTS--Items of the fatigue, emotion, and mastery dimensions showed a high internal consistency reliability (alpha = 0.71-0.88) as well as a high test retest reliability (p above 0.90). These three dimensions correlated with comparable dimensions of the SCL-90. Items of the dyspnoea dimension showed a low internal consistency reliability (alpha = 0.53) and a test retest reliability of p = 0.73. CONCLUSIONS--Items of the dimensions fatigue, emotion, and mastery of the CRQ are reliable and valid and can be used to assess quality of life in patients with severe airways obstruction. Items of the dyspnoea dimension are less reliable and should not be included in the overall score of the CRQ in comparative research. However, by scoring the items of dyspnoea separately they may be useful for the evaluation of the effects of intervention in a specific patient.
The aim was to evaluate the outcomes of a comprehensive pulmonary rehabilitation (PR) in chronic obstructive pulmonary disease (COPD) and to establish whether in early disease stage PR is as effective as in late stages of disease.
A total of 55 stable COPD patients, 28 with early and 27 with late disease stages, were assessed. Patients underwent a comprehensive out-patient PR program for 8 weeks. To eluciate the effects of PR and compare the level of improvement; lung function, dyspnea sensation [Medical Research Council (MRC)], body composition [body mass index (BMI), fat free mass (FFM), fat free mass index (FFMI)], exercise capacity [incremental shuttle walking test, endurance shuttle walking test], health related quality of life (HRQoL) with St. George Respiratory Disease Questionnaire, psycohological status (Hospital anxiety–depression (HAD) scale) were evaluated before and after PR.
At the end of PR in the early disease stage group, the improvement in forced vital capacity (FVC) reached a statistically significant level (P < 0.05). In both disease stages, there were no significant differences in BMI, FFM, and FFMI. The decrease in exertional dyspnea for the two groups evaluated with the modified BORG scale were not found statistically significant, though the dyspnea scores evaluated with MRC showed significant improvements (P < 0.001). HRQoL and exercise capacity were significantly improved for the two groups (P < 0.001). Psychological status evaluated with the HAD scale improved after PR (P < 0.001) both in early and late stages. Gainings in the study parameters did not differ in the early and the late disease stages.
These results showed that patients with COPD had benefited from a comprehensive PR program in an out-patient setting regardless of disease severity. Even patients with earlier stage of disease should be referred and encouraged to participate in a PR program.
Chronic obstructive pulmonary disease; disease severity; functional status; pulmonary rehabilitation; shuttle walk test
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
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.
Investigate long-term effects 4 years after the end of a 1-year self-management program (SMP) with 30 hours of education and 16 hours of physical activity in patients with chronic obstructive pulmonary disease (COPD).
Prospective observational outcome study. SMP focused on improving disease related self-care skills. Main outcome measures were health-related quality of life, HRQoL, (St Georges Respiratory Questionnaire, SGRQ total) and exercise capacity (6-minute walk test, 6MWT).
Thirty patients participated, 47% women. Baseline mean age was 67 years and mean pre-bronchodilator FEV1 (forced expiratory volume in 1 second) percentage predicted was 41.3. HRQoL showed a statistical significant improvement during the 1-year intervention. Four years after the end of the program SGRQ total was similar to baseline value, 1.4 points (95% CI: −3.6 to 6.3, P = 0.580). Also 6MWT was similar to baseline value at the same test point, −10 m (95% CI: −27 to 8, P = 0.262), and 63% reported having continued to exercise regularly a minimum of three times per week during the follow-up period.
The participants in a 1-year self-management program with additional training had maintained their pre-intervention level of HRQoL and exercise capacity 4 years after the end of the program. Two out of three participants had continued to exercise regularly.
chronic obstructive pulmonary disease; outpatient; patient education; self-care ability; self-management
There is little data about the combined effects of COPD and obesity. We compared dyspnea, health-related quality of life (HRQoL), exacerbations, and inhaled medication use among patients who are overweight and obese to those of normal weight with COPD.
We performed secondary data analysis on 364 Veterans with COPD. We categorized subjects by body mass index (BMI). We assessed dyspnea using the Medical Research Council (MRC) dyspnea scale and HRQoL using the St. George's Respiratory Questionnaire. We identified treatment for an exacerbation and inhaled medication use in the past year. We used multiple logistic and linear regression models as appropriate, with adjustment for age, COPD severity, smoking status, and comorbidities.
The majority of our population was male (n=355, 98%) and either overweight (n=115, 32%) or obese (n=138, 38%). Obese and overweight subjects had better lung function (obese: mean FEV1 55.4% ±19.9% predicted, overweight: mean FEV1 50.0% ±20.4% predicted) than normal weight subjects (mean FEV1 44.2% ±19.4% predicted), yet obese subjects reported increased dyspnea [adjusted OR of MRC score ≥2= 4.91 (95% CI 1.80, 13.39], poorer HRQoL, and were prescribed more inhaled medications than normal weight subjects. There was no difference in any outcome between overweight and normal weight patients.
Despite having less severe lung disease, obese patients reported increased dyspnea and poorer HRQoL than normal weight patients. The greater number of inhaled medications prescribed for obese patients may represent overuse. Obese patients with COPD likely need alternative strategies for symptom control in addition to those currently recommended.
Obesity; COPD; health-related quality of life; symptoms; inhaled medications; exacerbations
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
Background. Chronic obstructive pulmonary disease (COPD) is gaining an importance over the world, and its effect on quality of life is better grasped. Our objective was to use the Clinical COPD Questionnaire (CCQ) to describe the respiratory quality of life in the Lebanese population, stressing on differences between smokers and nonsmokers. Methods. Using data from a cross-sectional national study, we checked the construct validity and reliability of the CCQ. Factors and items correlation with postbronchodilator FEV1/FVC were reported, in addition to factors and scale association with COPD and its severity. We then conducted a multiple regression to find predictors of quality of life. Results. The CCQ demonstrated excellent psychometric properties, with adequacy to the sample and high consistency. Smokers had a decreased respiratory quality of life versus nonsmokers, independently of their respiratory disease status and severity. This finding was confirmed in COPD individuals, where several environmental factors, lower education, and cumulative smoking of cigarette and of waterpipe were found to be independent predictors of a lower quality of life, after adjusting for COPD severity. Conclusions. Smoking decreases the respiratory quality of life of Lebanese adults; this issue has to be further emphasized during smoking cessation and patients' education.
Perception of quality of life may differ depending on the perspective. The aim of the study was to assess the psychometric properties of the Spanish version of the 'TOlerability and quality Of Life' (TOOL) questionnaire, a specific self-rated instrument to evaluate the impact of side effects of antipsychotic drugs on health-related quality of life (HRQoL). The questionnaire consists of eight items answered on a four-point Likert scale.
A psychometric study was conducted with clinically stable outpatients with schizophrenia and bipolar disorder under antipsychotic treatment. The translation and cultural adaptation of the questionnaire was performed according to international standards. Internal consistency using the Cronbach α coefficient and test-retest reliability using the intraclass correlation coefficient (ICC) was used to assess the reliability of the instrument. Patients completed generic and specific measures of quality of life and clinical severity.
A total of 238 patients were analysed, with a mean age of 42 years (SD 10.9). The mean completion time was 4.9 min (SD 4.4). Internal consistency and intraclass correlation coefficient were adequate (Cronbach α = 0.757 and ICC = 0.90). Factorial analysis showed a unidimensional structure (a single eigenvalue >1, accounting for 39.1% of variance). Significant Spearman's rank correlations between the TOOL and both generic and specific measures were found. The questionnaire was able to discriminate among the Clinical Global Impression - Severity scores (Mann-Whitney U test, P < 0.001).
The TOOL questionnaire shows appropriate feasibility, reliability, and discriminative performance as a patient-reported outcome. TOOL constitutes a valuable addition to measure the impact of adverse events of antipsychotic drugs from the patient perspective.
Improving patients' health status is one of the major goals in COPD treatment. Questionnaires could facilitate the guidance of patient-tailored disease management by exploring which aspects of health status are problematic, and which aspects are not. Health status consists of four main domains (physiological functioning, symptoms, functional impairment, and quality of life), and at least sixteen sub-domains. A prerequisite for patient-tailored treatment is a detailed assessment of all these sub-domains. Most questionnaires developed to measure health status consist of one or a few subscales and measure merely some aspects of health status. The question then rises which aspects of health status are measured by these instruments, and which aspects are not covered. As it is one of the most frequently used questionnaires in COPD, we evaluated which aspects of health status are measured and which aspects are not measured by the St George's Respiratory Questionnaire (SGRQ).
One hundred and forty-six outpatients with COPD participated. Correlations were calculated between the three sections of the SGRQ and ten sub-domains of the Nijmegen Integral Assessment Framework, covering Symptoms, Functional Impairment, and Quality of Life. As the SGRQ was not expected to measure physiological functioning, we did not include this main domain in the statistical analyses. Pearson's r ≥ 0.70 was used as criterion for conceptual similarity.
The SGRQ sections Symptoms and Total showed conceptual similarity with the sub-domain Subjective Symptoms (main domain Symptoms). The sections Activity, Impacts and Total were conceptual similar to Subjective Impairment (main domain Functional Impairment). The SGRQ sections were not conceptual similar to other sub-domains of Symptoms, Functional Impairment, nor to any sub-domain of Quality of Life.
The SGRQ could facilitate the guidance of disease management in COPD only partially. The SGRQ is appropriately only for measuring problems in the sub-domains Subjective Symptoms and Subjective Impairment, and not for measuring problems in other sub-domains of health status, such as Quality of Life.
Without clinical input on what constitutes a significant change, health-related quality of life (HRQoL) measures are less likely to be adopted by clinicians for use in daily practice. Although standards can be determined empirically by within-person change studies based on patient self-reports, these anchor-based methods incorporate only the patients' perspectives of important HRQoL change, and do not reflect an informed clinical evaluation. The objective of this study was to establish clinically important difference standards from the physician's perspective for use of 2 HRQoL measures among patients with chronic obstructive pulmonary disease (COPD).
We assembled a 9-person expert panel of North American physicians familiar with the use of the Chronic Respiratory Questionnaire (CRQ), a disease-specific HRQoL measure, or the generic Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36, Version 2.0) among patients with COPD.
Using 2 rounds of the Delphi process, 1 in-person meeting, and an iterative improvement process for circulating and correcting the final report, the expert panel established small, moderate, and large clinically important change levels for the CRQ and SF-36.
For this expert physician panel, levels for detecting clinically important differences on the CRQ were equal to or slightly higher than previous studies based on patient-reported differences. Clinically important differences on the SF-36, Version 2.0, were noticeably larger than previous estimates based on cross-sectional differences between clinically defined patient groups.
quality of life; COPD; important change; consensus panel; RAND method; Delphi process