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Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a large, multicentre, multi-national, randomised, double-blind, 24-week trial. EMAX evaluated the efficacy and safety of dual bronchodilator therapy with umeclidinium bromide (UMEC)/vilanterol (VI) versus monotherapy with either UMEC or salmeterol (SAL) in symptomatic patients with chronic obstructive pulmonary disease (COPD) at low exacerbation risk who were not taking concomitant inhaled corticosteroid (ICS). EMAX generated evidence covering a wide range of patient-centred endpoints in COPD in addition to measures of lung function, clinical deterioration and safety. In addition, prospective and post hoc secondary analyses have generated clinically valuable information regarding the effects of baseline patient characteristics on treatment outcomes. Importantly, as concomitant ICS use was not permitted in this study, EMAX compared dual long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) therapy with LAMA or LABA monotherapy without potential confounding due to concurrent ICS use or withdrawal. EMAX demonstrated beneficial treatment effects of UMEC/VI over UMEC or SAL monotherapy as maintenance treatment across a range of different patient characteristics, with no forfeit in safety. Thus, the trial provided novel insights into the role of LAMA/LABA versus LABA and LAMA monotherapies as maintenance therapy for patients with symptomatic COPD at low risk of exacerbations. This article will explore the clinical implications of the main findings to date of the EMAX trial and consider the key learnings this trial offers for future trial design in COPD.

Purpose Limited data exist on the quantitative validity of the St George's Respiratory Questionnaire (SGRQ) in asthma populations. This study evaluated the psychometric properties of the SGRQ in patients with severe asthma. Methods This was a post-hoc analysis of pooled data from MENSA (N = 576; NCT01691508) and SIRIUS (N = 135; NCT01691521), two randomized, placebo controlled trials of mepolizumab in patients with severe asthma. Patients completed the SGRQ at Baseline and Exit (MENSA Week 32; SIRIUS Week 24). Distributional characteristics, internal consistency reliability, test-retest reliability, convergent and discriminant validity, known-groups validity and responsiveness were assessed. Results Internal consistency reliability was acceptable for the total and domain scores at Baseline and Exit (Cronbach's α was 0.92 and 0.94 at Baseline and Exit, respectively, for the Total score). Test-retest reliability was demonstrated (intraclass correlation coefficients >0.7) for Total score and the Activity and Impacts domains. Convergent and discriminant validity were demonstrated with measures associated or not associated with respiratory-related health status. Known groups validity based on baseline FEV 1 % predicted, Asthma Control Questionnaire (ACQ)-5 score, exacerbations and eosinophil counts was demonstrated for the SGRQ total and domain scores. Responses to therapy based on clinician-rated response, patient-rated response, ACQ-5 change score and exacerbations generally correlated with improvements in SGRQ scores. Conclusions This analysis demonstrated that the SGRQ has acceptable psychometric properties in patients with severe asthma, exceeding the thresholds for adequate reliability, validity and responsiveness. The SGRQ appears to be a good instrument for identifying response to therapy in patients with severe asthma.

Purpose Content validity is the extent to which a patient-reported outcome measure evaluates the concepts most relevant to a patient's condition and treatment. The St George's Respiratory Questionnaire (SGRQ) has been validated in a range of respiratory conditions. This study evaluated the content validity of the SGRQ in patients with severe asthma. Methods A qualitative study, guided by a protocol, which included concept elicitation and cognitive debriefing of the SGRQ, was conducted in patients aged ≥18 years with history of severe asthma and blood eosinophil counts of ≥150/μL (past month) or ≥300/μL (past 12 months). Patients were recruited until saturation for concept elicitation was achieved (i.e. no additional concepts identified). Concepts identified by the patients were then mapped to the SGRQ. Results 18 patient interviews provided concept saturation. Concept elicitation confirmed that the SGRQ includes the commonly reported asthma symptoms and their impact on daily life. In total, 89–100% of patients routinely experienced cough, nighttime awakenings, shortness of breath, chest tightness, sleep difficulty, phlegm/mucus, and wheezing. Patients reported asthma impacting daily and physical activities, mood and sleep. Cognitive interviewing confirmed that patients understood the instructions, items and response options in the SGRQ. Nearly half of the concepts in the SGRQ were endorsed by ≥12 patients; of the 17 items with scoring weights ≥85, 11 were mentioned by ≥12 patients. Conclusions This study demonstrates that the SGRQ is a relevant, comprehensive and content-valid instrument to assess health status in patients with severe asthma.

INTRODUCTION: Improving health-related quality of life (HRQoL) in COPD patients is an important pharmacotherapeutic objective. This study investigated the extent, consistency, and durability of tiotropium maintenance therapy impact on HRQoL in moderate-to-very severe COPD. METHODS: Patients received once-daily tiotropium 18 μg (n = 5244) or placebo (n = 4799) via HandiHaler(®) (10 trials), or once-daily tiotropium 5 μg (n = 2622) or placebo (n = 2618) via Respimat(®) inhaler (3 trials). St George's Respiratory Questionnaire (SGRQ) total scores were measured at baseline, and 6 months (13 trials) and 1 year (9 trials) from treatment start. Adjusted mean differences between treatments for change from baseline in total scores were calculated at each time-point for each trial. Responder and deteriorator rates (decrease or increase in score ≥4 units from baseline, respectively), net benefit (responder rate increase plus deteriorator rate decrease), and cumulative improvement and deterioration were determined. RESULTS: Adjusted mean total score differences between treatments for change from baseline were significant (p

SummaryWe evaluated the predictive value of the COPD assessment test (CAT™) for exacerbation in the following six months or time to first exacerbation among COPD patients with previous exacerbations.COPD outpatients with a history of exacerbation from 19 hospitals completed the CAT questionnaire and spirometry over six months. Exacerbation events were prospectively collected using a structured questionnaire.The baseline CAT score categorised into four groups (0–9, 10–19, 20–29, and 30–40) showed strong prediction for time to first exacerbation and modest prediction for any exacerbation or moderate-severe exacerbation (AUC 0.83, 0.64, and 0.63 respectively). In multivariate analyses, the categorised CAT score independently predicted all three outcomes (p = 0.001 or p 24, 14, 9, and 5 weeks and the adjusted RR was 1.00, 1.30, 1.37, and 1.50 in the category of 0–9, 10–19, 20–29, and 30–40 respectively. Exacerbation history (≥2 vs. 1 event in the past year) was related to time to first exacerbation (adjusted HR 1.35; p = 0.023) and any exacerbation during the study period (adjusted RR 1.15; p = 0.016).The results of this study support the use of the CAT as a simple tool to assist in the identification of patients at increased risk of exacerbations. This could facilitate timely and cost-effective implementation of preventive interventions, and improve health resource allocation.Trial registrationClinicaltrials.gov: NCT01254032.

SummaryGOLD proposed a COPD assessment framework focussed on symptoms measured by the COPD Assessment Test™ (CAT) or the mMRC and on exacerbation risk based on poor lung function (FEV1

SummaryBackgroundIndacaterol is a novel, inhaled, ultra-long-acting β2-agonist bronchodilator for maintenance use in patients with COPD. The aim of this paper is to assess the effect of indacaterol on dyspnoea and health status, using pooled study data to evaluate the relative efficacy of indacaterol and existing bronchodilators.MethodsIndividual patient data were pooled from three randomized, placebo-controlled studies (NCT00393458; NCT00567996; NCT00463567), conducted in patients with moderate-to-severe COPD. Treatments were double-blind indacaterol 150 μg (n = 746) or 300 μg (n = 853) once-daily, formoterol 12 μg twice-daily (n = 556), salmeterol 50 μg twice-daily (n = 333) and placebo (n = 1185); and open-label tiotropium 18 μg once-daily (n = 415). Evaluation after 6 months' treatment was by transition dyspnoea index (TDI; minimum clinically important difference [MCID] ≥1 point), and St George’s Respiratory Questionnaire (SGRQ; MCID ≥4 units).ResultsDifferences from placebo in TDI total score were 1.01 (indacaterol 150 μg) 1.28 (indacaterol 300 μg), 0.74 (formoterol), 0.92 (salmeterol) and 0.88 (tiotropium) (all p

Pan-European data on health-related quality of life (HRQL) in chronic obstructive pulmonary disease (COPD) are lacking.This cross-sectional epidemiological study evaluated health status in 1817 COPD patients from an 'all-comers' primary care population in seven European countries (87% stable disease; 13% with current exacerbation) using: St George's Respiratory Questionnaire-COPD specific (SGRQ-C), the short form health survey (SF-12) and the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale.Mean total score for SGRQ was 44.7 +/- 19.4 showing marked impairment of HRQL. Scores differed little between countries (range 39.2-50.1). Impairment was associated with the severity of airway obstruction, but within each GOLD stage the variation (SD) was wide [Stage I: 38.5 +/- 19.3 (n = 223); Stage II: 40.4 +/- 18.1 (n = 868); Stage III: 50.2 +/- 18.6 (n = 551); Stage IV: 58.6 +/- 17.7 (n = 144)]. Patients suffering an exacerbation had a worse SGRQ score (54.9 +/- 19.3) than those with stable disease (43.3 +/- 19.0). The presence of >= 3 co-morbidities (CM) was also associated with a significantly worse score (49.9 +/- 19.1) vs. 1-2 CM (42.1 +/- 19.1) or no CM (42.3 +/- 18.6). Findings with the SF-12 and FACIT-F results were consistent with those from the SGRQ-C.This large observational primary care study shows that health status is significantly impaired in COPD patients of all severities, even in those with mild airway obstruction. Within each GOLD stage of severity there is considerable heterogeneity in HRQL impairment among patients. (Study number: 111749). (C) 2010 Elsevier Ltd. All rights reserved.

Summary Aim To assess and compare health status among chronic obstructive pulmonary disease (COPD) patients presenting for treatment in six countries and in two healthcare settings using a generic health status instrument. Methods A population based cross-sectional survey was conducted among 2703 patients and their physicians (1381 in primary and 1322 in specialty care) in five EU countries and the USA. Information was collected on demographic and clinical characteristics, exacerbations and health status estimated using EQ-5D. Results The mean EQ-5D score for COPD patients was similar between primary and specialty settings in all countries except Italy. Approximately, half of the patients indicated some impairment in health status on mobility, usual activities, pain/discomfort and anxiety/depression domains of EQ-5D. Approximately, 5% of patients in EU countries except UK had health status valued as worse than death based on valuations of the general population. Patients suffering from severe breathlessness, experiencing ⩾3 exacerbations in the previous year, categorised as severe according to GOLD criteria, and experiencing day-time and night-time symptoms had significantly impaired health status. Conclusion COPD patients classified as moderate/severe in clinical practice have worse health status compared to mild patients. This impairment is similar in primary and specialty setting across western countries.

Summary Background It is not always possible to collect information about health from patients, so information from proxies (relatives and others) is used to aid medical decision-making, but there has been no formal evaluation of the reliability of their reports. The aim of this study was to analyse the reliability and validity of the St. George's Respiratory Questionnaire (SGRQ) answered by proxies and to determine their accuracy as raters. Methods Stable symptomatic male COPD patients and relatives living in the same house independently completed the same version of the SGRQ. Results Forty-six male patients were studied; age 72.1±7.3 years, pre-bronchodilator FEV 1 37.9±14.7% predicted, 30.4% on long-term oxygen therapy. Internal consistency (Cronbach's α ) was over 0.73 for all domains and >0.9 for the total score. Their scores correlated with dyspnoea ( r = 0.30 – 0.45 ) and FEV 1 ( r = 0.4 – 0.61 ). The proxies could distinguish between levels of disease severity, but with a weaker discriminant power compared to patients. Seventy-two per cent of proxies over-reported the degree of the patient's overall health status impairment, especially at mild–moderate scores. Proxies showed weaker correlations at the more severe scores. Conclusions The SGRQ was reliable and valid when administered to relatives of male COPD patients; however due to the systematic over-reporting of the level of the patient's health status impairment, caution should be applied whilst trying to use proxies as surrogates for male COPD patients.

Pulmonary rehabilitation (PR) programmes produce initial improvements in exercise tolerance and health status in patients with chronic obstructive pulmonary disease (COPD). However, there is limited data on the longer term effects of PR. This study has examined whether the initial benefits gained in exercise tolerance and health status may be maintained after a 1-year follow-up programme. Sixty-six patients with COPD were assessed with the MRC Dyspnoea Scale and found to be moderately disabled due to dyspnoea (MRC Grades 3 and 4). These patients were then randomised to an 8 week outpatient programme of either exercise training and education (Exercise group) or to education alone (Control group). Exercise performance was assessed with the shuttle walking test and health status assessed with two disease-specific measures, the St George's Respiratory Questionnaire and the Chronic Respiratory Disease Questionnaire. After PR, all patients were invited to attend monthly follow-up sessions for 1 year. Fifty-six patients were available for follow-up immediately after the programme and were assessed at 6 months and 1 year.This study has shown that the patients in the Exercise group maintained improvements in exercise capacity and health status up to 6 months after an 8 week programme. At 1 year there was a significant difference between the Exercise and Control groups in terms of exercise tolerance due to a considerable decline experienced by the Control group. However, neither group had maintained improvements in health status at 1 year. Further study is required to assess whether benefit may be sustained for a longer period using alternative follow-up strategies.

Reviews are an essential component of modern medicine. The volume of literature is large, even about a single treatment for pulmonary disease. The task of retrieving all the relevant papers, then assessing the evidence to reach a valid conclusion is very time consuming. At every stage there is the risk of sampling error (failure to get all the evidence) and bias (a systematic distortion of the results due to a weakness in the methodology). There are essentially two types of review: narrative reviews that follow no rules, exposing them to sampling error and bias; and systematic reviews that attempt to minimise these effects by following an explicit structure for retrieving all of the evidence and attempting an objective synthesis of the results from the different trials. A good review can serve a number of purposes including: assembling all the relevant evidence in one place, providing a valid estimate of the overall effect of treatment, producing guidance for clinical practice and generating hypotheses for further trials about patients or settings in which the treatment effect may be less or more effective.

Chronic obstructive pulmonary disease (COPD) is associated with a large economic and social burden. Few economic studies have examined the benefits of inhaled therapy for patients with COPD. This 16-week study examined the cost–effectiveness of salmeterol in this patient group. Patients with a history of COPD were randomised to treatment with salmetrol 50mcg (229 patients) or placebo (227 patients) twice daily, administered by metered-dose inhaler in addition to normal therapy. Forced expiratory volume (FEV 1 ) was measured and patients recorded the impact of their symptoms in a daily diary. Health status was assessed using the St George's Respiratory Questionnaire. A significantly higher proportion of salmeterol-treated patients had an increase of >15% in FEV 1 . Salmeterol patients had a higher mean proportion of symptom-free days and nights than those in the placebo group. More salmeterol patients had a clinically significant improvement in health status. Total healthcare costs were increased in the salmeterol group, but hospital and GP visit costs and concurrent COPD medication costs were lower. The reduction in hospital costs was sufficient to offset a substantial portion of the acquisition cost of salmeterol. Addition of salmeterol to COPD patients' current therapy improved lung function, health status at the expense of a modest increase in costs compared with usual therapy.

Patients with bronchiectasis often complain of abnormal tiredness, difficulty in concentrating or low spirits. This study was carried out to examine levels of anxiety and depression in bronchiectasis and their relationship with other measures of lung health. One hundred and eleven patients with bronchiectasis determined by high-resolution computed tomography (CT) scan were studied using a range of physiological and psychological outcome measures. Patients completed anxiety and depression, health status (quality of life), fatigue and dypnoea questionnaires. Lung function was measured and exercise capacity was assessed using a shuttle walk test. Anxiety and depression scores formed a continuum. Moderate–severe anxiety was more frequent than equivalent levels of depression (17 vs 9% of patients). Anxiety and depression scores were associated with perceived health status (r=0.33 and 0.55). Neither anxiety nor depression was associated with the extent of bronchiectasis on CT scan. Depression was correlated with breathlessness and exercise performance (r=0.33 and 0.40), but anxiety was not. The correlation between depression and exercise performance was not simply due to the influence of somatic items in the depression questionnaire. We conclude that anxiety and depression are quite common in bronchiectasis in that 34% of patients had elevated scores for anxiety, depression or both. The non-somatic components of depression were linked to dyspnoea and exercise performance, but anxiety was only related to perceived health. Therefore, treatment aimed at reducing symptoms and improving exercise capacity will not reduce levels of anxiety which need alternative therapy.

Evidence-based medicine has been described as the “conscientious, explicit and judicious use of current best evidence in making decisions about the healthcare of individual patients.” Many sources of information may be used by doctors when making decisions about initiating asthma therapy. These include: personal experience, postgraduate education, continuous professional development and publications in peer-reviewed journals. However, despite these sources of information, available data suggest that it is often difficult to practice evidence-based medicine, particularly in general practice. In the future, physicians will be provided with better evidence of the relative efficacy of treatment to aid changes in clinical practice. This will be provided, in part, by large well-conducted clinical trials, systematic reviews and meta-analyses. Linked with these, will be other methods of presenting data, for example, the number of patients needed to treat (NNT) to prevent one clinically significant event (for example, an asthma exacerbation). Despite these advances, incorporation of evidence-based practice into routine asthma care will be a slow and complex process. However, this process can be facilitated by physician education and participation in intervention programmes. In addition, it is important that clinicians are trained in how to convey the best possible evidence to their asthma patients.

Compliance by patients to prescribed treatment regimens can be considered as the interface between effective therapy and effective disease management. Compliance can be affected by the nature of the relationship between the practitioner and the patient, and their attitudes towards each other. It has also been suggested that practitioner behaviour can influence patient behaviour and health status. However, each individual patient is influenced in his or her attitudes, and reactions to disease and its management, by a wide variety of patient-related factors. These include psychological variables such as mood, beliefs, and the knowledge, motivation and ability of the patient. Social factors may also play a role: these include age, marital and socioeconomic status and level of education. Results from a range of studies in patients with pulmonary or other diseases show that the psychosocial determinants of compliance are only poorly understood, and suggest that compliance cannot be predicted from patients' health status and that social factors are weak indicators only. Furthermore, it appears from available data that patients' beliefs about health issues are not as useful as indicators of likely compliance as was previously believed.

Health status (Quality of Life) questionnaires for use in asthma are generally too long or complex for routine use. A new short and simple measure of health status in asthma has been developed for this purpose. There are two versions, one containing 30 items (AQ30) and the other 20 items (AQ20). This study examined their cross-sectional and longitudinal properties and compared them with those of two established measures — the St. George's Respiratory Questionnaire (SGRQ) and the Asthma Quality of Life Questionnaire (AQLQ).Ninety asthmatic patients (mean age 46 years) participated. Mean post-bronchodilator forced expiratory volume in one second (FEV1) was 73 ± 25 (sd) % predicted at baseline. Questionnaire data were collected twice, 12 weeks apart. Diary records of peak expiratory flow rate (PEFR) and daily asthma were kept for 14 days.The new questionnaires each took 3 min or less to complete. At baseline they correlated well with the SGRQ and AQLQ and showed the same pattern of correlations with clinical measures of asthma. Change scores for the new questionnaires correlated with those for the established measures. There was no advantage of the AQ30 over the AQ20.The AQ20 provides a simple method for obtaining valid health status estimates of asthmatics in routine clinical practice and has properties similar to more complex research instruments.

The St George's Respiratory Questionnaire is a standardized self-completed questionnaire for measuring impaired health and perceived well-being ('quality of life') in airways disease. It has been designed to allow comparative measurements of health between patient populations and quantify changes in health following therapy. The background and rationale for its development are discussed together with an analysis of its performance.

SummaryInhaled corticosteroids form the cornerstone of treatment for most patients with asthma. A range of compounds are available with a wide range of prescribable doses. In this overview, we summarize the findings from a number of Cochrane systematic reviews that have examined the relative benefits of different doses of beclometasone dipropionate, budesonide and fluticasone propionate when used to treat children and adults. The key findings are that all inhaled corticosteroids demonstrate a dose–response relationship for efficacy measures, but most of the benefit in mild-to-moderate severity disease is gained in the low-to-moderate dose range of each drug. In this group, high doses of fluticasone lead to small improvements in measures of control at the expense of a steep increase in the incidence of oral side-effects. In patients with severe disease who are dependent on oral steroids, there may be appreciable benefit in reducing oral steroids from very high compared with high doses of fluticasone.

Summary Study objectives This study was aimed at assessing health-related quality of life (HRQL) in patients with chronic respiratory failure (CRF) and long-term survival following prolonged intensive care mechanical ventilation. Design Observational cohort study. Setting Patients with CRF who had been transferred to our specialized weaning centre due to prolonged mechanical ventilation (>14 days) and weaning failure. Patients and participants Out of 87 long-term survivors (>6 months), 73 patients (mean age: 60.3±13.6 years, chronic obstructive pulmonary disease (COPD, 43%), thoraco-restrictive (21%) or neuromuscular disorders (15%), various chronic diseases (22%)) returned the MOS 36-Item Short-Form Health Status Survey (SF-36) and the St. George's respiratory questionnaire (SGRQ). Measurements and results The total ventilation time was 38.7±45.9 days. The time between discharge from ICU and HRQL assessment was 31.0±22.2 months. Physical health was markedly reduced compared to general population norm, but mental health was mildly impaired. HRQL was comparable to patients with stable CRF receiving non-invasive ventilation who did not need prolonged invasive MV. In addition, general HRQL was better in patients with restrictive respiratory disease compared to patients with neuromuscular diseases ( P 0.0 5 ). Physiological parameters such as blood gases or lung function parameters were not correlated to any HRQL measurements. Conclusions In patients with CRF surviving prolonged ventilation on ICU, the presence of CRF itself is the major determinant of HRQL. Here, the underlying cause of CRF is the major factor which determines the degree of HRQL impairment with patients suffering from restrictive ventilatory disorders reporting the best HRQL when compared to patients with COPD or neuromuscular diseases. Despite severe physical handicaps due to CRF mental health is only mildly compromised.

This study describes the correlations and reproducibility of AQ20, a simple health status questionnaire with 20 questions, which was designed to be useful especially in time sparing situations. A formal language validation process was done, in order to validate the AQ20 before studying its reproducibility. Thirty stable COPD patients answered the final version twice within 15 days. To test the reproducibility of AQ20, the interclass correlation coefficient and Bland-Altman display were used. Results were correlated with FEV1, SpO2, BMI, Mahler BDI, and the Saint George Respiratory Questionnaire (SGRQ). Twenty-five patients (83.3%) were male, with a mean age of 68.6 years. The mean predicted FEV1 (%) was 56.8%. The interclass correlation ratio for the total score was alpha=0.90 for the intraobserver variability and alpha=0.93 for the interobserver variability. The correlation with total SGRQ score was 0.76, with P

Breathing retraining is used increasingly throughout the world by many patients with asthma in addition to their usual medical care. We undertook a systematic review of the literature in order to determine the effectiveness of breathing retraining in the management of asthma. Six randomised-controlled trials were identified that involved breathing retraining in asthma. Due to the variation in reported trial outcomes, limited reporting of study data and small number of included trials it was not possible to draw any firm conclusions as to its effectiveness. However, outcomes that were reported from individual trials do show that breathing retraining may have a role in the treatment and management of asthma. Further large-scale trials using breathing retraining techniques in asthma are required to address this important issue.

Activities of daily living (ADL) may be severely restricted in patients with COPD and assessment requires evaluation of the impact of disability and handicap on daily life. This study is concerned with the development and validation of a standardized 15-item questionnaire to assess routine ADL. Sixty (33 male, 27 female) patients with severe COPD, mean (SD) FEV1 0.91 (0.43) l, median (range) age 70 (50-82) years, completed a 59-item ADL list previously generated by open-ended interview and by literature review. Patients also performed the Shuttle Walk Test (SWT), and completed the St George's Respiratory Questionnaire (SGRQ), the Nottingham Extended Activity of Daily Living Questionnaire (EADL) and the Hospital Anxiety and Depression score (HAD). Criteria for item reduction in the development of The London Chest ADL scale (LCADL) consisted of removal of items where the majority of respondents showed no limitation in the activity (n = 19), where there was no association with perception of global health (n = 9), where an association with age or gender was detected (n = 4), or where items showed poor reliability on test re-test (n = 9). Fifteen items were identified as core activities of daily living. The LCADL was then compared with other measures of health status in these patients. There were good correlations with the SGRQ activity and impact components (p=0.70; P

To evaluate the physiological and symptom determinants of exercise performance (EP) as measured by a 6-min walking test (6MWD), Watt(max), and peak oxygen consumption (VO2 ml/min/kg), 105 patients with chronic airway obstruction (CAO) [50 chronic obstructive pulmonary disease (COPD): 44 men, aged 63+/-7 years, forced expiratory volume in 1 sec (FEV1) forced vital capacity (FVC)(-1)% 54+/-13; and 55 asthmatic: 23 men, aged 55+/-10 years, FEV1 FVC(-1) % 65+/-10] underwent evaluation of 6MWD, symptom limited cyclo-ergometer exercise test, spirometry, respiratory muscle function, arterial blood gases and sensation of dyspnoea [using the Borg scale, Visual Analogue Scale (VAS) and Baseline Dyspnoea Index (BDI)]. A hierarchical method of analysis identified the residual volume (RV), total lung capacity (TLC)(-1) ratio, BDI and the patient's age as the strongest and most consistent correlates of EP (r2 = 0.14-0.21). The correlation between EP and its various determinants was not influenced by diagnosis. The relationship between breathlessness and EP was different between men and women: at any given level of exercise, women were more breathless than men. In multivariate analyses that contained both RV TLC(-1) and BDI, the RV TLC(-1) ratio was the strongest correlate of EP, although the BDI remained a significant covariate. Overall, age was the major determinant of EP but inclusion of the RV TLC(-1) ratio and the BDI into the model explained a further 9-15% of the variance in EP. These three covariates together explained 26-34% of the variance between patients. We conclude that in stable CAO patients, the prediction of exercise capacity by anthropometric, demographic, clinical and physiological variables is likely to be low. Age, pulmonary hyperinflation and dyspnoea are the strongest and most consistent correlates of impaired exercise performance. Airways obstruction, measured during expiration using FEV1, does not appear to be a predictor of physiological impairment. These results underline the importance of performing exercise evaluation in CAO patients.

SummaryEvaluation of the effectiveness of treatment for chronic obstructive pulmonary disease (COPD) requires the assessment of both clinical and physiological measures. Parameters such as the forced expiratory volume in 1s are well established in providing an indication of the degree of airflow limitation. However, additional measurements, such as dyspnoea, functional status and health status, are required to provide a complete picture of COPD. Indeed, dyspnoea is the predominant symptom of COPD experienced by the patient, which treatment is designed to reduce. Methods of assessing dyspnoea have developed over the previous five decades. The most widely used instruments for assessing the impact of dyspnoea are the baseline dyspnoea index, the transition dyspnoea index and the Medical Research Council Questionnaire.A more comprehensive approach to the assessment of disability caused by dyspnoea and fatigue is provided by assessments of functional status, such as the pulmonary functional status and dyspnoea questionnaire. Respiratory-specific health status questionnaires, such as the St. George's Respiratory Questionnaire, attempt to capture the wide range of effects of COPD into a single score that reflects the overall impact of the disease.Developing the means to measure the effects of COPD is important, both in terms of understanding disease pathophysiology for research purposes, and in terms of accurately assessing the effects of treatment on the patient. Future developments will include computerising these methodologies to permit faster and more individual patient-centred measurements.

The objective of this study was to assess the validity and performance of the Arabic and Turkish versions of the COPD Assessment Test (CAT) for evaluating the severity and impact of COPD symptoms. The data were obtained from the BREATHE study in the Middle East and North Africa region, a large general population survey of COPD conducted in ten countries of the region (Algeria, Egypt, Jordan, Lebanon, Morocco, Saudi Arabia, Syria, Tunisia, Turkey and United Arab Emirates), using a standardised methodology. A total of 62,086 subjects were screened, of whom a random sample of 5,681 subjects were administered the CAT by telephone. 5,639 evaluable questionnaires were recovered, representing a completion rate of 99%. In addition, the CAT was administered to an additional 833 subjects fulfilling the epidemiological diagnostic criteria for COPD. Mean scores in the general population were 6.99 ± 6.91 for the Arabic version and 9.88 ± 9.04 for the Turkish version. In patients with COPD, mean scores were 16.2 ± 9.1 and 20.9 ± 10.2 respectively. Scores were consistently higher in smokers than in non-smokers. In the general population, the proportion of respondents fulfilling criteria for COPD rose with higher CAT scores, and particularly above the 80th percentile, where 63% of COPD cases were to be found. This suggests that the CAT may be useful as a case-finding tool in the general population. In the COPD population, healthcare resource consumption rose linearly with CAT score above a threshold score of twenty, arguing in favour of the good criterion validity of the CAT. The internal consistency of the CAT was high (Cronbach's α 0.85 for the Arabic and 0.86 for the Turkish versions) and the factorial structure was unidimensional. In conclusion, this study performed in Arabic and Turkish speaking populations confirms the utility and validity of the CAT as a simple tool to collect data on the severity and impact of COPD symptoms, and suggests that it may potentially be useful as a case-finding tool to identify people at risk for COPD in the general population.