Jan Willem van den Berg

The Validity and Precision of the Leicester Cough Questionnaire in COPD Patients with Chronic Cough

BackgroundA 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.MethodsConcurrent validity, internal consistency, reproducibility and responsiveness were determined. The St. Georges 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.ResultsIn 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 (Cronbachs 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.ConclusionThe LCQ is a valid, reliable, responsive instrument to measure health status in COPD patients with chronic productive cough.Trial RegistrationClinicalTrials.gov: NCT01071161

Reliability and validity of a Dutch version of the Leicester Cough Questionnaire

BackgroundChronic cough is a common condition with a significant impact on quality of life. Currently, no health status measure specific for chronic cough exists in the Netherlands. Thus we developed a Dutch version of the Leicester Cough Questionnaire (LCQ) and tested its scaling and clinical properties.MethodsThe LCQ was adapted for Dutch conditions following a forward-backward translation procedure. All patients referred to our cough clinic between May 2004 and February 2005 completed five questionnaires, the LCQ, the modified Borg score for cough, the Short-Form 36 (SF-36), the Hospital Anxiety and Depression Scale (HADS) and the Global Rating of Change (GRC) upon presentation, after two weeks and after 6 months. Concurrent validation, internal consistency, repeatability and responsiveness were determined.ResultsFor the concurrent validation the correlation coefficients (n = 152 patients) between the LCQ and the other outcome measures varied between 0.22 and 0.61. The internal consistency of the LCQ (n = 58) was high for each of the domains with a Crohnbachs alpha coefficient between 0.77 and 0.91. The two week repeatability of the LCQ in patients with no change in cough (n = 48) was high with intraclass correlation coefficients varying between 0.86 and 0.93. Patients who reported an improvement in cough (n = 140) after 6 months demonstrated significant improvement on each of the domains of the LCQ.ConclusionThe Dutch version of the LCQ is a valid and reliable questionnaire to measure (changes of) health status in patients with chronic cough.

Day-to-day measurement of patient-reported outcomes in exacerbations of chronic obstructive pulmonary disease

Background Exacerbations of chronic obstructive pulmonary disease (COPD) are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes. Methods Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients) were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ), and the St George’s Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study. Results All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found to be less impaired than in hospitalized patients, while the rate and pattern of recovery was remarkably similar. Conclusion Daily health status measurements were found to predict treatment failure, which could help decision-making for patients hospitalized due to an exacerbation of COPD.

Telemedicine, the effect of nurse-initiated telephone follow up, on health status and health-care utilization in COPD patients: A randomized trial

Telemedicine, care provided by electronic communication, may serve as an alternative or extension to traditional outpatient visits. This pilot study determined the effects of telemedicine on health‐care utilization and health status of chronic obstructive pulmonary disease (COPD) patients.

Azithromycin and cough-specific health status in patients with chronic obstructive pulmonary disease and chronic cough: a randomised controlled trial

BackgroundMacrolides reduce exacerbations in patients with COPD. Their effects on health status has not been assessed as primary outcome and is less clear. This study assessed the effects of prophylactic azithromycin on cough-specific health status in COPD-patients with chronic productive cough.MethodsIn this randomised controlled trial 84 patients met the eligibility criteria: age of ≥40 years, COPD GOLD stage ≥2 and chronic productive cough. The intervention-group (n = 42) received azithromycin 250 mg 3 times a week and the control-group (n = 42) received a placebo. Primary outcome was cough-specific health status at 12 weeks, measured with the Leicester Cough Questionnaire (LCQ). Secondary outcomes included generic and COPD-specific health status and exacerbations. Changes in adverse events and microbiology were monitored.ResultsMean age of participants was 68 ± 10 years and mean FEV1 was 1.36 ± 0.47 L. The improvement in LCQ total score at 12 weeks was significantly greater with azithromycin (difference 1.3 ± 0.5, 95% CI 0.3;2.3, p = 0.01) and met the minimal clinically important difference. Similar results were found for the domain scores, and COPD-specific and generic health status questionnaires. Other secondary endpoints were non-significant. No imbalances in adverse events were found.ConclusionsProphylactic azithromycin improved cough-specific health status in COPD-patients with chronic productive cough to a clinically relevant degree.Trial registrationClinicalTrials.gov NCT01071161

Depression and heart failure associated with clinical COPD questionnaire outcome in primary care COPD patients: a cross-sectional study.

Background:Improvement in health-related quality of life (HRQoL) is one of the main goals in treating chronic obstructive pulmonary disease (COPD). Impaired HRQoL in COPD is associated with increased morbidity and mortality, hospitalisations and burden on our health-care system. The Clinical COPD Questionnaire (CCQ) is a validated, reliable, short questionnaire for the evaluation of disease-specific HRQoL in patients with COPD in primary care.Aims:To investigate factors that might be associated with CCQ outcome in COPD in a primary care setting.Methods:In a population of COPD patients in primary care, multiple regression analyses were used to assess associations between CCQ outcome and depression, heart failure, FEV1% predicted, FEV1/FVC, age, sex, body mass index and current smoking.Results:Data from 341 patients (mean age 68.1±10.3, COPD GOLD class I–III) were used for analyses. Together, heart failure and depression explained 23% of the variance in CCQ total score (P<0.001, N=93). Heart failure was most strongly associated with CCQ functional score (27% explained variance, P<0.001, N=100), whereas depression was most strongly associated with CCQ mental score (22% explained variance, P<0.001, N=93).Conclusions:CCQ outcomes are higher in COPD patients with heart failure and depression. These findings might imply that heart failure and depression affect HRQoL of patients with COPD, and thus emphasise the importance of a holistic approach of this complex disease, leading to a correct diagnosis of COPD and its comorbidities, to achieve better tailored treatment of chronic patients.

The effect of an outpatient care on-demand-system on health status and costs in patients with COPD. A randomized trial

BACKGROUND Traditionally, outpatient visits for COPD are fixed, pre-planned by the pulmonologist. This is not a patient centered method, nor, in times of increasing COPD prevalence and resource constraints, perhaps the optimal method. OBJECTIVES This pilot study, determined the effect of an on-demand-system, patient initiated outpatient visits, on health status, COPD-related healthcare resource-use and costs. METHODS Patients were randomized between on-demand-system (n = 49) and usual care (n = 51), with a 2-year follow-up. Primary, health status was assessed with Clinical COPD Questionnaire (CCQ). Secondary endpoints were: St. Georges Respiratory Questionnaire (SGRQ), Short Form-36 (SF-36) scores, visits to general practitioners (GP), pulmonologists, and pulmonary nurse practitioners (PNP), exacerbations and total treatment costs from healthcare providers and healthcare insurance perspectives. RESULTS Participants had a mean FEV(1) 1.3 ± 0.4 liters and were 69 ± 9 years. CCQ total scores deteriorated in both groups, with no significant difference between them. CCQ symptom domain did show a significant and clinically relevant difference in favor of the on-demand-group, -0.4 ± 0.21, CI95% -0.87; -0.02, p = 0.04. Similar tendency was found for the SGRQ whereas results for SF-36 were inconsistent. Patients in the on-demand-group visited GP significantly less (p = 0.01), but PNP significantly more, p = 0.003. Visits to pulmonologists and exacerbations were equally frequent in both groups. Mean total costs per patient were lower in the on-demand-group in comparison with usual care, difference of €-518 (-1993; 788) from healthcare provider and €-458 (-2700; 1652) insurance perspective. CONCLUSIONS The on-demand-system was comparable with usual care, had a cost-saving tendency, and can be instituted with confidence in the COPD outpatient care setting.

health status in patients with coexistent COPD and heart failure: a validation and comparison between the Clinical COPD Questionnaire and the Minnesota living with heart Failure Questionnaire

Background Chronic obstructive pulmonary disease (COPD) and heart failure (HF) are both common diseases that coexist frequently. Patients with both diseases have worse stable state health status when compared with patients with one of these diseases. In many outpatient clinics, health status is monitored routinely in COPD patients using the Clinical COPD Questionnaire (CCQ) and in HF patients with the Minnesota Living with Heart Failure Questionnaire (MLHF-Q). This study validated and compared which questionnaire, ie, the CCQ or the MLHF-Q, is suited best for patients with coexistent COPD and HF. Methods Patients with both COPD and HF and aged ≥40 years were included. Construct validity, internal consistency, test–retest reliability, and agreement were determined. The Short-Form 36 was used as the external criterion. All questionnaires were completed at baseline. The CCQ and MLHF-Q were repeated after 2 weeks, together with a global rating of change. Results Fifty-eight patients were included, of whom 50 completed the study. Construct validity was acceptable. Internal consistency was adequate for CCQ and MLHF-Q total and domain scores, with a Cronbach’s alpha ≥0.70. Reliability was adequate for MLHF-Q and CCQ total and domain scores, and intraclass correlation coefficients were 0.70–0.90, except for the CCQ symptom score (intraclass correlation coefficient 0.42). The standard error of measurement on the group level was smaller than the minimal clinical important difference for both questionnaires. However, the standard error of measurement on the individual level was larger than the minimal clinical important difference. Agreement was acceptable on the group level and limited on the individual level. Conclusion CCQ and MLHF-Q were both valid and reliable questionnaires for assessment of health status in patients with coexistent COPD and HF on the group level, and hence for research. However, in clinical practice, on the individual level, the characteristics of both questionnaires were not as good. There is room for a questionnaire with good evaluative properties on the individual level, preferably tested in a setting of patients with COPD or HF, or both.

Diagnosis of airways obstruction should be based on symptoms and an FEV1/FVC ratio below the lower limit of normal

In their article on the diagnosis of chronic obstructive pulmonary disease (COPD) in primary care, Conway and colleagues state that the diagnosis can be confirmed by a low FEV1/FVC (forced expiratory volume in one second/forced vital capacity) ratio,1 with a ratio <0.70 confirming a diagnosis of pathological airflow limitation. The GOLD (Global Initiative for Chronic Obstructive Lung Disease) group recommended this cut-off …

Safety, feasibility and patient reported outcome measures of outpatient treatment of pulmonary embolism

BACKGROUND Despite growing evidence on safe and feasible outpatient treatment for acute pulmonary embolism (PE), the majority of patients is still treated in an inpatient setting. This is probably due to a lack of clear guidelines on this subject. OBJECTIVES To evaluate safety and patient reported outcome measures (PROM) on outpatient treatment of acute PE. METHODS We conducted a prospective cohort study. 250 patients presenting with acute PE and Pulmonary Embolism Severity Index (PESI) class I or II were enrolled. Safety of outpatient treatment was assessed by measuring all-cause mortality, recurrent venous thromboembolism (VTE) and episodes of relevant bleeding, with a follow-up period of four weeks and six months. Additionally, PROMs on outpatient treatment were evaluated by repeatedly measuring VAS-scores for pain and dyspnea during the recovery, and by assessing the improvement in SF-36 scores between admission and after six months. RESULTS We found an all-cause mortality rate of 0.4% (95% CI 0.07-2.23), rate of recurrent VTE of 0% (95% CI 0-1.51) and rate of relevant bleeding episodes of 6.4% (95% CI 3.98-10.14). VAS-scores improved significantly during the first 24-h after admission, and continued to improve significantly after five days of home treatment. SF-36 scores on 6 out of 8 domains improved significantly between admission and after six months. CONCLUSIONS Our study shows that outpatient treatment is safe in selected low-risk patients based on their PESI score. Additionally, our data on patient reported outcome measures support the presumption of a good course of recovery during outpatient treatment.