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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. George's 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 FEV1 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 (sic)-518 (-1993; 788) from healthcare provider and (sic)-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. (C) 2014 Elsevier Ltd. All rights reserved.

Jan Willem H Kocks,1,2 Jan Willem K van den Berg,3 Huib AM Kerstjens,2,4 Steven M Uil,3 Judith M Vonk,2,5 Ynze P de Jong,3 Ioanna G Tsiligianni,1,2 Thys van der Molen1,2 1Department of General Practice, 2Groningen Research Institute for Asthma and COPD, University of Groningen, University Medical Center Groningen, Groningen, 3Department of Pulmonary Diseases, Isala Klinieken, Zwolle, 4Department of Pulmonary Diseases and Tuberculosis, 5Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands 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. Keywords: health status, Clinical COPD Questionnaire, hospital, admission, prediction

Background Delayed diagnosis of pulmonary embolism (PE) is common because symptoms can be non-specific. The few studies that have investigated diagnostic delay have not taken into account the role of primary care physicians in the diagnostic process. Aim To document and quantify the stages of diagnostic delay of PE and to identify clinical factors associated with this delay. Design and setting A retrospective cohort study conducted in Zwolle and its surroundings in the Netherlands. Method Primary and secondary care records of all patients diagnosed with PE between January 2008 and December 2009 were reviewed for dates of symptom onset, date of presentation and diagnosis, and for clinical findings. Relationships between delay and clinical parameters were tested using multivariate regression analysis. Results The 261 patients enrolled in the study had an average total delay of 8.6 days. Patient delay (4.2 days average) and delay in primary care (3.9 days) were the major contributors to this delay. Chest pain (odds ratio [OR] 0.51, 95% confidence interval [CI] = 0.28 to 0.92, P = 0.03) and symptoms of deep venous thrombosis (calf pain) (OR 0.49, 95% CI = 0.24 to 0.98, P = 0.05) were associated with an early diagnosis. Patient delay was shorter in patients with chest pain (OR 0.49, 95% CI = 0.25 to 0.95, P = 0.03) and longer in patients with dyspnoea (OR 2.95, 95% CI = 0.99 to 8.85, P = 0.05). In primary care, chest pain (OR 0.37, 95% CI = 0.17 to 0.84, P = 0.02) and rales (OR 0.22, 95% CI = 0.06 to 0.83, P = 0.03) were associated with an early referral, whereas comorbidity led to a delayed referral. Conclusion This study shows that the diagnostic delay of PE is substantial, especially patient delay and delay in primary care. There is room to reduce this delay by increasing the awareness of both patients and GPs. Further research is needed on clinical factors that raise suspicion of PE in primary care.

Farida F Berkhof,1 Leola Metzemaekers,1 Steven M Uil,1 Huib AM Kerstjens,2 Jan WK van den Berg11Department of Pulmonary Diseases, Isala Hospital, Zwolle, 2Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the NetherlandsBackground: 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.Keywords: Clinical COPD Questionnaire, Minnesota Living with Heart Failure Questionnaire, chronic obstructive pulmonary disease, heart failure

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. To investigate factors that might be associated with CCQ outcome in COPD in a primary care setting. 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. 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

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.One hundred and one patients were randomized, 52 patients received telemedicine care and 49 had traditional outpatient visits. The primary outcome was COPD-specific health status, measured with the Clinical COPD Questionnaire (CCQ). Secondary outcomes included St. George's Respiratory Questionnaire (SGRQ) and the Short Form-36 (SF-36) and resource use in primary and secondary care.The mean age of the participants was 68 ± 9 years and the mean per cent of predicted forced expiratory volume in 1 s was 40.4 ± 12.5. The CCQ total score deteriorated by 0.14 ± 0.13 in the telemedicine group, and improved by -0.03 ± 0.14 in the control group (difference 0.17 ± 0.19, 95% confidence interval (CI): -0.21-0.55, P = 0.38). The CCQ symptom domain showed a significant and clinically relevant difference in favour of the control group, 0.52 ± 0.24 (95% CI: 0.04-0.10, P = 0.03). Similar results were found for the SGRQ, whereas results for SF-36 were inconsistent. Patients in the control group had significantly fewer visits to the pulmonologist in comparison to patients in the telemedicine group (P = 0.05). The same trend, although not significant, was found for exacerbations after 6 months.This telemedicine model of initiated phone calls by a health-care provider had a negative effect on health status and resource use in primary and secondary care, in comparison with usual care and therefore cannot be recommended in COPD patients in its current form.

Background Macrolides 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. Methods In 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. Results Mean 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. Conclusions Prophylactic azithromycin improved cough-specific health status in COPD-patients with chronic productive cough to a clinically relevant degree. Trial registration ClinicalTrials.gov NCT01071161

Treatment with systemic corticosteroids for exacerbations of COPD results in improvement in clinical outcomes. On hospitalization, corticosteroids are generally administered IV. It has not been established whether oral administration is equally effective. We conducted a study to demonstrate that therapy with oral prednisolone was not inferior to therapy with IV prednisolone using a double-blind, double-dummy design.Patients hospitalized for an exacerbation of COPD were randomized to receive 5 days of therapy with prednisolone, 60 mg IV or orally. Treatment failure, the primary outcome, was defined as death, admission to the ICU, readmission to the ICU because of COPD, or the intensification of pharmacologic therapy during a 90-day follow-up period.A total of 435 patients were referred for a COPD exacerbation warranting hospitalization; 107 patients were randomized to receive IV therapy, and 103 to receive oral therapy. Overall treatment failure within 90 days was similar, as follows: IV prednisolone, 61.7%; oral prednisolone, 56.3% (one-sided lower bound of the 95% confidence interval [CI], -5.8%). There were also no differences in early (ie, within 2 weeks) treatment failure (17.8% and 18.4%, respectively; one-sided lower bound of the 95% CI, -9.4%), late (ie, after 2 weeks) treatment failure (54.0% and 47.0%, respectively; one-sided lower bound of the 95% CI, -5.6%), and mean (+/- SD) length of hospital stay (11.9 +/- 8.6 and 11.2 +/- 6.7 days, respectively). Over 1 week, clinically relevant improvements were found in spirometry and health-related quality of life, without significant differences between the two treatment groups.Therapy with oral prednisolone is not inferior to IV treatment in the first 90 days after starting therapy. We suggest that the oral route is preferable in the treatment of COPD exacerbations.Clinicaltrials.gov Identifier: NCT00311961.

Summary Background No consensus exists on the exact treatment of pneumothorax (PTX). Some guidelines are proposing manual aspiration (MA) to be preferred over tube thoracostomy (TT) in uncomplicated primary spontaneous pneumothorax (PSP). However, only a few studies reported a direct comparison of both methods. Our aim was to re-evaluate this with a randomised trial in a single centre in the Netherlands. Methods Patients with a first episode of symptomatic PTX admitted to the ER or asymptomatic PTX with a size of ≥20% were recruited during 2007–2009 and followed-up for one year. Randomisation between MA and TT was balanced by a computer minimisation program for cause of PTX, smoking and gender. When first MA attempt failed, a second attempt was not undertaken and patients underwent TT. (registered at ClinicalTrials.gov (NCT00556335). Results 56 patients were included. Baseline characteristics were similar. Immediate success rates were 68.0% for MA versus 80.6% for TT ( p = 0.28). Two week success rates were 100% in both groups. There was a significant difference in hospital stay in favour of MA: 2.4 ± 2.6 versus 4.4 ± 3.3 days ( p = 0.02). One year recurrence rates in MA were lower than in TT, although not statistically significant (4.0% and 12.9% p = 0.37). Predictors of immediate success were traumatic PTX and female sex. One patient died during follow-up due to heart failure. Conclusion MA is simple, safe, cheap, minimal invasive in uncomplicated PSP/traumatic PTX with similar success and recurrence rates and a shorter hospital stay in comparison to TT and therefore the treatment of choice.

Background 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. Methods 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. Results 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. Conclusion The LCQ is a valid, reliable, responsive instrument to measure health status in COPD patients with chronic productive cough. Trial Registration ClinicalTrials.gov: NCT01071161