Association between COPD exacerbations and lung function decline during maintenance therapy.

BACKGROUND: Little is known about the impact of exacerbations on COPD progression or whether inhaled corticosteroid (ICS) use and blood eosinophil count (BEC) affect progression. We aimed to assess this in a prospective observational study. METHODS: The study population included patients with mild to moderate COPD, aged ≥35 years, with a smoking history, who were followed up for ≥3 years from first to last spirometry recording using two large UK electronic medical record databases: Clinical Practice Research Datalink (CPRD) and Optimum Patient Care Research Database (OPCRD). Multilevel mixed-effects linear regression models were used to determine the relationship between annual exacerbation rate following initiation of therapy (ICS vs non-ICS) and FEV1 decline. Effect modification by blood eosinophils was studied through interaction terms. RESULTS: Of 12178 patients included (mean age 66 years; 48% female), 8981 (74%) received ICS. In patients with BEC ≥350 cells/µL not on ICS, each exacerbation was associated with subsequent acceleration of FEV1 decline of 19.4 mL/year (95% CI 12.0 to 26.7, p<0.0001). This excess decline was reduced by 15.1 mL/year (6.6 to 23.6) to 4.3 mL/year (1.9 to 6.7, p<0.0001) in those with BEC ≥350 cells/µL treated with ICS. CONCLUSION: Exacerbations are associated with a more rapid loss of lung function among COPD patients with elevated blood eosinophils, defined as ≥350 cells/µL, not treated with ICS. More aggressive prevention of exacerbations using ICS in such patients may prevent excess loss of lung function.

Assessing the Needs and Perspectives of Patients With Asthma and Chronic Obstructive Pulmonary Disease on Patient Web Portals: Focus Group Study.

BACKGROUND: As accessibility to the internet has increased in society, many health care organizations have developed patient Web portals (PWPs), which can provide a range of self-management options to improve patient access. However, the available evidence suggests that they are used inefficiently and do not benefit patients with low health literacy. Asthma and chronic obstructive pulmonary disease (COPD) are common chronic diseases that require ongoing self-management. Moreover, patients with COPD are typically older and have lower health literacy. OBJECTIVE: This study aimed to obtain and present an overview of patients' perspectives of PWPs to facilitate the development of a portal that better meets the needs of patients with asthma and COPD. METHODS: We performed a focus group study using semistructured interviews in 3 patient groups from the north of the Netherlands who were recruited through the Dutch Lung Foundation. Each group met 3 times for 2 hours each at a 1-week interval. Data were analyzed with coding software, and patient descriptors were analyzed with nonparametric tests. The consolidated criteria for reporting qualitative research were followed when conducting the study. RESULTS: We included 29 patients (16/29, 55% male; mean age 65 [SD 10] years) with COPD (n=14), asthma-COPD overlap (n=4), asthma (n=10), or other respiratory disease (n=1). There was a large variation in the internet experience; some patients hardly used the internet (4/29, 14%), whereas others used internet >3 times a week (23/29, 79%). In general, patients were positive about having access to a PWP, considering access to personal medical records as the most important option, though only after discussion with their physician. A medication overview was considered a useful option. We found that communication between health care professionals could be improved if patients could use the PWP to share information with their health care professionals. However, as participants were worried about the language and usability of portals, it was recommended that language should be adapted to the patient level. Another concern was that disease monitoring through Web-based questionnaire use would only be useful if the results were discussed with health care professionals. CONCLUSIONS: Participants were positive about PWPs and considered them a logical step. Today, most patients tend to be better educated and have internet access, while also being more assertive and better informed about their disease. A PWP could support these patients. Our participants also provided practical suggestions for implementation in current and future PWP developments. The next step will be to develop a portal based on these recommendations and assess whether it meets the needs of patients and health care providers.

Real-life data on antibiotic prescription and sputum culture diagnostics in acute exacerbations of COPD in primary care.

BACKGROUND: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are generally treated with optimization of bronchodilation therapy and a course of oral corticosteroids, mostly without antibiotics. The Dutch guidelines recommend prudent use of antibiotics, with amoxicillin or doxycycline as first choice. Here we evaluate adherence to these guidelines with regard to antibiotic prescription in AECOPD in primary care and the use of sputum cultures. METHODS: We retrospectively analyzed a longitudinal cohort of patients in three primary care practices in the north-eastern region of the Netherlands from 2009 to 2013 (n=36,172 subjects) participating in the Registration Network Groningen. Antibiotics prescribed for AECOPD -10/+28 days from the start date of corticosteroid courses were evaluated. In addition, we assessed regional data on the susceptibility of respiratory pathogens from COPD patients. RESULTS: We identified 1,297 patients with COPD. Of these, 616 experienced one or more exacerbations, resulting in a total of 1,558 exacerbations, for which 1,594 antibiotic courses were prescribed. The recommended antibiotics doxycycline and amoxicillin accounted for 56% of the prescribed antibiotics overall and for 35% in subsequent antibiotic courses. The alternative choices were not based on culture results because only in 67 AECOPD events (2.9%) sputum samples were taken. Regional data including 3,638 sputum samples showed that pathogens relevant in AECOPD were detected in 19% of cultures. CONCLUSION: Our study shows that guidelines regarding the prescription of antibiotics are poorly followed, particularly in recurrent exacerbations. Sputum cultures were performed in a small minority of cases. Performing sputum diagnostics in patients with early treatment failure or a repeated exacerbation when antibiotic treatment is started may further rationalize antibiotic treatment.

Development of an allergy management support system in primary care.

BACKGROUND: Management of allergic patients in the population is becoming more difficult because of increases in both complexity and prevalence. Although general practitioners (GPs) are expected to play an important role in the care of allergic patients, they often feel ill-equipped for this task. Therefore, the aim of this study was to develop an allergy management support system (AMSS) for primary care. METHODS: Through literature review, interviewing and testing in secondary and primary care patients, an allergy history questionnaire was constructed by allergists, dermatologists, GPs and researchers based on primary care and specialists' allergy guidelines and their clinical knowledge. Patterns of AMSS questionnaire responses and specific immunoglobulin E (sIgE)-test outcomes were used to identify diagnostic categories and develop corresponding management recommendations. Validity of the AMSS was investigated by comparing specialist (gold standard) and AMSS diagnostic categories. RESULTS: The two-page patient-completed AMSS questionnaire consists of 12 (mainly) multiple choice questions on symptoms, triggers, severity and medication. Based on the AMSS questionnaires and sIgE-test outcome of 118 patients, approximately 150 diagnostic categories of allergic rhinitis, asthma, atopic dermatitis, anaphylaxis, food allergy, hymenoptera allergy and other allergies were identified, and the corresponding management recommendations were formulated. The agreement between the allergy specialists' assessments and the AMSS was 69.2% (CI 67.2-71.2). CONCLUSION: Using a systematic approach, it was possible to develop an AMSS that allows for the formulation of diagnostic and management recommendations for GPs managing allergic patients. The AMSS thus holds promise for the improvement of the quality of primary care for this increasing group of patients.

Cost-effectiveness and budget impact of the fixed-dose dual bronchodilator combination tiotropium-olodaterol for patients with COPD in the Netherlands.

PURPOSE: The fixed-dose dual bronchodilator combination (FDC) of tiotropium and olodaterol showed increased effectiveness regarding lung function and health-related quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with the use of its mono-components. Yet, while effectiveness and safety have been shown, the health economic implication of this treatment is still unknown. The aim of this study was to assess the cost-utility and budget impact of tiotropium-olodaterol FDC in patients with moderate to very severe COPD in the Netherlands. PATIENTS AND METHODS: A cost-utility study was performed, using an individual-level Markov model. To populate the model, individual patient-level data (age, height, sex, COPD duration, baseline forced expiratory volume in 1 second) were obtained from the tiotropium-olodaterol TOnado trial. In the model, forced expiratory volume in 1 second and patient-level data were extrapolated to utility and survival, and treatment with tiotropium-olodaterol FDC was compared with tiotropium. Cost-utility analysis was performed from the Dutch health care payer's perspective using a 15-year time horizon in the base-case analysis. The standard Dutch discount rates were applied (costs: 4.0%; effects: 1.5%). Both univariate and probabilistic sensitivity analyses were performed. Budget impact was annually assessed over a 5-year time horizon, taking into account different levels of medication adherence. RESULTS: As a result of cost increases, combined with quality-adjusted life-year (QALY) gains, results showed that tiotropium-olodaterol FDC had an incremental cost-effectiveness ratio of €7,004/QALY. Without discounting, the incremental cost-effectiveness ratio was €5,981/QALY. Results were robust in univariate and probabilistic sensitivity analyses. Budget impact was estimated at €4.3 million over 5 years assuming 100% medication adherence. Scenarios with 40%, 60%, and 80% adherence resulted in lower 5-year incremental cost increases of €1.7, €2.6, and €3.4 million, respectively. CONCLUSION: Tiotropium-olodaterol FDC can be considered a cost-effective treatment under current Dutch cost-effectiveness thresholds.

Investigating sensitivity, specificity, and area under the curve of the Clinical COPD Questionnaire, COPD Assessment Test, and Modified Medical Research Council scale according to GOLD using St George's Respiratory Questionnaire cutoff 25 (and 20) as reference.

BACKGROUND: In the GOLD (Global initiative for chronic Obstructive Lung Disease) strategy document, the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT), or modified Medical Research Council (mMRC) scale are recommended for the assessment of symptoms using the cutoff points of CCQ ≥1, CAT ≥10, and mMRC scale ≥2 to indicate symptomatic patients. The current study investigates the criterion validity of the CCQ, CAT and mMRC scale based on a reference cutoff point of St George's Respiratory Questionnaire (SGRQ) ≥25, as suggested by GOLD, following sensitivity and specificity analysis. In addition, areas under the curve (AUCs) of the CCQ, CAT, and mMRC scale were compared using two SGRQ cutoff points (≥25 and ≥20). MATERIALS AND METHODS: Two data sets were used: study A, 238 patients from a pulmonary rehabilitation program; and study B, 101 patients from primary care. Receiver-operating characteristic (ROC) curves were used to assess the correspondence between the recommended cutoff points of the questionnaires. RESULTS: Sensitivity, specificity, and AUC scores for cutoff point SGRQ ≥25 were: study A, 0.99, 0.43, and 0.96 for CCQ ≥1, 0.92, 0.48, and 0.89 for CAT ≥10, and 0.68, 0.91, and 0.91 for mMRC ≥2; study B, 0.87, 0.77, and 0.9 for CCQ ≥1, 0.76, 0.73, and 0.82 for CAT ≥10, and 0.21, 1, and 0.81 for mMRC ≥2. Sensitivity, specificity, and AUC scores for cutoff point SGRQ ≥20 were: study A, 0.99, 0.73, and 0.99 for CCQ ≥1, 0.91, 0.73, and 0.94 for CAT ≥10, and 0.66, 0.95, and 0.94 for mMRC ≥2; study B, 0.8, 0.89, and 0.89 for CCQ ≥1, 0.69, 0.78, and 0.8 for CAT ≥10, and 0.18, 1, and 0.81 for mMRC ≥2. CONCLUSION: Based on data from these two different samples, this study showed that the suggested cutoff point for the SGRQ (≥25) did not seem to correspond well with the established cutoff points of the CCQ or CAT scales, resulting in low specificity levels. The correspondence with the mMRC scale seemed satisfactory, though not optimal. The SGRQ threshold of ≥20 corresponded slightly better than SGRQ ≥25, recently suggested by GOLD 2015, with the established cutoff points for the CCQ, CAT, and mMRC scale.