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Despite current guidelines and decades of evidence on the benefits of a self-management approach, self-management of COPD remains relatively under-utilized in clinical care compared with other chronic diseases. However, self-management interventions can play a valuable role in supporting people with COPD to respond to changing symptoms, and thereby make appropriate decisions regarding the management of their own chronic condition. In this review, we discuss the history and evolution of the concept of self-management, assess current multidisciplinary support programs and clinical interactions designed to optimize self-management, and reflect on how effective these are in terms of clinical and humanistic outcomes. We also evaluate the mechanisms for encouraging change from protocol-based care towards a more personalized care approach, and discuss the role of digital self-management interventions and the importance of addressing health inequalities in COPD treatment, which have been accelerated by the COVID-19 pandemic. Reflecting on the importance of self-management in the context of symptom monitoring and provision of educational support, including information from patient organizations and charities, we discuss the ideal components of a self-management plan for COPD and provide six key recommendations for its implementation: 1) better education for healthcare professionals on disease management and consultation skills; 2) new targets and priorities for patient-focused outcomes; 3) skills gap audits to identify barriers to self-management; 4) best practice sharing within primary care networks and ongoing professional development; 5) enhanced initial consultations to establish optimal self-management from the outset; and 6) negotiation and sharing of self-management plans at the point of diagnosis.

Acute COPD exacerbations account for much of the rising disability and costs associated with COPD, but data on predictive risk factors are limited. The goal of the current study was to develop a robust, clinically based model to predict frequent exacerbation risk. Patients identified from the Optimum Patient Care Research Database (OPCRD) with a diagnostic code for COPD and a forced expiratory volume in 1 second/forced vital capacity ratio <0.7 were included in this historical follow-up study if they were ≥40 years old and had data encompassing the year before (predictor year) and year after (outcome year) study index date. The data set contained potential risk factors including demographic, clinical, and comorbid variables. Following univariable analysis, predictors of two or more exacerbations were fed into a stepwise multivariable logistic regression. Sensitivity analyses were conducted for subpopulations of patients without any asthma diagnosis ever and those with questionnaire data on symptoms and smoking pack-years. The full predictive model was validated against 1 year of prospective OPCRD data. The full data set contained 16,565 patients (53% male, median age 70 years), including 9,393 patients without any recorded asthma and 3,713 patients with questionnaire data. The full model retained eleven variables that significantly predicted two or more exacerbations, of which the number of exacerbations in the preceding year had the strongest association; others included height, age, forced expiratory volume in 1 second, and several comorbid conditions. Significant predictors not previously identified included eosinophilia and COPD Assessment Test score. The predictive ability of the full model (C statistic 0.751) changed little when applied to the validation data set (n=2,713; C statistic 0.735). Results of the sensitivity analyses supported the main findings. Patients at risk of exacerbation can be identified from routinely available, computerized primary care data. Further study is needed to validate the model in other patient populations.

Chronic obstructive pulmonary disease (COPD) is a prevalent condition characterized by persistent airflow obstruction and respiratory symptoms. Single-Inhaler Triple Therapy (SITT) has been shown to improve patient adherence, reduce exacerbations, and lower healthcare resource utilization in patients who are not controlled despite being on dual therapy or Multiple-Inhaler Triple Therapy (MITT). Despite evidence supporting SITT, payer-driven access rules across Europe sometimes limit its use in primary care, creating barriers to optimal COPD management. Through expert consensus, the study seeks to generate a shared understanding of the unintended consequences of payer-driven access criteria for SITT in managing moderate-to-severe COPD in primary care. A targeted literature review (TLR) was conducted to assess SITT initiation in primary care across Europe and examine the impact of access criteria. Semi-structured interviews were held with 14 experts from nine European countries, including clinicians, health economists, and patient advocacy representatives. A consensus generation workshop was conducted, where experts evaluated the findings and developed position statements to highlight the challenges posed by payer-driven access criteria. The TLR identified variability in access to SITT in Europe, with several countries restricting its initiation to specialists, thus limiting primary care physicians' (PCPs) ability to prescribe SITT. The expert panel generated seven consensus points stating that enabling PCPs to step up or switch eligible patients to SITT has the potential to support care continuity, enhance clinical autonomy for PCPs, reduce reliance on potentially less effective treatment options, improve patient and healthcare system outcomes, avoid unnecessary referrals to specialists, enable prompt initiation of guideline-directed medical therapy for COPD in primary care and reduce access inequalities. Restrictions for SITT initiation in primary care may need to be revisited to mitigate their unintended health and cost consequences and improve equitable access to treatment. This should take into consideration each country's unique healthcare system.

The use of real-world evidence (RWE) studies, including pragmatic randomised controlled trials (RCTs; randomised RWE studies), to aid the development of treatment guidelines, is gradually becoming a mainstay within clinical practice. RWE is an integral part of patient-driven decision-making and offers important value to add complimentary evidence to traditional RCTs; these provide a more well-rounded view of the benefits to patient-reported outcomes and improve the external validity of a given treatment versus findings from traditional RCTs alone. Discussions in recent scientific workshops explored the importance of pragmatic RCTs in optimising guideline development and patient care in chronic obstructive pulmonary disease (COPD) and asthma. The Salford Lung Study in patients with COPD (NCT01551758) and asthma (NCT01706198) were the world’s first prelicence pragmatic RCTs that compared novel investigational treatments with existing COPD and asthma treatments and, more recently (2021), RWE studies have been used by the American Thoracic Society and the US Food and Drug Administration to support the approval of an immunosuppressant drug in patients receiving lung transplants. This highlights the importance of RWE data in supporting clinical guideline development and emphasises the advantages for the use of pragmatic RCTs in guiding clinical practice.

Randomized controlled trials indicate that addition of a long-acting muscarinic antagonist (LAMA) such as tiotropium may improve asthma control and reduce exacerbation risk in patients with poorly controlled asthma, but broader clinical studies are needed to investigate the effectiveness of LAMA in real-life asthma care. Medical records of adults with asthma (aged ≥18 years) prescribed tiotropium were obtained from the UK Optimum Patient Care Research Database for the period 2001-2013. Patients diagnosed with chronic obstructive pulmonary disease were excluded, but no other clinical exclusions were applied. Two primary outcomes were compared in the year before (baseline) and the year after (outcome) addition of tiotropium: exacerbations (asthma-related hospital emergency department attendance or inpatient admission, or acute oral corticosteroid course) and acute respiratory events (exacerbation or antibiotic prescription with lower respiratory consultation). Secondary outcomes included lung function test results and short-acting β2 agonist usage. The Wilcoxon signed-rank test was used for variables measured on the interval scale, the marginal homogeneity test for categorized variables, and the paired t-test for lung function indices. Of the 2,042 study patients, 83% were prescribed an inhaled corticosteroid and 68% a long-acting β2 agonist during the baseline year; 67% were prescribed both. Comparing baseline and outcome years, the percentage of patients having at least one exacerbation decreased from 37% to 27% (P<0.001) and the percentage having at least one acute respiratory event decreased from 58% to 47% (P<0.001). There were no significant changes in lung function, and usage of short-acting β2 agonists (in salbutamol/albuterol equivalents) increased from a median (interquartile range) of 274 (110, 548) to 329 (110, 603) μg/day (P=0.01). In this real-life asthma population, addition of LAMA therapy was associated with significant decreases in the incidence of exacerbations and antibiotic prescriptions for lower respiratory tract infections in the following year.

Kerkhof M, Freeman D, Jones R, Chisholm A, Price DB. Int J Chron Obstruct Pulmon Dis. 2015;10:2439–2450. Page 2450, the formula shown in the Supplementary materials is incorrect. The correct formula is shown below. The formula: Risk of ≥2 COPD exacerbations within the next 12 months =1/{1 + exp[- (-0.7306 + 0.8840 × 1 previous exacerbation in last 12 months + 1.4786 × 2 previous exacerbations in last 12 months + 1.9857 × 3 previous exacerbations in last 12 months + 2.8811 × ≥4 previous exacerbations in last 12 months - 0.0093 × FEV1% predicted + 0.0360 × age - 0.0004 × age2 - 1.2194 × height (in meter) + 0.2518 × (blood eosinophil count ≥400/μL in a patient who is not currently smoking) + 0.2953 × any evidence of asthma × 0.3018 × history of non allergic rhinitis + 0.3298 × history of nasal polyps + 0.1164 × history of ischemic heart disease + 0.1071 × history of anxiety or depression + 0.1689 × history of GERD)]}. For the yes/no variables, a value of 1 should be used for “yes” and a value of 0 for “no.” .

Background Incorrect inhaler technique is a common cause of poor asthma control. This two-phase pragmatic study evaluated inhaler technique mastery and maintenance of mastery with DuoResp® (budesonide-formoterol [BF]) Spiromax® compared with Symbicort® (BF) Turbuhaler® in patients with asthma who were receiving inhaled corticosteroids/long-acting β2-agonists. Methods In the initial cross-sectional phase, patients were randomized to a 6-step training protocol with empty Spiromax and Turbuhaler devices. Patients initially demonstrating ≥1 error with their current device, and then achieving mastery with both Spiromax and Turbuhaler (absence of healthcare professional [HCP]-observed errors), were eligible for the longitudinal phase. In the longitudinal phase, patients were randomized to BF Spiromax or BF Turbuhaler. Co-primary endpoints were the proportions of patients achieving device mastery after three training steps and maintaining device mastery (defined as the absence of HCP-observed errors after 12 weeks of use). Secondary endpoints included device preference, handling error frequency, asthma control, and safety. Exploratory endpoints included assessment of device mastery by an independent external expert reviewing video recordings of a subset of patients. Results Four hundred ninety-three patients participated in the cross-sectional phase, and 395 patients in the longitudinal phase. In the cross-sectional phase, more patients achieved device mastery after three training steps with Spiromax (94%) versus Turbuhaler (87%) (odds ratio [OR] 3.77 [95% confidence interval (CI) 2.05–6.95], p  < 0.001). Longitudinal phase data indicated that the odds of maintaining inhaler mastery at 12 weeks were not statistically significantly different (OR 1.26 [95% CI 0.80–1.98], p  = 0.316). Asthma control improved in both groups with no significant difference between groups (OR 0.11 [95% CI -0.09–0.30]). An exploratory analysis indicated that the odds of maintaining independent expert-verified device mastery were significantly higher for patients using Spiromax versus Turbuhaler (OR 2.11 [95% CI 1.25–3.54]). Conclusions In the cross-sectional phase, a significantly greater proportion of patients using Spiromax versus Turbuhaler achieved device mastery; in the longitudinal phase, the proportion of patients maintaining device mastery with Spiromax versus Turbuhaler was similar. An exploratory independent expert-verified analysis found Spiromax was associated with higher levels of device mastery after 12 weeks. Asthma control was improved by treatment with both BF Spiromax and BF Turbuhaler. Trial registration EudraCT 2013-004630-14 (registration date 23 January 2014); NCT02570425 .

Background: Symptom-based questionnaires may enhance chronic obstructive pulmonary disease (COPD) screening in primary care. Objectives: We prospectively tested questions to help identify COPD among smokers without prior history of lung disease. Methods: Subjects were recruited via random mailing to primary care practices in Aberdeen, UK, and Denver, Colo., USA. Current and former smokers aged 40 or older with no prior respiratory diagnosis and no respiratory medications in the past year were enrolled. Participants answered questions covering demographics and symptoms and then underwent spirometry with reversibility testing. A study diagnosis of COPD was defined as fixed airway obstruction as measured by postbronchodilator FEV 1 /FVC <0.70. We examined the ability of individual questions in a multivariate framework to correctly discriminate between persons with and without COPD. Results: 818 subjects completed all investigations and proceeded to analysis. The list of 54 questions yielded 52 items for analysis, which was reduced to 17 items for entry into multivariate regression. Eight items had significant relationships with the study diagnosis of COPD, including age, pack-years, body mass index, weather-affected cough, phlegm without a cold, morning phlegm, wheeze frequency, and history of any allergies. Individual items yielded odds ratios ranging from 0.23 to 12. This questionnaire demonstrated a sensitivity of 80.4 and specificity of 72.0. Conclusions: A simple patient self-administered questionnaire can be used to identify patients with a high likelihood of having COPD, for whom spirometric testing is particularly important. Implementation of this questionnaire could enhance the efficiency and diagnostic accuracy of current screening efforts.