Background: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. Purpose: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. Methods: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. Results: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. Conclusion: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.

Despite current guidelines and decades of evidence on the benefits of a selfmanagement 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 selfmanagement, 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.

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.

Randomised controlled trials (RCTs) are universally considered as the gold standard for evaluating the efficacy of treatments. Their main strength is that, through randomisation, they avoid any major imbalance between compared groups: therefore, observed outcome differences between groups at the end of the trial are most likely related to treatment effects. Since they are inherently prospective by design, they also permit stability throughout the study to ensure that all conditions remain optimal to test the hypothesis of interest. These include high-quality follow-up, reinforced adherence, etc . Consequently, these studies can reach the highest level of internal validity, provided that all quality standards are followed, such as those defined by CONSORT guidelines [1]. This document has been Endorsed by the International Primary Care Respiratory Group and the World Allergy Organization. The authors wish to thank the Respiratory Effectiveness Group Team (Michael Walker, CEO and Supporter Liaison, Naomi Launders, Senior Scientific Researcher and Sarah Lucas, Researcher) and Oversight Committee (Keith Allan, Trevor Lambert and Nick May).

This abstract is funded by: Observational & Pragmatic Research Institute Pte Ltd, and Circassia Presented at thematic poster session: A34 ASTHMA CLINICAL STUDIES I Sunday 20th May

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.

Background: Fractional exhaled nitric oxide (FeNO) can predict treatment response in asthma, but little is known of its utility in patients with non-specific respiratory symptoms (NSRS). Aims and objectives: To evaluate the association between baseline FeNO and response to treatment with inhaled corticosteroids (ICS) in patients with NSRS. Methods: This was a multi-centre randomised, placebo-controlled trial, carried out in UK and Singapore. It consisted of a 2-week assessment period to establish baseline measurements and a 4-week treatment period with either extrafine ICS (200 µ beclomethasone bid) or placebo. NIOX VERO (Circassia) was used to measure baseline FeNO. The primary endpoint was change in ACQ7 score (Asthma Control Questionnaire, 7 questions). Analysis was carried out in a Main Analysis Set (MAS), which contained all randomised patients who complied with their study treatment and completed follow-up within 6 weeks of randomisation, and in a Per Protocol (PP) set, which included all patients in the MAS but excluded protocol violations. Results: In the PP set (n=214), we found that higher baseline FeNO was associated with a greater treatment effect. Improvement of ACQ7 was 0.071 (95% confidence interval [CI], 0.002-0.139) greater in patients receiving extrafine ICS compared to patients receiving placebo, for every 10 ppb increase in baseline FeNO. The equivalent effect was not significant in the MAS set (n=259) (0.049; 95% CI, -0.012-0.110). Conclusions: FeNO measurement is a simple, near patient, quantitative and non-invasive diagnostic tool that could support treatment decisions for patients with NSRS. Further research is needed to establish a treatment paradigm.

Background Chronic non-specific respiratory symptoms are difficult to manage. This trial aimed to evaluate the association between baseline fractional exhaled nitric oxide (FENO) and the response to inhaled corticosteroids in patients with non-specific respiratory symptoms. Methods In this double-blind randomised placebo-controlled trial, we enrolled undiagnosed patients, aged 18-80 years, with cough, wheeze, or dyspnoea and less than 20% bronchodilator reversibility across 26 primary care centres and hospitals in the UK and Singapore. Patients were assessed for 2 weeks before being randomly assigned (1: 1) to 4 weeks of treatment with extrafine inhaled corticosteroids (QVAR 80 mu g, two puffs twice per day, equivalent to 800 mu g per day beclomethasone dipropionate) or placebo. Randomisation was stratified by baseline FENO measurement: normal (<= 25 parts per billion [ppb]), intermediate (>25 tp <40 ppb), and high (>= 40 ppb). The primary endpoint was change in Asthma Control Questionnaire (ACQ7) mean score. We used generalised linear modelling to assess FENO as a predictor of response, estimating an interaction effect between FENO and treatment on change in ACQ7. We did our primary and secondary analyses in the per-protocol set, which excluded patients with non-completion of the primary endpoint, non-compliance to treatment (ascertained by patient report), and study visits made outside the predefined visit windows. This study is registered on ClinicalTrials.gov, number NCT02294279. Findings Between Feb 4, 2015, and July 12, 2016, we randomly assigned 294 patients to extrafine inhaled corticosteroid treatment (n=148) or placebo (n=146). Following exclusions due to protocol violations, we analysed 214 patients (114 extrafine inhaled corticosteroids and 100 placebo). We observed a significant interaction between baseline FENO and treatment group for every 10 ppb increase in baseline FENO, with the change in ACQ7 greater in the extrafine inhaled corticosteroids group than in the placebo group (difference between groups 0.071, 95% CI 0.002 to 0.139; p=0.044). The most common adverse events were nasopharyngitis (18 [12%] patients in the treatment group vs 13 [9%] in the placebo group), infections and infestations (25 [17%] vs 21 [14%]), and respiratory, thoracic, and mediastinal disorders (13 [9%] vs 17 [12%]). Interpretation FENO measurement is an easy and non-invasive tool to use in clinical practice in patients with nonspecific respiratory symptoms to predict response to inhaled corticosteroids. Further research is needed to examine its role in patients with evidence of other airway diseases, such as chronic obstructive pulmonary disease.

Introduction The purpose of the quality standards document is to provide healthcare professionals, commissioners, service providers and patients with a guide to standards of care that should be met for home oxygen provision in the UK, together with measurable markers of good practice. Quality statements are based on the British Thoracic Society (BTS) Guideline for Home Oxygen Use in Adults. Methods Development of BTS Quality Standards follows the BTS process of quality standard production based on the National Institute for Health and Care Excellence process manual for the development of quality standards. Results 10 quality statements have been developed, each describing a key marker of high-quality, cost-effective care for home oxygen use, and each statement is supported by quality measures that aim to improve the structure, process and outcomes of healthcare. Discussion BTS Quality Standards for home oxygen use in adults form a key part of the range of supporting materials that the society produces to assist in the dissemination and implementation of a guideline's recommendations.

The ability to provide oxygen in a patient’s home can offer enormous benefits, including improvements in life expectancy when given in the appropriate setting. Confusingly, however, home oxygen is available in many forms, including long-term oxygen therapy (LTOT), ambulatory oxygen therapy (AOT), palliative oxygen therapy (POT) and short-burst oxygen therapy (SBOT)—each with varying degrees of supporting evidence. The British Thoracic Society (BTS) has recently published new guidance on home oxygen therapy, after collating the available evidence. This article aims to summarise those guidelines, focusing on who should and should not be considered for oxygen therapy. Although the BTS guidelines target a UK audience, many of the principles covered below are applicable internationally, even if the availability of certain oxygen modalities and supporting service arrangements may vary between different healthcare systems.

Prescribing in PracticeFree Access Use of home oxygen therapy in adults Maxine Hardinge, Maxine HardingeSearch for more papers by this authorDaryl Freeman, Daryl FreemanSearch for more papers by this authorSabi Hippolyte, Sabi HippolyteSearch for more papers by this authorJay Suntharalingam, Jay SuntharalingamSearch for more papers by this author Maxine Hardinge, Maxine HardingeSearch for more papers by this authorDaryl Freeman, Daryl FreemanSearch for more papers by this authorSabi Hippolyte, Sabi HippolyteSearch for more papers by this authorJay Suntharalingam, Jay SuntharalingamSearch for more papers by this author First published: 07 June 2016 https://doi.org/10.1002/psb.1457AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Home oxygen therapy can provide significant health benefits in selected patients with chronic respiratory disease. This article provides a summary of the main types of oxygen therapy and the guidelines for their use. Volume27, Issue5May 2016Pages 14-17 RelatedInformation

Background: Airway inflammation is the fundamental mechanism in asthma and can be measured non-invasively by means of fractional exhaled nitric oxide (FeNO). Both, The National Institute for Health and Care Excellence (NICE) diagnostics guidance 12 and British guideline on the management of asthma, are recommending the inclusion of FeNO testing as part of diagnosis in patients that have an intermediate probability of having asthma. Furthermore, FeNO testing is recommended as an option for monitoring response to corticosteroid treatment in patients with increased FeNO. However, there is a need for establishing routine data predictors for individuals with increased FeNO, to identify those that would benefit from FeNO measurement as a tool for aiding asthma diagnosis and monitoring treatment responsiveness. To provide a real-life predictive model for the identification of individuals at risk of asthma that have increased FeNO. Methods: An analysis of real-life standard care and FeNO data derived from a randomised, multi-centre, double-blind, placebo-controlled study entitled: ‘The evaluation of FeNO for predicting response to an inhaled corticosteroid in subjects with non-specific respiratory symptoms’ was carried out. Data from study participants with non-specific respiratory symptoms and an Asthma Control Questionnaire (ACQ) score ≥1 were analysed cross-sectionally. Logistic regression was used to investigate the relationship between FeNO levels, categorised in normal (≤25 ppb) and intermediate (>25 and <40 ppb)/high (≥40 ppb), and a number of determinants, including demographic variables, smoking status, history of atopy, number of short acting beta agonist (SABA) inhalers in the year preceding study participation, symptoms of cough, wheeze and dyspnoea, prior history of oral steroid use, blood eosinophil count (cut off 0.2×109/L) and forced expiratory volume in the first second percent predicted (FEV1% pred). Results: Overall, 90 individuals were assessed, with a mean ± standard deviation (SD) age of 46±17.1, 50 (56%) were female, and 59 (67%) were non-smokers. Sixty individuals (67%) had normal FeNO levels compared to 30 (33%) with intermediate/high levels. From univariate analyses, the odds ratio (OR) and 95% confidence interval (CI) of being in the intermediate/high FeNO group were increased if individuals were male [4.00 (1.58, 10.14)], had a history of atopy [4.3 (1.6, 11.54)], eosinophils >0.2×109/L [3.07 (1.10, 8.61)] and decreased with age [0.97 (0.94, 0.99)]. Finally, in a multivariable model, only male gender and history of atopy remained significant, independent factors, 4.32 (1.61, 11.68) and 4.65 (1.63, 13.26), respectively. Conclusions: Our research shows that a history of atopy and being male are the strongest, independent predictors for increased FeNO levels in individuals at risk of asthma, while an eosinophil count >0.2×109/L and young age also retain some predictive ability.

Background: North Norfolk Clinical Commissioning Group (NNCCG) comprises of 19 GP surgeries (rural approx. 168,000 patients) and has seen an increase in COPD admissions of 30% 2012–13 and 2013–14.The change in the way Healthcare is delivered in England as a result of the 2012 Health & Social Care Act means that CCG’s are under increasing financial pressure, Social Care budgets have been cut by up to 40% in some regions, and care is becoming increasingly fragmented between different organisations. The five year forward plan set out by the NHS highlights the use of Specialist Primary & Community Care Clinicians as an important way of aligning healthcare, reducing admissions and reducing the inequalities seen in Primary Care across England. Reducing short stay COPD admissions is a priority for this CCG as is reducing inappropriate high dose ICS prescriptions in an area where high dose ICS/LABA combinations are often the single highest prescription cost per practice. Improving patient access to good quality COPD care was an aim as was asking patients what they would find useful when they were acutely unwell with a COPD exacerbation. Methods: A 7-point risk tool (designed by Respiratory Effectiveness Group) using data extracted by Optimum Patient Care (OPC) from GP clinical systems was used to identify patients at risk from two or more COPD exacerbations and those on high dose ICS who may be suitable for stepping down or stopping ICS therapy. Practices were taught how to use the spreadsheets provided by OPC to maximise the benefits and produce a list of patients at risk of 2 or more exacerbations and additionally those who are at low risk and suitable for ICS reduction or cessation. Fifteen out of nineteen practices took part and mentored clinics were held with DF, VG, or another nurse specialist to improve the management of both groups of patients and to assess the current expertise in each practice. A unified approach across the CCG was encouraged with standardised documents namely self-management plans, step down guidance & high risk patient management. All practices have access to good quality pulmonary rehabilitation and prompt radiology, smoking cessation services. Results: Q2–3 2016 further data extraction will take place to evaluate impact on exacerbations and prescribing. Patient feedback was used to influence future services, and following on from this work a respiratory network and more focus on high risk patients are planned. This will include standardised respiratory management templates for GP clinical systems, drug formularies, management guidelines and a separate service for high risk patients. Conclusions: Considerable variation in nurse standards was seen across the CCG during delivery of the mentored clinics with some excellent care & some training needs identified. A unified approach is required and should be part of the restructuring of health care in the CCG in line with the 5-year forward plan set out by NHS England.

Background 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. Methods 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. Results 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). Conclusion 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.

Introduction and objectives Technical errors in the use of inhalers are associated with poor asthma control. This study evaluated achievement of mastery in a training environment using a randomised cross-over design (stage 1), followed by randomization into a prospective 12-week trial to assess maintenance of mastery in patients receiving inhaled corticosteroids (ICS)/long-acting β2-agonists (LABA) via SPIROMAX versus ICS/LABA received via TURBOHALER (stage 2). Methods Patients with asthma were randomised to a 6-step training protocol using empty Spiromax and empty Turbohaler devices. The proportion of patients achieving and maintaining inhaler mastery, respectively defined as the absence of health care professional (HCP)-observed errors by training step 3 (instructional video) in stage 1, and the absence of HCP-observed errors after 12 weeks of inhaler use in stage 2, were analysed using logistic regression. The maintenance of independent expert video-observed inhaler mastery was analysed using logistic regression. Total observed errors (HCP and technology) were analysed using a negative binomial regression model. Vitalograph Pneumatic Spirometry results were compared using a Mann Whitney U test. Results A total of 493 (89.1%) patients (stage 1) and 305 (61.9%) (stage 2) were eligible for the full analysis set. The odds of maintaining inhaler mastery were not significantly different for patients using either inhaler, although achieving inhaler mastery was significantly greater in patients using Spiromax compared with Turbohaler at baseline. A higher, non-significant percentage of patients using Spiromax maintained inhaler mastery (assessed by HCPs). This result was supported by significantly higher odds of maintaining mastery when HCP errors were calibrated using independent video assessment in patients using Spiromax (consented videos available for 243/305 patients [79%]). Maintaining inhaler mastery improved asthma control in both treatment groups and was not significantly different (Table 1).Abstract P154 Table 1 Inhaler technique variables Spiromax Turbohaler p-value‡ Odds ratios(95% CI)§ Rate ratios(95% CI) Treatment difference(95% CI)# Inhaler mastery achievement, stage 1, n (%)* Yes 454 (94) 418 (87) <0.001 3.77(2.05−6.95) — — No 27 (6) 63 (13) Inhaler mastery maintenance, stage 2, n (%) † Yes 89 (59) 82 (53) 0.316 1.26(0.80−1.98) — — No 62 (41) 72 (47) — — Total HCP-observed errors, mean (SD) — 0.50 (0.67) 0.81 (1.10) — — 0.61(0.44− 0.84) — HCP-observed mastery assessed by independent video review, n (%) Yes 122 (81) 92 (60) ˂0.001 2.84(1.69−4.76) — — No 29 (19) 62 (40) — Change in 6-item Asthma Control Questionnaire, week 12, mean (SD) — -0.22 (0.95) -0.36 (1.05) — — — 0.13(-0.10−0.37) *In stage 1, 493 patients were randomly assigned to either empty Spiromax followed by empty Turbohaler or empty Turbohaler followed by empty Spiromax. Achieving inhaler mastery was defined as the absence of HCP-observed errors by the end of step 3 of a 6-step standardised inhaler training protocol for empty Spiromax compared to empty Turbohaler inhalers; †In stage 2, 305 out of 395 patients (61.9%) patients were eligible for the full analysis set. Maintaining inhaler mastery was defined as the absence of HCP-observed errors after 12 weeks of inhaler use; ‡The p-value for the treatment comparison is based on chi-square. p < 0.05 considered statistically significant; §Logistic regression; Negative binomial regression; #Analysis of variance; CI: confidence interval; HCP: Health care professional; SD, standard deviation. Conclusions The proportion of patients achieving inhaler mastery at baseline was significantly greater for Spiromax compared with Turbohaler; no significant difference was found in inhaler mastery at 12 weeks. Patients using Spiromax made significantly fewer errors overall (HCP-observed and HCP- and technology-observed) than patients using Turbohaler. Maintaining inhaler mastery improved asthma control in both treatment groups. Independent video assessment can assist HCPs in evaluating device mastery, and is proposed as the gold standard in such studies.

Introduction and objectives Technical errors in the use of inhalers are associated with poor asthma control. This study evaluated achievement of mastery in a training environment using a randomised cross-over design (stage 1), followed by randomization into a prospective 12-week trial to assess maintenance of mastery in patients receiving inhaled corticosteroids (ICS)/long-acting β2-agonists (LABA) via SPIROMAX versus ICS/LABA received via TURBOHALER (stage 2). Methods Patients with asthma were randomised to a 6-step training protocol using empty Spiromax and empty Turbohaler devices. The proportion of patients achieving and maintaining inhaler mastery, respectively defined as the absence of health care professional (HCP)-observed errors by training step 3 (instructional video) in stage 1, and the absence of HCP-observed errors after 12 weeks of inhaler use in stage 2, were analysed using logistic regression. The maintenance of independent expert video-observed inhaler mastery was analysed using logistic regression. Total observed errors (HCP and technology) were analysed using a negative binomial regression model. Vitalograph Pneumatic Spirometry results were compared using a Mann Whitney U test. Results A total of 493 (89.1%) patients (stage 1) and 305 (61.9%) (stage 2) were eligible for the full analysis set. The odds of maintaining inhaler mastery were not significantly different for patients using either inhaler, although achieving inhaler mastery was significantly greater in patients using Spiromax compared with Turbohaler at baseline. A higher, non-significant percentage of patients using Spiromax maintained inhaler mastery (assessed by HCPs). This result was supported by significantly higher odds of maintaining mastery when HCP errors were calibrated using independent video assessment in patients using Spiromax (consented videos available for 243/305 patients [79%]). Maintaining inhaler mastery improved asthma control in both treatment groups and was not significantly different (Table 1). Conclusions The proportion of patients achieving inhaler mastery at baseline was significantly greater for Spiromax compared with Turbohaler; no significant difference was found in inhaler mastery at 12 weeks. Patients using Spiromax made significantly fewer errors overall (HCP-observed and HCP- and technology-observed) than patients using Turbohaler. Maintaining inhaler mastery improved asthma control in both treatment groups. Independent video assessment can assist HCPs in evaluating device mastery, and is proposed as the gold standard in such studies.

PURPOSE: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 AND METHODS: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.RESULTS: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.CONCLUSION: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.