Characteristics of patients making serious inhaler errors with a dry powder inhaler and association with asthma-related events in a primary care setting.

OBJECTIVE: Correct inhaler technique is central to effective delivery of asthma therapy. The study aim was to identify factors associated with serious inhaler technique errors and their prevalence among primary care patients with asthma using the Diskus dry powder inhaler (DPI). METHODS: This was a historical, multinational, cross-sectional study (2011-2013) using the iHARP database, an international initiative that includes patient- and healthcare provider-reported questionnaires from eight countries. Patients with asthma were observed for serious inhaler errors by trained healthcare providers as predefined by the iHARP steering committee. Multivariable logistic regression, stepwise reduced, was used to identify clinical characteristics and asthma-related outcomes associated with ≥1 serious errors. RESULTS: Of 3681 patients with asthma, 623 (17%) were using a Diskus (mean [SD] age, 51 [14]; 61% women). A total of 341 (55%) patients made ≥1 serious errors. The most common errors were the failure to exhale before inhalation, insufficient breath-hold at the end of inhalation, and inhalation that was not forceful from the start. Factors significantly associated with ≥1 serious errors included asthma-related hospitalization the previous year (odds ratio [OR] 2.07; 95% confidence interval [CI], 1.26-3.40); obesity (OR 1.75; 1.17-2.63); poor asthma control the previous 4 weeks (OR 1.57; 1.04-2.36); female sex (OR 1.51; 1.08-2.10); and no inhaler technique review during the previous year (OR 1.45; 1.04-2.02). CONCLUSIONS: Patients with evidence of poor asthma control should be targeted for a review of their inhaler technique even when using a device thought to have a low error rate.

The distribution of COPD in UK general practice using the new GOLD classification.

The new Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 document recommends a combined assessment of chronic obstructive pulmonary disease (COPD) based on current symptoms and future risk. A large database of primary-care COPD patients across the UK was used to determine COPD distribution and characteristics according to the new GOLD classification. 80 general practices provided patients with a Read code diagnosis of COPD. Electronic and hand searches of patient medical records were undertaken, optimising data capture. Data for 9219 COPD patients were collected. For the 6283 patients with both forced expiratory volume in 1 s (FEV1) and modified Medical Research Council scores (mean±sd age 69.2±10.6 years, body mass index 27.3±6.2 kg·m(-2)), GOLD 2011 group distributions were: A (low risk and fewer symptoms) 36.1%, B (low risk and more symptoms) 19.1%, C (high risk and fewer symptoms) 19.6% and D (high risk and more symptoms) 25.3%. This is in contrast with GOLD 2007 stage classification: I (mild) 17.1%, II (moderate) 52.2%, III (severe) 25.5% and IV (very severe) 5.2%. 20% of patients with FEV1 ≥50% predicted had more than two exacerbations in the previous 12 months. 70% of patients with FEV1 <50% pred had fewer than two exacerbations in the previous 12 months. This database, representative of UK primary-care COPD patients, identified greater proportions of patients in the mildest and most severe categories upon comparing 2011 versus 2007 GOLD classifications. Discordance between airflow limitation severity and exacerbation risk was observed.

Novel study design to assess the utility of the copd assessment test in a primary care setting.

The quality of a consultation provided by a physician can have a profound impact on the quality of care and patient engagement in treatment decisions. When the COPD Assessment Test (CAT) was developed, one of its aims was to aid the communication between physician and patient about the impact of COPD. We developed a novel study design to assess this in a primary care consultation. Primary care physicians across five countries in Europe conducted videoed consultations with six standardised COPD patients (played by trained actors) which had patient-specific issues that the physician needed to identify through questioning. Half the physicians saw the patients with the completed CAT, and half without. Independent assessors scored the physicians on their ability to identify and address the patient-specific issues, review standard COPD aspects, their understanding of the case and their overall performance. This novel study design presented many challenges which needed to be addressed to achieve an acceptable level of robustness to assess the utility of the CAT. This paper discusses these challenges and the measures adopted to eliminate or minimise their impact on the study results.

The Primary Care Respiratory Society-UK Quality Award: development and piloting of quality standards for primary care respiratory medicine.

In an attempt to improve the standards of primary respiratory care in the UK, the Primary Care Respiratory Society-UK (PCRS-UK), in conjunction with other leading respiratory-interested health professional and patient groups, has devised a General Practice Quality Award for Respiratory Medicine. The Award is divided into three modules separated into a total of seven clinical standards (in parentheses): 'Clinical' (prevention, early and accurate diagnosis, acute care, chronic care); 'Organisational' (equipment); and 'The Practice Team' (practice learning needs, educational strategy). Assessment is by submission of a written portfolio of 37 pieces of evidence including audit, reflective learning, patient feedback, and significant event analyses. The Award was piloted in five respiratory-interested practices across the UK. The practices reported improvements in practice organisation, practice teamwork, improved process measures such as improvement in quality of spirometry, and improved patient access to patient services. All practices in the UK are being invited to apply for the Award in 2013. It is hoped that it will provide a framework and stimulus for provision of high-quality primary respiratory care, not only in the UK, but also some aspects of the Award may be applicable on a wider international scale.

A woman with breathlessness: a practical approach to diagnosis and management.

Worsening breathless in a patient with severe chronic obstructive pulmonary disease (COPD) is a common diagnostic and management challenge in primary care. A systematic approach to history-taking and examination combined with targeted investigation of pulmonary, cardiovascular, thromboembolic and systemic causes is essential if co-morbidities are to be identified and managed. Distinguishing between heart failure and COPD is a particular challenge as symptoms and signs overlap. In low and middle income countries additional priorities are the detection of infections such as tuberculosis and human immunodeficiency virus (HIV). Clinicians need to be alert to the possibility of atypical presentations (such as pain-free variants of angina) and less common conditions (including chronic thromboembolic pulmonary hypertension) in order not to overlook important potentially treatable conditions.

Clinical and cost effectiveness of switching asthma patients from fluticasone-salmeterol to extra-fine particle beclometasone-formoterol: a retrospective matched observational study of real-world patients.

BACKGROUND: Efficacy trials suggest that extra-fine particle beclometasone dipropionate-formoterol (efBDP-FOR) is comparable to fluticasone propionate-salmeterol (FP-SAL) in preventing asthma exacerbations at a clinically equivalent dosage. However, switching from FP-SAL to efBDP-FOR has not been evaluated in real-world asthma patients. AIMS: The REACH (Real-world Effectiveness in Asthma therapy of Combination inHalers) study investigated the clinical and cost effectiveness of switching typical asthma patients from FP-SAL to efBDP-FOR. METHODS: A retrospective matched (1:3) observational study of 1,528 asthma patients aged 18-80 years from clinical practice databases was performed. Patients remaining on FP-SAL (n=1,146) were compared with those switched to efBDP-FOR at an equivalent or lower inhaled corticosteroid (ICS) dosage (n=382). Clinical and economic outcomes were compared between groups for the year before and after the switch. Non-inferiority (at least equivalence) of efBDP-FOR was tested against FP-SAL by comparing exacerbation rates during the outcome year. RESULTS: efBDP-FOR was non-inferior to FP-SAL (adjusted exacerbation rate ratio 1.01 (95% CI 0.74 to 1.37)). Switching to efBDP-FOR resulted in significantly better (p<0.05) odds of achieving overall asthma control (no asthma-related hospitalisations, bronchial infections, or acute oral steroids; salbutamol ≤200µg/day) and lower daily short-acting ß2-agonist usage at a lower daily ICS dosage (mean -130µg/day FP equivalents; p<0.001). It also reduced mean asthma-related healthcare costs by £93.63/patient/year (p<0.001). CONCLUSIONS: Asthma patients may be switched from FP-SAL to efBDP-FOR at an equivalent or lower ICS dosage with no reduction in clinical effectiveness but a significant reduction in cost.

Utility of COPD Assessment Test (CAT) in primary care consultations: a randomised controlled trial.

BACKGROUND: One of the aims of the COPD Assessment Test (CAT) is to aid communication between the physician and patient about the burden of chronic obstructive pulmonary disease (COPD) on the patient's life. AIMS: To investigate the impact of the CAT on the quality of primary care consultations in COPD patients. METHODS: Primary care physicians across Europe conducted six consultations with standardised COPD patients (played by trained actors). Physicians were randomised to see the patient with the completed CAT (CAT+ arm) or without (no CAT arm) during the consultation. These were videoed and independent assessors scored the physicians on their ability to identify and address patient-specific issues such as depression (sub-score A); review standard COPD issues such as breathlessness (sub-score B); their understanding of the case (understanding score); and their overall performance. The primary endpoint was the global score (sub-scores A+B; scale range 0-40). RESULTS: A total of 165 physicians enrolled in the study and carried out six consultations each; 882 consultations were deemed suitable for analysis. No difference was seen between the arms in the global score (no CAT arm 20.3; CAT+ arm 20.7; 95% CI -1.0 to 1.8; p=0.606) or on sub-score A (p=0.255). A statistically significant difference, though of limited clinical relevance, was observed in mean sub-score B (no CAT arm 8.8; CAT+ arm 9.6; 95% CI 0.0 to 1.6; p=0.045). There was no difference in understanding score (p=0.824) or overall performance (p=0.655). CONCLUSIONS: The CAT is a disease-specific instrument that aids physician assessment of COPD. It does not appear to improve detection of non-COPD symptoms and co-morbidities.

GOLD guidelines 2011: what are the implications for primary care?

A major revision of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines was published in December 2011, which takes account of the fact that chronic obstructive pulmonary disease (COPD) is a multi-system disease with effects on the patient beyond the effects of airflow limitation alone. The guidelines present a novel way of assessing the patient with COPD, linked to the major goals of stable COPD management of reducing symptoms (measured by the modified Medical Research Council Dyspnoea Score and/or COPD Assessment Tool) and reducing future risk (measured by the severity of airflow limitation and/or exacerbation history in the previous 12 months). Four patient groups are identified on the basis of their symptom/risk profile and a pharmacotherapy strategy is described using this profile. Emphasis is still placed on three pivotal features of non-pharmacological management: (1) reduction of exposure to risk factors (principally tobacco smoke); (2) promotion of exercise; and (3) immunisation against influenza and pneumococcal disease. In addition, there is a new chapter on the importance of assessing and treating co-morbid disease. The guidelines are a welcome advance in the management of COPD, but need further development to guide the more holistic approach to the management of patients with COPD in primary care.

Clinical implications of the Royal College of Physicians three questions in routine asthma care: a real-life validation study.

BACKGROUND: Annual recording of the Royal College of Physicians three questions (RCP3Q) morbidity score is rewarded within the UK 'pay-for-performance' Quality and Outcomes Framework. AIMS: To investigate the performance of the RCP3Qs for assessing control in real-life practice compared with the validated Asthma Control Questionnaire (ACQ) administered by self-completed questionnaire. METHODS: We compared the RCP3Q score extracted from a patient's computerised medical record with the ACQ self-completed after the consultation. The anonymous data were paired by practice, age, sex, and dates of completion. We calculated the sensitivity and specificity of the RCP3Q scale compared with the threshold for good/poor asthma control (ACQ ≥1). RESULTS: Of 291 ACQ questionnaires returned from 12 participating practices, 129 could be paired with complete RCP3Q data. Twenty-five of 27 patients who scored zero on the RCP3Q were well controlled (ACQ <1). An RCP3Q score ≥1 predicted inadequate control (ACQ ≥1) with a sensitivity of 0.96 and specificity of 0.34. Comparable values for RCP3Q≥2 were sensitivity 0.50 and specificity 0.94. The intraclass correlation coefficient of 0.13 indicated substantial variability between practices. Exacerbations and use of reliever inhalers were moderately correlated with ACQ (Spearman's rho 0.3 and 0.35) and may reflect different aspects of control. CONCLUSIONS: In routine practice, an RCP3Q score of zero indicates good asthma control and a score of 2 or 3 indicates poor control. An RCP3Q score of 1 has good sensitivity but poor specificity for suboptimal control and should provoke further enquiry and consideration of other aspects of control such as exacerbations and use of reliever inhalers.

British Thoracic Society Quality Standard for Clinically Significant Bronchiectasis in Adults 2022.

This British Thoracic Society Quality Standard for Clinically Significant Bronchiectasis in Adults 2022 aims to encourage good practice by setting standards of high-quality respiratory care that services should follow.

Quality Standard Position Statements for Health System Policy Changes in Diagnosis and Management of COPD: A Global Perspective.

INTRODUCTION: Despite being a leading cause of death worldwide, chronic obstructive pulmonary disease (COPD) is underdiagnosed and underprioritized within healthcare systems. Existing healthcare policies should be revisited to include COPD prevention and management as a global priority. Here, we propose and describe health system quality standard position statements that should be implemented as a consistent standard of care for patients with COPD. METHODS: A multidisciplinary group of clinicians with expertise in COPD management together with patient advocates from eight countries participated in a quality standards review meeting convened in April 2021. The principal objective was to achieve consensus on global health system priorities to ensure consistent standards of care for COPD. These quality standard position statements were either evidence-based or reflected the combined views of the panel. RESULTS: On the basis of discussions, the experts adopted five quality standard position statements, including the rationale for their inclusion, supporting clinical evidence, and essential criteria for quality metrics. These quality standard position statements emphasize the core elements of COPD care, including (1) diagnosis, (2) adequate patient and caregiver education, (3) access to medical and nonmedical treatments aligned with the latest evidence-based recommendations and appropriate management by a respiratory specialist when required, (4) appropriate management of acute COPD exacerbations, and (5) regular patient and caregiver follow-up for care plan reviews. CONCLUSIONS: These practical quality standards may be applicable to and implemented at both local and national levels. While universally applicable to the core elements of appropriate COPD care, they can be adapted to consider differences in healthcare resources and priorities, organizational structure, and care delivery capabilities of individual healthcare systems. We encourage the adoption of these global quality standards by policymakers and healthcare practitioners alike to inform national and regional health system policy revisions to improve the quality and consistency of COPD care worldwide.

The 2010 NICE COPD Guidelines: how do they compare with the GOLD guidelines?

The UK National Institute for Health and Clinical Excellence (NICE) has produced a 2010 partial update of its original 2004 Guidelines on COPD management. The definition of airflow obstruction has been altered to a post-bronchodilator FEV1/FVC ratio < 0.7 and the severity of airflow obstruction has been similarly aligned with the Global initiative for Obstructive Lung Disease (GOLD) guideline definition. However, patients with GOLD Stage 1 (i.e. FEV1 predicted ≥ 80%) must be symptomatic for a diagnosis of COPD to be made under the new NICE criteria. Recent large scale trials have resulted in a new inhaled pharmacotherapy algorithm which includes early use of inhaled corticosteroid/long-acting ß2-agonist combination therapy for patients with an FEV1 < 50% predicted. In spite of an apparent emphasis on pharmacotherapy, both GOLD and NICE Guidelines emphasise that COPD is a multi-system disease requiring a multidimensional approach to treatment. In particular, the importance of smoking cessation and pulmonary rehabilitation is reiterated, the latter not only being of use in managing stable disease but also following hospital discharge.

A Patient Charter for Chronic Obstructive Pulmonary Disease.

Chronic obstructive pulmonary disease (COPD) has a profound impact on people living with the disease and has a high global economic and social burden. Often, people with COPD are undiagnosed, while those diagnosed are undertreated and undereducated on different aspects of COPD care. Although there are many published evidence-based treatment guidelines from different expert groups and societies, they are frequently not adhered to, which results in significant gaps in care. In particular, 'flare-ups' (known as exacerbations of COPD), which accelerate disease progression, are often under-reported, despite guidelines recommending an escalation of maintenance treatment to prevent subsequent flare-ups. Management of COPD should be proactive to prevent worsening of symptoms and to reduce the risk of future flare-ups and premature death, rather than a secondary reaction to a worsening health status. Key to this is patient access to accurate diagnosis, effective treatment and specialist care, which can vary widely due to socioeconomic differences, geographical locations and poor guideline implementation. In addition, the stigma associated with COPD can act as a barrier, which can result in people being reluctant to access treatment or clinicians being nihilistic. As global patient advocates, we have co-developed this patient charter to set a standard of care that people living with COPD should expect, raising awareness and understanding of the causes and consequences of COPD as well as the potential to improve patient care. Patients with COPD should be empowered to live the highest quality of life possible with the least number of flare-ups. We set out six principles in line with current COPD guideline recommendations, that should be implemented by governments, healthcare providers, policymakers, lung health industry partners and patients/caregivers to drive meaningful change in COPD care.

A pilot study of identification and case management of high-risk COPD patients in a general practice.

BACKGROUND: A variety of individual therapeutic interventions have been shown to reduce hospital admissions and improve quality of life in patients with chronic obstructive pulmonary disease (COPD). However, there is a paucity of data of looking at the effect of case management in primary care (i.e. using an integrated care approach) of people at higher risk of mortality from COPD. OBJECTIVE: To examine the effect of case management in primary care of patients with COPD at high risk of hospital admission, identified using a novel multidimensional index of disease severity (DOSE index). METHODS: Observational pilot study in a single general practice. High-risk patients were identified using the DOSE index and case managed using an IT system according to British National Guidelines over a 6-month period. RESULTS: Eleven patients entered and completed the study. There was no improvement in health status, but there was a non-significant reduction in total hospital admissions (three versus zero) and total bed days (16 versus 0) compared to the same reference period in the previous year. There was an increase in self-management knowledge. CONCLUSIONS: Case management of high-risk patients in primary care may reduce hospital admissions. This needs to be tested in a randomized controlled trial.

Summary of the consultation on a strategy for services for chronic obstructive pulmonary disease (COPD) in England.

The Consultation on a Strategy for Services for COPD in England is the culmination of five years' work by respiratory specialists from all disciplines, as well as representatives from the voluntary sector, patients, carers and planners. It has been led by the Department of Health in England and the joint National Directors for the programme, Professor Sue Hill and Dr Robert Winter. The Strategy outlines service standards for providers of COPD care and is complementary to the UK National Institute for Health and Clinical Excellence (NICE) guidelines on the management of COPD. Its key elements are: • preventing the development and progression of COPD • diagnosing COPD accurately and at an early stage • developing structured care based on national guidance • promoting self-management education • reducing the number of people admitted to hospital • improving access to end-of-life care • promoting good asthma services. In essence this is an aspirational strategy which aims to change the way that the NHS in England delivers care for people with COPD by identifying them earlier and managing them optimally in order to reduce the likelihood of progression to the more severe stages of the disease. An economic impact assessment shows that implementing the Strategy will save approximately £1billion over 10 years as well as sparing many people from a debilitating illness. This supplement is based on the Strategy Consultation document as well as the NICE guidelines for COPD management. It aims to elucidate practical implementation of the COPD Strategy, and includes verbatim the Strategy recommendations as well as highly relevant clinical information from the NICE guidelines. Implementation of the Strategy recommendations should lead to optimum care for patients with COPD.

Working for Better Asthma Control: How Can We Improve the Dialogue Between Patients and Healthcare Professionals?

Asthma is a chronic disease affecting more than 300 million people globally. Poor asthma control that leads to unnecessary symptoms is estimated to affect nearly half of people with asthma. A critical way to address poor control is for healthcare professionals (HCPs) and patients to enter a shared dialogue on treatment and asthma management. This article explores the views of both patient and HCP to better understand how to achieve asthma control. From the patient's perspective, being a person with asthma has ramifications to one's sense of identity, and thus one's ability and willingness to actively manage their asthma. Furthermore, lack of education and concerns about the effectiveness of treatment can also ultimately lead to poor control, a term that can be understood differently by patients and HCPs. One goal is to help to normalise life for people with asthma. For this, HCPs need to align on what this means for each individual and then work together to produce a plan that can be applied to the patient's daily life. Training for HCPs on good communication skills and empowering patients to be involved in their asthma management are both critical to ensure effective shared decision-making and, ultimately, improved quality of life for people with asthma. FUNDING: Boehringer Ingelheim. Plain language summary available for this article.

Efficacy and Safety of LAMA/LABA Fixed-Dose Combination Therapies in Chronic Obstructive Pulmonary Disease: A Systematic Review of Direct and Indirect Treatment Comparisons.

Background: This literature review assessed comparative efficacy and safety of long-acting muscarinic antagonist/long-acting ß2-agonist (LAMA/LABA) fixed-dose combinations (FDCs) in patients with COPD and moderate-to-very severe airflow limitation, using evidence from direct (head-to-head) and indirect treatment comparisons. Methods: Two systematic literature reviews were conducted to identify direct comparisons (head-to-head randomized controlled trials [RCTs]) and indirect comparisons (network meta-analyses [NMAs]; indirect treatment comparisons; meta-analyses) in patients with COPD with moderate-to-very severe airflow limitation. Study/Analysis characteristics, eligibility criteria, patient characteristics, and overall conclusions were extracted from relevant publications. The review of indirect comparisons focused on NMAs reporting efficacy outcomes at 12 and 24 weeks of treatment (established durations of symptomatic studies in COPD recommended by regulators). Results: Direct comparisons: Four RCTs that provided head-to-head comparisons of LAMA/LABA FDCs were identified, and these varied in their study design, included patient population and reported endpoints. While some differences in lung function outcomes were noted, where assessed, LAMA/LABA FDCs had comparable efficacy in improving symptoms, health status, exacerbations, and comparable safety profiles. However, the differences in study methodology and patient characteristics between these studies made it difficult to draw generalizable conclusions regarding the comparative effectiveness of LAMA/LABA FDCs from the direct comparisons alone. Indirect comparisons: Six NMAs were identified that reported indirect comparisons between LAMA/LABA FDCs; five of these were within the pre-defined scope of this review. Although the scope of each NMA varied, all five concluded that LAMA/LABA FDCs were generally comparable in terms of lung function improvements, patient-reported outcomes, and safety (where assessed). Conclusion: Although there were some inconsistencies between the outcomes of RCTs and NMAs for lung function, the totality of lung function, symptoms, exacerbations, and safety data suggests that currently available LAMA/LABA FDCs have comparable efficacy and safety in patients with COPD and moderate-to-very severe airflow limitation.

The Burden of Self-Reported Rhinitis and Associated Risk for Exacerbations with Moderate-Severe Asthma in Primary Care Patients.

PURPOSE: There is a dearth of research regarding the prevalence and nature of patient-reported rhinitis and its relationship with risk of asthma exacerbations. The aim of this study was to (i) determine the prevalence, severity and treatment of self-reported rhinitis symptoms among adults aged ≥18 years with asthma treated at Global Initiative for Asthma (GINA) Step 3 and above and (ii) compare the demographics, clinical characteristics, medication use, side-effects and healthcare practitioner review between patients who report rhinitis symptoms and those who do not and (iii) determine whether patient-reported rhinitis is associated with risk of asthma exacerbations in the total patient sample. PATIENTS AND METHODS: This analysis used data from the iHARP (Initiative Helping Asthma in Real-life Patients) asthma review service - a cross-sectional observational study (2011 and 2014) in seven countries that captured data on patient demographics, rhinitis symptoms, asthma symptoms, indicators of exacerbations, medication use, oropharyngeal effects and side-effects, using practitioner- and patient-reported questionnaires. Comparisons between patients with and without rhinitis were tested. Univariate logistic regression was used to identify variables associated with risk of exacerbations for entry into multivariable logistic regression. RESULTS: This report contains data from 4274 patients: 67.4% (2881/4274) reported rhinitis symptoms and of which 65.7% (1894/2881) had not received a doctor diagnosis; 36.5% (1052/2881) had moderate-severe rhinitis, 12.4% (358/2881) had used intranasal corticosteroids and 19.8% (569/2881) oral antihistamines. Patients with coexisting moderate-severe rhinitis were more likely to have GINA-defined uncontrolled asthma than those with mild rhinitis or no rhinitis. Moderate-severe rhinitis was associated with 40% increased risk of asthma exacerbations (OR=1.40, 95% CI: 1.02-1.90). CONCLUSION: This study identified a major gap in the diagnosis and management of rhinitis in a cohort of people with asthma treated at GINA Step 3 and above who are managed in general practice. It highlights the need for practitioners to identify, evaluate and optimally treat rhinitis in adults with asthma, which is a significant factor associated with exacerbation risk.