An overview of the core elements of the quality standard position statements across the COPD care pathway is presented in Fig. 2.
Quality Standard Position Statement 1 (Diagnosis)
Individuals at risk and healthcare practitioners should recognize risk factors and early symptoms of COPD. Clinicians should have access to and select the most appropriate tools with which they can make an informed, timely, and accurate diagnosis.
Rationale
The clinical probability of a diagnosis of COPD hinges on a combination of medical history and physical examination, including exposure to risk factors, symptoms, exacerbations, and comorbidities [1]. Diagnosis of COPD is confirmed by spirometry, which confirms the presence of poorly reversible airflow limitation [1]. However, results from a database study of more than 5000 patients reported that only approximately one-third of those with a clinical suspicion of COPD had undergone spirometry [33]. To ensure a timely and accurate diagnosis, spirometry should be performed in the primary care setting, where patients may present with early symptoms of or risk factors for COPD. Therefore, the role of multidisciplinary primary care personnel, including nurses who often interact directly with patients, is particularly important in ensuring diagnostic confirmation [34]. However, many primary care physicians, nurses, and other healthcare professionals receive little formal training in the proper administration and interpretation of spirometry [35] with cost and access to spirometry devices being additional barriers. Crucially, the use of spirometry in primary care may continue to be challenging unless it is tied to reimbursement. Indeed, it has been reported that countries that provide reimbursement for spirometry and extra financial incentives for primary care physicians to perform spirometry have higher rates of spirometry testing [34, 36]. Consequently, healthcare systems should ensure that their providers are adequately trained, compensated, and experienced in performing spirometry in cases with a strong suspicion of COPD, and are proactive in repeating lung function tests in at-risk patients with borderline FEV1 values.
The use of a machine learning/artificial intelligence framework that integrates lung function with clinical variables may improve the accuracy of the American Thoracic Society/European Respiratory Society (ATS/ERS) spirometry interpretation algorithm [37]. However, spirometry may lack the sensitivity to diagnose COPD in its incipient stages and therefore other diagnostic procedures, such as chest computed tomography (CT) scans, body plethysmography, and diffusion capacity, may be required [38]. Healthcare practitioners also should recognize that while 17–24% of patients with preserved lung function may not fulfill the spirometry criterion for a diagnosis of COPD [39], they may nonetheless experience respiratory symptoms, exacerbation-like events, and activity limitations with some evidence of airway disease [40]. Notably, a subset of patients with preserved ratio impaired spirometry (PRISm) eventually progress to meet the spirometric criterion for COPD and are at increased risk of respiratory symptoms, respiratory exacerbations, and mortality [41,42,43]. Currently, however, GOLD recommendations do not address the therapeutic management of patients with PRISm, who represent a heterogenous population, that is possibly underdiagnosed and underappreciated. Therefore, further research is required to examine a diagnostic approach that will help identify the underlying diseases or conditions associated with PRISm and potential treatment options to improve overall prognosis. Finally, not all individuals with post-bronchodilator airflow obstruction have COPD, particularly among those residing in low- and middle-income regions which, in 2020, accounted for 98% of reported cases of tuberculosis (TB) globally [44].
Importantly, a positive diagnosis of a chronic, progressive disease such as COPD should be communicated to patients with educational materials that are culturally appropriate and available in their native languages, recognizing varying degrees of health literacy. Such an endeavor may require modified content and formats to accommodate specific regional or local healthcare systems. In accomplishing this ambitious goal, the education of primary care physicians, nurses, and allied health professionals will contribute importantly to patient instruction and facilitate a physician–patient partnership in COPD care.
COPD is generally diagnosed in middle-aged or older adults, who may be asymptomatic in the early stages of the disease or manifest mild symptoms that may overlap those of other respiratory or extrapulmonary conditions, resulting in underreporting [45]. In addition, the social stigma of symptoms often ascribed to ageing, smoking, or exposure to other environmental irritants may deter patients from seeking timely medical intervention [32]. Consequently, 65–80% of COPD cases remain undiagnosed [46]. Although there is limited evidence of the disease-modifying effects of treatment in the early stages of disease [47, 48], smoking cessation can retard the progression of mild COPD [48]. Additionally, early and accurate diagnosis, as well as appropriate pharmacological and/or nonpharmacological treatment, may attenuate deterioration [26]. Therefore, all patients should have access to necessary resources, including education on COPD risk factors and symptoms, and clinical consultation, to enable timely evaluation and confirmatory diagnosis of COPD [32]. Case-finding strategies, which target individuals or groups at risk of COPD, are practical means by which to identify patients in the initial stages of disease [49]. As an example, tools such as the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE™) may prove useful in identifying symptomatic patients with mild-to-moderate airflow obstruction who might benefit from a comprehensive assessment for COPD [50].
Essential Criterion 1A
Individuals should have access to spirometry performed by healthcare professionals trained in conducting and interpreting pulmonary function tests to facilitate an accurate diagnosis of COPD.
Essential Criterion 1B
All individuals aged over 40 years with known risk factors for COPD, such as smoking, environmental and occupational exposures to organic and inorganic dusts, chemical agents, and fumes identified through case-finding approaches [51], and those presenting with respiratory symptoms, should have access to diagnostic pulmonary function testing, as-needed imaging tests for lung cancer screening and biomarker assessments.
Quality Indicators/Metrics
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1.
Proportion of individuals who present with respiratory symptoms and/or exposures to risk factors who are suspected of having or considered to be at risk of COPD.
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2.
Proportion of individuals who have undergone timely and accurate spirometry to confirm or exclude a diagnosis of COPD following clinical suspicion or considered at risk of COPD.
-
3.
Proportion of patients classified with COPD with documented evidence of quality-assured spirometry [52].
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4.
Time from first symptom presentation to spirometry-confirmed diagnosis.
Quality Standard Position Statement 2 (Adequate Patient and Caregiver Education)
Patients should be educated on the risk factors for COPD, symptom manifestations, exacerbations, and the importance of active engagement in their self-management plan. Caregivers also should be included in educational initiatives to improve clinical outcomes.
Rationale
COPD is a heterogeneous disease in terms of symptom presentation, characterized by daily, weekly, and seasonal variability as one common factor [53]. Patients tend to experience the worst symptoms of dyspnea, cough, and sputum production in the morning hours [54]. However, nocturnal symptoms and ensuing sleep disturbances, which are often underrecognized, may be associated with alterations in lung function, increased exacerbation frequency, and the development or worsening of other comorbidities, such as cardiometabolic diseases and depression in the long term [55, 56].
Over the years, a number of risk factors for COPD have been identified, including tobacco smoke exposure, occupational exposure to noxious particles and gases, ambient and household air pollution, lower socioeconomic status, congenital lung abnormalities, and genetic predisposition [1, 57,58,59,60]. Notably, although tobacco history is only informed by cigarette use in the GOLD recommendations as tobacco cigarette smoking is the most frequently encountered risk factor for COPD [1], other modes of tobacco consumption (e.g., pipes, cigars, hookahs) also significantly increase the risk for COPD [61, 62]. Additionally, in utero and early-life exposure to tobacco, low birth weight, lower respiratory tract infections, and childhood asthma are also known risk factors for the subsequent development of COPD [63]. Therefore, it is essential that patients receive education on the types, onset, frequency, and severity of COPD symptoms [32]. To this end, national awareness campaigns may assist patients to identify signs and symptoms of the disease and encourage evaluation without fear of stigma.
COPD self-management strategies, particularly those which focus on an individualized action plan (Fig. 3) to prevent exacerbations together with structured patient education, tailored case management, and timely access to a healthcare network, are of critical importance [64, 65]. However, the extent of healthcare practitioner engagement with patients can influence the impact of action plans, which may require modification to accommodate country-specific health literacy levels and healthcare access [66, 67]. In addition, action plans should be ideally personalized with treatment goals that are specific, measurable, achievable, realistic, and time bound. Other COPD self-management strategies include smoking cessation, reducing exposure to environmental irritants and infections, and improving exercise and physical activity levels, medication adherence, and proper nutrition. Furthermore, personal coping skills, increased vaccine uptake, breathing and airway clearance techniques (e.g., pursed-lip breathing, huff cough), and promoting safe supplemental oxygen therapy in cases of hypoxemia or during exercise training can also help patients manage their condition [1, 64, 68]. Overall, such self-management interventions among patients with COPD have been associated with a reduction in symptoms and hospital admissions and improved patient-reported health-related quality of life (HRQoL) [69]. Patients should receive personalized education and training on how COPD may interact with or exacerbate comorbid conditions, to empower them as partners in their own care and report any changes to their clinicians to prevent symptom exacerbation and further disease progression [32]. In addition, caregivers of patients with COPD contribute significantly to optimizing patient care. Results from a systematic review of seven studies reported that educational sessions for patients with COPD and their caregivers delivered by healthcare practitioners were effective in improving a broad range of clinical outcomes [70]. Given the importance of educational and training initiatives, healthcare systems could reimburse these activities to encourage uptake.
Shared decision-making among healthcare practitioners, patients, and caregivers will enable patients to play a pivotal role in their healthcare management, which in turn may improve treatment compliance. This is particularly important for older patients, many of whom have multiple comorbidities, to ensure that they achieve their therapeutic goals with minimum treatment-related adverse effects and disruption to their daily lives [71]. Indeed, the importance of shared decision-making and patient engagement (SDM-PE) was reported in a randomized controlled trial in patients hospitalized for acute COPD exacerbations. In this study, patients who received standard treatment and individualized SDM-PE experienced significant improvement in perceived health status at discharge. In addition, COPD knowledge, medication adherence, and general functionality were significantly better at the 3-month follow-up among those who received standard treatment combined with individualized SDM-PE compared with those assigned to standard treatment alone [72]. Consequently, it is crucial that patients, caregivers, and clinicians actively engage in shared and informed decision-making and that patients develop confidence in their self-management plan to maximize its clinical benefits.
Essential Criterion 2
Patients should receive personalized education appropriate to their individual needs and abilities in terms of risk factors, diagnosis, treatment, and follow-up, and be involved in the decision-making process and their self-management plans.
Quality Indicators/Metrics
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1.
Proportion of patients with confirmed COPD who have evidence of receiving education on risk factors, identification of symptoms, and overall disease management.
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2.
Proportion of patients with a confirmed diagnosis of COPD who have evidence of a self-management plan, including an action plan.
Quality Standard Position Statement 3 (Treatment Aligned with the Latest Evidence-Based Recommendations)
Patients should have access to evidence-based, personalized treatments and receive appropriate management of their disease by a respiratory specialist when required.
Rationale
While the GOLD strategy report is widely recognized, its dissemination and implementation remain suboptimal across global primary and specialist care settings [12,13,14,15,16,17,18], and it does not provide resource-stratified recommendations. Moreover, many patients with COPD are managed in primary care settings, which presents unique challenges. Family physicians, nurse practitioners, physician assistants, and others report a lack of awareness and application of COPD guidelines, as well as limited knowledge of the potential, clinical benefits of pharmacologic and non-pharmacologic interventions including pulmonary rehabilitation [73]. Additionally, primary care physicians are limited in their time allocation to the individual patient [74]. Consequently, misdiagnosis and misclassification of patients with COPD occur more commonly in primary than in specialist care settings [75]. Indeed, results from a global survey of more than 50,000 physicians reported that respiratory specialists devoted greater attention to spirometry or the trajectory of disease, while primary care physicians primarily focused on treatment history and symptoms for diagnosis and determination of treatment [76]. The National Asthma and Chronic Obstructive Pulmonary Disease Audit Program reported that in the UK, receipt of specialist care for COPD within 24 h of hospitalization was associated with reduced inpatient mortality and increased smoking cessation initiatives [77]. Thus, streamlined referral pathways should be developed to ensure effective, timely, and appropriate transfer of patients through the respective healthcare system. To that effect, respiratory therapists who work in a variety of settings from critical and acute care to primary and home care can make a substantial contribution to respiratory care, by addressing the cardiorespiratory health needs of the community, providing health education, improving respiratory care policies and protocols, and developing respiratory treatment protocols [78]. Pharmacists also may support individuals with COPD by addressing questions on appropriate medication usage, frequency of administration, and treatment-emergent adverse effects, as well as redirecting them to pulmonary specialists, when required [79]. In terms of access to specialist care, distance to healthcare services may present challenges, with important consequences for health and well-being. Indeed, results from a study which assessed country-level geographic accessibility to pulmonologists for adults with COPD in the USA reported that only 34.5% of patients living in rural areas had access to at least one pulmonologist available within a 10-mile radius of their residence in 2013 [80]. Although telehealth consultations can overcome geographical barriers, virtual diagnostic testing has its own limitations [81]. For instance, although smart phone-connected spirometry equipment may be useful for monitoring patients with an existing diagnosis of COPD, its application in the diagnosis of new cases of COPD has not been fully investigated [82]. In addition, it may not be a viable, long-term option for all patients with severe disease. Nevertheless, it is essential that patient care is not restricted by digital exclusions irrespective of geography or socioeconomic background.
The management of COPD includes both pharmacological and nonpharmacological treatment options [1]. However, several notable gaps exist in patient access to appropriate and affordable care. Despite the GOLD recommendations for inhaled bronchodilator-based maintenance therapy [1], approximately two-thirds of all patients were not prescribed maintenance, inhalation therapy based on a retrospective analysis of medical and pharmacy claims data in more than 50,000 US patients [83]. Results from an analysis of UK patients with both established COPD and those initiating maintenance therapy reported that up to three-quarters of patients who experienced at least two exacerbations were undertreated [13] according to GOLD 2019 recommendations. Importantly, patients should have access not only to evidence-based treatments but also to the most cost-effective therapies, which facilitate effective COPD management within often limited healthcare budgets [84]. Correct inhaler technique is also essential to the optimal management of COPD. Therefore, patients should receive training in proper inhaler technique, which should be regularly re-evaluated by a healthcare practitioner. The choice of inhaler device should be tailored to the needs of the individual patient, acknowledging a number of factors, such as the cost of the drug, patient preference, and ensuring freedom of choice for inhalation therapy [1]. Nonpharmacological interventions complement pharmacological treatments and should be recommended to patients as part of their comprehensive COPD management plan [1]. In particular, post-discharge pulmonary rehabilitation has been reported to reduce mortality in patients hospitalized for a recent exacerbation [85]. As limited access to support with smoking cessation, pulmonary rehabilitation, and immunizations impedes effective COPD management [86], such nonpharmacological treatments should be made more readily accessible to patients.
Essential Criterion 3A
Patients should have access to timely assessment, diagnosis, and medical intervention, either in institutional or community settings, and healthcare systems should have established and reliable referral systems in place to transition patients from primary care to secondary or tertiary care when required.
Essential Criterion 3B
Patients should have access to the most cost-effective and optimal, evidence-based pharmacological and non-pharmacological treatments informed by clinical guidelines.
Quality Indicators/Metrics
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1.
Proportion of patients who have consulted a respiratory specialist or practitioner with expertise in respiratory medicine (including those in primary care) in accordance with local or national guidelines.
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2.
Time from clinical suspicion of COPD to a spirometry-confirmed diagnosis of COPD.
-
3.
Time from confirmation of a COPD diagnosis to review by a specialist (as defined above) as soon as the need for referral to specialist care is established in accordance with local or national guidelines.
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4.
Proportion of patients with COPD whose care conforms to the latest evidence-based treatment recommendations, including access to smoking cessation programs, vaccinations, pulmonary rehabilitation, and inhaled or oral pharmacotherapy.
Quality Standard Position Statement 4 (Post-exacerbation Management)
Patients should undergo timely review of their management plan following recovery from an acute COPD exacerbation to prevent or mitigate recurrent exacerbations and/or disease progression.
Rationale
Patients report exacerbations, which often result in hospital admissions or emergency department visits, as the most disruptive aspect of living with COPD [87]. Furthermore, COPD exacerbations increase the risk of cardiovascular events, including myocardial infarction, stroke [88], and mortality [89], and accelerate decline in lung function, which is often irreversible [89, 90]. In addition, a history of exacerbations strongly predicts future exacerbations [91]. Indeed, results from a large database claims study including more than 70,000 plan members hospitalized for the first time for a coded diagnosis of COPD and followed for up to 17 years found that the risk of a subsequent, severe exacerbation increased three-fold after the second exacerbation and 24-fold after the tenth exacerbation versus the first exacerbation [92]. However, medical reviews of both patients with COPD and their management plans remain suboptimal [32], with only one-quarter of patients with an exacerbation history estimated to receive adequate follow-up reassessment [93]. Whenever and wherever possible, patients hospitalized following a COPD exacerbation should receive care from a respiratory specialist team and at discharge be provided with a personalized written and/or digital management plan [94]. As the results from a population-based cohort study reported that over one in every five patients with COPD died within a year of their discharge [95], patients also should be re-evaluated within 2 weeks of discharge with the objective of optimizing their therapeutic regimen to improve clinical outcomes [26]. Although exacerbations often require treatment with systemic corticosteroids or antibiotics [1], both drug classes increase the risk of adverse effects. Long-term use of systemic corticosteroids is linked to osteoporosis, hyperglycemia, susceptibility to infections, ocular complications, and cardiovascular events [96], while inappropriate use of antibiotics may promote bacterial resistance [97]. Therefore, patients should be educated on the importance of both preventing and managing an exacerbation, and the need for adequate follow-up to minimize their negative impacts [90].
Essential Criterion 4
Following a COPD exacerbation, patients should be reviewed within 2 weeks of onset of treatment of a non-hospitalized exacerbation or following an exacerbation-related hospital discharge to ensure treatment optimization.
Quality Indicator/Metrics
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1.
Proportion of patients receiving a review within 2 weeks of onset of treatment of a non-hospitalized exacerbation or 2 weeks following an exacerbation-related hospital discharge and overall time from onset of an exacerbation to a post-exacerbation review.
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2.
Proportion of patients referred for pulmonary rehabilitation after an exacerbation.
Quality Standard Position Statement 5 (Regular Patient Review)
All patients with COPD should be evaluated annually regardless of their exacerbation history, and more frequently with the occurrence of exacerbations, to ensure the appropriateness and adequacy of their tailored care plan.
Rationale
COPD exacerbations are often a portal into the healthcare system, with patients directly interacting with healthcare practitioners during those events. However, healthcare systems also should accommodate and assist patients who do not experience exacerbations or those whose symptoms overlap with other respiratory diseases [98]. Even patients with seemingly stable disease require regular re-evaluation to proactively assess current levels of symptom control, the presence of comorbidities, physical activity levels and exercise capacity, and requirements for adjusted, different or additional treatment [1]. Healthcare practitioners also should assess therapeutic effectiveness and potential treatment-related adverse effects to determine whether any modifications to pharmacological treatment or the introduction of nonpharmacological modalities are warranted. Accordingly, patient action plans should be reviewed and updated as needed [1]. Patients with COPD should be reevaluated at least annually for treatment adherence, inhalation technique, treatment side effects, mild (self-treated) exacerbations and their management, follow-up spirometry (if appropriate), and a risk assessment according to GOLD. In addition, healthcare practitioners should facilitate caregiver attendance at follow-up appointments, so that their unique perception of the health of the patient can be discussed [99]. As COPD is associated with substantial cognitive, mobility, and auditory disability [100], a holistic approach to preventive care, smoking cessation, pulmonary rehabilitation, and patient and caregiver education that extends beyond exacerbation management should be considered.
Essential Criterion 5
Regardless of exacerbation status, all patients with COPD should have access to a suitably trained practitioner for an annual review.
Quality Indicator/Metrics
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1.
Proportion of patients with a confirmed diagnosis of COPD who receive a review at least annually.