A Practical Guide to the GOLD and COPD Foundation Guidelines

Introduction

Chronic obstructive pulmonary disease (COPD) is a progressive disease that is both preventable and treatable.¹ COPD is currently the third leading cause of death in the United States after heart disease and cancer and leads to substantial clinical and economic burden.^2,3 According to the Behavioral Risk Factor Surveillance Survey, an estimated 15 million people (6.3% of adults in the United States) have been diagnosed with COPD.⁴ The incidence of COPD increases with age; 6.6% among those ages 45 to 54 years, 9.2% among those ages 55 to 64 years, and >11.6% among those ages ≥65 years.⁴ However, it has been suggested that COPD may be underdiagnosed and improperly treated (both under- and over-treated) in the primary care setting.^5-9 Better utilization of 2 prominently used COPD guidelines may assist in diagnosis and treatment of COPD: the Global Initiative for Chronic Obstructive Lung Disease (GOLD) consensus report – Global Strategy for the Diagnosis, Management, and Prevention of COPD, updated annually¹; and the COPD Foundation Guide for Diagnosis and Management of COPD.¹⁰ The aim of this newsletter is to provide an overview of the most recently published guidelines from the 2015 GOLD consensus report and the 2013 COPD Foundation Guide and describe how the differences between these guidelines may affect clinical practice.


Guidelines At-A-Glance

GOLD Consensus Report
The GOLD report was first released in 2001 and provided evidence-based consensus recommendations from the GOLD Scientific Committee on the diagnosis, classification, and treatment of COPD based on published literature.¹ Since the first report in 2001, the GOLD report has undergone numerous revisions with the most recent update in 2015.¹ The GOLD report is designed as a "strategy document" for health care professionals (HCPs) to use as a tool in implementing effective COPD management programs in any clinical setting.¹ Specifically, the goal of the report is to provide assessment of COPD based on: patient's level of symptoms, risk of future exacerbations, severity of spirometric abnormality, and identification of comorbidities.¹ However, the identification of comorbidities does not currently have an impact on treatment recommendations.

The full GOLD report is a comprehensive 80-page document with extensive details geared primarily to a specialist audience and for clinical trial design. The GOLD report is composed of 7 sections: definition and overview, diagnosis and assessment, therapeutic options, management of stable COPD, management of exacerbations, COPD and comorbidities, and asthma and COPD overlap syndrome (ACOS). In addition to the full 80-page report,¹ there is also a shorter 26-page GOLD Pocket Guide¹¹ and a downloadable mobile application.¹² The mobile application is currently only supported by the Apple operating system and provides clinicians with the GOLD strategy for assessing and treating COPD using interactive tables and charts.¹²

COPD Foundation Guide for Diagnosis and Management of COPD
The COPD Foundation Guide was first released in 2013 and aims to provide a "practical, easy to use tool for clinicians."¹⁰ A primary manuscript was published in 2013 to discuss the rationale for development of the guide, insights into the development process, rationale for specific recommendations, and plans for future development.¹⁰ The major recommendations from the COPD Foundation are summarized in the COPD Foundation Pocket Consultant Guide, which is available at the COPD Foundation website at no charge.¹⁰ The pocket guide was designed to assist the practicing clinician with the diagnosis and treatment of COPD patients and covers: identifying patients for whom spirometry should be performed; how to classify patients based on spirometry; how to evaluate and include symptom- and function-based assessments in therapy choices using the Modified Medical Research Council (mMRC) Dyspnea Scale and COPD Assessment Test (CAT); and how to use diagnostic evaluations for comorbidities to influence therapy decisions.¹⁰

The COPD Foundation Guide is specifically focused on providing "practical recommendations for the problems that are frequently encountered in clinical practice and to do so in a format that could be readily used in the context of a busy clinical practice."¹⁰ The COPD Foundation Guide is available in 3 different versions. First, there is a "skinny" 2-panel card (see Figure 1 on page 380 and panel A page 381 of the COPD Foundation Guide¹⁰) that contains diagnostic recommendations of disease severity and therapeutic recommendations. Second, there is a 6-panel card, which contains: diagnostic recommendations of disease severity, therapeutic recommendations, CAT, mMRC questionnaire, and all product names (available as either generic or brand-named version).¹⁰ Third, there is a free downloadable mobile application¹³ for smartphones that contains all of the information in the 6-panel guide, along with the ability to actively calculate spirometry grades (SG), mMRC scores, and CAT scores.^10,14 Many other additional useful interactive materials are also available through the COPD Foundation website.

COPD Disease Definitions

GOLD defines COPD as a common, preventable, and treatable disease, characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases.¹ Exacerbations and comorbidities are recognized as contributing to the overall severity in individual patients. The GOLD report does not include the terms "emphysema" or "chronic bronchitis" as part of the definition of COPD.¹ The COPD Foundation uses COPD as an umbrella term to describe progressive lung diseases including emphysema, chronic bronchitis, refractory (nonreversible) asthma, and some forms of bronchiectasis.¹⁵

COPD Diagnosis and Spirometry

Spirometry is central to providing a clinical diagnosis of COPD, and both GOLD and the COPD Foundation guidelines require its use for patients with suspected COPD.^1,10 A postbronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) ratio of <0.70 is strongly suggestive of a diagnosis of COPD.^1,10 In most cases, this ratio helps differentiate COPD from asthma. Unlike COPD patients whose FEV₁/FVC ratio remains constant, asthma patients may have a ratio in the normal range when the disease is quiescent. In addition, many patients with COPD will have reversibility where their FEV₁ is increased to >12% and 200 mL from baseline after a short-acting bronchodilator (SABA); however, their airway remains obstructed (FEV₁/FVC <0.70).¹⁶ Some asthma patients may also display airflow limitation that is not reversible (most often in severe patients), so it is also important to evaluate risk factors for asthma and COPD.¹⁷

Both the GOLD report and the COPD Foundation recommend spirometry in patients with symptoms such as dyspnea, chronic cough, or chronic sputum.¹⁰ Subtle differences between the 2 guideline recommendations on when to perform spirometry are highlighted in Table 1. The GOLD report recommends that spirometry, and not peak expiratory flow, be considered in addition to symptoms and risk factor assessment, and other parameters consistent with a clinical diagnosis.¹ The COPD Foundation Guide recommends spirometry be indicated for individuals presenting with symptoms of COPD or with risk factors and ≥1 comorbid condition(s), such as heart disease, metabolic syndrome, osteoporosis, sleep apnea, depression, lung cancer, or premature skin wrinkling.¹

In contrast, the COPD Foundation Guide singles out several distinct parameters called "severity domains," which consider crucial assessments in addition to airflow limitation. It recommends assessment of all patients for symptoms; exacerbations; adequacy of oxygenation; and presence of emphysema, chronic bronchitis, and comorbidities (see Figure 1 on page 380 of the COPD Foundation Guide).^1,10 The COPD Foundation Guide directs use of clinical judgment to determine when diagnostic assessments should be performed (eg, assess pulse oxygen or later high-resolution computed tomographic (CT) scan for evaluation of emphysema or blood gases for oxygenation). Although the GOLD report suggests that comorbidities should be assessed, it does not include this within the combined assessment classifications.¹ A similarity between the guidelines is that both use the CAT and mMRC questionnaire scores to assess symptom severity or impact on functionality.¹ The GOLD classification groups and COPD Foundation domains are intended to guide therapeutic intervention.

Classification of Airflow Limitation

Another major difference between the GOLD report and COPD Foundation Guide is how they categorize the severity of airflow limitations. GOLD classifies patients into 4 different groups based on the severity of their measured airflow limitation, which constitutes only half of the overall combined assessment of COPD (see Table 2.5 on page 14 of the GOLD report): GOLD 1 (mild obstruction) at FEV₁ ≥80% predicted; GOLD 2 (moderate obstruction) at FEV₁ ≥50% and <80% predicted; GOLD 3 (severe obstruction) at FEV₁ ≥30% and <50% predicted; and GOLD 4 (very severe obstruction) at FEV₁ <30% predicted.¹

The COPD Foundation Guide uses spirometry values to assign 1 of 5 grades of severity (see Figure 1 on page 380 of the COPD Foundation Guide).¹⁰ Unlike the GOLD report, this is the only categorization of patients. Patients classified with COPD based on spirometry are grouped into 3 grades: SG 1 (mild obstruction) at FEV₁/FVC <0.70 and FEV₁ ≥60% predicted; SG 2 (moderate obstruction) at FEV₁/FVC <0.70 and FEV₁ ≥30% and <60% predicted; and SG 3 (severe obstruction) at FEV₁/FVC <0.70 and FEV₁ <30% predicted.¹⁰ Two additional classifications are also included for individuals who may have COPD but do not fall into the defined spirometry classifications. SG 0 describes patients who have normal spirometry, but this categorization does not rule out emphysema, chronic bronchitis, asthma, or risk of developing exacerbations. This SG 0 category is also important for symptomatic patients who do not meet the obstruction criteria. SG U represents those patients with a normal FEV₁/FVC ratio (FEV₁/FVC >0.70), but low FEV₁ <80% predicted); this categorization is consistent with restriction, muscle weakness, and other pathologies. A comparison of GOLD and COPD Foundation classification of mild, moderate, or severe patients by airflow limitation measures of FEV₁/FVC is presented in Figure 1.

Figure 1. Comparison of GOLD and COPD Foundation Spirometric Classifications of Severity1,10

Abbreviations: COPD, chronic obstructive pulmonary disease; GOLD, Global Initiative for Chronic Obstructive Lung Disease; SG, spirometric grade.

Once a classification of COPD severity and/or risk has been established using either guideline approach, the next step is to consider treatment recommendations. For the GOLD report, treatment is based on the A–D group risk/symptom classification of the patient. A grid of the available options is provided including recommendations of alternative therapies (see Table 4.4 on page 36 of the GOLD Report).¹ In the COPD Foundation Guide, each of the severity domains in addition to spirometry play separate roles in treatment considerations (see Panel A on page 381 of the COPD Foundation Guide).¹⁰ Clinicians can then use the table provided to select the most appropriate treatment for that characteristic and identify both first-line therapy and second-line choices.¹⁰ While it is important that these severity domains are evaluated to develop a comprehensive therapeutic plan, not all are required for every COPD patient at the time of diagnosis; timing and use are based on clinical judgment.¹⁰ For example, assessment of oxygenation becomes more important as the loss of lung function increases (eg, FEV₁ falls).

Case Study (continued) You decide to use the GOLD report as a guide for your diagnosis and treatment. Angela's spirometry results suggest a moderate airflow obstruction category, which you combine with her frequency of exacerbations (1 per year for the past 3 years), mMRC of 3, and CAT of 14 to put her in category B (low risk of exacerbations/more symptoms). Therefore, you select therapy based on category B — single or dual long-acting bronchodilator therapy, pulmonary rehabilitation, appropriate pneumococcal immunization, and yearly influenza immunization. As an academic exercise, you decide to explore the diagnosis and treatment options for Angela using the COPD Foundation Guide. Therefore, in addition to airflow obstruction, you also consider other areas of risk such as oxygenation, emphysema, and comorbidities. Because Angela seems to have more problems with activity than you might anticipate from her FEV1 % predicted, you find that her blood oxygenation is 90% at rest, but after a period of 3 to 4 minutes of walking, saturation decreases to 84%. You would begin initial COPD therapy of long-acting bronchodilators, pulmonary rehabilitation, and immunizations. However, because of her 35-pack-year smoking history and age, you order a low-dose CT scan to screen for lung cancer. Her low-dose screening CT scan was not suggestive of lung cancer but had some areas of large translucency, and you also note that she may be having some arm pain as well as dyspnea with activity. Therefore, you evaluate for deoxygenation with activity, the possibility of significant emphysema, and cardiovascular disease with possible angina. You refer her for high-resolution CT scan and a cardiac stress test and, of course, review all of her cardiovascular risk factors beyond her long-term smoking history. Angela's stress test is negative, so you invite her to come back again in 4 to 6 weeks to evaluate her improvement, consider other changes to her COPD action plan, discuss the results of her high-resolution CT scan, and possibly refer her for oxygen therapy with activity if she continues to have desaturation with walking. While assessing her response to therapy, you will review adherence and inhaler technique, further review possible comorbid conditions (eg, screen for depression), and confirm that she remains smoke-free.

Note: This is a hypothetical case description for teaching purposes.

Both the GOLD report and COPD Foundation Guide recommend that patients receive support and therapy to cease smoking and are vaccinated against influenza and pneumococcus.^1,10 The COPD Foundation Guide also recommends an additional vaccination against pertussis.¹⁰ Although both guidelines have only recently been developed, an analysis of data from 1067 patients showed that outcomes, exacerbation frequency, and health-related quality of life were similar for patients adhering to the therapy recommended by COPD Foundation or GOLD guidelines.¹⁸

Conclusions

Overall, both the GOLD report and COPD Foundation Guide provide essential information to help clinicians diagnose and manage COPD. Spirometry is central to the diagnosis of COPD in both guidelines; however, the classification of patients using spirometry differs, which may affect the choice in treatment pathway. The GOLD system requires 2 separate classification systems within a single management strategy and requires the clinician to assess patient risk. The COPD Foundation Guide provides a more streamlined approach to diagnosis and management of COPD and provides additional considerations for the role of comorbidities. Both the GOLD report and COPD Foundation Guide are available via a downloadable mobile application, which may ease access to these guidelines in clinical practice. At present, there is insufficient evidence to suggest that one strategy is superior to the other.

Acknowledgments

The author thanks Scientific Connexions, an Ashfield Company, part of UDG Healthcare plc (Lyndhurst, NJ, USA) for medical writing support funded by AstraZeneca LP (Wilmington, DE, USA).

References

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