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Journal Article•DOI•

Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary

Claus Vogelmeier1, Gerard J. Criner2, Fernando J. Martinez3, Antonio Anzueto4, Peter J. Barnes5, Jean Bourbeau6, Bartolome R. Celli7, Rongchang Chen8, Marc Decramer9, Leonardo M. Fabbri10, Peter Frith11, David M.G. Halpin12, M. Victorina López Varela13, Masaharu Nishimura14, Nicolas Roche15, Roberto Rodriguez-Roisin16, Don D. Sin17, Dave Singh18, Robert Stockley19, Jørgen Vestbo18, Jadwiga A. Wedzicha20, Alvar Agusti16 •
University of Marburg1, Temple University2, NewYork–Presbyterian Hospital3, University of Texas Health Science Center at San Antonio4, National Institutes of Health5, McGill University Health Centre6, Brigham and Women's Hospital7, Guangzhou Medical University8, Katholieke Universiteit Leuven9, University of Modena and Reggio Emilia10, Flinders University11, Royal Devon and Exeter Hospital12, University of the Republic13, Hokkaido University14, Paris Descartes University15, University of Barcelona16, University of British Columbia17, University of Manchester18, United Nations Industrial Development Organization19, Imperial College London20
01 Mar 2017-Archivos De Bronconeumologia (Ediciones Doyma, S.L.)-Vol. 53, Iss: 3, pp 128-149
TL;DR: The assessment of COPD has been refined to separate the spirometric assessment from symptom evaluation, and the concept of de-escalation of therapy is introduced in the treatment assessment scheme.
Abstract: This Executive Summary of the Global Strategy for the Diagnosis, Management, and Prevention of COPD (GOLD) 2017 Report focuses primarily on the revised and novel parts of the document. The most significant changes include: 1) the assessment of COPD has been refined to separate the spirometric assessment from symptom evaluation. ABCD groups are now proposed to be derived exclusively from patient symptoms and their history of exacerbations; 2) for each of the groups A to D, escalation strategies for pharmacological treatments are proposed; 3) the concept of de-escalation of therapy is introduced in the treatment assessment scheme; 4) nonpharmacologic therapies are comprehensively presented and; 5) the importance of comorbid conditions in managing COPD is reviewed.

Summary (7 min read)

Jump to: [Definition and Factors That Influence COPD Development and Progression] – [Factors That Influence Disease Development and Progression] – [Key Points] – [Diagnosis] – [Symptoms] – [Medical History] – [Physical examination] – [Spirometry] – [Assessment] – [Assessment of symptoms] – [Assessment of exacerbation risk] – [Alpha-1 antitrypsin deficiency] – [Additional investigations] – [Smoking Cessation] – [Vaccinations] – [Overview of medications] – [Bronchodilators] – [Combination bronchodilator therapy] – [Inhaled corticosteroids] – [Triple inhaled therapy] – [Phosphodiesterase-4 inhibitors] – [Pulmonary Rehabilitation] – [Education, Self-Management, and Integrative Care] – [Oxygen Therapy and Ventilatory Support] – [Interventional Therapy] – [Identify and Reduce Exposure to Risk Factors] – [Pharmacologic Treatment] – [Pharmacologic treatment algorithms] – [Group B] – [Group C] – [Group D] – [End-of-life and palliative care] – [Vaccination] – [Ventilatory support] – [Interventional bronchoscopy and surgery] – [Monitoring and Follow-Up] – [Management of Exacerbations] – [Treatment Setting] – [Respiratory Support] – [Hospital Discharge and Follow-Up] – [Ischemic heart disease] – [Arrhythmias] – [Osteoporosis] and [Metabolic Syndrome and Diabetes]

Definition and Factors That Influence COPD Development and Progression

  • Key Points[TS: Set all “Key Points”] boxes as they were in original GOLD (http://www.atsjournals.org/doi/pdf/10.1164/rccm.201204-0596PP).] COPD is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.
  • Dyspnea, cough and/or sputum production are the most frequent symptoms; symptoms are commonly under-reported by patients.
  • Tobacco smoking is the main risk exposure for COPD, but environmental exposures like biomass fuel exposure and air pollution may contribute.
  • Besides exposures, host factors (genetic abnormalities, abnormal lung development and accelerated aging) predispose individuals to develop COPD.
  • In most patients, COPD is associated with significant concomitant chronic diseases, which increase morbidity and mortality.

Factors That Influence Disease Development and Progression

  • Epidemiologic studies demonstrate that non-smokers may also develop chronic airflow limitation.
  • Compared to smokers with COPD, never smokers with chronic airflow limitation have fewer symptoms, milder disease and a low r burden of systemic inflammation.
  • Processes occurring during gestation, birth, and exposures during childhood and adolescence affect lung growth.
  • Cigarette smokers have a higher prevalence of respiratory symptoms and lung function abnormalities, a greater annual rate of decline in FEV1, and a greater COPD mortality rate than non-smokers.

Key Points

  • COPD often coexists with other diseases that may significantly impact patient outcome.
  • The presence of comorbidities should not alter COPD treatment and comorbidities should be treated per usual standards regardless of the presence of COPD.
  • When COPD is part of a multi-morbidity care plan, attention should be directed to ensure simplicity of treatment and minimize polypharmacy.
  • COPD often coexists with other diseases that may have a significant impact on prognosis.
  • Some of these arise independently of COPD whereas others may be causally related, either with shared risk factors, or by one disease increasing the risk or compounding the severity of the other.308 Management of the COPD patient must include identification and treatment of its comorbidities; the most common in COPD are outlined below.

Diagnosis

  • COPD should be considered in any patient with dyspnea, chronic cough or sputum production, and/or a history of exposure to risk factors for the disease .
  • Spirometry is required to make the diagnosis in this clinical context31; a post- bronchodilator FEV1/FVC < 0.70 confirms the presence of persistent airflow limitation and identifies the presence of COPD in patients with appropriate symptoms and predisposing risks.

Symptoms

  • Chronic and progressive dyspnea is the most characteristic symptom of COPD.
  • The terms used to describe dyspnea vary individually and culturally.
  • Regular sputum production > 3 months in 2 consecutive years is the classical definition of chronic bronchitis;34 an arbitrary definition that does not reflect the range of sputum production reported in COPD.
  • For Review O nly Additional features in severe disease.
  • Fatigue, weight loss and anorexia are common in patients with more severe forms of COPD.

Medical History

  • A detailed medical history of any patient who is known, or suspected, to have COPD should include: Exposure to risk factors, such as smoking and occupational or environmental exposures.
  • Past medical history, including asthma, allergy, sinusitis, or nasal polyps; respiratory infections in childhood; other chronic respiratory and non-respiratory diseases.
  • Pattern of symptom development: age of onset, type of symptom, more frequent or prolonged “winter colds,” and social restriction.
  • Presence of comorbidities, such as heart disease, osteoporosis, musculoskeletal disorders, and malignancies.
  • Impact of disease on patient’s life, including limitation of activity, missed work and economic impact, and feelings of depression or anxiety.

Physical examination

  • A physical examination is rarely diagnostic in COPD.
  • Physical signs of airflow limitation/hyperinflation are usually not identifiable until significantly impaired lung function is present.

Spirometry

  • Spirometry is the most reproducible and objective measurement of airflow limitation.
  • It is a noninvasive and readily available test.
  • 41,42 Using GLI equations, z scores were calculated for FEV1, FVC, and FEV1/FVC and compared to fixed ratio data.
  • These findings await additional study in other cohorts.
  • The risk of misdiagnosis and over-treatment using the fixed ratio as a diagnostic criterion is limited since spirometry is only one parameter used to establish the clinical diagnosis of COPD.

Assessment

  • To achieve these goals, COPD assessment must consider separately the following aspects of the disease: Presence and severity of the spirometric abnormality Current nature and magnitude of symptoms .
  • The role of spirometry for the diagnosis, assessment and follow-up of COPD is summarized in Table 2.

Assessment of symptoms

  • COPD was previously viewed as a disease largely characterized by breathlessness.
  • A simple measure of breathlessness such as the Modified British Medical Research Council (mMRC) Questionnaire48 was considered adequate for assessment of symptoms49, 50,51 However, COPD impacts patients well beyond dyspnea.
  • The most For Review O nly comprehensive disease-specific health status questionnaires include the Chronic Respiratory Questionnaire (CRQ)53 and St. George’s Respiratory Questionnaire (SGRQ).
  • These are too complex to use in clinical practice, but shorter measures e.g., the COPD Assessment Test are suitable.

Assessment of exacerbation risk

  • 59 Hospitalization for a COPD exacerbation has a poor prognosis and an increased risk of death.60 Blood eosinophil count.
  • These findings suggest that blood eosinophil counts are 1) a biomarker of exacerbation risk in patients with a history of exacerbations and 2) can predict the effects of ICS on exacerbation prevention.
  • To address these concerns, the 2017 GOLD Report provides a refinement of the ABCD assessment that separates spirometric grades from “ABCD” groupings.
  • This approach acknowledges the limitations of FEV1 in making treatment decisions for individualized patient care and highlights the importance of patient symptoms and exacerbation risks in guiding therapies in COPD.
  • With the new proposed scheme, the subject with 3 exacerbations in the past year would be labelled GOLD grade 4, group D. Individual decisions on pharmacotherapeutic approaches would use the recommendations based on the ABCD assessment to treat the patient’s major problem at this time, i.e., persistent exacerbations.

Alpha-1 antitrypsin deficiency

  • The World Health Organization recommends that all patients with a diagnosis of COPD be screened once for alpha-1 antitrypsin deficiency.
  • Family members should be screened and together with the patient referred to specialist centres for advice and management.

Additional investigations

  • In order to rule out other concomitant disease contributing to respiratory symptoms, or in cases where patients do not respond to the treatment plan as expected, additional testing may be required.
  • The BODE (Body mass index, Obstruction, Dyspnea, and Exercise) method gives a composite score that is a better predictor of subsequent survival than any single component.
  • 72,73 For Review O nly Differential diagnoses.
  • In some patients, features of asthma and COPD may coexist.
  • Some patients without evidence of airflow limitation have evidence of structural lung disease on chest imaging (emphysema, gas trapping, airway wall thickening).

Smoking Cessation

  • Smoking cessation influences the natural history of COPD.
  • E-cigarettes are increasingly used as a form of nicotine replacement therapy, although their efficacy remains controversial.
  • Varenicline,83 bupropion,84 and nortriptyline85 increase longterm quit rates,85 but should be used as part of an interventional program rather than as a sole intervention.
  • A five-step program for intervention86,87 provides a framework to guide healthcare providers to help patients stop smoking.
  • 77,86,88 Counseling delivered by health professionals significantly increases quit rates over selfinitiated strategies.

Vaccinations

  • Influenza vaccine and Pneumococcal vaccines Influenza vaccination reduces serious illness,91 death,92-95 the risk of ischemic heart disease96 and the total number of exacerbations.
  • 92 Vaccines containing either killed or live inactivated viruses are recommended97 as they are more effective in elderly patients with COPD.98 Pneumococcal vaccinations, PCV13 and PPSV23, are recommended for all patients ≥ 65 years of age .

Overview of medications

  • Pharmacologic therapy for COPD reduces symptoms, the frequency and severity of exacerbations, and improves exercise tolerance and health status.
  • No existing medication modifies the long-term decline in lung function.
  • The choice within each class depends on the availability and cost of medication and favorable clinical response balanced against side effects.
  • Each treatment regimen needs to be individualized as the relationship between severity of symptoms, airflow limitation, and severity of exacerbations varies between patients.

Bronchodilators

  • Bronchodilators increase FEV1, reduce dynamic hyperinflation, at rest and during exercise,104,105 and improve exercise performance.
  • Beta2-agonists, including short-acting (SABA) and long-acting (LABA) agents, relax airway smooth muscle.
  • Ipratropium, a short acting muscarinic antagonist, provides small benefits over short-acting beta2-agonist in terms of lung function, health status and requirement for oral steroids.

Combination bronchodilator therapy

  • Combining bronchodilators with different mechanisms and durations of action may increase the degree of bronchodilation with a lower risk of side-effects compared to increasing the dose of a single bronchodilator (Table 3).
  • These combinations improve lung function compared to placebo122 and have a greater impact on patient reported outcomes compared to monotherapies.

Inhaled corticosteroids

  • In patients with moderate to very severe COPD and exacerbations, an inhaled corticosteroid (ICS) combined with a LABA is more effective than either component alone in improving lung function, health status and reducing exacerbations.
  • Observational studies suggest that ICS treatment could be associated with increased risks of diabetes/poor control of diabetes,140 cataracts,141 and mycobacterial infection142 including tuberculosis.143,144 ICS withdrawal.
  • Withdrawal studies provide equivocal results regarding the consequences of withdrawal on lung function, symptoms and exacerbations.

Triple inhaled therapy

  • Combination of LABA plus LAMA plus ICS (triple therapy) may improve lung function and patient reported outcomes.
  • One RCT failed to demonstrate any benefit of adding an ICS to LABA plus LAMA on exacerbations.

Phosphodiesterase-4 inhibitors

  • Roflumilast reduces moderate and severe exacerbations treated with systemic corticosteroids in patients with chronic bronchitis, severe to very severe COPD, and a history of exacerbations.
  • The most frequent are diarrhea, nausea, reduced appetite, weight loss, abdominal pain, sleep disturbance, and headache.
  • Roflumilast should be avoided in underweight patients and used with caution in patients with depression.

Pulmonary Rehabilitation

  • Pulmonary rehabilitation is a comprehensive intervention based on thorough patient assessment followed by patient-tailored therapies (e.g., exercise training, education, self-management interventions aimed at behavior changes to improve physical and psychological condition and promote adherence to health-enhancing behaviors in patients with COPD).
  • Pulmonary rehabilitation can reduce readmissions and mortality in patients following a recent exacerbation (≤ 4 weeks from prior hospitalization).

Education, Self-Management, and Integrative Care

  • Smoking cessation, correct use of inhaler devices, early recognition of exacerbation, decision making, when to seek help, surgical interventions, and the consideration of advance directives, are examples of educational topics.
  • Self-management interventions that use written negotiated action plans for worsening symptoms may lead to less respiratory-related hospitalization and all cause hospitalizations and improved health status.

Oxygen Therapy and Ventilatory Support

  • The long-term administration of oxygen (> 15 hours per day) to patients with chronic respiratory failure increases survival in patients with severe resting hypoxemia.
  • Whether to use NPPV chronically at home to treat patients with acute on chronic respiratory failure following hospitalization remains undetermined.
  • Retrospective studies have provided inconclusive data.200,201 RCTs have yielded conflicting data on the use of home NPPV on survival and re-hospitalization in chronic hypercapnic COPD.202-205.
  • In patients with both COPD and obstructive sleep apnea continuous positive airway pressure improves survival and avoids hospitalization .

Interventional Therapy

  • A RCT confirmed that COPD patients with upper- lobe emphysema and low post-rehabilitation exercise capacity experienced improved survival when treated with lung volume reduction surgery (LVRS) compared to medical treatment.
  • Subsequently, efficacy of the same endobronchial valve has been studied in patients with heterogeneous,217 or heterogeneous and homogenous emphysema218 with mixed outcomes.

Identify and Reduce Exposure to Risk Factors

  • Cigarette smoking is the most commonly encountered and easily identifiable risk factor for COPD; smoking cessation should be continually encouraged for current smokers.
  • Reduction of total personal exposure to occupational dusts, fumes, and gases, and to indoor and outdoor air pollutants, should be addressed.

Pharmacologic Treatment

  • The most commonly used classes of medications for COPD exacerbations are bronchodilators, corticosteroids, and antibiotics.
  • Intravenous methylxanthines are not recommended due to side effects.
  • Systemic glucocorticoids in COPD exacerbations shorten recovery time and improve FEV1.
  • A study in patients with exacerbations requiring mechanical ventilation (invasive or noninvasive) reported increased mortality and a higher incidence of secondary nosocomial pneumonia when antibitoics were not given.

Pharmacologic treatment algorithms

  • A proposed model for the initiation, and then subsequent escalation and/or de- escalation of pharmacologic management according to the individualized assessment of symptoms and exacerbation risk is shown in Figure 3.
  • In past GOLD Reports, recommendations were only given for initial therapy.
  • Many COPD patients are already on treatment and return with persistent symptoms after initial therapy, or less commonly with resolution of some symptoms that may subsequently require less therapy.
  • Therefore, the authors now suggest escalation and de-escalation strategies.
  • The recommendations are based on available efficacy and safety data.

Group B

  • Initial therapy should be a long acting bronchodilator.
  • Long-acting bronchodilators are superior to short-acting bronchodilators taken intermittently.
  • There is no evidence to recommend one class of long-acting bronchodilators over another for symptom relief, the choice should depend on individual patient response.
  • For patients with persistent breathlessness on monotherapy222 the use of two bronchodilators is recommended.
  • For patients with severe breathlessness, initial therapy with two bronchodilators may be considered.

Group C

  • Initial therapy should be a single long acting bronchodilator.
  • In two head-to head comparisons112,223 the LAMA tested superior to the LABA regarding exacerbation prevention, therefore the authors recommend initiating a LAMA in this group.
  • Patients with persistent exacerbations may benefit from adding a second long acting bronchodilator (LABA/LAMA), or using a combination of a long acting beta2-agonist and an inhaled corticosteroid (LABA/ICS).
  • As ICS increases the risk for developing pneumonia, their primary choice is LABA/LAMA.

Group D

  • The authors recommend initiating a LABA/LAMA combination because: LABA/LAMA combination was superior to LABA/ICS combination in preventing exacerbations and improving other patient reported outcomes in Group D patients.
  • Group D patients are at higher risk for pneumonia when receiving ICS treatment.
  • These patients may have a history and/or findings suggestive of asthma-COPD overlap and/or high blood eosinophil counts.
  • The possibility of developing resistant organisms should be factored into the decision making.

End-of-life and palliative care

  • Patients should be informed that should they become critically ill, they or their family members may need to decide whether a course of intensive care is likely to achieve their personal goals of care.
  • Simple, structured conversations about these possible scenarios should be discussed while patients are in their stable state.

Vaccination

  • Influenza vaccination is recommended for all patients with COPD.
  • Pneumococcal vaccinations, PCV13 and PPSV23, are recommended for all patients > 65 years of age.
  • The PPSV23 is also recommended for younger COPD patients with significant comorbid conditions including chronic heart or lung disease.

Ventilatory support

  • NIV is occasionally used in patients with stable very severe COPD.
  • NIV may be considered in a selected group of patients, particularly those with pronounced daytime hypercapnia and recent hospitalization, although contradictory evidence exists regarding its effectiveness.
  • In patients with both COPD and obstructive sleep apnea continuous positive airway pressure is indicated.

Interventional bronchoscopy and surgery

  • In selected patients with heterogeneous or homogenous emphysema and significant hyperinflation refractory to optimized medical care, surgical or bronchoscopic modes of lung volume reduction (e.g., endobronchial one-way valves or lung coils) may be considered.
  • An algorithm depicting the various interventions based on radiological and physiological features is shown in Figure 4.
  • Criteria for referral for lung transplantation include COPD with progressive disease, not a candidate for endoscopic or surgical lung volume reduction, BODE index of 5 to 6, Pco2 > 50 mmHg or 6.6 kPa and/or PaO2 < 60 mmHg or 8 kPa, and FEV1 < 25% predicted.

Monitoring and Follow-Up

  • Routine follow-up of COPD patients is essential.
  • Symptoms, exacerbations and objective measures of airflow limitation should be monitored to determine when to modify management and to identify any complications and/or comorbidities that may develop.
  • In order to adjust therapy appropriately as the disease progresses, each follow-up visit should include a discussion of the current therapeutic regimen.
  • Symptoms that indicate worsening or development of another comorbid condition should be evaluated and treated.

Management of Exacerbations

  • The most common causes are respiratory tract infections.
  • The goal for treatment of exacerbations is to minimize the negative impact of the current exacerbation and to prevent subsequent events.
  • Maintenance therapy with long-acting bronchodilators should be initiated as soon as possible before hospital discharge.
  • Exacerbations are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression.
  • Other symptoms include increased sputum purulence and volume, together with increased cough and wheeze.

Treatment Setting

  • The goals of exacerbation treatment are to minimize the negative impact of the current exacerbation, and to prevent the development of subsequent events.
  • More than 80% of exacerbations are managed on an outpatient basis with bronchodilators, corticosteroids, and antibiotics.
  • Key points for the management of exacerbations Duration of therapy should not be more than 5-7 days (Evidence A). Antibiotics, when indicated, can shorten recovery time, reduce the risk of early relapse, treatment failure, and hospitalization duration.

Respiratory Support

  • Supplemental oxygen should be titrated to improve hypoxemia with a target saturation of 88-92%.283.
  • Once oxygen is started, blood gases should be checked to ensure satisfactory oxygenation without carbon dioxide retention and/or worsening acidosis.
  • Some patients require admission to the intensive care unit.
  • NIV has been studied in RCTs showing a success rate of 80-85%.284-288 Mortality and intubation rates are reduced by NIV.284,289-291 Invasive mechanical ventilation.
  • In patients who fail non-invasive ventilation as initial therapy and receive invasive ventilation as For Review O nly subsequent rescue therapy, morbidity, hospital length of stay and mortality are greater.

Hospital Discharge and Follow-Up

  • Lack of spirometric assessment and arterial blood gas analysis have been associated with re-hospitalization and mortality.
  • There is insufficient data that they influence readmission rates, short-term mortality293,294,296,297 or cost-effectiveness.
  • An assessment of the presence and management of comorbidities should also be undertaken .

Ischemic heart disease

  • There is an increased risk of myocardial damage in patients with concomitant ischemic heart disease who have an acute exacerbation of COPD.
  • Patients who demonstrate abnormal cardiac troponins are at an increased risk of adverse outcomes including short-term (30 day) and long-term mortality.

Arrhythmias

  • Cardiac arrhythmias are common in COPD and vice versa.
  • Atrial fibrillation is frequent and directly associated with FEV1.
  • Bronchodilators have been previously described as potentially pro-arrhythmic agents;314,315 however, evidence suggests an overall acceptable safety profile for long-acting beta2-agonists, 316 anticholinergic drugs (and inhaled corticosteroids).

Osteoporosis

  • Osteoporosis is often associated with emphysema,325,326 decreased body mass index327 and low fat-free mass.328 Low bone mineral density and fractures are common in COPD patients even after adjustment for steroid use, age, pack-years of smoking, current smoking, and exacerbations.
  • An association between inhaled corticosteroids and fractures has been found in pharmaco-epidemiological studies.
  • Systemic corticosteroids significantly increase the risk of osteoporosis.

Metabolic Syndrome and Diabetes

  • Metabolic syndrome and diabetes are more frequent in COPD and the latter is likely to affect prognosis.
  • The prevalence of metabolic syndrome has been estimated to be more than 30%.339.

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Figures (5)

Content maybe subject to copyright    Report

For Review Only
Global Strategy for th
e Diagnosis, Management, and
Prevention of Chronic Obstructive Lung Disease 2017
Report: GOLD Executive Summary
Journal:
American Journal of Respiratory And Critical Care Medicine
Manuscript ID
Blue-201701-0218PP
Manuscript Type:
PP - Pulmonary Perspective
Date Submitted by the Author:
26-Jan-2017
Complete List of Authors:
Vogelmeier, Claus; University of Marburg
Criner, Gerard; Lewis Katz School of Medicine at Temple University
Martinez, Fernando J; New York-Presbyterian Hospital/Weill Cornell Medical
Center
Anzueto, Antonio; University of Texas Health Science Center and South
Texas Veterans Health Care System
Barnes, Peter; National Heart & Lung Institute, Imperial College London,
Airway Disease Section,
Bourbeau, Jean; McGill University Health Centre, McGill University
Celli, Bartolome; Brigham and Women's Hospital,
Chen, Rongchang; State Key Lab for Respiratory Disease, Guangzhou
Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou
Medical University
Decramer, Marc; University of Leuven
Fabbri, Leonardo; University of Modena & Reggio Emilia
Frith, Peter; Flinders University Faculty of Medicine
Halpin, David; Royal Devon & Exeter Hospital
López Varela, M. Victorina ; Universidad de la República, Hospital Maciel
Nishimura, Masaharu; Hokkaido University School of Medicine
Roche, Nicolas; Hôpital Cochin (APHP), University Paris Descartes
Rodriguez-Roisin, Roberto; Thorax Institute, Hospital Clinic Universitat de
Barcelona
Sin, Don; St. Paul's Hospital, University of British Columbia
Singh, Dave; University of Manchester
Stockley, Robert; University Hospital
Vestbo, Jørgen; University of Manchester
Wedzicha, Jadwiga; Imperial College London, National Heart and Lung
Institute
Agusti, Alvar; Hospital Clínic, Universitat de Barcelona, Ciberes
Subject Category:
9.09 COPD: General < LUNG DISEASES
Keywords:
Diagnosis, Management and Prevention of COPD
For Review Only
Page 1 of 74
For Review Only
Global Strategy for the Diagnosis, Management, and Prevention of Chronic
Obstructive Lung Disease 2017 Report
GOLD Executive Summary
Claus F. Vogelmeier
1*
, Gerard J. Criner
2*
, Fernando J. Martinez
3*
, Antonio Anzueto
4
,
Peter J. Barnes
5
, Jean Bourbeau
6
, Bartolome R. Celli
7
, Rongchang Chen
8
, Marc
Decramer
9
, Leonardo M. Fabbri
10
, Peter Frith
11
, David M. G. Halpin
12
, M. Victorina
López Varela
13
, Masaharu Nishimura
14
, Nicolas Roche
15
, Roberto Rodriguez-Roisin
16
,
Don D. Sin
17
, Dave Singh
18
, Robert Stockley
19
, Jørgen Vestbo
18
, Jadwiga A.
Wedzicha
20
and Alvar Agusti
21
.
*These authors contributed equally to the manuscript
1
University of Marburg, Marburg, Germany, Member of the German Center for Lung
Research (DZL);
2
Lewis Katz School of Medicine at Temple University, Philadelphia,
Pennsylvania, USA;
3
New York-Presbyterian Hospital, Weill Cornell Medical Center,
New York, New York, USA;
4
University of Texas Health Science Center and South
Texas Veterans Health Care System, San Antonio, Texas, USA;
5
National Heart and
Lung Institute, Imperial College, London, United Kingdom;
6
McGill University Health
Centre, McGill University, Montreal, Canada;
7
Brigham and Women’s Hospital Boston,
Massachusetts, USA;
8
State Key Lab for Respiratory Disease, Guangzhou Institute of
Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University,
Guangzhou, PRC;
9
University of Leuven, Leuven, Belgium;
10
University of Modena &
Reggio Emilia, Modena, Italy;
11
Flinders University Faculty of Medicine, Bedford Park,
South Australia, Australia;
12
Royal Devon & Exeter Hospital, Exeter, UK;
13
Universidad
de la República, Hospital Maciel, Montevideo, Uruguay;
14
Hokkaido University School of
Medicine Sapporo, Japan;
15
Hôpital Cochin (APHP), University Paris Descartes, Paris,
France;
16
Thorax Institute, Hospital Clinic Universitat de Barcelona, Barcelona, Spain;
17
St. Paul's Hospital, University of British Columbia, Vancouver, Canada;
18
University of
Manchester, Manchester, UK;
19
University Hospital, Birmingham, UK;
20
Imperial College
London, London, UK;
21
Hospital Clínic, Universitat de Barcelona, Ciberes, Barcelona,
Spain.
For reprint requests, please contact Diane Gern at dgern@thoracic.org or 212-315-
6441.
Page 2 of 74
For Review Only
Abstract
This Executive Summary of the Global Strategy for the Diagnosis, Management, and
Prevention of COPD (GOLD) 2017 Report focuses primarily on the revised and novel
parts of the document. The most significant changes include: i) the assessment of
COPD has been refined to separate the spirometric assessment from symptom
evaluation. ABCD groups are now proposed to be derived exclusively from patient
symptoms and their history of exacerbations; ii) for each of the groups A to D,
escalation strategies for pharmacological treatments are proposed; iii) the concept of
de-escalation of therapy is introduced in the treatment assessment scheme; iv)
nonpharmacologic therapies are comprehensively presented and; v) the importance of
comorbid conditions in managing COPD is reviewed.
Page 3 of 74
For Review Only
CONTENTS
Introduction
Definition and Factors That Influence COPD Development and Progression
Key Points
Definition and Pathogenesis
Factors That Influence Disease Development and Progression
Diagnosis and Initial Assessment
Key Points
Diagnosis
Symptoms
Dyspnea
Cough
Sputum production
Wheezing and chest tightness
Additional features in severe disease
Medical History
Physical examination
Spirometry
Assessment
Classification of severity of airflow limitation
Assessment of symptoms
Choice of thresholds
Assessment of exacerbation risk
Blood eosinophil count
Assessment of concomitant chronic diseases (comorbidities)
Revised combined COPD assessment
Example
Alpha-1 antitrypsin deficiency
Additional investigations
Composite scores
Differential diagnoses
Other considerations
Prevention and Maintenance Therapy
Key Points
Smoking Cessation
Nicotine replacement products
Pharmacologic products
Smoking cessation programs
Vaccinations
Influenza vaccine and Pneumococcal vaccines
Pharmacologic Therapy for Stable COPD
Overview of medications
Bronchodilators
Beta
2
-agonists
Antimuscarinic drugs
Methylxanthines
Combination bronchodilator therapy
Page 4 of 74
Citations
More filters
Journal Article•DOI•
Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015

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Joan B. Soriano1, Joan B. Soriano2, Amanuel Alemu Abajobir3, Kalkidan Hassen Abate4, Semaw Ferede Abera, Anurag Agrawal, Muktar Beshir Ahmed4, Amani Nidhal Aichour, Ibtihel Aichour, Miloud Taki Eddine Aichour, Khurshid Alam, Noore Alam, Juma Alkaabi5, Fatma Al-Maskari5, Nelson Alvis-Guzman6, Alemayehu Amberbir, Yaw Ampem Amoako, Mustafa Geleto Ansha, Josep M. Antó, Hamid Asayesh7, Tesfay Mehari Atey8, Euripide Frinel G Arthur Avokpaho, Aleksandra Barac9, Sanjay Basu10, Neeraj Bedi, Isabela M. Benseñor11, Adugnaw Berhane12, Addisu Shunu Beyene13, Addisu Shunu Beyene14, Zulfiqar A Bhutta, Stan Biryukov, Dube Jara Boneya15, Michael Brauer, David O. Carpenter16, David O. Carpenter17, Daniel C Casey, Devasahayam J. Christopher18, Lalit Dandona, Rakhi Dandona, Samath D Dharmaratne19, Huyen Phuc Do, Florian Fischer20, TT Gebrehiwot21, TT Gebrehiwot13, TT Gebrehiwot22, Ayele Geleto21, Ayele Geleto13, Ayele Geleto22, Aloke Gopal Ghoshal, Richard F. Gillum23, Ibrahim Abdelmageem Mohamed Ginawi, Vipin Gupta24, Simon I. Hay, Mohammad Taghi Hedayati25, Nobuyuki Horita26, Nobuyuki Horita27, H. Dean Hosgood28, Mihajlo Jakovljevic, Spencer L. James, Jost B. Jonas, Amir Kasaeian, Yousef Khader, Ibrahim A Khalil, Ejaz Ahmad Khan, Young-Ho Khang, Jagdish Khubchandani, Luke D. Knibbs, Soewarta Kosen, Parvaiz A Koul, G Anil Kumar, Cheru Tesema Leshargie, Xiaofeng Liang, Hassan Magdy Abd El Razek, Azeem Majeed, Deborah Carvalho Malta, Treh Manhertz, Neal Marquez, Alem Mehari, George A. Mensah, Ted R. Miller, Karzan Abdulmuhsin Mohammad, Kedir Endris Mohammed, Shafiu Mohammed, Ali H. Mokdad, Mohsen Naghavi, Cuong Tat Nguyen, Grant Nguyen, Quyen Nguyen, Trang Huyen Nguyen, Dina Nur Anggraini Ningrum, Vuong Minh Nong, Jennifer Ifeoma Obi, Yewande E Odeyemi, Felix Akpojene Ogbo, Eyal Oren, Padukudru Anand Mahesh, Eun-Kee Park, George C Patton, Katherine R. Paulson, Mostafa Qorbani, Reginald Quansah, Anwar Rafay, Mohammad Hifz Ur Rahman, Rajesh Kumar Rai, Salman Rawaf, Nik Reinig, Saeid Safiri, Rodrigo Sarmiento-Suarez, Benn Sartorius, Miloje Savic, Monika Sawhney, Mika Shigematsu, Mari Smith, Fentaw Tadese, George D. Thurston, Roman Topor-Madry, Bach Xuan Tran, Kingsley N. Ukwaja, Job F M van Boven, Vasiliy Victorovich Vlassov, Stein Emil Vollset, Xia Wan, Andrea Werdecker, Sarah Wulf Hanson, Yuichiro Yano, Hassen Hamid Yimam, Naohiro Yonemoto, Chuanhua Yu, Zoubida Zaidi, Maysaa El Sayed Zaki, Alan D. Lopez, Christopher J L Murray, Theo Vos •
Autonomous University of Madrid1, Spanish National Research Council2, University of Queensland3, Jimma University4, United Arab Emirates University5, University of Cartagena6, University of Qom7, Mekelle University8, University of Belgrade9, Stanford University10, University of São Paulo11, Debre Berhan University12, Haramaya University13, Bahir Dar University14, Debre markos University15, State University of New York System16, University System of Georgia17, Christian Medical College & Hospital18, University of Peradeniya19, Bielefeld University20, University of Newcastle21, Newcastle University22, Howard University23, University of Delhi24, University of Mazandaran25, Yokohama City University26, Juntendo University27, Albert Einstein College of Medicine28
01 Sep 2017-The Lancet Respiratory Medicine
TL;DR: The GBD study provides annual updates on estimates of deaths, prevalence, and disability-adjusted life years (DALYs), a summary measure of fatal and non-fatal disease outcomes, for over 300 diseases and injuries, for 188 countries from 1990 to the most recent year.

1,601 citations

Journal Article•DOI•
Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD

[...]

David A. Lipson1, Frank Barnhart2, Noushin Brealey3, Jean Brooks4, Gerard J. Criner5, Nicola C. Day6, Mark T. Dransfield7, David M.G. Halpin8, MeiLan K. Han, C. Elaine Jones, Sally Kilbride, Peter Lange, David A. Lomas, Fernando J. Martinez, Dave Singh, Maggie Tabberer, Robert A. Wise, Steven Pascoe •
University of Pennsylvania1, Research Triangle Park2, Manchester Academic Health Science Centre3, University of Alabama at Birmingham4, University of Michigan5, University of Copenhagen6, NewYork–Presbyterian Hospital7, Johns Hopkins University School of Medicine8
18 Apr 2018-The New England Journal of Medicine
TL;DR: Triple therapy with fluticasone furoate, umeclidinium, and vilanterol resulted in a lower rate of moderate or severe COPD exacerbations than flutic asonefuroate–vilanterol or u meclid inium–vilAnterol in this population.
Abstract: Background The benefits of triple therapy for chronic obstructive pulmonary disease (COPD) with an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β2-agonist (LABA), as compared with dual therapy (either inhaled glucocorticoid–LABA or LAMA–LABA), are uncertain. Methods In this randomized trial involving 10,355 patients with COPD, we compared 52 weeks of a once-daily combination of fluticasone furoate (an inhaled glucocorticoid) at a dose of 100 μg, umeclidinium (a LAMA) at a dose of 62.5 μg, and vilanterol (a LABA) at a dose of 25 μg (triple therapy) with fluticasone furoate–vilanterol (at doses of 100 μg and 25 μg, respectively) and umeclidinium–vilanterol (at doses of 62.5 μg and 25 μg, respectively). Each regimen was administered in a single Ellipta inhaler. The primary outcome was the annual rate of moderate or severe COPD exacerbations during treatment. Results The rate of moderate or severe exacerbations in the triple-therapy group was 0.91 per year, as...

760 citations

Journal Article•DOI•
Guía española de la enfermedad pulmonar obstructiva crónica (GesEPOC) 2017. Tratamiento farmacológico en fase estable

[...]

Marc Miravitlles, Juan José Soler-Cataluña, Myriam Calle1, Jesús Molina, Pere Almagro, José Antonio Quintano, Juan Antonio Trigueros, Borja G. Cosío, Ciro Casanova2, Juan Antonio Riesco, Pere Simonet, David Rigau3, Joan B. Soriano4, Julio Ancochea4 •
Complutense University of Madrid1, University of La Laguna2, Cochrane Collaboration3, Autonomous University of Madrid4
01 Jun 2017-Archivos De Bronconeumologia
TL;DR: The original severity classification has been replaced by a much simpler risk classification (low or high risk), on the basis of lung function, dyspnea grade, and history of exacerbations, while determination of clinical phenotype is recommended only in high-risk patients.
Abstract: The clinical presentation of chronic obstructive pulmonary disease (COPD) varies widely, so treatment must be tailored according to the level of risk and phenotype. In 2012, the Spanish COPD Guidelines (GesEPOC) first established pharmacological treatment regimens based on clinical phenotypes. These regimens were subsequently adopted by other national guidelines, and since then, have been backed up by new evidence. In this 2017 update, the original severity classification has been replaced by a much simpler risk classification (low or high risk), on the basis of lung function, dyspnea grade, and history of exacerbations, while determination of clinical phenotype is recommended only in high-risk patients. The same clinical phenotypes have been maintained: non-exacerbator, asthma-COPD overlap (ACO), exacerbator with emphysema, and exacerbator with bronchitis. Pharmacological treatment of COPD is based on bronchodilators, the only treatment recommended in low-risk patients. High-risk patients will receive different drugs in addition to bronchodilators, depending on their clinical phenotype. GesEPOC reflects a more individualized approach to COPD treatment, according to patient clinical characteristics and level of risk or complexity.

321 citations

Journal Article•DOI•
Update on the Pathogenesis of Chronic Obstructive Pulmonary Disease

[...]

Alvar Agusti1, James C Hogg2•
University of Barcelona1, Carlos III Health Institute2
25 Sep 2019-The New England Journal of Medicine
TL;DR: The current understanding of the biology, diagnosis, and treatment of chronic obstructive pulmonary disease is examined in a pair of review articles.
Abstract: Update on the Pathogenesis of COPD A pair of review articles examines our current understanding of the biology, diagnosis, and treatment of chronic obstructive pulmonary disease. This article focus...

278 citations

Journal Article•DOI•
Procalcitonin-Guided Use of Antibiotics for Lower Respiratory Tract Infection

[...]

David T. Huang, Donald M. Yealy, Michael R. Filbin1, Aaron M. Brown, Chung-Chou H. Chang2, Yohei Doi, Michael W. Donnino1, Jonathan M. Fine3, Michael J. Fine4, Michelle A. Fischer5, John M. Holst, Peter C. Hou1, John A. Kellum2, Feras Khan6, Michael C. Kurz7, Shahram Lotfipour8, Frank LoVecchio, Octavia M Peck-Palmer2, Francis Pike9, Heather Prunty, Robert Sherwin10, Lauren T. Southerland11, Thomas E. Terndrup11, Thomas E. Terndrup5, Lisa A. Weissfeld, Jonathan G. Yabes, Derek C. Angus2 •
Harvard University1, University of Pittsburgh2, Yale University3, Veterans Health Administration4, Pennsylvania State University5, University of Maryland, Baltimore6, University of Alabama at Birmingham7, University of California, Irvine8, Eli Lilly and Company9, Detroit Receiving Hospital10, Ohio State University11
20 May 2018-The New England Journal of Medicine
TL;DR: The provision of procalcitonin assay results, along with instructions on their interpretation, to emergency department and hospital‐based clinicians did not result in less use of antibiotics than did usual care among patients with suspected lower respiratory tract infection.
Abstract: Background The effect of procalcitonin-guided use of antibiotics on treatment for suspected lower respiratory tract infection is unclear. Methods In 14 U.S. hospitals with high adherence to quality measures for the treatment of pneumonia, we provided guidance for clinicians about national clinical practice recommendations for the treatment of lower respiratory tract infections and the interpretation of procalcitonin assays. We then randomly assigned patients who presented to the emergency department with a suspected lower respiratory tract infection and for whom the treating physician was uncertain whether antibiotic therapy was indicated to one of two groups: the procalcitonin group, in which the treating clinicians were provided with real-time initial (and serial, if the patient was hospitalized) procalcitonin assay results and an antibiotic use guideline with graded recommendations based on four tiers of procalcitonin levels, or the usual-care group. We hypothesized that within 30 days after e...

268 citations

References
More filters
Journal Article•DOI•
Reduced lung-cancer mortality with low-dose computed tomographic screening.

[...]

Denise R. Aberle, Amanda M. Adams, Christine D. Berg, William C. Black, Jonathan D. Clapp, Richard M. Fagerstrom, Ilana F. Gareen, Constantine Gatsonis, Pamela M. Marcus, JoRean D. Sicks 
04 Aug 2011-The New England Journal of Medicine
TL;DR: Screening with the use of low-dose CT reduces mortality from lung cancer, as compared with the radiography group, and the rate of death from any cause was reduced.
Abstract: Background The aggressive and heterogeneous nature of lung cancer has thwarted efforts to reduce mortality from this cancer through the use of screening. The advent of low-dose helical computed tomography (CT) altered the landscape of lung-cancer screening, with studies indicating that low-dose CT detects many tumors at early stages. The National Lung Screening Trial (NLST) was conducted to determine whether screening with low-dose CT could reduce mortality from lung cancer. Methods From August 2002 through April 2004, we enrolled 53,454 persons at high risk for lung cancer at 33 U.S. medical centers. Participants were randomly assigned to undergo three annual screenings with either low-dose CT (26,722 participants) or single-view posteroanterior chest radiography (26,732). Data were collected on cases of lung cancer and deaths from lung cancer that occurred through December 31, 2009. Results The rate of adherence to screening was more than 90%. The rate of positive screening tests was 24.2% with low-dose CT and 6.9% with radiography over all three rounds. A total of 96.4% of the positive screening results in the low-dose CT group and 94.5% in the radiography group were false positive results. The incidence of lung cancer was 645 cases per 100,000 person-years (1060 cancers) in the low-dose CT group, as compared with 572 cases per 100,000 person-years (941 cancers) in the radiography group (rate ratio, 1.13; 95% confidence interval [CI], 1.03 to 1.23). There were 247 deaths from lung cancer per 100,000 person-years in the low-dose CT group and 309 deaths per 100,000 person-years in the radiography group, representing a relative reduction in mortality from lung cancer with low-dose CT screening of 20.0% (95% CI, 6.8 to 26.7; P=0.004). The rate of death from any cause was reduced in the low-dose CT group, as compared with the radiography group, by 6.7% (95% CI, 1.2 to 13.6; P=0.02). Conclusions Screening with the use of low-dose CT reduces mortality from lung cancer. (Funded by the National Cancer Institute; National Lung Screening Trial ClinicalTrials.gov number, NCT00047385.).

7,710 citations

Journal Article•DOI•
Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper

[...]

Bartolome R. Celli1, William MacNee1, Alvar Agusti, Antonio Anzueto, B. Berg, A. S. Buist, Peter M.A. Calverley, Niels H. Chavannes, T. Dillard, Bonnie F. Fahy, Alan M. Fein, John E. Heffner, Suzanne C. Lareau, Paula Meek, Fernando J. Martinez, Walter T. McNicholas, Jean W M Muris, E. Austegard, Romain Pauwels, S. I. Rennard, Adriano G. Rossi, NM Siafakas, B. Tiep, Jørgen Vestbo, E. F. M. Wouters, Richard ZuWallack •
Tufts University1
01 Jun 2004-European Respiratory Journal
TL;DR: The main goals of the updated document are to improve the quality of care provided to patients with COPD and to develop the project using a disease-oriented approach.
Abstract: The Standards for the Diagnosis and Treatment of Patients with COPD document 2004 updates the position papers on chronic obstructive pulmonary disease (COPD) published by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) in 1995 1, 2. Both societies felt the need to update the previous documents due to the following. 1) The prevalence and overall importance of COPD as a health problem is increasing. 2) There have been enough advances in the field to require an update, especially adapted to the particular needs of the ATS/ERS constituency. 3) It allows for the creation of a “live” modular document based on the web; it should provide healthcare professionals and patients with a user friendly and reliable authoritative source of information. 4) The care of COPD should be comprehensive, is often multidisciplinary and rapidly changing. 5) Both the ATS and the ERS acknowledge the recent dissemination of the Global Initiative of Obstructive Lung Disease (GOLD) 3 as a major worldwide contribution to the battle against COPD. However, some specific requirements of the members of both societies require adaptation of the broad GOLD initiative. Those requirements include specific recommendations on oxygen therapy, pulmonary rehabilitation, noninvasive ventilation, surgery in and for COPD, sleep, air travel, and end-of-life. In addition, special emphasis has been placed on issues related to the habit of smoking and its control. ### Goals and objectives The main goals of the updated document are to improve the quality of care provided to patients with COPD and to develop the project using a disease-oriented approach. To achieve these goals, both organisations have developed a modular electronic web-based document with two components. 1) A component for health professionals that intends to: raise awareness of COPD; inform on the latest advances in the overall pathogenesis, diagnosis, monitoring and management of COPD; and …

4,312 citations

Journal Article•DOI•
The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity Index in Chronic Obstructive Pulmonary Disease

[...]

Bartolome R. Celli1, Claudia Cote, Jose M. Marin, Ciro Casanova, Maria Montes de Oca, Reina A. Mendez, Victor Pinto Plata, Howard Cabral •
Tufts University1
04 Mar 2004-The New England Journal of Medicine
TL;DR: The BODE index, a simple multidimensional grading system, is better than the FEV1 at predicting the risk of death from any cause and from respiratory causes among patients with COPD.
Abstract: background Chronic obstructive pulmonary disease (COPD) is characterized by an incompletely reversible limitation in airflow. A physiological variable — the forced expiratory volume in one second (FEV 1 ) — is often used to grade the severity of COPD. However, patients with COPD have systemic manifestations that are not reflected by the FEV 1 . We hypothesized that a multidimensional grading system that assessed the respiratory and systemic expressions of COPD would better categorize and predict outcome in these patients. methods We first evaluated 207 patients and found that four factors predicted the risk of death in this cohort: the body-mass index (B), the degree of airflow obstruction (O) and dyspnea (D), and exercise capacity (E), measured by the six-minute–walk test. We used these variables to construct the BODE index, a multidimensional 10-point scale in which higher scores indicate a higher risk of death. We then prospectively validated the index in a cohort of 625 patients, with death from any cause and from respiratory causes as the outcome variables. results There were 25 deaths among the first 207 patients and 162 deaths (26 percent) in the validation cohort. Sixty-one percent of the deaths in the validation cohort were due to respiratory insufficiency, 14 percent to myocardial infarction, 12 percent to lung cancer, and 13 percent to other causes. Patients with higher BODE scores were at higher risk for death; the hazard ratio for death from any cause per one-point increase in the BODE score was 1.34 (95 percent confidence interval, 1.26 to 1.42; P<0.001), and the hazard ratio for death from respiratory causes was 1.62 (95 percent confidence interval, 1.48 to 1.77; P<0.001). The C statistic for the ability of the BODE index to predict the risk of death was larger than that for the FEV 1 (0.74 vs. 0.65).

3,688 citations

Journal Article•DOI•
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.

[...]

Julie A. Anderson, Bartolome R. Celli, Gary T. Ferguson, Christine Jenkins, Paul W. Jones, Julie C. Yates, Jørgen Vestbo 
22 Feb 2007-The New England Journal of Medicine
TL;DR: The reduction in death from all causes among patients with COPD in the combination-therapy group did not reach the predetermined level of statistical significance, and there were significant benefits in all other outcomes among these patients.
Abstract: We conducted a randomized, double-blind trial comparing salmeterol at a dose of 50 μg plus fluticasone propionate at a dose of 500 μg twice daily (combination regimen), administered with a single inhaler, with placebo, salmeterol alone, or fluticasone propionate alone for a period of 3 years. The primary outcome was death from any cause for the comparison between the combination regimen and placebo; the frequency of exacerbations, health status, and spirometric values were also assessed. Results Of 6112 patients in the efficacy population, 875 died within 3 years after the start of the study treatment. All-cause mortality rates were 12.6% in the combinationtherapy group, 15.2% in the placebo group, 13.5% in the salmeterol group, and 16.0% in the fluticasone group. The hazard ratio for death in the combination-therapy group, as compared with the placebo group, was 0.825 (95% confidence interval [CI], 0.681 to 1.002; P = 0.052, adjusted for the interim analyses), corresponding to a difference of 2.6 percentage points or a reduction in the risk of death of 17.5%. The mortality rate for salmeterol alone or fluticasone propionate alone did not differ significantly from that for placebo. As compared with placebo, the combination regimen reduced the annual rate of exacerbations from 1.13 to 0.85 and improved health status and spirometric values (P<0.001 for all comparisons with placebo). There was no difference in the incidence of ocular or bone side effects. The probability of having pneumonia reported as an adverse event was higher among patients receiving medications containing fluticasone propionate (19.6% in the combination-therapy group and 18.3% in the fluticasone group) than in the placebo group (12.3%, P<0.001 for comparisons between these treatments and placebo). Conclusions The reduction in death from all causes among patients with COPD in the combinationtherapy group did not reach the predetermined level of statistical significance. There were significant benefits in all other outcomes among these patients. (ClinicalTrials.gov number, NCT00268216.)

3,037 citations

Journal Article•DOI•
A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire.

[...]

Paul W. Jones1, Frances Quirk, C M Baveystock, Peter Littlejohns•
St George's Hospital1
01 Jun 1992-The American review of respiratory disease
TL;DR: The St. George's Respiratory Questionnaire is a valid measure of impaired health in diseases of chronic airflow limitation that is repeatable and sensitive andMultivariate analysis demonstrated that SGRQ scores summed a number of areas of disease activity.
Abstract: A need was identified for a fixed-format self-complete questionnaire for measuring health in chronic airflow limitation. A 76-item questionnaire was developed, the St. George's Respiratory Questionnaire (SGRQ). Three component scores were calculated: symptoms, activity, and impacts (on daily life), and a total score. Three studies were performed. (1) Repeatability was tested over 2 wk in 40 stable asthmatic patients and 20 patients with stable COPD. The coefficient of variation for the SGRQ total score was 19%. (2) SGRQ scores were compared with spirometry, 6-min walking distance (6-MWD), MRC respiratory symptoms questionnaire, anxiety, depression, and general health measured using the Sickness Impact Profile score. A total of 141 patients were studied, mean age 63 yr (range 31 to 75) and prebronchodilator FEV1, 47% (range 11 to 114%). SGRQ scores correlated with appropriate comparison measures. For example, symptom score versus frequency of wheeze, r2 = 0.32, p less than 0.0001; activity versus 6-MWD, r2 = 0.50, p less than 0.0001; impact versus anxiety, r2 = 0.38, p less than 0.0001. Multivariate analysis demonstrated that SGRQ scores summed a number of areas of disease activity. (3) Changes in SGRQ scores and other measures were studied over 1 yr in 133 patients. Significant correlations were found between changes in SGRQ scores and the comparison measures (minimum r2 greater than 0.05, p less than 0.01). Multivariate analysis showed that change in total SGRQ score summed changes in a number of aspects of disease activity. We conclude that the SGRQ is a valid measure of impaired health in diseases of chronic airflow limitation that is repeatable and sensitive.

2,835 citations

Related Papers (5)
Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary.

[...]

15 Sep 2007-American Journal of Respiratory and Critical Care Medicine
Jørgen Vestbo, Suzanne S. Hurd, Alvar Agusti, Paul W. Jones, Claus Vogelmeier, Antonio Anzueto, Peter J. Barnes, Leonardo M. Fabbri, Fernando J. Martinez, Masaharu Nishimura, Robert A. Stockley, Don D. Sin, Roberto Rodriguez-Roisin 
Susceptibility to Exacerbation in Chronic Obstructive Pulmonary Disease

[...]

16 Sep 2010-The New England Journal of Medicine
John R. Hurst, Jørgen Vestbo, Jørgen Vestbo, Antonio Anzueto, Nicholas Locantore, Hana Müllerová, Ruth Tal-Singer, Bruce E. Miller, David A. Lomas, Alvar Agusti, William MacNee, Peter M.A. Calverley, Stephen I. Rennard, Emiel F.M. Wouters, Jadwiga A. Wedzicha 
Development and first validation of the COPD Assessment Test

[...]

01 Sep 2009-European Respiratory Journal
Paul W. Jones, Gale Harding, Pamela Berry, Ingela Wiklund, Wen-Hung Chen, N. Kline Leidy 
Standardisation of spirometry

[...]

01 Aug 2005-European Respiratory Journal
Martin R. Miller, John L. Hankinson, Vito Brusasco, Felip Burgos, Richard Casaburi, Allan L. Coates, Robert O. Crapo, Paul L. Enright, C.P.M. van der Grinten, P. Gustafsson, R. Jensen, D.C. Johnson, Neil R. MacIntyre, Roy T. McKay, Daniel Navajas, O. F. Pedersen, Riccardo Pellegrino, Giovanni Viegi, J. Wanger 
Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010

[...]

15 Dec 2012-The Lancet
Rafael Lozano, Mohsen Naghavi, Kyle J Foreman  +193 more
Frequently Asked Questions (14)
Q1. What are the contributions in this paper?

The Global Strategy for the Diagnosis, Management, and Prevention of COPD ( GOLD ) 2017 report is based on peer-reviewed publications this paper. 

when indicated, can shorten recovery time, reduce the risk of earlyrelapse, treatment failure, and hospitalization duration. 

Pharmacologic therapy for COPD reduces symptoms, the frequency and severity ofexacerbations, and improves exercise tolerance and health status. 

18 Indoor pollution from biomass cooking and heating, in poorly ventilated dwellings, is a risk for COPD.19-21Asthma may be a risk for the development of chronic airflow limitation and COPD. 

Reduction of total personal exposure to occupational dusts, fumes, and gases, and toindoor and outdoor air pollutants, should be addressed. 

Long-term prognosis following hospitalization for COPD exacerbation is poor; five-year mortality rate is about 50%.254 Factors associated with poor outcome include older age,lower body mass index, comorbidities (e.g., cardiovascular disease or lung cancer),previous hospitalizations for COPD exacerbations, clinical severity of the index exacerbation, and need for long-term oxygen therapy at discharge. 

Besides exposures, host factors (genetic abnormalities, abnormal lung development and accelerated aging) predispose individuals to develop COPD.• COPD may be punctuated by acute worsening of respiratory symptoms, called exacerbations.• 

The mostFor Review Onlycomprehensive disease-specific health status questionnaires include the Chronic Respiratory Questionnaire (CRQ)53 and St. George’s Respiratory Questionnaire (SGRQ). 

2,7 Factorsin early life termed “childhood disadvantage factors” are as important as heavy smoking in predicting lung function in adult life. 

spirometry,in conjunction with patient symptoms and exacerbation history, remains vital for thediagnosis, prognostication and consideration of other important therapeutic approaches,especially non-pharmacological therapies. 

The goals of COPD assessment to guide therapy are 1) to determine the level of airflowlimitation; 2) to define its impact on the patient’s health status and; 3) identify the risk offuture events (such as exacerbations, hospital admissions or death). 

238 Other factors associated with an increased risk of acute exacerbationsand/or severity of exacerbations include an increase in the ratio of the pulmonary artery to aorta cross sectional dimension (i.e., ratio > 1),246 a greater percentage ofFor Review Onlyemphysema or airway wall thickness247 measured by chest CT imaging and the presence of chronic bronchitis.248,249 

The risk of misdiagnosis and over-treatment using the fixed ratio as a diagnosticcriterion is limited since spirometry is only one parameter used to establish the clinicaldiagnosis of COPD. 

FEV1 is a very important parameter at the population-level in the prediction of important clinical outcomes such as mortality andhospitalizations or prompting consideration for non-pharmacologic therapies such aslung reduction or lung transplantation.