NHLBI/WHO Workshop Summary

Am J Respir Crit Care Med Vol 163. pp 12561276, 2001Internet address: www.atsjournals.org

(

Received in original form January 10, 2001

)

List of participants (GOLD Scientific Committee):

Nicholas Anthonisen, Winnipeg,Canada; William C. Bailey, Birmingham, US; Peter J. Barnes, London, UK; TimClark, London, UK; Leonardo Fabbri, Modena, Italy; Yoshinosuke Fukuchi, Tokyo,Japan; Lawrence Grouse, Seattle, US; James C. Hogg, Vancouver, Canada; DirkjeS. Postma, Groningen, the Netherlands; Klaus F. Rabe, Leiden, the Netherlands;Scott D. Ramsey, Seattle, US; Stephen I. Rennard, Omaha, US; Roberto Rod-riguez-Roisin, Barcelona, Spain; Nikos Siafakas, Heraklion, Greece; Sean D. Sulli-van, Seattle, US; Wan-Cheng Tan, Singapore; Claude Lenfant, NHLBI, Bethesda,US; Nikolai Khaltaev, WHO, Geneva, Switzerland.

Correspondence and requests for reprints should be addressed to Romain Pau-wels, Department of Respiratory Diseases, University Hospital, De Pintelaan 185,B9000 Ghent, Belgium. E-mail: romain.pauwels@rug.ac.be

Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease

NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop Summary

ROMAIN A. PAUWELS, A. SONIA BUIST, PETER M. A. CALVERLEY, CHRISTINE R. JENKINS, and SUZANNE S. HURD,on behalf of the GOLD Scientific Committee

T

HIS

DOCUMENT

WAS

ENDORSED

BY

THE

E

XECUTIVE

C

OMMITTEE

OF

THE

A

MERICAN

T

HORACIC

S

OCIETY

, M

ARCH

2001

CONTENTS

PrefaceIntroductionDefinition and Classification of Severity

DefinitionClassification of SeverityPathogenesisPathologyPathophysiology

Burden of COPDEpidemiologyEconomic and Social Burden of COPDRisk Factors

The Four Components of COPD ManagementIntroductionComponent 1: Assess and Monitor Disease

DiagnosisOngoing Monitoring and Assessment

Component 2: Reduce Risk FactorsSmoking Prevention and CessationOccupational ExposuresIndoor/Outdoor Air Pollution

Component 3: Manage Stable COPDIntroductionEducationPharmacologic Treatment

BronchodilatorsGlucocorticosteroidsOther Pharmacologic Treatments

Nonpharmacologic TreatmentRehabilitationOxygen Therapy

Ventilatory SupportSurgical Treatments

Component 4: Manage ExacerbationsDiagnosis and Assessment of SeverityHome ManagementHospital ManagementHospital Discharge and Follow-up

Future ResearchReferences

PREFACE

Chronic obstructive pulmonary disease (COPD) is a major pub-lic health problem. It is the fourth leading cause of chronic mor-bidity and mortality in the United States (1) and is projected torank fifth in 2020 as a worldwide burden of disease according toa study published by the World Bank/World Health Organiza-tion (2). Yet, COPD fails to receive adequate attention fromthe health care community and government officials. Withthese concerns in mind, a committed group of scientists encour-aged the U.S. National Heart, Lung, and Blood Institute andthe World Health Organization to form the Global Initiative forChronic Obstructive Lung Disease (GOLD). Among GOLDsimportant objectives are to increase awareness of COPD and tohelp the thousands of people who suffer from this disease anddie prematurely from COPD or its complications.

The first step in the GOLD program was to prepare a con-sensus Workshop Report,

Global Strategy for the Diagnosis,Management, and Prevention of COPD

. The GOLD ExpertPanel, a distinguished group of health professionals from thefields of respiratory medicine, epidemiology, socioeconomics,public health, and health education, reviewed existing COPDguidelines, as well as new information on pathogenic mecha-nisms of COPD as they developed a consensus document. Manyrecommendations will require additional study and evaluationas the GOLD program is implemented.

A major problem is the incomplete information about thecauses and prevalence of COPD, especially in developing coun-tries. While cigarette smoking is a major known risk factor, muchremains to be learned about other causes of this disease. TheGOLD Initiative will bring COPD to the attention of govern-ments, public health officials, health care workers, and the gen-eral public, but a concerted effort by all involved in health carewill be necessary to control this major public health problem.

I would like to acknowledge the dedicated individuals whoprepared the Workshop Report and the effective leadership ofthe Workshop Chair, Professor Romain Pauwels. It is a privi-lege for the National Heart, Lung, and Blood Institute to serveas one of the cosponsors. We look forward to working with the

NHLBI/WHO Workshop Summary 1257

World Health Organization, and all other interested organiza-tions and individuals, to meet the goals of the GOLD Initiative.

Development of the Workshop Report was supportedthrough educational grants to the Department of RespiratoryDiseases of the Ghent University Hospital, Belgium (WHOCollaborating Center for the Management of Asthma andCOPD) from ASTA Medica, AstraZeneca, Aventis, Bayer,Boehringer-Ingelheim, Byk Gulden, Chiesi, Glaxo Wellcome,Merck, Sharp & Dohme, Mitsubishi-Tokyo, Nikken Chemi-cals, Novartis, Schering-Plough, SmithKline Beecham, Yaman-ouchi, and Zambon.

C

LAUDE

L

ENFANT

, M.D.

DirectorNational Heart, Lung, and Blood Institute

INTRODUCTION

Chronic obstructive pulmonary disease (COPD) is a majorcause of chronic morbidity and mortality throughout theworld. COPD is currently the fourth leading cause of death inthe world (3), and further increases in the prevalence and mor-tality of the disease can be predicted in the coming decades. Aunified international effort is required to reverse these trends.

The

G

lobal Initiative for Chronic

O

bstructive

L

ung

D

is-ease (

GOLD

) is a collaborative project of the U.S. NationalHeart, Lung, and Blood Institute (NHLBI) and the WorldHealth Organization (WHO). Its goals are to increase aware-ness of COPD and decrease morbidity and mortality from thisdisease. GOLD aims to improve prevention and managementof COPD through a concerted worldwide effort of people in-volved in all facets of health care and health care policy, andto encourage a renewed research interest in this extremelyprevalent disease.

The GOLD Workshop Report,

Global Strategy for the Di-agnosis, Management, and Prevention of COPD

, presents aCOPD management plan with four components: (

1

) Assessand Monitor Disease; (

2

) Reduce Risk Factors; (

3

) ManageStable COPD; (

4

) Manage Exacerbations. The Workshop Re-port is based on the best-validated current concepts of COPDpathogenesis and the available evidence on the most appro-priate management and prevention strategies. It has been de-veloped by individuals with expertise in COPD research andpatient care and extensively reviewed by many experts and sci-entific societies. Before its release for publication, the Work-shop Report was reviewed by the NHLBI and the WHO. ThisExecutive Summary provides key information about COPD;the full Workshop Report provides more details.

In Section 3, Four Components of COPD Management,levels of evidence are assigned to statements, where appropri-ate, using a system developed by the NHLBI (Table 1). Levelsof evidence are indicated in parentheses after the relevantstatement, e.g., (Evidence A).

DEFINITION AND CLASSIFICATION OF SEVERITY

Definition

COPD is a disease state characterized by airflow limitationthat is not fully reversible. The airflow limitation is usuallyboth progressive and associated with an abnormal inflamma-tory response of the lungs to noxious particles or gases.

A diagnosis of COPD should be considered in any patientwho has symptoms of cough, sputum production, or dyspnea,and/or a history of exposure to risk factors for the disease. Thediagnosis is confirmed by spirometry. The presence of a post-bronchodilator FEV

1

,

80% of the predicted value in combi-nation with an FEV

1

/FVC

,

70% confirms the presence ofairflow limitation that is not fully reversible. Where spirome-try is unavailable, the diagnosis of COPD should be made us-ing all available tools. Clinical symptoms and signs, such as ab-

TABLE 1. DESCRIPTION OF LEVELS OF EVIDENCE

EvidenceCategory

Sources ofEvidence Definition

A RCTs. Rich bodyof data.

Evidence is from endpoints of well-designed RCTs that provide a consistentpattern of findings in the population forwhich the recommendation is made.Category A requires substantial numbersof studies involving substantial numbers ofparticipants.

B RCTs. Limitedbody of data.

Evidence is from endpoints of interventionstudies that include only a limited numberof patients,

post hoc

or subgroup analysisof RCTs, or meta-analysis of RCTs. Ingeneral, Category B pertains when fewrandomized trials exist, they are small insize, or they were undertaken in apopulation that differs from the targetpopulation of the recommendation, or theresults are somewhat inconsistent.

C Nonrandomized trials.Observational studies.

Evidence is from outcomes of uncontrolled or nonrandomized trials orfrom observational studies.

D Panel ConsensusJudgment.

This category is used only in cases wherethe provision of some guidance wasdeemed valuable but the clinical literatureaddressing the subject was deemedinsufficient to justify placement in one ofthe other categories. The Panel Consensusis based on clinical experience orknowledge that does not meet the above-listed criteria.

Definition of abbreviation

: RCT

5

randomized controlled trial.

TABLE 2. CLASSIFICATION OF COPD BY SEVERITY

Stage Characteristics

0: At Risk Normal spirometryChronic symptoms

(cough, sputum production)

I: Mild COPD FEV

1

/FVC

,

70%FEV

1

>

80%predicted

With or withoutchronic symptoms(cough, sputumproduction)

II: Moderate COPD FEV

1

/FVC

,

70%30%