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:
[email protected]
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%