Global Definition of GERD

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IntroductionIntroduction


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Why is a new definition needed?Why is a new definition needed?

No globally accepted terminology relating to GERD

Confusion over symptoms and complications ofGERD, in primary care and other disciplines

Confusion about Barrett's esophagus terminology

Many proposed but unproven extra-esophagealdisorders

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AimAim

To develop a definition and

classification for reflux disease that is

global in application and addresses theneeds of patients, physicians

(all disciplines) and regulators

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Needs assessmentNeeds assessmentPrimary care physician surveyPrimary care physician survey

Web-based needs assessment with Primary Care Physicians

352 predominantly community based primary carephysicians (77% community based)

18 countries 39% reported 'no definition of GERD was in place'

Disorders related to GERD

Esophageal Adenocarcinoma 51% Asthma 47%

Cough 74%

Hoarseness 51%


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The Delphi ProcessThe Delphi Process


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What is the Delphi process?What is the Delphi process?

The Delphi technique may be characterized as a

method for structuring a group communication

process so that the process is effective in allowing a

group of individuals as a whole to deal with a

complex problem

Linstone H & Turoff M. The Delphi Process. www.is.njit.edu/pubs/delphibook/


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Application of the Delphi processApplication of the Delphi process

Stage 1:

Selection of the expert panel and non-voting chair

Stage 2: Submission, assessment and feedback

of the Delphi statements

Stage 3:

Final analysis and conclusions


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Delphi process: unique aspectsDelphi process: unique aspects

Anonymity Allows change of views without loss of face

Iteration

A series of rounds with modification of statements,allows members to change the statements to reflectgroup opinion

Controlled feedback

Each round analyzed by a non-voting central researcher

Responses for the given statement are fed back to theDelphi group


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Working and Consensus GroupsWorking and Consensus Groups


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Working Group


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Consensus group 18 countries, 43 expertsConsensus group 18 countries, 43 experts

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Consensus group 18 countries, 43 expertsConsensus group 18 countries, 43 experts(Europe)(Europe)

United Kingdom

France

Italy

Germany

SwedenDenmark

Netherlands

Belgium

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Consensus group 18 countries, 43 expertsConsensus group 18 countries, 43 experts(North America)(North America)

Canada

North America

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Consensus group 18 countries, 43 expertsConsensus group 18 countries, 43 experts(Latin America)(Latin America)

BrazilPeru

Argentina

Mexico

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Consensus group 18 countries, 43 expertsConsensus group 18 countries, 43 experts(Asia and Australia)(Asia and Australia)

Japan

China

Hong Kong

Australia

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Consensus groupConsensus group

Demonstrated knowledge/expertise in GERD by: Participation in national or regional GERD Consensus

guidelines

Interest in guideline development and dissemination

International representation

Diversity of views

Experts on GERD and Barretts esophagus

Primary care physicians

Surgeons

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The Consensus ProcessThe Consensus Process


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Evaluating and GradingEvaluating and Gradingthe evidencethe evidence


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Systematic reviewsSystematic reviews

Medline, Embase, Cochrane Trials register, CINALH

Key words submitted by Working Group

Search strings developed by librarians

1980 onwards including key meeting abstracts of2004 and 2005

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h did i iWh did t ti i


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Why did we use systematic reviewsWhy did we use systematic reviewsof the literature?of the literature?

Systematic review orients the panel away fromclinical opinion to methodologically sound evidence

Convincing to journal editors

Systematic review of the literature offers the mostconvincing method of assessing the evidence

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Definition of grades of evidenceDefinition of grades of evidence

High: Further research is unlikely to change ourconfidence in the estimate of effect

Moderate: Further research is likely to have animportant impact on our confidence in the estimate of

effect and may change the estimate Low: Further research is likely to have an

important impact on our confidence in the estimate ofeffect and is very likely to change the estimate

Very low: Any estimate of effect is uncertain

GRADE Working Group BMJ;2004:328:14904


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Voting scale for votes 3 and 4Voting scale for votes 3 and 4

1 Agree stronglyAgree stronglyAgree with minor reservationAgree with minor reservation

Agree with major reservationAgree with major reservation

Disagree with minor reservationDisagree with minor reservation

Disagree with major reservationDisagree with major reservation

Disagree stronglyDisagree strongly

Disagree

Agree

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% of statements that were agreed toby more than 90% of the participants

% of statements that were agreed to

by more than 67% of the participants

Voting summaryVoting summary

A priori consensus was classed as 67% agreement

Vote 1(Baseline) Vote 2 Vote 4Vote 3

86%86% 88%88% 100%100%94%94%

40%40% 61%61% 83%83% 94%94%

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The Global DefinitionThe Global Definitionof GERDof GERD


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Definition of disease and syndromeDefinition of disease and syndrome

Disease: A morbid entity characterized usually byat least two of these criteria: recognized etiologicagent(s), identifiable group of signs and symptoms,or consistent anatomic alterations

Syndrome: The aggregate of symptoms and signsassociated with any morbid process, and

constituting together the picture of the disease

Stedmans Medical Dictionary (www.stedmans.com)


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GERD is a condition which develops when the refluxof gastric content causes troublesome symptoms

or complications

EsophagealSyndromes

ExtraesophagealSyndromes

SymptomaticSyndromes

EstablishedAssociations

ProposedAssociations

Syndromes withEsophageal Injury

Reflux Esophagitis

Reflux Stricture

Barretts esophagusEsophagealAdenocarcinoma

Reflux CoughSyndrome

Reflux LaryngitisSyndrome

Reflux AsthmaSyndrome

Reflux Dental ErosionSyndrome

Pharyngitis

Sinusitis

IdiopathicPulmonary Fibrosis

Recurrent OtitisMedia

Typical RefluxSyndrome

Reflux Chest PainSyndrome

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Gastroesophageal Reflux Disease (GERD)Gastroesophageal Reflux Disease (GERD)is a condition which develops when the refluxis a condition which develops when the reflux

of stomach contents causes troublesomeof stomach contents causes troublesome

symptoms and/or complicationssymptoms and/or complications

100%100%

STATEMENT 1 Vote % Agree

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Gastroesophageal Reflux Disease is commonGastroesophageal Reflux Disease is commonand its prevalence varies in different partsand its prevalence varies in different parts

of the worldof the world100%100%


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Symptoms related to gastroesophageal refluxSymptoms related to gastroesophageal refluxbecome troublesome when they adverselybecome troublesome when they adversely

affect an individualaffect an individuals well-beings well-being100%100%

Reflux symptoms that are not troublesomeReflux symptoms that are not troublesomeshould not be diagnosed as Gastroesophagealshould not be diagnosed as Gastroesophageal

Reflux DiseaseReflux Disease95%95%

STATEMENTS 3 & 4 Vote % Agree

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In population based studies, mild symptomsIn population based studies, mild symptomsoccurring two or more days a week,occurring two or more days a week,

or moderate/severe symptoms occurring moreor moderate/severe symptoms occurring more

than one day a week, are often consideredthan one day a week, are often considered

troublesome by patientstroublesome by patients

95%95%

In clinical practice, the patient shouldIn clinical practice, the patient should

determine if their reflux symptomsdetermine if their reflux symptoms

are troublesomeare troublesome 100%100%

STATEMENTS 5 & 6 Vote % Agree

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Clinical implications of statements 1Clinical implications of statements 166

Definition and criteria are patient-centered i.e.patient determines if symptoms are troublesome

Patients may meet diagnostic criteria based on

symptoms, if they are troublesome, or by evidenceof injury

Over-diagnosis is prevented by the concept oftroublesome

Severe symptoms that occur infrequently maymeet the criteria for a diagnosis

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Esophageal Syndromes:Esophageal Syndromes:SymptomaticSymptomatic


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Heartburn is defined as a burningHeartburn is defined as a burningsensation in the retrosternal areasensation in the retrosternal area

(behind the breastbone)(behind the breastbone)100%100%


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Regurgitation is defined as the perceptionRegurgitation is defined as the perceptionof flow of refluxed stomach content into theof flow of refluxed stomach content into the

mouth or hypopharynxmouth or hypopharynx100%100%


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Heartburn and regurgitation are theHeartburn and regurgitation are thecharacteristic symptoms of the Typicalcharacteristic symptoms of the Typical

Reflux SyndromeReflux Syndrome100%100%


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Gastroesophageal reflux is the mostGastroesophageal reflux is the mostcommon cause of heartburncommon cause of heartburn 100%100%


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Heartburn can have a number of non-refluxHeartburn can have a number of non-refluxrelated causes. The prevalence of theserelated causes. The prevalence of these

is unknown.is unknown.98%98%


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The Typical Reflux Syndrome can be diagnosedThe Typical Reflux Syndrome can be diagnosedon the basis of the characteristic symptoms,on the basis of the characteristic symptoms,

without diagnostic testingwithout diagnostic testing100%100%


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Non-erosive reflux disease is defined by theNon-erosive reflux disease is defined by thepresence ofpresence oftroublesome reflux-associatedtroublesome reflux-associated

symptomssymptoms and the absence of mucosal breaksand the absence of mucosal breaks

at endoscopyat endoscopy

100%100%


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Epigastric pain can be the major symptomEpigastric pain can be the major symptomof Gastroesophageal Reflux Diseaseof Gastroesophageal Reflux Disease 91%91%


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Gastroesophageal Reflux Disease is frequentlyGastroesophageal Reflux Disease is frequentlyassociated with sleep disturbanceassociated with sleep disturbance 96%96%


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Night-time heartburn and sleep disturbanceNight-time heartburn and sleep disturbancereported by patients with Gastroesophagealreported by patients with Gastroesophageal

Reflux Disease are substantially improvedReflux Disease are substantially improved

by proton pump inhibitor therapyby proton pump inhibitor therapy

or anti-reflux surgeryor anti-reflux surgery

98%98%


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Physical exercise may induce troublesomePhysical exercise may induce troublesomesymptoms of Gastroesophageal Reflux Diseasesymptoms of Gastroesophageal Reflux Disease

in patients who have no or minimal symptomsin patients who have no or minimal symptoms

at other times (exercise-inducedat other times (exercise-induced

gastroesophageal reflux)gastroesophageal reflux)

100%100%


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Reflux Esophagitis

Reflux Stricture



or complications

EsophagealSyndromes


Symptomatic

Syndromes

Established

Associations

Proposed

Associations

Syndromes with

Esophageal Injury


Reflux Laryngitis

Syndrome

Reflux AsthmaSyndrome


Pharyngitis

Sinusitis




Reflux Chest Pain

Syndrome

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Chest pain indistinguishable fromChest pain indistinguishable fromischemic cardiac pain can be causedischemic cardiac pain can be caused

by Gastroesophageal Reflux Diseaseby Gastroesophageal Reflux Disease100%100%

Gastroesophageal reflux can cause episodesGastroesophageal reflux can cause episodes

of chest pain that resemble ischemic cardiacof chest pain that resemble ischemic cardiac

pain, without accompanying heartburnpain, without accompanying heartburn

or regurgitationor regurgitation

98%98%

Vote % AgreeSTATEMENTS 18 & 19

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Esophageal motor disorders can cause painEsophageal motor disorders can cause painthat resembles ischemic cardiac pain by athat resembles ischemic cardiac pain by a

mechanism separate frommechanism separate from

gastroesophageal refluxgastroesophageal reflux

100%100%

Gastroesophageal reflux is more frequentlyGastroesophageal reflux is more frequently

a cause of chest pain than esophageala cause of chest pain than esophageal

motor disordersmotor disorders100%100%


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li i l i li i fCli i l i li ti f t t t 18 21


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Patients with chest pain related to GERD may havesymptoms that resemble ischemic heart disease

Heartburn and regurgitation may not be reported by

these patients

Esophageal motor disorders are an unusual cause

of chest pain

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Esophageal Syndromes: SyndromesEsophageal Syndromes: Syndromeswith Esophageal Injurywith Esophageal Injury


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Symptomatic

Syndromes


or complications

EsophagealSyndromes


Established

Associations

Proposed

Associations

Syndromes with

Esophageal Injury

Reflux Esophagitis

Reflux Stricture



Reflux Laryngitis

SyndromeReflux AsthmaSyndrome


Pharyngitis

Sinusitis




Reflux Chest Pain

Syndrome

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STATEMENT 22


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Esophageal complications of GastroesophagealEsophageal complications of GastroesophagealReflux Disease are Reflux Esophagitis,Reflux Disease are Reflux Esophagitis,

Haemorrhage, Stricture, BarrettHaemorrhage, Stricture, Barretts esophaguss esophagus

and Adenocarcinomaand Adenocarcinoma

84%84%

Vote % AgreeSTATEMENT 22

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Symptomatic

Syndromes

Established

Associations

Proposed

Associations


or complications

EsophagealSyndromes


Syndromes with

Esophageal Injury

Reflux Esophagitis

Reflux Stricture



Reflux Laryngitis



Pharyngitis

Sinusitis




Reflux Chest Pain

Syndrome

Vakil N et al.AJG2006;101:1900-1920

%STATEMENT 23


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Reflux Esophagitis is defined endoscopicallyReflux Esophagitis is defined endoscopicallyby visible breaks of the distal esophagealby visible breaks of the distal esophageal

mucosamucosa100%100%


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V t % ASTATEMENTS 24 & 25


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Mucosal breaks may be intermittently presentMucosal breaks may be intermittently presentin patients with the Reflux Esophagitisin patients with the Reflux Esophagitis

SyndromeSyndrome98%98%

Over a twenty year period, the severityOver a twenty year period, the severity

of Reflux Esophagitis does not increaseof Reflux Esophagitis does not increase

in most patientsin most patients93%93%


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V t % ASTATEMENTS 27 28 & 29


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A Reflux StrictureA Reflux Stricture is defined as a persistentis defined as a persistentluminal narrowing of the esophagus causedluminal narrowing of the esophagus caused

by Gastroesophageal Reflux Diseaseby Gastroesophageal Reflux Disease100%100%

The characteristic symptom of a strictureThe characteristic symptom of a strictureis persistent troublesome dysphagiais persistent troublesome dysphagia 100%100%

Dysphagia is a perceived impairment ofDysphagia is a perceived impairment of

the passage of food from the mouth intothe passage of food from the mouth into

the stomachthe stomach100%100%

Vote % AgreeSTATEMENTS 27, 28 & 29

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Vote % AgreeSTATEMENTS 30 31 & 32


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Troublesome dysphagia is present whenTroublesome dysphagia is present whenpatients need to alter eating patternspatients need to alter eating patterns

or report food impactionor report food impaction

Dysphagia is troublesome in a small proportionDysphagia is troublesome in a small proportionof patients with Gastroesophageal Reflux Diseaseof patients with Gastroesophageal Reflux Disease

Persistent, progressive or troublesomePersistent, progressive or troublesome

dysphagia is a warning symptom for stricturedysphagia is a warning symptom for strictureor cancer of the esophagus and warrantsor cancer of the esophagus and warrants

investigationinvestigation

96%96%

100%100%

98%98%


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Clinical implications of statements 22Clinical implications of statements 22 3232


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Reflux Esophagitis is the most commonmanifestation of esophageal injury

A novel definition of regurgitation andtroublesome dysphagia is provided

A novel definition for a stricture is provided

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Symptomatic

Syndromes

Established

Associations

Proposed

Associations


or complications

EsophagealSyndromes


Syndromes with

Esophageal Injury

Reflux Esophagitis

Reflux Stricture

Barretts esophagus

EsophagealAdenocarcinoma


Reflux Laryngitis



Pharyngitis

Sinusitis




Reflux Chest Pain

Syndrome

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The term BarrettThe term Barretts esophagus is variablys esophagus is variably

interpreted at the present time and lacks theinterpreted at the present time and lacks the

clarity needed for clinical and scientificclarity needed for clinical and scientific

communication about columnar metaplasiacommunication about columnar metaplasia

of the esophageal mucosaof the esophageal mucosa

93%93%


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Neither the frequency nor the severityNeither the frequency nor the severityof heartburn is useful for prediction of theof heartburn is useful for prediction of the

presence, type or extent of esophagealpresence, type or extent of esophageal

columnar metaplasiacolumnar metaplasia

98%98%


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Endoscopically Suspected EsophagealEndoscopically Suspected EsophagealMetaplasia (ESEM) describes endoscopicMetaplasia (ESEM) describes endoscopic

findings consistent with Barrettfindings consistent with Barretts esophaguss esophagus

that await histological evaluationthat await histological evaluation

98%98%


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Multiple, closely-spaced biopsies are necessaryMultiple, closely-spaced biopsies are necessaryto characterize endoscopically suspectedto characterize endoscopically suspected

esophageal metaplasiaesophageal metaplasia96%96%


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The description of endoscopically suspectedThe description of endoscopically suspectedesophageal metaplasia should include aesophageal metaplasia should include a

standardized measure of endoscopic extentstandardized measure of endoscopic extent100%100%


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When biopsies of endoscopically suspectedWhen biopsies of endoscopically suspectedesophageal metaplasia show columnaresophageal metaplasia show columnar

epithelium it should be called Barrettepithelium it should be called Barrettss

esophagus and the presence or absence ofesophagus and the presence or absence of

intestinal metaplasia specifiedintestinal metaplasia specified

86%86%


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GERD i diti hi h d l h th fl


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Symptomatic

Syndromes

Established

Associations

Proposed

Associations


or complications

EsophagealSyndromes


Syndromes with

Esophageal Injury

Reflux Esophagitis

Reflux Stricture

Barretts esophagus



Reflux Laryngitis



Pharyngitis

Sinusitis




Reflux Chest Pain

Syndrome

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Adenocarcinoma of the esophagusAdenocarcinoma of the esophagusis a complication of Gastroesophagealis a complication of Gastroesophageal

Reflux DiseaseReflux Disease100%100%

The risk of Adenocarcinoma of the esophagusThe risk of Adenocarcinoma of the esophagus

rises with increasing frequency and durationrises with increasing frequency and duration

of heartburnof heartburn96%96%


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Long-segment BarrettLong-segment Barretts esophagus withs esophagus withintestinal-type metaplasia is the most importantintestinal-type metaplasia is the most important

identified risk factor for Esophagealidentified risk factor for Esophageal

AdenocarcinomaAdenocarcinoma

100%100%


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Resolved the international controversy onBarretts esophagus by redefining it

Introduced a new concept: EndoscopicallySuspected Esophageal Metaplasia (ESEM)

ESEM eliminates the risk of an inappropriatediagnosis of Barretts esophagus being applied toan individual without esophageal metaplasia

Recognised the lack of data on the risk of cancerwith gastric metaplasia in the esophagus

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Extra-esophageal Syndromes:Extra-esophageal Syndromes:Established AssociationsEstablished Associations

GERD is a condition which develops when the reflux


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Reflux Esophagitis

Reflux Stricture

Barretts esophagus


Symptomatic

Syndromes

Proposed

Associations

Syndromes with

Esophageal Injury


or complications

EsophagealSyndromes


Established

Associations


Reflux Laryngitis



Pharyngitis

Sinusitis




Reflux Chest Pain

Syndrome

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Chronic cough, chronic laryngitis,Chronic cough, chronic laryngitis,and asthma are significantly associatedand asthma are significantly associated

with Gastroesophageal Reflux Diseasewith Gastroesophageal Reflux Disease93%93%

Chronic cough, chronic laryngitis, and asthmaChronic cough, chronic laryngitis, and asthmaare usually multi-factorial disease processes andare usually multi-factorial disease processes and

gastroesophageal reflux can be an aggravatinggastroesophageal reflux can be an aggravating

co-factorco-factor

98%98%

Gastroesophageal reflux is rarely the sole causeGastroesophageal reflux is rarely the sole causeof chronic cough, chronic laryngitis,of chronic cough, chronic laryngitis,

or asthmaor asthma95%95%

g,

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In the absence of heartburn or regurgitation,In the absence of heartburn or regurgitation,unexplained asthma and laryngitis areunexplained asthma and laryngitis are

unlikely to be related tounlikely to be related to GastroesophagealGastroesophageal

Reflux DiseaseReflux Disease

84%84%

g

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Medical and surgical treatment trials aimed atMedical and surgical treatment trials aimed atimproving presumed Reflux Cough, Refluximproving presumed Reflux Cough, Reflux

Laryngitis, and Reflux Asthma Syndromes byLaryngitis, and Reflux Asthma Syndromes by

treating Gastroesophageal Reflux Disease aretreating Gastroesophageal Reflux Disease are

associated with uncertain and inconsistentassociated with uncertain and inconsistenttreatment effecttreatment effect

98%98%

g

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The prevalence of dental erosion, especially onThe prevalence of dental erosion, especially onthe lingual and palatal tooth surfaces, isthe lingual and palatal tooth surfaces, is

increased in patients with Gastroesophagealincreased in patients with Gastroesophageal

Reflux DiseaseReflux Disease

96%96%

g

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Extra-esophageal Syndromes:Extra-esophageal Syndromes:Proposed AssociationsProposed Associations

GERD is a condition which develops when the reflux


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Reflux Esophagitis

Reflux Stricture

Barretts esophagus


Symptomatic

Syndromes

Established

Associations

Syndromes with

Esophageal Injury


or complications

EsophagealSyndromes


Proposed

Associations


Reflux Laryngitis



Pharyngitis

Sinusitis

Idiopathic

Pulmonary Fibrosis



Reflux Chest Pain

Syndrome

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It is unclear whether gastroesophageal refluxIt is unclear whether gastroesophageal reflux

plays a role in triggering apneic episodesplays a role in triggering apneic episodes

in patients with obstructive sleep apneain patients with obstructive sleep apnea100%100%

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Clinical implications of statements 42p 50

Recognised that reflux can be an aggravatingco-factor in extra-esophageal disorders

Reflux is unlikely to be a factor in extra-esophagealdisorders if heartburn and regurgitation are absent

Medical and surgical treatment trials have hadinconsistent success

A number of proposed extra-esophageal disordershave no high quality evidence to support a causalassociation

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AcknowledgementsAcknowledgements


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AcknowledgementsAcknowledgements

Endorsement by the World Organisation ofGastroenterology (WGO-OMGE):an important development in a critical areaof gastroenterology worldwide

Sponsor:AstraZeneca Research and Development, Sweden

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Evaluation of the consensus processEvaluation of the consensus process


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Evaluation of the consensus processa uat o o t e co se sus p ocess

Anonymous votes on the consensus process:

90% agreed that the voting process was fair andthat they had a chance to input adequately

92% agreed that the sponsor had not, in any way,influenced their voting

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ConclusionsConclusions


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Conclusions

A patient-centered global definition of GERD hasbeen developed with consensus from variouscountries and has been endorsed by the WorldOrganization of Gastroenterology

Adoption of a universally accepted terminologywhich bridges cultures and countries and maysimplify disease management, allow collaborativeresearch and make studies more generalizable,assisting patients, physicians and regulatoryagencies

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Conclusions

For practicing physicians, this definition andclassification

Clarifies the criteria necessary for a diagnosisof GERD

Simplifies the classification of suspected and provenBarretts esophagus

Defines the state of our incomplete knowledge inextraesophageal disorders

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For patients, the consensus statement provides

Clarity on a diagnosis which is based on a patient-centered definition of troublesome symptoms

Assistance for patients by preventing aninappropriate diagnosis of Barretts esophagus

Clarification of the role of GERD in patients with

cough, hoarseness and wheezing may also help themanagement of patients with these difficultconditions

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Regulatory agencies may benefit from:

An appropriate diagnosis of GERD that guidesmanagement

A uniform terminology and classification that isapplicable to clinical trials

Ability to generalise data-sets across countries andcultures globally

Global Definition of GERD

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