Global Definition Of Gerd

Introduction

Why is a new definition needed? • No globally accepted terminology relating to GERD • Confusion over symptoms and complications of GERD, in primary care and other disciplines

• Confusion about Barrett's esophagus terminology • Many proposed but unproven extra-esophageal disorders

Vakil N et al. AJG 2006;101:1900-1920

Aim To develop a definition and classification for reflux disease that is global in application and addresses the needs of patients, physicians (all disciplines) and regulators

Vakil N et al. AJG 2006;101:1900-1920

Needs assessment

Primary care physician survey

• Web-based needs assessment with Primary Care Physicians • 352 predominantly community based primary care physicians (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%

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/

Application 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

Delphi 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 reflect group opinion

Controlled feedback

• Each round analyzed by a non-voting central researcher • Responses for the given statement are fed back to the Delphi group

Working and Consensus Groups

Working Group

Consensus group 18 countries, 43 experts

Vakil N et al. AJG 2006;101:1900-1920

Consensus group 18 countries, 43 experts (Europe)

Sweden

Denmark United Kingdom

France

Netherlands Belgium

Germany

Italy

Vakil N et al. AJG 2006;101:1900-1920

Consensus group 18 countries, 43 experts (North America)

Canada

North America

Vakil N et al. AJG 2006;101:1900-1920

Consensus group 18 countries, 43 experts (Latin America)

Mexico

Brazil

Peru

Argentina

Vakil N et al. AJG 2006;101:1900-1920

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

Japan China Hong Kong

Australia

Vakil N et al. AJG 2006;101:1900-1920

Australia: John Dent Peter Katelaris Argentina: Graciela Salis Belgium: Jan Tack Brazil: Joachim Prado Canada: David Armstrong Nigel Flook Paul Moayyedi Sander van Zanten China: Mainland Fan Dai-ming Lin San-ren Hong Kong Benjamin Wong

Denmark: Peter Bytzer

Netherlands: Elly C Klinkenberg- Knol

France: Jean-Francois Bergmann Marc-Andre Bigard Jean-Paul Galmiche

Peru: Carlos Zapata

Germany: Joachim Labenz Peter Malfertheiner Italy: Gianfranco Delle Fave Fabio Pace Vincenzo Stanghellini Japan: Tsutomu Chiba Hiroto Miwa Michio Hongo Yoshikazu Kinoshita

Mexico: Francisco Martin Huerta Iga

Sweden: Lars Agréus Folke Johnsson UK: Stephen Atwood Janusz Jankowski Roger Jones USA: Patricia Blount Hashem El-Serag Ronnie Fass David Johnson Peter Kahrilas Harley Liker Joel Richter Prateek Sharma Nicholas J Talley Nimish Vakil (Chairman) Vakil N et al. AJG 2006;101:1900-1920

Consensus 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 Barrett’s esophagus • Primary care physicians • Surgeons Vakil N et al. AJG 2006;101:1900-1920

The Consensus Process

Consensus development process 3 Working Group meetings

October 2003 – June 2004

Statements developed by Working Group

September 2004

Working Group meeting

Vote 1 (baseline): Electronic

November 2004

Working Group meeting

Vote 2: First Consensus Group meeting: evidence review

January 2005

Working Group meeting

Vote 3: Electronic

May 2005

Working Group meeting

Vote 4: Final Consensus Group meeting: evidence review

June 2005

Vakil N et al. AJG 2006;101:1900-1920

Evaluating and Grading the evidence

Systematic reviews • Medline, Embase, Cochrane Trials register, CINALH • Key words submitted by Working Group • Search strings developed by librarians • 1980 onwards including key meeting abstracts of 2004 and 2005

Vakil N et al. AJG 2006;101:1900-1920

Why did we use systematic reviews of the literature? • Systematic review orients the panel away from

clinical opinion to methodologically sound evidence

• Convincing to journal editors • Systematic review of the literature offers the most convincing method of assessing the evidence

Vakil N et al. AJG 2006;101:1900-1920

Definition of grades of evidence • High:

Further research is unlikely to change our confidence in the estimate of effect

• Moderate:

Further research is likely to have an important 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 of effect and is very likely to change the estimate

• Very low:

Any estimate of effect is uncertain

GRADE Working Group BMJ;2004:328:1490–4

Voting scale for votes 3 and 4 1 Agree strongly Agree

2 Agree with minor reservation 3 Agree with major reservation 4 Disagree with minor reservation

Disagree

5 Disagree with major reservation 6 Disagree strongly Vakil N et al. AJG 2006;101:1900-1920

Voting summary A priori consensus was classed as ≥67% agreement Vote 1 (Baseline)

Vote 2

Vote 3

Vote 4

% of statements that were agreed to by more than 67% of the participants

86%

88%

94%

100%

% of statements that were agreed to by more than 90% of the participants

40%

61%

83%

94%

Vakil N et al. AJG 2006;101:1900-1920

The Global Definition of GERD

Definition of disease and syndrome • Disease: A morbid entity characterized usually by

at least two of these criteria: recognized etiologic agent(s), identifiable group of signs and symptoms, or consistent anatomic alterations

• Syndrome: The aggregate of symptoms and signs associated with any morbid process, and constituting together the picture of the disease

Stedman’s Medical Dictionary (www.stedmans.com)

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 1

Vote % Agree

Gastroesophageal Reflux Disease (GERD) is a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 2

Vote % Agree

Gastroesophageal Reflux Disease is common and its prevalence varies in different parts of the world

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENTS 3 & 4

Vote % Agree

Symptoms related to gastroesophageal reflux become troublesome when they adversely affect an individual’s well-being

100%

Reflux symptoms that are not troublesome should not be diagnosed as Gastroesophageal Reflux Disease

95%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENTS 5 & 6

Vote % Agree

In population based studies, mild symptoms occurring two or more days a week, or moderate/severe symptoms occurring more than one day a week, are often considered troublesome by patients In clinical practice, the patient should determine if their reflux symptoms are troublesome

95%

100%

Vakil N et al. AJG 2006;101:1900-1920

Clinical implications of statements 1–6

• 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 evidence of injury

– Over-diagnosis is prevented by the concept of troublesome

– Severe symptoms that occur infrequently may meet the criteria for a diagnosis

Vakil N et al. AJG 2006;101:1900-1920

Esophageal Syndromes: Symptomatic

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 7

Heartburn is defined as a burning sensation in the retrosternal area (behind the breastbone)

Vote % Agree

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 8

Regurgitation is defined as the perception of flow of refluxed stomach content into the mouth or hypopharynx

Vote % Agree

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 9

Heartburn and regurgitation are the characteristic symptoms of the Typical Reflux Syndrome

Vote % Agree

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 10

Gastroesophageal reflux is the most common cause of heartburn

Vote % Agree

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 11

Heartburn can have a number of non-reflux related causes. The prevalence of these is unknown.

Vote % Agree

98%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 12

Vote % Agree

The Typical Reflux Syndrome can be diagnosed on the basis of the characteristic symptoms, without diagnostic testing

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 13

Vote % Agree

Non-erosive reflux disease is defined by the presence of troublesome reflux-associated symptoms and the absence of mucosal breaks at endoscopy

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 14

Epigastric pain can be the major symptom of Gastroesophageal Reflux Disease

Vote % Agree

91%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 15

Vote % Agree

Gastroesophageal Reflux Disease is frequently associated with sleep disturbance

96%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 16

Night-time heartburn and sleep disturbance reported by patients with Gastroesophageal Reflux Disease are substantially improved by proton pump inhibitor therapy or anti-reflux surgery

Vote % Agree

98%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 17

Vote % Agree

Physical exercise may induce troublesome symptoms of Gastroesophageal Reflux Disease in patients who have no or minimal symptoms at other times (exercise-induced gastroesophageal reflux)

100%

Vakil N et al. AJG 2006;101:1900-1920

Clinical implications of statements 7–17 • Typical symptoms of heartburn and regurgitation are

sufficient to diagnose GERD if the symptoms are troublesome to the patient

• Nocturnal reflux can cause sleep disturbance • Epigastric pain is reported by many patients with GERD and may be the major symptom

• Some patients have reflux related symptoms only with physical exercise

• Non-erosive reflux disease falls into a symptomatic reflux

syndrome because no signs of esophageal injury are evident Vakil N et al. AJG 2006;101:1900-1920

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENTS 18 & 19

Chest pain indistinguishable from ischemic cardiac pain can be caused by Gastroesophageal Reflux Disease

Gastroesophageal reflux can cause episodes of chest pain that resemble ischemic cardiac pain, without accompanying heartburn or regurgitation

Vote % Agree

100%

98%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENTS 20 & 21

Vote % Agree

Esophageal motor disorders can cause pain that resembles ischemic cardiac pain by a mechanism separate from gastroesophageal reflux

100%

Gastroesophageal reflux is more frequently a cause of chest pain than esophageal motor disorders

100%

Vakil N et al. AJG 2006;101:1900-1920

Clinical implications of statements 18–21

• Patients with chest pain related to GERD may have symptoms 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

Vakil N et al. AJG 2006;101:1900-1920

Esophageal Syndromes: Syndromes with Esophageal Injury

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 22

Vote % Agree

Esophageal complications of Gastroesophageal Reflux Disease are Reflux Esophagitis, Haemorrhage, Stricture, Barrett’s esophagus and Adenocarcinoma

84%

Vakil N et al. AJG 2006;101:1900-1920

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 23

Reflux Esophagitis is defined endoscopically by visible breaks of the distal esophageal mucosa

Vote % Agree

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENTS 24 & 25

Vote % Agree

Mucosal breaks may be intermittently present in patients with the Reflux Esophagitis Syndrome

98%

Over a twenty year period, the severity of Reflux Esophagitis does not increase in most patients

93%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 26

Although heartburn frequency and intensity correlate with the severity of mucosal injury, neither will accurately predict the severity of mucosal injury in the individual patient

Vote % Agree

95%

Vakil N et al. AJG 2006;101:1900-1920

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENTS 27, 28 & 29

Vote % Agree

A Reflux Stricture is defined as a persistent luminal narrowing of the esophagus caused by Gastroesophageal Reflux Disease

100%

The characteristic symptom of a stricture is persistent troublesome dysphagia

100%

Dysphagia is a perceived impairment of the passage of food from the mouth into the stomach

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENTS 30, 31 & 32

Vote % Agree

Troublesome dysphagia is present when patients need to alter eating patterns or report food impaction

96%

Dysphagia is troublesome in a small proportion of patients with Gastroesophageal Reflux Disease Persistent, progressive or troublesome dysphagia is a warning symptom for stricture or cancer of the esophagus and warrants investigation

100%

98%

Vakil N et al. AJG 2006;101:1900-1920

Clinical implications of statements 22–32

• Reflux Esophagitis is the most common manifestation of esophageal injury

• A novel definition of regurgitation and troublesome dysphagia is provided

• A novel definition for a stricture is provided

Vakil N et al. AJG 2006;101:1900-1920

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 33

The term Barrett’s esophagus is variably interpreted at the present time and lacks the clarity needed for clinical and scientific communication about columnar metaplasia of the esophageal mucosa

Vote % Agree

93%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 34

Neither the frequency nor the severity of heartburn is useful for prediction of the presence, type or extent of esophageal columnar metaplasia

Vote % Agree

98%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 35

Endoscopically Suspected Esophageal Metaplasia (ESEM) describes endoscopic findings consistent with Barrett’s esophagus that await histological evaluation

Vote % Agree

98%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 36

Vote % Agree

Multiple, closely-spaced biopsies are necessary to characterize endoscopically suspected esophageal metaplasia

96%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 37

The description of endoscopically suspected esophageal metaplasia should include a standardized measure of endoscopic extent

Vote % Agree

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 38

When biopsies of endoscopically suspected esophageal metaplasia show columnar epithelium it should be called Barrett’s esophagus and the presence or absence of intestinal metaplasia specified

Vote % Agree

86%

Vakil N et al. AJG 2006;101:1900-1920

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENTS 39 & 40

Vote % Agree

Adenocarcinoma of the esophagus is a complication of Gastroesophageal Reflux Disease

100%

The risk of Adenocarcinoma of the esophagus rises with increasing frequency and duration of heartburn

96%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 41

Vote % Agree

Long-segment Barrett’s esophagus with intestinal-type metaplasia is the most important identified risk factor for Esophageal Adenocarcinoma

100%

Vakil N et al. AJG 2006;101:1900-1920

Clinical implications of statements 33–41

• Resolved the international controversy on Barrett’s esophagus by redefining it

• Introduced a new concept: Endoscopically Suspected Esophageal Metaplasia (ESEM)

• ESEM eliminates the risk of an inappropriate

diagnosis of Barrett’s esophagus being applied to an individual without esophageal metaplasia

• Recognised the lack of data on the risk of cancer with gastric metaplasia in the esophagus

Vakil N et al. AJG 2006;101:1900-1920

Extra-esophageal Syndromes: Established Associations

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENTS 42, 43 & 44

Vote % Agree

Chronic cough, chronic laryngitis, and asthma are significantly associated with Gastroesophageal Reflux Disease

93%

Chronic cough, chronic laryngitis, and asthma are usually multi-factorial disease processes and gastroesophageal reflux can be an aggravating co-factor

98%

Gastroesophageal reflux is rarely the sole cause of chronic cough, chronic laryngitis, or asthma

95%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 45

Vote % Agree

Potential causal mechanisms of Reflux Cough, Reflux Laryngitis, and Reflux Asthma Syndromes include direct (aspiration) or indirect (neurally mediated) effects of gastroesophageal reflux

96%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 46

In the absence of heartburn or regurgitation, unexplained asthma and laryngitis are unlikely to be related to Gastroesophageal Reflux Disease

Vote % Agree

84%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 47

Vote % Agree

Medical and surgical treatment trials aimed at improving presumed Reflux Cough, Reflux Laryngitis, and Reflux Asthma Syndromes by treating Gastroesophageal Reflux Disease are associated with uncertain and inconsistent treatment effect

98%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 48

Vote % Agree

The prevalence of dental erosion, especially on the lingual and palatal tooth surfaces, is increased in patients with Gastroesophageal Reflux Disease

96%

Vakil N et al. AJG 2006;101:1900-1920

Extra-esophageal Syndromes: Proposed Associations

GERD is a condition which develops when the reflux of gastric content causes troublesome symptoms or complications Esophageal Syndromes

Symptomatic Syndromes

Syndromes with Esophageal Injury

Typical Reflux Syndrome

Reflux Esophagitis

Reflux Chest Pain Syndrome

Barrett’s esophagus

Reflux Stricture Esophageal Adenocarcinoma

Extraesophageal Syndromes

Established Associations

Proposed Associations

Reflux Cough Syndrome

Pharyngitis

Reflux Laryngitis Syndrome

Idiopathic Pulmonary Fibrosis

Sinusitis

Reflux Asthma Syndrome Reflux Dental Erosion Syndrome

Recurrent Otitis Media

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 49

Vote % Agree

It is unclear whether gastroesophageal reflux is a significant causal or exacerbating factor in the pathogenesis of sinusitis, idiopathic pulmonary fibrosis, pharyngitis or recurrent otitis media

100%

Vakil N et al. AJG 2006;101:1900-1920

STATEMENT 50

Vote % Agree

It is unclear whether gastroesophageal reflux plays a role in triggering apneic episodes in patients with obstructive sleep apnea

100%

Vakil N et al. AJG 2006;101:1900-1920

Clinical implications of statements 42–50

• Recognised that reflux can be an aggravating co-factor in extra-esophageal disorders

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

• Medical and surgical treatment trials have had inconsistent success

• A number of proposed extra-esophageal disorders have no high quality evidence to support a causal association

Vakil N et al. AJG 2006;101:1900-1920

Acknowledgements • Endorsement by the World Organisation of

Gastroenterology (WGO-OMGE): “an important development in a critical area of gastroenterology worldwide”

• Sponsor:

AstraZeneca Research and Development, Sweden

Vakil N et al. AJG 2006;101:1900-1920

Evaluation of the consensus process Anonymous votes on the consensus process:

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

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

Vakil N et al. AJG 2006;101:1900-1920

Conclusions • A patient-centered global definition of GERD has been developed with consensus from various countries and has been endorsed by the World Organization of Gastroenterology

• Adoption of a universally accepted terminology

which bridges cultures and countries and may simplify disease management, allow collaborative research and make studies more generalizable, assisting patients, physicians and regulatory agencies Vakil N et al. AJG 2006;101:1900-1920

Conclusions For practicing physicians, this definition and classification

• Clarifies the criteria necessary for a diagnosis of GERD

• Simplifies the classification of suspected and proven Barrett’s esophagus

• Defines the state of our incomplete knowledge in extraesophageal disorders

Vakil N et al. AJG 2006;101:1900-1920

Conclusions For patients, the consensus statement provides

• Clarity on a diagnosis which is based on a patientcentered definition of troublesome symptoms

• Assistance for patients by preventing an

inappropriate diagnosis of Barrett’s esophagus

• Clarification of the role of GERD in patients with

cough, hoarseness and wheezing may also help the management of patients with these difficult conditions Vakil N et al. AJG 2006;101:1900-1920

Conclusions Regulatory agencies may benefit from:

• An appropriate diagnosis of GERD that guides management

• A uniform terminology and classification that is applicable to clinical trials

• Ability to generalise data-sets across countries and cultures globally

Vakil N et al. AJG 2006;101:1900-1920