Rome process

The "Rome Process" is an international effort to define and categorize the functional gastrointestinal disorders, or FGIDs, (of unknown cause) such as Irritable bowel syndrome and Functional dyspepsia. This approach represents a substantial change in thinking given that doctors have usually relied on basic science and palpable “evidence” to diagnose all kinds of ailments. More than half of gut disorders encountered by physicians are functional (i.e. disorders of gut function) and there is no structural or biochemical explanation for them, so it was necessary to develop alternate methods to identify them. This process is akin to that followed by psychiatrists to categorize and diagnose psychiatric entities, which culminated in the DSM-IV criteria. These should not be “diagnoses of exclusion"; they demand a more positive approach.

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History

There were systematic approaches that attempted to classify the then hazy area of functional gastrointestinal disorders from as early as 1962 when Chaudhary and Truelove published a retrospective review of IBS patients at Oxford, England. Later on, the "Manning Criteria" for irritable bowel syndrome were derived from a paper published in 1978 by Manning and colleagues. This seminal classification started a new era and, from then on, scientific work on functional gastrointestinal disorders proceeded with increased enthusiasm.

The Rome criteria have been evolving from the first set of criteria issued in 1989 (The Rome Guidelines for IBS) through the Rome Classification System for FGIDs (1990), or Rome-1, the Rome I Criteria for IBS (1992) and the FGIDs (1994), the Rome II Criteria for IBS (1999) and the FGIDs (1999) to the recent Rome III Criteria (2006). "Rome II" and "Rome III" incorporated pediatric criteria to the consensus.

Process

The Rome criteria are achieved and finally issued through a consensual process, using the Delphi method (or Delphi Technique). The effort is organised by the Rome Coordinating Committee. This process typically takes many months of work by investigators, organized into committees. The committees work by mail and telephone conferences until the final, defining meeting, which (logically) takes place in Rome, Italy. The Rome III effort encompassed 87 participants from 18 countries in 14 committees. Members were added from countries outside the more industrialized Western nations; this time there were members from China, Brazil, Chile, Venezuela, Hungary, and Romania. Additional working teams were created to work on issues like: gender, society, patient, and social issues; and pharmacology and pharmacokinetics. Two committees (neonate/toddler and child/adolescent), rather than one, served the pediatrics FGIDs.

Classification

Adult patients

In the Rome III classification, the Functional GI Disorders (FGIDs) are classified into six major domains for adults:

• Esophageal (category A)
• Gastroduodenal (category B)
• Bowel (category C)
• Functional Abdominal Pain Syndrome (category D)
• Biliary (category E)
• Anorectal (category F)

The functional bowel disorders (category C) include: Irritable bowel syndrome (C1); Functional bloating (C2); Functional constipation (C3); Functional diarrhea (C4)

Irritable bowel syndrome (C1) is more specifically defined as pain associated with change in bowel habit, which is different from functional diarrhea.

Pediatric patients

The pediatric domains are classified first by age range and then by symptom pattern or area of symptom. Each domain contains several disorders, each with relatively specific clinical features.

• Neonate/Toddler (category G)
  • G1. Infant regurgitation
  • G2. Infant rumination syndrome
  • G3. Cyclic vomiting syndrome
  • G4. Infant colic
  • G5. Functional diarrhea
  • G6. Infant dyschezia
  • G7. Functional constipation

• Child/Adolescent (category H)
  • H1. Vomiting and aerophagia: H1a. Adolescent rumination syndrome; H1b. Cyclic vomiting syndrome; H1c. Aerophagia
  • H2. Abdominal pain–related FGIDs: H2a. Functional dyspepsia; H2b. Irritable bowel syndrome; H2c. Abdominal migraine; H2d. Childhood functional abdominal pain
  • H3. Constipation and incontinence: H3a. Functional constipation; H3b. Nonretentive fecal incontinence

Rome Process for Diagnosing IBS

Physicians rely on a variety of procedures and laboratory tests to confirm a diagnosis. The cardinal requirement for the diagnosis of IBS is abdominal pain. The Rome II criteria is used to diagnose IBS after a careful examination of the patient's medical history and physical abdominal examination which looks for any 'red flag' symptoms. More recently, the Rome III criteria, incorporating some changes over the previous set of criteria, have been issued. The Rome II and III efforts have integrated pediatric contents to their set of criteria.

According to the Rome II committees and the Functional Brain Gut Research Group,^[1] IBS can be diagnosed based on at least 12 weeks, which need not be consecutive, of the preceding 12 months there was abdominal discomfort or pain that had two out of three of these features:^[2]

• Relieved with defecation; and/or
• Onset associated with a change in frequency of stool; and/or
• Onset associated with a change in form (appearance) of stool.

Symptoms that cumulatively support the diagnosis of IBS:

• Abnormal stool frequency (for research purposes, "abnormal" may be defined as greater than 3 bowel movements per day and less than 3 bowel movements per week);
• Abnormal stool form (lumpy/hard or loose/watery stool);
• Abnormal stool passage (straining, urgency, or feeling of incomplete evacuation);

• Bloating or feeling of abdominal distention.

Supportive symptoms of IBS:

• A) Fewer than three bowel movements a week
• B) More than three bowel movements a day
• C) Hard or lumpy stools
• D) Loose (mushy) or watery stools
• E) Straining during a bowel movement
• F) Urgency (having to rush to have a bowel movement)
• G) Feeling of incomplete bowel movement
• H) Passing mucus (white material) during a bowel movement
• I) Abdominal fullness, bloating, or swelling

Diarrhea-predominant: At least 1 of B, D, F and none of A, C, E; or at least 2 of B, D, F and one of A or E.
Constipation-predominant: At least 1 of A, C, E and none of B, D, F; or at least 2 of A, C, E and one of B, D, F.

Red flag symptoms which are not typical of IBS:

• Pain that awakens/interferes with sleep
• Diarrhea that awakens/interferes with sleep
• Blood in the stool (visible or occult)
• Weight loss
• Fever
• Abnormal physical examination

An update to these criteria was issued at the Rome III conference and published in May 2006.^[3] The validity of subtypes is called into question:

• The validity and stability of such subtypes over time is unknown and should be the subject of future research.
• Because of the characteristic symptom instability, we prefer the terms IBS with constipation and IBS with diarrhea instead of constipation- and diarrhea-predominant IBS. In this categorical system, many people whose features place them close to a subtype boundary change pattern without a major change in pathophysiology. Moreover, the heterogeneity and variable natural history of IBS significantly limit clinical trials of motility-active drugs and drug therapy in practice.

In addition to meeting these positive criteria, patients have initial laboratory testing with a complete blood count, basic chemistry panel, and an erythrocyte sedimentation rate. Diagnostic accuracy for IBS is over 95% when Rome II criteria are met, history and physical exam do not suggest any other cause, and initial laboratory testing is negative.

In the past it was thought that the diagnosis of IBS relied on a diagnosis of exclusion; that is, if one cannot find a cause then IBS is the diagnosis. Currently the diagnosis of IBS relies on meeting Rome II inclusion criteria (updated by Rome III criteria) and excluding other illnesses based on history, physical exam, and laboratory testing. Although the Rome II and III criteria were not designed to be a management guideline, it is currently a "gold standard" for the diagnosis of IBS. Unfortunately, an IBS diagnosis in an adult patient is still only useful as a tool to rule out more serious problems unless further investigation is employed to discern an addressable condition.

References and Sources

• Gastroenterology (Journal) 2006;130:1552–1556
• The Rome Criteria