ROME I, ROME II, ROME III, AND THE ROME COMMITTEES: TERMINOLOGY AND BIBLIOGRAPHY

Douglas A. Drossman MD, Chair
Multinational Working Teams for Diagnosis of Functional GI Disorders (Rome III)

     Recently there has been some uncertainty relating to the citing of references for the various Rome Criteria, particularly when related to the use of criteria in treatment trials for IBS. This is understandable since the Rome committee process has been in constant evolution for over a decade and previously no standard terminology for Rome I, Rome II, etc., has been published. In fact, the Rome Committees (officially called the Multinational Working Teams for Diagnosis of Functional GI Disorders) and particularly the term "Rome Criteria" did not actually come into play until after the initial work was completed. Thus much of the history of the Rome process predates the current terminology. What follows is a description of the history of the Rome classification system and the terminology recommended by the Rome III Coordinating Committee. For more detailed information about the history of the Rome committee process, the reader is referred elsewhere (1-4)

Pre-Rome
The first paper to address diagnostic criteria for IBS was a working team report published in 1989 for the 1988 International Congress of Gastroenterology in Rome, Italy (Roma '88) (5). This antedated the Rome process since there was no classification system set up at the time for the functional GI disorders.

Establishment of Rome Committee Process
Following the 1989 publication, a committee was set up the same year to develop for the first time a classification system for all the 21 functional GI disorders (FGID). This report was published in 1990 (6), and heralded the beginning of the Rome Criteria process: it set the stage for organizing a series of committees (esophageal, gastroduodenal, bowel, biliary, anorectal) that further elaborated on the 21 functional GI disorders subsumed under these categories.
The criteria for IBS in the 1989 paper (5) and the criteria for IBS published in the 1990 paper (6) are NOT consistent with the current Rome criteria for this disorder. These criteria should not be used in treatment trials. This is because the presence of pain, now a requirement for the diagnosis of IBS, was not listed as such in these documents, and this did not occur until 1992 (7).

Rome I
  1. From 1990-1995, seven committees formed to elaborate on the 1990 classification system, and the articles from these committees were published in Gastroenterology International (7-11;11-13).
  2. Knowledge of this classification system was quite limited, since the journal had a small circulation and was not listed in MEDLINE.
  3. Primarily to increase awareness of these disorders, the coordinating committee at the time (Drossman, Corazziari, Richter, Talley, Thompson, and Whitehead) were able to get a publisher, Little Brown & Co. to compile these articles into a book (14). Included was also a chapter on the first national epidemiological study of the FGID's using the Rome I criteria, and this was also published in a journal as the US Householder Study (15). This official Rome I book, had limited sales of only about 2,000 copies. Of note, the IBS criteria included in the 1992 publication (7) was a 3rd revision; it was the first time that pain was required for the diagnosis.
  4. All documents published in the Gastroenterology International Journal from 1992-1995, as well as the Rome I book (14) is considered as Rome I
  5. The idea of using diagnostic criteria, particularly for IBS, caught the attention of several pharmaceutical companies who began using the Rome I criteria in their phase II and phase III clinical trials.
Rome II
  1. By 1995, the interest from pharmaceutical sponsors and clinical investigators in the field had grown to the point that the coordinating committee was able to secure funding from 6 pharmaceutical companies to support a new project, the Rome II committees.
  2. The number of committees were expanded, new committees were added (including basic science, physiology, psychosocial and pediatric committees) and a series of articles were produced as a supplement in GUT in 1999 (4;16-26).
  3. Following this, the Rome II book was published in 2000 which contained expanded information from the work of these committees (27). To date over 15,000 copies have been sold.
  4. All documents published either in the GUT supplement or the book is considered as Rome II.
Rome III
  1. Because of the success of the Rome II process, support from the pharmaceutical industry was secured almost immediately to begin the Rome III process.
  2. A coordinating committee was formed in 2001 for Rome III (Drossman, Corazziari, Delvaux, Spiller, Talley, Thompson and Whitehead) and the group began by identifying the committees that will be in place. Most of the Rome II committees were retained, and additional ones (Pharmacology, Gender, Culture, Society and the Patient, 2 pediatric committees, Functional Abdominal Pain) were identified
  3. By summer, 2002, the chairs were selected, and by December, 2002 all committee members were identified.
  4. The committees will begin their work in May, 2003.
  5. The publications will be released in 2006 as a supplement in GASTROENTEROLOGY, and as the Rome III book.
  6. All documents published in 2006 will be considered as Rome III.
For additional information, please feel free to contact Ms. Carlar Blackman () or Mr. George Degnon ().

Reference List

(1) Thompson WG. The road to Rome. In: Drossman DA, Corazziari E, Talley NJ, Thompson WG, Whitehead WE, eds. Rome II. Functional gastrointestinal disorders: Diagnosis, pathophysiology, and treatment-A multinational consensus. 2nd ed. McLean, VA: Degnon Associates; 2000: 629-35.

(2) Thompson WG. The road to Rome. Gut. 1999;45:II80-II81.

(3) Drossman DA. The functional gastrointestinal disorders, their diagnosis, and the Rome II process. In: Drossman DA, Corazziari E, Talley NJ, Thompson WG, Whitehead WE, eds. Rome II. The functional gastrointestinal disorders: Diagnosis, pathophysiology and treatment; A multinational consensus. 2nd ed. 2000: 1-29.

(4) Drossman DA. The functional gastrointestinal disorders and the Rome II process. Gut. 1999;45:II1-II5.

(5) Thompson WG, Dotevall G, Drossman DA, Heaton KW, Kruis W. Irritable bowel syndrome: Guidelines for the diagnosis. Gastroenterology International. 1989;2:92-95.

(6) Drossman DA, Thompson WG, Talley NJ, Funch-Jensen P, Janssens J, Whitehead WE. Identification of subgroups of functional bowel disorders. Gastroenterology International. 1990;3:159-72.

(7) Thompson WG, Creed F, Drossman DA, Heaton KW, Mazzacca G. Functional bowel disorders and chronic functional abdominal pain. Gastroenterology International. 1992;5:75-91.

(8) Richter JE, Baldi F, Clouse RE, Diamant NE, Janssens J, Staiano A. Functional Oesophageal Disorders. Gastroenterology International. 1992;5:3-17.

(9) Whitehead WE, Devroede G, Habib FI, Meunier P, Wald A. Functional Disorders of the Anorectum. Gastroenterology International. 1992;5:92-108.

(10) Corazziari E, Funch-Jensen P, Hogan WJ, Tanaka M, Toouli J. Working team report: Functional disorders of the biliary tract. Gastroenterology International. 1993;6:129-44.

(11) Talley NJ, Nyren O, Drossman DA, Heaton KW, Veldhuyzen van Zanten SJO, Koch MM et al. The irritable bowel syndrome: Toward optimal design of controlled treatment trials. Gastroenterology International. 1993;4:189-211.

(12) Talley NJ, Colin-Jones D, Koch KL, Koch M, Nyren O, Stanghellini V. Functional dyspepsia: A classification with guidelines for diagnosis and management. Gastroenterology International. 1991;4:145-60.

(13) Drossman DA, Creed FH, Fava GA, Olden KW, Patrick DL, Toner BB et al. Psychosocial aspects of the functional gastrointestinal disorders. Gastroenterology International. 1995;8:47-90.

(14) Drossman DA, Richter JE, Talley NJ, Thompson WG, Corazziari E, Whitehead WE. The Functional Gastrointestinal Disorders: Diagnosis, Pathophysiology and Treatment. 1 ed. McLean, VA: Degnon Associates; 1994.

(15) Drossman DA, Li Z, Andruzzi E, Temple R, Talley NJ, Thompson WG et al. U.S. Householder Survey of Functional Gastrointestinal Disorders: Prevalence, Sociodemography and Health Impact. Dig Dis Sci. 1993;38:1569-80.

(16) Wood JD, Alpers DH, Andrews PLR. Fundamentals of neurogastroenterology. Gut. 1999;45:II6-II16.

(17) Kellow JE, Delvaux M, Azpiroz F, Camilleri M, Quigley EMM, Thompson DG. Principles of applied neurogastroenterology: physiology/motility-sensation. Gut. 1999;45:II17-II24.

(18) Drossman DA, Creed FH, Olden KW, Svedlund J, Toner BB, Whitehead WE. Psychosocial aspects of the functional gastrointestinal disorders. Gut. 1999;45:II25-II30.

(19) Clouse RE, Richter J, Heading RC, Janssens J, Wilson JA. Functional espophageal disorders. Gut. 1999;45:II31-II36.

(20) Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GNJ. Functional gastroduodenal disorders. Gut. 1999;45:II37-II42.

(21) Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Mueller-Lissner SA. Functional Bowel Disorders and Functional Abdominal Pain. Gut. 1999;45:II43-II46.

(22) Corazziari E, Shaffer EA, Hogan WJ, Sherman S, Toouli J. Functional disorders of the biliary tract and pancreas. Gut. 1999;45:II48-II54.

(23) Whitehead WE, Wald A, Diamant NE, Enck P, Pemberton JH, Rao SSC. Functional disorders of the anus and rectum. Gut. 1999;45:II55-II59.

(24) Rasquin-Weber A, Hyman PE, Cucchiara S, Fleisher DR, Hyams JS, Milla PJ et al. Childhood functional gastrointestinal disorders. Gut. 1999;45:II60-II68.

(25) Veldhuyzen van Zanten SJO, Talley NJ, Bytzer P, Klein KB, Whorwell PJ, Zinsmeister A. Design of treatment trials for functional gastrointestinal disorders. Gut. 1999;45:II69-II77.

(26) Whitehead WE, Corrazziari E, Prizont R, Senior JR, Thompson WG, Veldhuyzen van Zanten SJO. Definition of a responder in clinical trials for functional gastrointestinal disorders: report ona symposium. Gut. 1999;45:II78-II79.

(27) Drossman DA, Corazziari E, Talley NJ, Thompson WG, Whitehead WE. Rome II. The Functional Gastrointestinal Disorders. Diagnosis, Pathophysiology and Treatment: A Multinational Consensus. 2 ed. McLean, VA: Degnon Associates; 2000.