{{Short description|Diagnostic criteria for gastrointestinal disorders}} The '''Rome process and Rome criteria''' are an international effort to create scientific data to help in the diagnosis and treatment of functional gastrointestinal disorders, such as irritable bowel syndrome, functional dyspepsia and rumination syndrome. The Rome diagnostic criteria are set forth by '''Rome Foundation''', a not for profit 501(c)(3) organization based in Raleigh, North Carolina, United States.
==History== Several systematic approaches attempted to classify functional gastrointestinal disorders (FGIDs). As a result, there were several key events which ultimately led to the current Rome Classification. In 1962, Chaudhary and Truelove published their study of IBS patients in Oxford, England. This was the first attempt to classify the new field of functional gastrointestinal disorders. Much of what they reported has persisted to the present day.<ref>Chaudhary NA, Truelove SC. The irritable colon syndrome. A study of the clinical features, predisposing causes, and prognosis in 130 cases. Q J Med 1962;31:307–322.</ref>
Subsequently, in 1978 came the "Manning Criteria" developed by Kenneth Heaton and colleagues in Bristol. This characterized IBS-D (IBS with predominant diarrhea), but importantly, a cluster of symptoms which were characteristic for this disorder. This ultimately became the basis for Rome's symptom-based criteria for IBS.<ref>Manning AP, Thompson WG, Heaton KW et al. Towards positive diagnosis of the irritable bowel. Br Med J 1978;2:653–654.</ref>
From 1980 to 1994, there were several epidemiological and clinical studies evaluating symptom prevalence and frequency in healthy subjects and IBS patients. Thompson, Drossman, Talley, Whitehead, and Kruis.<ref name ="rome5">Torsoli A, Corazziari E. The WTR's, the Delphic Oracle and the Roman Conclaves Gastroenterol Int 1991;4:44–45.</ref><ref>Thompson WG, Heaton KW. Functional bowel disorders in apparently healthy people. Gastroenterology 1980;79:283–288.</ref><ref>Drossman DA, Sandler RS, McKee DC, et al. Bowel patterns among subjects not seeking health care. Use of a questionnaire to identify a population with bowel dysfunction. Gastroenterology 1982;83:529–534.</ref><ref name = "rome10">Sandler RS, Drossman DA, Nathan HP, et al. Symptom complaints and health care seeking behavior in subjects with bowel dysfunction. Gastroenterology 1984;87:314–318.</ref><ref name = "rome11">Talley NJ, Phillips SF, Melton LJ, et al. A patient questionnaire to identify bowel disease. Ann Intern Med 1989;111:671–674</ref><ref name = "rome12">Kruis W, Thieme CH, Weinzierl M, et al. A diagnostic score for the irritable bowel syndrome. Its value in the exclusion of organic disease. Gastroenterology 1984;87:1–7.</ref><ref name = "rome13">Drossman DA. Diagnosis of the irritable bowel syndrome: A simple solution? Gastroenterology 1984;87:224–225</ref> In 1989, the first consensus-based diagnostic criteria for IBS were established.<ref name ="rome5"/><ref name = "rome14">Thompson WG, Dotevall G, Drossman DA, et al. Irritable bowel syndrome: Guidelines for the diagnosis. Gastroenterol Int 1989;2:92–95.</ref> The following year, a classification system for FGIDs was established.<ref name ="rome5"/><ref name = "rome15">Drossman DA, Thompson WG, Talley NJ, et al. Identification of subgroups of functional bowel disorders. Gastroenterol Int 1990;3:159–172.</ref>
From 1991 to 1993, several working teams (esophagus, gastroduodenal, bowel, biliary, anorectal) published symptom-based criteria and clinical features of the functional GI disorders within these anatomic domains in ''Gastroenterology International''.<ref name ="rome5"/><ref name = "rome16">Richter JE, Baldi F, Clouse RE, et al. Functional oesophageal disorders. Gastroenterol Int 1992;5:3–17</ref><ref name = "rome17">Talley NJ, Colin-Jones D, Koch KL, et al. Functional dyspepsia: a classification with guidelines for diagnosis and management. Gastroenterol Int 1991;4:145–160</ref><ref name = "rome18">Thompson WG, Creed F, Drossman DA, et al. Functional bowel disorders and chronic functional abdominal pain. Gastroenterol Int 1992;5:75–91</ref><ref name = "rome19">Corazziari E, Funch-Jensen P, Hogan WJ, et al. Working team report: functional disorders of the biliary tract. Gastroenterol Int 1993;6:129–144.</ref><ref name = "rome20">Whitehead WE, Devroede G, Habib FI, et al. Functional disorders of the anorectum. Gastroenterol Int 1992;5:92–108.</ref><ref name = "rome21">Talley NJ, Nyren O, Drossman DA, et al. The irritable bowel syndrome: toward optimal design of controlled treatment trials. Gastroenterol Int 1993;4:189–211</ref>
In 1993, a validated questionnaire of all the diagnostic criteria was created and was then applied in a national survey, the US Householder Survey: the first national epidemiological database on the prevalence, demographic factors, and health care seeking features of people with FGIDs.<ref name ="rome5"/><ref name = "rome22">Drossman DA, Li Z, Andruzzi E, et al. U.S. householder survey of functional gastrointestinal disorders: prevalence, sociodemography and health impact. Dig Dis Sci 1993;38:1569–1580.</ref>
In 1994, FGIDs were categorized into anatomical domains and resulted in a book now recognized as Rome I – ''The Functional Gastrointestinal Disorders: Diagnosis, Pathophysiology and Treatment – A Multinational Consensus''.<ref name ="rome5"/><ref name = "rome23">Drossman DA, Richter JE, Talley NJ, et al. The functional gastrointestinal disorders: diagnosis, pathophysiology and treatment. McLean (VA): Degnon Associates, 1994.</ref>
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 functional gastrointestinal disorders (1990), or Rome-1, the Rome I Criteria for IBS (1992) and the functional gastrointestinal disorders (1994), the Rome II Criteria for IBS (1999) and the functional gastrointestinal disorders (1999) to the Rome III Criteria (2006). "Rome II" and "Rome III" incorporated pediatric criteria to the consensus. The Rome IV update was published 10 years later in May 2016.<ref name="pmid27147121">{{cite journal |vauthors=Drossman DA, Hasler WL |title=Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction |journal=Gastroenterology |volume=150 |issue=6 |pages=1257–61 |year=2016 |pmid=27147121 |doi=10.1053/j.gastro.2016.03.035 }}</ref> This covers epidemiology, pathophysiology, psychosocial and clinical features, and diagnostic evaluation and treatment recommendations for 33 adult and 17 pediatric functional gastrointestinal disorders.<ref name="pmid27144617">{{cite journal |vauthors=Drossman DA |title=Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV |journal=Gastroenterology |volume=150 |issue=6 |pages=1262–1279|year=2016 |pmid=27144617 |doi=10.1053/j.gastro.2016.02.032 |url=https://cdr.lib.unc.edu/downloads/12579z328 }}</ref>
==Process== The Rome criteria are achieved and finally issued through a consensual process, using the Delphi method (or Delphi technique). The Rome Foundation process is an international effort to create scientific data to help in the diagnosis and treatment of functional gastrointestinal disorders, also known as disorders of gut-brain interaction.<ref name="rome1">Drossman DA. The Rome IV Committees, editor. Functional Gastrointestinal Disorders and the Rome IV process. In: Drossman DA, Chang L, Chey WD, Kellow J, Tack J, Whitehead WE, editors. Rome IV functional gastrointestinal disorders: disorders of gut-brain interaction. I. Raleigh, NC: The Rome Foundation; 2016. pp. 1–32.</ref> The Rome Diagnostic criteria are set forth by the Rome Foundation, an independent, not for profit 501(c)(3) organization.<ref name="rome1"/><ref name="rome2">{{cite web |url=https://theromefoundation.org/ |title=Home |website=theromefoundation.org}}</ref>
== The Rome Foundation == The Rome Foundation, incorporated in 1996 and based in Raleigh, North Carolina, is an independent not for profit 501(c) 3 organization. The foundation provides support for activities which foster clinical research, data and educational information which aid in the diagnosis and treatment of functional gastrointestinal disorders.<ref name="rome1"/><ref name="rome2"/><ref name ="rome3">"Meet the Rome Foundation," 2017. Retrieved from https://theromefoundation.org/wp-content/uploads/Meet-The-Rome-Foundation-2017-web.pdf</ref><ref name="rome4">{{cite web | url=https://theromefoundation.org/presentations-videos/ | title=Presentations & Videos }}</ref>
Over the last 25 years, the Rome organization has sought to legitimize and update the knowledge of functional GI disorders. This has been accomplished by bringing together scientists and clinicians from around the world to classify and critically appraise the science of gastrointestinal function and dysfunction. This knowledge permits clinical scientists to make recommendations for diagnosis and treatment that can be applied in research and clinical practice. The mission is to improve the lives of people with these disorders.{{citation needed|date=January 2022}}
The goals of the Rome Foundation are to promote global recognition and legitimization of FGIDs, advance the scientific understanding of their pathophysiology, optimize clinical management for these patients and develop and provide educational resources to accomplish these goals.<ref name="rome2"/>
==Definition of functional gastrointestinal disorders/disorders of gut-brain interaction== {{See also|Functional gastrointestinal disorder}}
Using the Delphi method, the Rome Foundation and its board of directors, chairs and co-chairs of the ROME IV committees developed the current definition for disorders of gut-brain interaction.<ref name="rome1"/>
A group of disorders classified by GI symptoms related to any combination of:<ref name="rome1"/> * Motility disturbance * Visceral hypersensitivity * Altered mucosal and immune function * Altered gut microbiota * Altered central nervous system (CNS) processing
==Evolution of Rome criteria== ===Rome I=== In 1994, Rome I was published as The Functional Gastrointestinal Disorders:Diagnosis, Pathophysiology, and Treatment—A Multinational Consensus.<ref name="rome23"/>
===Rome II=== By the mid-1990s, the concept of FGID classification and the use of diagnostic criteria was promoted due to the US Food and Drug Administration (FDA) recommended the use of the IBS criteria for selection into pharmaceutical studies, and the pharmaceutical companies took interest in supporting the efforts of the Rome Foundation to improve the understanding, diagnosis, and treatment of FGIDs and to also apply the use of these criteria in their pharmaceutical studies. In Rome II, the pediatric population of FGIDs was added.
===Rome III=== After publication of Rome II, the number of studies published using the Rome criteria in clinical trials grew tremendously over the next 15 years. Rome III differed from Rome I and II by the use of more evidence-based rather than consensus-based data.
===Rome IV=== After publication of Rome III in 2006, the Rome Foundation was well recognized as the authoritative body developing diagnostic criteria for research and also for providing education about the FGIDs. Rome IV tried to address the limitations of a symptom-based criteria in several ways: * Some criteria have been simplified and cases not meeting criteria for research can still be identified and treated. * Global education on FGIDs help to understand and characterize the cross-cultural differences in symptom reporting. * Provide translations into other languages * Creation of diagnostic algorithms for a functional GI disorder diagnosis or other diagnosis # To address the severity and variability of clinical presentation, a Multidimensional Clinical Profile (MDCP) system has been created that incorporates the diagnostic criteria with additional clinical, quality of life, psychosocial, and physiological (including biomarker) parameters to more precisely create an individualized treatment plan for the patient. * To help clinicians be better trained in the diagnostic algorithms and the MDCP, the Rome Foundation is developing an interactive, intelligent software platform that will help clinicians make real-time treatment decisions using the diagnostic algorithms and MDCP knowledge base.<ref name="Rome 1">Drossman DA. The Rome IV Committees, editor. Functional Gastrointestinal Disorders and the Rome IV process. In: Drossman DA, Chang L, Chey WD, Kellow J, Tack J, Whitehead WE, editors. Rome IV functional gastrointestinal disorders: disorders of gut-brain interaction.I. Raleigh, NC: The Rome Foundation; 2016. pp 1–32.</ref><ref name ="rome5"/>
In Rome IV, the classification moved from a physiologically based classification to a symptom-based classification. The classifications were based upon organ regions (i.e. esophageal, gastroduodenal, bowel, biliary, anorectal).
== Rome IV criteria/classification == The original Rome classification was first published in 1990 and has since been modified with each iteration to develop the subsequent classifications with Rome II, III and IV. Beginning with the original publication in 1990 and leading to Rome I, the classification moved from a physiologically based classification to a symptom-based classification with additional classifications based upon organ regions (i.e. esophageal, gastroduodenal, bowel, biliary, anorectal).<ref name="rome1"/> The current Rome IV classification<ref name="rome1"/> is the culmination of the evolution of a series of iterations (Rome I,<ref name = "rome23"/> Rome II,<ref name="rome8">Drossman DA, Corazziari E, Talley NJ, et al., eds. Rome II: the functional gastrointestinal disorders. 2nd ed. McLean (VA): Degnon Associates, 2000.</ref> and Rome III<ref name="rome9">Drossman DA, Corazziari E, Delvaux M, et al., eds. Rome III: the functional gastrointestinal disorders. 3rd ed. McLean (VA): Degnon Associates, 2006.</ref>) with its inception as Rome I.<ref name = "rome23"/>
The Rome criteria are a set of criteria used by clinicians to classify a diagnosis of a patient with an FGID (disorder of gut-brain interaction). These Rome criteria are updated every 6–10 years.<ref name ="rome3"/>
The current Rome IV classification, published in 2016, is as follows:<ref name="pmid27144617"/>
'''A. Esophageal Disorders''' * A1. Functional chest pain * A2. Functional heartburn * A3. Reflux hypersensitivity * A4. Globus * A5. Functional dysphagia
'''B. Gastroduodenal Disorders''' * B1. Functional dyspepsia ** B1a. Postprandial distress syndrome (PDS) ** B1b. Epigastric pain syndrome (EPS) * B2. Belching disorders ** B2a. Excessive supragastric belching ** B2b. Excessive gastric belching * B3. Nausea and vomiting disorders ** B3a. Chronic nausea vomiting syndrome (CNVS) ** B3b. Cyclic vomiting syndrome (CVS) ** B3c. Cannabinoid hyperemesis syndrome (CHS) * B4. Rumination syndrome
'''C. Bowel Disorders''' * C1. Irritable bowel syndrome (IBS) ** IBS with predominant constipation (IBS-C) ** IBS with predominant diarrhea (IBS-D) ** IBS with mixed bowel habits (IBS-M) ** IBS unclassified (IBS-U) * C2. Functional constipation * C3. Functional diarrhea * C4. Functional abdominal bloating/distension * C5. Unspecified functional bowel disorder * C6. Opioid-induced constipation
'''D. Centrally Mediated Disorders of Gastrointestinal Pain''' * D1. Centrally mediated abdominal pain syndrome (CAPS) * D2. Narcotic bowel syndrome (NBS)/ Opioid-induced GI hyperalgesia
'''E. Gallbladder and Sphincter of Oddi disorders''' * E1. Biliary pain ** E1a. Functional gallbladder disorder ** E1b. Functional biliary sphincter of Oddi disorder * E2. Functional pancreatic sphincter of Oddi disorder
'''F. Anorectal Disorders''' * F1. Fecal incontinence * F2. Functional anorectal pain ** F2a. Levator ani syndrome ** F2b. Unspecified functional anorectal pain ** F2c. Proctalgia fugax * F3. Functional defecation disorders ** F3a. Inadequate defecatory propulsion ** F3b. Dyssynergic defecation
'''G. Childhood Functional GI Disorders: Neonate/Toddler''' * G1. Infant regurgitation * G2. Rumination syndrome * G3. Cyclic vomiting syndrome (CVS) * G4. Infant colic * G5. Functional diarrhea * G6. Infant dyschezia * G7. Functional constipation
'''H. Childhood Functional GI Disorders: Child/Adolescent''' * H1. Functional nausea and vomiting disorders ** H1a. Cyclic vomiting syndrome (CVS) ** H1b. Functional nausea and functional vomiting *** H1b1. Functional nausea *** H1b2. Functional vomiting ** H1c. Rumination syndrome ** H1d. Aerophagia * H2. Functional abdominal pain disorders ** H2a. Functional dyspepsia *** H2a1. Postprandial distress syndrome *** H2a2. Epigastric pain syndrome ** H2b. Irritable bowel syndrome (IBS) ** H2c. Abdominal migraine ** H2d. Functional abdominal pain ‒ NOS * H3. Functional defecation disorders ** H3a. Functional constipation ** H3b. Nonretentive fecal incontinence
==Sponsors==
As a non-profit organization the Rome Foundation has a number of industry sponsors who provide financial support.<ref>{{Cite web | title=Rome IV Sponsors - Rome Foundation | url=https://theromefoundation.org/rome-iv/rome-iv-sponsors/ | access-date=2025-08-25 | website=theromefoundation.org}}</ref>
* Allergan plc * Astellas Pharma Global Development, Inc. * AstraZeneca, LP * Danone Nutricia Research * Ironwood Pharmaceuticals, Inc. (formerly Microbia, Inc.) * Salix Pharmaceuticals/Valeant Pharmaceuticals International, Inc. * Shire Pharmaceuticals USA * Sucampo AG * Zeria Pharmaceutical Co., Ltd
==Notable people== * Douglas Drossman, gastroenterologist * Brian Lacy, gastroenterologist * Magnus Simren, gastroenterologist * Robin Spiller, gastroenterologist * Jan Tack, gastroenterologist * Nicholas Talley, researcher, gastroenterologist
==See also== * Functional gastrointestinal disorders
==References and sources==
{{reflist|30em}} * {{cite journal|author=Thompson WG|title=The Road to Rome|journal=Gastroenterology|year=2006|volume=130|issue=5|pages=1552–1556|doi=10.1053/j.gastro.2006.03.011|pmid=16678568|url=http://www.gastrojournal.org/article/S0016-5085(06)00546-4/fulltext|url-access=subscription}}
== External links == * [http://www.theromefoundation.org The Rome Foundation]
Category:Gastroenterology Category:Diagnostic gastroenterology