The DiagnosisSymptom-Based CriteriaThe use of symptom-based criteria allows the physician tomake a "positive diagnosis" of IBS, thereby reducing the needfor excess diagnostic tests/studies to exclude other conditions.These criteria also serve to legitimize the disorder to patientsand physicians. However, developing diagnostic criteria ischallenging because of the absence of specific physical orbiochemical findings, the variability of the symptoms (withregard to pattern, location, and severity) among patients -- andeven in the same patient over time, and the inconsistency of theclinical course. Several symptom-based diagnostic approachesfor IBS have been proposed over the last 2 decades in anattempt to standardize the diagnosis and increase its specificity.These criteria were selected through use of clusters ofsymptoms thought to be consistent with the disorder.[11,12] In a study done 20 years ago, 6 symptoms were identified thatdifferentiate between patients with irritable bowel from thosewith organic intestinal diseases.[41] These symptoms, laterknown as the "Manning criteria," for the first time suggested thefeasibility of a positive diagnostic approach to IBS based onsymptom criteria. Although widely used in epidemiologic andclinical studies, these criteria have been of limited clinicalvalue in differentiating IBS from organic, lower GI tractdiseases.[42] Nevertheless, they have provided the basis for themore recent "Rome criteria," first published for IBS in 1989[43]and for all of the functional GI disorders in 1990.[10] The Rome criteria. The Rome criteria were first developed byinternational consensus ("Delphi" approach). Thesemultinational working teams also critically reviewed theliterature on the epidemiology, pathophysiology, diagnosticapproach, and treatment for IBS and other functional GIdisorders. The original criteria (ie, "Rome I")[44] have recentlybeen revised ("Rome II") and published as a book[3] and journalsupplement.[45] The Rome II criteria for IBS are shown in theTable below. Over the 20 years since publication of theManning criteria, the use of symptom-based criteria for thediagnosis of IBS has become accepted as the diagnosticstandard for research and clinical care. According to these criteria, the presence of abdominalpain/discomfort is required for the diagnosis of IBS. The painor discomfort must be associated with at least 2 of the 3criteria that link the pain to change in bowel habit (see Table).Therefore, pain/discomfort alone, or with only 1 of the 3criteria, or the existence of altered stool habit (ie, frequency orstool form) without pain/discomfort is not sufficient for thediagnosis of IBS. Patients may have other functional bowelsymptoms that do not fulfill the criteria for IBS. Thesesymptoms may represent different functional bowel diagnoses,such as functional abdominal pain, functional constipation,functional diarrhea, functional abdominal bloating, orunspecified functional bowel disorder.[3]The Rome criteria also require certain temporal features for thediagnosis. Symptoms must be present "at least 12 weeks ormore, which need not be consecutive, in the preceding 12months," and this can apply to any 12 weeks in a year. Thus,symptoms need not be consecutive, and the chronicity criterioncan be fulfilled even if the symptoms are present for only 1 dayin a week. For epidemiologic surveys, symptoms may bepresent for 3 weeks over a 3-month period (25% of the time).The Rome II criteria for IBS have been modified from theRome I criteria in several ways[3]: (1) They have beensimplified by defining the specific symptoms regarding bowelhabit (eg, > 3 bowel movements per week, straining at stool,hard stool) as only supportive rather than diagnostic of IBS; (2)Two of the 3 major criteria (rather than 1 of 3 for Rome Icriteria) are now required for the diagnosis; and (3) Symptomsmust be present for a longer time frame (12 weeks/year, ratherthan 3 weeks/3 months). These symptom item changes werebased on new empiric evidence that helps to validate thecriteria (primarily, factor analytic studies).Subclassification of IBSIBS can be stratified by subgroup based on predominantsymptom or severity. These subclassifications can help theclinician to determine diagnostic (to exclude other diseases)and treatment approaches, and to stratify study populations forclinical trials.Predominant symptom subclassification. IBS is oftensubclassified as diarrhea-predominant,constipation-predominant, or alternating (combination of both)at varying times. The Rome multinational working teamproposed guidelines for predominant symptomsubclassification based on stool frequency, stool form, andstool passage.[3] However, because IBS is characterized bydysregulation of bowel function, patients may often alternatebetween these subgroups, and thus their predominant symptommay change over time.[18,46] Moreover, a long-term study on thenatural history of IBS and dyspepsia has shown that thepredominant functional symptom can change over time not onlywithin the specific diagnosis/disorder (eg, IBS), but alsobetween different functional disorders (eg, IBS anddyspepsia).[17,18] Symptom severity subclassification. Another strategy ofsubclassifying IBS patients is by the severity of the symptoms.Most subjects who have IBS symptoms do not see physiciansfor their symptoms (ie, IBS nonpatients). The majority (about70%) of the subjects who do see physicians (ie, IBS patients)have mild and infrequent symptoms associated with littledisability.[47] Twenty-five percent of IBS patients havemoderate symptoms, which may occasionally interfere withdaily activities (such as missing school, work, or socialfunctions), and only a small proportion (about 5%) have severesymptoms that considerably affect daily activities and qualityof life.The severity of IBS symptoms is determined by their intensity,constancy, the degree of psychosocial difficulties, and thefrequency of healthcare utilization.[11,31,47] Subclassifying IBSpatients according to the severity of their symptoms can behelpful in guiding proper management. For example, patientswith mild and infrequent symptoms can be managed by primarycare physicians and usually require only reassurance,education, and dietary or lifestyle changes. Patients withmoderate symptoms may require, in addition, pharmacologicand/or behavioral treatments. Patients who have severe, morefrequent, or constant symptoms often requirepsychopharmacologic (eg, antidepressants) and/orpsychological (eg, cognitive-behavioral) interventions and mayneed to be referred to tertiary centers.[11,12,47]Diagnostic TestingOnce the diagnostic criteria have been met, it is necessary toexclude other medical disorders having similar clinicalpresentations. This is done by looking for alarm signs (seeabove) and by performing limited diagnostic screening tests.The diagnostic strategy should be planned in a cost-effectivemanner with consideration of the duration of the symptoms, ageof onset of symptoms, family history of colon cancer, severityof the symptoms, previous diagnostic evaluations, psychosocialstatus, and change of symptoms over time.[3] Detailed recommendations for diagnostic tests that can be usedin this setting are found elsewhere.[3,11,12] In brief, the initialscreening evaluation should include at least blood tests (eg,blood count, erythrocyte sedimentation rate, serumchemistries), stool tests (eg, for ova and parasites and blood),and sigmoidoscopy. Other studies such as colonoscopy, bariumenema, ultrasound, or CT scan will depend on the presence of"alarm" signs as well as factors such as the patient's age andfamily history. More specific studies (eg, lactose breathhydrogen test, thyroid-stimulating hormone determination,celiac sprue serology) should be considered if indicated byfeatures in the patient history or results of screening studies thatpoint to other diagnoses.If the initial screening evaluation is normal, further diagnosticstudies should be withheld and treatment may be started with afollow-up visit within 4-6 weeks.[11] The patient should bereevaluated over time and additional diagnostic tests obtaineddepending on changes in clinical status and response totreatment. Nevertheless, it should be emphasized that the merepersistence of symptoms does not justify further diagnostictesting. Because IBS is a chronic disorder with frequentrelapses, repeating diagnostic studies to "convince" the patient,or to rule out other disease entities, is not only unjustified butmay be harmful in that it undermines the patient's confidence inboth the diagnosis and the physician.[3]Factors such as the severity of the symptoms, the patient'sillness behavior (eg, recurrent complaints, recurrent physicianvisits and phone calls, requests for further testing), and even anincomplete response to symptomatic treatment must beconsidered in the management approach. However, thesefactors do not justify additional diagnostic testing in theabsence of other "alarm" signs (eg, blood in the stool, abnormalphysical examination, or laboratory studies). Rather, they mayreflect the degree of psychosocial difficulties. As discussedearlier, psychosocial assessment is an essential part of thepatient's evaluation and diagnostic planning. Clinicians shouldlook for psychosocial factors that may exacerbate the clinicalexpression of the symptoms as well as the patient's illnessbehavior. Identifying or excluding these factors is helpful inestablishing an appropriate diagnostic plan and in minimizingunneeded investigative studies. Validity of the DiagnosisHow confident can a physician (and the patient) be with thediagnosis? In addition to the symptoms included in the majorcriteria, the Rome committee also listed symptoms that are notessential for the diagnosis but that are commonly present inpatients with IBS (see Table). The presence of these symptomscan add to the physician's confidence regarding the origin of thesymptoms (ie, GI) and the diagnosis (ie, IBS).[41] Nevertheless,development of symptom-based criteria in the absence of adiagnostic ("gold") standard has obvious limitations. Theconsensus achieved by expert clinicians and investigators canonly provide face validity, and additional validation studiesare needed to support the utility of the published criteria.Unfortunately, available data on the validity of the Romecriteria are still limited. In a recent study, Vanner and colleagues[48] examined thepredictive value of the Rome I criteria using thegastroenterologist's final diagnosis as the gold standard. Thestudy authors found that the combination of the Rome criteriaand the absence of "red flags" (weight loss, nocturnalsymptoms, blood in stools, recent antibiotic use, family historyof colon cancer, and abnormal physical examination) yielded63% sensitivity and 100% specificity, with a positivepredictive value (PPV) of 98% to 100% and negativepredictive value of 76%. Additional studies on the validationof the Rome criteria, particularly the new (Rome II) criteria,are currently under way.Additional support for a positive diagnosis of IBS also comesfrom studies that have looked at long-term outcomes. Inlong-term follow-up studies (up to 9 years from the diagnosis),no other explanation for the symptoms was found in 95% to100% of patients.[49-51] This suggests that a positive diagnosisusing symptom-based criteria, the absence of "red flags," andlimited investigations rarely requires revision.