April 2000

1296

DEVELOPMENT OF A QUESTIONNAIRE TO ASSESS THE FI­NANCIAL AND EMOTIONAL BURDENS TO PATmNT ANDFAMILY AS A RESULT OF OUTPATmNT MANAGEMENT OFACUTE GASTROINTESTINAL HEMORRHAGE.Sachin Goel, Robert Morlock, Tamir Ben-Menachem, Henry Ford HealthSci Ctr, Detroit, MI.

PURPOSE: Care of patients with minor gastrointestinal hemorrhage isshifting to the outpatient arena. As a result, there may be an increasedfinancial and emotional burden to patients and their families. We describethe development and testing of a questionnaire to measure the economicand emotional burdens of caring for patients with acute GIH in theoutpatient setting. METHODS: Patient and physician focus groups wereused to identify the issues and components that require evaluation. Theinitial instrument was reviewed by physicians, social workers, and apsychiatrist. After revision, it was pilot tested for clarity by 12 patients andfamily members. and revised again. IS items assessing financial burden,and 14 items addressing emotional burden were retained. The questionnairewas then administered to a cohort of 112 patients with acute gastrointes­tinal hemorrhage and their family members. Temporal stability was as­sessed at a seven day interval. Multitrait testing techniques were employedto examine the items addressing emotional burden. Subscales of the MOSSF-36, and the Michel Uncertainty in Illness Scale (MUIS) were used toassess criterion validity of the instrument's components. RESULTS: An­swers were complete for more than 90% of items. Temporal stability of thefinancial items was consistently greater than 0.9. Test-retest of the emo­tional items was lower (0.82). Factor analysis with Varimax rotationyielded two constructs representing emotional burden: Anxiety and Addi­tional Work. Cronbach's alpha for the two were 0.81 and 0.74, respec­tively. Item means and standard deviations were comparable within thescales. Item-scale correlations were 0.63 or higher for all items, and werewithin 0.21 and 0.24 of each other within each scale. Items for oneconstruct did not load on the other construct with coefficients of > 0.2. Themean total MUIS score for families was 90.(Higher than MUIS of familiesof patients with myocardial infarction.) Correlation coefficients of 0.43 and0.44 respectively, were noted between the two burden scales and the MUISfor families. Correlations between the MUIS for patients and SF 36subscales were greatest for physical function and vitality. CONCLU­SIONS: Initial testing of the outpatient burden questionnaire demonstratesgood reliability, and adequate validity. Future revisions will result indeletions of unnecessary items, and improve item-discriminant validity.

1297

APPROPRIATE RESOURCE UTILIZATION IN THE MANAGE­MENT OF ACUTE UPPER GASTROINTESTINAL HEMOR­RHAGE: A CONSENSUS PANEL APPROACH.Sachin Gael, Tamir Ben-Menachem, Henry Ford Hosp, Detroit, MI.

Objective: Several equally-effective approaches to managing acute, non­variceal upper gastrointestinal hemorrhage (UGIH) have reported. Thecost-effectiveness of each approach is unknown, partially because resourceutilization for UGIH varies greatly among researchers and institutions. Wedescribe the use of a consensus panel approach to determine appropriateresource utilization for UGIH. Methods: The Nominal Group Techniquewas used to measure and achieve consensus. Eleven physicians participated(gastroenterologists, surgeons, internists, and emergency physicians). Afterextensive literature review. 6 landmark, or review articles were chosen topresent to the panelists. The questionnaire consisted of 25-33 items for theemergency room encounter, and each of the 3 days following. On a 1-9Likert scale, panelists were asked to rank the importance of performing thespecific tasks, tests, or therapeutic interventions. Each item allowed re­sponses for nine different patients, based on three levels of risk of recurrenthemorrhage, and three levels of comorbid conditions. Panelists rankedresponses independently. A structured conference was held to resolvedisagreement according to pre-defined rules. Results: 97% of the 909possible responses were completed. Analysis of initial responses revealedagreement for only 12-19% of items. The consensus conference alloweddiscussion of items until agreement or impasse. Re-ranking of items afterthe conference improved overall agreement to 65%. Agreement was great­est for day I of hospitalization (72%), and lowest for day 3(57%). Agree­ment was greatest for therapeutics (endoscopy, medications, transfusions);and . lowest for frequency of tests such as hemoglobin and electrolytedetermination. Agreement tended to be greater among physicians of similarspecialties, rather than across specialties (76% and 56%, respectively).Consensus was greater for patients at the extremes of the spectrum; ie, lowrisk of rebleeding with low comorbidity score, or high risk of both). Theoverwhelming majority of disagreements were within 4-5 Likert-scalepoints. Panelists expressed the desire to conduct another conference afterre-reading the literature. Conclusions: A consensus approach was useful indefining appropriate resource utilization for UGIH. Agreement wasachieved for high-cost resources, which will ultimately drive the cost­effectiveness model.

AGAA211

1298

VALIDITY OF THE ROME CRITERIA FOR PREDICTING IRRI­TABLE BOWEL SYNDROME (mS): A FIVE YEAR STUDY OF 104PATmNTS IN A COMMUNITY·BASED OUTPATIENT SETTING.M. Scott Harris, Univ of Wisconsin Med Sch, Milwaukee, WI.

The Rome Criteria are purported to have good predictive value for irritablebowel syndrome (ffiS) in controlled studies, but their usefulness in routineclinical practice remains uncertain. Newer recognition of'occult' causes ofdiarrhea such as microscopic and collagenous colitis or sprue suggests theneed for invasive studies to exclude organic causes of diarrhea. The aim ofthis study was to assess the predictive value of the Rome Criteria and therole of endoscopy for diarrhea-predominant IBS in routine communitypractice. Between 1994-1998, 815 patients were referred to a community­based GI practice for evaluation of diarrhea, bloating, flatulence, or lowerabdominal pain. 165 had symptoms consistent with Rome I Criteria for~3

mos duration. Patients were excluded if they had undergone prior colonos­copy or evaluation by a gastroenterologist, hematochezia suggesting anon-anal source, active psychiatric disease, systemic illnesses associatedwith diarrhea, or constipation-predominant symptoms (n = 51). The remain­ing 104 patients ranged in age from 17 to 81 years (mean 35::t5.1) with afemale: male ratio of 3.5:1. Patients were followed for an average 18.1::t7mos. Reasons for referral included refractory symptoms (n= 65), new orchanging symptoms (n=27), weight loss or anorexia (n= 12), or familyhistory of colon cancer (n= 11). Colonoscopy was performed in 62 pa­tients, upper endoscopy in 24, sigmoidoscopy in 26, and serologic studiesfor gluten enteropathy in 31. RESULTS: 7 patients with organic causeswith diarrhea were identified: Crohn's disease with ileal involvement(n=2), ulcerative colitis (n=2), and microscopic or collagenous colitis(n=3). Endoscopic intensity of inflammation was always low-grade. Du­odenal biopsies and serology for gluten enteropathy were negative in all 31patients. No cases of cancer were identified. Traditional "red flags" such asweight loss, anorexia, or new onset of symptoms did not differentiateorganic causes of disease. Of the 7 patients with organic diarrhea, only 2had symptoms of ~ 6 mos. duration. 96% of patients were stable orimproved with conservative therapy. CONCLUSIONS: I) The Rome Cri­teria distinguishes functional and organic causes of diarrhea, with greatestdiscrimination realized when symptom duration is ~6 mos; 2) goodoutcomes can be achieved if these criteria are applied in routine practice;3) traditional "red flags" may not be as predictive of organic disease aspreviously anticipated.

1299

COST·EFFECTIVENESS OF GENETIC TESTING IN HNPCC.Leon B. Henderson, Maren T. Scheuner, Joshua 1. Ofman, Cedars-SinaiMed Ctr, Los Angeles, CA.

Hereditary non-polyposis colorectal cancer (HNPCC) is an autosomaldominantly inherited cancer susceptibility syndrome characterized by anincreased risk for colorectal cancer(CRC). Genetic testing for HNPCC­,when informative, can distinguish the genetic status of at-risk familymembers. Those lacking the familial susceptibility can avoid costly andfrequent colonoscopic surveillance. Our aim was to evaluate the cost­effecti veness of a genetic testing strategy compared to conventional coloncancer recommendations for a family member at risk for inheriting asusceptibility to HNPCC-related CRe. A decision analytic model wasdesigned to simulate health and economic outcomes. A hypothetical cohortof asymptomatic consultands from Amsterdam criteria-positive HNPCCkindreds progressed through the decision tree from age 20. We assumedthat surveillance prevents colorectal cancer, and that such patients wouldaverage a life expectancy of 80 years. The genetic testing strategy includedmismatch repair gene mutation analysis with and without screening afamily member's tumor tissue for evidence of microsatellite instability(MSI) and immunohistochemical (IHC) staining for the MLHI and MSH2gene products. Patients testing negative for a familial mutation underwentsurveillance as recommended by the American Cancer Society, and thosepositive for a familial mutation underwent surveillance as recommended bythe International Collaborative Group for high-risk patients. Probabilityestimates for the model were derived from a systematic review of theMEDLINE and HEALTSTAR databases. Cost estimates were derivedfrom the Medicare 1999 Physician Fee Schedule-Area 18. Sensitivityanalyses were performed on all probability and cost estimates. The out­come was cost-per-strategy to prevent colorectal cancer. The genetic test­ing strategy yielded an average savings of $869.73 per patient comparedwith the conventional management strategy. As long as the rate of MSI andIHC positivity remained greater than 12%, cost-effectiveness of genetictesting was preserved. The genetic testing strategy, by identifying patientsat normal risk, resulted in 67% fewer invasive, endoscopic procedures. Thecost-effectiveness of genetic testing persisted over a wide range of bothprobability and cost variables. In conclusion, both costs and procedures forcolorectal cancer surveillance and prevention are substantially reduced forat-risk individuals from an HNPCC kindred who participate in a strategythat begins with genetic testing.