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Tu1019

A Prospective Evaluation of the Feasibility of Process Engineering Interventionon the Screening and Testing of Lynch Syndrome in Individuals With aPersonal and/or Family History of Lynch-Associated CancersJames A. DiSario, Daniel G. Luba, Colleen Rock, Devki Saraiya, Kelsey Moyes, KristenRushton, Maydeen M. Ogara, Dayna Zimmerman, Mona Raphael, Kimmie Garrido,Evelyn Silguero, Jonathan Nelson, Brian L. Abbott, Fay Kastrinos, Richard J. Wenstrup,Sapna Syngal

Introduction: Lynch syndrome is the most common hereditary colorectal cancer syndrome,affecting 1 in 300-500 people. It is estimated that although 875,000 Americans have Lynch,only 4,375 (8%) have been identified (per Myriad data). The PREMM1,2,6 model providesa quantitative risk estimate for persons who may carry mutations associated with Lynchsyndrome. Testing unaffected individuals who score >5% with PREMM1,2,6 has been calcu-lated to be cost effective. However, this process has not been implemented in a community-based medical practice setting where patients are identified, screened, tested, and counseled.The aim of this study is to assess the feasibility and outcomes of performing risk basedscreening and testing for Lynch syndrome in a community-based gastroenterology practice.Methods: This is a prospective, single arm process-intervention study. Implementation ofan office-wide method started with training all relevant staff, including providers (10 MDs,1 NP), medical assistants, and those involved with scheduling and intake. The total studyperiod was six months and included a 60 day initiation phase for process implementation.Screening, testing and counseling were performed throughout the entire period. Duringintake, the PREMM1,2,6 was offered to eligible patients who were unique to the study. Adultpatients proficient in English were eligible to take the PREMM1,2,6. Persons with a confirmedscore of >5% were offered genetic testing for Lynch mutations. Consenting patients submittedbuccal and/or blood samples which were analyzed by Myriad Genetic Laboratories, Inc.Sequencing and large rearrangement analysis was conducted using a panel which includedMLH1, MSH2, MSH6, PMS2, and EPCAM. MYH was also analyzed as part of the panel.Results: During the six month period, 138 patients were tested. Table 1 shows all identifiedmutations. During the 60 day initiation phase, 27 patients were tested and three werepositive for deleterious Lynch mutations with PREMM1,2,6 scores of 12.9%, 15.4%, and91.8%. In the subsequent four month study period, 3,884 of 3,969 (97.9%) unique patientswere offered screening with the PREMM1,2,6 model. Of these participants, 133 (3.4%) scored>5%, and one deleterious Lynch mutation was detected in a woman with uterine cancer atage 69 and a score of only 5.3%. Two heterozygous MYH mutations and one variant werealso detected. Operations of the practice and patient flow were not significantly impactedby the process once systems were implemented. Conclusion: It is feasible to incorporatesystematic risk based screening, counseling, and testing for Lynch Syndrome in a community-based gastroenterology practice. Genetic risk assessment of both affected and unaffectedindividuals provides the opportunity to implement appropriate screening, surveillance andprophylactic surgery in at risk individuals and families.Table 1. Patient Test Results

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Tu1020

Are Fecal Immunochemical Tests With the Same Hemoglobin Cut-offConcentration Equal? A Population-Based StudyYi-Chia Lee, Han-Mo Chiu, Tsung-Hsien Chiang, Ming-Shiang Wu

Objective: Although a standardized unit system has been proposed to report the results offecal immunochemical test (FIT), it remains unclear whether two quantitative FITs with thesame cut-off concentration would have the same performance. We made a thorough compari-son between two FITs using a longitudinal dataset composed of nearly one million residentswho were aged 50 to 69 years and participated in Taiwanese Nationwide Colorectal CancerScreening Program with biennial FIT. Method: Between 2004 and 2009, there were 747,076and 208,929 residents who received the FIT with OC-SENSOR (Eiken Chemical Co, Tokyo,Japan) and the HM-JACK (Kyowa Medex Co Ltd, Tokyo, Japan), respectively. The cut-offhemoglobin concentrations for a positive result were 100 nanograms and 8 nanograms ofhemoglobin per milliliter of buffer, respectively; both were equivalent to 20 micrograms ofhemoglobin per gram of feces. We made a comparison of performance between two tests.Short-term performance indicators included the positive predictive value for colorectal cancerand cancer detection rate while long-term indicators included interval cancer rate andcolorectal cancer-specific mortality by linking the screening database with Taiwan CancerRegistry and National Death Registry of Taiwan. The program sensitivity was estimated withadjustment of the variation in sojourn time when colorectal cancer was in the preclinicaldetectable phase. To consider the differences in city/county, age, and gender distributionsbetween two screened populations, Poisson regression analyses were performed. Results:Regarding the short-term indicators, the positive predictive value for colorectal cancer andcancer detection rate were 6.8% and 0.21%, respectively, for OC-SENSOR; the results were5.2% and 0.17%, respectively, for HM-JACK. Regarding the long-term indicators, the intervalcancer rate and cumulative cancer-specific mortality were 30.7 and 75.6 per 100,000,respectively, for OC-SENSOR; the results were 40.6 and 78.6 per 100,000, respectively, forHM-JACK. Sensitivities were estimated at 80% (95% confidence interval (CI): 76-84%) and68% (95% CI: 61-76%), respectively, for OC-SENSOR and HM-JACK (P=0.005). Using themultivariate Poisson regression models, significant differences were noted in the positivepredictive value (adjusted relative risk: 1.28, 95% CI: 1.14-1.44), cancer detection rate(1.23, 95% CI: 1.05-1.43), and interval cancer rate (0.76, 95% CI: 0.62-0.93) but notcancer-specific mortality rate (1.17, 95% CI: 0.89-1.55). Conclusions: Although the samehemoglobin cut-off concentration in feces has been claimed by two different manufacturers,our population-based study showed that their performances were not the same, whichhighlights the importance of external validation and the need for continuous refinement ofexisting FITs.

Tu1021

Prep Clinic: A Cost-Effective Intervention to Improve ColonoscopyCompletion Rates, Quality of Bowel Preparation, and Adenoma Detection RateStephen M. Vindigni, Tatiana Dejneka, Susan Pochepan, Kathryn Stiff, Johanna Taniguchi,Cindy D. Artico-Carson, Elizabeth Broussard

Background: Colonoscopy requires patient understanding and adherence to bowel prepara-tion for an adequate examination. Poor bowel preparation leads to longer procedures withthe potential need for rescheduling, increased need for anesthetics, and decreased polypand adenoma detection. Patient group education models for procedures such as dialysis andchronic illnesses such as diabetes have been successful in increasing patient compliance.We hypothesized that patient education regarding colonoscopy would impact the followingmeasures: 1. Completion rates of colonoscopy procedures, 2. Quality of bowel preparation,3. Adenoma detection rate (ADR), and 4. Cost effectiveness. Methods: De-identified patient-level data of colonoscopies performed at a large, safety net and county hospital were obtainedfrom 2008-2013. Between 2008-2012, patients were scheduled for colonoscopy withoutspecialized group education. In 2013, patients referred for screening or diagnostic colonos-copy were directed to a patient bowel preparation education class (Prep Clinic) with colonos-copy scheduling dependent on class attendance. Procedure completion rates, bowel prepara-tion quality and adenoma detection rates (ADR) were compared before and after the PrepClinic was initiated. Procedure costs, insurance reimbursement and estimated losses fromcanceled and no-show appointments were calculated. Results: From 2008-2012, only 63.7%(range: 60.1-68.5, S.D. 3.8) of scheduled colonoscopies (diagnostic and screening ) werecompleted, with 28.1% cancelled appointments and 8.2% no shows. Of the 77 patientsreferred for screening colonoscopy in 2012, 20.8 % had excellent, and 24.7% poor bowelpreparations, and ADR was 42.8%. In 2013, 317 patients were referred for colonoscopy,and 233 of 317 (73.5%) referred patients attended Prep Clinic. Of these, 188 patientscompleted the scheduled colonoscopy (80.7%), an increase of 17% (p=0.0016 ) from theyear prior. Among these patients, 42% demonstrated excellent bowel preparation (p=0.025)and only 3.5% of patients demonstrated poor bowel preparation (p=0.002). Of the 57patients who completed screening colonoscopy, ADR was 54.4 % (p=0.311). We estimatea cost of $28.00 per patient to attend Prep Clinic. For each canceled or no-show procedureappointment, there is a cost of $102.00 (time of patient schedulers and endoscopy staff).If the Prep Clinic were available in 2012, an additional 507 patients could have completedcolonoscopy, resulting in additional revenue of $606,235 with customary Medicare rates or$571,810 with customary Medicaid rates. Conclusion: The institution of a bowel preparationclinic is a simple, cost-effective intervention that significantly increases procedure completionrates,significantly improves the quality of bowel preparations and demonstrates a trendtowards increased ADR.

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