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T1064 Knowledge, Attitudes and Beliefs of Asians On Gastric Cancer and Screening for Gastric Cancer
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Do Gastroenterologists Evaluate Patient GERD Symptom Severity and Treatment Outcome More Accurately Than Other Medical Specialists? Usefulness of a Combined Patient Self-Assessment Questionnaire (ReQuest®) and a Physician Symptom Likert Scale Sergio R. Sobrino-Cossio, Miguel Morales-Arambula, Juan C. Lopez-Alvarenga, JoseAntonio Vargas, Aurelio López-Colombo, Julio-Cesar Soto-Perez, Oscar TeramotoMatsubara, Yasmin Crespo, Armando Ramirez, Jorge Gonzalez, Antonio Orozco-Gamiz, Anthony G. Comuzzie, Luis H López-Salazar, Ramirez-Barba Ector BACKGROUND: Socioeconomic status and cultural background modify patient perception regarding symptom severity of GERD (ssGERD). Meanwhile, medical specialty can modify physician perception of ssGERD. There are few studies on how the physicians' specialty affects patient symptom evaluation or interpretation. There is no correlation between the ssGERD, patient perception and physician interpretation. AIM: Assess perception of ssGERD among different medical specialties and their correlation with patients' self-assessment using PMS ReQuest® questionnaire after 4 week treatment with oral magnesium pantoprazole (PMg) 40 mg o.d. METHOD: A longitudinal open-labeled nationwide clinical study on 3665 GERD patients was performed. Acid regurgitation & heartburn severity and 16 other frequently associated GERD symptoms were measured using both a 4-point Likert-scale by physicians and a patient self-assessment questionnaire ReQuest® that used a 10 cm visual analogue scale (VAS). Both measurements were taken before and after 4 week PMg treatment. A MANOVA analysis was performed for ssGERD and their predictors like medical specialty and ReQuest® scores adjusted by age, BMI, gender and geographical residence zone. RESULTS: 3665 GERD patients (53.8% females, 36±7 yrs, BMI 26±4) were diagnosed by gastroenterologists (GMD 12.1%), internal medicine specialists (IMMD 19.9%), general surgeons (GSMD 4.9%), and general practitioners (GPMD 63.2%). GMD patients were slightly younger (34.4±7 vs others 35.5±7, p< 0.001) and had lower BMI scores (25.7±4 vs others 26.5±4, p<0.001). GMD patients showed the highest Likert symptom intensity scores for heartburn. GSMD had the highest scores for globus, disphagia, odinophagia, chronic cough and hoarseness. Meanwhile, GPMD patients scored higher for epigastric pain, flatulence, and sleep disturbances. Spearman rho showed moderate to low correlation between patients' ReQuest® and physicians' Likert scale: Sleep disturbances (r=0.51, p<0.01), nausea (r=0.44, p<0.01), heartburn (r=0.25, p<0.01), upper abdominal discomfort (vs belching r= 0.16, p<0.01), lower abdominal discomfort (vs early satiety and flatulence r= 0.25, p<0.01). In spite of the difference between patients' (ReQuest®) and physicians' (Likert-scale) symptom evaluation, the 4 week PMg treatment showed improvement. CONCLUSION: The physicians' specialty affects the type of symptoms considered and their severity. Both scores have moderate to poor correlation with patient severity perception. Despite discrepancies between specialists' and patients' evaluations the outcome after a 4week treatment with PMg was good.
Age-, Gender-, and Symptom-specific Yield for Barrett's Esophagus T1063 Incidence of Esophageal Adenocarcinoma in Patients with Gastroesophageal Reflux in Context of Other Screened Cancers Joel H. Rubenstein, James M. Scheiman, Shahram Sadeghi, David Whiteman, John M. Inadomi Background: Gastroesophageal reflux symptoms (GERS) are known risk factors for development of esophageal adenocarcinoma (EAC), but the actual incidence of EAC in a patient with GERS is not known. There is little consensus regarding whether patients with GERS should be offered screening, and if so, which patients and at what age. We aimed to estimate the age-, and gender-specific incidence of EAC in the U.S. among people with GERS, and to compare that to the incidence of two cancers for which screening is offered, colorectal cancer (CRC) and breast cancer (BrCa). Methods: A Markov computer model was created to calculate the age-, and gender-specific incidence of EAC in the general white population, and a second model in the population stratified by presence of GERS. The incidences of EAC, CRC, and BrCa in the white population were obtained from Surveillance Epidemiology and End Results cancer registry. The standardized incidence ratio (SIR) of at least once weekly GERS for EAC was based on the odds ratio obtained from meta-analysis of published literature. The prevalence of GERS in the U.S. was based on published literature. The SIR for EAC among people without GERS compared to the general population was then calibrated to result in identical cumulative incidences of EAC in the stratified and unstratified Markov models. Two-way sensitivity analyses were performed varying the SIR of GERS for EAC and the prevalence of GERS. Results: The age- and gender-specific incidence of CRC was at least twice that of EAC in people with GERS at all ages and in both genders. The incidence of CRC in white women at age 50 was 35.6/100,000 (the lowest gender- & age-specific incidence at which screening is offered for CRC or BrCa). The incidence of EAC in white men with GERS did not surpass that level until age 61. In sensitivity analyses, the incidence of EAC in white men with GERS may surpass that level as early as age 53, but that level was never surpassed among women. The age-specific incidence of EAC in white women with GERS was similar to the age-specific incidence of BrCa in white men (e.g. at age 50, 1.3/100,000 vs. 1.0/100,000). Conclusions: The incidence of EAC in white men over the age of 60 with weekly GERS is substantial, and may warrant screening. The risk of CRC (in both men and women) is greater than the risk of EAC in patients with GERS at any age. Therefore, screening for EAC likely should not be performed on patients with GERS younger than age 50 years unless screening for CRC at those ages are also deemed appropriate. Screening women with GERS for EAC would have similar yield as screening men for BrCa.
T1062 Assessment of Risk for Barrett's Esophagus By Demographic Features Joel H. Rubenstein, Nora Mattek, Glenn M. Eisen Background: Barrett's esophagus is a precursor of esophageal adenocarcinoma, both of which are associated with gastroesophageal reflux disease (GERD). Screening GERD patients for Barrett's esophagus is recommended, but guidelines do not specify which patients should be screened, and at what age. Methods: We conducted retrospective analyses of the National Endoscopic Database of the Clinical Outcomes Research Initiative (CORI) to determine the yield of screening for histologically-confirmed Barrett's esophagus stratified by age, gender, and race. Nine CORI sites that routinely entered pathology results during the time period 2000 to 2005 were identified. The study was limited to patients aged 18 to 79 years undergoing their first upper endoscopy at one of these 9 sites. Results: 25,337 patients undergoing first-time upper endoscopy were identified. Among white men with GERD, the yield for Barrett's esophagus rises steeply from early adulthood (2.1% in 3rd decade of life) to late adulthood (9.3% in 6th decade), and then plateaus (difference for 8th decade minus 6th decade = -1.1%, 95% confidence interval [CI] = -3.9%, +1.7%). There is no difference in yield of Barrett's esophagus between older white women with GERD and white men without GERD (difference = -0.46%, 95% CI = -1.23%, +0.31%). Nonetheless, the majority of endoscopies for GERD are performed in women, and a substantial minority are performed in young patients. Conclusions: The yield of upper endoscopy for diagnosis of Barrett's esophagus increases rapidly among white men with GERD until approximately age 50, then reaches a plateau. White women with GERD are at no increased risk compared to white men without GERD. Screening ought to focus on white men with GERD over the age of 50.
T1064 Knowledge, Attitudes and Beliefs of Asians On Gastric Cancer and Screening for Gastric Cancer Damien M. Tan, Yu Tien Wang, Boon Bee Goh, Zhongxian Poh, Khoon-Lin Ling Background Gastric cancer (GC) is the second most common cause of death from cancer worldwide. In Singapore it is the fifth most common cancer among Singaporean males. Most GC in Singapore are diagnosed at an advanced stage with a 5-year survival of only 10-20%. This may be due to inadequate knowledge about GC and the role of screening. Aims To evaluate knowledge, attitudes and beliefs of the Singaporean public on GC and screening for GC Methods Self-administered questionnaires to obtain information on knowledge, attitudes and beliefs towards GC and screening for GC were distributed to attendees of a public forum. Results 400 questionnaires were distributed with a response rate of 86%. Mean age was 56(±11) years. 56.1% were female and 91.6% Chinese. Knowledge: Most could not identify the major risk factors for GC. Only 38.4%, 28.5%, 32.3%, and 36.0% correctly identified age, Chinese race, male gender, high salt intake as risk factors. Slightly more than half knew that Helicobacter pylori (HP) infection, smoking, low vegetables and fruits intake, family history of GC were associated with increased risk for GC (57.3%, 54.9%,. 58.4%, 55.8% respectively). 80.8% knew GC detected early is potentially curable. However only 50.6% knew GC may be asymptomatic. Majority knew that GC was best diagnosed by endoscopy (66.9%). Attitudes: Only 27.6% knew where to find information on GC. Beliefs: 46.8% felt the best time to diagnose was when asymptomatic. Only 21.2% thought that they were at risk for GC. However 52.0% felt that it was worthwhile to undergo
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screening and 64.0% would undergo screening gastroscopy if found to be HP positive. For those willing to pay for screening endoscopy, the mean cost that they were willing to pay was USD $166 (USD $0 -$1000). Conclusions From this survey of predominantly elderly Chinese, most did not have much knowledge about the risk factors for and the symptoms of GC. Significantly, only 50% knew that GC may be asymptomatic and less than half knew that GC screening was best done when asymptomatic. The majority did not think that they were at risk for GC. We also found that cost and a positive test for HP may influence a patient's attitude towards cancer screening.
T1067 A Prospective Study of Upper Gastrointestinal Cancers: Current UK FastTrack Referral Criteria Only Detect More Oesophageal Cancers Compared to Conventional Referrals Sarah L. Addis, Alexander C. Ford, Sulleman Moreea Background: Patients in the UK with suspected upper gastrointestinal(UGI) cancer are referred through a fast-track(FT) system to ensure they are seen within 2 weeks by a hospital specialist, discussed at a regional multi-disciplinary team(MDT) meeting, and treated within 62 days of referral. Failure to adhere to this time scale results in financial penalties. Aims: We prospectively compared detection rates for oesophageal(O), gastric(G), pancreatic(P), and hepatobiliary(HB) malignancy using the current FT referral criteria with those detected via conventional routes. Methods: The following was extracted from our MDT database: number of FT referrals, number of possible cancer cases from both FT referrals and conventional routes discussed at the MDT, and total number of confirmed cancers from both routes, according to type. The proportion of confirmed O, G, P, and HB cancers diagnosed among possible cases of cancer discussed at the MDT from an FT and non-FT route were compared using Fisher's exact test. Results: Between June 2006-May 2007 there were 483(209 males[43%]) FT referrals for suspected UGI cancer. Cancer was definitely excluded in 394 patients, and the remaining 89(18%)cases were discussed at the MDT meeting. Of these, 46 (9.5% of the total number of FT referrals, and 52% of possible cases of cancer discussed) had confirmed cancer (22O, 14G, 5P, and 5HB), 28 males (mean age 68 yrs) and 18 females (mean age 74 yrs). In comparison, during the same period, 186 cases of possible UGI cancer referred via a conventional route were discussed at the MDT. There were 103(55%) confirmed cancers among these (18O, 33G, 32P, and 20HB), 60 males (mean age 72 yrs) and 43 females (mean age 71 yrs). Of the 149 confirmed cancers, diagnosed via both routes, only oesophageal cancers were diagnosed significantly more often in FT patients (22/89 vs 18/ 186, P = 0.002). There was no difference in the detection rates for gastric (14vs33,P = 0.69) or hepatobiliary (5vs20,P = 0.17) cancers. There were significantly fewer pancreatic (5vs32,P = 0.006) cancers detected in FT referrals with possible malignancy. Conclusion: The detection rate for UGI cancers in fast-tracked patients is <10%. Only oesophageal cancers are being detected more frequently in FT patients than via conventional referral routes. Current FT referral criteria for gastric, pancreatic, and hepatobiliary cancer have poor sensitivity and positive predictive value. Unless these are revised, many people will undergo needless urgent investigation, whilst larger absolute numbers of patients with cancer who are being referred conventionally may have their diagnosis and treatment delayed.
T1065 Relation Between Reflux Bile Acid Into the Stomach and Gastric Mucosal Atrophy, Intestinal Metaplasia- a Multi-Center Study of 2,283 Cases Takeshi Matsuhisa, Ken Haruma, Tetsuo Arakawa, Tetsuo Watanabe, Seisuke Okamura, Masanori Ito, Tadashi Tokutomi, Atsushi Sugiyama, Shinji Chono, Hiroshi Sasaki Background and Aim: The relationship between reflux bile acid in the stomach and gastric mucosal atrophy, intestinal metaplasia is not well understood. To clarify this, we measured reflux bile acid from patients who had undergone an endoscopic examination. Methods: This study was performed from May 2006 to March 2007 in 14 facilities in Japan with the approval of the ethics committee and 2,283 samples were collected. Informed consent was obtained from all patients before examination. Gastric juice was collected under endoscopic observation and bile acid concentration in the gastric juice was measured by the enzyme method. The diagnosis of Helicobacter pylori (Hp) infection was also performed. The subjects who had bile acid concentrations equal to or higher than the limit of detection (3 μmol/L) were divided into four groups of the same size (group A: -25%, group B: 25-50%, group C: 50-75%, and group D: 75-100%). Thus, including those who had concentrations lower than the limit of detection (control group), all the subjects were divided into five groups. For atrophic gastritis and intestinal metaplasia, the odds that the control group would develop such diseases according to Hp infection was set as 1, and the odds ratios (ORs) and 95% CIs of the four groups were obtained, by which their differences from the control group were estimated. Results: Reflux of bile acid was recognized in 65.9% (1,505 of 2,283 cases). Regarding atrophic gastritis, there was no significant relation between control group and groups A, B, C, and D, both for Hp positive and negative cases. OR values for intestinal metaplasia with and without Hp infection were both significantly high in group D compared with the control group (Hp positive cases: OR 2.4, 95% CI 1.4-4.3, Hp negative cases: OR 2.2, 95% CI 1.2-4.1). Conclusion: Reflux bile acid did not influence gastric mucosal atrophy. On the other hand, reflux of high-concentration bile acid influenced intestinal metaplasia. It is suggested that reflux of high-concentration bile acid influences intestinal metaplasia as a factor other than Hp infection.
T1068 Effect of Esomeprazole On Work Productivity and Regular Daily Activities in Patients with Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances David A. Johnson, Joseph A. Crawley, Clara Hwang, Kurt A. Brown
T1066 Proton Pump Inhibitor Compliance Does Not Impact GERD Symptom Resolution Tushar S. Dabade, Sunanda V. Kane, Colin W. Howden, Michael D. Crowell, Steven C. Adamson, Ramona DeJesus, Felicity Enders, Andrew J. Majka, Matthew R. Lohse, Judith L. McElhiney, Debra M. Geno, Mary Fredericksen, Yvonne Romero
Aim: To determine the effect of esomeprazole on work productivity and regular daily activities in patients with GERD-related sleep disturbances. Methods: Patients in the US with GERD aged 18-85 y who met the following inclusion criteria were enrolled in a 4-wk multicenter, randomized, double-blind, placebo-controlled study (D9612L00122; NCT00660660): any history of erosive esophagitis or episodes of heartburn or acid regurgitation for ≥3 mo, a history of GERD-related sleep disturbances for >1 mo, and nighttime symptoms averaging ≥2 episodes in a 7-d period. Patients with conditions other than GERD known to affect sleep were excluded. Following a 1-2-wk run-in period, patients with GERDrelated sleep disturbances and moderate or severe nighttime heartburn on ≥3 of the last 7 nights of the run-in period were randomized to esomeprazole 20 mg before breakfast or placebo for 4 wk. Patients completed the Work Productivity and Activity Impairment Questionnaire (WPAI-SLEEP-GERD) at the randomization and final visits. The WPAI-SLEEPGERD, a validated 6-item questionnaire, assesses the impact of GERD-related sleep disturbances on work productivity and regular activities. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Changes in WPAI-SLEEP-GERD end points from baseline were analyzed using analysis of covariance taking the baseline value as a covariate. Patients in the ITT analysis with baseline and week 4 data were included in the analysis. Results: Patients who received esomeprazole lost significantly fewer equivalent number of work hours, had work productivity significantly less impaired, and had regular activities outside of work (ie, work around the house, shopping, childcare, exercising, studying) significantly less impaired due to GERD-related sleep disturbances (Table). The monetary value of work hours saved per patient at week 4 using the US Bureau of Labor Statistics labor compensation standard from June 2008 of $28.48/h was significantly greater with esomeprazole vs placebo (Table; P=.004). Conclusion: Esomeprazole 20 mg once daily is effective in improving work productivity, regular daily activities, and monetary value of work hours saved in patients with GERD-related sleep disturbances. Supported by AstraZeneca LP Least-Squares Mean Changes in WPAI-SLEEP-GERD End Points After 4 Weeks
Background: Although prior clinical trials have shown that scheduled Proton Pump Inhibitor (PPI) therapy is superior to on-demand therapy for healing erosive esophagitis, how patients actually take their PPI's in real world settings is unknown. Specific aim: To assess the correlation between GERD symptom resolution with compliance in taking a daily PPI for 8 weeks in patients with Los Angeles (LA) grade B, C or D esophagitis. METHODS: This prospective descriptive cohort study enrolled symptomatic patients with LA grade B-D erosive esophagitis. Patients were started on esomeprazole 40 mg once daily for 8 weeks. Patients' GERD symptoms were assessed by the validated Mayo Dysphagia Questionnaire 30. Medication compliance was quantified using the Medication Event Monitoring System ® (MEMS) and by tablet counting. By convention, compliance was defined as taking medication greater than 80% of the prescribed number of days in the 8 weeks as per MEMS. RESULTS: Between 1/30/2008 and 10/09/2008, 360 patients with LA grades B-D esophagitis were screened; 81 were eligible to participate. The majority of screen failures were inpatients (N= 88) and patients without sufficient GERD symptoms (N=79). Of the 81 eligible patients, 51 (63%) enrolled in the study [26 males (51%), mean age 49 years; LA grade B=40, C= 6, D=5] and 18 (19%) declined. Evaluating physicians did not allow contact with 15 patients due to a plan for twice daily dosing. To date, 45 subjects have completed the trial of whom 28 (62%) were compliant and 17 (38%) non-compliant in taking their prescribed daily PPI. GERD symptoms resolved in 22 (79%) 28 compliant subjects and 11 (73%) non-compliant subject (p=NS). Patients with LA grades C and D esophagitis were all compliant (7/7, 100%), while those with grade B had 55% compliance (21/38, p=0.025). Compliance assessed by MEMS technology was 62%, while compliance assessed by pill counting was 89% (p=0.003) Of the 45 subjects, 9 had a repeat endoscopy after the 8 weeks of PPI therapy. 8 (89%) had completely healed esophagitis. One compliant subject did not heal but improved from LA B to A. CONCLUSION: Results indicate a large percentage of patients taking PPI's for symptomatic grade B-D esophagitis are non-compliant in the short term. Both compliant and non-compliant patients have GERD symptom resolution. This likely indicates that patients switch to an on-demand PPI regimen when symptoms resolve. Patients with grades C and D esophagitis are more compliant than those with grade B esophagitis. The MEMS technology was more accurate at assessing compliance when compared to tablet counting
*P<.001; †P=.003; ‡P=.004.
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Do Gastroenterologists Evaluate Patient GERD Symptom Severity and Treatment Outcome More Accurately Than Other Medical Specialists? Usefulness of a Combined Patient Self-Assessment Questionnaire (ReQuest®) and a Physician Symptom Likert Scale Sergio R. Sobrino-Cossio, Miguel Morales-Arambula, Juan C. Lopez-Alvarenga, JoseAntonio Vargas, Aurelio López-Colombo, Julio-Cesar Soto-Perez, Oscar TeramotoMatsubara, Yasmin Crespo, Armando Ramirez, Jorge Gonzalez, Antonio Orozco-Gamiz, Anthony G. Comuzzie, Luis H López-Salazar, Ramirez-Barba Ector BACKGROUND: Socioeconomic status and cultural background modify patient perception regarding symptom severity of GERD (ssGERD). Meanwhile, medical specialty can modify physician perception of ssGERD. There are few studies on how the physicians' specialty affects patient symptom evaluation or interpretation. There is no correlation between the ssGERD, patient perception and physician interpretation. AIM: Assess perception of ssGERD among different medical specialties and their correlation with patients' self-assessment using PMS ReQuest® questionnaire after 4 week treatment with oral magnesium pantoprazole (PMg) 40 mg o.d. METHOD: A longitudinal open-labeled nationwide clinical study on 3665 GERD patients was performed. Acid regurgitation & heartburn severity and 16 other frequently associated GERD symptoms were measured using both a 4-point Likert-scale by physicians and a patient self-assessment questionnaire ReQuest® that used a 10 cm visual analogue scale (VAS). Both measurements were taken before and after 4 week PMg treatment. A MANOVA analysis was performed for ssGERD and their predictors like medical specialty and ReQuest® scores adjusted by age, BMI, gender and geographical residence zone. RESULTS: 3665 GERD patients (53.8% females, 36±7 yrs, BMI 26±4) were diagnosed by gastroenterologists (GMD 12.1%), internal medicine specialists (IMMD 19.9%), general surgeons (GSMD 4.9%), and general practitioners (GPMD 63.2%). GMD patients were slightly younger (34.4±7 vs others 35.5±7, p< 0.001) and had lower BMI scores (25.7±4 vs others 26.5±4, p<0.001). GMD patients showed the highest Likert symptom intensity scores for heartburn. GSMD had the highest scores for globus, disphagia, odinophagia, chronic cough and hoarseness. Meanwhile, GPMD patients scored higher for epigastric pain, flatulence, and sleep disturbances. Spearman rho showed moderate to low correlation between patients' ReQuest® and physicians' Likert scale: Sleep disturbances (r=0.51, p<0.01), nausea (r=0.44, p<0.01), heartburn (r=0.25, p<0.01), upper abdominal discomfort (vs belching r= 0.16, p<0.01), lower abdominal discomfort (vs early satiety and flatulence r= 0.25, p<0.01). In spite of the difference between patients' (ReQuest®) and physicians' (Likert-scale) symptom evaluation, the 4 week PMg treatment showed improvement. CONCLUSION: The physicians' specialty affects the type of symptoms considered and their severity. Both scores have moderate to poor correlation with patient severity perception. Despite discrepancies between specialists' and patients' evaluations the outcome after a 4week treatment with PMg was good.
Age-, Gender-, and Symptom-specific Yield for Barrett's Esophagus T1063 Incidence of Esophageal Adenocarcinoma in Patients with Gastroesophageal Reflux in Context of Other Screened Cancers Joel H. Rubenstein, James M. Scheiman, Shahram Sadeghi, David Whiteman, John M. Inadomi Background: Gastroesophageal reflux symptoms (GERS) are known risk factors for development of esophageal adenocarcinoma (EAC), but the actual incidence of EAC in a patient with GERS is not known. There is little consensus regarding whether patients with GERS should be offered screening, and if so, which patients and at what age. We aimed to estimate the age-, and gender-specific incidence of EAC in the U.S. among people with GERS, and to compare that to the incidence of two cancers for which screening is offered, colorectal cancer (CRC) and breast cancer (BrCa). Methods: A Markov computer model was created to calculate the age-, and gender-specific incidence of EAC in the general white population, and a second model in the population stratified by presence of GERS. The incidences of EAC, CRC, and BrCa in the white population were obtained from Surveillance Epidemiology and End Results cancer registry. The standardized incidence ratio (SIR) of at least once weekly GERS for EAC was based on the odds ratio obtained from meta-analysis of published literature. The prevalence of GERS in the U.S. was based on published literature. The SIR for EAC among people without GERS compared to the general population was then calibrated to result in identical cumulative incidences of EAC in the stratified and unstratified Markov models. Two-way sensitivity analyses were performed varying the SIR of GERS for EAC and the prevalence of GERS. Results: The age- and gender-specific incidence of CRC was at least twice that of EAC in people with GERS at all ages and in both genders. The incidence of CRC in white women at age 50 was 35.6/100,000 (the lowest gender- & age-specific incidence at which screening is offered for CRC or BrCa). The incidence of EAC in white men with GERS did not surpass that level until age 61. In sensitivity analyses, the incidence of EAC in white men with GERS may surpass that level as early as age 53, but that level was never surpassed among women. The age-specific incidence of EAC in white women with GERS was similar to the age-specific incidence of BrCa in white men (e.g. at age 50, 1.3/100,000 vs. 1.0/100,000). Conclusions: The incidence of EAC in white men over the age of 60 with weekly GERS is substantial, and may warrant screening. The risk of CRC (in both men and women) is greater than the risk of EAC in patients with GERS at any age. Therefore, screening for EAC likely should not be performed on patients with GERS younger than age 50 years unless screening for CRC at those ages are also deemed appropriate. Screening women with GERS for EAC would have similar yield as screening men for BrCa.
T1062 Assessment of Risk for Barrett's Esophagus By Demographic Features Joel H. Rubenstein, Nora Mattek, Glenn M. Eisen Background: Barrett's esophagus is a precursor of esophageal adenocarcinoma, both of which are associated with gastroesophageal reflux disease (GERD). Screening GERD patients for Barrett's esophagus is recommended, but guidelines do not specify which patients should be screened, and at what age. Methods: We conducted retrospective analyses of the National Endoscopic Database of the Clinical Outcomes Research Initiative (CORI) to determine the yield of screening for histologically-confirmed Barrett's esophagus stratified by age, gender, and race. Nine CORI sites that routinely entered pathology results during the time period 2000 to 2005 were identified. The study was limited to patients aged 18 to 79 years undergoing their first upper endoscopy at one of these 9 sites. Results: 25,337 patients undergoing first-time upper endoscopy were identified. Among white men with GERD, the yield for Barrett's esophagus rises steeply from early adulthood (2.1% in 3rd decade of life) to late adulthood (9.3% in 6th decade), and then plateaus (difference for 8th decade minus 6th decade = -1.1%, 95% confidence interval [CI] = -3.9%, +1.7%). There is no difference in yield of Barrett's esophagus between older white women with GERD and white men without GERD (difference = -0.46%, 95% CI = -1.23%, +0.31%). Nonetheless, the majority of endoscopies for GERD are performed in women, and a substantial minority are performed in young patients. Conclusions: The yield of upper endoscopy for diagnosis of Barrett's esophagus increases rapidly among white men with GERD until approximately age 50, then reaches a plateau. White women with GERD are at no increased risk compared to white men without GERD. Screening ought to focus on white men with GERD over the age of 50.
T1064 Knowledge, Attitudes and Beliefs of Asians On Gastric Cancer and Screening for Gastric Cancer Damien M. Tan, Yu Tien Wang, Boon Bee Goh, Zhongxian Poh, Khoon-Lin Ling Background Gastric cancer (GC) is the second most common cause of death from cancer worldwide. In Singapore it is the fifth most common cancer among Singaporean males. Most GC in Singapore are diagnosed at an advanced stage with a 5-year survival of only 10-20%. This may be due to inadequate knowledge about GC and the role of screening. Aims To evaluate knowledge, attitudes and beliefs of the Singaporean public on GC and screening for GC Methods Self-administered questionnaires to obtain information on knowledge, attitudes and beliefs towards GC and screening for GC were distributed to attendees of a public forum. Results 400 questionnaires were distributed with a response rate of 86%. Mean age was 56(±11) years. 56.1% were female and 91.6% Chinese. Knowledge: Most could not identify the major risk factors for GC. Only 38.4%, 28.5%, 32.3%, and 36.0% correctly identified age, Chinese race, male gender, high salt intake as risk factors. Slightly more than half knew that Helicobacter pylori (HP) infection, smoking, low vegetables and fruits intake, family history of GC were associated with increased risk for GC (57.3%, 54.9%,. 58.4%, 55.8% respectively). 80.8% knew GC detected early is potentially curable. However only 50.6% knew GC may be asymptomatic. Majority knew that GC was best diagnosed by endoscopy (66.9%). Attitudes: Only 27.6% knew where to find information on GC. Beliefs: 46.8% felt the best time to diagnose was when asymptomatic. Only 21.2% thought that they were at risk for GC. However 52.0% felt that it was worthwhile to undergo
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screening and 64.0% would undergo screening gastroscopy if found to be HP positive. For those willing to pay for screening endoscopy, the mean cost that they were willing to pay was USD $166 (USD $0 -$1000). Conclusions From this survey of predominantly elderly Chinese, most did not have much knowledge about the risk factors for and the symptoms of GC. Significantly, only 50% knew that GC may be asymptomatic and less than half knew that GC screening was best done when asymptomatic. The majority did not think that they were at risk for GC. We also found that cost and a positive test for HP may influence a patient's attitude towards cancer screening.
T1067 A Prospective Study of Upper Gastrointestinal Cancers: Current UK FastTrack Referral Criteria Only Detect More Oesophageal Cancers Compared to Conventional Referrals Sarah L. Addis, Alexander C. Ford, Sulleman Moreea Background: Patients in the UK with suspected upper gastrointestinal(UGI) cancer are referred through a fast-track(FT) system to ensure they are seen within 2 weeks by a hospital specialist, discussed at a regional multi-disciplinary team(MDT) meeting, and treated within 62 days of referral. Failure to adhere to this time scale results in financial penalties. Aims: We prospectively compared detection rates for oesophageal(O), gastric(G), pancreatic(P), and hepatobiliary(HB) malignancy using the current FT referral criteria with those detected via conventional routes. Methods: The following was extracted from our MDT database: number of FT referrals, number of possible cancer cases from both FT referrals and conventional routes discussed at the MDT, and total number of confirmed cancers from both routes, according to type. The proportion of confirmed O, G, P, and HB cancers diagnosed among possible cases of cancer discussed at the MDT from an FT and non-FT route were compared using Fisher's exact test. Results: Between June 2006-May 2007 there were 483(209 males[43%]) FT referrals for suspected UGI cancer. Cancer was definitely excluded in 394 patients, and the remaining 89(18%)cases were discussed at the MDT meeting. Of these, 46 (9.5% of the total number of FT referrals, and 52% of possible cases of cancer discussed) had confirmed cancer (22O, 14G, 5P, and 5HB), 28 males (mean age 68 yrs) and 18 females (mean age 74 yrs). In comparison, during the same period, 186 cases of possible UGI cancer referred via a conventional route were discussed at the MDT. There were 103(55%) confirmed cancers among these (18O, 33G, 32P, and 20HB), 60 males (mean age 72 yrs) and 43 females (mean age 71 yrs). Of the 149 confirmed cancers, diagnosed via both routes, only oesophageal cancers were diagnosed significantly more often in FT patients (22/89 vs 18/ 186, P = 0.002). There was no difference in the detection rates for gastric (14vs33,P = 0.69) or hepatobiliary (5vs20,P = 0.17) cancers. There were significantly fewer pancreatic (5vs32,P = 0.006) cancers detected in FT referrals with possible malignancy. Conclusion: The detection rate for UGI cancers in fast-tracked patients is <10%. Only oesophageal cancers are being detected more frequently in FT patients than via conventional referral routes. Current FT referral criteria for gastric, pancreatic, and hepatobiliary cancer have poor sensitivity and positive predictive value. Unless these are revised, many people will undergo needless urgent investigation, whilst larger absolute numbers of patients with cancer who are being referred conventionally may have their diagnosis and treatment delayed.
T1065 Relation Between Reflux Bile Acid Into the Stomach and Gastric Mucosal Atrophy, Intestinal Metaplasia- a Multi-Center Study of 2,283 Cases Takeshi Matsuhisa, Ken Haruma, Tetsuo Arakawa, Tetsuo Watanabe, Seisuke Okamura, Masanori Ito, Tadashi Tokutomi, Atsushi Sugiyama, Shinji Chono, Hiroshi Sasaki Background and Aim: The relationship between reflux bile acid in the stomach and gastric mucosal atrophy, intestinal metaplasia is not well understood. To clarify this, we measured reflux bile acid from patients who had undergone an endoscopic examination. Methods: This study was performed from May 2006 to March 2007 in 14 facilities in Japan with the approval of the ethics committee and 2,283 samples were collected. Informed consent was obtained from all patients before examination. Gastric juice was collected under endoscopic observation and bile acid concentration in the gastric juice was measured by the enzyme method. The diagnosis of Helicobacter pylori (Hp) infection was also performed. The subjects who had bile acid concentrations equal to or higher than the limit of detection (3 μmol/L) were divided into four groups of the same size (group A: -25%, group B: 25-50%, group C: 50-75%, and group D: 75-100%). Thus, including those who had concentrations lower than the limit of detection (control group), all the subjects were divided into five groups. For atrophic gastritis and intestinal metaplasia, the odds that the control group would develop such diseases according to Hp infection was set as 1, and the odds ratios (ORs) and 95% CIs of the four groups were obtained, by which their differences from the control group were estimated. Results: Reflux of bile acid was recognized in 65.9% (1,505 of 2,283 cases). Regarding atrophic gastritis, there was no significant relation between control group and groups A, B, C, and D, both for Hp positive and negative cases. OR values for intestinal metaplasia with and without Hp infection were both significantly high in group D compared with the control group (Hp positive cases: OR 2.4, 95% CI 1.4-4.3, Hp negative cases: OR 2.2, 95% CI 1.2-4.1). Conclusion: Reflux bile acid did not influence gastric mucosal atrophy. On the other hand, reflux of high-concentration bile acid influenced intestinal metaplasia. It is suggested that reflux of high-concentration bile acid influences intestinal metaplasia as a factor other than Hp infection.
T1068 Effect of Esomeprazole On Work Productivity and Regular Daily Activities in Patients with Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances David A. Johnson, Joseph A. Crawley, Clara Hwang, Kurt A. Brown
T1066 Proton Pump Inhibitor Compliance Does Not Impact GERD Symptom Resolution Tushar S. Dabade, Sunanda V. Kane, Colin W. Howden, Michael D. Crowell, Steven C. Adamson, Ramona DeJesus, Felicity Enders, Andrew J. Majka, Matthew R. Lohse, Judith L. McElhiney, Debra M. Geno, Mary Fredericksen, Yvonne Romero
Aim: To determine the effect of esomeprazole on work productivity and regular daily activities in patients with GERD-related sleep disturbances. Methods: Patients in the US with GERD aged 18-85 y who met the following inclusion criteria were enrolled in a 4-wk multicenter, randomized, double-blind, placebo-controlled study (D9612L00122; NCT00660660): any history of erosive esophagitis or episodes of heartburn or acid regurgitation for ≥3 mo, a history of GERD-related sleep disturbances for >1 mo, and nighttime symptoms averaging ≥2 episodes in a 7-d period. Patients with conditions other than GERD known to affect sleep were excluded. Following a 1-2-wk run-in period, patients with GERDrelated sleep disturbances and moderate or severe nighttime heartburn on ≥3 of the last 7 nights of the run-in period were randomized to esomeprazole 20 mg before breakfast or placebo for 4 wk. Patients completed the Work Productivity and Activity Impairment Questionnaire (WPAI-SLEEP-GERD) at the randomization and final visits. The WPAI-SLEEPGERD, a validated 6-item questionnaire, assesses the impact of GERD-related sleep disturbances on work productivity and regular activities. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Changes in WPAI-SLEEP-GERD end points from baseline were analyzed using analysis of covariance taking the baseline value as a covariate. Patients in the ITT analysis with baseline and week 4 data were included in the analysis. Results: Patients who received esomeprazole lost significantly fewer equivalent number of work hours, had work productivity significantly less impaired, and had regular activities outside of work (ie, work around the house, shopping, childcare, exercising, studying) significantly less impaired due to GERD-related sleep disturbances (Table). The monetary value of work hours saved per patient at week 4 using the US Bureau of Labor Statistics labor compensation standard from June 2008 of $28.48/h was significantly greater with esomeprazole vs placebo (Table; P=.004). Conclusion: Esomeprazole 20 mg once daily is effective in improving work productivity, regular daily activities, and monetary value of work hours saved in patients with GERD-related sleep disturbances. Supported by AstraZeneca LP Least-Squares Mean Changes in WPAI-SLEEP-GERD End Points After 4 Weeks
Background: Although prior clinical trials have shown that scheduled Proton Pump Inhibitor (PPI) therapy is superior to on-demand therapy for healing erosive esophagitis, how patients actually take their PPI's in real world settings is unknown. Specific aim: To assess the correlation between GERD symptom resolution with compliance in taking a daily PPI for 8 weeks in patients with Los Angeles (LA) grade B, C or D esophagitis. METHODS: This prospective descriptive cohort study enrolled symptomatic patients with LA grade B-D erosive esophagitis. Patients were started on esomeprazole 40 mg once daily for 8 weeks. Patients' GERD symptoms were assessed by the validated Mayo Dysphagia Questionnaire 30. Medication compliance was quantified using the Medication Event Monitoring System ® (MEMS) and by tablet counting. By convention, compliance was defined as taking medication greater than 80% of the prescribed number of days in the 8 weeks as per MEMS. RESULTS: Between 1/30/2008 and 10/09/2008, 360 patients with LA grades B-D esophagitis were screened; 81 were eligible to participate. The majority of screen failures were inpatients (N= 88) and patients without sufficient GERD symptoms (N=79). Of the 81 eligible patients, 51 (63%) enrolled in the study [26 males (51%), mean age 49 years; LA grade B=40, C= 6, D=5] and 18 (19%) declined. Evaluating physicians did not allow contact with 15 patients due to a plan for twice daily dosing. To date, 45 subjects have completed the trial of whom 28 (62%) were compliant and 17 (38%) non-compliant in taking their prescribed daily PPI. GERD symptoms resolved in 22 (79%) 28 compliant subjects and 11 (73%) non-compliant subject (p=NS). Patients with LA grades C and D esophagitis were all compliant (7/7, 100%), while those with grade B had 55% compliance (21/38, p=0.025). Compliance assessed by MEMS technology was 62%, while compliance assessed by pill counting was 89% (p=0.003) Of the 45 subjects, 9 had a repeat endoscopy after the 8 weeks of PPI therapy. 8 (89%) had completely healed esophagitis. One compliant subject did not heal but improved from LA B to A. CONCLUSION: Results indicate a large percentage of patients taking PPI's for symptomatic grade B-D esophagitis are non-compliant in the short term. Both compliant and non-compliant patients have GERD symptom resolution. This likely indicates that patients switch to an on-demand PPI regimen when symptoms resolve. Patients with grades C and D esophagitis are more compliant than those with grade B esophagitis. The MEMS technology was more accurate at assessing compliance when compared to tablet counting
*P<.001; †P=.003; ‡P=.004.
AGA Abstracts
A-492