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sPPI in first trimester. All the results in the studies were adjusted to confounding factorssuch as maternal smoking, alcohol use, parity, use of other non teratogenic drugs, pastmiscarriages and maternal diabetes. Anomalies secondary to genetic and infectious causeswere excluded. PPI use was associated with an increased risk of congenital malformations(RR-1.25, CI-1.0-1.39, p=0.00). Risk of low birth weight was lower in pregnant womenexposed to PPI (RR-0.6, CI-0.5-0.89, p=0.006). There was no significant increase in pretermdeliveries in patients exposed to PPI (RR-1.09, CI-0.8-1.31,p=0.37).There was no significantincrease in total number of still births compared to control group(RR-2.2,CI-0.57-8.6,p=0.2). Heterogeneity was not present (I square= 0%). No significant publication bias present.Conclusion-Exposure to proton pump inhibitors during pregnancy is associated with anincreased risk of congenital malformations. Risk of low birth weight, still birth and pre-term deliveries are not increased with PPI use.

Mo1105

Side Effects Are Side Issues: Completeness of Reporting of Harms AmongSystematic Reviews in GastroenterologySuzanne E. Mahady, Timothy E. Schlub, Lisa Bero, Jacob George, Jonathan Craig

Background Systematic reviews are an integral component of evidence based health care,however little is known on how well they report the potential harms of interventions. Weassessed the reporting of harms in recent systematic reviews of interventions relevant toclinical gastroenterology. Methods We identified all systematic reviews of randomized trialsof gastroenterology interventions published from 2008 to 2012 in ten gastroenterologyjournals and five general medical journals with the highest impact factors. We adapted theCONSORT reporting guidelines for harms and used this to assess qualitative and quantitativeparameters of harms reporting. Regression analyses were undertaken to determine predictorsof more comprehensive harms reporting. Results In total, 78 systematic reviews were identi-fied, with 72 published in gastroenterology journals and 6 published in general medicaljournals. Overall, 1 in 3 systematic reviews (26/78, 33%) did not refer to harms of theintervention anywhere in the manuscript. Less than half of the studies included adverseevents as an outcome measure, and data on absolute rates of adverse events were onlyprovided in 28% of studies. The majority (65%) did not include any figures/tables on adverseevents, however, all included figures/tables on efficacy outcomes with a mean of 3 (1-7).The absence of reporting on harms was often misinterpreted as safety in the discussionsections. Regression analyses indicated that the use of reporting guidelines was significantlyassociated with more comprehensive harms reporting (p=0.04). Conclusion The coverage ofharms in gastroenterology systematic reviews is largely inadequate, and is highly asymmetricalcompared with the reporting of benefits. It is likely that existing systematic reviews haveunderestimated potential harms, and may be misleading for clinical decision making andevidence based guidelines. We suggest review authors consider adverse events as primaryoutcome measures equal in status with efficacy outcomes, and that an extension of thePRISMA reporting guidelines, specifically targeting harms reporting, be developed.

Mo1106

Gastrointestinal Bleeding in Patients With Continuous-Flow Left-VentricularAssist Devices: a Systematic Review and Meta-AnalysisKaren Draper, Robert J. Huang, Lauren B. Gerson

Background: Patients with left ventricular assist devices (LVADs) are at increased risk ofgastrointestinal hemorrhage (GIB), primarily from gastrointestinal angiodysplastic lesions(GIAD). We conducted a systematic review to estimate the pooled risk of developing a GIBin patients with LVADs. Methods: We searched PUBMED, SCOPUS, and the Cochraneregistry to identify studies. GIB was defined as the presence of overt bleeding with anassociated decrease in hematocrit of at least 2 gm/dl, or as the presence of occult hemorrhage.Subjects with both pulsatile and non-pulsatile LVADs were included. We extracted rates forincidence of GIB, rebleeding episodes, and overall mortality rates from each study. Wecompared ages of patients with and without bleeding using standard difference in means.(SDm) Summary odds ratios (OR) were computed using the DerSimonian and Laird randomeffects model in order to assess differences for patients with and without GIB with regardsto gender, type of LVAD therapy (bridge versus destination), presence of associated co-morbid conditions, usage of medications (including aspirin, anticoagulants, or proton pumpinhibitor therapy) and prior history of GIB. Data were pooled using a random effects modelwhen three or more studies reported the same outcome of interest and we created Forestplots with 95% confidence intervals (CIs). We assessed heterogeneity between studies byusing the I2 statistic with a threshold of > 50% and the X2 test with a p value <0.10 todefine statistically significant heterogeneity. All statistical analyses were performed usingComprehensive Meta-Analysis (CMA Version 3.0, Biostat Inc., Englewood, NJ). Results: Theliterature search resulted in 2573 articles. We included 17 studies that included 1839 LVADpatients. The pooled incidence of GIB in patients with continuous flow LVADs (N=1697)was 23% (95% CI 20.5-27%, Figure). Subgroup analysis demonstrated risk factors associatedwith GIB included older age (standard difference in means (Sdm) 0.69, 95% CI 0.23-1.15),elevated creatinine (SDm 0.65, 95% CI 0.12-1.18), LVAD as destination therapy (OR 1.85,95% CI 0.8-4.3), prior history of GIB (OR 2.22, 95% CI 0.83-5.96), hypertension (OR 1.6,95% CI 0.87-2.97), and presence of a continuous-flow LVAD (OR 4.5, 95% CI 2.1-9.5,Table). The pooled event rate for recurrence of GIB was 9.3% (95% CI 7-12%) with GIBmortality rate of 23% (95% CI 16-32%). The pooled event rates were 48% (95% CI 39-57%) for upper GIB, 22% (95% CI 16-31%) for lower GIB, and 15% (95% CI 8-25%) forsmall bowel bleeding. GIAD in the proximal GI tract were the most common cause of GIBin 29% of patients. Conclusions: The prevalence of GIB is increased in patients with continu-ous-flow LVADs, primarily secondary to the presence of gastrointestinal angiodysplasticlesions in the upper GI tract.Subgroup Analysis of Potential Factors Associated with GIB

S-558AGA Abstracts

I2 is measure of heterogeneity where values over 50% are considered to be significant

Pooled Incidence Rates of GIB in LVAD Patients

Mo1107

A Cost-Utility Analysis of Novel and Current Strategies for the Management ofUninvestigated DyspepsiaMichelle C. Buresi, Christopher N. Andrews, Kerri L. Novak, Mark G. Swain, ColleenJohnston, Barb Kathol, Steven J. Heitman

Functional dyspepsia is common and leads to substantial health care utilization. Managementin individuals without concerning features remains controversial. Many patients undergoendoscopy (EGD), although serious pathology is rarely found and there is little change inmanagement. Aim: To conduct a cost-utility analysis comparing existing and novel manage-ment strategies for adult patients with uninvestigated dyspepsia, without alarm symptoms.Methods: A simple tree using TreeAge Pro 2012 software was created. Four strategies werecompared over a one-year time horizon from the perspective of the publicly funded healthcare system. The strategies included: 1) "current therapy", which consisted of testing andtreating Helicobacter pylori (HP), or a 4-week trial of PPI in negative cases. Gastroenterologyconsult and EGD were performed for those who remained symptomatic; 2) prompt EGDor 3) prompt unsedated Thin Scope Endoscopy (TSE), where patients are seen by a gastroen-terologist and an EGD or TSE is performed during the same visit. Biopsies are taken for HPwith treatment of positive cases or trial of PPI if negative; and 4) the "Nurse Navigator"(NN) approach, whereby a gastroenterology nurse arranges Celiac screen, urea breath test,and a trial of PPI therapy. Patients then attend a group session led by the nurse clinician,a dietician, and a mental health therapist. Patients are followed-up by phone and if symptomspersist, they are referred for an EGD. Outcomes included the costs of each strategy, qualityadjusted life years (QALYs) gained, and incremental costs per QALYs gained. One-waysensitivity analyses were performed on all model parameters. Results: The most effectivestrategy is the NN while the cheapest strategy is TSE. Both current therapy and promptEGD are dominated by these strategies. The NN has an ICER of $1565.28 compared toTSE. Since TSE was the only strategy where a proportion of patients did not undergo EGD,it was the cheapest option. The NN strategy was the source of greatest uncertainty but thisapproach remains most effective over a wide range of input probabilities. There was nochange in outcome with varying the probabilities of finding gastric cancer with prompt vs.delayed endoscopy, or with varying the chance of survival if the cancer was in an early vsadvanced stage. Conclusions: The Nurse Navigator represents a cheaper and more effectiveapproach to patients with uninvestigated dyspepsia than what is currently being practiced.Prompt TSE is less effective than the NN but cheaper than the current practice. There isno change in cancer outcomes if the NN is used, rather than prompt endoscopy. Implementa-tion of the NN approach would entail overall cost savings for the publicly funded healthcare system, particularly when combined with TSE, if available, rather than EGD.Table 1: Incremental cost effectiveness ratios referenced to common baseline