American Gastroenterological Association Guidelines Research Articles

Practice Trends among US Gastroenterologists following the 2020 American Gastroenterological Association Guidelines on Gastric Intestinal Metaplasia: Data from a Tertiary Care Center.

Studies show variability in gastroenterologists' management of gastric intestinal metaplasia (GIM) in the United States. In 2020, the American Gastroenterological Association published GIM guidelines, recommending physician-patient shared decision-making on GIM surveillance based on risk factors. We compared gastroenterologists' communication trends of a GIM finding and surveillance recommendations before and after 2020 and evaluated patient and provider factors associated with a surveillance recommendation. A sample of patients diagnosed with GIM on biopsies from upper endoscopies performed in 2018 (cohort A) and 2021 (cohort B) were included. Logistic regression analysis assessed the association between patient/provider characteristics and surveillance recommendations in the overall cohort and over time. In all, 347 patients were included: 175 in cohort A and 172 in B. Median age was 65.7 (56.0, 73.4), and 54.5% were females. Communication to patients about GIM findings and surveillance recommendations increased from 24.6% <2020 to 50% >2020 (P<0.001) and 20% <2020 to 41.3% >2020 (P<0.001), respectively. Overall, endoscopy >2020, family history of gastric cancer, autoimmune gastritis, female providers, and gastroenterologists with 10 to 20 years of experience were associated with a surveillance recommendation. The effect of family history of gastric cancer and the effect of the patient's female sex on surveillance was significantly different between both cohorts [Odds ratio (OR): 0.13, 95% (Confidence interval) CI: 0.02, 0.97 and OR 3.39, 95% CI: 1.12, 10.2, respectively). Despite a 2-fold increase in surveillance recommendations after 2020, there was no meaningful effect of any of the patients' factors on a recommendation for surveillance over time, which raises the question as to whether surveillance is being offered to both average and high-risk patients without thorough risk stratification.

UPADACITINIB RESOLVES DIARRHEA AND FECAL CALPROTECTIN ABNORMALITIES IN BUDESONIDE-DEPENDENT MICROSCOPIC COLITIS

Abstract BACKGROUND Current American Gastroenterological Association guidelines are devoid of recommendations for steroid and biologic refractory microscopic colitis (MC). Upadacitinib (UPA) is a small molecule that selectively inhibits janus kinase-1 (JAK1). Evidence pertaining to its utility in the management of steroid and biologic refractory MC remains limited. Herein, we report efficacy and safety of UPA in medically refractory MC. METHODS Three patients presenting with severe MC refractory to budesonide and biologic therapy (vedolizumab, Table 1) were treated with standard UPA therapy. UPA was initiated at standard induction of 45 mg/day for 8 weeks. All patients had their UPA reduced to 30 mg/d for maintenance. Therapeutic response was assessed using Hjortswang’s criteria (HC), and serial fecal calprotectin measurements. HC defines clinical remission as &amp;lt; 3 bowel movements (BM)/day and &amp;lt; 1 watery stools/day. Active disease was defined as ≥ 3 BM/day or ≥1 watery stool/day. FC &amp;lt; 150 ug/g was deemed normal. RESULTS Three patients (Table 1) were included in this study. Overall, our cohort had 2 cases of collagenous colitis and 1 case of lymphocytic colitis. Two patients had an association with diagnosis of celiac disease. All patients failed steroid and biologic therapy (Table 1) with an average of 5 failed medications. At the end of UPA induction, all patients attained &amp;lt; 3 BM/day (% reduction: -79%±6). Resolution of abdominal pain, nocturnal stooling, fatigue and fecal urgency were observed. As per HC, 1 patient displayed clinical remission and two achieved significant symptomatic improvement (Table 2). All patients displayed significant reductions in FC (-71%±1.5). At 16 weeks, none of the patients experienced LBM (-100%±0) and all resolved abdominal pain, nocturnal stooling, fatigue and fecal urgency (Table 2). FC normalized (-93%±6.4) in all three patients (Table 3). No serious infections, cardiovascular events or thromboembolic events occurred. One patient experienced gout and required further UPA dose reduction to 15 mg/day. This patient continues to maintain remission at 15 mg/day. DISCUSSION UPA is a novel JAK1 inhibitor with a favorable pharmacokinetic profile. It’s rapid onset of action and relative safe profile compared to chronic steroid use makes it an ideal treatment for refractory MC. The pathophysiology of MC remains poorly elucidated. It is postulated that JAK1 is involved in IL-2, IL-4, IL-6, IL-15 and IFN signaling. UPA-inhibited JAK-STAT ameliorates IFN-γ and IL-6, implicated in MC pathogenesis. Data here supports UPA use in steroid and biologic refractory MC. Further large-scale studies are warranted to delineate long term efficacy and safety of UPA in MC. Table 1 Demographics and Baseline Disease Characteristics. Table 2 Trends in clinical parameters at baseline versus Weeks 8 and 16 Table 3 Percentage reduction in loose bowel movements (LBM) and fecal calprotectin (FC)

A Shift Toward Early Oral Feeding in Acute Pancreatitis.

The 2018 American Gastroenterological Association (AGA) guidelines strongly recommended early oral feeding as tolerated in patients with acute pancreatitis (AP). We compare early oral feeding rates in AP patients hospitalized in the periods before (2013-2016, Period A) and after (2019-2020, Period B) publication of the AGA guidelines, hypothesizing increased adherence in Period B. We performed a retrospective cohort study of AP patients presenting to the emergency department during each period. Early oral feeding was defined as diet initiation within the first 48 hours of presentation. The cohort included 276 AP cases in period A and 104 in period B. A higher percentage of patients were offered early oral feeding during period B as compared to period A (70.2% vs. 43.5%). Similarly, more patients in period B were started on solid diet as compared to period A (34.6% vs. 20.3%). On multivariable regression analysis, the independent predictors of delayed oral feeding included early opioid analgesics use (OR 0.37), presence of pancreatic necrosis (OR 0.14), and organ failure (OR 0.33). More AP patients were initiated on early oral feeding in the period following the publication of the AGA guidelines. Opioid analgesics use, pancreatic necrosis, and organ failure were associated with delayed oral feeding.

S1880 Communication and Surveillance Recommendations on Gastric Intestinal Metaplasia by US Gastroenterologists Before and After the 2020 American Gastroenterological Association Guidelines: Data From a Tertiary Care Center

S1880 Communication and Surveillance Recommendations on Gastric Intestinal Metaplasia by US Gastroenterologists Before and After the 2020 American Gastroenterological Association Guidelines: Data From a Tertiary Care Center

Acute Pancreatitis Review.

Acute pancreatitis, a prevalent illness with devastating consequences, poses a grave threat to those affected. There has been a steady increase in the occurrence of acute pancreatitis at about 3% per year from 1961 to 2016. There are 3 main guidelines on acute pancreatitis, including the American College of Gastroenterology, the International Association of Pancreatology/American Pancreatic Association guideline in 2013, and the American Gastroenterological Association guideline in 2018. However, several milestone studies have been published since then. We hereby reviewed the current acute pancreatitis guidelines with an update on clinical practicechanging literature. The aggressive or moderate fluid resuscitation in acute pancreatitis (WATERFALL) trial recommended fluid resuscitation with lactated Ringer's solution at a moderate aggressive rate. All guidelines did not recommend prophylactic antibiotics use. Early enteral feeding reduces morbidity. A clear liquid diet is no longer recommended. Nutrition with nasogastric or nasojejunal feeding does not have a difference. The upcoming high vs. low-energy administration in the early phase of acute pancreatitis (GOULASH) trial will provide more information on the impact of calorie intake. Pain management should be individualized based on the degree of pain and severity of pancreatitis. In patients with moderate to severe and severe acute pancreatitis, a step-down approach with epidural analgesia can be considered for moderate to severe pain. The management of acute pancreatitis has evolved. New research on the impact of electrolytes, pharmacologic agents, the role of anticoagulants, and nutrition support will provide scientific and clinical evidence to improve patient care and decrease morbidity and mortality.

An Overview of Emerging Trends and Technologies in Ulcerative Colitis

&#x0D; This report provides an overview of the evolving therapeutic landscape for moderate to severe ulcerative colitis (UC), including recent changes to clinical practice guidelines, key trends in therapeutic strategies, and new or emerging treatment options, with a focus on biologics and small-molecule therapies.&#x0D; Recent guidelines on the medical management of patients with UC include those of the American Gastroenterological Association (AGA), American College of Gastroenterology (ACG), and European Crohn’s and Colitis Organisation (ECCO), which were published in 2019, 2020, and 2022, respectively. These guidelines provide an accurate reflection of how clinical practice has changed to incorporate newer therapies that have entered the market and newer evidence that has been published since the release of the Canadian guidelines in 2015. The ACG, AGA, and ECCO guidelines all recommend use of a tumour necrosis factor (TNF) antagonist, vedolizumab, or tofacitinib for induction of remission in patients with moderate to severe UC; the AGA and ECCO guidelines also recommend ustekinumab as an option and recommend vedolizumab over adalimumab, whereas the AGA guidelines recommend early use of biologic drugs over a step-up approach after failure of 5-aminosalicylates.&#x0D; Two important trends in therapeutic strategies for UC include changes in the use and definition of treatment targets and recommendations regarding therapeutic drug monitoring (TDM).&#x0D; &#x0D; The 2021 Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE-II) guidelines provide contemporary consensus recommendations for using new and updated targets throughout an individualized treatment timeline in patients with inflammatory bowel disease (IBD). Although histologic remission is not considered a formal UC treatment target in STRIDE-II, it is acknowledged as an adjunctive measure to endoscopic remission to represent a deeper level of healing and is the focus of many current studies.&#x0D; The use of TDM emerged from challenges associated with the use of older biologics (primarily TNF antagonists), which posed difficulties related to immunogenicity and dosing. The relevance of TDM for newer biologics with different mechanisms of action, reduced immunogenicity, and fixed dosing (e.g., vedolizumab and ustekinumab) is a topic of ongoing debate. Although AGA guidelines on TDM in IBD and expert consensus statements support the use of reactive TDM for patients with UC who lose response to a TNF antagonist, evidence gaps remain regarding appropriate use of proactive TDM, utility of TDM for small molecules and biologics outside of the TNF antagonist class, and consistent target concentration thresholds to guide dose changes.&#x0D; &#x0D; &#x0D; There is a substantial pipeline of new and emerging drugs for the treatment of adults with moderate to severe UC, with many in phase IIb or III of clinical development; several notable trends of emerging pharmacotherapies exist, including an increasing number of Janus kinase inhibitors, several therapies with biologic targets that are new in UC (e.g., interleukin-23 antibodies, TNF-like ligand 1A inhibitors), an increasing number of oral therapies, and the first combination of 2 biologic therapies in UC.&#x0D; The Canadian health care system should be prepared to adapt to the rapidly evolving treatment landscape and potential clinical practice changes in moderate to severe UC. Drugs with new mechanisms of action in the treatment area and the new paradigm of combination therapy with multiple biologics of different classes may lead to improved patient outcomes but can also further complicate the treatment decision-making process. Therefore, it is important for health care providers to stay up to date on new and upcoming treatment options, which may require educational initiatives for both providers and patients as well as updates to the Canadian treatment guidelines. Overall, potential changes on the horizon may have substantial implications for the health care system given the prevalence of UC in Canada, the costs of advanced therapies, and the increasing number of available treatment options.&#x0D;

Multicentre Analysis of Cost, Uptake and Safety of Canadian Multidisciplinary Pancreatic Cyst Guidelines.

Pancreatic cystic lesions (PCLs) are common, with several guidelines providing surveillance recommendations. The Canadian Association of Radiologists published surveillance guidelines (CARGs) intended to provide simplified, cost-effective and safe recommendations. This study aimed to evaluate cost savings of CARGs compared to other North American guidelines including American Gastroenterology Association guidelines (AGAG) and American College of Radiology guidelines (ACRG), and to evaluate CARG safety and uptake. This is a multicentre retrospective study evaluating adults with PCL from a single health zone. MRIs completed from September 2018-2019, one year after local CARG guideline implementation, were reviewed to identify PCLs. All imaging following 3-4 years of CARG implementation was reviewed to evaluate true costs, missed malignancy and guideline uptake. Modelling, including MRI and consultation, predicted and compared costs associated with surveillance based on CARGs, AGAGs and ACRGs. 6698 abdominal MRIs were reviewed with 1001 (14.9%) identifying PCL. Application of CARGs over 3.1 years demonstrated a >70% cost reduction compared to other guidelines. Similarly, the modelled cost of surveillance for 10-years for each guideline was $516,183, $1,908,425 and $1,924,607 for CARGs, AGAGs and ACRGs respectively. Of patients suggested to not require further surveillance per CARGs, approximately 1% develop malignancy with fewer being candidates for surgical resection. Overall, 44.8% of initial PCL reports provided CARG recommendations while 54.3% of PCLs were followed as per CARGs. CARGs are safe and offer substantial cost and opportunity savings for PCL surveillance. These findings support Canada-wide implementation with close monitoring of consultation requirements and missed diagnoses.

Diagnostic accuracy of the AGA, IAP, and European guidelines for detecting advanced neoplasia in intraductal papillary mucinous neoplasm/neoplasia

BackgroundFollow-up in patients with intraductal papillary mucinous neoplasm (IPMN) aims to detect advanced neoplasia (high-grade dysplasia/cancer) in an early stage. The 2015 American Gastroenterological Association (AGA), 2017 International Association of Pancreatology (IAP), and the 2018 European Study Group on Cystic tumours of the Pancreas (European) guidelines differ in their recommendations on indications for surgery. However, it remains unclear which guideline is most accurate in predicting advanced neoplasia in IPMN. MethodsPatients who underwent surgery were extracted from a prospective database (January 2006–January 2021). In patients with IPMN, final pathology was compared with the indication for surgery according to the guidelines. ROC-curves were calculated to determine the diagnostic accuracy for each guideline. ResultsOverall, 247 patients underwent surgery for cystic lesions. In 145 patients with IPMN, 52 had advanced neoplasia, of which the AGA guideline would have advised surgery in 14 (27%), the IAP and European guideline in 49 (94%) and 50 (96%). In 93 patients without advanced neoplasia, the AGA, IAP, and European guidelines would incorrectly have advised surgery in 8 (8.6%), 77 (83%) and 71 (76%). ConclusionThe European and IAP guidelines are clearly superior in detecting advanced neoplasia in IPMN as compared to the AGA, albeit at the cost of a higher rate of unnecessary surgery. To harmonize care and to avoid confusion caused by conflicting statements, a global evidence-based guideline for PCN in collaboration with the various guidelines groups is required once the current guidelines require an update.

S3438 Malignant Gastrointestinal Neuroectodermal Tumor of the Small Intestine: A Rare Cause of Iron Deficiency Anemia

Introduction: Gastrointestinal neuroectodermal tumors (GNET) are a type of high-grade sarcoma of the gastrointestinal (GI) tract that share features with clear cell carcinoma of tendon sheaths and aponeuroses. Patients typically present with clinical signs and symptoms of small bowel obstruction, intussusception or abdominal mass. These tumors can arise in the stomach, colon, as well as metastasis to liver or regional lymph nodes. We present a case of ileal GNET in an otherwise asymptomatic patient with Iron-deficiency Anemia (IDA) diagnosed using video capsule endoscopy (VCE). Case Description/Methods: A 58-year-old Hispanic male with a past medical history of GERD and obesity presented for evaluation of chronic microcytic anemia. Workup revealed: hemoglobin 8.6 g/dl, MCV 62.2, iron saturation 2.6%, transferrin 307 mg/dl, ferritin < 5 ng/ml, reticulocyte index of 1.34; serum folate, vitamin B12 and TSH levels were within normal limits. He was taking oral ferrous sulfate and vitamin C for IDA. He reported heartburn but denied melena, hematochezia, hematemesis, weight loss and had an unremarkable colonoscopy four years prior. Upper endoscopy revealed mild erosive esophagitis and mild chronic active gastritis with negative biopsies. Colonoscopy was unremarkable in the setting of optimal bowel preparation. VCE revealed an ulcerated mass occupying 35% of the ileal lumen. CT of the abdomen noted asymmetric wall thickening with enhancement of the small bowel. The patient underwent laparoscopy-assisted enteroscopy with rendezvous technique allowing direct visualization of a 3 cm proximal ileum mass requiring open segmental resection with primary anastomosis. Pathology suggested malignant GNET or clear cell sarcoma-like tumor of the GI tract. Immunohistochemistry was positive for neural crest markers (S100, SOX10) and Vimentin; negative for CD117, DOG1, HMB45, MART1, MAA, chromogranin, and synaptophysin. Fluorescence in-situ hybridization was positive for EWSR1 (22q12) rearrangement. Given the clear surgical margins, absent regional lymph node spread and lack of standard guidelines for this rare pT1N0M0 tumor, surveillance imaging every three months without adjuvant radiation or systemic chemotherapy was recommended. (Figure) Discussion: This case highlights the importance of VCE for small bowel assessment after negative bidirectional endoscopy to identify the etiology of IDA per American Gastroenterology Association guidelines. In this case, an ulcerated GNET was the etiology of IDA persisting despite iron supplementation.Figure 1.: A-Luminal view of small bowel tumor on Video Capsule Endoscopy (VCE) B–Close up view of ulceration of small bowel tumor on VCE C–Histopathology slide showing epithelioid cells with eosinophilic cytoplasm, pleomorphic nuclei with prominent nucleoli and vesicular nucleoli. Scattered mitotic figures identified.

Confocal Laser Endomicroscopy Is a Useful Alternative “Optical” Biopsy Modality in Diagnosis of Gastric Intestinal Metaplasia

A recently published American Gastroenterological Association (AGA) guideline supported endoscopic surveillance of gastric intestinal metaplasia (GIM) for patients at higher risk of gastric cancer (GC).1 However, the optimal surveillance endoscopic modality for GIM is yet solidified in the United States. Although the updated Sydney System, a comprehensive endoscopic biopsy protocol, has been advocated for GIM mapping,2 the challenges are the heterogeneous distribution of GIM, suboptimal diagnostic accuracy of high-definition white light (HDWL) endoscopy to detect GIM, and the cost burden and safety of multiple biopsies.

Application of Artificial Intelligence in the Management of Pancreatic Cystic Lesions.

The rate of incidentally detected pancreatic cystic lesions (PCLs) has increased over the past decade and was recently reported at 8%. These lesions pose a unique challenge, as each subtype of PCL carries a different risk of malignant transformation, ranging from 0% (pancreatic pseudocyst) to 34–68% (main duct intraductal papillary mucinous neoplasm). It is imperative to correctly risk-stratify the malignant potential of these lesions in order to provide the correct care course for the patient, ranging from monitoring to surgical intervention. Even with the multiplicity of guidelines (i.e., the American Gastroenterology Association guidelines and Fukuoka/International Consensus guidelines) and multitude of diagnostic information, risk stratification of PCLs falls short. Studies have reported that 25–64% of patients undergoing PCL resection have pancreatic cysts with no malignant potential, and up to 78% of mucin-producing cysts resected harbor no malignant potential on pathological evaluation. Clinicians are now incorporating artificial intelligence technology to aid in the management of these difficult lesions. This review article focuses on advancements in artificial intelligence within digital pathomics, radiomics, and genomics as they apply to the diagnosis and risk stratification of PCLs.

AGA Institute Quality Measure Development for the Management of Gastric Intestinal Metaplasia With Helicobacter pylori

Gastric cancer is the third leading cause of cancer-related deaths worldwide, with more than 1 million incident cases diagnosed globally.1Sung H. Ferlay J. Siegel R.L. et al.Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.CA Cancer J Clin. 2021; 71: 209-249Crossref PubMed Scopus (26505) Google Scholar Non-cardia intestinal-type gastric cancer, the most common subtype of gastric cancer, develops through the Correa cascade in which chronic inflammation of normal gastric mucosa leads to atrophic gastritis, followed by gastric intestinal metaplasia (GIM), dysplasia, and ultimately gastric cancer.2Correa P. Gastric cancer: overview.Gastroenterol Clin North Am. 2013; 42: 211-217Abstract Full Text Full Text PDF PubMed Scopus (348) Google Scholar GIM has an estimated prevalence of 4.8% in the United States based on an analysis of gastric biopsies from a large pathology database, but higher rates of GIM have been reported in certain racial and ethnic groups (14.8% in Asian Americans, 18.2% in Native Americans, 25.5% in African Americans, and 29.5% in Hispanic Americans).3Nguyen T.H. Tan M.C. Liu Y. et al.Prevalence of gastric intestinal metaplasia in a multiethnic US veterans population.Clin Gastroenterol Hepatol. 2021; 19: 269-276.e3Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar,4Altayar O. Davitkov P. Shah S.C. et al.AGA technical review on gastric intestinal metaplasia-epidemiology and risk factors.Gastroenterology. 2020; 158: 732-744.e16Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar Additional risk factors for GIM include tobacco use, autoimmune gastritis, and living or immigrating from an endemic area. The annual risk of progression from GIM to non-cardia intestinal-type gastric cancer is 0.16%, and factors such as persistent Helicobacter pylori infection, family history, anatomic extent and location of GIM, and histologic subtypes may confer increased risk of progression to gastric cancer.5Gupta S. Li D. El Serag H.B. et al.AGA Clinical practice guidelines on management of gastric intestinal metaplasia.Gastroenterology. 2020; 158: 693-702Abstract Full Text Full Text PDF PubMed Scopus (105) Google Scholar Studies of U.S. endoscopists show variation in the management of patients with GIM, including use and interval for endoscopic surveillance, prompting the development of guidelines for the management of GIM.6Vance R.B. Kubiliun N. Dunbar K.B. How do we manage gastric intestinal metaplasia? A survey of clinical practice trends for gastrointestinal endoscopists in the United States.Dig Dis Sci. 2016; 61: 1870-1878Crossref PubMed Scopus (10) Google Scholar,7Huang R.J. Ende A.R. Singla A. et al.Prevalence, risk factors, and surveillance patterns for gastric intestinal metaplasia among patients undergoing upper endoscopy with biopsy.Gastrointest Endosc. 2020; 91: 70-77.e1Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar Helicobacter pylori infection is one of the most common causes of atrophic gastritis and GIM and is a major driver of progression along the Correa cascade. The overall prevalence of H pylori in the U.S. is 35.6% but has been reported to be much higher in specific racial and ethnic groups: 74.8%, 61.6%, and 52.7% in Alaskan Native Americans, Hispanic Americans, and non-Hispanic African Americans, respectively, and disproportionately affecting vulnerable populations frequently affected by health care disparities.8Hooi J.K.Y. Lai W.Y. Ng W.K. et al.Global prevalence of Helicobacter pylori infection: systematic review and meta-analysis.Gastroenterology. 2017; 153: 420-429Abstract Full Text Full Text PDF PubMed Scopus (1383) Google Scholar,9Everhart J.E. Kruszon-Moran D. Perez-Perez G.I. et al.Seroprevalence and ethnic differences in Helicobacter pylori infection among adults in the United States.J Infect Dis. 2000; 181: 1359-1363Crossref PubMed Scopus (271) Google Scholar Helicobacter pylori is readily treatable with a short course of antibiotics, and treatment is cost-effective in the prevention of gastric cancer.10Lansdorp-Vogelaar I. Meester R.G.S. Laszkowska M. et al.Cost-effectiveness of prevention and early detection of gastric cancer in Western countries.Best Pract Res Clin Gastroenterol. 2021; 50–51: 101735Crossref PubMed Scopus (13) Google Scholar However, rates of failed H pylori eradication are rising, so repeated testing to confirm eradication is recommended.11El-Serag H.B. Kao J.Y. Kanwal F. et al.Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States.Clin Gastroenterol Hepatol. 2018; 16: 992-1002.e6Abstract Full Text Full Text PDF PubMed Scopus (125) Google Scholar Despite the high prevalence of H pylori infection and release of evidence-based guidelines, quality gaps in testing and treatment exist in the management of H pylori.12Shah S.C. Itzkowitz S.H. Jandorf L. Knowledge gaps among physicians caring for multiethnic populations at increased gastric cancer risk.Gut Liver. 2018; 12: 38-45Crossref PubMed Scopus (11) Google Scholar,13El-Zimaity H. Serra S. Szentgyorgyi E. et al.Gastric biopsies: the gap between evidence-based medicine and daily practice in the management of gastric Helicobacter pylori infection.Can J Gastroenterol. 2013; 27: e25-e30Crossref PubMed Scopus (26) Google Scholar The American Gastroenterological Association (AGA) recently published a clinical practice guideline on the management of GIM, highlighting best practices for treatment and eradication of coexistent H pylori.5Gupta S. Li D. El Serag H.B. et al.AGA Clinical practice guidelines on management of gastric intestinal metaplasia.Gastroenterology. 2020; 158: 693-702Abstract Full Text Full Text PDF PubMed Scopus (105) Google Scholar Owing to the high incidence of gastric cancer, widespread prevalence of GIM and concomitant H pylori infection, and variation in practice patterns, development of quality measures for the management of GIM will provide meaningful aspirational care targets, promote adherence to evidence-based effective care, and allow benchmarking for quality practice to improve the care of patients with GIM. This document presents the official recommendations of the AGA regarding quality measures related to the diagnosis and management of GIM. The current report outlines the process by which the Quality Committee (QC) evaluates guidance statements published by the AGA’s Clinical Guidelines Committee (CGC) to inform measure development. The following recommendations were developed by the QC in consultation with the CGC. Their development was funded by the AGA Institute, with no additional outside funding. The recommendation statements from the AGA’s GIM guideline were evaluated for development as potential quality measures. A standardized process first implemented by the AGA in 2016 and outlined elsewhere14Adams M.A. Allen J.I. Saini S.D. Translating best practices to meaningful quality measures: from measure conceptualization to implementation.Clin Gastroenterol Hepatol. 2019; 17: 805-808Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar was used for this evaluation and concordant with previously used methods for measure development.15Mosko J.D. Leiman D.A. Ketwaroo G.A. et al.Development of quality measures for acute pancreatitis: a model for hospital-based measures in gastroenterology.Clin Gastroenterol Hepatol. 2020; 18: 272-275.e5Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar Optimal understanding of this measure evaluation process can be enhanced by reading applicable portions of the topic guidelines. Briefly, the AGA QC follows a “guidelines to measures” protocol that has been used for the creation of other measures. This process relies on the evaluation of forthcoming guideline recommendations to be reviewed by the QC. Recommendation statements are evaluated as potential measure concepts along several axes, including the strength of the recommendation and quality of the evidence as specified with the use of GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology. Only those statements with strong recommendations based on high or moderate quality evidence are considered for further measure development, which includes an assessment of their potential utility for practicing gastroenterologists. This assessment involves QC subcommittee analysis of measure importance and, when appropriate, is followed by the formal creation of a measure prioritization brief outlining the decision rationale whereby topics are rated on their meaningfulness, potential magnitude of effect, quality gaps, feasibility, and applicability to gastroenterologists. High-priority measure concepts subsequently undergo review and voting by all QC members ahead of a 30-day public comment period before testing and formal adoption. Finally, measures that receive 60% or more of the full QC vote are recommended for national implementation. The AGA Clinical Practice Guidelines on Management of GIM were reviewed and each recommendation statement independently evaluated by the AGA QC for the potential to develop into quality measures.5Gupta S. Li D. El Serag H.B. et al.AGA Clinical practice guidelines on management of gastric intestinal metaplasia.Gastroenterology. 2020; 158: 693-702Abstract Full Text Full Text PDF PubMed Scopus (105) Google Scholar The assessment from that evaluation is outlined in Table 1.Table 1Summary of Recommendations and Rationale for Quality Measure Development in the Guideline on the Management of Gastric Intestinal Metaplasia (GIM)StatementGRADEDecisionRationaleIn patients with GIM, the AGA recommends testing for H pylori followed by eradication over no testing and eradication.Strong recommendation, moderate quality of evidenceProceed with measure concept developmentQuality gap in confirmation of H pylori eradicationIn patients with GIM, the AGA suggests against routine use of endoscopic surveillance.Conditional recommendation, very low quality of evidenceNo measure concept to developInsufficient strength of recommendation and certainty of evidenceIn patients with GIM, the AGA suggests against routine short-interval repeated endoscopy for the purpose of risk stratification.Conditional recommendation, very low quality of evidenceNo measure concept to developInsufficient strength of recommendation and certainty of evidenceAGA, American Gastroenterological Association. Open table in a new tab AGA, American Gastroenterological Association. Recommendations with low or very low quality of evidence were not considered for quality measure development because of the limited certainty of evidence; thus, new high-quality studies may change the clinical practice recommendations. Conditional recommendations also were not considered for measure development. As a result, the suggestions against the routine use of endoscopic surveillance or routine short-interval repeated endoscopy for the purpose of risk stratification in patients with GIM were not developed. Indeed, there are no prospective studies to support nor argue against the routine performance of endoscopic surveillance in patients with GIM in preventing gastric cancer, mortality, or other patient-related outcomes. There are patient-specific factors, such as family history of gastric cancer, race/ethnicity, smoking, autoimmune gastritis/pernicious anemia, anatomic extent of GIM, and histologic subtype of GIM within the stomach that may affect the risk of developing gastric cancer.4Altayar O. Davitkov P. Shah S.C. et al.AGA technical review on gastric intestinal metaplasia-epidemiology and risk factors.Gastroenterology. 2020; 158: 732-744.e16Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar Balancing this significantly increased risk of GIM progression in some groups (up to 4.5-fold higher) with the uncertain evidence in U.S. populations, AGA guidelines recommended against the routine surveillance of GIM (conditional recommendation, very low quality of evidence) but commented that there are populations at high risk for whom a shared discussion regarding the potential benefit of endoscopic surveillance at regular intervals should be considered.5Gupta S. Li D. El Serag H.B. et al.AGA Clinical practice guidelines on management of gastric intestinal metaplasia.Gastroenterology. 2020; 158: 693-702Abstract Full Text Full Text PDF PubMed Scopus (105) Google Scholar However, because of the conditional recommendation provided against GIM surveillance among all patients diagnosed with GIM, regardless of additional risk factors, the AGA QC cannot generate a quality measure on routine endoscopic GIM surveillance. The data are also insufficient to indicate that routine short-interval repeated endoscopy for risk stratification in patients with GIM affects gastric cancer detection or treatment. In contrast, recommendations with moderate or strong quality of evidence were reviewed for suitability of quality measure development. In this case, the recommendation for patients with GIM to have testing for H pylori followed by eradication, over no testing and eradication, was assessed and developed as a fully specified measure. Helicobacter pylori, a class I carcinogen per the World Health Organization, is a major risk factor for GIM and non-cardia gastric cancer. Helicobacter pylori infection can be detected by stool antigen, breath testing, gastric biopsies, or serology. GIM may lower the sensitivity of H pylori detection in gastric biopsies, so repeated H pylori testing with either stool or breath testing—off proton pump inhibitor therapy for at least 2 weeks—is recommended. Helicobacter pylori eradication in individuals with or without GIM has been associated with a 32% pooled relative risk reduction for developing gastric cancer.16Gawron A.J. Shah S.C. Altayar O. et al.AGA technical review on gastric intestinal metaplasia—natural history and clinical outcomes.Gastroenterology. 2020; 158: 705-731.e5Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar However, H pylori antibiotic resistance is increasing, and post-treatment confirmation of eradication is recommended owing to rising rates of H pylori eradication failure.17Savoldi A. Carrara E. Graham D.Y. et al.Prevalence of antibiotic resistance in Helicobacter pylori: a systematic review and meta-analysis in World Health Organization regions.Gastroenterology. 2018; 155: 1372-1382.e17Abstract Full Text Full Text PDF PubMed Scopus (503) Google Scholar,18Chey W.D. Leontiadis G.I. Howden C.W. et al.ACG Clinical guideline: treatment of Helicobacter pylori infection.Am J Gastroenterol. 2017; 112: 212-239Crossref PubMed Scopus (768) Google Scholar Serology cannot reliably distinguish between active or previous infection, therefore methods other than serology are recommended to confirm H pylori eradication. Ensuring adequate assessment and eradication of H pylori in patients with GIM is of critical importance and addresses a significant quality gap because 1) gastric cancer incidence and mortality are high, 2) a strong association exists between H pylori, GIM, and gastric cancer, 3) H pylori eradication is associated with decreased gastric cancer incidence and mortality, 4) H pylori eradication failure rates are rising, resulting in the need for multiple courses of antibiotics that may further worsen antibiotic resistance, and 5) H pylori antibiotic resistance testing is difficult to obtain. We therefore proposed the development of a quality measure to ensure H pylori testing and confirmation of eradication in patients with GIM. The recent publication of International Classification of Diseases, 10th Revision, codes specific for GIM in October 2021 allowed the QC to proceed with development of a GIM quality measure (Figure 1). Following its development, the measure specification was posted for public comment in November 2021. Comments and suggestions that were received included the addition of Current Procedural Terminology (CPT) code descriptions into the measure specifications and revision of the measure specifications to emphasize testing for H pylori 4 weeks after completion of therapy. In response to these comments, we updated CPT codes with descriptions and emphasized the timing of repeated H pylori testing 4 weeks after completion of treatment. Comments in support of this measure were also received from the College of American Pathologists. The finalized measure reflects these comments. The AGA CGC systematically reviewed data and issued recommendations for the management of GIM based on the quality of available evidence. The AGA QC develops quality measures based on CGC guidelines with moderate or high quality of evidence and strong recommendations. Quality measure development entails a rigorous process of measure specification, testing, and submission to quality programs such as the Merit-Based Incentive Payment System. Data on long-term outcomes of GIM and endoscopy for risk stratification or surveillance in a U.S. population are lacking. Factors such as family history, histologic features, and anatomic extent of GIM all affect risk of progression of GIM to gastric cancer. International guidelines recommend endoscopic surveillance of GIM at varying intervals depending on anatomic extent of GIM and presence or absence of additional risk factors for gastric cancer.19Pimentel-Nunes P. Libânio D. Marcos-Pinto R. et al.Management of epithelial precancerous conditions and lesions in the stomach (MAPS II): European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter and Microbiota Study Group (EHMSG), European Society of Pathology (ESP), and Sociedade Portuguesa de Endoscopia Digestiva (SPED) guideline update 2019.Endoscopy. 2019; 51: 365-388PubMed Google Scholar,20Banks M. Graham D. Jansen M. et al.British Society of Gastroenterology guidelines on the diagnosis and management of patients at risk of gastric adenocarcinoma.Gut. 2019; 68: 1545-1575Crossref PubMed Scopus (225) Google Scholar However, in the absence of high-quality data regarding the role of endoscopic surveillance of GIM and optimal surveillance intervals regarding patient-related outcomes, current evidence is not strong enough to support the development of quality measures for endoscopic surveillance of GIM. Until more evidence is available regarding endoscopic surveillance for GIM, ensuring eradication of H pylori is an attainable goal that would improve patient outcomes. Given the disparate impacts of gastric cancer, GIM, and H pylori on certain portions of the U.S. population, there may be a role for future measure development or measure stratification for populations at high risk when additional data are available. In the meantime, studies have shown nonadherence to H pylori testing guidelines and knowledge gaps in the management of patients at increased risk for gastric cancer.12Shah S.C. Itzkowitz S.H. Jandorf L. Knowledge gaps among physicians caring for multiethnic populations at increased gastric cancer risk.Gut Liver. 2018; 12: 38-45Crossref PubMed Scopus (11) Google Scholar,13El-Zimaity H. Serra S. Szentgyorgyi E. et al.Gastric biopsies: the gap between evidence-based medicine and daily practice in the management of gastric Helicobacter pylori infection.Can J Gastroenterol. 2013; 27: e25-e30Crossref PubMed Scopus (26) Google Scholar Beyond GIM, H pylori assessment and eradication have been shown to improve outcomes in peptic ulcer disease–associated gastrointestinal bleeding and dyspepsia.21Hung K.W. Knotts R.M. Faye A.S. et al.Factors associated with adherence to Helicobacter pylori testing during hospitalization for bleeding peptic ulcer disease.Clin Gastroenterol Hepatol. 2020; 18: 1091-1098.e1Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 22Guo C.G. Cheung K.S. Zhang F. et al.Delay in retreatment of Helicobacter pylori infection increases risk of upper gastrointestinal bleeding.Clin Gastroenterol Hepatol. 2021; 19: 314-322.e2Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 23Chiba N. van Zanten S.J. Sinclair P. et al.Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: the Canadian Adult Dyspepsia Empiric Treatment—Helicobacter pylori positive (CADET-Hp) randomised controlled trial.BMJ. 2002; 324: 1012-1016Crossref PubMed Scopus (201) Google Scholar Wide variations of care exist, so efforts to confirm eradication are important opportunities for improvement in the care of patients with GIM. Future quality improvement opportunities will include creating mechanisms to identify patients with H pylori and GIM, with a focus on tracking and increasing rates of H pylori eradication confirmation within a confined episode of care to reduce the risk of gastric cancer. Importantly, there are no other quality measures related to the management of H pylori. The current measure therefore represents an opportunity to improve the quality of care for patients with the most common bacterial infection worldwide, affecting more than half of the world’s population and disproportionately affecting vulnerable populations frequently affected by health care disparities.8Hooi J.K.Y. Lai W.Y. Ng W.K. et al.Global prevalence of Helicobacter pylori infection: systematic review and meta-analysis.Gastroenterology. 2017; 153: 420-429Abstract Full Text Full Text PDF PubMed Scopus (1383) Google Scholar Because of the strong relationship between H pylori and atrophic gastritis, dyspepsia, and peptic ulcer disease, development of quality measures to promote H pylori testing, treatment, and confirmation of eradication in these conditions is a potential next step. The development of a broader quality measure for H pylori treatment and confirmation of eradication in all individuals who test positive for H pylori is another potential future direction in improving care of patients with H pylori in general. This will require thorough review and grading of the quality of available evidence regarding H pylori testing and treatment and patient-related outcomes, including benefits and harms, to determine the appropriateness and magnitude of the effect of a broader H pylori measure. Management of H pylori infection is beyond the scope of this document and has been discussed in numerous guidelines, consensus documents, and clinical practice updates.18Chey W.D. Leontiadis G.I. Howden C.W. et al.ACG Clinical guideline: treatment of Helicobacter pylori infection.Am J Gastroenterol. 2017; 112: 212-239Crossref PubMed Scopus (768) Google Scholar,24Shah S.C. Iyer P.G. Moss S.F. AGA Clinical practice update on the management of refractory Helicobacter pylori infection: expert review.Gastroenterology. 2021; 160: 1831-1841Abstract Full Text Full Text PDF PubMed Scopus (56) Google Scholar,25Fallone C.A. Chiba N. van Zanten S.V. et al.The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults.Gastroenterology. 2016; 151: 51-69.e14Abstract Full Text Full Text PDF PubMed Scopus (508) Google Scholar Successful eradication on the initial treatment attempt is imperative owing to declining eradication rates with subsequent treatment regimens. A renewed focus on the treatment and eradication of H pylori has the potential to greatly improve global health, and emphasizing the need to confirm eradication will result in a greater understanding of current resistance patterns. This may have the potential to create a virtuous cycle whereby other best practices can be recognized, including tailoring treatment to local antimicrobial resistance and improving antibiotic stewardship.11El-Serag H.B. Kao J.Y. Kanwal F. et al.Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States.Clin Gastroenterol Hepatol. 2018; 16: 992-1002.e6Abstract Full Text Full Text PDF PubMed Scopus (125) Google Scholar,25Fallone C.A. Chiba N. van Zanten S.V. et al.The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults.Gastroenterology. 2016; 151: 51-69.e14Abstract Full Text Full Text PDF PubMed Scopus (508) Google Scholar In conclusion, the AGA QC has created a novel quality measure for H pylori testing and eradication in patients with GIM. Future inclusion of this measure in a Quality Payment Program or endorsement by organizations such as the National Quality Forum will depend on real-world usage, testing, and refinement. In the meantime, the measure may be used for ongoing quality improvement interventions, and continued measurement will be essential to addressing the quality gap and improving the care of patients who are at risk for gastric cancer. We particularly acknowledge the work of David Godzina and members of the American Gastroenterological Association Quality Committee, who participated in generating and evaluating this measure.

A178 BIOLOGIC THERAPY DURING PREGNANCY AS PER GUIDELINE RECOMMENDATIONS REDUCES ADVERSE PREGNANCY RELATED OUTCOMES

BackgroundInflammatory bowel disease (IBD) disease activity during pregnancy is associated with adverse neonatal and pregnancy-related outcomes. Biologics are used to suppress disease activity but crosses the placenta in the third trimester. Conflicting studies and guidelines on the timing of biologic dosing in pregnancy persist as we try to balance the risk of disease flare and possible adverse drug effects. The American Gastroenterology Association (AGA) recommends timing the final dose according to the half-life and dosing regimen of each biologic agent.AimsTo compare neonatal and pregnancy-related outcomes in early versus late dosing of biologics.MethodsThis was a single-center retrospective cohort study conducted at Mount Sinai Hospital from 2016–2021. We included patients with an established diagnosis of IBD before pregnancy who were at least 18 years of age at the time of conception. All patients must have been treated with an IBD-specific biologic agent and had a documented final dose during the pregnancy. The early group received their last biologic dose earlier than the AGA recommendations and the late group received it within the recommended interval. A patient was considered to have a flare based on the overall clinical impression of their gastroenterologist informed by reported symptoms, investigations (fecal calprotectin, endoscopy), and response to treatment. Neonatal and pregnancy-related outcomes were compared amongst the two groups using the student’s t-test (for continuous variables) and Fischer’s exact test (for categorical variables) using SPSS Version 27.ResultsOf 322 patients who had a completed pregnancy at Mount Sinai Hospital, 107 were included in this study. 67 (62.6%) were in the early and 40 (37.4%) were in the late groups. Baseline characteristics including age, comorbidities, IBD phenotype and disease activity were similar between the two groups. The late group had significantly later gestational ages (37.4 vs 38.7 weeks, p=0.006), higher 5-minute Apgar scores (8.7 vs. 9.0, p=0.042), fewer NICU admissions (25.4% vs 5.0%, p=0.036), and fewer IBD flares (28.3% vs 11.1%, p=0.039) in the 6-month post-partum period. There were no significant differences in the rates of premature birth, caesarian sections, infections, and congenital abnormalities. Results are displayed in figure 1.ConclusionsOur study suggests that late dosing of biologics according to the AGA guidelines was associated with favourable outcomes. However, this is an unadjusted analysis based on retrospective data and findings should be confirmed in a prospective manner to account for confounders. Funding AgenciesNone

Understanding Compliance, Practice Patterns, and Barriers Among Gastroenterologists and Primary Care Providers Is Crucial for Developing Strategies to Improve Screening for Barrett’s Esophagus

Esophageal adenocarcinoma (EAC) is a highly fatal disease with an increasing incidence from 0.54 to 3.76 per 100,000 person-years from 1975 to 20161Kolb J.M. Han S. Scott F.I. et al.Early-onset esophageal adenocarcinoma presents with advanced-stage disease but has improved survival compared with older individuals.Gastroenterology. 2020; 159: 2238-2240Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar that has been mirrored by a rise in EAC-related mortality. Because Barrett’s esophagus (BE) is the only known precursor lesion to EAC, early recognition and intervention could potentially reduce the societal burden of EAC by detecting cancers at an earlier stage and improving outcomes. Accordingly, professional gastroenterology society guidelines recommend screening upper endoscopy for at-risk individuals (chronic gastroesophageal reflux disease [GERD] along with the presence of other risk factors such as age >50 years, male sex, White race, smoking, obesity, and family history of BE or EAC).2Shaheen N.J. Falk G.W. Iyer P.G. et al.ACG clinical guideline: diagnosis and management of Barrett’s esophagus.Am J Gastroenterol. 2016; 111: 30-50Crossref PubMed Scopus (983) Google Scholar, 3Spechler S.J. Sharma P. Souza R.F. et al.American Gastroenterological Association technical review on the management of Barrett’s esophagus.Gastroenterology. 2011; 140: e18-e52Abstract Full Text Full Text PDF PubMed Scopus (522) Google Scholar, 4Qumseya B. Sultan S. et al.ASGE Standards of Practice CommitteeASGE guideline on screening and surveillance of Barrett’s esophagus.Gastrointest Endosc. 2019; 90: 335-359Abstract Full Text Full Text PDF PubMed Scopus (155) Google Scholar, 5Fitzgerald R.C. di Pietro M. Ragunath K. et al.British Society of Gastroenterology guidelines on the diagnosis and management of Barrett’s oesophagus.Gut. 2014; 63: 7-42Crossref PubMed Scopus (852) Google Scholar Notably, most of these are conditional recommendations with weak evidence, and there are no screening guidelines from the US Preventive Services Task Force or other internal medicine societies. Current programs are ineffective because nearly 90% of patients with EAC do not have known BE at the time of cancer diagnosis, and the majority of EACs are found outside of dedicated screening programs.6Tan M.C. Mansour N. White D.L. et al.Systematic review with meta-analysis: prevalence of prior and concurrent Barrett’s oesophagus in oesophageal adenocarcinoma patients.Aliment Pharmacol Ther. 2020; 52: 20-36Crossref PubMed Scopus (17) Google Scholar Screening algorithms largely rely on the diagnosis of GERD, but only 7% to 10% of GERD patients have BE, up to 25% of BE patients are asymptomatic, and 20% to 50% of EAC patients have no prior GERD symptoms.7Lagergren J. Bergström R. Lindgren A. et al.Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma.N Engl J Med. 1999; 340: 825-831Crossref PubMed Scopus (2597) Google Scholar,8Eusebi L.H. Telese A. Cirota G.G. et al.Systematic review with meta-analysis: risk factors for Barrett’s oesophagus in individuals with gastro-oesophageal reflux symptoms.Aliment Pharmacol Ther. 2021; 53: 968-976Crossref PubMed Scopus (4) Google Scholar Not only will patients at risk for BE/EAC be missed if GERD is required for screening, but from a societal and resource standpoint, this approach is not practical, given that GERD is very common. Results from a population-based survey of 78,812 persons in the United States demonstrated that nearly 2 out of 5 patients (44%) had GERD symptoms in the past, and this number is likely to increase with the obesity epidemic.9Delshad S.D. Almario C.V. Chey W.D. et al.Prevalence of gastroesophageal reflux disease and proton pump inhibitor-refractory symptoms.Gastroenterology. 2020; 158: 1250-1261Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar Thus, the current paradigm for screening according to GERD and other risk factors needs to be changed. Nguyen et al10Nguyen T.H. Thrift A.P. Rugge M. et al.Prevalence of Barrett’s esophagus and performance of societal screening guidelines in an unreferred primary care population of U.S. veterans.Gastrointest Endosc. 2021; 93: 409-419Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar evaluated the performance characteristics of screening guidelines among 513 veterans evaluated in primary care clinics and demonstrated that published guidelines are suboptimal in predicting BE (sensitivity, 38.6%–43.2%; specificity, 71.%–75.1%). The 2011 American Gastroenterological Association guidelines, which do not mandate the presence of GERD symptoms to screen for BE, had a sensitivity of 100% and specificity of 0.2%.10Nguyen T.H. Thrift A.P. Rugge M. et al.Prevalence of Barrett’s esophagus and performance of societal screening guidelines in an unreferred primary care population of U.S. veterans.Gastrointest Endosc. 2021; 93: 409-419Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar Ongoing efforts to incorporate risk prediction models that go beyond the presence of GERD symptoms will help better target individuals who would benefit most from screening.11Rubenstein J.H. McConnell D. Waljee A.K. et al.Validation and comparison of tools for selecting individuals to screen for Barrett’s esophagus and early neoplasia.Gastroenterology. 2020; 158: 2082-2092Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar There are also more nuanced limitations to screening in the clinical setting and a lack of studies characterizing practice patterns among gastroenterologists (GIs) and primary care providers (PCPs). Prior data demonstrate significant heterogeneity among GIs regarding BE screening practices,12Menezes A. Tierney A. Yang Y.X. et al.Adherence to the 2011 American Gastroenterological Association medical position statement for the diagnosis and management of Barrett’s esophagus.Dis Esophagus. 2015; 28: 538-546Crossref PubMed Scopus (21) Google Scholar but overall, there are minimal data to explain if BE screening is inadequate because of providers failing to recognize at-risk patients and refer them for endoscopy, patients failing to heed their physicians’ recommendation, system-level factors preventing patients from completing screening endoscopy, or a combination of these. Additionally, PCPs often serve at the front line in managing reflux symptoms and assessing candidacy for BE and EAC screening, but their attitudes and barriers to screening are not known. A detailed understanding of provider practice patterns, predictors of behavior, and key barriers to effective screening are essential to develop and implement interventions to improve BE screening and ultimately make population-level improvements in EAC outcomes. We conducted the Study of Compliance, Practice Patterns, and Barriers Regarding Established National Screening Programs for Barrett’s Esophagus (SCREEN-BE), a Web-based survey study to define GI and PCP knowledge, attitudes, and barriers to BE screening and to evaluate how these relate to their application of screening guidelines in clinical practice. This was performed at 4 tertiary care referral and 2 affiliated safety-net health systems in the United States (NCT04408105) (Supplementary Figure 1). Surveys were developed using a theoretical model of physician behavior based on social cognitive theory13Bandura A. Health promotion by social cognitive means.Health Educ Behav. 2004; 31: 143-164Crossref PubMed Scopus (4130) Google Scholar and the theory of reasoned action, and questions were adapted from earlier validated cancer screening-based surveys.14Singal A.G. Tiro J.A. Murphy C.C. et al.Patient-reported barriers are associated with receipt of hepatocellular carcinoma surveillance in a multicenter cohort of patients with cirrhosis.Clin Gastroenterol Hepatol. 2021; 19: 987-995Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar To assess knowledge of BE screening, we designed 9 clinical vignettes and categorized provider responses as concordant or discordant with published guidelines2Shaheen N.J. Falk G.W. Iyer P.G. et al.ACG clinical guideline: diagnosis and management of Barrett’s esophagus.Am J Gastroenterol. 2016; 111: 30-50Crossref PubMed Scopus (983) Google Scholar,4Qumseya B. Sultan S. et al.ASGE Standards of Practice CommitteeASGE guideline on screening and surveillance of Barrett’s esophagus.Gastrointest Endosc. 2019; 90: 335-359Abstract Full Text Full Text PDF PubMed Scopus (155) Google Scholar (the criterion standard for construct validity for this study) (Supplementary Figure 2). To evaluate responses to 9 clinical vignettes, 1 point was assigned for each guideline-concordant recommendation (score range, 0–9). GIs were given a point for a guideline concordant recommendation to perform screening endoscopy and PCPs for ordering screening endoscopy or referring to a GI to discuss screening (see Supplementary Methods). The multicenter administration of rigorously developed surveys with multiple domains of physician behavior across different health care systems with geographic, socioeconomic, and cultural diversity adds to the generalizability of results and enhances validity. We obtained a GI and PCP response rate of 74.5% (120/161) and 49.2% (195/396), respectively (Supplementary Table 1). Most respondents were physicians (91.5%), with a wide distribution of numbers of years in practice. The majority (76.3% GI, 92.0% PCP) reported seeing 2 or more patients with reflux per week. Despite the high volume of patients, the majority of GI and PCP clinics did not have a mechanism to remind providers when patients were eligible for BE screening; most believed this should be incorporated into the electronic health record. Although more than 70% of GIs and PCPs believe that BE screening is effective for early EAC detection, few believed it reduced all-cause mortality (22.6% and 21.9%, respectively), and PCPs in particular expressed concerns regarding cost effectiveness (Table 1). Most providers agreed that more data evaluating the screening benefits (GI, 74.8%; PCP, 65.7%) and harms (GI, 67.0%; PCP, 59.0%) are needed, including data from randomized controlled trials for BE screening (GI, 90.4%; PCP, 80.3%). This perspective is not particularly surprising, given the lack of randomized controlled trials demonstrating the effectiveness or mortality reduction from BE screening. Prior survey data indicate that 85% of GIs believe the evidence for BE screening is inadequate; only 48% think it is cost-effective to screen; and many perform screening despite concerns about effectiveness, most commonly because of medicolegal liability.15Lin O.S. Mannava S. Hwang K.L. et al.Reasons for current practices in managing Barrett’s esophagus.Dis Esophagus. 2002; 15: 39-45Crossref PubMed Scopus (15) Google Scholar Support for screening is largely derived from retrospective cohort studies showing better outcomes among BE/EAC patients who received screening endoscopy. Furthermore, BE screening with endoscopy and alternative methods appears to be cost effective in high-risk groups; however, this may depend on the potential mortality benefit afforded by treating dysplastic BE.16Ladabaum U. How I do it: does this cost-effectiveness analysis convince me about screening for Barrett’s esophagus?.Gastrointest Endosc. 2019; 89: 723-725Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar,17Heberle C.R. Omidvari A.H. Ali A. et al.Cost effectiveness of screening patients with gastroesophageal reflux disease for Barrett’s esophagus with a minimally invasive cell sampling device.Clin Gastroenterol Hepatol. 2017; 15: 1397-1404Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar Although recent data from a randomized controlled trial indicates the benefit of a noninvasive screening method in the primary care setting to detect BE compared to usual care,18Fitzgerald R.C. di Pietro M. O’Donovan M. et al.Cytosponge-trefoil factor 3 versus usual care to identify Barrett’s oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial.Lancet. 2020; 396: 333-344Abstract Full Text Full Text PDF PubMed Scopus (83) Google Scholar studies comparing screening to no screening may never show a reduction in mortality at the population level given the relatively low incidence of EAC and low number of cancers arising from BE. This remains a challenge in widespread adoption of BE screening, especially considering our results showing that 90% of GIs and 80% of PCPs desire strong data from a randomized controlled trial to affect their decision making.Table 1Gastroenterology and Primary Care Provider Attitudes Related to BE ScreeningProvider attitudesGI, n (%)PCP, n (%)P value(n = 120)(n = 195)BE screening with upper endoscopy is effective for early esophageal cancer detectionaThere were 21 missing..02 Strongly agree or agree83 (72.2)127 (70.9) Neither agree nor disagree20 (17.4)46 (25.7) Strongly disagree or disagree,12 (10.4)6 (3.4)BE screening with upper endoscopy reduces all-cause mortalitybThere were 22 missing.<.01 Strongly agree or agree26 (22.6)39 (21.9) Neither agree nor disagree36 (31.3)109 (60.7) Strongly disagree or disagree53 (46.1)31 (17.4)BE screening with upper endoscopy is cost-effective for at-risk individualsaThere were 21 missing.<.01 Strongly agree or agree64 (55.7)68 (38.0) Neither agree nor disagree34 (29.6)92 (51.4) Strongly disagree or disagree17 (14.8)19 (10.6)Not performing Barrett’s esophagus screening poses malpractice liabilityaThere were 21 missing.<.01 Strongly agree or agree47 (40.9)46 (25.7) Neither agree nor disagree45 (39.1)103 (57.5) Strongly disagree or disagree23 (20.00)30 (16.8)Primary care providers should not order BE screening based on lack of recommendation from the US Preventive Services Task ForceaThere were 21 missing.<.01 Strongly agree or agree20 (17.4)51 (28.5) Neither agree nor disagree44 (38.3)92 (51.4) Strongly disagree or disagree51 (44.3)36 (20.1)Better data on the benefits of BE screening are neededbThere were 22 missing.<.01 Strongly agree or agree86 (74.8)117 (65.7) Neither agree nor disagree14 (12.2)56 (31.5) Strongly disagree or disagree15 (13.0)5 (2.8)Better data on the harms of BE screening are neededbThere were 22 missing.<.01 Strongly agree or agree77 (67.0)105 (59.0) Neither agree nor disagree20 (17.4)66 (37.1) Strongly disagree or disagree18 (15.7)7 (3.9)A randomized trial on BE screening would impact my decision to refer patients for screeningbThere were 22 missing..03 Strongly agree or agree104 (90.4)143 (80.3) Do not agree or strongly agree11 (9.6)35 (19.7)BE screening with upper endoscopy has equally strong supporting data as colon cancer screening with colonoscopybThere were 22 missing.<.01 Strongly agree or agree7 (6.1)8 (4.5) Neither agree nor disagree24 (20.9)77 (43.3) Strongly disagree or disagree84 (73.0)93 (52.2)BE, Barrett’s esophagus; GI, gastroenterologist; PCP, primary care provider.a There were 21 missing.b There were 22 missing. Open table in a new tab BE, Barrett’s esophagus; GI, gastroenterologist; PCP, primary care provider. Whereas half (54.2%) of GI providers order at least 1 upper endoscopy for BE screening per month, only 17.4% of PCPs reported ordering BE screening, and 29.7% reported referring patients to a GI to discuss BE screening per month. More than two thirds of GIs but only 31.8% of PCPs discuss the benefits and harms of BE screening in detail with patients with chronic GERD. These results highlighting provider practice patterns are consistent with epidemiologic data showing that only 10% of individuals with GERD undergo upper endoscopy within the first year of diagnosis.19Kramer J.R. Shakhatreh M.H. Naik A.D. et al.Use and yield of endoscopy in patients with uncomplicated gastroesophageal reflux disorder.JAMA Intern Med. 2014; 174: 462-465Crossref PubMed Scopus (13) Google Scholar GI providers were more consistently able to identify BE risk factors that would prompt screening compared to PCPs, who tend to overlook key risk factors and are less likely to recommend screening when appropriate (Supplementary Table 2). This failure to recognize the demographic and clinical factors that warrant consideration for BE screening may be a modifiable target to improve the early detection of EAC. When GIs were asked about the relevance of the US Preventative Services Task Force not having a recommendation on BE screening, 80% believed that this would not prevent GIs from ordering BE screening, and 44.3% of GIs believed that this would not prevent PCPs from ordering BE screening. PCPs appear to value data on benefits and risks of BE screening over direct endorsement from the US Preventative Services Task Force to conduct screening. Unlike most other cancers, where a negative examination result should be followed by additional screening at a future date, BE screening is recommended as a one-time test that does not require repeated screening. Although 18.0% of GIs would not recommend BE screening at all, most GIs (65.8%) appropriately would not recommend repeat screening after a negative endoscopy result for BE. The rest did recommended repeat screening after a negative examination result at either 3, 5, or 10 years (4.2%, 10.0%, and 1.7%, respectively). Approximately 32.0% of PCPs do not recommend screening at all, 31.8% of PCPs would not recommend repeat screening after a negative upper endoscopy result, and the rest recommend repeat screening at 1, 3, 5, or 10 years (2.1%, 16.4%, 14.9%, and 2.6%, respectively). Notably, only two thirds of GIs and one third of PCPs in this study appreciate current recommendations for one-time BE screening. Although screening for BE is grossly underused, these results highlight the potential for overuse or unnecessary repeated examinations and the need for education and clarification of this point in future guidelines. Whereas GIs reported minimal barriers to performing BE screening, PCPs identified several barriers at the provider and system levels (Figure 1A and Supplementary Table 3). Only 15.8% of GIs have difficulty knowing who should undergo upper endoscopy for BE screening, whereas 58.2% of PCPs note difficulty. Similarly, 75.8% of GIs reported that they know the current BE screening guidelines, compared to only 15.5% of PCPs. Neither group believed that patients would have difficulty understanding information about BE or would be hesitant to undergo endoscopy. Most GI providers (62.8%) and PCPs (75.9%) reported they would be interested to learn more about BE screening. In contrast to GIs, PCPs identified multiple barriers at the provider and system levels that hinder their ability to screen appropriately for BE. PCPs report a lack of knowledge related to screening guidelines and have difficulty identifying which patients to screen, despite seeing many patients with GERD. One potential contributing factor is that the published literature on BE risk factors and screening has been largely confined to GI journals and professional circles. Additionally, efforts to dissuade PCPs from referring patients to endoscopy before a trial of acid-suppressive medication or to limit the use of proton pump inhibitors may cause confusion among PCPs about diagnostic vs screening examinations. In a previous questionnaire of >1,000 PCPs attending industry-sponsored conferences on GERD, 87% of respondents agreed that patients with GERD for ≥5 years should have screening endoscopy for BE; however, 50% were unable to order the procedure through open access endoscopy and needed consultation with a GI provider.20Chey W.D. Inadomi J.M. Booher A.M. et al.Primary-care physicians’ perceptions and practices on the management of GERD: results of a national survey.Am J Gastroenterol. 2005; 100: 1237-1242Crossref PubMed Scopus (56) Google Scholar More PCPs than GIs identified competing clinical issues and time limitations that prevented them from addressing screening for BE (44.3% vs 12.5% and 32.8% vs 7.5%, respectively). These barriers are consistent across other cancer screenings, including colorectal cancer and hepatocellular carcinoma.21Simmons O.L. Feng Y. Parikh N.D. et al.Primary care provider practice patterns and barriers to hepatocellular carcinoma surveillance.Clin Gastroenterol Hepatol. 2019; 17: 766-773Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar Several types of interventions, such as provider training or best practice alerts in the electronic health record may be effective in improving cancer screening quality in the primary care setting.22Hamel C. Ahmadzai N. Beck A. et al.Screening for esophageal adenocarcinoma and precancerous conditions (dysplasia and Barrett’s esophagus) in patients with chronic gastroesophageal reflux disease with or without other risk factors: two systematic reviews and one overview of reviews to inform a guideline of the Canadian Task Force on Preventive Health Care (CTFPHC).Syst Rev. 2020; 9: 20PubMed Google Scholar Leveraging new technologies within the electronic health record for population health management may prove effective. Our results highlight the need for more robust educational and advocacy efforts on the part of GIs as well as improved partnership with our colleagues because PCPs are at the front line for screening. When presented with clinical scenarios, GI providers were more likely to provide guideline-concordant screening recommendations than PCPs (mean composite score, 7.0 ± 1.3 vs 5.7 ± 1.1; P < .01) (Figure 1B). For the 4 vignettes where screening was not indicated, PCPs were more likely to recommended screening (47.2%) compared to GIs (35.1%; P < .001). Similarly, in the 5 vignettes where screening was indicated, PCPs did not recommend screening 31.8% of the time compared to 14.0% among GIs (P < .001). These results suggest a clear need for education and dissemination of current societal guidelines among primary care audiences. Granular data from the SCREEN-BE study identified multiple knowledge gaps and barriers to appropriate BE screening, mainly in the primary care setting. These potential modifiable targets are ripe for future studies that focus on the following:•intervention trials using decision-support algorithms along with integrated reminder systems to incorporate BE screening during PCP visits and improve the adherence and effectiveness of BE screening.•qualitative research to understand the opinions of key stakeholders (patients and caregivers, GIs, PCPs, pathologists, public health experts) and create screening algorithms that consider resources, cost, and feasibility.•education and dissemination of screening guidelines among PCPs, given their lack of knowledge and nonadherence to GI society guidelines

Подбор антикоагулянтной терапии пациентам с циррозом печени

Patients with liver diseases have a higher risk of hemostatic disorders. Meanwhile, despite a well-established opinion on a low risk of thromboses in cirrhosis, thromboembolic events cannot be totally ruled out in these patients. Increased risks of thrombotic events and venous thromboembolism in cirrhosis are accounted for by external (immobilization, surgeries, infections, comorbidities) and internal factors (reduced synthesis of anticoagulants, increased levels of estrogens). Practically, the selection of anticoagulant therapy in cirrhosis is difficult because of divergent hemostatic disorders and requires continuous and careful monitoring of hemostasis. In 2019, the American Gastroenterological Association (AGA) released guidelines on anticoagulant therapy in patients with cirrhosis and pulmonary embolism. We describe a patient with cirrhosis and pulmonary embolism. A management strategy was tailored to the AGA guidelines, the Russian Society on Liver Research guidelines, and the Russian Gastroenterological Association on Fibrosis and Cirrhosis and Complication Diagnosis and Treatment guidelines. This example of successful selection of anticoagulant therapy, multidisciplinary approach, and dynamic evaluation of all available methods of hemostasis control will be useful for practitioners. KEYWORDS: cirrhosis, hemostasis, thrombosis, hemorrhage, venous thromboembolism, pulmonary embolism, thromboelastometry, anticoagulant, low-molecular-weight heparin. FOR CITATION: Arykan N.G., Shestopalov A.E., Khvorostinina E.E. et al. Selecting anticoagulant therapy in patients with cirrhosis. Russian Medical Inquiry. 2022;6(5):286–292 (in Russ.). DOI: 10.32364/2587-6821-2022-6-5-286-292.

Pancreatic intraductal papillary mucinous neoplasms: Current diagnosis and management.

Intraductal papillary mucinous neoplasms (IPMNs) represent approximately 1% of all pancreatic neoplasms and 25% of cystic neoplasms. They are divided into three types: main duct-IPMN (MD-IPPMN), branch duct-IPMN (BD-IPMN), and mixed type-IPMN. In this review, diagnostics, including clinical presentation and radiological investigations, were described. Magnetic resonance imaging is the most useful for most IPMNs. Management depends on the type and radiological features of IPMNs. Surgery is recommended for MD-IPMN. For BD-IPMN, management involves surgery or surveillance depending on the tumor size, cyst growth rate, solid components, main duct dilatation, high-grade dysplasia in cytology, the presence of symptoms (jaundice, new-onset diabetes, pancreatitis), and CA 19.9 serum level. The patient’s age and comorbidities should also be taken into consideration. Currently, there are different guidelines regarding the diagnosis and management of IPMNs. In this review, the following guidelines were presented: Sendai International Association of Pancreatology guidelines (2006), American Gastroenterological Association guidelines, revised international consensus Fukuoka guidelines (2012), revised international consensus Fukuoka guidelines (2017), and European evidence-based guidelines according to the European Study Group on Cystic Tumours of the Pancreas (2018). The Verona Evidence-Based Meeting 2020 was also presented and discussed.

American Gastroenterological Association Institute and College of American Pathologists Quality Measure Development for Detection of Mismatch Repair Deficiency and Lynch Syndrome Management

This document presents the official recommendations of the American Gastroenterological Association (AGA) and the College of American Pathologists (CAP) regarding quality measures and quality payment measures related to the diagnosis and management of Lynch syndrome (LS).1Rubenstein J.H. Enns R. Heidelbaugh J. et al.American Gastroenterological Association Institute guideline on the diagnosis and management of Lynch syndrome.Gastroenterology. 2015; 149: 777-782Abstract Full Text Full Text PDF PubMed Scopus (116) Google Scholar The current report outlines the process by which the Quality Committee (QC) evaluates guidance statements published by the AGA’s Clinical Guidelines Committee (CGC) and the CAP’s Pathology and Laboratory Quality Center for Evidence-Based Guidelines to inform quality measure development, including for submission in a quality payment program (QPP) such as the Centers for Medicare & Medicaid Services (CMS) Merit-Based Incentive Payment System.2Bocsi G.T. Kang J. Kennedy A. et al.Developing pathology measures for the Quality Payment Program—Part I: a quest for meaningful measures.Arch Pathol Lab Med. 2020; 144: 686-696Crossref PubMed Scopus (2) Google Scholar The following recommendations were developed by the QC in consultation with the CGC as well as the CAP Measure and Performance Assessment Subcommittee through a measure harmonization process. Their development was funded by the AGA Institute with no additional outside funding. As the most common hereditary colorectal cancer (CRC) syndrome, LS accounts for up to 3%–5% of all CRCs and also raises the risk of numerous other malignancies such as gastric, small intestinal, pancreaticobiliary, endometrial, ovarian, genitourinary (kidney, renal pelvis, ureter, bladder, and prostate), and brain cancers, as well as sebaceous neoplasms of the skin.3Yurgelun M.B. Hampel H. Recent advances in Lynch syndrome: diagnosis, treatment, and cancer prevention.Am Soc Clin Oncol Educ Book. 2018; 38: 101-109Crossref PubMed Scopus (35) Google Scholar,4Duraturo F. Liccardo R. De Rosa M. et al.Genetics, diagnosis and treatment of Lynch syndrome: old lessons and current challenges.Oncol Lett. 2019; 17: 3048-3054PubMed Google Scholar The current prevalence of LS is estimated at 1 in 279.5Win A.K. Jenkins M.A. Dowty J.G. et al.Prevalence and penetrance of major genes and polygenes for colorectal cancer.Cancer Epidemiol Biomarkers Prev. 2017; 26: 404-412Crossref PubMed Scopus (180) Google Scholar Identification of individuals with LS is important because of their own elevated risk of CRCs and extracolonic cancers as well as to identify relatives with an increased risk of earlier-onset cancer compared to the general population. Adherence to regular colonoscopy guidelines for LS has been shown to reduce mortality from CRC.6Järvinen H.J. Aarnio M. Mustonen H. et al.Controlled 15-year trial on screening for colorectal cancer in families with hereditary nonpolyposis colorectal cancer.Gastroenterology. 2000; 118: 829-834Abstract Full Text Full Text PDF PubMed Scopus (1083) Google Scholar Furthermore, a diagnosis of LS can affect surgical and chemotherapeutic management decisions. Indeed, histologic and laboratory screening for LS, through immunohistochemistry (IHC), polymerase chain reaction (PCR), or next-generation sequencing can be accomplished by reflexively testing all resected colon adenocarcinomas and pretreated rectal adenocarcinomas for mismatch repair (MMR) deficiency via universal testing. This approach, when combined with somatic germline testing panels to confirm a diagnosis, has been found to be cost-effective.7Ladabaum U. Wang G. Terdiman J. et al.Strategies to identify the Lynch syndrome among patients with colorectal cancer: a cost-effectiveness analysis.Ann Intern Med. 2011; 155: 69-79Crossref PubMed Scopus (276) Google Scholar Finally, tumor screening for LS in the context of noncolorectal malignancies also leads to improved detection with the associated benefit of long-term risk stratification.8Latham A. Srinivasan P. Kemel Y. et al.Microsatellite instability is associated with the presence of Lynch syndrome pan-cancer.J Clin Oncol. 2019; 37: 286-295Crossref PubMed Scopus (207) Google Scholar,9Adar T. Rodgers L.H. Shannon K.M. et al.Universal screening of both endometrial and colon cancers increases the detection of Lynch syndrome.Cancer. 2018; 124: 3145-3153Crossref PubMed Scopus (50) Google Scholar A universal testing approach has been endorsed by a number of professional organizations, including the AGA, National Comprehensive Cancer Network, US Multi-Society Task Force on Colorectal Cancer, and others.10Giardiello F.M. Allen J.I. Axilbund J.E. et al.Guidelines on genetic evaluation and management of Lynch syndrome: a consensus statement by the US Multi-Society Task Force on colorectal cancer.Gastroenterology. 2014; 147: 502-526Abstract Full Text Full Text PDF PubMed Scopus (283) Google Scholar, 11Bruegl A.S. Ring K.L. Daniels M. et al.Clinical challenges associated with universal screening for Lynch syndrome-associated endometrial cancer.Cancer Prev Res (Phila). 2017; 10: 108-115Crossref PubMed Scopus (33) Google Scholar, 12Salvador M.U. Truelson M.R.F. Mason C. et al.Comprehensive paired tumor/germline testing for Lynch syndrome: bringing resolution to the diagnostic process.J Clin Oncol. 2019; 37: 647-657Crossref PubMed Scopus (20) Google Scholar Acknowledging these best practices, the current commentary focuses on the creation, and opportunities for implementation, of a measure to track the performance of universal testing for LS. The resulting quality measure is distinct from, but based on, guideline recommendations. This accountability measure provides clinicians across specialties, such as gastroenterology and pathology, as well as health systems an opportunity to monitor and report their performance within this important clinical context. It also provides the basis for quality improvement. Moreover, the development process used and described herein creates a framework for future collaborative measure development across disciplines. The AGA published its guidance documents to assist in the diagnosis and management of LS in 2015, and CAP published recommendations for the use of molecular biomarkers for the evaluation of CRC in 2017.1Rubenstein J.H. Enns R. Heidelbaugh J. et al.American Gastroenterological Association Institute guideline on the diagnosis and management of Lynch syndrome.Gastroenterology. 2015; 149: 777-782Abstract Full Text Full Text PDF PubMed Scopus (116) Google Scholar,13Sepulveda A.R. Hamilton S.R. Allegra C.J. et al.Molecular biomarkers for the evaluation of colorectal cancer: guideline from the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology.Arch Pathol Lab Med. 2017; 141: 625-657Crossref PubMed Scopus (40) Google Scholar The aggregate recommendation statements from these documents were evaluated for development as potential quality measures. A standardized process first implemented by the AGA in 2016 and outlined elsewhere was used for measure development.14Adams M.A. Allen J.I. Saini S.D. Translating best practices to meaningful quality measures: from measure conceptualization to implementation.Clin Gastroenterol Hepatol. 2019; 17: 805-808Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar,15Leiman D.A. Maratt J.K. Ketwaroo G.A. et al.AGA Institute quality measure development for the diagnosis and management of COVID-19.Gastroenterology. 2020; 160: 985-992Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar The AGA’s quality measures for acute pancreatitis were developed using the same process.16Mosko J.D. Leiman D.A. Ketwaroo G.A. et al.Development of quality measures for acute pancreatitis: a model for hospital-based measures in gastroenterology.Clin Gastroenterol Hepatol. 2020; 18: 272-275Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar Optimal understanding of this measure evaluation process will be enhanced by reading the applicable portions of the topic guideline. Briefly, the AGA QC follows a guidelines-to-measures protocol that is based on best practices outlined by the American Thoracic Society.17Kahn J.M. Gould M.K. Krishnan J.A. et al.An official American Thoracic Society workshop report: developing performance measures from clinical practice guidelines.Ann Am Thorac Soc. 2014; 11: S186-S195Crossref PubMed Scopus (28) Google Scholar Guideline recommendation statements are evaluated as potential measure concepts along several axes, including the strength of the recommendation and quality of the evidence, as specified using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Only those statements with strong recommendations based on high- or moderate-quality evidence are considered for further measure development, which includes an assessment of their potential utility for practicing gastroenterologists. This level of rigor in development is vital, especially when a recent analysis of a sample of 271 measures within a QPP rated 30 as “not valid,” of which 19 were judged to be insufficiently supported by evidence.18MacLean C.H. Kerr E.A. Qaseem A. Time out—charting a path for improving performance measurement.N Engl J Med. 2018; 378: 1757-1761Crossref PubMed Scopus (81) Google Scholar The assessment also involves QC subcommittee analysis of measure importance, including rating topics on their meaningfulness, potential magnitude of effect, quality gaps, feasibility, and applicability to gastroenterologists. High-priority measure concepts subsequently undergo review and voting by the entire QC ahead of a 30-day public comment period before testing and formal adoption. Finally, measures that receive 60% or more of the full QC vote are recommended for national implementation. By adhering to these standards, trust in the validity and confidence in the utility of quality measures is increased, which is particularly important to reduce the lingering sense that quality measurement is rote rather than intimately aligned with clinicians’ professional duty. The initial LS quality measure was developed in 2017 and stated the following: “testing of all patients with colorectal adenocarcinoma diagnosed by colonoscopy for potential cases of Lynch Syndrome using immunohistochemistry (IHC) or microsatellite instability (MSI) by polymerase chain reaction (PCR).” This was then subject to public comment in 2018. Several themes arose from this feedback, which included questions related to primary measure ownership (“Would caution that any quality measures need to be under the control of the gastroenterologist” and “This is likely a marker more reflective of the quality of a hospital’s surgical pathology department or their oncologist rather than their GI [gastrointestinal]”), measure scope (“Many institutions prefer to do MMR testing on surgically resected CRC specimens so colonoscopic biopsies are not routinely tested” and “Recommend that the metric include testing of biopsy and noncolonic tissue (ie, metastatic tissue) in addition to resected colon tumors”), specificity to identify the appropriate patient population (“Concerned that the CPT [Current Procedural Terminology] codes for IHC will not capture the data you want—these codes are generic, and would include people who have IHC for BRAF, KRAS, etc” and “Differentiate the MMR IHC from other IHCs that may be performed by pathology”), methodology used for testing (“Recommend that the metric include tumor sequencing as a modality for assessment of deficient mismatch repair status” and “Consider measure satisfied if patient has germline genetic testing”), and responsibility of clinical follow-up (“Recommend that the metric explicitly state that follow-up of abnormal universal tumor test results is critical to ensure proper diagnosis of Lynch syndrome” and “Identifying patients at risk for Lynch syndrome is the first step, but that needs to be communicated to the patient and follow-up steps (such as germline testing) should be recommended”). Concurrently, the CAP was developing a related quality measure for Lynch testing applicable to pathologists, which read as follows: “the percentage of all primary or metastatic colorectal carcinoma surgical pathology reports that address the status of biomarker evaluation for mismatch repair (MMR) by immunohistochemistry (biomarkers MLH1, MSH2, MSH6, and PMS2), or microsatellite instability (MSI) by DNA-based testing status, or both.” Based on the opportunity to resolve the issues outlined during the public comment feedback, the AGA and CAP undertook a process of measure harmonization.19Guidance for measure harmonization: a consensus report. National Quality Forum, Washington, DC2010Google Scholar The AGA has previously used the harmonization process to develop quality measures for age-appropriate screening colonoscopy, which are co-owned with the American Society of Gastrointestinal Endoscopists and American College of Gastroenterology. Measure harmonization may improve quality measurement and tracking20Anema A. Fielden S.J. Castleman T. et al.Food security in the context of HIV: towards harmonized definitions and indicators.AIDS Behav. 2014; 18: S476-S489Crossref PubMed Scopus (23) Google Scholar and is appropriate when separate measures are intended to address the same focus (eg, LS screening testing) or target population (eg, patients with CRC).19Guidance for measure harmonization: a consensus report. National Quality Forum, Washington, DC2010Google Scholar The current harmonization process for an LS screening measure began in 2019 and was completed in 2020. The resulting measure and collaborative development addressed the previous concerns outlined during the initial feedback. Namely, there was an invested partner who would co-own and steward the measure (CAP), which included screening on either biopsy or surgical resection specimens; patients were identified by pathology specimen and diagnostic test (not via claims codes); the testing methodology was not prespecified; and the intent of the measure and responsibility of follow-up were more clearly defined to account for “communicating the information for care coordination” in a pathology report. In anticipation of forthcoming CAP guideline recommendations that encompass screening for LS and its implications for guiding checkpoint inhibitor therapy and in consultation with CMS, the scope of the measure was expanded to include extracolonic tumors as well, which is reflected in the measure workflow detailed in Figure 1. The resulting measure subsequently underwent additional alpha, or feasibility, testing. During this process, gastroenterology, pathology, and genetic counseling practices were invited to provide comments via a scorecard regarding the practicality of extracting the necessary information for measure reporting from their existing clinical workflow or data. This encompasses an assessment of whether the data elements needed to report on a measure are regularly collected and how such data are structured to facilitate reporting. A total of 29 practices (14 GI, 4 pathology, 7 genetic counseling, and 4 multispecialty medical center representatives) reported. The average feasibility, as measured by data availability, was 72.9% among gastroenterologists, genetic counselors, and multispecialty medical centers compared to 70.3% for pathologists. These results indicated practices have an average 72.6% overall chance of having the data elements already available in their electronic health record before starting to report on this measure. Identifying individuals with LS is paramount to provide appropriate guidance for cancer screening and surveillance intervals, both for patients and their relatives. An approach using universal screening of tumor specimens is evidence based and supported by multiple society guidelines, including those of the AGA. Recognizing the broad impact of testing for LS beyond CRC and the shared accountability in performing, interpreting, and reporting these results is particularly important for generating a meaningful LS quality measure. Within this context, the QC recommended and developed a harmonized inclusive quality measure with the CAP. This measure expanded the initial recommendation for universal tumor testing of CRCs, based on the strong recommendation and moderate quality of evidence, to include non-CRCs as well. Additional recommendation statements from the AGA Guideline on the Diagnosis and Management of LS were independently evaluated, and an assessment was made, as outlined in Table 1.Table 1Summary of Recommendations and Rationale for Quality Measure Development: Guideline on the Diagnosis and Management of Lynch SyndromeStatementGRADEDecisionRationaleIn patients without a personal history of colorectal or another cancer but with a family history suggestive of Lynch syndrome, the AGA suggests that risk prediction models be offered rather than doing nothing.Conditional recommendation, very low quality of evidenceNo measure concept to developInsufficient quality of evidence and strength of recommendationIn patients without a personal history of colorectal or another cancer but with a family history suggestive of Lynch syndrome, the AGA suggests that risk prediction models be offered rather than proceeding directly with germline genetic testing.Conditional recommendation, very low quality of evidenceNo measure concept to developInsufficient quality of evidence and strength of recommendationThe AGA recommends testing the tumors of all patients with colorectal cancer with either IHC or for microsatellite instability to identify potential cases of Lynch syndrome vs doing no testing for Lynch syndrome.Strong recommendation, moderate quality of evidenceMeasure concept approved for developmentStrength of recommendation and quality of evidence support measure development. Existing quality gaps are recognized. Collaborative and inclusive design widens the impact of the measure.The AGA suggests that in patients with colorectal cancer with IHC absent for MLH1, second-stage tumor testing for a BRAF mutation or for hypermethylation of the MLH1 promoter should be performed rather than proceeding directly to germline genetic testing.Conditional recommendation, very low quality of evidenceNo measure concept to developInsufficient quality of evidence and strength of recommendationThe AGA recommends surveillance colonoscopy (vs doing nothing) in persons with Lynch syndrome.Strong recommendation, moderate quality of evidenceNo measure concept to developLack of demonstrated or suspected quality gapThe AGA suggests that surveillance colonoscopy should be performed every 1 to 2 years vs at less frequent intervals in persons with Lynch syndrome.Conditional recommendation, low quality of evidenceNo measure concept to developInsufficient strength of recommendation and certainty of evidenceThe AGA suggests that aspirin be offered for cancer prevention in patients with Lynch syndrome.Conditional recommendation, low quality of evidenceNo measure concept to developInsufficient strength of recommendation and certainty of evidence Open table in a new tab The most frequently identified limitation for further quality measure concept development was related to insufficient quality of the available evidence and, relatedly, the strength of recommendations. For example, for recommendations regarding the use of risk prediction models to identify patients with LS, the recommendations were weak and based on very low quality of evidence. In other cases, the interval for surveillance colonoscopy and offering of aspirin as a chemopreventive agent were conditional recommendations based on a low quality of evidence. Finally, the recommendation to perform surveillance colonoscopy in persons with LS vs doing nothing, despite a strong recommendation and moderate quality of evidence, was lacking a demonstrated quality gap. Indeed, it is unlikely that clinicians would recommend no CRC surveillance for patients with LS, and the resulting minimal gap would be insufficient for inclusion in future reporting programs. Given the burden of LS as a proportion of CRCs as well as the value of identifying and performing surveillance on affected patients, universal screening of tumors followed by confirmation testing is a widely accepted and cost-effective practice. However, it is not broadly used.21Beamer L.C. Grant M.L. Espenschied C.R. et al.Reflex immunohistochemistry and microsatellite instability testing of colorectal tumors for Lynch syndrome among US cancer programs and follow-up of abnormal results.J Clin Oncol. 2012; 30: 1058-1063Crossref PubMed Scopus (165) Google Scholar,22Hissong E. Crowe E.P. Yantiss R.K. et al.Assessing colorectal cancer mismatch repair status in the modern era: a survey of current practices and re-evaluation of the role of microsatellite instability testing.Mod Pathol. 2018; 31: 1756-1766Crossref PubMed Scopus (19) Google Scholar Studies have shown that preoperative testing of specimens to help guide therapy may be as low as 17%, and among adults with CRC in a national database, only 28% had MMR testing performed.23Karlitz J.J. Hsieh M.C. Liu Y. et al.Population-based Lynch syndrome screening by microsatellite instability in patients ≤50: prevalence, testing determinants, and result availability prior to colon surgery.Am J Gastroenterol. 2015; 110: 948-955Crossref PubMed Scopus (36) Google Scholar,24Shaikh T. Handorf E.A. Meyer J.E. et al.Mismatch repair deficiency testing in patients with colorectal cancer and nonadherence to testing guidelines in young adults.JAMA Oncol. 2018; 4e173580Crossref PubMed Scopus (46) Google Scholar In the context of this demonstrable benefit but observed gap in care, the current quality measure is poised to be useful in tracking health care delivery over time. Importantly, collecting data necessary to report on the developed measure is feasible based on testing conducted during measure development. Although it is expected—and desired—that improvement will occur, the apparent gap helps ensure that the measure will be meaningful going forward. Furthermore, this measure would provide a pathway for reporting on the proportion of patients with CRC who undergo screening for LS at the time of their diagnosis, which is an aim for the US Department of Health and Human Service’s Healthy People 2030 goals, which set data-driven national objectives to improve health and well-being over the next decade. Moreover, the cross-cutting nature of the measure and applicability to multiple clinician types provides additional rationale for development and use. Implicit in the measure is the shared accountability that all members of the health care team have in delivering high-quality care. The harmonization of Lynch testing measures with the CAP is an important collaboration that provides a pathway toward more inclusive measures in the future, which is an opportunity to increase relevance to subspecialists. Previous studies25Noll A. Parekh P.J. Zhou M. et al.Barriers to Lynch syndrome testing and preoperative result availability in early-onset colorectal cancer: a national physician survey study.Clin Transl Gastroenterol. 2018; 9: e185Crossref PubMed Scopus (20) Google Scholar and feedback received during the public comment period suggested that a gastroenterology-only measure would not address the opinion that tumor screening for LS was a responsibility shared by multiple providers. The current measure resolves this tension. In addition, although specialty practices have identified quality reporting through government programs such as the Merit-Based Incentive Payment System as costly and less relevant to their performance than to primary care providers,26Khullar D. Bond A.M. Qian Y. et al.Physician practice leaders’ perceptions of Medicare’s Merit-Based Incentive Payment System (MIPS).J Gen Intern Med. 2021; 36: 3752-3758Crossref PubMed Scopus (2) Google Scholar the inclusion of additional specialty-specific measures may combat this perception. The AGA’s CGC has provided guidance regarding the diagnosis and treatment of patients with LS. Although several recommendations were not proposed for quality measure development, it is acknowledged that with future guideline updates, new data may strengthen the recommendation or increase the quality of evidence on which a best practice statement is generated, and the QC will re-evaluate these recommendations for measure development. The current measure for universal testing, meanwhile, was submitted to CMS for inclusion in the QPP. Preliminary feedback from CMS was favorable; current indications are that the measure will be included in the list of measures under consideration later this year. Regardless of the outcome of this submission, we believe the measure will remain relevant and should be tracked for quality improvement purposes across health systems and could serve to reinforce interdisciplinary collaboration in an environment where balancing and sharing risk will be increasingly relevant. The CAP has existing infrastructure and data registries through which pathologists can report on measures, and future steps may include developing an architecture for gastroenterologists to document measure adherence. It is also acknowledged that tumor screening is a necessary, though not sufficient, first step. Systems are needed to follow up on testing results and perform germline confirmation as well as cascade testing among family members appropriately, which can occur less frequently among some populations.27Muller C. Lee S.M. Barge W. et al.Low referral rate for genetic testing in racially and ethnically diverse patients despite universal colorectal cancer screening.Clin Gastroenterol Hepatol. 2018; 16: 1911-1918Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar However, the importance of including issues of equity and health systems improvement into quality measures are not challenges unique to LS and should be the focus of future improvements. In conclusion, the current best practices, guidelines, and recommendation statements from the AGA represent an important framework for the diagnosis and treatment of patients with LS. The quality of the evidence, strength of recommendations, and lack of known quality gaps currently preclude the development of some statements into quality measures at this time. The QC nonetheless encourages practitioners to adhere to these recommendations when appropriate and feasible and track their impact through active engagement in quality improvement. Overall, the harmonized universal testing quality measure now defined is an opportunity to quantify and improve the care of patients with LS and helps develop a framework for future collaborative measure development. We would like to particularly acknowledge the work of David Godzina and Drs Jennifer Maratt, Miriam Naveed, Ellen Stein, Chioma Anjou, and Won Kyoo Cho, who participated in generating and evaluating this measure while members of the American Gastroenterological Association Quality Committee. Within the College of American Pathologists, we would also like to acknowledge Colleen Skau and Drs Sarah Eakin, Jennifer Laudadio, Jason Kang, Leilani Valdes, and James Kelley as contributing members in the creation and submission of this measure while members of the CAP Measure and Performance Assessment Subcommittee.

Delayed Drainage of Infected Pancreatic Necrosis Is Safe

The current American Gastroenterological Association guidelines recommend strong consideration of catheter drainage of infected necrotic pancreatitis

S877 Views of Patients With Inflammatory Bowel Disease on the Safety of Biologics and Vaccination During the COVID-19 Pandemic

Introduction: The American Gastroenterological Association (AGA) guidelines recommend continuing the use of biologics in those who have not tested positive for COVID-19 and are asymptomatic.1 This study evaluated the views of patients with IBD on biologics and COVID-19 vaccination during the COVID-19 pandemic. Methods: We surveyed 204 participants through Amazon Mechanical Turk that fulfilled the inclusion criteria of: >18 years old, diagnosed with IBD, and on a biologic. The study was approved by the institutional review board. A five-point Likert scale was used to gauge participants’ level of understanding of the risks and benefits of biologics during the pandemic. Participants were also asked what they would do with their biologic if tested positive for COVID-19 and their willingness to accept the COVID-19 vaccine. Descriptive statistics were used to analyze data. Results: Majority of the participants were male (60.1%), under the age of 50 (95.1%), had at least a high school degree/GED (99%), and were insured (90.6%). Participants reported moderate understanding (mean ± SD, 2.8 ± 1.1) of the risks and benefits of biologic use for IBD during the COVID-19 pandemic. A remarkable number of participants, 43.6%, reported stopping their biologic due to fear of contracting COVID-19. Also, the majority of participants would “somewhat” agree to be vaccinated against COVID-19 vaccine if the vaccine is available to them (mean ± SD, 2.0 ± 1.1) and their attitude toward the vaccination did not change even if their gastroenterologists were to recommend the vaccine (Table 1). Conclusion: Despite recommendations from the AGA to continue one’s biologic, a significant number of participants reported either decreasing their dose or stopping their biologic. The participants also reported only a “moderate understanding” of the risks and benefits of using biologics during the pandemic. Most striking, participants' attitude towards receiving a COVID-19 vaccine did not change even if a gastroenterologist were to recommend it. Thus, there is a need to evaluate each patient’s biologic compliance and educate patients on the impact of COVID-19 on their treatment plan at their gastroenterology appointments. Further inquiry at appointments is also needed to understand vaccination hesitancy.Table 1.: Participants’ understanding and views on their biologic use and vaccination during COVID-19 Pandemic.

Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185).

TPS10608 Background: The optimal surveillance strategy for pancreatic cysts, which occur in up to 20% of the adult population, is ill defined. Although risk of malignant degeneration of these cysts is low, pancreatic cancer mortality remains high. Two cyst surveillance guidelines, one proposed by an international consensus group (Fukuoka) and the other by the American Gastroenterological Association (AGA), are accepted standards. Both rely on radiographic and endoscopic ultrasonographic imaging. They differ in indications for, and intervals between, imaging tests, with the Fukuoka guideline advocating more intensive imaging. Clinical guidelines that provide discordant recommendations may undercut the quality and/or value of care, and have implications for societal health care costs. The primary objective of this prospective trial is to compare the clinical effectiveness and associated resource utilization of the Fukuoka and AGA guidelines for pancreatic cyst surveillance. Secondary objectives include a comparison of resource utilization and patient reported outcomes. We are also collecting and banking radiomics data and biospecimens to identify novel methods that might improve cancer risk stratification. Methods: 4606 asymptomatic patients with newly identified pancreatic cysts ≥1cm in diameter are being randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance. The primary endpoint is a composite of any pancreatic cancer without surgery, unresectable pancreatic cancer or cancer &gt; T1a, N0 at surgery, and benign disease at surgery. This sample size will provide 90% power to identify a 30% relative difference in the primary outcome at 5 years between the two study arms. Study duration is 8 years in total, allowing for 2 years of cohort enrollment, 5 years of prospective follow-up, and six months reserved for study initiation and close out. Study participants must be ≥ 50 years and ≤ 75 years with an ECOG Performance Status 0-1 at baseline. Participants must have received a CT or MRI within 6 months of registration that identifies a new ≥1 cm pancreatic cyst. Patients with a prior diagnosis of a pancreatic cyst, pancreatic malignancy or a history of pancreatic resection are not eligible. Additional exclusion criteria include a history of acute or chronic pancreatitis, a family history of pancreatic adenocarcinoma in 1 or more first degree relatives, imaging findings or clinical signs that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct &gt; 10mm, cyst causing obstructive jaundice), a comorbid illness that precludes pancreatic cyst resection, pregnancy or current participation in an established surveillance program. As of February 4, 2021, thirty three (33) participants have been enrolled from two hundred (200) potential sites. Clinical trial information: NCT04239573 .