New-onset atrial fibrillation (AF) is common among acutely hospitalized patients and is associated with increased risks of stroke and mortality. However, anticoagulation in this setting involves a temporal tradeoff between early bleeding during recovery and potential long-term stroke prevention, and data guiding direct oral anticoagulant (DOAC) initiation at discharge remain limited. We conducted a retrospective cohort study of adults with newly diagnosed AF identified between 3 days before hospital admission and hospital discharge within the Baylor Scott & White Health system (July 2020 to June 2024), comparing patients initiated on DOAC therapy at discharge with those who were not. Outcomes included major adverse cardiovascular events (MACE: all-cause death, nonfatal myocardial infarction, or ischemic stroke/transient ischemic attack) and net adverse clinical events (NACE: MACE or major bleeding) at 30 days and 3 years. Cox proportional hazards models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs), and landmark cumulative incidence analyses assessed temporal trends after discharge. Among 16,641 patients (mean age 75.1 years; 41.8% women), 7,181 (43.2%) were discharged on a DOAC. In adjusted analyses, DOAC use was associated with lower risk of 3-year MACE (HR 0.61, 95% CI 0.58 to 0.65, p < 0.001) and NACE (HR 0.64, 95% CI 0.61 to 0.68, p < 0.001) compared with those not receiving DOAC therapy. Landmark analyses showed consistent reductions in MACE at both 30 days (HR 0.61, 95% CI 0.57 to 0.65) and 3 years (HR 0.68, 95% CI 0.62 to 0.74). Patients treated with DOACs had a lower risk of NACE at both 30 days (HR 0.65, 95% CI 0.61 to 0.69) and 3 years (HR 0.67, 95% CI 0.62 to 0.73). Overall, DOAC initiation at discharge in patients with newly diagnosed AF identified between 3 days before hospital admission and hospital discharge was associated with lower early and long-term ischemic risk, with lower rates of both MACE and NACE observed at 30 days and 3 years, underscoring the need for individualized decision-making regarding anticoagulation during acute hospitalization.
BACKGROUND:This retrospective study, conducted using the U.S. National Inpatient Sample (NIS), examines the outcomes and management of nonvariceal upper gastrointestinal bleeding (NVUGIB) in COVID-19 patients and identifies predictive factors to enhance patient prognosis. METHODS:We analyzed the 2020 U.S. NIS data involving adult patients (≥18 years) admitted with NVUGIB and categorized them based on the presence of COVID-19. Primary and secondary outcomes, NVUGIB-related procedures, and predictive factors were evaluated. RESULTS:Of 184,885 adult patients admitted with NVUGIB, 1.6% (2990) had COVID-19. Patients with NVUGIB and COVID-19 showed higher inpatient mortality, acute kidney injury, need for intensive care, and resource utilization metrics. Notably, there was a lower rate of early esophagogastroduodenoscopy (EGD). Multivariate logistic regression revealed conditions like peptic ulcer disease, mechanical ventilation, and alcohol abuse as significant positive predictors for NVUGIB in COVID-19 patients, whereas female gender and smoking were negative predictors. CONCLUSION:Our findings suggest that COVID-19 significantly increases the risk of mortality and complications in NVUGIB patients. The observed decrease in early EGD interventions, potentially contributing to higher mortality rates, calls for a review of treatment strategies. Further multicenter, prospective studies are needed to validate these results and improve patient care strategies.
OBJECTIVE:Alcoholic hepatitis (AH) represents a severe manifestation of alcoholic liver disease (ALD) associated with a wide severity spectrum. ALD is linked to nutritional deficiencies, with the gravity of malnutrition escalating as alcohol abuse and ALD progress. This study aims to delve into the impact of malnutrition on the clinical trajectory of AH. METHODS:We identified adult patients admitted with AH using the National Readmission Database (NRD) 2016-2020. We further classified AH patients based on the severity of malnutrition. We compared the outcomes of AH hospitalizations using a multivariate regression model. RESULTS:We included 82,367 AH patients, of whom 15,693 (19.00%) had malnutrition. 4,243 (5.15%) patients exhibited mild to moderate malnutrition, 5,862 (7.07%) patients had severe malnutrition, and 5,588 (6.78%) patients had unspecified severity of malnutrition. We found that adjusted in-hospital mortality due to AH was higher in patients with malnutrition, corresponding to the severity of malnutrition (adjusted odds ratio [aOR] 1.62 and 3.14 in mild-moderate malnutrition and severe malnutrition, respectively; p < .01). Additionally, patients with malnutrition had progressively elevated odds of septic shock, vasopressor requirement, mechanical ventilation, and intensive care unit (ICU) admission with escalating intensity of malnutrition. Liver-related complications, such as spontaneous bacterial peritonitis, coagulopathy, hepatorenal syndrome, and hepatic encephalopathy, were also found to have an increased likelihood in the presence of malnutrition. Furthermore, resource utilization showed a progressive increase with increasing severity of malnutrition. CONCLUSION:Our findings indicate that malnutrition is a common comorbidity in AH patients, with varying degrees of severity, which correlates with higher mortality rates, emphasizing the critical role of nutritional status in the prognosis of AH. These findings underscore the importance of addressing and managing malnutrition in patients with AH, not only for its potential contribution to mortality but also because of its association with a spectrum of complications and increased healthcare resource utilization.
Introduction: Epidemiological studies using administrative or retrospective data have highlighted racial differences in the susceptibility and progression of pancreatitis. However, limited research has been conducted to investigate the impact of race on the outcome of acute pancreatitis (AP). Methods: Using the 2017-2020 National Inpatient Sample (NIS) database and the International Classification of Diseases, Tenth Revision, Clinical Modifications (ICD-10- CM) codes, we identified adult patients (aged ≥18 years) who were admitted with a principal diagnosis of AP. Using Whites as the reference category, we compared the outcomes of AP in African Americans, Hispanics, and Asians. Multivariate logistic regression models were used to compare the different races. Results: We reviewed 219,835 admissions for AP. After adjusting for confounding variables, we found that African Americans had the lowest mortality rates (aOR 0.76, P< 0.01) when compared to Whites (Table 1). Additionally, African Americans had the lowest odds of septic shock (aOR 0.53, P< 0.01), acute respiratory distress syndrome (ARDS) (aOR 0.64, P< 0.01), need for mechanical ventilation (aOR 0.53, P< 0.01), and intensive care unit (ICU) admission (aOR 0.54, P< 0.01) compared to White patients. Furthermore, African Americans had shorter lengths of hospital stay (adjusted mean difference [aMD] 0.54, P< 0.01) and incurred lower average hospitalization charges (aMD -$6,844, P< 0.01) than Whites. In contrast, the Hispanic population demonstrated the lowest odds of developing acute kidney injury (AKI) (aOR 0.93, P< 0.01), portal venous thrombosis (aOR 0.51, P< 0.01), and the need for pancreatic necrosectomy (aOR 0.67, P< 0.01). Conclusion: Our study found notable racial disparities in the outcomes of AP. African Americans demonstrated lower mortality rates, lower odds of critical complications, shorter hospital stays, and lower hospitalization charges than Caucasians. These findings warrant further investigation of racial differences to achieve equitable healthcare outcomes. Table 1. - Unadjusted and adjusted outcomes of acute pancreatitis among different racial groups Acute pancreatitis +Age >=18: (n= 219,835) Outcomes Race White (62.3%) African American (16.7%) Hispanic (12.8%) Asian (2.1%) *aOR (95% CI) P-value *aOR (95% CI) P-value *aOR (95% CI) P-value *aOR (95% CI) P-value Mortality, % Reference 0.76 (0.64 – 0.91) < 0.01 0.86 (0.72 – 1.04) 0.13 0.88 (0.61 – 1.27) 0.50 Septic shock, % Reference 0.53 (0.42 – 0.65) < 0.01 0.90 (0.73 – 1.10) 0.31 1.15 (0.78 – 1.70) 0.49 Paralytic ileus, % Reference 0.75 (0.56 – 0.99) 0.05 0.77 (0.57 – 1.06) 0.11 0.89 (0.46 – 1.73) 0.74 AKI, % Reference 1.28 (1.24 – 1.34) < 0.01 0.93 (0.89 – 0.98) 0.01 1.08 (0.98 – 1.19) 0.11 Portal venous thrombosis, % Reference 0.57 (0.50 – 0.65) < 0.01 0.51 (0.44 – 0.60) < 0.01 0.68 (0.50 – 0.92) 0.01 ARDS, % Reference 0.64 (0.46 – 0.89) 0.01 1.08 (0.79 – 1.49) 0.62 1.73 (0.96 – 3.12) 0.07 Mechanical ventilation, % Reference 0.53 (0.47 – 0.60) < 0.01 0.76 (0.67 – 0.87) < 0.01 1.03 (0.80 – 1.33) 0.81 Requiring ICU admission, % Reference 0.54 (0.48 – 0.61) < 0.01 0.77 (0.68 – 0.87) < 0.01 1.05 (0.83 – 1.34) 0.68 Pancreatic necrosectomy, % Reference 0.68 (0.57 – 0.82) < 0.01 0.67 (0.54 – 0.82) < 0.01 1.03 (0.76 – 1.42) 0.84 *Adjusted Mean Difference (95% CI) Length of hospital stay, days Reference -0.54 (-0.60 – 0.48) < 0.01 -0.23 (-0.30 – -0.18) < 0.01 0.12 (-0.07 – 0.30) 0.21 Total hospitalization charges, mean, USD Reference -6,844 (-7,780 – -5,907) < 0.01 10,512 (9,109 – 11,914) < 0.01 13,260 (9,810 – 16,711) < 0.01 *Adjusted for age, insurance status, sex, Charlson index, hospital bed size, hospital location, teaching status, ESRD, alcohol abuse, and obesity. CI means confidence interval. ARDS, Acute respiratory distress syndrome; AKI, Acute kidney injury; ICU, Intensive care unit; ESRD, End-stage renal disease.
Introduction: Since the outbreak of the COVID-19 pandemic, there has been limited data regarding the association between COVID-19 and Nonvariceal Upper Gastrointestinal Bleeding (NVUGIB). Some studies showed an association between COVID-19 and esophageal injury, while others speculated that NVUGIB may be in the setting of concomitant use of anticoagulants or severe infection. Our objective was to investigate the impact of COVID infection on mortality and other outcomes of NVUGIB. Methods: Using the 2020 National Inpatient Sample (NIS) database and International Classification of Diseases, Tenth Revision, Clinical Modifications (ICD-10- CM) codes, we identified adult patients (aged ≥18 years) admitted with NVUGIB. The patients were further divided into two groups based on the presence or absence of COVID-19 on admission. Multivariate regression models were used to compare the outcomes between the two groups. Outcomes were adjusted for confounding variables and the severity of COVID-19 infection (i.e., sepsis and acute respiratory distress syndrome). STATA 14.2 was utilized for statistical analysis. Results: A total of 36,977 adult patients with NVUGIB were admitted, of whom 598 (16.17%) were COVID-positive. Analysis showed that NVUGIB patients who were COVID-positive had increased odds of mortality compared to patients without COVID (adjusted odds ratio [aOR] 3.64, P< 0.01) (Table 1). NVUGIB patients with COVID-19 also had higher odds of developing acute kidney injury (AKI) (aOR 1.56, P< 0.01), requiring vasopressors (aOR 1.93, P< 0.01), and intensive care unit (ICU) admission (aOR 3.08, P< 0.01). Other interesting observations included significantly reduced diagnostic esophagogastroduodenoscopy (EGD) (aOR 0.28, P< 0.01) and repeat EGDs (aOR 0.67, P = 0.01) during the same hospitalization in the COVID arm. NVUGIB patients with COVID-19 also had a longer length of hospital stay and much higher total hospitalization cost. Conclusion: Our study identifies COVID-19 as an independent predictor of mortality and morbidity in patients with NVUGIB. It places the NVUGIB patient population at a higher risk of mortality, AKI, and ICU admission. Since EGD within 24 hours of admission in patients with NVUGIB is associated with lower in-hospital mortality as compared to delayed or no EGD, the significant reduction in early endoscopy in our COVID NVUGIB patient sample may be causally associated with their observed increased mortality. Prospective, multicenter studies are warranted to validate these findings. Table 1. - Unadjusted and Adjusted Outcomes of NVUGIB in Patients With and Without COVID-19 NVUGIB + age >18 y = 36,977 Outcomes With COVID (n=598) Without COVID (n=36,379) *Adjusted OR (95% CI) P-value Mortality, % 28.98 6.86 3.64 (2.81- 4.71) < 0.01 Total parenteral nutrition, % 2.34 1.62 1.08 (0.58-1.99) 0.81 Acute kidney Injury, % 57.02 39.42 1.56 (1.26-1.91) < 0.01 Blood transfusion, % 34.62 32.76 0.93 (0.76 - 1.14) 0.47 Vasopressor requirement, % 11.54 3.74 1.93 (1.33- 2.80) < 0.01 Requiring ICU admission, % 43.14 14.85 3.08 (2.43- 3.90) < 0.01 Diagnostic EGD without intervention, % 33.28 64.65 0.28 (0.23 - 0.33) < 0.01 EGD with intervention, % 23.75 23.95 1.00 (0.82 - 1.23) 0.99 Any EGD, % 49.83 78.55 0.27 (0.23 - 0.33) < 0.01 EGD within 24 hours of admission, % 8.19 34.26 0.18 (0.13 - 0.25) < 0.01 Repeat EGD during the hospitalization, % 24.50 33.00 0.67 (0.51 - 0.89) 0.01 Radiography-guided embolization, % 0.84 0.84 0.89 (0.33 - 2.42) 0.82 Adjusted Mean Difference Mean Length of hospital stay, days (95% CI) 20.53 (18.91- 22.15) 9.52 (9.32- 9.72) 6.50 (4.82- 8.19) < 0.01 Total Hospitalization Charges, mean, USD 329,716 (278,991-380,442) 144,978 (138,792-151,164) 77,511 (28,651-126,371) < 0.01 *Adjusted for sex, age, hospital bed size, Charlson index, hospital location, hospital teaching status, hospital region, Median household income in the patient’s zip code, race, SIRS or severe sepsis, ARDS, anticoagulation, use of antiplatelets, coronary artery disease, end-stage renal disease, cirrhosis, obesity, and congestive heart failure. CI means confidence interval.Abbreviations: NVUGIB: nonvariceal Upper GI Bleed, COVID: Coronavirus Disease, ICU: Intensive care unit; EGD: esophagogastroduodenoscopy; SIRS: Systemic inflammatory response syndrome, ARDS: Acute Respiratory Distress Syndrome.
Improving diversity in the biomedical workforce in the United States has been a long-standing goal.1Nickens H.W. Ready T.P. Petersdorf R.G. Project 3000 by 2000. Racial and ethnic diversity in U.S. medical schools.N Engl J Med. 1994; 331: 472-476Crossref PubMed Scopus (125) Google Scholar, 2Steinbrook R. Diversity in medicine.N Engl J Med. 1996; 334: 1327-1328Crossref PubMed Scopus (25) Google Scholar, 3Komaromy M. Grumbach K. Drake M. et al.The role of black and Hispanic physicians in providing health care for underserved populations.N Engl J Med. 1996; 334: 1305-1310Crossref PubMed Scopus (653) Google Scholar While efforts have been made, the needle has not moved toward this goal regardless whether this pertains to trainees, practicing physicians in gastroenterology (GI), or across all medical specialties.4Merchant J.L. Omary M.B. Underrepresentation of underrepresented minorities in academic medicine: the need to enhance the pipeline and the pipe.Gastroenterology. 2010; 138: 19-26Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar, 5Diversity in Medicine: Facts and Figures 2019. Association of American Medical Colleges.https://www.aamc.org/data-reports/workforce/report/diversity-medicine-facts-and-figures-2019Google Scholar, 6Carr R.M. Quezada S. Gangarosa L.M. et al.From intention to action: Operationalizing AGA diversity policy to combat racism and health disparities in gastroenterology.Gastroenterology. 2020; 159: 1637-1647Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar Benefits of growing and maintaining a culture that embraces, promotes, and actively pursues diversity, equity, and inclusion (DEI) have many positives for academic health centers, community practices, population and individual health, research, and innovation advancement to grow and sustain our biomedical research and healthcare workforce. Within academic medicine, diversity is recognized as key to excellence. As articulated by Dr David Acosta, “practicing conscious inclusion and equity-mindedness to achieve inclusion excellence — an environment where diversity is a strategic imperative, inclusivity is intentional, and exclusionary practices have been identified, critically deconstructed, and eliminated — will enable the bonuses of diversity to be revealed, actualized, and leveraged.”7Acosta D. Achieving excellence through equity, diversity, and inclusion.Association of American Medical Colleges. January 14, 2020; https://www.aamc.org/news-insights/achieving-excellence-through-equity-diversity-and-inclusionGoogle Scholar Among the many benefits are enhanced engagement and morale, increased productivity and job satisfaction, and increased trustworthiness and community responsiveness.7Acosta D. Achieving excellence through equity, diversity, and inclusion.Association of American Medical Colleges. January 14, 2020; https://www.aamc.org/news-insights/achieving-excellence-through-equity-diversity-and-inclusionGoogle Scholar A diverse faculty has a tremendous multiplier effect, including the ability to recruit diverse learners who view those faculty as mentors and role models. Underrepresented minority (URM) individuals, as defined by the National Institutes of Health and the National Science Foundation, are those whose racial or ethnic makeup is from 1 of the following groups: African American/Black, Hispanic/Latinx, Native American/Alaskan Native, or Native Hawaiian/Other Pacific Islander. Diversity provides tremendous benefit to patient care, particularly in underserved communities, when those who provide care are themselves diverse.8Saha S. Komaromy M. Koepsell T.D. et al.Patient-physician racial concordance and the perceived quality and use of health care.Arch Intern Med. 1999; 159: 997-1004Crossref PubMed Scopus (688) Google Scholar,9Takeshita J. Wang S. Loren A.W. et al.Association of racial/ethnic and gender concordance between patients and physicians with patient experience ratings.JAMA Netw Open. 2020; 3e2024583Crossref PubMed Scopus (148) Google Scholar A tangible aspect is better patient care, in part, because of improved compliance and trust by patients. There is also the impact of cultural competence10Blewett L.A. Hardeman R.R. Hest R. et al.Patient perspectives on the cultural competence of US health care professionals.JAMA Netw Open. 2019; 2e1916105Crossref PubMed Scopus (9) Google Scholar that contributes toward better patient-provider communication and trust. Importantly, the number of URM physicians who elect to practice in underserved communities is proportionately higher than other physicians.3Komaromy M. Grumbach K. Drake M. et al.The role of black and Hispanic physicians in providing health care for underserved populations.N Engl J Med. 1996; 334: 1305-1310Crossref PubMed Scopus (653) Google Scholar GI has had challenges in recruiting women and URMs. As of 2010, only 3.2% of GI fellows were African American, and 8.5% were Hispanic (Figure 1). For women, only 16% of GI fellows are women, despite 47% of U.S. medical students being women. By comparison, in the general U.S. population the racial, ethnic, and general comparisons are African-American (13%), Hispanic (11%), and women (51%).11U.S. Census BureauQuick Facts.July 1, 2021https://www.census.gov/quickfacts/fact/table/US/RHI725220#RHI725220Google Scholar Presently, there are 202 accredited GI fellowship programs with approximately 1735 GI fellows.12Brotherton S.E. Etzel S.I. Graduate medical education, 2019-2020.JAMA. 2020; 324: 1230-1250Crossref PubMed Scopus (41) Google Scholar Several interventions have been implemented to increase diversity within GI.13Carethers J.M. Quezada S. Carr R.M. et al.Diversity within US gastroenterology physician practices: the pipeline, cultural competencies, and gastroenterology societies approaches.Gastroenterology. 2019; 156: 829-833Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar,14Day L. Gonzalez S. Ladd A.M. et al.ASGE Membership and Diversity CommitteeDiversity in gastroenterology in the United States: where are we now? Where should we go?.Gastrointest Endosc. 2016; 83: 679-683Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar However, over the last decade we have not had much success is increasing the number of URM and female applicants to GI training programs (Figure 2).15American Association of Medical CollegesERAS statistics.https://www.aamc.org/data-reports/interactive-data/eras-statistics-dataGoogle Scholar The percentage of URM internal medicine (IM) residents applying to GI has been around 12.0% for the last 8 years, with a decline noted from 2015 to 2018 that has since improved (Figure 2).16Brotherton S.E. Etzel S.I. Graduate medical education, 2016-2017.JAMA. 2017; 318: 2368-2387Crossref PubMed Scopus (43) Google Scholar Alarmingly, profound declines have occurred among American Indian/Alaska Native and Native Hawaiian/Pacific Islander residents applying to GI fellowships (–37.5% and –25.0% annual change in applications, respectively) with only modest increases noted for African American/Black and Latinx applicants. With women, minimal changes noted in this number over the last decade (Figure 2).16Brotherton S.E. Etzel S.I. Graduate medical education, 2016-2017.JAMA. 2017; 318: 2368-2387Crossref PubMed Scopus (43) Google Scholar How do U.S. GI fellowship programs compare with other IM subspecialties and medical residencies as it relates to diversity? GI, in addition to pulmonary and critical care and hematology and oncology, are the only IM fellowships with a proportion of URMs under 10% (Figure 3A), and only 6 medical residencies (among 16) had a similar or lower proportion of URM residents when compared with GI (Figure 3B).17Santhosh L. Babik J.M. Trends in racial and ethnic diversity in internal medicine subspecialty fellowships from 2006 to 2018.JAMA Netw Open. 2020; 3e192048Crossref PubMed Scopus (39) Google Scholar Clearly, U.S. GI fellowship programs do not reflect either the U.S. racial-ethnic or gender diversity. Low numbers of URMs and women apply to and matriculate into GI fellowship programs, with little changes to these trends over the last decade.6Carr R.M. Quezada S. Gangarosa L.M. et al.From intention to action: Operationalizing AGA diversity policy to combat racism and health disparities in gastroenterology.Gastroenterology. 2020; 159: 1637-1647Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar Over the past decade, the American Gastroenterological Association (AGA) has begun to tackle lack of diversity in GI through prior programs that have reached a total of 2609 URM individuals at the medical student, GI fellow, and early career faculty levels. These programs established our ability to recruit individuals from URM backgrounds. In November 2017, the AGA both conducted online surveys and held interactive discussion focus groups of 20 early career URM gastroenterologists, hepatologists, pediatric gastroenterologists, and GI fellows. Surveys were designed to identify obstacles that dissuade or impede development of early career URM gastroenterologists and hepatologists. While many of the answers would be common to any physician interested in pursuing research (time, mentoring, departmental support), we also identified 7 areas in which URM GI fellows and early career gastroenterologists particularly struggle (Table 1).Table 1Academic Development Areas in Which URMs Struggle1. Lack of knowledge about how to become an investigator2. Lack of exposure to role models (ie, inspiration)3. Lack of mentorship4. Lack of sponsorship from mentors5. Lack of visibility within both the AGA and their institution for general leadership opportunities, not just leadership opportunities in the URM space6. Lack of programs within their home institution for leadership training7. Lack of support for pursuit of a career and personal identity as a physician-scientistData are derived from the AGA survey of URM GI fellows and early career gastroenterologists (5 years for fewer since completion of gastroenterology training).AGA, American Gastroenterological Association; URM, underrepresented minority. Open table in a new tab Data are derived from the AGA survey of URM GI fellows and early career gastroenterologists (5 years for fewer since completion of gastroenterology training). AGA, American Gastroenterological Association; URM, underrepresented minority. Three main themes emerged from these factors and were a lack of (1) research fundamentals, (2) leadership training, and (3) mentoring. Based on these lessons learned, AGA proposed a professional development program, through a competitive R-25 grant received from National Institute of Diabetes and Digestive and Kidney Diseases for early career gastroenterologists and GI trainees called the AGA FORWARD (Fostering Opportunities Resulting in Workforce and Research Diversity) Program that incorporates specific strategies to lower barriers and improve likelihood that URM physicians will pursue careers in biomedical investigation.18Anyane-Yeboa A. Balzora S. Gray 2nd, D.M. Improving diversity and inclusion in GI.Am J Gastroenterol. 2020; 115: 1147-1149Crossref PubMed Scopus (15) Google Scholar The AGA FORWARD program, through hands-on work with mentors and external coaches, trains URM physician-scientists with new skills and connections to successfully pursue research careers in GI. AGA FORWARD scholars develop skills in research and proposal development, planning for personnel, publications, and the timing of grant submissions. The AGA believes that this approach to integrating skills will provide a solid foundation for success. Other GI societies have also implemented programs to increase diversity in GI, including the American College of Gastroenterology’s “Prescription for Success” and #DiversityinGI social media campaign, the American Society for Gastrointestinal Endoscopy’s 5-year DEI Action Plan and the American Association for the Study of Liver Diseases’ global speaker database to guide nominations for committee assignments, speakers, and moderators for their programs. At the trainee level, the vast majority of programs recruit fellows through a national fellowship match progress. This time-tested process lends itself to the natural selection of candidates across a wide spectrum of backgrounds, experiences, and sexes. However, URMs represent only 9% of GI fellows in the United States.19Jackson C.L. Food for thought: opportunities to improve diversity, inclusion, representation, and participation in epidemiology.Am J Epidemiol. 2020; 189: 1016-1022Crossref PubMed Scopus (6) Google Scholar A structured trainee selection process would benefit from a keen eye toward attempting to balance race and sex when contemplating merit and other considerations. GI fellowship programs should consider URMs for leadership positions and members selection committees. Implicit bias training may help identify and address biases and lead to a more open-minded evaluation. A diverse fellowship program will ultimately improve faculty diversity through retention. In order for academic GI to be successful at creating a diverse environment, divisional leaders must make DEI initiatives a priority. Alignment with institutional goals is critical. A dedicated leadership position to focus on these initiatives, regular cultural humility and implicit bias training, collaboration with local agencies, and an infrastructure built to support and encourage research and mentorship of URMs is imperative for moving the needle in this realm (Figure 4). Conscious bias is relatively easy to identify and confront. However, unconscious bias is more insidious and probably more harmful, as the individuals delivering bias are often unaware.20Lewis D. Paulsen E. Proceedings of the Diversity and Inclusion Innovation Forum: Unconscious Bias in Academic Medicine. How the Prejudices We Don’t Know We Have Affect Medical Education, Medical Careers, and Patient Health. Association of American Medical Colleges, Washington, DC2017Google Scholar For example, women and African Americans may be labeled aggressive for the same behaviors that are called assertive in a White man. Therefore, before embarking on changing the recruitment process, some program evaluation is in order. Fellow selection is a process of balancing a candidate’s cognitive and noncognitive skills. Cognitive skills that are easily measured by grades, board scores, and papers written, tend to dominate. Noncognitive skills like interpersonal communication, maturity, commitment, dependability, and honesty are often assessed during the interview and may be biased by cognitive achievements, the so-called halo effect. Exam scores and research productivity are frequently used to determine whom to interview.21Hartman N.D. Lefebvre C.W. Manthey D.E. A narrative review of the evidence supporting factors used by residency program directors to select applicants for interviews.J Grad Med Educ. 2019; 11: 268-273Crossref PubMed Scopus (32) Google Scholar, 22Crowley A.L. Damp J. Sulistio M.S. et al.Perceptions on diversity in cardiology: a survey of cardiology fellowship training program directors.J Am Heart Assoc. 2020; 9e017196Crossref PubMed Scopus (14) Google Scholar, 23Lam C.C. Zimmern A. Colon and rectal surgery residency selection criteria: a National Program Director Survey.J Surg Educ. 2021; 78: 519-524Crossref PubMed Scopus (5) Google Scholar, 24Bonifacino E. Ufomata E.O. Farkas A.H. et al.Mentorship of underrepresented physicians and trainees in academic medicine: a systematic review.J Gen Intern Med. 2021; 36: 1023-1034Crossref PubMed Scopus (33) Google Scholar Yet, there is no firm evidence regarding what predicts success in advanced trainees. Speaking to the candidates’ referees to confirm areas of uncertainty is a good strategy. Interview bias may be decreased by blinding interviewers to a candidate's scores and letters; structuring the interview by asking everyone the same questions and scoring answers consistently; using questions that have no right or wrong answer but include a hypothetical that tests judgment, ethics, or team play21Hartman N.D. Lefebvre C.W. Manthey D.E. A narrative review of the evidence supporting factors used by residency program directors to select applicants for interviews.J Grad Med Educ. 2019; 11: 268-273Crossref PubMed Scopus (32) Google Scholar; having multiple interviewers, and requiring all interviewers to have implicit bias training. Reach out to colleagues at other institutions who are women or URMs and who may know of promising candidates. Develop relationships with programs that traditionally train more URM and female residents. Affiliate with Historically Black Colleges and Universities medical schools. For example, Veterans Affairs and Municipal hospital systems like Cook County, Chicago; Health + Hospitals system, New York; and Miami-Dade County also train larger numbers of URMs. Residents from these programs are often hardworking multitaskers who have mastered systems creativity in resource poor settings. The absence of faculty members who are women or persons of color can make your program seem uninviting. Talented candidates will not want to be pioneers navigating that system alone. They will need and want a cultural mentor whom they can trust. Well-organized and institutionally supported mentorship programs increase candidate satisfaction and aid in retention and recruitment.25Farkas A.H. Bonifacino E. Turner R. et al.Mentorship of women in academic medicine: a systematic review.J Gen Intern Med. 2019; 34: 1322-1329Crossref PubMed Scopus (92) Google Scholar While you may not be a cultural mentor, you can be an effective skills mentor. Grant writing, manuscript preparation, CV formatting, interview skills, and contract negotiation to name a few areas in which formal mentorship relationships can be made and built upon. In the private sector, a good recommendation is to take an actual picture of your organization to see who is literally seated at the table and to decide who you would like to be there (https://biasinterrupters.org). Invest in formal anti-bias training resources26D’Angelo R. White Fragility: Why It’s So Hard for White People to Talk About Racism. Penguin Random House, New York2018Google Scholar and embark on individual study to understand the history of bias in America and in medicine.27Washington H.A. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present. Doubleday, New York, NY2006Google Scholar,28Stephenson-Famy A. Houmard B.S. Oberoi S. et al.Use of the interview in resident candidate selection: a review of the literature.J Grad Med Educ. 2015; 7: 539-548Crossref PubMed Scopus (94) Google Scholar We recommend a multipronged approach to diversification of the recruitment pool at multiple levels: in premedical education, medical school, residency, GI fellowships, and early GI careers: •Career development opportunities such as the AGA FORWARD Program. •Take a balanced unbiased approach to assessing cognitive and noncognitive candidate skills.•Implicit bias training for program directors, search committees, and selection committee members.•GI fellowship training program self-assessment on communities served; fellows’ opportunities for engaging community; curricular elements designed to enhance cultural humility and linguistic competence and amplify understanding of racism as a public health crisis, and social determinants of health. •Mitigate bias in job announcements by removing gendered language in job postings.•Competitive recruitment packages—assess for implicit bias in how these are offered.•Insertion of explicit statements that raise awareness of how the institution values DEI beyond an Equal Opportunity Employer statement.•Diverse search committee structure.•Well-organized mentorship program.•National Institutes of Health funding opportunities (eg, diversity supplements to existing supplements, Office of Minority Health).•Diversification of faculty and leadership positions.•Engage clinical faculty with faculty in research and academic endeavors. •Actively look for qualified candidates in programs who have historically trained women and URMs in large numbers.•Diversification of content in our journals in social media (journals, conferences, social media, listservs).•Post career opportunities in nontraditional sources (eg, social media and listservs). By employing these recommendations to improve diversity in digestive diseases, we will ultimately improve care for our patients. Espousing diversity in healthcare can lead to cultural humility and agility as well as the ability of providers to offer services that meet their patients’ unique social, cultural, and linguistic needs. The better our patients are represented and understood, the better they can be treated. Health equity is achievable through these proactive, short-term and long-term measures. As Owen Seymour Arthur (former prime minister of Barbados) is quoted, “For he who has health, has hope; and he who has hope, has everything” (https://www.quotetab.com/quotes/by-owen-arthur).
The American Gastroenterological Association (AGA) maintains a strong history of creating and sustaining impactful programming to support diversity and inclusion for physicians and scientists in gastroenterology (GI) and hepatology. After the inception of its Diversity Committee in 1993 (formerly the Underrepresented Minority Committee), AGA expanded its commitment to diversity, equity, inclusion, and justice in 2020 with the Equity Project. This 3-year equity strategic plan more concretely and systematically operationalizes the organization's diversity policy throughout the organization, identifying opportunities for greater impact by means of leveraging all levels and stakeholders in the society to be invested in the success of the project, extending beyond the scope of the Diversity Committee alone.1Carr R.M. Quezada S.M. Gangarosa L.M. et al.From intention to action: operationalizing AGA diversity policy to combat racism and health disparities in gastroenterology.Gastroenterology. 2020; 159: 1637-1647Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar The AGA Equity Project's vision to achieve equity and eradicate health disparities in digestive diseases outlines an implementation plan across the following 6 domain areas, with desired future states (Figure 1): (1) Justice, Equity, and Education, with a just world free of health disparities in digestive diseases and free of inequities in access and effective health care delivery; (2) Research and Funding, with state-of-the-art and well-funded research that aligns with the realities of the current multicultural patient population and disease states; (3) Workforce and Leadership, with a world where it is expected and normal that both members and society leadership structures are diverse, and people of color and women are included in organizational decision making; (4) Recognition, with increased visibility and awareness of accomplishments of diverse leaders; (5) Bias, with an engaged AGA membership and staff educated about unconscious bias and committed to the eradication of racism and prejudice toward patients, colleagues, and communities; and (6) Engaged Next Generation, with a diverse, culturally and socially aware, large, and vocal early career membership that leads the field toward achieving this vision. This vision and plan were developed collaboratively, with important input from AGA staff, by a diverse group of members who now serve as the Equity Project Advisory Board, with representation from clinical and basic sciences, private and academic practice, and physicians and advanced practice providers, all with expertise in various digestive disease processes. Approved by the AGA Governing Board in summer 2020, the Equity Project was effectively backed with tangible resources that catalyzed mobilization of its collective vision and plan. Now in its third and final implementation year, the Equity Project has yielded meaningful results while continuing to drive the organization forward toward achieving its goal of equity and eradicating GI health disparities. This commentary provides a status update on the AGA Equity Project's objectives and identifies future directions for the organization to sustain momentum beyond the 3-year plan as a national leader in equity, diversity, and inclusion in GI and medicine at large. Reinvigorated national discourse on social determinants of health and their driving impact on disparate health care outcomes, in conjunction with broader recognition of systemic social barriers perpetuated by policy, have inspired even more robust participation in advocacy efforts among AGA members. In September 2022, an all-time high of 91 AGA members participated in "Advocacy Day," with a specific increase in representation of women and people of color advocating for policies that impact gastrointestinal health and increase access to gastrointestinal care for our nation's diverse patient populations. Overall, there have been 4 specific congressional briefings on DEI topics since summer 2020. This increase in congressional briefings produced a major policy victory in 2022, eliminating financial barriers to colorectal cancer screening by requiring private insurers and Medicare to cover the full screening continuum, which is critical to achieving health equity in colorectal cancer.2Huge wins for patients: CRC coverage continuum is complete. American Gastroenterological Association.https://gastro.org/news/huge-win-for-patients-crc-screening-coverage-continuum-is-complete/Google Scholar Preventive care is being challenged again, and AGA signed a joint statement led by the American Medical Association alongside 61 medical associations and societies to continue to advocate for preventive care access for all.3Physicians sound alarm on lawsuit threatening preventive care. American Medical Association.https://www.ama-assn.org/press-center/press-releases/physicians-sound-alarm-lawsuit-threatening-preventive-careGoogle Scholar In concert with its growing advocacy work, AGA amplified its efforts to enhance provider awareness of health inequities and tools to address these challenges through educational platforms, such as existing career development workshops and Digestive Disease Week (DDW) sessions, as well as via new platforms, such as the "Small Talk, Big Topics" podcast, which targets the GI trainee and early career community.4Small Talk Big Topics – An AGA Podcast. American Gastroenterological Association.https://gastro.org/fellows-and-early-career/small-talk-big-topics-podcast/Google Scholar In its first season, 16 episodes of "Small Talk, Big Topics" focused on topics most relevant to early career and future gastroenterologists, including building resilience, women in GI innovation, and GI health disparities. While amplifying provider education, AGA also invested additional resources to update and enhance patient education material, incorporating language diversity and a lens of cultural humility in its content.5Welcome to the AGA Patient Center.https://patient.gastro.org/Google Scholar A deeper understanding of the underlying causes and overall impact of GI health disparities will prompt strategic investment of resources and efforts that generate positive change. To accelerate the pace of knowledge growth in this area, AGA established a Healthcare Disparities Research Award for meritorious work in racial and ethnic health care disparities and created a fundraising event, known as "AGA Giving Day," which raised more than $300,000 earmarked specifically to support health disparities research with 9 pilot research awards, 38 abstract awards, and diverse investigators through an AGA Research Scholar Award supported by the AGA Research Foundation.6AGA Research Foundation.https://foundation.gastro.org/Google Scholar
In 2016, the American Gastroenterological Association (AGA) codified its commitment to diversity, equity, and inclusion (Figure 1)1National Multicultural InstituteDiversity Terms.https://our.ptsem.edu/UploadedFiles/Multicultural/MCRDiversityTerms.pdfDate: 2003Date accessed: July 8, 2020Google Scholar,2UC Berkeley Initiative for Equity, Inclusion, and Diversity. Glossary of terms.http://diversity.berkeley.edu/sp_glossary_of_termsDate: 2011Date accessed: July 8, 2020Google Scholar through the adoption of its organizational Diversity Policy.3American Gastroenterological Association Diversity Policy.https://aga-cms-assets.s3.amazonaws.com/2020327173230---COM20-009%20AGA%20Diversity%20Policy.pdfDate accessed: June 30, 2020Google Scholar Developed in collaboration with the AGA Diversity Committee, the policy establishes that the AGA aims to "reflect the interests of the diverse patient population we serve" and that the AGA is "committed to the "promotion of diversity within the practice of gastroenterology and in the individualized care of patients of all backgrounds," the "recruitment and retention of GI providers and researchers from diverse backgrounds," and the "elimination of disparities in GI diseases through community engagement, research and advocacy." Four years after the crafting of that policy, the AGA bolstered that commitment by condemning racism, bigotry, and discrimination in a Joint GI society statement with the American Association for the Study of Liver Diseases, American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy.4Racism, social injustice and our pledge to lead change. Joint GI society statement from AGA, AASLD, ACG and ASGE.https://gastro.org/news/racism-social-injustice-and-our-pledge-to-lead-changeDate accessed: June 30, 2020Google Scholar The statement was in direct response to both the systemic racism laid bare by George Floyd's death at the hands of a white police officer and also to the burgeoning coronavirus disease-19–related racial health disparities.5Gray 2nd, D.M. Anyane-Yeboa A. Balzora S. Issaka R.B. May F.P. COVID-19 and the other pandemic: populations made vulnerable by systemic inequity.Nat Rev Gastroenterol Hepatol. 2020; 17: 520-522Crossref PubMed Scopus (140) Google Scholar Although the AGA had previously established diversity, equity, and inclusion as a major pillar of its organizational vitality, in the wake of these recent events, the specific inclusion of anti-racism initiatives is imperative to eliminate health care disparities and promote diversity within the practice of gastroenterology. Although AGA leadership and staff felt that they had been paying close attention to diversity issues, they deemed it essential (as detailed in this Commentary) to not only undertake a self-reflection in terms of its past and current initiatives, but also to establish a major equity initiative to further convert intentions to actions. The AGA has >16,000 US and international members who span the spectrum of academia, trainees, private, federal, and community-based practice; and industry. Its leadership is composed of both professional staff and volunteer members who serve on 18 committees (https://gastro.org/committees/). Of the 64% of full AGA members who have provided race and ethnicity information, approximately 11% are underrepresented minorities. Underrepresented minorities include American Indian/Alaskan Native, Black/African American, Hawaiian/Pacific Islander, and Hispanic/Latinx6National Institutes of HealthRacial and Ethnic Categories and Definitions for NIH Diversity Programs and for Other Reporting Purposes.https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-089.html 2015Google Scholar and comprise 0.2%, 4.6%, 0.03%, and 6.0% of the reporting AGA full members and 0.4%, 6.1%, 0.7%, and 6.4% of the reporting AGA trainee members, respectively (Table 1 and Table 2). Underserved communities additionally include those with disabilities and those who are economically disadvantaged. Although the AGA underrepresented minority representation mirrors the national GI underrepresented minority percentages, these numbers have plateaued over the past decade and remain well below the expected 30% based on national underrepresented minority population data when comparing 2010 and 2020 census data (Table 1).7Carethers J.M. Quezada S.M. Carr R.M. Day L.W. Diversity within US gastroenterology physician practices: the pipeline, cultural competencies, and gastroenterology societies approaches.Gastroenterology. 2019; 156: 829-833Abstract Full Text Full Text PDF PubMed Scopus (38) Google ScholarTable 1Racial and Ethnic Demographics of AGA Members and US GastroenterologistsRace and EthnicityAGA Full Members 2010 (US)AGA Full Members 2020 (US)US Gastroenterologists 2010 (US)aFrom the AMA Physician Masterfile, December 31, 2018.US Gastroenterologists 2018 (US)bAMA Physician Characteristics and Distribution in the United States, December 31, 2010. Percentages are of total reporting.US Population (%)n%n%n%n%2010cThe percentages add to 100.2 owing to approximation. The 2010 census data were obtained from: https://data.census.gov/cedsci/table?q=United%20States&g=0100000US&tid=ACSDP1Y2010.DP05.2020dThe percentages add to 100.1 owing to approximation. The 2020 census data are an estimate and were obtained from: https://data.census.gov/cedsci/all?q=ZCTA5%2012020&hidePreview=false&tid=ACSDP5Y2018.DP05.American- Indian/Alaskan NativeeUnderrepresented minorities (first 4 rows).80.2130.280.07150.120.70.7Black/African AmericaneUnderrepresented minorities (first 4 rows).1613.72834.64313.95634.412.312.3Hawaiian/Pacific IslandereUnderrepresented minorities (first 4 rows).10.0220.03N.A.N.A.90.070.20.2HispaniceUnderrepresented minorities (first 4 rows).2114.83706.07176.58476.616.417.8Asian92521.13177328.8253822.8355227.84.75.4Multiracial——————1441.12.02.4Other————3052.71230.960.20.2White307170.2372560.4711264752758.963.761.1Total reporting437753.5616664.211,11184.112,780—n.a.n.a.Total URM3818.766810.8115610.4143411.229.631Not reporting379846.5344035.8209915.9——n.a.n.a.Total8175100960610013,210100——309.4 M322.9 MM, million; N.A., non-available; n.a., not applicable; URM, underrepresented minorities.a From the AMA Physician Masterfile, December 31, 2018.b AMA Physician Characteristics and Distribution in the United States, December 31, 2010. Percentages are of total reporting.c The percentages add to 100.2 owing to approximation. The 2010 census data were obtained from: https://data.census.gov/cedsci/table?q=United%20States&g=0100000US&tid=ACSDP1Y2010.DP05.d The percentages add to 100.1 owing to approximation. The 2020 census data are an estimate and were obtained from: https://data.census.gov/cedsci/all?q=ZCTA5%2012020&hidePreview=false&tid=ACSDP5Y2018.DP05.e Underrepresented minorities (first 4 rows). Open table in a new tab Table 2Racial and Ethnic Demographics of AGA Trainee Members, 2020AGA Trainee MembersRace and Ethnicity2010aAs of July 2010.2020bAs of July 2020.n%N%American-Indian/Alaskan NativecUnderrepresented minorities (first 4 rows).20.240.4Black/African AmericancUnderrepresented minorities (first 4 rows).484.7646.1Hawaiian/Pacific IslandercUnderrepresented minorities (first 4 rows).0070.7HispaniccUnderrepresented minorities (first 4 rows).484.7676.4Asian38737.845143.2White53852.645243.2Total reporting102381.3104574.5Total URM989.614213.6Not Reporting23518.735725.5Total12581001402100URM, underrepresented minorities.a As of July 2010.b As of July 2020.c Underrepresented minorities (first 4 rows). Open table in a new tab M, million; N.A., non-available; n.a., not applicable; URM, underrepresented minorities. URM, underrepresented minorities. The AGA Governing Board includes 13 members who are charged with developing the AGA's strategic plan. The board is committed to making a significant impact on the goals enumerated in the AGA Diversity Policy and works with the AGA professional staff, a diverse staff of 101 employees, 30% of whom are underrepresented minorities, to achieve those aims (Table 3). Eighteen percent of the governing board are underrepresented minority members. Among AGA committees, underrepresented minorities volunteer on 12 of 18 committees, accounting for 13% of AGA committee participation (Table 3). Among these committees, the Diversity and Government Affairs Committees have the highest underrepresented minority representation. The AGA has been tracking diversity on committees since before the inception of the appointments committee in 2011. To further ensure that all ethnicities are appropriately represented within the leadership structure, in 2016 the Diversity Committee implemented an annual assessment of all committees. Although members may opt out of disclosing race/ethnicity information, data are now available for 75% of committee members (Table 2).Table 3Racial and Ethnic Demographics of AGA Staff and Committee Members, 2010 and 2020AGA StaffAGA Committee MembersRace and ethnicity2010aAs of July 2010.2020bAs of July 2020.2020bAs of July 2020.n%n%n%American- Indian/Alaskan NativecUnderrepresented minorities (first 4rows).000010.5Black/ African-AmericancUnderrepresented minorities (first 4rows).1922.92524.8136.0Hawaiian/Pacific IslandercUnderrepresented minorities (first 4rows).00000HispaniccUnderrepresented minorities (first 4rows).3355.0136.0Asian22.465.95224.1White5971.16564.411452.8Other————2310.6Total reporting83100101100216Total URM2226.53029.72712.5Not Reporting0072Total83101288URM, underrepresented minorities.a As of July 2010.b As of July 2020.c Underrepresented minorities (first 4rows). Open table in a new tab URM, underrepresented minorities. The Diversity Committee (formerly the Underrepresented Minorities Committee) has been in existence since 1993. The committee helps the AGA to address challenges with health care access and use among diverse patient populations inclusive of racial, cultural, religious, sexual orientation, gender, disability, age, and economic diversity. The committee also advocates for the inclusion, advancement and recognition of members from underrepresented groups in all AGA activities. The AGA disbanded this committee and the Women's Committee (which focuses on the promotion and advancement of women members of the AGA and women's health issues) for a 3-year period from 2005 to 2008 until AGA task forces recommended their re-establishment, thus demonstrating that even well-intentioned organizations can contribute to actions that may perpetuate inequity. The Diversity Committee has since created and supported several organizational initiatives to drive its core values of diversity, equity, and inclusion to the forefront. Examples include sponsorship of initiatives involving unconscious and implicit bias, gastroenterological (GI) care for the immigrant population, and increasing the diversity of the GI pipeline for fellowship training and society leadership positions. The current Diversity Committee has 4 main initiatives: (i) improving the collection of demographic data from both AGA members-at-large and committee members; (ii) using AGA communication outlets to educate members about GI health disparities and unconscious/implicit bias; (iii) creating the first of its kind repository of renowned underrepresented minority GI physicians and scientists to be used by the AGA committees when seeking mentors, speakers, and nominations for committees and potential awards; and (iv) increasing the visibility of GI disparities research during the annual Digestive Disease Week (DDW) conference through dedicated e-Poster sessions and poster tours. The Diversity Committee also sponsors an annual symposium at DDW, with past symposia topics including unconscious and implicit bias, diversity in GI research, and GI care for the immigrant population. The national proportion of only 11% underrepresented minority GI physicians reflects a striking contrast with the racial and ethnic diversity of the patient populations we serve. This racial and ethnic disparity among GI physicians also exists for the GI pipeline of medical student and GI trainees.7Carethers J.M. Quezada S.M. Carr R.M. Day L.W. Diversity within US gastroenterology physician practices: the pipeline, cultural competencies, and gastroenterology societies approaches.Gastroenterology. 2019; 156: 829-833Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar,8Day L.W. Gonzalez S. Ladd A.M. Bucobo J.C. Pickett-Blakely O. Tilara A. Christie J. Diversity in gastroenterology in the United States: where are we now? Where should we go?.Gastrointest Endosc. 2016; 83: 679-683Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar In a 2019 DDW Diversity Committee symposium and follow-up article, Carethers et al7Carethers J.M. Quezada S.M. Carr R.M. Day L.W. Diversity within US gastroenterology physician practices: the pipeline, cultural competencies, and gastroenterology societies approaches.Gastroenterology. 2019; 156: 829-833Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar highlighted our current state whereby both the tributaries that produce future gastroenterologists and the systems that support the retention of underrepresented minority gastroenterologists have been unable to increase GI underrepresented minority representation to a level commensurate with population demographics. In fact, GI fellowship applications by underrepresented minority residents have been decreasing over time. Some strategies that may mitigate these trends include programs designed to specifically recruit underrepresented minorities to the field of GI, increasing mentorship opportunities, and integrating cultural humility curricula.7Carethers J.M. Quezada S.M. Carr R.M. Day L.W. Diversity within US gastroenterology physician practices: the pipeline, cultural competencies, and gastroenterology societies approaches.Gastroenterology. 2019; 156: 829-833Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar The AGA has had several programs to help expand the pool of underrepresented minority students, GI trainees, and GI research; to promote the retention of underrepresented minority AGA members; and to create a diverse leadership within the AGA. Examples of these initiatives include the following. (a) The Investing in the Future Program, a now discontinued program owing to cessation of funding focused on exposing underrepresented minority medical students to the field of gastroenterology and engaging them in summer research opportunities. This program is likely to restart via a generous gift from an AGA member. (b) The Future Leaders Program, an organizational leadership development and mentorship program available to all AGA members that also aims to identify and provide opportunities for underrepresented minority members. (c) The Fostering Opportunities Resulting in Workforce And Research Diversity (FORWARD) program, an ongoing National Institutes of Health–funded R25 leadership development program for underrepresented minority AGA members. Investing in the Future Program (I and II) were R25 National Institutes of Health–supported programs that started in 2001 in collaboration with American Society for Gastrointestinal Endoscopy. Underrepresented minority medical students and residents were introduced to gastroenterology through presentations, hands-on endoscopy simulations and 8- to 10-week long summer research opportunities. Through this program, AGA members performed outreach to >2300 students spanning 7 institutions and 19 regional and national conferences. The FORWARD Program is the newest AGA initiative established in 2019 for underrepresented minority AGA members who wish to participate in a structured active mentorship program that helps to develop leadership, research, and management skills, and affords networking opportunities to promote investigational or leadership careers in academic medicine. These programs, although important and worthy of support, are by themselves insufficient to reverse the trends in recruitment and retention of underrepresented minority AGA members. The AGA has proudly supported many research, scholarship, and honorific awards since its inception. The AGA research portfolio has included $12 million of Research Foundation funding from 2016 to 2020. Eleven percent of AGA awards were competitively awarded to underrepresented minority members (excluding abstract and travel awards) amounting to approximately 15% of AGA Research Foundation funding. Currently, there are no underrepresented minority–specific research award mechanisms within the AGA, although such awards did exist in the past. Honorific awards (ie, distinguished recipient awards) were received by 10% of underrepresented minorities over the same time period. Among them are 2 Distinguished Clinician Awards, 2 Distinguished Mentor Awards, and 1 Distinguished Achievement Award in Basic Science. The main venue to showcase the scholarship of AGA members is DDW, the largest GI conference in the world, attracting >14,000 attendees per year. Although 10% of the AGA members are underrepresented minorities, only 5% of DDW speakers are underrepresented minorities. This differential may reflect what has been recently termed the "diversity–innovation paradox in science" in which underrepresented minority groups are less likely to receive academic recognition for their research contributions despite innovating at higher levels than their majority counterparts.9Hofstra B. Kulkarni V.V. Munoz-Najar Galvez S. He B. Jurafsky D. McFarland D.A. The diversity-innovation paradox in science.Proc Natl Acad Sci U S A. 2020; 117: 9284-9291Crossref PubMed Scopus (472) Google Scholar This paradox again highlights a systemic need for alternative and additional approaches to encourage and sustain underrepresented minority engagement and leadership in research and discovery as an integral component of the AGA's mission. The AGA has five journals that it sponsors. During the past 5 years, AGA publications have featured several articles on diversity, equity and inclusion. AGA members have advanced this topic in the flagship journal, Gastroenterology,7Carethers J.M. Quezada S.M. Carr R.M. Day L.W. Diversity within US gastroenterology physician practices: the pipeline, cultural competencies, and gastroenterology societies approaches.Gastroenterology. 2019; 156: 829-833Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar,10Lang L. Racial diversity among medical students may better prepare them for minority patient care.Gastroenterology. 2008; 135: 1439Scopus (4) Google Scholar,11Merchant J.L. Omary M.B. Underrepresentation of underrepresented minorities in academic medicine: the need to enhance the pipeline and the pipe.Gastroenterology. 2010; 138: 19-26 e1–3Abstract Full Text Full Text PDF PubMed Scopus (88) Google Scholar and in GI and Hepatology News, The New Gastroenterologist,12Quezada S.M. Diversity in GI training: a timely goal. GI and Hepatology News. The New Gastroenterologist, Frontline Medical Communications Inc., Parsippany, NJ2017Google Scholar,13Badurdeen DPA, Malespin M, Oduyebo I, Quezada S, Stephen O. Promoting diversity through the AGA. Parsippany, NJ: GI and Hepatology News: The New Gastroenterologist Frontline Medical Communications Inc.Google Scholar and AGA Perspectives.14Gray D. Diversity in gastroenterology: purpose and progress. AGA Perspectives, 2017Google Scholar,15Munroe C.A. Quezada S.M. Lamousé-Smith E. The AGA Diversity Committee: opening up a conversation about unconscious bias in GI practice. AGA Perspectives, 2019Google Scholar Although this is evidence of a growing commitment to diversity, equity, and inclusion within the AGA, this commitment has not extended to journal editorship. Of the 260 current journal editors and editorial board members among all AGA publications, currently only 6 (2.3%) are underrepresented minorities, compared with 3% in 2010. Correcting this limited underrepresented minority editorial board representation is of paramount importance for the AGA. Racial health disparities exist for a number of GI diseases and the AGA's Diversity Policy calls for their elimination. With minor exception, African Americans are most affected by these disparities in the United States. In fact, based on 2002 data, approximately 84,000 excess deaths could have been prevented if the mortality disparity between Black and Caucasian patients were eliminated.16Satcher D. Fryer Jr., G.E. McCann J. Troutman A. Woolf S.H. Rust G. What if we were equal? A comparison of the black-white mortality gap in 1960 and 2000.Health affairs. 2005; 24: 459-464Crossref PubMed Scopus (231) Google Scholar Using colorectal cancer disparities in African Americans as an example, several strategies have been proposed, including improvement of patient access and provider education.17Kupfer S. Carr R.M. Carethers J.M. Reducing colorectal cancer risk Among African Americans.Gastroenterology. 2015; 149: 1302-1304Abstract Full Text Full Text PDF PubMed Scopus (22) Google Scholar Although most of the AGA's activities on patient access occur through advocacy activities (detailed elsewhere in this Commentary), the AGA previously sponsored the Colon Cancer Roundtable designed to improve colon cancer screening rates in African Americans. Efforts in provider education have included the incorporation of racial/ethnic disparity data in GI clinical guidelines and a DDW session specifically focused on delivering culturally competent care. Attendees were encouraged to complete implicit bias testing as part of that session. The AGA also cosponsors with the American Society of Clinical Oncology, AstraZeneca, and the Society of Surgical Oncology an annual Gastrointestinal Cancers Symposium that focuses on the cancer care continuum that includes racial and ethnic differences in epidemiology, treatment, and survivorship. To date, however, there is no AGA-wide curriculum on health disparities or cultural humility. The numbers of GI researchers engaged in health disparities work has increased over time as evidenced by the number of DDW presentations. In 2017, the DDW Council adopted the Diversity Committee's recommendation to include a "Health Care Delivery, Disparities and Practice Management" track. In 2019, this track was renamed the "Healthcare Delivery, Disparities, and Quality" track, and has had a greater volume of programming in care delivery and quality compared with programming in GI health disparities. Although the Diversity Committee has remained consistent in its commitment to symposium planning for DDW, these symposia have had modest attendance. Despite evidence for continued, systemic underrepresented minority racial and ethnic disparities in GI disease prevalence and outcomes, underrepresented minorities are also underrepresented in clinical research participation. During the Diversity Committee's sponsored symposium at the 2017 DDW "Closing the Data Gaps: Strategies to Recruit and Retain Diverse Patient Populations in Clinical Studies," AGA members initiated a discussion of some of the patient-, provider-, and system-level barriers that contribute to such low inclusion of underrepresented minorities in GI research. Although this conversation was critical, the AGA does not currently have specific mechanisms to improve underrepresented minority enrollment in clinical trials. This national crisis needs to be addressed as a priority.18US Food and Drug AdministrationEnhancing the diversity of clinical trial populations — eligibility criteria, enrollment practices, and trial designs guidance for industry.2019www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trialDate accessed: July 6, 2020Google Scholar The AGA has a long track record of advocacy engagement on behalf of patients and members. The Government Affairs committee works to define the AGA advocacy priorities. Members and staff of this committee and members who participate in the Congressional Advocates and Young Delegates programs facilitate this advocacy work on state and national levels. Although not based on a race- or ethnicity-based platform, the AGA advocacy priorities include ensuring patient access to and coverage of specialty care, ensuring patient access to and coverage of evidence-based preventive screenings without cost sharing, and preventing insurers from discriminating on the basis of preexisting conditions. These fundamental differences in access often underlie racial health disparities. Unique among GI organizations, the AGA also has a nonpartisan Political Action Committee that actively supports candidates who support these advocacy efforts. The AGA has long advocated for access to specialty care for patients. In the 1990s when managed care penetration restricted access to specialists like gastroenterologists, the AGA pushed for a patient bill of rights legislation to ensure patients were able to seek unfettered access to specialists. Since 2010, the AGA has advocated for fixing the screening colonoscopy "surprise billing" practice for Medicare patients wherein a patient is charged the rate of a therapeutic colonoscopy if during a screening colonoscopy a polyp is removed. More recently, the AGA has been advocating for Congress and the Centers for Medicare and Medicaid Services to ease administrative burdens for prior authorization and other use management policies that restrict timely access to care for patients. These policies have a disproportionate impact on minority communities, given the higher rates of uninsured and underinsured patients in these communities and the potential for delayed or unfunded care. In addition to the Colon Cancer Roundtable discussed above in this article that addressed the higher incidence of colorectal cancer and lower screening rates in African Americans, AGA advocates have worked with Representative Donald Payne Jr. (D-NJ), a member of the Congressional Black Caucus whose father died of colorectal cancer and who authored H.R. 1570, the "Removing Barriers to Colorectal Cancer Screening Act" that would fix the screening colonoscopy cost-sharing problem. Together with the Congressional Black Caucus, the AGA has also collaborated on raising awareness of health disparities and the need to increase minority participation in clinical research, especially in areas like liver disease and hepatitis C, which have significant racial and ethnic disparities. This latter collaboration resulted in AGA members meeting with the US Food and Drug Administration (FDA) at the 2016 AGA–FDA Office of Minority Health Meeting. The meeting resulting in the FDA agreeing to (1) share information with the AGA about FDA grants through their Broad Area Announcement process, (2) provide the AGA with more information about existing regulatory science fellowship programs in which the FDA participates, (3) send information about how the AGA could subscribe to the FDA's hepatitis listserve, and (4) share information with the AGA about the FDA Advisory Committee participation and how AGA members could get involved. The AGA, in turn, agreed to (1) actively communicate upcoming guidelines, clinical practice updates, position papers, and white papers to FDA staff and (2) explore opportunities to host educational programs on regulatory science with FDA input. The recent unjustified killings of Breonna Taylor, George Floyd, and many other African Americans have heightened our national awareness of longstanding, systemic racism against African Americans and its related health inequities. Despite many gains made in the last 50-plus years toward increasing equity in health care and digestive diseases, as of today, priorities of the AGA have not adequately kept pace with the rapid and significant demographic changes in the United States. Nor have they kept pace with the diverse, evolving needs in research, education, clinical care, and community engagement. The gap between societal health care needs and delivery in the United States is also reflected globally. On June 2, 2020, leaders of the AGA, American Association for the Study of Liver Diseases, American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy adopted an anti-racism policy that condemns "racism, bigotry and discrimination based on race, religion, gender, country of origin and sexual orientation." The 4 GI societies pledged to "continue to advocate for diversity in our staff and governance, grant awards to research health care disparities, ensure quality care for all and work tirelessly to reduce inequalities in health care delivery and access."4Racism, social injustice and our pledge to lead change. Joint GI society statement from AGA, AASLD, ACG and ASGE.https://gastro.org/news/racism-social-injustice-and-our-pledge-to-lead-changeDate accessed: June 30, 2020Google Scholar Here, we use this platform to delineate specifically how the AGA as an organization plans to engage anti-racism as a mechanism to go beyond its mission of "empowering clinicians and researchers to improve digestive health" toward reducing the effects of structural racism on health inequities and promoting equity for all. Anti-racism is an intentional set of behaviors and policies that work to combat racism, which can be defined as the rules, practices, and customs that permeate societal systems.19Understanding commonly used terms, ideas related to racism, injustice.https://abc30.com/society/understanding-commonly-used-terms-about-racism-inequality/6248593/Date accessed: July 1, 2020Google Scholar Although diversity, equity, and inclusion are necessarily components of successful anti-racism strategies, these 3 terms and anti-racism are not equivalent, because diversity, equity, and inclusion represent outcomes, whereas anti-racism strategies lead to these desired outcomes. We have elected to undertake the following framework to ensure long-term success in incorporating anti-racism as a cross-cutting actionable strategy to bolster diversity, equity, and inclusion within our organization and in much broader terms within the field of gastroenterology. We additionally commit to using this framework to improve the care of the diverse groups of GI patients we serve. Adapting an organizational anti-racism framework established by the National Juvenile Justice Network,20National Juvenile Justice NetworkMoving a racial justice agenda: organizational assessment: are you ready?.http://www.njjn.org/uploads/digital-library/westernstates3.pdf?phpMyAdmin=14730ab3483c51c94ca868bccffa06efDate accessed: June 25, 2020Google Scholar the AGA leadership recognizes that a commitment to anti-racism requires that the AGA: (1) establish organizational readiness through self-assessments of its anti-racism activities and anti-racism institutional culture, including an evaluation of the racial diversity of the membership and leadership; audit of resource allocation for prior anti-racism programming and initiatives; and an analysis of the past and ongoing alliances with racially diverse organizations; (2) develop leaders who receive formal instruction in diversity, equity and inclusion, cultural humility, unconscious bias, and anti-racism; (3) commit to educating and engaging membership and stakeholders in anti-racism efforts; (4) commit to coalition building with other organizations who are working toward incorporating anti-racism as a strategy to improve diversity and reduce disparities; (5) perform a financial and resource audit to identify current resources that can be applied to new initiatives and develop a plan for fundraising for initiatives that cannot be accommodated with current resources; and (6) establish an interval assessment to permit determining how we have done and to assess the need for any calibration of efforts and resource allocation. Informed by the results of this self-assessment and the need to develop concrete and actionable strategies and tactics, the AGA has established the AGA Equity Project, led by the AGA Equity Task Force (https://gastro.org/aga-leadership/initiatives-and-programs/aga-equity-project/). The Task Force was established June 12, 2020, and was charged with developing a vision of equity for the organization overseeing AGA initiatives designed to make this vision a reality. The Task Force proposed a vision to "achieve equity in digestive health and eradicate disparities in digestive disease" focused on the following six domains: (1) justice, equity, and education (2) research and funding, (3) workforce and leadership, (4) recognition, (5) unconscious bias, and (6) engagement of the next generation (Figure 2). The following is a preview of the Task Force's assessment of the current state, and its vision for each domain. Many individuals have assumptions (we believe incorrect) that justice and equity for all have already been achieved in 2020, resulting in general assumptions that racism, discrimination, and bias do not exist on personal or systemic levels, and thus there is no current need for a solution or paradigm change. We envision a just world free of health disparities in digestive diseases and free of inequities in access and effective health care delivery. There is greater emphasis on funding and prominence of research that focuses on GI diseases that primarily affect the majority population, and a relative lack of funding and research that advances the science of health care disparities and scientific understanding of diseases most prevalent in minority populations. We envision state-of-the-art and well-funded research that aligns with the realities of the current multicultural patient population and disease states to achieve health equity for all.
Aspirin (acetylsalicylic acid, ASA) can lead to gastrointestinal mucosal injury through disruption of its protective phospholipid bilayer. A liquid formulation of a novel pharmaceutical lipid–aspirin complex (PL-ASA) was designed to prevent this disruption. We sought to determine the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of PL-ASA compared with immediate release aspirin (IR-ASA). In this active-control crossover study, 32 healthy volunteers were randomized to receive 1 of 2 dose levels (a single dose of 325 mg or 650 mg) of either PL-ASA or IR-ASA. After a 2-week washout period between treatment assignments, subjects received a single dose of the alternative treatment, at the same dose level. The primary objectives of the study were to assess, for PL-ASA and IR-ASA at 325 mg and 650 mg dose levels, PK and PD bioequivalence, and safety, over a 24–h period after administration of both drugs. PK parameters were similar for PL-ASA and IR-ASA, and met FDA-criteria for bioequivalence. Regarding PD, both drugs also showed C min TxB2 values below 3.1 ng/mL (cut-off associated with decreased cardiovascular events) and > 99% inhibition of serum TxB2 ( ≥ 95% inhibition represents the cut-off for aspirin responders) along with similar results in several secondary PK/PD parameters. There were no serious adverse events or changes from baseline in vital signs or laboratory values in either of the 2 treatment groups. PL-ASA’s novel liquid formulation has similar PK and PD performance compared with IR-ASA, supporting functional and clinical equivalence. These data coupled with the improved gastric safety of PL-ASA suggest that this novel formulation may exhibit an improved benefit-risk profile, warranting evaluation in future trials. Clinical trial registration: http://www.clinicaltrials.gov . Unique Identifier: NCT04008979
Objective:The efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer pain were evaluated in a randomized, double-blind, placebo-controlled study. These data were also pooled with those from two similar phase 3 studies to explore the effects of methadone on treatment response.Methods:In the primary study, adults with OIC (fewer than three spontaneous bowel movements [SBMs] per week) were randomized to receive lubiprostone 24 mcg or placebo twice daily for 12 weeks. The primary end point was a change from baseline in the frequency of SBMs at week 8 in patients without a prior dose reduction. For the pooled analysis, the efficacy of lubiprostone was compared with placebo in patients receiving methadone or nonmethadone opioids. Responders were defined as patients with nine or more weeks of nonmissing SBM data who had one or more additional SBMs per week from baseline for each week that data were available and three or more SBMs per week for nine or more weeks.Results:In the primary study, the change from baseline at week 8 in SBM frequency was similar in the lubiprostone and placebo groups (P = 0.842). In the pooled analysis, the response rate was significantly higher with lubiprostone treatment vs placebo for patients receiving nonmethadone opioids (P = 0.002) but was similar between lubiprostone treatment and placebo in patients receiving methadone (P = 0.692). The safety profile of lubiprostone was unaffected by methadone use.Conclusions:The phase 3 study did not meet its primary efficacy end point. However, analysis of pooled data from all phase 3 studies in the OIC clinical development program, stratified by methadone opioid usage, confirmed that lubiprostone is effective for treatment of OIC in patients taking nonmethadone opioids; no safety concerns were identified based on the type of opioid used.
Lubiprostone is a ClC-2 chloride channel activator approved for the treatment of chronic idiopathic constipation (CIC) and opioid-induced constipation (OIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women. Lubiprostone is generally well tolerated, with nausea being the most common adverse event.
Drs. Cerit and Duygu raise an interesting question of whether diabetic gastroparesis may play a role in apparent “aspirin resistance” in diabetic patients [(1)][1]. It is possible that in some patients, diabetic gastroparesis impairs absorption of a number of enteric-coated (EC) drugs, including
BACKGROUND A limitation of aspirin is that some patients, particularly those with diabetes, may not have an optimal antiplatelet effect.OBJECTIVES The goal of this study was to determine if oral bioavailability mediates nonresponsiveness.METHODS The rate and extent of serum thromboxane generation and aspirin pharmacokinetics were measured in 40 patients with diabetes in a randomized, single-blind, triple-crossover study. Patients were exposed to three 325-mg aspirin formulations: plain aspirin, PL2200 (a modified-release lipid-based aspirin), and a delayed-release enteric-coated (EC) aspirin. Onset of antiplatelet activity was determined by the rate and extent of inhibition of serum thromboxane B-2 (TXB2) generation. Aspirin nonresponsiveness was defined as a level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 > 3.1 ng/ml) within 72 h after 3 daily aspirin doses.RESULTS The rate of aspirin nonresponsiveness was 15.8%, 8.1%, and 52.8% for plain aspirin, PL2200, and EC aspirin, respectively (p < 0.001 for both comparisons vs. EC aspirin; p = 0.30 for comparison between plain aspirin and PL2200). Similarly, 56% of EC aspirin-treated subjects had serum TXB2 levels > 3.1 ng/ml, compared with 18% and 11% of subjects after administration of plain aspirin and PL2200 (p < 0.0001). Compared with findings for plain aspirin and PL2200, this high rate of nonresponsiveness with EC aspirin was associated with lower exposure to acetylsalicylic acid (63% and 70% lower geometric mean maximum plasma concentration [ C-max] and 77% and 82% lower AUC(0-t) [ area under the curve from time 0 to the last time measured]) and 66% and 72% lower maximum decrease of TXB2, with marked interindividual variability.CONCLUSIONS A high proportion of patients treated with EC aspirin failed to achieve complete inhibition of TXB2 generation due to incomplete absorption. Reduced bioavailability may contribute to "aspirin resistance" in patients with diabetes. (Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients; NCT01515657) (C) 2017 by the American College of Cardiology Foundation.
Helicobacter pylori antibiotic resistance leads to frequent treatment failure. However, the current US prevalence of H. pylori clarithromycin resistance and treatment failure is unknown.
Summary Introduction In two, 6‐month, randomized, double‐blind Phase 3 trials, PA 32540 (enteric‐coated aspirin 325 mg and immediate‐release omeprazole 40 mg) compared to aspirin alone was associated with fewer endoscopic gastric and duodenal ulcers in patients requiring aspirin therapy for secondary cardiovascular disease ( CVD ) prevention who were at risk for upper gastrointestinal ( UGI ) events. Aims In this 12‐month, open‐label, multicenter Phase 3 study, we evaluated the long‐term cardiovascular and gastrointestinal safety of PA 32540 in subjects who were taking aspirin 325 mg daily for ≥3 months for secondary CVD prevention and were at risk for aspirin‐associated UGI events. Enrolled subjects received PA 32540 once daily for up to 12 months and were assessed at baseline, month 1, month 6, and month 12. Results The overall safety population consisted of 379 subjects, and 290 subjects (76%) were on PA 32540 for ≥348 days (12‐month completers). Adverse events ( AE s) caused study withdrawal in 13.5% of subjects, most commonly gastroesophageal reflux disease (1.1%). Treatment‐emergent AE s occurred in 76% of the safety population (11% treatment‐related) and 73% of 12‐month completers (8% treatment‐related). The most common treatment‐related AE was dyspepsia (2%). One subject had a gastric ulcer observed on for‐cause endoscopy. There were five cases of adjudicated nonfatal myocardial infarction, one nonfatal stroke, and one cardiovascular death, but none considered treatment‐related. Conclusions Long‐term treatment with PA 32540 once daily for up to 12 months in subjects at risk for aspirin‐associated UGI events is not associated with any new or unexpected safety events.
BACKGROUND The COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial) showed that proton-pump inhibitors (PPIs) safely reduced rates of gastrointestinal (GI) events in patients requiring dual antiplatelet therapy (DAPT). However, utilization of appropriate prophylactic PPI therapy remains suboptimal, especially with low-dose aspirin.OBJECTIVES The authors investigated the safety and efficacy of PPI therapy in patients receiving DAPT in low- and high-dose aspirin subsets.METHODS Randomized patients with available aspirin dosing information in COGENT (N = 3,752) were divided into "low-dose" (<= 100 mg) and "high-dose" (>100 mg) aspirin groups. The primary GI and cardiovascular endpoints were composite upper GI events and major adverse cardiac events, respectively. All events were adjudicated by independent, blinded gastroenterologists and cardiologists.RESULTS Median duration of follow-up was 110 days. Low-dose aspirin users (n = 2,480; 66.1%) were more likely to be older, female, and have higher rates of peripheral artery disease, prior stroke, and hypertension, whereas high-dose aspirin users (n = 1,272; 33.9%) had higher rates of hyperlipidemia, smoking, a history of percutaneous coronary intervention, and were more than twice as likely to be enrolled from sites within the United States (80.4% vs. 39.8%). High-dose aspirin was associated with similar 180-day Kaplan-Meier estimates of adjudicated composite GI events (1.7% vs. 2.1%; adjusted hazard ratio: 0.88; 95% confidence interval: 0.46 to 1.66) and major adverse cardiac events (4.8% vs. 5.5%; adjusted hazard ratio: 0.73; 95% confidence interval: 0.48 to 1.11) compared with low-dose aspirin. Randomization to PPI therapy reduced 180-day Kaplan-Meier estimates of the primary GI endpoint in low-dose (1.2% vs. 3.1%) and high-dose aspirin subsets (0.9% vs. 2.6%; p for interaction = 0.80), and did not adversely affect the primary cardiovascular endpoint in either group.CONCLUSIONS Gastroprotection with PPI therapy should be utilized in appropriately selected patients with coronary artery disease requiring DAPT, even if the patients are on low-dose aspirin. (C) 2016 by the American College of Cardiology Foundation.
BACKGROUND:Nonsteroidal anti-inflammatory drugs (NSAIDs) are some of the most commonly used medications worldwide. The availability of hundreds of products containing an NSAID, combined with a lack of recognition and understanding of NSAIDs, can increase the potential of consumers to inadvertently exceed the recommended NSAID dosage, which can cause potentially serious side effects. Physician and consumer education regarding the appropriate use of NSAIDs can help prevent NSAID misuse. Evaluations of current consumer patterns of NSAID use and perceptions about NSAIDs are necessary to develop targeted educational programs.MATERIALS AND METHODS:An online and telephone survey of 1,750 U.S. adults was conducted to obtain information about the patterns of use and perceptions about prescription and over-the-counter NSAIDs and medicines. The survey was compared to similar surveys conducted in 1997, 2001 and 2002.RESULTS:NSAIDs are widely used, with 63% of respondents reporting use within the past 12 months. NSAIDs were not well recognized by generic or brand names and many respondents were unaware or unconcerned about potential side effects. NSAID misuse was common, with 19% using more than the recommended dose and 24% using multiple NSAIDs concomitantly. NSAID use appears to have increased since 2002 but the level of NSAID awareness and pattern of NSAID misuse has not changed.CONCLUSIONS:NSAIDs are widely used and often used in a manner that increases the risk of serious side effects. Sufficient knowledge and understanding of NSAIDs is lacking and educational interventions directed to consumers and physicians are needed.