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Role of gastroenterologists in the U.S. in the management of gastric cancer
Introduction
Although gastric cancer is one of the most common causes of cancer death in the world, the burden of gastric cancer in the United States tends to be underestimated relative to that of other cancers of the digestive system. In fact, the 5-year survival rate from gastric cancer remains poor (~32%)1 in the United States, and this is largely because gastric cancers are not diagnosed at an early stage when curative therapeutic options are available. Cumulative epidemiologic data consistently demonstrate that the incidence of gastric cancer in the United States varies according to ethnicity, immigrant status, and country of origin. It is important for practicing gastroenterologists in the United States to recognize individual risk profiles and identify people at higher risk for gastric cancer. Hereditary diffuse gastric cancer is an inherited form of diffuse-type gastric cancer and has pathogenic variants in the E-cadherin gene that are inherited in an autosomal dominant pattern. The lifetime risk of gastric cancer in individuals with HDGC is very high, and prophylactic total gastrectomy is usually advised. This article focuses on intestinal type cancer.
Epidemiology
Gastric cancer (proximal and distal gastric cancer combined) is the fifth most frequently diagnosed cancer and the third most common cause of cancer death worldwide, with 1,033,701 new cases and 782,685 deaths in 2018.2 Gastric cancer is subcategorized based on location (proximal [i.e., esophagogastric junctional, gastric cardia] and distal) and histology (intestinal and diffuse type), and each subtype is considered to have a distinct pathogenesis. Distal intestinal type gastric cancer is most commonly encountered in clinical practice. In this article, gastric cancer will signify distal intestinal type gastric cancer unless it is otherwise noted. In general, incidence rates are about twofold higher in men than in women. There is marked geographic variation in incidence rates, and the age-standardized incidence rates in eastern Asia (32.1 and 13.2, per 100,000) are approximately six times higher than those in northern America (5.6 and 2.8, per 100,000) in both men and women, respectively.2 Recent studies evaluating global trends in the incidence and mortality of gastric cancer have demonstrated decreases worldwide.3-5 However, the degree of decrease in the incidence and mortality of gastric cancer varies substantially across geographic regions, reflecting the heterogeneous distribution of risk profiles. A comprehensive analysis of a U.S. population registry demonstrated a linear decrease in the incidence of gastric cancer in the United States (0.94% decrease per year between 2001 and 2015),6 though the annual percent change in the gastric cancer mortality in the United States was lower (around 2% decrease per year between 1980 and 2011) than in other countries.3Several population-based studies conducted in the United States have demonstrated that the incidence of gastric cancer varied by ethnicity, immigrant status, and country of origin, and the highest incidence was observed among Asian immigrants.7,8 A comprehensive meta-analysis examining the risk of gastric cancer in immigrants from high-incidence regions to low-incidence regions found a persistently higher risk of gastric cancer and related mortality among immigrants.9 These results indicate that there are important risk factors such as environmental and dietary factors in addition to the traditionally considered risk factors including male gender, age, family history, and tobacco use. A survey conducted in an ethnically and culturally diverse U.S. city showed that gastroenterology providers demonstrated knowledge deficiencies in identifying and managing patients with increased risk of gastric cancer.10 Recognizing individualized risk profiles in higher-risk groups (e.g., immigrants from higher-incidence/prevalence regions) is important for optimizing management of gastric cancer in the United States.
Assessment and management of modifiable risk factors
Helicobacter pylori, a group 1 carcinogen, is the most well-recognized risk factor for gastric cancer, particularly noncardia gastric cancer.11 Since a landmark longitudinal follow-up study in Japan demonstrated that people with H. pylori infection are more likely to develop gastric cancer than those without H. pylori infection,12 accumulating evidence largely from Asian countries has shown that eradication of H. pylori is associated with a reduced incidence of gastric cancer regardless of baseline risk.13 There are also data on the protective effect for gastric cancer of H. pylori eradication in asymptomatic individuals. Another meta-analysis of six international randomized control trials demonstrated a 34% relative risk reduction of gastric cancer occurrence in asymptomatic people (relative risk of developing gastric cancer was 0.66 in those who received eradication therapy compared with those with placebo or no treatment, 95% CI, 0.46-0.95).14 A U.S. practice guideline published after these meta-analyses recommends that all patients with a positive test indicating active infection with H. pylori should be offered treatment and testing to prove eradication,15 though the recommendation was not purely intended to reduce the gastric cancer risk in U.S. population. Subsequently, a Department of Veterans Affairs cohort study added valuable insights from a U.S. experience to the body of evidence from other countries with higher prevalence. In this study of more than 370,000 patients with a history of H. pylori infection, the detection and successful eradication of H. pylori was associated with a 76% lower incidence of gastric cancer compared with people without H. pylori treatment.16 This study also provided insight into H. pylori treatment practice patterns. Of patients with a positive H. pylori test result (stool antigen, urea breath test, or pathology), approximately 75% were prescribed an eradication regimen and only 21% of those underwent eradication tests. A low rate (24%) of eradication testing was subsequently reported by the same group among U.S. patients regardless of gastric cancer risk profiles.17 The lesson from the aforementioned study is that treatment and eradication of H. pylori even among asymptomatic U.S. patients reduces the risk of subsequent gastric cancer. However, it may be difficult to generalize the results of this study given the nature of the Veterans Affairs cohort, and more data are required to justify the implementation of nationwide preventive H. pylori screening in the general U.S. population.
Smoking has been recognized as the other important risk factor. A study from the European prospective multicenter cohort demonstrated a significant association of cigarette smoking and gastric cancer risk (HR for ever-smokers 1.45 [95% CI, 1.08-1.94], current-smokers in males 1.73 [95% CI, 1.06-2.83], and current smokers in females 1.87 [95% CI, 1.12-3.12], respectively) after adjustment for educational level, dietary consumption profiles, alcohol intake, and body mass index (BMI).18 A subsequent meta-analysis provided solid evidence of smoking as the important behavioral risk factor for gastric cancer.19 Smoking also predisposed to the development of proximal gastric cancer.20 Along with other cancers in the digestive system such as in the esophagus, colon and rectum, liver, gallbladder, and pancreas, a significant association of BMI and the risk of proximal gastric cancer (RR of the highest BMI category compared with normal BMI, 1.8 [95% CI, 1.3-2.5]) was reported, with positive dose-response relationships; however, the association was not sufficient for distal gastric cancer.21 There is also evidence to show a trend of greater alcohol consumption (>45 grams per day [about 3 drinks a day]) associated with the increased risk of gastric cancer.21 It has been thought that salt and salt-preserved food increase the risk of gastric cancer. It should be noted that the observational studies showing the associations were published from Asian countries where such foods were a substantial part of traditional diets (e.g., salted vegetables in Japan) and the incidence of gastric cancer is high. There is also a speculation that preserved foods may have been eaten in more underserved, low socioeconomic regions where refrigeration was not available and prevalence of H. pylori infection was higher. Except for documented inherited form of gastric cancer (e.g., HDGC or hereditary cancer syndromes), most gastric cancers are considered sporadic. A recent randomized study published from South Korea investigated a cohort of higher-risk asymptomatic patients with family history significant for gastric cancer. This study of 1,676 subjects with a median follow-up of 9.2 years showed that successful eradication of H. pylori in the first-degree relatives of those with gastric cancer significantly reduced the risk (HR 0.45 [95% CI, 0.21-0.94]) of developing gastric cancer.22 As previously discussed, in the United States where the prevalence of H. pylori and the incidence of gastric cancer are both lower than in some Asian countries, routine screening of asymptomatic individuals for H. pylori is not justified yet. There may be a role for screening individuals who are first-generation immigrants from areas of high gastric cancer incidence and also have a first-degree relative with gastric cancer.
Who should we consider high risk and offer screening EGD?
With available evidence to date, screening for gastric cancer in a general U.S. population is not recommended. However, it is important to acknowledge the aforementioned varying incidence of gastric cancer in the United States among ethnicity, immigrant status, and country of origin. Immigrants from high-incidence regions maintain a higher risk of gastric cancer and related mortality even after migration to lower-incidence regions. The latter comprehensive study estimated that as many as 12.7 million people (29.4% of total U.S. immigrant population) have emigrated from higher-incidence regions including East Asian and some Central American countries.9 Indeed, an opportunistic nationwide gastric cancer screening program has been implemented in South Korea (beginning at age 40, biannually)23 and Japan (beginning at age 50, biannually).24 Two decision-analytic simulation studies have provided insight into the uncertainty about the cost effectiveness for potential targeted gastric cancer screening in higher-risk populations in the United States. One study demonstrated that esophagogastroduodenoscopy (EGD) screening for otherwise asymptomatic Asian American people (as well as Hispanics and non-Hispanic Blacks) at the time of screening colonoscopy at 50 years of age with continued endoscopic surveillance every 3 years was cost effective, only if gastric intestinal metaplasia (GIM) or more advanced lesions were diagnosed at the index screening EGD.25 Previous studies analyzing the cost effectiveness for gastric cancer screening in the United States had the limitation of not stratifying according to race or ethnicity, or accounting for patients diagnosed with GIM. Subsequently, the same research group extended this model analysis and has published additional findings that this strategy is cost effective for each of the most prevalent Asian American ethnicities (Chinese, Filipino, Southeast Asian, Vietnamese, Korean, and Japanese Americans) in the United States irrespective of sex.26 Although the authors raised a limitation that additional risk factors such as family history, tobacco use, or persistent H. pylori infection were not considered in the model because data regarding differentiated noncardia gastric cancer risk among Asian American ethnicities based on these risk factors are not available.
These two model analytic studies added valuable insights to the body of evidence that subsequent EGDs after the one-time bundled EGD is cost effective for higher-risk asymptomatic people in the United States, if the index screening EGD with gastric mucosal biopsies demonstrates at least GIM. Further population-based research to elucidate risk stratification among higher-risk people will provide a schema that could standardize management and resource allocation as well as increase the cost effectiveness of a gastric cancer screening program in the United States. The degree of risk of developing gastric cancer in autoimmune gastritis varies among the reported studies.27-29 Although the benefit of endoscopic screening in patients with autoimmune gastritis has not been established, a single endoscopic evaluation should be recommended soon after the diagnosis of autoimmune gastritis in order to identify prevalent neoplastic lesions.30
Practical consideration when we perform EGD for early gastric cancer screening
Identification of higher-risk patients should alert an endoscopist to observe mucosa with greater care with a lower threshold to biopsy any suspicious lesions. Preprocedural risk stratification for each individual before performing diagnostic EGD will improve early gastric cancer detection. While we perform EGD, detecting precursor lesions (atrophic gastritis and GIM) is as important as diagnosing an early gastric cancer. Screening and management of patients with precursor lesions (i.e., atrophic gastritis and GIM) is beyond the scope of this article, and this was published in a previous issue of the New Gastroenterologist. It is important to first grossly survey the entire gastric mucosa using high-definition while light (HDWL) endoscopy and screen for any focal irregular (raised or depressed) mucosal lesions. These lesions are often erythematous and should be examined carefully. Use of mucolytic and/or deforming agents (e.g., N-acetylcysteine or simethicone) is recommended for the improvement of visual clarity of gastric mucosa.31 Simethicone is widely used in the United States for colonoscopy and should also be available at the time of EGD for better gastric mucosal visibility. If irregular mucosal lesions are noted, this area should also be examined under narrowband imaging (NBI) in addition to HDWL. According to a simplified classification consisting of mucosal and vascular irregularity, NBI provides better mucosal surface morphology for diagnosis of early gastric cancer compared with HDWL, and a thorough examination of the surface characteristics is a prerequisite.32 This classification was further validated in a randomized control trial, and NBI increased sensitivity for the diagnosis of neoplasia compared with HDWL (92 % vs. 74 %).33 The majority of institutions in the United States have a newer-generation NBI (Olympus America, EVIS EXERA III video system, GIF-HQ190), which provides brighter endoscopic images to better characterize gastric neoplastic lesions. Once we recognize an area suspicious for neoplasia, we should describe the macroscopic features according to a classification system.
The Paris classification, one of the most widely recognized classification systems among U.S. gastroenterologists, is recommended for gastric neoplastic lesions.34Gastric neoplastic lesions with a “superficial” endoscopic appearance are classified as subtypes of “type 0.” The term “type 0” was chosen to distinguish the classification of “superficial” lesions from the Borrmann classification for “advanced” gastric tumors, which includes types 1 to 4. In the classification, a neoplastic lesion is called “superficial” when its endoscopic appearance suggests that the depth of penetration in the digestive wall is not more than into the submucosa (i.e., there is no infiltration of the muscularis propria). The distinctive characters of polypoid and nonpolypoid lesions are summarized in Table 1. Endoscopic submucosal dissection (ESD) has steadily gained acceptance for the treatment of early gastric cancer in the United States. The American Gastroenterological Association recommended in the 2019 institutional updated clinical practice guideline that ESD should be considered the first-line therapy for visible, endoscopically resectable, superficial gastric neoplasia.35 This recommendation is further supported by the published data on efficacy and safety of ESD for early gastric neoplasia in a large multicenter cohort in the United States.36 For all suspicious lesions, irrespective of pathological neoplastic confirmation, referral to an experienced center for further evaluation and endoscopic management should be considered. Lastly, all patients with early gastric cancer should be evaluated for H. pylori infection and treated if the test is positive. Eradication of H. pylori is associated with a lower rate of metachronous gastric cancer,37 and treatment of H. pylori as secondary prevention is also recommended.
Conclusion
As summarized above, cumulative epidemiologic data consistently demonstrate that the incidence of gastric cancer in the U.S. varies according to ethnicity, immigrant status, and country of origin. New gastroenterologists will need to recognize individual risk profiles and identify people at higher risk for gastric cancer. Risk stratification before performing endoscopic evaluation will improve early gastric cancer detection and make noninvasive, effective therapies an option.
References
1. Surveillance, Epidemiology, and End Results Program cancer statistics. https://seer.cancer.gov/statfacts/html/stomach.html.
2. Bray F et al. Ca Cancer J Clin. 2018;68:394-424.
3. Ferro A et al. Eur J Cancer. 2014;50:1330-44.
4. Luo G et al. Int J Cancer. 2017;141:1333-44.
5. Arnold M et al. Eur J Cancer. 2015;51:1164-87.
6. Thrift AP, El-Serag HB. Clin Gastroenterol Hepatol. 2020;18:534-42.
7. Kim Y et al. Epidemiol Health. 2015;37:e2015066.
8. Kamineni A et al. Cancer Causes Control. 1999;10:77-83.
9. Pabla BS et al. Clin Gastroenterol Hepatol. 2020;18:347-59.
10. Shah SC et al. Knowledge Gaps among Physicians Caring for Multiethnic Populations at Increased Gastric Cancer Risk. Gut Liver. 2018 Jan 15;12(1):38-45.
11. International Agency for Research on Cancer. Monographs on the Identification of Carcinogenic Hazards to Humans. IARC. July 7, 2019. 12. Uemura N et al. N Engl J Med. 2001;345:784-9.
13. Lee YC et al. Gastroenterology. 2016;150:1113-24.
14. Ford AC et al. BMJ. 2014;348:g3174.
15. Chey W et al. Am J Gastroenterol. 2017;112:212-39.
16. Kumar S et al. Gastroenterology. 2020;158:527-36.
17. Kumar S et al. Clin Gastroenterol Hepatol. 2020 Apr 6;S1542-3565(20)30436-5.
18. González CA et al. Int J Cancer. 2003;107:629-34.
19. Ladeiras-Lopes R et al. Cancer Causes Control. 2008;19:689-701.
20. Cavaleiro-Pinto M et al. Cancer Causes Control. 2011;22:375-87.
21. Lauby-Secretan B et al. N Engl J Med. 2016;375:794-8.
22. Choi IJ et al. N Engl J Med. 2020;382:427-36.
23. Kim BJ et al. World J Gastroenterol. 2013;19:736-41.
24. Hamashima C. Jpn J Clin Oncol. 2018;48:278–86.
25. Saumoy M et al. Gastroenterology. 2018;155:648-60.
26. Shah SC et al. Clin Gastroenterol Hepatol. 2020 Jul 21:S1542-3565(20)30993-9. doi: 10.1016/j.cgh.2020.07.031.
27. Brinton LA et al. Br J Cancer. 1989;59:810-3.
28. Hsing AW et al. Cancer. 1993;71:745-50.
29. Schafer LW et al. Mayo Clin Proc. 1985;60:444-8.
30. American Society for Gastrointestinal Endoscopy Standards of Practice Committee. Gastrointest Endosc. 2015;82:1-8.
31. Chiu PWY et al. Gut. 2019;68:186-97.
32. Pimentel-Nunes P et al. Endoscopy. 2012;44:236-46.
33. Pimentel-Nunes P et al. Endoscopy. 2016;48:723-30.
34. Participants in the Paris Workshop. Gastrointest Endosc. 2003;58:S3-43.
35. Draganov PV et al. Clin Gastroenterol Hepatol. 2019;17:16-25.
36. Ngamruengphong S et al. Clin Gastroenterol Hepatol. 2020 Jun 18;S1542-3565(20)30834-X. Online ahead of print.
37. Choi IJ et al. N Engl J Med. 2018;378:1085-95.
Dr. Tomizawa is a clinical assistant professor of medicine in the division of gastroenterology, University of Washington, Seattle.
Introduction
Although gastric cancer is one of the most common causes of cancer death in the world, the burden of gastric cancer in the United States tends to be underestimated relative to that of other cancers of the digestive system. In fact, the 5-year survival rate from gastric cancer remains poor (~32%)1 in the United States, and this is largely because gastric cancers are not diagnosed at an early stage when curative therapeutic options are available. Cumulative epidemiologic data consistently demonstrate that the incidence of gastric cancer in the United States varies according to ethnicity, immigrant status, and country of origin. It is important for practicing gastroenterologists in the United States to recognize individual risk profiles and identify people at higher risk for gastric cancer. Hereditary diffuse gastric cancer is an inherited form of diffuse-type gastric cancer and has pathogenic variants in the E-cadherin gene that are inherited in an autosomal dominant pattern. The lifetime risk of gastric cancer in individuals with HDGC is very high, and prophylactic total gastrectomy is usually advised. This article focuses on intestinal type cancer.
Epidemiology
Gastric cancer (proximal and distal gastric cancer combined) is the fifth most frequently diagnosed cancer and the third most common cause of cancer death worldwide, with 1,033,701 new cases and 782,685 deaths in 2018.2 Gastric cancer is subcategorized based on location (proximal [i.e., esophagogastric junctional, gastric cardia] and distal) and histology (intestinal and diffuse type), and each subtype is considered to have a distinct pathogenesis. Distal intestinal type gastric cancer is most commonly encountered in clinical practice. In this article, gastric cancer will signify distal intestinal type gastric cancer unless it is otherwise noted. In general, incidence rates are about twofold higher in men than in women. There is marked geographic variation in incidence rates, and the age-standardized incidence rates in eastern Asia (32.1 and 13.2, per 100,000) are approximately six times higher than those in northern America (5.6 and 2.8, per 100,000) in both men and women, respectively.2 Recent studies evaluating global trends in the incidence and mortality of gastric cancer have demonstrated decreases worldwide.3-5 However, the degree of decrease in the incidence and mortality of gastric cancer varies substantially across geographic regions, reflecting the heterogeneous distribution of risk profiles. A comprehensive analysis of a U.S. population registry demonstrated a linear decrease in the incidence of gastric cancer in the United States (0.94% decrease per year between 2001 and 2015),6 though the annual percent change in the gastric cancer mortality in the United States was lower (around 2% decrease per year between 1980 and 2011) than in other countries.3Several population-based studies conducted in the United States have demonstrated that the incidence of gastric cancer varied by ethnicity, immigrant status, and country of origin, and the highest incidence was observed among Asian immigrants.7,8 A comprehensive meta-analysis examining the risk of gastric cancer in immigrants from high-incidence regions to low-incidence regions found a persistently higher risk of gastric cancer and related mortality among immigrants.9 These results indicate that there are important risk factors such as environmental and dietary factors in addition to the traditionally considered risk factors including male gender, age, family history, and tobacco use. A survey conducted in an ethnically and culturally diverse U.S. city showed that gastroenterology providers demonstrated knowledge deficiencies in identifying and managing patients with increased risk of gastric cancer.10 Recognizing individualized risk profiles in higher-risk groups (e.g., immigrants from higher-incidence/prevalence regions) is important for optimizing management of gastric cancer in the United States.
Assessment and management of modifiable risk factors
Helicobacter pylori, a group 1 carcinogen, is the most well-recognized risk factor for gastric cancer, particularly noncardia gastric cancer.11 Since a landmark longitudinal follow-up study in Japan demonstrated that people with H. pylori infection are more likely to develop gastric cancer than those without H. pylori infection,12 accumulating evidence largely from Asian countries has shown that eradication of H. pylori is associated with a reduced incidence of gastric cancer regardless of baseline risk.13 There are also data on the protective effect for gastric cancer of H. pylori eradication in asymptomatic individuals. Another meta-analysis of six international randomized control trials demonstrated a 34% relative risk reduction of gastric cancer occurrence in asymptomatic people (relative risk of developing gastric cancer was 0.66 in those who received eradication therapy compared with those with placebo or no treatment, 95% CI, 0.46-0.95).14 A U.S. practice guideline published after these meta-analyses recommends that all patients with a positive test indicating active infection with H. pylori should be offered treatment and testing to prove eradication,15 though the recommendation was not purely intended to reduce the gastric cancer risk in U.S. population. Subsequently, a Department of Veterans Affairs cohort study added valuable insights from a U.S. experience to the body of evidence from other countries with higher prevalence. In this study of more than 370,000 patients with a history of H. pylori infection, the detection and successful eradication of H. pylori was associated with a 76% lower incidence of gastric cancer compared with people without H. pylori treatment.16 This study also provided insight into H. pylori treatment practice patterns. Of patients with a positive H. pylori test result (stool antigen, urea breath test, or pathology), approximately 75% were prescribed an eradication regimen and only 21% of those underwent eradication tests. A low rate (24%) of eradication testing was subsequently reported by the same group among U.S. patients regardless of gastric cancer risk profiles.17 The lesson from the aforementioned study is that treatment and eradication of H. pylori even among asymptomatic U.S. patients reduces the risk of subsequent gastric cancer. However, it may be difficult to generalize the results of this study given the nature of the Veterans Affairs cohort, and more data are required to justify the implementation of nationwide preventive H. pylori screening in the general U.S. population.
Smoking has been recognized as the other important risk factor. A study from the European prospective multicenter cohort demonstrated a significant association of cigarette smoking and gastric cancer risk (HR for ever-smokers 1.45 [95% CI, 1.08-1.94], current-smokers in males 1.73 [95% CI, 1.06-2.83], and current smokers in females 1.87 [95% CI, 1.12-3.12], respectively) after adjustment for educational level, dietary consumption profiles, alcohol intake, and body mass index (BMI).18 A subsequent meta-analysis provided solid evidence of smoking as the important behavioral risk factor for gastric cancer.19 Smoking also predisposed to the development of proximal gastric cancer.20 Along with other cancers in the digestive system such as in the esophagus, colon and rectum, liver, gallbladder, and pancreas, a significant association of BMI and the risk of proximal gastric cancer (RR of the highest BMI category compared with normal BMI, 1.8 [95% CI, 1.3-2.5]) was reported, with positive dose-response relationships; however, the association was not sufficient for distal gastric cancer.21 There is also evidence to show a trend of greater alcohol consumption (>45 grams per day [about 3 drinks a day]) associated with the increased risk of gastric cancer.21 It has been thought that salt and salt-preserved food increase the risk of gastric cancer. It should be noted that the observational studies showing the associations were published from Asian countries where such foods were a substantial part of traditional diets (e.g., salted vegetables in Japan) and the incidence of gastric cancer is high. There is also a speculation that preserved foods may have been eaten in more underserved, low socioeconomic regions where refrigeration was not available and prevalence of H. pylori infection was higher. Except for documented inherited form of gastric cancer (e.g., HDGC or hereditary cancer syndromes), most gastric cancers are considered sporadic. A recent randomized study published from South Korea investigated a cohort of higher-risk asymptomatic patients with family history significant for gastric cancer. This study of 1,676 subjects with a median follow-up of 9.2 years showed that successful eradication of H. pylori in the first-degree relatives of those with gastric cancer significantly reduced the risk (HR 0.45 [95% CI, 0.21-0.94]) of developing gastric cancer.22 As previously discussed, in the United States where the prevalence of H. pylori and the incidence of gastric cancer are both lower than in some Asian countries, routine screening of asymptomatic individuals for H. pylori is not justified yet. There may be a role for screening individuals who are first-generation immigrants from areas of high gastric cancer incidence and also have a first-degree relative with gastric cancer.
Who should we consider high risk and offer screening EGD?
With available evidence to date, screening for gastric cancer in a general U.S. population is not recommended. However, it is important to acknowledge the aforementioned varying incidence of gastric cancer in the United States among ethnicity, immigrant status, and country of origin. Immigrants from high-incidence regions maintain a higher risk of gastric cancer and related mortality even after migration to lower-incidence regions. The latter comprehensive study estimated that as many as 12.7 million people (29.4% of total U.S. immigrant population) have emigrated from higher-incidence regions including East Asian and some Central American countries.9 Indeed, an opportunistic nationwide gastric cancer screening program has been implemented in South Korea (beginning at age 40, biannually)23 and Japan (beginning at age 50, biannually).24 Two decision-analytic simulation studies have provided insight into the uncertainty about the cost effectiveness for potential targeted gastric cancer screening in higher-risk populations in the United States. One study demonstrated that esophagogastroduodenoscopy (EGD) screening for otherwise asymptomatic Asian American people (as well as Hispanics and non-Hispanic Blacks) at the time of screening colonoscopy at 50 years of age with continued endoscopic surveillance every 3 years was cost effective, only if gastric intestinal metaplasia (GIM) or more advanced lesions were diagnosed at the index screening EGD.25 Previous studies analyzing the cost effectiveness for gastric cancer screening in the United States had the limitation of not stratifying according to race or ethnicity, or accounting for patients diagnosed with GIM. Subsequently, the same research group extended this model analysis and has published additional findings that this strategy is cost effective for each of the most prevalent Asian American ethnicities (Chinese, Filipino, Southeast Asian, Vietnamese, Korean, and Japanese Americans) in the United States irrespective of sex.26 Although the authors raised a limitation that additional risk factors such as family history, tobacco use, or persistent H. pylori infection were not considered in the model because data regarding differentiated noncardia gastric cancer risk among Asian American ethnicities based on these risk factors are not available.
These two model analytic studies added valuable insights to the body of evidence that subsequent EGDs after the one-time bundled EGD is cost effective for higher-risk asymptomatic people in the United States, if the index screening EGD with gastric mucosal biopsies demonstrates at least GIM. Further population-based research to elucidate risk stratification among higher-risk people will provide a schema that could standardize management and resource allocation as well as increase the cost effectiveness of a gastric cancer screening program in the United States. The degree of risk of developing gastric cancer in autoimmune gastritis varies among the reported studies.27-29 Although the benefit of endoscopic screening in patients with autoimmune gastritis has not been established, a single endoscopic evaluation should be recommended soon after the diagnosis of autoimmune gastritis in order to identify prevalent neoplastic lesions.30
Practical consideration when we perform EGD for early gastric cancer screening
Identification of higher-risk patients should alert an endoscopist to observe mucosa with greater care with a lower threshold to biopsy any suspicious lesions. Preprocedural risk stratification for each individual before performing diagnostic EGD will improve early gastric cancer detection. While we perform EGD, detecting precursor lesions (atrophic gastritis and GIM) is as important as diagnosing an early gastric cancer. Screening and management of patients with precursor lesions (i.e., atrophic gastritis and GIM) is beyond the scope of this article, and this was published in a previous issue of the New Gastroenterologist. It is important to first grossly survey the entire gastric mucosa using high-definition while light (HDWL) endoscopy and screen for any focal irregular (raised or depressed) mucosal lesions. These lesions are often erythematous and should be examined carefully. Use of mucolytic and/or deforming agents (e.g., N-acetylcysteine or simethicone) is recommended for the improvement of visual clarity of gastric mucosa.31 Simethicone is widely used in the United States for colonoscopy and should also be available at the time of EGD for better gastric mucosal visibility. If irregular mucosal lesions are noted, this area should also be examined under narrowband imaging (NBI) in addition to HDWL. According to a simplified classification consisting of mucosal and vascular irregularity, NBI provides better mucosal surface morphology for diagnosis of early gastric cancer compared with HDWL, and a thorough examination of the surface characteristics is a prerequisite.32 This classification was further validated in a randomized control trial, and NBI increased sensitivity for the diagnosis of neoplasia compared with HDWL (92 % vs. 74 %).33 The majority of institutions in the United States have a newer-generation NBI (Olympus America, EVIS EXERA III video system, GIF-HQ190), which provides brighter endoscopic images to better characterize gastric neoplastic lesions. Once we recognize an area suspicious for neoplasia, we should describe the macroscopic features according to a classification system.
The Paris classification, one of the most widely recognized classification systems among U.S. gastroenterologists, is recommended for gastric neoplastic lesions.34Gastric neoplastic lesions with a “superficial” endoscopic appearance are classified as subtypes of “type 0.” The term “type 0” was chosen to distinguish the classification of “superficial” lesions from the Borrmann classification for “advanced” gastric tumors, which includes types 1 to 4. In the classification, a neoplastic lesion is called “superficial” when its endoscopic appearance suggests that the depth of penetration in the digestive wall is not more than into the submucosa (i.e., there is no infiltration of the muscularis propria). The distinctive characters of polypoid and nonpolypoid lesions are summarized in Table 1. Endoscopic submucosal dissection (ESD) has steadily gained acceptance for the treatment of early gastric cancer in the United States. The American Gastroenterological Association recommended in the 2019 institutional updated clinical practice guideline that ESD should be considered the first-line therapy for visible, endoscopically resectable, superficial gastric neoplasia.35 This recommendation is further supported by the published data on efficacy and safety of ESD for early gastric neoplasia in a large multicenter cohort in the United States.36 For all suspicious lesions, irrespective of pathological neoplastic confirmation, referral to an experienced center for further evaluation and endoscopic management should be considered. Lastly, all patients with early gastric cancer should be evaluated for H. pylori infection and treated if the test is positive. Eradication of H. pylori is associated with a lower rate of metachronous gastric cancer,37 and treatment of H. pylori as secondary prevention is also recommended.
Conclusion
As summarized above, cumulative epidemiologic data consistently demonstrate that the incidence of gastric cancer in the U.S. varies according to ethnicity, immigrant status, and country of origin. New gastroenterologists will need to recognize individual risk profiles and identify people at higher risk for gastric cancer. Risk stratification before performing endoscopic evaluation will improve early gastric cancer detection and make noninvasive, effective therapies an option.
References
1. Surveillance, Epidemiology, and End Results Program cancer statistics. https://seer.cancer.gov/statfacts/html/stomach.html.
2. Bray F et al. Ca Cancer J Clin. 2018;68:394-424.
3. Ferro A et al. Eur J Cancer. 2014;50:1330-44.
4. Luo G et al. Int J Cancer. 2017;141:1333-44.
5. Arnold M et al. Eur J Cancer. 2015;51:1164-87.
6. Thrift AP, El-Serag HB. Clin Gastroenterol Hepatol. 2020;18:534-42.
7. Kim Y et al. Epidemiol Health. 2015;37:e2015066.
8. Kamineni A et al. Cancer Causes Control. 1999;10:77-83.
9. Pabla BS et al. Clin Gastroenterol Hepatol. 2020;18:347-59.
10. Shah SC et al. Knowledge Gaps among Physicians Caring for Multiethnic Populations at Increased Gastric Cancer Risk. Gut Liver. 2018 Jan 15;12(1):38-45.
11. International Agency for Research on Cancer. Monographs on the Identification of Carcinogenic Hazards to Humans. IARC. July 7, 2019. 12. Uemura N et al. N Engl J Med. 2001;345:784-9.
13. Lee YC et al. Gastroenterology. 2016;150:1113-24.
14. Ford AC et al. BMJ. 2014;348:g3174.
15. Chey W et al. Am J Gastroenterol. 2017;112:212-39.
16. Kumar S et al. Gastroenterology. 2020;158:527-36.
17. Kumar S et al. Clin Gastroenterol Hepatol. 2020 Apr 6;S1542-3565(20)30436-5.
18. González CA et al. Int J Cancer. 2003;107:629-34.
19. Ladeiras-Lopes R et al. Cancer Causes Control. 2008;19:689-701.
20. Cavaleiro-Pinto M et al. Cancer Causes Control. 2011;22:375-87.
21. Lauby-Secretan B et al. N Engl J Med. 2016;375:794-8.
22. Choi IJ et al. N Engl J Med. 2020;382:427-36.
23. Kim BJ et al. World J Gastroenterol. 2013;19:736-41.
24. Hamashima C. Jpn J Clin Oncol. 2018;48:278–86.
25. Saumoy M et al. Gastroenterology. 2018;155:648-60.
26. Shah SC et al. Clin Gastroenterol Hepatol. 2020 Jul 21:S1542-3565(20)30993-9. doi: 10.1016/j.cgh.2020.07.031.
27. Brinton LA et al. Br J Cancer. 1989;59:810-3.
28. Hsing AW et al. Cancer. 1993;71:745-50.
29. Schafer LW et al. Mayo Clin Proc. 1985;60:444-8.
30. American Society for Gastrointestinal Endoscopy Standards of Practice Committee. Gastrointest Endosc. 2015;82:1-8.
31. Chiu PWY et al. Gut. 2019;68:186-97.
32. Pimentel-Nunes P et al. Endoscopy. 2012;44:236-46.
33. Pimentel-Nunes P et al. Endoscopy. 2016;48:723-30.
34. Participants in the Paris Workshop. Gastrointest Endosc. 2003;58:S3-43.
35. Draganov PV et al. Clin Gastroenterol Hepatol. 2019;17:16-25.
36. Ngamruengphong S et al. Clin Gastroenterol Hepatol. 2020 Jun 18;S1542-3565(20)30834-X. Online ahead of print.
37. Choi IJ et al. N Engl J Med. 2018;378:1085-95.
Dr. Tomizawa is a clinical assistant professor of medicine in the division of gastroenterology, University of Washington, Seattle.
Introduction
Although gastric cancer is one of the most common causes of cancer death in the world, the burden of gastric cancer in the United States tends to be underestimated relative to that of other cancers of the digestive system. In fact, the 5-year survival rate from gastric cancer remains poor (~32%)1 in the United States, and this is largely because gastric cancers are not diagnosed at an early stage when curative therapeutic options are available. Cumulative epidemiologic data consistently demonstrate that the incidence of gastric cancer in the United States varies according to ethnicity, immigrant status, and country of origin. It is important for practicing gastroenterologists in the United States to recognize individual risk profiles and identify people at higher risk for gastric cancer. Hereditary diffuse gastric cancer is an inherited form of diffuse-type gastric cancer and has pathogenic variants in the E-cadherin gene that are inherited in an autosomal dominant pattern. The lifetime risk of gastric cancer in individuals with HDGC is very high, and prophylactic total gastrectomy is usually advised. This article focuses on intestinal type cancer.
Epidemiology
Gastric cancer (proximal and distal gastric cancer combined) is the fifth most frequently diagnosed cancer and the third most common cause of cancer death worldwide, with 1,033,701 new cases and 782,685 deaths in 2018.2 Gastric cancer is subcategorized based on location (proximal [i.e., esophagogastric junctional, gastric cardia] and distal) and histology (intestinal and diffuse type), and each subtype is considered to have a distinct pathogenesis. Distal intestinal type gastric cancer is most commonly encountered in clinical practice. In this article, gastric cancer will signify distal intestinal type gastric cancer unless it is otherwise noted. In general, incidence rates are about twofold higher in men than in women. There is marked geographic variation in incidence rates, and the age-standardized incidence rates in eastern Asia (32.1 and 13.2, per 100,000) are approximately six times higher than those in northern America (5.6 and 2.8, per 100,000) in both men and women, respectively.2 Recent studies evaluating global trends in the incidence and mortality of gastric cancer have demonstrated decreases worldwide.3-5 However, the degree of decrease in the incidence and mortality of gastric cancer varies substantially across geographic regions, reflecting the heterogeneous distribution of risk profiles. A comprehensive analysis of a U.S. population registry demonstrated a linear decrease in the incidence of gastric cancer in the United States (0.94% decrease per year between 2001 and 2015),6 though the annual percent change in the gastric cancer mortality in the United States was lower (around 2% decrease per year between 1980 and 2011) than in other countries.3Several population-based studies conducted in the United States have demonstrated that the incidence of gastric cancer varied by ethnicity, immigrant status, and country of origin, and the highest incidence was observed among Asian immigrants.7,8 A comprehensive meta-analysis examining the risk of gastric cancer in immigrants from high-incidence regions to low-incidence regions found a persistently higher risk of gastric cancer and related mortality among immigrants.9 These results indicate that there are important risk factors such as environmental and dietary factors in addition to the traditionally considered risk factors including male gender, age, family history, and tobacco use. A survey conducted in an ethnically and culturally diverse U.S. city showed that gastroenterology providers demonstrated knowledge deficiencies in identifying and managing patients with increased risk of gastric cancer.10 Recognizing individualized risk profiles in higher-risk groups (e.g., immigrants from higher-incidence/prevalence regions) is important for optimizing management of gastric cancer in the United States.
Assessment and management of modifiable risk factors
Helicobacter pylori, a group 1 carcinogen, is the most well-recognized risk factor for gastric cancer, particularly noncardia gastric cancer.11 Since a landmark longitudinal follow-up study in Japan demonstrated that people with H. pylori infection are more likely to develop gastric cancer than those without H. pylori infection,12 accumulating evidence largely from Asian countries has shown that eradication of H. pylori is associated with a reduced incidence of gastric cancer regardless of baseline risk.13 There are also data on the protective effect for gastric cancer of H. pylori eradication in asymptomatic individuals. Another meta-analysis of six international randomized control trials demonstrated a 34% relative risk reduction of gastric cancer occurrence in asymptomatic people (relative risk of developing gastric cancer was 0.66 in those who received eradication therapy compared with those with placebo or no treatment, 95% CI, 0.46-0.95).14 A U.S. practice guideline published after these meta-analyses recommends that all patients with a positive test indicating active infection with H. pylori should be offered treatment and testing to prove eradication,15 though the recommendation was not purely intended to reduce the gastric cancer risk in U.S. population. Subsequently, a Department of Veterans Affairs cohort study added valuable insights from a U.S. experience to the body of evidence from other countries with higher prevalence. In this study of more than 370,000 patients with a history of H. pylori infection, the detection and successful eradication of H. pylori was associated with a 76% lower incidence of gastric cancer compared with people without H. pylori treatment.16 This study also provided insight into H. pylori treatment practice patterns. Of patients with a positive H. pylori test result (stool antigen, urea breath test, or pathology), approximately 75% were prescribed an eradication regimen and only 21% of those underwent eradication tests. A low rate (24%) of eradication testing was subsequently reported by the same group among U.S. patients regardless of gastric cancer risk profiles.17 The lesson from the aforementioned study is that treatment and eradication of H. pylori even among asymptomatic U.S. patients reduces the risk of subsequent gastric cancer. However, it may be difficult to generalize the results of this study given the nature of the Veterans Affairs cohort, and more data are required to justify the implementation of nationwide preventive H. pylori screening in the general U.S. population.
Smoking has been recognized as the other important risk factor. A study from the European prospective multicenter cohort demonstrated a significant association of cigarette smoking and gastric cancer risk (HR for ever-smokers 1.45 [95% CI, 1.08-1.94], current-smokers in males 1.73 [95% CI, 1.06-2.83], and current smokers in females 1.87 [95% CI, 1.12-3.12], respectively) after adjustment for educational level, dietary consumption profiles, alcohol intake, and body mass index (BMI).18 A subsequent meta-analysis provided solid evidence of smoking as the important behavioral risk factor for gastric cancer.19 Smoking also predisposed to the development of proximal gastric cancer.20 Along with other cancers in the digestive system such as in the esophagus, colon and rectum, liver, gallbladder, and pancreas, a significant association of BMI and the risk of proximal gastric cancer (RR of the highest BMI category compared with normal BMI, 1.8 [95% CI, 1.3-2.5]) was reported, with positive dose-response relationships; however, the association was not sufficient for distal gastric cancer.21 There is also evidence to show a trend of greater alcohol consumption (>45 grams per day [about 3 drinks a day]) associated with the increased risk of gastric cancer.21 It has been thought that salt and salt-preserved food increase the risk of gastric cancer. It should be noted that the observational studies showing the associations were published from Asian countries where such foods were a substantial part of traditional diets (e.g., salted vegetables in Japan) and the incidence of gastric cancer is high. There is also a speculation that preserved foods may have been eaten in more underserved, low socioeconomic regions where refrigeration was not available and prevalence of H. pylori infection was higher. Except for documented inherited form of gastric cancer (e.g., HDGC or hereditary cancer syndromes), most gastric cancers are considered sporadic. A recent randomized study published from South Korea investigated a cohort of higher-risk asymptomatic patients with family history significant for gastric cancer. This study of 1,676 subjects with a median follow-up of 9.2 years showed that successful eradication of H. pylori in the first-degree relatives of those with gastric cancer significantly reduced the risk (HR 0.45 [95% CI, 0.21-0.94]) of developing gastric cancer.22 As previously discussed, in the United States where the prevalence of H. pylori and the incidence of gastric cancer are both lower than in some Asian countries, routine screening of asymptomatic individuals for H. pylori is not justified yet. There may be a role for screening individuals who are first-generation immigrants from areas of high gastric cancer incidence and also have a first-degree relative with gastric cancer.
Who should we consider high risk and offer screening EGD?
With available evidence to date, screening for gastric cancer in a general U.S. population is not recommended. However, it is important to acknowledge the aforementioned varying incidence of gastric cancer in the United States among ethnicity, immigrant status, and country of origin. Immigrants from high-incidence regions maintain a higher risk of gastric cancer and related mortality even after migration to lower-incidence regions. The latter comprehensive study estimated that as many as 12.7 million people (29.4% of total U.S. immigrant population) have emigrated from higher-incidence regions including East Asian and some Central American countries.9 Indeed, an opportunistic nationwide gastric cancer screening program has been implemented in South Korea (beginning at age 40, biannually)23 and Japan (beginning at age 50, biannually).24 Two decision-analytic simulation studies have provided insight into the uncertainty about the cost effectiveness for potential targeted gastric cancer screening in higher-risk populations in the United States. One study demonstrated that esophagogastroduodenoscopy (EGD) screening for otherwise asymptomatic Asian American people (as well as Hispanics and non-Hispanic Blacks) at the time of screening colonoscopy at 50 years of age with continued endoscopic surveillance every 3 years was cost effective, only if gastric intestinal metaplasia (GIM) or more advanced lesions were diagnosed at the index screening EGD.25 Previous studies analyzing the cost effectiveness for gastric cancer screening in the United States had the limitation of not stratifying according to race or ethnicity, or accounting for patients diagnosed with GIM. Subsequently, the same research group extended this model analysis and has published additional findings that this strategy is cost effective for each of the most prevalent Asian American ethnicities (Chinese, Filipino, Southeast Asian, Vietnamese, Korean, and Japanese Americans) in the United States irrespective of sex.26 Although the authors raised a limitation that additional risk factors such as family history, tobacco use, or persistent H. pylori infection were not considered in the model because data regarding differentiated noncardia gastric cancer risk among Asian American ethnicities based on these risk factors are not available.
These two model analytic studies added valuable insights to the body of evidence that subsequent EGDs after the one-time bundled EGD is cost effective for higher-risk asymptomatic people in the United States, if the index screening EGD with gastric mucosal biopsies demonstrates at least GIM. Further population-based research to elucidate risk stratification among higher-risk people will provide a schema that could standardize management and resource allocation as well as increase the cost effectiveness of a gastric cancer screening program in the United States. The degree of risk of developing gastric cancer in autoimmune gastritis varies among the reported studies.27-29 Although the benefit of endoscopic screening in patients with autoimmune gastritis has not been established, a single endoscopic evaluation should be recommended soon after the diagnosis of autoimmune gastritis in order to identify prevalent neoplastic lesions.30
Practical consideration when we perform EGD for early gastric cancer screening
Identification of higher-risk patients should alert an endoscopist to observe mucosa with greater care with a lower threshold to biopsy any suspicious lesions. Preprocedural risk stratification for each individual before performing diagnostic EGD will improve early gastric cancer detection. While we perform EGD, detecting precursor lesions (atrophic gastritis and GIM) is as important as diagnosing an early gastric cancer. Screening and management of patients with precursor lesions (i.e., atrophic gastritis and GIM) is beyond the scope of this article, and this was published in a previous issue of the New Gastroenterologist. It is important to first grossly survey the entire gastric mucosa using high-definition while light (HDWL) endoscopy and screen for any focal irregular (raised or depressed) mucosal lesions. These lesions are often erythematous and should be examined carefully. Use of mucolytic and/or deforming agents (e.g., N-acetylcysteine or simethicone) is recommended for the improvement of visual clarity of gastric mucosa.31 Simethicone is widely used in the United States for colonoscopy and should also be available at the time of EGD for better gastric mucosal visibility. If irregular mucosal lesions are noted, this area should also be examined under narrowband imaging (NBI) in addition to HDWL. According to a simplified classification consisting of mucosal and vascular irregularity, NBI provides better mucosal surface morphology for diagnosis of early gastric cancer compared with HDWL, and a thorough examination of the surface characteristics is a prerequisite.32 This classification was further validated in a randomized control trial, and NBI increased sensitivity for the diagnosis of neoplasia compared with HDWL (92 % vs. 74 %).33 The majority of institutions in the United States have a newer-generation NBI (Olympus America, EVIS EXERA III video system, GIF-HQ190), which provides brighter endoscopic images to better characterize gastric neoplastic lesions. Once we recognize an area suspicious for neoplasia, we should describe the macroscopic features according to a classification system.
The Paris classification, one of the most widely recognized classification systems among U.S. gastroenterologists, is recommended for gastric neoplastic lesions.34Gastric neoplastic lesions with a “superficial” endoscopic appearance are classified as subtypes of “type 0.” The term “type 0” was chosen to distinguish the classification of “superficial” lesions from the Borrmann classification for “advanced” gastric tumors, which includes types 1 to 4. In the classification, a neoplastic lesion is called “superficial” when its endoscopic appearance suggests that the depth of penetration in the digestive wall is not more than into the submucosa (i.e., there is no infiltration of the muscularis propria). The distinctive characters of polypoid and nonpolypoid lesions are summarized in Table 1. Endoscopic submucosal dissection (ESD) has steadily gained acceptance for the treatment of early gastric cancer in the United States. The American Gastroenterological Association recommended in the 2019 institutional updated clinical practice guideline that ESD should be considered the first-line therapy for visible, endoscopically resectable, superficial gastric neoplasia.35 This recommendation is further supported by the published data on efficacy and safety of ESD for early gastric neoplasia in a large multicenter cohort in the United States.36 For all suspicious lesions, irrespective of pathological neoplastic confirmation, referral to an experienced center for further evaluation and endoscopic management should be considered. Lastly, all patients with early gastric cancer should be evaluated for H. pylori infection and treated if the test is positive. Eradication of H. pylori is associated with a lower rate of metachronous gastric cancer,37 and treatment of H. pylori as secondary prevention is also recommended.
Conclusion
As summarized above, cumulative epidemiologic data consistently demonstrate that the incidence of gastric cancer in the U.S. varies according to ethnicity, immigrant status, and country of origin. New gastroenterologists will need to recognize individual risk profiles and identify people at higher risk for gastric cancer. Risk stratification before performing endoscopic evaluation will improve early gastric cancer detection and make noninvasive, effective therapies an option.
References
1. Surveillance, Epidemiology, and End Results Program cancer statistics. https://seer.cancer.gov/statfacts/html/stomach.html.
2. Bray F et al. Ca Cancer J Clin. 2018;68:394-424.
3. Ferro A et al. Eur J Cancer. 2014;50:1330-44.
4. Luo G et al. Int J Cancer. 2017;141:1333-44.
5. Arnold M et al. Eur J Cancer. 2015;51:1164-87.
6. Thrift AP, El-Serag HB. Clin Gastroenterol Hepatol. 2020;18:534-42.
7. Kim Y et al. Epidemiol Health. 2015;37:e2015066.
8. Kamineni A et al. Cancer Causes Control. 1999;10:77-83.
9. Pabla BS et al. Clin Gastroenterol Hepatol. 2020;18:347-59.
10. Shah SC et al. Knowledge Gaps among Physicians Caring for Multiethnic Populations at Increased Gastric Cancer Risk. Gut Liver. 2018 Jan 15;12(1):38-45.
11. International Agency for Research on Cancer. Monographs on the Identification of Carcinogenic Hazards to Humans. IARC. July 7, 2019. 12. Uemura N et al. N Engl J Med. 2001;345:784-9.
13. Lee YC et al. Gastroenterology. 2016;150:1113-24.
14. Ford AC et al. BMJ. 2014;348:g3174.
15. Chey W et al. Am J Gastroenterol. 2017;112:212-39.
16. Kumar S et al. Gastroenterology. 2020;158:527-36.
17. Kumar S et al. Clin Gastroenterol Hepatol. 2020 Apr 6;S1542-3565(20)30436-5.
18. González CA et al. Int J Cancer. 2003;107:629-34.
19. Ladeiras-Lopes R et al. Cancer Causes Control. 2008;19:689-701.
20. Cavaleiro-Pinto M et al. Cancer Causes Control. 2011;22:375-87.
21. Lauby-Secretan B et al. N Engl J Med. 2016;375:794-8.
22. Choi IJ et al. N Engl J Med. 2020;382:427-36.
23. Kim BJ et al. World J Gastroenterol. 2013;19:736-41.
24. Hamashima C. Jpn J Clin Oncol. 2018;48:278–86.
25. Saumoy M et al. Gastroenterology. 2018;155:648-60.
26. Shah SC et al. Clin Gastroenterol Hepatol. 2020 Jul 21:S1542-3565(20)30993-9. doi: 10.1016/j.cgh.2020.07.031.
27. Brinton LA et al. Br J Cancer. 1989;59:810-3.
28. Hsing AW et al. Cancer. 1993;71:745-50.
29. Schafer LW et al. Mayo Clin Proc. 1985;60:444-8.
30. American Society for Gastrointestinal Endoscopy Standards of Practice Committee. Gastrointest Endosc. 2015;82:1-8.
31. Chiu PWY et al. Gut. 2019;68:186-97.
32. Pimentel-Nunes P et al. Endoscopy. 2012;44:236-46.
33. Pimentel-Nunes P et al. Endoscopy. 2016;48:723-30.
34. Participants in the Paris Workshop. Gastrointest Endosc. 2003;58:S3-43.
35. Draganov PV et al. Clin Gastroenterol Hepatol. 2019;17:16-25.
36. Ngamruengphong S et al. Clin Gastroenterol Hepatol. 2020 Jun 18;S1542-3565(20)30834-X. Online ahead of print.
37. Choi IJ et al. N Engl J Med. 2018;378:1085-95.
Dr. Tomizawa is a clinical assistant professor of medicine in the division of gastroenterology, University of Washington, Seattle.
Calendar
For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.
UPCOMING EVENTS
Jan. 15-17, 2021
Gastrointestinal Cancers Symposium
Through an engaging lineup of novel science, education, and exhibits, the virtual 2021 Gastrointestinal (GI) Cancers Symposium offers new, innovative findings in GI cancer treatment, research, and care.
Early-bird deadline: Dec. 16, 2020.
Jan. 21-24, 2021
Crohn’s & Colitis Congress®Join health care professionals and researchers virtually at the Crohn’s & Colitis Congress® for the premier conference on IBD. Discover different perspectives, practical information you can immediately implement, and potential treatments on the horizon.
Early-bird deadline: Friday, Nov. 6, 2020.
May 21-23, 2021
Digestive Disease Week® (DDW)
Save the date for the world’s leading event in digestive disease. DDW® brings professionals in gastroenterology, hepatology, endoscopy, and GI surgery together. Experience growth when you share your research, converge with trailblazers, and improve the lives of patients suffering from GI and liver diseases.
Abstract submission window Oct. 15 to Dec. 3, 2020.
AWARD DEADLINES
American Gastroenterological Association (AGA) Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students,or medical residents (residents up to postgraduate year 3) giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Student Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
AGA–Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award provides support to early-career (that is, 35 years of age or younger at the time of DDW) basic, translational or clinical investigators residing outside North America to offset travel and related expenses to attend DDW.
Application deadline: Feb. 24, 2021
AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD, or equivalent fellows giving abstract-based oral or poster presentations DDW. The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.
UPCOMING EVENTS
Jan. 15-17, 2021
Gastrointestinal Cancers Symposium
Through an engaging lineup of novel science, education, and exhibits, the virtual 2021 Gastrointestinal (GI) Cancers Symposium offers new, innovative findings in GI cancer treatment, research, and care.
Early-bird deadline: Dec. 16, 2020.
Jan. 21-24, 2021
Crohn’s & Colitis Congress®Join health care professionals and researchers virtually at the Crohn’s & Colitis Congress® for the premier conference on IBD. Discover different perspectives, practical information you can immediately implement, and potential treatments on the horizon.
Early-bird deadline: Friday, Nov. 6, 2020.
May 21-23, 2021
Digestive Disease Week® (DDW)
Save the date for the world’s leading event in digestive disease. DDW® brings professionals in gastroenterology, hepatology, endoscopy, and GI surgery together. Experience growth when you share your research, converge with trailblazers, and improve the lives of patients suffering from GI and liver diseases.
Abstract submission window Oct. 15 to Dec. 3, 2020.
AWARD DEADLINES
American Gastroenterological Association (AGA) Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students,or medical residents (residents up to postgraduate year 3) giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Student Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
AGA–Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award provides support to early-career (that is, 35 years of age or younger at the time of DDW) basic, translational or clinical investigators residing outside North America to offset travel and related expenses to attend DDW.
Application deadline: Feb. 24, 2021
AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD, or equivalent fellows giving abstract-based oral or poster presentations DDW. The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.
UPCOMING EVENTS
Jan. 15-17, 2021
Gastrointestinal Cancers Symposium
Through an engaging lineup of novel science, education, and exhibits, the virtual 2021 Gastrointestinal (GI) Cancers Symposium offers new, innovative findings in GI cancer treatment, research, and care.
Early-bird deadline: Dec. 16, 2020.
Jan. 21-24, 2021
Crohn’s & Colitis Congress®Join health care professionals and researchers virtually at the Crohn’s & Colitis Congress® for the premier conference on IBD. Discover different perspectives, practical information you can immediately implement, and potential treatments on the horizon.
Early-bird deadline: Friday, Nov. 6, 2020.
May 21-23, 2021
Digestive Disease Week® (DDW)
Save the date for the world’s leading event in digestive disease. DDW® brings professionals in gastroenterology, hepatology, endoscopy, and GI surgery together. Experience growth when you share your research, converge with trailblazers, and improve the lives of patients suffering from GI and liver diseases.
Abstract submission window Oct. 15 to Dec. 3, 2020.
AWARD DEADLINES
American Gastroenterological Association (AGA) Student Abstract Award
This $500 travel award supports recipients who are graduate students, medical students,or medical residents (residents up to postgraduate year 3) giving abstract-based oral or poster presentations at Digestive Disease Week® (DDW). The top-scoring abstract will be designated the Student Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
AGA–Moti L. & Kamla Rustgi International Travel Awards
This $750 travel award provides support to early-career (that is, 35 years of age or younger at the time of DDW) basic, translational or clinical investigators residing outside North America to offset travel and related expenses to attend DDW.
Application deadline: Feb. 24, 2021
AGA Fellow Abstract Award
This $500 travel award supports recipients who are MD, PhD, or equivalent fellows giving abstract-based oral or poster presentations DDW. The top-scoring abstract will be designated the Fellow Abstract of the Year and receive a $1,000 award.
Application deadline: Feb. 24, 2021
Quality measures and initiatives in private practices
It has been almost 15 years since the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy established the Task Force on Quality Endoscopy and published the first set of quality indicators for GI endoscopic procedures.
This work was motivated by two seminal reports on patient safety that fostered a demand by the public, policy makers, and payers to accurately define and measure the quality of health care services.
While the Centers for Medicare & Medicaid Services initially designated and required reporting on several basic outcome measures, leaders within the field of gastroenterology recognized the importance of developing evidence-based quality measures for our field, and specifically for endoscopic procedures.
Integrating safety measures into our daily operations has always been important, and over the years, policies have been implemented to incentivize health care providers to meet standards in everything from patient safety to patient satisfaction.
Defining quality and how to measure it
The goals of implementing quality measures within private practices include effective patient care and safety, but they also include issues like access and affordability, as well as the professionalism of your physicians and advanced practice providers.
As a larger practice, we have the resources to support a quality coordinator who spends half their time focused on quality measures. Every provider is required to complete annual education on quality parameters.
We have two committees that propose and track quality initiatives in our practice. We have one on the practice side and one for our ambulatory surgery centers (ASCs). The committees are made of physicians who have a particular interest in quality measures. On the ASC side, our ASC center director from our management partner AmSurg is also a member of the committee.
The road to improving quality within a private practice starts by defining the aspects of care that affect the quality of the patient experience.
Tracking quality in the office and in the surgery center
In our practices we have about 60 physicians. Start times and coding accuracy are good examples of what we have tracked in the past as areas of quality improvement. For instance, if only one or two providers get started late, it can cause a domino effect. Schedules get cramped, which can increase stress and possibly cause our team members to rush. Even things that seem like patient satisfaction issues can affect patient care, so it is important to make sure they are being measured.
On the ASC side, we track adenoma detection rates, colonoscopy intervals, complication rates, and many other additional criteria. As an example, when a pathology report is issued, we require our physicians to provide results to our patients within 72 hours.
Data on all providers are tabulated quarterly and then distributed to the providers in the form of a scorecard. The scorecard is then used for constructive feedback on improvements that can be made. A cumulative annual report is given to the providers, which is also incorporated into reviews. Not paying attention to quality measures can potentially have financial ramifications for providers in our group.
Find the right fit from a quality standpoint
In terms of what we are tracking, we are probably not that different from most groups of our size. Standardization will continue to increase, and it is important as an early career physician to familiarize yourself with quality measures in gastroenterology.
I often interview early career physicians who would like to join Regional GI, and the most impressive are the young men and women who ask about our processes for tracking quality measures and implementing programs geared toward improvement. If you are thinking of joining a practice, bring it up. You will be glad you did.
The interest in quality shows that you are invested in providing the best evidence-based patient care. As an independent group, this is critical because so much of what we do depends on having a track record of measurement. For instance, an ASC might not be credentialed if the quality metrics do not meet a certain threshold.
We are looking for potential partners who are seriously interested in joining us on our mission to provide the highest-quality care to our patients. After all, that is why became gastroenterologists in the first place.
Dr. Lalani serves as treasurer on the executive committee of the Digestive Health Physicians Association and is a practicing gastroenterologist at U.S. Digestive Health.
It has been almost 15 years since the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy established the Task Force on Quality Endoscopy and published the first set of quality indicators for GI endoscopic procedures.
This work was motivated by two seminal reports on patient safety that fostered a demand by the public, policy makers, and payers to accurately define and measure the quality of health care services.
While the Centers for Medicare & Medicaid Services initially designated and required reporting on several basic outcome measures, leaders within the field of gastroenterology recognized the importance of developing evidence-based quality measures for our field, and specifically for endoscopic procedures.
Integrating safety measures into our daily operations has always been important, and over the years, policies have been implemented to incentivize health care providers to meet standards in everything from patient safety to patient satisfaction.
Defining quality and how to measure it
The goals of implementing quality measures within private practices include effective patient care and safety, but they also include issues like access and affordability, as well as the professionalism of your physicians and advanced practice providers.
As a larger practice, we have the resources to support a quality coordinator who spends half their time focused on quality measures. Every provider is required to complete annual education on quality parameters.
We have two committees that propose and track quality initiatives in our practice. We have one on the practice side and one for our ambulatory surgery centers (ASCs). The committees are made of physicians who have a particular interest in quality measures. On the ASC side, our ASC center director from our management partner AmSurg is also a member of the committee.
The road to improving quality within a private practice starts by defining the aspects of care that affect the quality of the patient experience.
Tracking quality in the office and in the surgery center
In our practices we have about 60 physicians. Start times and coding accuracy are good examples of what we have tracked in the past as areas of quality improvement. For instance, if only one or two providers get started late, it can cause a domino effect. Schedules get cramped, which can increase stress and possibly cause our team members to rush. Even things that seem like patient satisfaction issues can affect patient care, so it is important to make sure they are being measured.
On the ASC side, we track adenoma detection rates, colonoscopy intervals, complication rates, and many other additional criteria. As an example, when a pathology report is issued, we require our physicians to provide results to our patients within 72 hours.
Data on all providers are tabulated quarterly and then distributed to the providers in the form of a scorecard. The scorecard is then used for constructive feedback on improvements that can be made. A cumulative annual report is given to the providers, which is also incorporated into reviews. Not paying attention to quality measures can potentially have financial ramifications for providers in our group.
Find the right fit from a quality standpoint
In terms of what we are tracking, we are probably not that different from most groups of our size. Standardization will continue to increase, and it is important as an early career physician to familiarize yourself with quality measures in gastroenterology.
I often interview early career physicians who would like to join Regional GI, and the most impressive are the young men and women who ask about our processes for tracking quality measures and implementing programs geared toward improvement. If you are thinking of joining a practice, bring it up. You will be glad you did.
The interest in quality shows that you are invested in providing the best evidence-based patient care. As an independent group, this is critical because so much of what we do depends on having a track record of measurement. For instance, an ASC might not be credentialed if the quality metrics do not meet a certain threshold.
We are looking for potential partners who are seriously interested in joining us on our mission to provide the highest-quality care to our patients. After all, that is why became gastroenterologists in the first place.
Dr. Lalani serves as treasurer on the executive committee of the Digestive Health Physicians Association and is a practicing gastroenterologist at U.S. Digestive Health.
It has been almost 15 years since the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy established the Task Force on Quality Endoscopy and published the first set of quality indicators for GI endoscopic procedures.
This work was motivated by two seminal reports on patient safety that fostered a demand by the public, policy makers, and payers to accurately define and measure the quality of health care services.
While the Centers for Medicare & Medicaid Services initially designated and required reporting on several basic outcome measures, leaders within the field of gastroenterology recognized the importance of developing evidence-based quality measures for our field, and specifically for endoscopic procedures.
Integrating safety measures into our daily operations has always been important, and over the years, policies have been implemented to incentivize health care providers to meet standards in everything from patient safety to patient satisfaction.
Defining quality and how to measure it
The goals of implementing quality measures within private practices include effective patient care and safety, but they also include issues like access and affordability, as well as the professionalism of your physicians and advanced practice providers.
As a larger practice, we have the resources to support a quality coordinator who spends half their time focused on quality measures. Every provider is required to complete annual education on quality parameters.
We have two committees that propose and track quality initiatives in our practice. We have one on the practice side and one for our ambulatory surgery centers (ASCs). The committees are made of physicians who have a particular interest in quality measures. On the ASC side, our ASC center director from our management partner AmSurg is also a member of the committee.
The road to improving quality within a private practice starts by defining the aspects of care that affect the quality of the patient experience.
Tracking quality in the office and in the surgery center
In our practices we have about 60 physicians. Start times and coding accuracy are good examples of what we have tracked in the past as areas of quality improvement. For instance, if only one or two providers get started late, it can cause a domino effect. Schedules get cramped, which can increase stress and possibly cause our team members to rush. Even things that seem like patient satisfaction issues can affect patient care, so it is important to make sure they are being measured.
On the ASC side, we track adenoma detection rates, colonoscopy intervals, complication rates, and many other additional criteria. As an example, when a pathology report is issued, we require our physicians to provide results to our patients within 72 hours.
Data on all providers are tabulated quarterly and then distributed to the providers in the form of a scorecard. The scorecard is then used for constructive feedback on improvements that can be made. A cumulative annual report is given to the providers, which is also incorporated into reviews. Not paying attention to quality measures can potentially have financial ramifications for providers in our group.
Find the right fit from a quality standpoint
In terms of what we are tracking, we are probably not that different from most groups of our size. Standardization will continue to increase, and it is important as an early career physician to familiarize yourself with quality measures in gastroenterology.
I often interview early career physicians who would like to join Regional GI, and the most impressive are the young men and women who ask about our processes for tracking quality measures and implementing programs geared toward improvement. If you are thinking of joining a practice, bring it up. You will be glad you did.
The interest in quality shows that you are invested in providing the best evidence-based patient care. As an independent group, this is critical because so much of what we do depends on having a track record of measurement. For instance, an ASC might not be credentialed if the quality metrics do not meet a certain threshold.
We are looking for potential partners who are seriously interested in joining us on our mission to provide the highest-quality care to our patients. After all, that is why became gastroenterologists in the first place.
Dr. Lalani serves as treasurer on the executive committee of the Digestive Health Physicians Association and is a practicing gastroenterologist at U.S. Digestive Health.
November 2020 – ICYMI
Gastroenterology
July 2020
Role of cannabis and its derivatives in gastrointestinal and hepatic disease. Jonathan Gotfried et al. 2020 July;159(1):62-80. doi: 10.1053/j.gastro.2020.03.087
Effects of blended (yellow) vs forced coagulation (blue) currents on adverse events, complete resection, or polyp recurrence after polypectomy in a large randomized trial. Heiko Pohl et al. 2020 July;159(1):119-28.e2. doi: 10.1053/j.gastro.2020.03.014
Calculating the starting age for screening in relatives of patients with colorectal cancer based on data from large nationwide data sets.
Yu Tian et al. July 2020;159(1):159-168.e3. doi: 10.1053/j.gastro.2020.03.063
August 2020
Corticosteroids, but not TNF antagonists, are associated with adverse COVID-19 outcomes in patients with inflammatory bowel diseases: results from an international registry. Erica J. Brenner et al. 2020 Aug 159;(2):481-91.e3. doi: 10.1053/j.gastro.2020.05.032
Collagenous colitis is associated with HLA signature and shares genetic risks with other immune-mediated diseases. Eli Stahl et al. 2020 Aug;159(2):549-61.e8. doi: 10.1053/j.gastro.2020.04.063
Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Alessandro Repici et al. 2020 Aug;159(2):512-20.e7. doi: 10.1053/j.gastro.2020.04.062
September 2020
Dietary inflammatory potential and risk of Crohn’s disease and ulcerative colitis. Chun-Han Lo et al. 2020 Sept;159(3):p873-83.e1. doi: 10.1053/j.gastro.2020.05.011
Rates of incomplete resection of 1- to 20-mm colorectal polyps: A systematic review and meta-analysis. Roupen Djinbachian et al. 2020 Sept;159(3):904-14.e12. doi: 10.1053/j.gastro.2020.05.018
Clinical Gastroenterology and Hepatology
August 2020
Prevalence and characteristics of avoidant/restrictive food intake disorder in adult neurogastroenterology patients. Helen Burton Murray et al. 2020 Aug;18(9):1995-2002.e1. doi: 10.1016/j.cgh.2019.10.030
Ten things every gastroenterologist should know about antireflux surgery. Steven Park et al. 2020 Aug;18(9):1923-9. doi: 10.1016/j.cgh.2020.02.041
Biopsies from ascending and descending colon are sufficient for diagnosis of microscopic colitis. Boris Virine et al. 2020 Aug;18(9):2003-9. doi: 10.1016/j.cgh.2020.02.036
September 2020
Association between endoscopist annual procedure volume and colonoscopy quality: Systematic review and meta-analysis. Nauzer Forbes et al. 2020 Sept:18(10):2192-208.e12. doi: 10.1016/j.cgh.2020.03.046
Plans to reactivate gastroenterology practices following the COVID-19 pandemic: A survey of North American centers. Vladimir M. Kushnir et al on Behalf of the North American Alliance for the Study of Digestive Manifestations of COVID-19. 2020 Sept;18(10):2287-94.e1. doi: 10.1016/j.cgh.2020.05.030
Cost effectiveness of different strategies for detecting cirrhosis in patients with nonalcoholic fatty liver disease based on United States health care system. Eduardo Vilar-Gomez et al. 2020 Sept;18(10):2305-14.e12. doi: 10.1016/j.cgh.2020.04.017
October 2020
AGA Clinical Practice Update on young adult–onset colorectal cancer diagnosis and management: Expert review. Lisa A. Boardman et al. 2020 Oct:18(11):2415-24. doi: 10.1016/j.cgh.2020.05.058
Frequency of eating disorder pathology among patients with chronic constipation and contribution of gastrointestinal-specific anxiety. Helen Burton Murray et al. 2020 Oct;18(11):2471-8. doi: 10.1016/j.cgh.2019.12.030
Correction of dyssynergic defecation, but not fiber supplementation, reduces symptoms of functional dyspepsia in patients with constipation in a randomized trial. Jose-Walter Huaman et al. 2020 Oct;18(11):2463-70.e1. doi: 10.1016/j.cgh.2019.11.048
Cellular and Molecular Gastroenterology and Hepatology
A new treatment for chronic hepatitis B and D offers novel insights into obesity and hepatic steatosis. Robert Schierwagen et al. 2020;10(3):649-51. doi: 10.1016/j.jcmgh.2020.05.011
Techniques and Innovations in Gastrointestinal Endoscopy
The impact of endoscopic submucosal dissection for gastric adenocarcinomas in the United States. Shria Kumar et al. 2020 July:22(3):93-8. doi: 10.1016/j.tige.2020.03.009
Gastroenterology
July 2020
Role of cannabis and its derivatives in gastrointestinal and hepatic disease. Jonathan Gotfried et al. 2020 July;159(1):62-80. doi: 10.1053/j.gastro.2020.03.087
Effects of blended (yellow) vs forced coagulation (blue) currents on adverse events, complete resection, or polyp recurrence after polypectomy in a large randomized trial. Heiko Pohl et al. 2020 July;159(1):119-28.e2. doi: 10.1053/j.gastro.2020.03.014
Calculating the starting age for screening in relatives of patients with colorectal cancer based on data from large nationwide data sets.
Yu Tian et al. July 2020;159(1):159-168.e3. doi: 10.1053/j.gastro.2020.03.063
August 2020
Corticosteroids, but not TNF antagonists, are associated with adverse COVID-19 outcomes in patients with inflammatory bowel diseases: results from an international registry. Erica J. Brenner et al. 2020 Aug 159;(2):481-91.e3. doi: 10.1053/j.gastro.2020.05.032
Collagenous colitis is associated with HLA signature and shares genetic risks with other immune-mediated diseases. Eli Stahl et al. 2020 Aug;159(2):549-61.e8. doi: 10.1053/j.gastro.2020.04.063
Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Alessandro Repici et al. 2020 Aug;159(2):512-20.e7. doi: 10.1053/j.gastro.2020.04.062
September 2020
Dietary inflammatory potential and risk of Crohn’s disease and ulcerative colitis. Chun-Han Lo et al. 2020 Sept;159(3):p873-83.e1. doi: 10.1053/j.gastro.2020.05.011
Rates of incomplete resection of 1- to 20-mm colorectal polyps: A systematic review and meta-analysis. Roupen Djinbachian et al. 2020 Sept;159(3):904-14.e12. doi: 10.1053/j.gastro.2020.05.018
Clinical Gastroenterology and Hepatology
August 2020
Prevalence and characteristics of avoidant/restrictive food intake disorder in adult neurogastroenterology patients. Helen Burton Murray et al. 2020 Aug;18(9):1995-2002.e1. doi: 10.1016/j.cgh.2019.10.030
Ten things every gastroenterologist should know about antireflux surgery. Steven Park et al. 2020 Aug;18(9):1923-9. doi: 10.1016/j.cgh.2020.02.041
Biopsies from ascending and descending colon are sufficient for diagnosis of microscopic colitis. Boris Virine et al. 2020 Aug;18(9):2003-9. doi: 10.1016/j.cgh.2020.02.036
September 2020
Association between endoscopist annual procedure volume and colonoscopy quality: Systematic review and meta-analysis. Nauzer Forbes et al. 2020 Sept:18(10):2192-208.e12. doi: 10.1016/j.cgh.2020.03.046
Plans to reactivate gastroenterology practices following the COVID-19 pandemic: A survey of North American centers. Vladimir M. Kushnir et al on Behalf of the North American Alliance for the Study of Digestive Manifestations of COVID-19. 2020 Sept;18(10):2287-94.e1. doi: 10.1016/j.cgh.2020.05.030
Cost effectiveness of different strategies for detecting cirrhosis in patients with nonalcoholic fatty liver disease based on United States health care system. Eduardo Vilar-Gomez et al. 2020 Sept;18(10):2305-14.e12. doi: 10.1016/j.cgh.2020.04.017
October 2020
AGA Clinical Practice Update on young adult–onset colorectal cancer diagnosis and management: Expert review. Lisa A. Boardman et al. 2020 Oct:18(11):2415-24. doi: 10.1016/j.cgh.2020.05.058
Frequency of eating disorder pathology among patients with chronic constipation and contribution of gastrointestinal-specific anxiety. Helen Burton Murray et al. 2020 Oct;18(11):2471-8. doi: 10.1016/j.cgh.2019.12.030
Correction of dyssynergic defecation, but not fiber supplementation, reduces symptoms of functional dyspepsia in patients with constipation in a randomized trial. Jose-Walter Huaman et al. 2020 Oct;18(11):2463-70.e1. doi: 10.1016/j.cgh.2019.11.048
Cellular and Molecular Gastroenterology and Hepatology
A new treatment for chronic hepatitis B and D offers novel insights into obesity and hepatic steatosis. Robert Schierwagen et al. 2020;10(3):649-51. doi: 10.1016/j.jcmgh.2020.05.011
Techniques and Innovations in Gastrointestinal Endoscopy
The impact of endoscopic submucosal dissection for gastric adenocarcinomas in the United States. Shria Kumar et al. 2020 July:22(3):93-8. doi: 10.1016/j.tige.2020.03.009
Gastroenterology
July 2020
Role of cannabis and its derivatives in gastrointestinal and hepatic disease. Jonathan Gotfried et al. 2020 July;159(1):62-80. doi: 10.1053/j.gastro.2020.03.087
Effects of blended (yellow) vs forced coagulation (blue) currents on adverse events, complete resection, or polyp recurrence after polypectomy in a large randomized trial. Heiko Pohl et al. 2020 July;159(1):119-28.e2. doi: 10.1053/j.gastro.2020.03.014
Calculating the starting age for screening in relatives of patients with colorectal cancer based on data from large nationwide data sets.
Yu Tian et al. July 2020;159(1):159-168.e3. doi: 10.1053/j.gastro.2020.03.063
August 2020
Corticosteroids, but not TNF antagonists, are associated with adverse COVID-19 outcomes in patients with inflammatory bowel diseases: results from an international registry. Erica J. Brenner et al. 2020 Aug 159;(2):481-91.e3. doi: 10.1053/j.gastro.2020.05.032
Collagenous colitis is associated with HLA signature and shares genetic risks with other immune-mediated diseases. Eli Stahl et al. 2020 Aug;159(2):549-61.e8. doi: 10.1053/j.gastro.2020.04.063
Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Alessandro Repici et al. 2020 Aug;159(2):512-20.e7. doi: 10.1053/j.gastro.2020.04.062
September 2020
Dietary inflammatory potential and risk of Crohn’s disease and ulcerative colitis. Chun-Han Lo et al. 2020 Sept;159(3):p873-83.e1. doi: 10.1053/j.gastro.2020.05.011
Rates of incomplete resection of 1- to 20-mm colorectal polyps: A systematic review and meta-analysis. Roupen Djinbachian et al. 2020 Sept;159(3):904-14.e12. doi: 10.1053/j.gastro.2020.05.018
Clinical Gastroenterology and Hepatology
August 2020
Prevalence and characteristics of avoidant/restrictive food intake disorder in adult neurogastroenterology patients. Helen Burton Murray et al. 2020 Aug;18(9):1995-2002.e1. doi: 10.1016/j.cgh.2019.10.030
Ten things every gastroenterologist should know about antireflux surgery. Steven Park et al. 2020 Aug;18(9):1923-9. doi: 10.1016/j.cgh.2020.02.041
Biopsies from ascending and descending colon are sufficient for diagnosis of microscopic colitis. Boris Virine et al. 2020 Aug;18(9):2003-9. doi: 10.1016/j.cgh.2020.02.036
September 2020
Association between endoscopist annual procedure volume and colonoscopy quality: Systematic review and meta-analysis. Nauzer Forbes et al. 2020 Sept:18(10):2192-208.e12. doi: 10.1016/j.cgh.2020.03.046
Plans to reactivate gastroenterology practices following the COVID-19 pandemic: A survey of North American centers. Vladimir M. Kushnir et al on Behalf of the North American Alliance for the Study of Digestive Manifestations of COVID-19. 2020 Sept;18(10):2287-94.e1. doi: 10.1016/j.cgh.2020.05.030
Cost effectiveness of different strategies for detecting cirrhosis in patients with nonalcoholic fatty liver disease based on United States health care system. Eduardo Vilar-Gomez et al. 2020 Sept;18(10):2305-14.e12. doi: 10.1016/j.cgh.2020.04.017
October 2020
AGA Clinical Practice Update on young adult–onset colorectal cancer diagnosis and management: Expert review. Lisa A. Boardman et al. 2020 Oct:18(11):2415-24. doi: 10.1016/j.cgh.2020.05.058
Frequency of eating disorder pathology among patients with chronic constipation and contribution of gastrointestinal-specific anxiety. Helen Burton Murray et al. 2020 Oct;18(11):2471-8. doi: 10.1016/j.cgh.2019.12.030
Correction of dyssynergic defecation, but not fiber supplementation, reduces symptoms of functional dyspepsia in patients with constipation in a randomized trial. Jose-Walter Huaman et al. 2020 Oct;18(11):2463-70.e1. doi: 10.1016/j.cgh.2019.11.048
Cellular and Molecular Gastroenterology and Hepatology
A new treatment for chronic hepatitis B and D offers novel insights into obesity and hepatic steatosis. Robert Schierwagen et al. 2020;10(3):649-51. doi: 10.1016/j.jcmgh.2020.05.011
Techniques and Innovations in Gastrointestinal Endoscopy
The impact of endoscopic submucosal dissection for gastric adenocarcinomas in the United States. Shria Kumar et al. 2020 July:22(3):93-8. doi: 10.1016/j.tige.2020.03.009
AGA News
Receive $300,000 for your research in health disparities
Applications for the research scholar award are due by Nov. 9, 2020.
The American Gastroenterological Association Research Foundation is pleased to announce an important addition to its prestigious awards portfolio. The AGA Research Scholar Award in Digestive Disease Health Disparities supports early-career faculty dedicated to investigating digestive diseases or disorders that disproportionately affect racial or ethnic minority populations in North America.
Applicants must have a full-time faculty (or equivalent) position and may be performing any type of research (clinical, basic, or translational). Awardees will receive a total of $300,000 over 3 years with funding to commence in July 2021. The deadline to apply is Nov. 9, 2020.
This award is just one example of how AGA is helping to improve patient care for those who need it most. Support AGA Giving Day and learn more about the AGA Equity Project – a multiyear effort spanning all aspects of our organization to achieve equity and eradicate disparities in digestive diseases.
Save the date for DDW Virtual™
In 2021, Digestive Disease Week® moves online as a fully virtual meeting with slightly new dates: May 21-23, 2021.
For more than 50 years, the digestive disease community has connected over the best science, education, and networking at DDW, and we’re confident this year will be no exception. In fact, we’re excited by opportunities the new format provides to learn, share, and connect with each other.
Watch the DDW website for more information as it becomes available. In the meantime, check out our FAQs about DDW Virtual™. If you have a question we didn’t answer, please submit a ticket to our help desk.
DDW is jointly sponsored by AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
Virtual 2021 Crohn’s & Colitis Congress® now open for registration
Help forge the roadmap to advance prevention, treatments, and cures for all patients living with inflammatory bowel disease (IBD).
Join the Crohn’s & Colitis Foundation, AGA, and a true community of friends and colleagues at the premier conference on IBD. The fourth annual Crohn’s & Colitis Congress®, taking place virtually Jan. 21-24, 2021, is now open for registration.
The 2021 Crohn’s & Colitis Congress virtual experience will look a little different but will still bring you all the benefits and quality programming you have come to expect. The Congress will offer 4 days of learning, with more than 100 speakers and more than 200 expected abstracts – all from the safety of your home or work. Now at an even more affordable price, access from anywhere, and the ability to hear from the top leaders in the IBD field – this is a unique opportunity to join us as we come together virtually.
By moving our event online, we can now pass on greater savings to you. Registration for the conference provides you with substantial savings over last year and access to all sessions and networking opportunities. This virtual experience will bring our community of IBD professionals together in an engaging, interactive setting which will include breakout rooms, receptions, and much more.
The 2021 congress committee chair David T. Rubin, MD, AGAF, University of Chicago, and cochair Bruce E. Sands, MD, MS, AGAF, Icahn School of Medicine at Mount Sinai, New York, lead a faculty that includes thought leaders in the fields of GI, research investigation, surgery, pediatrics, advanced practice, IBD nursing, diet and nutrition, mental health, radiology, pathology, and more.
Register and get inspired to improve skills and patient outcomes, learn practical information you can immediately implement, hear what’s on the horizon in potential IBD treatments, discover fresh perspectives from multidisciplinary faculty and attendees.
You don’t want to miss the 2021 Crohn’s & Colitis Congress, connecting virtually on Jan. 21-24, 2021.
Register today to save before the early bird deadline of Friday, Nov. 6.
Learn more, submit an abstract, and register by visiting crohnscolitiscongress.org.
AGA releases largest real-world report on safety and effectiveness of fecal microbiota transplantation
About 90% of patients tracked in the AGA FMT National Registry were cured of Clostridioides difficile infection with few serious side effects.
AGA has released the first results from the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the largest real-world study on the safety and effectiveness of FMT. Published in Gastroenterology, the registry reported that FMT led to a cure of C. difficile infection in 90% of patients across 20 North American FMT practice sites. Few serious side effects were reported.
“While the value of fecal microbiota transplantation for treating recurrent C. difficile infection is clear from research studies, the potential long-term consequences of altering a patient’s gut microbiota are not fully known,” says Colleen R. Kelly, MD, AGAF, associate professor of medicine at Brown University, Providence, R.I. and coprincipal investigator of the AGA FMT National Registry. “Releasing the initial results of the AGA FMT National Registry is an important step toward understanding the true risks and benefits of microbiota therapeutics in a real-world setting.”
This new report details effectiveness and safety outcomes from the first 259 patients enrolled in the registry between December 2017 and September 2019. Almost all participants received FMT using an unknown donor from stool banks. The most common method of FMT delivery was colonoscopy followed by upper endoscopy. Of the 222 participants who returned for the 1-month follow-up, 200 participants (90%) had their C. difficile infection cured with 197 of those requiring only a single FMT. Infections were reported in 11 participants, but only 2 were thought to be possibly related to the procedure. FMT response was deemed durable, with recurrence of C. difficile infection in the 6 months after successful FMT occurring in only 4% of participants. This data includes patients with comorbidities, such as IBD and immunocompromised status, who are typically excluded from FMT clinical trials.
“These initial results show a high success rate of FMT in the real-world setting. We’ll continue to track these patients for 10 years to assess long-term safety, which will be critical to determining the full safety profile of FMT,” added Dr. Kelly.
AGA raises concerns about recent executive order
We are speaking out to ensure a brighter and more equitable future.
AGA is concerned by the Executive Order on Combating Race and Sex Stereotyping issued on Sept. 22, 2020. This order, while confirming that training of the federal workforce to create an inclusive workspace is beneficial, also leads to a misguided perception of the purpose and outcomes of this type of training. In addition, it may have unintended ramifications for institutions receiving federal research funding.
We believe it is critical and necessary to understand both the positive and negative realities of our nation’s history, so that together we can forge forward into a brighter, and more equitable future.
As highlighted in AGA’s commentary published in Gastroenterology, AGA believes that equity is defined by fair treatment, access, opportunity, and advancement for all, acknowledging that there are historically underserved and underrepresented populations. Equity requires identifying and eliminating barriers that have created unbalanced conditions and prevented the full participation of some groups in order to provide equal opportunity for all groups.
By default, teaching and practicing equity, diversity and inclusion aims not to place any group above or below any other group, or to create division. It rather seeks to achieve fairness and understanding, and fully recognize the dignity of all groups, identities, and individuals.
AGA stands with the Association of American Medical Colleges in our commitment to being a diverse, inclusive, equitable, and antiracist organization.
Our commitment to this issue is manifest in the AGA Equity Project.
Receive $300,000 for your research in health disparities
Applications for the research scholar award are due by Nov. 9, 2020.
The American Gastroenterological Association Research Foundation is pleased to announce an important addition to its prestigious awards portfolio. The AGA Research Scholar Award in Digestive Disease Health Disparities supports early-career faculty dedicated to investigating digestive diseases or disorders that disproportionately affect racial or ethnic minority populations in North America.
Applicants must have a full-time faculty (or equivalent) position and may be performing any type of research (clinical, basic, or translational). Awardees will receive a total of $300,000 over 3 years with funding to commence in July 2021. The deadline to apply is Nov. 9, 2020.
This award is just one example of how AGA is helping to improve patient care for those who need it most. Support AGA Giving Day and learn more about the AGA Equity Project – a multiyear effort spanning all aspects of our organization to achieve equity and eradicate disparities in digestive diseases.
Save the date for DDW Virtual™
In 2021, Digestive Disease Week® moves online as a fully virtual meeting with slightly new dates: May 21-23, 2021.
For more than 50 years, the digestive disease community has connected over the best science, education, and networking at DDW, and we’re confident this year will be no exception. In fact, we’re excited by opportunities the new format provides to learn, share, and connect with each other.
Watch the DDW website for more information as it becomes available. In the meantime, check out our FAQs about DDW Virtual™. If you have a question we didn’t answer, please submit a ticket to our help desk.
DDW is jointly sponsored by AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
Virtual 2021 Crohn’s & Colitis Congress® now open for registration
Help forge the roadmap to advance prevention, treatments, and cures for all patients living with inflammatory bowel disease (IBD).
Join the Crohn’s & Colitis Foundation, AGA, and a true community of friends and colleagues at the premier conference on IBD. The fourth annual Crohn’s & Colitis Congress®, taking place virtually Jan. 21-24, 2021, is now open for registration.
The 2021 Crohn’s & Colitis Congress virtual experience will look a little different but will still bring you all the benefits and quality programming you have come to expect. The Congress will offer 4 days of learning, with more than 100 speakers and more than 200 expected abstracts – all from the safety of your home or work. Now at an even more affordable price, access from anywhere, and the ability to hear from the top leaders in the IBD field – this is a unique opportunity to join us as we come together virtually.
By moving our event online, we can now pass on greater savings to you. Registration for the conference provides you with substantial savings over last year and access to all sessions and networking opportunities. This virtual experience will bring our community of IBD professionals together in an engaging, interactive setting which will include breakout rooms, receptions, and much more.
The 2021 congress committee chair David T. Rubin, MD, AGAF, University of Chicago, and cochair Bruce E. Sands, MD, MS, AGAF, Icahn School of Medicine at Mount Sinai, New York, lead a faculty that includes thought leaders in the fields of GI, research investigation, surgery, pediatrics, advanced practice, IBD nursing, diet and nutrition, mental health, radiology, pathology, and more.
Register and get inspired to improve skills and patient outcomes, learn practical information you can immediately implement, hear what’s on the horizon in potential IBD treatments, discover fresh perspectives from multidisciplinary faculty and attendees.
You don’t want to miss the 2021 Crohn’s & Colitis Congress, connecting virtually on Jan. 21-24, 2021.
Register today to save before the early bird deadline of Friday, Nov. 6.
Learn more, submit an abstract, and register by visiting crohnscolitiscongress.org.
AGA releases largest real-world report on safety and effectiveness of fecal microbiota transplantation
About 90% of patients tracked in the AGA FMT National Registry were cured of Clostridioides difficile infection with few serious side effects.
AGA has released the first results from the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the largest real-world study on the safety and effectiveness of FMT. Published in Gastroenterology, the registry reported that FMT led to a cure of C. difficile infection in 90% of patients across 20 North American FMT practice sites. Few serious side effects were reported.
“While the value of fecal microbiota transplantation for treating recurrent C. difficile infection is clear from research studies, the potential long-term consequences of altering a patient’s gut microbiota are not fully known,” says Colleen R. Kelly, MD, AGAF, associate professor of medicine at Brown University, Providence, R.I. and coprincipal investigator of the AGA FMT National Registry. “Releasing the initial results of the AGA FMT National Registry is an important step toward understanding the true risks and benefits of microbiota therapeutics in a real-world setting.”
This new report details effectiveness and safety outcomes from the first 259 patients enrolled in the registry between December 2017 and September 2019. Almost all participants received FMT using an unknown donor from stool banks. The most common method of FMT delivery was colonoscopy followed by upper endoscopy. Of the 222 participants who returned for the 1-month follow-up, 200 participants (90%) had their C. difficile infection cured with 197 of those requiring only a single FMT. Infections were reported in 11 participants, but only 2 were thought to be possibly related to the procedure. FMT response was deemed durable, with recurrence of C. difficile infection in the 6 months after successful FMT occurring in only 4% of participants. This data includes patients with comorbidities, such as IBD and immunocompromised status, who are typically excluded from FMT clinical trials.
“These initial results show a high success rate of FMT in the real-world setting. We’ll continue to track these patients for 10 years to assess long-term safety, which will be critical to determining the full safety profile of FMT,” added Dr. Kelly.
AGA raises concerns about recent executive order
We are speaking out to ensure a brighter and more equitable future.
AGA is concerned by the Executive Order on Combating Race and Sex Stereotyping issued on Sept. 22, 2020. This order, while confirming that training of the federal workforce to create an inclusive workspace is beneficial, also leads to a misguided perception of the purpose and outcomes of this type of training. In addition, it may have unintended ramifications for institutions receiving federal research funding.
We believe it is critical and necessary to understand both the positive and negative realities of our nation’s history, so that together we can forge forward into a brighter, and more equitable future.
As highlighted in AGA’s commentary published in Gastroenterology, AGA believes that equity is defined by fair treatment, access, opportunity, and advancement for all, acknowledging that there are historically underserved and underrepresented populations. Equity requires identifying and eliminating barriers that have created unbalanced conditions and prevented the full participation of some groups in order to provide equal opportunity for all groups.
By default, teaching and practicing equity, diversity and inclusion aims not to place any group above or below any other group, or to create division. It rather seeks to achieve fairness and understanding, and fully recognize the dignity of all groups, identities, and individuals.
AGA stands with the Association of American Medical Colleges in our commitment to being a diverse, inclusive, equitable, and antiracist organization.
Our commitment to this issue is manifest in the AGA Equity Project.
Receive $300,000 for your research in health disparities
Applications for the research scholar award are due by Nov. 9, 2020.
The American Gastroenterological Association Research Foundation is pleased to announce an important addition to its prestigious awards portfolio. The AGA Research Scholar Award in Digestive Disease Health Disparities supports early-career faculty dedicated to investigating digestive diseases or disorders that disproportionately affect racial or ethnic minority populations in North America.
Applicants must have a full-time faculty (or equivalent) position and may be performing any type of research (clinical, basic, or translational). Awardees will receive a total of $300,000 over 3 years with funding to commence in July 2021. The deadline to apply is Nov. 9, 2020.
This award is just one example of how AGA is helping to improve patient care for those who need it most. Support AGA Giving Day and learn more about the AGA Equity Project – a multiyear effort spanning all aspects of our organization to achieve equity and eradicate disparities in digestive diseases.
Save the date for DDW Virtual™
In 2021, Digestive Disease Week® moves online as a fully virtual meeting with slightly new dates: May 21-23, 2021.
For more than 50 years, the digestive disease community has connected over the best science, education, and networking at DDW, and we’re confident this year will be no exception. In fact, we’re excited by opportunities the new format provides to learn, share, and connect with each other.
Watch the DDW website for more information as it becomes available. In the meantime, check out our FAQs about DDW Virtual™. If you have a question we didn’t answer, please submit a ticket to our help desk.
DDW is jointly sponsored by AGA, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
Virtual 2021 Crohn’s & Colitis Congress® now open for registration
Help forge the roadmap to advance prevention, treatments, and cures for all patients living with inflammatory bowel disease (IBD).
Join the Crohn’s & Colitis Foundation, AGA, and a true community of friends and colleagues at the premier conference on IBD. The fourth annual Crohn’s & Colitis Congress®, taking place virtually Jan. 21-24, 2021, is now open for registration.
The 2021 Crohn’s & Colitis Congress virtual experience will look a little different but will still bring you all the benefits and quality programming you have come to expect. The Congress will offer 4 days of learning, with more than 100 speakers and more than 200 expected abstracts – all from the safety of your home or work. Now at an even more affordable price, access from anywhere, and the ability to hear from the top leaders in the IBD field – this is a unique opportunity to join us as we come together virtually.
By moving our event online, we can now pass on greater savings to you. Registration for the conference provides you with substantial savings over last year and access to all sessions and networking opportunities. This virtual experience will bring our community of IBD professionals together in an engaging, interactive setting which will include breakout rooms, receptions, and much more.
The 2021 congress committee chair David T. Rubin, MD, AGAF, University of Chicago, and cochair Bruce E. Sands, MD, MS, AGAF, Icahn School of Medicine at Mount Sinai, New York, lead a faculty that includes thought leaders in the fields of GI, research investigation, surgery, pediatrics, advanced practice, IBD nursing, diet and nutrition, mental health, radiology, pathology, and more.
Register and get inspired to improve skills and patient outcomes, learn practical information you can immediately implement, hear what’s on the horizon in potential IBD treatments, discover fresh perspectives from multidisciplinary faculty and attendees.
You don’t want to miss the 2021 Crohn’s & Colitis Congress, connecting virtually on Jan. 21-24, 2021.
Register today to save before the early bird deadline of Friday, Nov. 6.
Learn more, submit an abstract, and register by visiting crohnscolitiscongress.org.
AGA releases largest real-world report on safety and effectiveness of fecal microbiota transplantation
About 90% of patients tracked in the AGA FMT National Registry were cured of Clostridioides difficile infection with few serious side effects.
AGA has released the first results from the NIH-funded AGA Fecal Microbiota Transplantation (FMT) National Registry, the largest real-world study on the safety and effectiveness of FMT. Published in Gastroenterology, the registry reported that FMT led to a cure of C. difficile infection in 90% of patients across 20 North American FMT practice sites. Few serious side effects were reported.
“While the value of fecal microbiota transplantation for treating recurrent C. difficile infection is clear from research studies, the potential long-term consequences of altering a patient’s gut microbiota are not fully known,” says Colleen R. Kelly, MD, AGAF, associate professor of medicine at Brown University, Providence, R.I. and coprincipal investigator of the AGA FMT National Registry. “Releasing the initial results of the AGA FMT National Registry is an important step toward understanding the true risks and benefits of microbiota therapeutics in a real-world setting.”
This new report details effectiveness and safety outcomes from the first 259 patients enrolled in the registry between December 2017 and September 2019. Almost all participants received FMT using an unknown donor from stool banks. The most common method of FMT delivery was colonoscopy followed by upper endoscopy. Of the 222 participants who returned for the 1-month follow-up, 200 participants (90%) had their C. difficile infection cured with 197 of those requiring only a single FMT. Infections were reported in 11 participants, but only 2 were thought to be possibly related to the procedure. FMT response was deemed durable, with recurrence of C. difficile infection in the 6 months after successful FMT occurring in only 4% of participants. This data includes patients with comorbidities, such as IBD and immunocompromised status, who are typically excluded from FMT clinical trials.
“These initial results show a high success rate of FMT in the real-world setting. We’ll continue to track these patients for 10 years to assess long-term safety, which will be critical to determining the full safety profile of FMT,” added Dr. Kelly.
AGA raises concerns about recent executive order
We are speaking out to ensure a brighter and more equitable future.
AGA is concerned by the Executive Order on Combating Race and Sex Stereotyping issued on Sept. 22, 2020. This order, while confirming that training of the federal workforce to create an inclusive workspace is beneficial, also leads to a misguided perception of the purpose and outcomes of this type of training. In addition, it may have unintended ramifications for institutions receiving federal research funding.
We believe it is critical and necessary to understand both the positive and negative realities of our nation’s history, so that together we can forge forward into a brighter, and more equitable future.
As highlighted in AGA’s commentary published in Gastroenterology, AGA believes that equity is defined by fair treatment, access, opportunity, and advancement for all, acknowledging that there are historically underserved and underrepresented populations. Equity requires identifying and eliminating barriers that have created unbalanced conditions and prevented the full participation of some groups in order to provide equal opportunity for all groups.
By default, teaching and practicing equity, diversity and inclusion aims not to place any group above or below any other group, or to create division. It rather seeks to achieve fairness and understanding, and fully recognize the dignity of all groups, identities, and individuals.
AGA stands with the Association of American Medical Colleges in our commitment to being a diverse, inclusive, equitable, and antiracist organization.
Our commitment to this issue is manifest in the AGA Equity Project.
Endoscopic drainage of pancreatic fluid collections
Pancreatic fluid collections (PFCs) are common after acute pancreatitis but almost always resolve spontaneously. Persistent collections that cause symptoms, become infected, and/or compress vital structures require treatment. Open surgery had traditionally been considered the standard method for this indication;1 Given its inherently less invasive nature, endoscopic transmural drainage (ETMD) has become a mainstay of this step-up philosophy – it is now the dominant strategy for pseudocyst drainage and, on the basis of emerging randomized trial data, compares very favorably with surgery for the treatment of walled-off necrosis (WON).
According to the step-up approach, the initial treatment of symptomatic and/or infected collections that are within 4 weeks of an attack of pancreatitis involves conservative management because the wall of the collection is typically immature; the systemic inflammation may be significantly exacerbated by definitive drainage, particularly surgery. In this early phase, failure of conservative management is addressed by percutaneous catheter placement, stepping up to a minimally invasive operation if the response to percutaneous drainage and antibiotics is insufficient.
Collections that are at least 4 weeks from the onset of acute pancreatitis are considered mature and termed pseudocysts or WONs depending on whether they contain pure fluid or necrotic tissue. In this phase, endoscopic treatment plays a primary management role because these collections are generally adherent to the stomach or duodenal wall and their capsule is organized enough to withstand endoscopic intervention. If treatment can be held off until this phase, then percutaneous and surgical drainage can often be avoided.
In practice, the 4-week rule holds true for most, but not all, PFCs. ETMD can be performed in some particularly mature collections prior to 4 weeks if the indication is strong and the collection appears to have a mature wall. However, the potential for cyst wall perforation is higher and should be considered in the risk-benefit discussion. Conversely, some collections beyond 4 weeks lack an adequately organized wall and require additional time for maturation.
While endoscopic drainage of pseudocysts has essentially supplanted surgery, the management of WON is more complex and remains multidisciplinary. Two recent randomized trials demonstrated no difference in major complications and/or death between a surgical and endoscopic step-up strategy for WON.2,3 Rates of pancreatic fistulae, hospital stay, and overall treatment costs, however, favored endoscopy. Nevertheless, defining the ideal strategy for many of these patients with complexity requires multidisciplinary discussion. Surgery continues to play a primary role in several scenarios, including collections that are not close to the upper GI tract, those that are particularly complex and extend caudally, and situations in which the endoscopic progress is too slow.
The three most important questions when deciding to embark on ETMD are: (1) whether drainage is indicated (that is, is the patient symptomatic or is there evidence that the PFC is infected?), (2) whether the wall of the collection is adequately mature and apposed to the GI tract wall; and (3) whether the collection contains necrosis? This last question has critical implications in the technical approach to drainage. While CT scan with IV contrast is accurate for assessing wall maturity, it is inadequate to evaluate the presence or quantity of necrosum. Transabdominal ultrasound, endoscopic ultrasound, and MRI (on a T2 sequence) are all superior for this purpose. MRI has the additional benefit of assessing the pancreatic duct integrity, which may influence subsequent management.
Pseudocysts can be managed by cyst-gastrostomy or cyst-duodenostomy alone, whereas most WONs require the additional step of endoscopic necrosectomy – the process of entering the cyst cavity to mechanically debride necrotic tissue. Because of a higher rate of technical success, endoscopic ultrasound–directed creation of the transmural drainage pathway has become standard practice. In addition, it is likely safer, allowing for the identification and avoidance of interceding vessels and other vital structures. The role of endoscopic retrograde cholangiopancreatography with pancreatic stent placement as primary therapy for PFCs is limited to the drainage of small collections (<5 cm), for which it is the preferred treatment strategy. It is as effective as ETMD, which may not be feasible or safe for small PFCs.
Plastic double-pigtail stents have traditionally been used to maintain the transmural tract for both pseudocyst and WON. Recently, however, metallic stents have become more popular. Fully covered biliary self-expanding metallic stents (SEMS) are easier to place, have a larger lumen, and are associated with improved outcomes, compared with plastic stents in observational studies of pseudocyst drainage. Lumen-apposing metallic stents (LAMS) have become the preferred prosthesis for WON drainage given the ability to near-simultaneously establish access and deploy the stent, as well as their much larger caliber lumen which permits seamless entry into the cavity with an endoscope. Based on ease and efficiency of use, LAMS are also commonly employed for pseudocyst drainage, although entry into the cavity is unnecessary.
Plastic stents have been shown to be more cost effective than LAMS for pseudocyst drainage, although the economics around biliary SEMS in this context have not been explored. Robust comparative effectiveness data defining the optimal prostheses for pseudocysts are needed. The literature comparing LAMS to plastic stents for the management of WON is mixed. Studies have shown LAMS to be more cost effective, but a small randomized trial demonstrated no difference in clinical success or in the number of procedures to achieve WON resolution.4 We generally favor LAMS for WON since large-caliber balloon dilation of the tract seems safer within the lumen of the LAMS (which could seal small perforations and tamponade bleeding vessels) than within a freshly created tract.
Secondary infection of the cavity, usually because of stent occlusion, and bleeding are the most common complications of ETMD. Even in the absence of stent occlusion, contamination of the collection after ETMD is ubiquitous and, as such, we prescribe prophylactic antibiotics for 1-2 weeks after the procedure, although this practice is not evidence based. Hemorrhage appears to be increasing in frequency with the diffusion of LAMS; this has been postulated to be due to particularly rapid cyst cavity collapse resulting in erosion of the stent into contralateral cyst wall vessels. CT angiography followed by an embolization procedure for a possible pseudoaneurysm is the mainstay of treatment. Serious venous bleeding is more challenging to address because angiographic options are limited.
Despite tremendous recent advances, several important controversies in the endoscopic management of PFCs persist. The optimal prosthesis, the importance of first-session endoscopic necroscopy (compared with stepping up to endoscopic necroscopy only if necessary), the roles of adjunctive drain placement and chemical debridement (such as hydrogen peroxide), the need for concomitant pancreatic stent placement, and the preferred long-term management of a disconnected pancreatic duct are areas for which additional research is sorely needed. We further discuss these questions and many additional technical considerations pertaining to endoscopic drainage in a recent review.5
In summary, endoscopic transmural drainage of mature PFCs is effective and safe. Existing evidence supports its use as the favored treatment modality in appropriate candidates and has rendered it a mainstay of the therapeutic armamentarium for this disease. Further studies are needed to address critical unanswered questions and to develop a uniform endoscopic management paradigm.
References
1. van Santvoort HC et al. N Engl J Med. 2010;362(16):1491-502.
2. van Brunschot S et al. Lancet. 2018;391(10115):51-8.
3. Bang JY et al. Gastroenterology. 2019;156(4):1027-40.
4. Bang JY et al. Gut. 2019;68(7):1200-9.
5. Elmunzer BJ. Clin Gastroenterol Hepatol. 2018;16(12):1851-63.
Dr. Moran is assistant professor of medicine, division of gastroenterology and hepatology, Medical University of South Carolina, Charleston; Dr. Elmunzer is the Peter Cotton Professor of Medicine and Endoscopic Innovation, division of gastroenterology and hepatology, Medical University of South Carolina. The authors have no conflicts of interest pertaining to this review.
Pancreatic fluid collections (PFCs) are common after acute pancreatitis but almost always resolve spontaneously. Persistent collections that cause symptoms, become infected, and/or compress vital structures require treatment. Open surgery had traditionally been considered the standard method for this indication;1 Given its inherently less invasive nature, endoscopic transmural drainage (ETMD) has become a mainstay of this step-up philosophy – it is now the dominant strategy for pseudocyst drainage and, on the basis of emerging randomized trial data, compares very favorably with surgery for the treatment of walled-off necrosis (WON).
According to the step-up approach, the initial treatment of symptomatic and/or infected collections that are within 4 weeks of an attack of pancreatitis involves conservative management because the wall of the collection is typically immature; the systemic inflammation may be significantly exacerbated by definitive drainage, particularly surgery. In this early phase, failure of conservative management is addressed by percutaneous catheter placement, stepping up to a minimally invasive operation if the response to percutaneous drainage and antibiotics is insufficient.
Collections that are at least 4 weeks from the onset of acute pancreatitis are considered mature and termed pseudocysts or WONs depending on whether they contain pure fluid or necrotic tissue. In this phase, endoscopic treatment plays a primary management role because these collections are generally adherent to the stomach or duodenal wall and their capsule is organized enough to withstand endoscopic intervention. If treatment can be held off until this phase, then percutaneous and surgical drainage can often be avoided.
In practice, the 4-week rule holds true for most, but not all, PFCs. ETMD can be performed in some particularly mature collections prior to 4 weeks if the indication is strong and the collection appears to have a mature wall. However, the potential for cyst wall perforation is higher and should be considered in the risk-benefit discussion. Conversely, some collections beyond 4 weeks lack an adequately organized wall and require additional time for maturation.
While endoscopic drainage of pseudocysts has essentially supplanted surgery, the management of WON is more complex and remains multidisciplinary. Two recent randomized trials demonstrated no difference in major complications and/or death between a surgical and endoscopic step-up strategy for WON.2,3 Rates of pancreatic fistulae, hospital stay, and overall treatment costs, however, favored endoscopy. Nevertheless, defining the ideal strategy for many of these patients with complexity requires multidisciplinary discussion. Surgery continues to play a primary role in several scenarios, including collections that are not close to the upper GI tract, those that are particularly complex and extend caudally, and situations in which the endoscopic progress is too slow.
The three most important questions when deciding to embark on ETMD are: (1) whether drainage is indicated (that is, is the patient symptomatic or is there evidence that the PFC is infected?), (2) whether the wall of the collection is adequately mature and apposed to the GI tract wall; and (3) whether the collection contains necrosis? This last question has critical implications in the technical approach to drainage. While CT scan with IV contrast is accurate for assessing wall maturity, it is inadequate to evaluate the presence or quantity of necrosum. Transabdominal ultrasound, endoscopic ultrasound, and MRI (on a T2 sequence) are all superior for this purpose. MRI has the additional benefit of assessing the pancreatic duct integrity, which may influence subsequent management.
Pseudocysts can be managed by cyst-gastrostomy or cyst-duodenostomy alone, whereas most WONs require the additional step of endoscopic necrosectomy – the process of entering the cyst cavity to mechanically debride necrotic tissue. Because of a higher rate of technical success, endoscopic ultrasound–directed creation of the transmural drainage pathway has become standard practice. In addition, it is likely safer, allowing for the identification and avoidance of interceding vessels and other vital structures. The role of endoscopic retrograde cholangiopancreatography with pancreatic stent placement as primary therapy for PFCs is limited to the drainage of small collections (<5 cm), for which it is the preferred treatment strategy. It is as effective as ETMD, which may not be feasible or safe for small PFCs.
Plastic double-pigtail stents have traditionally been used to maintain the transmural tract for both pseudocyst and WON. Recently, however, metallic stents have become more popular. Fully covered biliary self-expanding metallic stents (SEMS) are easier to place, have a larger lumen, and are associated with improved outcomes, compared with plastic stents in observational studies of pseudocyst drainage. Lumen-apposing metallic stents (LAMS) have become the preferred prosthesis for WON drainage given the ability to near-simultaneously establish access and deploy the stent, as well as their much larger caliber lumen which permits seamless entry into the cavity with an endoscope. Based on ease and efficiency of use, LAMS are also commonly employed for pseudocyst drainage, although entry into the cavity is unnecessary.
Plastic stents have been shown to be more cost effective than LAMS for pseudocyst drainage, although the economics around biliary SEMS in this context have not been explored. Robust comparative effectiveness data defining the optimal prostheses for pseudocysts are needed. The literature comparing LAMS to plastic stents for the management of WON is mixed. Studies have shown LAMS to be more cost effective, but a small randomized trial demonstrated no difference in clinical success or in the number of procedures to achieve WON resolution.4 We generally favor LAMS for WON since large-caliber balloon dilation of the tract seems safer within the lumen of the LAMS (which could seal small perforations and tamponade bleeding vessels) than within a freshly created tract.
Secondary infection of the cavity, usually because of stent occlusion, and bleeding are the most common complications of ETMD. Even in the absence of stent occlusion, contamination of the collection after ETMD is ubiquitous and, as such, we prescribe prophylactic antibiotics for 1-2 weeks after the procedure, although this practice is not evidence based. Hemorrhage appears to be increasing in frequency with the diffusion of LAMS; this has been postulated to be due to particularly rapid cyst cavity collapse resulting in erosion of the stent into contralateral cyst wall vessels. CT angiography followed by an embolization procedure for a possible pseudoaneurysm is the mainstay of treatment. Serious venous bleeding is more challenging to address because angiographic options are limited.
Despite tremendous recent advances, several important controversies in the endoscopic management of PFCs persist. The optimal prosthesis, the importance of first-session endoscopic necroscopy (compared with stepping up to endoscopic necroscopy only if necessary), the roles of adjunctive drain placement and chemical debridement (such as hydrogen peroxide), the need for concomitant pancreatic stent placement, and the preferred long-term management of a disconnected pancreatic duct are areas for which additional research is sorely needed. We further discuss these questions and many additional technical considerations pertaining to endoscopic drainage in a recent review.5
In summary, endoscopic transmural drainage of mature PFCs is effective and safe. Existing evidence supports its use as the favored treatment modality in appropriate candidates and has rendered it a mainstay of the therapeutic armamentarium for this disease. Further studies are needed to address critical unanswered questions and to develop a uniform endoscopic management paradigm.
References
1. van Santvoort HC et al. N Engl J Med. 2010;362(16):1491-502.
2. van Brunschot S et al. Lancet. 2018;391(10115):51-8.
3. Bang JY et al. Gastroenterology. 2019;156(4):1027-40.
4. Bang JY et al. Gut. 2019;68(7):1200-9.
5. Elmunzer BJ. Clin Gastroenterol Hepatol. 2018;16(12):1851-63.
Dr. Moran is assistant professor of medicine, division of gastroenterology and hepatology, Medical University of South Carolina, Charleston; Dr. Elmunzer is the Peter Cotton Professor of Medicine and Endoscopic Innovation, division of gastroenterology and hepatology, Medical University of South Carolina. The authors have no conflicts of interest pertaining to this review.
Pancreatic fluid collections (PFCs) are common after acute pancreatitis but almost always resolve spontaneously. Persistent collections that cause symptoms, become infected, and/or compress vital structures require treatment. Open surgery had traditionally been considered the standard method for this indication;1 Given its inherently less invasive nature, endoscopic transmural drainage (ETMD) has become a mainstay of this step-up philosophy – it is now the dominant strategy for pseudocyst drainage and, on the basis of emerging randomized trial data, compares very favorably with surgery for the treatment of walled-off necrosis (WON).
According to the step-up approach, the initial treatment of symptomatic and/or infected collections that are within 4 weeks of an attack of pancreatitis involves conservative management because the wall of the collection is typically immature; the systemic inflammation may be significantly exacerbated by definitive drainage, particularly surgery. In this early phase, failure of conservative management is addressed by percutaneous catheter placement, stepping up to a minimally invasive operation if the response to percutaneous drainage and antibiotics is insufficient.
Collections that are at least 4 weeks from the onset of acute pancreatitis are considered mature and termed pseudocysts or WONs depending on whether they contain pure fluid or necrotic tissue. In this phase, endoscopic treatment plays a primary management role because these collections are generally adherent to the stomach or duodenal wall and their capsule is organized enough to withstand endoscopic intervention. If treatment can be held off until this phase, then percutaneous and surgical drainage can often be avoided.
In practice, the 4-week rule holds true for most, but not all, PFCs. ETMD can be performed in some particularly mature collections prior to 4 weeks if the indication is strong and the collection appears to have a mature wall. However, the potential for cyst wall perforation is higher and should be considered in the risk-benefit discussion. Conversely, some collections beyond 4 weeks lack an adequately organized wall and require additional time for maturation.
While endoscopic drainage of pseudocysts has essentially supplanted surgery, the management of WON is more complex and remains multidisciplinary. Two recent randomized trials demonstrated no difference in major complications and/or death between a surgical and endoscopic step-up strategy for WON.2,3 Rates of pancreatic fistulae, hospital stay, and overall treatment costs, however, favored endoscopy. Nevertheless, defining the ideal strategy for many of these patients with complexity requires multidisciplinary discussion. Surgery continues to play a primary role in several scenarios, including collections that are not close to the upper GI tract, those that are particularly complex and extend caudally, and situations in which the endoscopic progress is too slow.
The three most important questions when deciding to embark on ETMD are: (1) whether drainage is indicated (that is, is the patient symptomatic or is there evidence that the PFC is infected?), (2) whether the wall of the collection is adequately mature and apposed to the GI tract wall; and (3) whether the collection contains necrosis? This last question has critical implications in the technical approach to drainage. While CT scan with IV contrast is accurate for assessing wall maturity, it is inadequate to evaluate the presence or quantity of necrosum. Transabdominal ultrasound, endoscopic ultrasound, and MRI (on a T2 sequence) are all superior for this purpose. MRI has the additional benefit of assessing the pancreatic duct integrity, which may influence subsequent management.
Pseudocysts can be managed by cyst-gastrostomy or cyst-duodenostomy alone, whereas most WONs require the additional step of endoscopic necrosectomy – the process of entering the cyst cavity to mechanically debride necrotic tissue. Because of a higher rate of technical success, endoscopic ultrasound–directed creation of the transmural drainage pathway has become standard practice. In addition, it is likely safer, allowing for the identification and avoidance of interceding vessels and other vital structures. The role of endoscopic retrograde cholangiopancreatography with pancreatic stent placement as primary therapy for PFCs is limited to the drainage of small collections (<5 cm), for which it is the preferred treatment strategy. It is as effective as ETMD, which may not be feasible or safe for small PFCs.
Plastic double-pigtail stents have traditionally been used to maintain the transmural tract for both pseudocyst and WON. Recently, however, metallic stents have become more popular. Fully covered biliary self-expanding metallic stents (SEMS) are easier to place, have a larger lumen, and are associated with improved outcomes, compared with plastic stents in observational studies of pseudocyst drainage. Lumen-apposing metallic stents (LAMS) have become the preferred prosthesis for WON drainage given the ability to near-simultaneously establish access and deploy the stent, as well as their much larger caliber lumen which permits seamless entry into the cavity with an endoscope. Based on ease and efficiency of use, LAMS are also commonly employed for pseudocyst drainage, although entry into the cavity is unnecessary.
Plastic stents have been shown to be more cost effective than LAMS for pseudocyst drainage, although the economics around biliary SEMS in this context have not been explored. Robust comparative effectiveness data defining the optimal prostheses for pseudocysts are needed. The literature comparing LAMS to plastic stents for the management of WON is mixed. Studies have shown LAMS to be more cost effective, but a small randomized trial demonstrated no difference in clinical success or in the number of procedures to achieve WON resolution.4 We generally favor LAMS for WON since large-caliber balloon dilation of the tract seems safer within the lumen of the LAMS (which could seal small perforations and tamponade bleeding vessels) than within a freshly created tract.
Secondary infection of the cavity, usually because of stent occlusion, and bleeding are the most common complications of ETMD. Even in the absence of stent occlusion, contamination of the collection after ETMD is ubiquitous and, as such, we prescribe prophylactic antibiotics for 1-2 weeks after the procedure, although this practice is not evidence based. Hemorrhage appears to be increasing in frequency with the diffusion of LAMS; this has been postulated to be due to particularly rapid cyst cavity collapse resulting in erosion of the stent into contralateral cyst wall vessels. CT angiography followed by an embolization procedure for a possible pseudoaneurysm is the mainstay of treatment. Serious venous bleeding is more challenging to address because angiographic options are limited.
Despite tremendous recent advances, several important controversies in the endoscopic management of PFCs persist. The optimal prosthesis, the importance of first-session endoscopic necroscopy (compared with stepping up to endoscopic necroscopy only if necessary), the roles of adjunctive drain placement and chemical debridement (such as hydrogen peroxide), the need for concomitant pancreatic stent placement, and the preferred long-term management of a disconnected pancreatic duct are areas for which additional research is sorely needed. We further discuss these questions and many additional technical considerations pertaining to endoscopic drainage in a recent review.5
In summary, endoscopic transmural drainage of mature PFCs is effective and safe. Existing evidence supports its use as the favored treatment modality in appropriate candidates and has rendered it a mainstay of the therapeutic armamentarium for this disease. Further studies are needed to address critical unanswered questions and to develop a uniform endoscopic management paradigm.
References
1. van Santvoort HC et al. N Engl J Med. 2010;362(16):1491-502.
2. van Brunschot S et al. Lancet. 2018;391(10115):51-8.
3. Bang JY et al. Gastroenterology. 2019;156(4):1027-40.
4. Bang JY et al. Gut. 2019;68(7):1200-9.
5. Elmunzer BJ. Clin Gastroenterol Hepatol. 2018;16(12):1851-63.
Dr. Moran is assistant professor of medicine, division of gastroenterology and hepatology, Medical University of South Carolina, Charleston; Dr. Elmunzer is the Peter Cotton Professor of Medicine and Endoscopic Innovation, division of gastroenterology and hepatology, Medical University of South Carolina. The authors have no conflicts of interest pertaining to this review.
Fellowship procedure logs: A word of advice for fellows and a call to action for fellowship programs
As a GI fellow, I never would have imagined I would be writing an article on GI fellowship procedure logs. At the time, in my naiveté, I looked at the procedure log as a necessary evil and part of the “red tape” imposed on fellowship programs by the Accreditation Council for Graduate Medical Education (ACGME). While the importance of keeping a log was highlighted and enforced by my program, the large majority of the recommended numbers were easily achievable. As a result, even my sporadic tracking of completed procedures was sufficient to meet the requirements. My poor compliance wasn’t because I was lazy or careless, but rather because of the absence of a formal system, which resulted in homegrown methods that were highly inaccurate. I wasn’t alone in my follies. As I discussed this issue with fellows across the nation, I learned that these sentiments were universally shared. It seemed that everyone had come up with their own unique way of keeping a log – from Word and Excel documents, to a binder of patient stickers, to a daily folded sheet of paper with scribbled technical notes – all of which were an inconvenience to trainees already stretched thin. However, when the time came for employee credentialing, I came to realize the importance of keeping an accurate record. This once-neglected document would become the ultimate record of my capabilities for independent practice. The pitfalls and shortcomings of how we currently log procedures is why it was the first thing I worked on improving once I was an academic faculty member. There had to be a better way!
I started by reviewing what ACGME actually mandates trainees in GI to track, and to my surprise, they no longer set minimum procedure requirements, but rather competencies. The current requirements state that “Fellows must demonstrate competence in performance of ... procedures”1 and specifically state that competence should “not be based solely on a minimum number of procedures performed.” So, where does the need for a procedure log and minimum numbers come from? Your fellowship programs’ review committee. Programs recognize that, in order to approve requests for independent practice privileges, they need to substantiate the competency of the fellow, which ultimately is best evidenced through procedure logs. Therefore, the committee sets the minimum number of cases they believe is necessary for trainees to practice safely and independently.2 Our program leadership at UConn Health in Farmington, Conn., annually assesses our procedure activity and, over the years, has settled on the procedure guideline numbers provided to fellows at orientation and reviewed with them semiannually.
Once I understood exactly why we need procedure logs, I started looking at how other specialties handle them, particularly surgical programs in which accurate procedure logs are vitally important. It turns out that they universally use, and look favorably on, the ACGME Case Log System - an online, all encompassing, tracking software. This system is provided to surgical programs despite ACGME’s focus on competencies rather than numbers. Why this system is not offered for GI programs is unclear. However, in my endeavor, I was able to find the American Gastroenterological Association (AGA) Procedure Log system. When we reviewed the system in 2015 for use in our program, it was more of a concept than an all-encompassing tool. Fortunately, the AGA Information Technology (IT) and Training departments were kind enough to work with us to develop a complete online tracking tool that could be used nationally by all trainees in GI. Finally, we had a system to keep an accurate, secure log online and in real time.
A plea to fellows
With this, understand that in today’s document driven and litigious world, your procedure log is as vital to endoscopy as the scope itself. Without it, you may not be granted permission to do x, y, or z procedure. Indirectly, it can lead to delays in patient care and may prevent you from performing certain tasks and ultimately lead to repetitive training. Treat it as an official legal document of what you’ve done and what you are capable of doing. Recognize that it will be used by your mentors as supporting evidence regarding your competency for independent practice. Ask your training program to provide a clear list of expectations and requirements for graduation and a method for you to accurately track them, such as the AGA Procedure Log. An online, mobile system will allow you to document cases immediately after you finish while the procedure is fresh in your mind. Taking an extra minute after each case will prevent headaches down the road. The faculty and your cofellows all know of the end of the year “procedure scavenger” (i.e., the fellow who searches for procedures and takes them from others to make sure they meet their numbers for graduation). Please don’t be that person.
A request for program directors
As GI educators, we all know the mention of procedure logs to fellows is typically accompanied by eye rolls. It doesn’t have to be that way. Provide your fellows with clear expectations and a quick, easy, and accurate way to track their accomplishments. Help them recognize the importance of an accurate and complete procedure log. Consider an online tracking system such as the AGA Procedure Log. Studies have demonstrated that a computer-based system increases compliance and accuracy.3 Not providing one will surely lead to difficulties in the long run and is a disservice to those we work to empower, educate, and prepare for success.
References
1. ACGME Program Requirements for Graduate Medical Education in Gastroenterology. Accreditation Council for Graduate Medical Education. 2020 Jul 1. pp 21, 28. Accessed Sept. 13, 2020. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/144_Gastroenterology_2020.pdf.
2. Steven J et al. J Grad Med Educat. 2012;4(2):257-60.
3. Rowe BH et al. Can Fam Physician. 1995;41:2113–20.
Dr. Rezaizadeh is an assistant professor of medicine, associate program director, gastroenterology fellowship program, UConn Health, Farmington, Conn.
As a GI fellow, I never would have imagined I would be writing an article on GI fellowship procedure logs. At the time, in my naiveté, I looked at the procedure log as a necessary evil and part of the “red tape” imposed on fellowship programs by the Accreditation Council for Graduate Medical Education (ACGME). While the importance of keeping a log was highlighted and enforced by my program, the large majority of the recommended numbers were easily achievable. As a result, even my sporadic tracking of completed procedures was sufficient to meet the requirements. My poor compliance wasn’t because I was lazy or careless, but rather because of the absence of a formal system, which resulted in homegrown methods that were highly inaccurate. I wasn’t alone in my follies. As I discussed this issue with fellows across the nation, I learned that these sentiments were universally shared. It seemed that everyone had come up with their own unique way of keeping a log – from Word and Excel documents, to a binder of patient stickers, to a daily folded sheet of paper with scribbled technical notes – all of which were an inconvenience to trainees already stretched thin. However, when the time came for employee credentialing, I came to realize the importance of keeping an accurate record. This once-neglected document would become the ultimate record of my capabilities for independent practice. The pitfalls and shortcomings of how we currently log procedures is why it was the first thing I worked on improving once I was an academic faculty member. There had to be a better way!
I started by reviewing what ACGME actually mandates trainees in GI to track, and to my surprise, they no longer set minimum procedure requirements, but rather competencies. The current requirements state that “Fellows must demonstrate competence in performance of ... procedures”1 and specifically state that competence should “not be based solely on a minimum number of procedures performed.” So, where does the need for a procedure log and minimum numbers come from? Your fellowship programs’ review committee. Programs recognize that, in order to approve requests for independent practice privileges, they need to substantiate the competency of the fellow, which ultimately is best evidenced through procedure logs. Therefore, the committee sets the minimum number of cases they believe is necessary for trainees to practice safely and independently.2 Our program leadership at UConn Health in Farmington, Conn., annually assesses our procedure activity and, over the years, has settled on the procedure guideline numbers provided to fellows at orientation and reviewed with them semiannually.
Once I understood exactly why we need procedure logs, I started looking at how other specialties handle them, particularly surgical programs in which accurate procedure logs are vitally important. It turns out that they universally use, and look favorably on, the ACGME Case Log System - an online, all encompassing, tracking software. This system is provided to surgical programs despite ACGME’s focus on competencies rather than numbers. Why this system is not offered for GI programs is unclear. However, in my endeavor, I was able to find the American Gastroenterological Association (AGA) Procedure Log system. When we reviewed the system in 2015 for use in our program, it was more of a concept than an all-encompassing tool. Fortunately, the AGA Information Technology (IT) and Training departments were kind enough to work with us to develop a complete online tracking tool that could be used nationally by all trainees in GI. Finally, we had a system to keep an accurate, secure log online and in real time.
A plea to fellows
With this, understand that in today’s document driven and litigious world, your procedure log is as vital to endoscopy as the scope itself. Without it, you may not be granted permission to do x, y, or z procedure. Indirectly, it can lead to delays in patient care and may prevent you from performing certain tasks and ultimately lead to repetitive training. Treat it as an official legal document of what you’ve done and what you are capable of doing. Recognize that it will be used by your mentors as supporting evidence regarding your competency for independent practice. Ask your training program to provide a clear list of expectations and requirements for graduation and a method for you to accurately track them, such as the AGA Procedure Log. An online, mobile system will allow you to document cases immediately after you finish while the procedure is fresh in your mind. Taking an extra minute after each case will prevent headaches down the road. The faculty and your cofellows all know of the end of the year “procedure scavenger” (i.e., the fellow who searches for procedures and takes them from others to make sure they meet their numbers for graduation). Please don’t be that person.
A request for program directors
As GI educators, we all know the mention of procedure logs to fellows is typically accompanied by eye rolls. It doesn’t have to be that way. Provide your fellows with clear expectations and a quick, easy, and accurate way to track their accomplishments. Help them recognize the importance of an accurate and complete procedure log. Consider an online tracking system such as the AGA Procedure Log. Studies have demonstrated that a computer-based system increases compliance and accuracy.3 Not providing one will surely lead to difficulties in the long run and is a disservice to those we work to empower, educate, and prepare for success.
References
1. ACGME Program Requirements for Graduate Medical Education in Gastroenterology. Accreditation Council for Graduate Medical Education. 2020 Jul 1. pp 21, 28. Accessed Sept. 13, 2020. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/144_Gastroenterology_2020.pdf.
2. Steven J et al. J Grad Med Educat. 2012;4(2):257-60.
3. Rowe BH et al. Can Fam Physician. 1995;41:2113–20.
Dr. Rezaizadeh is an assistant professor of medicine, associate program director, gastroenterology fellowship program, UConn Health, Farmington, Conn.
As a GI fellow, I never would have imagined I would be writing an article on GI fellowship procedure logs. At the time, in my naiveté, I looked at the procedure log as a necessary evil and part of the “red tape” imposed on fellowship programs by the Accreditation Council for Graduate Medical Education (ACGME). While the importance of keeping a log was highlighted and enforced by my program, the large majority of the recommended numbers were easily achievable. As a result, even my sporadic tracking of completed procedures was sufficient to meet the requirements. My poor compliance wasn’t because I was lazy or careless, but rather because of the absence of a formal system, which resulted in homegrown methods that were highly inaccurate. I wasn’t alone in my follies. As I discussed this issue with fellows across the nation, I learned that these sentiments were universally shared. It seemed that everyone had come up with their own unique way of keeping a log – from Word and Excel documents, to a binder of patient stickers, to a daily folded sheet of paper with scribbled technical notes – all of which were an inconvenience to trainees already stretched thin. However, when the time came for employee credentialing, I came to realize the importance of keeping an accurate record. This once-neglected document would become the ultimate record of my capabilities for independent practice. The pitfalls and shortcomings of how we currently log procedures is why it was the first thing I worked on improving once I was an academic faculty member. There had to be a better way!
I started by reviewing what ACGME actually mandates trainees in GI to track, and to my surprise, they no longer set minimum procedure requirements, but rather competencies. The current requirements state that “Fellows must demonstrate competence in performance of ... procedures”1 and specifically state that competence should “not be based solely on a minimum number of procedures performed.” So, where does the need for a procedure log and minimum numbers come from? Your fellowship programs’ review committee. Programs recognize that, in order to approve requests for independent practice privileges, they need to substantiate the competency of the fellow, which ultimately is best evidenced through procedure logs. Therefore, the committee sets the minimum number of cases they believe is necessary for trainees to practice safely and independently.2 Our program leadership at UConn Health in Farmington, Conn., annually assesses our procedure activity and, over the years, has settled on the procedure guideline numbers provided to fellows at orientation and reviewed with them semiannually.
Once I understood exactly why we need procedure logs, I started looking at how other specialties handle them, particularly surgical programs in which accurate procedure logs are vitally important. It turns out that they universally use, and look favorably on, the ACGME Case Log System - an online, all encompassing, tracking software. This system is provided to surgical programs despite ACGME’s focus on competencies rather than numbers. Why this system is not offered for GI programs is unclear. However, in my endeavor, I was able to find the American Gastroenterological Association (AGA) Procedure Log system. When we reviewed the system in 2015 for use in our program, it was more of a concept than an all-encompassing tool. Fortunately, the AGA Information Technology (IT) and Training departments were kind enough to work with us to develop a complete online tracking tool that could be used nationally by all trainees in GI. Finally, we had a system to keep an accurate, secure log online and in real time.
A plea to fellows
With this, understand that in today’s document driven and litigious world, your procedure log is as vital to endoscopy as the scope itself. Without it, you may not be granted permission to do x, y, or z procedure. Indirectly, it can lead to delays in patient care and may prevent you from performing certain tasks and ultimately lead to repetitive training. Treat it as an official legal document of what you’ve done and what you are capable of doing. Recognize that it will be used by your mentors as supporting evidence regarding your competency for independent practice. Ask your training program to provide a clear list of expectations and requirements for graduation and a method for you to accurately track them, such as the AGA Procedure Log. An online, mobile system will allow you to document cases immediately after you finish while the procedure is fresh in your mind. Taking an extra minute after each case will prevent headaches down the road. The faculty and your cofellows all know of the end of the year “procedure scavenger” (i.e., the fellow who searches for procedures and takes them from others to make sure they meet their numbers for graduation). Please don’t be that person.
A request for program directors
As GI educators, we all know the mention of procedure logs to fellows is typically accompanied by eye rolls. It doesn’t have to be that way. Provide your fellows with clear expectations and a quick, easy, and accurate way to track their accomplishments. Help them recognize the importance of an accurate and complete procedure log. Consider an online tracking system such as the AGA Procedure Log. Studies have demonstrated that a computer-based system increases compliance and accuracy.3 Not providing one will surely lead to difficulties in the long run and is a disservice to those we work to empower, educate, and prepare for success.
References
1. ACGME Program Requirements for Graduate Medical Education in Gastroenterology. Accreditation Council for Graduate Medical Education. 2020 Jul 1. pp 21, 28. Accessed Sept. 13, 2020. https://www.acgme.org/Portals/0/PFAssets/ProgramRequirements/144_Gastroenterology_2020.pdf.
2. Steven J et al. J Grad Med Educat. 2012;4(2):257-60.
3. Rowe BH et al. Can Fam Physician. 1995;41:2113–20.
Dr. Rezaizadeh is an assistant professor of medicine, associate program director, gastroenterology fellowship program, UConn Health, Farmington, Conn.
Breaking the glass ceiling in interventional endoscopy: Practical considerations for women
Subspecialty training in advanced endoscopy has become increasingly appealing to GI fellows. The allure of an ever-evolving and innovative field is demonstrated by a substantial increase in the number of training programs over the last 2 decades, from 10 in the year 2000 to over 100 currently.1 Despite its increasing popularity, women interventionalists have been a glaring absence in this phenomenon.
For the 2018-2019 academic year, women represented only 12% of incoming advanced endoscopy fellows who matched through the American Society for Gastrointestinal Endoscopy (ASGE) match program. Perhaps more concerning, studies have found that the percentage of female trainees interested in advanced endoscopy diminishes as general GI fellowship progresses.2
Several potential contributors have been cited that elucidate this disparity including work-life balance, radiation exposure, and lack of mentorship.2 Implicit bias also undoubtedly plays a role.
Choosing a career path: Academia vs. private practice
The decision to pursue academia versus private practice in the field of advanced endoscopy is not always straightforward. For a relatively saturated subspecialty, geographic constraints and availability of positions may limit one path or another. Although an interventional practice is best supported by a tertiary care center, there is a known opportunity conflict between the number of advanced endoscopy trainees and the availability of academic positions.3
Although private practice may offer more autonomy in scheduling and fewer nonclinical responsibilities, there may be increased pressure to retain high clinical volumes with direct financial consequences, as well as limitations in overall career advancement. Pursuing an academic path, however, may lead to less flexibility in scheduling, more travel involved with speaking engagements, and teaching and/or research responsibilities disrupting a favorable work-life balance.3 Regardless of career path, the best environment to thrive as an advanced endoscopist and a mother is one in which there is recognition and support of the challenging early family years.
Family planning
Given the long and arduous training, along with the pressures of the early faculty/clinical years, there is no perfect time for a pregnancy. Even when a pregnancy is planned, there is no certainty it will follow the intended course. The challenges specific to a career in advanced endoscopy are not well described.
Considerations during a pregnancy
When to divulge
For female interventionalists, determining when to divulge a pregnancy and the duration of maternity leave can be elusive. There is a fine balance between revealing prematurely given the risk of miscarriage and waiting so long that appropriate precautions are forsaken. One might consider disclosing the pregnancy to a few key personnel in the endoscopy unit and/or a radiation safety officer to optimize early measures to prevent occupational hazards.
Maternity leave
Every institution and practice differ in the details of maternity leave policies. These details should be reviewed and negotiated in advance. At a minimum, they are guided by the federal Family and Medical Leave Act, which entitles employees to 12 weeks of unpaid, job-protected leave.4 Each pregnancy, delivery, and postpartum period is unique and unpredictable. While early planning and consideration of coverage are crucial, it is imperative to be realistic and fluid about the postpartum journey. The unpredictable need for an extended leave has the potential to lead to career stagnancy. It is important to remember that this is a small fraction of time in the context of an entire career.
Fluoroscopy exposure
The exposure to fluoroscopy and potential adverse effects on a pregnancy has been cited frequently by women as a barrier to pursuing advanced endoscopy.2 Given the paucity of women in this field, there has yet to be definitive data on the management of fluoroscopy risk while pregnant. The ASGE Quality Assurance Endoscopy Committee has acknowledged the importance of such data and is currently preparing guidelines for radiation safety that will address the risks for pregnant endoscopists and strategies to minimize fetal exposure. The use of a fetal monitor and an early discussion with the institution’s radiation safety officer are essential to minimize fetal exposure.
Optimizing ergonomics
There have been several publications demonstrating the deleterious musculoskeletal impacts of poor ergonomics while performing endoscopy, with women being at greater risk.5The New Gastroenterologist has also published a primer on this topic. In addition to inadequate education on biomechanics and inconsistent implementation of preventative safeguards, poor endoscope design has been shown to contribute. This can be accentuated for women in advanced endoscopy who perform complex procedures with therapeutic endoscopes equipped with suboptimal handle size and dial placement.
The potential for musculoskeletal injury increases during pregnancy. The standard measures to optimize biomechanics include screen at eye level, bed at hip height, a cushioned mat, and an athletic stance.6 In addition, back injury during pregnancy in advanced endoscopy is not uncommon. Several considerations should be entertained including use of double lead versus standard two-piece 0.5-mm lead with shielding curtains and walls, sitting during procedures when possible, and incorporating short breaks in the endoscopy schedule. Furthermore, more focus and innovation are required from endoscope manufacturers to tailor toward female hand anatomy. Until then, these small but meaningful measures may help to ensure optimal biomechanics to prevent injury.
Breastfeeding/pumping
Breastfeeding in the field of advanced endoscopy has traditionally been challenging. Navigating the collection and storage of breast milk during a busy day of interventional cases can be overwhelming. The previously stagnant industry of electric breast pumps has recently been revolutionized by the innovation of wearable breast pumps. Women are no longer required to find private space to connect to a loud, wired, contraption at least 30 minutes at a time, several times a day. In the context of a busy endoscopy schedule, this antiquated ritual is nearly incompatible with the continuation of breast feeding after returning to work. With relatively silent, wearable breast pumps, it is now possible to continue patient care whether in the clinic or in the endoscopy suite with minimal disruption to a productive day.
Resources
Although there continues to be a void for dedicated mentorship for female interventionalists, there have been many organizational initiatives to unite female gastroenterologists and promote the advancement of women. Several specific initiatives have been particularly effective. Women in Endoscopy (WIE) is a global organization that champions the advancement of women in GI through education, professional growth, and leadership development. In collaboration with the American Gastroenterological Association, they have recently held a virtual event focused on career advancement in the context of unique challenges for women, “Cross Your T’s to Success: How to Deliver a Great Talk, Get Your New Title and Seize Your Next Career Twist.” WIE has also recently launched a webinar series, “Women in Advanced Endoscopy: Fellows Educational Series,” that highlights practicing female interventionalists and illuminating the path to entering the field for trainees. In addition, the ASGE Leadership Education and Development (LEAD) Program has had longstanding success in providing young female gastroenterologists an opportunity to enhance their career advancement skills and facilitate the path to leadership positions. The popularity and success of the LEAD program has led the ASGE to create a special interest group known as ASGE Women in Endoscopy (AWE) with a mission to develop resources for career development during the first 5 years after fellowship. The American College of Gastroenterology also has a unique networking platform for women known as the Women in GI Circle. Furthermore, social media platforms such as Facebook’s Physician Moms Group (PMG) and Ladies of the Gut (LOG; group accessible by invitation only) have proved powerful in connecting female endoscopists and providing a great resource for quick guidance, encouragement, and commiseration. There are also multiple Facebook groups for breastfeeding physicians including Dr. Milk and other pump-specific groups. These online communities have facilitated the dissemination of high-quality resources for troubleshooting and general camaraderie.
Conclusion
Women remain a minority in GI, and especially in advanced endoscopy. Compared with surgical subspecialties that have witnessed substantial progress in the recruitment of women over the past decade, advanced endoscopy seems to be lagging far behind. Recent studies have shown that unified efforts from the surgical societies, such as establishing mentorship programs for trainees, have managed to increase the rates of women in general surgery programs from 14% in 2001 to 40% in 2017.7,8 As the barriers for women entering advanced endoscopy are further understood, the underlying concern of reconciling a challenging field and motherhood has emerged as a common thread. While the practical information presented here cannot overcome the cultural constructs and implicit biases in which women practice advanced endoscopy, the hope is to provide a pragmatic approach to the perceived barriers and promote dialogue among women so that they, too, can pursue and thrive in the field of advanced endoscopy.
References
1. Trindade AJ et al. Characteristics, goals, and motivations of applicants pursuing a fourth-year advanced endoscopy fellowship. Gastrointest Endosc. 2012;76(5):939-44.
2. Pollack MJ et al. Gender disparities and gastroenterology trainee attitudes toward advanced endoscopic training. Gastrointest Endosc. 2010;72(5):1111.
3. Granato CM et al. Career prospects and professional landscape after advanced endoscopy fellowship training: a survey assessing graduates from 2009 to 2013. Gastrointest Endosc. 2016;84(2):266-71.
4. Family and Medical Leave Act. US Department of Labor. Accessed May 15, 2020. https://www.dol.gov/agencies/whd/fmla.
5. Pedrosa MC et al. Minimizing occupational hazards in endoscopy: Personal protective equipment, radiation safety, and ergonomics. Gastrointest Endosc. 2010;72(2):227-35.
6. Singla M et al. Training the endo-athlete: An update in ergonomics in endoscopy. Clin Gastro Hepatol. 2018;16(7):1003-6.
7. Aziz HB et al. 2018 ACS Governors Survey: Gender inequality and harassment remain a challenge in surgery. Bulletin of the American College of Surgeons. Accessed August 22, 2020. https://bulletin.facs.org/2019/09/2018-acs-governors-survey-gender-inequality-and-harassment-remain-a-challenge-in-surgery/
8. Abelson JS et al. The climb to break the glass ceiling in surgery: trends in women progressing from medical school to surgical training and academic leadership from 1994 to 2015. Am J Surg. 2016;212(4):566-72.e1.
Dr. Hasan is director of interventional endoscopy, department of gastroenterology and hepatology, NorthBay Healthcare Group; Dr. Schulman is an assistant professor, director of bariatric endoscopy, division of gastroenterology and hepatology, University of Michigan, Ann Arbor.
Subspecialty training in advanced endoscopy has become increasingly appealing to GI fellows. The allure of an ever-evolving and innovative field is demonstrated by a substantial increase in the number of training programs over the last 2 decades, from 10 in the year 2000 to over 100 currently.1 Despite its increasing popularity, women interventionalists have been a glaring absence in this phenomenon.
For the 2018-2019 academic year, women represented only 12% of incoming advanced endoscopy fellows who matched through the American Society for Gastrointestinal Endoscopy (ASGE) match program. Perhaps more concerning, studies have found that the percentage of female trainees interested in advanced endoscopy diminishes as general GI fellowship progresses.2
Several potential contributors have been cited that elucidate this disparity including work-life balance, radiation exposure, and lack of mentorship.2 Implicit bias also undoubtedly plays a role.
Choosing a career path: Academia vs. private practice
The decision to pursue academia versus private practice in the field of advanced endoscopy is not always straightforward. For a relatively saturated subspecialty, geographic constraints and availability of positions may limit one path or another. Although an interventional practice is best supported by a tertiary care center, there is a known opportunity conflict between the number of advanced endoscopy trainees and the availability of academic positions.3
Although private practice may offer more autonomy in scheduling and fewer nonclinical responsibilities, there may be increased pressure to retain high clinical volumes with direct financial consequences, as well as limitations in overall career advancement. Pursuing an academic path, however, may lead to less flexibility in scheduling, more travel involved with speaking engagements, and teaching and/or research responsibilities disrupting a favorable work-life balance.3 Regardless of career path, the best environment to thrive as an advanced endoscopist and a mother is one in which there is recognition and support of the challenging early family years.
Family planning
Given the long and arduous training, along with the pressures of the early faculty/clinical years, there is no perfect time for a pregnancy. Even when a pregnancy is planned, there is no certainty it will follow the intended course. The challenges specific to a career in advanced endoscopy are not well described.
Considerations during a pregnancy
When to divulge
For female interventionalists, determining when to divulge a pregnancy and the duration of maternity leave can be elusive. There is a fine balance between revealing prematurely given the risk of miscarriage and waiting so long that appropriate precautions are forsaken. One might consider disclosing the pregnancy to a few key personnel in the endoscopy unit and/or a radiation safety officer to optimize early measures to prevent occupational hazards.
Maternity leave
Every institution and practice differ in the details of maternity leave policies. These details should be reviewed and negotiated in advance. At a minimum, they are guided by the federal Family and Medical Leave Act, which entitles employees to 12 weeks of unpaid, job-protected leave.4 Each pregnancy, delivery, and postpartum period is unique and unpredictable. While early planning and consideration of coverage are crucial, it is imperative to be realistic and fluid about the postpartum journey. The unpredictable need for an extended leave has the potential to lead to career stagnancy. It is important to remember that this is a small fraction of time in the context of an entire career.
Fluoroscopy exposure
The exposure to fluoroscopy and potential adverse effects on a pregnancy has been cited frequently by women as a barrier to pursuing advanced endoscopy.2 Given the paucity of women in this field, there has yet to be definitive data on the management of fluoroscopy risk while pregnant. The ASGE Quality Assurance Endoscopy Committee has acknowledged the importance of such data and is currently preparing guidelines for radiation safety that will address the risks for pregnant endoscopists and strategies to minimize fetal exposure. The use of a fetal monitor and an early discussion with the institution’s radiation safety officer are essential to minimize fetal exposure.
Optimizing ergonomics
There have been several publications demonstrating the deleterious musculoskeletal impacts of poor ergonomics while performing endoscopy, with women being at greater risk.5The New Gastroenterologist has also published a primer on this topic. In addition to inadequate education on biomechanics and inconsistent implementation of preventative safeguards, poor endoscope design has been shown to contribute. This can be accentuated for women in advanced endoscopy who perform complex procedures with therapeutic endoscopes equipped with suboptimal handle size and dial placement.
The potential for musculoskeletal injury increases during pregnancy. The standard measures to optimize biomechanics include screen at eye level, bed at hip height, a cushioned mat, and an athletic stance.6 In addition, back injury during pregnancy in advanced endoscopy is not uncommon. Several considerations should be entertained including use of double lead versus standard two-piece 0.5-mm lead with shielding curtains and walls, sitting during procedures when possible, and incorporating short breaks in the endoscopy schedule. Furthermore, more focus and innovation are required from endoscope manufacturers to tailor toward female hand anatomy. Until then, these small but meaningful measures may help to ensure optimal biomechanics to prevent injury.
Breastfeeding/pumping
Breastfeeding in the field of advanced endoscopy has traditionally been challenging. Navigating the collection and storage of breast milk during a busy day of interventional cases can be overwhelming. The previously stagnant industry of electric breast pumps has recently been revolutionized by the innovation of wearable breast pumps. Women are no longer required to find private space to connect to a loud, wired, contraption at least 30 minutes at a time, several times a day. In the context of a busy endoscopy schedule, this antiquated ritual is nearly incompatible with the continuation of breast feeding after returning to work. With relatively silent, wearable breast pumps, it is now possible to continue patient care whether in the clinic or in the endoscopy suite with minimal disruption to a productive day.
Resources
Although there continues to be a void for dedicated mentorship for female interventionalists, there have been many organizational initiatives to unite female gastroenterologists and promote the advancement of women. Several specific initiatives have been particularly effective. Women in Endoscopy (WIE) is a global organization that champions the advancement of women in GI through education, professional growth, and leadership development. In collaboration with the American Gastroenterological Association, they have recently held a virtual event focused on career advancement in the context of unique challenges for women, “Cross Your T’s to Success: How to Deliver a Great Talk, Get Your New Title and Seize Your Next Career Twist.” WIE has also recently launched a webinar series, “Women in Advanced Endoscopy: Fellows Educational Series,” that highlights practicing female interventionalists and illuminating the path to entering the field for trainees. In addition, the ASGE Leadership Education and Development (LEAD) Program has had longstanding success in providing young female gastroenterologists an opportunity to enhance their career advancement skills and facilitate the path to leadership positions. The popularity and success of the LEAD program has led the ASGE to create a special interest group known as ASGE Women in Endoscopy (AWE) with a mission to develop resources for career development during the first 5 years after fellowship. The American College of Gastroenterology also has a unique networking platform for women known as the Women in GI Circle. Furthermore, social media platforms such as Facebook’s Physician Moms Group (PMG) and Ladies of the Gut (LOG; group accessible by invitation only) have proved powerful in connecting female endoscopists and providing a great resource for quick guidance, encouragement, and commiseration. There are also multiple Facebook groups for breastfeeding physicians including Dr. Milk and other pump-specific groups. These online communities have facilitated the dissemination of high-quality resources for troubleshooting and general camaraderie.
Conclusion
Women remain a minority in GI, and especially in advanced endoscopy. Compared with surgical subspecialties that have witnessed substantial progress in the recruitment of women over the past decade, advanced endoscopy seems to be lagging far behind. Recent studies have shown that unified efforts from the surgical societies, such as establishing mentorship programs for trainees, have managed to increase the rates of women in general surgery programs from 14% in 2001 to 40% in 2017.7,8 As the barriers for women entering advanced endoscopy are further understood, the underlying concern of reconciling a challenging field and motherhood has emerged as a common thread. While the practical information presented here cannot overcome the cultural constructs and implicit biases in which women practice advanced endoscopy, the hope is to provide a pragmatic approach to the perceived barriers and promote dialogue among women so that they, too, can pursue and thrive in the field of advanced endoscopy.
References
1. Trindade AJ et al. Characteristics, goals, and motivations of applicants pursuing a fourth-year advanced endoscopy fellowship. Gastrointest Endosc. 2012;76(5):939-44.
2. Pollack MJ et al. Gender disparities and gastroenterology trainee attitudes toward advanced endoscopic training. Gastrointest Endosc. 2010;72(5):1111.
3. Granato CM et al. Career prospects and professional landscape after advanced endoscopy fellowship training: a survey assessing graduates from 2009 to 2013. Gastrointest Endosc. 2016;84(2):266-71.
4. Family and Medical Leave Act. US Department of Labor. Accessed May 15, 2020. https://www.dol.gov/agencies/whd/fmla.
5. Pedrosa MC et al. Minimizing occupational hazards in endoscopy: Personal protective equipment, radiation safety, and ergonomics. Gastrointest Endosc. 2010;72(2):227-35.
6. Singla M et al. Training the endo-athlete: An update in ergonomics in endoscopy. Clin Gastro Hepatol. 2018;16(7):1003-6.
7. Aziz HB et al. 2018 ACS Governors Survey: Gender inequality and harassment remain a challenge in surgery. Bulletin of the American College of Surgeons. Accessed August 22, 2020. https://bulletin.facs.org/2019/09/2018-acs-governors-survey-gender-inequality-and-harassment-remain-a-challenge-in-surgery/
8. Abelson JS et al. The climb to break the glass ceiling in surgery: trends in women progressing from medical school to surgical training and academic leadership from 1994 to 2015. Am J Surg. 2016;212(4):566-72.e1.
Dr. Hasan is director of interventional endoscopy, department of gastroenterology and hepatology, NorthBay Healthcare Group; Dr. Schulman is an assistant professor, director of bariatric endoscopy, division of gastroenterology and hepatology, University of Michigan, Ann Arbor.
Subspecialty training in advanced endoscopy has become increasingly appealing to GI fellows. The allure of an ever-evolving and innovative field is demonstrated by a substantial increase in the number of training programs over the last 2 decades, from 10 in the year 2000 to over 100 currently.1 Despite its increasing popularity, women interventionalists have been a glaring absence in this phenomenon.
For the 2018-2019 academic year, women represented only 12% of incoming advanced endoscopy fellows who matched through the American Society for Gastrointestinal Endoscopy (ASGE) match program. Perhaps more concerning, studies have found that the percentage of female trainees interested in advanced endoscopy diminishes as general GI fellowship progresses.2
Several potential contributors have been cited that elucidate this disparity including work-life balance, radiation exposure, and lack of mentorship.2 Implicit bias also undoubtedly plays a role.
Choosing a career path: Academia vs. private practice
The decision to pursue academia versus private practice in the field of advanced endoscopy is not always straightforward. For a relatively saturated subspecialty, geographic constraints and availability of positions may limit one path or another. Although an interventional practice is best supported by a tertiary care center, there is a known opportunity conflict between the number of advanced endoscopy trainees and the availability of academic positions.3
Although private practice may offer more autonomy in scheduling and fewer nonclinical responsibilities, there may be increased pressure to retain high clinical volumes with direct financial consequences, as well as limitations in overall career advancement. Pursuing an academic path, however, may lead to less flexibility in scheduling, more travel involved with speaking engagements, and teaching and/or research responsibilities disrupting a favorable work-life balance.3 Regardless of career path, the best environment to thrive as an advanced endoscopist and a mother is one in which there is recognition and support of the challenging early family years.
Family planning
Given the long and arduous training, along with the pressures of the early faculty/clinical years, there is no perfect time for a pregnancy. Even when a pregnancy is planned, there is no certainty it will follow the intended course. The challenges specific to a career in advanced endoscopy are not well described.
Considerations during a pregnancy
When to divulge
For female interventionalists, determining when to divulge a pregnancy and the duration of maternity leave can be elusive. There is a fine balance between revealing prematurely given the risk of miscarriage and waiting so long that appropriate precautions are forsaken. One might consider disclosing the pregnancy to a few key personnel in the endoscopy unit and/or a radiation safety officer to optimize early measures to prevent occupational hazards.
Maternity leave
Every institution and practice differ in the details of maternity leave policies. These details should be reviewed and negotiated in advance. At a minimum, they are guided by the federal Family and Medical Leave Act, which entitles employees to 12 weeks of unpaid, job-protected leave.4 Each pregnancy, delivery, and postpartum period is unique and unpredictable. While early planning and consideration of coverage are crucial, it is imperative to be realistic and fluid about the postpartum journey. The unpredictable need for an extended leave has the potential to lead to career stagnancy. It is important to remember that this is a small fraction of time in the context of an entire career.
Fluoroscopy exposure
The exposure to fluoroscopy and potential adverse effects on a pregnancy has been cited frequently by women as a barrier to pursuing advanced endoscopy.2 Given the paucity of women in this field, there has yet to be definitive data on the management of fluoroscopy risk while pregnant. The ASGE Quality Assurance Endoscopy Committee has acknowledged the importance of such data and is currently preparing guidelines for radiation safety that will address the risks for pregnant endoscopists and strategies to minimize fetal exposure. The use of a fetal monitor and an early discussion with the institution’s radiation safety officer are essential to minimize fetal exposure.
Optimizing ergonomics
There have been several publications demonstrating the deleterious musculoskeletal impacts of poor ergonomics while performing endoscopy, with women being at greater risk.5The New Gastroenterologist has also published a primer on this topic. In addition to inadequate education on biomechanics and inconsistent implementation of preventative safeguards, poor endoscope design has been shown to contribute. This can be accentuated for women in advanced endoscopy who perform complex procedures with therapeutic endoscopes equipped with suboptimal handle size and dial placement.
The potential for musculoskeletal injury increases during pregnancy. The standard measures to optimize biomechanics include screen at eye level, bed at hip height, a cushioned mat, and an athletic stance.6 In addition, back injury during pregnancy in advanced endoscopy is not uncommon. Several considerations should be entertained including use of double lead versus standard two-piece 0.5-mm lead with shielding curtains and walls, sitting during procedures when possible, and incorporating short breaks in the endoscopy schedule. Furthermore, more focus and innovation are required from endoscope manufacturers to tailor toward female hand anatomy. Until then, these small but meaningful measures may help to ensure optimal biomechanics to prevent injury.
Breastfeeding/pumping
Breastfeeding in the field of advanced endoscopy has traditionally been challenging. Navigating the collection and storage of breast milk during a busy day of interventional cases can be overwhelming. The previously stagnant industry of electric breast pumps has recently been revolutionized by the innovation of wearable breast pumps. Women are no longer required to find private space to connect to a loud, wired, contraption at least 30 minutes at a time, several times a day. In the context of a busy endoscopy schedule, this antiquated ritual is nearly incompatible with the continuation of breast feeding after returning to work. With relatively silent, wearable breast pumps, it is now possible to continue patient care whether in the clinic or in the endoscopy suite with minimal disruption to a productive day.
Resources
Although there continues to be a void for dedicated mentorship for female interventionalists, there have been many organizational initiatives to unite female gastroenterologists and promote the advancement of women. Several specific initiatives have been particularly effective. Women in Endoscopy (WIE) is a global organization that champions the advancement of women in GI through education, professional growth, and leadership development. In collaboration with the American Gastroenterological Association, they have recently held a virtual event focused on career advancement in the context of unique challenges for women, “Cross Your T’s to Success: How to Deliver a Great Talk, Get Your New Title and Seize Your Next Career Twist.” WIE has also recently launched a webinar series, “Women in Advanced Endoscopy: Fellows Educational Series,” that highlights practicing female interventionalists and illuminating the path to entering the field for trainees. In addition, the ASGE Leadership Education and Development (LEAD) Program has had longstanding success in providing young female gastroenterologists an opportunity to enhance their career advancement skills and facilitate the path to leadership positions. The popularity and success of the LEAD program has led the ASGE to create a special interest group known as ASGE Women in Endoscopy (AWE) with a mission to develop resources for career development during the first 5 years after fellowship. The American College of Gastroenterology also has a unique networking platform for women known as the Women in GI Circle. Furthermore, social media platforms such as Facebook’s Physician Moms Group (PMG) and Ladies of the Gut (LOG; group accessible by invitation only) have proved powerful in connecting female endoscopists and providing a great resource for quick guidance, encouragement, and commiseration. There are also multiple Facebook groups for breastfeeding physicians including Dr. Milk and other pump-specific groups. These online communities have facilitated the dissemination of high-quality resources for troubleshooting and general camaraderie.
Conclusion
Women remain a minority in GI, and especially in advanced endoscopy. Compared with surgical subspecialties that have witnessed substantial progress in the recruitment of women over the past decade, advanced endoscopy seems to be lagging far behind. Recent studies have shown that unified efforts from the surgical societies, such as establishing mentorship programs for trainees, have managed to increase the rates of women in general surgery programs from 14% in 2001 to 40% in 2017.7,8 As the barriers for women entering advanced endoscopy are further understood, the underlying concern of reconciling a challenging field and motherhood has emerged as a common thread. While the practical information presented here cannot overcome the cultural constructs and implicit biases in which women practice advanced endoscopy, the hope is to provide a pragmatic approach to the perceived barriers and promote dialogue among women so that they, too, can pursue and thrive in the field of advanced endoscopy.
References
1. Trindade AJ et al. Characteristics, goals, and motivations of applicants pursuing a fourth-year advanced endoscopy fellowship. Gastrointest Endosc. 2012;76(5):939-44.
2. Pollack MJ et al. Gender disparities and gastroenterology trainee attitudes toward advanced endoscopic training. Gastrointest Endosc. 2010;72(5):1111.
3. Granato CM et al. Career prospects and professional landscape after advanced endoscopy fellowship training: a survey assessing graduates from 2009 to 2013. Gastrointest Endosc. 2016;84(2):266-71.
4. Family and Medical Leave Act. US Department of Labor. Accessed May 15, 2020. https://www.dol.gov/agencies/whd/fmla.
5. Pedrosa MC et al. Minimizing occupational hazards in endoscopy: Personal protective equipment, radiation safety, and ergonomics. Gastrointest Endosc. 2010;72(2):227-35.
6. Singla M et al. Training the endo-athlete: An update in ergonomics in endoscopy. Clin Gastro Hepatol. 2018;16(7):1003-6.
7. Aziz HB et al. 2018 ACS Governors Survey: Gender inequality and harassment remain a challenge in surgery. Bulletin of the American College of Surgeons. Accessed August 22, 2020. https://bulletin.facs.org/2019/09/2018-acs-governors-survey-gender-inequality-and-harassment-remain-a-challenge-in-surgery/
8. Abelson JS et al. The climb to break the glass ceiling in surgery: trends in women progressing from medical school to surgical training and academic leadership from 1994 to 2015. Am J Surg. 2016;212(4):566-72.e1.
Dr. Hasan is director of interventional endoscopy, department of gastroenterology and hepatology, NorthBay Healthcare Group; Dr. Schulman is an assistant professor, director of bariatric endoscopy, division of gastroenterology and hepatology, University of Michigan, Ann Arbor.
Evaluating a paper: Take care not to be confounded
In an earlier article, we looked at the meaning of the P value.1 This time we will look at another crucial statistical concept: that of confounding.
Confounding, as the name implies, is the recognition that crude associations may not reflect reality, but may instead be the result of outside factors. To illustrate, imagine that you want to study whether smoking increases the risk of death (in statistical terms, smoking is the exposure, and death is the outcome). You follow 5,000 people who smoke and 5,000 people who do not smoke for 10 years. At the end of the follow-up you find that about 40% of nonsmokers died, compared with only 10% of smokers. What do you conclude? At face value it would seem that smoking prevents death. However, before reaching this conclusion you might want to look at other factors. A look at the dataset shows that the average baseline age among nonsmokers was 60 years, whereas among smokers was 40 years. Could this be the cause of the results? You repeat the analysis based on strata of age (i.e., you compare smokers who were aged 60-70 years at baseline with nonsmokers who were aged 60-70 years, smokers who were aged 50-60 years with nonsmokers who were aged 50-60 years, and so on). What you find is that, for each category of age, the percentage of death among smokers was higher. Hence, you now reach the opposite conclusion, namely that smoking does increase the risk of death.
What happened? Why the different result? The answer is that, in this case, age was a confounder. What we initially thought was the effect of smoking was, in reality, at least in part, the effect of age. Overall, more deaths occurred among nonsmokers in the first analysis because they were older at baseline. When we compare people with similar age but who differ on smoking status, then the difference in mortality between them is not because of age (they have the same age) but smoking. Thus, in the second analysis we took age into account, or, in statistical terms, we adjusted for age, whereas the first analysis was, in statistical terms, an unadjusted or crude analysis. We should always be aware of studies with only crude results, because they might be biased/misleading.2
In the example above, age is not the only factor that might influence mortality. Alcohol or drug use, cancer or heart disease, body mass index, or physical activity can also influence death, independently of smoking. How to adjust for all these factors? We cannot do stratified analyses as we did above, because the strata would be too many. The solution is to do a multivariable regression analysis. This is a statistical tool to adjust for multiple factors (or variables) at the same time. When we adjust for all these factors, we are comparing the effect of smoking in people who are the same with regard to all these factors but who differ on smoking status. In statistical terms, we study the effect of smoking, keeping everything else constant. In this way we “isolate” the effect of smoking on death by taking into account all other factors, or, in statistical terms, we study the effect of smoking independently of other factors.
How many factors should be included in a multivariable analysis? As a general rule, the more the better, to reduce confounding. However, the number of variables to include in a regression model is limited by the sample size. The general rule of thumb is that, for every 10 events (for dichotomous outcomes) or 10 people (for continuous outcomes), we can add one variable in the model. If we add more variables than that, then in statistical terms the model becomes overfitted (i.e., it gives results that are specific to that dataset, but may not be applicable to other datasets). Overfitted models can be as biased/misleading as crude models.3
What are we to do about other factors that may affect mortality independently of smoking (e.g., diet), but which are not found in our dataset? Unfortunately, nothing. Since we do not have that information, we cannot adjust for it. In this case, diet is in statistical terms an unmeasured confounder. Unfortunately, in all observational studies there is always at least some degree of unmeasured confounding, because there may be many factors that can influence the outcome (and the exposure) which are not part of the dataset. While some statistical tools have been developed to estimate unmeasured confounding, and therefore interpret the results in its light, unmeasured confounding remains one of the major limitations of observational studies.4
Randomized, controlled trials (RCTs) on the other side do not have this problem in theory. With properly designed RCTs, all confounders, both measured and unmeasured, will be balanced between the two groups. For example, imagine an RCT where some patients are randomized to take drug A or drug B. Because patients are randomly allocated to one group or the other, it is assumed that all other factors are also randomly distributed. Hence, the two groups should be equal to each other with respect to all other factors except our active intervention, namely the type of drug they are taking (A or B). For this reason, in RCTs there is no need to adjust for multiple factors with a multivariable regression analysis, and crude unadjusted results can be presented as unbiased.
There is however a caveat. What happens if one patient who was randomized to take drug A takes drug B instead? Should she still be counted in analysis under drug A (as randomized) or under drug B (as she took it)? The usual practice is to do this and present both. In the first case, we will have the intention-to-treat (ITT) analysis, and in the second case, the per-protocol analysis (PPA). The advantage of the ITT is that it keeps the strength of randomization, namely the balancing of confounders, and therefore can present unbiased results. The advantage of the PPA is that it measures what was actually done in reality. However, in this case there is a departure from the original randomization, and hence there is the possibility of introducing confounding, because now patients are not randomly allocated to one treatment or the other. The larger the departure from randomization, the more probable the introduction of bias/confounding. For example, what if patients with more severe disease took drug A, even though they were randomized to take drug B? That will have an influence the outcome. For this reason, outcomes of the ITT analysis are considered the main results of RCTs, because PPA results can be confounded.
In summary, when reading studies, do not simply accept the results as they are presented, but rather ask yourself: “Could they be confounded by other factors, and therefore be unreliable? What steps did the authors take to reduce confounding? If they presented only crude analyses, and this was not justified by a RCT design, do they recognize it as a major limitation?” There are many nuances in every paper that can be appreciated only through a careful reading of the methods section. Hopefully, this article can shed some light on these issues and help the readers to not be confounded.
References
1. The P value: What to make of it? A simple guide for the uninitiated. GI and Hepatology News. 2019 Sep 23. https://www.mdedge.com/gihepnews/article/208601/mixed-topics/p-value-what-make-it-simple-guide-uninitiated
2. VanderWeele TJ et al. Ann Stat. 2013 Feb;41(1):196-220.
3. Concato J et al. Ann Intern Med. 1993 Feb 1;118(3):201-10.
4. VanderWeele TJ et al. Ann Intern Med. 2017 Aug 15;167(4):268-74.
Dr. Jovani is a therapeutic endoscopy fellow in the division of gastroenterology and hepatology at Johns Hopkins Hospital, Baltimore.
In an earlier article, we looked at the meaning of the P value.1 This time we will look at another crucial statistical concept: that of confounding.
Confounding, as the name implies, is the recognition that crude associations may not reflect reality, but may instead be the result of outside factors. To illustrate, imagine that you want to study whether smoking increases the risk of death (in statistical terms, smoking is the exposure, and death is the outcome). You follow 5,000 people who smoke and 5,000 people who do not smoke for 10 years. At the end of the follow-up you find that about 40% of nonsmokers died, compared with only 10% of smokers. What do you conclude? At face value it would seem that smoking prevents death. However, before reaching this conclusion you might want to look at other factors. A look at the dataset shows that the average baseline age among nonsmokers was 60 years, whereas among smokers was 40 years. Could this be the cause of the results? You repeat the analysis based on strata of age (i.e., you compare smokers who were aged 60-70 years at baseline with nonsmokers who were aged 60-70 years, smokers who were aged 50-60 years with nonsmokers who were aged 50-60 years, and so on). What you find is that, for each category of age, the percentage of death among smokers was higher. Hence, you now reach the opposite conclusion, namely that smoking does increase the risk of death.
What happened? Why the different result? The answer is that, in this case, age was a confounder. What we initially thought was the effect of smoking was, in reality, at least in part, the effect of age. Overall, more deaths occurred among nonsmokers in the first analysis because they were older at baseline. When we compare people with similar age but who differ on smoking status, then the difference in mortality between them is not because of age (they have the same age) but smoking. Thus, in the second analysis we took age into account, or, in statistical terms, we adjusted for age, whereas the first analysis was, in statistical terms, an unadjusted or crude analysis. We should always be aware of studies with only crude results, because they might be biased/misleading.2
In the example above, age is not the only factor that might influence mortality. Alcohol or drug use, cancer or heart disease, body mass index, or physical activity can also influence death, independently of smoking. How to adjust for all these factors? We cannot do stratified analyses as we did above, because the strata would be too many. The solution is to do a multivariable regression analysis. This is a statistical tool to adjust for multiple factors (or variables) at the same time. When we adjust for all these factors, we are comparing the effect of smoking in people who are the same with regard to all these factors but who differ on smoking status. In statistical terms, we study the effect of smoking, keeping everything else constant. In this way we “isolate” the effect of smoking on death by taking into account all other factors, or, in statistical terms, we study the effect of smoking independently of other factors.
How many factors should be included in a multivariable analysis? As a general rule, the more the better, to reduce confounding. However, the number of variables to include in a regression model is limited by the sample size. The general rule of thumb is that, for every 10 events (for dichotomous outcomes) or 10 people (for continuous outcomes), we can add one variable in the model. If we add more variables than that, then in statistical terms the model becomes overfitted (i.e., it gives results that are specific to that dataset, but may not be applicable to other datasets). Overfitted models can be as biased/misleading as crude models.3
What are we to do about other factors that may affect mortality independently of smoking (e.g., diet), but which are not found in our dataset? Unfortunately, nothing. Since we do not have that information, we cannot adjust for it. In this case, diet is in statistical terms an unmeasured confounder. Unfortunately, in all observational studies there is always at least some degree of unmeasured confounding, because there may be many factors that can influence the outcome (and the exposure) which are not part of the dataset. While some statistical tools have been developed to estimate unmeasured confounding, and therefore interpret the results in its light, unmeasured confounding remains one of the major limitations of observational studies.4
Randomized, controlled trials (RCTs) on the other side do not have this problem in theory. With properly designed RCTs, all confounders, both measured and unmeasured, will be balanced between the two groups. For example, imagine an RCT where some patients are randomized to take drug A or drug B. Because patients are randomly allocated to one group or the other, it is assumed that all other factors are also randomly distributed. Hence, the two groups should be equal to each other with respect to all other factors except our active intervention, namely the type of drug they are taking (A or B). For this reason, in RCTs there is no need to adjust for multiple factors with a multivariable regression analysis, and crude unadjusted results can be presented as unbiased.
There is however a caveat. What happens if one patient who was randomized to take drug A takes drug B instead? Should she still be counted in analysis under drug A (as randomized) or under drug B (as she took it)? The usual practice is to do this and present both. In the first case, we will have the intention-to-treat (ITT) analysis, and in the second case, the per-protocol analysis (PPA). The advantage of the ITT is that it keeps the strength of randomization, namely the balancing of confounders, and therefore can present unbiased results. The advantage of the PPA is that it measures what was actually done in reality. However, in this case there is a departure from the original randomization, and hence there is the possibility of introducing confounding, because now patients are not randomly allocated to one treatment or the other. The larger the departure from randomization, the more probable the introduction of bias/confounding. For example, what if patients with more severe disease took drug A, even though they were randomized to take drug B? That will have an influence the outcome. For this reason, outcomes of the ITT analysis are considered the main results of RCTs, because PPA results can be confounded.
In summary, when reading studies, do not simply accept the results as they are presented, but rather ask yourself: “Could they be confounded by other factors, and therefore be unreliable? What steps did the authors take to reduce confounding? If they presented only crude analyses, and this was not justified by a RCT design, do they recognize it as a major limitation?” There are many nuances in every paper that can be appreciated only through a careful reading of the methods section. Hopefully, this article can shed some light on these issues and help the readers to not be confounded.
References
1. The P value: What to make of it? A simple guide for the uninitiated. GI and Hepatology News. 2019 Sep 23. https://www.mdedge.com/gihepnews/article/208601/mixed-topics/p-value-what-make-it-simple-guide-uninitiated
2. VanderWeele TJ et al. Ann Stat. 2013 Feb;41(1):196-220.
3. Concato J et al. Ann Intern Med. 1993 Feb 1;118(3):201-10.
4. VanderWeele TJ et al. Ann Intern Med. 2017 Aug 15;167(4):268-74.
Dr. Jovani is a therapeutic endoscopy fellow in the division of gastroenterology and hepatology at Johns Hopkins Hospital, Baltimore.
In an earlier article, we looked at the meaning of the P value.1 This time we will look at another crucial statistical concept: that of confounding.
Confounding, as the name implies, is the recognition that crude associations may not reflect reality, but may instead be the result of outside factors. To illustrate, imagine that you want to study whether smoking increases the risk of death (in statistical terms, smoking is the exposure, and death is the outcome). You follow 5,000 people who smoke and 5,000 people who do not smoke for 10 years. At the end of the follow-up you find that about 40% of nonsmokers died, compared with only 10% of smokers. What do you conclude? At face value it would seem that smoking prevents death. However, before reaching this conclusion you might want to look at other factors. A look at the dataset shows that the average baseline age among nonsmokers was 60 years, whereas among smokers was 40 years. Could this be the cause of the results? You repeat the analysis based on strata of age (i.e., you compare smokers who were aged 60-70 years at baseline with nonsmokers who were aged 60-70 years, smokers who were aged 50-60 years with nonsmokers who were aged 50-60 years, and so on). What you find is that, for each category of age, the percentage of death among smokers was higher. Hence, you now reach the opposite conclusion, namely that smoking does increase the risk of death.
What happened? Why the different result? The answer is that, in this case, age was a confounder. What we initially thought was the effect of smoking was, in reality, at least in part, the effect of age. Overall, more deaths occurred among nonsmokers in the first analysis because they were older at baseline. When we compare people with similar age but who differ on smoking status, then the difference in mortality between them is not because of age (they have the same age) but smoking. Thus, in the second analysis we took age into account, or, in statistical terms, we adjusted for age, whereas the first analysis was, in statistical terms, an unadjusted or crude analysis. We should always be aware of studies with only crude results, because they might be biased/misleading.2
In the example above, age is not the only factor that might influence mortality. Alcohol or drug use, cancer or heart disease, body mass index, or physical activity can also influence death, independently of smoking. How to adjust for all these factors? We cannot do stratified analyses as we did above, because the strata would be too many. The solution is to do a multivariable regression analysis. This is a statistical tool to adjust for multiple factors (or variables) at the same time. When we adjust for all these factors, we are comparing the effect of smoking in people who are the same with regard to all these factors but who differ on smoking status. In statistical terms, we study the effect of smoking, keeping everything else constant. In this way we “isolate” the effect of smoking on death by taking into account all other factors, or, in statistical terms, we study the effect of smoking independently of other factors.
How many factors should be included in a multivariable analysis? As a general rule, the more the better, to reduce confounding. However, the number of variables to include in a regression model is limited by the sample size. The general rule of thumb is that, for every 10 events (for dichotomous outcomes) or 10 people (for continuous outcomes), we can add one variable in the model. If we add more variables than that, then in statistical terms the model becomes overfitted (i.e., it gives results that are specific to that dataset, but may not be applicable to other datasets). Overfitted models can be as biased/misleading as crude models.3
What are we to do about other factors that may affect mortality independently of smoking (e.g., diet), but which are not found in our dataset? Unfortunately, nothing. Since we do not have that information, we cannot adjust for it. In this case, diet is in statistical terms an unmeasured confounder. Unfortunately, in all observational studies there is always at least some degree of unmeasured confounding, because there may be many factors that can influence the outcome (and the exposure) which are not part of the dataset. While some statistical tools have been developed to estimate unmeasured confounding, and therefore interpret the results in its light, unmeasured confounding remains one of the major limitations of observational studies.4
Randomized, controlled trials (RCTs) on the other side do not have this problem in theory. With properly designed RCTs, all confounders, both measured and unmeasured, will be balanced between the two groups. For example, imagine an RCT where some patients are randomized to take drug A or drug B. Because patients are randomly allocated to one group or the other, it is assumed that all other factors are also randomly distributed. Hence, the two groups should be equal to each other with respect to all other factors except our active intervention, namely the type of drug they are taking (A or B). For this reason, in RCTs there is no need to adjust for multiple factors with a multivariable regression analysis, and crude unadjusted results can be presented as unbiased.
There is however a caveat. What happens if one patient who was randomized to take drug A takes drug B instead? Should she still be counted in analysis under drug A (as randomized) or under drug B (as she took it)? The usual practice is to do this and present both. In the first case, we will have the intention-to-treat (ITT) analysis, and in the second case, the per-protocol analysis (PPA). The advantage of the ITT is that it keeps the strength of randomization, namely the balancing of confounders, and therefore can present unbiased results. The advantage of the PPA is that it measures what was actually done in reality. However, in this case there is a departure from the original randomization, and hence there is the possibility of introducing confounding, because now patients are not randomly allocated to one treatment or the other. The larger the departure from randomization, the more probable the introduction of bias/confounding. For example, what if patients with more severe disease took drug A, even though they were randomized to take drug B? That will have an influence the outcome. For this reason, outcomes of the ITT analysis are considered the main results of RCTs, because PPA results can be confounded.
In summary, when reading studies, do not simply accept the results as they are presented, but rather ask yourself: “Could they be confounded by other factors, and therefore be unreliable? What steps did the authors take to reduce confounding? If they presented only crude analyses, and this was not justified by a RCT design, do they recognize it as a major limitation?” There are many nuances in every paper that can be appreciated only through a careful reading of the methods section. Hopefully, this article can shed some light on these issues and help the readers to not be confounded.
References
1. The P value: What to make of it? A simple guide for the uninitiated. GI and Hepatology News. 2019 Sep 23. https://www.mdedge.com/gihepnews/article/208601/mixed-topics/p-value-what-make-it-simple-guide-uninitiated
2. VanderWeele TJ et al. Ann Stat. 2013 Feb;41(1):196-220.
3. Concato J et al. Ann Intern Med. 1993 Feb 1;118(3):201-10.
4. VanderWeele TJ et al. Ann Intern Med. 2017 Aug 15;167(4):268-74.
Dr. Jovani is a therapeutic endoscopy fellow in the division of gastroenterology and hepatology at Johns Hopkins Hospital, Baltimore.
A practical approach to utilizing cannabis as adjuvant therapy in inflammatory bowel disease
Case 1
A 30 year-old female with longstanding ulcerative colitis who has a history of medically refractory steroid-dependent disease and was able to achieve remission with vedolizumab for the last 5 years. Most recent objective assessment showed histologic remission. She has been using daily cannabis medicinally for the last year (high CBD:THC [cannabidiol:delta-9-tetracannabidol] concentration). She notes that she has felt better in the last year since introducing cannabis (improved stool frequency/formation, sleep quality). She inquires about discontinuing her biologic therapy in the hope of using cannabis alone to maintain remission.
Figure 1.
Case 2
A 22-year-old male with ileocolonic inflammatory Crohn’s disease escalated to adalimumab requiring an intensification of therapy to weekly dosing to normalize C-reactive protein (CRP). A recent colonoscopy showed endoscopic improvement (colonic normalization and rare aphthae in ileum). He notes clear clinical improvement, but he continues to experience diarrhea and abdominal cramping (no relationship to meals). Declines addition of immunomodulator (nervous about returning to college during the COVID-19 pandemic). He wonders whether cannabis could be effective in controlling his symptoms as he has had improvement in symptoms during his sporadic recreational cannabis exposure.
Discussion
These cases outline the challenges that providers face when managing patients with inflammatory bowel disease (IBD) when a patient would like to either substitute or incorporate cannabis into their treatment plan. Studies have shown a high prevalence of cannabis use among patients with IBD. With the restrictions surrounding the use of cannabis – either medically or recreationally – being liberalized in many states, these conversations are likely to become more frequent in your practice. However, one of the first challenges that providers face surrounding cannabis is that many patients who use cannabis do not disclose use to their health care team for fear of being judged negatively. In addition, many providers do not routinely ask about cannabis use during office visits. This might be directly related to being unprepared to have a knowledge-based discussion on the risks and benefits of cannabis use in IBD, with the same confidence present during discussion of biologic therapies.
For background, Cannabis sativa (cannabis) is composed of hundreds of phytocannabinoids, the two most common are THC and CBD. These cannabinoids act at the endocannabinoid receptors, which are expressed in the central and peripheral nervous systems and immune cells/tissues, and help explain the clinical changes experienced by cannabis users. Both THC and CBD have been studied in varying doses and routes of administration in patients with IBD, making it challenging to translate into real-world recommendations for patients. Some of the most common reported benefits of cannabis use (particularly in an IBD population) are improvement in pain, diarrhea, nausea, and joint pain. Some studies have shown overall improvement in quality of life (Figure 1).
Some common questions that arise surrounding cannabis use in IBD patients include:
1. Is it possible to stop traditional medical therapy and replace it with cannabis therapy?
No studies have directly addressed this exact question. The small studies, both randomized controlled trials and retrospective ones, have studied the effects of cannabis as adjuvant therapy only. None of the data available to date suggest that cannabis has any anti-inflammatory properties with absence of improvement in biomarkers or endoscopic measures of inflammation. In effect, any attempt to discontinue standard therapy with substitution of cannabis-based therapy should be seen as no different than simply discontinuing standard therapy. There exists the argument that – among those with moderate to severe disease – cannabis might suppress the investigation of mild symptoms which may herald a flare of disease, thus lulling the patient into a state of false stability. We do not advocate the substitution of cannabis products in place of standard medical therapy.
2. Is there a role for cannabis as adjuvant therapy in patients with IBD?
Studies to date have included only symptomatic patients with objective evidence of inflammation and assessed clinical, biochemical, or endoscopic endpoints. In Crohn’s disease, two studies showed no improvement in clinical remission rates but showed improvement in clinical response; a third study showed both improvement in clinical remission/response as well as improved quality of life. No study showed a change in disease markers of activity including CRP, fecal calprotectin, or endoscopic scoring. In one study, all patients relapsed shortly after cannabis discontinuation suggesting that, while there was benefit in symptom control, there was no improvement of the underlying chronic inflammation.
In patients with ulcerative colitis, there were two studies. One study showed no improvement and high rates of intolerance in the treatment group, while the other study reported improved disease activity but no objective improvement. The variation in results between disease states and between studies might be because of cannabis formulations. In patients with persistent symptoms despite current medical therapy, there might be a role in those patients for adjuvant therapy for improvement symptom control but not disease control. Optimization of medical therapy would still be indicated.
3. What dose and formulation of cannabis should I recommend to a patient as adjuvant therapy?
This is an excellent question and one that unfortunately we do not have the answer to. As mentioned previously, the studies have looked at varying formulations (THC alone, CBD:THC with varying percentages of THC, CBD alone) and varying routes of administration (sublingual, oral, inhalation). The IBD studies looking at CBD-alone formulations lacked clinical efficacy. In states where cannabis products have been accessible to IBD patients, no data on the product type (THC:CBD), method of administration, or prescriber preferences have been published.
4. What risks should I advise my patients about with cannabis use?
The challenge is that we don’t have large population-based studies in IBD looking at long-term risks of cannabis use. However, in the small RCT studies there were minimal reported side effects and no major adverse events over 8-10 weeks. Larger IBD population-based studies have shown that cannabis users were more likely to discontinue traditional medical therapy, and there is an increased risk for surgery in patients with Crohn’s disease. Larger studies in non-IBD patients have shown risk for addiction to other substances, diminished life achievement, increased motor vehicle accidents, chronic bronchitis, psychiatric disturbances and cannabis dependence, and cannabis hyperemesis syndrome (with an uncanny presentation resembling Crohn’s disease flare with partial small bowel obstruction). Patients should also be advised about legal implications of use (given its continued classification as a federal schedule 1 drug), possible drug interactions, and special considerations in pediatric patients (increased risk of addiction), elderly patients (increased risk of neuropsychological effects), and during pregnancy (with national obstetric society guidelines warning against use because of fetal exposure and increased risk of stillbirth).
5. What are the legal implications for providers? Patients?
As of July 2020, cannabis is available for recreational use in 12 states, for medicinal use in 28 states, and illegal in 11 states. So the answer really depends on what state the patient lives in. As a provider who might certify patients (in some medicinal states) or recommend cannabis to patients, you should consider legal and licensing implications. Again, this might vary state to state, and you should also take into account federal status. Providers acting in compliance with state laws are unlikely to have federal consequences. However, remember that malpractice insurance only covers FDA-approved medical therapies. Patients should be advised to consider the potential (although highly unlikely) to face federal prosecution and implications of use for employment, school, camp, or travel, and driving restrictions.
Take home points
- Inquire about cannabis to start the conversation.
- Know your state’s legalization status surrounding cannabis.
- Patients with IBD report improvement in symptoms and quality of life with adjuvant cannabis use; however, there is no change in disease activity.
- Encourage your patients to continue and optimize their maintenance therapy.
- Educate your patients about the legal considerations and known risks.
In conclusion, the use of cannabis in IBD patients has increased in recent years. It is important to be able to discuss the risks and benefits of use with your IBD patients. Focus on the lack of data showing that cannabis improves disease activity, and has shown benefit only in improving IBD-associated symptoms. In some patients there might be a role for adjuvant cannabis therapy to improve overall symptom control and quality of life.
Dr. Kinnucan is an assistant professor of medicine, division of gastroenterology, Michigan Medicine, University of Michigan, Ann Arbor; Dr. Swaminath is an associate professor of medicine, division of gastroenterology, Lenox Hill Hospital, Northwell Health, New York.
Case 1
A 30 year-old female with longstanding ulcerative colitis who has a history of medically refractory steroid-dependent disease and was able to achieve remission with vedolizumab for the last 5 years. Most recent objective assessment showed histologic remission. She has been using daily cannabis medicinally for the last year (high CBD:THC [cannabidiol:delta-9-tetracannabidol] concentration). She notes that she has felt better in the last year since introducing cannabis (improved stool frequency/formation, sleep quality). She inquires about discontinuing her biologic therapy in the hope of using cannabis alone to maintain remission.
Figure 1.
Case 2
A 22-year-old male with ileocolonic inflammatory Crohn’s disease escalated to adalimumab requiring an intensification of therapy to weekly dosing to normalize C-reactive protein (CRP). A recent colonoscopy showed endoscopic improvement (colonic normalization and rare aphthae in ileum). He notes clear clinical improvement, but he continues to experience diarrhea and abdominal cramping (no relationship to meals). Declines addition of immunomodulator (nervous about returning to college during the COVID-19 pandemic). He wonders whether cannabis could be effective in controlling his symptoms as he has had improvement in symptoms during his sporadic recreational cannabis exposure.
Discussion
These cases outline the challenges that providers face when managing patients with inflammatory bowel disease (IBD) when a patient would like to either substitute or incorporate cannabis into their treatment plan. Studies have shown a high prevalence of cannabis use among patients with IBD. With the restrictions surrounding the use of cannabis – either medically or recreationally – being liberalized in many states, these conversations are likely to become more frequent in your practice. However, one of the first challenges that providers face surrounding cannabis is that many patients who use cannabis do not disclose use to their health care team for fear of being judged negatively. In addition, many providers do not routinely ask about cannabis use during office visits. This might be directly related to being unprepared to have a knowledge-based discussion on the risks and benefits of cannabis use in IBD, with the same confidence present during discussion of biologic therapies.
For background, Cannabis sativa (cannabis) is composed of hundreds of phytocannabinoids, the two most common are THC and CBD. These cannabinoids act at the endocannabinoid receptors, which are expressed in the central and peripheral nervous systems and immune cells/tissues, and help explain the clinical changes experienced by cannabis users. Both THC and CBD have been studied in varying doses and routes of administration in patients with IBD, making it challenging to translate into real-world recommendations for patients. Some of the most common reported benefits of cannabis use (particularly in an IBD population) are improvement in pain, diarrhea, nausea, and joint pain. Some studies have shown overall improvement in quality of life (Figure 1).
Some common questions that arise surrounding cannabis use in IBD patients include:
1. Is it possible to stop traditional medical therapy and replace it with cannabis therapy?
No studies have directly addressed this exact question. The small studies, both randomized controlled trials and retrospective ones, have studied the effects of cannabis as adjuvant therapy only. None of the data available to date suggest that cannabis has any anti-inflammatory properties with absence of improvement in biomarkers or endoscopic measures of inflammation. In effect, any attempt to discontinue standard therapy with substitution of cannabis-based therapy should be seen as no different than simply discontinuing standard therapy. There exists the argument that – among those with moderate to severe disease – cannabis might suppress the investigation of mild symptoms which may herald a flare of disease, thus lulling the patient into a state of false stability. We do not advocate the substitution of cannabis products in place of standard medical therapy.
2. Is there a role for cannabis as adjuvant therapy in patients with IBD?
Studies to date have included only symptomatic patients with objective evidence of inflammation and assessed clinical, biochemical, or endoscopic endpoints. In Crohn’s disease, two studies showed no improvement in clinical remission rates but showed improvement in clinical response; a third study showed both improvement in clinical remission/response as well as improved quality of life. No study showed a change in disease markers of activity including CRP, fecal calprotectin, or endoscopic scoring. In one study, all patients relapsed shortly after cannabis discontinuation suggesting that, while there was benefit in symptom control, there was no improvement of the underlying chronic inflammation.
In patients with ulcerative colitis, there were two studies. One study showed no improvement and high rates of intolerance in the treatment group, while the other study reported improved disease activity but no objective improvement. The variation in results between disease states and between studies might be because of cannabis formulations. In patients with persistent symptoms despite current medical therapy, there might be a role in those patients for adjuvant therapy for improvement symptom control but not disease control. Optimization of medical therapy would still be indicated.
3. What dose and formulation of cannabis should I recommend to a patient as adjuvant therapy?
This is an excellent question and one that unfortunately we do not have the answer to. As mentioned previously, the studies have looked at varying formulations (THC alone, CBD:THC with varying percentages of THC, CBD alone) and varying routes of administration (sublingual, oral, inhalation). The IBD studies looking at CBD-alone formulations lacked clinical efficacy. In states where cannabis products have been accessible to IBD patients, no data on the product type (THC:CBD), method of administration, or prescriber preferences have been published.
4. What risks should I advise my patients about with cannabis use?
The challenge is that we don’t have large population-based studies in IBD looking at long-term risks of cannabis use. However, in the small RCT studies there were minimal reported side effects and no major adverse events over 8-10 weeks. Larger IBD population-based studies have shown that cannabis users were more likely to discontinue traditional medical therapy, and there is an increased risk for surgery in patients with Crohn’s disease. Larger studies in non-IBD patients have shown risk for addiction to other substances, diminished life achievement, increased motor vehicle accidents, chronic bronchitis, psychiatric disturbances and cannabis dependence, and cannabis hyperemesis syndrome (with an uncanny presentation resembling Crohn’s disease flare with partial small bowel obstruction). Patients should also be advised about legal implications of use (given its continued classification as a federal schedule 1 drug), possible drug interactions, and special considerations in pediatric patients (increased risk of addiction), elderly patients (increased risk of neuropsychological effects), and during pregnancy (with national obstetric society guidelines warning against use because of fetal exposure and increased risk of stillbirth).
5. What are the legal implications for providers? Patients?
As of July 2020, cannabis is available for recreational use in 12 states, for medicinal use in 28 states, and illegal in 11 states. So the answer really depends on what state the patient lives in. As a provider who might certify patients (in some medicinal states) or recommend cannabis to patients, you should consider legal and licensing implications. Again, this might vary state to state, and you should also take into account federal status. Providers acting in compliance with state laws are unlikely to have federal consequences. However, remember that malpractice insurance only covers FDA-approved medical therapies. Patients should be advised to consider the potential (although highly unlikely) to face federal prosecution and implications of use for employment, school, camp, or travel, and driving restrictions.
Take home points
- Inquire about cannabis to start the conversation.
- Know your state’s legalization status surrounding cannabis.
- Patients with IBD report improvement in symptoms and quality of life with adjuvant cannabis use; however, there is no change in disease activity.
- Encourage your patients to continue and optimize their maintenance therapy.
- Educate your patients about the legal considerations and known risks.
In conclusion, the use of cannabis in IBD patients has increased in recent years. It is important to be able to discuss the risks and benefits of use with your IBD patients. Focus on the lack of data showing that cannabis improves disease activity, and has shown benefit only in improving IBD-associated symptoms. In some patients there might be a role for adjuvant cannabis therapy to improve overall symptom control and quality of life.
Dr. Kinnucan is an assistant professor of medicine, division of gastroenterology, Michigan Medicine, University of Michigan, Ann Arbor; Dr. Swaminath is an associate professor of medicine, division of gastroenterology, Lenox Hill Hospital, Northwell Health, New York.
Case 1
A 30 year-old female with longstanding ulcerative colitis who has a history of medically refractory steroid-dependent disease and was able to achieve remission with vedolizumab for the last 5 years. Most recent objective assessment showed histologic remission. She has been using daily cannabis medicinally for the last year (high CBD:THC [cannabidiol:delta-9-tetracannabidol] concentration). She notes that she has felt better in the last year since introducing cannabis (improved stool frequency/formation, sleep quality). She inquires about discontinuing her biologic therapy in the hope of using cannabis alone to maintain remission.
Figure 1.
Case 2
A 22-year-old male with ileocolonic inflammatory Crohn’s disease escalated to adalimumab requiring an intensification of therapy to weekly dosing to normalize C-reactive protein (CRP). A recent colonoscopy showed endoscopic improvement (colonic normalization and rare aphthae in ileum). He notes clear clinical improvement, but he continues to experience diarrhea and abdominal cramping (no relationship to meals). Declines addition of immunomodulator (nervous about returning to college during the COVID-19 pandemic). He wonders whether cannabis could be effective in controlling his symptoms as he has had improvement in symptoms during his sporadic recreational cannabis exposure.
Discussion
These cases outline the challenges that providers face when managing patients with inflammatory bowel disease (IBD) when a patient would like to either substitute or incorporate cannabis into their treatment plan. Studies have shown a high prevalence of cannabis use among patients with IBD. With the restrictions surrounding the use of cannabis – either medically or recreationally – being liberalized in many states, these conversations are likely to become more frequent in your practice. However, one of the first challenges that providers face surrounding cannabis is that many patients who use cannabis do not disclose use to their health care team for fear of being judged negatively. In addition, many providers do not routinely ask about cannabis use during office visits. This might be directly related to being unprepared to have a knowledge-based discussion on the risks and benefits of cannabis use in IBD, with the same confidence present during discussion of biologic therapies.
For background, Cannabis sativa (cannabis) is composed of hundreds of phytocannabinoids, the two most common are THC and CBD. These cannabinoids act at the endocannabinoid receptors, which are expressed in the central and peripheral nervous systems and immune cells/tissues, and help explain the clinical changes experienced by cannabis users. Both THC and CBD have been studied in varying doses and routes of administration in patients with IBD, making it challenging to translate into real-world recommendations for patients. Some of the most common reported benefits of cannabis use (particularly in an IBD population) are improvement in pain, diarrhea, nausea, and joint pain. Some studies have shown overall improvement in quality of life (Figure 1).
Some common questions that arise surrounding cannabis use in IBD patients include:
1. Is it possible to stop traditional medical therapy and replace it with cannabis therapy?
No studies have directly addressed this exact question. The small studies, both randomized controlled trials and retrospective ones, have studied the effects of cannabis as adjuvant therapy only. None of the data available to date suggest that cannabis has any anti-inflammatory properties with absence of improvement in biomarkers or endoscopic measures of inflammation. In effect, any attempt to discontinue standard therapy with substitution of cannabis-based therapy should be seen as no different than simply discontinuing standard therapy. There exists the argument that – among those with moderate to severe disease – cannabis might suppress the investigation of mild symptoms which may herald a flare of disease, thus lulling the patient into a state of false stability. We do not advocate the substitution of cannabis products in place of standard medical therapy.
2. Is there a role for cannabis as adjuvant therapy in patients with IBD?
Studies to date have included only symptomatic patients with objective evidence of inflammation and assessed clinical, biochemical, or endoscopic endpoints. In Crohn’s disease, two studies showed no improvement in clinical remission rates but showed improvement in clinical response; a third study showed both improvement in clinical remission/response as well as improved quality of life. No study showed a change in disease markers of activity including CRP, fecal calprotectin, or endoscopic scoring. In one study, all patients relapsed shortly after cannabis discontinuation suggesting that, while there was benefit in symptom control, there was no improvement of the underlying chronic inflammation.
In patients with ulcerative colitis, there were two studies. One study showed no improvement and high rates of intolerance in the treatment group, while the other study reported improved disease activity but no objective improvement. The variation in results between disease states and between studies might be because of cannabis formulations. In patients with persistent symptoms despite current medical therapy, there might be a role in those patients for adjuvant therapy for improvement symptom control but not disease control. Optimization of medical therapy would still be indicated.
3. What dose and formulation of cannabis should I recommend to a patient as adjuvant therapy?
This is an excellent question and one that unfortunately we do not have the answer to. As mentioned previously, the studies have looked at varying formulations (THC alone, CBD:THC with varying percentages of THC, CBD alone) and varying routes of administration (sublingual, oral, inhalation). The IBD studies looking at CBD-alone formulations lacked clinical efficacy. In states where cannabis products have been accessible to IBD patients, no data on the product type (THC:CBD), method of administration, or prescriber preferences have been published.
4. What risks should I advise my patients about with cannabis use?
The challenge is that we don’t have large population-based studies in IBD looking at long-term risks of cannabis use. However, in the small RCT studies there were minimal reported side effects and no major adverse events over 8-10 weeks. Larger IBD population-based studies have shown that cannabis users were more likely to discontinue traditional medical therapy, and there is an increased risk for surgery in patients with Crohn’s disease. Larger studies in non-IBD patients have shown risk for addiction to other substances, diminished life achievement, increased motor vehicle accidents, chronic bronchitis, psychiatric disturbances and cannabis dependence, and cannabis hyperemesis syndrome (with an uncanny presentation resembling Crohn’s disease flare with partial small bowel obstruction). Patients should also be advised about legal implications of use (given its continued classification as a federal schedule 1 drug), possible drug interactions, and special considerations in pediatric patients (increased risk of addiction), elderly patients (increased risk of neuropsychological effects), and during pregnancy (with national obstetric society guidelines warning against use because of fetal exposure and increased risk of stillbirth).
5. What are the legal implications for providers? Patients?
As of July 2020, cannabis is available for recreational use in 12 states, for medicinal use in 28 states, and illegal in 11 states. So the answer really depends on what state the patient lives in. As a provider who might certify patients (in some medicinal states) or recommend cannabis to patients, you should consider legal and licensing implications. Again, this might vary state to state, and you should also take into account federal status. Providers acting in compliance with state laws are unlikely to have federal consequences. However, remember that malpractice insurance only covers FDA-approved medical therapies. Patients should be advised to consider the potential (although highly unlikely) to face federal prosecution and implications of use for employment, school, camp, or travel, and driving restrictions.
Take home points
- Inquire about cannabis to start the conversation.
- Know your state’s legalization status surrounding cannabis.
- Patients with IBD report improvement in symptoms and quality of life with adjuvant cannabis use; however, there is no change in disease activity.
- Encourage your patients to continue and optimize their maintenance therapy.
- Educate your patients about the legal considerations and known risks.
In conclusion, the use of cannabis in IBD patients has increased in recent years. It is important to be able to discuss the risks and benefits of use with your IBD patients. Focus on the lack of data showing that cannabis improves disease activity, and has shown benefit only in improving IBD-associated symptoms. In some patients there might be a role for adjuvant cannabis therapy to improve overall symptom control and quality of life.
Dr. Kinnucan is an assistant professor of medicine, division of gastroenterology, Michigan Medicine, University of Michigan, Ann Arbor; Dr. Swaminath is an associate professor of medicine, division of gastroenterology, Lenox Hill Hospital, Northwell Health, New York.
